Embryo transplantation system

Abstract

A device (100) adapted to deliver a fertilized egg or embryo into a maternal endometrium of a human or any other mammalian species comprises a body (110) configured to fit inside a cavity of a female reproductive system. The body (110) includes one or more cavities 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), where a first cavity (120) of the one or more cavities slidably receives an inner body (160) having a distal end adapted to penetrate the endometrial epithelium. The inner body (160) includes an inner cavity for receiving a fertilized egg. An actuator (195) is operable to expel fertilized eggs from the lumen. The cover layer (170a) at least partially covers the distal opening of at least one of the one or more cavities and at least partially covers the distal opening (150) of the first cavity (120), and the inner body (160) is configured to be perforated through the cover layer (170a) when the inner body (160) is pushed out of the distal opening (150) of the body (110).

Description

Technical Field

[0001] The present disclosure relates to systems and methods for implanting a fertilized egg or embryo into the endometrial epithelium. The present disclosure also relates to an apparatus for guiding such a system and for engaging a speculum. Background Art

[0002] In vitro fertilization (IVF) and embryo transfer (ET) was first successfully performed in 1978 and has become a widely practiced procedure for treating infertile couples who have failed more conventional treatments such as superovulation and intrauterine insemination. The most common indications for IVF and related procedures such as gamete in vitro fertilization or gamete intrafallopian transfer (GIFT) include blocked or damaged fallopian tubes in women and include poor sperm and / or egg quality. Relevant factors include the woman's age, and the receptivity of the endometrium. The procedure can also be used in cases of severe male factor, in which case direct (intracytoplasmic) sperm injection is an option.

[0003] The IVF / ET procedure typically involves stimulating a woman's hormones to first suppress her ability to ovulate on her own, and then stimulating the development of follicles in her ovaries with fertility drugs. The mature eggs are removed from the ovaries transvaginally with a needle, preferably under ultrasound guidance. After the eggs are harvested, they are identified and sorted according to maturity and then placed with a sperm sample from the man. About 24 hours after fertilization, the eggs are examined to confirm fertilization, which occurs in about 65% to 85% of the harvested eggs.

[0004] After a brief development period, the embryo is transferred to the uterus along with a volume of fluid using a transfer catheter. The transfer catheter is usually made of a soft plastic material to avoid damaging the endometrium. There are many potential difficulties in achieving a successful implantation. Due to the soft nature of standard transfer catheters, in many cases the tip of the catheter may bend back on itself or bend away from the fundus of the uterus. The tip may also accidentally pass between the endometrial layer and the myometrium. Conversely, stiffer catheters increase the risk of uterine or cervical trauma, which may result in the release of prostaglandins and the expulsion of the egg from the endometrium.

[0005] One particular difficulty in achieving successful implantation is the difficulty the surgeon has in visualizing the uterus and the endometrium in which the embryo is implanted. Specifically, mucus and other body fluids can make it difficult for the surgeon to determine whether the endometrial epithelium has been reached.

[0006] It has also been found that the fertilized egg may be expelled from the endometrial epithelium or dislodged after the implantation procedure, thereby increasing the risk of procedural failure. Similarly, the fertilized egg may remain attached to the implantation device even after the medium containing the fertilized egg is injected into the endometrial epithelium.

[0007] Furthermore, the use of specula of various shapes and sizes makes it difficult to spatially lock the embryo transfer device to the patient's anatomy to improve the accuracy of embryo delivery.

[0008] Therefore, there is a need for an improved embryo transfer device with increased reliability and a method of locking such an embryo transfer device to a variety of speculum shapes. Summary of the invention

[0009] According to a first aspect of the present invention, a system for delivering a fertilized egg or embryo into the maternal endometrium of a human or any other mammalian species is provided, comprising: a body having a distal end suitable for penetrating the endometrial epithelium; a plunger slidably received in a cavity of the body; an actuator operable to advance the plunger to expel the fertilized egg from the cavity of the body; a first injectable medium; and a second injectable medium for accommodating the fertilized egg; wherein the viscosity of the first injectable medium is higher than that of the second injectable medium.

[0010] According to a second aspect of the present invention, there is provided a method for loading a system for delivering a fertilized egg or embryo into the maternal endometrium of a human or any other mammalian species, the system comprising: a body having a distal end suitable for penetrating the endometrial epithelium; a plunger slidably received in a cavity of the body; and an actuator operable to advance the plunger to expel the fertilized egg from the cavity of the body; wherein the method comprises: drawing a first injectable medium into the cavity; and subsequently drawing a second injectable medium containing the fertilized egg into the cavity; wherein the viscosity of the first injectable medium is higher than that of the second injectable medium.

[0011] According to a third aspect of the present invention, there is provided a device suitable for delivering a fertilized egg or embryo to the endometrium of a human or any other mammalian species, comprising a body configured to fit inside a cavity of a female reproductive system, the body comprising: one or more cavities extending from a proximal end of the body to a distal portion of the body and having a distal opening at the distal portion of the body, wherein a first cavity of the one or more cavities can slidably receive an inner body having a distal end suitable for penetrating the endometrial epithelium, the inner body comprising an inner cavity for receiving a fertilized egg; an actuator operable to discharge the fertilized egg from the inner cavity; and a covering layer at least partially covering the distal opening of at least one of the one or more cavities.

[0012] According to a fourth aspect of the present invention, there is provided an apparatus for engaging a speculum, comprising: two or more expandable engagement elements for outwardly engaging the speculum to secure the apparatus to the speculum, wherein the two or more expandable engagement elements comprise a plurality of expansion configurations for engaging a plurality of speculum sizes; and a guide for guiding an embryo transfer device between the expandable engagement elements and through the speculum when the apparatus is secured to the speculum.

[0013] According to a fifth aspect of the present invention, there is provided a device suitable for delivering a fertilized egg or embryo to the maternal endometrium of a human or any other mammalian species, comprising a body configured to fit inside a cavity of a female reproductive system, the body comprising: a cavity extending from a proximal end of the body to a distal portion of the body and having a distal opening at the distal portion of the body, the cavity slidably receiving an inner body having a distal end suitable for penetrating the endometrial epithelium; the device further comprising: a first actuator and a second actuator, the first actuator being operable to push the inner body out of the distal opening of the body, the second actuator being operable to expel the fertilized egg from the inner cavity of the inner body; wherein the inner body comprises a hydrophobic coating formed on the distal portion of the inner body. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In order to better understand the present disclosure and explain how to put it into practice, reference is now made to the attached schematic diagram by way of example only, in which:

[0015] Figure 1A A perspective view of a device suitable for delivering a fertilized egg or embryo to a maternal endometrium is shown according to one or more embodiments shown and described herein.

[0016] Figure 1B Shown is a perspective view of another device suitable for delivering a fertilized egg or embryo to a maternal endometrium according to one or more embodiments shown and described herein.

[0017] Figure 1C Shown is a perspective view of another device suitable for delivering a fertilized egg or embryo to a maternal endometrium according to one or more embodiments shown and described herein.

[0018] Figure 1D Shows Figure 1C A side view of the distal portion of the device is shown.

[0019] Figure 1E Shows Figure 1C Front view of the device shown.

[0020] Figure 1F Shown is a perspective view of another device suitable for delivering a fertilized egg or embryo to a maternal endometrium according to one or more embodiments shown and described herein.

[0021] Figure 1G Shown is a perspective view of another device suitable for delivering a fertilized egg or embryo to a maternal endometrium according to one or more embodiments shown and described herein.

[0022] Figure 1HShown is a perspective view of another device suitable for delivering a fertilized egg or embryo to a maternal endometrium according to one or more embodiments shown and described herein.

[0023] Figure 1J A schematic side view of a body for use with an apparatus according to one or more embodiments shown and described herein is shown.

[0024] Figure 1K A schematic side view of a probe for use with an apparatus according to one or more embodiments shown and described herein is shown.

[0025] Figure 1L A device according to one or more embodiments is shown inserted into a body for use in a device. Figure 1K Schematic cross-sectional side view of a probe.

[0026] Figure 2A A schematic perspective view of a system for delivering a fertilized egg or embryo to a maternal endometrium in a first configuration is shown according to one or more embodiments shown and described herein.

[0027] FIG. 2B to FIG. 2D Shows Figure 2A Schematic perspective views of the system in second to fourth configurations.

[0028] Figure 2E A schematic diagram showing the first, second and third media located in the endometrial epithelium.

[0029] Figure 3 A schematic diagram of a beveled tip is shown according to one or more embodiments shown and described herein.

[0030] Figure 4 A schematic diagram of a pointing device is shown according to one or more embodiments shown and described herein.

[0031] Figure 5 A schematic diagram of a computer that can be used to control an apparatus according to one or more embodiments shown and described herein is shown.

[0032] Fig. 6A Shown is a cross-sectional perspective view of a connector according to one or more embodiments shown and described herein.

[0033] Figure 6B Shows Fig. 6A A close-up view of a portion of the connector is shown.

[0034] Figure 6C Shown is a perspective view of a proximal end of a connector according to one or more embodiments shown and described herein.

[0035] Fig.6D A perspective view of a distal end of a motion controller is shown according to one or more embodiments shown and described herein.

[0036] Fig. 6E Shows Fig. 6A An exploded view of the connector is shown.

[0037] Fig. 6F A perspective view is shown of a connection between a body connector and a distal end of a motion controller according to one or more embodiments shown and described herein.

[0038] Figure 6G A perspective view of a proximal portion of a motion controller is shown according to one or more embodiments shown and described herein.

[0039] Figure 6H A perspective view of a motion controller is shown according to one or more embodiments shown and described herein.

[0040] Fig. 7A Shown is a cross-sectional side view of an apparatus for engaging a speculum according to one or more embodiments shown and described herein.

[0041] Figure 7B Shown is a cross-sectional side view of an apparatus for engaging a speculum according to one or more embodiments shown and described herein.

[0042] Figure 7C The second configuration is shown Figure 7B equipment.

[0043] Fig. 8A A schematic perspective front view of an apparatus for engaging a speculum in accordance with one or more embodiments shown and described herein is shown in a first configuration.

[0044] Figure 8B Shows Fig. 8A Schematic perspective side view of a device in a first configuration.

[0045] Figure 8C Shows Fig. 8A Schematic perspective front view of the device in a second configuration.

[0046] Fig.8D Shows Fig. 8A Schematic perspective front view of the device in a third configuration.

[0047] Fig.9A Shown is a side view of a steering mechanism according to some embodiments shown and described herein.

[0048] Fig. 9BShown is a side view of another steering mechanism according to some embodiments shown and described herein.

[0049] Fig. 9C Shows Fig.9A or Fig. 9B A top view of the steering mechanism is shown.

[0050] Fig.9D A side view of a steering mechanism is shown with the cable in a retracted position according to one or more embodiments shown and described herein.

[0051] Fig.9E Shown is a perspective view of a third actuator according to some embodiments shown and described herein.

[0052] Fig.9F Shows Fig.9E A perspective view of a third actuator is shown, with the housing depicted as transparent.

[0053] Figure 9G A perspective view of internal components of a steering mechanism is shown according to some embodiments shown and described herein.

[0054] Figure 9H A perspective view of a steering mechanism is shown with the housing shown partially transparent, according to some embodiments shown and described herein.

[0055] Fig.10 A perspective view of an apparatus according to one or more embodiments is shown.

[0056] Fig.11 A perspective schematic diagram of an apparatus according to one or more embodiments is shown.

[0057] Fig. 12A and Fig. 12B A schematic side view of an apparatus according to one or more embodiments is shown.

[0058] Fig.13 A schematic side view of an apparatus according to one or more embodiments is shown.

[0059] Fig.14A A schematic top view of an apparatus according to one or more embodiments is shown.

[0060] Fig. 14B Shows Fig.14A A cross-sectional side view of the device shown taken along line AA. DETAILED DESCRIPTION

[0061] Figure 1AA perspective view of a device 100 suitable for delivering a fertilized egg or embryo to the endometrium of a mother is shown, wherein the device 100 includes a body 110 (e.g., a catheter, also referred to as an outer body) configured to fit inside a cavity of a female reproductive system. The body includes one or more cavities, one or more cavities including a cavity 120 extending from a proximal end 130 of the body 110 to a distal portion 140 of the body 110 and having a distal opening 150 at the distal portion 140 of the body. The cavity 120 is configured to slidably receive an inner body 160 having a distal end suitable for penetrating the endometrial epithelium. The device 100 may also include a first actuator 190 operable to push the inner body 160 out of the distal opening 150 of the body 110 and a second actuator 195 operable to eject the fertilized egg or embryo from the inner body.

[0062] The device 100 may include a cover layer 170a that at least partially covers the distal opening of one or more cavities (e.g., at Figure 1A In the illustrated embodiment, the covering layer 170a covers the distal opening 150 of the cavity 120. The provision of the covering layer 170a restricts mucus and other bodily fluids from entering the cavity 120 when the device is advanced through the female reproductive system. This prevents components (e.g., the inner body 160 or the measurement assembly) that are slidably received within one or more of the covered cavities from being exposed to bodily fluids, which may allow them to be reused when they are removable from the device 100. In addition, when the covering layer 170a is used with a cavity that houses the measurement assembly, the covering layer 170a reduces the variability of the measurements made by the measurement assembly, thereby providing a more reliable measurement for determining when the endometrial epithelium has been reached. For example, if the covering layer 170a is not provided, mucus and other bodily fluids may enter the cavity in an unpredictable manner, and this may affect the measurements made by the measurement assembly, thereby reducing the accuracy of determining when the endometrial epithelium has been reached. For example, when the measurement assembly includes a capacitive sensor configured to be in electrical contact with the distal portion of the inner body, it has been observed that the presence of mucus in the cavity reduces the ability of the capacitive sensor to distinguish between a first state and a second state. Similarly, when the device includes a camera, mucus entering the cavity that receives the camera may cause the camera's field of view to be partially or even completely blocked.

[0063] For the sake of clarity, Figures 1A to 1G The size of the body 110 is enlarged in FIG. 1 , but in reality the body 110 is a narrow, elongated body configured to extend to the endometrial epithelium of the uterus.

[0064] Figure 1B Shows Figure 1AEmbodiments of the device 100 of the present invention, wherein the device 100 further comprises an inner body 160 having a distal end adapted to penetrate the endometrial epithelium. In this embodiment, the inner body 160 is shown as being located in the cavity 120 of the body 110. The plunger 165 is housed within the inner body 160 and is configured to be pushed toward the distal end of the inner body 160 and to discharge the fertilized egg located within the inner body 160 when actuated by the second actuator 195. The cover layer 170a may at least partially cover the distal opening 150, and the inner body 160 may be configured to perforate through the cover layer 170a when the inner body 160 is pushed out of the distal opening of the body, so that the inner body 160 may be pushed through the cover layer 170a and pushed out of the distal opening 150 to penetrate the endometrial epithelium. As used herein, the term "perforation" should be understood as piercing to create a hole in the cover layer 170a. In other words, prior to perforation, the portion of the cover layer 170a to be perforated has no holes, slits or gaps through which mucus or other fluids can enter.

