Embryo transfer device kit

Abstract

This embryo transfer device kit comprises: a connection component (2) which is connected to the base end of a tube the leading end thereof being disposed inside a uterus and the base end thereof disposed outside the uterus; and an embryo transfer device (1), at least a portion of which is housed in a housing unit (71A) that is provided to the connection component (2) so as to extend in a prescribed direction. The embryo transfer device (1) is provided with an embryo storage unit (20) having a recess (21) that opens in a direction intersecting with the prescribed direction. In a state in which the embryo storage unit (20) is disposed in a uterine cavity, the embryo storage unit holds an embryo, which is disposed in the recess (21), in a space surrounded by the recess (21) and the endometrium of the uterine cavity which is present in the opening direction of the recess (21).

Description

Embryo Transfer Device Kit

[0001] The present disclosure relates to an embryo transfer device kit.

[0002] Conventionally, an embryo transfer device kit for transferring an embryo into the uterine cavity has been known that includes a sheath whose distal end is placed inside the uterus and whose proximal end is placed outside the uterus, and a soft tube that is inserted into the sheath from the proximal end side of the sheath so as to protrude from the distal end, and that delivers the embryo to the uterus through the hollow portion of the soft tube (see, for example, Patent Document 1).

[0003] Japanese Patent Application Laid-Open No. 2023-126548

[0004] Various conditions contribute to improving the implantation rate, such as the force applied to the uterus from the device, damage to the cervix and uterine cavity during device insertion / removal, and the state of the embryo being placed for transfer. A practical and effective embryo transfer device kit that can increase the implantation rate is desired.

[0005] The embryo transfer device kit of the first aspect comprises a connecting part connected to the base end of a tube whose tip is placed inside the uterus and whose base end is placed outside the uterus, and an embryo transfer device at least a portion of which is accommodated in a storage part provided on the connecting part so as to extend in a predetermined direction, wherein the embryo transfer device comprises an embryo storage part having a recess which opens in a direction intersecting the predetermined direction, and when the embryo storage part is placed in the uterine cavity, it is for holding an embryo placed in the recess in a space surrounded by the endometrium of the uterine cavity which is present in the direction of the opening of the recess and the recess.

[0006] 10 ; a perspective view of an embryo transfer device of the embryo transfer device kit of the first embodiment; a plan view of the embryo transfer device of the first embodiment; a side view of the embryo transfer device of the first embodiment; a cross-sectional view of the embryo transfer device in a tube of the first embodiment; a partial cross-sectional view of the tube and stylet of the embryo transfer device kit of the first embodiment; a partial cross-sectional view of the embryo transfer device kit of the first embodiment; a partial cross-sectional view of the embryo transfer device kit of the first embodiment; a plan view of the embryo transfer device of the first embodiment; a perspective view of a connecting part of the embryo transfer device kit of the first embodiment; a plan view of the connecting part of the first embodiment; a cross-sectional view taken along line XI-XI in FIG. 10 ; a plan view of the connecting part housing the embryo transfer device of the first embodiment; a cross-sectional view of the connecting part housing the embryo transfer device of the first embodiment; a partial cross-sectional plan view of the connecting part housing the embryo transfer device of the first embodiment; a partial cross-sectional plan view of the first embodiment, showing the connecting part housing the embryo transfer device and the proximal end of the tube; a partial cross-sectional plan view of a first modified example of the first embodiment, showing the connecting part housing the embryo transfer device and the proximal end of the tube; a plan view of an embryo transfer device of a second modified example of the first embodiment; and a plan view of an embryo transfer device of a third modified example of the first embodiment. 23. A plan view of an embryo transfer device according to a fourth modified example of the first embodiment. A plan view of an embryo transfer device according to a fifth modified example of the first embodiment. A plan view of an embryo transfer device according to a sixth modified example of the first embodiment. A cross-section of the guide section of the sixth modified example of the first embodiment. A perspective view of an embryo transfer device in an embryo transfer device kit according to the second embodiment. A plan view of an embryo transfer device according to the second embodiment. A cross-sectional view taken along XXIV-XXIV in FIG. 23. A plan view of an embryo transfer device in an embryo transfer device kit according to the third embodiment. A cross-sectional view of a connecting part accommodating an embryo transfer device according to a seventh modified example of the first embodiment. A cross-sectional view of a connecting part accommodating an embryo transfer device according to an eighth modified example of the first embodiment. A partially sectional plan view of an embryo transfer device according to a ninth modified example of the first embodiment. A cross-sectional view in the X direction of an embryo storage section of an embryo transfer device according to a tenth modified example of the first embodiment. A plan view of an embryo transfer device and a pusher according to a modified example of the second embodiment. A cross-sectional view taken along XXXI-XXXI in FIG. 30.10A is a cross-sectional view of a connecting part accommodating an embryo transfer device in an eleventh modified example of the first embodiment. FIG. 11A is a cross-sectional view of a connecting part accommodating an embryo transfer device in a twelfth modified example of the first embodiment. FIG. 12B is a cross-sectional view of a connecting part accommodating an embryo transfer device in a thirteenth modified example of the first embodiment, taken along the X-axis. FIG. 13A is a plan view of an embryo transfer device in an embryo transfer device kit of a fourth embodiment. FIG. 14A is a side view of an embryo transfer device in a fourth embodiment. FIG. 14B is a cross-sectional view of an embryo transfer device in a fourth embodiment. FIG. 15A is a cross-sectional view of an embryo transfer device and a pusher in an embryo transfer device kit of a fourth embodiment. FIG. 16A is a cross-sectional view of an embryo transfer device and a pusher in an embryo transfer device kit of a fourth embodiment. FIG. 17A is a plan view of an embryo transfer device, a connecting part, and a pusher in an embryo transfer device kit of a fourth embodiment. FIG. 18A is a partial cross-sectional plan view of an embryo transfer device, a pusher, and a tube in an embryo transfer device kit of a fourth embodiment. FIG. 19A is a partial cross-sectional plan view of an embryo transfer device, a connecting part, a pusher, and a tube in an embryo transfer device kit of a fourth embodiment. FIG. 19B is a partial cross-sectional plan view of an embryo transfer device, a pusher, and a tube of a modified example of the embryo transfer device kit of a fourth embodiment. FIG. 19C is a partial cross-sectional plan view of an embryo transfer device, a pusher, and a tube of another modified example of the embryo transfer device kit of a fourth embodiment.

[0007] An embryo transfer device kit according to a first embodiment will be described below with reference to the drawings. As shown in Figures 6 and 7, the embryo transfer device kit according to the first embodiment includes an embryo transfer device 1, a connecting part 2, a tube P, a pusher 3 such as a push rod, and a stylet 4.

[0008] First, an example of an embryo transfer device 1 will be described below with reference to the drawings. The embryo transfer device 1 is inserted into the uterine cavity 210 using a tube P inserted into the cervix 220 (see FIGS. 4, 7, etc.). In this embodiment, the cervix 220 refers primarily to the cervical canal between the internal and external cervical os. In this embodiment, the embryo transfer device 1 is retained in the uterine cavity 210 for 48 hours or more. The retention time may also be other lengths of time, such as several hours or more, 12 hours or more, 24 hours or more, or 72 hours or more.

[0009] The embryo transfer device 1 is used to implant an embryo E ( FIG. 13 ) by placing it in the uterine cavity 210. In this embodiment, the term "embryo E" includes a fertilized egg, a fertilized oocyte, and a blastocyst. The embryo transfer device 1 of this embodiment maintains the embryo E in a state where it can or is in contact with the endometrium of the uterine cavity 210 or other part of the uterus, thereby increasing the probability of implantation of the embryo E. For implantation, the embryo E may be attached to the endometrium or may burrow into the endometrium. In one example, the embryo transfer device 1 helps the embryo E to become attached to the endometrium. Therefore, in this embodiment, the embryo transfer device 1 holds the embryo E in a space surrounded by the endometrium and a recess 21 of the embryo storage unit 20 (described below).

[0010] The embryo transfer device 1 is preferably configured to exert as little unnecessary force or impact on the uterus as possible. For example, reducing the force applied to the endometrium by the embryo transfer device 1 placed in the uterine cavity 210 is expected to contribute to successful implantation. Minimizing damage to the cervix 220, uterine cavity 210, the patient's body, and the patient's mind during insertion and removal of the embryo transfer device 1 is also important. Meanwhile, despite movements of internal organs such as the uterus and the body containing the uterus, the embryo transfer device 1 must be securely placed in the uterine cavity 210, and the embryo E must be able to or maintain contact with the endometrium for implantation. Improving one of these conditions tends to degrade another. For example, while contraceptive devices are designed to be securely placed in the uterine cavity 210, adopting such a configuration likely reduces the success rate of implantation because relatively large forces are applied at various locations within the uterine cavity 210.

[0011] The configuration of the embryo transfer device 1 of this embodiment shown in Figures 1 to 5 will be described below. The embryo transfer device 1 has a proximal end 1A and a distal end 1B, and is inserted into the uterine cavity 210 from the distal end 1B side using a tube P that is inserted into the cervix 220 and uterine cavity 210 through the cervical os, as shown in Figure 5 and other figures. In this embodiment, the proximal end 1A and the distal end 1B correspond to the proximal and distal ends of the embryo transfer device 1 when placed in the tube P, as shown in Figure 6 and other figures. The embryo transfer device 1 has a proximal end 10 that forms at least a portion of the proximal end 1A, and an embryo storage section 20 that is provided on the distal end 1B side and stores an embryo E. In the description of this embodiment, as shown in Figures 1 to 3, the X-axis passes through the proximal end 10 and the embryo storage section 20, the Y-axis that is perpendicular to the X-axis extends in the direction in which the expansion frame section 30 (described below) expands, and the Z-axis is perpendicular to the X-axis and Y-axis. In this embodiment, the Y axis extends perpendicular to the opening direction of the opening 22 of the recess 21 and the direction in which the X axis extends. In this embodiment, the distal end 1B is the end of the embryo storage unit guide 60 extending from the embryo storage unit 20, but the distal end 1B may also be the embryo storage unit 20.

[0012] The embryo transfer device 1 of this embodiment has two expansion frame parts 30 connecting the proximal end part 10 and the embryo storage part 20. One end of each expansion frame part 30 is connected to the proximal end part 10, and the other end is connected to the embryo storage part 20. Each expansion frame part 30 is made of a material having rubber-like elasticity. Examples of materials having rubber-like elasticity include rubber materials such as silicone rubber, and other elastic materials.

[0013] Other types of rubber materials may also be used. The rubber hardness of the rubber material of this embodiment, when measured with a Type A durometer at 23±2°C, is in the range of 90 points or less, but is not limited thereto. For example, the rubber hardness of the rubber material of this embodiment, when measured with an Asker Type A durometer manufactured by Kobunshi Keiki Co., Ltd. at 23±2°C, is in the range of 10 to 90 points. This value of 10 to 90 points refers to the durometer hardness according to JIS K 6253. Because each of the expansion frame portions 30 and the like in this embodiment is thin, an approximate value of the Type A durometer (Asker Type A durometer) may be measured using a durometer manufactured by Techlock Co., Ltd. under the product name GS-680sel, and the rubber hardness of each expansion frame portion 30 may be determined using this approximate value. A micro rubber hardness tester manufactured by Kobunshi Keiki Co., Ltd. under the product name MD-1capa may be used instead of the GS-680sel.

