技术领域Technical Field
本发明涉及一种医疗器械，更具体地说，涉及一种用于介入治疗设备的扩张器。The present invention relates to a medical device, and more particularly to a dilator used in interventional treatment equipment.
背景技术Background technique
介入治疗是利用现代高科技手段进行的一种微创性治疗，是在医学影像设备的引导下，将特制的导管，导丝等精密器械，引入人体，对体内病态进行诊断和局部治疗。介入治疗的切口（穿刺点）小，不用切开人体组织就可治疗过去无法治疗的、必须手术或内科治疗疗效欠佳的疾病，如血栓、肿瘤、各种出血等。Interventional therapy is a minimally invasive treatment using modern high-tech means. Under the guidance of medical imaging equipment, special catheters, guide wires and other precision instruments are introduced into the human body to diagnose and treat local diseases in the body. The incision (puncture point) of interventional therapy is small, and diseases that were previously untreatable and required surgery or poor medical treatment effects can be treated without cutting into human tissue, such as thrombosis, tumors, various bleeding, etc.
现有的介入手术中扩张器一般配合穿刺置管使用，其作用是在介入手术入路时，追踪导丝无损伤的扩开皮肤，皮下组织及血管，为手术中配合使用的器械打通通路，同时作为导向将相配合的导管输送到位，与其相配合的导管鞘长度一般短于扩张器。In existing interventional surgeries, dilators are generally used in conjunction with puncture and catheterization. Their function is to track the guide wire to non-damagely expand the skin, subcutaneous tissue and blood vessels during the interventional surgery, open up a pathway for the instruments used in the surgery, and serve as a guide to deliver the corresponding catheter into place. The length of the corresponding catheter sheath is generally shorter than the dilator.
常用的介入手术扩张器系统具有以下特征：Commonly used interventional dilator systems have the following characteristics:
1. 材料：PP（聚丙烯）、HDPE（高密度聚乙烯）等便宜且密度低的塑料，但这些材料一般硬度较高，通常为65～70D，柔顺性和过弯能力不强；1. Materials: PP (polypropylene), HDPE (high-density polyethylene) and other cheap and low-density plastics, but these materials are generally hard, usually 65-70D, and have poor flexibility and bending ability;
2. 尺寸：长度一般较短，不会到达病变部位；2. Size: The length is generally short and will not reach the lesion site;
3. 形状：扩张器杆远端（头端）成角度较小的锥形，能方便且相对安全地扩开皮肤，皮下组织及血管，除远端外扩张器杆其他部分为同径的圆柱体；3. Shape: The distal end (head end) of the dilator rod is a cone with a small angle, which can easily and relatively safely expand the skin, subcutaneous tissue and blood vessels. Except for the distal end, the rest of the dilator rod is a cylinder with the same diameter;
4. 结构：轴向方向上，扩张器杆中心会开孔，目的是顺应导丝导向，防止入路时戳到血管造成损伤；扩张器杆近端会连接一个带锁的机械结构的座，目的是将扩张器杆与配合的导管鞘固定相对位置，防止术中输送时因器械错位导致器械输送不到位。4. Structure: In the axial direction, a hole will be opened in the center of the dilator rod to follow the guide wire guidance and prevent the blood vessel from being pierced and damaged during entry. A seat with a locking mechanical structure will be connected to the proximal end of the dilator rod to fix the relative position of the dilator rod and the matching catheter sheath to prevent the instrument from being misplaced during delivery during surgery.
如上所述，因现有器械的结构和材料所限，当相配合的导管需到达较远的病变部位，且器械入路路径迂曲时，传统扩张器系统的输送性、安全性以及位置准确性均难以满足此类术式要求。As mentioned above, due to the limitations of the structure and materials of existing instruments, when the matching catheter needs to reach a distant lesion site and the instrument access path is tortuous, the delivery, safety and positioning accuracy of the traditional dilator system are difficult to meet the requirements of such procedures.
发明内容Summary of the invention
针对现有技术存在的，本发明提供一种用于介入治疗设备的扩张器，以解决传统设备扩张器中因材料和设计结构缺陷导致其柔顺性不佳，从而对患者体内血管造成意外损伤；设备输送范围小；导管输送位置准确性低等问题。In view of the existing technology, the present invention provides a dilator for interventional treatment equipment to solve the problems of poor flexibility of traditional equipment dilators due to defects in materials and design structures, thereby causing accidental damage to blood vessels in the patient's body; small equipment delivery range; and low accuracy of catheter delivery position.
为实现上述目的，本发明采用如下技术方案：To achieve the above object, the present invention adopts the following technical solution:
一种用于介入治疗设备的扩张器，其特征在于，包括：扩张器杆，扩张器杆为中空杆状部件，扩张器杆从远端到近端依次包括第一杆段、第二杆段、第三杆段，第一杆段包括尖端；其中，扩张器杆的第二杆段的外径小于或等于第一杆段的外径，且第一杆段的外径小于或等于第三杆段的外径；第一杆段、第二杆段的材料硬度低于第三杆段的材料硬度。A dilator for interventional therapy equipment, characterized in that it includes: a dilator rod, the dilator rod is a hollow rod-shaped component, the dilator rod includes a first rod segment, a second rod segment, and a third rod segment from the distal end to the proximal end, and the first rod segment includes a tip; wherein the outer diameter of the second rod segment of the dilator rod is less than or equal to the outer diameter of the first rod segment, and the outer diameter of the first rod segment is less than or equal to the outer diameter of the third rod segment; the material hardness of the first rod segment and the second rod segment is lower than the material hardness of the third rod segment.
作为本发明的一种实施方式，第一杆段、第二杆段、第三杆段的内径和外径比A:B为：30%≤A:B≤50%，其中A为第一杆段、第二杆段、第三杆段的内径，B为第一杆段、第二杆段、第三杆段的外径；第一杆段、第二杆段、第三杆段的材料硬度为25D～45D，其中D为肖氏硬度单位。As an embodiment of the present invention, the ratio of the inner diameter to the outer diameter of the first rod segment, the second rod segment, and the third rod segment A:B is: 30%≤A:B≤50%, wherein A is the inner diameter of the first rod segment, the second rod segment, and the third rod segment, and B is the outer diameter of the first rod segment, the second rod segment, and the third rod segment; the material hardness of the first rod segment, the second rod segment, and the third rod segment is 25D~45D, wherein D is the Shore hardness unit.
作为本发明的一种实施方式，第一杆段、第二杆段、第三杆段的内径和外径比A:B为：50%＜A:B≤70%，其中A为第一杆段、第二杆段、第三杆段的内径，B为第一杆段、第二杆段、第三杆段的外径；第一杆段、第二杆段、第三杆段的材料硬度为55D～72D，其中D为肖氏硬度单位。As an embodiment of the present invention, the ratio of the inner diameter to the outer diameter of the first rod segment, the second rod segment, and the third rod segment A:B is: 50%＜A:B≤70%, wherein A is the inner diameter of the first rod segment, the second rod segment, and the third rod segment, and B is the outer diameter of the first rod segment, the second rod segment, and the third rod segment; the material hardness of the first rod segment, the second rod segment, and the third rod segment is 55D~72D, wherein D is the Shore hardness unit.
