CN116407395A - Oviduct embolism instrument and oviduct embolism system - Google Patents
Oviduct embolism instrument and oviduct embolism system Download PDFInfo
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- CN116407395A CN116407395A CN202111669293.9A CN202111669293A CN116407395A CN 116407395 A CN116407395 A CN 116407395A CN 202111669293 A CN202111669293 A CN 202111669293A CN 116407395 A CN116407395 A CN 116407395A
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
- A61F6/20—Vas deferens occluders; Fallopian occluders
- A61F6/22—Vas deferens occluders; Fallopian occluders implantable in tubes
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Abstract
Description
技术领域technical field
本发明涉及医疗器械技术领域,特别涉及一种输卵管栓塞器械及输卵管栓塞系统。The invention relates to the technical field of medical devices, in particular to a fallopian tube embolization device and a fallopian tube embolization system.
背景技术Background technique
在现有的输卵管栓塞手术中,通常是采用一栓塞器械以物理方式对输卵管进行机械性栓塞,术中通过输送器械将栓塞器械输送至输卵管的间质部和峡部完成栓塞,从而作为一种绝育或永久避孕的手段,而在另外一些场景其也被用作试管婴儿前输卵管有积水患者的输卵管积水栓塞治疗。In the existing tubal embolization operation, an embolization device is usually used to mechanically embolize the fallopian tube in a physical way. During the operation, the embolization device is transported to the interstitium and isthmus of the fallopian tube to complete embolization. Or permanent means of contraception, and in other scenarios it is also used as hydrosalpinx embolization treatment for patients with hydrosalpinx before IVF.
但是,现有的栓塞器械在植入输卵管之前的状态和植入输卵管之后的状态基本相同,通常会导致栓塞器械实际上用于栓堵作用的部位的体积较小,并且栓塞器械与输卵管的锚定效果也较差,容易在输卵管中移动,以上都会导致栓塞器械对输卵管的栓塞效果不太理想。另外,现有的栓塞器械多用于健康女性的避孕,目前尚无一种较为理想的输卵管栓塞措施来帮助准备做试管婴儿手术却有输卵管积水的患者。However, the state of the existing embolization device before and after implantation into the fallopian tube is basically the same, which usually results in a smaller volume of the part where the embolization device is actually used for embolization, and the embolization device is not compatible with the anchor of the fallopian tube. The setting effect is also relatively poor, and it is easy to move in the fallopian tubes. All of the above will cause the embolization device to have a less than ideal embolization effect on the fallopian tubes. In addition, the existing embolization devices are mostly used for contraception in healthy women. At present, there is no ideal tubal embolization method to help patients who are preparing for IVF but have hydrosalpinx.
发明内容Contents of the invention
本发明的目的在于提供一种输卵管栓塞器械及输卵管栓塞系统,以解决现有的栓塞器械对输卵管的栓塞效果不太理想的问题。The purpose of the present invention is to provide a fallopian tube embolization device and a fallopian tube embolization system, so as to solve the problem that the existing embolization device has an unsatisfactory embolization effect on the fallopian tube.
为解决上述技术问题,基于本发明的一个方面,本发明提供一种输卵管栓塞器械,其包括:具有一级形态和二级形态的栓塞本体,所述栓塞本体的外侧用于与输卵管的内侧贴靠;所述一级形态包括柱状形态;所述二级形态为改变所述一级形态的延伸方向而成;所述栓塞本体可在外力的作用下由所述二级形态拉伸到所述一级形态,且在撤去外力后,所述栓塞本体可由所述一级形态恢复到所述二级形态。In order to solve the above-mentioned technical problems, based on one aspect of the present invention, the present invention provides a fallopian tube embolization device, which includes: a plug body with a primary shape and a secondary shape, and the outside of the plug body is used to stick to the inside of the fallopian tube. rely on; the primary form includes a columnar form; the secondary form is formed by changing the extension direction of the primary form; the plug body can be stretched from the secondary form to the The first-order form, and after the external force is removed, the plug body can recover from the first-order form to the second-order form.
可选的,所述二级形态包括波浪形态、螺旋形态和多面体形态中的一者或者至少两者的组合。Optionally, the secondary shape includes one or a combination of at least two of wave shape, spiral shape and polyhedron shape.
可选的,所述栓塞本体包括至少一节锚定段和至少一节栓塞段,所述锚定段与所述栓塞段连接。Optionally, the plug body includes at least one anchor segment and at least one plug segment, and the anchor segment is connected to the plug segment.
可选的,所述栓塞本体包括一节所述锚定段和两节所述栓塞段,所述锚定段位于两节所述栓塞段之间。Optionally, the plug body includes one anchor segment and two plug segments, and the anchor segment is located between the two plug segments.