[0014] In this embodiment, the Young's modulus of the muscle layer beneath the endometrium during contraction is assumed to be around 10 MPa, and the rubber hardness is set as described above so that the Young's modulus of the material of each unfolding frame portion 30 is equal to or lower than that. This setting may have the effect of preventing each unfolding frame portion 30 from being recognized as a foreign body within the uterine cavity 210. Note that the Young's modulus of blood vessels beneath the endometrium may be lower than the above Young's modulus. In consideration of the Young's modulus of blood vessels, etc., it may be better for the material of each unfolding frame portion 30 to have a lower Young's modulus. In this case, the rubber hardness of the material of each unfolding frame portion 30 is set to 70 points or less, 65 points or less, 60 points or less, 55 points or less, or 50 points or less.

[0015] In addition, when it is difficult to measure the rubber hardness of each unfolding frame portion 30 etc. using an Asker Type A rubber hardness tester, a sheet of the same material having a thickness of 6 mm to 10 mm can be molded using a mold, and the hardness of the sheet can be measured using an Asker Type A rubber hardness tester at 23±2°C, and the measurement result can be used as the rubber hardness of each unfolding frame portion 30.

[0016] Preferably, the proximal end portion 10 and the embryo storage portion 20 are also made of a material with the same Young's modulus (rubber hardness). In this embodiment, the proximal end portion 10, the embryo storage portion 20, and the two expansion frame portions 30 are integrally formed using a mold, and are made of the same material. The structure of the embryo transfer device 1 is not limited to this example.

[0017] The two unfolding frame parts 30 are brought close to each other due to elastic deformation when stored in the tube P for insertion into the uterine cavity 210 ( FIG. 6 ). At this time, in this embodiment, parts of the two unfolding frame parts 30 come into contact with each other. When removed from the tube P, the two unfolding frame parts 30 are unfolded in the direction along the Y axis due to the restoring force of the elastic deformation ( FIGS. 7 and 8 ). In this embodiment and the following embodiments, the "direction along the X axis," the "direction along the Y axis," and the "direction along the Z axis" may be referred to as the "X direction," the "Y direction," and the "Z direction," respectively.

[0018] In this embodiment, when the two unfolding frame units 30 are removed from the tube P, the restoring force of the elastic deformation causes at least the intermediate portions in the longitudinal direction to move away from each other and away from the X-axis, thereby unfolding. Because the X-axis in the tube P is aligned with the central axis of the distal end of the tube P, the intermediate portions can also be said to move away from the central axis CL ( FIG. 6 ). Furthermore, in this embodiment, when the embryo storage unit 20 is removed from the tube P, it can be said that it opens along an axis (Z-axis) perpendicular to the central axis CL. Note that, in this embodiment, when the embryo transfer device 1 is placed in the tube P as shown in FIG. 6 , the direction of the X-axis passing through the proximal end 10 of the embryo transfer device 1 and the embryo storage unit 20 coincides or substantially coincides with the central axis CL, but this is not limiting. In this embodiment, substantially coincident means that the angle between the direction of the X-axis and the central axis CL is 10° or less, preferably 5° or less. Similar effects can be achieved even if the angle is greater than the above-mentioned angle. During deployment, the two unfolding frame sections 30 are also allowed to move in directions such as along the Z axis. In other words, deployment in the Y direction refers to the movement of the two unfolding frame sections 30 at least in the Y direction as described above. It is preferable that the movement of the two unfolding frame sections 30 in the Y direction during deployment is greater than the movements in the X and Z directions. In this case, it can be said that the two unfolding frame sections 30 move mainly in the Y direction during deployment.

[0019] Here, a typical example of the tube P is a plastic tube. In order to reduce the damage to the uterus mentioned above during insertion / removal, the tube P preferably has an outer diameter of 2.5 mm or less, more preferably 2.0 mm or less, and even more preferably 1.5 mm or less. Therefore, the inner diameter of the tube P is 2.3 mm or less, 1.8 mm or less, 1.3 mm or less, etc. The tube P may be called a guide, sheath, etc., or may also be called a catheter, although tubes with other names may also be used.

[0020] To place the embryo transfer device 1 in the hollow portion of such a narrow tube P, the cross-sectional area of ​​each expanding frame 30 is reduced. For example, if the inner diameter (diameter of the hollow portion) of the tube P is 1.8 mm, each of the two expanding frames 30 is placed in a narrow area that is half the cross-sectional area of ​​the hollow portion of the tube P. For example, as shown in FIG. 4 , the cross-sectional shape of each expanding frame 30 may be an isosceles triangle or a shape close to an isosceles triangle. Therefore, as shown in FIG. 4 , the cross-section of each expanding frame 30 has two approximately straight sides 30B extending obliquely from one side in the Z direction and the other side in the Y direction toward the apex 30A. The cross-sectional shape of each expanding frame 30 may also be semicircular, or a shape between or similar to these. This configuration allows the cross-sectional area of ​​each expanding frame 30 to be maximized in the narrow area. This contributes to the desired placement of the embryo storage unit 20, as described below.

[0021] The proximal end 10 may have a cross-sectional area equal to or smaller than the hollow portion of the tube P. In this embodiment, the proximal end 10 has a cylindrical or conical shape with a maximum diameter approximately 0.1 mm smaller than the inner diameter of the tube P. The proximal end 10 may have other shapes. In this embodiment, the end of the pulling thread 11 is fixed to the proximal end 10. In this embodiment, the proximal end 10 can also be said to be the part that is pushed by the pusher 3 described below. In other embodiments, the proximal end 10 is the location where the thread 11 exits the embryo transfer device 1. In still other embodiments, the thread 11 may not exit from the proximal end 10, or the proximal end 10 may not be pushed by the pusher 3.

[0022] The embryo storage unit 20 opens along the Z-axis. In this embodiment, as shown in Figures 1 and 13, the embryo storage unit 20 has a recess 21 recessed along the Z-axis, and the opening 22 of the recess 21 opens along the Z-axis. The embryo E is stored in the recess 21. In this embodiment, the opening direction of the opening 22 is completely aligned with the Z-axis. However, if the angle between the opening direction and the Z-axis is 60° or less, preferably 45° or less, and more preferably 30° or less, the effects described below can be achieved, and the opening 22 can be said to open along the Z-axis. Furthermore, the shape of the uterine cavity 210 varies from person to person, and the embryo transfer device 1 is formed from a material with rubber-like elasticity. Therefore, the opening direction of the embryo storage unit 20 within the uterine cavity 210 is adjusted to match the shape of the uterine cavity 210. Adjusting the opening direction is useful for maintaining the endometrium in the opening direction. In this embodiment, the opening direction is perpendicular to an imaginary plane along the edge of the opening 22. Even if the angle between the opening direction and the Z-axis exceeds 60°, the effect described below may be expected depending on the shape of the uterine cavity 210. Because the embryo storage unit 20 opens along the Z-axis in an unloaded state, when the embryo transfer device 1 is placed in the uterine cavity 210, the opening 22 comes into contact with or is close to the endometrium, and the embryo E in the embryo storage unit 20 is maintained in a state where it can or is in contact with the endometrium.

[0023] The shape of each unfolding frame part 30 will be described below in an unloaded state where no load is applied to each unfolding frame part 30. The unloaded state is, for example, a state where the embryo transfer device 1 is placed on a horizontal surface 100 as shown in Figure 3, with only gravity acting on the embryo transfer device 1. In Figure 3, one end side, middle part, etc. of each unfolding frame part 30 is in contact with the horizontal surface 100.

[0024] In an unloaded state, each unfolding frame portion 30 has a first bent portion 31 that is bent in a direction away from the X-axis from the one end toward the other end, and a second bent portion 32 that is positioned closer to the other end than the first bent portion 31 and is bent in a direction approaching the X-axis from the one end toward the other end.

[0025] Furthermore, in the unloaded state, each unfolding frame portion 30 has a third bent portion 33 that is arranged closer to the other end than the second bent portion 32 and bent in a direction away from the X-axis from the other end toward the one end. Furthermore, in the unloaded state, each unfolding frame portion 30 has a fourth bent portion 34 that is arranged closer to the other end than the second bent portion 32 and closer to the one end than the third bent portion 33 and bent in a direction approaching the X-axis from the one end toward the other end. The second bent portion 32 and the fourth bent portion 34 may be continuous bent portions.

[0026] In each embodiment, the portion between the first bend 31 and the second bend 32 is referred to as the first connection portion 41, the portion between the second bend 32 and the fourth bend 34 is referred to as the second connection portion 42, and the portion between the fourth bend 34 and the third bend 33 is referred to as the third connection portion 43.

[0027] 6 , when the embryo transfer device 1 is placed in the tube P, the curvature (degree of bending) of each of the bent portions 31, 32, 33, and 34 becomes gentler and may even become nearly straight. When the embryo transfer device 1 is placed in the tube P, the first bent portion 31, the second bent portion 32, the fourth bent portion 34, the third bent portion 33, the embryo storage section 20, and the embryo storage section guide 60 are arranged in this order from the proximal end 1A toward the distal end 1B. Note that the entire embryo transfer device 1 may be completely contained within the tube P, or a portion of the embryo transfer device 1, such as the proximal end 10 or a portion of the embryo storage section guide 60, may be exposed from the tube P.

[0028] For example, when a user places the embryo transfer device 1 in the uterine cavity 210, the user first inserts the distal end of the tube P through the external cervical os into the cervix 220 and places the distal end of the tube P in the uterine cavity 210 ( FIG. 5 ). In this embodiment, the stylet 4 is placed in the tube P so as to pass through it, as shown in FIG. 5 . Note that the user at this time is, for example, a practitioner. Furthermore, if the tube P is provided with a stopper PS that clings to its outer periphery, the insertion depth of the tube P into the cervix 220 by the user is limited. In one example, the stopper PS comes into contact with the external cervical os, thereby limiting the insertion depth of the tube P. The stopper PS is made of a material with rubber-like elasticity, such as silicone rubber, or plastic, and the attachment position of the stopper PS relative to the tube P is adjustable along the central axis of the tube P.

[0029] In one example, the user positions the distal ends of the tube P and the stylet 4 within the uterine cavity 210 while confirming the positions of the distal ends of the tube P and the stylet 4 through ultrasound observation. For this purpose, a visibility-enhancing portion is preferably provided on the distal end of the tube P and / or the stylet 4, thereby making it easier for the user to recognize the positions of the tube P and / or the stylet 4 through ultrasound observation. The visibility-enhancing portion may be provided by changing the material of the distal end of the tube P or the stylet 4, by providing a characteristic shape such as minute irregularities or grooves on the surface of the distal end, by embedding air bubbles, microspheres, microparticles, etc. within the distal end, or by other methods. The visibility-enhancing portion may also be provided on the embryo storage unit 20, the spreading frame unit 30, etc. In this case, the user can place the embryo transfer device 1 within the uterine cavity 210 while confirming the positions of the embryo storage unit 20, the spreading frame unit 30, etc. through ultrasound observation. As the microspheres or microparticles, well-known small spheres or particles such as hollow beads can be used. The hollow beads can be made of glass, plastic, etc. To provide the air bubbles, well-known porous members such as porous silicon can be embedded in the tube P, stylet 4, embryo storage unit 20, expansion frame unit 30, etc.

