Novel urinary guide wire and preparation method thereof

Abstract

The invention belongs to the technical field of medical instruments, and discloses a novel urinary guide wire and a preparation method thereof.The novel urinary guide wire comprises a guide wire body, the guide wire body is composed of a nickel-titanium supporting section and a tip silica gel soft head, and the middle of the nickel-titanium supporting section and the middle of the tip silica gel soft head are fixed through welding; a knurling section structure and a smooth section structure are arranged in the middle of the nickel-titanium supporting section; the ultra-soft medical silica gel material is creatively adopted to design the silica gel dyeing head, the mechanical injury risk of the urethral mucosa is remarkably reduced, clinical data shows that the problems of serious complications such as urethral mucosa injury and tissue perforation are reduced, and the application prospect is wide. A high-safety instrument is provided for urinary system interventional therapy, and a safer treatment choice is provided for a patient.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and specifically relates to a novel urinary guidewire and a preparation method thereof. Background Art

[0002] In the clinical diagnosis and treatment of urinary system diseases, traditional guidewires, as commonly used auxiliary instruments, have exposed a series of defects and deficiencies that need to be addressed in clinical practice, which has brought many adverse effects on surgical operations and patient prognosis. Traditional guidewires have a significant drawback in design, that is, their hardness distribution lacks a reasonable gradient change, the overall hardness is relatively uniform, and they lack the necessary flexibility and compliance. When passing through urethral stenosis or performing delicate operations, they are prone to damage to the urethral mucosa. Mild damage may lead to damage and bleeding on the mucosal surface, and patients will experience pain, hematuria and other discomfort symptoms after surgery; severe damage may directly cause perforation of the urethral mucosa. Once perforation occurs, urine may leak into the surrounding tissue gaps, causing serious complications such as infection and abscess formation. The perforation rate can reach 2.3%. At the same time, during the pushing process, due to the lack of effective friction enhancement design, pushing is prone to difficulty, and the success rate of novice doctors is low, only 78%.

[0003] Existing guidewires have deficiencies in structure and function. Although some guidewires have attempted to be improved, the problems of tip damage and difficulty in pushing have not been effectively solved. For example, some guidewires have innovated in coating but have not fundamentally improved the structural design of the guidewire. Other guidewires have attempted to change the hardness distribution, but the process is complex and the cost is high, making it difficult to achieve large-scale production and application. Therefore, a new urological guidewire and a preparation method thereof are proposed. Summary of the Invention

[0004] In order to solve the problems of guidewire tip damage and difficulty in pushing, resulting in high cost and difficulty in large-scale production and application, the present invention provides a novel urological guidewire and a preparation method thereof.

[0005] To achieve the above objectives, the present invention provides the following technical solutions: a novel urology guidewire, comprising a guidewire body, the guidewire body comprising a nickel-titanium support segment and a silicone soft tip, the nickel-titanium support segment and the silicone soft tip being fixed by welding, the nickel-titanium support segment being provided with a knurled segment structure and a smooth segment structure in the middle; The smooth segment structure is located at one end of the nickel-titanium support segment close to the tip silicone soft head.

[0006] Preferably, the nickel-titanium support segment uses a traditional nickel-titanium wire with a hardness of 60A and a length of 57 cm.

[0007] Preferably, one end of the nickel-titanium support segment is knurled by using a knurling machine to form a knurled segment structure, the specifications of the knurled segment structure are set to a knurling depth of 80-120 μm and a pitch of 0.8-1.2 mm, and the outside of the nickel-titanium support segment is coated with a coating, which is an antibacterial layer of 7% nano-silver chitosan.

[0008] Preferably, a transition zone with a taper slope of 1:5 is provided between the pointed silicone soft head and the nickel-titanium support segment.

[0009] Preferably, the length of the pointed silicone soft head is set to 3 cm, the diameter is set to 1.2 mm, and the pointed silicone soft head is formed by injection molding using LSR material with a Shore hardness of 30A.

[0010] Preferably, a nickel-titanium core shaft with a diameter of 0.8 mm is provided inside the pointed silicone soft head, and the nickel-titanium core shaft is fixed to the pointed silicone soft head by welding.