作为本发明的一种实施方式，第一杆段、第二杆段、第三杆段的外径相等。As an implementation manner of the present invention, the outer diameters of the first rod segment, the second rod segment, and the third rod segment are equal.
作为本发明的一种实施方式，第二杆段的外径小于第一杆段的外径，且第一杆段的外径等于第三杆段的外径；或者，第二杆段的外径小于第一杆段的外径，且第一杆段的外径小于第三杆段的外径。As an embodiment of the present invention, the outer diameter of the second rod segment is smaller than the outer diameter of the first rod segment, and the outer diameter of the first rod segment is equal to the outer diameter of the third rod segment; or, the outer diameter of the second rod segment is smaller than the outer diameter of the first rod segment, and the outer diameter of the first rod segment is smaller than the outer diameter of the third rod segment.
作为本发明的一种实施方式，第二杆段和第一杆段之间、第二杆段和第三杆段之间包括过渡段，过渡段的坡角范围为10°～60°。As an implementation manner of the present invention, a transition section is included between the second rod section and the first rod section, and between the second rod section and the third rod section, and the slope angle of the transition section ranges from 10° to 60°.
作为本发明的一种实施方式，第一杆段的尖端为锥形，其角度范围为10°～60°。As an implementation mode of the present invention, the tip of the first rod segment is conical, and the angle range of the tip of the first rod segment is 10° to 60°.
作为本发明的一种实施方式，第一杆段的外径大于或等于3mm，且第一杆段外径与介入治疗设备的导管之间具有0.076～0.36mm的间隙；第一杆段的内径大于等于1mm。As an embodiment of the present invention, the outer diameter of the first rod segment is greater than or equal to 3 mm, and there is a gap of 0.076-0.36 mm between the outer diameter of the first rod segment and the catheter of the interventional treatment device; the inner diameter of the first rod segment is greater than or equal to 1 mm.
作为本发明的一种实施方式，第二杆段的外径比第一杆段的外径小0～3mm。As an implementation manner of the present invention, the outer diameter of the second rod segment is 0-3 mm smaller than the outer diameter of the first rod segment.
作为本发明的一种实施方式，第三杆段的外径大于等于3mm，且第三杆段外径与介入治疗设备的导管之间具有0.08mm的间隙；第三杆段的内径大于等于1mm。As an embodiment of the present invention, the outer diameter of the third rod segment is greater than or equal to 3 mm, and there is a gap of 0.08 mm between the outer diameter of the third rod segment and the catheter of the interventional treatment device; the inner diameter of the third rod segment is greater than or equal to 1 mm.
作为本发明的一种实施方式，扩张器座，扩张器座安装于第三杆段的外表面，且扩张器座包括卡扣，卡扣将扩张器座与介入治疗设备相固定；卡扣为安装于扩张器座的翼片，且卡扣沿扩张器杆轴向延伸。As an embodiment of the present invention, the expander seat is installed on the outer surface of the third rod segment, and the expander seat includes a buckle, which fixes the expander seat to the interventional treatment device; the buckle is a wing installed on the expander seat, and the buckle extends axially along the expander rod.
作为本发明的一种实施方式，卡扣包括两个在周向上间隔180°的第一卡扣和第二卡扣，其中第一卡扣的翼片末端包括朝向扩张器杆的中心轴线径向伸出的卡紧机构。As an embodiment of the present invention, the buckle includes a first buckle and a second buckle spaced 180° apart in the circumferential direction, wherein the wing end of the first buckle includes a clamping mechanism radially extending toward the central axis of the expander rod.
在上述技术方案中，本发明优化了扩张器的柔顺性和输送性，能更好得将大口径的导管/鞘输送至更远更迂曲的体内病变位置，比如心内；确保了过弯时导管系统不会因为扩张器过硬而难以推进，避免由于扩张器的过弯能力差导致导管系统发生折弯，从而引发对人体血管的损伤。扩张器座的锁扣机构保证扩张器与导管在输送过程中的相对位置始终不变，提高了导管输送位置的准确性。In the above technical solution, the present invention optimizes the flexibility and transportability of the dilator, and can better transport large-caliber catheters/sheaths to farther and more tortuous lesion locations in the body, such as the heart; it ensures that the catheter system will not be difficult to advance when passing through a bend due to the dilator being too hard, and avoids the catheter system from bending due to the poor bending ability of the dilator, thereby causing damage to human blood vessels. The locking mechanism of the dilator seat ensures that the relative position of the dilator and the catheter remains unchanged during the delivery process, thereby improving the accuracy of the catheter delivery position.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
图1是导管系统示意图；Fig. 1 is a schematic diagram of a catheter system;
图2是三段式扩张器系统示意图；FIG2 is a schematic diagram of a three-stage expander system;
图3是两段式扩张器系统示意图；FIG3 is a schematic diagram of a two-stage expander system;
图4是三段式扩张器爆炸图；FIG4 is an exploded view of a three-stage expander;
图5是两段式扩张器爆炸图；FIG5 is an exploded view of a two-stage expander;
图6是三段式扩张器结构图；Fig. 6 is a structural diagram of a three-stage expander;
图7是过渡段呈椭圆状时的示意图；FIG7 is a schematic diagram of a transition section in an elliptical shape;
图8是过渡段呈斜坡形时的示意图；FIG8 is a schematic diagram of a transition section in a slope shape;
图9是单边卡扣锁紧示意图；FIG9 is a schematic diagram of a single-sided buckle locking;
图10是单边卡扣松开示意图；FIG10 is a schematic diagram of a unilateral buckle release;
图11是双边卡扣锁紧示意图；FIG11 is a schematic diagram of bilateral buckle locking;
图12是双边卡扣松开示意图。FIG. 12 is a schematic diagram of releasing the double-sided buckle.
图中：1-扩张器座，101-第一卡扣，102-第二卡扣，103-直边部，2-扩张器杆，201-第一杆段，202-第二杆段，203-第三杆段，3-止血阀，4-导管。In the figure: 1-dilator seat, 101-first buckle, 102-second buckle, 103-straight edge, 2-dilator rod, 201-first rod segment, 202-second rod segment, 203-third rod segment, 3-hemostatic valve, 4-catheter.
具体实施方式Detailed ways
下面结合附图和实施例，对本发明实施例中的技术方案进一步作清楚、完整地描述。显然，所描述的实施例用来作为解释本发明技术方案之用，并非意味着已经穷举了本发明所有的实施方式。The following is a further clear and complete description of the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings and embodiments. Obviously, the described embodiments are used to explain the technical solutions of the present invention, and do not mean that all implementation methods of the present invention have been exhaustively listed.
