WO2020125028A1 - 一种用于穿刺器的密封件及穿刺器 - Google Patents
一种用于穿刺器的密封件及穿刺器 Download PDFInfo
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- WO2020125028A1 WO2020125028A1 PCT/CN2019/100326 CN2019100326W WO2020125028A1 WO 2020125028 A1 WO2020125028 A1 WO 2020125028A1 CN 2019100326 W CN2019100326 W CN 2019100326W WO 2020125028 A1 WO2020125028 A1 WO 2020125028A1
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- deformable body
- hole
- seal
- puncture device
- air
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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
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
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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
- A61B17/34—Trocars; Puncturing needles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3498—Valves therefor, e.g. flapper valves, slide valves
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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
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B2017/3419—Sealing means between cannula and body
Definitions
- the invention relates to the field of medical instruments, in particular to a seal and a puncture device for a puncture device.
- Disposable puncture device is an important instrument in laparoscopic surgery. It is a matching surgical instrument for thoracic cavity and laparoscopic surgery. It is suitable for thoracic cavity and laparoscopic surgery and an instrument for establishing a working channel for thoracic cavity and abdominal cavity during surgery .
- the minimally invasive surgical methods represented by laparoscopic surgery have developed rapidly in recent years, especially in gynecology, general surgery and other operations involving the abdominal cavity, are gradually changing from open to intracavity Minimally invasive surgery.
- 2 to 5 puncture holes are generally used. One is used to place the laparoscope, and the remaining holes are used to place surgical instruments.
- the outer diameter of the surgical instruments is roughly divided into 5mm, 10mm, 12mm, and 15mm.
- a matching inner diameter puncture cannula is provided to avoid leakage of pneumoperitoneum and affect the operation.
- a surgery usually requires a variety of surgical instruments, and they are used alternately during the operation.
- a variety of surgical instruments are used on a puncture cannula, resulting in leaky pneumoperitoneum.
- the surgical instruments It is active, and the commonly used duckbill seal structure is difficult to obtain a good sealing effect, and because the duckbill structure is unidirectional, it is difficult to remove the tissue excisions in the reverse operation, which makes the operation difficult and causes pain to the patient.
- the main purpose of the present invention is to overcome the shortcomings of the prior art, and discloses a seal for a puncture device, which is characterized by including a deformable body made of a flexible material, A gas inlet and outlet channel is provided on the deformable body, and a through hole is provided on the deformable body, and the center of the through hole is on the same straight line as the central axis of the puncture sleeve; when air is introduced, the deformable body expands, causing the The through hole shrinks; when venting, the deformed body contracts and the through hole expands.
- the deformable body is provided separately and is composed of at least two parts.
- the deformable body has a ring shape, and the through hole is provided at the center of the deformable body.
- the flexible material is rubber or fabric with a sealing layer.
- a guide frame for restricting and guiding expansion of the deformable body toward the center of the through hole is provided around the deformable body.
- the guide frame includes a support plate and a guide plate, the guide plate is fixed on the support plate, and the cross section is in a “concave” shape.
- a plurality of positioning posts are provided on the contact surface of the guide plate and the support plate, and positioning holes matching the positioning posts are provided at corresponding positions of the support plate.
- a fixing edge is provided on the periphery of the deformable body, and the deformable body is fixed to the guide frame through the fixing edge.
- a puncture device includes the above-mentioned seal, and further includes an air inlet channel, and the gas inlet and outlet channels of the deformable body are respectively communicated with the air inlet channel and the outside through a valve.
- a puncture device includes the above-mentioned seal, and further includes an air intake channel and a smoke exhaust channel.
- the gas inlet and outlet channels of the deformable body communicate with the puncture air intake channel and the smoke exhaust channel through a valve, respectively.
- the deformable body sealing structure of the sealing member of the invention is extremelyly designed, suitable for surgical instruments of different sizes, and has reliable sealing performance and safe clinical use of the product.
- it is used in conjunction with the guide frame to ensure that the deformable body expands toward the center of the through hole, so that the deformable body closely fits the surgical instrument, which greatly improves the sealing performance.