[0011] Preferably, the pointed silicone soft head is provided with a coating, and the surface of the knurled section structure is specially treated and coated with an ultra-soft PVP hydrogel lubricating layer, and the coating thickness is between 5 μm and 8 μm, so that the friction coefficient is less than 0.06.

[0012] A novel method for preparing a urinary guidewire comprises the following steps: S1. Use a high-precision optical projector with a ring light source to eliminate surface reflection interference. Clamp the support segment vertically on the rotating fixture and rotate it 360° at 15° intervals. The projector automatically collects axial profile data to detect the straightness and performance of the nickel-titanium support segment, ensuring that the coaxiality of the nickel-titanium support segment is maintained less than or equal to 0.1mm. S2. Use a double-cavity injection mold. The mold needs to be preheated to 60°C to avoid condensation of silicone. The injection molding machine is driven by a servo motor. The pressure fluctuation range is ≤±2bar, the temperature control accuracy is ±1°C, and the injection molding parameters are set. Injection pressure: 80±3bar; Mold temperature: 120±2℃; Curing time: 30±2 seconds; This completes the injection molding of the pointed silicone soft head; S3. Use laser welding equipment; perform circular scanning along the joint between the nickel-titanium support section and the tip silicone soft head during welding. Monitor the joint temperature with an infrared thermometer to avoid performance degradation caused by phase change of the nickel-titanium alloy. Perform an appearance inspection after welding. The weld surface must be smooth and continuous, without cracks, pores or melt-through defects. Then perform a tensile test: apply an axial load along the welding direction, and the breaking force must be ≥5N. S4. Slowly add PVP to 40°C preheated water and stir until completely dissolved; after cooling to 25°C, add glycerol, continue stirring for 1 hour and sterilize through a 0.22μm filter membrane.

[0013] Set environmental conditions and parameters: The coating tank temperature is kept constant at 4±0.5℃ and the humidity is ≤40% to reduce water evaporation; Dipping time: 20±1 seconds; After dipping, the soft tip was left to stand horizontally at room temperature for 30 minutes to allow the solvent to evaporate naturally, thereby forming an ultra-soft lubricating layer with a thickness of 5-8 μm on the surface of the tip silicone soft tip; S5. Perform knurling on the nickel-titanium support segment using a knurling machine to form a knurled segment structure, and then dip-coat with a high concentration of 7% HAg-01 at room temperature for 15 seconds to form an antibacterial layer on the outside of the nickel-titanium support segment; S6. For the transition area between the nickel-titanium support segment and the knurled segment structure, an elastic polyurethane intermediate layer with a Shore hardness of 45A is dip-coated for 10 seconds to form a protective layer with a thickness of 3 μm in the transition area.

[0014] Compared with the prior art, the present invention has the following beneficial effects: This invention innovatively uses ultra-soft medical silicone material to design a silicone dye tip, significantly reducing the risk of mechanical damage to the urethral mucosa. Clinical data also shows that it reduces serious complications such as urethral mucosal damage and tissue perforation, providing a highly safe device for urinary system interventional treatment and offering patients a safer treatment option. The present invention improves the success rate of doctors' operations by coordinating structures such as the nickel-titanium support segment and the knurled segment structure. The knurled segment structure and reasonable coating design set on the nickel-titanium support segment enhance the pushing force and operation stability, thereby improving the success rate of doctors' operations and reducing the learning cost and difficulty of novice doctors. In addition, the preparation method of the present invention is based on the transformation of the existing production line, the cost of new equipment is low, the process is simple, and it is easy for workers to master, making it suitable for large-scale production and promotion and application. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 Schematic diagram of the overall structure of the guidewire of the present invention; Figure 2 This is a schematic diagram of the appearance of the pointed silicone soft head of the present invention; Figure 3 This is a partial enlarged view of the knurling structure of the support section of the present invention; Figure 4 Schematic diagram of the operation of the guidewire of the present invention in the urethra model.

[0016] In the figure: 1. Nickel-titanium support segment; 2. Knurled segment structure; 3. Smooth segment structure; 4. Tip silicone soft head. DETAILED DESCRIPTION

[0017] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. 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 making creative efforts are within the scope of protection of the present invention.

