Oocyte collection needle and embryo transfer instrument

Abstract

An oocyte collection needle 1 comprises a hollow needle 2 having a puncture blade surface 23, a hollow grip 3 having an indicating protrusion 34 associated with the direction of the puncture blade surface, and a tubular covering part 33 covering a part including the indicating protrusion 34. An embryo transfer instrument 10 comprises a flexible tube 6 having a curved tip, and a hollow grip 7. The hollow grip 7 comprises an indicating protrusion 74 associated with the curved direction of the flexile tube 6, and a tubular covering part 73 covering a part including the indicating protrusion 74. The tubular covering parts 33 and 73 have high static friction, transparency and flexibility. The indicating protrusions can be visually and tactilely recognized from outside the tubular covering parts.

Description

Egg collection needles and embryo transfer instruments

[0001] The present invention relates to an oocyte collection needle for collecting oocytes and an embryo transfer instrument used when transferring an embryo (a fertilized egg) fertilized in vitro into the uterus of a living organism.

[0002] Instruments used in reproductive medicine, such as oocyte collection needles and embryo transfer instruments, have a tubular body (needle tube) as their main component, and some have a cutting edge and a curved tip at their tip. During and after insertion into a living body, it has been difficult to confirm the direction of the cutting edge and the curved tip after the tip of the tubular body has been inserted into the living body.

[0003] The present inventors have proposed an egg collection needle for collecting eggs, as disclosed in Utility Model Registration No. 3149897 (Patent Document 1). This egg collection needle 1 comprises a hollow needle 2 having a hollow main body 22 extending a predetermined length, a hollow small-diameter tip portion 21 that extends distally from the main body 22 and has a smaller diameter than the main body 22, and a hub 34 fixed to the proximal end of the main body 22 of the hollow needle 2. Furthermore, the tip of the hollow small-diameter tip portion 21 is provided with a cutting edge portion consisting of a puncturing blade surface 23 and a curved side portion that curves toward the puncturing blade surface 23, the hollow small-diameter tip portion 21 is coated with a low-friction material, and the hub 34 is provided with a marker 38 associated with the orientation of the puncturing blade surface 23.

[0004] Embryo transfer instruments have also been used for transferring embryos (fertilized eggs) fertilized in vitro into the uterus of a living organism. The present inventors have proposed an embryo transfer instrument, as disclosed in Japanese Patent Laid-Open Publication No. 2004-129789 (Patent Document 2). This embryo transfer instrument 1 includes a flexible sheath 2 having a passageway extending from its distal end to its proximal end and a spherical bulge 22 on the outer surface of the distal end; a flexible stylet 3 that is removably inserted into the flexible sheath and whose distal end protrudes slightly beyond the distal end surface of the sheath; and a transplantation tube body 4 that can be inserted into the flexible sheath 2 after the stylet has been removed and that has a soft distal end portion 41a that protrudes a predetermined length beyond the distal end of the flexible sheath 2.

[0005] Utility Model Registration No. 3149897 JP 2004-129789 A

[0006] In the device disclosed in Patent Document 1, the hub is provided with a marker that corresponds to the orientation of the puncture blade, making it easy to confirm the orientation of the blade. However, the marker is formed from a rib, which can be confirmed by touch. However, the inventors of the present application found that, because it is a rib, there is a possibility that a finger may slip on the surface of the rib.

[0007] Furthermore, in the embryo transfer instrument of Cited Document 2, the tip of the flexible sheath 2 has a curved portion, but after the curved tip of the flexible sheath 2 is inserted into a living body, it is difficult to grasp the direction of curvature of the tip of the flexible sheath 2, and it is not easy to position the curved tip of the flexible sheath 2 in the appropriate direction.

[0008] The object of the present invention is to provide an ovum collection needle and embryo transfer instrument for use in reproductive medicine, such as an ovum collection needle or embryo transfer instrument, which has a tubular body (needle tube) as its main component and which has a cutting edge and a curved tip at its tip, and which allows easy confirmation of the direction of the cutting edge and the direction of curvature of the curved tip after the tip of the tubular body is inserted into the living body during and after insertion into the living body, and which provides good gripping ability of the hollow grip fixed to the rear end of the tubular body (needle tube) during insertion into the living body.

[0009] The above object is achieved by the following: An egg collection needle for collecting eggs from follicles, the egg collection needle comprising: a hollow needle with a cutting edge having a puncturing blade surface; and a hollow grip fixed to the rear end of the hollow needle, the hollow grip comprising: a hollow grip body; an index protrusion that is associated with the orientation of the puncturing blade surface and extends in the direction of the cutting edge of the hollow needle at the axial center of the hollow grip body; and a non-slip tubular covering that covers the axial center of the hollow grip body including the index protrusion, the tubular covering having high static friction, transparency, and flexibility, and the index protrusion that is associated with the orientation of the puncturing blade surface covered by the tubular covering can be recognized visually and tactilely from the outside of the tubular covering.

[0010] The above object can be achieved by the following: An embryo transfer instrument used when transferring an embryo into a living organism, the embryo transfer instrument comprising: an outer tube member having a flexible tube with a passageway penetrating from its front end to its rear end, and a hollow grip fixed to the rear end of the flexible tube; and a stylet member removably inserted into the outer tube member, the front end of which is substantially flush with or slightly protrudes from the front end surface of the flexible tube; The flexible tube has a curved tip portion, and the hollow grip has a hollow grip body, an index protrusion that is associated with the curved direction of the curved tip portion of the flexible tube and extends toward the tip of the flexible tube at the axial center of the hollow grip body, and a non-slip tubular covering that covers the axial center of the hollow grip body including the index protrusion, the tubular covering having high static friction, transparency, and flexibility, and the index protrusion that is associated with the curved direction of the flexible tube covered by the tubular covering can be recognized visually and tactilely from outside the tubular covering.

[0011] FIG. 1 is a partially omitted front view of one embodiment of the ovum collection needle of the present invention. FIG. 2 is a partially omitted external view of the ovum collection needle shown in FIG. 1. FIG. 3 is a partially omitted enlarged cross-sectional view of the ovum collection needle shown in FIG. 2. FIG. 4 is an enlarged front view of a hollow grip used in the ovum collection needle shown in FIG. 1. FIG. 5 is a plan view of the hollow grip shown in FIG. 4. FIG. 6 is a perspective view of the hollow grip shown in FIG. 4. FIG. 7 is a cross-sectional view taken along line A-A in FIG. 4. FIG. 8 is a cross-sectional view taken along line B-B in FIG. 5. FIG. 9 is a cross-sectional view taken along line C-C in FIG. 4. FIG. 10 is an enlarged cross-sectional view of the tip of a hollow needle used in the ovum collection needle shown in FIG. 1. FIG. 11 is an enlarged cross-sectional view of the tip of a hollow needle of another embodiment of the present invention. FIG. 12 is a front view of one embodiment of the embryo transfer instrument of the present invention. FIG. 13 is a left side view of the embryo transfer instrument shown in FIG. 12. FIG. 14 is a front view of a stylet member used in the embryo transfer instrument shown in FIG. 12. Figure 15 is an enlarged cross-sectional view of the distal end portion of the outer tubular member of the embryo transfer instrument shown in Figure 12 with a stylet member inserted. Figure 16 is an enlarged cross-sectional view of the rear end portion of the outer tubular member and the rear end portion of the stylet member of the embryo transfer instrument shown in Figure 12 with a stylet member inserted. Figure 17 is a cross-sectional view taken along line D-D in Figure 16. Figure 18 is an enlarged cross-sectional view of the rear end portion of a transplantation tube member used in the embryo transfer instrument shown in Figure 12. Figure 19 is a front view of the outer tubular member of the embryo transfer instrument shown in Figure 12 with the stylet member removed and the transplantation tube member inserted.

[0012] The ovum collection needle of the present invention will be described using an embodiment shown in the drawings. The ovum collection needle 1 of the present invention comprises a hollow needle 2 with a cutting edge 24 having a puncturing blade surface 23 formed at its tip, and a hollow grip 3 fixed to the rear end of the hollow needle 2. The hollow grip 3 comprises a hollow grip body 30, an index protrusion 34 associated with the orientation of the puncturing blade surface 23 and provided on the hollow grip body 30, extending toward the cutting edge 24 of the hollow needle 2 at the axial center of the hollow grip body 30, and a non-slip tubular covering 33 covering the axial center of the hollow grip body 30 including the index protrusion 34. The tubular covering 33 has high static friction, transparency, and flexibility, and the index protrusion 34 associated with the orientation of the puncturing blade surface 23 covered by the tubular covering 33 can be recognized visually and tactilely from outside the tubular covering 33. As shown in Figures 1 and 2, the ovum collection needle 1 of the present invention comprises a hollow needle 2, a hollow grip 3 fixed to the rear end of the hollow needle 2, and a suction means connection part 4 having a connection tube 52. Figure 2 is an external view showing the assembly of the hollow needle 2 and hollow grip 3 shown in Figure 1 rotated by 90 degrees.