[0030] Next, the user withdraws the stylet 4 from the canal P, at which time bodily fluids tend to enter the canal P. The bodily fluids may contribute to the smooth movement of the embryo transfer device 1 within the canal P, as will be described later.

[0031] Next, as described below, the user applies force to the embryo transfer device 1 toward the distal end of the tube P using the pusher 3, thereby moving the embryo transfer device 1 from the connecting part 2 into the tube P. The user then applies force to the embryo transfer device 1 toward the distal end of the tube P using the pusher 3, thereby moving the embryo transfer device 1 in the tube P into the uterine cavity 210. At this time, the user may also move the tube P in a direction to remove it from the cervix 220. When moving the embryo transfer device 1 in the tube P into the uterine cavity 210, the user holds the proximal end of the pusher 3. In this embodiment, the pusher 3, which is a push rod, has a thin pipe shape made of plastic, metal, or the like; however, the pusher 3 may also be formed of other materials and have other shapes. To reduce the resistance to movement of the pusher 3 within the tube P, the pusher 3 is preferably made of a fluororesin such as PTFE.

[0032] 7, the embryo storage unit guide 60 emerges first from the tube P within the uterine cavity 210, followed by the embryo storage unit 20 and the third bent portion 33. Next, the fourth bent portion 34, the second bent portion 32, the first bent portion 31, and the proximal end portion 10 emerge from the tube P in this order, and the embryo transfer device 1 is positioned within the uterine cavity 210 (FIG. 8).

[0033] After the other end of each unfolded frame portion 30 emerges from the pipe P, the two unfolded frame portions 30 unfold in the Y direction before the one end emerges. When unfolded in this manner, the third connection portion 43 of each unfolded frame portion 30 is disposed so as to extend primarily in the Y direction when viewed from the direction along the Z axis ( FIG. 2 ). In one example, the extension direction 43A ( FIG. 2 ), which is the direction in which the third connection portion 43 extends, is the direction in which a straight line connecting both ends of the third connection portion 43 extends. When the angle between the extension direction 43A and the Y axis when viewed from the direction along the Z axis is less than 45°, it can be said that the third connection portion 43 extends primarily in the Y direction.

[0034] In FIG. 2 , the third connecting portion 43 extends substantially linearly when viewed along the Z axis. However, the third connecting portion 43 may be curved when viewed along the Z axis. Even in this case, the direction of the line connecting the two end points can be specified. Furthermore, when the third bend portion 33 and the fourth bend portion 34 are directly connected, the third bend portion 33 and the fourth bend portion 34 may be connected via a short third connecting portion 43. In these cases, a predetermined range in each unfolding frame portion 30 including the connection between the third bend portion 33 and the fourth bend portion 34 functions as the third connecting portion 43. The predetermined range is, for example, a range extending obliquely from the other end toward the one end of each unfolding frame portion 30 toward the rear of the uterine cavity 210. This rear side is the side of the distal end 1B in the direction along the X axis. The third connecting portion 43 in this embodiment also extends obliquely from the other end toward the one end of each unfolding frame portion 30 toward the rear of the uterine cavity 210.

[0035] Although other portions of the embryo transfer device 1 also contact the uterus, in this embodiment, the widthwise outer portions 18 ( FIG. 2 ) of the two unfolding frame portions 30 constituting both sides of the embryo transfer device 1 in the Y direction contact the side walls of the uterine cavity 210. As shown in FIG. 8 , these side walls are typically the two widthwise walls of the body in the uterine cavity 210. In this embodiment, this width direction may also be referred to as the width direction of the uterine cavity 210. This contact provides resistance to movement of the widthwise outer portions 18 relative to the uterus. Note that the portions of each unfolding frame portion 30 closer to the one end than the widthwise outer portions 18 also provide resistance to movement. Note that in this embodiment, as shown in FIG. 2 , a portion of the second bent portion 32, a portion of the fourth bent portion 34, and the second connecting portion 42 constitute the widthwise outer portions 18. Alternatively, a part of the fourth bent portion 34 and the second connecting portion 42 may form the widthwise outer portion 18, a part of the second bent portion 32 and the second connecting portion 42 may form the widthwise outer portion 18, or only the second connecting portion 42 may form the widthwise outer portion 18. In any case, in this embodiment, the widthwise outer portions 18, which are the middle portions of each unfolding frame portion 30, come into contact with both widthwise walls of the uterine cavity 210.

[0036] In this way, the widthwise outer portion 18 is positioned farther from the X-axis than the embryo storage unit 20. This has the effect of making it difficult for the embryo storage unit 20 to be positioned outside the width direction of the uterine cavity 210. Furthermore, this configuration has the effect of preventing or reducing the embryo E from being positioned on the fallopian tube side.

[0037] Each expanding frame 30 is expanded in the Y direction, with one end connected to the proximal end 10 and the other end connected to the embryo storage unit 20. Therefore, although each expanding frame 30 is formed of a thin, rubber-like material as described above, the position of the embryo storage unit 20 in the Y direction is more easily stabilized than when the embryo storage unit 20 is supported by a thin rubber rod extending from the proximal end 10 along the X axis and insertable into the tube P. Furthermore, the embryo storage unit 20 is supported by a pair of widthwise outer parts 18 via a pair of third connecting parts 43, and each third connecting part 43 extends mainly in the Y direction. Alternatively, as described above, a predetermined range of each expanding frame 30, including the connecting part between the third bent part 33 and the fourth bent part 34, extends mainly in the Y direction. Therefore, the aforementioned effect of stabilizing the position of the embryo storage unit 20 in the Y direction is more reliably achieved.

[0038] In this embodiment, each of the unfolding frame parts 30 is unfolded in the Y direction, with one end connected to the proximal end part 10 and the other end connected to the embryo storage part 20. With this configuration, the middle parts of the pair of unfolding frame parts 30 are arranged on both sides of the width of the uterine cavity 210, the other end side of the pair of unfolding frame parts 30 is arranged on the back side of the uterine cavity 210, and the one end side of the pair of unfolding frame parts 30 is arranged on the side of the entrance (cervix) of the uterine cavity 210. In this embodiment, both sides of the width of the uterine cavity 210 may be referred to as both side walls.

[0039] In this way, the pair of unfolding frame parts 30 are arranged across both side walls, the back side, and the entrance side within the uterine cavity 210. In some cases, the pair of unfolding frame parts 30 are arranged within the uterine cavity 210 so as not to come into contact with both side walls. In one example, the intermediate parts (widthwise outer parts 18) of the pair of unfolding frame parts 30 are arranged along both side walls within the uterine cavity 210, and the one end side of the pair of unfolding frame parts 30 is arranged between the intermediate parts in the width direction of the uterine cavity 210. In addition, the other end side of the pair of unfolding frame parts 30 is arranged deeper in the uterine cavity 210 than the one end side, and is arranged between the intermediate parts in the width direction of the uterine cavity 210. In this embodiment, such an arrangement of the pair of unfolding frame parts 30 may be referred to as an annular arrangement.

[0040] In this embodiment, more precisely, the pair of unfolding frame parts 30, the embryo storage part 20, and the proximal end part 10 are arranged along both side walls, the innermost part, and the entrance side of the uterine cavity 210, but the annular arrangement can be considered just within the range of the pair of unfolding frame parts 30. It is preferable that the pair of unfolding frame parts 30 occupy 70% or more, more preferably 80% or more, and even more preferably 90% or more of the circumferential length of the annulus in order to stabilize the position of the embryo storage part 20 within the uterine cavity 210 and reduce the force applied to the endometrium by the embryo transfer device 1.

[0041] As described above, each unfolding frame part 30 is thin and made of a material with rubber-like elasticity. The annular arrangement provides the effect of stabilizing the position of the embryo storage unit 20. In other words, when the embryo storage unit 20 moves in the Y direction, a force is applied to the entire unfolding frame part 30, for example, around the center of the ring. Resistance to movement occurs in each unfolding frame part 30 due to contact with the uterine cavity 210, etc. Therefore, the annular arrangement of each unfolding frame part 30, which is thin and made of rubber-like elasticity, provides the effect of stabilizing the position of the embryo storage unit 20. This effect of the annular arrangement can be obtained even when the angle between the extension direction 43A and the Y axis when viewed from the Z axis is 45° or more.

[0042] In this embodiment, the embryo storage unit guide 60 extends from the embryo storage unit 20, and acts as a resistance when the embryo storage unit 20 moves in the Y direction. One of the effects of this configuration is that it is possible to stabilize the position of the embryo storage unit 20.

[0043] Furthermore, in this embodiment, the extending direction 43A is inclined toward the back of the uterine cavity 210 from the other end toward the one end of each unfolding frame part 30, and the distal ends 1B of the pair of unfolding frame parts 30 have a sloped shoulder shape. Alternatively, the extending direction 43A may be inclined from the other end toward the one end of each unfolding frame part 30 toward the entrance of the uterine cavity 210 (the side of the proximal end 1A in the direction along the X-axis), and the distal ends 1B of the pair of unfolding frame parts 30 may have a sloped shoulder shape. The effect of the annular arrangement can be obtained even when the unfolding frame parts 30 have a sloped shoulder shape.

[0044] The annular arrangement is also expected to have the effect of stabilizing the position of the embryo storage unit 20 in the X direction. In order to stabilize the position of the embryo storage unit 20 mainly in the X direction, it is also possible to set the angle between the extension direction 43A when viewed from the direction along the Z axis and the Y axis to be 45° or more.

[0045] Taking into consideration individual differences in the shape, size, condition, etc. of the uterine cavity 210, multiple types of embryo transfer devices 1 may be prepared, each having a different length, shape, etc. of the unfolding frame portion 30. For example, the unfolding frame portions 50, 51, 52, and 53 shown in Figures 16 to 19 may be used instead of the unfolding frame portion 30. The unfolding frame portions 50, 51, 52, and 53 shown in Figures 15 to 18 are longer than the unfolding frame portion 30 and have a different shape from the unfolding frame portion 30.

[0046] In this embodiment, the recess 21 in the embryo storage unit 20 where the embryo E is stored is located closer to the distal end 1B than the other end of each unfolding frame unit 30. It is believed that the implantation probability is higher at the back of the uterine cavity 210, and the above configuration has the effect of improving the implantation probability in patients who meet these conditions.

[0047] In this embodiment, when viewed from the direction along the Z axis in the unloaded state, the angle α between the extension direction 43A and the X axis on the side of the distal end 1B (the back side of the uterine cavity 210) is less than 90° ( FIG. 2 ). That is, in the unloaded state, the other end side of each unfolded frame part 30 has an inclined portion (third connecting portion 43) that extends obliquely from the other end side toward the one end side toward the back side of the uterine cavity 210 (the side of the distal end 1B in the direction along the X axis). The one end side of the third bent portion 33 can also function as the inclined portion. Alternatively, in the unloaded state, each unfolded frame part 30 has a portion (the third connecting portion 43, a part of the fourth bent portion 34, etc.) that is located closer to the one end side than the third bent portion 33 and is positioned further back in the uterine cavity 210 than the terminal end of the one end side of the third bent portion 33.