[0018] like Figures 1 to 4 As shown, the present invention provides a novel urological guidewire, including a guidewire body, which is composed of a nickel-titanium support segment 1 and a sharp silicone soft head 4. The nickel-titanium support segment 1 and the sharp silicone soft head 4 are fixed in the middle by welding. A knurled segment structure 2 and a smooth segment structure 3 are provided in the middle of the nickel-titanium support segment 1. The smooth section structure 3 is located at one end of the nickel-titanium support section 1 close to the tip silicone soft head 4 .

[0019] The above solution is adopted: by setting a pointed silicone soft head 4, the tip contact force can be effectively reduced, the risk of urethral mucosal damage and perforation is reduced, and a safer treatment option is provided for patients. At the same time, the knurled section structure 2 set on the nickel-titanium support section 1 can enhance the pushing force, thereby performing stability during the pushing operation, improving the success rate of the doctor's operation, being more suitable for novice doctors to perform actual operations, and having stronger versatility.

[0020] like Figure 1 and Figure 3 As shown, the nickel-titanium support segment 1 adopts a traditional nickel-titanium wire with a hardness of 60A and a length set to 57 cm; one end of the nickel-titanium support segment 1 is knurled by using a knurling machine to form a knurled segment structure 2, and the specifications of the knurled segment structure 2 are set to a knurling depth of 80-120 μm and a pitch of 0.8-1.2 mm. The outside of the nickel-titanium support segment 1 is coated with a coating, which is an antibacterial layer of 7% nano-silver chitosan.

[0021] The above scheme is adopted: by setting a knurled segment structure 2 on the nickel-titanium support segment 1, and setting knurling with a depth of 80-120μm and a pitch of 0.8-1.2mm on the knurled segment structure 2, the holding friction force of the doctor when holding the guide wire body is increased. After actual testing, the design of the knurled segment structure 2 makes the pushing torque of the guide wire body 17% higher than that of the traditional guide wire, which increases the pushing success rate of novice doctors from 78% to 94%, achieving a substantial increase and greatly reducing the difficulty of operation.

[0022] like Figures 1 to 4As shown, a transition zone with a 1:5 taper slope is provided between the tip silicone soft head 4 and the nickel-titanium support segment 1 , and the transition zone is coated with an elastic polyurethane intermediate layer with a Shore hardness of 45A.

[0023] The above solution is adopted: by setting a transition zone with a 1:5 slope taper between the tip silicone soft head 4 and the nickel-titanium support segment 1, the transition zone protects the welding point between the nickel-titanium support segment 1 and the tip silicone soft head 4, reducing stress concentration. At the same time, the setting of the elastic polyurethane intermediate layer further improves the bonding strength and crack resistance of the transition zone, reducing the risk of fracture at the welding point between the nickel-titanium support segment 1 and the tip silicone soft head 4.

[0024] like Figures 2 to 4 As shown, the length of the tip silicone soft head 4 is set to 3 cm, the diameter is set to 1.2 mm, and the tip silicone soft head 4 is injection molded using LSR material with a Shore hardness of 30A. A nickel-titanium core shaft with a diameter of 0.8 mm is provided inside the tip silicone soft head 4. The nickel-titanium core shaft and the tip silicone soft head 4 are fixed by welding. The tip silicone soft head 4 is provided with a coating, and the surface of the knurled section structure 2 is specially treated and coated with an ultra-soft PVP hydrogel lubricating layer, and the coating thickness is between 5 μm and 8 μm, so that the friction coefficient is less than 0.06.

