A medical engineering incision protection sleeve and a production process thereof

Abstract

The application discloses a medical engineering incision protective sleeve and a production process thereof, and comprises an outer protective film which is composed of a polytetrafluoroethylene base material and a nano-silver composite layer coated on the surface, wherein the density of the nano-silver coating layer is 1.5-3.0 mg / cm2, the thickness is 0.1-0.3 mm, the diameter of the hollow microsphere is 50-200 microns, the wall thickness is 5-15 microns, and the filling rate is 10%-30% of the volume of the buffer ring; the material innovation: the PTFE-nano-silver composite layer has antibacterial and durability, the collagen-silica gel buffer layer promotes tissue repair, the structural innovation: the magnetic fixation + shape memory support realizes 'one-key' rapid installation, reduces the operation time in the operation by more than 20%, the process innovation: the laser welding and the plasma spraying technology are combined, the product consistency (tolerance ± 0.05 mm) is ensured, and the clinical value: through animal experiment verification, the postoperative infection rate is reduced to 1.2% (8.7% for the control group), and the incision healing time is shortened by 3-5 days.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, in particular to an incision protective cover for medical engineering and a production process thereof. Background Art

[0002] In surgical procedures, wound protection is a key step in reducing postoperative infection and promoting healing. In existing technologies, wound protection devices are mostly made of silicone or polyurethane materials, which have the following drawbacks:

[0003] 1. Inadequate material performance: Some materials have poor biocompatibility and are prone to tissue irritation. Long-term contact with body fluids may cause corrosion or deformation, resulting in protection failure.

[0004] 2. Single structural design: Traditional protective covers are mostly single-layer cylindrical structures, which cannot effectively isolate external pollutants and lack buffer protection for the incision edges, which can easily cause secondary damage;

[0005] 3. Unstable fixation: It relies on tape or suture fixation, which is easy to fall off and the operation is cumbersome, increasing the operation time;

[0006] 4. Limited adaptability: It cannot be flexibly adjusted according to the incision depth or patient body shape, resulting in insufficient fit. Summary of the Invention

[0007] In view of the above-mentioned shortcomings of the prior art, the purpose of the present invention is to provide an incision protection cover for medical engineering and its production process, which adopts a multi-layer composite structure to improve anti-infection and mechanical properties; designs an adjustable fixing device to adapt to different incision depths and patient body shapes; and optimizes the production process to achieve low-cost, high-precision manufacturing.

[0008] To achieve the above objectives, the present invention provides the following technical solution: a medical engineering incision protective cover, comprising: an outer protective film: composed of a polytetrafluoroethylene substrate and a surface-coated nanosilver composite layer, wherein the nanosilver coating has a density of 1.5-3.0 mg / cm² and a thickness of 0.1-0.3 mm, and the nanosilver particles have a particle size of 20-50 nm;

[0009] Inner buffer ring: Made of medical silica gel and collagen in a mass ratio of 6:4 to 8:2, with hollow microspheres evenly dispersed inside. The diameter of the hollow microspheres is 50-200μm, the wall thickness is 5-15μm, and the filling rate is 10%-30% of the volume of the buffer ring;

[0010] Adjustable fixation system: includes a magnetic anchor and a shape memory alloy stent. The stent is woven into a mesh structure with nickel-titanium alloy wires. The alloy wires have a diameter of 0.1-0.3 mm and are annealed at 300-400°C. They have the property of triggering shape recovery at 35-45°C.

[0011] Integrated drainage channel: located on the side wall of the protective sleeve, including at least 3 drainage holes with a pore size of 1-3mm, the inner wall of the hole is coated with a heparinized coating, the channel is externally connected to a standard negative pressure interface, and the interface diameter matches the clinical drainage tube.

[0012] Preferably, the magnetic anchor sheet is composed of a composite of a flexible magnet and medical-grade polyurethane, the surface of which is plasma-sprayed with a hydroxyapatite coating with a coating thickness of 10-30 μm, the magnetic induction intensity of the magnet is 0.3-0.8 T, and the surface in contact with the skin is covered with a biocompatible adhesive layer.

[0013] Preferably, the ratio of the expanded diameter to the compressed diameter of the shape memory alloy stent is 2:1 to 5:1, the fitting pressure with the incision edge after expansion is 0.1-0.5N / cm², and the surface of the stent is treated with titanium nitride coating with a coating thickness of 2-5μm.

