WO2023131190A1 - 一种胚胎移植装置和系统 - Google Patents

一种胚胎移植装置和系统 Download PDF

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Publication number
WO2023131190A1
WO2023131190A1 PCT/CN2023/070463 CN2023070463W WO2023131190A1 WO 2023131190 A1 WO2023131190 A1 WO 2023131190A1 CN 2023070463 W CN2023070463 W CN 2023070463W WO 2023131190 A1 WO2023131190 A1 WO 2023131190A1
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outer catheter
embryo transfer
inner catheter
transfer device
catheter
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PCT/CN2023/070463
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English (en)
French (fr)
Inventor
孙丽华
吴艳雪
方浩
宗果
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上海市东方医院（同济大学附属东方医院）
上海明悦医疗科技有限公司
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Application filed by 上海市东方医院（同济大学附属东方医院）, 上海明悦医疗科技有限公司 filed Critical 上海市东方医院（同济大学附属东方医院）
Publication of WO2023131190A1 publication Critical patent/WO2023131190A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A61B17/425—Gynaecological or obstetrical instruments or methods for reproduction or fertilisation
    • A61B17/435—Gynaecological or obstetrical instruments or methods for reproduction or fertilisation for embryo or ova transplantation

Definitions

  • the present application relates to the technical field of embryo transfer, in particular to an embryo transfer device and system.
  • in vitro fertilization-embryo transfer technology (commonly known as test-tube baby) is an effective means to treat refractory infertility. In general, it is divided into the following steps: ovulation induction, egg retrieval, in vitro fertilization, embryo transfer and luteal support. Among them, in vitro fertilization-embryo transfer is a process in which gametes form embryos outside the body and then transfer the embryos back into the female body.
  • embryo transfer plays a connecting role.
  • the embryo transfer process generally includes sucking the embryos to the front end of the implantation catheter through a syringe, transporting the embryos to the cervix through the inner tube of the embryo transfer catheter, and then implanting them into the uterine cavity through the implantation outer catheter.
  • the existing embryo transfer catheters are prone to problems such as embryo displacement when sucking embryos, uterine contractions or hemorrhage, resulting in failure of embryo implantation, which reduces the transfer efficiency of embryo transfer.
  • the first purpose of this application is to provide an embryo transfer device
  • the inner catheter assembly includes an inner catheter and an inner catheter connector, the inner catheter connector is located at the proximal end of the inner catheter, and the distal end of the inner catheter has a sampling part, and the end surface of the sampling part is a bevel structure or an arc surface structure , the sampling part is used to absorb embryos, the inner catheter assembly has a second accommodating channel, the second accommodating channel runs through the inner catheter and the inner catheter connector, and the second accommodating channel is used to provide a The adsorption force or provide a delivery channel for the embryo;
  • the outer catheter assembly includes a first receiving channel, the distal end of the first receiving channel is used to be arranged at the target position of the implanted object, and the sampling part is detachably connected with the first receiving channel, so that the The sampling part reaches the target position through the first containing channel.
  • the radial dimension of the sampling portion increases gradually toward the proximal end of the inner catheter.
  • the included angle between the end surface of the sampling part and the axis of the inner conduit is about 20° to about 70°.
  • the sampling part is provided with a physical mark, and the physical mark is used to indicate the orientation of the end surface of the sampling part.
  • the outer catheter assembly includes a flexible head tube, an outer catheter, and an outer catheter joint from the distal end to the proximal end. Tubes, outer conduits, and outer conduit connectors.
  • the outer catheter includes a main body part and a connecting part that are bent and connected, the connecting part is connected to the soft head tube at the distal end, and the main body part is connected to the outer catheter joint at the proximal end. connect.
  • the knuckle angle between the main body part and the connecting part of the outer catheter is about 10° to about 50°.
  • the outer catheter assembly further includes a positioning block for abutting against the proximal end of the cervix of the implanted object, and the positioning block is sleeved on the outer catheter and can slide relative to the outer catheter.
  • the outer catheter is provided with a second positioning scale, and the positioning block cooperates with the second positioning scale to indicate the length of the outer catheter entering the uterus of the implanted object; or,
  • a second indicator mark is arranged on the positioning block, and the second indicator mark cooperates with the second positioning scale to indicate the length of the outer catheter entering the uterus of the implanted object.
  • the radial dimension of the positioning block gradually increases toward the proximal end of the positioning block, and the positioning block is made of elastic body.
  • the embryo transfer device includes a liner assembly, the hardness of which is greater than that of the outer catheter, the distal end of the liner is hemispherical, and the liner assembly can be detachably connected to the first accommodating channel.
  • the inner catheter assembly further includes a support tube, the support tube is sheathed outside the inner catheter, or the support tube is connected between the inner catheter and the inner catheter joint, and the hardness of the support tube is greater than that of the inner catheter .
  • the support tube is provided with a first positioning scale, and the first positioning scale is used to indicate the length of the inner catheter assembly entering the uterus of the implanted subject.
  • the second purpose of the present application is to provide an embryo transfer system, including a syringe and the above-mentioned embryo transfer device.
  • the syringe and the connector of the inner catheter are adapted to provide suction for aspirating embryos or provide thrust for conveying embryos.
  • FIG. 1 is a schematic structural diagram of an outer catheter assembly provided by one or more embodiments of the present application.
  • Fig. 2 is a schematic structural diagram of an inner catheter assembly provided by one or more embodiments of the present application
  • Fig. 3 is a structural schematic diagram of an angle of the sampling part of the inner catheter provided by one or more embodiments of the present application;
  • Fig. 4 is a structural schematic diagram of another angle of the sampling part of the inner catheter provided by one or more embodiments of the present application;
  • Fig. 5 is a schematic structural view of a liner assembly provided by one or more embodiments of the present application.