[0013] The hollow needle 2 is provided with a cutting edge 24 having a puncture blade surface 23 formed at its tip, and has an internal cavity that penetrates from the tip (cutting edge 24) to the rear end, as shown in FIG. 3 . The hollow needle preferably has a length of approximately 20 to 40 cm, an outer diameter of approximately 0.50 to 1.50 mm, and an inner diameter of 0.3 to 1.20 mm. As shown in FIG. 10 , the tip of the hollow needle 2 is provided with the puncture blade surface 23 and a cutting edge 24 that forms an acute angle with the puncture blade surface 23. The puncture blade surface 23 extends obliquely toward the central axis of the hollow needle 2. The cutting edge 24 is provided with a curved side portion 26 that curves toward the puncture blade surface 23. By providing the curved side portion 26, the cutting edge 24 is positioned slightly toward the central axis from the extension of the side surface of the tip portion 21. By providing the curved side portion 26, the puncturing blade surface 23 becomes nearly parallel to the hollow needle 2 and has a sufficient opening area, facilitating the operation of collecting oocytes. The cutting edge portion 24 may be a normal cutting edge portion without curved sides, as shown in Figure 11 described below, in which the tip of the hollow needle is cut obliquely.

[0014] The hollow needle may be a hollow needle 2a as shown in Figure 11. The hollow needle 2a of this embodiment has a hollow main body portion 22 extending a predetermined length from the base end toward the tip, and a small-diameter tip portion 21a extending distally from the main body portion 22. The small-diameter tip portion 21a is formed to be shorter than the length of the main body portion 22 and to have a smaller diameter than the main body portion 22. Specifically, as shown in Figure 11, the small-diameter tip portion 21a is formed to have a smaller diameter by being thinner than the main body portion 22. The small-diameter tip portion 21a is also formed hollow. As a result, the hollow needle 2a has an internal cavity that runs from the tip of the small-diameter tip portion 21a to the base end of the main body portion 22, as shown in Figure 3.

[0015] The hollow main body 22 preferably has a length of approximately 20 to 30 cm, an outer diameter of approximately 0.90 to 1.50 mm, and an inner diameter of approximately 0.60 to 1.20 mm. The small-diameter tip 21a preferably has a length of approximately 3 to 10 cm, an outer diameter of approximately 0.50 to 1.00 mm, and an inner diameter of approximately 0.3 to 0.8 mm. By providing the hollow needle 2a, which is the part that is inserted into the subject, with the small-diameter tip 21a, pain experienced by the subject during the ovum collection operation is alleviated, and the insertion resistance during the collection operation is reduced, making the collection operation easier. Furthermore, if the hollow small-diameter tip 21a is thinner than the hollow main body 22, the insertion resistance can be further reduced.

[0016] As shown in Fig. 11, a tapered portion 25 is preferably formed between the main body 22 and the small-diameter tip 21a. The tapered portion 25 ensures that the puncture resistance of the tapered portion 25 into the subject is significantly higher than that of the small-diameter tip 21a, thereby preventing the tapered portion 25 from puncturing the subject. In this embodiment, the cutting edge 24 is formed by obliquely cutting the small-diameter tip 21a of the hollow needle 2a, as shown in Fig. 11, and is a normal cutting edge without curved sides. Note that the cutting edge 24 of the hollow needle 2a of this embodiment may also have curved sides 26 that curve toward the puncture blade surface 23, as in the cutting edge shown in Fig. 10.

[0017] The hollow needle is formed from a metal tube or a hard synthetic resin tube. Stainless steel is preferred as the metal. Fluoroplastic resins such as PTFE and ETFE are preferred as the hard synthetic resin. The outer surface of the tip 21, 21a is preferably coated with a low-friction material. The low-friction material is preferably silicone oil or silicone resin. Silicone oils that comply with the Silicone Oil Standard (II: Pharmaceutical Affairs Bureau, Ministry of Health, Labor and Welfare, No. 327) or equivalent or higher foreign standards are preferred. A solidified silicone solution containing dimethylpolysiloxane or the like as a primary component is preferred as the silicone resin. Fluoroplastic resins, such as PTFE (polytetrafluoroethylene) and ETFE (ethylenetetrafluoroethylene), may also be used as the low-friction material.

[0018] The tip of the hollow needle, which is the part that is inserted into the subject, is coated with a low-friction material, which reduces the pain felt by the subject during the egg collection operation and also reduces the resistance to insertion during the collection operation, making the collection operation easier.

[0019] A hollow grip 3 is fixed to the rear end of the main body 22 of the hollow needle 2. In this embodiment, the tip of the hollow grip 3 is fixed to the rear end of the hollow needle 2 by a fixing part 39. The rear end of the hollow needle 2 passes over the fixing part 39 with the hollow grip 3 and enters the hollow grip 3. Furthermore, the rear end of the hollow needle 2 that extends rearward beyond the fixing part 39 with the hollow grip 3 is fitted with the tip of a connection tube 52. A fixing tube 51 is fitted over the tip of the connection tube 52. The tip of the fixing tube 51 is fixed to the hollow grip 3. The tip of the connection tube 52 is located near the rear end of the fixing part 39 of the hollow grip 3. The tip of the fixing tube 51 is located near the axial center of the hollow grip 3, and the rear end protrudes a predetermined length beyond the rear end of the hollow grip 3.

[0020] As shown in Figures 3 to 9, the hollow grip 3 comprises a hollow grip body 30 and a cylindrical covering portion 33 that covers the axial center portion of the hollow grip body 30. As shown in Figures 4 to 9, the hollow grip body 30 comprises a cylindrical main body portion 31, a small diameter portion 35 that protrudes from the tip of the cylindrical main body portion 31, a tip-side annular bulge portion 36 located at the tip of the cylindrical main body portion 31, a rear-side annular bulge portion 37 located at the rear end, and an index protrusion 34 that is associated with the orientation of the puncture blade surface 23 and extends toward the cutting edge portion 24 of the hollow needle 2 at the axial center of the hollow grip body 30. In this embodiment, the hollow grip body 30 is cylindrical.

[0021] In addition, the cylindrical main body 31 (between the tip-side annular bulge 36 and the rear-side annular bulge 37) has a narrowed diameter from the tip-side annular bulge 36 toward the minimum diameter section 38 at the axial center, and similarly narrows in diameter from the rear-side annular bulge 37 toward the minimum diameter section 38 at the axial center, so that the minimum diameter section 38 at the axial center has a narrowed shape with its minimum diameter.

[0022] An index protrusion 34 is provided on the side surface of the cylindrical main body 31 of the hollow grip body 30 (between the distal annular bulge 36 and the proximal annular bulge 37), protruding outward and extending toward the cutting edge 24 of the hollow needle 2. In this embodiment, the index protrusion 34 is a linearly extending rib that has its starting end at the proximal end of the distal annular bulge 36 and its terminal end at the distal end of the proximal annular bulge 37. It is also preferable that the upper end of the index protrusion 34 from its starting end to its terminal end be at the same height, in other words, parallel to the central axis of the hollow grip body 30.

[0023] The width of the indicator protrusion 34 is preferably 0.5 to 2.5 mm, and particularly preferably 0.7 to 2.0 mm. The upper surface of the indicator protrusion 34 preferably has a shape without edges, as shown in Fig. 7. Specifically, the upper surface of the indicator protrusion 34 preferably has chamfered or rounded corners, and the cross section of the upper part of the indicator protrusion 34 perpendicular to the axial direction is preferably semicircular or semielliptical.

[0024] As shown in Figures 6, 8 and 9, the hollow grip body 30 has an inner cavity 32 that runs from the tip to the rear end, and the tip of the inner cavity 32 is a small-diameter inner cavity portion 32a for storing and fixing the rear end of the hollow needle 2.

[0025] 1 to 9, an index protrusion 34 that corresponds to the orientation of the puncture blade surface 23 is formed on the outer surface of the hollow grip 3. In this embodiment, the index protrusion 34 is a protrusion formed in a straight line from the tip to the base end of the hollow grip 3. The index protrusion 34 also extends parallel to the central axis of the hollow needle 2.