可选的,所述栓塞本体包括至少两节所述锚定段和至少两节所述栓塞段时,相邻的两节所述栓塞段之间排布一节所述锚定段,且相邻的两节所述锚定段之间排布一节所述栓塞段。Optionally, when the plug body includes at least two anchor segments and at least two plug segments, one anchor segment is arranged between two adjacent plug segments, and A section of the embolization section is arranged between two adjacent sections of the anchor section.
可选的,所述栓塞本体包括至少两节所述栓塞段时,至少一部分所述栓塞段的径向尺寸各不相同;和/或,Optionally, when the plug body includes at least two plug segments, at least some of the plug segments have different radial dimensions; and/or,
所述栓塞本体包括至少两节所述锚定段时,至少一部分所述锚定段的径向尺寸各不相同。When the plug body includes at least two anchor segments, at least a part of the anchor segments have different radial dimensions.
可选的,所述输卵管栓塞器械包括抗解旋丝,所述抗解旋丝的形态与所述栓塞本体的二级形态相适应,所述抗解旋丝的两端分别连接所述栓塞本体的两端。Optionally, the fallopian tube embolization device includes an anti-unwinding wire, the shape of the anti-unwinding wire is adapted to the secondary shape of the embolization body, and the two ends of the anti-unwinding wire are respectively connected to the embolization body both ends.
可选的,所述一级形态的栓塞本体具有沿自身的轴向贯通的内腔。Optionally, the plug body in the primary form has an inner cavity penetrating along its axial direction.
可选的,所述栓塞本体的一级形态根据一丝线螺旋盘绕形成。Optionally, the first-order shape of the plug body is formed according to a thread helically coiled.
可选的,所述栓塞本体的一级形态包括多股丝线交叉形成的具有多个网格的网结构。Optionally, the primary form of the plug body includes a network structure with multiple grids formed by crossing strands of wires.
可选的,单股所述丝线的线径大于或者等于0.0001英寸,且小于或等于0.0070英寸。Optionally, the wire diameter of a single strand of the wire is greater than or equal to 0.0001 inch and less than or equal to 0.0070 inch.
可选的,所述栓塞本体的一级形态根据球囊沿自身的轴向延伸形成。Optionally, the primary shape of the plug body is formed according to the axial extension of the balloon itself.
可选的,所述一级形态的栓塞本体的径向尺寸大于或等于0.01mm,且小于或等于2mm。Optionally, the radial dimension of the plug body in the primary form is greater than or equal to 0.01 mm and less than or equal to 2 mm.
可选的,所述一级形态的栓塞本体的轴向尺寸大于或等于0.1cm,且小于或等于30cm。Optionally, the axial dimension of the plug body in the primary form is greater than or equal to 0.1 cm and less than or equal to 30 cm.
可选的,所述输卵管栓塞器械包括第一涂层,所述第一涂层涂覆于所述栓塞本体的外表面,所述第一涂层具有遇水膨胀的属性。Optionally, the fallopian tube embolization device includes a first coating, the first coating is coated on the outer surface of the embolization body, and the first coating has a water-swellable property.
可选的,所述输卵管栓塞器械包括芯轴,所述芯轴设置于所述栓塞本体的内部,且所述芯轴沿所述栓塞本体的轴向延伸,所述芯轴具有遇水膨胀的属性。Optionally, the fallopian tube embolization device includes a mandrel, the mandrel is arranged inside the embolization body, and the mandrel extends along the axial direction of the embolization body, and the mandrel has a water-swellable Attributes.
可选的,所述输卵管栓塞器械包括第二涂层,所述第二涂层包覆于所述栓塞本体的外表面,所述第二涂层包括药物涂层。Optionally, the fallopian tube embolization device includes a second coating, the second coating covers the outer surface of the embolization body, and the second coating includes a drug coating.
可选的,所述栓塞本体的外表面设有纤维结构。Optionally, the outer surface of the plug body is provided with a fiber structure.
可选的,所述栓塞本体的材料包括可降解材料。Optionally, the material of the plug body includes degradable materials.
基于本发明的另一个方面,本发明还提供一种输卵管栓塞系统,其包括:Based on another aspect of the present invention, the present invention also provides a fallopian tube embolization system, which includes:
如上所述的输卵管栓塞器械;以及a tubal embolization device as described above; and
输送器械,所述输送器械与所述输卵管栓塞器械可拆卸地连接,并用于驱动所述输卵管栓塞器械植入输卵管中。A delivery instrument, which is detachably connected to the fallopian tube embolization instrument and used to drive the fallopian tube embolization instrument to be implanted into the fallopian tube.
