Everting Catheter Alignment for Twist-Free Embryo Transfer
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Solution Overview
Problem
Existing everting catheters face issues such as balloon membrane twisting, rotation, over-elongation, inconsistent pressurization, and the need for two-handed operation during embryo transfer procedures, which can compromise procedure efficiency and patient comfort.
Innovation Solution
The everting catheter system incorporates an internal alignment mechanism to prevent rotation, a compliant pressurization apparatus for controlled pressure, a one-handed operation mechanism, and a speculum design for enhanced visibility and comfort, along with a mechanism to stabilize the inner catheter during embryo transfer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an everting catheter is used for embryo transfer, then the catheter can traverse the cervical canal without imparting shear forces, but the balloon membrane may twist or rotate during insertion
Solution Approach 1:
The balloon membrane incorporates asymmetric features including a radiopaque marker at one end and a tail at the opposite end, creating inherent directional orientation. This asymmetry prevents random rotation during insertion while maintaining the frictionless everting traversal mechanism through the cervical canal
2Ease of operation
If the inner catheter is advanced manually during embryo transfer, then the procedure can be performed, but two-handed operation is required reducing efficiency
Solution Approach 1:
The system combines the inner catheter advancement mechanism with the outer catheter assembly into an integrated unit. The pre-attached configuration allows the operator to advance both catheters simultaneously with one hand, merging two separate manual operations into a single coordinated action that improves procedural efficiency
3Measurement precision
If the inner catheter is advanced too far during embryo transfer, then the embryo may be deposited correctly, but over-elongation can occur causing discomfort or complications
Solution Approach 1:
The system incorporates pre-marked insertion depth indicators on the outer catheter before the procedure begins. These visual guides allow the operator to stop advancement at the appropriate depth, preventing over-elongation while ensuring accurate embryo deposition in the uterine cavity
4Speed
If pressure is applied to evert the balloon membrane, then the catheter can traverse the vessel, but inconsistent pressurization may occur affecting traversal
Solution Approach 1:
The system incorporates a pressure regulator that provides feedback control during balloon inflation. This mechanism monitors and adjusts the pressurization rate to maintain consistent, controlled expansion of the balloon membrane, ensuring reliable everting traversal through the cervical canal without abrupt pressure changes
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 system ensures stable, untwisted balloon passage, precise pressure control, single-handed operation, and improved patient comfort, facilitating efficient embryo transfer procedures with enhanced visibility and reduced procedural complexity.
Implementation Method 1
inconsistent pressurization... The system ensures stable, untwisted balloon passage, precise pressure control
Implementation Method 2
Everting catheters utilize a traversing action in which a balloon is inverted and with the influence of hydraulic pressure created by a compressible or incompressible fluid or media, rolls inside out or everts with a propulsion force through the vessel
Data Source
AI summary
Everting balloon systems and methods for using the same with an alignment element for stability and anti-rotation of the everting balloon are disclosed herein. The systems can be configured to access and deliver instruments, media, or other catheters into bodily lumens and cavities. The alignment element can eliminate the potential for the everting membrane to become twisted or rotated which could impact access or the ability of the system to deliver materials. A compliance member can facilitate internal pressurization of the everting catheter system. An everting catheter system can be configured for use with transvaginal ultrasound and a lower profile speculum is described.