WO2020125030A1 - 一种腹腔镜外科手术用气体灌注和再循环系统 - Google Patents

一种腹腔镜外科手术用气体灌注和再循环系统 Download PDF

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Publication number
WO2020125030A1
WO2020125030A1 PCT/CN2019/100444 CN2019100444W WO2020125030A1 WO 2020125030 A1 WO2020125030 A1 WO 2020125030A1 CN 2019100444 W CN2019100444 W CN 2019100444W WO 2020125030 A1 WO2020125030 A1 WO 2020125030A1
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WIPO (PCT)
Prior art keywords
gas
deformable body
air
recirculation system
laparoscopic surgery
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PCT/CN2019/100444
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English (en)
French (fr)
Inventor
朱健
刘国宁
高俊
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江苏人冠医疗科技有限公司
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Publication of WO2020125030A1 publication Critical patent/WO2020125030A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/03—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs

Definitions

  • the invention relates to the field of medical equipment, in particular to a gas perfusion and recirculation system for laparoscopic surgery.
  • the pneumoperitoneum machine is required to provide air pressure and expand the inner cavity to provide a suitable surgical space. And the surgical field of view, the instability of air pressure will bring about the displacement of soft tissue with the change of air pressure, affecting the doctor's judgment on the precise location of the surgical site.
  • the intra-abdominal pressure at the start of inflation is lower than the set value.
  • the inflation valve in the machine opens to inflate the abdominal cavity at the set flow rate. When the pressure in the abdominal cavity reaches the set value, the inflation valve closes and inflation stops.
  • the electrocautery in the puncture device will inevitably produce a large amount of smoke and water vapor when burning or electrocoagulating human tissue.
  • the smoke generated by the burning of this organic matter is a strong carcinogen and will cause surgery.
  • the medical staff in the operating room cause unnecessary injuries, and when performing deep surgery on the human body, especially when scorching deep blood vessels and other important organs, the smoke will blur the electron microscope inside, affecting the sight of the medical staff, causing difficulty in hemostasis , Even causing blindness or hesitation in the operation, so a smoke removal device is needed to ensure the smooth operation of the operation.
  • the current situation of removing smoke in the operating room : 1).
  • the traditional method is to open the exhaust valve of the puncture sleeve to directly remove smoke until the vision is clear and then close the valve. If the valve is not closed in time, the pneumoperitoneum pressure will be reduced. The valve must be closed and the pneumoperitoneum pressure will rise again before continuing the operation, breaking the continuity of the operation.
  • the laparoscopic chimney effect causes airflow to flow from the laparoscopic puncture sleeve to the operating room staff, and is directly discharged into the operating room, causing physical harm to the operating room staff and environmental pollution.
  • the self-controllable suction device can be used to continuously suck smoke, but harmful surgical smoke will be discharged into the operating room or suction negative pressure suction pump without harmless treatment, causing equipment pollution.
  • carbon dioxide needs to be continuously filled during the operation to maintain the pelvic repulsion, which increases the amount of carbon dioxide used and the risk of patient absorption.
  • the main purpose of the present invention is to overcome the shortcomings of the prior art, and discloses a gas perfusion and recirculation system for laparoscopic surgery, which is characterized by including an air pump and a gas injection device , A first piercer, a second piercer, a filter, and a control module that controls the gas injection device, the air pump, and the pressure sensor.
  • the first piercer includes an air intake channel and a smoke exhaust channel.
  • the gas pipeline communicates the gas injection device with the intake channel, and the air pump communicates with the smoke exhaust channel through the exhaust pipeline, the filter is provided on the exhaust pipeline, and the air pump It is configured to inject the gas of the smoke exhaust channel into the gas injection device, and connect the pressure sensor with the second puncture device through a pressure measuring pipeline.
  • the filter is provided on the pressure measurement pipeline.
  • the filter is provided on the air intake line.
  • a seal for opening and closing the surgical channel of the first piercer is also included.
  • the seal includes 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, the center of the through hole and the central axis of the puncture sleeve On the same straight line; when intake air, the deformable body expands to shrink the through hole; when exhaust air, the deformable body shrinks 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 one of rubber, plastic, thermoplastic elastomer and 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.
  • 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.
  • the present invention detects the air pressure in the abdominal cavity in real time through the pressure sensor, and the gas injection device can accurately control the gas entering the operation cavity in real time and keep the pressure in the operation cavity stable. Due to the real-time suction of the gas pump, the smoke in the operating cavity can be discharged in a timely, rapid and efficient manner, thereby ensuring the continuity and efficiency of the operation. Because the air pump circulates the gas, the risk of physical harm and environmental pollution for the operating room staff is reduced.
  • the adaptability is strong, the through hole can be adjusted according to the size of the surgical instrument, and the sealing performance is reliable, and the product is safe for clinical use.
  • the guide frame 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 tightness; through the gas inlet and outlet channels, the gas inside the deformable body is controlled to pass the 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 tissue excisions.
