CN115737085A

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

Info

Publication number: CN115737085A
Application number: CN202211495427.4A
Authority: CN
Inventors: 王忠堂; 于福林
Original assignee: Accuragen Inc
Current assignee: Accuragen Inc
Priority date: 2022-11-27
Filing date: 2022-11-27
Publication date: 2023-03-07

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 establishing amniotic cavity channel through mother body and use method thereof

Technical Field

The invention relates to the field of medical instruments, in particular to a device for manufacturing a amniotic cavity channel established by a mother body and a use method thereof.

Background

The incidence rate of birth defects of the fetus is 4 to 6 percent, and the birth defects become important public health and social problems all over the world. Compared with the post-natal deformity correction, the intrauterine surgical correction of the congenital deformity has various advantages, including that the maternal placenta provides safe support, the delay or death of the intrauterine development of the fetus is avoided, the scar of the operative area is not obvious, and the psychological and financial burden of a family is reduced.

Clinical data in recent 30 years have shown that fetal surgery does not provide satisfactory results in correcting birth defects due to high incidence of premature birth caused by premature labor resulting from premature placental stripping and contraction of the mother's uterus after surgery.

Existing fetal surgery includes at least the following disadvantages, including: (1) Dissecting to extract partial amniotic fluid, taking out fetus, and inducing uterus contraction; (2) The fetus is taken out by cutting open the uterus, the placenta is damaged inevitably, and the early stripping of the placenta is easily induced; (3) The fetus completely or partially leaves the mother uterus, so that the fetus is separated from the uterus and is safely protected by amniotic fluid, and the fetus is potentially damaged; (4) Although the abdominal and uterine trauma can be reduced by laparoscopic surgery, the fetus swims in the uterus, defects or deformities are difficult to expose, and the difficulty of the surgery is greatly increased.

The fundamental reason for the deficiencies of the above prior art is that the surgical trauma is large. If a fetal intrauterine minimally invasive surgery passage is constructed through a mother body, such as a single-hole or multi-hole channel of a vagina cervix, a navel and an abdominal wall of a natural cavity, the damage to the mother body uterus and the placenta can be avoided or reduced, and the incidence rate of premature delivery caused by the premature dehiscence of a placenta and the contraction of the mother body uterus after surgery is reduced.

Disclosure of Invention

The technical problem to be solved.

Provides a medical appliance used for manufacturing a amnion cavity access for carrying out the intrauterine minimally invasive operation treatment of a fetus through a cervical natural cavity, a navel or an abdominal wall.

The second technical proposal.

The device for establishing the amniotic cavity channel through the mother body is used for manufacturing a transcompartmental amniotic cavity channel to provide an operation channel for implementing the intrauterine minimally invasive surgical treatment of the fetus, and comprises a transcompartmental vaginal and amniotic cavity puncture assembly for constructing the transcompartmental vaginal and amniotic cavity channel; and a mother abdominal wall uterine fetal membrane puncture assembly used for constructing a passage through a mother umbilical region or an abdominal wall amniotic cavity.

The medical instrument set for manufacturing the cervical natural cavity comprises a vaginal speculum, a cervical dilator, a fetal membrane puncture device and a vaginal and cervical dilator. The vaginal speculum comprises a handheld vaginal dilator and a light source module, and is used for dilating a vagina and implementing cervical dilation operation under direct vision; the cervical dilator comprises a cervical dilating rod and an air bag module and is used for improving the cervical dilating efficiency; the front end of the fetal membrane puncture outfit is provided with self-tapping threads for controlling the propelling distance of the fetal membrane puncture outfit and assisting the vaginal cervix dilator to be inserted into the amniotic cavity; the vagina and cervix dilator comprises a combined sheath, a one-way valve and a fastening assembly, wherein the combined sheath is used for establishing a channel penetrating through a vagina, a cervix and a fetal membrane, the one-way valve is used for preventing amniotic fluid from flowing outwards, and the fastening assembly is used for being connected with an operating table bracket so as to further stabilize the vagina and cervix dilator.

Preferably, the light source module comprises a battery, LED lamps, a circuit and a switch, wherein the switch is disposed on a handle of the handheld vaginal speculum, the number of the LED lamps can be multiple, and the LED lamps can also be replaced by cold light source lamps.

Preferably, the light source module is detachably connected with the handheld vaginal speculum, so that the vaginal speculum can be manufactured by a conventional handheld vaginal speculum.

Preferably, the gasbag module includes utricule, pipeline, injection kettle, the utricule wraps and is fixed in cervical dilating stick, cervical dilating stick includes handheld end, cervical dilating end diameter is no more than 3 millimeters, the injection kettle is used for connecting the syringe needle.

Preferably, the fetal membrane puncture outfit comprises a handle and a puncture end, wherein the puncture end is conical and is provided with self-tapping threads, and the thread distance is close to the thickness of the fetal membrane wall, and is usually 0.1-0.25 mm.

Preferably, the combined sheath comprises a vaginal sheath, a cervical sheath and an amniotic cavity sheath, wherein the vaginal sheath is used for expanding and supporting the vagina, is used for accommodating a surgical robot cervical mechanical arm and protecting the vulva and the vaginal wall; the cervical section sheath is used for expanding and supporting a cervical tube and protecting a cervical opening and a cervical wall through an intrauterine section mechanical arm of a surgical robot and a surgical instrument; the amniotic cavity section sheath penetrates through the amniotic cavity and extends into the amniotic cavity to protect the rupture port of the amniotic cavity.

Preferably, a detachable interface is arranged between the vagina segment sheath and the cervical segment sheath, and is used for separating and combining the vagina segment sheath and the cervical segment sheath. The detachable interface comprises a bolt and a nut, a clamping ring or a buckle.

Preferably, the far end of the amnion cavity sheath is provided with at least one camera module, and the camera module comprises a camera, a circuit, a lighting lamp, a power supply and a wireless communication component and is used for observing amnion, amniotic fluid, placenta and fetus in the amnion cavity.

Preferably, the medical instrument set for manufacturing the cervical natural cavity can also comprise an operating table and a support beside the operating table.