所述实施例的示例在附图中示出，其中自始至终相同或类似的标号表示相同或类似的元件或具有相同或类似功能的元件。下面通过参考附图描述的实施例是示例性的，旨在用于解释本发明，而不能理解为对本发明的限制。Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are intended to be used to explain the present invention, and should not be construed as limiting the present invention.
关于本说明书中的术语“远侧/远端”和“近侧/近端”，其中近端/近侧指的是靠近操作人员的一端，而远端/远侧指的是远离操作人员，或者进入人体血管的一端。每一个部件均可以具有近端和远端，近端/远端是对于相对方向/位置的描述，不直接代表距离的远近。Regarding the terms "distal side/distal end" and "proximal side/proximal end" in this specification, the proximal side/proximal end refers to the end close to the operator, and the distal side/distal end refers to the end away from the operator or entering the human blood vessel. Each component may have a proximal end and a distal end, and the proximal end/distal end is a description of the relative direction/position, and does not directly represent the distance.
参照图1，本发明公开了一种用于介入治疗设备的扩张器，其通过扩张器座1连接到介入设备的止血阀3上，止血阀3远端与导管4近端连接。扩张器部件主要包括：扩张器座1、扩张器杆2。扩张器座1与扩张器杆2近端处连接。扩张器通过扩张器座1的锁扣结构与止血阀3固定，扩张器杆2穿过止血阀3插入导管4内，形成介入治疗设备上的扩张系统。Referring to Fig. 1, the present invention discloses a dilator for an interventional treatment device, which is connected to a hemostatic valve 3 of the interventional treatment device through a dilator seat 1, and the distal end of the hemostatic valve 3 is connected to the proximal end of a catheter 4. The dilator components mainly include: a dilator seat 1 and a dilator rod 2. The dilator seat 1 is connected to the proximal end of the dilator rod 2. The dilator is fixed to the hemostatic valve 3 through the locking structure of the dilator seat 1, and the dilator rod 2 passes through the hemostatic valve 3 and is inserted into the catheter 4 to form a dilator system on the interventional treatment device.
参照图2、图4和图6，作为本发明扩张器杆2的第一种实施方式，扩张器杆2为中空杆状部件,可分为三段：第一杆段201是具有过渡段的远端、第二杆段202是具有相对较小外径的中段、第三杆段203是与第一杆段201内径一致且具有过渡段的近端,第一杆段201包括尖端。参照图4，扩张器座1和第三杆段203的近端粘接构成扩张器。扩张器座1再与止血阀3通过锁扣结构相互固定，扩张器杆2穿过止血阀3和与止血阀相连接的导管4，使扩张器安装于介入治疗设备中。Referring to Fig. 2, Fig. 4 and Fig. 6, as the first embodiment of the expander rod 2 of the present invention, the expander rod 2 is a hollow rod-shaped component, which can be divided into three sections: the first rod section 201 is a distal end with a transition section, the second rod section 202 is a middle section with a relatively small outer diameter, and the third rod section 203 is a proximal end with a transition section having the same inner diameter as the first rod section 201, and the first rod section 201 includes a tip. Referring to Fig. 4, the expander seat 1 and the proximal end of the third rod section 203 are bonded to form a expander. The expander seat 1 is then fixed to the hemostatic valve 3 by a locking structure, and the expander rod 2 passes through the hemostatic valve 3 and the catheter 4 connected to the hemostatic valve, so that the expander is installed in the interventional treatment device.
参照图6，本实例中，扩张器杆2的第二杆段202的外径小于或等于第一杆段201的外径，且第一杆段201的外径小于或等于第三杆203段的外径。作为本发明的一种实施方式，扩张器杆2的第二杆段202的内径和外径比A:B为：30%≤A:B≤50%，其中A为第二杆段的内径，B为第二杆段的外径。第二杆段202的材料硬度为25D～45D，其中D为肖氏硬度单位。作为本发明的另一种实施方式，第二杆段202的内径和外径比A:B为：50%＜A:B≤70%，其中A为第二杆段202的内径，B为第二杆段202的外径。第二杆段202的材料硬度为55D～72D，其中D为肖氏硬度单位。6, in this example, the outer diameter of the second rod segment 202 of the expander rod 2 is less than or equal to the outer diameter of the first rod segment 201, and the outer diameter of the first rod segment 201 is less than or equal to the outer diameter of the third rod segment 203. As one embodiment of the present invention, the inner diameter and outer diameter ratio A:B of the second rod segment 202 of the expander rod 2 is: 30%≤A:B≤50%, wherein A is the inner diameter of the second rod segment, and B is the outer diameter of the second rod segment. The material hardness of the second rod segment 202 is 25D~45D, wherein D is the Shore hardness unit. As another embodiment of the present invention, the inner diameter and outer diameter ratio A:B of the second rod segment 202 is: 50%＜A:B≤70%, wherein A is the inner diameter of the second rod segment 202, and B is the outer diameter of the second rod segment 202. The material hardness of the second rod segment 202 is 55D~72D, wherein D is the Shore hardness unit.
与第一杆段201和第三杆段203杆段相较，第二杆段202的外径较小是为了增强扩张器的柔顺性，使其拥有更好的过弯性能，第二杆段202材料可根据内外径比例（壁厚）决定硬度，当内径与外径比例较大（A:B比值）,即杆的壁厚小时，材料硬度可以相对提高，若比例小，即壁厚大时则材料硬度需要相对偏软。当杆的内外径比例，即壁厚变化时，通过不同硬度的材料搭配，也可以达到相同的柔顺性。Compared with the first rod segment 201 and the third rod segment 203, the second rod segment 202 has a smaller outer diameter in order to enhance the flexibility of the expander and enable it to have better cornering performance. The hardness of the material of the second rod segment 202 can be determined according to the ratio of the inner and outer diameters (wall thickness). When the ratio of the inner diameter to the outer diameter is large (A:B ratio), that is, the wall thickness of the rod is small, the material hardness can be relatively improved. If the ratio is small, that is, the wall thickness is large, the material hardness needs to be relatively soft. When the ratio of the inner and outer diameters of the rod, that is, the wall thickness changes, the same flexibility can also be achieved by matching materials of different hardness.
