Catheter for uterine cervix insertion

Abstract

To provide a catheter for uterine cervix insertion which has improved operability and reduces invasiveness.SOLUTION: A catheter 100 for uterine cervix insertion having a longitudinal direction x includes: a wire 30 extending in the longitudinal direction x of the catheter 100 for uterine cervix insertion; and a first shaft 10 having a first lumen 11 penetrating in the longitudinal direction x of the catheter 100 for uterine cervix insertion and a second lumen 12 extending in the longitudinal direction x of the catheter 100 for uterine cervix in which the wire 30 is disposed. A distal end of the wire 30 is fixed to a distal end of the first shaft 10. In the cross section perpendicular to the longitudinal direction x of the catheter 100 for uterine cervix, an eccentric distance of a centroid of the wire 30 with respect to a centroid of the first shaft 10 is larger than an eccentric distance of a centroid of the first lumen 11 with respect to the centroid of the first shaft 10.SELECTED DRAWING: Figure 7

Description

Technical Field

[0001] The present invention relates to a catheter for cervical insertion used during embryo transfer or artificial insemination.

Background Art

[0002] In infertility treatment, artificial insemination, in vitro fertilization, micro-insemination, embryo transfer, etc. are performed. In vitro fertilization is a method of injecting sperm around an egg placed in a culture solution to cause fertilization. Micro-insemination is a method of injecting sperm into an egg using a thin glass tube under a microscope to cause fertilization. Embryo transfer is a method of transplanting a fertilized and grown embryo into the uterus of a patient at an appropriate timing by performing in vitro fertilization or micro-insemination. Artificial insemination is a method of increasing the probability of sperm reaching an egg by injecting sperm washed with a culture solution into the uterus.

[0003] When performing embryo transfer, for example, an embryo transfer instrument as described in Patent Document 1 is used.

[0004] Patent Document 1 describes an embryo transfer instrument including a flexible sheath having a passage penetrating from the tip to the rear end and a spherical bulge, a flexible stylet removably inserted into the flexible sheath and having a tip substantially equal to or slightly protruding from the tip surface of the flexible sheath, and a transplant tube body having a flexible tip portion that can be inserted into the flexible sheath with the flexible stylet removed and can protrude a predetermined length from the tip of the flexible sheath.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0006] The embryo transfer device described in Patent Document 1 had a flexible stylet disposed in the lumen of a flexible sheath, with a part thereof being curved. However, there are not a few cases where it is difficult to place the distal end of the flexible sheath in which the flexible stylet is disposed in the uterus due to stenosis or flexion of the cervical canal. In such cases, in some cases, the tissue of the cervix was grasped with the instrument and pulled, or the distal end of the flexible sheath in which the flexible stylet was disposed was pushed into the cervix using forceps. For this reason, depending on the skill of the doctor, it took a lot of time to place the flexible sheath in the uterus, or there was bleeding from the tissue, and there were problems from the viewpoints of operability and invasiveness.

[0007] The present invention has been made in view of the above circumstances, and an object thereof is to provide a catheter for cervical insertion that can improve operability and reduce invasiveness.

Means for Solving the Problems

[0008] The catheter for cervical insertion according to an embodiment of the present invention that has solved the above problems is as follows. [1] A catheter for cervical insertion having a longitudinal direction, a wire extending in the longitudinal direction, a first shaft having a first lumen penetrating in the longitudinal direction and a second lumen extending in the longitudinal direction and in which the wire is disposed, the distal end of the wire is fixed to the distal end of the first shaft, A catheter for cervical insertion in which, in a cross section perpendicular to the longitudinal direction, the eccentricity of the centroid of the wire with respect to the centroid of the first shaft is larger than the eccentricity of the centroid of the first lumen with respect to the centroid of the first shaft.

[0009] The catheter for cervical insertion according to an embodiment of the present invention has a distal end portion of a wire fixed to a distal end portion of a first shaft, and an eccentricity distance of the centroid of the wire with respect to the centroid of the first shaft in a cross section perpendicular to the longitudinal direction of the catheter for cervical insertion is larger than an eccentricity distance of the centroid of a first lumen with respect to the centroid of the first shaft in the cross section. Therefore, by pulling the wire toward the proximal side, the distal end portion of the catheter for cervical insertion is likely to bend in the direction in which the wire exists in the radial direction of the first shaft. Further, by setting a state in which no external force is applied to the wire, the catheter for cervical insertion can return to its original linear shape. In this way, by adjusting the traction of the wire toward the proximal side, operations such as bending the distal end portion of the catheter for cervical insertion or returning it to a linear shape can be easily performed. Thereby, the operability of the catheter for cervical insertion can be improved and the invasiveness can be reduced.

[0010] The catheter for cervical insertion according to an embodiment of the present invention is preferably any one of the following [2] to [9]. [2] The first shaft has, in the circumferential direction of the first shaft, a reinforcing portion in which a reinforcing member is disposed inside, on the outer surface, or on the inner surface of the first shaft, and a non-reinforcing portion in which no reinforcing member is disposed inside, on the outer surface, and on the inner surface of the first shaft. The catheter for cervical insertion according to [1]. [3] The first shaft has, in the circumferential direction of the first shaft, a first portion made of resin and a second portion made of resin having a lower bending rigidity than the first portion. The catheter for cervical insertion according to [1] or [2]. [4] Two or more wires are provided, the two or more wires include a first wire and a second wire, At the distal end of the first shaft, the first inner cavity is located between the first wire and the second wire. The catheter for cervical insertion according to any one of [1] to [3]. [5] The first shaft has only one second inner cavity. The catheter for cervical insertion according to any one of [1] to [4]. [6] The second inner cavity includes a second - 1 inner cavity and a second - 2 inner cavity provided at a position different from the second - 1 inner cavity. The first wire is disposed in the second - 1 inner cavity, and the second wire is disposed in the second - 2 inner cavity. The catheter for cervical insertion according to [4]. [7] Further having a second shaft having an inner cavity penetrating in the longitudinal direction and disposed in the first inner cavity of the first shaft. The catheter for cervical insertion according to any one of [1] to [6]. [8] A pressure - sensitive sensor is provided at the distal end of the first shaft. The catheter for cervical insertion according to any one of [1] to [7]. [9] The first shaft has, at its distal end, a bulging portion bulging outward in the radial direction of the first shaft, and a gas is enclosed inside the bulging portion. The catheter for cervical insertion according to any one of [1] to [8].

