An amniotic sac protection device based on 3D printing and its preparation method

Abstract

The present invention provides an amniotic sac protection device based on 3D printing and a preparation method thereof. Among them, the amniotic sac protection device includes a sheath tube and a support sac formed by 3D printing; the support sac is detachably installed at the upper end of the sheath tube, and the inside of the support sac is a cavity; a liquid injection channel communicating with the internal cavity of the support sac is arranged in the sheath tube, and a liquid injection joint communicating with the liquid injection channel is further arranged at the liquid injection port of the liquid injection channel. The amniotic sac protection device has a simple structure, which is convenient for the disassembly and installation of the support sac and the sheath tube, has high surgical hygiene and safety, and the support sac can be personalized designed based on 3D printing of the support sac, can better meet the needs of cervical cerclage surgery for different patients, makes the surgical operation more convenient and efficient, and reduces the surgical risk.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to an amniotic sac protection device based on 3D printing and a preparation method thereof. Background Art

[0002] Cervical incompetence is also known as incomplete internal os of the cervix and relaxation of the cervical os. Patients with cervical incompetence will have painless dilation of the cervix in the second or third trimester of pregnancy, which may lead to the amniotic sac bulging into the vagina through the dilated cervical os, resulting in premature birth and repeated miscarriages in the second and third trimesters. Therefore, a cerclage operation is required on the external os of the cervix to narrow the cervical os and prevent the amniotic sac from being infected by vaginal bacteria and bulging into the vagina during the second and third trimesters, which may cause rupture of the fetal membranes.

[0003] However, since the amniotic sac has protruded into the vagina during the second and third trimesters of pregnancy, and the amniotic sac has a large tension and the vaginal field of view is small, it is easy to puncture the amniotic sac during cervical cerclage, resulting in premature birth or miscarriage. Therefore, to ensure the smooth progress of the cervical cerclage operation, an auxiliary device is needed to isolate the amniotic sac from the cervix, so as to facilitate the cervical cerclage operation and improve the success rate of the operation.

[0004] However, existing technologies often use auxiliary devices with fixed sizes and shapes to isolate the amniotic sac from the uterine cavity. For example, an amniotic sac pusher for cerclage provided by the patent application No. CN201420049277.9. However, the dilation of the cervical os of different patients is different, and there are also individual differences in the size and shape of the amniotic sac bulging into the vagina. Therefore, in the cervical cerclage operation, using existing auxiliary devices with fixed sizes and shapes cannot fully meet the needs of each patient, increasing the uncertainty during the operation, easily prolonging the operation time, and increasing the operation risk. Summary of the Invention

[0005] In order to solve the deficiencies of the existing technology, the present invention provides an amniotic sac protection device based on 3D printing. The amniotic sac protection device has a simple structure, is convenient for disassembling and installing the sac support and the sheath tube, has high surgical hygiene and safety, and the sac support can be customized based on 3D printing of the sac support, can better meet the needs of different patients for cervical cerclage operations, makes the operation more convenient and efficient, and reduces the operation risk.

[0006] The present invention also provides a preparation method for an amniotic sac protection device based on 3D printing.

[0007] To solve the above problems, the present invention discloses an amniotic sac protection device based on 3D printing, which includes a sheath tube and a sac support formed by 3D printing; the sac support is detachably installed at the upper end of the sheath tube, and the inside of the sac support is a cavity; a liquid injection channel communicating with the internal cavity of the sac support is provided in the sheath tube, and a liquid injection joint communicating with the liquid injection channel is further provided at the liquid injection port of the liquid injection channel.

[0008] Preferably, the supporting sac is spirally installed at the upper end of the sheath tube; a connecting piece communicating with the internal cavity is arranged at the bottom of the supporting sac, an external thread is arranged on the outer side wall of the connecting piece, and an internal thread matching the external thread is arranged on the inner side wall of the upper end of the sheath tube.

[0009] More preferably, a sealing ring is arranged at the threaded connection between the connecting piece and the sheath tube.

[0010] Preferably, the longitudinal section of the supporting sac is in an arc shape with the upper end extending outwards and the lower end contracting inwards, and the side surface of the supporting sac is in a fan shape.