作为本发明的一种实施方式，表1列举了一些第二杆段202材料和壁厚的搭配，其中所列聚醚嵌段酰胺材料来自法国Arkema公司。表1中的最小弯曲直径数据由测试获得，测试方式是将第二杆段202缠在特定的圆柱形工装上180°，当拿走工装后，第二杆段202未发生弯折，则判定其通过该工装对应的外径。第二杆段202的长度一般根据实际情况中的迂曲段入路路径的长度而决定。作为本实例的一种应用，对于选用材质较软的PEBAX2533材料制成内外径比为30%（壁厚较厚）的杆段，和选用材质较硬的PEBAX6333制成内外径比为50%（壁厚较薄）的杆段，实验数据显示两者的柔顺性相同，即无论选择那种搭配方式均可达到等同的材质要求，As an embodiment of the present invention, Table 1 lists some combinations of materials and wall thicknesses of the second rod segment 202, among which the polyether block amide materials listed are from Arkema, France. The minimum bending diameter data in Table 1 are obtained by testing, in which the second rod segment 202 is wrapped around a specific cylindrical tooling for 180°. When the tooling is removed, the second rod segment 202 does not bend, and the outer diameter corresponding to the tooling is determined. The length of the second rod segment 202 is generally determined according to the length of the tortuous access path in actual conditions. As an application of this example, for a rod segment made of softer PEBAX2533 material with an inner/outer diameter ratio of 30% (thicker wall thickness), and a rod segment made of harder PEBAX6333 material with an inner/outer diameter ratio of 50% (thinner wall thickness), experimental data show that the flexibility of the two is the same, that is, no matter which combination is selected, the same material requirements can be achieved.
表1 第二杆段202材料与壁厚搭配示例。Table 1 Examples of the combination of materials and wall thickness of the second rod segment 202.
除了第二杆段202之外，第一杆段201和第三杆段203的外径大于或等于3mm，比第二杆段202的外径大0～0.076mm。且第一杆段201外径与介入治疗设备的导管4之间具有0.076～0.36mm的间隙；第三杆段203外径与介入治疗设备的导管4之间具有0.08mm的间隙。第一杆段201和第三杆段203的内径大于等于1mm，内、外径比例范围为1：1.4～1：3.3。参照图７，第一杆段的尖端为锥形，其角度（图7所示的角X）范围为10°～60°。锥形尖端的内孔也是锥形，其角度范围与外部一致为10°～60°。锥形尖端内孔的最远端的孔径范围为0.88～1mm，其作用是顺应导丝导向。Except for the second rod segment 202, the outer diameters of the first rod segment 201 and the third rod segment 203 are greater than or equal to 3 mm, which is 0 to 0.076 mm larger than the outer diameter of the second rod segment 202. There is a gap of 0.076 to 0.36 mm between the outer diameter of the first rod segment 201 and the catheter 4 of the interventional treatment device; there is a gap of 0.08 mm between the outer diameter of the third rod segment 203 and the catheter 4 of the interventional treatment device. The inner diameters of the first rod segment 201 and the third rod segment 203 are greater than or equal to 1 mm, and the ratio of the inner diameter to the outer diameter ranges from 1:1.4 to 1:3.3. Referring to FIG. 7, the tip of the first rod segment is conical, and its angle (angle X shown in FIG. 7) ranges from 10° to 60°. The inner hole of the conical tip is also conical, and its angle range is consistent with the outer portion, which is 10° to 60°. The aperture range of the farthest end of the inner hole of the conical tip is 0.88 to 1 mm, and its function is to comply with the guide wire guidance.
继续参照图6，作为本发明的一种实施方式，第一杆段201、第三杆段203的内径和外径比A:B为：30%≤A:B≤50%，其中A为第一杆段201、第三杆段203的内径，B为第一杆段201、第三杆段203的外径。第一杆段201、第三杆段203的材料硬度为25D～45D，其中D为肖氏硬度单位。作为本发明的另一种实施方式，当材料硬度选择不同时，第一杆段201、第三杆段203的内径和外径比A:B为：50%＜A:B≤70%，其中A为第一杆段201和第三杆段203的内径，B为第一杆段201和第三杆段203的外径。第一杆段201、第三杆段203的材料硬度为55D～72D，其中D为肖氏硬度单位。一般而言，第一杆段201、第二杆段202的材料硬度低于第三杆段203的材料硬度。6, as an embodiment of the present invention, the ratio of the inner diameter to the outer diameter A:B of the first rod segment 201 and the third rod segment 203 is: 30%≤A:B≤50%, wherein A is the inner diameter of the first rod segment 201 and the third rod segment 203, and B is the outer diameter of the first rod segment 201 and the third rod segment 203. The material hardness of the first rod segment 201 and the third rod segment 203 is 25D-45D, wherein D is the Shore hardness unit. As another embodiment of the present invention, when the material hardness is different, the ratio of the inner diameter to the outer diameter A:B of the first rod segment 201 and the third rod segment 203 is: 50%＜A:B≤70%, wherein A is the inner diameter of the first rod segment 201 and the third rod segment 203, and B is the outer diameter of the first rod segment 201 and the third rod segment 203. The material hardness of the first rod segment 201 and the third rod segment 203 is 55D-72D, wherein D is the Shore hardness unit. Generally speaking, the material hardness of the first rod segment 201 and the second rod segment 202 is lower than the material hardness of the third rod segment 203 .
相较第二杆段202，第一杆段201外径较大是为了更好地与导管４内径配合，起到封堵血液进入导管4管腔内的作用。同时，第一杆段201外径与导管4内径保留一定的间隙以确保扩张器在推送时相对顺畅，间隙大小需根据扩张器杆2整体的软硬程度决定，扩张器杆2如果较软则其与导管4的间隙要大，反之则间隙要小。与第二杆段202同理，第一杆段201材料硬度需根据内外径比例做调整。Compared with the second rod segment 202, the first rod segment 201 has a larger outer diameter in order to better match the inner diameter of the catheter 4, thereby blocking blood from entering the lumen of the catheter 4. At the same time, a certain gap is reserved between the outer diameter of the first rod segment 201 and the inner diameter of the catheter 4 to ensure that the expander is relatively smooth when pushed. The size of the gap needs to be determined according to the overall hardness of the expander rod 2. If the expander rod 2 is softer, the gap between it and the catheter 4 should be larger, otherwise the gap should be smaller. Similar to the second rod segment 202, the hardness of the material of the first rod segment 201 needs to be adjusted according to the ratio of the inner and outer diameters.
作为本发明的实施方式，材料和壁厚的搭配可参照下表2，其中所列聚醚嵌段酰胺材料来自法国Arkema公司，且最小弯曲直径数据的测得方式与表1相同。由于第一杆段201的直径略大于第二杆段202，最小弯曲直径的测得数值也略高于后者。由此可以体现出相对第二杆段202而言，201杆段的柔顺性要求相对较低，As an embodiment of the present invention, the combination of materials and wall thickness can refer to the following Table 2, where the polyether block amide materials listed are from Arkema, France, and the minimum bending diameter data is measured in the same way as in Table 1. Since the diameter of the first rod segment 201 is slightly larger than that of the second rod segment 202, the measured value of the minimum bending diameter is also slightly higher than that of the latter. This shows that the flexibility requirement of the rod segment 201 is relatively low compared to the second rod segment 202.
表2 第一杆段201材料与壁厚搭配示例。Table 2 Examples of combinations of materials and wall thicknesses for the first rod segment 201.