  • first and second are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features.
  • the features defined as “first” and “second” may explicitly or implicitly include at least one of these features.
  • “plurality” means at least two, such as two, three, etc., unless otherwise specifically defined.
  • proximal end means that the proximal end refers to the end closest to the operator, and the distal end refers to the end farthest from the operator.
  • the proximal end and the distal end are also Respectively refer to the end of the member closest to the operator and the end farthest away from the operator.
  • the embryo transfer catheter needs to be moved slowly and accurately to transfer the embryo to the appropriate position, thereby improving the clinical pregnancy rate.
  • the existing embryo transfer catheters are prone to displacement when sucking embryos.
  • problems such as uterine contractions or bleeding are prone to occur, resulting in failure of implantation, and the existing transfer catheters cannot accurately control embryo transfer. s position.
  • the first aspect of the present application provides an embryo transfer device, including an inner catheter assembly and an outer catheter assembly, wherein the outer catheter assembly is shown in Figure 1, and the inner catheter assembly is shown in Figure 2 , the outer catheter assembly is used to insert the embryo into the uterus of the subject and fix the relative position of the uterus, and has the function of accommodating the inner catheter assembly, which is used to suck the embryo and transport the embryo to the embryo implantation through the outer catheter assembly into the target location within the subject's uterine cavity.
  • This application improves the inner catheter assembly in the embryo transfer device, increases the contact area between the sampling part of the inner catheter assembly and the embryo, reduces the occurrence of embryo displacement when sucking the embryo, and improves the speed and accuracy of sucking the embryo. Thereby improving the transfer efficiency of embryo transfer.
  • the outer catheter assembly includes a soft head tube 101 , an outer catheter 102 , a positioning block 103 and an outer catheter joint 104 from the distal end (that is, the end away from the operator) to the proximal end (that is, the end close to the operator).
  • the outer catheter joint 104 is connected to the proximal end of the outer catheter 102, and the flexible head tube 101 is connected to the distal end of the outer catheter 102, and both the soft head tube 101 and the outer catheter 102 are in a bent structure, and the soft head tube 101 is used for Placed within the cervix of the implanted subject.
  • connection between the outer conduit 102 and the soft conduit 101 avoids the bending position, so as to facilitate the connection between the soft head tube 101 and the outer conduit 102 , so that the connection strength between the soft head tube 101 and the outer conduit 102 is higher.
  • the positioning block 103 is sleeved on the outer catheter 102, and is slidably connected with the outer catheter 102, and is used for abutting against the proximal end of the cervix of the implanted object when the outer catheter assembly is inserted into the implanted object, and pushed by external force
  • the relative positions of the outer catheter 102 and the positioning block 103 can be adjusted.
  • the outer catheter 102 includes a main body 1021 and a connecting part 1022, the outer catheter connector 104 is connected to one end of the main body 1021, one end of the connecting part 1022 is connected to the other end of the main body 1021, and the soft head tube 101 is connected to
  • the portion 1022 is arranged in a straight line as a whole in a static state, and the connecting portion 1022 and the main body portion 1021 are in a bent structure.
  • the bending angle of the bending structure is about 10° to about 50°, for example, about 20°, about 25°, about 30°, about 35°, about 40°, about 45°, the angle range Being able to adapt to the shape of the bent cervix not only increases the strength of the outer catheter 102 but also improves the matching degree between the outer catheter 102 and the cervix.
  • the outer catheter assembly also includes a first accommodating passage 100 that runs through the soft head tube 101, the outer catheter 102 and the outer catheter joint 104.
  • the target position, the uterus includes the cervix and the uterine cavity from the proximal end (that is, the end close to the operator) to the distal end (that is, the end away from the operator).
  • the target position is at least close to the distal end of the cervix. intrauterine.
  • the positioning block 103 and the outer catheter 102 are slidably connected.
  • the positioning block 103 is used to abut against the cervix, the relative position of the outer catheter 102 and the positioning block 103 is adjusted by external force, and the insertion position of the outer catheter is fixed by the fitting effect of the positioning block and the cervix.
  • the positioning block 103 has a positioning hole, and the positioning block 103 has elasticity.
  • the sliding connection between the outer catheter and the positioning block can be realized under the action of an external force, ensuring
  • the outer catheter 102 can slide relative to the positioning block 103 under the push of an external force, and the relative position of the outer catheter 102 and the positioning block 103 can be fixed through the elastic action of the positioning block 103, so that the outer catheter 102 can be fixed by the abutment effect of the positioning block 103 and the cervix.
  • the positioning hole runs through the positioning block 103 to accommodate the outer catheter 102.
  • the positioning hole is a tunnel with a uniform diameter.
  • the diameter of the positioning hole is not greater than the diameter of the outer catheter, and the positioning block is made of elastic material so that the outer catheter 102 can be inserted.
  • the positioning hole can not only ensure that the outer catheter 102 can slide relative to the positioning block 103 under the push of an external force, but also use the elastic fixing effect of the positioning block 103 and the outer catheter 102 to fix the position where the outer catheter 102 is inserted into the uterine cavity, thereby enabling more Accurately control the position of embryo transfer and improve the transfer efficiency of embryo transfer.
  • the radial dimension of the positioning block 103 gradually increases toward the proximal end of the positioning block 103 (ie, the end close to the operator), and the positioning block is made of elastic material.