[0048] This configuration may have the effect of contributing to preventing the embryo E from being placed on the fallopian tube side. Furthermore, in this embodiment, when the pair of widthwise outer parts 18 move closer to each other compared to the unloaded state due to force from the uterus or the like, the embryo storage part 20 is more likely to be subjected to a force moving away from the uterine fundus 230 than a force moving closer to the uterine fundus 230. This can have the effect of minimizing the application of unnecessary force to the uterus.

[0049] In the embryo transfer device 1 of this embodiment, the two unfolding frame parts 30 unfold and annularly arrange to position the embryo storage part 20 toward the center of the width of the uterine cavity 210. This configuration has the effect of making it difficult for the embryo storage part 20 to be positioned outside the width of the uterine cavity 210, and has the effect of preventing or reducing the placement of the embryo E toward the fallopian tube.

[0050] 2 and other drawings, at least one of the first connecting portion 41, which is a portion extending from the terminal end of the first bending portion 31 on the other end side, a portion of the first connecting portion 41 and the second bending portion 32, and a portion of the second bending portion 32 is an inclined portion extending obliquely from the one end toward the other end toward the entrance side of the uterine cavity 210 (the side of the proximal end 1A in the direction along the X-axis). This has the effect of reducing the possibility of the embryo transfer device 1 being unintentionally expelled from the uterine cavity 210 even when there is movement of internal organs such as the uterus or movement of the body containing the uterus.

[0051] In this embodiment, the embryo storage unit guide 60 is formed integrally with the embryo storage unit 20 and other components using the aforementioned mold, and is made of the same rubber-like elastic material as the embryo storage unit 20 and other components. In this embodiment, the embryo storage unit guide 60 has a pair of guide parts 61 aligned in the Y direction. The base end of each guide part 61 is fixed to the distal end 1B of the embryo storage unit 20, and the tip end of each guide part 61 extends toward the distal end 1B and away from the X axis. In this way, each guide part 61 extends obliquely outward from the embryo storage unit 20 in the Y direction (the width direction of the body).

[0052] Because this configuration is adopted, when the embryo transfer device 1 moves from inside the tube P into the uterine cavity 210 as described above, even if the embryo transfer device 1 is pressed against the uterine fundus 230 as shown in Figure 7, the embryo storage unit guide 60 will hit the uterine fundus 230 before the embryo storage unit 20. One of the effects of this configuration is that it is useful for reducing the pressure applied to the uterine fundus 230.

[0053] In this embodiment, each guide portion 61 is bent or curved from the base end to the tip end in a direction away from the X-axis. One of the effects of this configuration is that it is useful for reducing the pressure applied to the uterine fundus 230.

[0054] Furthermore, in this embodiment, each guide portion 61 has a tapered portion 61A in which the outer diameter gradually decreases from the base end toward the tip end (see FIG. 2, etc.). In this embodiment, the tapered portion 61A is formed over substantially the entire length of the guide portion 61. This configuration allows each guide portion 61 to be smoothly inserted into the uterine cavity 210 when the embryo transfer device 1 exits the tube P within the uterine cavity 210 as described above. One of the effects of this configuration is that it is useful for reducing the pressure applied to the uterine cavity 210.

[0055] 9 to 12, the connection part 2 of the embryo transfer device kit of this embodiment has a housing portion 71A capable of housing a part of the embryo transfer device 1. The connection part 2 of this embodiment has a tubular portion 71 extending in the X direction in Fig. 10 and a rotation restricting portion 72 extending radially from the tubular portion 71.

[0056] In this embodiment, the housing portion 71A is a hollow portion of the tube portion 71, and also extends in the X direction (a predetermined direction). In this embodiment, as shown in Figure 12, the X direction of the embryo transfer device 1 housed in the housing portion 71A is referred to as the X direction of the connecting part 2, and the Z direction of the embryo transfer device 1 housed in the housing portion 71A is referred to as the Z direction of the connecting part 2.

[0057] In this embodiment, as shown in FIG. 12 , a window 73 is formed at the distal end of the connecting part 2, and the window 73 connects the outside of the connecting part 2 to the storage part 71A in the radial direction of the tubular part 71. The distal end of the connecting part 2 is the side that connects to the proximal end PD when the connecting part 2 is connected to the proximal end PD of the tubular part 71, as shown in FIG. 14 . In this embodiment, the proximal end PD has a hole PH extending in the direction along the central axis of the tubular part P (longitudinal direction). The distal end of the connecting part 2 is inserted into the hole PH, and the distal end of the connecting part 2 fits into the hole PH. This connects the distal end of the connecting part 2 to the proximal end PD. The opening side of the hole PH is a tapered hole whose cross-sectional area decreases from the proximal end to the distal end of the tubular part P. One of the effects of this configuration is that it is useful for stably transferring the embryo E in the embryo storage part 20 to the uterine cavity 210.

[0058] It should be noted that the distal end side of the connection part 2 may be connected to the proximal end PD of the tube P using other structures. For example, a fixing part may be provided separately to fix the proximal end of the tube P, which does not have a proximal end PD, and the connection part 2 to each other, and the proximal end of the tube P and the connection part 2 may be connected by the fixing part. As the fixing part, a user may employ a plastic fixing member that grips the proximal end of the tube P and the distal end of the tube portion 71, which are arranged coaxially. The distal end side of the connection part 2 may be connected to the proximal end PD of the tube P using other methods or structures.

[0059] In this embodiment, the distal end 1B and the middle part of the embryo transfer device 1 are accommodated in the accommodation section 71A of the connection part 2 before it is connected to the proximal end PD. The middle part includes a part of the unfolding frame part 30, such as the third bend 33. In this embodiment, the user places the embryo transfer device 1 into the accommodation section 71A starting from the distal end of the connection part 2, followed by the thread 11 and the proximal end 10. One of the effects of this method is that it is useful for smoothly placing the embryo storage unit 20, which has the embryo storage unit guide 60, into the accommodation section 71A.

[0060] The rotation restricting portion 72 restricts the rotation of the tube portion 71 having the accommodation portion 71A around an axis extending in the X direction. In this embodiment, this axis is the central axis of the accommodation portion 71A. In this embodiment, the tube portion 71 is a tube with a substantially circular cross section, but the cross section of the tube portion 71 may be polygonal, elliptical, or the like.

[0061] It is also possible to employ a connection part 2' having the shape shown in Fig. 15. The connection part 2' has, for example, a substantially rectangular parallelepiped shape and has a storage portion 71A and a window 73 similar to those of the connection part 2. In the case of Fig. 15, rotation of the connection part 2' around an axis extending in the X direction is restricted by both ends of the connection part 2' in the Y direction. In other words, both ends of the connection part 2' in the Y direction function as rotation restricting portions.

[0062] A hole 74 is formed on the distal end side of the connection part 2'. The proximal end of the tube P, which does not have a proximal end PD, is inserted into the hole 74, and the proximal end fits into the hole 74. This connects the distal side of the connection part 2' to the proximal end of the tube P, and the hollow portion of the tube P and the accommodation part 71A are arranged coaxially.

[0063] When the user places a part of the embryo transfer device 1 into the storage section 71A as shown in Fig. 12, the embryo storage section 20 is located at a position corresponding to the window 73. In other words, the window 73 is located at a position corresponding to the opening of the embryo storage section 20 of the embryo transfer device 1, at least a part of which is stored in the storage section 71A. Unlike Fig. 12, the entire embryo transfer device 1 may be stored in the storage section 71A.

[0064] As described above, when the user places at least a portion of the embryo transfer device 1 in the storage section 71A, it is sufficient that the user places the opening of the embryo storage section 20 at a position corresponding to the window 73. It can be said that such a window 73 is located at a position corresponding to the opening of the embryo storage section 20 of the embryo transfer device 1, at least a portion of which is stored in the storage section 71A.

[0065] The user can access the embryo storage unit 20 through the window 73. The user places the connection part 2, with at least a portion of the embryo transfer device 1 disposed in the storage unit 71A, on a predetermined surface such as the bottom surface of the container 110. The container 110 is a petri dish or the like. In this embodiment, the user passes the thread 11 through the pipe-shaped pusher 3 and places the pusher tip, which is the tip of the pusher 3, near the proximal end 10, before placing the connection part 2 on the surface.

[0066] Next, the user uses the embryo injector 80 to inject the embryo E and a predetermined liquid into the recess 21 of the embryo storage unit 20 through the window 73, as shown in FIG. 13 . In this embodiment, the embryo injector 80 is a glass dropper, syringe, or the like, but other instruments can also be used. In this embodiment, the predetermined liquid is the culture medium used to culture the embryo E, or a liquid containing culture medium, high-concentration hyaluronic acid, and growth factors, but other liquids such as body fluids can also be used. In this embodiment, when the embryo E and liquid are injected into the recess 21, some of the liquid enters the gap between the embryo storage unit 20 and the storage unit 71A. This allows for smooth movement of the embryo transfer device 1 within the storage unit 71A. Furthermore, the amount of liquid injected through the window 73 increases, which can suppress changes in concentration due to liquid evaporation.

[0067] After placing the embryo E in the recess 21 and / or when placing the embryo E in the recess 21, the user observes the embryo E in the recess 21 using a microscope such as a stereo microscope. At this time, the presence of air bubbles in the recess 21 may hinder the observation of the embryo E. For this reason, it is preferable that the recess 21 be subjected to a hydrophilization treatment. The hydrophilization treatment is performed, for example, by irradiation with deep ultraviolet light, but the hydrophilization treatment may also be performed by other known methods. The hydrophilization treatment may be performed on the entire embryo storage unit 20 or the entire embryo transfer device 1.

[0068] The inner circumferential surface of the container 71A and the inner circumferential surface of the tube P are preferably made of a material with a small coefficient of friction against the embryo transfer device 1, such as fluororesin.

[0069] Next, the user moves the embryo transfer device 1, with the embryo E and liquid injected into the recess 21, housed in the connecting part 2, near the patient, for example, together with the container. The connecting part 2 has a rotation restricting portion 72. This configuration facilitates maintaining the recess 21 facing upward, which is useful for stable and efficient transfer. More specifically, the rotation restricting portion 72 prevents the connecting parts 2, 2' from rotating, for example, when injecting the embryo E into the embryo storage part 20 or when transporting the connecting parts 2, 2' with the embryo E stored therein. Then, the user connects the distal end of the connecting part 2 to the proximal end PD of the tube P, the distal end of which is positioned within the uterine cavity 210 as described above, as shown in FIG. 14 .