[0011] The present invention further provides the following transplantation method.

[10] A transplantation method for transplanting cells into the uterus using a catheter for cervical insertion having a longitudinal direction. The catheter for cervical insertion is a wire extending in the longitudinal direction, a first shaft having a first inner cavity penetrating in the longitudinal direction and a second inner cavity extending in the longitudinal direction in which the wire is disposed, and a second shaft having an inner cavity penetrating in the longitudinal direction. The distal end of the wire is fixed to the distal end of the first shaft. In a cross-section perpendicular to the longitudinal direction, the eccentricity of the centroid of the wire with respect to the centroid of the first shaft is greater than the eccentricity of the centroid of the first inner cavity with respect to the centroid of the first shaft. The transplantation method is as follows. A first step of disposing the first shaft at the cervix such that the distal end of the first shaft is located within the uterus. A second step of aspirating the cells with the second shaft after the first step. A third step of disposing the second shaft in the first inner cavity of the first shaft such that the distal end of the second shaft protrudes from the distal end of the first shaft after the second step. A fourth step of discharging the cells from the second shaft after the third step, and the transplantation method includes: In the first step, the transplantation method of moving the wire toward the proximal side.

[0012] In the transplantation method according to the embodiment of the present invention, in the first step of disposing the first shaft at the cervix such that the distal end of the first shaft is located within the uterus, the wire is moved toward the proximal side. For this reason, the distal end of the catheter for inserting into the cervix is likely to bend in the direction in which the wire exists in the radial direction of the first shaft. By adjusting the pulling of the wire toward the proximal side to bend the distal end of the catheter for inserting into the cervix, transplantation of cells can be performed using a catheter for inserting into the cervix that can improve operability and reduce invasiveness, thereby reducing the burden on the patient.

[0013] The transplantation method according to the embodiment of the present invention is preferably the following

[11] .

[11] The transplantation method according to

[10] , wherein the cells are embryos or sperm.

Effect of the Invention

[0014] The catheter for inserting into the cervix according to the embodiment of the present invention can improve operability and reduce invasiveness.

Brief Description of the Drawings

[0015]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Embodiments for Carrying Out the Invention

[0016] Hereinafter, the present invention will be specifically described with reference to the drawings. However, the present invention is not limited to the illustrated examples, and it is also possible to appropriately modify and implement it within the scope that can conform to the gist of the foregoing and following descriptions, and all of them are included in the technical scope of the present invention. In each figure, for the sake of convenience, hatching, reference signs, etc. may be omitted, but in such cases, reference shall be made to the specification and other figures. Also, the dimensions of various components in the drawings may differ from the actual dimensions because the priority is to facilitate the understanding of the features of the present invention.

[0017] The catheter for cervical insertion according to an embodiment of the present invention is a catheter for cervical insertion having a longitudinal direction, and includes a wire extending in the longitudinal direction of the catheter for cervical insertion, a first lumen penetrating in the longitudinal direction of the catheter for cervical insertion, and a second lumen extending in the longitudinal direction of the catheter for cervical insertion and in which the wire is disposed. The distal end portion of the wire is fixed to the distal end portion of the first shaft. In a cross-section perpendicular to the longitudinal direction of the catheter for cervical insertion, the gist lies in that the eccentricity distance of the centroid of the wire with respect to the centroid of the first shaft is larger than the eccentricity distance of the centroid of the first lumen with respect to the centroid of the first shaft.

[0018] With reference to FIGS. 1 to 9, the overall configuration of the catheter for cervical insertion according to an embodiment of the present invention will be described. In this drawing, a catheter for cervical insertion 100 including a first shaft 10 and a wire 30 is shown. In this drawing, the longitudinal direction of the catheter for cervical insertion 100 is indicated by x, the radial direction by y, and the circumferential direction by c. For ease of understanding, in this drawing, the longitudinal direction of the first shaft 10 coincides with the longitudinal direction x of the catheter for cervical insertion 100, the radial direction of the first shaft 10 coincides with the radial direction y of the catheter for cervical insertion 100, and the circumferential direction of the first shaft 10 coincides with the circumferential direction c of the catheter for cervical insertion 100. However, the present invention is not limited to this mode.

[0019] In this specification, the proximal side refers to the direction toward the user's hand side with respect to the longitudinal direction x of the catheter 100 for cervical insertion, and the distal side refers to the opposite side of the proximal side, that is, the direction toward the treatment target side. Also, when each member or each part is bisected in the longitudinal direction x of the catheter 100 for cervical insertion, the part located on the distal side among each member or each part is referred to as the distal part of each member or each part, and the part located on the proximal side among each member or each part is referred to as the proximal part of each member or each part. The distal end of each member or each part is the end located on the most distal side among each member or each part. The proximal end of each member or each part is the end located on the most proximal side among each member or each part. The end portion includes the peripheral portion of the end. That is, the distal end portion refers to the distal end and the peripheral portion of the distal end, and the proximal end portion refers to the proximal end and the peripheral portion of the proximal end.