  • the radial dimension is the diameter of the cross section of the positioning block 103 , and the section of the positioning block 103 perpendicular to the extending direction of the outer catheter in contact with it is the cross section of the positioning block 103 .
  • the positioning block 103 is a truncated circular structure, and the smaller end of the truncated circular structure is close to the distal end of the outer catheter (that is, the end away from the operator), and the positioning holes run through the two circular surfaces of the truncated circular structure to reduce the Difficulty in advancing and joining the cervix with small positioning blocks.
  • the positioning block 103 is made of rubber, so that the positioning block 103 has elasticity.
  • the outer catheter 102 in order to accurately control the insertion position of the outer catheter, is provided with a second positioning scale 105, and the positioning block cooperates with the second positioning scale 105 to indicate the length of the outer catheter 102 entering the uterus of the implanted subject; or, The positioning block 103 is provided with a second indicator mark, and the second indicator mark cooperates with the second positioning scale 105 to indicate the length of the outer catheter 102 entering the uterus of the implanted subject.
  • the outer catheter 102 is provided with a second positioning scale 105, and the second positioning scale 105 is located at the distal end of the outer catheter 102.
  • the positioning block 103 can cover the second positioning scale 105, and then according to The positioning block 103 covers the position on the positioning scale to determine the insertion length of the outer catheter 102 .
  • the hardness of the soft head tube 101 is less than 95A.
  • the soft head tube 101 uses at least one of polyurethane elastomer and polyether block polyamide production.
  • the hardness of the outer catheter is required to be greater than 50D
  • the outer catheter is made of polytetrafluoroethylene, ethyl fluoride It is made of at least one of propylene, nylon, polyethylene and polypropylene, so as to ensure that the outer catheter can be quickly and smoothly inserted into the cervix and improve the implantation efficiency of embryo transfer.
  • the flexible head tube 101 and the outer catheter 102 are connected by heat welding.
  • the inner catheter assembly includes an inner catheter 201 , a support tube 202 and an inner catheter joint 203 connected to the proximal end of the inner catheter.
  • the support tube 202 is sleeved outside the inner conduit 201, or the support tube 202 is connected between the inner conduit 201 and the inner conduit joint 203, the hardness of the support tube 202 is greater than the hardness of the inner conduit 201, and the support tube 202 is used for inner conduit 201.
  • the catheter 201 provides supporting force and pushing force, so as to prevent the inner catheter 201 from bending, causing extrusion to the embryo, and affecting the success rate of embryo implantation.
  • the inner catheter 201 stretches out from the support tube 202, and the distal end of the inner catheter 201 (that is, the end away from the operator) has a sampling part 204 for absorbing embryos, and the end surface of the sampling part 204 is inclined or
  • the curved surface has a curvature that matches the surface of the embryo, which is used to increase the contact area with the embryo, reduce the occurrence of embryo displacement, improve the success rate of embryo suction, and then improve the transfer efficiency of embryo transfer.
  • the inner catheter assembly has a second accommodating channel 200 passing through the inner catheter 201, and the second accommodating channel 200 is used to provide an adsorption force for embryos or to provide a delivery channel for embryos.
  • the inner catheter connector 201 has a receiving cavity, which is a part of the second receiving channel, and is used for connecting a syringe, so that the syringe sucks embryos through the inner catheter 201 or pushes the embryos in the second receiving channel 200 .
  • the hardness of the sampling part 204 is less than 95A.
  • the sampling part 204 uses at least one of polyurethane elastomer and polyether block polyamide It is made to reduce the damage to the embryo when sucking the embryo, and at the same time reduce the friction of the inner catheter on the embryo during the embryo transfer process, thereby improving the success rate of embryo implantation.
  • the end of the sampling part 204 is set as a bevel structure, and the edges of the bevel structure are designed with circular arc obtuse angles to reduce Friction and damage to the embryo.
  • the end surface of the sampling part 204 is provided with a physical mark, and the physical mark cooperates with the slope or arc surface of the end face to indicate the direction in which the sampling part sucks the embryo, thereby increasing the success rate of embryo suction.
  • the inner catheter is generally made of transparent material, so whether the embryos are sucked and how to suck the embryos efficiently can be determined by this physical mark, for example, when the sampling part 204
  • the physical mark faces upward, so that when the operator can observe the physical mark, it can be confirmed that the end face of the sampling part is facing down, ensuring that the sampling part has a larger contact area with the embryo and is easier to absorb
  • the physical mark is an ink mark, or a bulge, or other visual marks
  • the marking method is not further limited, as long as the suction direction of the sampling part can be correctly indicated when the embryo is sucked.
  • the included angle between the plane where the slope of the slope structure of the sampling part 204 is located and the axis of the inner conduit 204 is about 20° to about 70°, for example, about 30°, about 35°, About 40°, about 45°, about 50°, about 55°, about 60°, about 65°, so as to increase the contact area between the sampling part and the embryo, and improve the success rate of embryo suction.
  • the radial dimension of the sampling part 201 increases gradually along the direction close to the inner catheter joint 203, so that the sampling part can enter the uterine cavity more easily.
  • the radial dimension is the diameter of the sampling part 201 .
  • the support tube 202 is provided with a first positioning scale 205, the first positioning scale 205 is located at the proximal end of the support tube 202, and is used to indicate the internal
  • the length of the catheter assembly entering the uterus of the implanted object can more accurately control the implantation position of the embryo after entering the uterine cavity, increase the accuracy of embryo implantation, and improve the implantation efficiency of embryo transfer.