The device for manufacturing the amniotic cavity access device comprises a puncture device and a combined sheath, wherein the puncture device comprises an abdominal wall uterine wall perforator and a fetal membrane borer, the abdominal wall uterine wall perforator is used for manufacturing holes in an abdominal wall and a uterine wall, the fetal membrane borer is used for puncturing a fetal membrane and assisting the combined sheath to be inserted into an amniotic cavity, and the combined sheath comprises an abdominal wall uterine wall section sheath and an amniotic cavity section sheath and is used for establishing a channel penetrating through the abdominal wall, the uterine wall and the fetal membrane.

Preferably, the fetal membrane drill includes a handle, a drill bit.

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

Preferably, the thread pitch of the self-tapping threads is 0.1 mm to 0.25 mm, and the thread height of the self-tapping threads is not more than 2 mm.

Preferably, the combined sheath comprises an abdominal wall section sheath and an amniotic cavity section sheath, wherein the abdominal wall section sheath is used for expanding and supporting the navel or the abdominal incision and protecting the navel or the abdominal incision through an intrauterine mechanical arm of a surgical robot and surgical instruments; the amniotic cavity section sheath penetrates through the amniotic cavity and extends into the amniotic cavity to protect the rupture port of the amniotic cavity.

Preferably, the abdominal wall section sheath is used for protecting the abdominal wall and the uterine wound through an intrauterine section mechanical arm of a surgical robot and surgical instruments.

Preferably, the abdominal wall segment sheath comprises an outer sheath comprising a fastening assembly for rigidly coupling the union sheath with an operating table side support.

Preferably, the amniotic cavity segment sheath is used for penetrating the fetal membrane and extending into the amniotic cavity to protect the amniotic cavity from being split.

Preferably, the amnion cavity section sheath comprises a second self-tapping thread, and the second self-tapping thread is arranged on the outer side wall of the front end of the amnion cavity section sheath.

Preferably, the amnion cavity sheath comprises a camera module, wherein the camera module comprises a circuit, a lighting lamp, a power supply, a wireless communication assembly and at least one camera and is used for observing amnion, amniotic fluid, placenta and fetus in the amnion cavity.

Preferably, the device for making the amniotic cavity access device of the abdominal wall and the uterine wall further comprises a support beside an operating table.

The method for establishing the amniotic cavity channel through the mother body comprises the steps of constructing a through-mother-body-vagina amniotic cavity channel by adopting a through-mother-body-vagina fetal membrane puncture assembly; and/or a percutaneous mother abdominal wall endometrium puncture assembly is adopted for constructing a percutaneous mother umbilical region or abdominal wall amniocentesis channel.

The process of using the medical instrument set for manufacturing the cervical natural cavity channel of one embodiment of the invention comprises the following steps.

Step 1, a vaginal speculum expands a vagina, a cervical dilator is placed under direct vision, an air bag is inflated or filled with water, the cervical dilation degree reaches or exceeds the expectation, and generally, the cervix can pass through a cervical dilation rod with the number of 10.5 or more.

And 2, taking out the cervical dilator under direct vision, placing the fetal membrane puncture device under ultrasonic guidance, enabling the fetal membrane puncture device to touch the amniotic sac, rotating the fetal membrane puncture device, and pushing the fetal membrane puncture device to stretch into the amniotic cavity, wherein the pushing distance is usually 0.5 cm to 1.5 cm, so that the safety distance between the fetal membrane puncture device and a fetus is ensured.

And 3, under the direct vision combined with the ultrasonic guidance, placing the puncture outfit into a vagina and cervix dilator, wherein the handle of the fetal membrane puncture outfit penetrates through the one-way valve, and the front end of the amniotic cavity sheath is close to the amniotic sac.

And 4, withdrawing the vaginal speculum.

And 5, pushing the vaginal and cervical dilator by ultrasonic detection and camera observation to enable the amnion cavity sheath to enter the amnion cavity and exit the fetal membrane puncture outfit.

And 6, rigidly and stably connecting the fastening assembly with the operating table bracket.

Preferably, step 1 is performed slowly while the balloon is inflated or filled with water.

Preferably, in step 3, the vaginal speculum may be withdrawn first and then the vaginal-cervical dilator may be placed.

Preferably, in step 5, the amnion cavity section sheath of the vaginal cervical spreader is pushed into the amnion cavity by 0.5 cm to 1.5 cm, so as to ensure the safety distance between the amnion cavity section sheath and the fetus.

The method for manufacturing the amniotic cavity access device comprises the following steps.

Step a, selecting positions of holes made in the abdominal wall and the uterine wall, preferably selecting navel or beside the navel or other parts of the abdomen if the positions can avoid the placenta, and respectively making the holes in the abdominal wall and the uterine wall by using abdominal wall uterine wall hole makers under the guidance of ultrasonic waves.

And b, under the ultrasonic guide combined direct vision, penetrating through the abdominal wall hole and the uterine wall hole, placing the fetal membrane borer, and rotating a handle of the fetal membrane borer and pushing the fetal membrane borer to extend into a amniotic cavity after the front end of a drill bit of the fetal membrane borer touches the fetal membrane.

And c, under the combination of ultrasonic guidance and direct vision, inserting the combined sheath into an abdominal wall hole and a uterine wall hole through a handle of the fetal membrane borer, and enabling the front end of the amniotic cavity section sheath to be close to the fetal membrane.

And d, slightly lifting and pulling the fetal membrane borer upwards through ultrasonic guidance and observation of images shot by a camera at the front end of the amnion cavity section sheath, and simultaneously, rotationally pushing the combined sheath to enable the amnion cavity section sheath to enter the amnion cavity.

And e, slightly withdrawing the fetal membrane borer.

And f, rigidly and stably connecting the combined sheath with a side support of the operating table, or suturing and fixing the combined sheath on the abdominal skin.

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

(III) the beneficial effects.

(1) The instrument set combination comprises a vaginal speculum, a cervical dilator, a fetal membrane puncture device and a vaginal cervical dilator, and can be used in a matched manner to efficiently and safely manufacture a passage for carrying out the operation treatment on the fetus in the uterus via a cervical natural cavity.

(2) The front end of the fetal membrane puncture outfit in the prior art is a round and blunt cone, the fetal membrane wall is thin and tough, when the fetal membrane is punctured, violence has to be relied on, the force and the propelling distance are not easy to control, and the fetal membrane can be torn in a large range or even hurt by mistake. The utility model provides a fetal membrane puncture ware sets up self tapping screw, rotates gently and can impale the fetal membrane, can accurate control fetal membrane puncture ware advancing speed and distance according to rotatory speed, has avoided the fetal membrane to tear on a large scale and the miscarriage fetus probably.