[0014] Preferably, the hollow microspheres are made of polylactic acid-glycolic acid copolymer, which has a degradation period of 30-90 days and a pH value of the degradation product of 6.5-7.5. The microspheres are filled with chitosan gel with a gel concentration of 5%-15% (w / v).

[0015] Preferably, the heparinized coating of the drainage channel is formed by mixing sodium heparin and polyvinyl pyrrolidone in a mass ratio of 1:3 to 1:5, the coating thickness is 5-20 μm, and the heparin release rate is 0.1-0.5 μg / cm²·h.

[0016] Preferably, the porosity of the PTFE substrate of the outer protective membrane is 30-50%, the pore size is 0.5-5 μm, and the nanosilver composite layer is bonded to the PTFE substrate through a chemical vapor deposition process, with a bonding strength of ≥5 MPa.

[0017] A production process for an incision protective cover for medical engineering comprises the following steps:

[0018] Step S1: Preparation of outer protective film: Immerse the PTFE film in a dispersion containing nanosilver particles at a concentration of 5-10 mg / mL, ultrasonicate for 20-40 minutes, and then dry in a vacuum drying oven at 50-70°C to form a nanosilver composite layer;

[0019] Step S2: Inner buffer ring molding: medical silica gel and collagen are mixed in proportion, PLGA hollow microspheres are added, degassed under vacuum ≤ 0.1 MPa for 30-60 minutes, injected into a mold, and vulcanized at 80-100°C for 10-30 minutes;

[0020] Step S3: Structural assembly: Use a Nd:YAG laser welding machine with a wavelength of 1064nm, a power of 15-25W, and a welding speed of 3-8mm / s to seamlessly weld the outer protective film and the inner buffer ring along the edge, with a weld width of 0.1-0.5mm;

[0021] Step S4: Fixation system integration: The nickel-titanium alloy wire is annealed at 350±10°C for 10-15 minutes under a protective atmosphere (argon), then woven into a mesh stent and embedded into the edge of the protective sheath via a hot-pressing process. The magnetic anchor sheet is plasma-sprayed with a hydroxyapatite coating and then bonded to the stent using medical-grade epoxy resin. Curing conditions are 25°C and 50% humidity for 24 hours.

[0022] Step S5: Functionalization treatment: spraying the heparin sodium-PVP mixed solution on the inner wall of the drainage channel at a spraying rate of 0.5-1.5 mL / min, and then curing in an oven at 40-60°C for 2-4 hours;

[0023] Step S6: Sterilization packaging: Use ethylene oxide for sterilization, control the gas concentration to 600-1000 mg / L, relative humidity to 50-70%, temperature to 45-55°C, sterilization time to 3-6 hours, and then seal in a double-layer aluminum-plastic sterile bag.

[0024] Preferably, the annealing treatment of the nickel-titanium alloy wire in step S4 includes:

[0025] Stage 1: Heat to 350°C at 10-15°C / min and keep warm for 10 minutes;

[0026] The second stage: cooling to 200℃ at 5-10℃ / min, and then cooling naturally to room temperature.

[0027] Preferably, the preparation method of the heparin sodium-PVP mixed solution in step S5 is: dissolving heparin sodium and PVP in deionized water at a mass ratio of 1:4, stirring at a speed of 200-400 rpm and a temperature of 25-40° C. until a homogeneous transparent solution is formed.

[0028] Preferably, the inner layer of the double-layer aluminum-plastic aseptic bag in step S6 is a polyethylene film, the outer layer is an aluminum foil composite film, the sealing strength is ≥3.0N / 15mm, and the air permeability is ≤0.1cm³ / (m²·24h·0.1MPa).

[0029] Compared with the prior art, the present invention has the following beneficial effects:

[0030] 1. Material innovation: The PTFE-nanosilver composite layer combines antibacterial and durability, and the collagen-silicone buffer layer promotes tissue repair.

[0031] 2. Structural innovation: Magnetic fixation + shape memory stent enables "one-click" quick installation, reducing intraoperative operation time by more than 20%.

[0032] 3. Process innovation: Combining laser welding with plasma spraying technology to ensure product consistency (tolerance ±0.05mm).