[0070] As described above, one of the advantages of the configuration in which the connecting part 2 can accommodate at least a portion of the embryo transfer device 1 and the connecting part 2 can be connected to the proximal end of the tube P placed in the uterine cavity 210 is that it is useful for safely placing the embryo E in the recess 21 into the uterine cavity 210. Conversely, if the distal end of the tube P is inserted into the uterine cavity 210 with the embryo transfer device 1 placed in the tube P, it may be difficult to insert the stylet 4 all the way to the distal end of the tube P, and the distal end of the tube P may lack strength, making the insertion of the tube P difficult. Note that, depending on the shape of the tube P and the shape of the embryo storage unit 20, it may be possible to safely place the embryo E contained in the recess 21 in the tube P into the uterine cavity 210 regardless of the rotational position and orientation of the tube P. In this case, a method in which the distal end of the tube P is inserted into the uterine cavity 210 with the embryo transfer device 1 placed in the tube P may be employed.

[0071] Next, the user uses the pusher 3 to move the embryo transfer device 1 from the connecting part 2 to the tube P (FIG. 6), as described above, and moves the embryo transfer device 1 in the tube P to the uterine cavity 210 (FIG. 7). Then, the user removes the tube P from the uterine cavity 210 and the cervix 220, and leaves the embryo transfer device 1 in the uterine cavity 210.

[0072] As an example, the embryo transfer device 1 of this embodiment maintains a state in which the embryo E can contact or is in contact with the endometrium of a target wall of the uterine cavity 210 that is located in a direction intersecting or substantially perpendicular to the width direction of the body, rather than both walls of the uterine cavity 210 in the body's width direction. Therefore, if the embryo storage unit 20 rotates around the X-axis after emerging from the tip of the tube P, the embryo E is more likely to fall out of the recess 21 or be damaged. The embryo transfer device 1 of this embodiment includes an embryo storage unit guide 60. One of the effects of this configuration is to stabilize the posture of the embryo storage unit 20 when it emerges from the tip of the tube P and enters the uterine cavity 210. More specifically, this configuration suppresses or prevents rotation of the embryo storage unit 20 around the X-axis when it emerges from the tip of the tube P and enters the uterine cavity 210, thereby enabling the opening 22 of the recess 21 to maintain contact with or close to the target wall.

[0073] One of the effects of this configuration is that it may stabilize the posture of the embryo storage unit 20 as described above when the embryo storage unit 20 moves within the uterine cavity 210 due to the force from the pusher 3, or when parts of the embryo transfer device 1 other than the embryo storage unit 20 come out of the tube P due to the force from the pusher 3.

[0074] In order to achieve this effect, the dimension between the base end and the tip end of each guide portion 61 (longitudinal dimension) is preferably at least 1 time, more preferably at least 1.5 times, and even more preferably at least 2 times the maximum dimension of the cross section perpendicular to the longitudinal direction. Note that the configuration of this embodiment is not limited to these numerical values ​​as long as the above effect can be achieved.

[0075] In each of the above embodiments, the embryo transfer device 1 may have an embryo storage section guide 65 shown in Fig. 20 instead of the embryo storage section guide 60. The embryo storage section guide 65 is also formed integrally with the embryo storage section 20, etc. using the above-mentioned mold, and is made of the same rubber-like elastic material as the embryo storage section 20, etc.

[0076] The embryo storage unit guide 65 has a pair of guide portions 66 aligned in the Y direction. The base end of each guide portion 66 is fixed to the distal end 1B of the embryo storage unit 20, and the tips of the pair of guide portions 66 are connected to each other. In other words, the embryo storage unit guide 65 has a loop shape, or the embryo storage unit guide 65 has a loop shape together with a part of the embryo storage unit 20.

[0077] Each guide part 66 has a first part 66A that extends from its base end toward the distal end 1B and away from the X-axis. Thus, the first part 66A of each guide part 66 extends obliquely from the embryo storage part 20 outward in the Y-direction (the width direction of the body). Each guide part 66 also has a second part 66B that extends from the tip of the first part 66A toward the distal end 1B and toward the X-axis. The second parts 66B of a pair of guide parts 66 are connected to each other. With this configuration, the embryo storage part guide 65 can achieve the same effects as the embryo storage part guide 60.

[0078] In this embodiment, the embryo storage section guide 65 has a cross-sectional shape shown in FIG. 21 throughout its entire longitudinal direction. The cross-sectional shape of the embryo storage section guide 65 may be an isosceles triangle, a shape close to an isosceles triangle, or the like. In the example shown in FIG. 21 , the cross section of the embryo storage section guide 65 has an apex 65A that protrudes radially outward from the loop shape, and two substantially straight sides 65B that extend obliquely from one side and the other in the Z direction toward the apex 65A. This cross-sectional shape allows the embryo storage section guide 65 to be smoothly inserted into the uterine cavity 210 when the embryo transfer device 1 exits the tube P within the uterine cavity 210 as described above. One of the effects of this configuration is useful for reducing pressure applied to the uterine cavity 210.

[0079] An embryo transfer device kit according to the second embodiment will be described below with reference to Figures 22 to 24. The embryo transfer device kit according to the second embodiment includes an embryo transfer device 1' shown in Figures 22 to 24, a connecting part 2 similar to that of the first embodiment, a tube P, a pusher 3 such as a push rod, and a stylet 4. In the second embodiment, a description of the same components as those in the first embodiment will be omitted, and the symbols and names of the same components will be used in the second embodiment as needed.

[0080] The embryo transfer device 1' of the second embodiment includes an embryo storage unit 20 similar to that of the first embodiment, and is inserted into and placed in the uterine cavity 210 using a tube P, similar to the first embodiment. The embryo transfer device 1' also has a proximal end 1A and a distal end 1B, a proximal end 10 forming at least a portion of the proximal end 1A, and an embryo storage unit 20 located on the distal end 1B side for storing an embryo E. In the second embodiment, the X-axis also passes through the proximal end 10 and the embryo storage unit 20, and the Z-axis is perpendicular to the X-axis. In the second embodiment, as in the first embodiment, the Z-axis also extends in the direction in which the embryo storage unit 20 is open. In the second embodiment, the Y-axis also is perpendicular to the X-axis and Z-axis.

[0081] In the second embodiment, an embryo storage unit guide 60 similar to that in the first embodiment extends from the embryo storage unit 20. The embryo transfer device 1′ of the second embodiment includes a rod-shaped member 54 extending in the X direction instead of the pair of expansion frame members 30 of the first embodiment. The base end of the rod-shaped member 54 is fixed to the proximal end portion 10, and the tip of the rod-shaped member 54 is fixed to the base end portion of the embryo storage unit 20.

[0082] In the second embodiment, as in the first embodiment, the embryo storage unit guide 60, the embryo storage unit 20, the rod-shaped member 54, and the proximal end portion 10 are integrally molded in a mold using the same rubber material as in the first embodiment. Note that in the second embodiment, the embryo storage unit guide 60 and the embryo storage unit 20 may be integrally molded, and the embryo storage unit 20 may be fixed to the separately molded rod-shaped member 54 with an adhesive or the like. Similarly in the first embodiment, the embryo storage unit 20 may be fixed to the other end of the separately molded expansion frame member 30 with an adhesive or the like.

[0083] In the second embodiment, as in the first embodiment, the embryo transfer device 1' is placed in the storage section 71A of the connecting part 2, and in this state, an embryo E is placed in the recess 21. The user then connects the connecting part 2 to the proximal end PD of the tube P and uses the pusher 3 to move the embryo transfer device 1' in the connecting part 2 to the uterine cavity 210 via the tube P. At this time, the embryo storage section guide 60 is deployed in the Y direction within the uterine cavity 210.

[0084] In the second embodiment of the embryo transfer device 1', a rod-shaped member 54 instead of the unfolding frame portion 30 suppresses the movement of the embryo storage portion 20 placed within the uterine cavity 210, and the embryo storage portion guide 60 also suppresses the movement of the embryo storage portion 20 placed therein, as in the first embodiment.

[0085] As in the first embodiment, the embryo storage section guide 65 can be provided in place of the embryo storage section guide 60 in the embryo transfer device 1 ′ of the second embodiment.

[0086] An embryo transfer device kit according to the third embodiment will be described below with reference to Figure 25. The embryo transfer device kit of the third embodiment includes an embryo transfer device 1" shown in Figure 25, a connecting part 2 similar to that of the first embodiment, a tube P, a pusher 3 such as a push rod, and a stylet 4. In the third embodiment, a description of the same components as those in the first embodiment will be omitted, and the symbols and names of the same components will be used in the third embodiment as needed.

[0087] The embryo transfer device 1" of the third embodiment includes an embryo storage section 20 similar to that of the first embodiment, and is inserted into and placed in the uterine cavity 210 using a tube P, similar to that of the first embodiment. The embryo transfer device 1" also has a proximal end 1A and a distal end 1B. The embryo transfer device 1" also has the embryo storage section 20 forming at least a part of the proximal end 1A, and an embryo storage section guide 67 similar to the embryo storage section guide 65 of the first embodiment is provided closer to the distal end 1B than the embryo storage section 20. In one example, an end of a thread 11 is fixed to the embryo storage section 20 of the embryo transfer device 1".

[0088] The embryo storage unit guide 67 has a pair of guide portions 68 aligned in the Y direction. The base end of each guide portion 68 is fixed to the distal end 1B of the embryo storage unit 20, and the tips of the pair of guide portions 68 are connected to each other. In other words, the embryo storage unit guide 67 has a loop shape similar to the embryo storage unit guide 65, or the embryo storage unit guide 67 has a loop shape together with a part of the embryo storage unit 20.

[0089] Each guide 68 has a first portion 68A extending from its base end in a direction away from the X-axis. Thus, the first portion 68A of each guide 68 extends outward from the embryo storage unit 20 in the Y-direction (the width direction of the body). Furthermore, a portion 68C of the first portion 68A extends from the base end of the guide 68 toward the tip, toward the distal end 1B, and away from the X-axis. Each guide 68 also has a second portion 68B extending from the tip of the first portion 68A toward the distal end 1B and toward the X-axis. The second portions 68B of a pair of guides 68 are connected to each other. This configuration allows the embryo storage unit guide 67 to achieve the same effects as the embryo storage unit guides 60 and 65.

[0090] 25, the widthwise outer portions 18' of each guide part 68 may come into contact with both widthwise walls of the body in the uterine cavity 210, similar to the widthwise outer portions 18 of the first embodiment. When each guide part 68 is configured in this manner, each guide part 68 more effectively suppresses the movement of the embryo storage part 20 placed inside the uterine cavity 210. In this case, the pair of guide parts 68 can function as the pair of expansion frame parts 30 of the first embodiment.

[0091] In the third embodiment, as in the first embodiment, the embryo transfer device 1" is placed in the storage section 71A of the connecting part 2, and in this state, an embryo E is placed in the recess 21. The user then connects the connecting part 2 to the proximal end PD of the tube P and uses the pusher 3 to move the embryo transfer device 1" in the connecting part 2 through the tube P to the uterine cavity 210. At this time, the embryo storage section guide 67 deploys in the Y direction within the uterine cavity 210.