相较第一杆段201和第二杆段202，第三杆段203外径较大是为了保证扩张器整体具有良好的推送性，又细又软的杆部在实际使用时会使得推送力无法完全延扩张器轴向传递，导致扩张器杆2在患者血管内推送困难。另外，第三杆段203因为靠近近端穿刺入路口，所经过的路径较直，因此对于柔软性能的要求低于201、202段，所以第三杆段203的材料通常也会比其他两段的具有更高的硬度。与第一杆段201同理，第三杆段203的外径与导管4内径间隙需要根据扩张器杆2整体软硬程度决定，目的是为了进出导管4时顺畅。因此第三杆段203材料硬度需根据内外径比例（A:B的比值）做调整。Compared with the first rod segment 201 and the second rod segment 202, the third rod segment 203 has a larger outer diameter to ensure that the expander as a whole has good pushing performance. The thin and soft rod portion will make it impossible to completely transmit the pushing force along the axial direction of the expander during actual use, resulting in difficulty in pushing the expander rod 2 into the patient's blood vessels. In addition, because the third rod segment 203 is close to the proximal puncture entrance and the path it passes through is relatively straight, the requirements for softness are lower than those of segments 201 and 202, so the material of the third rod segment 203 will usually have a higher hardness than the other two segments. Similar to the first rod segment 201, the gap between the outer diameter of the third rod segment 203 and the inner diameter of the catheter 4 needs to be determined based on the overall hardness of the expander rod 2, in order to ensure smooth entry and exit of the catheter 4. Therefore, the hardness of the material of the third rod segment 203 needs to be adjusted according to the ratio of the inner and outer diameters (the ratio of A:B).
作为本发明的实施方式，材料和壁厚的搭配可参照下表3，其中所列聚醚嵌段酰胺材料来自法国Arkema公司，且最小弯曲直径数据的测得方式与表1相同。由于第三杆段203的材料硬度略大于第一杆段201，所以最小弯曲直径的测得数值略高于后者。由此可以体现相对第一杆段201而言，第三杆段203的柔顺性要求更加低。如若对于第三杆段203有高柔软性能的要求，则可参考第一段杆201的外径、材料及壁厚的搭配，As an embodiment of the present invention, the combination of materials and wall thickness can refer to the following Table 3, in which the polyether block amide materials listed are from Arkema, France, and the minimum bending diameter data is measured in the same way as in Table 1. Since the material hardness of the third rod segment 203 is slightly greater than that of the first rod segment 201, the measured value of the minimum bending diameter is slightly higher than the latter. This shows that the flexibility requirement of the third rod segment 203 is lower than that of the first rod segment 201. If there is a requirement for high softness for the third rod segment 203, the outer diameter, material and wall thickness of the first rod segment 201 can be referred to.
表3 第三杆段203材料与壁厚搭配示例。Table 3 Examples of the combination of materials and wall thickness of the third rod segment 203.
参照图７和图8，在第一杆段201的近端与第二杆段202远端相连处和第三杆段203的远端与第二杆段202近端相连处均有一小段过渡段。过渡段的坡角范围在10°到60°之间。过渡段的形状可以是图7所示201a的椭圆形，也可以是图8所述201b的斜坡形，或者其他具有直径渐变趋势的外形结构。这种过渡结构的作用是为了配合图1中止血阀3的开关结构，当扩张器进入和抽出止血阀时，引导血液正常流动，使其不会因为没有过渡段而在导管4与第二杆段202之间形成的狭小的血液回流空间，造成扩张器杆2卡在止血阀3中，影响手术的进程。Referring to Fig. 7 and Fig. 8, there is a small transition section at the place where the proximal end of the first rod segment 201 is connected to the distal end of the second rod segment 202 and at the place where the distal end of the third rod segment 203 is connected to the proximal end of the second rod segment 202. The slope angle of the transition section ranges from 10° to 60°. The shape of the transition section can be an ellipse 201a as shown in Fig. 7, or a slope 201b as shown in Fig. 8, or other external shapes with a gradual diameter change trend. The function of this transition structure is to cooperate with the switch structure of the hemostatic valve 3 in Fig. 1. When the dilator enters and withdraws from the hemostatic valve, it guides the blood to flow normally, so that the dilator rod 2 will not be stuck in the hemostatic valve 3 due to the narrow blood reflux space formed between the catheter 4 and the second rod segment 202 due to the absence of the transition section, thereby affecting the progress of the operation.
第一杆段201、第二杆段202和第三杆段203均可以以PEBAX（聚醚嵌段聚酰胺）、TPU（热塑性聚氨酯弹性体橡胶）、LDPE（低密度聚乙烯）、HDPE（高密度聚乙烯）等软塑料为材料。选用上述4种材料主要因为较传统材料而言，其质量较轻，柔软性好，弹性恢复能力强，低温下具有良好的稳定一致性，良好的抗疲劳，优秀的加工性能，精确的尺寸稳定性。管材通过挤出或注塑等工艺成型。然后通过焊接、粘接或者热合等工艺将第一杆段201的近端与第二杆段202的远端相连；将第二杆段202的近端与第三杆段203的远端相连。通过粘接将第三杆段203的近端与扩张器座1相连。The first rod segment 201, the second rod segment 202 and the third rod segment 203 can all be made of soft plastics such as PEBAX (polyether block polyamide), TPU (thermoplastic polyurethane elastomer rubber), LDPE (low-density polyethylene), HDPE (high-density polyethylene). The above four materials are mainly selected because compared with traditional materials, they are lighter, softer, have strong elastic recovery ability, have good stability and consistency at low temperatures, good fatigue resistance, excellent processing performance, and precise dimensional stability. The pipe is formed by processes such as extrusion or injection molding. Then, the proximal end of the first rod segment 201 is connected to the distal end of the second rod segment 202 by welding, bonding or heat sealing; the proximal end of the second rod segment 202 is connected to the distal end of the third rod segment 203. The proximal end of the third rod segment 203 is connected to the expander seat 1 by bonding.
结合上述参数可见，在本发明扩张器杆2的第一种实施方式中，上述材料硬度的组合可以是多样的，只要满足第一杆段、第二杆段的材料硬度低于第三杆段的材料硬度，并且在上述表1～表3的具体取值范围内，对于第一杆段、第二杆段、第三杆段的参数取值是灵活多样的。此外，第一杆段、第二杆段、第三杆段的硬度与其各自的内径、外径取值有关。Combined with the above parameters, it can be seen that in the first embodiment of the expander rod 2 of the present invention, the combination of the above material hardness can be diverse, as long as the material hardness of the first rod segment and the second rod segment is lower than the material hardness of the third rod segment, and within the specific value range of Tables 1 to 3 above, the parameter values of the first rod segment, the second rod segment, and the third rod segment are flexible and diverse. In addition, the hardness of the first rod segment, the second rod segment, and the third rod segment is related to the values of their respective inner diameters and outer diameters.