- the hole is contracted until it is sealed, and the through hole can also be expanded to facilitate the replacement of surgical instruments and the removal of surgical residues.
- FIG. 1 is a schematic structural view of a seal for a puncture device of the present invention
- Figure 2 is a schematic diagram of the installation of seals
- Figure 3 is the installation diagram of the guide frame
- Figure 4 is a top view of the guide frame
- FIG. 5 is a cross-sectional view of B-B in FIG. 4;
- FIG. 6 is a schematic structural view of a puncture device
- FIG. 7 is a schematic diagram of the structure of the deformable body connected to the valve
- FIG. 8 is a schematic diagram of the connection of the deformable body of an embodiment
- FIG. 9 is a schematic diagram of a deformable body connection according to another embodiment.
- FIG. 10 is a schematic structural view of another deformable body
- a seal for a puncture device includes a deformable body made of a flexible material, a gas inlet and outlet channel 1 is provided on the deformable body, and the gas inlet and outlet channel includes an air inlet and an exhaust Port, which expands or contracts by inflating or exhausting the deformable body; the intake and exhaust ports can be opened and closed by valves, thereby achieving the intake and exhaust functions.
- the air hole can be provided on the deformable body, the air hole is compatible with the intake and exhaust functions, and the air hole is connected with two valves (intake valve 11 and exhaust valve 12), as shown in FIG. 7
- the gas inlet and outlet channels 1 are connected to the intake valve 11 and the exhaust valve 12, respectively, and the intake and exhaust functions are realized through valve control.
- the deformation body is provided with a through hole 3 through which surgical instruments enter the abdominal cavity.
- the center of the through hole 3 and the central axis of the puncture sleeve 4 are on the same line; when the air inlet is opened, the gas enters the deformable body, the deformable body expands, the through hole is reduced, and the surgical instrument is wrapped to achieve the sealing function; if the through hole No surgical instruments are placed in the 3, the deformable body is inflated and the through hole 3 is contracted until it is closed.
- the deformed body contracts and the through hole 3 expands, so that the surgical instrument can be easily taken out; in addition, the body gas in the deformed body is evacuated through the exhaust port Since the deformable body is made of a flexible material, the through hole 3 expands toward the periphery of the deformable body, and the diameter of the through hole 3 is opened to the maximum, which does not affect the placement and removal of surgical instruments.
- the cross section of the deformed body is a symmetrical vertebral structure. Conducive to the contraction of the through hole 3.
- the deformable body is arranged separately and is composed of at least two parts.
- the deformable body is formed by joining two parts; this can improve the tightness of the through hole 3.
- the deformable body is infinitely divided into several parts around the center of the through hole 3, it can be imagined that when each part is inflated, each part expands toward the center of the circle, and a better sealing effect can be achieved.
- the cross-section of the deformable body 31 is a vertebral structure, because the deformable body is composed of two parts, and the connecting seam is equivalent to the through hole 311 through which the surgical instrument passes. Can meet the sealing effect.
- the deformable body has a ring shape, and the through hole 3 is provided in the center of the deformable body.
- the deformable body and the through-hole 3 are concentric circles to ensure that the deformable body is uniformly stressed when inflated, to avoid excessive expansion at some positions, and to deform and deform the deformable body, which affects the tightness of the through-hole 3.
- the flexible material may be one of rubber, plastic, thermoplastic elastomer, and fabric with a sealing layer, wherein the rubber is a highly elastic polymer compound, has elasticity, and has good sealing performance, when inflated When inflated, it can closely fit with surgical instruments.
- the flexible material can also be a fabric with a sealing layer.
- a guide frame 5 for restricting and guiding expansion of the deformable body toward the center of the through hole 3 is provided around the deformable body.
- the guide frame 5 includes a guide plate 51 and a support plate 52.
- the guide plate 51 is mounted on the support plate 52 and has a "concave" shape in cross section.