综上所述,在本发明提供的输卵管栓塞器械及输卵管栓塞系统中,输卵管栓塞器械包括:具有一级形态和二级形态的栓塞本体,栓塞本体的外侧用于与输卵管的内侧贴靠;一级形态包括柱状形态;二级形态为改变一级形态的延伸方向而成;栓塞本体可在外力的作用下由二级形态拉伸到一级形态,且在撤去外力后,栓塞本体可由一级形态恢复到二级形态。如上配置,栓塞本体的一级形态包括柱状形态,即一级形态的延伸方向为线性方向,栓塞本体的二级形态为改变一级形态的延伸方向形成,即二级形态的延伸方向为非线性方向,在空间上具有更多的自由度,栓塞本体在外力的作用由一级形态植入输卵管中,并在撤去外力后在输卵管中恢复到二级形态,处于二级形态的栓塞本体与输卵管的内侧贴靠后,栓塞本体能够对输卵管起到很好的锚定支撑作用,且二级形态的栓塞本体实际上用于栓堵作用的部位的体积也可得到相应增大,提高栓塞本体与输卵管的填充密实性,从而提升输卵管栓塞器械的栓塞效果,进而可以帮助健康女性正常避孕以及帮助准备做试管婴儿手术却有输卵管积水的患者降低漏液率。In summary, in the fallopian tube embolization device and fallopian tube embolization system provided by the present invention, the fallopian tube embolization device includes: an embolization body with a primary form and a secondary form, and the outside of the embolization body is used to abut against the inner side of the fallopian tube; The secondary form includes columnar form; the secondary form is formed by changing the extension direction of the primary form; the plug body can be stretched from the secondary form to the primary form under the action of external force, and after the external force is removed, the plug body can be stretched from the primary form Form reverts to secondary form. As configured above, the primary shape of the plug body includes a columnar shape, that is, the extension direction of the primary shape is a linear direction, and the secondary shape of the plug body is formed by changing the extension direction of the primary shape, that is, the extension direction of the secondary shape is nonlinear Direction, with more degrees of freedom in space, the embolism body is implanted in the fallopian tube from the primary form under the action of external force, and returns to the secondary form in the fallopian tube after the external force is removed, the embolism body in the secondary form and the fallopian tube After the inner side of the embolism is attached, the plug body can play a good role in anchoring and supporting the fallopian tubes, and the volume of the part where the plug body in the secondary form is actually used for embolization can also be correspondingly increased, improving the relationship between the plug body and the fallopian tube. The filling compactness of the fallopian tubes can improve the embolization effect of the fallopian tube embolization device, which can help healthy women to prevent pregnancy normally and help patients who are preparing for IVF surgery but have hydrosalpinx to reduce the leakage rate.
附图说明Description of drawings
本领域的普通技术人员应当理解,提供的附图用于更好地理解本发明,而不对本发明的范围构成任何限定。其中:Those skilled in the art should understand that the accompanying drawings are provided for better understanding of the present invention, and do not constitute any limitation to the scope of the present invention. in:
图1是本发明实施例一的栓塞本体的二级形态的示意图;FIG. 1 is a schematic diagram of the secondary form of the plug body of Embodiment 1 of the present invention;
图2是本发明实施例一的栓塞本体的二级形态的另一示意图;Fig. 2 is another schematic diagram of the secondary form of the plug body of the first embodiment of the present invention;
图3是本发明实施例一的栓塞本体的二级形态的再一示意图;Fig. 3 is another schematic diagram of the secondary form of the plug body in Embodiment 1 of the present invention;
图4是本发明实施例二的栓塞本体的一级形态的示意图;Fig. 4 is a schematic diagram of the primary form of the plug body of the second embodiment of the present invention;
图5是本发明实施例二的栓塞本体的二级形态的示意图;Fig. 5 is a schematic diagram of the secondary form of the plug body of the second embodiment of the present invention;
图6是本发明实施例二的栓塞本体的二级形态的另一示意图;Fig. 6 is another schematic diagram of the secondary form of the plug body of the second embodiment of the present invention;
图7是本发明实施例三的栓塞本体的一级形态的示意图;Fig. 7 is a schematic diagram of the primary form of the plug body of the third embodiment of the present invention;
图8是本发明实施例三的栓塞本体的一级形态的另一示意图;Fig. 8 is another schematic diagram of the primary form of the plug body of the third embodiment of the present invention;
图9是本发明实施例三的栓塞本体的二级形态的示意图;Fig. 9 is a schematic diagram of the secondary form of the plug body of the third embodiment of the present invention;
图10是本发明实施例四的栓塞本体的示意图。Fig. 10 is a schematic diagram of a plug body according to Embodiment 4 of the present invention.