[0033] 4. Clinical value: Animal experiments have shown that the postoperative infection rate is reduced to 1.2% (8.7% in the control group) and the wound healing time is shortened by 3-5 days. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 It is a three-dimensional diagram of the present invention;

[0035] Figure 2 It is a front view of the present invention;

[0036] Figure 3 It is a cross-sectional view of the present invention;

[0037] Figure 4 This is a process flow chart for producing the incision protection cover of the present invention.

[0038] Numbers in the figure: 101, outer protective film; 102, inner buffer ring; 103, adjustable fixation system; 103a, magnetic anchor plate; 103b, shape memory alloy bracket; 104, integrated drainage channel; 104a, negative pressure interface. DETAILED DESCRIPTION

[0039] See also Figure 1-4 , the present invention provides a technical solution: Example

[0040] A medical engineering incision protection sleeve, comprising: an outer protective film 101: composed of a polytetrafluoroethylene substrate and a surface-coated nanosilver composite layer, wherein the nanosilver coating has a density of 1.5-3.0 mg / cm², a thickness of 0.1-0.3 mm, and a particle size of 20-50 nm; an inner buffer ring 102: composed of a mixture of medical silica gel and collagen in a mass ratio of 6:4 to 8:2, with hollow microspheres uniformly dispersed inside, with a diameter of 50-200 μm, a wall thickness of 5-15 μm, and a filling rate of 10%-30% of the volume of the buffer ring. Adjustable fixation system 103: including magnetic anchoring sheet 103a and shape memory alloy stent 103b. The stent is woven into a mesh structure with nickel-titanium alloy wire. The diameter of the alloy wire is 0.1-0.3mm. After annealing at 300-400℃, it has the characteristic of triggering shape recovery at 35-45℃. Integrated drainage channel 104: provided on the side wall of the protective sleeve, including at least 3 drainage holes with an aperture of 1-3mm. The inner wall of the hole is coated with heparinized coating. The channel is connected to a standard negative pressure interface 104a. The interface diameter matches the clinical drainage tube. The magnetic anchoring sheet 103a is composed of a flexible magnet and a medical The surface is composited with high-grade polyurethane, and the surface is plasma-sprayed with hydroxyapatite coating with a coating thickness of 10-30μm. The magnetic induction intensity of the magnet is 0.3-0.8T, and the surface in contact with the skin is covered with a biocompatible adhesive layer. The ratio of the expanded diameter to the compressed diameter of the shape memory alloy stent 103b is 2:1 to 5:1. After expansion, the fitting pressure with the incision edge is 0.1-0.5N / cm², and the surface of the stent is treated with titanium nitride coating with a coating thickness of 2-5μm. The material of the hollow microspheres is polylactic acid-glycolic acid copolymer, and its degradation period is 30-90 days. The pH value of the decomposition product is 6.5-7.5, and the microspheres are filled with chitosan gel with a gel concentration of 5%-15% (w / v). The heparinized coating of the drainage channel 104 is formed by mixing sodium heparin and polyvinyl pyrrolidone in a mass ratio of 1:3 to 1:5. The coating thickness is 5-20 μm, and the heparin release rate is 0.1-0.5 μg / cm²·h. The PTFE substrate of the outer protective membrane 101 has a porosity of 30-50% and a pore size of 0.5-5 μm. The nanosilver composite layer is bonded to the PTFE substrate through a chemical vapor deposition process, and the bonding strength is ≥5 MPa.

[0041] A production process for an incision protective cover for medical engineering comprises the following steps:

[0042] Step S1: Preparation of the outer protective film 101: Immerse the PTFE film in a dispersion containing nanosilver particles at a concentration of 5-10 mg / mL, ultrasonicate for 20-40 minutes, and then dry in a vacuum drying oven at 50-70°C to form a nanosilver composite layer;

[0043] Step S2: Molding the inner buffer ring 102: After mixing medical silica gel and collagen in a certain proportion, add PLGA hollow microspheres, degas under vacuum degree ≤ 0.1 MPa for 30-60 minutes, inject into the mold, and vulcanize at 80-100°C for 10-30 minutes;

[0044] Step S3: Structural assembly: Using a Nd:YAG laser welding machine with a wavelength of 1064 nm, at a power of 15-25 W and a welding speed of 3-8 mm / s, the outer protective film 101 and the inner buffer ring 102 are seamlessly welded along the edges, with a weld width of 0.1-0.5 mm;

[0045] Step S4: Fixation system integration: The nickel-titanium alloy wire is annealed at 350±10°C for 10-15 minutes under a protective atmosphere (argon), then woven into a mesh stent 103b and embedded into the edge of the protective sleeve via a hot pressing process. The magnetic anchor sheet 103a is plasma-sprayed with a hydroxyapatite coating and then bonded to the stent 103b using a medical-grade epoxy resin. The curing conditions are 25°C and 50% humidity for 24 hours.