  • FIG. 1 is a schematic diagram of a gas perfusion and recirculation system for laparoscopic surgery of the present invention
  • FIG. 2 is a perspective view of a puncture device of the present invention
  • Figure 3 is a plan view of the structure of the sheath assembly
  • Figure 4 is a right side view of the sheath assembly
  • FIG. 5 is a cross-sectional view of L-L in FIG. 4;
  • FIG. 6 is a cross-sectional view of B-B in FIG. 3;
  • FIG. 7 is a cross-sectional view of C-C in FIG. 3;
  • Figure 10 is a schematic diagram of the installation of the guide frame
  • Figure 11 is a top view of the guide frame
  • FIG. 12 is a cross-sectional view of B-B in FIG. 11;
  • FIG. 13 is a schematic structural view of another deformable body
  • FIG. 16 is a cross-sectional view of P-P in FIG. 4;
  • Puncture rod 2. Sheath tube assembly, 3. Seal, 6, filter, 7, first piercer, 8, second piercer, 9, control module, 21, outer tube, 22, inner tube, 23.
  • a gas perfusion and recirculation system for laparoscopic surgery of the present invention includes an air pump, a gas injection device, a first puncture device, a second puncture device, a filter, and a control gas injection device, an air pump and
  • the control module 9 of the pressure sensor, the first piercer 7 includes an air intake channel 24 and a smoke exhaust channel 23, a gas injection device is connected to the air intake channel 24 through an air intake line 51, and an air pump and smoke exhaust are connected through an exhaust line 52
  • the channel 23 is connected, and the exhaust line 52 is provided with a filter 6 for filtering the gas sucked inside the abdominal cavity, and the filtered gas is reinjected into the gas injection device through the air pump, and the gas is recharged through the gas injection device Abdominal cavity.
  • the pressure sensor is connected to the second piercer through the pressure measuring line 53 8.
  • the pressure sensor measures the pressure in the abdominal cavity through the pressure measuring line 53 in real time, and feeds back the data to the control module 9.
  • the control module 9 controls the gas injection device to increase the gas injection amount; otherwise, Then reduce the amount of gas injection. Achieve stable air pressure in the abdominal cavity.
  • a filter device is provided on the intake line 51 to prevent the impurities from entering the abdominal cavity and causing secondary injury to the human body.
  • a filter is provided on the pressure measuring line 53, and the pressure is measured after filtering the gas. Simultaneously performing pressure measurement and inflation can measure the air pressure in the abdominal cavity in real time, and can reduce the influence of the inflation end on the measurement data of the pressure sensor.
  • the existing measuring equipment performs inflation and pressure measurement on a periodic basis, and cannot obtain the real-time pressure in the abdominal cavity.
  • the gas injection equipment has a large fluctuation in the control of the gas injection volume, and the abdominal cavity will be large. It will be small for a while, which is not conducive to the operation of the operation; in addition, excessive inflation may cause harm to the human body again.
  • the control module 9 includes an operation display module, an operation control module and a main control module, sets a preset pressure through the display module, and displays the real-time pressure value in the abdominal cavity.
  • the pressure sensor transmits the detected data to the main control module.
  • the main control module transmits a signal to the operation control module, and the operation control module controls the gas injection device to increase the gas injection amount. On the contrary, the gas injection amount is reduced.
  • the puncture device includes a surgical channel, a smoke exhaust channel 23, and an air intake channel 24.
  • the puncture device includes a puncture rod 1 for creating a penetration port and a sheath tube assembly 2 sleeved outside the puncture rod 1 as a surgical channel.
  • the sheath tube assembly 2 includes an external The tube 21 and the inner tube 22, the outer tube 21 is sleeved with the outer side of the inner tube 22, and the thin ends of the outer tube 21 and the inner tube 22 are connected together to form an interlayer; it is conceivable that in order to make the sheath tube assembly 2 convenient Inserted into the abdominal cavity, the thin end of the outer tube 21 gradually gathers from the top to the center.
  • the head of the outer tube 21 is also provided with an exhaust port 211 for exhaust.
  • a smoke exhaust channel 23 is provided in the interlayer, and an opening 221 is provided at the thin end of the inner tube 22, and the exhaust port 211 is communicated with the opening 221 through the smoke exhaust channel.
  • the interlayer can be directly used as the smoke exhaust channel 23 to connect the exhaust port 211 and the buckle 221; a pipeline can also be additionally provided as the smoke exhaust channel 23 in the interlayer, and the interlayer can be used as the protective sleeve of the pipeline.
  • it further includes an air inlet 212 and an air inlet channel 24.
  • the air inlet 212 is provided at the head of the outer tube 21, and an air outlet 213 is provided at the thin end of the outer tube 21.
  • the port 212 communicates with the air outlet 213; that is, the gas enters the air intake passage 24 through the air inlet 212, and then is discharged from the air outlet 213.
  • the air outlet 213 is of an elongated structure and has a crescent shape. At least one air outlet 213 is provided at the thin end of the outer tube 21 extending from the center of the thin end of the outer tube 21 to the outer periphery.
  • the slender outlet can accelerate the speed of gas injection, so that the gas can be sprayed farther, and reduce the interference to the air flow of the smoke exhaust port.
  • a plurality of gas outlets 213 are evenly arranged around the thin end of the outer tube 21 so that gas can be sprayed into place at all angles.
  • two partitions 25 are provided vertically in the interlayer of the outer tube 21 and the inner tube 22 to divide the interlayer into an intake channel 24 and a smoke exhaust channel 23, opening 221 between the two partitions 25 of the smoke exhaust channel.