[0026] 1 and 2, the puncture blade surface 23 is formed so as to be offset by a predetermined angle in the circumferential direction of the hollow needle 2 from the position of the index protrusion 34. Specifically, it is formed so as to be offset by approximately 90° in the circumferential direction of the hollow needle 2 from the position of the index protrusion 34. By providing the index protrusion 34, it is possible to easily confirm the orientation of the puncture blade surface 23. Furthermore, if the puncture blade surface 23 is offset by approximately 90° in the circumferential direction of the hollow needle 2 from the position of the index protrusion 34 of the hollow grip 3, it becomes even easier to confirm the orientation of the puncture blade surface 23.

[0027] The hollow grip body 30 is preferably made of a synthetic resin, such as polyvinyl chloride resin, polyolefins such as polypropylene and polyethylene, polycarbonate, polyamide, or polystyrene, especially a high-performance thermoplastic resin. Furthermore, the hollow grip body 30 is preferably made of a colored, opaque material. Any color may be used, but white, yellow, blue, black, etc. are preferred.

[0028] 2 , when the egg collection needle 1 of this embodiment is held in the right hand with the index protrusion 34 of the hollow grip 3 facing upward, the puncturing blade surface 23 faces substantially to the left (palm side), and when held in the left hand, the puncturing blade surface 23 faces substantially to the left (dorsal side of the hand). As a result, by holding the hollow grip 3 (index protrusion 34) when operating the egg collection needle 1, it is easy to recognize the orientation of the puncturing blade surface during the egg collection operation, and this recognition makes it easier to operate the egg collection needle 1. The index protrusion 34 of this embodiment is a protrusion formed in a straight line from the tip to the base end of the hollow grip 3, but is not limited to this and may be any other shape that allows the orientation of the puncturing blade surface 23 to be confirmed.

[0029] The hollow grip body 3 is provided with an anti-slip cylindrical covering portion 33 that covers the axial center portion of the hollow grip body 30, including the index protrusion 34. The cylindrical covering portion 33 has high static friction, transparency, and flexibility, and the index protrusion 34, which is associated with the orientation of the puncture blade surface 23 covered by the cylindrical covering portion 33, can be recognized visually and tactilely from the outside of the cylindrical covering portion 33.

[0030] In this ovum collection needle 1, the index protrusion 34 covered by the cylindrical covering 33 forms a raised index portion 33c. In other words, as shown in Figures 1 to 8, and particularly as shown in Figure 7, the index protrusion 34 and the portion of the cylindrical covering 33 covering it are raised as a whole, thereby forming the raised index portion 33c. Therefore, the protrusions (raised portions) of the index protrusion 34 and the portion of the cylindrical covering 33 covering it can be recognized by touch with a finger. In addition, in this embodiment, the entire index protrusion 34 is covered by the cylindrical covering 33, and the outer surface of the index protrusion 34 is not exposed.

[0031] The cylindrical covering portion 33 is formed from a material that has high static friction, transparency, and flexibility. The high static friction of the cylindrical covering portion 33 can provide the hollow grip 3 with excellent anti-slip properties. This improves the operability of the egg collection needle. Furthermore, the transparency of the cylindrical covering portion 33 allows visual recognition of the index protrusion 34 of the hollow grip 3, making it easy to place the thumb on the index protrusion 34 when gripping the egg collection needle. Furthermore, the flexibility of the cylindrical covering portion 33 improves adhesion to the hollow grip main body 30, preventing the cylindrical covering portion 33 from moving alone or coming off the hollow grip 3. It is more preferable that the cylindrical covering portion 33 be elastic.

[0032] The material forming the cylindrical covering portion 33 is preferably a rubber or elastomer having elasticity and transparency. The transparency may be such that the indicator protrusion 34 can be easily recognized visually from the outside of the cylindrical covering portion 33. The cylindrical covering portion 33 may be fitted to the hollow grip body 30 in an expanded state and then be in close contact with the outer surface of the hollow grip body 30 upon contraction. This improves the adhesion with the hollow grip body 30, reliably preventing the cylindrical covering portion 33 from moving alone or coming off the hollow grip 3.

[0033] 3 to 9, the hollow grip body 30 includes a tip-side annular bulge 36 and a rear-side annular bulge 37, with the tip end 33a of the cylindrical covering portion 33 covering the rear end of the tip-side annular bulge 36 and the rear end 33b of the cylindrical covering portion 33 covering the tip end of the rear-side annular bulge 37, and both ends of the cylindrical covering portion 33 do not protrude beyond the hollow grip body 30. In this way, by having both ends of the cylindrical covering portion 33 not protrude beyond the hollow grip body 30, peeling from the ends of the cylindrical covering portion 33 is prevented, and movement of the cylindrical covering portion 33 alone relative to the hollow grip body 30 and removal from the hollow grip 3 are reliably prevented. 9, the rear end of the front annular bulge 36 covered by the front end 33a of the cylindrical covering 33 is an expanded diameter portion, and the front end of the rear annular bulge 37 covered by the rear end 33b of the cylindrical covering 33 is an expanded diameter portion. In this embodiment, the front end 33a of the cylindrical covering 33 becomes thinner toward the front end, and the rear end 33b of the cylindrical covering 33 becomes thinner toward the rear end. Therefore, the front end 33a and the rear end 33b of the cylindrical covering 33 have a rounded shape without corners.

[0034] Furthermore, in this embodiment, as described above, the hollow grip body 30 has a constricted shape in which the cross section becomes smaller from the front and rear ends toward the axial center 38. The tubular covering portion 33 also adheres closely to the outer surface of the axial center 38 of the hollow grip body 30. In this embodiment, the tubular covering portion 33 is made of an elastic material and is stretchable, and as shown in Figure 7, the portion of the tubular covering portion 33 that covers the indicator protrusion 34 of the hollow grip body 30 is in a more stretched state than the other portions.

[0035] Examples of materials that can be used to form the cylindrical covering portion 33 include synthetic rubbers such as urethane rubber, silicone rubber, and butadiene rubber, natural rubbers such as latex rubber, elastomers such as polyolefin elastomers, polyamide elastomers, and styrene elastomers (for example, styrene-butadiene-styrene copolymer, styrene-isoprene-styrene copolymer, and styrene-ethylenebutylene-styrene copolymer), and polyurethanes.

[0036] The connecting tube 52 is a flexible tube having approximately the same outer diameter and approximately the same inner diameter from the distal end to the proximal end. The connecting tube 52 and the fixing tube 51 are preferably made of a material having a certain degree of flexibility and stiffness, and examples of materials that can be used include polyolefins (e.g., polyethylene, polypropylene, ethylene-propylene copolymers), polyamides (e.g., nylon 6, nylon 66), polyesters (e.g., polyethylene terephthalate), synthetic rubbers such as urethane rubber, silicone rubber, and butadiene rubber, natural rubbers such as latex rubber, polyolefin elastomers, and polyamide elastomers.

[0037] The connection tube 52 has a length of 100 to 700 mm, preferably 150 to 250 mm. The outer diameter is 1.0 to 2.0 mm, preferably 1.46 to 1.79 mm. The inner diameter is 0.7 to 1.5 mm, preferably 0.86 to 1.19 mm. The inclusion of the connection tube 52 makes the oocyte collection process easier.

[0038] As shown in FIGS. 1 to 3 , the suction means connector 4 is fixed to the rear end of the connection tube 52. The suction means connector 4 includes a stopper 45 for attachment to the opening of the sampling tool and a suction means attachment 46 attached to the stopper 45. The connection tube 52 has one end attached to the base end of the hollow needle 2 and the other end penetrating the stopper 45. The other end of the connection tube 52 forms an expanded diameter section. As shown in FIG. 3 , the rear end of the connection tube 52 includes a tube reinforcing member 48 that penetrates the stopper from near the base end of the connection tube 52 and extends a predetermined length toward the distal end of the tube member. The reinforcing member 48 is preferably a tubular member extending within the connection tube 52. Alternatively, the reinforcing member 48 may be a tubular member extending on the outer surface of the rear end of the connection tube 52. The tubular member is preferably a rigid tubular member or a coil spring. Metals, synthetic resins, and the like can be used to form the tubular member.

[0039] The suction means attachment part 46 includes an attachment part main body and a shaft part 47 that extends from the main body and passes through the plug body 45. The shaft part 47 is bent. The inner surface of the rear end part of the attachment part main body has a shape that allows connection to a connector of a suction device (not shown).