[0046] Step S5: Functionalization treatment: spraying the heparin sodium-PVP mixed solution on the inner wall of the drainage channel 104 at a spraying rate of 0.5-1.5 mL / min, and then curing in an oven at 40-60° C. for 2-4 hours;

[0047] Step S6: Sterilization packaging: Use ethylene oxide for sterilization, control the gas concentration to 600-1000 mg / L, relative humidity to 50-70%, temperature to 45-55°C, sterilization time to 3-6 hours, and then seal in a double-layer aluminum-plastic sterile bag.

[0048] The annealing treatment of the nickel-titanium alloy wire in step S4 includes:

[0049] Stage 1: Heat to 350°C at 10-15°C / min and keep warm for 10 minutes;

[0050] The second stage: cooling to 200℃ at 5-10℃ / min, and then cooling naturally to room temperature.

[0051] The preparation method of the heparin sodium-PVP mixed solution in step S5 is: dissolving heparin sodium and PVP in deionized water at a mass ratio of 1:4, stirring at a speed of 200-400 rpm and a temperature of 25-40° C. until a homogeneous transparent solution is formed.

[0052] In step S6, the inner layer of the double-layer aluminum-plastic sterile bag is a polyethylene film, the outer layer is an aluminum foil composite film, the sealing strength is ≥3.0N / 15mm, and the air permeability is ≤0.1cm³ / (m²·24h·0.1MPa).

[0053] Example 2: Laparoscopic surgery application

[0054] Select the protective sleeve model based on the incision length (5 cm) and pre-compress the stent to a diameter of 2 cm;

[0055] After insertion into the incision, the shape memory alloy is activated with 40°C saline, and the stent automatically expands to 5 cm, fitting the abdominal wall;

[0056] The magnetic anchor sheet is adsorbed on the skin surface with a fixing force of ≥0.5N / cm²;

[0057] The negative pressure drainage device was connected and the protective cover was removed 24 hours after the operation. There was no tissue adhesion.

[0058] Example 3: Optimization of production process parameters

[0059] Nanosilver coating concentration: 2.5mg / cm² (antibacterial rate 99.3%);

[0060] Laser welding power: 20W, speed 5mm / s, weld strength up to 15MPa;

[0061] Sterilization conditions: ethylene oxide concentration 800 mg / L, humidity 60%, temperature 50°C, action time 4 hours.

Claims

1. A medical engineering incision protection cover, characterized in that: include: The outer protective film (101) is composed of a polytetrafluoroethylene substrate and a nano-silver composite layer coated on the surface, wherein the density of the nano-silver coating is 1.5-3.0 mg / cm², the thickness is 0.1-0.3 mm, and the particle size of the nano-silver particles is 20-50 nm; Inner buffer ring (102): made of medical silica gel and collagen mixed in a mass ratio of 6:4 to 8:2, with hollow microspheres uniformly dispersed inside, the diameter of the hollow microspheres being 50-200 μm, the wall thickness being 5-15 μm, and the filling rate being 10%-30% of the volume of the buffer ring; An adjustable fixing system (103): comprising a magnetic anchoring sheet (103a) and a shape memory alloy stent (103b), wherein the stent is woven into a mesh structure by nickel-titanium alloy wires, the alloy wires have a diameter of 0.1-0.3 mm, are annealed at 300-400°C, and have the characteristic of triggering shape recovery at 35-45°C; An integrated drainage channel (104) is provided on the side wall of the protective sleeve and includes at least three drainage holes with a pore size of 1-3 mm. The inner wall of the hole is coated with a heparinized coating. The channel is externally connected to a standard negative pressure interface (104a), and the interface diameter matches that of a clinical drainage tube.

2. The medical engineering incision protection cover according to claim 1, characterized in that: The magnetic anchoring sheet (103a) is composed of a composite of a flexible magnet and medical-grade polyurethane, and its surface is plasma-sprayed with a hydroxyapatite coating with a thickness of 10-30 μm. The magnetic induction intensity of the magnet is 0.3-0.8 T, and the surface in contact with the skin is covered with a biocompatible adhesive layer.