[0020] Figure 1 represents a side view showing the catheter for cervical insertion according to an embodiment of the present invention. Figure 1 shows a side view when observed from the horizontal direction in the use state. More specifically, the upper side toward the drawing is the upper side in the vertical direction, and the lower side toward the drawing is the lower side in the vertical direction. In this drawing, the horizontal direction coincides with the direction indicated by arrow x, and the vertical direction coincides with the direction indicated by arrow y. Figure 2 represents a cross-sectional view (partially schematic view) of the catheter for cervical insertion shown in Figure 1. In Figure 2, the shape when the catheter for cervical insertion is bent is shown by a dashed line. Figure 3 represents an end face view of the cut portion at line III-III of the catheter for cervical insertion shown in Figure 2. Figures 4 and 5 represent end face views of the cut portion showing a modified example of the catheter for cervical insertion shown in Figure 3. Figure 6 represents a cross-sectional view (partially schematic view) showing a modified example of the catheter for cervical insertion shown in Figure 2. Figure 7 represents a cross-sectional view (partially schematic view) showing a modified example of the catheter for cervical insertion shown in Figure 2. Figure 8 represents an end face view of the cut portion at line VIII-VIII of the catheter for cervical insertion shown in Figure 7. Figure 9 represents an end face view of the cut portion showing a modified example of the catheter for cervical insertion shown in Figure 8.

[0021] As shown in FIGS. 1, 2, 6, and 7, the cervical insertion catheter 100 has a longitudinal direction x. The cervical insertion catheter 100 includes a wire 30 and a first shaft 10. At least a part of the cervical insertion catheter 100 is inserted into the cervix.

[0022] As shown in FIGS. 2, 6, and 7, the wire 30 extends in the longitudinal direction x of the cervical insertion catheter 100.

[0023] As shown in FIGS. 2 to 9, the first shaft 10 has a first lumen 11 that penetrates in the longitudinal direction x of the cervical insertion catheter 100 and a second lumen 12 that extends in the longitudinal direction x of the cervical insertion catheter 100 and in which the wire 30 is disposed. It is preferable that the wire 30 is not disposed in the first lumen 11.

[0024] The distal end portion of the wire 30 is fixed to the distal end portion of the first shaft 10.

[0025] The eccentricity distance of the centroid 30s of the wire 30 with respect to the centroid 10s of the first shaft 10 in a cross-section perpendicular to the longitudinal direction x of the cervical insertion catheter 100 is greater than the eccentricity distance of the centroid 11s of the first lumen 11 with respect to the centroid 10s of the first shaft 10 in a cross-section perpendicular to the longitudinal direction x of the cervical insertion catheter 100. The eccentricity distance of the centroid 30s of the wire 30 with respect to the centroid 10s of the first shaft 10 refers to the distance between the centroid 10s of the first shaft 10 and the centroid 30s of the wire 30 in a cross-section perpendicular to the longitudinal direction x of the cervical insertion catheter 100. The eccentricity distance of the centroid 11s of the first lumen 11 with respect to the centroid 10s of the first shaft 10 in a cross-section perpendicular to the longitudinal direction x of the cervical insertion catheter 100 refers to the distance between the centroid 10s of the first shaft 10 and the centroid 11s of the first lumen 11 in a cross-section perpendicular to the longitudinal direction x of the cervical insertion catheter 100.

[0026] The catheter 100 for cervical insertion according to the embodiment of the present invention has the distal end of the wire 30 fixed to the distal end of the first shaft 10, and the eccentricity distance of the centroid 30s of the wire 30 with respect to the centroid 10s of the first shaft 10 in a cross section perpendicular to the longitudinal direction x of the catheter 100 for cervical insertion is larger than the eccentricity distance of the centroid 11s of the first lumen 11 with respect to the centroid 10s of the first shaft 10 in this cross section. Therefore, by pulling the wire 30 proximally, the distal end of the catheter 100 for cervical insertion is likely to curve in the direction in which the wire 30 exists in the radial direction of the first shaft 10. In the example shown in FIG. 7, the catheter 100 for cervical insertion is likely to curve upward in the vertical direction. Further, by making the state where no external force is applied to the wire 30, the catheter for cervical insertion can return to its original linear shape. In this way, by adjusting the traction of the wire 30 proximally, operations such as curving the distal end of the catheter 100 for cervical insertion or returning it to a linear shape can be easily performed. Thereby, the operability of the catheter 100 for cervical insertion can be improved and the invasiveness can be reduced.

[0027] When the catheter 100 for cervical insertion is inserted into the cervix, it is preferable that a part of the catheter 100 for cervical insertion is disposed in the uterus. It is more preferable that the distal end of the catheter 100 for cervical insertion is disposed in the uterus.

[0028] The catheter 100 for cervical insertion is preferably used when performing infertility treatment. In particular, it is preferably used when performing embryo transfer or artificial insemination.

[0029] As shown in FIGS. 2 to 6, two or more wires 30 are provided, and it is preferable that the two or more wires 30 include a first wire 31 and a second wire 32. Further, at the distal end portion of the first shaft 10, it is preferable that the first lumen 11 is located between the first wire 31 and the second wire 32. Thereby, by pulling the first wire 31 proximally, the distal end portion of the uterine cervical insertion catheter 100 is likely to curve in the direction in which the first wire 31 exists in the radial direction of the first shaft 10. In the example shown in FIG. 2, the uterine cervical insertion catheter 100 is likely to curve upward in the vertical direction. Also, by pulling the second wire 32 proximally, the distal end portion of the uterine cervical insertion catheter 100 is likely to curve in the direction in which the second wire 32 exists in the radial direction of the first shaft 10. In the example shown in FIG. 2, the uterine cervical insertion catheter 100 is likely to curve downward in the vertical direction. Thus, by adjusting the proximal traction of the first wire 31 and the second wire 32, operations such as curving or linearly returning the distal end portion of the uterine cervical insertion catheter 100 can be easily performed. Thereby, the operability of the uterine cervical insertion catheter 100 can be improved and invasiveness can be reduced.

