CN115737085A - Device for establishing amniotic cavity channel through mother body and use method thereof - Google Patents

Abstract

The device for establishing the amniotic cavity channel through the mother body comprises a mother body vagina amniotic membrane puncture component and a mother body abdominal wall uterus amniotic membrane puncture component which are respectively used for establishing a channel through the mother body vagina amniotic cavity, a channel through the mother body abdominal wall amniotic cavity, a fetal abdominal cavity channel which is manufactured by placing a fetal positioning manipulator mechanical arm and a fetal abdominal cavity puncture device through the amniotic cavity channel, so that an operation channel is provided for implementing a mother body inner tube child minimally invasive operation.

Description

Device for transmaternal amniotic passage and its use

technical field

The invention relates to the field of medical devices, in particular to a device for making a channel through the mother's body and its usage.

Background technique

The incidence of fetal birth defects is 4%-6%. Birth defects have become an important public health and social problem in the world. Compared with deformity correction after birth, intrauterine surgical correction of congenital malformations has many advantages, including maternal placenta providing safe support, avoiding fetal intrauterine growth delay or death, scarring in the surgical area is not obvious, and reducing family psychological and financial burdens.

Clinical data in the past 30 years shows that the results of fetal surgical correction of birth defects are not satisfactory, because the incidence of premature birth due to postoperative placental abruption and maternal uterine contraction is high.

Existing fetal surgery includes at least the following deficiencies, including: (1) cesarean section extracts part of the amniotic fluid and takes out the fetus, which seriously traumatizes the uterus and easily induces maternal uterine contraction; (2) cesarean section takes out the fetus, which inevitably damages the placenta and causes placental Damage to the placenta can easily induce placental abruption; (3) The fetus completely or partially leaves the mother’s uterus, making the fetus out of the uterus and amniotic fluid safety protection, resulting in potential damage to the fetus; (4) Although laparoscopic surgery can reduce abdominal and uterine trauma, However, the fetus swims in the uterus, and it is difficult to reveal the defect or deformity, which greatly increases the difficulty of the operation.

The root cause of the above-mentioned deficiencies in the prior art is that the surgical trauma is large. If the fetal intrauterine minimally invasive surgical access is constructed through the mother, such as the natural orifice of the vagina, cervix, navel, and single-hole or multi-hole channels on the abdominal wall, damage to the mother’s uterus and placenta can be avoided or reduced, thereby reducing postoperative placental abruption, maternal uterine Shrinkage contributes to the incidence of preterm birth.

Contents of the invention

(1) Technical problems to be solved.

A medical device is provided, which is used for making an amniotic cavity passage for fetal intrauterine minimally invasive surgical treatment through the natural cervical canal, navel or abdominal wall.

(2) Technical solutions.

According to an embodiment of the present invention, a device for establishing a passage through the amniotic cavity of the mother is used to make a passage through the amniotic cavity of the mother to provide an operation passage for the implementation of minimally invasive surgery in the fetus. It includes a maternal vaginal puncture component for Constructing transvaginal amniotic access; and transabdominal uterine amniocentesis components for constructing transmaternal or abdominal amniotic access.

According to one embodiment of the present invention, the medical equipment set for making the natural cervical cavity includes a vaginal speculum, a cervical dilator, a puncturer of the membranes, and a vaginal cervical retractor. Among them, the vaginal speculum includes a hand-held vaginal dilator and a light source module, which are used to dilate the vagina and perform cervical dilation under direct vision; the cervical dilator includes a cervical dilation rod and a balloon module, which are used to improve the efficiency of cervical dilation; The front end of the membrane puncture device is provided with self-tapping threads, which are used to control the advancing distance of the membrane puncture device and assist the vaginal cervical spreader to insert into the amniotic cavity; the vaginal cervical spreader includes a joint sheath, a one-way valve, and a fastening component for establishing The passage through the vagina, cervix, and fetal membranes, the one-way valve is used to prevent amniotic fluid from flowing out, and the fastening component is used to connect with the operating table support, thereby stabilizing the vaginal cervical spreader.

Preferably, the light source module includes a battery, an LED lamp, a circuit, and a switch, wherein the switch is arranged on the handle of the hand-held shade diffuser, the number of LED lamps can be multiple, and the LED lamp can also be composed of a cold light source lamp. substitute.

Preferably, the light source module is detachably connected to the hand-held vaginal speculum, so that a conventional hand-held vaginal speculum can be used to manufacture the vaginal speculum.

Preferably, the air bag module includes a balloon body, a pipeline, and an injection pot, the balloon body surrounds and is fixed on the cervical dilation rod, the cervical dilation rod includes a hand-held end and a cervical dilation end, and the cervical dilation rod The end diameter does not exceed 3 mm, the injection pot is used to connect the syringe needle.

Preferably, the membrane puncturer includes a handle and a puncture end, the puncture end is conical, provided with self-tapping threads, and the pitch of the threads is close to the thickness of the membrane wall, usually 0.1 mm to 0.25 mm.

Preferably, the combined sheath includes a vaginal segment sheath, a cervical segment sheath, and an amniotic cavity segment sheath, wherein the vaginal segment sheath is used to expand and support the vagina, to accommodate the mechanical arm of the outer segment of the cervix of the surgical robot, and to protect the vulva and vagina. wall; the cervical segment sheath is used to expand and support the cervical canal, and is used to protect the cervical os and cervical wall through the intrauterine segment mechanical arm of the surgical robot and surgical instruments; the amniotic cavity segment sheath passes through the amniotic cavity and extends into the amniotic membrane Cavity, protecting the rupture of the amniotic cavity.

Preferably, a detachable interface is provided between the vaginal sheath and the cervical sheath for the separation and combination of the vaginal sheath and the cervical sheath. The detachable interface includes bolts and nuts, snap rings or buckles.

Preferably, at least one camera module is provided at the far end of the amniotic sheath, and the camera module includes a camera, a circuit, a lighting lamp, a power supply, and a wireless communication component for observing amniotic membrane, amniotic fluid, placenta, fetus.

Preferably, the medical instrument kit for making the natural cervical canal can also include an operating table and a stand next to the table.

An embodiment of the present invention makes a device for making abdominal wall amniotic cavity passage including a puncturer and a combined sheath, wherein the puncturer includes an abdominal wall puncturer and a fetal membrane perforator, and the abdominal wall The hole maker is used to make holes in the abdominal wall and uterine wall, and the fetal membrane puncher is used to penetrate the fetal membranes and assist the combined sheath to be inserted into the amniotic cavity. , used to establish a channel through the abdominal wall, uterine wall, and fetal membranes.

Preferably, the membrane perforator includes a handle and a drill bit.

Preferably, the drill bit includes a first self-tapping thread, and the self-tapping thread is provided at the front end of the drill bit.

Preferably, the thread pitch of the self-tapping thread is 0.1 mm-0.25 mm, and the thread height of the self-tapping thread is no more than 2 mm.

Preferably, the combined sheath includes an abdominal wall sheath and an amniotic cavity sheath, wherein the abdominal wall sheath is used to expand and support the navel or abdominal incision, and is used to protect the navel or abdominal incision through the intrauterine segment mechanical arm of the surgical robot and surgical instruments. Incision in the abdominal wall; the amniotic segmental sheath passes through the amniotic cavity and extends into the amniotic cavity to protect the rupture of the amniotic cavity.