  • the support tube 202 in order to ensure the supporting force of the support tube 202, is made of a stainless steel tube, and the stainless steel tube has a third accommodation channel for placing the inner catheter 201, so that the support tube 202 is connected to the inner catheter 201.
  • the support tube 202 In order to ensure the supporting force of the support tube 202, the support tube 202 is made of a stainless steel tube, and the stainless steel tube has a third accommodation channel for placing the inner catheter 201, so that the support tube 202 is connected to the inner catheter 201.
  • the support tube 202 has a third accommodation channel for placing the inner catheter 201, so that the support tube 202 is connected to the inner catheter 201.
  • the embryo transfer device also includes a liner assembly as shown in FIG.
  • the pushing force makes it possible to insert the outer catheter assembly into the cervix also for patients with deformed cervix.
  • the liner assembly includes a liner 301 and a liner joint 302, one end of the liner is in a smooth hemispherical shape, and the smooth hemispherical structure helps the liner 301 to be inserted into the outer catheter and helps the outer catheter 102 to be more smoothly To enter the cervix, the end of the liner 301 away from the smooth hemispherical shape is connected with the liner joint 302 .
  • different lining cores 301 can be selected according to the specific conditions of different patients, and the lining cores 301 can be placed in the first accommodation channel 100 to improve the strength and supporting force of the outer catheter 201 , so that it is easier to insert into the cervix when the outer catheter 201 is pushed.
  • the liner 301 in order to ensure the pushing force of the liner 301, the liner 301 adopts a solid structure, and the hardness of the liner assembly is greater than that of the outer conduit 102, specifically, the hardness of the liner 301 is greater than 50D.
  • the liner 301 is made of at least one of polytetrafluoroethylene, fluorinated ethylene propylene, nylon, polyethylene and polypropylene, so as to ensure the smooth and fast insertion of the outer catheter 201 into the cervix and improve the accuracy of embryo transfer.
  • the second aspect of the present application provides an embryo transfer system, including a syringe and the above-mentioned embryo transfer device, and the syringe is adapted to the cavity of the inner catheter connector 203 to provide suction for sucking embryos or provide thrust for transferring embryos.
  • the present application improves the inner catheter assembly and the outer catheter assembly.
  • the outer catheter assembly adopts a soft soft head tube, which can reduce the stimulation and damage to the cervix and/or uterine cavity when the outer catheter is inserted into the uterine cavity from the cervix.