- the deformable body is provided between the guide plate 51 and the support plate 52, that is, the " In the concave-shaped groove, the deformation body is restricted from expanding upward and downward, so that it expands and deforms toward the center of the through hole 3.
- a plurality of positioning posts 511 are provided on the contact surface of the guide plate 51 and the support plate 52, and positioning holes 521 matching the fixed position 511 are provided at corresponding positions of the support plate 52.
- the plate 52 can be firmly connected together, and the positioning hole 521 and the positioning post 511 have an interference fit.
- the positioning post 511 protrudes from the positioning hole 521 to fix the protruding part with the piercer. It is possible to avoid setting more installation parts.
- a fixed edge 6 is provided on the periphery of the deformable body, and the fixed edge 6 is fixed to the guide frame 5 to prevent the deformable body from shifting and affecting the sealing effect of the through hole 3.
- a fixing hole 61 corresponding to the positioning post 511 can be provided on the positioning edge 6.
- the present invention also discloses a puncture device, as shown in FIGS. 6 and 8, which includes the seal in the above embodiment, and further includes an air inlet channel 7 through which gas is inflated into the abdominal cavity to form an insufflation
- the seal is provided in the puncture device, and the intake port of the deformable body is connected or disconnected with the intake channel 7 through the valve.
- the air outlet is directly discharged through the valve. When the valve of the air outlet is closed, the valve of the air inlet is opened, and the deformable body is inflated by means of the gas in the air inlet channel 7 to expand and deform the deformable body.
- the valve of the air outlet When the valve of the air outlet is opened and the valve of the air inlet is closed, the gas in the deformed body is directly discharged into the operating room, and the through hole 3 expands.
- the deformed body is controlled by the gas filled by the pneumoperitoneum, and no external gas source is needed, so that the structure is simple and the cost is reduced.
- the present invention also discloses another puncture device, as shown in FIGS. 2 and 9, which includes the seal of the above embodiment, and further includes an air intake channel 7 and a smoke exhaust channel 8.
- the gas is inflated into the abdominal cavity through the air intake channel 7.
- the pneumoperitoneum is formed, and then the smoke and water vapor generated during the operation of the 8 pairs of surgical procedures are discharged out of the abdominal cavity.
- the seal is provided in the puncture device, and the air inlet of the deformable body is controlled by the valve to communicate or disconnect with the air inlet channel 7, and the air outlet of the deformable body is controlled by the valve to communicate or disconnect with the smoke exhaust channel 8.
- the valve of the air outlet When the valve of the air outlet is closed, the valve of the air inlet is opened, and the deformable body is inflated by means of the gas in the air inlet channel 7 to expand and deform the deformable body.
- the valve of the air outlet When the valve of the air outlet is opened and the valve of the air inlet is closed, the deformable body is exhausted, and the through hole 3 expands. Through the negative pressure of the smoke exhaust channel, the gas in the deformable body can be quickly discharged.
- the through hole 3 expands to the periphery of the deformed body, and the diameter of the through hole 3 is opened to the maximum, which does not affect the placement and removal of surgical instruments.
- the deformation body is controlled by using the intake passage 7 and the smoke exhaust passage 8 in conjunction with a valve, and the deformation body can be controlled without external equipment, which makes the structure simple and reduces the cost.
