Single-cavity multi-channel laparoscope puncture outfit and preparation method thereof

By designing a shape memory polymer film channel with an expanded diameter structure, the problem of the film channel limiting the surgical operation angle and space in the prior art is solved, and the expansion structure is restored at body temperature to increase the operating space while reducing the risk of patient trauma.

CN120022063APending Publication Date: 2025-05-23DONGGUAN SOUTHEAST CENTRAL HOSPITAL (DONGGUAN SOUTHEAST TRADITIONAL CHINESE MEDICINE MEDICAL SERVICE CENTER DONGGUAN FIRST HOSPITAL AFFILIATED TO GUANGDONG MEDICAL UNIVERSITY)
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Patent Information

Application Number
CN202510337776.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-03-21
Publication Date
2025-05-23

AI Technical Summary

Technical Problem

The thin-film channel straight-cylindrical type of existing single-chamber multi-channel laparoscopic puncturers limits the angle and space of the operation of surgical instruments, and is susceptible to intra-abdominal pressure to narrow the channel, making it difficult to pass or place more surgical instruments, increasing the risk of patient trauma and abdominal hernia.

Method used

A film channel with an expanded diameter structure is designed, with a diameter gradually increasing from the side close to the porous platform to the side facing away from the porous platform, with a cone angle of 15° to 35°. The film channel is made of shape memory polymer (SMP) to restore the expanded diameter structure at body temperature, increase the operating space, and maintain a small diameter at the incision to reduce the risk of trauma.

Benefits of technology

Through the membrane channel with an expanded diameter structure, the angle and space of the surgical instrument operation are increased, the operation convenience is improved, and the risk of trauma and abdominal hernia in the patient is reduced.

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Abstract

The invention discloses a single-cavity multi-channel laparoscope puncture outfit and a preparation method thereof.The puncture outfit comprises a porous platform and a film channel, the porous platform is provided with an air inlet pipe, an air outlet pipe and a plurality of operation channels, the film channel is of a first shape, and the first shape is of a diameter expanding structure; the diameter of the cone is gradually increased from one end close to the porous platform to one end away from the porous platform, and the cone angle is 15-35 degrees; the film channel is made of an SMP material, and when the temperature is lower than the first temperature, the film channel keeps a second shape; when the temperature is higher than the first temperature, the film channel recovers and keeps the first shape, the taper angle of the first shape is larger than that of the second shape, and the diameter of the first shape is larger than that of the second shape on the side away from the porous platform. The thin film channel is of an expanding structure, a large space can be maintained in the abdominal cavity, the operation angle and space of a surgical instrument are increased, convenience is improved, and meanwhile the trauma of a patient and the occurrence risk of abdominal hernia are reduced.
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Description

Technical Field

[0001] The invention relates to the technical field of medical devices, in particular to a single-lumen multi-channel laparoscopic puncture device and a preparation method thereof. Background Art

[0002] Single-lumen multi-channel laparoscopic puncture devices are usually used in minimally invasive abdominal surgery, including multi-porous platforms and thin film channels. Various types of abdominal surgery usually choose to make a 2-3 cm incision in the navel, insert the thin film channel into the incision, and insert laparoscopic instruments into each channel hole of the multi-porous platform for surgical operation. Since the navel incision cannot be further expanded (the risk of umbilical hernia increases by 30% for every 1 cm increase in the navel incision), there are two main difficulties in the surgical operation:

[0003] 1. The thin film channel of the single-lumen multi-channel laparoscopic puncture device commonly used in clinical practice is generally straight-cylindrical. The opening of the straight-cylindrical channel on the side away from the porous platform (the end inserted into the incision) has a limited angle, which limits the angle and space for the operation of surgical instruments. Once the area to be treated is too large, it is necessary to place the abdominal puncture device in combination with multiple incision channels to complete the surgical operation, which increases the risk of patient trauma and abdominal hernia.

[0004] 2. The thin membrane channel is easily squeezed by the internal pressure of the abdominal cavity, causing the channel to narrow, making it difficult to pass or put in more surgical instruments. Summary of the invention

[0005] In order to address the deficiencies in the prior art, the present invention provides a single-lumen, multi-channel laparoscopic puncture device and a preparation method thereof. When in use, the thin film channel is an expanded diameter structure, so that the thin film channel has a larger space at the opening on the side away from the porous platform, thereby increasing the angle and space for operating surgical instruments and improving convenience. At the same time, the thin film channel at the incision maintains a smaller diameter, reducing the risk of patient trauma and abdominal hernia.