[0092] The embryo transfer device 1" may further include the rod-shaped member 54 of the second embodiment connected to the base end of the embryo storage unit 20. In this case, one end of the thread 11 is fixed to the base end of the rod-shaped member 54. The embryo transfer device 1" may also include the pair of spreading frame members 30 of the first embodiment, the other ends of which, as referred to in the first embodiment, are fixed to the base end of the embryo storage unit 20. In this case, the proximal end portions 10 are fixed to the one ends, as referred to in the first embodiment, of the pair of spreading frame members 30, and one end of the thread 11 is fixed to the base end of the proximal end portions 10. The other end of the thread 11 may be loop-shaped or the like to facilitate removal of the embryo transfer device 1.

[0093] In each of the above embodiments, a configuration without an embryo storage unit guide may also be employed. For example, as shown in Figures 23 and 24 of the second embodiment, the cross-sectional shape of the base end of the embryo storage unit 20 may be a substantially polygonal shape, such as a substantially hexagonal shape, and part or all of the inner circumferential surface of the tube P may have a cross-sectional shape complementary to that of the base end of the embryo storage unit 20. In the example shown in Figure 24, two convex portions (protrusions) are formed at the two upper vertices of the cross-section of the base end of the embryo storage unit 20, and two concave portions (grooves) are formed at corresponding positions on the inner circumferential surface of the tube P. In Figure 24, the two convex portions and the two concave portions are configured to engage with each other around the X axis. One of the effects of this configuration is to suppress or prevent rotation of the embryo storage unit 20 after it leaves the tip of the tube P.

[0094] 24, not only the base end of the embryo storage unit 20 but also the cross-sectional shape of the rod-shaped member 54 and / or the cross-sectional shape of the proximal end 10 may be similar to that of the base end of the embryo storage unit 20. One of the effects of this configuration is to more effectively suppress or prevent rotation of the embryo storage unit 20 after it leaves the tip of the tube P.

[0095] Furthermore, a protrusion may be provided on at least one of the embryo storage unit 20, the rod-shaped member 54, and the proximal end 10, and a groove that engages with the protrusion around the X-axis may be formed on the inner circumferential surface of the tube P. One of the effects of this configuration is to suppress or prevent rotation of the embryo storage unit 20 after it leaves the tip of the tube P. Note that the protrusion may be provided on the inner circumferential surface of the tube P, and the groove may be provided on at least one of the embryo storage unit 20, the rod-shaped member 54, and the proximal end 10. The configuration in which the protrusion and the recess engage with each other around the X-axis and the configuration in which the protrusion and the groove engage with each other around the X-axis may also be adopted as appropriate in the first and third embodiments.

[0096] Furthermore, it is preferable that the cross-sectional shape of the inner peripheral surface of the tube P is substantially elliptical or substantially polygonal. As described in the above embodiments, the pair of spreading frame members 30, 50, 51, 52, 53 and the pair of guide members 61, 66, 68 of the embryo storage unit guides 60, 65, 67 are close to each other when inserted into the tube P, and a restoring force is generated in the Y-direction to open them. Therefore, if the cross-sectional shape of the inner peripheral surface of the tube P is elliptical or polygonal, the restoring force makes it difficult for the pair of spreading frame members 30, 50, 51, 52, 53 and the pair of guide members 61, 66, 68 to rotate around the X-axis within the tube P. In other words, one of the effects of having the cross-sectional shape of the inner peripheral surface of the tube P be that it suppresses or prevents rotation of the embryo storage unit 20 after it leaves the tip of the tube P. As described above, the rotational restriction around the X-axis of the embryo transfer device 1, 1', 1'', the unfolding frame 30, 50, 51, 52, 53, the guide 61, 66, 68, etc. within the tube P can be typically achieved by the fact that the cross section of the inner circumferential surface of the tube P perpendicular to the X-axis is not perfectly circular, as described above. In this case, as described above, the rotational restriction can be achieved even if the cross section of many parts of the embryo transfer device 1, 1', 1'' perpendicular to the X-axis is circular. The non-circular cross section of the inner circumferential surface of the tube P can also be achieved by providing one or more protrusions or grooves extending in the X-axis direction on the inner circumferential surface having a circular cross section. When multiple protrusions or grooves are provided, the height of each protrusion or the depth of each groove is 3 μm or more, preferably 8 μm or more, and more preferably 10 μm or more. Even such small protrusions or grooves can sufficiently achieve the rotational restriction, which, as one of its effects, contributes to securing space within the tube P and reducing the diameter of the tube P.

[0097] In each of the above embodiments, a configuration may be adopted in which the embryo storage unit guides 60, 65, and 67 are not provided. Even in this case, the rotation of the embryo storage unit 20 can be suppressed or prevented by the above-mentioned configuration or other configurations.

[0098] Furthermore, a rotation restriction structure may be provided on the distal end of the connection part 2, 2'. The rotation restriction structure restricts rotation of the connection part 2, 2' relative to the tube P around an axis extending in the X direction. As the rotation restriction structure, for example, a convex portion (protrusion) is formed on the distal outer peripheral surface of the tube part 71. In this case, a concave portion (groove) is formed at a position corresponding to the convex portion on the inner peripheral surface of the hole PH of the tube P. As the rotation restriction structure, the distal end of the tube part 71 may be formed to have a polygonal cross section. In this case, the hole PH is formed so that the distal end of the tube part 71 engages with the axis. One of the effects of the rotation restriction structure is that it is useful for achieving stable implantation of the embryo E.

[0099] It is also possible for the embryo transfer device 1 to have three or more expanding frame parts. For example, in the embodiment of Fig. 2, one expanding frame part 30 in the Y direction may be made up of two expanding frame parts arranged overlapping in the Z direction, and the other expanding frame part 30 in the Y direction may be made up of two expanding frame parts arranged overlapping in the Z direction. In this case, the embryo transfer device 1 would have four expanding frame parts.

[0100] 2 of the embryo transfer device 1, one end of the member may be connected to the proximal end portion 10, and the other end of the member may be connected to the embryo storage portion 20. In this way, in each of the above embodiments, additional members, structures, etc. not explicitly stated in the above description may be added as appropriate.

[0101] It is also possible to provide an embryo storage section 20 at the distal end 1B of the embryo transfer device 1" shown in Figure 25. In this case, two embryo storage sections would be provided in the embryo transfer device 1". Alternatively, it is also possible to provide an embryo storage section 20 on each of the pair of unfolding frame sections 30 of the embryo transfer device 1. In this case, multiple embryo storage sections would be provided in the embryo transfer device 1. It is also possible that the tips of the two guide sections 68 of the embryo transfer device 1" are not connected to each other. Even in this case, the guide sections 68 provide resistance to the movement of the embryo storage section 20 within the uterine cavity 210.

[0102] 26, a flat portion (curvature reduction portion) 73A may be provided around the window 73 of the connection part 2. There may also be portions around the window 73 where the flat portion 73A is not provided. In the case of FIG. 26, flat portions 73A are provided on both sides of the window 73 in the Y direction, extending over the entire X direction of the window 73, and no flat portion 73A is provided in other portions. The presence of the flat portions 73A reduces the curvature of the central liquid surface WS at the center of the window 73 when the injected liquid becomes convex at the window 73 due to surface tension, as shown in FIG. 26. One of the effects of this configuration is that it is useful for accurately observing the interior of the recess 21 with the liquid injected using a microscope or the like. Note that, as shown in FIG. 27, an extension portion 71B extending in the Y direction from the tube portion 71 may also be provided as the curvature reduction portion.

[0103] In the first embodiment, the embryo transfer device 1, connecting part 2, tube P, pusher 3, and stylet 4 may be sold in the same package, or only some of these may be sold in the same package. In the first embodiment, the embryo transfer device kit may not include the tube P, pusher 3, and stylet 4. Even in this case, the user can use other tubes, push rods, stylets, etc. to place the embryo transfer device 1 with an embryo E stored in the embryo storage unit 20 into the uterine cavity 210 as described above. This modification of the first embodiment can also be applied to the embryo transfer device kits of the second and third embodiments.

[0104] The thread 11 can be a multifilament thread made of synthetic resin, a monofilament thread, or other known threads. Alternatively, as shown in FIG. 28 , the thread 11′ can be formed integrally with the embryo transfer device 1 using the mold. In this case, the thread 11′ is also formed from the same rubber-like elastic material as the embryo transfer device 1. In this case, a coating layer 12 made of synthetic resin or a rubber-like elastic material can be formed around the thread 11′. The rubber-like elastic material of the coating layer 12 preferably has a rubber hardness that is 5 points or more higher, more preferably 10 points or more higher, than the material of the embryo transfer device 1. One of the effects of the coating layer 12 is to prevent or suppress elongation of the thread 11′, which improves the operability when removing the embryo transfer device 1 from the uterine cavity 210.

[0105] The pair of guide portions 61, 66, 68 of the embryo storage unit guides 60, 65, 67 are close to each other inside the connecting part 2 and the tube P, and when removed from the tube P, they move apart in the Y direction, thereby unfolding the pair of guide portions 61, 66, 68. When removed from the tube P, the pair of guide portions 61, 66, 68 unfold in a direction away from the central axis CL of the distal end of the tube P. One of the effects of this configuration of the pair of guide portions 61, 66, 68 is that it is useful for reducing damage to the cervix 220, uterine cavity 210, etc. during device insertion / removal and for improving the success rate of implantation. Note that one of the guide portions 61, 66, 68 in the Y direction may be composed of two guide portions overlapping in the Z direction, and the other guide portion 61, 66, 68 in the Y direction may be composed of two guide portions overlapping in the Z direction. In this case, the embryo transfer device 1, 1', 1'' would have four unfolding frame portions.

[0106] Here, it is preferable that the thickness of the wall 21A near the opening 22 in the X-direction intermediate portion of the recess 21 of the embryo storage unit 20 shown in FIG. 13 be thin. In this embodiment, the thickness of the wall 21A is 0.15 mm or less. The thickness of the wall 21A is preferably 0.2 mm or less, more preferably 0.15 mm or less, and even more preferably 0.12 mm or less. In this embodiment, the height of the wall 21A along the Z-axis is 0.4 mm or more. This height is preferably 0.3 mm or more. It is preferable that the thickness of the wall 21A near the opening 22 in the Z-axis direction be 0.2 mm or more, more preferably 0.3 mm or more. Note that the effects described below can be achieved with dimensions other than those described above. Furthermore, the effects described below can be achieved even if the thickness dimensions of the walls other than the X-direction intermediate portion of the recess 21 and the walls 21B and 21C ( FIG. 29 ) at one and the other ends of the recess 21 in the X-direction are not the above dimensions.

[0107] In this embodiment, the wall 21A near the opening 22 of the recess 21 elastically deforms toward the inside of the recess 21 within the connecting part 2, as shown by the two-dot chain line in Fig. 13. In this embodiment, the wall 21A is hardly elastically deformed within the range of the window 73 of the connecting part 2, but is elastically deformed within the range of the window 73 of the connecting part 2 as shown by the two-dot chain line in Fig. 13. Note that the wall 21A near the opening 22 is also elastically deformed within the tube P. When the embryo storage part 20 is removed from the tube P, the wall 21A returns or attempts to return to its shape before elastic deformation due to the restoring force of the elastic deformation.