(3) The combined sheath of the vagina and cervix dilator can integrally penetrate through the vagina, the cervix and the fetal membranes, so that the structure of the instrument is simplified, and the operation efficiency is improved.

(4) The front end of the amnion cavity section sheath of the combined sheath of the vaginal cervix dilator is provided with self-tapping threads, when the vaginal cervix dilator is placed in, the self-tapping threads at the front end of the amnion cavity section sheath move forward, meanwhile, the self-tapping threads at the front end of the fetal membrane puncture outfit have the function of preventing local fetal membranes from sliding, the fetal membrane puncture outfit is slightly pulled outwards, and the self-tapping threads at the front end of the fetal membrane puncture outfit can also drive the local fetal membranes to move towards the direction of an operator, so that the amnion cavity section sheath can more easily enter the amniotic cavities.

(5) The front end of the amnion cavity sheath of the vagina-cervix dilator is provided with the camera module, so that a real-time image can be provided in the process of placing the vagina-cervix dilator, the human body is prevented from being accidentally injured by blind operation, and the dynamic conditions of the amnion, amniotic fluid, placenta and fetus in the amnion cavity can be observed in real time after the vagina-cervix dilator is placed into a mother body.

(6) The vagina and cervix dilator is provided with the one-way valve and the fastening component, the one-way valve can prevent amniotic fluid from flowing outwards, meanwhile, medical instruments or surgical robot mechanical arms can freely pass through, the fastening component can be rigidly connected with an operating table support, so that the vagina and cervix dilator is stable and fixed, and the vagina and cervix dilator can be used as a stable and firm supporting point of the surgical robot mechanical arms.

(7) The device for manufacturing the abdominal wall and uterine wall amniotic cavity passage comprises an abdominal wall and uterine wall hole maker, a fetal membrane borer and a combined sheath, wherein the abdominal wall and uterine wall hole maker is used for making holes in the abdominal wall and the uterine wall, the fetal membrane borer is inserted into the abdominal wall and uterine wall holes and penetrates into the fetal membrane, and then the combined sheath enters the amniotic cavity through the abdominal wall, the uterine wall and the fetal membrane holes, so that a passage penetrating through the abdominal wall, the uterine wall and the fetal membrane is constructed efficiently and conveniently, and the device is used for performing the surgical treatment of the intrauterine inner tube in the uterus by using a laparoscope technology or an operation robot.

(8) The diameter of the hole made on the abdominal wall, the uterine wall and the fetal membrane is usually not more than 3 cm, the damage to the uterus of the parent is slight, and the postoperative recovery is fast, so that the induction factor of the uterine contraction of the parent can be reduced.

(9) The diameter of a hole for manufacturing the fetal membrane is usually not more than 3 cm, the position of the placenta can be completely avoided, the placenta is not damaged, and factors for inducing premature rupture of the placenta can be reduced.

(10) The application of the instrument suite is simple in use process, safe and efficient, and provides a small-wound and fetus-friendly surgical condition for the fetus intrauterine operation, so that the treatment range of the fetus intrauterine operation is increased, and the human prenatal and postnatal care level is provided.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed to be used in the description of the embodiments are briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without inventive efforts.

Furthermore, the drawings are merely schematic illustrations of the present application and are not necessarily drawn to scale. The same reference numerals in the drawings denote the same or similar parts, and a repetitive description thereof will be omitted. Some of the block diagrams shown in the figures are functional entities that do not necessarily correspond to physically or logically separate entities, which may be implemented in one or more hardware modules or combinations of components.

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 view of another vaginal speculum according to the embodiment of the present application.

Fig. 3 is a schematic view of a vaginal speculum including multiple lamps in accordance with an embodiment of the present application.

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

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

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

Fig. 7 is a schematic view of another cervical dilator according to an 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 diagram of a simplified version of a cervical dilator according to an embodiment of the present application.

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

Fig. 11 is a schematic view of a puncture tip structure of a fetal membrane puncture outfit according to an embodiment of the present application.

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

Fig. 13 is a schematic structural view of a vaginal-cervical distractor including a camera module according to an embodiment of the present application.

Fig. 14 is a schematic view of a detachable combination structure of a vaginal section sheath and a cervical section sheath of the vaginal-cervical dilator according to an embodiment of the present application.

Fig. 15 is a schematic view of a detachable combination structure of a vaginal-segment sheath and a cervical-segment sheath of the second vaginal-cervical dilator according to the embodiment of the present application.

Fig. 16 is a schematic view of a detachable combination structure of a vaginal-segment sheath and a cervical-segment sheath of the third vaginal-cervical dilator according to the embodiment of the present application.

Fig. 17 is a schematic view of a connection structure of the vaginal cervical spreader and the operating table frame according to the embodiment of the present application.

FIG. 18 is a schematic diagram of a fetal membrane reamer construction according to an embodiment of the present application.

FIG. 19 is a schematic view of a configuration of a drill bit of a fetal membrane reamer according to an embodiment of the present application.

Fig. 20 is a schematic view of a combination sheath configuration according to an embodiment of the present application.

Figure 21 is a schematic view of an amniotic membrane lumen segment sheath configuration according to an embodiment of the present disclosure.

Figure 22 is a schematic view of another amniotic luminal segment sheath configuration according to an embodiment of the present application.

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

FIG. 24 is a schematic view of a combination sheath suture secured to abdominal skin in accordance with an embodiment of the present application.

Detailed Description

In order to make the objects, technical solutions and advantages of the present application more apparent, the present application is further described in detail with reference to the following embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the application and do not limit the application.

It should be noted that the terms of orientation such as up, down, left, right, etc. in the present embodiment are only relative concepts or reference to the normal use state of the product, and should not be considered as limiting.

Referring to fig. 1-16, a medical instrument kit for making a cervical natural orifice of an embodiment of the present application may include a vaginal speculum 100, a cervical dilator 200, a fetal membrane puncture device 300, and a vaginal cervical spreader 400.

As shown in fig. 1, a vaginal speculum 100 according to an embodiment of the present application may include a handheld vaginal speculum, a light source module.