[0030] The first shaft 10 preferably has flexibility. Thereby, the first shaft 10 can be easily deformed along the shape of the body cavity. Also, for shape retention, the first shaft 10 preferably has elasticity.

[0031] The first shaft 10 preferably has a lower bending rigidity from the proximal side to the distal side. Thereby, it becomes easier to improve the operability at the distal portion of the first shaft 10.

[0032] The first shaft 10 can be in a cylindrical shape, a hollow cylindrical shape, a hollow polygonal cylindrical shape, or a combination of these shapes.

[0033] As the first shaft 10, a resin tube can be used. The resin tube can be manufactured, for example, by extrusion molding. The resin tube may be single-layered or may have a plurality of layers. In the longitudinal direction of the first shaft 10 or in the circumferential direction of the first shaft 10, a part of the first shaft 10 may be composed of a single layer and the other part may be composed of a plurality of layers.

[0034] The first shaft 10 can be composed of, for example, synthetic resins such as polyolefin resins (for example, polyethylene and polypropylene), polyamide resins (for example, nylon), polyester resins (for example, PET), aromatic polyether ketone resins (for example, PEEK), polyether polyamide resins, polyurethane resins, polyimide resins, fluororesins (for example, PTFE, PFA, ETFE), etc. These may be used alone only one kind, or two or more kinds may be used in combination.

[0035] The first shaft 10 preferably has a distal end 10a and a proximal end 10b. Further, the first shaft 10 preferably has an inner surface 10c facing the first inner cavity 11 of the first shaft 10 and an outer surface 10d facing the outside of the first shaft 10.

[0036] The outer surface 10d of the first shaft 10 is preferably coated with a hydrophilic polymer. This can make it easier to insert the first shaft 10 into the cervix. Examples of the hydrophilic polymer include maleic anhydride copolymers such as poly(2-hydroxyethyl methacrylate), polyacrylamide, polyvinylpyrrolidone, methyl vinyl ether maleic anhydride copolymer, and polyethylene glycol.

[0037] The inner surface 10c of the first shaft 10 preferably has a portion made of a fluororesin or a polyolefin resin. Only a part of the inner surface 10c of the first shaft 10 may be made of a fluororesin or a polyolefin resin, or the entire inner surface 10c of the first shaft 10 may be made of a fluororesin or a polyolefin resin. Thereby, since the first shaft 10 easily slides with respect to the second shaft 20 described later, the operability of the catheter 100 can be easily improved.

[0038] The outer diameter of the first shaft 10 can be, for example, 1.0 mm or more, 1.3 mm or more, 1.6 mm or more, etc. Also, the outer diameter of the first shaft 10 can be, for example, 5.0 mm or less, 4.0 mm or less, 3.0 mm or less, etc.

[0039] The diameter of the first lumen 11 of the first shaft 10 can be, for example, 3.0 mm or less, 2.5 mm or less, 2.0 mm or less, etc. Also, the diameter of the first lumen 11 of the first shaft 10 can be, for example, 1.1 mm or more, 1.2 mm or more, 1.3 mm or more, etc. It is also preferable that the diameter of the first lumen 11 of the first shaft 10 is large enough for the second shaft 20 to pass through.

[0040] As shown in FIG. 2, the first shaft 10 has a distal opening 11a that communicates the first lumen 11 of the first shaft 10 with the outside of the first shaft 10 at the distal end of the first shaft 10, and may have a proximal opening 11b that communicates the first lumen 11 of the first shaft 10 with the outside of the first shaft 10 at the proximal end of the first shaft 10.

[0041] The length of the first shaft 10 in the longitudinal direction x of the catheter 100 for cervical insertion can be, for example, 140 mm or more, 150 mm or more, 160 mm or more, etc. Also, the length of the first shaft 10 in the longitudinal direction x of the catheter 100 for cervical insertion can be, for example, 200 mm or less, 190 mm or less, 180 mm or less, etc.

[0042] As shown in FIGS. 2, 3, 7, and 8, the catheter 100 for cervical insertion may have a reinforcing member 13. Although not shown, the reinforcing member 13 may be embedded inside the first shaft 10. In other words, the reinforcing member 13 may be located radially outward of the first shaft 10 with respect to the inner surface 10c of the first shaft 10 and radially inward of the first shaft 10 with respect to the outer surface 10d of the first shaft 10. The reinforcing member 13 may be disposed on the outer surface 10d of the first shaft 10. As shown in FIG. 3, the reinforcing member 13 may be disposed on the inner surface 10c of the first shaft 10.

[0043] As shown in FIGS. 2, 3, 7, and 8, the reinforcing member 13 is preferably a plate or sheet formed in an arc shape. The reinforcing member 13 may be a braid in which wires are woven, or a plate or sheet in which a plurality of holes or grooves are formed.

[0044] The reinforcing member 13 may be made of resin. In this case, it is preferably made of a resin having a higher flexural rigidity than the resin constituting the first shaft 10. The reinforcing member 13 may be made of metal. The reinforcing member 13 may be entirely composed of only metal, or entirely composed of only resin. The reinforcing member 13 may have a part made of metal and another part made of resin.