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Abstract
一种用于穿刺器的密封件及穿刺器，包括由柔性材料制成的变形体，变形体上设置气体进出通道（1），并且变形体上设置通孔（3），通孔（3）的圆心与穿刺套管（4）的中心轴在同一直线上；当进气时，变形体膨胀，使通孔（3）缩小；当排气时，变形体收缩，通孔（3）扩张。配合导向框（5）使用，保证变形体向通孔（3）的圆心膨胀，使变形体与手术器械紧密贴合，进而极大的提高了密封性；通过气体进出通道（1），控制变形体内部气体，能够将通孔（3）收缩至密封，也可以将通孔（3）扩张，方便手术器具的更换。密封件的变形体密封结构设计精巧，适用于不同尺寸的手术器械，而且密封性能可靠，产品临床使用安全。
Description
本发明涉及医用器械领域，特别涉及一种用于穿刺器的密封件及穿刺器。
一次性使用穿刺器是腹腔镜手术中重要的器械，它是一种胸外、腹外腔镜配套手术器械，适用于胸腔、腹腔腔镜检查和手术过程中建立胸腔、腹腔手术工作通道的器械。随着影像技术和摄像技术的发展，以腹腔镜手术为代表的微创手术方法在最近几年迅速发展，尤其在妇科、普外科等涉及腹腔内的手术，正在逐步由开放式转变为腔内微创手术。腹腔镜手术中，一般采用的是2～5个穿刺孔，一个放置腹腔镜，其余的孔用于放置手术器械，手术器械以外径大概分为5mm、10mm、12mm、15mm等在使用过程中需要配套相适应的内径穿刺套管，以避免气腹漏气，影响手术进行。
在临床上，一台手术通常需要多种规格的手术器械，并在手术过程中交替使用，在一个穿刺套管上使用多种规格的手术器械，导致气腹漏气，同时手术中，手术器械是活动的，常用的鸭嘴密封结构很难取得良好的密封效果，并且由于鸭嘴结构是单向结构的，在操作时很难反向取出组织切除物，造成手术困难，给病人造成痛苦。
发明内容
针对以上现有技术存在的缺陷，本发明的主要目的在于克服现有技术的不足之处，公开了一种用于穿刺器的密封件，其特征在于，包括由柔性材料制成的变形体，所述变形体上设置气体进出通道，并且所述变形体上设置通孔，所述通孔的圆心与穿刺套管的中心轴在同一直线上；当进气时， 变形体膨胀，使所述通孔缩小；当排气时，变形体收缩，所述通孔扩张。
进一步地，所述变形体分体设置，通过至少两部分组成。
进一步地，所述变形体呈环形，并且所述通孔设置在所述变形体的中心。
进一步地，所述柔性材料为橡胶或者带有密封层的织物。
进一步地，所述变形体周边设置用于限制和引导所述变形体向所述通孔中心膨胀的导向框。
进一步地，所述导向框包括支撑板和导向板，所述导向板固定在所述支撑板上，且截面为“凹”字形。
进一步地，所述导向板与所述支撑板的接触面设置若干个定位柱，并且在所述支撑板的对应位置设置与所述定位柱匹配的定位孔。
进一步地，所述变形体的周边设置固定边，通过所述固定边将所述变形体与所述导向框固定。
一种穿刺器，包括上述的密封件，还包括进气通道，所述变形体的所述气体进出通道通过阀门分别与所述进气通道和外界连通。
一种穿刺器，包括上述的密封件，还包括进气通道和排烟通道，所述变形体的所述气体进出通道通过阀门分别与所述穿刺器进气通道和所述排烟通道连通。
本发明取得的有益效果：
本发明的密封件的变形体密封结构设计精巧，适用于不同尺寸的手术器械，而且密封性能可靠，产品临床使用安全。另外，配合导向框使用，保证变形体向通孔的圆心膨胀，使变形体与手术器械紧密贴合，进而极大的提高了密封性；通过气体进出通道，控制变形体内部气体，能够将通孔收缩至密封，也可以将通孔扩张，方便手术器具的更换和取出手术残留物。
图1为本发明的一种用于穿刺器的密封件的结构示意图；
图2为密封件的安装示意图；
图3为导向框的安装示意图；
图4为导向框的俯视图；
图5为图4中B-B的剖视图；