The handheld vaginal speculum may include an upper peeping plate 110 and a lower peeping plate 120, the upper peeping plate 110 and the lower peeping plate 120 may be hinged by a rotating shaft 130, the tail end of the upper peeping plate 110 and the handle 121 of the lower peeping plate 120 may be provided with a threaded rod 140, and the opening and closing between the upper peeping plate 110 and the lower peeping plate 120 may be adjusted by the threaded rod 140 for dilating the vagina.

The light source module may include a battery 154, an LED lamp 151, a circuit 152, and a switch 153, wherein the switch 153 may be disposed on the handle 121 of the handheld vaginal speculum, the LED lamp 151 may be disposed on the inner side of the front section of the lower speculum plate 120, and the LED lamp 151 may also be replaced by a cold light source lamp. The handheld vaginal dilator expands the vagina, and an operator can perform cervical dilatation under direct vision by means of light rays provided by the light source module.

As shown in fig. 2, the battery 154 of the light source module of the vaginal speculum 100 according to an embodiment of the present application may also be disposed independently, or may be powered by an external power source.

As shown in fig. 3, a plurality of LED lamps 151 may be disposed in the light source module of the vaginal speculum 100 according to an embodiment of the present application, and the LED lamps 151 may be disposed on the inner side of the front section of the lower peeping plate 120 and the inner side of the front section of the upper peeping plate 110.

It is understood that the light source module can be detachably coupled to the handheld vaginal speculum, for example, the LED lamp 151 and the circuit 152 are adhered to the inner side of the upper speculum plate 110 and/or the lower speculum plate 120 of the conventional handheld vaginal speculum by using a sterile adhesive tape or glue, and the battery 154 and the switch 153 are left outside the conventional handheld vaginal speculum, so that the conventional handheld vaginal speculum or the disposable handheld vaginal speculum can also be used for performing the cervical dilatation under direct vision. Of course, the detachable light source module can also be designed simply, so that the disposable article becomes a low-cost disposable article.

In addition, the hand-held vaginal speculum may also be provided with a fixing assembly by means of which the hand-held vaginal speculum is rigidly connected to the bedside support, so that the operator can do something else with one hand.

As shown in fig. 4, a cervical dilator 200 according to an embodiment of the present application may include a cervical dilating rod and a balloon module, wherein the cervical dilating rod may include a handheld end 210 and a cervical dilating end 220, the balloon module may include a balloon 230, a pipeline 240 and an injection pot 250, the balloon 230 may surround and be fixed on the cervical dilating end 220, the injection pot 250 has a one-way valve effect, and the injection pot 250 may use a syringe to inject or withdraw gas or liquid, but the gas or liquid injected into the balloon 230 does not automatically overflow. It should be noted that the diameter of the cervical dilating end 220 is usually not more than 3 mm, the balloon 230 can be made of medical silica gel, and the wall of the balloon 230 is usually not more than 0.5 mm, so that the cervical dilating end 220 can be easily inserted into the mother's cervical canal without inflating the balloon 230.

As shown in fig. 5, a syringe needle (not shown) is inserted into the injection pot 250, and air or saline or artificial amniotic fluid is injected, and the air or saline or artificial amniotic fluid enters the balloon 230 through the tube 240, so that the balloon 230 is expanded, and cervical canal dilatation can be achieved. It should be noted that the volume of the medical silica gel material used for the balloon 230 can be at least 30 times larger, so as to achieve a sufficient cervical canal dilatation effect. The injector can be a high-pressure injector so as to reduce the injection difficulty.

In addition, when air, physiological saline or artificial amniotic fluid is injected into the capsule 230, the injection must be performed slowly and at a constant speed to prevent cervical injury due to too fast injection.

In addition, the whole process of inserting the cervical dilator 200 and injecting air, physiological saline or artificial amniotic fluid into the balloon 230 is preferably performed under direct vision and ultrasonic guidance, so that the position of inserting the cervical dilator 200 is relatively accurate, meanwhile, the dynamic change of the cervix is observed in real time, the speed of injecting air, physiological saline or artificial amniotic fluid into the balloon 230 is guided, and if the cervix is suddenly and rapidly dilated, part of air, physiological saline or artificial amniotic fluid can be pumped back, thereby preventing adverse effects such as permanent damage to the cervix and the like.

As shown in fig. 6, in the cervical end structure of the cervical dilator according to the embodiment of the present application, the balloon 230 is peripherally wrapped around the cervical dilating end 220, the first and second stop rings 260-2 and 260-2 can be respectively disposed at the front and rear parts of the cervical dilating end 220, and the first and second stop rings 260-2 and 260-2 can be made of high-hardness medical silica gel, can be fastened to the cervical dilating end 220, and can be moved along the cervical dilating end 220 under an external force.

Because of the great difference in the length of the cervical, the cervical dilator 200 with different lengths of the cervical dilating end 220 can be manufactured, but medical resources are wasted. According to the technical scheme, the accurate adjustment of the length of the capsule 230 can be realized by adjusting the first limiting ring 260-2 and the second limiting ring 260-2, the cervical dilatation requirements of different parent cervical lengths are met, and therefore medical resource waste is avoided.

As shown in fig. 7, a cervical dilator 200 according to an embodiment of the present application may include a cervical dilating rod, an air bag module, the cervical dilating rod may include a handheld end 210 and a cervical dilating end 220, the air bag module may include a bag body 230, a pipeline 240 and an injection pot 250, wherein the injection pot 250 may also be of a rod-shaped structure, so that a needle of the injection syringe may be inserted deeper, and the needle may not be pulled out, or the needle tip may be overflowed or overflowed, thereby improving the working efficiency.

It is understood that the cervical dilating rod may be made of high-strength polymer medical material, or the handle 210 may be made of hollow stainless steel tube, so as to reduce the weight of the cervical dilating rod. The tube 240 may be relatively thick so that the tube 240 does not deform significantly when inflated or filled.