  • the opening 221 By setting the opening 221 at the thin end of the sheath assembly 2, the opening is located near the surgical instrument, and the opening 221 is small, therefore, the suction force at the opening 211 is large, and the smoke near the surgical instrument can be quickly sucked away to maintain the operation
  • the field of view is clear; and multiple crescent-shaped air outlets 213 are evenly arranged.
  • the elongated air outlet 213 accelerates the gas injection speed, and the gas can be injected farther. If the air outlet 213 is set too large, the gas injection speed is slow, and can only be sprayed near the air outlet 213, and the suction force at the opening 221 is large.
  • the gas just ejected from the air outlet 213 is immediately discharged by the opening 221, which greatly reduces the smoke exhaust effect.
  • the sheath tube assembly 2 includes an outer tube 21 and an inner tube 22, and the outer tube 21 The sleeve is placed outside the inner tube 22, and the thin ends of the outer tube 21 and the inner tube 22 are connected together to form a sandwich; it is conceivable that in order to allow the sheath assembly 2 to be easily inserted into the abdominal cavity, the thin end of the outer tube 21 is removed from From top to bottom, it gradually gathers towards the center.
  • the head of the outer tube 21 is also provided with an exhaust port 211 for exhaust.
  • a smoke exhaust channel 23 is provided in the interlayer, and an opening 221 is provided at the thin end of the inner tube 22, and the exhaust port 211 is communicated with the opening 221 through the smoke exhaust channel.
  • the interlayer can be directly used as the smoke exhaust channel 23 to connect the exhaust port 211 and the buckle 221; a pipeline can also be additionally provided as the smoke exhaust channel 23 in the interlayer, and the interlayer can be used as the protective sleeve of the pipeline.
  • it further includes an air inlet 212 and an air inlet channel 24.
  • the air inlet 212 is provided at the head of the outer tube 21, and an air outlet 213 is provided at the thin end of the outer tube 21.
  • the port 212 communicates with the air outlet 213; that is, the gas enters the air intake passage 24 through the air inlet 212, and then is discharged from the air outlet 213.
  • the air outlet 213 is of an elongated structure and has a crescent shape. At least one air outlet 213 is provided at the thin end of the outer tube 21 extending from the center of the thin end of the outer tube 21 to the outer periphery.
  • the elongated outlet can accelerate the speed of gas ejection, so that the gas can be ejected farther, and keep the air pressure in the entire abdominal cavity stable.
  • a plurality of gas outlets 213 are evenly arranged around the thin end of the outer tube 21 so that gas can be sprayed into place at various angles.
  • two partitions 25 are provided vertically in the interlayer of the outer tube 21 and the inner tube 22 to divide the interlayer into an intake channel 24 and a smoke exhaust channel 23, opening 221 between the two partitions 25 of the smoke exhaust channel.
  • the opening 221 By setting the opening 221 at the thin end of the sheath assembly 2, the opening is located near the surgical instrument, and the opening 221 is small, therefore, the suction force at the opening 211 is large, and the smoke near the surgical instrument can be quickly sucked away to maintain the operation
  • the field of view is clear; and multiple crescent-shaped air outlets 213 are evenly arranged.
  • the elongated air outlet 213 accelerates the gas injection speed, and the gas can be injected farther. If the air outlet 213 is set too large, the gas injection speed is slow, and can only be sprayed near the air outlet 213, and the suction force at the opening 221 is large.
  • the gas just ejected from the air outlet 213 is immediately discharged by the opening 221, which greatly reduces the smoke exhaust effect.
  • a seal 3 for opening and closing the surgical channel is also included.
  • the seal 3 is provided at the head of the inner tube 22.
  • the seal 3 closely fits the surgical instrument to achieve The effect of sealing; when the surgical instruments and tissue shears are taken out, the sealing member 3 is opened to facilitate its removal, and after the removal, the sealing member 3 is sealed again to partition the surgical channel.
  • the sealing member 3 includes a deformable body 31 made of a flexible material, and a gas inlet and outlet channel 32 is provided on the deformable body, which expands or contracts by inflating or exhausting the deformable body;
  • the inlet and outlet channels 32 can be opened and closed by the intake valve 35 and the exhaust valve 36, thereby achieving the intake and exhaust functions.
  • only one air hole is provided on the deformable body 31, and the air hole is compatible with the air intake and exhaust functions.
  • the air hole is externally connected to two valves, and the air intake and exhaust functions are realized by valve control. It is also possible to set two air holes independently to achieve exhaust and intake.
  • the deformable body 31 is provided with a through hole 311 through which surgical instruments enter the abdominal cavity.
  • the center of the through hole 311 is on the same straight line as the central axis of the inner tube 22; when the intake valve 35 opens, the gas enters the deformable body, the deformable body expands, shrinks the through hole 311, and wraps the surgical instrument to achieve the sealing function; No surgical instrument is placed in the hole 311, the interior of the deformable body is inflated, and the through hole 311 is contracted until it is closed.
  • the exhaust valve 36 When the inlet port is closed, the exhaust valve 36 is opened, and the gas inside the deformed body is discharged, the deformed body contracts and the through hole 311 expands, so that the surgical instrument can be easily taken out; in addition, the gas in the deformed body is carried out through the gas inlet and outlet channels 32 Pumping, because the deformable body is made of a flexible material, the through hole 311 expands toward the periphery of the deformable body, and the diameter of the through hole 311 is opened to the maximum, which does not affect the placement and removal of surgical instruments.