[0065] Figure 1C A perspective view of another device 100 suitable for delivering a fertilized egg or embryo to a maternal endometrium is shown, the device 100 including a body 110 (eg, a catheter, also referred to as an outer body) configured to fit within a cavity of a female reproductive system. Figure 1D and Figure 1E Shows Figure 1C1 and 10 are side views and front views of the distal portion of the device 100 shown. The body 110 includes one or more cavities, the one or more cavities including a cavity 120 extending from the proximal end 130 of the body 110 to the distal portion 140 of the body 110 and having a distal opening 150 at the distal portion 140 of the body. The cavity 120 is configured to slidably receive an inner body 160, the inner body 160 having a distal end adapted to penetrate the endometrial epithelium. The device 100 also includes a measurement assembly, the measurement assembly including a measurement portion 170 disposed at the distal portion 140 of the body 110 (i.e., near the distal opening 150). The measurement assembly 170 is configured to measure whether the device is in a first state or a second state, the first state indicating that the distance between the distal opening 150 of the body 110 and the endometrial epithelium is greater than a predetermined distance (i.e., in the direction of advancing the inner body from the distal opening 150), and the second state indicating that the distance between the distal opening 150 of the body 110 and the endometrial epithelium is equal to or less than a predetermined distance. The device 100 also includes an indication device 180, which is coupled to the measurement assembly 170 via a connection extending through the cavity 175 and is configured to indicate whether the measurement assembly 170 is in the first state or the second state. The measurement assembly can be detached from the body 110. Specifically, the measurement portion 170 can be slidably received in the cavity of the body so that the measurement portion 170 can be removed from the body 110 through the cavity, which means that the measurement assembly can be reused. The inner body 160 and the measurement assembly can be received in the same or different cavities. The device 100 also includes a first actuator 190 and a second actuator 195, the first actuator 190 is operable to push the inner body 160 out of the distal opening 150 of the body 110 by at least a predetermined distance, and the second actuator 195 is operable to eject the fertilized egg from the inner body (e.g., advance the plunger 165). The covering layer 170a at least partially covers at least one distal opening of the cavity. When the covering layer 170a covers the distal opening of the cavity 175 and thereby covers the measuring portion 170, the covering layer prevents the measuring portion 170 from being exposed to mucus, and when the measuring component is detachable from the device (i.e., in embodiments where the measuring component is not fixedly attached to the inner cavity body 175 and is thereby detachable), the covering layer increases its reusability.

[0066] In some embodiments, the measurement portion 170 is a camera proximate to the opening 150 and is configured to view a portion of the endometrial epithelium.

[0067] The cover layer 170a preferably comprises a biocompatible transparent or translucent film, and more preferably comprises or consists of: polyether block amide (PEBAX), polyolefins, PVC, paraffin, cellulose and its derivatives, hyaluronic acid film, polyparaxylene C film, collagen, gelatin, plant casing, alginate, or a complex or combination thereof. Although the cover layer 170a is expected to reduce the clarity of the image of the endometrial epithelium, in fact, the cover layer 170a provides a clearer image than when mucus is able to enter the cavity 175 and block the camera.

[0068] The predetermined distance may be, for example, less than 6 mm. The inner body may be slidably extended from the distal opening to any suitable distance, which is determined by the predetermined distance to the endometrial epithelium and the desired embryo implantation depth. For example, the inner body 160 may be slidably extended from the distal opening 150 of the body 110 to 0 to 6 mm.

[0069] The body 110 can be an elongated body made of any suitable flexible biocompatible material, such as PTFE, FEP, PEEK or other flexible lubricating material. The elongated body 110 and the cavity can be formed, for example, by extrusion using known methods. The outer diameter of the body 110 can be between 1 mm and 1.6 mm, more preferably between 1.2 mm and 1.4 mm, and even more preferably 1.3 mm. The total length of the body 110 can be any suitable length for insertion into a position close to the endometrial epithelium. For example, the length of the body 110 can be 400 mm to 500 mm, such as 450 mm.

[0070] The inner body 160 can be made of any suitable biocompatible material, such as PEEK and PI (polyimide). Such materials can make the wall of the inner body 160 relatively thin while maintaining the rigidity required for the inner body 160 to penetrate the endometrial epithelium. The inner body 160 can have any suitable outer diameter that can be slidably fitted inside the cavity 120 of the body 110. For example, the inner diameter of the cavity 120 can be greater than 0.45 mm, and the outer diameter of the inner body can be about 0.45 mm.

[0071] The plunger 165 may also be made of, for example, PTFE, FEP, PEEK or other flexible lubricating materials. The plunger 165 may have a suitable diameter that closely matches the inner diameter of the inner body 160 to effectively draw or discharge the fluid from the inner body 160. For example, the inner diameter of the inner body and the diameter of the plunger 165 may be about 0.28 mm.

[0072] The measuring assembly can be any suitable measuring assembly capable of determining whether the distance between the distal opening 150 of the body 110 and the endometrial epithelium is greater than or less than a predetermined distance. It should be noted that the measuring assembly can provide a qualitative measurement (e.g., the measuring assembly can be switched between two states) or a quantitative measurement (e.g., actually measuring a parameter indicating a distance value to the endometrial epithelium and comparing the parameter with a threshold indicating a predetermined distance). The measuring portion 170 is a portion of the measuring assembly that is configured to interact with the endometrial epithelium for the measuring assembly to perform a measurement and can include any suitable one or more elements. The elements of the measuring portion 170 can be connected to components at the proximal end of the device 100 (e.g., components of the measuring assembly (not shown)) and the indicating device 180 via a connection extending through one or more cavities 175 of the body 110. For example, the measuring portion can include components that are optically, acoustically, or electrically connected to the proximal components of the measuring assembly, such as a light transmitter or receiver or a sound transmitter or receiver, an electrical signal component, or a power supply. The measurement component can be any measurement component disclosed in PCT application number PCT / EP2021 / 078712, which is incorporated herein by reference in its entirety.

[0073] As long as the difference between the two states of the measurement component can be determined, the indicating device 180 is coupled to the measurement component (i.e., functionally coupled). The indicating device 180 can be any suitable device capable of indicating the difference between the two states. For example, if the measurement component provides a qualitative visual difference between the two states, the indicating device 180 can be a display (e.g., an oscilloscope display or a digital display) configured to display the visual difference to the user of the device, or the indicating device can include suitable software and / or hardware to receive data (such as image data) from the measurement component and perform analysis on the data to determine the state of the measurement component (or display image data). The analysis results can be displayed. Alternatively, the measurement component can include software / hardware and provide the analysis results to the indicating device 180.

[0074] If the first actuator 190 is to be manually actuated by a user, an indication provided by the indication device 180 (e.g., a visual indication on a display or an audio indication from a speaker) may be provided to the user of the apparatus 100, or if the first actuator 190 is to be automatically actuated by an electronic controller, the indication may be provided as a command signal to the electronic controller (e.g., a motion controller disclosed herein). The indication provides a means for the operator or controller to verify that the distal opening is sufficiently close to the endometrial epithelium to deliver a fertilized egg through the inner body.

[0075] The first actuator 190 and the second actuator 195 can be any suitable actuator that can be controlled to advance the inner body 160 and discharge the fertilized egg. For example, the first actuator 190 can be a push rod or other hand tools for advancing the inner body, or the first actuator 190 can include a motor system configured to advance the inner body. Similarly, the second actuator 195 can be configured to slide a plunger that can move in the inner body to pressurize the fluid in the inner body and discharge the egg at a distance. The second actuator can include a lead screw for advancing the plunger, that is, the second actuator can be actuated by applying torque, and the resulting rotational motion is converted into a linear motion of the plunger. The rotational actuation of the lead screw allows a high degree of controllability of linear motion, thereby making the amount of liquid sucked and distributed highly controllable. The first actuator 190 and the second actuator 195 can be accommodated in a housing connected to the proximal end of the inner body 160 and the plunger 165.

[0076] Although Figure 1D The measuring portion 170 and the distal opening 150 of the body 110 are shown to be located at the distal tip of the body 110, but in other embodiments, the measuring portion 170 and the distal openings of one or more cavities (such as the distal opening 150) can be located on one side of the distal portion 140 of the body 110, such as Figure 1G The cavity 120 includes a gradually curved portion near the distal opening 150 of the body 110 to laterally guide the inner body 160. The cover layer 170a may be at least partially disposed on the sidewall of the body 110 to cover one or more distal openings of one or more cavities on the sidewall of the body 110.

[0077] Figure 1C A measurement assembly is shown that includes a measurement portion 170 disposed at the distal portion 140 of the body 110. In other embodiments, the measurement portion 170 may be located at a different location (e.g., at the distal portion of the inner body 160), or the measurement assembly may be configured to interact with an element of the device 100 to provide a qualitative or quantitative measurement and may include any suitable one or more elements without requiring the measurement portion to be disposed within the measurement assembly. Figure 1F 1, wherein the device 100 includes an inner body 160 having a distal portion 161, the distal portion 161 including a distal end adapted to penetrate the endometrial epithelium. The device 100 also includes a body 110 (e.g., a catheter) configured to fit inside a cavity of a female reproductive system. The body includes a cavity 120 extending from a proximal end 130 of the body 110 to a distal portion 140 of the body 110 and having a distal opening 150 at the distal portion 140 of the body. The cavity 120 is configured to slidably receive the inner body 160. Figure 1FThe device 100 further includes a measuring component 162. The measuring component 162 is configured to measure whether the device 100 is in a first state or a second state, the first state indicating that the distance between the distal end of the inner body 160 and the endometrial epithelium is greater than a predetermined distance (i.e., in the direction of advancing the inner body from the distal opening 150 of the body 110), and the second state indicating that the distance between the distal end of the inner body 160 and the endometrial epithelium is equal to or less than the predetermined distance. Figure 1F The apparatus 100 also includes an indication device 180 coupled to the measurement assembly 162 and configured to indicate whether the apparatus 100 is in the first state or in the second state. The apparatus 100 also includes a first actuator 190 and a second actuator 195, the first actuator 190 being operable to push the inner body 160 out of the distal opening 150 of the body 110, and the second actuator 195 being operable to eject the fertilized egg from the inner body (e.g., to advance the plunger 165).

[0078] In one embodiment, the distal portion 161 of the inner body 160 is conductive, and the measurement assembly 162 is configured to be in electrical contact with such distal portion 161 of the inner body 160. Thus, the measurement assembly provides an indication of capacitance. In one embodiment, the first state is indicated by a capacitance measurement value below a threshold, and the second state is indicated by a capacitance measurement value above a threshold. The cover layer 170a can cover the distal opening 150 to prevent mucus from entering the cavity 120 and affecting the capacitance measurement of the distal portion 161 as the inner body 160 moves toward the distal opening 150. The inner body 160 is configured to perforate the cover layer 170a so that the inner body 160 can extend distally from the device 100 to penetrate the endometrial epithelium and implant a fertilized egg.

[0079] In a specific embodiment, the capacitance varies according to the change in the distance between the distal portion 161 of the inner body 160 and the endometrial epithelium, that is, the capacitance value varies according to the proximity of the distal portion 161 of the inner body 160 to the endometrial epithelium. In one embodiment, the predetermined distance is zero (thus meaning that the distal portion 161 of the inner body 160 is in contact with the endometrial epithelium). In one embodiment, the capacitance value is measured by a measurement component 162, which includes an electrical system that is electrically connected to the distal portion 161 of the inner body 160 to measure the capacitance.

[0080] The use of the measurement assembly in conjunction with the indication device helps to determine that the distal portion of the device is within a predetermined distance so that the inner body can be advanced into the endometrial epithelium to deliver a fertilized egg. In embodiments where the indication provides information about the distance between the distal portion of the body 110 and the endometrial epithelium, this can help to avoid direct contact between the distal portion of the body 110 and the endometrial epithelium. Further, prematurely extending the inner body 160 into the uterus while the device is still positioned may cause damage to the inner body 160. Therefore, the indication device helps to identify when it is appropriate to extend the inner body 160 out of the device.

[0081] In embodiments where the indication provides information about the distance between the distal end of the inner body 160 and the endometrial epithelium, the measurement assembly used in combination with the indication device helps determine that the distal end of the inner body is within a predetermined distance that allows the inner body to be further advanced to the endometrial epithelium for delivery of a fertilized egg and / or places the inner body in a position to deliver a fertilized egg. Thus, the indication device helps identify when it is appropriate to deliver a fertilized egg.

[0082] In one embodiment, Figures 1A to 1F The device 100 also includes an imaging device, in particular a camera, which is not shown in the figure (i.e., outside and independent of the measurement assembly). In one embodiment, the camera is attached to the body 110 and moves with the body 110 as an integral device. In a specific embodiment, the camera is housed in the body 110. Figure 1H A perspective view of a distal portion of a device 100 is shown, the device 100 including a camera 171 and an inner body 160 slidably received in a single cavity 120. Thus, the camera 171 may be removable and sterilizable for multiple uses between multiple devices 100. Figure 1H The device may include Figure 1F The embodiment of the present invention can be combined with all the features shown in the embodiment of the present invention, and adds a camera 171 disposed in the same cavity 120. One or more light sources (not shown) can be included to illuminate the area in front of the camera 171 to be imaged. The one or more light sources can be located near the camera to avoid glare when the camera 171 captures an image. A cover layer 170a covers the distal opening 150 of the cavity 120. The camera 171 can be included on an elongated body 172, which includes a longitudinal recess for receiving the inner body 160. The camera 171 can be connected to a display device (not shown) via an electrical connection extending through the elongated body 172 to display the viewing field of the camera 171.

[0083] Figure 1J A schematic side view of the main body 110 is shown, and the main body 110 may be as described above with reference to Figures 1A to 1HThe body 110 is described and may form part of the device 100 as previously described. The body 110 may include a covering layer 170a that partially or completely covers the distal end of the body 110 including one or more distal openings. The cavity 120 (see Figure 1L ) extends through the body 110, which may be configured to slidably or fixably receive the Figure 1H The camera described is as camera 171 and inner body 160. At the proximal end of body 110, body 110 may include first branch 109a and second branch 109b, each branch having a proximal opening. Cavity 120 bifurcates toward the proximal end of body 110 to form two cavities, one cavity extending along first branch 109a and the other cavity extending along second branch 109a, such that cavity 120 can be entered through either proximal opening of first branch 109a and second branch 109b. Body 110 may be made of any suitable material and may have any suitable length, particularly as previously described with reference to Figures 1A to 1H The material and length described. The body 110 can be a single piece or can be formed of several pieces connected by any suitable method (e.g., adhesive or welding). In some embodiments, the body 110 can include a distal portion 110b and a proximal portion 110a, each of which is formed separately and joined together by welding or adhesive to form a single body defining the cavity 120 and the branches 109a, 109b.