例如，在第一个扩张器中，选择第一杆段的材料硬度为25D，其内径为1mm，外径为3mm，内径和外径比为33.3%。第二杆段的材料硬度为35D，其内径为0.9mm，外径为2.95mm，内径和外径比为30.5%。第三杆段的材料硬度为45D，其内径为1mm，外径为3mm，内径和外径比为33.3%。与第一个扩张器的相适配的导管内径为3.08mm，其与第一杆段、第三杆段之间具有0.08mm间隙。For example, in the first dilator, the material hardness of the first rod segment is 25D, the inner diameter is 1mm, the outer diameter is 3mm, and the ratio of the inner diameter to the outer diameter is 33.3%. The material hardness of the second rod segment is 35D, the inner diameter is 0.9mm, the outer diameter is 2.95mm, and the ratio of the inner diameter to the outer diameter is 30.5%. The material hardness of the third rod segment is 45D, the inner diameter is 1mm, the outer diameter is 3mm, and the ratio of the inner diameter to the outer diameter is 33.3%. The inner diameter of the catheter matched with the first dilator is 3.08mm, and there is a 0.08mm gap between it and the first and third rod segments.
例如，在第二个扩张器中，选择第一杆段的材料硬度为55D，其内径为2.5mm，外径为4.0mm，内径和外径比为62.5%。第二杆段的材料硬度为63D，其内径为2mm，外径为3mm，内径和外径比为66.6%。第三杆段的材料硬度为72D，其内径为2.5mm，外径为4.0mm，内径和外径比为62.5%。与第二个扩张器的相适配的导管内径为4.06mm，其与第一杆段、第三杆段之间具有0.06mm间隙。For example, in the second dilator, the material hardness of the first rod segment is 55D, its inner diameter is 2.5mm, its outer diameter is 4.0mm, and the ratio of the inner diameter to the outer diameter is 62.5%. The material hardness of the second rod segment is 63D, its inner diameter is 2mm, its outer diameter is 3mm, and the ratio of the inner diameter to the outer diameter is 66.6%. The material hardness of the third rod segment is 72D, its inner diameter is 2.5mm, its outer diameter is 4.0mm, and the ratio of the inner diameter to the outer diameter is 62.5%. The inner diameter of the catheter matched with the second dilator is 4.06mm, and there is a 0.06mm gap between it and the first rod segment and the third rod segment.
例如，在第三个扩张器中，选择第一杆段的材料硬度为25D，其内径为3.0mm，外径为6.0mm，内径和外径比为50.0%。第二杆段的材料硬度为45D，其内径为1.5mm，外径为3.0mm，内径和外径比为50.0%。第三杆段的材料硬度为72D，其内径为3.0mm，外径为6.02mm，内径和外径比为49.8%。与第三个扩张器的相适配的导管内径为6.08mm，其与第一杆段之间具有0.08mm间隙；与第三杆段之间具有0.06mm间隙。For example, in the third dilator, the material hardness of the first rod segment is 25D, its inner diameter is 3.0mm, its outer diameter is 6.0mm, and the ratio of the inner diameter to the outer diameter is 50.0%. The material hardness of the second rod segment is 45D, its inner diameter is 1.5mm, its outer diameter is 3.0mm, and the ratio of the inner diameter to the outer diameter is 50.0%. The material hardness of the third rod segment is 72D, its inner diameter is 3.0mm, its outer diameter is 6.02mm, and the ratio of the inner diameter to the outer diameter is 49.8%. The inner diameter of the catheter matched with the third dilator is 6.08mm, and there is a gap of 0.08mm between it and the first rod segment; there is a gap of 0.06mm between it and the third rod segment.
参照图3和图5，作为本发明中扩张器杆2的另一种实施方式，与传统扩张器结构相似，扩张器杆2分为外径尺寸相当的三段，包括远端的第一杆段201、近端的第三杆段203，以及连接第一杆段201和第三杆段203的中间段第二杆段202。第一杆段201、第二杆段202、第三杆段203的外径是相等的。参照图5，扩张器座1和扩张器杆2的近端连接组成扩张器。扩张器座1再与止血阀3通过锁扣结构相互固定，扩张器杆2穿过止血阀3和与止血阀3相连接的导管4，使扩张器安装于介入治疗设备中。Referring to Fig. 3 and Fig. 5, as another embodiment of the expander rod 2 in the present invention, similar to the traditional expander structure, the expander rod 2 is divided into three sections with equivalent outer diameters, including a first rod section 201 at the distal end, a third rod section 203 at the proximal end, and a second rod section 202 in the middle section connecting the first rod section 201 and the third rod section 203. The outer diameters of the first rod section 201, the second rod section 202, and the third rod section 203 are equal. Referring to Fig. 5, the expander seat 1 and the proximal end of the expander rod 2 are connected to form a expander. The expander seat 1 is then fixed to the hemostatic valve 3 by a locking structure, and the expander rod 2 passes through the hemostatic valve 3 and the catheter 4 connected to the hemostatic valve 3, so that the expander is installed in the interventional treatment device.
继续参照图3和图5，第一杆段201、第二杆段202与第三杆段203的外径尺寸相当。第一杆段201、第二杆段202和第三杆段203的外径大于或等于3mm，且第一杆段201外径与介入治疗设备的导管4之间具有0.076～0.36mm的间隙。扩张器杆2外径与导管4内径保留一定的间隙以确保扩张器在推送时相对顺畅，间隙大小需根据扩张器杆整体的软硬程度决定，扩张器杆软则间隙要大，反之则间隙要小。三段杆的内径为大于等于1mm。第一杆段201的远端为锥形尖端，其角度范围为10°～60°，锥形尖端的内孔角度范围与外径一致。锥形尖端内孔的最远端的孔径范围为0.88～1mm，作用是顺应导丝导向。Continuing to refer to Figures 3 and 5, the outer diameters of the first rod segment 201, the second rod segment 202 and the third rod segment 203 are comparable. The outer diameters of the first rod segment 201, the second rod segment 202 and the third rod segment 203 are greater than or equal to 3mm, and there is a gap of 0.076 to 0.36mm between the outer diameter of the first rod segment 201 and the catheter 4 of the interventional treatment device. A certain gap is reserved between the outer diameter of the dilator rod 2 and the inner diameter of the catheter 4 to ensure that the dilator is relatively smooth when pushing. The size of the gap needs to be determined according to the overall hardness of the dilator rod. If the dilator rod is soft, the gap should be large, otherwise the gap should be small. The inner diameter of the three-section rod is greater than or equal to 1mm. The distal end of the first rod segment 201 is a conical tip, and its angle range is 10° to 60°. The angle range of the inner hole of the conical tip is consistent with the outer diameter. The aperture range of the farthest end of the inner hole of the conical tip is 0.88 to 1mm, which is used to comply with the guide wire guidance.