  • the inner catheter assembly When sucking into the inner catheter, the inner catheter assembly adopts a soft sampling part to quickly suck the embryos into the inner catheter and reduce the damage to the embryos when sucking the embryos, and then the inner catheter carrying the embryos enters the uterine cavity from the outer catheter, And push the embryo to the embryo implantation position, that is to say, the application has achieved faster, smoother and as non-invasive as possible implantation of the embryo as close as possible to the Embryo implantation position, thus improving the transfer efficiency of embryo transfer.

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Abstract

一种胚胎移植装置和系统，该装置包括内导管组件和外导管组件；内导管组件包括内导管（201）以及连接在内导管（201）近端的内导管接头（203），内导管（201）的远端具有用于吸附胚胎的取样部（204），取样部（204）的端面呈斜面结构或弧形面结构，内导管组件具有贯通内导管（201）和内导管接头（203）的第二容纳通道（200），第二容纳通道（200）用于提供对胚胎的吸附力或者提供对胚胎的输送通道；外导管组件包括第一容纳通道（100），第一容纳通道（100）的远端用于布置在植入对象的目标位置，以使取样部（204）由第一容纳通道（100）到达目标位置。

Description

一种胚胎移植装置和系统
相关申请的交叉引用
本申请要求于2022年01月04日申请的，申请号为2022100063039，名称为“一种胚胎移植装置和系统”的中国专利申请的优先权，在此将其全文引入作为参考。
技术领域
本申请涉及胚胎移植技术领域，具体涉及一种胚胎移植装置和系统。
背景技术
体外受精-胚胎移植技术(即俗称的试管婴儿)是治疗难治性不孕症的有效手段。总体而言，分为如下几个步骤：促排卵、取卵、体外受精、胚胎移植和黄体支持。其中，体外受精-胚胎移植是配子在体外形成胚胎，再将胚胎移植回女性体内的过程。
胚胎移植作为试管婴儿中一个关键的环节，起着承上启下的作用。在进行胚胎移植过程中，一般包括将胚胎通过注射器将胚胎抽吸至移植内导管前端，通过胚胎移植导管内管将胚胎输送至宫颈内，然后经由移植外导管移植进入子宫腔内着床。
因此，能否抽吸胚胎、能否顺利着床，是影响胚胎移植结果、临床妊娠率高低的重要因素。目前现有的胚胎移植导管在吸取胚胎时易出现胚胎移位以及易引起宫缩或出血导致胚胎着床失败等问题，降低了胚胎移植的移植效率。
发明内容
基于此，有必要提供一种胚胎移植装置，在胚胎移植过程中，至少解决前述 提及的一个技术问题，进而提高胚胎移植的移植效率。
本申请的第一目的在于提供一种胚胎移植装置，
包括内导管组件和外导管组件；
所述内导管组件包括内导管以及内导管接头，所述内导管接头位于所述内导管近端，所述内导管远端具有取样部，所述取样部的端面呈斜面结构或弧形面结构，所述取样部用于吸附胚胎，所述内导管组件具有第二容纳通道，所述第二容纳通道贯通所述内导管和所述内导管接头，所述第二容纳通道用于提供对胚胎的吸附力或者提供对胚胎的输送通道；
所述外导管组件包括第一容纳通道，所述第一容纳通道的远端用于布置在植入对象的目标位置，所述取样部与所述第一容纳通道可分离连接，以使所述取样部由所述第一容纳通道到达目标位置。
本申请的一种实现方式中，取样部的径向尺寸沿朝向内导管的近端的方向逐渐增大。
本申请的一种实现方式中，取样部的端面与内导管的轴线的夹角为约20°～约70°。
本申请的一种实现方式中，取样部设置有物理标记，物理标记用于指示取样部的端面的朝向。
本申请的一种实现方式中，外导管组件由远端至近端依次包括软头管、外导管和外导管接头，软头管与外导管整体呈弯折结构，第一容纳通道贯通软头管、外导管和外导管接头。
本申请的一种实现方式中，外导管包括弯折连接的主体部和连接部，所述连接部与远端的所述软头管连接，所述主体部与近端的所述外导管接头连接。
本申请的一种实现方式中，所述外导管的主体部与连接部的折角为约10° ～约50°。
本申请的一种实现方式中，外导管组件还包括用于与植入对象宫颈近端抵接的定位块，定位块套设于外导管上并可相对外导管滑动。
本申请的一种实现方式中，外导管上设有第二定位刻度，定位块与第二定位刻度配合以指示外导管进入植入对象子宫的长度；或者，
定位块上设置有第二指示标记，第二指示标记与第二定位刻度配合以指示外导管进入植入对象子宫的长度。
本申请的一种实现方式中，定位块的径向尺寸沿朝向定位块的近端的方向逐渐增大，且定位块由弹性体制成。
本申请的一种实现方式中，胚胎移植装置包括衬芯组件，衬芯组件的硬度大于外导管，衬芯的远端呈半球形，且衬芯组件能够与第一容纳通道可分离连接。
本申请的一种实现方式中，内导管组件还包括支撑管，支撑管套设于内导管外，或，支撑管连接于内导管与内导管接头之间，支撑管的硬度大于内导管的硬度。
本申请的一种实现方式中，支撑管上设置有第一定位刻度，第一定位刻度用以指示内导管组件进入植入对象子宫的长度。
本申请的第二目的在于提供一种胚胎移植系统，包括注射器和上述胚胎移植装置。
本申请的一种实现方式中，注射器和内导管接头相适配，用于为吸取胚胎提供吸力或者为输送胚胎提供推力。
本申请的一个或多个实施例的细节在下面的描述中提出。本申请的其他特征、目的和优点将从说明书以及权利要求书中变得明显。
附图说明
为了更好地描述和说明这里公开的那些发明的实施例和/或展示例，可以参考一幅或多幅附图。用于描述附图的附加细节或示例不应当被认为是对所公开的发明、目前描述的实施例和/或实施例以及目前理解的这些发明的最佳模式中的任何一者的范围的限制。