Preferably, the abdominal wall uterine segment sheath is used to protect the abdominal wall and uterine wound through the intrauterine segment mechanical arm of the surgical robot and surgical instruments.

Preferably, the abdominal uterine wall segment sheath includes an outer shield, and the outer shield includes a fastening component, and the fastening component is used for rigidly coupling the combined sheath with the support next to the operating table.

Preferably, the segmental sheath of the amniotic cavity is used to pass through the fetal membrane and extend into the amniotic cavity to protect the tear of the amniotic cavity.

Preferably, the amniotic segment sheath includes a second self-tapping thread, and the second self-tapping thread is arranged on the outer front end wall of the amniotic segment sheath.

Preferably, the segmental amniotic sheath includes a camera module, and the camera module includes a circuit, a lighting lamp, a power supply, a wireless communication component, and at least one camera for observing the amniotic membrane, amniotic fluid, placenta, and fetus in the amniotic cavity.

Preferably, making the abdominal wall and uterine wall amniotic cavity access device further includes a stent next to the operating table.

An embodiment of the present invention provides a method for establishing an amniotic cavity passage through the mother, including using a maternal vaginal amniotic passage through the maternal vaginal amniotic cavity; Construct the amniotic access through the maternal umbilicus or abdominal wall.

According to an embodiment of the present invention, the use of a medical device kit for making a natural cervical canal, the procedure includes the following steps.

Step 1. The vaginal speculum is used to dilate the vagina, and the cervical dilator is placed under direct vision. The balloon is inflated or filled with water. The dilation degree of the cervix meets or exceeds expectations. Usually, the cervix can pass through a cervical dilation rod with a number of 10.5 or above.

Step 2, take out the cervical dilator under direct vision, insert the amniocentesis under the guidance of ultrasound, touch the amniotic sac, rotate the amniocentesis, and push the amniocentesis into the amniotic cavity, usually The distance is 0.5 cm to 1.5 cm to ensure a safe distance from the fetus.

Step 3: Under the guidance of direct vision and ultrasound, a cervical retractor is placed in the vagina, the handle of the amniocentesis passes through the one-way valve, and the front end of the amniotic sheath approaches the amniotic sac.

Step 4, withdraw the vaginal speculum.

Step 5, through ultrasonic detection and camera observation, advance the cervical retractor, so that the segmental sheath of the amniotic cavity enters the amniotic cavity, and exits the amniotic membrane puncture device.

Step 6, rigidly and stably connecting the fastening component with the operating table bracket.

Preferably, in step 1, the air bag is inflated or filled with water slowly.

Preferably, in step 3, the vaginal speculum can be withdrawn first, and then the vaginal cervical retractor can be inserted.

Preferably, in step 5, the amniotic segment sheath of the vaginal cervical spreader is advanced into the amniotic cavity by a distance of 0.5 cm to 1.5 cm to ensure a safe distance from the fetus.

An embodiment of the present invention provides a method for making an abdominal wall and uterine wall amniotic cavity access device, which includes the following steps.

Step a: Select the location of the abdominal wall and uterine wall to make holes. If the placenta can be avoided, the navel or the navel or other parts of the abdomen are preferred. Under the guidance of ultrasound, use the abdominal wall hole maker to make holes in the abdominal wall and uterine wall.

Step b, ultrasound guidance combined with direct vision, through the hole in the abdominal wall and the uterine wall, insert the membrane puncher, after the front end of the drill bit of the membrane puncher touches the membrane, rotate the handle of the membrane puncher , and advance the membrane punch into the amniotic cavity.

Step c, under the guidance of ultrasound and direct vision, the combined sheath is inserted through the handle of the fetal membrane puncher into the hole in the abdominal wall and the hole in the uterine wall, and the front end of the sheath in the amniotic cavity is close to the fetal membrane.

Step d, through ultrasound guidance and observing the images taken by the camera at the front end of the amniotic segmental sheath, gently lift up the amniotic membrane puncher, and at the same time, rotate and advance the joint sheath, so that the amniotic segmental sheath enters the amniotic cavity.

Step e, gently withdraw the membrane piercer.

In step f, the joint sheath is rigidly and stably connected to the bracket next to the operating table, or the joint sheath is sutured and fixed to the abdominal skin.

Preferably, in step d, the amniotic sheath of the joint sheath is advanced into the amniotic cavity by a distance of 0.5 cm to 1.0 cm to ensure a safe distance from the fetus.

(3) Beneficial effects.

(1) The instrument kit combination of this application includes a vaginal speculum, a cervical dilator, a membrane puncture device, and a vaginal and cervical distractor. When used together, it can efficiently and safely produce a fetal intrauterine surgical treatment via the natural cervical canal. path.

(2) The front end of the membrane puncture device in the prior art is a round blunt vertebral body, and the membrane wall is thin and tough. When piercing the membrane, it has to rely on violence. The force and the advancing distance are not easy to control, which may cause a large-scale tear of the membrane , and even accidentally injure the fetus. The membrane puncture device of the present application is equipped with self-tapping thread, which can pierce the fetal membrane with a slight rotation. According to the speed of rotation, the advancing speed and distance of the membrane puncture device can be precisely controlled, avoiding the possibility of large-scale tearing of the membrane and accidental injury to the fetus. .

(3) The combined sheath of the vaginal cervical distractor can penetrate through the vagina, cervix, and fetal membranes in an integrated manner, which simplifies the device structure and improves the operation efficiency.

(4) The front end of the amniotic segment sheath of the combined sheath of the vaginal cervical spreader is provided with self-tapping threads. The self-tapping thread can prevent the partial membrane from sliding, and gently pull the membrane puncture device outward, and the self-tapping thread at the front end of the membrane puncture device can also drive the local membrane to move toward the operator, so that the amniotic cavity segment sheath enters The amniotic cavity is easier.

(5) The camera module is installed at the front end of the amniotic sheath of the vaginal cervical spreader, which can provide real-time images during the insertion of the vaginal cervical spreader, so as to avoid accidental injury to the human body during operation under blind vision. Observe the dynamic situation of amniotic membrane, amniotic fluid, placenta and fetus in the amniotic cavity.

(6) The vaginal cervical spreader is equipped with a one-way valve and a fastening component. On the one hand, the one-way valve can prevent the outflow of amniotic fluid, and at the same time, medical instruments or surgical robot arms can pass freely, and the fastening component can be connected with the operating table. The bracket is rigidly connected so that the vaginal cervical spreader can be stably fixed, and the vaginal cervical spreader can be used as a stable and firm support point for the mechanical arm of the surgical robot.

(7) The abdominal wall amniotic cavity access device of this application includes an abdominal wall hole maker, a fetal membrane puncher, and a combined sheath. First, the abdominal wall hole maker is used to make holes in the abdominal wall and uterine wall, and then the fetal The membrane perforator is inserted into the holes in the abdominal wall and uterine wall and pierces the fetal membranes, and then the combined sheath enters the amniotic cavity through the holes in the abdominal wall, uterine wall, and fetal membranes, thereby efficiently and conveniently constructing a hole that runs through the abdominal wall, uterine wall, and fetal membranes. Channel for intrauterine fetal surgery using laparoscopic techniques or surgical robotics.