[0006] In order to achieve the above object, the present invention is implemented through the following technical solutions:

[0007] A single-lumen multi-channel laparoscopic puncture device comprises a porous platform and a thin film channel, wherein the porous platform is provided with an air inlet pipe, an exhaust pipe and a plurality of operation channels, and the thin film channel has a first shape, wherein the first shape has an expansion structure, and its diameter gradually increases from a side close to the porous platform to a side away from the porous platform, and the cone angle is 15° to 35°.

[0008] A turning ring is arranged at one end of the film channel close to the porous platform, and an inner fixing ring is arranged at one end of the film channel away from the porous platform.

[0009] The porous platform and the membrane channel are connected by a connecting assembly, which includes a first connecting ring arranged on the membrane channel and a second connecting ring arranged on the porous platform. The inner cavity of the first connecting ring is provided with a first annular groove adapted to the turning ring. The first connecting ring and the second connecting ring are snap-fitted or threadedly connected.

[0010] A limiting flange is arranged on the outer periphery of the bottom end of the porous platform, and a second annular groove adapted to the limiting flange is arranged in the inner cavity of the second connecting ring.

[0011] A lifting belt is arranged on the inner fixing ring, and a pull ring is arranged on one end of the lifting belt away from the inner fixing ring.

[0012] The film channel is made of SMP material. When the temperature of the film channel is lower than the first temperature, the film channel maintains the second shape; when the temperature of the film channel is higher than the first temperature, the film channel recovers and maintains the first shape, the cone angle of the first shape is greater than the cone angle of the second shape, and on the side away from the porous platform, the diameter of the first shape is greater than the diameter of the second shape.

[0013] The inner fixing ring is made of SMP material. When the temperature of the inner fixing ring is higher than the first temperature, the diameter of the inner fixing ring increases by 10% to 50%.

[0014] The present invention also provides a method for preparing a single-lumen multi-channel laparoscopic puncture device, wherein the thin film channel is prepared by the following method:

[0015] Mixing and dissolving a plurality of first polymers having a glass transition temperature below a first temperature and a plurality of second polymers having a glass transition temperature above the first temperature in a solvent, and molding the dissolved mixture into a first shape above the first temperature to obtain a thin film channel of the first shape;

[0016] The film channel of the first shape is cooled to a temperature below the first temperature, and is formed into a second shape under the condition of applying stress.

[0017] The first polymer is one or more of poly (d, l-lactide-co-ε-caprolactone) PLCL and polyethylene glycol PEG; the second polymer is one or more of poly (L-lactide) PLLA, poly (d-lactide) PDLA, ω-pentadecalactone PDL, and poly (glycolide-lactide) PLGA.

[0018] Compared with the prior art, the present invention has the following beneficial effects:

[0019] 1. The thin film channel of the present invention has an expanded diameter structure when in use, so that there is a larger space at the opening of the thin film channel away from the porous platform, which increases the angle and space for the operation of surgical instruments and improves convenience. At the same time, the thin film channel at the incision maintains a smaller diameter, reducing the risk of patient trauma and abdominal hernia.

[0020] 2. The film channel of the present invention is made of SMP material. When the film channel is inserted into the human body through an incision, the film channel recovers and maintains the first shape due to the influence of body temperature, and has a larger diameter than the second shape at the opening away from the porous platform, thereby increasing the angle and space for operating surgical instruments and improving convenience. At the same time, the film channel at the incision maintains a smaller diameter.

[0021] 3. The internal fixation ring of the present invention is made of SMP material. Similarly, when the thin film channel is inserted into the human body through an incision, its diameter becomes larger due to the influence of body temperature, thereby increasing the angle and space for operating surgical instruments and improving convenience. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Attached Figure 1 This is one of the structural schematic diagrams of the single-lumen multi-channel laparoscopic puncture device of the present invention.

[0023] Attached Figure 2 Yes Figure 1 A schematic diagram of the enlarged structure of part A in the middle.