图1为本申请的一个或多个实施例提供的外导管组件的结构示意图；
图2为本申请的一个或多个实施例提供的内导管组件的结构示意图；
图3为本申请的一个或多个实施例提供的内导管的取样部一个角度的结构示意图；
图4为本申请的一个或多个实施例提供的内导管的取样部另一个角度的结构示意图；
图5为本申请的一个或多个实施例提供的衬芯组件的结构示意图。
具体实施方式
为使本申请的上述目的、特征和优点能够更加明显易懂，下面结合附图对本申请的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本申请。但是本申请能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本申请内涵的情况下做类似改进，因此本申请不受下面公开的具体实施例的限制。
此外，术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括至少一个该特征。在本申请的描述中，“多个”的含义是至少两个，例如两个，三个等，除非另有明确具体的限定。
如本文所用，术语“近端”是指近端是指最为靠近操作者的一端，远端是指最为远离操作者的一端，对本申请的任一构件个体而言，其近端和远端也分别指该构件最为靠近操作者和最为远离操作者的一端。
在本申请中，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”、“固定”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系，除非另有明确的限定。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本申请中的具体含义。
除非另有定义，本文所使用的所有的技术和科学术语与属于本申请的技术领域的技术人员通常理解的含义相同。本文中在本申请的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本申请。本文所使用的术语“和/或”包括一个或多个相关的所列项目的任意的和所有的组合。
在进行胚胎移植手术时，将胚胎移植导管通过宫颈通道的过程中，任何阻碍、延迟、损伤或微出血都可能对胚胎的植入过程造成灾难性的影响。此外，由于每个人的体质不同，胚胎移植的合适位置也不同，因此需要对胚胎移植导管进行缓慢精准的移动操作，才能够将胚胎移植到合适的位置，从而提高临床妊娠率。而现有胚胎移植导管存在吸取胚胎易发生移位，将外导管或内导管插入宫腔时，易出现宫缩或出血等导致着床失败的问题，并且现有移植导管也无法准确控制胚胎移植的位置。
为了解决以上至少一个技术问题，本申请的第一方面提供了一种胚胎移植装置，包括内导管组件和外导管组件，其中，外导管组件如图1所示，内导管组件如图2所示，外导管组件用于插入胚胎植入对象的子宫并且固定和子宫的相 对位置，具有用于容纳内导管组件的作用，内导管组件用于吸取胚胎，并将胚胎通过外导管组件输送至胚胎植入对象宫腔内的目标位置。
本申请通过对胚胎移植装置中的内导管组件进行改进，增加内导管组件中内导管的取样部和胚胎的接触面积，减少吸取胚胎时胚胎移位的产生，提高吸取胚胎的速度和准确率，从而提高胚胎移植的移植效率。
如图1所示，外导管组件由远端(即远离操作者的一端)至近端(即靠近操作者的一端)依次包括软头管101、外导管102、定位块103和外导管接头104。外导管接头104连接于外导管102的近端，软头管101连接于外导管102的远端，且软头管101与外导管102二者整体呈折弯的结构，软头管101用于放置在植入对象的宫颈内。
进一步的，外导管102与软导管101的连接处避开弯折位置，以便于软头管101和外导管102的连接，使得软头管101和外导管102的连接强度更高。
进一步，定位块103套设于外导管102上，并和外导管102滑动连接，并用于在将到外导管组件插入植入对象的体内时，与植入对象宫颈近端抵接，通过外力推送外导管101时，可以调整外导管102和定位块103的相对位置。
一些具体实施方案中，外导管102包括主体部1021和连接部1022，外导管接头104与主体部1021的一端连接，连接部1022的一端与主体部1021的另一端连接，软头管101与连接部1022在静置状态下整体呈直线布置，连接部1022与主体部1021呈弯折结构。
一些实施方案中，所述弯折结构的折角为约10°～约50°，例如，约20°、约25°、约30°、约35°、约40°、约45°，该角度范围能够适配弯折的宫颈形态，既增加外导管102的强度，同时也能提高外导管102与宫颈的匹配度。
外导管组件还包括贯穿软头管101、外导管102和外导管接头104的第一容 纳通道100，第一容纳通道100的远端(即远离操作者的一端)用于布置在植入对象的目标位置，子宫由近端(即靠近操作者的一端)至远端(即远离操作者的一端)包括宫颈和宫腔，该目标位置至少靠近宫颈远端，根据操作者的使用习惯也可以在宫腔内。
一些实施方案中，为了在外导管102插入宫腔中时，固定外导管102与宫腔中的相对位置，定位块103和外导管102滑动连接。当外导管插入宫腔时，定位块103用于和宫颈抵接，通过外力调整外导管102和定位块103的相对位置，并通过定位块和宫颈的贴合作用固定外导管的插入位置。
一些实施方案中，定位块103具有定位孔，定位块103具有弹性，通过定位块103的弹性和定位孔的尺寸的设置，既可以实现在外力的作用下外导管和定位块的滑动连接，保证外导管102在外力推送下能相对定位块103发生滑动，又能通过定位块103的弹性作用，固定外导管102和定位块103的相对位置，从而利用定位块103和宫颈的抵接作用固定外导管102插入宫腔的位置。
具体地，定位孔贯穿定位块103，用以容纳外导管102，定位孔为直径均一的孔道，定位孔的直径不大于外导管的直径，且定位块为弹性材质，以使得外导管102可以插入定位孔，既能保证外导管102在外力的推送下能相对定位块103发生滑动，又能利用定位块103和外导管102的弹性固定作用，固定外导管102插入宫腔的位置，从而能够更准确地控制胚胎移植的位置，提高胚胎移植的移植效率。
一些实施方案中，定位块103的径向尺寸沿朝向定位块103的近端(即靠近操作者的一端)的方向逐渐增大，且定位块由弹性材料制成。所述径向尺寸即所述定位块103横截面的直径，定位块103沿垂直与其接触的外导管延伸方向的切面即为定位块103的横截面。
一些具体实施方案中，定位块103为圆台结构，且圆台结构外径较小的一端靠近外导管的远端(即远离操作者的一端)，定位孔贯穿圆台结构的两个圆面，以减小定位块推进宫颈和与宫颈结合的难度。