In addition, as shown in fig. 8, the first and second position-limiting rings 260-2 and the airbag module can be designed and manufactured independently to obtain a reinforced airbag module, which at least includes a bag body 230, a pipeline 240, an injection pot 250, a first position-limiting ring 260-2 and a second position-limiting ring 260-2, and can be used for cervical dilatation in combination with a conventional cervical dilating rod. According to the ultrasonic examination result, the length of the cervical canal, the inner opening and the outer opening of the cervical canal of the mother can be known, and a proper conventional cervical dilating rod is selected, the second limiting ring 260-2 is sleeved on the cervical dilating end 220 of the conventional cervical dilating rod, then the bag body 230 is sleeved on the second limiting ring 260-2, then the first limiting ring 260-2 is sleeved on the bag body, and the distance between the first limiting ring 260-2 and the second limiting ring 260-2 is adjusted, so that the length of the long shaft of the bag body 230 at the cervical dilating end 220 is consistent with the length of the cervical canal which is expected to be dilated, and the cervical dilating operation can be implemented.

In addition, as shown in fig. 9, in addition to the reinforced version of the airbag module, a simplified version of the cervical dilator 200 can be obtained by combining the reinforced version of the airbag module with a cervical dilating tip 220 which is designed and manufactured independently. The simplified version of cervical dilator 200 may include a bladder 230, a tube 240, an injection pot 250, a first stop collar 260-2, a second stop collar 260-2, and a cervical dilating end 220. Wherein the tail end of the cervical dilating end 220 may include a engaging member 270, the engaging member 270 may establish a rigid coupling with the handle or may be firmly clamped by a clamping instrument. Thus, the manufacturing cost of the simplified cervical dilator 200 can be reduced, so that the cervical dilator 200 can be a disposable instrument.

As shown in fig. 10, a fetal membrane puncture instrument 300 of an embodiment of the present application may include a handle 310, a puncture tip 320. The handle 310 and the puncturing end 320 may be of an integral structure or may be a detachable rigid coupling. The handle 310 is typically no less than 20 cm in length, the piercing end 320 may be conical, the piercing end 320 is typically no less than 5 cm in length, and the thickest part of the piercing end 320 is typically no more than 2.5 cm in diameter.

As shown in fig. 11, the front end 321 of the puncture tip 320 of the fetal membrane puncture outfit 300 comprises first self-tapping threads 322, and the thread pitch of the first self-tapping threads 322 is close to the fetal membrane wall thickness, and is usually 0.1 mm to 0.25 mm. The first self-tapping thread 322 of the fetal membrane puncture outfit 300 makes it very easy to pierce the fetal membrane with thin and tough wall, and after entering the amniotic cavity, the fetal membrane puncture outfit 300 is rotationally pushed, so that the depth and speed of the fetal membrane puncture outfit 300 inserted into the amniotic cavity can be accurately controlled, and in addition, the vaginal cervix dilator 400 can be assisted to be inserted into the amniotic cavity. Of course, the operation of the fetal membrane puncture outfit 300 to perform fetal membrane puncture is performed under ultrasonic guidance so as to ensure the precision of fetal membrane puncture without injuring 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 either clockwise or counterclockwise. In addition, the most forward end of the piercing end 320 is the sharp portion of the first self-tapping thread 322, which is typically somewhat rounded in order to avoid accidental injury to the fetus. Further, the thread height of the first self-tapping threads 322 is generally not more than 2 mm.

As shown in fig. 12, a vaginal cervical distractor 400 of an embodiment of the present application may include a vaginal-segment sheath 410, a cervical-segment sheath 420, an amniotic-membrane-cavity-segment sheath 430, a one-way flap 440, and a guard 450, wherein the guard 450 includes a plurality of locking holes 451. Wherein, the vagina section sheath 410, the cervix uteri section sheath 420 and the amnion cavity section sheath 430 form a combined sheath for establishing a channel penetrating through vagina, cervix uteri and fetal membrane, the one-way valve 440 is used for preventing amniotic fluid from flowing outwards, and the locking hole 451 is used for being connected with the operating table bracket 500 so as to stabilize the vagina and cervix dilator 400.

It should be noted that the vaginal sheath 410 is generally a cylindrical or oblate cylindrical structure, generally having a diameter of not less than 5 cm and a length of not less than 15 cm, and is used for dilating and supporting the vagina, accommodating the mechanical arm of the cervical outer segment of the surgical robot, and protecting the vulva and the vaginal wall; the cervical sheath 420 is generally a cylindrical structure, generally having a diameter of not less than 1.5 cm and a length of not less than 2.5 cm, and is used for dilating and supporting the cervical canal and protecting the cervical opening and cervical wall by the surgical robot's mechanical arms and surgical instruments in the cervical region; the amniotic cavity segment sheath 430 is a generally cylindrical structure, typically not less than 1.5 cm in diameter and typically not less than 1.0 cm in length, for insertion through and into the amniotic cavity to protect the amniotic cavity opening.

As shown in fig. 13, a vaginal cervical spreader 400 according to an embodiment of the present disclosure may include a vaginal sheath 410, a cervical sheath 420, an amniotic luminal sheath 430, a one-way flap 440, and a guard 450, wherein the guard 450 includes a plurality of locking holes 451. The front end of the amnion cavity sheath 430 may include at least one camera module, the camera module may include a camera 460, a circuit 470, a lighting lamp (not shown), a power supply 480, and a wireless communication component (not shown), and the camera module may be used to observe amnion, amniotic fluid, placenta, and fetus in the amnion cavity.

As shown in fig. 13, a vaginal cervical spreader 400 according to an embodiment of the present disclosure may include a vaginal sheath 410, a cervical sheath 420, an amniotic luminal sheath 430, a one-way flap 440, and a guard 450, wherein the guard 450 includes a plurality of locking holes 451. The outer side sheath surface of the front end of the amniotic membrane cavity section sheath 430 can comprise second self-tapping threads 431, the thread pitch of the second self-tapping threads 431 is close to the thickness of a fetal membrane wall, usually 0.1-0.25 mm, the second self-tapping threads 431 enable the front end of the amniotic membrane cavity section sheath 430 to penetrate a fetal membrane with a thin and tough wall, and after entering the amniotic membrane cavity, the vaginal and cervical spreader 400 is rotationally pushed, so that the depth and the speed of the vaginal and cervical spreader 400 inserted into the amniotic membrane cavity can be accurately controlled. In addition, the device can also cooperate with the fetal membrane puncture outfit 300, for example, when the vaginal cervical dilator 400 is inserted, the fetal membrane puncture outfit 300 is kept still or the fetal membrane puncture outfit 300 is slightly pulled outwards, which is equivalent to applying an outward pushing force to a local fetal membrane, and the amniotic-membrane sheath 430 of the vaginal cervical dilator 400 applies an inward pushing force and an attacking force of the second self-tapping thread 431, so that the amniotic-membrane sheath 430 can be inserted into the amniotic cavity more easily. Of course, the vaginal-in cervical dilator 400 is operated under ultrasound guidance to ensure that the fetus is not injured.