[0040] The plug 45 can be made from synthetic rubbers such as urethane rubber, silicone rubber, and butadiene rubber, natural rubbers such as latex rubber, elastomers such as polyolefin elastomers, polyamide elastomers, and styrene elastomers (for example, styrene-butadiene-styrene copolymer, styrene-isoprene-styrene copolymer, and styrene-ethylenebutylene-styrene copolymer), polyurethane, etc. If the plug 45 is provided with a suction means connection part 4, the ovum collection operation can be made easier.

[0041] The suction means connecting part is not limited to the above, and may be provided with a connecting part (e.g., a hub, a connector) that can be connected to the tip part of the suction means (e.g., a syringe) at the rear end of the ovum collection needle, for example, the rear end of the connecting tube 52, the rear end of the fixing tube 51, or the rear end of the hollow grip 3.

[0042] The embryo transfer instrument of the present invention will now be described with reference to the embodiment shown in the drawings. The embryo transfer instrument 10 of the present invention comprises a flexible tube 6 having a passageway penetrating from its front to rear end, an outer tube member 11 having a hollow grip 7 fixed to the rear end of the flexible tube 6, and a stylet member 8 removably inserted into the outer tube member 11 and having a front end that is substantially flush with or slightly protrudes from the front end surface of the flexible tube 6.

[0043] The flexible tube 6 has a distal curved portion 62, and the hollow grip 7 has a hollow grip body 70, an index protrusion 74 that is associated with the curved direction of the distal curved portion 62 of the flexible tube 6 and extends in the distal direction of the flexible tube 6 at the axial center of the hollow grip body 70, and an anti-slip tubular covering portion 73 that covers the axial center of the hollow grip body 70 including the index protrusion 74. The tubular covering portion 73 has high static friction, transparency, and flexibility, and the index protrusion 74, which is associated with the curved direction of the flexible tube 6 covered by the tubular covering portion 73, can be recognized visually and tactilely from outside the tubular covering portion 73.

[0044] The embryo transfer instrument 10 of this embodiment also includes an embryo transfer tube member 9 that can be inserted into the flexible tube 6 after the stylet member 8 has been removed, and that has a soft tip that can protrude a predetermined length beyond the tip of the flexible tube 6. Thus, the embryo transfer instrument 10 of this embodiment includes an outer tube member 11, a stylet member 8, and an embryo transfer tube member 9.

[0045] As shown in Figures 12, 13, 15 to 17, the outer tube member 11 comprises a flexible tube 6 having a passage 67 passing through from the front end to the rear end, a spherical bulge 65 fixed to the front end of the flexible tube 6 so as not to block the front end opening of the flexible tube 6, and a hollow grip 7 fixed to the rear end of the flexible tube 6.

[0046] The flexible tube 6 has a length of 50 to 300 mm, preferably 100 to 250 mm. The outer diameter is 1 to 5 mm, preferably 1.5 to 3.5 mm. The inner diameter is 0.8 to 4.8 mm, preferably 1.3 to 3.3 mm. The flexible tube 6 preferably has a certain degree of shape retention. Materials that can be used to form the flexible tube 6 include polyester, polyolefin (e.g., polyethylene, polypropylene, ethylene-propylene copolymer), polyamide (e.g., nylon 6, nylon 66), polyester (e.g., polyethylene terephthalate), and fluororesin (e.g., PTFE, ETFE).

[0047] The flexible tube 6 also includes a linear main body portion 61 and a curved distal end bending portion 62. The distal end bending portion 62 is preferably formed by bending a portion of the flexible tube 6 that is 20 to 100 mm from the distal end. Furthermore, as shown in FIGS. 12 and 13 , it is preferable to provide an insertion depth confirmation marker 63 on the outer surface of the flexible tube 6. In this embodiment, the markers 63 are formed as multiple lines (black lines) that intersect perpendicularly with the central axis of the flexible tube 6. The first marker (line) provided at the distal end side is located at the distal end portion of the distal end bending portion 62 (specifically, at a position a predetermined length rearward from the distal end of the flexible tube 6), and the subsequent markers (lines) toward the rear end are arranged so as to be equidistant from the distance between the first marker and the distal end of the flexible tube 6. The final marker (line) at the rear end side is located at a position a predetermined length rearward from the distal end (the distal end of the linear portion) of the main body portion 61 of the flexible tube 6. In particular, in this embodiment, a double line marker 63a is attached near the rear end of the curved tip portion 62, and multiple (specifically, four) markers (lines) are provided on the tip side (tip curved portion) of this double line marker 63a, and multiple (specifically, three) markers (lines) are also provided on the rear side (straight main body portion 61) of the double line marker 63a.

[0048] The embryo transfer instrument 10 of this embodiment also includes a spherical bulge 65 fixed to the tip of the flexible tube 6. As shown in Figures 12, 13, and 15, the spherical bulge 65 is a hollow, bead-like member with a through passage, into which the tip of the flexible tube 6 is inserted and which is fixed to the flexible tube 6. The bulge 65 is fixed to the flexible tube 6 by adhesive, heat fusion, or the like. The outer diameter of the bulge 65 is preferably 0.7 to 3 mm larger than the outer diameter of the tip of the flexible tube 6, and more preferably 1 to 2 mm larger.

[0049] As shown in Figure 15, the spherical bulge 65 has a hemispherical shape at its tip end, tapering in diameter toward the tip. The rear end of the spherical bulge 65 also has a hemispherical shape tapering in diameter toward the rear end. By providing such a spherical bulge 65, damage to the inner wall of the living body can be prevented during insertion into and removal from the living body. By providing such a spherical bulge 65, when the bulge contacts the inner wall during insertion into the living body, the tip end can be easily removed, facilitating insertion of the tip end into the target site within the living body.

[0050] 15, in the embryo transfer instrument 10 of this embodiment, the bulging portion 65 has an expanded diameter portion on the base end side of the internal passage that can accommodate the tip end of the flexible tube 6, and the tip end side of the internal passage has a small diameter portion with an inner diameter smaller than the outer diameter of the flexible tube 6. Therefore, the tip end of the flexible tube 6 is formed by the bulging portion 65, and the tip end surface of the flexible tube 6 is not exposed. This prevents damage to the inner wall of the living body caused by the outer periphery of the tip end surface of the flexible tube 6.

[0051] A hard resin is preferable as the material for forming the spherical bulge 65. Furthermore, a material with low sliding resistance on the outer surface is more preferable. The material for forming the flexible tube 6 described above can be preferably used as the material for forming the bulge.

[0052] Furthermore, the flexible tube 6 preferably includes an ultrasound imaging section 66 provided at or behind the bulge 65. The ultrasound imaging section 66 is preferably a ring-shaped or coil-shaped member formed of an ultrasound contrast material. By providing such an ultrasound imaging section 66, it becomes easier to confirm the position of the tip of the flexible tube 6, and further the position of the bulge 65.

[0053] 12, 13 and 15, the ultrasound contrast section 66 is provided on the outer surface of the flexible tube 6 behind the bulging section 65. However, this is not limiting, and the ultrasound contrast section 66 may be provided between the bulging section 65 and the flexible tube 6, as in the embodiment shown in Fig. 19. Furthermore, the bulging section 65 itself may be endowed with ultrasound contrast properties.

[0054] Furthermore, the flexible tube 6 preferably includes an insertion depth adjustment member 64 that is movably provided on the outer surface of the flexible tube 6. By locating this adjustment member 64 in advance at a position that will provide the desired insertion length, the operation of inserting the flexible tube 6 into the living body becomes easier.

[0055] As shown in Figures 12, 13, and 16, the adjustment member 64 of this embodiment is formed with a tapered shape that tapers toward the distal end. This prevents the subject from experiencing pain due to contact with the adjustment member. The adjustment member 64 is a ring-shaped member whose inner diameter is equal to or slightly smaller than the outer diameter of the flexible tube 6. As shown in Figures 12, 13, and 16, the adjustment member 64 of this embodiment has a flange portion that tapers slightly in diameter, a central portion that tapers more rapidly than the flange portion, and a rounded distal portion. The adjustment member 64 slides along the flexible tube 6 by pushing it toward the distal end or pulling it toward the proximal end with a certain amount of force.