  • the cross section of the deformable body 31 is a symmetrical vertebral structure. It is conducive to the contraction of the through hole 311.
  • the deformable body 31 is provided separately, and is composed of at least two parts.
  • the deformable body 31 is formed by joining two parts; in this way, the tightness of the through hole 311 can be improved.
  • the deformable body 31 is infinitely divided into several parts around the center of the through hole 311, it is conceivable that when each part is inflated, each part expands toward the center of the circle, and a better sealing effect can be achieved.
  • the deformable body 31 is a split structure, as shown in FIG.
  • 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 a through hole 311 through which the surgical instrument passes Therefore, no additional through hole 311 is required, and the sealing effect can be satisfied.
  • the deformable body 31 has a ring shape, and the through hole 311 is provided in the center of the deformable body 31.
  • the deformable body 31 and the through hole 311 are concentric circles, which ensures that the deformable body 31 receives uniform force when inflated, avoids excessive expansion of some positions, causes the deformable body 31 to expand and deform, and affects the tightness of the through hole 311.
  • the flexible material is rubber, and the rubber is a highly elastic polymer compound, which has elasticity and good sealing performance. When inflated, it can be closely attached to surgical instruments.
  • the flexible material can also be plastic, thermoplastic elastomer or fabric with a sealing layer.
  • a guide frame 33 for restricting and guiding the expansion of the deformable body 31 toward the center of the through hole 311 is provided around the deformable body 31.
  • the guide frame 33 includes a guide plate 331 and a support plate 332.
  • the guide plate 331 is mounted on the support plate 332 and has a cross-sectional shape of "concave".
  • the deformable body 31 is disposed between the guide plate 331 and the support plate 332 In the concave-shaped groove, the deformation body 31 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 333 are provided on the contact surface of the guide plate 331 and the support plate 332, and positioning holes 334 matching the fixed positions 511 are provided at corresponding positions of the support plate 332.
  • the plate 332 can be firmly connected together, and the positioning hole 334 and the positioning post 333 have an interference fit.
  • the positioning post 333 protrudes from the positioning hole 334 to fix the protruding part with the piercer. It is possible to avoid setting more installation parts.
  • a fixed edge 34 is provided on the periphery of the deformable body 31, and the fixed edge 34 is fixed to the guide frame 33 to prevent the deformable body 31 from shifting and affecting the sealing effect of the through hole 311.
  • a fixing hole 341 corresponding to the positioning post 333 can be provided on the fixing transformer 34.
  • a plurality of deformation bodies 31 may be superposed. Two deformable bodies 31 are usually arranged in parallel.
  • the outer tube 21 is sleeved on the outer side of the inner tube 22, and the three seal rings provided by the coaxial core in the interlayer of the head, as shown in FIG. 6,
  • the interlayer is horizontally divided into a first air passage 41 and a second air passage 42.
  • a through hole 26 is provided at a position corresponding to the end of the inner pipe 22 and the smoke exhaust passage 23 to make the second air passage 42
  • the smoke passage 23 communicates
  • the second air passage 42 is connected to the exhaust port 211.
  • the sealing member 3 is sealed and fixed to the inner tube 22 by two sealing rings, and a third air passage 43 is formed by the two sealing rings.
  • the gas inlet and outlet channels 32 of the sealing member 3 are directly connected to the third channel 43, and the inner tube A connection hole is opened in 22 to connect the second channel 42 and the third channel 43 as shown in FIG. 16.
  • the gas inlet and outlet passage 32 of the deformable body 31 communicates with the inlet port 212 and the outlet port 211 through the inlet valve 35 and the outlet valve 36, respectively.
  • the intake passage 24 directly communicates with the intake port 212.
  • the air source directly enters the air intake channel 24 from the air inlet 212 and is discharged from the air outlet 213 to inflate the abdominal cavity.
  • the air pump draws air through the smoke exhaust channel 23.
  • the gas from the opening 221 enters the flue gas passage 23, then enters the second air passage 42, and then is directly discharged from the exhaust port 211.
  • the opening 221 Since the end of the air outlet 213 is positive pressure, the opening 221 is negative pressure, and the pressure difference between the two places is large , So that the smoke generated during surgery can be quickly discharged from the opening 221; and because the opening 221 is provided at the end of the thin end of the inner tube 22, it is close to the surgical instrument, and the opening 221 has a large suction force, which can quickly bring the instrument near The smoke is drawn away to ensure a clear field of vision near the instrument.
  • the air inlet valve 35 is opened, the gas at the air inlet 213 enters the third air passage 43 through the first air passage 41, and then enters and exits from the gas
  • the channel 32 enters the deformable body 31, expands the deformable body 31, and closely adheres to the surgical instrument to realize the sealing function.
  • the intake valve 35 is closed, and the exhaust valve 36 is opened. With the negative pressure of the air pump, the gas in the deformable body 31 is quickly discharged, and the deformable body contracts in reverse to open the through hole 311, which is convenient for surgery Remove instruments and tissue excisions.
  • the carbon dioxide gas source is passed into the gas injection device, the pressure required to set the abdominal cavity through the control module 9 is set, and then the gas injection device adjusts the output, and the gas is introduced through the intake line 51
  • the gas is sent into the abdominal cavity through the air intake channel 24, and the smoke in the abdominal cavity is filtered through the exhaust line 52 by the air pump and then sent back to the gas injection device to recycle the gas.