As shown in fig. 14, a vaginal cervical spreader 400 according to an embodiment of the present disclosure may include a vaginal sheath 410, a cervical sheath 420, an amnion lumen sheath 430, a one-way flap 440, and a guard 450, wherein the guard 450 includes a plurality of locking holes 451. The cervical sheath 420 and the amniotic cavity sheath 430 are of an integrated structure, the vaginal sheath 410 and the cervical sheath 420 are of a detachable combined structure, the front end of the vaginal sheath 410 comprises an internally recessed auxiliary cylinder, the inner wall of the auxiliary cylinder comprises a first nut 411, the outer wall of the rear end of the cervical sheath 420 comprises a first bolt 421, the first bolt 421 is matched with the first nut 411, and the vaginal sheath 410 and the cervical sheath 420 can be combined into a combined sheath through the first bolt 421 and the first nut 411. In addition, by adjusting the depth of the first bolt 421 into the first nut 411, the functional length of the cervical sheath 420 can be adjusted to accommodate mothers with different cervical canal lengths.

As shown in fig. 15, a second vaginal cervical spreader 400 according to an embodiment of the present application may include a vaginal sheath 410, a cervical sheath 420, an amniotic luminal sheath 430, a one-way flap 440, and a guard 450, wherein the guard 450 includes a plurality of locking holes 451. The cervical sheath 420 and the amniotic cavity sheath 430 are of an integrated structure, the vaginal sheath 410 and the cervical sheath 420 are of a detachable combined structure, the front end of the vaginal sheath 410 comprises a convex attached cylinder, the inner wall of the attached cylinder comprises a second nut 412, the outer wall of the rear end of the cervical sheath 420 comprises a second bolt 422, the second bolt 422 is matched with the second nut 412, and the vaginal sheath 410 and the cervical sheath 420 can be combined into a combined sheath through the second bolt 422 and the second nut 412. In addition, by adjusting the depth of the second bolt 422 into the second nut 412, the functional length of the cervical sheath 420 can be adjusted to accommodate mothers with different cervical canal lengths.

As shown in fig. 16, the third vaginal-cervical distractor 400 of the present embodiment may comprise a vaginal-segment sheath 410, a cervical-segment sheath 420, an amniotic-membrane-cavity-segment sheath 430, a one-way flap 440, and a protector plate 450, wherein the protector plate 450 comprises a plurality of locking holes 451. The cervical sheath 420 and the amnion cavity sheath 430 are of an integrated structure, the vaginal sheath 410 and the cervical sheath 420 are of a detachable combined structure, the front end of the vaginal sheath 410 comprises an outer convex auxiliary cylinder, the inner wall of the auxiliary cylinder comprises at least one group of convex points 413, the outer wall of the rear end of the cervical sheath 420 comprises at least one circle of concave rings 423, the convex points 413 are matched with the concave rings 423, and the vaginal sheath 410 and the cervical sheath 420 can be rigidly connected through the convex points 413 and the concave rings 423 to form a combined sheath.

Referring to fig. 17, a vaginal-cervical dilator 400 according to an embodiment of the present application is rigidly connected to a beside-table frame 500 and an operating table 600. As shown in fig. 17, the medical instrument set for creating a cervical natural orifice may further include a beside-table support 500 and an operating table 600. The beside support 500 can be rigidly and stably connected to the operating table 600 by the first fastening assembly 610 and the second fastening assembly 620, and the beside support 500 can be rigidly and stably connected to the plurality of locking holes 451 on the guard plate 450 of the vaginal-cervical spreader 400 by the third fastening assembly 510, the fourth fastening assembly 520 and the fifth fastening assembly 530. Thus, rigid and stable connection among the vaginal cervical spreader 400, the beside-table support 500 and the operating table 600 can be realized, and further, the vaginal cervical spreader 400 can provide stable supporting points for mechanical arms and medical instruments which need to enter the amniotic cavity to perform fetal surgical treatment.

It should be noted that the locking holes 451 of the guard plate 450 of the vaginal cervical distractor 400 usually leave a space allowing the third fastening assembly 510, the fourth fastening assembly 520, and the fifth fastening assembly 530 to be adjusted within a certain range, the operating table 600 usually leaves a space allowing the first fastening assembly 610 and the second fastening assembly 620 to be adjusted within a certain range, and in addition, the beside support 500 may be a square, rectangular, circular, or oval structure, if the beside support 500 is a square or rectangular structure, the distance between the frames thereof is allowed to be adjusted within a certain range, and if the beside support 500 is a circular or oval structure, the inside diameter thereof is allowed to be adjusted within a certain range, so as to adapt to the vaginal cervical distractors 400 with different specifications, and meet the requirements of different body types.

The use of the instrument set for manufacturing the vaginal, cervical and amniotic cavity channels of the invention comprises the following steps.

Step 1, after anesthesia succeeds, the drape is disinfected, a doctor uses a vaginal speculum to expand a vagina, and the vagina and the external opening of the cervix are checked by means of a vaginal speculum light source.

And 2, pulling the front lip of the external cervical orifice by pliers, placing a cervical dilator with a proper specification into a cervical canal from the external cervical orifice under direct vision, ensuring that a sac body at the expansion end of the cervical dilator is completely positioned in the cervical canal section expected to need expansion under ultrasonic guidance, inflating or filling water in the sac body, monitoring the expansion state of the cervical canal in real time under ultrasonic guidance, and stopping inflating or filling water in the sac body when the expansion degree of the cervical canal reaches or exceeds the expectation. The degree of dilation of the cervical canal depends on the outer diameter of the cervical sheath of the vaginal cervical dilator intended to be placed, and the inner diameter of the cervical canal is typically not less than 1.5 cm after dilation, and can pass through a conventional cervical dilation stick of 10.5 or more numbers.