[0045] Examples of the metal constituting the reinforcing member 13 include stainless steels such as SUS304 and SUS316, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloys, Co-Cr alloys, or combinations thereof.

[0046] Examples of the resin constituting the reinforcing member 13 include polyparaphenylene terephthalamide, polyetheretherketone (PEEK), polycarbonate (PC), and the like.

[0047] As shown in FIGS. 3 and 8, the first shaft 10 may have a reinforcing portion 131 in which a reinforcing member 13 is disposed inside the first shaft 10, on the outer surface 10d or on the inner surface 10c of the first shaft 10 in the circumferential direction of the first shaft 10, and a non-reinforcing portion 132 in which no reinforcing member 13 is disposed inside the first shaft 10, on the outer surface 10d and on the inner surface 10c thereof. In other words, the reinforcing portion 131 refers to a portion of the first shaft 10 in which a reinforcing member 13 is disposed on any one of the inside of the first shaft 10, the outer surface 10d or the inner surface 10c in the circumferential direction of the first shaft 10. The non-reinforcing portion 132 refers to a portion of the first shaft 10 in which no reinforcing member 13 is disposed on any of the inside of the first shaft 10, the outer surface 10d and the inner surface 10c in the circumferential direction of the first shaft 10. Thereby, in the circumferential direction c of the catheter 100 for cervical insertion, there will be a portion that is relatively easy to bend and a portion that is relatively difficult to bend. For this reason, the catheter 100 for cervical insertion is likely to bend in a predetermined direction. In the case of the embodiment shown in FIG. 3, in particular, the catheter 100 for cervical insertion is likely to bend in the direction in which the reinforcing portion 131 exists in the radial direction of the first shaft 10. In the case of the embodiment shown in FIG. 8, in particular, the catheter 100 for cervical insertion is likely to bend in the direction in which the non-reinforcing portion 132 exists in the radial direction of the first shaft 10. There will thus be a portion that is relatively easy to bend and a portion that is relatively difficult to bend.

[0048] Preferably, the length of the reinforcing portion 131 in the circumferential direction of the first shaft 10 is longer than the length of the non-reinforcing portion 132 in the circumferential direction of the first shaft 10. Thereby, it is possible to easily stabilize the bending direction of the catheter 100 for cervical insertion. Note that an embodiment in which the length of the reinforcing portion 131 in the circumferential direction of the first shaft 10 is shorter than the length of the non-reinforcing portion 132 in the circumferential direction of the first shaft 10 is also acceptable.

[0049] As shown in FIG. 3, in the circumferential direction of the first shaft 10, the wire 30 may be disposed in a section where the reinforcing portion 131 of the first shaft 10 exists. As shown in FIG. 8, in the circumferential direction of the first shaft 10, the wire 30 may be disposed in a section where the non-reinforcing portion 132 of the first shaft 10 exists.

[0050] As shown in FIGS. 4 and 9, the first shaft 10 may have, in the circumferential direction of the first shaft 10, a first portion 141 made of resin and a second portion 142 made of resin having a lower bending rigidity than the first portion 141. Thereby, in the circumferential direction c of the uterine cervical insertion catheter 100, there are a portion that is relatively easy to bend and a portion that is relatively difficult to bend. For this reason, the uterine cervical insertion catheter 100 is likely to bend in a predetermined direction. In the case of the embodiment shown in FIG. 4, in particular, the uterine cervical insertion catheter 100 is likely to bend in the direction in which the first portion 141 exists in the radial direction of the first shaft 10. In the case of the embodiment shown in FIG. 9, in particular, the uterine cervical insertion catheter 100 is likely to bend in the direction in which the second portion 142 exists in the radial direction of the first shaft 10.

[0051] It is preferable that the length of the first portion 141 in the circumferential direction of the first shaft 10 is longer than the length of the second portion 142 in the circumferential direction of the first shaft 10. Thereby, it is possible to easily stabilize the bending direction of the uterine cervical insertion catheter 100. Note that an embodiment in which the length of the first portion 141 in the circumferential direction of the first shaft 10 is shorter than the length of the second portion 142 in the circumferential direction of the first shaft 10 is also acceptable.

[0052] As shown in FIG. 4, in the circumferential direction of the first shaft 10, the wire 30 may be disposed in a section where the first portion 141 of the first shaft 10 exists. As shown in FIG. 9, in the circumferential direction of the first shaft 10, the wire 30 may be disposed in a section where the second portion 142 of the first shaft 10 exists.

[0053] As shown in FIGS. 2 to 5, in the state of use, it is preferable that the first wire 31 is located above the first inner cavity 11 and the second wire 32 is located below the first inner cavity 11. Thereby, the catheter 100 for cervical insertion can be easily bent in the vertical direction.

[0054] As shown in FIGS. 5, 8, and 9, the first shaft 10 may have only one second inner cavity 12. When two or more wires 30 are provided as shown in FIG. 5, both the first wire 31 and the second wire 32 are arranged in the second inner cavity 12.

[0055] When there is only one second inner cavity 12, the first shaft 10 preferably has an outer cylinder 2 having an inner cavity and an inner cylinder 3 arranged in the inner cavity of the outer cylinder 2 as shown in FIG. 5. In this case, it is preferable that the inner cavity of the inner cylinder 3 is the first inner cavity 11 and the space existing between the outer cylinder 2 and the inner cylinder 3 is the second inner cavity 12.