第一杆段201和第二杆段202使用硬度相对低的材料，第三杆段203使用硬度相对高的材料。材料硬度的选择需根据内外径比例（壁厚）决定。当内外径比例较大（壁厚小）时，材料硬度可以相对提高，若比例较小（壁厚大）则材料硬度需要相对偏软，材料的选择也可以按照实际情况选用表1～表３的参数配置。The first rod segment 201 and the second rod segment 202 use materials with relatively low hardness, and the third rod segment 203 uses materials with relatively high hardness. The selection of material hardness needs to be determined according to the ratio of inner and outer diameters (wall thickness). When the ratio of inner and outer diameters is large (small wall thickness), the material hardness can be relatively increased. If the ratio is small (large wall thickness), the material hardness needs to be relatively soft. The material selection can also be selected according to the actual situation. The parameter configuration of Tables 1 to 3.
第一杆段201和第三杆段203均可以以PEBAX（聚醚嵌段聚酰胺）、TPU（热塑性聚氨酯弹性体橡胶）、LDPE（低密度聚乙烯）、HDPE（高密度聚乙烯）等软塑料为材料。管材通过挤出或注塑等工艺成型。第一杆段201的近端可以通过焊接、粘接或者热合等工艺与第二杆段202的远端相连。第三杆段203的近端通过粘接等工艺于具有锁扣机构的扩张器座1相连接。其他未提及的部分与第一实施例相同。The first rod segment 201 and the third rod segment 203 can be made of soft plastics such as PEBAX (polyether block polyamide), TPU (thermoplastic polyurethane elastomer rubber), LDPE (low-density polyethylene), HDPE (high-density polyethylene). The pipe is formed by extrusion or injection molding. The proximal end of the first rod segment 201 can be connected to the distal end of the second rod segment 202 by welding, bonding or heat sealing. The proximal end of the third rod segment 203 is connected to the expander seat 1 with a locking mechanism by bonding. Other parts not mentioned are the same as the first embodiment.
对比图2和图3可见，图2种三段式的杆部特征更有利于提高扩张器杆2的柔顺性。提高柔顺性的主要因素来自第二杆端202的设计结构。第二杆端202的柔软性大大提高了第一杆端201在行进过程中的灵活程度。经过多次实验测试，图2中第二杆端202的可通过的最小弯曲直径（10mm）远小于另两段杆的测得数据（20mm和30mm），所以因为壁厚和材料的选择使第二杆端202本身就具有较强的柔顺性。其次，在图2结构中，第一杆端201与第二杆端202外径间的段差设计使得第一杆端201在患者血管行进过程中有比图3结构中更大的摆动幅度。因此图2三段式的扩张系统较图3的二段式而言更能应付较为迂曲复杂的血管构造。这些不同的组合及其选择均属于本发明的保护范围内。Comparing FIG. 2 and FIG. 3 , it can be seen that the three-stage rod feature of FIG. 2 is more conducive to improving the flexibility of the dilator rod 2. The main factor for improving flexibility comes from the design structure of the second rod end 202. The softness of the second rod end 202 greatly improves the flexibility of the first rod end 201 during the process. After many experimental tests, the minimum bending diameter (10mm) that can be passed through the second rod end 202 in FIG. 2 is much smaller than the measured data (20mm and 30mm) of the other two sections of the rod, so because of the choice of wall thickness and material, the second rod end 202 itself has strong flexibility. Secondly, in the structure of FIG. 2, the step difference design between the outer diameters of the first rod end 201 and the second rod end 202 enables the first rod end 201 to have a larger swing amplitude than the structure of FIG. 3 during the patient's blood vessel. Therefore, the three-stage expansion system of FIG. 2 can better cope with more tortuous and complex vascular structures than the two-stage expansion system of FIG. 3. These different combinations and their selections are all within the scope of protection of the present invention.
参照图9～图12，扩张器座1安装并固定于第三杆段203的外表面。扩张器座1包括卡扣结构，卡扣结构将扩张器座1与介入治疗设备相固定。作为本发明的一种实施方式，卡扣结构为安装于扩张器座1的翼片，且沿扩张器杆2轴向延伸。扩张器座1的卡扣结构包括两个间隔180°的第一卡扣101和第二卡扣102，其中第一卡扣101的翼片末端包括朝向所述扩张器杆的中心轴线径向伸出的卡紧机构。9 to 12, the expander seat 1 is installed and fixed to the outer surface of the third rod segment 203. The expander seat 1 includes a buckle structure, which fixes the expander seat 1 to the interventional treatment device. As an embodiment of the present invention, the buckle structure is a wing installed on the expander seat 1 and extends axially along the expander rod 2. The buckle structure of the expander seat 1 includes two first buckles 101 and a second buckle 102 spaced 180° apart, wherein the end of the wing of the first buckle 101 includes a clamping mechanism that radially extends toward the central axis of the expander rod.
扩张器座1与止血阀3通过锁扣结构互相连接。卡扣结构可以是如图9和图10所示的单边结构，也可是如图11和图12所示的双边结构。参照图12，双边结构是同时包含第一卡扣101和第二卡扣102的卡扣结构，而单边结构则如图10所示只包含第一卡扣101，第二卡扣202的位置变为直边部103。The dilator seat 1 and the hemostatic valve 3 are connected to each other through a locking structure. The locking structure can be a unilateral structure as shown in Figures 9 and 10, or a bilateral structure as shown in Figures 11 and 12. Referring to Figure 12, the bilateral structure is a locking structure that includes both the first buckle 101 and the second buckle 102, while the unilateral structure only includes the first buckle 101 as shown in Figure 10, and the position of the second buckle 202 becomes the straight edge 103.
无论是单边还是双边结构，使用时均通过术者施加轴向力将扩张器座1的卡扣压入止血阀3的固定槽中进行固定，形成图9和图11所示卡紧后的工作状态。卡扣和固定槽之间过盈配合固定住导管4与扩张器的相对位置。为了保证过盈量能达到防止扩张器自主回撤的情况，单边卡扣的过盈量应适当大于双边卡扣过盈量。相较于传统扩张器，本发明的扩张器座1上下侧均有加强筋的结构，增加扩张器座1与手指的接触面积，防止因为扩张器座1较小、术中血液及生理盐水附着在器械表面等原因导致的摩擦力较小问题，影响医生术中拔出扩张器。Regardless of whether it is a unilateral or bilateral structure, when in use, the operator applies an axial force to press the buckle of the dilator seat 1 into the fixing groove of the hemostatic valve 3 for fixing, forming the clamped working state shown in Figures 9 and 11. The interference fit between the buckle and the fixing groove fixes the relative position of the catheter 4 and the dilator. In order to ensure that the interference can prevent the dilator from withdrawing autonomously, the interference of the unilateral buckle should be appropriately larger than the interference of the bilateral buckle. Compared with the traditional dilator, the dilator seat 1 of the present invention has a reinforcing rib structure on the upper and lower sides to increase the contact area between the dilator seat 1 and the finger, and prevent the problem of small friction caused by the small size of the dilator seat 1, blood and saline adhering to the surface of the instrument during surgery, etc., which affects the doctor's removal of the dilator during surgery.