And 3, taking out the cervical dilator under direct vision, placing the fetal membrane puncture outfit under ultrasonic guidance, contacting the fetal membrane puncture outfit with a amniotic sac, rotating the fetal membrane puncture outfit, and pushing the fetal membrane puncture outfit to stretch into a amniotic cavity, wherein the pushing distance is usually 0.5 cm to 1.5 cm, so that the safety distance between the fetal membrane puncture outfit and a fetus is ensured.

And 4, under the direct vision combined with the ultrasonic guidance, placing the puncture outfit into a vagina and cervix dilator, wherein the handle of the fetal membrane puncture outfit penetrates through the one-way valve, and the front end of the amniotic cavity sheath is close to the amniotic sac.

And 5, withdrawing the vaginal speculum.

And 6, rotationally pushing the vaginal and cervical dilator through ultrasonic detection and camera observation, simultaneously slightly pulling the fetal membrane puncture device outwards, puncturing the fetal membrane by virtue of self-tapping threads of the amniotic cavity section sheath, so that the amniotic cavity section sheath enters the amniotic cavity, and then reversely rotating the fetal membrane puncture device, so that the fetal membrane puncture device is completely withdrawn.

And 7, finishing rigid and stable connection among the vaginal and cervical dilator, the beside-table bracket and the operating table.

It should be noted that, in step 2, the inflation or water filling of the balloon body is performed slowly, and if sudden and rapid dilation of the cervical canal is observed, the inflation or water filling of the balloon body can be suspended, or part of the gas or liquid in the balloon body can be pumped out, so as to avoid cervical injury.

In addition, in the step 4, the vaginal speculum can be withdrawn while the vaginal and cervical dilator is placed. In step 6, the amnion cavity section sheath of the vagina cervical dilator is pushed into the amnion cavity by a distance of 0.5 cm to 1.5 cm, so that the safety distance between the dilator and the fetus is ensured.

The device for manufacturing the amniotic cavity access of the abdominal wall can comprise a puncture device and a combined sheath, wherein the puncture device can comprise an abdominal wall uterine wall hole maker and a fetal membrane borer, the abdominal wall uterine wall hole maker can be used for making holes in the abdominal wall and the uterine wall, the fetal membrane borer can be used for puncturing the fetal membrane and assisting the combined sheath to be inserted into the amniotic cavity to construct a channel penetrating through the abdominal wall, the uterine wall and the fetal membrane.

Referring to fig. 18 and 19, a fetal membrane borer according to an embodiment of the present application is used to make a hole in a fetal membrane.

As shown in fig. 18, a fetal membrane reamer 800 of an embodiment of the present application may include a handle 810, a drill bit 820. The handle 810 and the drill bit 820 may be an integrated structure, and the handle 810 and the drill bit 820 may also be detachable and combined independent components, and are usually made of stainless steel, titanium alloy or high-temperature and high-pressure resistant polymer engineering plastics and other materials.

Handle 810 may be a round rod-like structure, typically having a diameter of no more than 1 cm and a length of no less than 15 cm, and the trailing end surface of handle 810 is typically textured to facilitate finger twirling of rotating fetal membrane reamer 800.

As shown in fig. 19, a drill bit 820 of a fetal membrane borer 800 according to an embodiment of the present invention may include a tip portion 821, a body portion 822, and a tail portion 823, wherein first self-tapping threads 824 are provided on front surfaces of the tip portion 821 and the body portion 822, a thread pitch of the first self-tapping threads 824 is 0.1 mm to 0.25 mm, and a thread height of the first self-tapping threads 824 is not more than 2 mm. In addition, the direction of the thread rotation of the first self-tapping threads 824 may be marked on the handle 810 for ease of reference by the physician during the procedure.

The drill bit 820 is typically no more than 2.5 cm in length, with the tip 821 being conical, typically no more than 0.5 cm in length, the body 822 typically no more than 1.5 cm in length, the tail 823 typically no more than 0.5 cm in length, and the mid-rear section of the body 822 typically being a rounded smooth structure, with the thickest diameter being no less than 1.5 cm.

The physician may insert the drill bit 820 into the amniotic cavity by slightly rotating the handle 810 with reference to the thread rotation direction of the first self-tapping threads 124 identified on the handle 810, thereby puncturing the fetal membrane by means of the first self-tapping threads 824 of the tip 810 and body 822 of the fetal membrane borer 800.

Referring to fig. 20-22, a combination sheath of one embodiment of the present application is used to access the amniotic cavity via the umbilicus or abdomen to create an abdominal wall uterine cavity channel.

As shown in fig. 20, a combination sheath 900 according to an embodiment of the present application may include an abdominal wall uterine wall section sheath 910, an amniotic cavity section sheath 920, an outer sheath 930, and a sheath cavity 950, wherein the outer sheath 930 is disposed at the tail end of the abdominal wall uterine wall section sheath 910, the outer sheath 930 may be in a shape of a leaflet or a disk, and the outer sheath 930 is provided with a plurality of locking holes 931 for suture fixation or rigid coupling of locking components.

The abdominal wall section sheath 910 and the amniotic cavity section sheath 920 are generally cylindrical, the inner diameter of the sheath cavity 950 is generally not less than 1.5 cm, the length of the abdominal wall section sheath 910 is generally not less than 5 cm, and the length of the amniotic cavity section sheath 920 is generally not less than 1 cm. The abdominal wall uterine wall section sheath 910 is used for expanding and supporting the abdominal wall uterine wall holes, and is used for accommodating surgical robot mechanical arms and protecting the abdominal wall and the uterine wall. The amnion cavity sheath 920 is used for expanding and supporting a fetal membrane hole, and protecting a fetal membrane wound through an intrauterine mechanical arm of a surgical robot and surgical instruments.

Of course, the combined sheath 900 may also be provided with a plurality of specification models classified according to the lengths of the abdominal wall uterine wall section sheath 910 and the amniotic membrane cavity section sheath 920 and the inner diameter of the sheath cavity 950, so as to meet the requirements of different human bodies and mechanical arms of surgical robots.