[0056] Furthermore, by forming the rear end of the adjustment member 64 into an edged end face, as in the case of the adjustment member of this embodiment, the above-mentioned movement operation becomes easier. The adjustment member 64 is preferably made of an elastic material. Examples of materials that can be used for the formation of the polyimide include synthetic rubbers such as urethane rubber, silicone rubber, and butadiene rubber; natural rubbers such as latex rubber; soft vinyl chloride; polyolefins (polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, and mixtures of polypropylene and polyethylene or polybutene); polyesters (polyethylene terephthalate, polybutylene terephthalate); polyamides; polyolefin elastomers; polyamide elastomers; and styrene elastomers (e.g., styrene-butadiene-styrene copolymer, styrene-isoprene-styrene copolymer, and styrene-ethylenebutylene-styrene copolymer). These materials include elastomers such as polyurethanes, and in particular, thermoplastic polyurethanes (thermoplastic polyether polyurethanes, thermoplastic polyester polyurethanes, and particularly, preferably, segmented thermoplastic polyether polyurethanes having soft segment portions and hard segment portions; more specifically, polytetramethylene ether glycol, polyethylene glycol, and polypropylene glycol are preferred as the main component of the soft segment, and 1,4-butanediol is preferred as the main component of the hard segment).

[0057] The hollow grip 7 is fixed to the rear end of the flexible tube 6. The fixing is preferably done using an adhesive, but fusion, insertion, or other methods are also possible. The hollow grip 7 is a hollow member having an inner cavity that communicates with the passage 67 inside the flexible tube 6. As shown in Figures 12, 13, and 16, the hollow grip 7 includes a hollow grip body 70 and a cylindrical covering portion 73 that covers the axial center portion of the hollow grip body 70.

[0058] 12, 13, and 16, the hollow grip body 70 includes a cylindrical main body portion 71, a small-diameter portion 75 protruding from the tip of the cylindrical main body portion 71, a tip-side annular bulge 76 located at the tip of the cylindrical main body portion 71, a rear-side annular bulge 77 located at the rear end, and an index protrusion 74 that is associated with the bending direction of the flexible tube 6 and extends toward the tip of the flexible tube 6 at the axial center of the hollow grip body 70. The main portion of the cylindrical main body portion 71 (between the tip-side annular bulge 76 and the rear-side annular bulge 77) tapers from the tip-side annular bulge 76 toward a narrowest portion 78 at the axial center, and similarly tapers from the rear-side annular bulge 77 toward the narrowest portion 78 at the axial center, forming a constricted shape with the narrowest portion 78 at the axial center.

[0059] In this embodiment, as shown in Figures 16 and 17, a rectangular tubular body is used for the hollow grip body 70. Specifically, the distal annular bulge 76 is cylindrical, and the outer shape becomes rectangular tubular from the rear end of the distal annular bulge 76, and this rectangular tubular shape continues to the rear annular bulge 77. The interior has a rectangular cross section at the rear annular bulge 77, and the section from there to the distal end is approximately circular.

[0060] An index protrusion 74 is provided on the side of the main portion of the hollow grip body 70 (between the distal annular bulge 76 and the rearward annular bulge 77), protruding outward and extending toward the distal end of the flexible tube 6. In this embodiment, the index protrusion 74 is a linearly extending rib that begins at the rear end of the distal annular bulge 76 and terminates at the distal end of the rearward annular bulge 77. It is also preferable that the upper end of the index protrusion 74, from its beginning to its terminal end, be at the same height as the central axis of the hollow grip body 70, in other words, be parallel to it.

[0061] The width of the indicator protrusion 74 is preferably 0.5 to 2.5 mm, and particularly preferably 0.7 to 2.0 mm. The upper surface of the indicator protrusion 74 preferably has a shape without edges. Specifically, the upper surface of the indicator protrusion 74 preferably has chamfered or rounded corners, and the cross section of the upper part of the indicator protrusion 74 perpendicular to the axial direction is preferably semicircular or semielliptical.

[0062] As shown in FIG. 16, the hollow grip body 70 has an inner cavity that runs from the tip to the rear end, and the tip end (small diameter portion 75) of the inner cavity accommodates the rear end of the flexible tube 6, and the two are fixed together.

[0063] As shown in Figures 12, 13 and 16, an indicator protrusion 74 associated with the bending direction of the flexible tube 6 is formed on the outer surface of the hollow grip 7. In this embodiment, the indicator protrusion 74 is formed as a protrusion that protrudes in the bending direction of the distal bending portion 62 of the flexible tube 6. Specifically, the indicator protrusion 74 is a protrusion formed in a straight line from the distal end to the proximal end of the hollow grip 7. The indicator protrusion 74 also extends parallel to the central axis of the flexible tube 6. By providing the indicator protrusion 74, the bending direction of the distal bending portion 62 of the flexible tube 6 can be easily confirmed.

[0064] The hollow grip body 70 is preferably made of a synthetic resin, such as polyvinyl chloride resin, polyolefins such as polypropylene and polyethylene, polycarbonate, polyamide, or polystyrene, especially a high-performance thermoplastic resin. Furthermore, the hollow grip body 70 is preferably made of a colored, opaque material. Any color may be used, but white, yellow, blue, black, etc. are preferred.

[0065] 12 , when the embryo transfer instrument 10 of this embodiment is placed so that the distal bending portion 62 of the flexible tube 6 is flat, the index protrusion 74 faces the bending direction of the distal bending portion 62 of the flexible tube 6. Therefore, as shown in FIG. 13 , when the hollow grip 7 is held by pressing the index protrusion 74 with the thumb, the bending direction of the distal bending portion 62 of the flexible tube 6 and the distal end of the flexible tube 6 face toward the operator's thumb. This makes it easy to recognize the bending direction of the distal bending portion 62 of the flexible tube 6 and the orientation of the distal end of the flexible tube 6 during the embryo transfer procedure, and this recognition facilitates operation of the embryo transfer instrument 10. The index protrusion 74 of this embodiment is a linear protrusion extending from the distal end to the proximal end of the hollow grip 7, but is not limited thereto and may be any other structure that allows the bending direction of the flexible tube 6 to be confirmed.

[0066] The hollow grip 7 is provided with a non-slip cylindrical covering portion 73 that covers the axial center portion of the hollow grip body 70, including the index protrusion 74. The cylindrical covering portion 73 has high static friction, transparency, and flexibility, and the index protrusion 74, which is associated with the bending direction of the flexible tube 6 covered by the cylindrical covering portion 73, can be recognized visually and tactilely from outside the cylindrical covering portion 73.

[0067] In this embryo transfer instrument 10, the index protrusion 74 covered by the cylindrical covering portion 73 forms a raised index portion 73a. In other words, as shown in Figures 12, 13, 16, and 17, the index protrusion 74 and the portion of the cylindrical covering portion 73 covering it are raised as a whole, thereby forming the raised index portion 73a. Therefore, the protrusions (raised portions) of the index protrusion 74 and the portion of the cylindrical covering portion 73 covering it can be recognized by touch with a finger. Furthermore, in this embodiment, the entire index protrusion 74 is covered by the cylindrical covering portion 73, and the outer surface of the index protrusion 74 is not exposed.

[0068] The cylindrical covering portion 73 is formed from a material that has high static friction, transparency, and flexibility. The high static friction of the cylindrical covering portion 73 provides the hollow grip 7 with excellent anti-slip properties, thereby improving the operability of the embryo transfer instrument. Furthermore, the transparency of the cylindrical covering portion 73 allows visual recognition of the index protrusion 74 of the hollow grip 7, making it easy to place the thumb on the index protrusion 74 when gripping the embryo transfer instrument. Furthermore, the flexibility of the cylindrical covering portion 73 ensures good adhesion to the hollow grip body 70, preventing the cylindrical covering portion 73 from moving alone or coming off the hollow grip 7. It is more preferable that the cylindrical covering portion 73 be elastic.

[0069] The material forming the cylindrical covering portion 73 is preferably a rubber or elastomer having elasticity and transparency. The transparency may be such that the indicator protrusion 74 can be easily recognized visually from the outside of the cylindrical covering portion 73. The cylindrical covering portion 73 may also be one that is fitted over the hollow grip body 70 in an expanded state and then adheres closely to the outer surface of the hollow grip body 70 upon contraction. This improves adhesion to the hollow grip body 70, reliably preventing the cylindrical covering portion 73 from moving alone or coming off the hollow grip 70.

[0070] In this embodiment, as shown in Figures 12, 13, and 16, the hollow grip body 70 includes a distal annular bulge 76 and a proximal annular bulge 77. As shown in Figures 12, 13, and 16, the proximal end of the hollow grip body 70 of the hollow grip 7 serves as an attachment portion for a stylet hub 82 of the stylet member 8, which will be described later. The outer tube member 11 and the stylet member 8 include rotation-restricting engagement portions 83, 79 that restrict relative rotation therebetween. Specifically, the protrusion-accommodating recess 79 that accommodates a protrusion 83 provided on the stylet hub 82 is formed at the proximal end of the hollow grip body 70. By engaging the protrusions 83 and 89, relative rotation therebetween is restricted.