图6为一种穿刺器的结构示意图；
图7为变形体连接阀门的结构示意图；
图8为一实施例的变形体连接示意图；
图9为另一实施例的变形体连接示意图；
图10为另一中变形体的结构示意图；
附图标记如下：
1、气体进出通道，3、通孔，4、穿刺套管，5、导向框，6、固定变，7、进气通道，8、排烟通道，11、进气阀门，12、排气阀门，51、导向板，52、支撑板，61、固定孔，511、定位柱，521、定位孔。
为了使本发明的目的、技术方案及优点更加清楚明白，下面结合附图及实施例对本发明作进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本发明，并不用于限定本发明。
本发明的一种用于穿刺器的密封件，如图1-2所示，包括由柔性材料制成的变形体，变形体上设置气体进出通道1，气体进出通道包括进气口和排气口，通过对变形体充气或者排气使其膨胀或者收缩；进气口和排气口能够通过阀门实现打开和关闭，进而实现进气和排气功能。当然，能够容易理解的，在变形体上可以仅设置一个气孔，该气孔兼容进气和排气功能，该气孔外接两个阀门(进气阀门11和排气阀门12)，如图7所示，气体进出通道1分别接进气阀门11和排气阀门12，通过阀门控制，实现进气和排气功能。
变形体上设置通孔3，手术器械通过该通孔3进入腹腔内。通孔3的 圆心与穿刺套管4的中心轴在同一直线上；当进气口打开，气体进入变形体内，变形体膨胀，使通孔缩小，将手术器械包裹，实现密封功能；如果通孔3内没有放置手术器械，变形体内部充气膨胀，通孔3收缩直至关闭。当关闭进气口，打开排气口，将变形体内部的气体排出时，变形体收缩，通孔3扩张，使手术器械能够方便取出；另外，通过排气口对变形体内体气体进行抽气，由于变形体由柔性材料制成，通孔3向变形体的周边扩张，将通孔3的直径打开至最大，不会影响手术器械的放置和取出。变形体的截面为对称设置的椎状结构。有利于通孔3的收缩。
在一实施例中，变形体分体设置，通过至少两部分组成。通过两部分拼接组成变形体；这样能够提高通孔3的密封性。当将变形体围绕通孔3的中心向四周无限分割成若干个部分，可以想到，当对各部分充气时，各部分均向圆心膨胀，能够达到更好的密封效果。如图10所示，变形体31的截面为椎状结构，因为变形体通过两部分组成，其连接缝处相当于使手术器械通过的通孔311，因此，不需要额外设置通孔311，也能满足密封的效果。
在一实施例中，变形体呈环形，并且通孔3设置在变形体的中心。这样，变形体与通孔3为同心圆，保证变形体在充气时受力均匀，避免发生部分位置过度膨胀，使变形体膨胀畸形，影响通孔3的密封性。
在一实施例中，柔性材料可以为橡胶、塑料、热塑性弹性体和带密封层的织物中的一种，其中，橡胶是高弹性高分子化合物，具有弹性，并且有良好的密封性，当充气膨胀时，能够与手术器械紧密贴合。当然，柔性材料还可以是带有密封层的织物。
在一实施例中，如图3-5所示，为了防止变形体在充气膨胀时向上下两个方向膨胀，造成气体的浪费，而且变形体的变形效率低，挤压力分散，通孔3的密封效果大大降低。因此，变形体周边设置用于限制和引导变形体向通孔3中心膨胀的导向框5。其中，导向框5包括导向板51和支撑板52，导向板51安装在支撑板52上，并且截面为“凹”字形，变形体设置在导向板51和支撑板52之间，即设置在“凹”字形的凹槽内，限制变形 体向上方和下方膨胀，使其向通孔3的中心膨胀变形。在一具体实施例中，导向板51与支撑板52的接触面设置若干个定位柱511，并且在支撑板52的对应位置设置与定位置511匹配的定位孔521，为了使导向板51和支撑板52能够牢固的连接在一起，定位孔521与定位柱511过盈配合；另外，为了方便导向框5安装在穿刺器内，将定位柱511突出定位孔521，使突出部分与穿刺器固定，能够避免设置更多的安装部件。