[0084] The cavity of branch 109b may be configured to receive a Figure 1H The camera 171 described above. In some embodiments, the cavity of branch 109b may include a guide (e.g., a protrusion) so that the camera 171 can only be inserted into the cavity 120 via branch 109a, so that the slender body 172 including a longitudinal recess is positioned in a predetermined direction within the cavity 120. The proximal end of branch 109b may include a connector (e.g., a thread) for connecting to a corresponding thread or Luer lock on a proximal housing of the camera, the housing including an electrical connection for connecting to a cable that controls the camera 171 (e.g., for powering the imaging device and one or more light sources of the camera 171 and for receiving image data from the camera 171). The cavity of branch 109a may be configured to receive a device as described in reference Figures 1A to 1HThe inner body 160 described. The proximal end of the branch 109a may include a connector for connecting to a housing containing the actuator 190 and the actuator 195. For example, the proximal end of the branch 109a may include a thread or a Luer lock, which is configured to be threadedly connected with a corresponding thread on the housing. Therefore, the inner body 160 and the plunger 165 can be inserted into the body 110 through the branch 109a and fixed to the body 110 by the housing containing the actuator 190 and the actuator 195. As described herein, by driving the actuator 190 and the actuator 195, the inner body 160 and the plunger 165 can be advanced and retracted relative to the body 110.

[0085] Figure 1K An apparatus according to one or more embodiments (eg, referring to Figures 1A to 1J 100) is a schematic side view of a probe 121 of a device 100 described in the present invention. The probe includes an elastic elongated element 123 (e.g., a wire or a strip) configured to extend slidably through the body 110. The elongated element 123 is made of an elastically deformable material that can provide hardness to the body 110 when it is initially inserted through the cervix in an embryo transfer procedure. For example, the elongated element 123 can be made of a material such as a nickel-titanium alloy or stainless steel. The elongated element 123 may have a rounded tip 123a to reduce damage or damage to the inner wall of the body 110 that defines the cavity 120 when the probe 121 is inserted into the body 110. In some embodiments, the probe may include a handle 122 that is grasped by a user during insertion into the body 110. The handle 122 may be connected to the elongated element 123 at its distal end, such as by an adhesive, welding, or friction fit. The handle may include a distal connector 122a thereof for connection to the proximal end of the body 110. For example, connector 122a may include threads configured to be threadedly connected to threads on the proximal end of body 110 (e.g., the proximal end of one of branches 109a, 109b), or may include a Luer lock or other suitable mechanism (e.g., friction fit). Thus, probe 121 can be fixed to body 110 during insertion through the cervix and then removed from body 110.

[0086] Figure 1LA schematic cross-sectional side view of a probe 121 inserted into the cavity 120 of the body 110 is shown. The length of the elongated element 123 can be less than the length of the cavity 120, such that when the probe 121 is fully inserted into the body 110 and fixedly connected to the body 110 (e.g., by threads, a Luer lock, or a friction fit), the distal tip 123a of the probe 121 does not reach the distal end of the body 110. In embodiments where the body 110 includes a cover layer 170a, this ensures that the cover layer 170a is not pierced by the probe 121 when the body 110 is advanced through the cervix. For example, in some embodiments, the length of the elongated body 123 can be such that the distal tip 123a is at least 5 mm from the distal end of the body 110 when fully inserted.

[0087] Figure 2A A system 101 for delivering a fertilized egg or embryo into the endometrium of a mother of a human or any other mammalian species is shown. The system 101 includes a body 160 having a distal end 162 adapted to penetrate the endometrial epithelium. The system 101 also includes a plunger 165 slidably received in a cavity of the body 160, and an actuator 195 operable to advance the plunger 165 to expel the fertilized egg from the cavity of the body 160. The actuator 195 can be any suitable actuator for advancing and retracting the plunger 165, and can be a manual actuator, such as a proximal end of the plunger 165 that remains accessible to a user when the system 101 is inserted into a cavity of the female reproductive system. The actuator 195 can be any actuator disclosed herein, and can be a lead screw that can be rotated to advance and retract the plunger 165, such as described in reference to 6A to 6H The system 101 further comprises a first injectable medium 111 and a second injectable medium 112 for containing a fertilized egg. The first injectable medium 111 has a higher viscosity than the second injectable medium 112.

[0088] The first injectable medium 111 can be any suitable biocompatible injectable medium having a higher viscosity than the second injectable medium 112. The second injectable medium 112 can be any injectable medium known in the art that is biocompatible and non-toxic to the fertilized egg. It should be understood that the lower limit of the viscosity of the first injectable medium 111 will depend on the viscosity of the selected second injectable medium 112. In some embodiments, the first injectable medium 111 includes or consists of one or more of the following: hyaluronic acid, a salt of hyaluronic acid, a biocompatible hydrogel, poloxamer, collagen, fibrinogen, gelatin, sodium hyaluronate, and a combination thereof. The use of hyaluronic acid can promote the repair of the endometrial epithelium at the perforation of the endometrial epithelium by the main body 160.

[0089] In some embodiments, a third injectable medium 113 is also provided, which also has a higher viscosity than the second injectable medium 112. The viscosity of the third injectable medium 113 can be the same or different from that of the first injectable medium 111, and can include or consist of the same or different substances as the first injectable medium 111. In some embodiments, the third injectable medium 113 includes or consists of one or more of the following: hyaluronic acid, a salt of hyaluronic acid, a biocompatible hydrogel, a poloxamer, collagen, gelatin, fibrinogen, sodium hyaluronate, and combinations thereof.

[0090] The first injectable medium 111 and the second injectable medium 112 (and optionally the third injectable medium 113) can be disposed in a medium reservoir (e.g., a vial or the like), and the user can manually load the injectable medium into the system 101 by inserting the body 160 into the reservoir and retracting the plunger 165 to draw each injectable medium into the cavity of the body 160. In some embodiments, the injectable medium can be pre-loaded into the body 160.

[0091] In one embodiment, the first injectable medium 111 and the second injectable medium 112 are received (i.e., pre-loaded) in the cavity of the body 160, wherein the second injectable medium 112 is located in front of the first injectable medium 111 relative to the distal end 162 of the body 160, so that when the actuator 195 is actuated to expel the fertilized egg, the second injectable medium 112 is expelled before the first injectable medium 111. Figure 2C This configuration is shown. Figure 2E As discussed in more detail, the first injectable medium 111 acts as a stopper, restricting the second injectable medium from being discharged from the endometrial epithelium E.

[0092] In one embodiment, the first injectable medium 111, the second injectable medium 112 and the third injectable medium 113 are received (i.e., pre-loaded) in the cavity of the main body 160, wherein the second injectable medium 112 is received between the first injectable medium 111 and the third injectable medium 113, so that when the actuator 195 is actuated to expel the fertilized egg, the second medium 112 is expelled before one of the first injectable medium 111 and the third injectable medium 113, and after the other of the first injectable medium 111 and the third injectable medium 113. Figure 2D This configuration is shown. Figure 2E Discussed in more detail, the first injectable medium 111 acts as a stopper to restrict the second injectable medium from being discharged from the endometrial epithelium E, and the third injectable medium 113 provides additional structural support to maintain the second injectable medium 112 containing the fertilized egg at the desired injection location within the endometrial epithelium E.

[0093] Figure 2A The system 101 (and FIG. 2A to FIG. 2D Any of the configurations shown in any of the above) can be as Figure 2A The system 101 is provided as shown, or can be incorporated into any suitable embryo transfer system. For example, the body 160 can be slidably received by a delivery catheter that can be positioned inside the cavity of the female reproductive system. The system 101 can optionally be incorporated into any embryo transfer system disclosed herein. Specifically, FIG. 2A to FIG. 2D The body 160 shown may be Figures 1B to 1H The inner body 160 shown in any one of the embodiments of the present invention may further include a body 110 (also referred to as an outer body) configured to fit inside a cavity of a female reproductive system, the body 110 including an outer cavity 120 extending from a proximal end 130 of the body 110 to a distal portion 140 of the body 110 and having a distal opening 150 at the distal portion 140 of the body 110, the cavity 120 being configured to slidably receive the body 160 (also referred to as an inner body). The system may further include an actuator 190 operable to push the inner body 160 out of the distal opening 150 of the outer body 110.

[0094] load Figure 2A The method of system 101 (whether or not incorporated by reference Figures 1B to 1H The system described herein or any other embryo transfer system) can be as follows. In a first step, the first injectable medium 111 can be drawn into the cavity of the body 160. Specifically, the body 160 can be inserted into a reservoir containing the first injectable medium 111, and the actuator 195 can be actuated to retract the plunger 165, thereby drawing the first injectable medium 111 into the cavity of the body 160 ( FIG. 2A to FIG. 2B ). In a second step following the first step, the second injectable medium 112 may be drawn into the cavity of the body 160. Specifically, the body 160 may be inserted into a reservoir containing the second injectable medium 112, and the actuator 195 may be actuated to retract the plunger 165, thereby drawing the second injectable medium 112 into the cavity of the body 160 ( Figure 2B to Figure 2C In some embodiments, in a third step after the second step, the third injectable medium 113 may be sucked into the cavity of the body 160. Specifically, the body 160 may be inserted into a reservoir containing the third injectable medium 113, and the actuator 195 may be actuated to retract the plunger 165, thereby sucking the third injectable medium 113 into the cavity of the body 160 ( Figure 2C to Figure 2D ).

[0095] It should be noted that the system 101 can be Figure 2C and Figure 2DIn any of the loading states shown, the first injectable medium 111 and the second injectable medium 112 are delivered to the endometrial epithelium E, and the actuator 195 can be actuated to deliver the first injectable medium 111 and the second injectable medium 112 to the endometrial epithelium E. Figure 2E The injectable medium 111, 112 and the optional injectable medium 113 are shown in the endometrial epithelium E after the system 101 is injected. When the system is removed from the endometrial epithelium E after the injection, it is observed that the endometrial epithelium E exerts an expulsion force F on the injected substance, and the injectable medium 112 is at risk of being expelled from the endometrial epithelium E immediately after the injection, thereby posing a risk of failure of the fertility treatment procedure. The first injectable medium 111 is placed in the endometrial epithelium E. Figure 2B The position shown allows the first injectable medium 111 to become the outermost portion of the injected substance in the endometrial epithelium E (e.g. Figure 2E ), and provide a high viscosity obstruction that better resists the expulsion force F, thereby reducing the risk of the endometrial epithelium E expelling the second injectable medium 112 from the endometrial epithelium E. In an embodiment using the third injectable medium 113, the third injectable medium 113 is disposed at Figure 2D The position shown allows the third injectable medium 113 to become the innermost part of the injected substance in the endometrial epithelium E, such as Figure 2E Therefore, the first injectable medium 111 and the third injectable medium 113 form a bag-like structure in the endometrial epithelium E, and the second injectable medium 112 is located in the bag-like structure. The first injectable medium 111 and the third injectable medium 113 provide structural support for both sides of the bag-like structure to restrict the force (such as the expulsion force F or any inward pressure from the surrounding tissue) from being transmitted to the second injectable medium 112, thereby further increasing the stability of the injected substance when it is located in the endometrial epithelium E.

[0096] In reference Figures 1A to 2E In any of the disclosed embodiments, the inner body 160 can include a hydrophobic coating formed on a distal portion of the inner body 160. The hydrophobic coating can be formed on one, both, or all of an inner surface 164 of the distal portion of the inner body 160, a distal tip 163 of the inner body 160, and an outer surface 166 of the distal portion of the inner body 160. Alternatively or additionally, the inner body 160 can include a beveled tip 163.

[0097] The beveled tip 163 helps perforate the cover when the cover is provided to cover the distal opening of the cavity containing the inner body 160. In addition, the beveled tip 163 reduces the force required to penetrate the endometrial epithelium.

[0098] The hydrophobic coating may include or consist of a polymer or polymer composite, preferably any of the following: polyparaxylene, acrylic acid, polyethylene, polyurethane and polytetrafluoroethylene and composites thereof. The hydrophobic coating restricts the fertilized egg or embryo from adhering to the distal portion of the inner body 160 (e.g., causing the embryo or egg to not be expelled first, or removed from the endometrial epithelium by the inner body 160), thereby reducing the risk of failure of the egg or embryo transfer procedure.

[0099] Figure 4 A schematic diagram of an indicating device 180 is shown, which can be used in any device disclosed herein that includes a measuring component when the output of the measuring component is a signal (e.g., if the measuring component includes a camera and / or a distance measuring probe such as a capacitive sensor). The indicating device includes a device interface 1100 configured to communicate with the measuring component (i.e., send signals to the measuring component and receive signals from the measuring component). The indicating device also includes a memory 1110, a processor 1120, and an indicator 1130. It should be understood that any suitable computing system can be used for the indicating device 180, and Figure 4 The device shown in is one of many devices that can be used. For example, using any known distributed computing technology, a distributed computer system can be used, for example, including one or more servers or client computing systems. In some examples, a general-purpose computer or any other processing system can be used to implement the methods disclosed herein. In addition, the steps disclosed below can be implemented using software, hardware, or any combination of these to implement the same steps.

[0100] The skilled person will understand that Figure 4 The indicating device can be powered by any suitable power supply means. The memory 1110 may include one or more of the following: a volatile or non-volatile memory device (such as DRAM, SRAM), flash memory, read-only memory, ferroelectric RAM, a hard disk drive, a floppy disk, a tape, an optical disk, or the like. Similarly, the processor 1120 may include one or more processing units, such as a microprocessor, a GPU, a CPU, a multi-core processor, or the like. The device interface 1100 may include a wired connection such as optical, fiber optic, Ethernet, or the like, or any suitable wireless communication.