参照图10，单边卡扣的目的是为了术者在手术中感受到一次卡扣和卡槽配合时的手感即可知道到扩张器已插入完毕。其优点在于使用方便快捷，所需施加的压力也相对较小。参照图12，双边卡扣的目的则是要让术者感受到两次的卡扣和卡槽配合时的手感，术者需要确认两侧卡扣都锁紧后再使用。其优点在于使用安全性较高，卡扣松动、或从止血阀3的卡槽中回撤的可能性较小。Referring to Figure 10, the purpose of the unilateral buckle is to allow the operator to feel the feel of the buckle and the slot fitting together once during the operation to know that the dilator has been inserted. Its advantage is that it is convenient and quick to use, and the pressure required to be applied is relatively small. Referring to Figure 12, the purpose of the bilateral buckle is to allow the operator to feel the feel of the buckle and the slot fitting together twice, and the operator needs to confirm that the buckles on both sides are locked before use. Its advantage is that it is safer to use, and the buckle is less likely to loosen or withdraw from the slot of the hemostatic valve 3.
扩张器座1主要以PC（聚碳酸酯塑料）、ABS（丙烯腈-丁二烯-苯乙烯塑料）、尼龙等塑料为材料。第三杆段203的近端通过粘接等工艺于具有锁扣机构的扩张器座1相连接。The expander seat 1 is mainly made of plastics such as PC (polycarbonate plastic), ABS (acrylonitrile-butadiene-styrene plastic), nylon, etc. The proximal end of the third rod segment 203 is connected to the expander seat 1 having a locking mechanism by bonding or other processes.
当本发明的扩张器参与手术过程时，具体使用步骤如下：When the expander of the present invention is used in a surgical procedure, the specific steps of use are as follows:
1.排空导管4；1. Empty the catheter 4;
2.排空扩张器杆2；2. Empty the expander rod 2;
3.将排空的扩张器插入排空的导管4，直到扩张器座1与止血阀3通过锁扣结构固定，组成扩张系统；3. Insert the emptied dilator into the emptied catheter 4 until the dilator seat 1 and the hemostatic valve 3 are fixed by the locking structure to form a dilation system;
4.扩张系统跟随导丝通过入路路径，直到导管4和扩张器到达患者体内病变部位的目标位置；4. The dilation system follows the guidewire through the access path until the catheter 4 and the dilator reach the target location of the lesion in the patient's body;
5.术后，将扩张器座1朝近端拔出，使其第一卡扣101和第二卡扣102与止血阀3过盈配合卡槽部分分离，向后缓慢拔出扩张器，直至扩张器完全抽出。至此，扩张器的整个使用过程完成。5. After the operation, the expander seat 1 is pulled out toward the proximal end, so that the first buckle 101 and the second buckle 102 are separated from the interference fit groove of the hemostatic valve 3, and the expander is slowly pulled out backwards until the expander is completely withdrawn. At this point, the entire use process of the expander is completed.
综上所述，本发明的扩张器具有以下有益效果：In summary, the expander of the present invention has the following beneficial effects:
1. 优化了扩张器的柔顺性和输送效率。通过改善传统介入设备的扩张器杆2的结构和材料，更好地将大口径的导管/鞘输送至患者体内更远更迂曲的病变位置；1. Optimized the flexibility and delivery efficiency of the dilator. By improving the structure and material of the dilator rod 2 of the traditional interventional device, the large-caliber catheter/sheath can be better delivered to the farther and more tortuous lesion location in the patient's body;
2. 提高了介入治疗设备的安全性。确保扩张器杆2在患者体内过弯时，导管系统不会因为扩张器杆部过硬而难以推进，避免由于扩张器杆2的过弯能力差导致导管系统发生折弯，从而引发患者体内血管的损伤；2. Improves the safety of interventional treatment equipment. Ensures that when the dilator rod 2 bends in the patient's body, the catheter system will not be difficult to advance due to the dilator rod being too hard, and avoids the catheter system from bending due to the poor bending ability of the dilator rod 2, thereby causing damage to the patient's blood vessels;
3. 扩张器座1的锁扣机构提高了导管输送位置的准确性。锁扣机构与止血阀3间的过盈配合保证了扩张器与导管4在输送过程中的相对位置始终不变。3. The locking mechanism of the dilator seat 1 improves the accuracy of the catheter delivery position. The interference fit between the locking mechanism and the hemostatic valve 3 ensures that the relative position of the dilator and the catheter 4 remains unchanged during the delivery process.
本说明书使用了特定词语来描述本说明书的实施例。如“一个实施例”和/或“一些实施例”意指与本说明书至少一个实施例相关的某一特征、结构或特点。因此，应强调并注意的是，本说明书中在不同位置两次或多次提及的“一实施例”或“一个实施例”“或一个替代性实施例”并不一定是指同一实施例。此外，本说明书的一个或多个实施例中的某些特征、结构或特点可以进行适当的组合。This specification uses specific words to describe the embodiments of this specification. For example, "one embodiment" and/or "some embodiments" refer to a certain feature, structure or characteristic related to at least one embodiment of this specification. Therefore, it should be emphasized and noted that "one embodiment" or "an embodiment" or "an alternative embodiment" mentioned twice or more in different locations in this specification does not necessarily refer to the same embodiment. In addition, certain features, structures or characteristics in one or more embodiments of this specification can be appropriately combined.
本技术领域中的普通技术人员应当认识到，以上的实施例仅是用来说明本发明，而并非用作为对本发明的限定，只要在本发明的实质精神范围内，对以上所述实施例的变化、变型都将落在本发明的权利要求书范围内。Those skilled in the art should recognize that the above embodiments are only used to illustrate the present invention, and are not intended to limit the present invention. As long as they are within the spirit of the present invention, any changes or modifications to the above embodiments will fall within the scope of the claims of the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211576730.7ACN115737010B (en) | 2022-12-09 | 2022-12-09 | A dilator for interventional therapy equipment |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211576730.7ACN115737010B (en) | 2022-12-09 | 2022-12-09 | A dilator for interventional therapy equipment |
| Publication Number | Publication Date |
|---|---|
| CN115737010A CN115737010A (en) | 2023-03-07 |
| CN115737010Btrue CN115737010B (en) | 2024-04-19 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202211576730.7AActiveCN115737010B (en) | 2022-12-09 | 2022-12-09 | A dilator for interventional therapy equipment |
| Country | Link |
|---|---|
| CN (1) | CN115737010B (en) |
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| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right | Denomination of invention:A dilator for interventional therapy equipment Granted publication date:20240419 Pledgee:Shanghai Rural Commercial Bank Co.,Ltd. Putuo Sub branch Pledgor:Shanghai Hengchang Medical Technology Co.,Ltd. Registration number:Y2025310000292 |