[0024] Attached Figure 3 This is the second structural schematic diagram of the single-lumen multi-channel laparoscopic puncture device of the present invention.

[0025] Attached Figure 4 It is a schematic diagram of the formation of the film channel of the present invention.

[0026] Attached Figure 5 The bursting force curve of Example 1.

[0027] Attached Figure 6 The bursting force curve of Example 3.

[0028] Attached Figure 7 The bursting force curve of Example 4.

[0029] Numbers shown in the accompanying drawings: 1. porous platform; 11. air inlet pipe; 12. exhaust pipe; 13. operating channel; 14. limiting flange; 2. film channel; 21. turn ring; 22. inner fixing ring; 23. pulling belt; 24. pull ring; 25. constant diameter part; 26. expanded diameter part; 3. first connecting ring; 31. first annular groove; 4. second connecting ring; 41. second annular groove. DETAILED DESCRIPTION

[0030] In conjunction with the accompanying drawings and specific embodiments, the present invention will be further described. It should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, it should be understood that after reading the content taught by the present invention, those skilled in the art may make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the application.

[0031] like Figure 1-Figure 3 As shown, the present invention provides a single-lumen multi-channel laparoscopic puncture device, comprising a porous platform 1 and a thin film channel 2, wherein the porous platform 1 is provided with an air inlet pipe 11, an exhaust pipe 12 and a plurality of operation channels 13, and the thin film channel 2 has a first shape, wherein the first shape has an expanding diameter structure, and its diameter gradually increases from a side close to the porous platform 1 to a side away from the porous platform 1, and the cone angle is 15° to 35°.

[0032] In one embodiment, the expansion structure of the film channel 2 can be a full expansion structure (such as Figure 1 As shown): the diameter expansion structure extends to the entire membrane channel 2, that is, the diameter gradually increases from the end close to the porous platform 1 to the end away from the porous platform 1.

[0033] In another embodiment, the expansion structure of the film channel 2 may be a partial expansion structure (eg Figure 3 As shown): the thin film channel (2) includes a constant diameter portion 25 and an expanded diameter portion 26, wherein the upper portion close to the porous platform 1 is the constant diameter portion 25 (with a constant diameter), and the end portion from the constant diameter portion to the end away from the porous platform 1 is the expanded diameter portion 26 (with a gradually increasing diameter).

[0034] The film channel 2 of the present invention is designed as an expanded diameter structure, so that the film channel 2 has a larger space at the opening on the side away from the porous platform 1, increasing the angle and space for operating surgical instruments and improving convenience. At the same time, the film channel 2 maintains a smaller diameter at the incision, reducing the risk of patient trauma and abdominal hernia.

[0035] In one embodiment, a turn ring 21 is provided at one end of the film channel 2 close to the porous platform 1, and an internal fixing ring 22 is provided at one end of the film channel 2 away from the porous platform 1, so as to better resist the intra-abdominal pressure and maintain the angle and space for the operation of surgical instruments.

[0036] In one embodiment, the porous platform 1 and the membrane channel 2 are connected by a connecting assembly, which includes a first connecting ring 3 arranged on the membrane channel 2 and a second connecting ring 4 arranged on the porous platform 1. The inner cavity of the first connecting ring 3 is provided with a first annular groove 31 adapted to the turning ring 21. The first connecting ring 3 and the second connecting ring 4 are snap-fitted or threadedly connected, and the connection is simple and convenient.

[0037] In one embodiment, a limiting flange 14 is provided on the outer periphery of the bottom end of the porous platform 1, and the inner cavity of the second connecting ring 4 is provided with a second annular groove 41 adapted to the limiting flange 14, which helps to ensure a stable connection between the porous platform 1 and the film channel 2.

[0038] In one embodiment, a lifting strap 23 is provided on the inner fixing ring 22 , and a pull ring 24 is provided at one end of the lifting strap 23 away from the inner fixing ring 22 , so as to facilitate the removal of the film channel 2 .