  • the pressure sensor detects the pressure in the abdominal cavity through the second puncture device 8 in real time, and transmits the data to the control module 9.
  • the control module 9 adjusts the gas injection amount of the gas injection device according to the pressure data.

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Abstract

一种腹腔镜外科手术用气体灌注和再循环系统，包括气泵、气体注入装置、第一穿刺器（7）、第二穿刺器（8）、过滤器（6）以及控制气体注入装置、气泵和压力传感器的控制模块（9），第一穿刺器（7）包括进气通道（24）和排烟通道（23），通过进气管路（51）将气体注入装置与进气通道（24）连通，通过排气管路（52）将气泵与排烟通道（23）连通，排气管路（52）上设置过滤器（6），气泵被配置为将排烟通道（23）的气体注入气体注入装置，通过测压管路（53）将压力传感器与第二穿刺器（8）连通。通过压力传感器检测腹腔内气压，气体注入装置可以精确控制进入手术腔体内的气体并保持手术腔体内压力稳定。

Description

一种腹腔镜外科手术用气体灌注和再循环系统 技术领域
本发明涉及医用设备领域，特别涉及一种腹腔镜外科手术用气体灌注和再循环系统。
背景技术
在微创手术时，由于人体的器官或者其他组织是挤压在一起的，没有足够的空间观察和手术，这个时候就需要气腹机提供气压，将内腔撑大，以便提供合适的手术空间和手术视野，气压的不稳定，会带来软性组织随着气压的变化而发生位移，影响医生对手术部位精确位置的判断。现有的常规气腹机工作时，充气开始腹内压力低于设定值，此时机器内的充气阀开启，以设定流速向腹腔内充气。当腹腔内压力达到设定值时，充气阀关闭，充气停止。随着手术的进行，伴随手术穿刺器的进出、冲洗腹腔并吸取冲洗液、标本取出等动作而出现漏气，腹腔内压力下降。当低于设定值时，充气阀再次开启进行充气。常规气腹机的“充气-测压”过程称为一个工作周期。整个手术过程反复重复这样一个工作周期，即形成周期冲击压力。其冲击压力值随手术过程中的气体泄漏而变化。这种压力变化会造成以下结果：(1)这种由气体冲击压力造成的腹腔内脏器缺血-再灌注-再缺血，损伤可能会加重。(2)有关气腹造成腹膜形态学改变的基础和临床研究均为基于常规脉冲式气腹机的模式。如：有学者分别报道了气腹环境下的小鼠腹膜和人体腹膜在电镜下可见间皮细胞肿胀、腹膜间皮细胞间连接断裂、基底膜连续性中断等现象(3)腹腔内瞬间压力升高导致的心肺负担加重，可能增加手术中的患者猝死几率，尤其是老年人和术前即有心肺功能障碍的患者。(4)随着手术过程的延长，手术创面的增大，瞬间压力增高造成的冲击力量可能增加CO2气体通过创面进入血液循环的量，加重 患者的酸中毒。因此，为了确保手术的安全，气腹机提供的气压的稳定性十分重要。
另外，在临床医疗中，穿刺器中的电刀在烧灼或电凝人体组织时，必然会产生大量的烟雾和水蒸气，这种有机物燃烧产生的烟雾是一种强烈的致癌物，会对手术者及手术室内的医护人员造成不必要的伤害，而且在进行人体深部手术时，特别是在电灼深部血管等重要器官时，烟雾会使里面的电镜模糊，影响医护人员的视线，造成止血困难，甚至造成手术盲目或忙乱，因此需要除烟装置来保证手术的顺利。目前，在手术室中排除烟雾的现状：1)、传统方法是打开穿刺套管的排气阀直接排除烟雾，直至视野清晰再关上阀门。如不及时关闭阀门，会导致气腹压力降低，需关上阀门等待气腹压力重新上升后才能继续手术，打破手术的连续性。腹腔镜烟囱效应造成气流由腹腔镜穿刺套管涌向手术室工作人员，直接排到手术间内，造成手术室工作人员身体危害和环境的污染。2)、采用自制可控性吸引器，虽能够连续抽吸烟雾，但有害的手术烟雾未经无害处理仍会排放到手术间或吸入负压吸引泵，造成设备污染。且手术中需持续充入二氧化碳以维持气腹斥力，增加了二氧化碳使用量和患者吸收的风险。
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，公开了一种腹腔镜外科手术用气体灌注和再循环系统，其特征在于，包括气泵、气体注入装置、第一穿刺器、第二穿刺器、过滤器以及控制所述气体注入装置、所述气泵和所述压力传感器的控制模块，所述第一穿刺器包括进气通道和排烟通道，通过进气管路将所述气体注入装置与所述进气通道连通，通过所述排气管路将所述气泵与所述排烟通道连通，所述排气管路上设置所述过滤器，所述气泵被配置为将所述排烟通道的气体注入所述气体注入装置，通过测压管路将所述压力传感器与所述第二穿刺器连通。
进一步地，所述测压管路上设置所述过滤器。
进一步地，所述进气管路上设置所述过滤器。
进一步地，还包括用于打开和关闭所述第一穿刺器的手术通道的密封件。
进一步地，所述密封件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、塑料，热塑性弹性体和带有密封层的织物中的一种。
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。
本发明取得的有益效果：