[0011] Preferably, the amniotic sac protection device further comprises a pressure-sensitive retraction device, which includes a controller, a pressure-sensitive sensor, a telescopic tube, a warning lamp and / or an alarm. The telescopic tube is arranged inside the sheath tube, and the liquid injection channel is located inside the telescopic tube. The telescopic tube can extend out of the upper end surface of the sheath tube, so that the supporting sac is detachably installed on the extended telescopic tube. The liquid injection joint and the controller are located at the lower end of the telescopic tube. The pressure-sensitive sensor is arranged at the upper end of the telescopic tube, and the pressure-sensitive sensor, the warning lamp and the alarm are all electrically connected to the controller. The controller is provided with a preset pressure value. When the pressure-sensitive sensor detects that the pressure value at the upper end of the sheath tube is lower than the preset pressure value, the warning lamp and / or the alarm prompts the operator to control the telescopic tube at the upper end of the sheath tube to retract.

[0012] The present invention also discloses a preparation method of an amniotic sac protection device based on 3D printing, comprising the following steps:

[0013] S1. Collect 3D image data of the amniotic sac and cervix of a patient through an ultrasonic device;

[0014] S2. Import the 3D image data in step S1 into medical 3D printing modeling software, and perform three-dimensional modeling according to the collected 3D image data to obtain a three-dimensional reconstruction model of the amniotic sac and cervix;

[0015] S3. In the three-dimensional reconstruction model in step S2, obtain the size and shape information of the supporting sac according to the size and shape of the amniotic sac bulging out of the cervical orifice and the position of the cervical orifice to be sutured;

[0016] S4. According to the size and shape information of the supporting sac in step S3, construct a three-dimensional model of the supporting sac for assisting cervical cerclage surgery;

[0017] S5. Connect the medical 3D printing modeling software to a 3D printer, perform 3D printing on the three-dimensional model of the supporting sac in step S4 to obtain a formed supporting sac, and install the supporting sac on the upper end of the sheath tube.

[0018] Preferably, the material of the supporting sac is TPU rubber or silicone rubber.

[0019] Compared with the prior art, the present invention has the following advantages:

[0020] The structure of the amniotic sac protection device is simple, and the supporting sac is detachably installed at the upper end of the sheath tube, which is convenient for the disassembly and installation of the supporting sac and the sheath tube, thus facilitating the replacement of the supporting sac and ensuring the hygiene and safety of the operation. Moreover, the supporting sac can be quickly obtained by 3D printing according to the cervical os dilation conditions, the size and shape of the amniotic sac bulging into the vagina of different patients. The supporting sac can better meet the requirements of cervical cerclage surgery for different patients, making the operation more convenient and accurate, ensuring the smooth progress of cervical cerclage surgery, and thus reducing the surgical risk.

[0021] In addition, the longitudinal section of the supporting sac of the amniotic sac protection device is in an arc shape with the upper end extending outwards and the lower end contracting inwards, which can isolate and protect the supporting sac from the cervix from the outer side of part of the amniotic sac. The arc-shaped supporting sac is not obtrusive, and the amniotic sac is not likely to rupture during the isolation process. Moreover, the side surface of the supporting sac is in a fan shape. Compared with the traditional bowl-shaped supporting sac, during cervical cerclage, the supporting sac can specifically isolate and protect part of the amniotic sac near the cervical suture from the cervix. The contact area between the supporting sac and the amniotic sac and the cervix is small, the frictional damage is small, and the effective isolation area of the fan-shaped supporting sac on the side is large, which can effectively prevent the amniotic sac from being punctured, thus achieving the effect of protecting the amniotic sac, ensuring the smooth progress of cervical cerclage surgery, reducing the surgical risk, and especially being suitable for local cervical suture occasions. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 is a schematic structural diagram of the supporting sac and the sheath tube of the amniotic sac protection device after disassembly.