一些具体实施方案中，定位块103采用橡胶制备而成，以使得定位块103具有弹性。
一些实施方案中，为了精准控制外导管的插入位置，外导管102上设有第二定位刻度105，定位块与第二定位刻度105配合以指示外导管102进入植入对象子宫的长度；或者，定位块103上设置有第二指示标记，第二指示标记与第二定位刻度105配合以指示外导管102进入植入对象子宫的长度。
具体地，外导管102上设置有第二定位刻度105，第二定位刻度105位于外导管102的远端，随着外导管102插入子宫时，定位块103能够覆盖第二定位刻度105，进而根据定位块103覆盖在定位刻度上的位置判断外导管102的插入长度。
一些实施方案中，为了减少对宫腔的刺激和摩擦，软头管101的硬度小于95A，为了实现这一效果，软头管101采用聚氨酯弹性体和聚醚嵌段聚酰胺中的至少一种制成。
一些实施方案中，为了保证外导管的推送力，尽可能快的将外导管插入宫颈中，外导管的硬度要求为大于50D，为了达到这一要求，外导管采用聚四氟乙烯、氟化乙丙烯、尼龙、聚乙烯和聚丙烯中的至少一种制成，以保证外导管快速、顺利的插入宫颈中，提高胚胎移植的移植效率。
一些具体实施方案中，软头管101和外导管102采用热焊接的方式相连接。
如图2所示，内导管组件包括内导管201、支撑管202以及连接在内导管近端的内导管接头203。其中，支撑管202套设于内导管201外，或，支撑管202 连接于内导管201与内导管接头203之间，支撑管202的硬度大于内导管201的硬度，支撑管202用于为内导管201提供支撑力和推送力，以防止内导管201发生弯折，对胚胎造成挤压，影响胚胎着床的成功率。
如图3和图4所示，内导管201从支撑管202伸出，内导管201远端(即远离操作者的一端)具有用于吸附胚胎的取样部204，取样部204的端面呈斜面或弧形面，弧形面具有与胚胎表面匹配的曲率，用于增大与胚胎的接触面积，降低胚胎移位的情况发生，提高胚胎吸取的成功率，进而提高胚胎移植的移植效率。
进一步，内导管组件具有贯通内导管201的第二容纳通道200，第二容纳通道200用于提供对胚胎的吸附力或者用于提供对胚胎的输送通道。内导管接头201具有容纳腔，该容纳腔为第二容纳通道的一部分，且用于连接注射器，以便注射器通过内导管201吸取胚胎或者在第二容纳通道200内对胚胎进行推送。
一些实施方案中，为了减小取样时内导管201对胚胎的损伤，取样部204的硬度小于95A，为了实现这一效果，取样部204采用聚氨酯弹性体和聚醚嵌段聚酰胺中的至少一种制成，以在吸取胚胎时减少对胚胎的损伤，同时较少胚胎转移过程中内导管对胚胎的摩擦，从而提高胚胎着床的成功率。
一些实施方案中，为了进一步避免取样部204对胚胎造成损伤，如图3和图4所示，取样部204的端部设置为斜面结构，所述斜面结构的边缘采用圆弧钝角设计，以减少对胚胎的摩擦和损伤。
一些实施方案中，取样部204的端面设置有物理标记，该物理标记和端面的斜面或者圆弧面相配合，用以指示取样部吸取胚胎的方向，从而增加胚胎吸取的成功率。可以理解的是，吸取胚胎到取样部时，需要在显微镜下进行，且内导管一般是透明材质，因此是否吸取到胚胎以及如何高效吸取胚胎，可以通过该物理标记，例如，当取样部204的端面布置在胚胎上方时，物理标记朝上，从而操 作人员能够观察到该物理标记时，也就能够确定该取样部的端面已朝下，确保取样部与胚胎有更大的接触面积，更易吸附胚胎，同时也更加有助于取样部在进行吸附前已处于端面朝下的状态，然后再进行吸附也更加能够避免取样部戳刺胚胎，减少因胚胎损坏导致胚胎移植失败的机率。具体地，物理标记为油墨标记，或者物理标记为一凸起，也可以为其他可视化标记，标记方式不作进一步限制，只要能在吸取胚胎时正确指示取样部的吸取方向即可。
一些实施方案中，如图3所示，所述取样部204的斜面结构的斜面所在平面和内导管204轴线的夹角为约20°～约70°，例如，约30°、约35°、约40°、约45°、约50°、约55°、约60°、约65°，从而增大取样部和胚胎的接触面积，提高胚胎吸取的成功率。
一些实施方案中，取样部201的径向尺寸沿靠近内导管接头203的方向逐渐增大，以便于取样部更易进入宫腔。所述径向尺寸即取样部201的直径。
一些实施方案中，支撑管202上设置有第一定位刻度205，第一定位刻度205位于支撑管202的近端，用以在将内导管201经外导管102插入宫腔时，用以指示内导管组件进入植入对象子宫的长度，能够更准确地控制胚胎进入宫腔后着床的位置，增加了胚胎着床的准确率，提高了胚胎移植的移植效率。
一些具体实施方案中，为了保证支撑管202的支撑力，支撑管202采用不锈钢管制备而成，不锈钢管具有用于放置内导管201的第三容纳通道，以使得支撑管202对内导管201起到保护作用，防止内导管202弯折，从而避免对第一容纳通道内的胚胎造成损伤。
一些实施方案中，胚胎移植装置还包括如图5所示的衬芯组件，外导管102的第一容纳通道100还能用于容纳衬芯组件，衬芯组件能够为外导管组件提供支撑力和推送力，使得对于宫颈形态畸形的患者，也能将外导管组件插入宫颈内。
如图5所示，衬芯组件包括衬芯301和衬芯接头302，衬芯的一端呈圆滑半球形，圆滑半球形的结构有助于衬芯301插入外导管中，帮助外导管102更顺利地进入宫颈中，衬芯301远离圆滑半球形的一端和衬芯接头302相连接。对于宫颈通道比较复杂甚至宫颈通道畸形的患者，可以根据不同患者的具体情况，选配不同的衬芯301，将衬芯301置于第一容纳通道100中，提高外导管201的强度和支撑力，从而在推送外导管201时更易插入宫颈中。
一些实施方案中，为了保证衬芯301的推送力，衬芯301采用实心结构，衬芯组件的硬度大于所述外导管102，具体地，衬芯301的硬度大于50D，为了达到这一要求，衬芯301采用聚四氟乙烯、氟化乙丙烯、尼龙、聚乙烯和聚丙烯中的至少一种制成，以保证外导管201顺利、快速插入宫颈内，提高胚胎移植的准确率。
本申请的第二方面提供了一种胚胎移植系统，包括注射器和上述胚胎移植装置，注射器和内导管接头203的容纳腔相适配，用于为吸取胚胎提供吸力或者为输送胚胎提供推力。
需要说明的是，更快、更顺利以及尽可能无创伤地将胚胎尽可能接近的移植至预先设计好的胚胎着床的位置，是实现胚胎植入和妊娠的决定性因素。本申请通过对内导管组件、外导管组件进行改进，外导管组件采用柔软的软头管能够在将外导管由宫颈插入宫腔时减少对宫颈和/或宫腔的刺激和损伤，在将胚胎吸取至内导管时，内导管组件采用柔软的取样部能够快速将胚胎吸取至内导管中并减小吸取胚胎时对胚胎造成的损伤，然后将携带有胚胎的内导管由外导管进入宫腔，并将胚胎推送至胚胎着床位置，也就是说，本申请通过对内导管组件和外导管组件的组合改进，实现了更快、更顺利以及尽可能无创伤地将胚胎尽可能接近的移植至胚胎着床的位置，从而提高了胚胎移植的移植效率。