相比于传统系统，本发明通过压力传感器实时检测腹腔内气压，气体注入装置可以实时精确控制进入手术腔体内的气体并保持手术腔体内压力稳定。由于有气体泵的实时抽吸，手术腔体内的烟雾可以及时、快速和高效的排出，从而保证手术的连续性和高效性。由于气泵使气体循环使用，减少了手术室内工作人员身体危害和环境污染的危险。另外，通过密封件的设置，并且密封件主体为由柔性材料支撑的变形体，适应性强，其通孔能够根据手术器械的大小进行调整，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 器具的更换和取出组织切除物。
附图说明
图1为本发明的一种腹腔镜外科手术用气体灌注和再循环系统原理图；
图2为本发明的一种穿刺器的立体图；
图3为鞘管组件的结构俯视图；
图4为鞘管组件的右视图；
图5为图4中L-L的剖视图；
图6为图3中B-B的剖视图；
图7为图3中C-C的剖视图；
图8为图4中Q-Q的剖视图；
图9为密封件的结构示意图；
图10为导向框的安装示意图；
图11为导向框的俯视图；
图12为图11中B-B的剖视图；
图13为另一种变形体的结构示意图；
图14为图4中M-M的剖视图；
图15为图4中O-O的剖视图；
图16为图4中P-P的剖视图；
附图标记如下：
1、穿刺杆，2、鞘管组件，3、密封件，6、过滤器，7、第一穿刺器，8、第二穿刺器，9、控制模块，21、外管，22、内管，23、排烟通道，24、进气通道，25、隔板，26、贯穿孔，31、变形体，32、气体进出通道，33、导向框，34、固定边，35、进气阀门，36、排气阀门，41、第一通道，42、第二通道，43、第三通道，51、进气管路，52、排气管路，53、测压管路， 211、排气口，212、进气口，213、出气口，221、开口，311、通孔，331、导向板，332、支撑板，333、定位柱，334、定位孔，341、固定孔。
具体实施方式
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。
本发明的一种腹腔镜外科手术用气体灌注和再循环系统，如图1所示，包括气泵、气体注入装置、第一穿刺器、第二穿刺器、过滤器以及控制气体注入装置、气泵和压力传感器的控制模块9，第一穿刺器7包括进气通道24和排烟通道23，通过进气管路51将气体注入装置与进气通道24连通，通过排气管路52将气泵与排烟通道23连通，排气管路52上设置过滤器6，用于将腹腔内部吸出的气体进行过滤，并且通过气泵将过滤后的气体重新注入气体注入装置内，通过气体注入装置再次将气体充入腹腔。另外，通过测压管路53将压力传感器与第二穿刺器连通8。压力传感器通过测压管路53实时测量腹腔内的压力，并且将数据反馈给控制模块9，根据测得的压力，当压力过小时，通过控制模块9控制气体注入装置增加气体注入量；反之，则减少气体注入量。达到腹腔内气压的稳定。另外，为了防止与气体注入装置连接的气源内存在杂质，或者循环使用的气体中存在杂质，因此，在进气管路51上设置过滤装置，以防止杂质进入腹腔，对人体造成二次伤害。在一优选实施例中，在手术时，电刀在烧灼或电凝人体组织时，必然会产生大量的烟雾和水蒸气，这些进入压力传感器中，可能会影响传感器的检测精度，甚至降低传感器的使用寿命，因此，在测压管路53上设置过滤器，将气体过滤后进行测压。将测压与充气两路同时进行，能够对腹腔内的气压进行实时测量，并且能够减小充气端对压力传感器测量数据的影响。与现有的测量设备相比，现有的测量设备通将充气和测压按周期进行，不能的得到腹腔内实时的压力，气体注入设备对气体注入量的控制起伏波动大，腹腔一会大一会小，不利于手术的操作；另外，过度充气，可能对人体再一次造成伤害。
控制模块9包括操作显示模块、操作控制模块和主控制模块，通过显示模块对设置预设压力，并且显示腹腔内实时压力值。压力传感器将检测到的数据传递给主控制模块，当压力低于预设压力时，主控制模块发射信号给操作控制模块，操作控制模块控制气体注入装置加大气体注入量。反之，则减小气体注入量。
通常，穿刺器包括手术通道、排烟通道23和进气通道24。在一实施例中，如图2-16所示，穿刺器包括用于造成贯穿口的穿刺杆1以及套设于穿刺杆1外侧的作为手术通道的鞘管组件2，鞘管组件2包括外管21和内管22，外管21套设与内管22外侧，且外管21和内管22的细端连接在一起，形成夹层；能够想到的是，为了使鞘管组件2能够方便的插入腹腔，外管21的细端从上至下逐渐向中心聚拢。外管21的头部还设置有用于排气的排气口211。夹层内设置排烟通道23，并且在内管22的细端设置开口221，通过排烟通道将排气口211与开口221连通。其中，可以直接利用夹层作为排烟通道23将排气口211与卡扣221连通；也可以在夹层内另外设置管路作为排烟通道23，将夹层作为该管路的保护套。
在一实施例中，还包括进气口212和进气通道24，进气口212设置在外管21的头部，并且在外管21的细端设置出气口213，通过进气通道24将进气口212和出气口213连通；即气体经过进气口212进入进气通道24内，而后从出气口213排出。
在一优选实施例中，出气口213为细长型结构，呈月牙形，在外管21的细端设置至少一个由外管21的细端的中心向外周延展设置一个出气口213。细长的出口能够加快气体喷出的速度，使气体能够喷射的更远，减少对排烟口气流的干扰。优选的，在外管21的细端的周边均匀设置多个出气口213，使气体能够在个角度都能喷射到位。
在一优选实施例中，如图4-5所示，在外管21和内管22的夹层内设置竖直设置两条隔板25，将夹层分隔为进气通道24和排烟通道23，开口221排烟通道两条隔板25之间。