[0023] Explanation of the reference numerals in the drawings: 1 supporting sac; 2 connecting piece; 3 external thread; 4 sealing ring; 5 sheath tube; 6 graduation line; 7 pressure-sensitive retraction device; 8 controller; 9 pressure-sensitive sensor; 10 telescopic tube; 11 internal thread; 12 liquid injection channel; 13 liquid injection joint; 14 water stop valve. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0024] In order to make the above objects, features and advantages of the present invention more obvious and understandable, the present invention will be further described in detail below with reference to the drawings and specific embodiments.

[0025] A 3D printing-based amniotic sac protection device of the present invention, referring to Figure 1 , includes a sheath tube 5 and a supporting sac 1 located above the sheath tube 5 and formed by 3D printing.

[0026] Among them, the sac 1 can be rapidly obtained by 3D printing according to the cervical os dilation conditions of different patients, the size and shape of the amniotic sac bulging into the vagina. This personalized-designed sac 1 can better meet the requirements of cervical cerclage surgery for different patients, making the surgical operation more convenient and efficient, ensuring the smooth progress of cervical cerclage surgery, and thus reducing the surgical risk.

[0027] Specifically, the longitudinal section of this personalized-designed sac 1 is preferably an arc shape that extends outward at the upper end and contracts inward at the lower end, which can enable the sac 1 to isolate and protect the cervix from the outer side of part of the amniotic sac. This arc-shaped sac 1 is not obtrusive, and during the isolation process, the amniotic sac is not easily ruptured. Moreover, the bottom surface of the sac 1 with an arc-shaped longitudinal section can also lift and push the amniotic sac protruding into the vagina into the cervix to facilitate the smooth progress of cervical cerclage surgery.

[0028] In addition, preferably, the side surface of the sac 1 is fan-shaped. Compared with the traditional bowl-shaped sac 1, during cervical cerclage, this sac 1 can specifically isolate part of the amniotic sac near the cervical suture from the cervix. Thus, the contact area between the sac 1 and the amniotic sac and the cervix is small, the frictional damage is small, and the effective isolation area of the sac 1 with a fan-shaped side surface is large, which can effectively prevent the amniotic sac from being punctured, thereby achieving the effect of protecting the amniotic sac, ensuring the smooth progress of cervical cerclage surgery, reducing the surgical risk, and especially being suitable for local cervical suture occasions.

[0029] Among them, the inside of the sac 1 is a cavity, and the 3D-printed sac 1 is detachably installed at the upper end of the sheath tube 5. Specifically, a connecting piece 2 communicating with the internal cavity is provided at the bottom of the sac 1, and an external thread 3 is provided on the outer side wall of the connecting piece 2; a telescopic tube 10 is provided inside the sheath tube 5, the telescopic tube 10 extends out of the upper end surface of the sheath tube 5, and an internal thread 11 matching the external thread 3 is provided on the inner side wall of the telescopic tube 10 extending out of the upper end surface of the sheath tube 5. A liquid injection channel 12 communicating with the internal cavity of the sac 1 through the connecting piece 2 is also provided inside the telescopic tube 10, and a liquid injection joint 13 communicating with the liquid injection port of the liquid injection channel 12 is provided at the lower end of the telescopic tube 10. Among them, a water stop valve 14 is also provided on the liquid injection joint 13.

[0030] The structure of this amniotic sac protection device is simple, and through the structures of the external thread 3 of the connecting piece 2 and the internal thread 11 of the telescopic tube 10, the 3D-printed sac 1 can be spirally installed on the telescopic tube 10 at the upper end of the sheath tube 5, which is convenient for the disassembly and installation of the sac 1 and the sheath tube 5, thereby facilitating the replacement of the sac 1 and ensuring the hygiene and safety of the surgery.

[0031] When using this amniotic sac protection device, water or other liquids can be injected from the liquid injection joint 13, and then successively pass through the liquid injection channel 12 and the connecting member 2 to reach the internal cavity of the supporting sac 1. The size of the supporting sac 1 can be adjusted by injecting liquid. Then, the water stop valve 14 is closed, thus completing the liquid injection process of the supporting sac 1, making the size of the supporting sac 1 controllable and the application more flexible.

