Guide wire of disposable endoscope

Abstract

The invention relates to the technical field of medical instruments, and discloses a disposable endoscope guide wire preparation process which comprises the following steps: step 1, polylactic acid and polycaprolactone are put into a reaction kettle, and are combined and polymerized by taking p-toluenesulfonic acid as a catalyst and dimethyl sulfoxide as a solvent carrier to finally obtain a polymer A; step 2, pretreating the polymer A obtained in the step 1, then putting the pretreated polymer A and vitamin C into a horizontal stirrer, controlling the stirring time to be 12-18min at normal temperature and the stirring speed to be 35-68r / min, and uniformly mixing to obtain a base material A; polymers of polylactic acid and polycaprolactone are adopted as base materials for manufacturing the guide wire, it is guaranteed that the guide wire has enough performance and service life stability, meanwhile, the good degradation rate is achieved, the disposable guide wire is more environmentally friendly, the used guide wire does not need to be treated by spending too much cost, and through cooperation between the spiral groove and the guide wire base body, the service life of the guide wire is prolonged. And good bending performance and toughness of the guide wire are ensured.

Description

Technical Field

[0001] The invention relates to the technical field of medical instruments, in particular to a disposable guide wire for an endoscope. Background Art

[0002] Endoscopic guidewires are commonly used in endoscopy and medical procedures to help navigate the endoscope to a specific target location. These guidewires are usually made of flexible metal wire or plastic material with a certain rigidity to pass through biological tissues or cavities under endoscopic guidance. Single-use guidewires help reduce the risk of infection transmission. After use, the guidewire is discarded and not used for another patient.

[0003] Currently, most disposable endoscope guidewires are discarded after use. However, in order to ensure the rigidity and toughness of the guidewire, the selected plastic material usually cannot meet the standard degradation requirements. At the same time, when degradable materials are used for preparation, the stability of the guidewire and its own performance requirements cannot be guaranteed. For this reason, the present invention proposes a disposable endoscope guidewire. Summary of the invention

[0004] In view of the deficiencies in the prior art, the present invention provides a disposable endoscope guidewire, which solves the problem that the plastic materials used for endoscope guidewires in the prior art usually cannot meet the standard degradation requirements, and at the same time, when degradable materials are used for preparation, the stability of the guidewire and its own performance requirements cannot be guaranteed.

[0005] To achieve the above objectives, the present invention is implemented through the following technical solutions: A disposable endoscope guide wire comprises a handle, one end of the handle is equipped with a guide wire, and the bottom of the guide wire is provided with a wiring port; The guide wire comprises a base body, the top of the base body is mounted on the bottom of the handle, a coating is arranged on the outer side of the base body, and a spiral groove is opened on the outer side of the base body.

[0006] A guide wire formula for a disposable endoscope comprises the following raw materials in mass fractions: 1200-1600 parts of polylactic acid, 140-260 parts of polycaprolactone, 43-76 parts of vitamin C, and 86-102 parts of polytetrafluoroethylene.

[0007] A process for preparing a guide wire for a disposable endoscope comprises the following steps: Step 1: Put polylactic acid and polycaprolactone into a reaction kettle, and carry out combined polymerization in the presence of p-toluenesulfonic acid as a catalyst and dimethyl sulfoxide as a solvent carrier to finally obtain polymer A; Step 2: pretreat the polymer A obtained in step 1, and then put it into a horizontal stirrer with vitamin C, control the stirring time to be 12 to 18 minutes at room temperature, and the stirring speed to be 35 to 68 r / min, and mix them evenly to obtain a substrate A; Step 3, taking out the substrate A obtained in step 2, adding it into a twin-screw extruder for heating and extrusion, and filling the inside of the extruder with nitrogen for protection during extrusion, and obtaining the initial guide wire A after cooling and shaping; Step 4: further processing the initial guide wire A obtained in step 3 to obtain the desired diameter, length and shape; Step 5: Cut and trim the initial guide wire A that has been further processed in step 4 according to the usage specifications and requirements to ensure that the obtained guide wire meets the specific length and shape requirements; Step 6: Use a coating machine to evenly coat the pretreated polytetrafluoroethylene on the outside of the guide wire obtained in step 5, so that a nano-scale thin film coating is formed on the outside of the guide wire to obtain a disposable endoscope guide wire; Step 7: Perform corresponding quality control and testing on the disposable guide wire obtained in step 6, then use a sterilization device to sterilize the disposable guide wire and the packaging bag, and finally put the disposable guide wire into the packaging bag for packaging and storage.

[0008] Preferably, in the step 1, the temperature of the reactor is 100-165° C., the reaction time is 1-1.6 d, and the stirring speed is 35-58 r / min.

[0009] Preferably, the pretreatment of polymer A in step 2 comprises the following steps: The polymer A is dried to remove excess water; The dried polymer A is pulverized to ensure that the polymer A is in a powdery state.