通过将开口221设置在鞘管组件2的细端，使开口处于手术器械附近， 并且开口221小，因此，开口211处的吸力大，能够快速的将手术器械附近的烟气吸走，保持操作区域视野清晰；并且均匀的设置多个月牙形出气口213，同样的，细长的出气口213使气体喷射的速度加快，气体更够喷射的更远。如果出气口213设置过大，气体喷射速度慢，仅能喷射在出气口213附近，而开口221处的吸力大，刚从出气口213喷出的气体立马被开口221排出，大大降低排烟的效果。
在一实施例中，包括用于造成贯穿口的穿刺杆1以及套设于穿刺杆1外侧的作为手术通道的鞘管组件2，鞘管组件2包括外管21和内管22，外管21套设与内管22外侧，且外管21和内管22的细端连接在一起，形成夹层；能够想到的是，为了使鞘管组件2能够方便的插入腹腔，外管21的细端从上至下逐渐向中心聚拢。外管21的头部还设置有用于排气的排气口211。夹层内设置排烟通道23，并且在内管22的细端设置开口221，通过排烟通道将排气口211与开口221连通。其中，可以直接利用夹层作为排烟通道23将排气口211与卡扣221连通；也可以在夹层内另外设置管路作为排烟通道23，将夹层作为该管路的保护套。
在一实施例中，还包括进气口212和进气通道24，进气口212设置在外管21的头部，并且在外管21的细端设置出气口213，通过进气通道24将进气口212和出气口213连通；即气体经过进气口212进入进气通道24内，而后从出气口213排出。
在一优选实施例中，出气口213为细长型结构，呈月牙形，在外管21的细端设置至少一个由外管21的细端的中心向外周延展设置一个出气口213。细长的出口能够加快气体喷出的速度，使气体能够喷射的更远，使整个腹腔内的气压保持平稳。优选的，在外管21的细端的周边均匀设置多个出气口213，使气体能够在各个角度都能喷射到位。
在一优选实施例中，如图4-5所示，在外管21和内管22的夹层内设置竖直设置两条隔板25，将夹层分隔为进气通道24和排烟通道23，开口221排烟通道两条隔板25之间。
通过将开口221设置在鞘管组件2的细端，使开口处于手术器械附近， 并且开口221小，因此，开口211处的吸力大，能够快速的将手术器械附近的烟气吸走，保持操作区域视野清晰；并且均匀的设置多个月牙形出气口213，同样的，细长的出气口213使气体喷射的速度加快，气体更够喷射的更远。如果出气口213设置过大，气体喷射速度慢，仅能喷射在出气口213附近，而开口221处的吸力大，刚从出气口213喷出的气体立马被开口221排出，大大降低排烟的效果。
在一实施例中，还包括用于打开和关闭手术通道的密封件3，密封件3设置在内管22的头部，当手术器械在操作室，密封件3与手术器械紧密贴合，达到密封的效果；当取出手术器械及组织剪切物时，密封件3打开，方便其取出，当取出后，密封件3再次密封，将手术通道隔断。
其中，如图6、9-13所示，密封件3包括由柔性材料制成的变形体31，变形体上设置气体进出通道32，通过对变形体充气或者排气使其膨胀或者收缩；气体进出通道32能够通过进气阀门35和排气阀门36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31上仅设置一个气孔，该气孔兼容进气和排气功能，该气孔外接两个阀门，通过阀门控制，实现进气和排气功能。也可以独立设置两个气孔实现排气和进气。
变形体31上设置通孔311，手术器械通过该通孔311进入腹腔内。通孔311的圆心与内管22的中心轴在同一直线上；当进气阀门35打开，气体进入变形体内，变形体膨胀，使通孔311缩小，将手术器械包裹，实现密封功能；如果通孔311内没有放置手术器械，变形体内部充气膨胀，通孔311收缩直至关闭。当关闭进阀门口，打开排气阀门36，将变形体内部的气体排出时，变形体收缩，通孔311扩张，使手术器械能够方便取出；另外，通过气体进出通道32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311向变形体的周边扩张，将通孔311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31的截面为对称设置的椎状结构。有利于通孔311的收缩。
在一实施例中，变形体31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31；这样能够提高通孔311的密封性。当将变形体31围绕通孔311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。另外，当变形体31为分体结构时，如图13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31呈环形，并且通孔311设置在变形体31的中心。这样，变形体31与通孔311为同心圆，保证变形体31在充气时受力均匀，避免发生部分位置过度膨胀，使变形体31膨胀畸形，影响通孔311的密封性。
在一实施例中，柔性材料为橡胶，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，柔性材料还可以是塑料，热塑性弹性体或者带有密封层的织物。