[0032] Wherein, to avoid liquid leakage, a sealing ring 4 is provided at the threaded connection between the connecting member 2 and the sheath tube 5. Specifically, the sealing ring 4 is arranged on the outer side wall of the connecting member 2. Thus, when the supporting sac 1 is spirally installed on the telescopic tube 10 at the upper end of the sheath tube 5, the sealing ring 4 can make the outer side wall of the connecting member 2 fit seamlessly with the inner side wall of the telescopic tube 10 under the action of external force, so as to avoid liquid leakage during the liquid injection process.

[0033] In addition, scale lines 6 are provided on the outer peripheral wall of the sheath tube 5, so that the surgical operator can estimate the inserted length of the sheath tube 5, which is convenient for the smooth progress of the operation.

[0034] In case of emergencies such as the rupture of the supporting sac 1, to prevent the upper end of the telescopic tube 10 of the sheath tube 5 from breaking through the amniotic sac due to a sudden decrease in pressure, thereby increasing the surgical risk of cervical cerclage, a pressure-sensitive retraction device 7 is also provided. The pressure-sensitive retraction device 7 includes a controller 8, a pressure-sensitive sensor 9, the telescopic tube 10 provided inside the sheath tube 5 as described above, a warning light and / or an alarm. The pressure-sensitive sensor 9 is arranged at the upper end of the telescopic tube 10, and the controller 8 is located at the lower end of the telescopic tube 10. The warning light and / or the alarm can be arranged on this amniotic sac protection device or outside this amniotic sac protection device. And no matter how the warning light and / or the alarm are arranged, the pressure-sensitive sensor 9, the warning light and the alarm are electrically connected to the controller 8. When in use, the controller 8 is electrically connected to an external terminal device (the warning light and / or the alarm can be arranged on the terminal device). The surgical operator first sets a preset minimum pressure value on the external terminal device. During the operation, when the pressure value at the upper end of the telescopic tube 10 monitored by the pressure-sensitive sensor 9 in real time is less than the preset minimum pressure value, it may indicate an emergency such as the rupture of the supporting sac 1. At this time, the warning light and / or the alarm prompt the operator to control the retraction of the telescopic tube 10 at the upper end of the sheath tube 5 to protect the amniotic sac and reduce the surgical risk. In addition, according to actual use requirements, a screw drive mechanism can be arranged between the telescopic tube 10 and the sheath tube 5. The screw drive mechanism is connected to a motor. When the pressure value at the upper end of the telescopic tube 10 monitored by the pressure-sensitive sensor 9 in real time is less than the preset minimum pressure value, the controller 8 can drive the motor to rotate by controlling the motor, so as to drive the screw to rotate, and then automatically retract the telescopic tube 10.

[0035] The present invention also relates to a preparation method of an amniotic sac protection device based on 3D printing, including the following steps:

[0036] S1. Collect 3D image data of the patient's amniotic sac and cervix using an ultrasonic device;

[0037] S2. Import the 3D image data in step S1 into a medical 3D printing modeling software (such as Arigin 3D), and perform three-dimensional modeling based on the collected 3D image data to obtain a three-dimensional reconstruction model of the amniotic sac and cervix;

[0038] S3. In the three-dimensional reconstruction model in step S2, obtain the size and shape information of the supporting sac 1 according to the size and shape of the amniotic sac bulging out of the cervical orifice and the position of the cervical orifice to be sutured;

[0039] S4. According to the size and shape information of the supporting sac 1 in step S3, construct a three-dimensional model of the supporting sac 1 for assisting cervical cerclage surgery;

[0040] S5. Connect the medical 3D printing modeling software to a 3D printer, and perform 3D printing on the three-dimensional model of the supporting sac 1 in step S4 to obtain a formed supporting sac 1, and install the supporting sac 1 on the upper end of the sheath tube 5.

[0041] The 3D-printed supporting sac 1 for assisting cervical cerclage surgery of the present invention has a simple structure, can effectively isolate the cervix and part of the amniotic sac at the cervical suture precisely, protect the amniotic sac, and can better meet the requirements of cervical cerclage surgery for different patients. The 3D-printed supporting sac 1 is modeled through the three-dimensional model reconstruction technology of medical 3D printing modeling software, and then formed by a 3D printer. Installing the supporting sac 1 obtained by 3D printing on the upper end of the above-mentioned sheath tube 5, the amniotic sac protection device is obtained. Applying this amniotic sac protection device as an auxiliary device in cervical cerclage surgery, the surgical operation is simpler and more accurate. Compared with traditional surgical methods, it is not easy to damage the amniotic sac, can shorten the operation time, reduce the surgical risk, and reduce the risk of surgical infection.