[0108] One of the effects of this configuration is that it is useful for increasing the volume within the recess 21. The embryo storage section 20 is formed to pass through a thin tube P, and the volume of the recess 21 is accordingly limited. Furthermore, the concentration of the liquid stored in the recess 21 together with the embryo E changes due to evaporation, etc., and the smaller the volume of the recess 21, the faster the concentration of the liquid changes. Since the concentration of the liquid may affect the implantation probability, the above configuration, which can increase the volume within the recess 21, is useful.

[0109] The inner diameter of the connection part 2 does not need to be constant. For example, it is possible to adopt a configuration in which the diameter of the inner peripheral surface of the tube portion 71 of the connection part 2 gradually decreases toward the tip of the connection part 2, or a configuration in which the cross-sectional shape of the inner peripheral surface of the connection part 2 changes.

[0110] The wall 21A, which flexibly and elastically deforms toward the inside of the recess 21 within the connecting part 2 and the tube P, is also likely to elastically deform when the embryo storage unit 20 leaves the tip of the tube P and enters the uterine cavity 210, or when it moves within the uterine cavity 210. This is undesirable for stabilizing the posture of the embryo storage unit 20 within the uterine cavity 210, but in this embodiment, the posture of the embryo storage unit 20 is stabilized by the embryo storage unit guides 60, 65, and 67. In other words, one of the effects of this embodiment is that it is possible to stabilize the posture of the embryo storage unit 20 within the uterine cavity 210 while suppressing changes in the concentration of the liquid within the recess 21.

[0111] FIG. 29 shows a modified example of the cross section taken along line XXIX-XXIX in FIG. 2. As shown in FIG. 29, the inner surfaces of the wall 21B at one end of the recess 21 in the X direction and the wall 21C at the other end thereof may be inclined away from each other from the bottom of the recess 21 toward the opening. In this embodiment, the inner surfaces of the walls 21B and 21C are inclined at an angle of 10° or more with respect to the Z axis, and more preferably at an angle of 15° or more. One of the effects of this configuration is that, when the opening 22 of the recess 21 is in contact with or close to the target wall of the uterine cavity 210, the embryo E can move smoothly toward the target wall. Another effect of this configuration is that it is useful for making it difficult for air bubbles to remain within the recess 21. To make it difficult for air bubbles to remain within the recess 21, it is preferable to form corners R within the recess 21. It can also be said that this reduces the likelihood of the embryo E becoming trapped in the corners of the recess 21 when the inner wall is parallel to the Z axis. In the cross section shown in FIG. 13, the inner surfaces of the walls 21A on both sides in the Y direction may be inclined in the same manner.

[0112] 29, the embryo storage unit 20 may be provided with one or more perfusion holes 21D that communicate from the outside of the embryo storage unit 20 to the inside of the recess 21. One of the effects of this configuration is to assist in replacing the liquid inside the recess 21 with the liquid outside the embryo storage unit 20 within the uterine cavity 210. In this embodiment, the inner diameter of the perfusion hole 21D is smaller than the outer diameter of the embryo E, and in one example, the inner diameter of the hole 21D is 0.1 mm or less.

[0113] Furthermore, it is preferable that a mark M shown in Fig. 7 be provided on the proximal end side of the pusher 3. A scale may be provided instead of the mark M. The mark M or scale is a guide for the user to recognize the insertion depth of the pusher 3 into the tube P. In the example shown in Fig. 7, the pusher 3 is configured so that when it is inserted into the tube P to the position required to push the entire embryo transfer device 1 out of the tube P, the mark M coincides with the proximal end of the tube P or the connecting part 2. In other words, the mark M or scale indicates that the pusher 3 has been inserted to the position required to push the entire embryo transfer device 1 out of the tube P.

[0114] 30 and 31 , in the second embodiment, the rod-shaped member 54 can be thinned so that it can be inserted into the pipe-shaped pusher 3. In this case, as shown in Fig. 30 and 31 , an engaging portion 3A, which is a notch, may be provided at the tip of the pusher 3, and an engaged portion 25 that engages with the engaging portion 3A in the circumferential direction of the pusher 3 may be provided at the tip of the rod-shaped member 54 or the embryo storage unit 20. One of the effects of this configuration is that it can prevent or suppress rotation of the embryo storage unit 20 around the central axis of the tube P when a user pushes the connecting part 2 and the embryo transfer device 1 in the tube P with the pusher 3.

[0115] A protrusion may be provided at the tip of the pusher 3, and a recess, groove, or the like corresponding to the protrusion may be provided at the tip of the embryo storage section 20 or the rod-shaped member 54. The engaging section 3A may be a groove or the like on the inner circumferential surface of the pusher 3. It is also possible to adopt another configuration in which the engaging section 3A and the engaged section 25 engage with each other in the circumferential direction. This configuration can also be applied to the third embodiment, and to the first embodiment in which the deployment frame section 30 and the proximal end section 10 are narrowed.

[0116] Although the above embodiment describes the application of a hydrophilic treatment to the interior of the recess 21, it is also possible to apply a hydrophobic treatment to the interior of the recess 21. The hydrophobic treatment can be performed by known methods such as fluororesin coating or surface film formation by CVD. Applying a hydrophobic treatment to the interior of the recess 21 makes it easier for the embryo E to escape from the recess 21. A structure in which the inner surfaces of the walls 21B and 21C are inclined away from each other from the bottom of the recess 21 toward the opening is also useful for facilitating the embryo E to escape from the recess 21. Such an ejection means for facilitating the embryo E to escape from the recess 21 is useful for improving the implantation rate. For example, when a user can easily observe the embryo E in the recess 21 using a microscope or when observation of the embryo E in the recess 21 is not necessary, the ejection means is extremely useful in the technical field because it improves the implantation rate. It is, of course, possible to apply a parylene coating, which is often used in medical devices, to the interior of the recess 21 as the treatment. By coating the recess 21 made of a material with rubber-like elasticity such as silicone rubber with parylene, it is expected that the biocompatibility of the recess 21 will be improved (the survival rate of the embryo will be increased) and that the embryo E will be able to roll more easily within the recess 21. When the portions of the embryo transfer device other than the recess 21 are coated with parylene, the effect of improving the slipperiness within the tube P of the embryo transfer device can be obtained.

[0117] Alternatively, a perfusion hole similar to the hole 21D may be provided in any one of the walls 21A, 21B, and 21C of the recess 21. When the embryo storage unit 20 is placed in the tube P or the storage unit 71A, any one of the walls 21A, 21B, and 21C may be elastically deformed so as to be folded inside the recess 21. In this case, when the embryo storage unit 20 is removed from the tube P, the folded portion of any one of the walls 21A, 21B, and 21C is deformed in the restoration direction by the reaction force of the elastic deformation.

[0118] Furthermore, in each of the above embodiments, after injecting the embryo E and liquid into the recess 21, the user may use an instrument such as tweezers to place a biodegradable membrane 90 on the opening of the recess 21 as shown in FIG. 32 so as to close the opening of the recess 21. In this embodiment, placing the membrane 90 so as to close the opening of the recess 21 means placing the membrane 90 so as to close 50% or more of the opening area. Preferably, the membrane 90 closes 70% or more of the opening area, and more preferably, the membrane 90 closes 80% or more of the opening area. The membrane 90 may be placed so that the edges of the membrane 90 adhere to any or all of the walls 21A, 21B, and 21C of the recess 21.

[0119] 33, a membrane 90 may be placed over the opening of the recess 21 to close the opening before the embryo E and liquid are injected into the recess 21. In this case, the edges of the membrane 90 are fixed to any or all of the walls 21A, 21B, and 21C of the recess 21 with a biodegradable adhesive or glue. In this case, when the embryo E and liquid are injected into the recess 21 using the embryo injector 80 as in each of the above embodiments, a hole can be made in the membrane 90 with the tip of the embryo injector 80, and the embryo E and liquid can be injected into the recess 21 through the hole.

[0120] Known biodegradable materials can be used for the membrane 90, the adhesive, or the glue. The membrane 90, the adhesive, and the glue are decomposed or dissolved by the liquid or body fluid, preferably within a few minutes, tens of minutes, or several hours. The dissolved state is a state in which the opening of the recess 21 is not substantially closed by the membrane 90, and the embryo E can come out of the recess 21.

[0121] One of the effects of each of the above configurations is that the membrane 90 prevents the embryo E from dropping out of the recess 21 before the embryo storage unit 20 leaves the tube P and is placed in the uterine cavity 210. Also, one of the effects of each of the above configurations is that the membrane 90 suppresses evaporation of the liquid in the recess 21.

[0122] Furthermore, another opening that opens in the opposite direction to the opening 22 in the Z direction may be provided in the embryo storage unit 20 at a position corresponding to the bottom surface of the recess 21. For example, the other opening may be provided across the entire bottom surface of the recess 21. In this case, for example, the edge of the membrane 90 may be fixed to the other opening, and the membrane 90 may be positioned to close the other opening. For example, the membrane 90 may completely close the other opening, or may close 90% or more of the opening area. After the embryo transfer device 1 is placed in the uterine cavity 210, if the membrane 90 decomposes or dissolves and the other opening opens, the embryo E may be implanted on the uterine inner wall on the side of the other opening.

[0123] In each of the above embodiments, a slanted portion 71C extending obliquely upward may be formed at one end or the other end of the storage portion 71A of the connecting part 2. When the connecting part 2 is viewed from the Y direction as shown in Figure 34, the direction of the central axis CL2 of the slanted portion 71C is inclined at 30° relative to the direction of the central axis CL1 of the central portion of the storage portion 71A. However, this inclination may be 3° or more, preferably 5° or more. When liquid and embryos E are injected into the recess 21 of the embryo storage portion 20 in the storage portion 71A, some of the liquid that does not enter the recess 21 enters the gap between the embryo storage portion 20 and the storage portion 71A, as shown in Figures 26 and 27. One of the effects of the configuration of the slanted portion 71C is that it prevents the liquid that has entered the gap from exiting the end of the storage portion 71A, which is useful for suppressing concentration changes due to evaporation of the liquid. The above concept of providing the slanted portion 71C also includes forming the entire storage portion 71A so that it is curved downward. Even in this case, an inclined portion 71C is formed on at least one of the ends of the storage portion 71A, and the inclination of the central axis CL2 of the inclined portion 71C with respect to the X-axis is equal to or greater than 3° as described above. Even if the angle is less than 3°, the configuration of the inclined portion 71C is useful as long as the effect of preventing liquid from leaking out of the end of the storage portion 71A is achieved as described above.

[0124] An embryo transfer device kit according to the fourth embodiment will be described below with reference to Figures 35 to 44. The embryo transfer device 5 according to the fourth embodiment is a modified version of the embryo transfer device 1' according to the second embodiment, as shown in Figures 35 to 37. In the embryo transfer device 5, descriptions of components similar to those in the second embodiment will be omitted, and the reference numerals and names of those components will be used as necessary in the fourth embodiment.

[0125] The configuration of the embryo storage section guide 60 on the distal end 1B side of the embryo transfer device 5 is the same as in the second embodiment, but the rod-shaped member 54 on the proximal end 1A side of the embryo transfer device 5 is different from the second embodiment.