[0101] In the case where the measuring assembly performs quantitative measurement (e.g., including a distance sensing probe), the memory 1110 may include a suitable instruction for performing a comparison of the received signal with a predetermined distance, and the processor 1120 may be configured to execute the instruction. For example, the indicating device 180 may receive a raw data signal through the device interface 1110, and the processor 1120 may convert the raw data into a numerical value for a predetermined distance, and the numerical value may be compared with the predetermined distance. If the numerical value is equal to or lower than the predetermined distance, the processor 1120 may instruct the indicator 1130 to indicate that the predetermined distance has been reached. For example, the indicator 1130 may provide an audio or visual signal to the operator, or may include an electronic controller configured to provide a command signal to the electronically controlled motion controller to perform the operation of advancing the needle and discharging the embryo (wherein the memory 1110 includes a suitable instruction for providing a control signal to the actuator). The indicating device 180 may also be configured to further indicate to the user (e.g., audio or visual signal) when the automatic program of advancing the needle and discharging the embryo has been completed. Alternatively, the indicator 1130 may include a display showing the measured distance and the predetermined distance.

[0102] In the case where the measuring assembly includes a camera and the measurement is a qualitative measurement, the indicating device can be only a display for displaying the real-time image captured by the camera, optionally with a contrast overlay diagram on the display in appropriate cases. Alternatively, the memory 1110 can store instructions for performing image analysis on the image data to automatically determine whether the image indicates that a predetermined distance has been reached. The processor 1120 can be configured to execute the instruction. Then, the processor 1120 can instruct the indicator 1130 to indicate that a predetermined distance has been reached. For example, the indicator 1130 can provide audio or visual signals to the operator, or can provide a command signal to the motion controller of the electronic control to perform the operation of advancing the needle and discharging the embryo.

[0103] Although Figure 4 The motion controller and the pointing device are shown as separate devices, but the pointing device and the motion controller may be combined into a single device. In addition, the measurement component may be indirectly connected to the pointing device via the device interface of the motion controller.

[0104] Figure 5 A schematic diagram of a computer 1200 that can be used to control one or more actuators disclosed herein is shown. The computer 1200 may include one or more of a controller 1210, a processor 1220, a user interface 1230, a display 1240, a network connection 1245, a device interface 1250, and a memory 1255 that stores instructions for a program 1260 and a data repository 1270. It should be understood that any suitable computing system may be used for the computer 1200, and Figure 5The device shown in is one of many devices that can be used. For example, using any known distributed computing technology, a distributed computer system can be used, for example, including one or more servers or client computing systems. In some examples, a general-purpose computer or any other processing system can be used to implement the methods disclosed herein. In addition, the steps disclosed below can be implemented using software, hardware, or any combination of these to implement the same steps.

[0105] Those skilled in the art will understand that Figure 5 The indicating device can be powered by any suitable power supply means. The memory 1255 may include one or more of the following: volatile or non-volatile memory devices (such as DRAM, SRAM), flash memory, read-only memory, ferroelectric RAM, hard disk drive, floppy disk, tape, optical disk, or the like. Similarly, the processor 1220 may include one or more processing units, such as a microprocessor, GPU, CPU, multi-core processor, or the like. The device interface 1250 may include a wired connection such as optical, fiber optic, Ethernet, or the like, or any suitable wireless communication.

[0106] The device interface 1250 is configured to communicate with (i.e., send and receive control information to) one or more electronically controlled actuators. Any actuator disclosed herein may be electronically controlled. The device interface 1250 may also be configured to communicate with the pointing device 180. Alternatively, the computer 1200 may include Figure 4 , and may itself be considered as pointing device 180 .

[0107] Computer 1200 provides manual control of the electronically controlled actuators by a user of the device. For example, memory 1255 may include instructions of program 1260 that, when executed by processor 1220, causes a graphical user interface (GUI) to be displayed on display 1240, or remotely displayed via network connection 1245. The GUI may include appropriate inputs to enable a user to actuate one or more of the actuators. For example, a user may select a function from the GUI, causing controller 1210 to send a corresponding control signal to one or more actuators to perform the function.

[0108] For example, the user can select a command from the GUI to advance the main body to a certain distance or to advance at a certain constant speed. The user can select one or more commands that the steering mechanism is turned to. The user can select one or more commands of the main body and / or plunger in the advancement. These commands can correspond to a sequence of commands, thereby executing several commands in sequence. For example, the memory 1255 can store the instruction of advancing the main body 110 until reaching a predetermined distance (i.e. until the indicating device indicates reaching a predetermined distance) and the instruction of the main body and plunger in the advancement subsequently to discharge the embryo. All actuators can be actuated by this automated process, or only some actuators can be automatically actuated, and the remaining actuators are manually actuated (i.e. controlled by the user through the GUI).

[0109] The computer 1200 may be configured to receive data from the measurement component directly or through the pointing device 180, and the data may be displayed on the GUI along with the command options. For example, the display 1240 may display real-time image data received from the measurement component. The GUI may also display an indication to the user that a predetermined distance has been reached.

[0110] In some embodiments, the device may further include a motion controller configured to be connected to the proximal portion of the body 100, wherein the controller is configured to actuate the first actuator, the second actuator, and / or the fourth actuator to advance the body relative to the motion controller. Any suitable motion controller may be used. For example, the motion controller may include one or more linear or rotary mechanisms for actuating the first actuator, the second actuator, and / or the fourth actuator. In some embodiments, one or more of the first actuator, the second actuator, and the fourth actuator may include a lead screw, each of which may be rotatable to advance the body 110, the inner body 160, or the plunger 165, and the motion controller may be configured to actuate one or more lead screws. The motion controller may be manually controlled or electronically controlled. The motion controller may be configured to be connected to the body via a connector.

[0111] Fig. 6A A cross-sectional perspective view of connector 1300 configured to connect to motion controller 1350 is shown. Fig. 6E An exploded view of connector 1300 is shown. Connector 1300 includes a connector housing 1310 that is insertable into a distal end of motion controller 1350. Connector 1300 also includes a body connector 1314 that fixedly receives a proximal portion of body 110 (e.g., by a friction fit or by an adhesive), an inner body connector 1324 that fixedly receives a proximal portion of inner body 160 (e.g., by a friction fit or by an adhesive), and a plunger connector 1332 that fixedly receives a proximal portion of plunger 165 (e.g., by a friction fit or by an adhesive).

[0112] The body connector 1314 is received by the connector housing 1310 and is slidable in a fixed rotational direction relative to the connector housing 1310. For example, the connector housing 1310 may include a longitudinally extending protrusion or recess, and the body connector 1314 may include a corresponding recess or protrusion, so that the body connector 1314 can only be received by the connector housing 1310 in a single rotational direction. The connector 1300 also includes a body lead screw 1316 having an external thread 1320 that corresponds to the internal thread 1312 of the connector housing 1310. The body lead screw 1316 is tightly against the body connector 1314 so that when the body lead screw 1316 is rotated to advance the body lead screw distally, the body connector 1314 is also advanced distally (but in a fixed direction). In the illustrated embodiment, the body lead screw 1316 is connected to the body connector 1314 by one or more protrusions 1318, and the one or more protrusions 1318 are received by corresponding recesses 1322 in the body connector. The interaction between the protrusion 1318 and the recess 1322 means that when the body lead screw 1316 slides distally and proximally, the body lead screw 1316 is close to the body connector 1314, which means that the body lead screw 1316 can simultaneously advance and retract the body connector 1314, thereby advancing and retracting the body 110. In some embodiments, the protrusion 1318 can alternatively be located on the body connector 1314 and the recess on the body lead screw 1316.

[0113] The inner body connector 1324 is received by the body connector 1314 and is slidable relative to the connector housing 1310 and the body connector 1314. In some embodiments, the inner body connector 1324 can slide in a fixed rotational direction relative to the connector housing 1310 and the body connector 1314 (e.g., via corresponding protrusions and recesses in the body connector 1314 and the inner body connector 1324 as previously disclosed).

[0114] Figure 6B Shows Fig. 6AA close-up of the inner body connector 1324 and the plunger connector 1332 is shown. The connector also includes an inner body lead screw 1328 having external threads 1326 that correspond to the internal threads 1327 of the body connector 1314. The inner body lead screw 1328 is tightly against the inner body connector 1324 so that when the inner body lead screw 1328 is turned to advance the inner body lead screw 1328 distally, the inner body connector 1324 is also advanced distally. In the illustrated embodiment, the inner body lead screw 1328 is connected to the inner body connector 1324 by one or more protrusions 1325, which are received by corresponding recesses in the inner body connector 1324. The interaction between the protrusion 1325 and the recess means that when the inner body lead screw 1328 slides distally and proximally, the inner body lead screw 1328 is close to the inner body connector 1324, which means that the inner body lead screw 1328 can advance and retract the inner body connector 1324, thereby advancing and retracting the inner body 160. In some embodiments, the protrusion 1325 can alternatively be located on the inner body connector 1324 and the recess on the inner body lead screw 1328. In some embodiments, the inner body connector 1324 and the inner body lead screw 1328 can be a single, integrated unit.

[0115] The plunger connector 1332 is received by the inner body connector 1324 and is slidable relative to the connector housing 1310, the body connector 1314, and the inner body connector 1324. In some embodiments, the plunger connector 1332 can slide relative to the connector housing 1310, the body connector 1314, and the inner body connector 1324 in a fixed rotational direction (e.g., by corresponding protrusions and recesses in the inner body connector 1324 and the plunger connector 1332 as previously disclosed). The connector also includes a plunger lead screw 1336 having an external thread 1333 that corresponds to the internal thread 1334 of the inner body connector 1324. The plunger lead screw 1336 is in close contact with the plunger connector 1332, so that when the plunger lead screw 1336 is rotated to advance the plunger lead screw 1336 distally, the plunger connector 1332 is also advanced distally. In the illustrated embodiment, the plunger lead screw 1336 is connected to the plunger connector 1332 by one or more protrusions 1335 in the plunger connector 1332, which are received by corresponding recesses in the plunger lead screw 1336. The interaction between the protrusions 1335 and the recesses means that when the plunger lead screw 1336 slides distally and proximally, the plunger lead screw 1336 abuts against the plunger connector 1332, which means that the plunger lead screw 1336 is able to advance and retract the plunger connector 1332, thereby advancing and retracting the plunger 165. In some embodiments, the protrusions 1335 may alternatively be located on the plunger lead screw 1336 and the recesses on the plunger connector 1332. In some embodiments, the plunger connector 1332 and the plunger lead screw 1336 may be a single, integrated unit.

[0116] The connector 1300 may include an interlocking feature 1340 at the distal end, such as a Luer lock, for securing the distal end of the connector 1300 to the next distal component of the device.

[0117] Figure 6C A perspective view of the proximal end of connector 1300 is shown. Fig.6DA perspective view of the distal end of the motion controller 1350 is shown. The proximal end of the connector 1300 is configured to connect with the distal end of the motion controller 1350. The body lead screw 1316 includes a toothed proximal end 1360 configured to engage with the body lead screw driver 1352 of the motion controller 1350. The inner body lead screw 1328 includes a toothed proximal end 1362 configured to engage with the inner body lead screw driver 1354 of the motion controller 1350. The plunger lead screw includes a toothed proximal end (not shown) configured to engage with the plunger lead screw driver 1356 of the motion controller 1350. The proximal end of connector housing 1310 may also include a locking feature, such as a protrusion 1364, which is configured to be received by a recess (not shown) at the distal end of the motion controller to prevent relative rotation of the distal end of motion controller 1350 and connector housing 1310. Connector 1300 may be connected to motion controller 1350 by a push fit, a plug fit, a friction fit, or a similar mechanism. Lead screw drivers 1352, 1354, and 1356 may be secured by springs 1358 (see Fig. 6A ) is biased distally to ensure engagement with the proximal end of the lead screw during rotation.

[0118] Although the illustrated embodiments illustrate a connector in which the main body connector, the inner body connector, and the plunger connector are actuated by a lead screw mechanism, it should be understood that in other embodiments, the connector actuates only one or more of the main body connector, the inner body connector, and the plunger connector by a lead screw mechanism. For example, the connector may include only the main body connector 1314, which is actuated by the main body lead screw 1316 as described above, while the needle and plunger may be actuated in a different manner (i.e., by a linear motion mechanism). It should also be understood that the outermost threads of a given embodiment engage with the inner threads 1312 of the connector housing 1310. For example, in an embodiment in which the connector 1300 actuates only the inner body 160 and the plunger 165 by the disclosed threaded mechanism, the outer threads 1326 of the inner body lead screw 1328 engage with the inner threads 1312 of the connector housing 1310, rather than the inner threads of the main body connector 1314.

[0119] Connector housing 1310, connectors 1314, 1324 and 1332 and lead screws 1316, 1328 and 1336 can be made of any suitable material (e.g., plastic) and can be molded or 3D printed. Similarly, lead screw drivers 1352, 1354 and 1356 can be made of any suitable material (e.g., plastic).

[0120] Electrical wiring and / or optical fibers from the measuring portion 170 extending from the distal end of the device through the body 110 can terminate at the connector 1300. Specifically, the proximal portion of the electrical wiring extending from the distal end of the device through the body 110 can be electrically connected to the electrical terminals of the connector. The motion controller can include corresponding electrical terminals that are biased toward the electrical terminals of the connector to maintain contact with the electrical terminals of the connector. Similarly, the proximal portion of the optical fiber can be optically connected to the optical terminals of the connector 1300, and the motion controller can include an optical terminal that is configured to form a face seal with the optical terminals of the connector 1300 and is biased toward the optical terminals of the connector 1300 to maintain a face seal with the first optical terminal.

[0121] Fig. 6F A perspective view of the connection between the body connector 1314 and the distal end of the motion controller 1350 is shown. The illustrated embodiment shows a proximal portion of a cable 312 extending from a measurement portion (e.g., camera 171) through the body 110 to the connector 1300. The cable 312 is electrically connected (e.g., by welding) to an electrical terminal (e.g., a printed circuit board) on the body connector 1314. The electrical terminal includes an electrical connection configured to engage with an electrical pin 1374 on the motion controller 1350. The electrical pin 1374 is biased distally so that as the body connector 1314 is pushed through the connector housing 1300, the electrical connection between the pin 1374 and the electrical terminal of the body connector 1314 is maintained. It should be understood that an optical connection between the connector 1300 and the motion controller 1350 can be similarly established and maintained.

[0122] Figure 6GA perspective view of a proximal portion of the motion controller 1350 is shown. The motion controller 1350 includes a first motor 1381, a second motor 1383, and a third motor 1385. In one embodiment, the first motor 1381 can be configured to drive the body lead screw driver 1352, the second motor 1383 can be configured to drive the inner body lead screw driver 1354, and the third motor can be configured to drive the plunger lead screw driver 1356. The motion controller 1350 can be configured to advance / retract the body 110, the inner body 160, and the plunger 165 at the same rate by synchronously operating the first motor 1381, the second motor 1383, and the third motor 1385 at a rate corresponding to the same advancement speed of the body 110, the inner body 160, and the plunger 165. The motion controller 1350 can also be configured to advance / retract the inner body 160 and the plunger 165 relative to the body 110 at the same rate by synchronously operating the second motor 1383 and the third motor 1385 at a rate corresponding to the same advancement speed of the inner body 160 and the plunger 165. The motion controller 1350 can also be configured to advance / retract the plunger 165 relative to the inner body 160 by operating the third motor 1385 alone.