[0010] Preferably, the step 2 of mixing vitamin C comprises the following steps: First, add an appropriate amount of water as a solvent into a horizontal mixer, and then add vitamin C powder into the horizontal mixer; The horizontal agitator was started to fully dissolve the added vitamin C in the water solvent, and then the pretreated polymer A was added into the horizontal agitator for mixing.

[0011] Preferably, in step three, the extrusion temperature of the twin-screw extruder is 82-105° C., and the extrusion rate is 12-17 m / min.

[0012] Preferably, the further processing of the initial guide wire A in step 4 comprises the following steps: Softening the initial guide wire A using a heat treatment device; According to the specifications and requirements of the guide wire, select a suitable mold to adjust the cross-sectional shape of the guide wire; The obtained initial guide wire A is stretched using a stretching device to adjust the size and strength of the guide wire.

[0013] Preferably, the pretreatment of polytetrafluoroethylene in step 6 comprises the following steps: Use ultrasonic cleaning technology to clean the surface of PTFE to ensure the surface is clean; The cleaned polytetrafluoroethylene is melted into a liquid state at 240-345°C; Plasma treatment of polytetrafluoroethylene is used to activate the surface of polytetrafluoroethylene.

[0014] Preferably, the quality control and testing in step seven includes: Inspect the appearance of the guidewire, including diameter measurement and surface defect detection; The guidewire performance is tested, including testing the tensile properties of the guidewire, measuring the hardness of the guidewire using a hardness tester, and performing a wear resistance test on the guidewire.

[0015] The present invention provides a disposable endoscope guide wire, which has the following beneficial effects: 1. The present invention ensures that the guide wire can adapt to complex environments when passing through human tissues through the coordination between the spiral groove and the guide wire matrix, and avoids discomfort to the patient caused by excessive toughness of the guide wire when bending.

[0016] 2. The present invention uses a polymer of polylactic acid and polycaprolactone as a base material for making a guide wire, which ensures that the guide wire has sufficient performance and life stability, and also has an excellent degradation rate, making the disposable guide wire more environmentally friendly, and does not require excessive costs to process the guide wire after use. At the same time, by adjusting the polycaprolactone content in the polymer, the degradation efficiency and stability of the guide wire can be controlled within a certain range, and the demand between the degradation efficiency and stability of the guide wire can be determined according to actual needs.

[0017] 3. The present invention protects the substrate 21 by adding vitamin C and nitrogen during the extrusion process to avoid oxidation of the substrate and improve the performance of the subsequent guide wire. In addition, the polytetrafluoroethylene is plasma treated to ensure that it can be more firmly attached to the outside of the substrate 21 during coating, thereby ensuring the stability of the outer coating of the guide wire and improving the performance of the guide wire. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 A perspective view of the present invention; Figure 2 for Figure 1 Enlarged view of point A in the middle; Figure 3It is a cross-sectional view of the substrate of the present invention.

[0019] Among them, 1. handle; 2. guide wire; 21. matrix; 22. coating; 23. spiral groove; 3. wiring port. DETAILED DESCRIPTION

[0020] The following will be combined with the drawings in the specification of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. Example

[0021] Please refer to the attached Figure 1 -Attached Figure 3 The embodiment of the present invention provides a disposable endoscope guide wire, including a handle 1, through which the guide wire 2 can be conveniently taken for guiding operation. The guide wire 2 is installed at one end of the handle 1, and a wiring port 3 is opened at the bottom of the guide wire 2. The wiring port 3 can cooperate with the guide wire to help the guide wire 2 move to the specified position accurately; The guide wire 2 includes a base 21, the top of the base 21 is mounted on the bottom of the handle 1, a coating 22 is arranged on the outside of the base 21, and a spiral groove 23 is opened on the outside of the base 21. The spiral groove 23 is pressed and formed by a specific mold. The spiral groove 23 can improve the overall bending performance of the guide wire 2, ensure that the guide wire 2 can adapt to a complex environment when passing through human tissue, and avoid the guide wire 2 being too tough and causing discomfort to the patient when bending.

[0022] A guide wire formula for a disposable endoscope comprises the following raw materials in different mass fractions: 1540 parts of polylactic acid, 215 parts of polycaprolactone, 56 parts of vitamin C and 96 parts of polytetrafluoroethylene.

