Embryo Transfer Catheter With Variable Rigidity and Dual-Medium Delivery
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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 a dual injectable medium with varying viscosities, along with expandable engaging elements for securing to different speculum sizes, enhances precision and reliability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a soft plastic delivery catheter is used, then damage to the endometrium is avoided, but the catheter tip bends back or curves away from the fundus of the uterus
Solution Approach 1:
The catheter incorporates a shape memory alloy wire that dynamically changes its rigidity properties. The wire remains flexible during insertion to avoid damage, then transforms to a rigid state at the target location to maintain precise positioning and prevent tip bending.
Solution Approach 2:
The catheter's mechanical parameters are changed along its length, with a shape memory alloy wire providing variable rigidity. The wire's phase transition capability allows it to change from a soft state during insertion to a rigid state at the fundus, resolving the contradiction between softness and positioning accuracy.
2Manufacturing precision
If a stiffer catheter is used, then catheter tip positioning accuracy is improved, but the risk of trauma to the uterus or cervix increases
Solution Approach 1:
The shape memory alloy wire provides dynamic rigidity control, remaining flexible during insertion to prevent trauma, then becoming rigid at the target to ensure positioning accuracy. This temporal separation of mechanical properties resolves the contradiction.
Solution Approach 2:
Different sections of the catheter have different mechanical properties. The shape memory alloy wire is positioned to provide rigidity only at the critical tip region when needed, while the rest of the catheter remains flexible to avoid trauma during insertion.
3Ease of operation
If standard delivery catheter is used, then procedure simplicity is maintained, but fertilized egg may be expelled or dislodged after transfer
Solution Approach 1:
The shape memory alloy wire is pre-positioned within the catheter to automatically activate and provide anchoring force upon reaching the fundus, preventing egg expulsion before the transfer is complete. This preliminary preparation ensures reliability without complicating the operator's actions.
Solution Approach 2:
The shape memory alloy wire automatically transforms and provides anchoring function without requiring additional operator actions. The system self-regulates to prevent egg expulsion, maintaining procedural simplicity while improving reliability.
4Ease of operation
If single viscosity medium is used, then injection process is simplified, but fertilized egg may remain stuck to transfer apparatus
Solution Approach 1:
The injectable medium is segmented into two components with different viscosities. The first medium provides initial flow and the second medium ensures complete egg detachment, dividing the complex function into manageable parts that work together.
Solution Approach 2:
The viscosity parameter of the injectable medium is changed by using two different mediums. The first medium has lower viscosity for initial injection, while the second medium has higher viscosity to ensure complete egg transfer and prevent sticking to the apparatus.
Data Source
Figure 1A~1B
Figure 1C~1F
Figure 1G~1H
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).