Bile duct suture protection device
By designing a bile duct suture protection device, which combines an arc-shaped metal sheet with biodegradable silicone, the problems of needle puncture and post-suture stenosis are solved, achieving a safe and reliable suture process and residue-free material degradation, thus improving surgical outcomes.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-12-19
- Publication Date
- 2026-03-10
AI Technical Summary
During the suturing of the bile duct lumen, traditional suturing methods carry the risk of the suture needle puncturing the posterior wall of the bile duct, and the lack of support after suturing can lead to scar hyperplasia and bile duct stenosis.
A bile duct suture protection device was designed, which uses an arc-shaped metal sheet that forms a hollow cylinder and biodegradable silicone. The metal sheet provides a physical barrier, while the silicone provides support and gradually degrades after suturing, thus avoiding secondary damage and stenosis.
It effectively prevents suture needles from puncturing the posterior wall of the bile duct, reducing the risk of postoperative bleeding and stenosis. The silicone support gradually degrades after healing, leaving no foreign body residue, thus improving surgical safety and patient recovery.
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Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to the medical technology field, and in particular to a bile duct suture protection device. BACKGROUND
[0002] At present, when the bile duct lumen is sutured, the surgeon usually directly sutures in the first stage under suitable conditions. However, this traditional method has several inherent defects.
[0003] Firstly, when the suture needle passes through the delicate bile duct tissue, especially the posterior wall, there is a risk of accidental injury or suture through the opposite posterior wall, which may cause iatrogenic injury, postoperative bleeding or local stenosis.
[0004] Secondly, there is a lack of support during the healing process after suturing, and the sutured part may be narrowed due to scar hyperplasia.
[0005] Therefore, the present application provides a bile duct suture protection device. SUMMARY
[0006] The purpose of the present application is to solve the defects in the prior art and provide a bile duct suture protection device.
[0007] In order to achieve the above-mentioned purpose, the present application adopts the following technical scheme: A bile duct suture protection device, comprising an arc-shaped metal sheet and a tab, the arc-shaped metal sheet is composed of an outer arc-shaped metal sheet and an inner arc-shaped metal sheet, and the two ends of the outer arc-shaped metal sheet are provided with a gap, the two ends of the degradable silica gel are located in the gap, and the head section of the arc-shaped metal sheet is not provided with degradable silica gel.
[0008] Preferably, one end of the arc-shaped metal sheet is provided with a tab, and the other end of the arc-shaped metal sheet is provided with a retention line.
[0009] Further, the degradable silica gel is composed of the following components in a mass ratio: Polydimethylsiloxane: 60-70 parts; as a basic polymer, it gives the material basic silica gel elasticity, flexibility and hydrophobicity; Fumed silica: 20-30 parts; as a reinforcing agent, it significantly improves the strength, hardness and wear resistance of the material; Polylactic acid: 5-10 parts; as the main degradable component, it can be gradually degraded to lactic acid under the action of hydrolytic enzyme and metabolized by the human body; Hydroxyapatite: 3-8 parts; as a kind of bioactive ceramic material, its composition is similar to the inorganic composition of human bone, which can significantly improve the bioactivity and cell affinity of the material, and its alkaline degradation product can neutralize the acidic environment that may be generated by the degradation of polylactic acid, and maintain the stability of the local physiological pH value; Vitamin C: 0.1-0.5 parts; as an antioxidant, it can effectively prevent the material from aging and deteriorating due to oxidation during processing and storage, and improve the stability of the material; Dibutyltin dilaurate: 0.5-1.5 parts. As a catalyst for crosslinking reaction, it promotes the formation of stable three-dimensional network structure between polydimethylsiloxane molecular chains, which is the key to obtaining the final use performance of the material.
[0010] On the basis of the foregoing scheme: the degradable silica gel is composed of the following mass ratio components: Polydimethylsiloxane: 65 parts; as a basic polymer, it gives the material basic silica gel elasticity, flexibility and hydrophobicity; Fumed silica: 25 parts; as a reinforcing agent, it significantly improves the strength, hardness and wear resistance of the material; Polylactic acid: 7.5 parts; as the main degradable component, it can be gradually degraded into lactic acid under the action of hydrolytic enzyme and metabolized by the human body; Hydroxyapatite: 6 parts; as a kind of bioactive ceramic material, its composition is similar to the inorganic composition of human bone, which can significantly improve the bioactivity and cell affinity of the material, and its alkaline degradation product can neutralize the acidic environment that may be generated by the degradation of polylactic acid, and maintain the stability of the local physiological pH value; Vitamin C: 0.3 parts; as an antioxidant, it can effectively prevent the material from aging and deteriorating due to oxidation during processing and storage, and improve the stability of the material; Dibutyltin dilaurate: 1 part. As a catalyst for crosslinking reaction, it promotes the formation of stable three-dimensional network structure between polydimethylsiloxane molecular chains, which is the key to obtaining the final use performance of the material.