[0023] A process for preparing a guide wire for a disposable endoscope comprises the following steps: Step 1: Put polylactic acid and polycaprolactone into a reactor at a temperature of 126°C, a reaction time of 1.2 days, and a stirring speed of 43 r / min. Then, p-toluenesulfonic acid is used as a catalyst and dimethyl sulfoxide is used as a solvent carrier for combined polymerization to finally obtain polymer A; Step 2: Pre-treat the polymer A obtained in step 1, dry the polymer A after taking out, and remove excess water; crush the dried polymer A to ensure that the polymer A is in powder form. Then put it into a horizontal agitator with vitamin C. First, add an appropriate amount of water as a solvent to the horizontal agitator, and add the vitamin C powder to the horizontal agitator; start the horizontal agitator to fully dissolve the added vitamin C in the water solvent, and then add the pre-treated polymer A to the horizontal agitator for mixing. Control the stirring time to 15 minutes at room temperature and the stirring speed to 53r / min. After mixing evenly, the substrate A is obtained; Step 3: Take out the substrate A obtained in step 2, add it into a twin-screw extruder for heating and extrusion, and fill the extruder with nitrogen for protection during extrusion, control the extrusion temperature to 96°C, and the extrusion rate to 13m / min. After cooling and shaping, the initial guide wire A is obtained; Step 4: Further process the initial guide wire A obtained in step 3, soften the initial guide wire A using heat treatment equipment; select a suitable mold to adjust the cross-sectional shape of the guide wire according to the specifications and requirements of the guide wire; use a stretching device to stretch the initial guide wire A to adjust the size and strength of the guide wire to obtain the desired diameter, length and shape; Step 5: Cut and trim the initial guide wire A that has been further processed in step 4 according to the usage specifications and requirements to ensure that the obtained guide wire meets the specific length and shape requirements; Step 6: Use ultrasonic cleaning technology to clean the surface of polytetrafluoroethylene to ensure that the surface is clean; melt the cleaned polytetrafluoroethylene into a liquid at 306°C; perform plasma treatment on the polytetrafluoroethylene and perform surface activation treatment on the polytetrafluoroethylene to improve its adhesion and firmness. Use a coating machine to evenly coat the pretreated polytetrafluoroethylene on the outside of the guide wire obtained in step 5, so that a nano-scale thin film coating is formed on the outside of the guide wire to obtain a disposable endoscope guide wire; Step 7: Perform corresponding quality control and testing on the disposable guidewire obtained in step 6, inspect the appearance of the guidewire, including diameter measurement and surface defect detection; inspect the performance of the guidewire, including testing the tensile performance of the guidewire, measuring the hardness of the guidewire using a hardness tester, and performing a wear resistance test on the guidewire. Then, use a disinfection device to disinfect the disposable guidewire and the packaging bag, and finally put the disposable guidewire into the packaging bag for packaging and storage.

[0024] The test data obtained during the application of the above guidewires include degradability, stability, degradation time, oxidation resistance during preparation, and stability of the coating, as shown in Table 1 below. Example

[0025] A disposable endoscope guidewire formulation includes the following raw materials by mass fraction: 1540 parts of polylactic acid, 150 parts of polycaprolactone, 56 parts of vitamin C, and 96 parts of polytetrafluoroethylene. The remaining process preparation steps are the same as those in Example 1. The degradability, stability, degradation time, oxidation resistance during preparation, and stability of the coating of the disposable guidewire obtained are shown in Table 1 below Example

[0026] An embodiment of the present invention provides a process for preparing a guidewire for a disposable endoscope, wherein the polycaprolactone in Embodiment 1 is removed, and the remaining steps are the same as the process steps in Embodiment 1. The final degradability, stability, degradation time, antioxidant property during preparation, and stability of the coating are shown in Table 1 below. Example

[0027] The embodiment of the present invention provides a process for preparing a guidewire for a disposable endoscope, wherein the step of plasma treating polytetrafluoroethylene in the first embodiment is removed, and the remaining steps are the same as the process steps in the first embodiment. The final degradability, stability, degradation time, oxidation resistance during preparation, and stability of the coating are shown in Table 1 below. Example

[0028] The embodiment of the present invention provides a process for preparing a guidewire for a disposable endoscope, wherein the vitamin C in the first embodiment is removed, and the remaining steps are the same as the process steps in the first embodiment. The final degradability, stability, degradation time, antioxidant property during preparation, and stability of the coating are shown in Table 1 below. Table 1 Conclusion: As can be seen from Table 1, the present invention uses polymers of polylactic acid and polycaprolactone as the base material for making guidewires, which ensures that the guidewires have sufficient performance and life stability while also having an excellent degradation rate, making disposable guidewires more environmentally friendly and not requiring excessive costs to process the guidewires after use. At the same time, by adjusting the polycaprolactone content in the polymer, the degradation efficiency and stability of the guidewire can be controlled within a certain range, and the requirements between the degradation efficiency and stability of the guidewire can be determined according to actual needs. At the same time, by adding vitamin C and nitrogen during the extrusion process to protect the matrix 21, oxidation of the matrix is ​​avoided, and the performance of the subsequent guidewires is improved. In addition, by plasma treatment of polytetrafluoroethylene, it is ensured that it can be more firmly attached to the outside of the matrix 21 during coating, the stability of the outer coating of the guidewire is ensured, and the performance of the guidewire is improved.