附图中:In the attached picture:
10-栓塞本体;11-锚定段;12-栓塞段;球囊100。10-embolization body; 11-anchor segment; 12-embolization segment;
具体实施方式Detailed ways
为使本发明的目的、优点和特征更加清楚,以下结合附图和具体实施例对本发明作进一步详细说明。需说明的是,附图均采用非常简化的形式且未按比例绘制,仅用以方便、明晰地辅助说明本发明实施例的目的。此外,附图所展示的结构往往是实际结构的一部分。特别的,各附图需要展示的侧重点不同,有时会采用不同的比例。In order to make the purpose, advantages and features of the present invention clearer, the present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in very simplified form and not drawn to scale, and are only used to facilitate and clearly assist the purpose of illustrating the embodiments of the present invention. In addition, the structures shown in the drawings are often a part of the actual structures. In particular, each drawing needs to display different emphases, and sometimes uses different scales.
如在本发明中所使用的,单数形式“一”、“一个”以及“该”包括复数对象,术语“或”通常是以包括“和/或”的含义而进行使用的,术语“若干”通常是以包括“至少一个”的含义而进行使用的,术语“至少两个”通常是以包括“两个或两个以上”的含义而进行使用的,此外,术语“第一”、“第二”、“第三”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”、“第三”的特征可以明示或者隐含地包括一个或者至少两个该特征,“一端”与“另一端”以及“近端”与“远端”通常是指相对应的两部分,其不仅包括端点,术语“安装”、“相连”、“连接”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。此外,如在本发明中所使用的,一元件设置于另一元件,通常仅表示两元件之间存在连接、耦合、配合或传动关系,且两元件之间可以是直接的或通过中间元件间接的连接、耦合、配合或传动,而不能理解为指示或暗示两元件之间的空间位置关系,即一元件可以在另一元件的内部、外部、上方、下方或一侧等任意方位,除非内容另外明确指出外。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发明中的具体含义。As used in the present invention, the singular forms "a", "an" and "the" include plural objects, the term "or" is usually used in the sense of including "and/or", and the term "several" Usually, the term "at least one" is used in the meaning of "at least one", and the term "at least two" is usually used in the meaning of "two or more". In addition, the terms "first", "second "Two" and "third" are used for descriptive purposes only, and should not be understood as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features. Thus, the features defined as "first", "second", and "third" may expressly or implicitly include one or at least two of these features, "one end" and "another end" and "near end" and "near end" "Remote" usually refers to the corresponding two parts, which not only includes the terminal, the terms "installation", "connection", and "connection" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection, or Integrate; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediary, can be the internal communication of two components or the interaction relationship between two components. In addition, as used in the present invention, an element is arranged on another element, usually only means that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the relationship between the two elements can be direct or indirect through an intermediate element. connection, coupling, fit or transmission, but cannot be understood as indicating or implying the spatial positional relationship between two elements, that is, one element can be in any orientation such as inside, outside, above, below or on one side of another element, unless the content Also clearly point out. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.
本发明提供一种输卵管栓塞器械及输卵管栓塞系统,以解决现有的栓塞器械对输卵管的栓塞效果不太理想的问题。The invention provides a fallopian tube embolization device and a fallopian tube embolization system to solve the problem that the existing embolization device has an unsatisfactory embolization effect on the fallopian tube.
本实施例的输卵管栓塞器械包括具有一级形态和二级形态的栓塞本体10,所述栓塞本体10的外侧用于与输卵管的内侧相贴靠;所述一级形态包括柱状形态,即一级形态的延伸方向为线性方向;所述二级形态为改变所述一级形态的延伸方向而成,可理解为二级形态的延伸方向为非线性方向,比如可以是弧形方向等,如此,二级形态的栓塞本体10可在空间上具有更大的自由度;所述栓塞本体10可在外力的作用下由所述二级形态拉伸到所述一级形态,且在撤去外力后,所述栓塞本体10可由所述一级形态恢复到所述二级形态。栓塞本体10在外力的作用由一级形态植入输卵管中,并在撤去外力后在输卵管中恢复到二级形态,处于二级形态的栓塞本体10与输卵管的内侧贴靠后,栓塞本体10能够对输卵管起到很好的锚定支撑作用,且二级形态的栓塞本体10实际上用于栓堵作用的部位的体积也可得到相应增大,提高栓塞本体10与输卵管的填充密实性,从而提升输卵管栓塞器械的栓塞效果,进而可以帮助健康女性正常避孕以及帮助准备做试管婴儿手术却有输卵管积水的患者降低漏液率。The fallopian tube embolization device of this embodiment includes an
本实施例中,所述二级形态包括波浪形态、螺旋形态和多面体形态中的一者或者至少两者的组合,可以提高栓塞本体10与输卵管的匹配效果。多面体形态比如可以是球形形态、六面体形态,或者其他立体形状的形态。二级形态可以提高输卵管的致密栓塞率(致密栓塞密度),提升栓塞效果,可理解的,致密栓塞率指的是栓塞本体10的横截有效面积与输卵管在相应部分的横截面积。较佳的,二级形态优选为多面体形态,可进一步提高致密栓塞密度。进一步,以二级形态呈螺旋形态为例,栓塞本体10在患者体体外首先呈螺旋形态,比如可以通过热定型工艺使栓塞本体10先形成二级形态,随后在外力的作用下拉伸呈柱状形态,接着在输送器械的作用下植入到患者的输卵管中,最后撤回输送器械,栓塞本体10在输卵管中由柱状形态恢复至螺旋形态。In this embodiment, the secondary shape includes one or a combination of at least two of wave shape, spiral shape and polyhedron shape, which can improve the matching effect between the
下面请参考附图并结合具体的实施例对本发明的输卵管栓塞器械的栓塞本体进行详细地描述。The embolization body of the fallopian tube embolization device of the present invention will be described in detail below with reference to the accompanying drawings and specific embodiments.