As shown in fig. 21, a combination sheath 900 according to an embodiment of the present application may include an abdominal wall uterine wall sheath 910, an amniotic cavity sheath 920, an outer sheath 930, and a sheath cavity 950, wherein the outer sheath 930 is provided with a plurality of locking holes 931. The amnion cavity section sheath 920 can comprise second self-tapping threads 921, the thread pitch of the second self-tapping threads 921 is close to the thickness of a fetal membrane wall, usually 0.1 mm-0.25 mm, the second self-tapping threads 921 enable the front end of the amnion cavity section sheath 920 to penetrate into the fetal membrane with thin wall and tough fetal membrane, after the amnion cavity enters, the combined sheath 900 is rotationally pushed, and the depth and speed of the combined sheath 900 inserted into the amnion cavity can be accurately adjusted.

Alternatively, the fetal membrane broach 800 may be operated in conjunction with, for example, the fetal membrane broach 800 being held stationary or pulled slightly upward during insertion of the combination sheath 900, which may correspond to an outward pushing force on the local fetal membrane, the amniotic membrane cavity section sheath 920 of the combination sheath 900 applying an inward pushing force and a tapping force of the second self-tapping thread 921, so that the amniotic membrane cavity section sheath 920 may be inserted into the amniotic membrane cavity more easily. Of course, the insertion union sheath 900 is operated under ultrasound guidance to ensure that the fetus is not injured.

As shown in fig. 22, a combination sheath 900 according to an embodiment of the present application may include an abdominal wall uterine wall sheath 910, an amniotic cavity sheath 920, an outer sheath 930, and a sheath cavity 950, wherein the outer sheath 930 is provided with a plurality of locking holes 931. The combined sheath 900 may further include a camera module 940, and the camera module 940 may include a camera, a circuit, a lighting lamp, a power supply, and a wireless communication component, wherein the camera is disposed at the front end of the amnion cavity sheath 920, and may be used to observe the conditions of the amnion, amniotic fluid, placenta, and fetus in the amnion cavity in real time.

Referring to fig. 23 and 24, a fixed connection unification sheath 900 version of the present application embodiment.

As shown in fig. 23, the device for making the amniotic cavity access device for the abdominal wall and the uterine wall can further comprise a beside-operation-table bracket 500 and an operation table 600 (not shown). The beside support 500 can be rigidly coupled to the operating table 600 (not shown), and the beside support 500 can be rigidly and stably coupled to the plurality of locking holes 931 on the corresponding outer protection plate 930 through the first fastening assembly 931-1, the second fastening assembly 931-2, the third fastening assembly 931-3, and the fourth fastening assembly 931-4, so that the combined sheath 900, the beside support 500, and the operating table 600 (not shown) can be rigidly and stably coupled to each other, and the combined sheath 900 can provide stable support points for mechanical arms and medical devices that need to enter the amniotic cavity to perform the fetal surgical treatment.

It should be noted that the plurality of locking holes 931 formed in the outer shield 930 of the joint sheath 900 generally leave a space allowing the first, second, third and fourth fastening members 931-1, 931-2, 931-3 and 931-4 to be adjusted within a certain range. In addition, the other support 500 of operating table can be square, rectangle, circular or oval structure, if the other support 500 of operating table is square or rectangular structure, the distance between its each frame is allowed to move the regulation within a certain limit, if the other support 500 of operating table is circular or oval structure, its internal diameter is allowed to move the regulation within a certain limit to adapt to the joint sheath 900 of different specifications, satisfy the human demand of different sizes.

As shown in FIG. 24, after the combination sheath 900 is placed into the amniotic cavity of the abdominal wall and uterine wall to construct the abdominal wall, uterine wall and amniotic cavity channel completely, the locking holes 931-5, 931-6, 931-7 and 931-8 of the outer guard 930 of the combination sheath 900 can be fixed to the abdominal skin of the mother body by sutures, thereby achieving the effect of fixing the combination sheath 900.

The process for manufacturing the amniocentesis access to the abdominal wall comprises the following steps.

And a, selecting and marking positions of holes made in the abdominal wall and the uterine wall, and making the abdominal wall holes and the uterine wall holes by using an abdominal wall and uterine wall hole maker under the guidance of ultrasonic waves.

In the step a, the body position, the amniotic fluid volume and the placenta position of the fetus are observed by means of ultrasonic detection, if the placenta can be avoided, the navel or the part near the navel of the mother is preferably selected as a perforation part, and if the placenta position is opposite to the navel or the part near the navel of the mother, other parts of the abdomen are selected as the perforation part.

The selection of an appropriate abdominal wall uterine wall perforator model is usually required with reference to the size and size of the abdominal wall cavity and uterine wall cavity expected to be used and the thickness of the maternal abdominal wall.

And b, under the direct vision of ultrasonic guidance, penetrating through the abdominal wall hole and the uterine wall hole, placing the fetal membrane borer, and rotating a handle of the fetal membrane borer and pushing the fetal membrane borer to extend into the amniotic cavity after the tip of a drill bit of the fetal membrane borer touches the fetal membrane.

In the step b, when the fetal membrane borer is rotated, a doctor slightly twists the handle of the fetal membrane borer and constantly observes the propelling condition of the tip of the drill bit, so that the safety distance between the fetal membrane borer and the fetus is ensured, and the fetus is prevented from being accidentally injured.

It is often necessary to select an appropriate model of the fetal membrane reamer with reference to the size of the abdominal wall cavity and uterine wall cavity that are expected to be used, and the thickness of the maternal abdominal wall.

The appropriate combination sheath type will generally need to be selected with reference to the size and dimensions of the abdominal and uterine wall cavities and the thickness of the maternal abdominal wall that are expected to be required.

Usually, the section of the amnion cavity of the combined sheath is advanced into the amnion cavity by a distance of 0.5 cm to 1.0 cm, so as to ensure a safe distance with the fetus.

Step e, the operator fixes the union sheath with one hand and gently withdraws the fetal membrane borer with the other hand.

And f, rigidly and stably connecting the combined sheath with the operating table bracket, or suturing and fixing the combined sheath on the abdominal skin of the parent.

The above description is only an example of the present application and is not intended to limit the technical scope of the present application, so that any minor modifications, equivalent changes and modifications made to the above example according to the technical essence of the present application are all within the technical scope of the present application. Those skilled in the art will recognize that the skilled in the art may use different methods to implement the described functionality for each particular application, but such implementation should not be considered beyond the scope of the present application.

Claims

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.