[0123] Alternatively, the first motor 1381 can be configured to rotate each of the lead screw drivers 1352, 1354, and 1356 (e.g., via a first threaded rod) to advance the lead screws 1316, 1328, and 1336 at the same rate (thereby advancing the body 110, the inner body 160, and the plunger 165 at the same rate). The second motor 1383 can be configured to rotate the inner body lead screw driver 1354 and the plunger lead screw driver 1356 (e.g., via a second threaded rod) to advance the inner body lead screw 1328 and the plunger lead screw 1336 at the same rate (thereby advancing the inner body 160 and the plunger 165 at the same rate). The third motor 1386 can be configured to rotate the plunger lead screw driver 1356 (e.g., via a threaded rod) to advance the plunger 165.

[0124] The motion controller 1350 may also include an axial motor (not shown) to retract the plunger lead screw driver 1352 before the connector 1300 is connected or disconnected to prevent damage to the plunger lead screw driver 1352 during the process of connecting or disconnecting the connector 1300.

[0125] The connector 1300 can be assembled according to the following steps (these steps are not necessarily performed in chronological order in the order shown). The proximal portion of the plunger 165 can be fixed to the plunger connector 1332. The plunger connector 1332 can be connected to the plunger lead screw 1336 (e.g., by pushing the connector and the lead screw together until the protrusion falls into the recess to fix the connector and the lead screw together). The proximal portion of the inner body 160 can be connected to the inner body connector 1324. The inner body connector 1324 can be connected to the inner body lead screw 1328 (e.g., by pushing the connector and the lead screw together until the protrusion falls into the recess to fix the connector and the lead screw together). The proximal portion of the body 110 can be connected to the body connector 1314. The body connector 1314 can be connected to the body lead screw 1316 (e.g., by pushing the connector and the lead screw together until the protrusion falls into the recess to fix the connector and the lead screw together). The distal end of the plunger 165 can pass from the proximal end through the inner body connector 1324 and through the inner body 160. The plunger lead screw 1336 can be screwed onto the inner body connector 1324. The distal end of the inner body 160 can pass from the proximal end through the body connector 1314 and through the body 110. The inner body lead screw 1328 can be screwed onto the body connector 1314. The distal end of the body can pass from the proximal end through the connector housing 1310. The body lead screw 1316 can be screwed onto the connector housing 1310. The lead screws can then be actuated to move the body 110, the inner body 160, and the plunger 165 to the correct relative positions.

[0126] When the connector 1300 is assembled, the plunger lead screw 1336 can be actuated to aspirate the fluid containing the embryos. The connector 1300 is then connected to the motion controller 1350.

[0127] The length from the proximal end of the main body connector 1314 to the distal tip of the main body 110 can be about 300 mm to 400 mm, preferably 325 mm to 375 mm, for example 358 mm. The maximum length of the connector 1300 from the proximal end to the distal tip of the main body 110 can be about 400 mm to 500 mm, preferably 425 mm to 475 mm, for example 450 mm.

[0128] Figure 6H 1 shows a perspective view of a motion controller 1350 according to one embodiment. The motion controller 1350 is configured to be connected to the proximal portion of the body 110 and to actuate the body 110. Figure 6HIn the illustrated embodiment, the motion controller 1350 includes two lead screws 1351, 1353, which are configured to advance / retract the body 110, and in one embodiment, are configured to rotate and advance / retract the external catheter that accommodates the body 110. In the illustrated embodiment, the motion controller 1350 also includes three actuation mechanisms 1357, 1359, 1361, each of which is configured to actuate one of the lead screws 1351, 1353. The actuation of the lead screws 1351, 1353 can be manual or motorized. Although two lead screws 1351, 1353 are shown in this embodiment, there can be only one lead screw in other embodiments, depending on the element intended to be moved by the motion controller 1350. The motion controller 1350 allows for fine and precise control of the movement of the body 110 and the external catheter that accommodates the body, as well as fixing the external catheter in a desired position. In one embodiment, motion controller 1350 may be actuated based on real-time images obtained by an imaging device (eg, a camera) present in apparatus 100 .

[0129] Fig. 7A A cross-sectional side view of a device 700a (also referred to as a speculum lock) for engaging a speculum is shown. The device 700a includes two or more expandable engagement elements 710 for outwardly engaging a speculum to secure the device to the speculum, wherein the two or more expandable engagement elements 710 include multiple expansion configurations for engaging multiple speculum sizes. The device 700a includes a guide 705 for guiding an embryo transfer device between the engagement elements 710 and through the speculum when the device 700a is secured to the speculum. Specifically, the guide 705 at least partially conforms to the outer surface of the embryo transfer device to allow the embryo transfer device to move longitudinally (i.e., in the x-direction) through the guide and prevent the embryo transfer device from moving laterally (i.e., in the y-direction) in the guide. The guide 705 may include a tubular body 701 having a tubular wall 702 defining a cavity 705 for slidably receiving an embryo transfer device, wherein the cross-sectional shape of the inner surface of the tubular wall 702 at least partially conforms to the outer surface of the embryo transfer device to allow the embryo transfer device to move longitudinally through the guide and prevent the embryo transfer device from moving laterally in the guide. The embryo transfer device may be incorporated into the reference Figures 1A to 6H A body 110 is provided in any of the devices described for delivering a fertilized egg.

[0130] The expandable engagement element 710 can be coupled to the tubular body 701. The engagement element 710 can be expanded using any suitable mechanism. For example, the device 700a may include one or more biasing elements, such as a spring connected between the tubular body 701 and the engagement element 710, to bias the engagement element 710 to an extended configuration. The engagement element 710 can be kept in a folded configuration by a sheath or a covering on the engagement element 710. The engagement element 710 can be inserted into a speculum and can be removed (e.g., retracted) from the engagement element 710 so that the engagement element 710 is biased to an extended configuration to engage the opposite side of the speculum, thereby fixing the device 700a to the speculum. Other mechanisms can be used, such as a motor connected to the engagement element 710, for moving the engagement element between a folded configuration and one or more extended configurations. In some embodiments, the engagement element 710 can be mounted to the guide 705 by a corresponding scissor lift 745. The scissor lift 745 may include one or more pairs of struts pivotally connected to each other, wherein one strut is pivotally mounted to the guide 705 (e.g., tubular body 701) and the corresponding engagement element 710, and the other strut is slidably mounted to the guide 705 (e.g., tubular body 701) and the corresponding engagement element. Compression of the scissor lift 745 in the longitudinal direction is converted into movement of the engagement element 710 in the lateral direction to move to the expanded configuration. The device 100 may include a ratchet actuator 746 that is slidably mounted to the guide 705 and is configured to move the scissor lift 745 between multiple positions corresponding to multiple expanded configurations of the expandable engagement element 710. The ratchet actuator 746 includes a plurality of teeth (not shown) that engage with corresponding teeth on the guide 705 to allow movement in the distal direction D rather than the opposite direction. The device 700a may further include a release mechanism (not shown) for releasing the ratchet mechanism (ie, by disengaging the teeth) and allowing movement in a proximal direction opposite to the distal direction D, thereby allowing movement from the expanded configuration to the collapsed configuration.

[0131] In some embodiments, guide 705 may include a first branch guide 725 and a second branch guide 730 at its proximal end, the first branch guide 725 and the second branch guide 730 defining respective cavities 707, 708 branching from cavity 706. Branch guides 725 and 730 allow detachable components of the embryo transfer device (e.g., a measurement assembly and an inner body) to be inserted into device 700a or 700b, respectively, while the detachable components move synchronously when device 700a or 700b is moved to position the embryo transfer device within the uterus.

[0132] Fig. 7A The expandable engagement element 710 may be a straight line as shown in the figure, or may include a reference Figure 7B and Figure 7CAny features of the disclosed engagement element 710.

[0133] Figure 7B Another device 700b for engaging a speculum, also referred to as a speculum lock, is shown in a perspective view in a folded configuration. Figure 7C Shown in extended configuration Figure 7B The device 700b is provided with a device 700b. Similarly, the device 700b includes two or more expandable engagement elements 710 for outwardly engaging a speculum to secure the device 700b to the speculum, wherein the two or more expandable engagement elements 710 include multiple expansion configurations for engaging multiple speculum sizes. The device also includes a guide 705 for guiding the embryo transfer device between the expandable engagement elements 710 and through the speculum when the device 700b is secured to the speculum. The guide 705 may include a tubular body 701 having a tube wall, the tube wall defining a cavity for slidably receiving the embryo transfer device, wherein the cross-sectional shape of the inner surface of the tube wall 702 at least partially conforms to the outer surface of the embryo transfer device to allow the embryo transfer device to move longitudinally through the guide and prevent the embryo transfer device from moving laterally in the guide.

[0134] The engagement element 710 may be extended using any suitable mechanism, such as that described in reference Fig. 7AAs described. In the illustrated embodiment, the engagement element 710 can be mounted to the guide 705 by a corresponding scissor lift 745. The scissor lift 745 may include one or more pairs of pillars pivotally connected to each other, one of which is pivotally mounted to the guide 705 (e.g., tubular body 701) and the corresponding engagement element 710, and the other pillar is slidably mounted to the guide 705 (e.g., tubular body 701) and the corresponding engagement element. The device 700b includes a proximal portion 735 and a distal portion 740 that are slidably connected. In the illustrated embodiment, the proximal portion 735 is slidably received in the cavity of the distal portion 740. One pillar of each scissor lift 745 is pivotally mounted to the proximal portion 735, and the other pillar is pivotally mounted to the distal portion 740. When the proximal portion 735 and the distal portion 740 move relative to each other, the scissor lift is actuated so that the expandable engagement element moves between various expansion configurations. The device 700b also includes a ratchet actuator 750, which includes a plurality of teeth on the proximal portion 735 that mesh with corresponding teeth on the distal portion 740 to allow the proximal portion 735 to move relative to the distal portion 740 in one direction but not in the opposite direction. The device 700a may also include a release mechanism (not shown) for releasing the ratchet mechanism (i.e., by disengaging the teeth) and allowing the proximal portion 735 to move in the opposite direction relative to the distal portion 740, thereby allowing movement from the extended configuration to the folded configuration. It should be understood that the direction of relative movement of the proximal portion 735 and the distal portion 740 that causes the engagement element 710 to move to the extended position will depend on which strut is pivotally attached to which portion. In the illustrated embodiment, the struts are attached so that the proximal portion 735 moves in the distal direction D causing the engagement element to move outwardly, thereby moving to the extended configuration.

[0135] In some embodiments, one or more expandable engagement elements 710 include an expandable engagement element that can be in a collapsed configuration (e.g., Fig. 7A ) and multiple extended configurations (such as Figure 7B The support 712 can be as shown. Fig. 7AThe device 700b may be linear as shown, or may have an outer portion 711, an inner portion 713 having a lower radial extent than the outer portion 711, and an intermediate portion 712 connecting the outer portion 711 and the inner portion 713. The posts of the scissor lift 745 are pivotally / slidably mounted to the inner surface of the outer portion 711. In either embodiment, the expandable engagement element 710 may also include a friction layer 715 mounted on the posts 712 and made of a material with a higher coefficient of friction than the posts 712. The posts 712 provide structural support for the engagement element, while the friction layer provides a contact area for the speculum. The posts 712 may be made of, for example, metal, while the friction layer 715 may be made of any suitable material having a higher friction. The use of the outer portion 711 and the inner portion 713 allows the device 700b to be less compact in its components outside of the speculum, while still allowing the distal end of the device 700b to be inserted into the speculum to have a lower radial profile, such as a speculum. Figure 7B shown.

[0136] The device 700b may include one or more branches at a proximal end. In the illustrated embodiment, the device 700b includes at its proximal end a first branch guide 725 and a second branch guide 730 that define respective lumens that diverge from the lumen of the tubular body 701 .

[0137] The device 700b may further include a connection mechanism 724, such as a Luer lock or a piercing fit connection, at the distal end of the guide 705 for connecting to another component of the embryo transfer device (e.g. 9A to 9H The device 700b may also include a handle 720 fixed to the distal portion 740.

[0138] During use, a speculum can be inserted into the vagina to dilate the vagina. The embryo delivery device can pass through equipment 700a or 700b, through the speculum and through the cervix. Engagement element 710 can be extended to an extended configuration so that equipment 700a or 700b is fixed to the speculum. Therefore, the embryo delivery device is limited in movement relative to the patient's body structure, making the controllability of the embryo delivery device higher.

[0139] Fig. 8AA device 700c for engaging a speculum is shown. The device 700c includes two or more expandable engagement elements 710 for outwardly engaging a speculum to secure the device to the speculum, wherein the two or more expandable engagement elements 710 include multiple expansion configurations for engaging multiple speculum sizes. The device 700c includes a guide 705 for guiding an embryo transfer device between the engagement elements 710 and through the speculum when the device 700c is secured to the speculum. Specifically, the guide 705 has a configuration in which the guide 705 at least partially conforms to an outer surface of the embryo transfer device to allow the embryo transfer device to move longitudinally through the guide (i.e., in the x-direction) and prevent the embryo transfer device from moving laterally in the guide (i.e., in the y-direction). In some embodiments, the guide 705 has an open configuration in which the embryo transfer device is released, such as Fig. 8A shown. Figure 8B Shown with Fig. 8A A side view of a device 700c of the same configuration is shown.

[0140] The device 700c includes a first half 760a and a second half 760b pivotally connected by a pivot joint 761 about which the halves 760a and 760b are articulated. Each half 760a, 760 includes a handle 762a, 762b and an expandable engagement element 710 for outwardly engaging the speculum, wherein each respective handle 762a, 762b is connected to the respective expandable engagement element 710 via a rod 770a, 770b. In the illustrated embodiment, the expandable engagement element 710 is connected to the handles 762a, 762b and the pivot joint 761 such that movement of the handles 762a, 762b together causes the expandable engagement element 710 to move apart, and movement of the handles 762a, 762b apart causes the expandable engagement element 710 to move together. In other embodiments, the expandable engagement element 710 can be connected to the handles 762a, 762b in a scissor-type arrangement such that movement of the handles 762a, 762b together causes the expandable engagement element 710 to move together, and movement of the handles 762a, 762b apart causes the expandable engagement element 710 to move apart. Although the handles 762a, 762b are shown as being ring-shaped, the handles can take any suitable shape without departing from the scope of the present invention.

