Embryo Transfer Catheter for Precise Endometrial Placement
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Solution Overview
Problem
Existing embryo transfer apparatuses face challenges such as catheter bending, difficulty in visualizing the uterus, fertilized egg expulsion, and incompatibility with various speculum shapes, leading to reduced implantation success and accuracy.
Innovation Solution
A system with a body having a distal end for penetrating the endometrial epithelium, a plunger for expelling the fertilized egg, and two injectable media of varying viscosities, along with a device for engaging speculums of different sizes, to enhance precision and reliability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a soft plastic delivery catheter is used to avoid damage to the endometrium, then the risk of trauma to the uterus is reduced, but the catheter tip may bend back on itself or curve away from the fundus of the uterus, reducing placement accuracy
Solution Approach 1:
The catheter incorporates a shape memory alloy wire that can dynamically change its shape in response to temperature changes. The wire is initially in a relaxed state for safe insertion, then transitions to a pre-formed curved shape at the distal end to guide the catheter tip to the fundus, and can be re-programmed to new shapes for different patient anatomies.
Solution Approach 2:
The catheter utilizes temperature-dependent shape changes of the shape memory alloy wire. The wire transitions between different shapes based on temperature, allowing it to maintain a safe configuration during insertion, then transform to a guiding curve when heated by body temperature or external heating, thereby controlling catheter tip position without increasing trauma risk.
2Manufacturing precision
If a stiffer catheter is used to maintain catheter tip position and prevent bending, then placement accuracy is improved, but the risk of trauma to the uterus or cervix increases
Solution Approach 1:
The catheter combines a flexible outer body with an embedded shape memory alloy wire that provides localized structural support. The wire is concentrated at the distal end where tip positioning is critical, while the proximal portion remains flexible for safe navigation through the cervix. This creates different mechanical properties in different sections of the same catheter.
3Ease of operation
If the fertilized egg is transferred using a standard delivery catheter, then the procedure can be completed, but the fertilized egg may be expelled from the endometrial epithelium or dislodged after transfer, reducing implantation success
Solution Approach 1:
The catheter is pre-programmed with a specific curved shape that anticipates the anatomical path to the fundus and the optimal insertion angle for endometrial epithelium penetration. This pre-formed shape ensures that when the catheter is inserted and the egg is deposited, the tip remains positioned within the epithelium, preventing post-transfer expulsion or dislodgement.
4Manufacturing precision
If the distal end of the catheter is made stiffer to prevent bending, then catheter tip position control is improved, but the difficulty of penetrating the endometrial epithelium increases
Solution Approach 1:
The shape memory alloy wire provides dynamic stiffness control. During insertion, the wire remains in a flexible state allowing the catheter to navigate easily through the cervix and uterus. When heated to body temperature or externally, the wire transitions to a stiffer pre-formed shape that provides tip position control and facilitates penetration of the endometrial epithelium.
Data Source
AI summary
An apparatus (100) suitable for delivering a fertilized egg or embryo into a maternal uterine endometrium in humans or any other mammalian species, comprising a body (110) configured to fit within a lumen of the female reproductive system. The body (110) comprises one or more lumens extending from a proximal end (130) of the body (110) to a distal portion of the body (110) and having a distal opening (150) at the distal portion of the body (110), wherein a first lumen (120) of the one or more lumens slidably receives an inner body (160) having a distal end suitable for penetrating the endometrial epithelium. The inner body (160) comprises an inner lumen for receiving a fertilized egg. An actuator (195) is operable to expel the fertilized egg from the inner lumen. A covering layer (170a) at least partially covers the distal opening of at least one lumen of the one or more lumens and at least partially covers the distal opening (150) of the first lumen (120) and the inner body (160) is configured to perforate through the covering layer (170a) when the inner body (160) is advanced out from the distal opening (150) of the body (110).