(8) The diameter of the holes made in the abdominal wall, uterine wall, and fetal membranes is usually not more than 3 cm, which will cause slight damage to the mother's uterus, and the postoperative recovery will be faster, thereby reducing the inducing factors of the mother's uterine contraction.

(9) The diameter of the hole in the fetal membrane is usually not more than 3 cm, which can completely avoid the placenta without damaging the placenta, and can reduce the triggering factors of placental abruption.

(10) The use process of the device kit of this application is simple, safe and efficient, and will provide fetal intrauterine surgery with less trauma to the mother and placenta and fetal-friendly surgical conditions, thereby increasing the scope of fetal intrauterine surgery and providing human eugenics. level.

Description of drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings that need to be used in the description of the embodiments. Obviously, the drawings in the following description are only some embodiments of the present application. Those skilled in the art can also obtain other drawings based on these drawings without creative work.

Furthermore, the drawings are merely schematic illustrations of the application and are not necessarily drawn to scale. The same reference numerals in the drawings denote the same or similar parts, and thus repeated descriptions thereof will be omitted. Some block diagrams shown in the drawings are functional entities, which do not necessarily correspond to physically or logically independent entities, and these functional entities can be implemented in one or more hardware modules or component combinations.

Fig. 1 is a schematic structural view of a vaginal speculum according to an embodiment of the present application.

Fig. 2 is a schematic structural diagram of another vaginal speculum according to the embodiment of the present application.

Fig. 3 is a schematic structural diagram of a vaginal speculum including multiple lamps according to an embodiment of the present application.

Fig. 4 is a schematic structural diagram of a cervical dilator according to an embodiment of the present application.

Fig. 5 is a schematic structural diagram of a cervical dilator after the balloon is inflated according to an embodiment of the present application.

Fig. 6 is a schematic diagram of the structure of the cervical end of a cervical dilator according to an embodiment of the present application.

Fig. 7 is a schematic structural diagram of another cervical dilator according to the embodiment of the present application.

Fig. 8 is a schematic structural diagram of an enhanced airbag module according to an embodiment of the present application.

Fig. 9 is a schematic structural diagram of a simplified cervical dilator according to an embodiment of the present application.

Fig. 10 is a schematic structural view of a membrane puncture device according to an embodiment of the present application.

Fig. 11 is a schematic diagram of the structure of a puncture end of a membrane puncture device according to an embodiment of the present application.

Fig. 12 is a schematic structural view of a cervical retractor according to an embodiment of the present application.

Fig. 13 is a schematic structural diagram of a vaginal and cervical retractor including a camera module according to an embodiment of the present application.

Fig. 14 is a schematic diagram of a detachable combined structure of a vaginal sheath and a cervical sheath of a vaginal cervical distractor according to an embodiment of the present application.

Fig. 15 is a schematic diagram of the detachable combined structure of the vaginal segment sheath and the cervical segment sheath of the second vaginal cervical retractor according to the embodiment of the present application.

Fig. 16 is a schematic diagram of the detachable combined structure of the vaginal segment sheath and the cervical segment sheath of the third vaginal cervical retractor according to the embodiment of the present application.

Fig. 17 is a schematic diagram of the connection structure between a vaginal cervical retractor and an operating table bracket according to an embodiment of the present application.

Fig. 18 is a schematic structural view of a membrane perforator according to an embodiment of the present application.

Fig. 19 is a schematic diagram of the structure of a drill bit of a membrane drill according to an embodiment of the present application.

Fig. 20 is a schematic diagram of the combined sheath structure of the embodiment of the present application.

Fig. 21 is a schematic diagram of the structure of an amniotic cavity segmental sheath according to an embodiment of the present application.

Fig. 22 is a schematic structural diagram of another amniotic cavity segmental sheath according to the embodiment of the present application.

Fig. 23 is a schematic diagram of a connection structure between a combined sheath and a bedside support according to an embodiment of the present application.

Fig. 24 is a schematic diagram of a combined sheath sutured and fixed to the abdominal skin according to an embodiment of the present application.

Detailed ways

In order to make the purpose, technical solution and advantages of the present application clearer, the present application will be further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described here are only used to explain the present application, not to limit the present application.

It should be noted that the orientation words such as up, down, left, and right in this embodiment are only relative concepts or refer to the normal use state of the product, and should not be regarded as limiting.

Referring to FIG. 1-FIG. 16 , a medical instrument kit for making a natural cervical canal according to an embodiment of the present application may include a vaginal speculum 100 , a cervical dilator 200 , a membrane puncturer 300 , and a vaginal cervical distractor 400 .

As shown in FIG. 1 , a vaginal speculum 100 according to an embodiment of the present application may include a hand-held vaginal dilator and a light source module.

The hand-held vaginal dilator can include an upper peeping board 110 and a lower peeping board 120, and the upper peeping board 110 and the lower peeping board 120 can be hinged by a rotating shaft 130, and the tail end of the upper peeping board 110 and the handle 121 of the lower peeping board 120 can be arranged The threaded rod 140 can adjust the opening and closing between the upper peeping board 110 and the lower peeping board 120 through the threaded rod 140, which is used to expand the vagina.

The light source module can include a battery 154, an LED lamp 151, a circuit 152, and a switch 153, wherein the switch 153 can be arranged on the handle 121 of the hand-held vaginal diffuser, and the LED lamp 151 can be arranged on the inner side of the front section of the peeping plate 120, of course , The LED lamp 151 can also be replaced by a cold light source lamp. The hand-held vaginal dilator expands the vagina, and with the light provided by the light source module, the operator can perform cervical dilation under direct vision.

As shown in FIG. 2 , the battery 154 of the light source module of a vaginal speculum 100 according to an embodiment of the present application can also be provided independently, or can be powered by an external power supply.

As shown in FIG. 3 , a light source module of a vaginal speculum 100 according to an embodiment of the present application can be provided with a plurality of LED lamps 151, and the LED lamps 151 can be arranged on the inner side of the front section of the lower peeping board 120 and the upper peeping board 110. the inner side of the anterior segment.

It can be understood that the light source module can be connected to the hand-held vaginal speculum in a detachable connection, for example, using sterile tape or glue to paste the LED lamp 151 and the circuit 152 on the upper peeping plate of the conventional handheld vaginal speculum 110 and/or the inner side of the peeping plate 120, the battery 154 and the switch 153 are left outside the conventional hand-held vaginal speculum, so that the conventional hand-held vaginal speculum or the disposable handheld vaginal speculum can also be used for direct vision Perform cervical dilation. Of course, the detachable light source module can also simplify the design, making it a low-cost disposable product.

In addition, the handheld vaginal speculum can also be provided with a fixing component, through which the handheld vaginal speculum is rigidly connected to the bedside support, so that the operator can do other things with one hand.