[0039] In one embodiment, the film channel 2 is made of a shape memory polymer (SMP). When the temperature of the film channel 2 is lower than the first temperature, the film channel 2 maintains the second shape. When the temperature of the film channel 2 is higher than the first temperature, the film channel 2 recovers and maintains the first shape. The cone angle of the first shape is greater than the cone angle of the second shape, and on the side away from the porous platform, the diameter of the first shape is greater than the diameter of the second shape. The first temperature is 34°C to 40°C, and preferably, the first temperature is close to the human body temperature range of 36°C to 38°C.

[0040] In this embodiment, when the film channel 2 is in the second shape, the film channel 2 is a slightly expanded structure, and the cone angle is less than 15°, such as 3°, 5°, 8°, 10°. Alternatively, when the film channel 2 is in the second shape, it is a straight-cylindrical structure, and its diameter is basically consistent from the end close to the porous platform 1 to the end away from the porous platform 1, which is basically consistent with the diameter of the film channel 2 at one end close to the porous platform 1 when it is in the first shape.

[0041] In this embodiment, before use, the single-lumen multi-channel laparoscopic puncture device is refrigerated and sterile. When in use, after the film channel 2 is placed in the abdominal incision, the film channel 2 returns to the first shape due to the influence of body temperature, that is, the diameter of the opening at the end of the film channel 2 away from the porous platform 1 becomes larger, so that the film channel 2 has a larger space at the opening on the side away from the porous platform 1, increasing the angle and space for the operation of surgical instruments and improving convenience. At the same time, the film channel 2 still maintains a smaller diameter at the incision, reducing the patient's trauma and the risk of abdominal hernia.

[0042] In one embodiment, the thickness of the film channel 2 in the first shape is 0.2-1.5 mm, such as 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.8 mm, 1 mm, 1.2 mm; the height is 4-10 cm, such as 4 cm, 4.5 cm, 5 cm, 5.5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm; the diameter of the end close to the porous platform 1 is 2-3 cm, such as 2 cm, 2.2 cm, 2.5 cm, 2.8 cm, 3 cm; the diameter of the end away from the porous platform 1 is 3-6 cm, such as 3 cm, 3.5 cm, 4 cm, 4.5 cm, 5 cm, 5.5 cm, 6 cm. Ensure that the film channel 2 has sufficient strength and can provide sufficient operating space.

[0043] In one embodiment, the inner fixing ring 22 is made of SMP material. When the temperature of the inner fixing ring 22 is higher than the first temperature, the diameter of the inner fixing ring 22 increases by 10-50%. The first temperature is 34°C-40°C. Preferably, the first temperature is in the range of 36°C-38°C, which is close to the human body temperature.

[0044] In this embodiment, the inner fixing ring 22 is made of SMP material. Due to the influence of body temperature, its diameter increases after being placed in the incision of the human body, thereby increasing the angle and space for the operation of surgical instruments.

[0045] The present invention also provides a method for preparing a single-lumen multi-channel laparoscopic puncture device, wherein the thin film channel is prepared by the following method:

[0046] Step S1: dissolve several first polymers with glass transition temperatures below the first temperature and several second polymers with glass transition temperatures above the first temperature in a solvent, mix and stir until uniform, obtain a polymer solution, and then mold it into a first shape above the first temperature, which can be extrusion injection molding or compression molding, to obtain a film channel of the first shape. The solvent in this step includes but is not limited to any one or more combinations of dichloromethane, N,N-dimethylformamide, chloroform, hexafluoroisopropanol, acetone, and ethyl acetate. In this step, the polymer solution can be injected into the prepared truncated cone ring mold, and placed under vacuum drying at room temperature until the solvent is completely volatilized, and demolded to obtain a film channel 2 of the first shape.

[0047] Step S2: Cooling the film in the first shape to a temperature below the first temperature through the cooling tube 2, and shaping it into the second shape under the condition of applying stress.

[0048] The first polymer is one or more of poly (d, l-lactide-co-ε-caprolactone) PLCL and polyethylene glycol PEG; the second polymer is one or more of poly (L-lactide) PLLA, poly (d-lactide) PDLA, ω-pentadecalactone PDL, and poly (glycolide-lactide) PLGA.

[0049] In one embodiment, the inner fixing ring is made of SMP material, and when the temperature of the inner fixing ring is higher than the first temperature, the diameter of the inner fixing ring increases by 10% to 50%. Specifically, when the temperature is lower than the first temperature, the inner fixing ring maintains the fourth shape; when the temperature is higher than the first temperature, the inner fixing ring recovers and maintains the third shape, and the diameter of the third shape increases by 10% to 50% compared with the diameter of the fourth shape.