[0141] The device 700c may include a ratchet mechanism 763 configured to allow the handles 762a, 762b to move in a direction that causes the engagement element 710 to move apart and to restrict the handles 762a, 762b from moving in an opposite direction. In the illustrated embodiment, the ratchet mechanism 763 includes a set of teeth 764a, 764b located on each half 760a, 760b, the sets of teeth 764a, 764b being configured to engage with each other so that the movement of the handles 762a, 762b together engages the sets of teeth and restricts the handles 762a, 762b from moving apart. The teeth 764a, 764b may be disengaged by displacing the handles 762a, 762b in the distal and proximal directions, respectively (i.e., in a direction perpendicular to the teeth 764a, 764b), to allow the handles 762a, 762b to move apart.

[0142] exist Fig. 8A In the embodiment of the present invention, the guide 705 includes opposite side walls 765a, 765b, each of which is shaped to conform at least partially to the outer surface of the embryo delivery device. Sidewall 765a is connected to the first half 760b via flexible arm 766a, and sidewall 765b is connected to the other half 760a via flexible arm 766b. Sidewall 765a is connected to half 760a, 760b so that when the engagement element 710 moves apart from each other, sidewalls 766a and 766b move toward each other. Flexible arms 766a, 766b can be made of any suitable elastically deformable material so that flexible arms 766a, 766b are configured to bend when sidewalls 765a, 765b are close to each other. This allows the expandable engagement element 710 to move within a certain range of positions, even if sidewalls 765a, 765b are close to each other, thereby allowing the device 700c to engage a wider range of speculum sizes.

[0143] The device 700c may also include a guide locking mechanism 767 having a first configuration and a second configuration, in which the guide locking mechanism 767 disengages the guide 705 and in which the guide locking mechanism 767 engages and clamps the guide 705. In the illustrated embodiment, the guide locking mechanism 767 includes a clamp pivotally connected to one of the side walls 765a, 765b. The clamp is movable to a closed configuration, in which the clamp covers the two side walls 765a, 765b and applies a compressive force to the guide 705 so that the embryo delivery device is tightly clamped. The guide 705 can be disposed proximate to the expandable engagement element 710 (see Figure 8B ) so that movement of the clamp is not impeded by the expandable engagement element 710. Although in the illustrated embodiment, the guide locking mechanism 767 is a pivotable clamp, in other embodiments, the guide locking mechanism 767 can be any suitable mechanism that can be actuatable to provide a compressive force on the guide 705, such as a clamp, a clamp, or a screw mechanism configured to compress the guide 705.

[0144] The device 700c can generally be made of any suitable material, such as a resilient plastic (e.g., a thermoplastic polymer such as polycarbonate or the like) or a metal (e.g., stainless steel, brass), or a combination thereof. The engaging element 710 can include a friction coating having a higher coefficient of friction than the material of the device 700c, such as silicone rubber, to increase the friction force applied by the engaging element 710 to the speculum. Similarly, the inner wall of the guide 705 (i.e., the radially inward surface of the side walls 766a, 766b) can include a friction coating having a higher coefficient of friction than the material of the device 700c, such as silicone rubber, to increase the friction between the embryo transfer device and the guide 705. In the case of a deformable material such as silicone rubber, the coating can also provide flexibility to accommodate specific shapes of the speculum and embryo transfer device.

[0145] Figure 8C The device 700c is shown in a second configuration, wherein the expandable engagement element 710 moves to an expanded configuration to engage the speculum. The side walls 765a, 765b move to a closed configuration, thereby forming a cavity for engaging the embryo delivery device. The guide locking mechanism 767 is in a disengaged configuration, thereby allowing the embryo delivery device to slide in a proximal or distal direction (i.e., toward or away from the endometrial wall).

[0146] Fig.8D The device 700c is shown in a third configuration, wherein the expandable engagement element 710 is maintained in the expanded configuration to engage the speculum, and wherein the guide locking mechanism 767 engages the guide 705 to provide a compressive force to the guide 705. In this configuration, sliding movement of the embryo transport device is constrained by the compressive force applied by the guide locking mechanism 767.

[0147] When used, the speculum can be inserted into the vagina to dilate the vagina. Fig. 8A The device 700c in the first configuration can be placed such that the expandable engagement element 710 is inserted into the speculum and the body 110 (eg, Figure 1J The device 700c may then be moved to the side walls 765a, 765b. Figure 8C 1. The second configuration shown. In the second configuration, the expandable engagement element 710 engages the interior of the speculum such that the device 700c is secured to the speculum. Further, the side walls 765a, 765b abut against each other to form a cavity for accommodating and conforming to the body 110, thereby forming a guide 705 in which the lateral movement of the body 110 is restricted but the sliding movement of the body 110 is allowed. Next, a device such as the body 110 (optionally with the probe 121 inserted) can be inserted through the guide 705 and through the cervix to the prepared position.

[0148] It should be noted that in some embodiments, the body 110 (with or without the probe 121) may be inserted into the vagina, through the cervix, and into the uterus after the speculum is inserted into the vagina but before the device 700c is inserted into the speculum. Fig. 8A The first configuration shown is inserted into the speculum. The device 700c can then be moved to Figure 8C A second configuration is shown in which the body 100 is retained between the side walls 765a, 765b until the device 700c engages the speculum and the body 100.

[0149] Once the device 700a is locked to the speculum and the body 110 is properly positioned within the uterus, the guide locking mechanism 767 can be moved to a closed position to restrict further sliding movement of the body 110. The probe 121 can be detached from the body 110. The camera 171 can be inserted into the body 110 and connected to a display device and a power source so that a user can view a real-time image of the distal end of the body 110. If necessary, the guide locking mechanism 767 can be released to allow adjustment of the insertion depth of the body 110 until it is determined that the distal end of the body 110 is close to the fundus of the uterus, after which the guide locking mechanism 767 is closed again to restrict sliding movement of the body 110. The inner body 160 containing the fertilized egg or embryo can then be inserted into the body 110, and the actuator 190 can advance the inner body 160 to the endometrial epithelium. Once it is determined that the inner body 160 has reached the endometrial epithelium (e.g., by observing a change in capacitance measured by a capacitive sensor electrically connected to the inner body 160), the inner body 160 is advanced a predetermined distance into the endometrial epithelium and the plunger is advanced to implant the fertilized egg or embryo.

[0150] It should be noted that in addition to embryo transfer devices, devices 700a, 700b, and 700c may also be used in conjunction with any suitable tertiary device for insertion into the body through a speculum.

[0151] Fig.9AA side view of a steering mechanism configured to steer a distal portion of a body 110 according to some embodiments is shown. The steering mechanism includes a plurality of connected rings 910 forming a tubular wall, the tubular wall being configured to at least partially surround a portion of the body 110. Specifically, the rings 910 are sized to receive the body 110 inside the tubular wall and can slidably receive the body 110. The mechanism also includes at least one cable 920 extending longitudinally along the tubular wall and attached to a distal end 930 of the tubular wall. For example, at least one cable can extend longitudinally along the inside or outside of the tubular wall, or can extend longitudinally through the tubular wall. The mechanism can include a plurality of said cables located at different circumferential positions around the tubular wall. The connected rings 910 can be connected only by the cables 920. The connected rings 910 can also be configured to maintain a predetermined alignment by including a set of interlocking features that constrain the rings 910 to rotate around the longitudinal axis. Fig.9A The steering mechanism shown includes a plurality of connected rings 910 that can pivot around each other. In other words, the connected rings are wavy so that adjacent rings are in close contact at tangential contact points. This enables the rings 910 to roll around each other to turn the body 110 when one of the cables 920 is retracted by a third actuator (not shown). The circumferential position of the tangential contact points along which the rings 910 roll can vary along the length of the steering mechanism. For example, continuous circumferential contact points can be offset by 90 degrees to accommodate the rolling of multiple cables in two perpendicular directions. Preferably, the steering mechanism includes two pairs of cables, each pair of cables including diametrically opposed cables to provide steering in multiple directions. Fig. 9C This configuration is shown, Fig. 9C This is a top view of the steering mechanism.

[0152] Fig.9A The connected ring shown can be made of any suitable material, such as a medical grade injection moldable or 3D printable plastic resin such as ABS, PET, DELRIN or PTFE. The cable 920 can be made of, for example, stainless steel and pass through a hole formed in the wall of the connected ring forming the tube wall. Fig.9A and 9C As shown, the cables 920 may each extend through a pair of holes in the connected rings and loop back at the distal end 930. The third actuator may be any suitable actuator for retracting one or more cables.

[0153] Fig. 9BA side view of a steering mechanism according to an alternative embodiment is shown. The steering mechanism includes a plurality of connected rings 915 forming a tubular wall that is configured to at least partially surround a portion of a body 110. Specifically, the rings 915 are sized to receive the body 110 within the tubular wall and can slidably receive the body 110. The mechanism also includes at least one cable 920 that extends longitudinally through the tubular wall and is attached to a distal end 930 of the tubular wall. The plurality of connected rings 910 are rings of compressible tubes or springs. When one of the cables is retracted by a third actuator (not shown), the tube or spring is compressed on one side of the retracted cable, causing the steering mechanism to steer toward the retracted side. Because the tube is compressible, tension is partially offset so that for a given tension, Fig. 9B The curve produced by the mechanism shown may be smaller than Fig.9A Again, preferably, the steering mechanism comprises two pairs of said cables, each pair of cables comprising diametrically opposed cables, to provide steering in multiple directions, such as Fig. 9C shown.

[0154] Fig. 9B The connecting ring shown can be a compressible tube or spring made of any suitable material (e.g., FEP, PTFE). The cable can be made of any suitable material (e.g., stainless steel) and pass through a hole formed in the wall of the connecting ring forming the tube wall. Fig.9A and 9C As shown, the cables 920 may each extend through a pair of holes in the connected rings and loop back at the distal end 930. The third actuator may be any suitable actuator for retracting one or more cables.

[0155] Fig.9D A side view of the steering mechanism is shown when one of the cables is retracted to cause the steering mechanism to steer in the direction indicated by arrow 925 .

[0156] Fig.9E A perspective view of a third actuator is shown, according to some embodiments. Fig.9F Shows Fig.9E940 and 950. The third actuator includes an inner element 940 and an outer shell 950 that accommodates the inner element 940. Each of the at least one cable 920 is fixed to the outer shell at a proximal portion 960, such as by welding, adhesive or around a fixed capstan. The inner element 940 is directly or indirectly fixedly connected to the tube wall 910 via one or more intermediate components. The outer shell 950 is rotatable relative to the inner element 940. Optionally, a handle 970 can be fixed to the inner element 940 by the outer shell 950. Rotating the outer shell 950 around the inner element 940 retracts one of the cables 920, thereby turning the tube wall to a certain direction, as discussed above. The body can extend through the handle 970 and the inner element 940, so that the body can be propelled by a steering mechanism.

[0157] Figure 9G A perspective view of an internal element according to some embodiments is shown. The internal element 940 may include one or more components that are biased to fit closely against the housing 950. For example, the internal element 940 may include two hemispheres 942a, 942b that are biased away from each other to fit closely against the inner surface of the housing 950. The biasing obtains a friction fit between the internal element 940 and the housing 950 so that they can slide relative to each other only when sufficient force is applied, which means that once the desired direction of the steering mechanism is achieved, the steering mechanism can be held in place by a third actuator. The internal element may be connected to the handle by a handle connector 946, and may be connected to the tube wall by an intermediate portion 948. The intermediate portion 948 may be incompressible, and the cable 920 may pass through the intermediate portion and reach the tube wall.

[0158] Figure 9H A perspective view of a steering mechanism is shown, with housing 950 shown as partially transparent, according to some embodiments. Figure 9H The steering mechanism also includes an inner element 940 and a housing 950, the housing 950 accommodating the inner element 940 and being rotatable relative to the inner element 940, as described above. The steering mechanism may also include a handle 970. In addition, each cable 920 is fixedly connected to the housing via a capstan 952 (i.e., the cable is wound around the capstan). The capstan can be wound or unwound using an adjuster 954 (e.g., a flat head adjuster), which can be accessed from the outside of the housing 950, which means that the default tension of each cable 920 can be calibrated after assembling the steering mechanism. The ring 910 forming the tube wall can be fixedly connected to the inner element 940 via an inflexible tubular intermediate piece 958. The tubular intermediate piece 958 can have any suitable length. For example, in an embodiment using an external catheter, the tubular intermediate piece 958 can be configured to extend through any inflexible portion of the external catheter.

[0159] The cable 920 can extend through a channel 956 formed in the inner surface of the outer shell 950 to avoid contact with the internal component 940 and to avoid damage to the cable when the outer shell rotates relative to the inner shell 940. The cable 920 can extend from the channel 956 and through a cavity formed in the wall of the tubular intermediate piece 958 and extend to the wall of the tube.

[0160] The housing 950, inner element 940, handle 970, capstan 952 and tubular intermediate piece 958 may be made from medical grade injection moldable or 3D printable plastic resins such as ABS, PET, DELRIN or PTFE.

[0161] The steering mechanism may be electronically controlled. For example, Figure 9H The steering mechanism shown may include an electronic controller secured to the inner element 940 and including a motor for actuating movement of the housing 950 relative to the inner element 940. Alternatively, the steering mechanism may include a plurality of connected rings forming a tubular wall configured to at least partially surround a portion of the body, and at least two opposing cables extending longitudinally through the tubular wall and attached to distal ends of the tubular wall, wherein the cables are connected to a motor configured to retract the cables to steer the steering mechanism.

[0162] The tube wall of the steering mechanism is sized to slidably receive the body 110. The outer diameter of the tube wall can be about 1.4 mm to 1.8 mm, or about 1.5 mm to 1.7 mm, such as 1.6 mm. In an embodiment using a steering mechanism, the body 110 can be configured to be advanced beyond the end of the steering mechanism by about 20 mm to 40 mm, such as about 30 mm.

[0163] The proximal end of the steering mechanism can be configured to connect to the distal end of the speculum lock 700a or 700b. For example, the steering mechanism can include a connection mechanism that is configured to connect to a corresponding connection mechanism on the speculum lock 700a or 700b, so that the guide 705 and the steering mechanism define a continuous cavity through which the body 110 can slidably extend.