As shown in Figure 4, a cervical dilator 200 according to an embodiment of the present application may include a cervical dilation rod and a balloon module, wherein the cervical dilation rod may include a hand-held end 210 and a cervical dilation end 220, and the air bag module may include The capsule body 230, the pipeline 240, and the injection pot 250, the capsule body 230 can wrap around and be fixed on the dilating end of the cervix 220, the injection pot 250 has the effect of a one-way valve, the injection pot 250 can use a syringe to inject or extract gas or liquid, but the injected The gas or liquid in the bladder 230 will not overflow by itself. It should be noted that the diameter of the dilating end 220 of the cervix is usually not more than 3 millimeters, the balloon 230 can be made of medical silicone material, and the wall of the sac 230 is usually not more than 0.5 mm, so that the dilating end 220 of the cervix can be Easy insertion into the maternal cervical canal.

As shown in Figure 5, the syringe needle (not shown) is inserted into the injection pot 250, and air or physiological saline or artificial amniotic fluid is injected, and the air, physiological saline or artificial amniotic fluid enters the capsule body 230 through the pipeline 240, and the capsule body 230 expands, and then Dilation of the cervical canal can be achieved. It should be noted that the medical silicone material used in the balloon body 230 can be expanded by at least 30 times in volume, so as to achieve a sufficient effect of dilating the cervical canal. The syringe can choose a high-pressure syringe to reduce the difficulty of injection.

In addition, when injecting air or physiological saline or artificial amniotic fluid into the capsule body 230, it must be injected slowly and uniformly to prevent cervical damage caused by too fast injection.

In addition, the entire process of inserting the cervical dilator 200 and injecting air, physiological saline or artificial amniotic fluid into the capsule 230 is preferably performed under direct vision and ultrasound guidance, so that the position of the cervical dilator 200 is more accurate. At the same time, observe the dynamic changes of the cervix in real time, and guide the speed of injecting air or saline or artificial amniotic fluid into the capsule 230. If the cervix suddenly expands rapidly, part of the air or saline or artificial amniotic fluid can be withdrawn to prevent permanent damage to the cervix. Adverse consequences.

As shown in FIG. 6 , the structure of the cervical end of a cervical dilator according to the embodiment of the present application, the outer periphery of the cervical dilation end 220 surrounds the capsule 230 , and the first stop can be set at the front and rear of the cervical dilation end 220 respectively. The ring 260-2, the second limiting ring 260-2, the first limiting ring 260-2 and the second limiting ring 260-2 can be made of high-hardness medical silicone, which can be fastened to the cervical dilation end 220, and The position can be moved along the dilation end 220 of the cervix under the action of external force.

Due to the great difference in the length of the cervix of the mother, although it is feasible to manufacture the cervical dilator 200 with the cervical dilation end 220 of different lengths, it will also cause a waste of medical resources. The technical solution of the present application can realize the precise adjustment of the length of the capsule 230 by adjusting the first limit ring 260-2 and the second limit ring 260-2, so as to meet the cervical dilation requirements of different maternal cervical lengths, thereby avoiding the waste of medical resources.

As shown in Figure 7, a cervical dilator 200 according to an embodiment of the present application may include a cervical dilation rod and a balloon module, the cervical dilation rod may include a hand-held end 210, and a cervical dilation end 220, and the air bag module may include a balloon 230. Pipeline 240, injection pot 250, wherein, the injection pot 250 can also adopt a rod-shaped structure, so that the syringe needle can be inserted deeper, so as to avoid needle prolapse, or needle tip air or liquid overflow during injection, and improve work efficiency.

It can be understood that the cervical dilation rod can be made of high-strength polymer medical materials, or the hand-held end 210 can be made of hollow stainless steel tube, so as to reduce the weight of the cervical dilation rod. The pipeline 240 can adopt a thicker tube wall so that the pipeline 240 has no obvious deformation when it is filled with air or liquid.

In addition, as shown in Figure 8, the first limiting ring 260-2, the second limiting ring 260-2 and the airbag module can also be independently designed and manufactured to obtain an enhanced version of the airbag module, the enhanced version of the airbag module The set includes at least a balloon body 230, a pipeline 240, an injection pot 250, a first limiting ring 260-2 and a second limiting ring 260-2, and the enhanced version of the air bag module can be used in combination with a conventional cervical dilation rod for cervical dilation. According to the results of ultrasound examination, the length of the maternal cervical canal, the shape of the internal orifice of the cervical canal and the shape of the external orifice can be known, and a suitable conventional cervical dilation rod is selected. , and then insert the capsule body 230, and then insert the first stop ring 260-2, adjust the distance between the first stop ring 260-2 and the second stop ring 260-2, so that the capsule body 230 is in the cervix The length of the long axis of the expansion end 220 is consistent with the expected dilated length of the cervix, which can be used to implement cervical dilation.

In addition, as shown in FIG. 9 , on the basis of the aforementioned enhanced version of the air bag module, it can also be combined with an independently designed and manufactured cervical dilation end 220 to obtain a simplified version of the cervical dilator 200 . The simplified version of the cervical dilator 200 may include a capsule body 230 , a pipeline 240 , an injection pot 250 , a first limiting ring 260 - 2 , a second limiting ring 260 - 2 , and a cervical dilating end 220 . Wherein, the tail end of the dilating end of the cervix 220 may include an engaging part 270, and the engaging part 270 may establish a rigid connection with the handle, or may be stably clamped by a clamping instrument. In this way, the manufacturing cost of the simplified version of the cervical dilator 200 can be reduced, so that the cervical dilator 200 can become a disposable device.

As shown in FIG. 10 , a membrane puncturer 300 according to the embodiment of the present application may include a handle 310 and a puncture end 320 . The handle 310 and the piercing end 320 can be an integrated structure, or can be a detachable rigid connection. The length of the handle 310 is usually not less than 20 cm, the puncture end 320 can be conical, the length of the puncture end 320 is usually not less than 5 cm, and the diameter of the thickest part of the middle section of the puncture end 320 is usually not more than 2.5 cm.

As shown in FIG. 11 , the front end 321 of the puncture end 320 of the membrane puncturer 300 includes first self-tapping threads 322 , and the thread pitch of the first self-tapping threads 322 is close to the thickness of the membrane wall, usually 0.1 mm to 0.25 mm. The first self-tapping thread 322 of the membrane trocar 300 makes it very easy to penetrate into the thin and tough membranes. After entering the amniotic cavity, the membrane trocar 300 can be rotated and advanced to precisely control the insertion of the membrane trocar 300 into the amniotic cavity. Depth and speed, in addition, may also assist insertion of vaginal cervical distractor 400 into the amniotic cavity. Certainly, operating the membrane puncture device 300 to implement the membrane puncture is performed under the guidance of ultrasound, so as to ensure the accuracy of the membrane puncture without harming the fetus.

It should be noted that the thread direction of the first self-tapping thread 322 can be marked on the handle 310 , and the thread direction can be designed clockwise or counterclockwise. In addition, the front end of the piercing end 320 is a sharp portion of the first self-tapping thread 322 , and in order to avoid accidentally injuring the fetus, the sharp portion is usually slightly blunt. In addition, the thread height of the first self-tapping thread 322 generally does not exceed 2 millimeters.