[0050] In one embodiment, the preparation method of the inner fixing ring is consistent with the preparation method of the thin film channel, and specifically comprises the following steps:

[0051] Mixing and dissolving a plurality of first polymers having a glass transition temperature below a first temperature and a plurality of second polymers having a glass transition temperature above the first temperature in a solvent, and molding the dissolved mixture into an inner fixed ring of a third shape above the first temperature;

[0052] The inner fixing ring in the third shape is cooled to a temperature below the first temperature and is formed into a fourth shape under a condition where stress is applied thereto.

[0053] The following examples provide several materials and methods for preparing the thin film channel 2. The internal fixing ring can use the same materials and methods. The thickness of the human abdominal wall is 5.5-7.5 cm, and the abdominal wall pressure is about 0-5 mmHg / 0.667 kPa / about 5 N (incision diameter 2 cm, abdominal wall thickness 6.5 cm). The pressure strength of the thin film channel 2 of the first shape is about 5 N / 54 pi cm 2 In order to test the pressure that the film channel 2 of the first shape can withstand, the prepared film channel 2 is restored to the first shape at the first temperature, and the bursting force test of the material side wall against the pressure is performed. The specific method is as follows:

[0054] A constant rate of extension tester (CRE) is used, which includes a sample holder and a spherical ejector assembly. During the test, the sample holder is fixed and the spherical ejector moves at a constant speed. The inner diameter R of the annular holder is 45mm±0.5mm, and the head end of the spherical ejector is a polished steel ball with a diameter of 25mm±0.02mm.

[0055] The sample with the expanded structure restored from the second shape to the first shape is cut into a circular specimen, and the specimen is clamped in a circular specimen clamp on a fixed base. The spherical push rod is vertically pushed toward the specimen at a constant moving speed of 300 mm / min to deform the specimen until it breaks, and the bursting force F is measured.

[0056] Embodiment 1:

[0057] The following materials and methods were used to prepare the thin film channel:

[0058] Raw materials: The mass ratio of poly(d,l-lactide-co-ε-caprolactone) PLCL, poly(L-lactide) PLLA, and poly(d-lactide) PDLA is 20:40:40.

[0059] The weight average molecular weight of PLCL is M W / Da is 30000, and the glass transition temperature Tg is 25-30°C;

[0060] The weight average molecular weight of PLLA is W / Da is 1000; glass transition temperature Tg is 60~65℃;

[0061] The weight average molecular weight of PDLA is W / Da is 1000, and the glass transition temperature Tg is 60-65°C.

[0062] The three raw materials of PLCL, PLLA and PDLA were dissolved and mixed with the solvent dichloromethane (DCM) and then injected into a truncated cone ring mold. After standing at room temperature for half an hour, they were vacuum dried for 3 days with circulating ventilation to remove the solvent; the mold was placed at 80°C and 8Mpa pressure for 10 minutes, and then the sample of the first shape was taken out (expanded diameter structure: upper diameter 3cm, lower diameter 5cm, sample thickness 0.30mm, height 6cm); then the temperature was lowered to 10°C, and a force of 1N / min was applied to the sample of the first shape to stretch and shape it to form a second shape (similar to a straight cylinder structure: upper and lower diameters are about 3cm, and the sample thickness is 0.25mm).

[0063] In order to test the shape recovery ability of the membrane channel 2 of this embodiment: the sample of the second shape is heated to 36-38°C again. Without external force, the sample of the second shape can quickly recover from the second shape of the straight cylinder structure to the first shape of the expanded diameter structure. The bursting force test of the first shape after recovery is carried out. The experimental results are as follows: Figure 5 As shown, the bursting force F can reach 2.5N, and the material side wall can withstand a pressure of 5-8N, which is sufficient to withstand the abdominal wall pressure (about 5N) when the material is implanted in the body.

[0064] Embodiment 2:

[0065] The following raw materials and methods are used to prepare the thin-film channel:

[0066] Raw materials: The mass ratio of poly(d,l-lactide-co-ε-caprolactone) PLCL to ω-pentadecanolide PDL is 75:25.