【实施例一】[Example 1]
本实施例请参阅图1至图3,其中,图1是本发明实施例一的栓塞本体的二级形态的示意图;图2是本发明实施例一的栓塞本体的二级形态的另一示意图,图3是本发明实施例一的栓塞本体的二级形态的再一示意图。Please refer to Figures 1 to 3 for this embodiment, wherein Figure 1 is a schematic diagram of the secondary form of the plug body in Embodiment 1 of the present invention; Figure 2 is another schematic diagram of the secondary form of the plug body in Embodiment 1 of the present invention , FIG. 3 is another schematic diagram of the secondary form of the plug body of Embodiment 1 of the present invention.
具体地,所述一级形态的栓塞本体10具有沿自身的轴向贯通的内腔(未图示),即栓塞本体10大致呈管状,可理解的,本实施例对于内腔的横截面的形状不做具体限制,可以是圆形、方形或不规则的平面形状。优选的,内腔的横截面形状与栓塞本体10的轮廓形状相同,譬如均是圆形。Specifically, the
进一步的,所述栓塞本体10的一级形态根据一丝线螺旋盘绕形成。如此,栓塞本体10的一级形态大致呈弹簧状或者波纹管(海波管)的形状,二级形态可以是以弹簧状为单体形成波浪形态(图1所示)、螺旋形态(图2所示)、多面体形态等。当然栓塞本体10的二级形态还可以是上述列举的形态的组合,比如图3中的二级形态是以弹簧状为单体形成螺旋形态和多面体形态的组合,即左边为螺旋形态,右边为多面体形态,螺旋形态起到锚定作用而多面体形态更利于在器械输送到目标位置后自身致密填塞或者在术者使用外部器械(如导丝)进一步挤压下致密填塞,且由于多面体形态没有螺旋形态的中空结构使得填塞效果更好。一般选择多形态组合是考虑到同时兼顾锚定性和致密填塞性。更进一步,单股所述丝线的线径大于或者等于0.0001英寸,且小于或等于0.0070英寸,这里的丝线的线径可理解为丝线的粗细大小。丝线的材料比如是形态记忆合金。Further, the primary shape of the
【实施例二】[Example 2]
本实施例请参阅图4至图6,其中,图4是本发明实施例二的栓塞本体的一级形态的示意图图5是本发明实施例二的栓塞本体的二级形态的示意图,图6是本发明实施例二的栓塞本体的二级形态的另一示意图。Please refer to Fig. 4 to Fig. 6 for this embodiment, wherein Fig. 4 is a schematic diagram of the primary form of the plug body according to
具体地,所述一级形态的栓塞本体10具有沿自身的轴向贯通的内腔(未图示),即栓塞本体10大致呈管状,可理解的,本实施例对于内腔的横截面的形状不做具体限制,可以是圆形、方形或不规则的平面形状。优选的,内腔的横截面形状与栓塞本体10的轮廓形状相同,譬如均是圆形。Specifically, the
进一步的,所述栓塞本体10的一级形态包括多股丝线交叉形成的具有多个网格的网结构,网结构可以是一层或多层,可理解为管状的栓塞本体设有多个贯穿管壁的网孔构造。更进一步,单股所述丝线的线径大于或者等于0.0001英寸,且小于或等于0.0070英寸,丝线的材料比如是形态记忆合金,譬如镍钛丝。栓塞本体10的二级形态以管状的网结构形成波浪形态、螺旋形态、多面体形态等,还可以是二级形态中至少两种的组合,比如图6示范出以管状的网结构形成波浪形态和形成的多面体形态的组合。Further, the first-order form of the
【实施例三】[Embodiment 3]
本实施例请参阅图7至图9,图7是本发明实施例三的栓塞本体的一级形态的示意图,图8是本发明实施例三的栓塞本体的一级形态的另一示意图,图9是本发明实施例三的栓塞本体的二级形态的示意图。Please refer to Figure 7 to Figure 9 for this embodiment, Figure 7 is a schematic diagram of the primary form of the plug body in Embodiment 3 of the present invention, and Figure 8 is another schematic diagram of the primary form of the plug body in Embodiment 3 of the present invention, Fig. 9 is a schematic diagram of the secondary form of the plug body of the third embodiment of the present invention.