[0011] In the foregoing scheme, a better scheme is: the polydimethylsiloxane is medical grade polydimethylsiloxane with a weight average molecular weight of 50000-100000; The particle size of the fumed silica is 5-50 nm, and the specific surface area is 100-400 m² / g; The degree of polymerization of the polylactic acid is 50-200.
[0012] As a further scheme of the present application: the preparation method of the degradable silica gel comprises the following steps: S1: Raw material pretreatment: Polydimethylsiloxane is heated and continuously stirred in a vacuum environment to increase its fluidity and fully remove residual moisture inside; fumed silica is dried in an oven to remove the moisture adsorbed on its surface and prevent moisture from affecting the efficiency of subsequent crosslinking reaction. S2: Mixing. Add the pretreated polydimethylsiloxane, fumed silica, polylactic acid, hydroxyapatite and vitamin C together to a reaction vessel equipped with a stirring and temperature control device, and stir until all components are evenly dispersed to form a viscous homogeneous mixture. S3: Crosslinking reaction: Under continuous stirring, dibutyltin dilaurate catalyst is added to the reactor, and the reaction system is replaced with high-purity nitrogen to create an inert gas protective environment. Then the temperature is slowly increased and the reaction is maintained so that polydimethylsiloxane can fully undergo crosslinking reaction under the action of catalyst to form a stable three-dimensional network structure. S4: While the viscous material after the cross-linking reaction is still hot, it is injected into a mold with a semi-circular arc cavity. Then, it is allowed to stand and cure at room temperature and normal pressure, and then it can be demolded to obtain biodegradable silicone.
[0013] Meanwhile, in step S1, the heating temperature of dimethylsiloxane is 60-80℃, the stirring time is 1-2 hours, the drying temperature of fumed silica is 100-120℃, and the drying time is 2-3 hours.
[0014] As a preferred embodiment of the present invention: in step S2, the temperature of the reactor is 80-100℃, the stirring speed is 300-500rpm, and the stirring time is 30-60min.
[0015] Meanwhile, in step S3, the temperature after slow heating is 120-150℃, the heating rate is 3-5℃ / min, and the reaction time after heating is 2-4 hours.
[0016] As a preferred embodiment of the present invention, in step S4, the static curing time is 24-48 hours.
[0017] The beneficial effects of this invention are as follows: 1. This invention provides a reliable physical barrier for the suture needle, which can effectively prevent the suture needle from accidentally puncturing or suturing through the posterior wall of the contralateral bile duct. It fundamentally avoids secondary damage to the bile duct exploration incision and stenosis caused by bile duct suturing due to improper operation, and reduces the risk of postoperative bleeding and stenosis.
[0018] 2. In this invention, after the device is removed, the biodegradable silicone can still support the suture site, preventing bile duct stenosis caused by scar hyperplasia. In addition, the biodegradable silicone is a biodegradable material, which will gradually degrade in the bile duct after the suture site heals, avoiding the trouble of removing non-degradable materials a second time. Its material properties also make it easy for surgical needles to pass through and sutures to slide on its surface. After the material has completed its protective mission, it can be gradually degraded and absorbed in the body, with no risk of foreign body residue, improving the safety of the operation and benefiting the patient's recovery.
[0019] 3. This invention, by introducing polylactic acid and hydroxyapatite, makes originally non-degradable silicone biodegradable. Hydroxyapatite buffers the pH changes during the degradation process, and the addition of vitamin C further enhances the biostability of the material. The overall biocompatibility is excellent. Furthermore, by adjusting the amount of fumed silica added and the degree of crosslinking, the hardness, strength, and elastic modulus of the material can be precisely controlled, allowing it to better match the mechanical environment of different implantation sites. At the same time, by changing the content and degree of polymerization of polylactic acid, the overall degradation cycle of the material in vivo can be effectively controlled. Attached Figure Description
[0020] Figure 1 This is a schematic diagram of the overall structure of a bile duct suture protection device proposed in this invention; Figure 2 This is a cross-sectional schematic diagram of a bile duct suture protection device proposed in this invention; Figure 3 This is a schematic diagram of the biodegradable silicone preparation process for a bile duct suture protection device proposed in this invention.
[0021] In the diagram: 1. Arc-shaped metal sheet; 2. Convex sheet; 3. Biodegradable silicone; 4. Indwelling line; 5. Gap; 101. Outer arc-shaped metal sheet; 102. Inner arc-shaped metal sheet. Detailed Implementation
[0022] The technical solution of the present invention will be further described in detail below with reference to specific embodiments.
[0023] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.