As shown in Figure 12, a vaginal cervical distractor 400 according to the embodiment of the present application may include a vaginal sheath 410, a cervical sheath 420, an amniotic cavity sheath 430, a one-way valve 440, a shield 450, and a shield 450 It includes a plurality of locking holes 451 . Among them, the vaginal sheath 410, the cervix sheath 420, and the amniotic cavity sheath 430 form a combined sheath for establishing a passage through the vagina, cervix, and fetal membranes. The one-way valve 440 is used to prevent the outflow of amniotic fluid, and the locking hole 451 is used to It is connected with the operating table bracket 500 to stabilize the vaginal cervical spreader 400 .

It should be noted that the vaginal sheath 410 is generally cylindrical or oblate cylindrical in shape, its diameter is usually not less than 5 cm, and its length is usually not less than 15 cm, and is used to expand and support the vagina and accommodate surgical procedures. The robotic arm of the outer segment of the cervix protects the vulva and the vaginal wall; the cervical segment sheath 420 is usually a cylindrical structure, its diameter is usually not less than 1.5 cm, and its length is usually not less than 2.5 cm, and is used to expand and support the cervical canal. It is used to protect the cervical os and cervical wall through the intrauterine mechanical arm of the surgical robot and surgical instruments; the amniotic sheath 430 is usually a cylindrical structure, its diameter is usually not less than 1.5 cm, and its length is usually not less than 1.0 cm , used to pass through the amniotic cavity and extend into the amniotic cavity to protect the rupture of the amniotic cavity.

As shown in Figure 13, a vaginal cervical distractor 400 according to the embodiment of the present application may include a vaginal sheath 410, a cervical sheath 420, an amniotic cavity sheath 430, a one-way valve 440, a shield 450, and a shield 450 It includes a plurality of locking holes 451 . Wherein, the front end of the amniotic sheath 430 may include at least one camera module, which may include a camera 460, a circuit 470, a lighting lamp (not shown), a power supply 480, and a wireless communication component (not shown), The camera module can be used to observe the amniotic membrane, amniotic fluid, placenta and fetus in the amniotic cavity.

As shown in Figure 13, a vaginal cervical distractor 400 according to the embodiment of the present application may include a vaginal sheath 410, a cervical sheath 420, an amniotic cavity sheath 430, a one-way valve 440, a shield 450, and a shield 450 It includes a plurality of locking holes 451 . Wherein, the outer sheath surface of the front end of the amniotic cavity segmental sheath 430 may include a second self-tapping thread 431, the thread pitch of the second self-tapping thread 431 is close to the thickness of the fetal membrane wall, usually 0.1 mm to 0.25 mm, the second self-tapping thread 431 It makes it very easy for the front end of the segmental sheath 430 of the amniotic cavity to penetrate into the thin and tough fetal membranes. After entering the amniotic cavity, the vaginal cervical spreader 400 can be rotated and advanced to accurately insert the vaginal cervical spreader 400 into the amniotic cavity. Depth and speed. In addition, it can also cooperate with the membrane puncture device 300, for example, when inserting the vaginal cervical retractor 400, keep the membrane puncture device 300 still or slightly pull the membrane puncture device 300 outward, which is equivalent to the partial fetal membrane puncture device 300. The membrane exerts an outward thrust, and the amniotic segmental sheath 430 of the vaginal cervical distractor 400 applies an inward thrust and the attacking force of the second self-tapping thread 431, making it easier to insert the amniotic segmental sheath 430 into the amniotic cavity. Certainly, inserting the cervical retractor 400 into the vagina is operated under the guidance of ultrasound, so as to ensure that the fetus is not injured.

As shown in Figure 14, a vaginal cervical distractor 400 according to the embodiment of the present application may include a vaginal sheath 410, a cervical sheath 420, an amniotic cavity sheath 430, a one-way valve 440, a shield 450, and a shield 450 It includes a plurality of locking holes 451 . Among them, the cervical segment sheath 420 and the amniotic cavity segment sheath 430 are an integrated structure, the vaginal segment sheath 410 and the cervical segment sheath 420 are a detachable combined structure, and the front end of the vaginal segment sheath 410 includes an indented accessory cylinder. The inner wall includes a first nut 411, the outer wall of the rear end of the cervical sheath 420 includes a first bolt 421, the first bolt 421 matches the first nut 411, and the vaginal sheath 410 and the cervical sheath 420 pass through the first bolt 421 and the first nut. 411 can be combined into a combined sheath. In addition, by adjusting the depth at which the first bolt 421 enters the first nut 411 , the functional length of the cervical sheath 420 can be adjusted so as to adapt to mothers with different lengths of the cervical canal.

As shown in Figure 15, the second vaginal cervical retractor 400 of the embodiment of the present application may include a vaginal segment sheath 410, a cervical segment sheath 420, an amniotic cavity segment sheath 430, a one-way valve 440, a guard plate 450, and a guard plate 450 includes a plurality of locking holes 451 . Among them, the cervical segment sheath 420 and the amniotic cavity segment sheath 430 are an integrated structure, the vaginal segment sheath 410 and the cervical segment sheath 420 are a detachable combined structure, and the front end of the vaginal segment sheath 410 includes a protruding auxiliary cylinder. The inner wall includes a second nut 412, and the outer wall of the rear end of the cervical sheath 420 includes a second bolt 422, the second bolt 422 matches the second nut 412, and the vaginal sheath 410 and the cervical sheath 420 connect with the second nut through the second bolt 422. 412 can be combined into a combined sheath. In addition, by adjusting the depth at which the second bolt 422 enters the second nut 412, the functional length of the cervical sheath 420 can be adjusted so as to adapt to mothers with different lengths of the cervical canal.

As shown in Figure 16, the third vaginal cervical retractor 400 of the embodiment of the present application may include a vaginal segment sheath 410, a cervical segment sheath 420, an amniotic cavity segment sheath 430, a one-way valve 440, a guard plate 450, and a guard plate 450 includes a plurality of locking holes 451 . Among them, the cervical segment sheath 420 and the amniotic cavity segment sheath 430 are an integrated structure, the vaginal segment sheath 410 and the cervical segment sheath 420 are a detachable combined structure, and the front end of the vaginal segment sheath 410 includes a protruding auxiliary cylinder. The inner wall includes at least one group of convex points 413, the rear outer wall of the cervical segment sheath 420 includes at least one circle of concave ring 423, the convex points 413 match the concave ring 423, and the vaginal segment sheath 410 and the cervical segment sheath 420 connect with the concave ring through the convex points 413. 423 can be rigidly connected and combined into a combined sheath.

Referring to FIG. 17 , a vaginal and cervical distractor 400 according to an embodiment of the present application is rigidly fixedly connected to a side support 500 and an operating table 600 . As shown in FIG. 17 , the medical instrument kit for making the natural cervical canal can also include a side support 500 and an operating table 600 . Wherein, the tableside support 500 can establish a rigid and stable connection with the operating table 600 through the first fastening assembly 610 and the second fastening assembly 620, and the tableside support 500 can pass through the third fastening assembly 510, the fourth fastening assembly 520, The fifth fastening component 530 respectively establishes a rigid and stable connection with a plurality of locking holes 451 on the guard plate 450 of the cervical retractor 400 . In this way, the rigid and stable connection between the vaginal cervical spreader 400, the tableside support 500, and the operating table 600 can be realized, and then the vaginal cervical spreader 400 can be used as a mechanical arm and a medical device that needs to enter the amniotic cavity to perform fetal surgery. The instrument provides a firm support point.