[0067] The weight-average molecular weight M W / Da of PLCL is 30000, and the glass transition temperature Tg is 25 - 30 °C;

[0068] The weight-average molecular weight M W / Da of PDL is 1000; the glass transition temperature Tg is 50 - 60 °C

[0069] Dissolve and mix the two raw materials PLCL and PDL in dichloromethane solvent, then inject them into a frustum ring-shaped mold. After standing at room temperature for half an hour, perform vacuum drying for 3 days with circulating air to remove the solvent. Place the mold at 100 °C and 10 Mpa pressure for 10 min to shape it, and then take out the sample of the first shape (expanded diameter structure: upper diameter 4 cm, lower diameter 5 cm, sample thickness 0.40 mm, height 6 cm); then lower the temperature to 0 °C, and apply a force of 2 N / min to the sample of the first shape for stretching and shaping to form the second shape (similar to a straight cylinder structure: upper and lower diameters are about 4 cm, sample thickness 0.30 mm).

[0070] Heat the sample of the second shape to 36 - 38 °C again. Without external force, the sample of the second shape can quickly recover from the similar straight cylinder structure of the second shape to the expanded diameter structure of the first shape. Perform a bursting force test on the recovered first shape, and the side wall of the material can withstand a pressure of 8 - 10 N, which is sufficient to withstand the abdominal wall pressure (about 5 N) when the material is implanted in the body.

[0071] Example 3:

[0072] The following raw materials and methods are used to prepare the thin-film channel:

[0073] Raw materials: The mass ratio of polyglycolide-lactide PLGA to polyethylene glycol PEG is 70:30.

[0074] The weight-average molecular weight M W / Da of PLGA is 40000 - 60000, and the glass transition temperature Tg is 45 - 55 °C;

[0075] The weight-average molecular weight M W / Da of PEG is 1000 - 2000; the glass transition temperature Tg is -60 °C.

[0076] After the two polymers PLGA and PEG are mixed and dissolved, they are injected into a truncated cone ring mold, and the mold is placed at 70°C and 8Mpa pressure for 30 minutes, followed by vacuum drying and circulating ventilation for 20 hours, and the sample of the first shape is taken out (expanded diameter structure: upper diameter 3cm, lower diameter 6cm, sample thickness 0.30mm, height 6cm); then the temperature is lowered to -20°C, and a force of 1N / min is applied to the sample of the first shape for stretching and shaping to form a second shape (similar to a straight cylinder structure: upper and lower diameters of about 3cm, sample thickness 0.20mm).

[0077] When the temperature is raised to 36-38℃, the sample of the second shape can be quickly restored from the straight-cylinder-like structure of the second shape to the expanded diameter structure of the first shape without external force. The bursting force test of the restored first shape is carried out. The experimental results are as follows: Figure 6 As shown, the bursting force can reach 6.5N, and the material side wall's pressure resistance strength is as high as 7-14N, which meets the abdominal wall pressure (about 5N) that the material is subjected to when implanted in the body.

[0078] Embodiment 4:

[0079] The following materials and methods were used to prepare the thin film channel:

[0080] Raw materials: The mass ratio of poly(glycolide-lactide) PLGA, polyethylene glycol PEG, and poly(d,l-lactide-co-ε-caprolactone) PLCL is 70:15:15.

[0081] The weight average molecular weight of PLGA is W / Da is 40000~60000, and the glass transition temperature Tg is 45~55℃;

[0082] The weight average molecular weight of PEG is W / Da is 1000-2000; glass transition temperature Tg is -60°C;

[0083] The weight average molecular weight of PLCL is M W / Da is 30000, and the glass transition temperature Tg is 25-30°C.

[0084] The three polymer components PLGA, PEG, and PLCL were evenly dissolved in hexafluoroisopropanol solvent and injected into a truncated cone ring mold. The mold was placed at 60°C and 8Mpa pressure for 45 minutes, followed by vacuum drying and circulating ventilation for 48 hours. The sample of the first shape (expanded diameter structure: upper diameter 3cm, lower diameter 6cm, sample thickness 0.30mm, height 6cm) was taken out, and then the temperature was lowered to 0°C, and a force of 1N / min was applied to the sample of the first shape for stretching and shaping to form a second shape (similar to a straight cylindrical structure, upper and lower diameters 3cm, sample thickness 0.20mm).