[0056] When a plurality of wires 30 are provided and there is only one second inner cavity 12, the first shaft 10 preferably extends in the longitudinal direction x of the catheter 100 for cervical insertion and has a recess in which the wires 30 are arranged. Thereby, it is easy to suppress the movement of the plurality of wires 30 to unintended positions or the entanglement of the plurality of wires 30 with each other. For example, as shown in FIG. 5, the inner cylinder 3 of the first shaft 10 may be configured to have a first recess 3a in which the first wire 31 is arranged and a second recess 3b in which the second wire 32 is arranged. Note that a mode in which a plurality of wires 30 are provided, there is only one second inner cavity 12, and the first shaft 10 does not have a recess in which the wires 30 are arranged is also allowed.

[0057] As shown in FIGS. 3 and 4, the second lumen 12 may include a second-1 lumen 121 and a second-2 lumen 122 provided at a position different from that of the second-1 lumen 121. In this case, it is preferable that the first lumen 11 is disposed between the second-1 lumen 121 and the second-2 lumen 122. When the second lumen 12 is configured as described above, it is preferable that the first wire 31 is disposed in the second-1 lumen 121 and the second wire 32 is disposed in the second-2 lumen 122. By disposing the first wire 31 and the second wire 32 in separate second lumens 12, it is possible to prevent the first wire 31 and the second wire 32 from moving to unintended positions or becoming entangled with each other.

[0058] In the state of use, it is preferable that the second-1 lumen 121 is located above the first lumen 11 and the second-2 lumen 122 is located below the first lumen 11. Thereby, it is possible to easily bend the catheter 100 for cervical insertion in the vertical direction.

[0059] As shown in FIG. 6, it is preferable that a pressure-sensitive sensor 15 is provided at the distal end portion of the first shaft 10. By disposing the pressure-sensitive sensor 15, it is possible to suppress tissue damage caused by applying too much force to the first shaft 10, and it becomes easier to suppress bleeding from the tissue. The pressure-sensitive sensor 15 may be provided on the distal end face of the first shaft 10.

[0060] As shown in FIGS. 1, 2, 6, and 7, it is preferable that the first shaft 10 has a bulging portion 16 that bulges outward in the radial direction of the first shaft 10 at its distal end portion. With the above configuration, it is possible to easily prevent the distal end portion of the first shaft 10 from damaging the tissue. Although not shown, as an aspect of the first shaft 10, an aspect without a bulging portion is also allowed.

[0061] The catheter 100 for cervical insertion preferably has an ultrasonic contrast marker portion formed of a material containing an ultrasonic contrast material at its distal end. More preferably, the catheter 100 for cervical insertion has an ultrasonic contrast marker portion formed of a material containing an ultrasonic contrast material in the vicinity of the bulging portion 16. By the catheter 100 for cervical insertion having the ultrasonic contrast marker portion, it becomes easier to improve the visibility of the distal end of the first shaft 10 or the bulging portion 16 under echography.

[0062] The ultrasonic contrast marker portion may be a ring-shaped member or a coil-shaped member provided in the vicinity of the distal end of the first shaft 10 or the bulging portion 16. By the distal end of the first shaft 10 or the bulging portion 16 being formed of a material containing an ultrasonic contrast material, at least a part of the distal end of the first shaft 10 or at least a part of the bulging portion 16 may constitute the ultrasonic contrast marker portion.

[0063] Holes or grooves may be formed at the distal end of the first shaft 10. In particular, it is preferable that holes or grooves are formed in the bulging portion 16. By forming holes or grooves, it is possible to preferably reflect ultrasonic waves more easily, and it becomes easier to improve the visibility of the distal end of the first shaft 10 or the bulging portion 16.

[0064] As shown in FIGS. 2, 6, and 7, it is preferable that a gas 17 is enclosed inside the bulging portion 16. With the above configuration, the bulging portion 16 in which the gas 17 is enclosed can preferably reflect ultrasonic waves more easily, and it becomes easier to improve the visibility at the distal end of the first shaft 10. The space in which the gas 17 is enclosed may be only one or a plurality. Although not shown, as an aspect of the first shaft 10, an aspect having a bulging portion 16 but in which no gas is enclosed inside the bulging portion 16 is also allowed.

[0065] As the gas 17, for example, air, nitrogen, or the like can be used.

[0066] The wire 30 may be made of a metal such as stainless steel or a synthetic resin such as a fluororesin.

[0067] In the drawings, the cervical insertion catheter 100 with only one or only two wires 30 is illustrated, but the present invention is not limited thereto. For example, the number of wires 30 may be three or more, or four or more. By increasing the number of wires 30, it becomes easier to finely adjust the bending direction of the cervical insertion catheter 100. Note that since the structure becomes complicated if the number of wires 30 is too large, the number of wires 30 is preferably ten or less.

[0068] As shown in FIGS. 1, 2, 6, and 7, the cervical insertion catheter 100 may include a handle 40 connected to the proximal end portion of the first shaft 10. In FIG. 1, the side surface of the handle 40 is shown. In FIGS. 2, 6, and 7, the internal structure of the handle 40 is shown.

[0069] The handle 40 is a portion that the user grips and operates. Therefore, the handle 40 preferably has a shape that is easy for the user to grip and operate.

[0070] The constituent material of the handle 40 is not particularly limited, and for example, polyolefin resins such as polypropylene (PP) and polyethylene (PE), polyester resins such as polyethylene terephthalate (PET), polycarbonate resin, ABS resin, and synthetic resins such as polyurethane resin can be used.

[0071] The proximal end portion of the wire 30 is preferably fixed to the handle 40. More specifically, it is preferable that the proximal end portion of the wire 30 is fixed to the handle 40 so that the wire 30 can be moved proximally or distally by operating the handle 40.