[0024] Example 1: A bile duct suture protection device, such as Figures 1-2As shown, it includes an arc-shaped metal sheet 1 and a protrusion 2 forming a hollow cylinder. The arc-shaped metal sheet 1 is composed of an outer arc-shaped metal sheet 101 and an inner arc-shaped metal sheet 102. The outer arc-shaped metal sheet 101 has gaps 5 at both ends. The two ends of the biodegradable silicone 3 are located in the gaps 5. The head section of the arc-shaped metal sheet 1 does not have biodegradable silicone 3.
[0025] One end of the arc-shaped metal sheet 1 is provided with a protrusion 2, and the other end of the arc-shaped metal sheet 1 is provided with a retention line 4.
[0026] In this embodiment, the device is first inserted into the inner wall of the bile duct through the bile duct incision, ensuring that the arc-shaped metal piece 1 adheres to the posterior wall of the bile duct. Then, the bile duct incision is sutured until the last part is sutured, leaving a suture gap. The device is then removed from the gap through the indwelling suture 4. During the removal process, the biodegradable silicone 3 is sutured together with the bile duct, making the biodegradable silicone 3 relatively fixed to the bile duct. This allows the biodegradable silicone 3 and the gap 5 to gradually come out of the gap 5 until the arc-shaped metal piece 1 is removed. The gap is then sutured again. During the healing process, the biodegradable silicone 3 will always be combined with the suture, maintaining a supporting state, and then gradually degrade inside the bile duct.
[0027] This invention provides a reliable physical barrier for the suture needle, which can effectively prevent the suture needle from accidentally puncturing or suturing through the posterior wall of the contralateral bile duct, fundamentally avoiding secondary damage to the anastomosis caused by improper operation, and reducing the risk of postoperative bleeding and stenosis.
[0028] Meanwhile, after the device is removed, the biodegradable silicone 3 can also support the suture site, preventing bile duct stenosis caused by scar hyperplasia. In addition, the biodegradable silicone 3 is a biodegradable material, which will gradually degrade in the bile duct after the suture site heals, avoiding the trouble of removing non-degradable materials a second time. Its material properties also make it easy for surgical needles to pass through and sutures to slide on its surface. After the material has completed its protective mission, it can be gradually degraded and absorbed in the body, with no risk of foreign body residue, improving the safety of the operation and benefiting the patient's recovery.
[0029] Example 2: A bile duct suture protection device, which is an improvement on Example 1 as follows: The biodegradable silicone 3 is composed of the following components in the indicated mass ratio: Polydimethylsiloxane: 60-70 parts; as a base polymer, it imparts basic silicone elasticity, flexibility, and hydrophobicity to the material; Fumed silica: 20-30 parts; as a reinforcing agent, it significantly improves the strength, hardness, and wear resistance of materials; Polylactic acid: 5-10 parts; as the main biodegradable component, it can be gradually degraded into lactic acid under the action of hydrolytic enzymes and metabolized by the human body; Hydroxyapatite: 3-8 parts; As a bioactive ceramic material, its composition is similar to the inorganic components of human bone, which can significantly improve the bioactivity and cell affinity of the material. At the same time, its alkaline degradation products can neutralize the acidic environment that may be generated by the degradation of polylactic acid and maintain the stability of local physiological pH. Vitamin C: 0.1-0.5 parts; as an antioxidant, it effectively prevents materials from aging and deteriorating due to oxidation during processing and storage, and improves the stability of the materials; Dibutyltin dilaurate: 0.5-1.5 parts. As a catalyst for the cross-linking reaction, it promotes the formation of a stable three-dimensional network structure between polydimethylsiloxane molecular chains, which is crucial for the material to achieve its final performance.
[0030] The polydimethylsiloxane is a medical-grade polydimethylsiloxane with a weight average molecular weight of 50,000-100,000.
[0031] The fumed silica has a particle size of 5-50 nm and a specific surface area of 100-400 m² / g.
[0032] The degree of polymerization of the polylactic acid is 50-200.
[0033] Example 3: A bile duct suture protection device, wherein the preparation method of the biodegradable silicone 3 includes the following steps: S1: Raw material pretreatment: Polydimethylsiloxane is heated and continuously stirred in a vacuum environment to increase its fluidity and fully remove residual moisture inside; fumed silica is dried in an oven to remove the moisture adsorbed on its surface and prevent moisture from affecting the efficiency of subsequent crosslinking reaction. S2: Mixing. Add the pretreated polydimethylsiloxane, fumed silica, polylactic acid, hydroxyapatite and vitamin C together to a reaction vessel equipped with a stirring and temperature control device, and stir until all components are evenly dispersed to form a viscous homogeneous mixture. S3: Crosslinking reaction: Under continuous stirring, dibutyltin dilaurate catalyst is added to the reactor, and the reaction system is replaced with high-purity nitrogen to create an inert gas protective environment. Then the temperature is slowly increased and the reaction is maintained so that polydimethylsiloxane can fully undergo crosslinking reaction under the action of catalyst to form a stable three-dimensional network structure. S4: While the viscous material after the cross-linking reaction is still hot, it is injected into a mold with a semi-circular arc cavity. Then, it is allowed to stand and cure at room temperature and normal pressure, and then it can be demolded to obtain biodegradable silicone 3.