[0126] The proximal end 10 of the embryo transfer device 5 is provided with a plurality of deployment sections 13. The base end of each deployment section 13 is fixed to the proximal end 10, and the other end of each deployment section 13 extends in a direction away from the X-axis. Similar to the deployment frame section 30 and the guide section 61, the multiple deployment sections 13 approach each other when they enter the tube P, and deploy in a direction away from the X-axis when they emerge from the tube P into the uterine cavity 210. In the fourth embodiment, the multiple deployment sections 13 deploy in the Y-direction.

[0127] A hole 54A extending in the X direction is formed inside the rod-shaped member 54 and the proximal end 10. As shown in Figure 37, a wall 54B is provided between the hole 54A and the recess 21 of the embryo storage section 20. In other words, the hole 54A extends from the proximal end 1A of the embryo transfer device 5 to the wall 54B.

[0128] A through-hole 54C is formed in the wall 54B, connecting the hole 54A and the recess 21. The diameter of the through-hole 54C is smaller than the diameter of the hole 54A, and is preferably equal to or smaller than half the diameter of the hole 54A. The through-hole 54C may have another shape, such as a cross shape. In one example, the diameter of the through-hole 54C is equal to or smaller than the outer diameter of the embryo E.

[0129] In the embryo transfer device kit according to the fourth embodiment, a pusher 6 is used instead of the pusher 3. The pusher 3 only pushes the proximal end 10, but in the fourth embodiment, the pusher 6 may also push the embryo storage unit 20 or its vicinity. The pusher 6 also has a thin pipe shape made of plastic, metal, or the like, and as shown in Figures 38 to 42, the tip 6A of the pusher 6 is thinner than its base end. The outer diameter of the tip 6A is preferably 1.2 mm or less, more preferably 1 mm or less, but the outer diameter of the tip 6A may exceed 1.2 mm.

[0130] 42, a discharge device 7 such as a micropipette or a microsyringe is attached to the base end of the pusher 6. The discharge device 7 can suck gas and / or liquid inside the base end side of the pusher 6, and can also supply gas and / or liquid inside the base end side of the pusher 6. It is also possible to use a discharge device 7 such as a micropipette whose cylinder is driven by a motor.

[0131] 38 to 41, the tip of the tip portion 6A is open not only in the X direction but also in directions intersecting the X direction (Z direction and / or Y direction). For this reason, an X-direction opening 6B and an intersecting direction opening 6C are formed at the tip of the tip portion 6A. Note that there may be cases where only the X-direction opening 6B is provided at the tip of the tip portion 6A.

[0132] In the first to third embodiments, the user uses an embryo injector 80 or the like to inject the embryo E and liquid into the recess 21 of the embryo storage unit 20 placed in the storage unit 71A. In the fourth embodiment, the user places the embryo E and the liquid inside the pusher 6. To do this, the user inserts the tip 6A into a container containing the embryo E and the liquid, and in this state, uses the discharge device 7 to aspirate the gas and / or liquid inside the base end side of the pusher 6. As a result, the embryo E and the liquid are placed inside the pusher 6 as shown in Figure 38. Typically, more liquid is placed inside the pusher 6 than in the state shown in Figure 38.

[0133] Next, the user inserts the tip 6A into the hole 54A from the side of the proximal end 1A of the embryo transfer device 5. If the rod-shaped member 54 has a groove or notch extending in the X direction instead of the hole 54A, the user inserts the tip 6A into the groove or notch. In this embodiment, this insertion is performed while the embryo transfer device 5 is placed in the container 71A (FIG. 40). As such, this insertion is preferably performed in a position that does not affect the patient's body. However, the above insertion may also be performed before the embryo transfer device 5 is placed in the container 71A.

[0134] During the insertion of the tip portion 6A into the hole 54A, the tip side of the tip portion 6A passes through the through-hole 54C, and the tip of the tip portion 6A is placed in the recess 21. Since the wall 54B is made of the same rubber-like elastic material as the embryo storage section 20 and the rod-shaped member 54, the tip portion 6A pushes and widens the through-hole 54C, thereby inserting the tip side of the tip portion 6A through the through-hole 54C. Therefore, after the pusher 6 is pulled out, the through-hole 54C returns to its original size.

[0135] Next, the user moves the embryo transfer device 5, housed within the connecting part 2, close to the patient. Then, the user connects the distal end of the connecting part 2 to the proximal end PD of the tube P, the distal end of which is placed within the uterine cavity 210 as described above, and in this state uses the pusher 6 to place the embryo transfer device 5 into the uterine cavity 210 via the tube P (FIG. 42). The movement and function of the embryo storage unit guide 60 at this time are the same as those in the first to third embodiments.

[0136] Next, the user supplies gas and / or liquid to the inside of the proximal end of the pusher 6 using the discharge device 7 in order to place the embryo E in the recess 21. At this time, the amount of gas and / or liquid supplied per unit time is preferably adjusted to be extremely small. As a result, the embryo E is placed in the recess 21 as shown in Figure 41.

[0137] Next, as shown in Figure 41 , the user pulls the pusher 6 in the direction of arrow A2 while applying force to the tube P in the direction of arrow A1 as needed, to remove the pusher 6 from the tube P. At this time, as shown in Figure 42 , the multiple deployment portions 13 protruding from the tube P are deployed in the Y direction. The deployed deployment portions 13 prevent or inhibit the proximal end 1A of the embryo transfer device 5 from re-entering the tube P, the embryo transfer device 5 from moving toward its proximal end 1A, etc.

[0138] The user then removes the tube P from the uterine cavity 210 and the cervix 220, and places the embryo transfer device 5 in the uterine cavity 210. Even in this case, the embryo transfer device 5 still exhibits the aforementioned effects of the embryo transfer device 1' placed in the uterine cavity 210, and the embryo storage unit guide 60 also exhibits the aforementioned effects. Note that it is also possible to eliminate the bottom wall of the recess 21 of the embryo storage unit 20 of the embryo transfer device 5 and instead make the recess 21 a hole penetrating in the Z direction.

[0139] 43, the embryo storage section guide 65 described above can be used instead of the embryo storage section guide 60. Also, the embryo storage section guide 67 described above can be used instead of the embryo storage section guide 60. In this case, the proximal end 1A of the embryo transfer device 5 can serve as the embryo storage section 20 as shown in FIG.

[0140] Furthermore, as shown in Figure 44, the opening at the tip of the tip portion 6A of the pusher 6 may be located within the area surrounded by the embryo storage section guides 65, 67. In Figure 44, a through-hole similar to the through-hole 54C is also provided in the wall 21B of the recess 21. In this case, the user supplies gas and / or liquid to the inside of the proximal end of the pusher 6 using the discharge device 7 to place the embryo E within the surrounded area. In this case, the embryo transfer device 5 is placed within the uterine cavity 210 with the embryo E placed within the surrounded area. This configuration and method may also achieve the same effect as when the embryo E is placed within the recess 21. In the case of Figure 44, an embryo transfer device 5 without an embryo storage section 20 may also be used.

[0141] As described above, when forming the unfolding frame portion 30 using a mold, a string-like member, a strip-like member, a thread-like member, or the like, with the small spheres or particles embedded therein, can be positioned in a position corresponding to the unfolding frame portion 30 of the mold. Using insert molding in this manner allows the small spheres or particles to be reliably positioned in a narrow portion such as the unfolding frame portion 30. Alternatively, a substrate having rubber-like elasticity, such as TPU (thermoplastic polyurethane elastomer), can be dissolved in a solvent, the small spheres or particles can be mixed into the solution, and the mixed solution can be applied to the unfolding frame portion 30 and allowed to dry, thereby allowing the small spheres or particles to be positioned in a narrow portion such as the unfolding frame portion 30. Depending on the conditions, it may also be possible to attach a metal marker to, for example, the outer widthwise portion 18 of the unfolding frame portion 30.

[0142] Although the embodiments of the present disclosure have been described in detail, the present disclosure is not limited to the individual embodiments described above. These embodiments can be variously added, replaced, modified, partially deleted, etc., without departing from the gist of the invention or the concept and spirit of the present invention derived from the content of the claims and their equivalents. For example, in the above-described embodiments, the order of each operation, the order of each process, the omission or addition of some operations depending on conditions, and the omission or addition of some processes depending on conditions can be changed without being bound by the above examples. The same applies when numerical values ​​or mathematical expressions are used in the description of the above embodiments.

[0143] DESCRIPTION OF SYMBOLS 1, 1', 1'': Embryo transfer device 1A: Proximal end 1B: Distal end 2, 2': Connecting part 3: Pusher 3A: Engagement part 4: Stylet 5: Embryo transfer device 6: Pusher 7: Discharge device 10: Proximal end 11, 11': Thread 12: Coating layer 20: Embryo storage part 21: Recess 21A, 21B, 21C: Wall 21D: Hole 22: Opening 25: Engaged part 30, 50, 51, 52, 53: Deployment frame part 54: Rod-shaped member 54A: Hole 54A 54B: Wall 54C: Through-hole 60, 65, 67: Embryo storage part guide 61, 66, 68: Guide part 71: Tube part 71A : Storage portion 72 : Rotation restricting portion 73 : Window 73A : Flat portion E : Embryo P : Tube PD : Base end portion PH : Hole CL : Central axis

Claims

1. An embryo transfer device kit comprising: a connecting part connected to a base end of a tube whose tip is placed inside a uterus and whose base end is placed outside the uterus; and an embryo transfer device at least a portion of which is contained in a container provided on the connecting part so as to extend in a predetermined direction, wherein the embryo transfer device has an embryo storage section having a recess which opens in a direction intersecting the predetermined direction, and when the embryo storage section is placed in the uterine cavity, it is for holding an embryo placed in the recess in a space surrounded by the endometrium of the uterine cavity which is present in the direction of the opening of the recess and the recess.

2. The embryo transfer device kit of claim 1, wherein the connection part has a window at a position corresponding to the embryo storage section of the embryo transfer device, at least a portion of which is accommodated in the accommodation section, and the window enables access to the recess of the embryo storage section from outside the connection part.

3. The embryo implantation device kit of claim 1, further comprising a pusher for moving the embryo implantation device, at least a portion of which is contained within the connection part connected to the base end of the tube, into the interior of the tube, the pusher being configured to be able to push out the embryo implantation device that has been moved into the interior of the tube from the tip of the tube.

4. An embryo transfer device kit according to any one of claims 1 to 3, wherein the connecting part has a rotation restricting portion that restricts rotation around an axis extending in the specified direction when placed on a flat surface.

5. An embryo transfer device kit as described in any one of claims 1 to 3, wherein a rotation control structure is provided on the tip side of the connecting part, and the rotation control structure controls the rotation of the connecting part relative to the tube.

6. An embryo transfer device kit according to any one of claims 1 to 3, wherein a hole having a cross-sectional area that decreases from the base end to the tip end is formed on the base end side of the tube.

7. The embryo transfer device kit of claim 3, wherein the pusher has a pusher tip and a pusher base end, is inserted into the base end of the tube from the pusher tip, and the pusher is provided with markings or scales that enable a user to recognize the position of the pusher tip relative to the tip of the tube.

Images