[0072] As shown in FIG. 6, the catheter 100 for cervical insertion has a lumen 21 penetrating in the longitudinal direction x of the catheter 100 for cervical insertion, and may further have a second shaft 20 disposed in the first lumen 11 of the first shaft 10. The second shaft 20 is preferably disposed in the first lumen 11 of the first shaft 10 after the first shaft 10 is inserted into the cervix. The second shaft 20 is preferably disposed in the first lumen 11 of the first shaft 10 with an embryo or sperm disposed in the lumen 21 after the first shaft 10 is inserted into the cervix. The embryo can be transplanted into the uterus by discharging the embryo from the second shaft 20. The sperm can be injected into the uterus by discharging the sperm from the second shaft 20.

[0073] As shown in FIG. 6, the handle 40 preferably has a lumen in which the second shaft 20 is disposed and which penetrates in the longitudinal direction x of the catheter 100 for cervical insertion. The lumen of the handle 40 preferably communicates with the first lumen 11 of the first shaft 10. In FIG. 6, the lumen of the handle 40 is shown by a dashed line.

[0074] In the longitudinal direction x of the catheter 100 for cervical insertion, the length of the second shaft 20 is preferably longer than the length of the first shaft 10. Thereby, it is possible to easily discharge the embryo or sperm from the second shaft 20 into the uterus.

[0075] The second shaft 20 preferably has a distal end 20a and a proximal end 20b. Further, the second shaft 20 preferably has an inner surface 20c facing the lumen 21 of the second shaft 20 and an outer surface 20d facing the outside of the second shaft 20.

[0076] Regarding the configuration related to the second shaft 20, such as the material constituting the second shaft 20, reference can be made to the parts described for the first shaft 10.

[0077] The outer diameter of the second shaft 20 can be, for example, 0.3 mm or more, 0.5 mm or more, 0.8 mm or more, etc. Also, the outer diameter of the second shaft 20 can be, for example, 2.0 mm or less, 1.6 mm or less, 1.2 mm or less, etc.

[0078] The diameter of the inner cavity 21 of the second shaft 20 can be, for example, 1.5 mm or less, 1.2 mm or less, 0.9 mm or less, etc. Also, the diameter of the inner cavity 21 of the second shaft 20 can be, for example, 0.1 mm or more, 0.2 mm or more, 0.3 mm or more, etc. It is also preferable that the diameter of the inner cavity 21 of the second shaft 20 is of a size through which the embryo can pass.

[0079] As shown in FIG. 6, the second shaft 20 has a distal opening 21a at the distal end of the second shaft 20 that communicates the inner cavity 21 of the second shaft 20 with the outside of the second shaft 20, and may have a proximal opening 21b at the proximal end of the second shaft 20 that communicates the inner cavity 21 of the second shaft 20 with the outside of the second shaft 20.

[0080] The length of the second shaft 20 in the longitudinal direction x of the catheter 100 for cervical insertion can be, for example, 300 mm or more, 340 mm or more, 380 mm or more, etc. Also, the length of the second shaft 20 in the longitudinal direction x of the catheter 100 for cervical insertion can be, for example, 600 mm or less, 550 mm or less, 500 mm or less, etc.

[0081] Next, a transplantation method according to an embodiment of the present invention will be described with reference to FIGS. 1 to 10. FIG. 10 shows a flowchart of the transplantation method according to the embodiment of the present invention. Note that descriptions of configurations that have already been described in the part where the catheter 100 for cervical insertion is described are omitted because of duplication of content.

[0082] The transplantation method according to an embodiment of the present invention is a transplantation method for transplanting cells into the uterus using a catheter for cervical insertion having a longitudinal direction, wherein the catheter for cervical insertion includes a wire extending in the longitudinal direction of the catheter for cervical insertion, a first lumen penetrating in the longitudinal direction of the catheter for cervical insertion, and a second lumen extending in the longitudinal direction of the catheter for cervical insertion and having the wire disposed therein, a first shaft having the first lumen and the second lumen, a second shaft having a lumen penetrating in the longitudinal direction of the catheter for cervical insertion, the distal end portion of the wire being fixed to the distal end portion of the first shaft, and in a cross section perpendicular to the longitudinal direction of the catheter for cervical insertion, the eccentricity distance of the centroid of the wire with respect to the centroid of the first shaft is larger than the eccentricity distance of the centroid of the first lumen with respect to the centroid of the first shaft, and the transplantation method includes a first step of disposing the first shaft at the cervix so that the distal end portion of the first shaft is located within the uterus, a second step of sucking cells with the second shaft after the first step, a third step of disposing the second shaft in the first lumen of the first shaft so that the distal end portion of the second shaft protrudes from the distal end portion of the first shaft after the second step, and a fourth step of discharging cells from the second shaft after the third step, and the gist of the first step is to move the wire toward the proximal side.

[0083] The above transplantation method is a method used when transplanting cells into the uterus. Examples of the cells to be transplanted include embryos or sperm.

[0084] The catheter 100 for cervical insertion used in the above transplantation method has a longitudinal direction x, and includes a first shaft 10 having a wire 30 extending in the longitudinal direction x of the catheter 100 for cervical insertion, a first lumen 11 penetrating in the longitudinal direction x of the catheter 100 for cervical insertion, and a second lumen 12 extending in the longitudinal direction x of the catheter 100 for cervical insertion and having the wire 30 disposed therein.

[0085] The distal end portion of the wire 30 is fixed to the distal end portion of the first shaft 10.

[0086] In a cross-section perpendicular to the longitudinal direction x of the catheter 100 for cervical insertion, the eccentricity distance of the centroid 30s of the wire 30 with respect to the centroid 10s of the first shaft 10 is larger than the eccentricity distance of the centroid 11s of the first lumen 11 with respect to the centroid 10s of the first shaft 10.