3. The medical engineering incision protection cover according to claim 1, characterized in that: The ratio of the expanded diameter to the compressed diameter of the shape memory alloy stent (103b) is 2:1 to 5:1, the fitting pressure with the incision edge after expansion is 0.1-0.5N / cm², and the surface of the stent is treated with titanium nitride coating with a coating thickness of 2-5μm.

4. The medical engineering incision protection cover according to claim 1, characterized in that: The hollow microspheres are made of polylactic acid-glycolic acid copolymer, which has a degradation period of 30-90 days and a pH value of the degradation product of 6.5-7.

5. The microspheres are filled with chitosan gel with a gel concentration of 5%-15% (w / v).

5. The medical engineering incision protection cover according to claim 1, characterized in that: The heparinized coating of the drainage channel (104) is formed by mixing sodium heparin and polyvinyl pyrrolidone in a mass ratio of 1:3 to 1:5, with a coating thickness of 5-20 μm and a heparin release rate of 0.1-0.5 μg / cm²·h.

6. The medical engineering incision protection cover according to claim 1, characterized in that: The PTFE substrate of the outer protective film (101) has a porosity of 30-50% and a pore size of 0.5-5 μm, and the nanosilver composite layer is bonded to the PTFE substrate through a chemical vapor deposition process, with a bonding strength of ≥5 MPa.

7. The production process of a medical engineering incision protection cover according to any one of claims 1 to 6, characterized in that: The following steps are involved: Step 1: Preparation of the outer protective film (101): immersing the PTFE film in a dispersion containing nanosilver particles at a concentration of 5-10 mg / mL, ultrasonically treating the film for 20-40 minutes, and then drying the film in a vacuum drying oven at 50-70°C to form a nanosilver composite layer; Step 2: Molding of the inner buffer ring (102): medical silica gel and collagen are mixed in proportion, PLGA hollow microspheres are added, degassed for 30-60 minutes under a vacuum degree of ≤0.1 MPa, injected into a mold, and vulcanized at 80-100°C for 10-30 minutes; Step 3: Structural assembly: using a Nd:YAG laser welding machine with a wavelength of 1064 nm, with a power of 15-25 W and a welding speed of 3-8 mm / s, the outer protective film (101) and the inner buffer ring (102) are seamlessly welded along the edge, with a weld width of 0.1-0.5 mm; Step S4: Fixation system integration: The nickel-titanium alloy wire is annealed at 350±10°C for 10-15 minutes under a protective atmosphere (argon), and then woven into a mesh stent (103b), and embedded into the edge of the protective cover by a hot pressing process; the magnetic anchor sheet (103a) is plasma-sprayed with a hydroxyapatite coating, and then bonded to the stent (103b) with a medical-grade epoxy resin, and the curing conditions are 25°C and 50% humidity for 24 hours; Step S5: functionalization treatment: spraying the heparin sodium-PVP mixed solution on the inner wall of the drainage channel (104) at a spraying rate of 0.5-1.5 mL / min, and then curing in an oven at 40-60°C for 2-4 hours; Step S6: Sterilization packaging: Use ethylene oxide for sterilization, control the gas concentration to 600-1000 mg / L, relative humidity to 50-70%, temperature to 45-55°C, sterilization time to 3-6 hours, and then seal in a double-layer aluminum-plastic sterile bag.

8. The production process of a medical engineering incision protection cover according to claim 7, characterized in that: The annealing treatment of the nickel-titanium alloy wire in step S4 includes: Stage 1: Heat to 350°C at 10-15°C / min and keep warm for 10 minutes; The second stage: cooling to 200℃ at 5-10℃ / min, and then cooling naturally to room temperature.

9. The production process of a medical engineering incision protection cover according to claim 7, characterized in that: The preparation method of the heparin sodium-PVP mixed solution in step S5 is: dissolving heparin sodium and PVP in deionized water at a mass ratio of 1:4, stirring at a speed of 200-400 rpm and a temperature of 25-40° C. until a homogeneous transparent solution is formed.

10. The production process of a medical engineering incision protection cover according to claim 7, characterized in that: In step S6, the inner layer of the double-layer aluminum-plastic sterile bag is a polyethylene film, the outer layer is an aluminum foil composite film, the sealing strength is ≥3.0N / 15mm, and the air permeability is ≤0.1cm³ / (m²·24h·0.1MPa).

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