Cervical Cerclage Loop Tightening for Noninvasive Closure
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Solution Overview
Problem
Current cervical cerclage procedures for preventing preterm birth are invasive and carry significant risks for both the mother and fetus, with limited effectiveness for women with multi-gestational pregnancies.
Innovation Solution
A noninvasive suture delivery device is designed to apply a cervical cerclage suture using a handheld device with a housing, arm assembly, and a suture loop, featuring a tightening mechanism that allows for the suture to be applied noninvasively around the cervix, utilizing a ratchet assembly and rotatable drum to control the loop's dimensions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical cervical cerclage is performed, then the cervix can be closed to prevent preterm birth, but the procedure carries significant risks including rupture of membranes, premature labor, injury to cervix or bladder, and requires general or spinal anesthesia
Solution Approach 1:
The patent introduces a noninvasive intermediary device (suture delivery system with loop and string) that applies external pressure to close the cervix without direct surgical penetration. The loop is positioned around the cervix and tightened using a ratchet mechanism, creating closure through mechanical pressure rather than surgical stitching, thereby eliminating risks associated with needle insertion and surgical anesthesia.
2Reliability
If cervical cerclage is performed to provide secure closure, then preterm birth risk is reduced, but the procedure requires invasive surgical intervention with potential complications
Solution Approach 1:
The patent replaces the traditional surgical mechanical system (needles, threads, surgical stitching) with a noninvasive mechanical system consisting of a deliverable loop, string, and ratchet mechanism. The loop is delivered through a catheter and tightened using a hand-operated ratchet system, substituting complex surgical procedures with a simpler, noninvasive mechanical tightening process that achieves secure closure without surgical intervention.
3Strength
If traditional cerclage suture is used, then the cervix can be strengthened, but the procedure has not shown clinical benefit in women with multi-gestational pregnancy
Solution Approach 1:
The patent changes the fundamental parameter of cervical support from internal surgical stitching to external compressive pressure. The deliverable loop applies uniform circumferential pressure around the cervix, which can be adjusted by tightening the string through the ratchet mechanism. This parameter change allows the device to provide effective support for multi-gestational pregnancies where traditional suturing has failed, as the external pressure adapts to different cervical conditions and pregnancy types.
Data Source
AI summary
A noninvasive suture delivery device includes a housing including a distal end and a trigger. An arm assembly is operably coupled to the distal end of the housing and includes a tubular body and a distal end. A suture includes a closed loop and a string. The closed loop defines an opening extending from the distal end of the arm assembly. The string extends from the closed loop and through the tubular body of the arm assembly. When the trigger is activated, a dimension of the opening of the closed loop decreases.