[0164] Fig.10A perspective view of a device 1 is shown, the device 1 comprising an elongated body, which may be the inner body 160 in any of the embodiments disclosed herein. The device 1 comprises an elongated body 2 (e.g., a needle), the elongated body 2 comprising a distal tip 4 and a cavity 3, the cavity 3 passing through the distal tip 4 and extending to an opening 6 at the distal tip 4. The cavity 3 is configured to receive and discharge a fertilized egg or embryo 5 (hereinafter referred to as an "egg" for simplicity) through the opening 6. A plunger (not shown) is slidably received in the cavity 3. The distal tip 4 is configured to pierce the maternal endometrium and comprises a first surface 4a beveled relative to the longitudinal axis of the elongated body 2. The distal tip 4 also comprises a piercing portion at its most distal end, which is a double beveled piercing portion, comprising a first surface 4b and a second surface 4c, the first surface 4b and the second surface 4c being beveled relative to the first surface 4a to form a sharp point at the distal end of the distal tip 4. When in use, the plunger can be retracted in the proximal direction opposite to the distal tip 4, thereby generating suction at the distal tip 4 and can be used to place the egg 5 in the cavity 3. The egg 5 is usually placed in a cavity with a fluid, wherein the fluid is close to the egg 5 in the cavity 3. In order to implant the egg 5 in the endometrium, the elongated body 2 penetrates the endometrium using the piercing distal tip, and the plunger is advanced distally to discharge the fluid and egg 5 in the cavity 3. Due to the pressure transmitted from the plunger via the fluid, the egg 5 is usually pushed distally. However, when the egg 5 reaches the farthest part of the elongated body 2, a gap (such as puncture) is formed in the opening 6. Fig.10 ), which means that the fluid contained in the cavity 3 can escape the cavity via the fluid path F, thereby expelling the fluid without applying pressure to the egg 5. Therefore, in some cases, even after the plunger is fully advanced and the fluid is completely expelled, the egg 5 can still be attached to the distal tip 4. This reduces the possibility of successful implantation, and as the elongated body 2 is removed, the egg 5 may be dislodged or even removed from the endometrium.

[0165] Fig.11A schematic perspective view of a device 10 suitable for delivering a fertilized egg or embryo 50 (hereinafter referred to as an "egg") to the maternal endometrium according to one or more embodiments is shown. The device 10 includes an elongated body 20, the elongated body 20 including a distal tip 40 and a cavity 30, the cavity 30 passing through the distal tip 40 and extending to an opening 60 at the distal tip 40. The elongated body 20 can be the inner body 160 in any embodiment disclosed herein. The cavity 30 is configured to receive and discharge the egg 50 through the opening 60. The device 10 also includes a plunger 44 configured to be slidably received in the cavity 30. The distal tip 40 includes a piercing portion 70 for piercing the maternal endometrium, and the opening 60 has a concave shape. The piercing portion can have any suitable shape and sharpness suitable for piercing the endometrium. In some embodiments, the piercing portion can include a point or edge with an edge radius of less than 2 μm, preferably less than 1 μm. The concave shape of the opening 60 reduces or eliminates the amount of fluid that can escape from the cavity 30 without applying pressure to the egg 50 at the distal end of the distal tip 40, making it less likely that the egg 50 will remain on the distal tip 40 when the fluid is completely drained. This increases the likelihood of successful implantation.

[0166] Fig. 12A and Fig. 12B Shows Fig.11 Different schematic side views of the device 10 are shown. Fig. 12A In FIG. 1 , the concave shape of the opening 60 is shown, which corresponds to the shape of the opening 6 of the device 1 . It can be seen that Fig.10 The available fluid path F is shown to be obstructed by the concave shape of the opening 60. Fig. 12B As shown, the piercing portion 70 may include a double beveled tip including a back-cut bevel for piercing the maternal endometrium. Specifically, the piercing portion 70 may include a first surface 72 and a second surface 74, the first surface 72 and the second surface 74 being beveled relative to the outer surface of the elongated body 20, and the beveled surfaces 72 and 74 forming a sharp point 75 at the distal end of the distal tip 40.

[0167] like Fig. 12A and Fig. 12B As shown, the distally facing surface 84 of the distal tip 40 defining the opening 60 may have a curved concave shape with a radius of curvature R, so that the opening 60 has a curved concave shape with a radius of curvature R. The curved concave shape with a radius of curvature is preferred because the opening 60 generally follows the spherical shape of the egg 50, so that when the egg 50 is distal to the distal tip 40, the opening conforms to the shape of the egg 50 and prevents any fluid path F from occurring. In a preferred embodiment, the radius of curvature R is between 1.5 times and 4 times the outer diameter D of the elongated body 20, which is considered to be optimal for preventing the occurrence of fluid paths F for conventional egg and embryo sizes.

[0168] like Fig. 12A As shown, preferably, the curved concave shape extends between the piercing portion 70 and the lowest portion of the distal tip 40, wherein the lowest portion of the distal tip 40 extends perpendicular to the longitudinal axis of the elongated body 20. This ensures that the fluid path is minimized while maintaining contact between the distal tip 40 and the egg 50 when the egg is located at the distal end of the elongated body 20.

[0169] In a preferred embodiment, the height of the distal tip 40 measured from the lowest portion 77 of the distal tip 40 to the distal end 75 of the piercing portion 70 is between 0.25 times and 1.25 times the outer diameter D of the slender body 20, and more preferably between 0.5 times and 1.25 times the outer diameter D of the slender body 20.

[0170] The distal tip may be made of a biocompatible metal, such as stainless steel.

[0171] In a preferred embodiment, the distal tip 40 includes a hydrophobic coating. The hydrophobic coating may be disposed on one or more of the inner surface 82 of the distal tip 40, the outer surface 86 of the distal tip 40, and the distal-facing surface 84 of the distal tip 40. The hydrophobic coating may include or consist of a polymer or polymer composite, preferably any of: polyparaxylene, acrylic acid, polyethylene, polyurethane, and polytetrafluoroethylene, and composites thereof. The hydrophobic coating further reduces the likelihood that the egg 50 will remain on the distal tip 40 after the fluid is expelled.

[0172] Fig.13 1 shows a schematic side view of another device 10' according to one or more embodiments. In addition to the opening 60 of the device 10' not including a curved concave shape, the device may include reference Fig.11 , Fig. 12A and Fig. 12B The opening 60 may be a concave shape formed by a plurality of flat surfaces, rather than Fig.11 , Fig. 12A and Fig.11 B shows a curved concave shape. It should be understood that although the concave shape is formed by two flat surfaces in the illustrated embodiment, the concave shape may also be formed by any number of multiple flat surfaces. The concave shape of the opening 60 is shown again, corresponding to the shape of the opening 6 of the device 1. It can be seen that Fig.10 The available fluid path F is shown to be obstructed by the concave shape of the opening 60 of the device 10'.

[0173] Fig.14A A schematic top view of an apparatus 200 is shown in accordance with one or more embodiments. Fig. 14B Shows Fig.14AThe device 200 is shown in a cross-sectional side view taken along line AA. The device 200 may include any features of the device described herein (e.g., device 10 or 10'). The piercing portion 70 includes a first surface 72 and a second surface 74, which are beveled relative to the outer surface of the elongated body 20, and the beveled surfaces 72 and 74 form a sharp point 75 (double beveled tip) at the distal end of the distal tip 40. The inclined surface 72 is defined by a bevel angle a in a plane perpendicular to the longitudinal axis of the elongated body 20 and a draft angle β relative to the longitudinal axis of the elongated body 20. The bevel angle a is defined as the angle between the plane containing the beveled surface 72 and the surface tangent of the elongated body 20 at point 75. The draft angle β is defined as the angle between the plane containing the beveled surface 72 and the longitudinal axis of the elongated body 20. The bevel angle and draft angle of the beveled surface 74 are defined in a similar manner. The bevel angles of the beveled surfaces 72 and 74 are preferably between 20° and 40°. The draft angle of the chamfered surfaces 72 and 74 is preferably between 1° and 20°. The chamfer and draft angles of the chamfered surfaces 72 and 74 may be the same (as shown) or different.

[0174] In a preferred embodiment, the diameter of the cavity 30 is between 1 and 2 times the outer diameter of the egg to be implanted, and more preferably between 1 and 1.5 times the outer diameter of the egg to be implanted.

[0175] In a preferred embodiment, the outer diameter of the elongated body 20 is between 1.5 and 3 times the diameter of the cavity 30 , and more preferably between 1.5 and 2 times the diameter of the cavity 30 .

[0176] The following clauses also form part of this disclosure:

[0177] 1. A system for delivering a fertilized egg or embryo into the endometrium of a human or any other mammalian species, comprising:

[0178] a body having a distal end adapted to penetrate the endometrial epithelium;

[0179] a plunger slidably received in the cavity of the body;

[0180] an actuator operable to advance the plunger to expel the fertilized egg from the cavity of the body;

[0181] a first injectable medium; and

[0182] a second injection medium for containing fertilized eggs;

[0183] The viscosity of the first injectable medium is higher than that of the second injectable medium.

[0184] 2. The system according to clause 1, wherein the first injectable medium comprises or consists of one or more of: hyaluronic acid, salts of hyaluronic acid, biocompatible hydrogels, poloxamers, collagen, fibrinogen, gelatin, sodium hyaluronate, and combinations thereof.

[0185] 3. A system according to claim 1 or 2, wherein a first injectable medium and a second injectable medium are received in a cavity of a body, wherein the second injectable medium is located in front of the first injectable medium relative to a distal end of the body, so that when the actuator is actuated to expel a fertilized egg, the second injectable medium is expelled before the first injectable medium.

[0186] 4. The system according to any of the preceding clauses further comprises a third injectable medium having a higher viscosity than the second medium, optionally wherein the third injectable medium comprises or consists of one or more of: hyaluronic acid, salts of hyaluronic acid, biocompatible hydrogels, poloxamers, collagen, fibrinogen, gelatin, sodium hyaluronate and combinations thereof.

[0187] 5. A system according to claim 4, wherein the first injectable medium, the second injectable medium and the third injectable medium are all received in the cavity of the body, wherein the second injectable medium is received between the first injectable medium and the third injectable medium, so that when the actuator is actuated to expel the fertilized egg, the second medium is expelled before one of the first injectable medium and the third injectable medium, and after the other of the first injectable medium and the third injectable medium.

[0188] 6. A system according to any of the preceding clauses, wherein the actuator operable to advance the plunger is a first actuator and the body is an inner body, the system further comprising:

[0189] an outer body configured to fit within a cavity of a female reproductive system, the outer body comprising an outer cavity extending from a proximal end of the outer body to a distal portion of the outer body and having a distal opening at the distal portion of the outer body, the outer cavity being configured to slidably receive the body; and

[0190] A second actuator is operable to push the inner body out of the distal opening of the outer body.

[0191] 7. A method of loading a system for delivering a fertilized egg or embryo into the endometrium of a human or any other mammalian species, the system comprising:

[0192] a body having a distal end adapted to penetrate the endometrial epithelium;

[0193] a plunger slidably received in the cavity of the body; and

[0194] an actuator operable to advance the plunger to expel the fertilized egg from the cavity of the body;

[0195] Among them, the method includes:

[0196] drawing a first injectable medium into the cavity; and

[0197] Then, a second injectable medium containing the fertilized egg is drawn into the cavity;

[0198] The viscosity of the first injectable medium is higher than that of the second injectable medium.

[0199] 8. The method according to clause 7, wherein the first injectable medium comprises or consists of one or more of: hyaluronic acid, salts of hyaluronic acid, biocompatible hydrogels, poloxamers, collagen, fibrinogen, gelatin, sodium hyaluronate, and combinations thereof.

[0200] 9. The method according to clause 7 or 8, further comprising subsequently drawing a third injectable medium into the inner cavity of the inner body after drawing the second injectable medium into the inner cavity of the inner body.

[0201] 10. The method according to clause 9, wherein the third injectable medium comprises or consists of one or more of the following: hyaluronic acid, salts of hyaluronic acid, biocompatible hydrogels, poloxamers, collagen, fibrinogen, gelatin, sodium hyaluronate, and combinations thereof.

[0202] 11. A method according to any one of clauses 7 to 10, wherein the actuator operable to advance the plunger is a first actuator and the body is an inner body, the system further comprising:

[0203] an outer body configured to fit within a cavity of a female reproductive system, the outer body comprising an outer cavity extending from a proximal end of the outer body to a distal portion of the outer body and having a distal opening at the distal portion of the outer body, the outer cavity being configured to slidably receive the body; and

[0204] A second actuator is operable to push the inner body out of the distal opening of the outer body.

[0205] 12. A device suitable for delivering a fertilized egg or embryo into the endometrium of a human or any other mammalian species, comprising a body configured to fit within a cavity of a female reproductive system, the body comprising:

[0206] one or more cavities extending from a proximal end of the body to a distal portion of the body and having a distal opening at the distal portion of the body, wherein a first cavity of the one or more cavities slidably receives an inner body having a distal end adapted to penetrate endometrial epithelium, the inner body comprising an inner cavity for receiving a fertilized egg;

[0207] an actuator operable to expel the fertilized egg from the inner cavity; and

[0208] A cover layer at least partially covers a distal opening of at least one of the one or more cavities.

[0209] 13. The device according to clause 12, wherein the cover layer at least partially covers the distal opening of the first cavity, and the inner body is configured to be perforated through the cover layer when the inner body is pushed out of the distal opening of the body.

[0210] 14. The device according to clause 12 or 13 further includes a measuring component, which extends through a cavity in one or more cavities and includes a measuring portion near a distal opening of the one or more cavities, the measuring portion being configured to measure whether the device is in a first state or a second state, the first state indicating that the distance between the distal end of the body or inner body and the endometrial epithelium is greater than a predetermined distance, and the second state indicating that the distance between the distal end of the body or inner body and the endometrial epithelium is equal to or less than a predetermined distance; wherein the measuring portion is at least partially covered by a covering layer.

[0211] 15. An apparatus according to clause 14, wherein the measuring component includes a capacitance sensor configured to electrically contact the conductive inner body distal portion and provide a capacitance indication, wherein the first state is indicated by a capacitance measurement value below a threshold and the second state is indicated by a capacitance measurement value above the threshold.

[0212] 16. The device according to any of clauses 12 to 15, further comprising a camera proximal to the distal opening and configured to view a portion of the endometrial epithelium.

[0213] 17. The device according to clause 16, wherein the cover covers the camera so that the camera is not exposed to mucus when the distal portion of the device is placed in the cavity of the female reproductive system.

[0214] 18. A device according to any one of clauses 12 to 17, wherein the covering layer comprises a biocompatible transparent or translucent film, preferably wherein the covering layer is a transparent or translucent film comprising or consisting of any of the following: polyether block amides, polyolefins, PVC, paraffin, cellulose and its derivatives, hyaluronic acid films, polyparaxylene C films, collagen, gelatin, plant casings, alginate and complexes or combinations thereof.