所述栓塞本体10的一级形态根据球囊100沿自身的轴向延伸形成,进一步,栓塞本体10的一级形态可以是根据一个(图7所示)或者多个球囊100(图9所示)形成,具有多个球囊时,多个球囊100沿轴向顺次连接。如此,栓塞本体10的一级形态大致呈类椭球状,二级形态可以是类椭球状为单体形成波浪形态、螺旋形态(图9所示)、多面体形态等。球囊100以收缩状输送至输卵管中,而后可以向球囊100内加入充盈介质使得球囊100恢复至扩张状,从而使得栓塞本体10恢复成一级形态,或者直接恢复成二级形态。当然,本实施例也可以是先在患者的体外向球囊100内部加入充盈介质让球囊100恢复至扩张状,从而使得栓塞本体10直接恢复成二级形态,随后外力的拉伸下使得二级形态恢复至一级形态,接着将栓塞本体10植入输卵管中,并在撤去外力后,根据球囊100形成的栓塞本体10再次恢复至二级形态。充盈介质比如是造影剂或生理盐水。球囊100可以是顺应性球囊100或者半顺应性球囊100。The primary form of the
需要说明的是,上述实施例一、实施例二和实施例三关于栓塞本体的一级形态和二级形态的描述可相互借鉴参考,对于其中某个实施例中未详尽描述的地方,可参阅其他实施例的相应说明部分。It should be noted that the descriptions of the first, second and third embodiments above about the primary and secondary forms of the embolism body can be used for reference. Corresponding description sections for other examples.
【实施例四】[Example 4]
本实施例请参阅图10,图10是本发明实施例四的栓塞本体的示意图。Please refer to FIG. 10 for this embodiment. FIG. 10 is a schematic diagram of a plug body according to Embodiment 4 of the present invention.
需说明的是,实施例四中的栓塞本体10的具体形成结构以及锚定段11的形态和栓塞段12的形态,可借鉴参阅实施例一、实施二或实施例三的描述,这里不再重复说明。It should be noted that the specific formation structure of the
本实施例中,所述栓塞本体10包括至少一节锚定段11和至少一节栓塞段12,所述锚定段11与所述栓塞段12连接。具体的,将栓塞本体10植入到输卵管后,锚定段11主要与输卵管较细的部分锚定贴合,将栓塞本体10进行固定,栓塞段12位于输卵管较粗的部分,起到栓塞作用,这样设置可以更好的适配输卵管,提升栓塞效果,并且可以减少患者的异物感。因此,栓塞本体10植入到输卵管后,由于输卵管的限制以及栓塞本体的锚定段11和栓塞段12的位置布置,锚定段11的径向尺寸通常是小于栓塞段12的径向尺寸,可理解的,这里的径向尺寸指的是沿径向最大的尺寸,若栓塞本体10的横截面为圆形,指的是直径。需说明的是,在栓塞本体10植入到输卵管之前,即栓塞本体10没有输卵管的限制而处于自然状态下,锚定段11的径向尺寸和栓塞段12的径向尺寸的大小不做限制,二者可以相等,也可不等,还可以是锚定段11的径向尺寸大于栓塞段12的径向尺寸。In this embodiment, the
需说明的是,本实施例对于锚定段11和栓塞段12的形态不做限制,比如二者所呈现的均是一级形态的栓塞本体10,或者均是二级形态的栓塞本体10,亦或是其中一个呈现的是一级形态的栓塞本体10,另一个呈现的是二级形态的栓塞本体10。比如,锚定段11呈柱状形态,栓塞段12呈螺旋形态;锚定段11呈波浪形态,栓塞段11呈球形形态;锚定段11呈螺旋形态,栓塞段12呈六面体形态;本领域技术人员可任意组合,在此不再一一列举。It should be noted that this embodiment does not limit the shape of the
进一步,所述栓塞本体10包括一节所述锚定段11和两节所述栓塞段12,所述锚定段11位于两节所述栓塞段12之间。输卵管包括依次连接的壶腹部、峡部和间质部,且壶腹部的径向尺寸和间质部的径向尺寸均大于峡部的径向尺寸,通过设置一节锚定段11和两节栓塞段12,可以让锚定段11锚定在峡部,起到锚定固定作用,两节栓塞段12分别位于壶腹部和间质部,起到输卵管栓塞的作用。如此,可以是使得栓塞本体10与输卵管的匹配效果更加,进一步减少患者的异物感,防止患者在静止状态或者运动状态下栓塞本体10向子宫侧移动或向卵巢侧移动。Further, the
较佳的,栓塞本体10包括至少两节锚定段11和至少两节栓塞段12时,相邻的两节所述栓塞段12之间排布一节所述锚定段11,且相邻的两节所述锚定段11之间排布一节所述栓塞段12。如此设置,一方面可以使得锚定段11排布均匀,栓塞段12排布均匀,另一方面,由于多个栓塞段的存在,使得栓塞本体的总体漏液率呈指数形式下降,即p总=p栓1*p栓2*…*p栓n,其中P栓n表示第n个栓塞段的漏液率。即当每一个栓塞段均发生漏液时,才会整体失效。对于输卵管积水的患者,可以进一步降低输卵管的漏液率。Preferably, when the