[0087] The catheter 100 for cervical insertion used in the above transplantation method includes a second shaft 20 having a lumen 21 penetrating in the longitudinal direction x of the catheter 100 for cervical insertion.

[0088] The above transplantation method has a first step of disposing the first shaft 10 at the cervical portion so that the distal end of the first shaft 10 is located in the uterus. In this first step, by moving the wire 30 toward the proximal side, the distal end of the catheter 100 for cervical insertion is likely to bend in the direction in which the wire 30 moved to the proximal side exists among the radial directions of the first shaft 10.

[0089] The above transplantation method has a second step of sucking cells with the second shaft 20 after the first step.

[0090] The above transplantation method has a third step of disposing the second shaft 20 in the first lumen 11 of the first shaft 10 so that the distal end of the second shaft 20 protrudes from the distal end of the first shaft 10 after the second step.

[0091] The above transplantation method has a fourth step of discharging cells from the second shaft 20 after the third step.

[0092] In the first step of arranging the first shaft 10 at the cervical portion such that the distal end of the first shaft 10 is positioned within the uterus in the above-described transplantation method, the wire 30 is moved toward the proximal side. For this reason, the distal end of the catheter 100 for inserting into the cervical portion is likely to bend in the direction in the radial direction of the first shaft 10 where the wire 30 is present. By adjusting the pulling of the wire 30 toward the proximal side to bend the distal end of the catheter 100 for inserting into the cervical portion, transplantation of cells is performed using the catheter 100 for inserting into the cervical portion, which can improve the operability and reduce the invasiveness, whereby the burden on the patient can be reduced.

[0093] The above-described transplantation method is preferably used when performing infertility treatment. In particular, it is preferably used when performing embryo transfer or artificial insemination.

[0094] When the transplantation method is used for embryo transfer, an embryo is used as the cell to be aspirated by the second shaft 20 in the second step. More specifically, as the cell to be aspirated by the second shaft 20 in the second step, it is preferable to aspirate, together with the culture solution, an embryo that has been cultured after in vitro fertilization or intracytoplasmic sperm injection and grown to the early embryo or blastocyst stage. The embryo may be an embryo that has not undergone cryopreservation or an embryo that has undergone cryopreservation.

[0095] When the transplantation method is used for artificial insemination, sperm are used as the cells to be aspirated by the second shaft 20 in the second step. More specifically, as the cells to be aspirated by the second shaft 20 in the second step, it is preferable to aspirate, together with the culture solution, sperm after washing with the culture solution using the second shaft 20. The sperm may be sperm that has not undergone cryopreservation or sperm that has undergone cryopreservation.

Explanation of Reference Numerals

[0096] 2: Outer cylinder 3: Inner cylinder 10: First shaft 10a: Distal end 10b: Proximal end 10c: Inner surface 10d: Outer surface 10s: Center of the figure 11: First inner cavity 11a: Distal opening 11b: Proximal opening 11s: Center of the figure 12: Second inner cavity 121: Second - 1 inner cavity 122: Second - 2 inner cavity 13: Reinforcing member 131: Reinforcing part 132: Non - reinforcing part 141: First part 142: Second part 15: Pressure - sensitive sensor 16: Bulging part 17: Gas 20: Second shaft 20a: Distal end 20b: Proximal end 20c: Inner surface 20d: Outer surface 21: Inner cavity 21a: Distal opening 21b: Proximal opening 30: Wire 30s: Center of the figure 31: First wire 32: Second wire 40: Handle 100: Catheter for cervical insertion

Claims

1. A catheter for cervical insertion having a longitudinal direction, comprising: a wire extending in the longitudinal direction; a first shaft having a first lumen penetrating in the longitudinal direction and a second lumen extending in the longitudinal direction and in which the wire is disposed; the distal end of the wire being fixed to the distal end of the first shaft; a catheter for cervical insertion, wherein in a cross-section perpendicular to the longitudinal direction, the eccentricity of the centroid of the wire with respect to the centroid of the first shaft is greater than the eccentricity of the centroid of the first lumen with respect to the centroid of the first shaft.

2. The catheter for cervical insertion according to claim 1, wherein the first shaft has, in the circumferential direction of the first shaft, a reinforcing portion in which a reinforcing member is disposed on the inner, outer or inner surface of the first shaft, and a non-reinforcing portion in which no reinforcing member is disposed on the inner, outer and inner surfaces of the first shaft.

3. The catheter for cervical insertion according to claim 1, wherein the first shaft has, in the circumferential direction of the first shaft, a first portion made of resin and a second portion made of resin having a lower bending rigidity than the first portion.

4. Two or more wires are provided, the two or more wires include a first wire and a second wire, the catheter for cervical insertion according to claim 1, wherein at the distal end of the first shaft, the first lumen is located between the first wire and the second wire.

5. The catheter for cervical insertion according to any one of claims 1 to 4, wherein the first shaft has only one second lumen.

6. The second lumen includes a second-1 lumen and a second-2 lumen provided at a position different from the second-1 lumen, the catheter for cervical insertion according to claim 4, wherein the first wire is disposed in the second-1 lumen and the second wire is disposed in the second-2 lumen.

7. The catheter for cervical insertion according to any one of claims 1 to 4, further comprising a second shaft having a lumen penetrating in the longitudinal direction and disposed in the first lumen of the first shaft.

8. The catheter for cervical insertion according to any one of claims 1 to 4, wherein a pressure sensor is provided at the distal end of the first shaft.

9. The first shaft has, at its distal end, a bulging portion that bulges outward in the radial direction of the first shaft, and a gas is enclosed inside the bulging portion. The catheter for cervical insertion according to any one of claims 1 to 4.

Images