[0042] Among them, the material of the supporting sac 1 is TPU rubber or silicone rubber. More preferably, the material of the supporting sac 1 is TPU rubber.

[0043] Although the preferred embodiments of the embodiments of the present invention have been described, those skilled in the art can make additional changes and modifications to these embodiments once they know the basic creative concept. Therefore, the appended claims are intended to be construed to include the preferred embodiments and all changes and modifications falling within the scope of the embodiments of the present invention.

[0044] The above has introduced the technical solution provided by the present invention in detail. Specific examples are used herein to elaborate on the principle and implementation manner of the present invention. The description of the above embodiments is only used to help understand the method and its core idea of the present invention; at the same time, for those of ordinary skill in the art, according to the idea of the present invention, there will be changes in the specific implementation manner and application scope. In summary, the content of this specification should not be construed as a limitation to the present invention.

Claims

1. An amniotic sac protection device based on 3D printing, characterized in that, It includes a sheath tube and a sac formed by 3D printing; the interior of the sac is a cavity; a liquid injection channel communicating with the interior cavity of the sac is arranged inside the sheath tube, and a liquid injection joint communicating with the liquid injection channel is further arranged at the liquid injection port of the liquid injection channel; The longitudinal section of the sac is in an arc shape that extends outward at the upper end and contracts inward at the lower end. The shape of the upper end surface of the sac is a non-closed arc shape, and the side surface of the sac is in a fan shape; The amniotic sac protection device further includes a pressure-sensitive retraction device. The pressure-sensitive retraction device includes a controller, a pressure-sensitive sensor, a telescopic tube, a warning light, and an alarm. The telescopic tube is arranged inside the sheath tube, and the liquid injection channel is located inside the telescopic tube. The telescopic tube can extend out of the upper end surface of the sheath tube, so that the sac is detachably installed on the extended telescopic tube. The liquid injection joint and the controller are located at the lower end of the telescopic tube; the pressure-sensitive sensor is arranged at the upper end of the telescopic tube, and the pressure-sensitive sensor, the warning light, and the alarm are all electrically connected to the controller; the controller is provided with a preset pressure value. When the pressure-sensitive sensor detects that the pressure value at the upper end of the sheath tube is lower than the preset pressure value, the warning light and the alarm prompt the operator to control the telescopic tube at the upper end of the sheath tube to retract; The sac is spirally installed at the upper end of the telescopic tube; a connecting piece communicating with the internal cavity is arranged at the bottom of the sac, and an external thread is arranged on the outer side wall of the connecting piece. An internal thread matching the external thread is arranged on the inner side wall of the upper end of the telescopic tube; A sealing ring is arranged at the threaded connection between the connecting piece and the telescopic tube.

2. A preparation method of the amniotic sac protection device based on 3D printing according to claim 1, characterized in that, It includes the following steps: S1. Collect 3D image data of the patient's amniotic sac and cervix through an ultrasonic device; S2. Import the 3D image data in step S1 into medical 3D printing modeling software, and perform three-dimensional modeling according to the collected 3D image data to obtain a three-dimensional reconstruction model of the amniotic sac and cervix; S3. In the three-dimensional reconstruction model in step S2, obtain the size and shape information of the sac according to the size and shape of the amniotic sac bulging out of the cervical orifice and the position of the cervical orifice to be sutured; S4. According to the size and shape information of the sac in step S3, construct a three-dimensional model of the sac for assisting cervical cerclage surgery; S5. Connect the medical 3D printing modeling software to a 3D printer, perform 3D printing on the three-dimensional model of the sac in step S4 to obtain a formed sac, and install the sac on the upper end of the telescopic tube.

3. The preparation method of the amniotic sac protection device based on 3D printing according to claim 2, wherein, The material of the sac is TPU rubber or silicone rubber.

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