It should be noted that a plurality of locking holes 451 on the guard plate 450 of the vaginal cervical spreader 400 are usually left to allow the third fastening component 510, the fourth fastening component 520, and the fifth fastening component 530 to move within a certain range. Adjustable space, the operating table 600 usually leaves a space that allows the first fastening component 610 and the second fastening component 620 to move and adjust within a certain range. In addition, the side bracket 500 can be square, rectangular, circular or elliptical Shaped structure, if the side bracket 500 is a square or rectangular structure, the distance between the frames can be moved and adjusted within a certain range; if the side bracket 500 is a circular or oval structure, its inner diameter can be moved and adjusted within a certain range , so as to adapt to vaginal and cervical retractors 400 of different specifications, and to meet the needs of human bodies of different sizes.

According to an embodiment of the present invention, the usage of the instrument kit for making vaginal-cervical-amniotic cavity channel includes the following steps.

Step 1. After the anesthesia is successful, sterilize and spread the towel. The doctor uses the vaginal speculum to expand the vagina, and uses the vaginal speculum light source to check the vagina and the external os of the cervix.

Step 2: Pull the anterior lip of the external os of the cervix with forceps, insert a cervical dilator of appropriate specifications into the cervical canal from the external os of the cervix under direct vision, and under the guidance of ultrasound, ensure that the capsule at the dilation end of the cervical dilator is completely located in the cervix that is expected to be dilated The tube section and the capsule are inflated with air or water. Under the guidance of ultrasound, the dilatation status of the cervical canal is monitored in real time. When the degree of dilation of the cervical canal reaches or exceeds the expected level, the inflatable or water-filled capsule is stopped. The degree of dilation of the cervical canal depends on the outer diameter of the cervical sheath of the vaginal cervical retractor that is expected to be placed. The inner diameter of the cervical canal is usually at least 1.5 cm after dilation, and a conventional cervical dilation rod with a size of 10.5 or above can be passed.

Step 3, take out the cervical dilator under direct vision, insert the amniocentesis under the guidance of ultrasound, touch the amniotic sac, rotate the amniocentesis, and push the amniocentesis into the amniotic cavity, usually The distance is 0.5 cm to 1.5 cm to ensure a safe distance from the fetus.

Step 4: Under the guidance of direct vision and ultrasound, a cervical retractor is placed in the vagina, the handle of the amniocentesis passes through the one-way valve, and the front end of the amniotic segmental sheath approaches the amniotic sac.

Step 5, withdraw the vaginal speculum.

Step 6, through ultrasonic detection and camera observation, rotate and push the vaginal cervical retractor, and at the same time, gently pull the amniocentesis outward, and puncture the fetal membranes with the help of the self-tapping thread of the amniotic sheath, so that the amniotic sheath Enter the amniotic cavity, and then reversely rotate the amniocentesis, so that the amniocentesis is completely withdrawn.

Step 7: Rigid and stable connection is completed between the vaginal cervical spreader, the side support and the operating table.

It should be noted that in step 2, the balloon is inflated or filled with water slowly. If the cervical canal is suddenly and rapidly dilated, the inflation or water filling of the balloon can be suspended, or part of the gas or liquid in the balloon can be pumped out to avoid cervical damage.

In addition, in step 4, the vaginal speculum can also be withdrawn while the vaginal cervical retractor is inserted. In step 6, the amniotic segment sheath of the vaginal cervical retractor is pushed into the amniotic cavity by usually 0.5 cm to 1.5 cm to ensure a safe distance from the fetus.

An embodiment of the present invention, a device for making an abdominal wall amniotic cavity access device may include a puncture device and a combined sheath, wherein the puncture device may include an abdominal wall uterine hole maker, a fetal membrane puncher, and an abdominal wall uterine wall hole maker It can be used to make holes in the abdominal wall and uterine wall, and the fetal membrane punch can be used to penetrate the fetal membranes, and can assist the joint sheath to insert into the amniotic cavity, and build a channel through the abdominal wall, uterine wall, and fetal membranes.

Referring to Fig. 18 and Fig. 19, a membrane perforator according to the embodiment of the present application is used to make holes in the membrane.

As shown in FIG. 18 , a membrane perforator 800 according to the embodiment of the present application may include a handle 810 and a drill bit 820 . The handle 810 and the drill bit 820 can be an integrated structure, and the handle 810 and the drill bit 820 can also be detachable and combined independent parts, usually made of materials such as stainless steel, titanium alloy or polymer high temperature and high pressure resistant engineering plastics.

The handle 810 can be in the shape of a round rod, with a diameter of usually not more than 1 cm and a length of not less than 15 cm. The surface of the tail end of the handle 810 is usually provided with textures, which is convenient for fingers to twist and rotate the membrane perforator 800 .

As shown in FIG. 19 , a drill bit 820 of a membrane drill 800 according to an embodiment of the present application may include a tip 821 , a body 822 , and a tail 823 . For the self-tapping threads 824, the pitch of the first self-tapping threads 824 is 0.1mm-0.25mm, and the thread height of the first self-tapping threads 824 is no more than 2mm. In addition, the rotation direction of the first self-tapping thread 824 can be clearly marked on the handle 810, which is convenient for the doctor to refer to during operation.

The length of the drill bit 820 is usually not more than 2.5 cm, wherein the tip 821 is conical and the length is usually not more than 0.5 cm, the length of the body 822 is usually not more than 1.5 cm, the length of the tail 823 is usually not more than 0.5 cm, and the middle and back of the body 822 The segment is usually round and smooth structure, the diameter of the thickest part is not less than 1.5 cm.

The doctor can turn the handle 810 slightly with reference to the thread rotation direction of the first self-tapping thread 124 marked on the handle 810, and the tire can be punctured with the help of the first self-tapping thread 824 of the tip 810 and the body 822 of the membrane perforator 800. membrane, the drill bit 820 is inserted into the amniotic cavity.

Referring to Figs. 20-22, a combination sheath according to an embodiment of the present application is used to enter the amniotic cavity through the umbilical cord or abdomen to make a channel for the amniotic cavity in the abdominal wall and uterine wall.

As shown in FIG. 20 , a combination sheath 900 according to an embodiment of the present application may include an abdominal uterine sheath 910 , an amniotic cavity sheath 920 , an outer shield 930 , and a sheath cavity 950 . The outer shield 930 is arranged on the abdominal wall. At the tail end of the wall segment sheath 910, the outer shield 930 can be leaf-shaped or disc-shaped, and a plurality of locking holes 931 are arranged on the outer shield 930, which can be used for suture suture fixation or for locking components Rigid link.