在一实施例中，如图10-12所示，为了防止变形体31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31的变形效率低，挤压力分散，通孔311的密封效果大大降低。因此，变形体31周边设置用于限制和引导变形体31向通孔311中心膨胀的导向框33。其中，导向框33包括导向板331和支撑板332，导向板331安装在支撑板332上，并且截面为“凹”字形，变形体31设置在导向板331和支撑板332之间，即设置在“凹”字形的凹槽内，限制变形体31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331与支撑板332的接触面设置若干个定位柱333，并且在支撑板332的对应位置设置与定位置511匹配的定位孔334，为了使导向板331和支撑板332能够牢固的连接在一起，定位孔334与定位柱333过盈配合；另外，为了方便导向框33安装在穿刺器内，将定位柱333突出定位孔334，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31的周边设置固定边34，通过固定边34与导向框33固定，防止变形体31发生移位，影响通孔311的密 封效果。优选的，在固定变34上能够设置与定位柱333对应的固定孔341。
为了使密封件的密封效果更好，可以叠加设置多个变形体31。通常平行设置两个变形体31。
在一具体实施例中，如图2-16所示，外管21套设在内管22外侧，其头部的夹层内通过同轴芯设置的三个密封圈，如图6所示，将夹层水平分隔为第一气道41和第二气道42，如图15所示，在内管22与排烟通道23端部对应的位置处设置贯穿孔26，使第二气道42与排烟通道23连通，并且第二气道42与排气口211接通。另外，密封件3通过两个密封圈与内管22密封固定，通过两个密封圈形成第三气道43，密封件3的气体进出通道32直接与第三通道43接通，并且在内管22上开设连接孔，将第二通道42与第三通道43连通如图16所示。
变形体31的气体进出通道32通过进气阀门35和排气阀门36分别与进气口212和排气口211连通。进气通道24直接与进气口212连通。在使用时，气源从进气口212直接进入进气通道24从出气口213排出，对腹腔进行充气，当腹腔内的气压达到指定压力后，气泵通过排烟通道23进行抽气，腹腔内的气体从开口221进入排烟通道23，后进入第二气道42内，而后直接从排气口211排出，由于出气口213端为正压，开口221处为负压，两处压力差距大，使在手术时产生的烟气能够迅速从开口221处排出；又因为开口221设置在内管22的细端的端部，其离手术器械近，并且开口221吸力大，能够快速的将器械附近的烟气抽离，保证器械附近视野清晰。另外，在手术器械从手术通道伸入时，需要对手术通道进行密封，打开进气阀门35，将进气口213处的气体经第一气道41进入第三气道43，而后从气体进出通道32进入变形体31内，使变形体31膨胀，与手术器械紧密贴合，实现密封功能。当需要将手术器械取出时，关闭进气阀门35，打开排气阀门36，借助气泵的负压力，将变形体31内的气体快速排出，变形体反向收缩，将通孔311打开，方便手术器械及组织切除物取出。
本发明在使用时，如图1所示，二氧化碳气源通入气体注入装置，设 定通过控制模块9设置腹腔内所需要的压力，而后气体注入装置调节输出量，通过进气管路51将气体通过进气通道24送入腹腔内，并且通过气泵将腹腔内的烟气通过排气管路52将气体过滤后送回气体注入装置内，使气体循环利用。压力传感器通过第二穿刺器8实时检测腹腔内的压力，并且将数据传递给控住模块9。控制模块9更具压力数据对气体注入装置的气体注入量进行调节。
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)

  1. 一种腹腔镜外科手术用气体灌注和再循环系统，其特征在于，包括气泵、气体注入装置、第一穿刺器、第二穿刺器、过滤器以及控制所述气体注入装置、所述气泵和所述压力传感器的控制模块，所述第一穿刺器包括进气通道和排烟通道，通过进气管路将所述气体注入装置与所述进气通道连通，通过所述排气管路将所述气泵与所述排烟通道连通，所述排气管路上设置所述过滤器，所述气泵被配置为将所述排烟通道的气体注入所述气体注入装置，通过测压管路将所述压力传感器与所述第二穿刺器连通。
  2. 根据权利要求1所述的一种腹腔镜外科手术用气体灌注和再循环系统，其特征在于，所述测压管路上设置所述过滤器。
  3. 根据权利要求1所述的一种腹腔镜外科手术用气体灌注和再循环系统，其特征在于，所述进气管路上设置所述过滤器。
  4. 根据权利要求1所述的一种腹腔镜外科手术用气体灌注和再循环系统，其特征在于，还包括用于打开和关闭所述第一穿刺器的手术通道的密封件。
  5. 根据权利要求4所述的一种腹腔镜外科手术用气体灌注和再循环系统，其特征在于，所述密封件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。
  6. 根据权利要求5所述的一种腹腔镜外科手术用气体灌注和再循环系统，其特征在于，所述变形体分体设置，通过至少两部分组成。
  7. 根据权利要求5所述的一种腹腔镜外科手术用气体灌注和再循环系统，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。
  8. 根据权利要求5所述的一种腹腔镜外科手术用气体灌注和再循环 系统，其特征在于，所述柔性材料为橡胶、塑料，热塑性弹性体和带有密封层的织物中的一种。
  9. 根据权利要求5所述的一种腹腔镜外科手术用气体灌注和再循环系统，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。
  10. 根据权利要求9所述的一种腹腔镜外科手术用气体灌注和再循环系统，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。
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