[0071] The tip of the cylindrical covering portion 73 covers the rear end of the tip-side annular bulge 76, and the rear end of the cylindrical covering portion 73 covers the tip of the rear-side annular bulge 77, and both ends of the cylindrical covering portion 73 do not protrude from the hollow grip body 70. Since both ends of the cylindrical covering portion 73 do not protrude from the hollow grip body 70 in this way, peeling of the ends of the cylindrical covering portion 73 is prevented, and movement of the cylindrical covering portion 73 alone relative to the hollow grip body 70 and removal from the hollow grip 7 are reliably prevented. Also in the embryo transfer instrument 10 of this embodiment, as in the hollow grip 3 of the ovum collection needle 1 described above, the rear end of the tip-side annular bulge covered by the tip of the cylindrical covering portion may be an enlarged diameter portion, and the tip of the rear-side annular bulge covered by the rear end of the cylindrical covering portion may also be an enlarged diameter portion, as shown in FIG. The cylindrical covering portion may have a front end that is tapered toward the front end and a rear end that is tapered toward the rear end, in which case the front and rear ends of the cylindrical covering portion have rounded shapes without corners.

[0072] Furthermore, in this embodiment, as described above, the hollow grip body 70 has a constricted shape in which the cross section becomes smaller from the front and rear ends toward the narrowest portion (axial center portion) 78. The cylindrical covering portion 73 also adheres tightly to the outer surface of the narrowest portion (axial center portion) 78 of the hollow grip body 70. In this embodiment, the cylindrical covering portion 73 is made of an elastic material and is stretchable, and as shown in FIG. 7 , the portion of the cylindrical covering portion 73 that covers the indicator protrusion 74 of the hollow grip body 70 is in a more stretched state than the other portions.

[0073] Examples of materials that can be used to form the cylindrical covering portion 73 include synthetic rubbers such as urethane rubber, silicone rubber, and butadiene rubber, natural rubbers such as latex rubber, elastomers such as polyolefin elastomers, polyamide elastomers, and styrene elastomers (for example, styrene-butadiene-styrene copolymer, styrene-isoprene-styrene copolymer, and styrene-ethylenebutylene-styrene copolymer), and polyurethanes.

[0074] As shown in Figures 14 and 16, the stylet member 8 comprises a shaft-shaped stylet body 81 and a stylet hub 82 fixed to its rear end. The inclusion of the stylet member 8 prevents biological secretions from entering the flexible tube 6 when the embryo transfer instrument 10 is inserted into a living body. In the embryo transfer instrument 10 of this embodiment, the stylet body 81 is configured so that its tip slightly protrudes beyond the tip of the flexible tube 6 when the stylet body 81 is inserted into the flexible tube 6 and the stylet hub 82 is engaged with the hollow grip 7. The length of protrusion of the stylet body 81 from the flexible tube 6 is preferably 5 mm or less, with 2 mm or less being particularly preferred. The tip of the stylet body 81 may be positioned approximately flush with the distal end of the flexible tube 6.

[0075] As shown in Figures 13 to 15, the tip 81a of the stylet member 81 is formed in a hemispherical shape with a diameter tapering toward the tip. This prevents damage to the inner wall of the living body when the stylet member is inserted into and removed from the living body. In this embodiment, the stylet body 81 is formed from a tubular member. However, the stylet body may also be formed from a solid member. Materials for forming the stylet body can be those described above for the flexible tube 6, as well as those described above for the adjustment member 64. The inner diameter of the stylet body 81 is preferably 0.1 to 0.5 mm smaller than the inner diameter of the flexible tube 6. Preferably, it is 0.1 to 0.2 mm smaller.

[0076] As shown in Figure 15, the stylet hub 82 is fixed to the rear end of the stylet body 81 with an adhesive. The stylet hub 82 includes a passage that houses the rear end of the stylet body 81 and serves as a fixing portion, as well as an inner cylindrical portion 85 that can enter the rear end portion 77 of the hollow grip 7, and an outer cylindrical portion 84 that encases this inner cylindrical portion 85. The outer cylindrical portion 84 is provided with a hub engaging protrusion 83 that protrudes toward the tip side. This hub engaging protrusion 83 engages with the protrusion accommodating recess 79 of the hollow grip 7. This engagement restricts rotation of the stylet member 8 relative to the outer tube member 11.

[0077] The embryo transfer instrument 10 of this embodiment includes an embryo transfer tube member 9 that can be inserted from the outer tube member 11 into the flexible tube 6 after the stylet member 8 has been removed, and that has a soft tip portion that can protrude a predetermined length from the tip of the flexible tube 6.

[0078] 18 and 19, the embryo transfer tube member 9 that is inserted into the flexible tube 6 after the stylet member has been removed has a soft tip portion 91a that can protrude a predetermined length from the tip of the flexible tube 6. The tube member 9 in this embodiment comprises a flexible tube 91, a stiffening tube member 92 that is inserted into the flexible tube 91 and has its tip located a predetermined length rearward from the tip of the flexible tube 91, and a tube hub 93 fixed to the rear end of the flexible tube 91.

[0079] The embryo transfer tube member 9 is a tube for transferring embryos and has a passageway penetrating from the tip to the rear end. This passageway is formed by the inside of the tube member 92 where the stiffening tube member 92 is present, and is formed by the inside of the flexible tube 91 at the tip end of the embryo transfer tube member 9 where the tube member 92 is not present.

[0080] The length of the embryo transfer tube member 9 is preferably about 70 to 800 mm, particularly about 200 to 600 mm, and the outer diameter of the embryo transfer tube member 9 is preferably about 0.5 to 3 mm, particularly about 1 to 2 mm. The inner diameter of the flexible tube 91 is preferably about 0.3 to 0.7 mm, particularly about 0.4 to 0.6 mm.

[0081] The material for forming the flexible tube 91 is preferably one having a certain degree of flexibility, and examples thereof that can be used include synthetic rubbers such as urethane rubber, silicone rubber, and butadiene rubber; natural rubbers such as latex rubber; soft vinyl chloride; polyolefins (polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, and mixtures of polypropylene and polyethylene or polybutene); polyesters (polyethylene terephthalate, polybutylene terephthalate); polyamides; polyolefin elastomers; polyamide elastomers; styrene elastomers (for example, styrene-butadiene-styrene copolymer, styrene-isoprene-styrene copolymer, and styrene-ethylenebutylene-styrene copolymer); polyurethanes; and in particular, thermoplastic polyurethanes (thermoplastic polyether polyurethanes, thermoplastic polyester polyurethanes; and particularly, segmented thermoplastic polyether polyurethanes having soft segment portions and hard segment portions; more specifically, polytetramethylene ether glycol, polyethylene glycol, polypropylene glycol, or the like is preferred as the main component of the soft segment, and 1,4-butanediol, or the like is preferred as the main component of the hard segment). Preferably, rubber such as silicone rubber or elastomer is used. Silicone rubber is particularly preferred. Silicone rubber has a 200% modulus of 30 to 90 kg / cm. ２ Preferably, 40 to 60 kg / cm ２ The following is used.

[0082] The stiffening tube member 92 is preferably provided so that its distal end is located 5 to 150 mm proximal to the distal end of the flexible tube 91. The length is particularly preferably 10 to 100 mm. Therefore, since the distal end of the embryo transfer tube member 9 is formed solely from the flexible tube 91, it is preferable because it causes less damage to the inner wall of the living body during insertion. Furthermore, since the stiffening tube member 92 is provided, the pushing force applied at the proximal end of the tube member 9 is easily transmitted, facilitating the insertion of the embryo transfer tube member 9 into the target site. The stiffening tube member 92 is preferably long enough to allow the distal end of the stiffening tube member 92 to protrude beyond the distal end of the flexible tube 6 when the embryo transfer tube member 9 is inserted into the flexible tube 6. The outer diameter of the stiffening tube member 92 is preferably approximately equal to or approximately 0.1 to 0.5 mm smaller than the inner diameter of the flexible tube 91.

[0083] The stiffening tube member 92 can be made of polyester, polyolefin (e.g., polyethylene, polypropylene, ethylene-propylene copolymer), polyamide (e.g., nylon 6, nylon 66), polyester (e.g., polyethylene terephthalate), fluororesin (e.g., PTFE, ETFE), or the like.