The abdominal uterine sheath 910 and the amniotic sheath 920 are usually cylindrical, the inner diameter of the sheath cavity 950 is usually not less than 1.5 cm, the length of the abdominal uterine sheath 910 is usually not less than 5 cm, and the length of the amniotic sheath 920 is usually Not less than 1 cm. The abdominal wall section sheath 910 is used to expand and support the hole in the abdominal wall, to accommodate the mechanical arm of the surgical robot, and to protect the abdominal wall and the uterine wall. The amniotic sheath 920 is used to expand and support the hole of the fetal membrane, and is used to protect the wound of the fetal membrane through the intrauterine segment mechanical arm of the surgical robot and surgical instruments.

Of course, the combined sheath 900 can also be provided with multiple specifications and models classified according to the length of the abdominal wall section sheath 910, the amniotic cavity section sheath 920, and the inner diameter of the sheath cavity 950, so as to meet the needs of different human bodies and surgical robot arms.

As shown in FIG. 21 , a combination sheath 900 according to an embodiment of the present application may include an abdominal wall segment sheath 910 , an amniotic cavity segment sheath 920 , an outer guard 930 , and a sheath cavity 950 . The outer guard 930 is provided with a plurality of Locking hole 931. Wherein, the amniotic cavity sheath 920 may include a second self-tapping thread 921, the thread pitch of the second self-tapping thread 921 is close to the thickness of the fetal membrane wall, usually 0.1 mm to 0.25 mm, the second self-tapping thread 921 makes the amniotic cavity segment sheath It becomes very easy for the front end of 920 to penetrate into the thin and tough fetal membranes. After entering the amniotic cavity, the combined sheath 900 can be rotated and advanced to precisely adjust the depth and speed of the combined sheath 900 inserted into the amniotic cavity.

In addition, it can also cooperate with the membrane puncher 800. For example, when inserting the combined sheath 900, keep the membrane puncher 800 still or slightly pull the membrane puncher 800 upwards, which is equivalent to removing the membrane puncher 800 from the local membrane. The amniotic segment sheath 920 of the combined sheath 900 exerts an inward thrust and the attacking force of the second self-tapping thread 921 by applying an outward thrust, so that the amniotic segment sheath 920 can be inserted into the amniotic cavity more easily. Of course, the insertion of the combination sheath 900 is performed under ultrasound guidance so as to ensure that the fetus is not harmed.

As shown in FIG. 22 , a combination sheath 900 according to an embodiment of the present application may include an abdominal wall segment sheath 910 , an amniotic cavity segment sheath 920 , an outer guard 930 , and a sheath cavity 950 , and the outer guard 930 is provided with multiple Locking hole 931. The combined sheath 900 can also include a camera module 940, which can include a camera, a circuit, a lighting lamp, a power supply, and a wireless communication component, wherein the camera is set at the front end of the amniotic segment sheath 920, and can be used for real-time observation of the amniotic membrane Amniotic membrane, amniotic fluid, placenta, and fetus in the cavity.

Referring to Fig. 23 and Fig. 24, a solution of a fixed connection joint sheath 900 according to the embodiment of the present application.

As shown in FIG. 23 , making the abdominal wall and uterine wall amniotic cavity access device may also include a bracket 500 next to the operating table and an operating table 600 (not shown). Wherein, while the tableside support 500 can be rigidly connected with the operating table 600 (not shown), the tableside support 500 can also pass the first fastening assembly 931-1, the second fastening assembly 931-2, the third fastening assembly The fastening component 931-3, the fourth fastening component 931-4 establish a rigid and stable connection with a plurality of locking holes 931 on the corresponding outer guard plate 930. In this way, the joint sheath 900, the bracket 500 next to the operating table, and the operating table 600 can be realized. ((not shown), the joint sheath 900 can provide a stable support point for the mechanical arm and medical instruments that need to enter the amniotic cavity to perform fetal surgery.

It should be noted that a plurality of locking holes 931 on the outer guard plate 930 of the combination sheath 900 are usually left to allow the first fastening component 931-1, the second fastening component 931-2, the third fastening component 931-3, The fourth fastening component 931-4 moves within a certain range to adjust the space. In addition, the support 500 next to the operating table can be in a square, rectangular, circular or oval structure. If the support 500 next to the operating table is a square or rectangular structure, the distance between each frame can be moved and adjusted within a certain range. The bracket 500 is a circular or elliptical structure, and its inner diameter allows movement and adjustment within a certain range, so as to adapt to the combination sheath 900 of different specifications and meet the needs of different body types.

As shown in Figure 24, after the combined sheath 900 is inserted into the amniotic cavity of the abdominal wall and uterine wall, and the channels of the abdominal wall, uterine wall, and amniotic cavity are perfectly constructed, the locking holes 931-5, 931-5, The locking hole 931-6, the locking hole 931-7, and the locking hole 931-8 are sutured and fixed on the abdominal skin of the mother, thereby achieving the effect of fixing the joint sheath 900.

According to an embodiment of the present application, a procedure for making an amniotic cavity passage in the abdominal wall and uterine wall includes the following steps.

In step a, select and mark the positions for making holes in the abdominal wall and uterine wall, and use the abdominal wall and uterine wall hole maker to make holes in the abdominal wall and uterine wall under the guidance of ultrasound.

In step a, with the help of ultrasonic detection, observe the fetal position, amniotic fluid volume, and placental position. If the placenta can be avoided, the mother's navel or the navel is the first choice as the perforation site. as a perforation site.

Usually, it is necessary to refer to the size of the abdominal wall hole and the uterine wall hole that are expected to be used, as well as the thickness of the maternal abdominal wall, to select the appropriate model of the abdominal wall uterine wall hole maker.

Step b, ultrasound guidance combined with direct vision, through the hole in the abdominal wall and the uterine wall, insert the membrane puncher, after the drill tip of the membrane puncher touches the membrane, rotate the handle of the membrane puncher , and advance the membrane punch into the amniotic cavity.

In step b, when rotating the perforator, the doctor gently twists the handle of the perforator and observes the advancement of the drill tip at all times to ensure a safe distance from the fetus and avoid accidental injury to the fetus.

Usually, it is necessary to refer to the size of the abdominal wall hole and the uterine wall hole that are expected to be used, as well as the thickness of the maternal abdominal wall, to select the appropriate type of membrane puncher.

Step c, under the guidance of ultrasound and direct vision, the combined sheath is inserted through the handle of the fetal membrane puncher into the hole in the abdominal wall and the hole in the uterine wall, and the front end of the sheath in the amniotic cavity is close to the fetal membrane.

Usually, it is necessary to refer to the size of the abdominal wall hole and the uterine wall hole that are expected to be used, as well as the thickness of the maternal abdominal wall, to select the appropriate combination sheath model.

Step d, through ultrasound guidance and observing the images taken by the camera at the front end of the amniotic segmental sheath, gently lift up the amniotic membrane puncher, and at the same time, rotate and advance the joint sheath, so that the amniotic segmental sheath enters the amniotic cavity.

Usually, the amniotic sheath of the combined sheath is advanced into the amniotic cavity by 0.5 cm to 1.0 cm to ensure a safe distance from the fetus.

In step e, the operator fixes the combined sheath with one hand, and gently withdraws the membrane perforator with the other hand.

In step f, the combined sheath is rigidly and stably connected to the operating table bracket, or the combined sheath is sutured and fixed to the skin of the mother's abdomen.