在上述实施例中的基础上，变形体的周边设置固定边6，通过固定边6与导向框5固定，防止变形体发生移位，影响通孔3的密封效果。优选的，在定位边6上能够设置与定位柱511对应的固定孔61。
为了使密封件的密封效果更好，可以叠加设置多个变形体。通常平行设置两个变形体。
本发明还公开了一种穿刺器，如图6和8所示，包括上述实施例中的密封件，还包括进气通道7，气体通过进气通道7向腹腔进行充气，使之形成气腹；密封件设置在穿刺器内，通过阀门控制变形体的进气口与进气通道7连通或者断开。出气口通过阀门直接排放。当关闭出气口的阀门，打开进气口的阀门，借助进气通道7内的气体对变形体进行充气，使变形体膨胀变形。当打开出气口的阀门，关闭进气口的阀门，变形体内的气体直接排到手术室内，通孔3扩张。借助气腹填充的气体对变形体进行控制，无需外接气源，使结构简单，降低成本。
本发明还公开了另一种穿刺器，如图2和9所示，包括上述实施例的密封件，还包括进气通道7和排烟通道8，气体通过进气通道7向腹腔进行充气，使之形成气腹，然后通过排烟通到8对手术过程中产生的烟雾和水蒸气排出腹腔。密封件设置在穿刺器内，通过阀门控制变形体的进气口与进气通道7连通或者断开，并且通过阀门控制变形体的排气口与排烟通道8连通或者断开。当关闭出气口的阀门，打开进气口的阀门，借助进气通道7内的气体对变形体进行充气，使变形体膨胀变形。当打开出气口的阀门，关闭进气口的阀门，变形体排气，通孔3扩张。通过排烟通道的负压，能够很快的排出变形体内的气体，通孔3向变形体的周边扩张，将通 孔3的直径打开至最大，不会影响手术器械的放置和取出。借助进气通道7和排烟通道8配合阀门对变形体进行控制，无需外接设备，就能实现对变形体的控制，使结构简单，降低成本。
以上仅为本发明的较佳实施例，并非用来限定本发明的实施范围；如果不脱离本发明的精神和范围，对本发明进行修改或者等同替换，均应涵盖在本发明权利要求的保护范围当中。
Claims (10)
- 一种用于穿刺器的密封件，其特征在于，包括由柔性材料制成的变形体，所述变形体上设置气体进出通道，并且所述变形体上设置通孔，所述通孔的圆心与穿刺套管的中心轴在同一直线上；当进气时，变形体膨胀，使所述通孔缩小；当排气时，变形体收缩，所述通孔扩张。
- 根据权利要求1所述的一种用于穿刺器的密封件，其特征在于，所述变形体分体设置，通过至少两部分组成。
- 根据权利要求1所述的一种用于穿刺器的密封件，其特征在于，所述变形体呈环形，并且所述通孔设置在所述变形体的中心。
- 根据权利要求1所述的一种用于穿刺器的密封件，其特征在于，所述柔性材料为橡胶、塑料、热塑性弹性体和带密封层的织物中的一种。
- 根据权利要求1所述的一种用于穿刺器的密封件，其特征在于，所述变形体周边设置用于限制和引导所述变形体向所述通孔中心膨胀的导向框。
- 根据权利要求5所述的一种用于穿刺器的密封件，其特征在于，所述导向框包括支撑板和导向板，所述导向板固定在所述支撑板上，且截面为“凹”字形。
- 根据权利要求6所述的一种用于穿刺器的密封件，其特征在于，所述导向板与所述支撑板的接触面设置若干个定位柱，并且在所述支撑板的对应位置设置与所述定位柱匹配的定位孔。
- 根据权利要求5所述的一种用于穿刺器的密封件，其特征在于，所述变形体的周边设置固定边，通过所述固定边将所述变形体与所述导向框固定。
- 一种穿刺器，其特征在于，包括权利要求1-8任一所述的一种用于穿刺器的密封件，还包括进气通道，所述变形体的所述气体进出通道通过阀门分别与所述进气通道和外界连通。
- 一种穿刺器，其特征在于，包括权利要求1-8任一所述的一种用于穿刺器的密封件，还包括进气通道和排烟通道，所述变形体的所述气体进出通道通过阀门分别与所述进气通道和所述排烟通道连通。
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