应理解的是,所述栓塞本体10包括至少两节所述栓塞段12时,至少一部分所述栓塞段12的径向尺寸可以各不相同。同理的,所述栓塞本体10包括至少两节所述锚定段11时,至少一部分所述锚定段11的径向尺寸也可以各不相同。It should be understood that, when the
【实施例五】[Embodiment 5]
需说明的是,实施例五作为描述输卵管栓塞器械的优选实施例,重点在于说明输卵管栓塞器械在栓塞本体的基础上的优选方案,对于栓塞本体的结构描述可借鉴参阅上述实施例一、实施例二、实施例三和实施例四的说明,这里不再重复说明。It should be noted that, as a preferred embodiment for describing the fallopian tube embolization device, the fifth embodiment focuses on explaining the preferred scheme of the fallopian tube embolization device on the basis of the embolization body. For the description of the structure of the embolization body, refer to the above-mentioned embodiment 1 and
本实施例中,所述一级形态的栓塞本体10的径向尺寸大于或等于0.01mm,且小于或等于2mm;所述一级形态的栓塞本体10的轴向尺寸(长度大小)大于或等于0.1cm,且小于或等于30cm。在实际场景中,操作者可根据患者的输卵管的情况配置合适的径向尺寸和轴向尺寸的栓塞本体10,以最大限度地与患者的输卵管相适配,尽可能地避免栓塞本体10植入到患者的输卵管后患者产生异物感,此外选择合适轴向尺寸的栓塞本体10,避免尺寸较短无法进行有效栓塞,以及避免尺寸太长可能会坠入输卵管的壶腹部甚至是卵巢。In this embodiment, the radial dimension of the
优选的,所述输卵管栓塞器械包括抗解旋丝,所述抗解旋丝的形态与所述栓塞本体10的二级形态相适应,所述抗解旋丝的两端分别连接所述栓塞本体10的两端。抗解旋丝的设置可以限制栓塞本体10的延展度(轴向延伸度),避免栓塞本体10植入到输卵管后,其二级形态被由于外部的压力而解除。比如栓塞本体10是根据一丝线螺旋盘绕形成弹簧状时,抗解旋丝可避免弹簧状的栓塞本体10被拉长解旋。抗解旋丝比如可以是弹性高分子材料、手术缝合线。Preferably, the fallopian tube embolization device includes an anti-untwisting wire, the shape of the anti-untwisting wire is adapted to the secondary shape of the
优选的,所述输卵管栓塞器械包括第一涂层,所述第一涂层涂覆于所述栓塞本体10的外表面,所述第一涂层具有遇水膨胀的属性。栓塞本体10植入输卵管后,第一涂层可遇水膨胀,填充栓塞本体10与输卵管的内侧之间的缝隙,提高填充密实性。第一涂层比如可以是凝胶涂层。Preferably, the fallopian tube embolization device includes a first coating, the first coating is coated on the outer surface of the
优选的,所述输卵管栓塞器械包括芯轴,所述芯轴设置于所述栓塞本体10的内部,且所述芯轴沿所述栓塞本体10的轴向延伸,所述芯轴具有遇水膨胀的属性。栓塞本体10植入输卵管后,芯轴遇水膨胀,从而驱使栓塞本体10外扩,使得栓塞本体10的外侧与输卵管的内侧贴合紧密,提高填充密实性。Preferably, the fallopian tube embolization device includes a mandrel, the mandrel is arranged inside the
可选的,本实施例的输卵管栓塞器械还可以与凝胶联用,将输卵管栓塞器械植入到输卵管后,可以从输卵管口注入适量凝胶以达到完全闭塞的效果。Optionally, the fallopian tube embolization device of this embodiment can also be used in combination with gel. After the fallopian tube embolization device is implanted into the fallopian tube, an appropriate amount of gel can be injected from the fallopian tube orifice to achieve a complete occlusion effect.