The above is only the embodiment of the application, and does not limit the technical scope of the application in any way. Therefore, any minor modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the application still belong to the application. within the scope of the technical program. Those skilled in the art should realize that skilled artisans may use different methods to implement the described functions for each specific application, but such implementation should not be regarded as exceeding the scope of the present application.

Claims (17)

1. A device for establishing a amniocentesis channel through a mother body, which is used for manufacturing an amniocentesis channel through the mother body to provide an operation channel for implementing intrauterine minimally invasive fetal surgery treatment, and is characterized by comprising:

a transcompartmental vaginal and fetal membrane puncture assembly for constructing a transcompartmental vaginal amniotic cavity minimally invasive pathway; and/or

A percutaneous abdominal wall uterine fetal membrane puncture component used for constructing a percutaneous umbilical region or abdominal wall amniotic cavity minimally invasive passage.

2. The device for transcompartmental creation of a amniotic cavity passageway according to claim 1, wherein said transcompartmental vaginal fetal membrane puncture assembly comprises:

the vaginal speculum is used for expanding the vagina and carrying out cervical dilatation operation under direct vision, and comprises a handheld vaginal expander and a light source module;

the cervical dilator is used for improving the cervical dilation efficiency and comprises a cervical dilation rod and an air bag module;

the fetal membrane puncture outfit is used for controlling the propelling distance of the fetal membrane puncture outfit and assisting the vaginal and cervical dilator to be inserted into a amniotic cavity and comprises a first self-tapping thread, and the first self-tapping thread is arranged at a puncture end;

the vagina and cervix dilator is used for establishing a passage penetrating through a vagina, a cervix and a fetal membrane, and comprises a combined sheath, a one-way valve and a fastening component.

3. The apparatus for maternally establishing a amniotic cavity passageway according to claim 2, wherein the balloon module comprises a balloon body, a tube, an injection pot, the balloon body surrounding and secured to the cervical dilating rod.

4. The device for maternally creating a amniotic cavity passageway according to claim 2, wherein the piercing tip is conical and the first self-tapping thread is provided on an anterior segment of the piercing tip.

5. The device for maternally establishing a amniotic cavity passageway according to claim 2, wherein the combination sheath comprises:

the vagina section sheath is used for expanding and supporting the vagina, accommodating a cervical outer section mechanical arm of the surgical robot and protecting the vulva and the vagina wall;

the cervical section sheath is used for expanding and supporting the cervical tube, and protecting the cervical opening and the cervical wall through the mechanical arm and the surgical instrument of the intrauterine section of the surgical robot;

the amniotic cavity segment sheath is used for protecting the amniotic cavity rupture port.

6. The device for maternally establishing a amniotic cavity channel according to claim 5, wherein a detachable interface is provided between the vaginal segment sheath and the cervical segment sheath, and the detachable interface comprises a threaded nut or a snap ring buckle.

7. The apparatus according to claim 5, wherein at least one camera module is disposed at the front end of the sheath of the amnion lumen segment for observing amnion, amniotic fluid, placenta, and fetus in the amnion lumen.

8. The device for maternally creating an amniotic cavity passageway according to claim 7, wherein the forward end of the amniotic cavity segment sheath includes a second self-tapping thread.

9. A device for maternal passage of a amniotic chamber according to claim 1, wherein said maternal abdominal wall endometrium puncture assembly comprises:

the abdominal wall and uterine wall hole making device is used for making holes in the abdominal wall and the uterine wall;

the fetal membrane borer is used for manufacturing holes in the fetal membrane;

the combined sheath is used for establishing a channel penetrating through an abdominal wall, a uterine wall and a fetal membrane and comprises an abdominal wall uterine wall section sheath and an amniotic membrane cavity section sheath.

10. The apparatus for maternally establishing a amniotic cavity passageway according to claim 9, wherein the fetal membrane drill includes a handle, a drill bit including a first self-tapping thread disposed at a forward end of the drill bit.

11. The apparatus for maternally establishing a amniotic cavity passageway according to claim 9, wherein the abdominal wall intrauterine wall sheath is used to open the abdominal wall and uterine wound, through a surgical robotic intrauterine arm and surgical instruments.

12. The maternal passage way to an amniotic chamber according to claim 11, wherein the abdominal wall segment sheath comprises an outer sheath comprising a fastening component.

13. The apparatus for maternally creating an amniotic cavity passageway according to claim 12, wherein the amniotic cavity section sheath includes a second self-tapping thread disposed on the exterior sidewall of the forward end of the amniotic cavity section sheath.

14. The apparatus according to claim 13, wherein the amnion lumen sheath comprises a camera module, the camera module comprises at least one camera, and the camera is disposed at a front end of the amnion lumen sheath for observing amnion, amniotic fluid, placenta, and fetus.

15. A method of creating a amniotic cavity passageway through a mother, comprising:

constructing a transvaginal amniotic cavity passage by adopting a transvaginal fetal membrane puncture assembly;

the amniocentesis assembly is used for constructing a path through the umbilical region or the abdominal wall of a parent body by adopting a puncture assembly through the abdominal wall and the endometrium of the parent body.

16. The method for transvaginal establishment of a amniotic fluid cavity passageway of claim 15, wherein said constructing a transvaginal vaginal amniotic fluid cavity passageway using a transvaginal vaginal fetal membrane puncture assembly comprises:

the vaginal speculum expands the vagina, the cervical dilator is placed, the air bag module is inflated or filled with water, and the cervical canal is expanded;

taking out the cervical dilator, placing the fetal membrane puncture outfit into the cervical dilator, enabling the fetal membrane puncture outfit to touch the amniotic sac, rotating the fetal membrane puncture outfit, and pushing the fetal membrane puncture outfit into the amniotic cavity;

a vaginal and cervical dilator is arranged, the handle of the fetal membrane puncture outfit passes through the one-way valve, and the front end of the amnion cavity sheath is close to the amniotic sac;

withdrawing the vaginal speculum;

rotationally pushing the vaginal and cervical dilator to enable the amnion cavity sheath to enter the amnion cavity and exit the fetal membrane puncture device;

the fastening component is rigidly and stably connected with the operating table bracket.

17. The method for maternal creation of a amniotic cavity channel according to claim 15, wherein said constructing a maternal umbilical region or abdominal wall amniotic cavity access using a maternal abdominal wall uterofetal membrane puncture assembly comprises:

the fetal membrane borer is arranged in the fetal membrane borer after penetrating through an abdominal wall hole and a uterine wall hole, the front end of the fetal membrane borer touches a fetal membrane, a handle of the fetal membrane borer is rotated, and the fetal membrane borer is pushed into a amniotic cavity;

the combined sheath passes through a fetal membrane drill and is inserted into an abdominal wall hole and a uterine wall hole, and the front end of the amniotic cavity section sheath is close to a fetal membrane;

slightly lifting the fetal membrane borer upwards, and simultaneously rotationally pushing the combined sheath to enable the amnion cavity section sheath to enter the amnion cavity;

withdrawing the fetal membrane borer;

the combined sheath is rigidly and stably connected with a side bracket of the operating table, or the combined sheath is sewed and fixed on the abdominal skin.

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