以上实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若干变形和改进，这些都属于本申请的保护范围。因此，本申请专利的保护范围应以所附权利要求为准。

Claims (15)

  1. 一种胚胎移植装置，其特征在于，包括内导管组件和外导管组件；
    所述内导管组件包括内导管以及内导管接头，所述内导管接头位于所述内导管近端，所述内导管远端具有取样部，所述取样部的端面呈斜面结构或弧形面结构，所述取样部用于吸附胚胎；所述内导管组件具有第二容纳通道，所述第二容纳通道贯通所述内导管和所述内导管接头，所述第二容纳通道用于提供对胚胎的吸附力或者提供对胚胎的输送通道；
    所述外导管组件包括第一容纳通道，所述第一容纳通道的远端用于布置在植入对象的目标位置，所述取样部与所述第一容纳通道可分离连接，以使所述取样部由所述第一容纳通道到达目标位置。
  2. 根据权利要求1所述的胚胎移植装置，其特征在于，所述取样部的径向尺寸沿朝向所述内导管的近端的方向逐渐增大。
  3. 根据权利要求1所述的胚胎移植装置，其特征在于，所述取样部的端面与所述内导管的轴线的夹角为约20°～约70°。
  4. 根据权利要求1所述的胚胎移植装置，其特征在于，所述取样部设置有物理标记，所述物理标记用于指示所述取样部的端面的朝向。
  5. 根据权利要求1所述的胚胎移植装置，其特征在于，所述外导管组件由远端至近端依次包括软头管、外导管和外导管接头，所述软头管与所述外导管整体呈弯折结构，所述第一容纳通道贯通所述软头管、所述外导管和所述外导管接头。
  6. 根据权利要求5所述的胚胎移植装置，其特征在于，所述外导管包括弯折连接的主体部和连接部，所述连接部与远端的所述软头管连接，所述主体部与近端的所述外导管接头连接。
  7. 根据权利要求5所述的胚胎移植装置，其特征在于，所述外导管的主体 部与连接部的折角为约10°～约50°。
  8. 根据权利要求1所述的胚胎移植装置，其特征在于，所述外导管组件还包括用于与所述植入对象宫颈近端抵接的定位块，所述定位块套设于所述外导管上并可相对所述外导管滑动。
  9. 根据权利要求8所述的胚胎移植装置，其特征在于，所述外导管上设有第二定位刻度，所述定位块与所述第二定位刻度配合以指示所述外导管进入所述植入对象子宫的长度；或者，
    所述定位块上设置有第二指示标记，所述第二指示标记与所述第二定位刻度配合以指示所述外导管进入所述植入对象子宫的长度。
  10. 根据权利要求8所述的胚胎移植装置，其特征在于，所述定位块的径向尺寸沿朝向所述定位块的近端的方向逐渐增大，且所述定位块由弹性体制成。
  11. 根据权利要求1所述的胚胎移植装置，其特征在于，所述胚胎移植装置包括衬芯组件，所述衬芯组件的硬度大于所述外导管，所述衬芯组件的远端呈半球形，且所述衬芯组件能够与所述第一容纳通道可分离连接。
  12. 根据权利要求1所述的胚胎移植装置，其特征在于，所述内导管组件还包括支撑管，所述支撑管套设于所述内导管外，或，所述支撑管连接于所述内导管与所述内导管接头之间，所述支撑管的硬度大于所述内导管的硬度。
  13. 根据权利要求12所述的胚胎移植装置，其特征在于，所述支撑管上设置有第一定位刻度，所述第一定位刻度用以指示所述内导管组件进入所述植入对象子宫的长度。
  14. 一种胚胎移植系统，其特征在于，包括注射器和如权利要求1～13任一项所述的胚胎移植装置。
  15. 根据权利要求14所述的胚胎移植系统，其特征在于，所述注射器和所 述内导管接头相适配，用于为吸取胚胎提供吸力或者为输送胚胎提供推力。
PCT/CN2023/070463 2022-01-04 2023-01-04 一种胚胎移植装置和系统 WO2023131190A1 (zh)

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US4642094A (en) * 1984-05-29 1987-02-10 North Jr Walter L Non-surgical embryo transfer device
CN1523971A (zh) * 2001-01-12 2004-08-25 �ɲ����� 一种子宫内的装置及其使用方法
JP2012125410A (ja) * 2010-12-15 2012-07-05 Central Institute For Experimental Animals 卵採取及び胚移植用器具
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CN109259887A (zh) * 2018-11-01 2019-01-25 西安交通大学 一种兔非手术胚胎移植器械、方法及其应用
CN217772475U (zh) * 2022-01-04 2022-11-11 上海市东方医院（同济大学附属东方医院） 一种胚胎移植装置和系统

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4642094A (en) * 1984-05-29 1987-02-10 North Jr Walter L Non-surgical embryo transfer device
CN1523971A (zh) * 2001-01-12 2004-08-25 �ɲ����� 一种子宫内的装置及其使用方法
JP2012125410A (ja) * 2010-12-15 2012-07-05 Central Institute For Experimental Animals 卵採取及び胚移植用器具
US20150342642A1 (en) * 2013-02-06 2015-12-03 Mark SILLENDER Embryo transfer catheter and method
CN109259887A (zh) * 2018-11-01 2019-01-25 西安交通大学 一种兔非手术胚胎移植器械、方法及其应用
CN217772475U (zh) * 2022-01-04 2022-11-11 上海市东方医院（同济大学附属东方医院） 一种胚胎移植装置和系统

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