[0084] The embryo transfer tube member 9 includes a tube hub 93. The tube hub 93 includes a hub body 94 and a kink prevention member 95. The flexible tube 91 is fixed to the hub body 94 by a crimping member (not shown) inserted into the rear end. The rear end of the stiffening tube member 92 is inserted into the crimping member. The stiffening tube member 92 is fixed to the hub within the tube hub, including the crimping member, or is fixed to the flexible tube with an adhesive or the like within the flexible tube. The tube hub 93 is designed so that an injection tool such as a syringe can be attached to its rear end. Specifically, the inner surface of the hub body 94 has a luer taper portion that allows the tip of a syringe to be attached liquid-tightly.

[0085] The operation of the embryo transfer instrument 10 of the present invention will now be described. Eggs are collected transvaginally or laparoscopically using an egg collection needle. The collected eggs are then placed in a culture vessel containing culture medium and cultured. The collected sperm are, for example, precipitated and concentrated using a centrifuge, resuspended, and added to the culture medium. This is then added to the egg culture medium that has been cultured for 4 to 6 hours for insemination. Fertilization is then confirmed by observing the male and female pronuclei. If male and female pronuclei (two pronuclei) are observed, the embryo is deemed to be a normal fertilized embryo (zygote), and further culture is continued. Furthermore, if three or more pronuclei are observed, the embryo is rejected due to the high probability of polyspermy, and degenerated eggs are also rejected. Although fertilized embryos can also be transferred, they are typically cultured and fertilized after bisection, quartering, or eighth division. Generally, four-cell stage embryos, which have been divided into four approximately 44 hours after insemination, are used for transfer.

[0086] A syringe (not shown) filled with the same culture medium as that used for culturing fertilized eggs is attached to the hub body 94 of the embryo transfer tube member 9 of the present invention, and the culture medium is filled into the lumen of the tube member 9. Then, the tip of the tube member 9 is inserted into a culture vessel, and the tip of the instrument is abutted against the bottom of the culture vessel near the embryo, and the embryo is sucked into the lumen of the tube member 9 by suction with the syringe. The opening at the tip surface of the tube member 9 makes the embryo suction process easy.

[0087] The outer tubular member 11 with the stylet member 8 attached is then inserted through the vaginal opening and passed through the cervical canal. Next, the embryo transfer tube member 9 containing the aspirated embryo is inserted into the flexible tube 6 of the outer tubular member 11, and the tube member 9 is further pushed in until its tip reaches the cervical opening, and the syringe is then pushed to transfer the embryo into the uterus. The tube member 9 and outer tubular member 11 are then removed, completing the transfer.

[0088] The ovum collection needle of the present invention comprises a hollow needle with a cutting edge having a puncturing blade surface, and a hollow grip fixed to the rear end of the hollow needle, the hollow grip comprising a hollow grip body, an index protrusion associated with the orientation of the puncturing blade surface and extending toward the cutting edge of the hollow needle at the axial center of the hollow grip body, and a non-slip tubular covering covering the axial center of the hollow grip body including the index protrusion, the tubular covering having high static friction, transparency, and flexibility, and the index protrusion associated with the orientation of the puncturing blade surface covered by the tubular covering can be recognized visually and tactilely from outside the tubular covering. Because the axial center of the hollow grip body including the index protrusion is covered by the non-slip tubular covering, this ovum collection needle provides good operability by preventing fingers from slipping on the index protrusion when gripping the hollow grip. In addition, the tubular covering portion has high static friction, transparency, and flexibility, and the indicator protrusion associated with the orientation of the puncture blade surface covered by the tubular covering portion can be recognized visually and tactilely from the outside of the tubular covering portion, making it easy to confirm the orientation of the puncture blade surface.

[0089] The embryo transfer instrument of the present invention comprises an outer tube member having a flexible tube with a passageway extending from its tip to its rear end and a hollow grip fixed to the rear end of the flexible tube, and a stylet member removably inserted into the outer tube member and having a tip that is approximately flush with or slightly protrudes from the tip surface of the flexible tube, the flexible tube having a curved portion at its tip, the hollow grip having a hollow grip body, an index protrusion that is associated with the bending direction of the flexible tube and extends from the axial center of the hollow grip body toward the tip of the flexible tube, and a non-slip tubular covering that covers the axial center of the hollow grip body including the index protrusion, the tubular covering having high static friction, transparency, and flexibility, and the index protrusion that is associated with the bending direction of the flexible tube covered by the tubular covering can be recognized visually and tactilely from the outside of the tubular covering. In this embryo transfer instrument, the axial center of the hollow grip body, including the index protrusion, is covered with a non-slip tubular covering, so that fingers do not slip on the index protrusion when gripping the hollow grip, providing good operability. Furthermore, the tubular covering has high static friction, transparency, and flexibility, and the index protrusion, which corresponds to the curvature direction of the flexible tube covered by the tubular covering, can be recognized visually and tactilely from outside the tubular covering, making it easy to confirm the curvature direction of the flexible tube.

[0090] The ovum collection needle of the present invention is as follows: (1) An ovum collection needle for collecting ovum from an ovarian follicle, the ovum collection needle comprising: a hollow needle with a cutting edge having a puncturing blade surface; and a hollow grip fixed to the rear end of the hollow needle, the hollow grip comprising: a hollow grip body; an index protrusion that is associated with the orientation of the puncturing blade surface and extends in the direction of the cutting edge of the hollow needle at the axial center of the hollow grip body; and a non-slip tubular covering that covers the axial center of the hollow grip body including the index protrusion, the tubular covering having high static friction, transparency, and flexibility, and the index protrusion that is associated with the orientation of the puncturing blade surface covered by the tubular covering can be recognized visually and tactilely from the outside of the tubular covering.

[0091] This ovum collection needle has an axial center portion of the hollow grip body, including the index protrusion, covered with a non-slip tubular covering, so that fingers do not slip on the index protrusion when gripping the hollow grip, providing good operability. Furthermore, the tubular covering has high static friction, transparency, and flexibility, and the index protrusion, which is associated with the orientation of the puncture blade surface covered by the tubular covering, can be recognized visually and tactilely from outside the tubular covering, making it easy to confirm the orientation of the puncture blade surface.

[0092] The above embodiments may also be as follows. (2) The egg collection needle according to (1) above, in which the puncturing blade surface is offset by approximately 90° in the circumferential direction of the hollow needle from the position of the index protrusion of the hollow grip, so that when the egg collection needle is held with the hollow grip on the right side and the cutting edge on the left side and the index protrusion facing upward, the puncturing blade surface faces approximately forward. (3) The egg collection needle according to (1) or (2) above, in which the index protrusion covered by the tubular covering portion forms an index protrusion. (4) The egg collection needle according to any of (1) to (3) above, in which the tubular covering portion is formed of elastic rubber or elastomer. (5) The egg collection needle according to any of (1) to (4) above, in which the tubular covering portion is formed of a transparent or translucent material, and the hollow grip main body is formed of a colored opaque material. (6) The ovum collection needle according to any one of (1) to (5) above, wherein the cylindrical covering portion is fitted over the hollow grip body in an expanded state and is in close contact with the outer surface of the hollow grip body upon contraction. (7) The ovum collection needle according to any one of (1) to (6) above, wherein the hollow grip body comprises a tip-side annular bulge portion and a rear-side annular bulge portion, the tip portion of the cylindrical covering portion covers the rear end portion of the tip-side annular bulge portion, and the rear end portion of the cylindrical covering portion covers the tip portion of the rear-side annular bulge portion, and both ends of the cylindrical covering portion do not protrude from the hollow grip body. (8) The ovum collection needle according to (7) above, wherein the rear end portion of the tip-side annular bulge portion covered by the tip portion of the cylindrical covering portion is an enlarged diameter portion, and the tip portion of the rear-side annular bulge portion covered by the rear end portion of the cylindrical covering portion is also an enlarged diameter portion. (9) The ovum collection needle according to (7) or (8) above, wherein the tip end of the cylindrical covering part is tapered toward the tip end, and the rear end end of the cylindrical covering part is tapered toward the rear end. (10) The ovum collection needle according to any of (1) to (9) above, wherein the cross section of the hollow grip body becomes smaller from the tip end and the rear end toward the axial center part, and the cylindrical covering part is in close contact with the outer surface of the axial center part of the hollow grip body.