[0029] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A disposable endoscope guide wire, comprising a handle (1), characterized in that: A guide wire (2) is installed at one end of the handle (1), and a wiring port (3) is provided at the bottom of the guide wire (2); The guide wire (2) comprises a base (21), the top of the base (21) is mounted on the bottom of the handle (1), a coating (22) is provided on the outside of the base (21), and a spiral groove (23) is provided on the outside of the base (21).

2. A disposable endoscope guidewire formulation, according to the disposable endoscope guidewire of claim 1, characterized in that: The invention comprises the following raw materials in mass fractions: 1200-1600 parts of polylactic acid, 140-260 parts of polycaprolactone, 43-76 parts of vitamin C and 86-102 parts of polytetrafluoroethylene.

3. A process for preparing a guide wire for a disposable endoscope, characterized in that: A disposable endoscope guide wire according to claim 1, comprising the following steps: Step 1: Put polylactic acid and polycaprolactone into a reaction kettle, and carry out combined polymerization in the presence of p-toluenesulfonic acid as a catalyst and dimethyl sulfoxide as a solvent carrier to finally obtain polymer A; Step 2: pretreat the polymer A obtained in step 1, and then put it into a horizontal stirrer with vitamin C, control the stirring time to be 12 to 18 minutes at room temperature, and the stirring speed to be 35 to 68 r / min, and mix them evenly to obtain a substrate A; Step 3, taking out the substrate A obtained in step 2, adding it into a twin-screw extruder for heating and extrusion, and filling the inside of the extruder with nitrogen for protection during extrusion, and obtaining the initial guide wire A after cooling and shaping; Step 4: further processing the initial guide wire A obtained in step 3 to obtain the desired diameter, length and shape; Step 5: Cut and trim the initial guide wire A that has been further processed in step 4 according to the usage specifications and requirements to ensure that the obtained guide wire meets the specific length and shape requirements; Step 6: Use a coating machine to evenly coat the pretreated polytetrafluoroethylene on the outside of the guide wire obtained in step 5, so that a nano-scale thin film coating is formed on the outside of the guide wire to obtain a disposable endoscope guide wire; Step 7: Perform corresponding quality control and testing on the disposable guide wire obtained in step 6, then use a sterilization device to sterilize the disposable guide wire and the packaging bag, and finally put the disposable guide wire into the packaging bag for packaging and storage.

4. A process for preparing a guide wire for a disposable endoscope according to claim 3, characterized in that: In the step 1, the temperature of the reactor is 100-165° C., the reaction time is 1-1.6 d, and the stirring speed is 35-58 r / min.

5. The process for preparing a guide wire for a disposable endoscope according to claim 3, characterized in that: The pretreatment of polymer A in step 2 comprises the following steps: The polymer A is dried to remove excess water; The dried polymer A is pulverized to ensure that the polymer A is in a powdery state.

6. The process for preparing a guide wire for a disposable endoscope according to claim 3, characterized in that: The step 2 of mixing vitamin C comprises the following steps: First, add an appropriate amount of water as a solvent into a horizontal mixer, and then add vitamin C powder into the horizontal mixer; The horizontal agitator was started to fully dissolve the added vitamin C in the water solvent, and then the pretreated polymer A was added into the horizontal agitator for mixing.

7. The process for preparing a guide wire for a disposable endoscope according to claim 3, characterized in that: In the step 3, the extrusion temperature of the twin-screw extruder is 82-105° C., and the extrusion rate is 12-17 m / min.

8. The process for preparing a guide wire for a disposable endoscope according to claim 3, characterized in that: The further processing of the initial guide wire A in step 4 includes the following steps: Softening the initial guide wire A using a heat treatment device; According to the specifications and requirements of the guide wire, select a suitable mold to adjust the cross-sectional shape of the guide wire; The obtained initial guide wire A is stretched using a stretching device to adjust the size and strength of the guide wire.

9. The process for preparing a guide wire for a disposable endoscope according to claim 3, characterized in that: The six steps of pre-treating polytetrafluoroethylene include the following steps: Use ultrasonic cleaning technology to clean the surface of PTFE to ensure the surface is clean; The cleaned polytetrafluoroethylene is melted into a liquid state at 240-345°C; Plasma treatment of polytetrafluoroethylene is used to activate the surface of polytetrafluoroethylene.

10. The process for preparing a guide wire for a disposable endoscope according to claim 3, characterized in that: The quality control and testing in step seven includes: Inspect the appearance of the guidewire, including diameter measurement and surface defect detection; The guidewire performance is tested, including testing the tensile properties of the guidewire, measuring the hardness of the guidewire using a hardness tester, and performing a wear resistance test on the guidewire.

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