[0215] 18a. The device according to any of clauses 12 to 18, further comprising a probe insertable into one or more cavities of the body, the probe comprising a resilient elongate element configured to slidably extend through the body to provide increased stiffness to the body.

[0216] 18b. The device according to clause 18a, wherein the probe has a rounded distal tip.

[0217] 18c. A device according to clause 18a or 18b, wherein the length of the probe is less than the length of the body, such that when the probe is fully inserted into the body, the distal tip of the probe is adjacent to the cover.

[0218] 19. An apparatus for engaging a speculum, comprising:

[0219] two or more expandable engagement elements for outwardly engaging the speculum to secure the device to the speculum, wherein the two or more expandable engagement elements include a plurality of expanded configurations for engaging a plurality of speculum sizes; and

[0220] A guide for guiding the tertiary device between the expandable engagement elements and through the speculum when the device is secured to the speculum.

[0221] 20. The device according to clause 19, further comprising a tertiary device, wherein the guide at least partially conforms to an outer surface of the tertiary device to allow the tertiary device to move longitudinally through the guide and prevent the tertiary device from moving laterally in the guide, optionally wherein the tertiary device is an embryo transfer device.

[0222] 21. The device according to clause 19 or 20 further comprises a first handle and a second handle connected to the first engagement element and the second engagement element respectively, the handles being pivotally connected to each other such that movement of the handles in a direction about the pivot axis causes the engagement elements to move apart to an extended configuration.

[0223] 22. An apparatus according to claim 21, wherein the guide comprises a first side wall connected to the first handle, and an opposing second side wall connected to the second handle, wherein the side walls are connected such that movement of the handles in a direction about the pivot causes the engaging elements to move apart to an extended configuration and the side walls to move toward each other.

[0224] 23. The device according to clause 21 or 22, further comprising a ratchet mechanism configured to allow the handle to move in a direction that causes the engagement elements to move apart and to restrict the handle from moving in an opposite direction.

[0225] 24. The device according to any one of clauses 19 to 23 further includes a guide locking mechanism having a first configuration and a second configuration, in which the guide locking mechanism is disengaged from the guide member in the first configuration, and in the second configuration, the guide locking mechanism clamps the guide member and provides a compression force to the guide member to restrict the longitudinal movement of the tertiary device through the guide member.

[0226] 24a. An apparatus according to any of clauses 19 to 24, wherein the inner surface of the guide is at least partially coated with a friction coating having a higher coefficient of friction than the inner surface of the guide, and / or wherein one or more surfaces of an engagement element configured to engage a speculum are at least partially coated with a friction coating having a higher coefficient of friction than the outer surface.

[0227] 24b. Device according to clause 24a, wherein the friction coating is a deformable material, preferably silicone rubber.

[0228] 25. A device suitable for delivering a fertilized egg or embryo into the endometrium of a human or any other mammalian species, comprising a body configured to fit within a cavity of a female reproductive system, the body comprising:

[0229] a cavity extending from a proximal end of the body to a distal portion of the body and having a distal opening at the distal portion of the body, the cavity slidably receiving an inner body having a distal end adapted to penetrate endometrial epithelium;

[0230] The device also includes:

[0231] a first actuator operable to eject the inner body from the distal opening of the body; and

[0232] a second actuator operable to expel the fertilized egg from the inner cavity of the inner body;

[0233] Wherein, the inner body includes a hydrophobic coating formed on a distal end portion of the inner body.

[0234] 26. The device according to clause 25, wherein the hydrophobic coating is provided on at least a distal portion of the inner surface of the inner body defining the inner cavity.

[0235] 27. The device according to clause 25 or 26, wherein a hydrophobic coating is provided on the outer surface of the inner body and / or the distal tip.

[0236] 28. The device according to any of clauses 25 to 27, wherein the inner body comprises a beveled tip.

[0237] 29. The device according to any of clauses 25 to 28, wherein the hydrophobic coating comprises or consists of a polymer or a polymer composite, preferably any of the following: parylene, acrylic, polyethylene, polyurethane and polytetrafluoroethylene and composites thereof.

[0238] 30. A device according to any one of clauses 25 to 29, wherein the inner body includes a distal tip and the inner cavity extends through the distal tip to an opening at the distal tip, wherein the distal tip includes a piercing portion for piercing the maternal endometrium, and the opening has a concave shape.

[0239] 31. The device according to clause 30, wherein the opening has a curved concave shape having a radius of curvature.

[0240] 32. The device of clause 31, wherein the elongated body has an outer diameter and the curved concave shape of the opening has a radius of curvature between 1.5 and 4 times the outer diameter of the elongated body.

[0241] 33. A device according to clause 31 or 32, wherein the curved concave shape extends between the piercing portion and the lowermost portion of the distal tip, wherein the lowermost portion of the distal tip extends perpendicular to the longitudinal axis of the elongated body.

[0242] 34. A device suitable for delivering a fertilized egg or embryo to the endometrium of a mother, comprising:

[0243] an elongated body including a distal tip and a cavity extending through the distal tip and to an opening at the distal tip, the cavity being configured to receive and discharge a fertilized egg or embryo through the opening; and

[0244] a plunger configured to be slidably received within the cavity;

[0245] Therein, the distal tip includes a piercing portion for piercing the maternal endometrium, and the opening has a concave shape.

[0246] 35. The device of clause 34, wherein the piercing portion comprises a double-beveled tip for piercing maternal endometrium.

[0247] 36. The device according to clause 35, wherein the double-beveled tip comprises two beveled surfaces having a bevel angle between 20° and 40° and a draft angle between 1° and 20°.

[0248] 37. The device according to any of clauses 34 to 36, wherein the opening has a curved concave shape having a radius of curvature.

[0249] 38. The device of clause 37, wherein the elongated body has an outer diameter and the curved concave shape of the opening has a radius of curvature between 1.5 and 4 times the outer diameter of the elongated body.

[0250] 39. The device according to clause 37 or 38, wherein the curved concave shape extends between the piercing portion and the lowermost portion of the distal tip, wherein the lowermost portion of the distal tip extends perpendicular to the longitudinal axis of the elongated body.

[0251] 40. The device of clause 39, wherein the elongated body has an outer diameter and the height of the distal tip as measured from the lowest portion to the distal end of the piercing portion is between 0.5 and 1.25 times the outer diameter of the elongated body.

[0252] 41. The device according to any of clauses 34 to 40, wherein the distal tip is made of a biocompatible metal, preferably stainless steel.

[0253] 42. The device of any one of clauses 34 to 40, wherein the distal tip comprises a hydrophobic coating.

[0254] 43. The device according to clause 42, wherein the hydrophobic coating is provided on at least one of: an inner surface of the distal tip, an outer surface of the distal tip, and a distal-facing surface of the distal tip.

[0255] 44. The device according to clause 42 or 43, wherein the hydrophobic coating comprises or consists of a polymer or a polymer composite, preferably any of the following: parylene, acrylic, polyethylene, polyurethane and polytetrafluoroethylene and composites thereof.

[0256] 45. The device according to any one of clauses 34 to 44, wherein the diameter of the cavity is between 1 and 1.5 times the outer diameter of the egg to be implanted.

[0257] 46. ​​The device according to any one of clauses 34 to 45, wherein the elongated body is an inner body, the device further comprising an outer body configured to fit inside a cavity of a female reproductive system, the outer body comprising:

[0258] a cavity extending from a proximal end of the body to a distal portion of the body and having a distal opening at the distal portion of the body, the cavity slidably receiving the inner body;

[0259] The device also includes:

[0260] a first actuator operable to eject the inner body from the distal opening of the body; and

[0261] A second actuator is operable to advance the plunger to expel the fertilized egg from the cavity of the body.

[0262] 47. The device according to clause 46 further includes a measuring component, which extends through a cavity in one or more cavities of the outer body and includes a measuring portion near the distal opening of the one or more cavities, and the measuring portion is configured to measure whether the device is in a first state or a second state, the first state indicating that the distance between the distal end of the body or the inner body and the endometrial epithelium is greater than a predetermined distance, and the second state indicating that the distance between the distal end of the body or the inner body and the endometrial epithelium is equal to or less than a predetermined distance.

[0263] 48. The device of clause 47, wherein the measuring assembly comprises a capacitive sensor configured to be in electrical contact with the distal portion of the inner body.

[0264] All of the above is fully within the scope of the present disclosure and is to be considered as forming the basis for alternative embodiments in which one or more combinations of the above features are applied, without being limited to the specific combinations disclosed above.

[0265] In view of this, there will be many alternatives to implement the teachings of the present disclosure. It is expected that those skilled in the art will be able to modify and adjust the above disclosure to suit their own circumstances and requirements within the scope of the present disclosure based on the general knowledge of those skilled in the art in this field, while retaining some or all of the technical effects disclosed or obtainable above. All such equivalents, modifications or adaptations are within the scope of the present disclosure.

Claims

1. A device suitable for delivering a fertilized egg or embryo into the endometrium of a human or any other mammalian species, the device comprising a body configured to fit inside a cavity of a female reproductive system, the body comprising: one or more cavities extending from a proximal end of the body to a distal portion of the body and having a distal opening at the distal portion of the body, wherein a first cavity of the one or more cavities slidably receives an inner body having a distal end adapted to penetrate endometrial epithelium, the inner body comprising an inner cavity for receiving a fertilized egg; an actuator operable to expel the fertilized egg from the inner cavity; and a cover layer at least partially covering a distal opening of at least one of the one or more cavities; wherein the cover layer at least partially covers the distal opening of the first cavity, and the inner body is configured to punch through the cover layer when the inner body is pushed out of the distal opening of the body.

2. The device according to claim 1 further comprises a measuring component, the measuring component extending through a cavity of the one or more cavities and comprising a measuring portion proximal to a distal opening of the one or more cavities, the measuring portion being configured to measure whether the device is in a first state or a second state, the first state indicating that the distance between the distal end of the main body or the inner body and the endometrial epithelium is greater than a predetermined distance, and the second state indicating that the distance between the distal end of the main body or the inner body and the endometrial epithelium is equal to or less than a predetermined distance; wherein, The measuring portion is at least partially covered by the covering layer.

3. The device according to claim 2, wherein: The measurement assembly includes a capacitance sensor configured to electrically contact the conductive distal portion of the inner body and provide a capacitance indication, wherein the first state is indicated by a capacitance measurement below a threshold and the second state is indicated by a capacitance measurement above the threshold.

4. The device of any one of claims 1 to 3, further comprising a camera proximal to the distal opening and configured to view a portion of the endometrial epithelium.

5. The device according to claim 4, wherein: The cover covers the camera so that the camera is not exposed to mucus when the distal portion of the device is placed in the cavity of the female reproductive system.

6. The device according to any one of claims 1 to 5, wherein: The covering layer comprises a biocompatible transparent or translucent film, preferably wherein the covering layer is a transparent or translucent film comprising or consisting of any of the following: polyolefins, PVC, paraffin, cellulose and its derivatives, hyaluronic acid films, polyparaxylene C films, collagen, gelatin, plant casings, alginate and complexes thereof.

7. A system comprising a device according to any one of claims 1 to 6 and an apparatus for engaging a speculum, the apparatus comprising: two or more expandable engagement elements for outwardly engaging a speculum to secure the device to the speculum, wherein the two or more expandable engagement elements include a plurality of expanded configurations for engaging a plurality of speculum sizes; as well as A guide is provided for guiding the body between the expandable engagement elements and through the speculum when the device is secured to the speculum.

8. The system according to claim 7, wherein: The guide at least partially conforms to an outer surface of the body to allow longitudinal movement of the body through the guide and prevent lateral movement of the body in the guide.

9. The device according to claim 7 or 8 also includes a first handle and a second handle connected to the first engagement element and the second engagement element respectively, and the handles are pivotally connected to each other so that movement of the handles in a direction around the pivot axis causes the engagement elements to move apart to an extended configuration.

10. The device according to claim 9, wherein: The guide includes a first side wall connected to the first handle and an opposing second side wall connected to the second handle, wherein the side walls are connected such that movement of the handles in a direction about a pivot axis causes the engagement elements to move apart to the extended configuration and the side walls to move toward each other.

11. The device of claim 9 or 10, further comprising a ratchet mechanism configured to allow the handle to move in a direction that causes the engagement elements to move apart and to restrict the handle from moving in an opposite direction.

12. The device according to any one of claims 7 to 11 further includes a guide locking mechanism, which has a first configuration and a second configuration, in which the guide locking mechanism is disengaged from the guide member in the first configuration, and in the second configuration, the guide locking mechanism clamps the guide member and provides a compression force to the guide member to restrict the longitudinal movement of the body through the guide member.

13. The apparatus according to any one of claims 7 to 12, wherein: The inner surface of the guide is at least partially coated with a friction coating, which has a higher coefficient of friction than the inner surface of the guide, and / or one or more surfaces of the engagement element configured to engage the speculum are at least partially coated with a friction coating, which has a higher coefficient of friction than the outer surface.

14. The device according to claim 13, wherein: The friction coating is a deformable material, preferably silicone rubber.

15. The device or system according to any one of the preceding claims, further comprising: a first actuator operable to eject the inner body from the distal opening of the body; and a second actuator operable to expel the fertilized egg from the inner cavity of the inner body; Wherein, the inner body includes a hydrophobic coating formed on a distal end portion of the inner body.

16. The device or system according to claim 15, wherein: The hydrophobic coating is disposed on at least a distal portion of an inner surface of the inner body defining the inner cavity.

17. The device or system according to claim 15 or 16, wherein: The hydrophobic coating is disposed on an outer surface of the inner body and / or the distal tip.

18. The device or system according to any one of claims 15 to 17, wherein: The inner body includes a beveled tip.

19. The device or system according to any one of claims 15 to 18, wherein: The hydrophobic coating comprises or consists of a polymer or a polymer composite, and the polymer or polymer composite is preferably any of the following: polyparaxylene, acrylic acid, polyethylene, polyurethane and polytetrafluoroethylene and composites thereof.

20. An apparatus or system according to any preceding claim, wherein: The inner body includes a distal tip and the inner cavity extends through the distal tip to an opening at the distal tip, wherein the distal tip includes a piercing portion for piercing the maternal endometrium and the opening has a concave shape.

21. The device or system of claim 20, wherein: The opening has a curved concave shape having a radius of curvature.

22. The device or system of claim 21, wherein: The elongated body has an outer diameter and the curved concave shape of the opening has a radius of curvature between 1.5 and 4 times the outer diameter of the elongated body.

23. The device or system according to claim 21 or 22, wherein: The curved concave shape extends between the piercing portion and a lowermost portion of the distal tip, wherein the lowermost portion of the distal tip extends perpendicular to a longitudinal axis of the elongated body.

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