[0085] The temperature is raised to 36 - 38 °C. Without external force, the sample in the second shape can quickly recover from the second shape similar to a straight cylinder structure to the expanded diameter structure in the first shape. The bursting force test is carried out on the recovered first shape, and the experimental results are as Figure 7 shown. The bursting force can reach 3 N, and the pressure resistance of the side wall of the material can reach 6 N, which can resist the abdominal wall pressure (about 5 N) received when the material is implanted into the body.

[0086] The joints between the thin film channel 2, the turned-up loop 21, the first connecting ring 3, the second connecting ring 4, and the porous platform 1 are tested and can withstand a tensile force of 40 - 55 N for 10 seconds, and the joints do not separate or fall off; the joint of the lifting belt 23 between the pull ring 24 and the internal fixing ring 22 can withstand 30 - 40 N for 10 seconds, and the joints do not separate or fall off.

Claims

1. A single-lumen multi-channel laparoscopic puncture device, comprising a porous platform and a thin film channel, wherein the porous platform is provided with an air inlet pipe, an exhaust pipe and a plurality of operation channels, characterized in that: The film channel has a first shape, and the first shape has an expanded diameter structure, the diameter of which gradually increases from the side close to the porous platform to the side away from the porous platform, and the cone angle is 15° to 35°.

2. The single-lumen multi-channel laparoscopic puncture device according to claim 1, characterized in that: A turning ring is arranged at one end of the film channel close to the porous platform, and an inner fixing ring is arranged at one end of the film channel away from the porous platform.

3. The single-lumen multi-channel laparoscopic puncture device according to claim 2, characterized in that: The porous platform and the membrane channel are connected by a connecting assembly, which includes a first connecting ring arranged on the membrane channel and a second connecting ring arranged on the porous platform. The inner cavity of the first connecting ring is provided with a first annular groove adapted to the turning ring. The first connecting ring and the second connecting ring are snap-fitted or threadedly connected.

4. The single-lumen multi-channel laparoscopic puncture device according to claim 3, characterized in that: A limiting flange is arranged on the outer periphery of the bottom end of the porous platform, and a second annular groove adapted to the limiting flange is arranged in the inner cavity of the second connecting ring.

5. The single-lumen multi-channel laparoscopic puncture device according to claim 2, characterized in that: A lifting belt is arranged on the inner fixing ring, and a pull ring is arranged on one end of the lifting belt away from the inner fixing ring.

6. The single-lumen multi-channel laparoscopic puncture device according to claim 1, characterized in that: The film channel is made of SMP material. When the temperature of the film channel is lower than the first temperature, the film channel maintains the second shape; when the temperature of the film channel is higher than the first temperature, the film channel recovers and maintains the first shape, the cone angle of the first shape is greater than the cone angle of the second shape, and on the side away from the porous platform, the diameter of the first shape is greater than the diameter of the second shape.

7. The single-lumen multi-channel laparoscopic puncture device according to claim 2, characterized in that: The inner fixing ring is made of SMP material. When the temperature of the inner fixing ring is higher than the first temperature, the diameter of the inner fixing ring increases by 10% to 50%.

8. The method for preparing the single-lumen multi-channel laparoscopic puncture device according to any one of claims 1 to 7, characterized in that: The thin film channel is prepared by the following method: Mixing and dissolving a plurality of first polymers having a glass transition temperature below a first temperature and a plurality of second polymers having a glass transition temperature above the first temperature in a solvent, and molding the dissolved mixture into a first shape above the first temperature to obtain a thin film channel of the first shape; The film channel of the first shape is cooled to a temperature below the first temperature, and is formed into a second shape under the condition of applying stress.

9. The method for preparing the single-lumen multi-channel laparoscopic puncture device according to claim 8, characterized in that: The first polymer is one or more of poly (d, l-lactide-co-ε-caprolactone) PLCL and polyethylene glycol PEG; the second polymer is one or more of poly (L-lactide) PLLA, poly (d-lactide) PDLA, ω-pentadecalactone PDL, and poly (glycolide-lactide) PLGA.