可选的,所述输卵管栓塞器械包括第二涂层,所述第二涂层包覆于所述栓塞本体10的外表面,所述第二涂层包括药物涂层。药物涂层可以提高输卵管栓塞器械的生物相容性,抑制输卵管的内皮细胞增生、抑制炎症。对于健康的女性,药物涂层可以涂覆缓释杀精的药品,用于健康女性的避孕需求。Optionally, the fallopian tube embolization device includes a second coating, the second coating is coated on the outer surface of the
优选的,所述栓塞本体10的外表面设有纤维结构,比如是纤维绒毛。栓塞本体10的外表面附有纤维绒毛,可增加与输卵管内壁的相容性,术后经过一段时间栓塞本体10的周围会发生无菌性炎症,从而进一步加强与输卵管的栓塞效果。Preferably, the outer surface of the
优选的,所述栓塞本体10的材料包括可降解材料,具体为生物降解材料,譬如可以是聚乳酸、聚羟基酸和多肽、聚乙醇酸[poly(glycolic acid),PGA]、聚己内酯(polycaprolactam,PCL)、聚醚、聚碳酸酯等。采用可降解材料制成的栓塞本体10,在使用一段时间后可溶解在人体内部,并可以被人体吸收,避免将栓塞本体10从输卵管中取出的过程中对患者造成伤害和不适感。Preferably, the material of the
基于上述的输卵管栓塞器械,本发明还提供一种输卵管栓塞系统,其包括如上所述的输卵管栓塞器械以及输送器械,所述输送器械与所述输卵管栓塞器械可拆卸地连接,并用于驱动所述输卵管栓塞器械植入输卵管中。本实施例对于输送器械的具体结构不做限制,本领域技术人员可根据现有技术优选配置。比如输送器械和输卵管栓塞器械通过一解脱结构连接,解脱结构可以是机械解脱结构、水解解脱结构或电解解脱结构,保证本发明的输卵管栓塞器械在输卵管中的植入效果较理想的情况下,可以方便输送器械与输卵管栓塞器械彼此分离。此外,输卵管栓塞器械在输卵管中的植入效果交较差的情况下,输送器械也可以将输卵管栓塞器械暂时回收至内部的鞘管中,而后再重新植入及释放。Based on the above-mentioned fallopian tube embolization device, the present invention also provides a fallopian tube embolization system, which includes the above-mentioned fallopian tube embolization device and a delivery device, the delivery device is detachably connected with the fallopian tube embolization device, and is used to drive the A tubal embolization device is inserted into the fallopian tubes. This embodiment does not limit the specific structure of the delivery device, and those skilled in the art can make preferred configurations according to the prior art. For example, the delivery device and the fallopian tube embolization device are connected by a release structure, and the release structure can be a mechanical release structure, a hydrolysis release structure or an electrolysis release structure, so as to ensure that the fallopian tube embolization device of the present invention has an ideal implantation effect in the fallopian tube, it can be It is convenient to separate the delivery device and the fallopian tube embolization device from each other. In addition, when the implantation effect of the fallopian tube embolization device in the fallopian tube is poor, the delivery device can also temporarily recover the fallopian tube embolization device into the inner sheath, and then re-implant and release it.
综上所述,在本发明提供的输卵管栓塞器械及输卵管栓塞系统中,输卵管栓塞器械包括:具有一级形态和二级形态的栓塞本体10,栓塞本体10的外侧用于与输卵管的内侧贴靠;一级形态包括柱状形态;二级形态为改变一级形态的延伸方向而成;栓塞本体10可在外力的作用下由二级形态拉伸到一级形态,且在撤去外力后,栓塞本体10可由一级形态恢复到二级形态。如上配置,栓塞本体10的一级形态包括柱状形态,即一级形态的延伸方向为线性方向,栓塞本体10的二级形态为改变一级形态的延伸方向形成,即二级形态的延伸方向为非线性方向,在空间上具有更多的自由度,栓塞本体10在外力的作用由一级形态植入输卵管中,并在撤去外力后在输卵管中恢复到二级形态,处于二级形态的栓塞本体10与输卵管的内侧贴靠后,栓塞本体10能够对输卵管起到很好的锚定支撑作用,且二级形态的栓塞本体10实际上用于栓堵作用的部位的体积也可得到相应增大,提高栓塞本体10与输卵管的填充密实性,从而提升输卵管栓塞器械的栓塞效果,进而可以帮助健康女性正常避孕以及帮助准备做试管婴儿手术却有输卵管积水的患者降低漏液率。In summary, in the fallopian tube embolization device and the fallopian tube embolization system provided by the present invention, the fallopian tube embolization device includes: an
上述描述仅是对本发明较佳实施例的描述,并非对本发明范围的任何限定,本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰,均属于本发明技术方案的保护范围。The above description is only a description of the preferred embodiments of the present invention, and does not limit the scope of the present invention. Any changes and modifications made by those of ordinary skill in the field of the present invention based on the above disclosures belong to the protection scope of the technical solution of the present invention.
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