[0034] In step S1, the heating temperature of dimethylsiloxane is 60-80℃, the stirring time is 1-2 hours, the drying temperature of fumed silica is 100-120℃, and the drying time is 2-3 hours.
[0035] In step S2, the temperature of the reactor is 80-100℃, the stirring speed is 300-500rpm, and the stirring time is 30-60min.
[0036] In step S3, the temperature after slow heating is 120-150℃, the heating rate is 3-5℃ / min, and the reaction time after heating is 2-4 hours.
[0037] In step S4, the curing time is 24-48 hours.
[0038] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.
Claims
1. A biliary tract suture protection device characterized by, The application relates to a hollow cylindrical arc-shaped metal sheet (1) and a tab (2), the arc-shaped metal sheet (1) is composed of an outer arc-shaped metal sheet (101) and an inner arc-shaped metal sheet (102), gaps (5) are arranged at the two ends of the outer arc-shaped metal sheet (101), the two ends of degradable silica gel (3) are located in the gaps (5), and the head section of the arc-shaped metal sheet (1) is not provided with the degradable silica gel (3).
2. The biliary tract suture protection device according to claim 1, characterized by One end of the arc-shaped metal sheet (1) is provided with the tab (2), and the other end of the arc-shaped metal sheet (1) is provided with a retention line (4).
3. The biliary tract suture protection device according to claim 1 or 2, characterized in that, The degradable silica gel (3) is composed of the following components in a mass ratio: polydimethylsiloxane: 60-70 parts; fumed silica: 20-30 parts; polylactic acid: 5-10 parts; hydroxyapatite: 3-8 parts; vitamin C: 0.1-0.5 parts; dibutyltin dilaurate: 0.5-1.5 parts.
4. The biliary tract suture protection device according to claim 3, characterized by The degradable silica gel (3) is composed of the following components in a mass ratio: polydimethylsiloxane: 65 parts; fumed silica: 25 parts; polylactic acid: 7.5 parts; hydroxyapatite: 6 parts; vitamin C: 0.3 parts; dibutyltin dilaurate: 1 part.
5. The biliary tract suture protection device according to claim 3, wherein The polydimethylsiloxane is medical-grade polydimethylsiloxane with a weight average molecular weight of 50000-100000; the fumed silica has a particle size of 5-50 nm and a specific surface area of 100-400 m2 / g; the polylactic acid has a polymerization degree of 50-200.
6. The biliary tract suture protection device according to claim 3, wherein The preparation method of the degradable silica gel (3) comprises the following steps: S1: raw material pretreatment: the polydimethylsiloxane is heated in a vacuum environment and continuously stirred to increase the fluidity and sufficiently remove internal residual moisture; the fumed silica is dried in an oven to remove the water adsorbed on the surface and prevent the water from affecting the crosslinking reaction efficiency; S2: mixing, the pretreated polydimethylsiloxane, fumed silica, polylactic acid, hydroxyapatite and vitamin C are added into a reaction kettle with stirring and temperature control devices, stirring is conducted until all the components are uniformly dispersed to form a viscous homogeneous mixture; S3: crosslinking reaction: under continuous stirring, the catalyst dibutyltin dilaurate is added into the reaction kettle, the reaction system is replaced with high-purity nitrogen to create an inert gas protection environment, then slow heating is conducted, and the reaction is maintained to enable the polydimethylsiloxane to fully undergo crosslinking reaction under the action of the catalyst to form a stable three-dimensional network structure; S4: the viscous material after the crosslinking reaction is injected into a mold with a semi-arc-shaped cavity while hot, then is cured under room temperature and normal pressure conditions, and is demolded to obtain the degradable silica gel (3).
7. The biliary tract suture protection device according to claim 6, wherein In the S1 step, the heating temperature of the dimethylsiloxane is 60-80 DEG C, the stirring time is 1-2 hours, and the drying temperature of the fumed silica is 100-120 DEG C, and the drying time is 2-3 hours.
8. The biliary tract suture protection device according to claim 6, wherein In the S2 step, the temperature of the reaction kettle is 80-100 DEG C, the stirring speed is 300-500 rpm, and the stirring time is 30-60 min.
9. The biliary tract suture protection device according to claim 6, wherein In the S3 step, the temperature after slow heating is 120-150℃, the heating rate is 3-5℃ / min, and the reaction time after heating is maintained for 2-4 hours.
10. The biliary tract suture protection device according to claim 6, wherein In the S4 step, the standing and curing time is 24-48 hours.