[0093] The embryo transfer instrument of the present invention is as follows: (11) An embryo transfer instrument used when transferring an embryo into a living organism, the embryo transfer instrument comprising: an outer tube member having a flexible tube with a passageway penetrating from its front end to its rear end, and a hollow grip fixed to the rear end of the flexible tube; and a stylet member removably inserted into the outer tube member, the front end of which is substantially flush with or slightly protrudes from the front end surface of the flexible tube; The flexible tube has a curved tip portion, and the hollow grip has a hollow grip body, an index protrusion that is associated with the curved direction of the curved tip portion of the flexible tube and extends toward the tip of the flexible tube at the axial center of the hollow grip body, and a non-slip tubular covering that covers the axial center of the hollow grip body including the index protrusion, the tubular covering having high static friction, transparency, and flexibility, and the index protrusion that is associated with the curved direction of the flexible tube covered by the tubular covering can be recognized visually and tactilely from outside the tubular covering.

[0094] In this embryo transfer instrument, the axial center of the hollow grip body, including the index protrusion, is covered with a non-slip tubular covering, so that fingers do not slip on the index protrusion when gripping the hollow grip, providing good operability. Furthermore, the tubular covering has high static friction, transparency, and flexibility, and the index protrusion, which corresponds to the curvature direction of the flexible tube covered by the tubular covering, can be recognized visually and tactilely from outside the tubular covering, making it easy to confirm the curvature direction of the flexible tube.

[0095] The above embodiments may also be as follows. (12) The embryo transfer instrument according to (11) above, comprising an embryo transfer tube member that can be inserted into the flexible tube when the stylet member has been removed and that has a soft tip portion that can protrude a predetermined length from the tip of the flexible tube. (13) The embryo transfer instrument according to (11) or (12) above, wherein the index protrusion protrudes in the curvature direction of the tip curved portion of the flexible tube. (14) The embryo transfer instrument according to any of (11) to (13) above, wherein the index protrusion covered by the tubular covering portion also forms an index protrusion in the hollow grip. (15) The embryo transfer instrument according to any of (11) to (14) above, wherein the tubular covering portion is formed of elastic rubber or elastomer. (16) The embryo transfer instrument according to any one of (11) to (15) above, wherein the cylindrical covering portion is formed of a transparent or translucent material and the hollow grip body is formed of a colored opaque material. (17) The embryo transfer instrument according to any one of (11) to (16) above, wherein the cylindrical covering portion is fitted over the hollow grip body in an expanded state and comes into close contact with the outer surface of the hollow grip body upon contraction. (18) The embryo transfer instrument according to any one of (11) to (17) above, wherein the hollow grip body comprises a front-end annular bulge portion and a rear-end annular bulge portion, the front end of the cylindrical covering portion covers the rear end of the front-end annular bulge portion, and the rear end of the cylindrical covering portion covers the front end of the rear-end annular bulge portion, and both ends of the cylindrical covering portion do not protrude beyond the hollow grip body. (19) An embryo transfer instrument according to any one of (11) to (18) above, wherein the cross section of the hollow grip body decreases from the tip and rear ends toward the axial center, and the tubular covering part is in close contact with the outer surface of the hollow grip body at the axial center.(20) An embryo transfer instrument according to any one of (11) to (19) above, wherein the stylet member comprises a shaft-shaped stylet body and a stylet hub fixed to the rear end of the stylet body, and the rear end of the hollow grip and the tip end of the stylet hub are provided with rotation-restricting engagement portions that restrict relative rotation therebetween.

Claims

1. an ovum collection needle for collecting ovum from an ovarian follicle, the ovum collection needle comprising: a hollow needle with a cutting edge having a puncturing blade surface; and a hollow grip fixed to the rear end of the hollow needle, the hollow grip comprising: a hollow grip body; an index protrusion which is associated with the orientation of the puncturing blade surface and extends in the direction of the cutting edge of the hollow needle at the axial center of the hollow grip body; and an anti-slip tubular covering which covers the axial center of the hollow grip body including the index protrusion, the tubular covering having high static friction, transparency and flexibility, and the index protrusion which is associated with the orientation of the puncturing blade surface covered by the tubular covering can be recognized visually and tactilely from the outside of the tubular covering.

2. 2. The egg collection needle according to claim 1, wherein the puncturing blade surface is offset by approximately 90° in the circumferential direction of the hollow needle from the position of the index protrusion of the hollow grip, and when the egg collection needle is held with the hollow grip on the right side and the cutting edge on the left side and with the index protrusion facing upward, the puncturing blade surface faces approximately forward.

3. The ovum collection needle according to claim 1 or 2, wherein the indicator protrusion covered by the cylindrical covering portion forms an indicator protuberance.

4. 3. The ovum collection needle according to claim 1, wherein the cylindrical covering portion is made of elastic rubber or elastomer.

5. 3. The ovum collection needle according to claim 1, wherein the cylindrical covering portion is made of a transparent or semi-transparent material, and the hollow grip body is made of a colored opaque material.

6. 3. The ovum collection needle according to claim 1, wherein the cylindrical covering part is fitted onto the hollow grip body in an expanded state, and is in close contact with the outer surface of the hollow grip body when contracted.

7. 3. The egg collection needle according to claim 1 or 2, wherein the hollow grip body comprises a tip-side annular bulge and a rear-end annular bulge, the tip of the tubular covering portion covers the rear end of the tip-side annular bulge, the rear end of the tubular covering portion covers the tip of the rear-end annular bulge, and both ends of the tubular covering portion do not protrude beyond the hollow grip body.

8. The egg collection needle according to claim 7, wherein a rear end of the tip-side annular bulge covered by the tip end of the cylindrical covering portion is an enlarged diameter portion, and a tip end of the rear-end-side annular bulge covered by the rear end of the cylindrical covering portion is an enlarged diameter portion.

9. The ovum collection needle according to claim 7, wherein the tip end of the cylindrical covering part is tapered toward the tip, and the rear end of the cylindrical covering part is tapered toward the rear end.

10. 3. The egg collection needle according to claim 1, wherein the cross section of the hollow grip body becomes smaller from the tip and rear ends toward the axial center, and the tubular covering portion is in close contact with the outer surface of the hollow grip body at the axial center.

11. An embryo transfer instrument used when transferring an embryo into a living organism, the embryo transfer instrument comprising: an outer tube member having a flexible tube with a passage extending from its front end to its rear end, and a hollow grip fixed to the rear end of the flexible tube; and a stylet member removably inserted into the outer tube member, the front end of which is substantially flush with or slightly protrudes from the front end surface of the flexible tube; an indicator protrusion that is associated with the bending direction of the flexible tube and extends in the direction of the tip of the flexible tube at the axial center of the hollow grip body; and an anti-slip tubular covering portion that covers the axial center of the hollow grip body including the indicator protrusion, wherein the indicator protrusion has high static friction, transparency, and flexibility, and the indicator protrusion that is associated with the bending direction of the flexible tube covered by the tubular covering portion can be recognized visually and tactilely from the outside of the tubular covering portion.

12. 12. The embryo transfer instrument according to claim 11, further comprising an embryo transfer tube member that can be inserted into the flexible tube after the stylet member has been removed and that has a soft tip portion that can protrude a predetermined length from the tip of the flexible tube.

13. 13. The embryo transfer instrument according to claim 11, wherein the index protrusion protrudes in a curved direction of the tip curved portion of the flexible tube.

14. 13. The embryo transfer instrument according to claim 11, wherein the index protrusion covered by the cylindrical covering portion forms an index protuberance also in the hollow grip.

15. 13. The embryo transfer instrument according to claim 11, wherein the cylindrical covering portion is made of elastic rubber or elastomer.

16. 13. The embryo transfer instrument according to claim 11 or 12, wherein the cylindrical covering portion is made of a transparent or translucent material, and the hollow grip body is made of a colored opaque material.

17. 13. The embryo transfer instrument according to claim 11, wherein the cylindrical covering part is fitted onto the hollow grip body in an expanded state, and is in close contact with the outer surface of the hollow grip body when contracted.

18. 13. The embryo transfer instrument according to claim 11 or 12, wherein the hollow grip body comprises a tip-side annular bulge and a rear-side annular bulge, the tip of the tubular covering portion covers the rear end of the tip-side annular bulge, the rear end of the tubular covering portion covers the tip of the rear-side annular bulge, and both ends of the tubular covering portion do not protrude beyond the hollow grip body.

19. 13. The embryo transfer instrument according to claim 11 or 12, wherein the cross section of the hollow grip body becomes smaller from the front and rear ends toward the axial center, and the tubular covering portion is in close contact with the outer surface of the hollow grip body at the axial center.

20. 13. The embryo transfer instrument according to claim 11, wherein the stylet member comprises a shaft-shaped stylet body and a stylet hub fixed to the rear end of the stylet body, and the rear end of the hollow grip and the tip end of the stylet hub are provided with rotation-restricting engagement portions that restrict relative rotation between the two.