[0025] The above scheme is adopted: the nickel-titanium core shaft arranged inside the tip silicone soft head 4 is used to support the tip silicone soft head 4, and at the same time facilitates the welding of the tip silicone soft head 4 and the nickel-titanium support segment 1. At the same time, the tip silicone soft head 4 is formed by injection molding using LSR material with a Shore hardness of 30A, so that the tip silicone soft head 4 has an overall soft texture, which can effectively disperse the pressure on the urethra when the tip silicone soft head 4 contacts the urethral mucosa. At the same time, after clinical testing, the tip contact force is reduced by 50% compared with the traditional guide wire, from 1.2N to 0.6N, which greatly reduces the risk of mucosal damage and the perforation rate from 2.3% to 0.8%. It effectively reduces the tip contact force and reduces the risk of urethral mucosal damage and perforation, providing patients with a safer treatment option. A novel method for preparing a urinary guidewire comprises the following steps: S1. Use a high-precision optical projector with a ring light source to eliminate surface reflection interference. Clamp the support segment vertically on the rotating fixture and rotate it 360° at 15° intervals. The projector automatically collects axial profile data to detect the straightness and performance of the nickel-titanium support segment 1, ensuring that the coaxiality of the nickel-titanium support segment 1 is maintained less than or equal to 0.1mm. S2. Use a double-cavity injection mold. The mold needs to be preheated to 60°C to avoid condensation of silicone. The injection molding machine is driven by a servo motor. The pressure fluctuation range is ≤±2bar, the temperature control accuracy is ±1°C, and the injection molding parameters are set. Injection pressure: 80±3bar; Mold temperature: 120±2℃; Curing time: 30±2 seconds; This completes the injection molding of the pointed silicone soft head 4; S3. Use laser welding equipment; perform circular scanning along the joint between the nickel-titanium support section 1 and the tip silicone soft head 4 during welding. Monitor the joint temperature with an infrared thermometer to avoid performance degradation caused by phase change of the nickel-titanium alloy. Perform an appearance inspection after welding. The weld surface must be smooth and continuous, without cracks, pores or melt-through defects. Then perform a tensile test: apply an axial load along the welding direction, and the breaking force must be ≥5N. S4. Slowly add PVP to 40°C preheated water and stir until completely dissolved; after cooling to 25°C, add glycerol, continue stirring for 1 hour and sterilize through a 0.22μm filter membrane.

[0026] Set environmental conditions and parameters: The coating tank temperature is kept constant at 4±0.5℃ and the humidity is ≤40% to reduce water evaporation; Dipping time: 20±1 seconds; After dipping, the soft tip is left horizontally at room temperature for 30 minutes to allow the solvent to evaporate naturally, thereby forming an ultra-soft lubricating layer with a thickness of 5-8 μm on the surface of the tip silicone soft tip 4; S5. Use a knurling machine to perform knurling on the nickel-titanium support segment 1 to form a knurled segment structure 2. Then use a high concentration of 7% HAg-01 to dip-coat for 15 seconds at room temperature to form an antibacterial layer on the outside of the nickel-titanium support segment 1. S6. For the transition area between the nickel-titanium support segment 1 and the knurled segment structure 2, an elastic polyurethane intermediate layer with a Shore hardness of 45A is dip-coated for 10 seconds to form a protective layer with a thickness of 3 μm in the transition area.

[0027] Notably, in clinical trials: For patients with urethral stricture: The design of the pointed silicone soft head 4 reduces the perforation rate from 2.3% to 0.8%. This data is hospital data for 200 patients. This data shows that the guidewire body greatly improves the safety of treatment.

[0028] For female patients with urinary catheterization: The time for the sharp silicone soft tip 4 to pass through the urethral sphincter is shortened by 40%, from 20 seconds for traditional guidewires to 12 seconds, reducing the pain received by patients and the operation time of doctors.

[0029] For novice doctors' operation: The setting of the sharp silicone soft head 4 increases the push success rate from 78% to 94%. The training data of 50 novice doctors shows that the guidewire body greatly reduces the difficulty of operation, shortens the learning cost, and improves the quality of medical services.

[0030] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements includes not only those elements but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus.

[0031] While 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 these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A novel urology guidewire, comprising a guidewire body, characterized in that: The guide wire body is composed of a nickel-titanium support section (1) and a silicone soft head (4) at the tip, the nickel-titanium support section (1) and the silicone soft head (4) are fixed in the middle by welding, and a knurled section structure (2) and a smooth section structure (3) are provided in the middle of the nickel-titanium support section (1); The smooth section structure (3) is located at one end of the nickel-titanium support section (1) close to the tip silicone soft head (4).

2. The novel urinary guidewire according to claim 1, characterized in that: The nickel-titanium support segment (1) uses a traditional nickel-titanium wire with a hardness of 60A and a length of 57 cm.

3. The novel urinary guidewire according to claim 1, characterized in that: One end of the nickel-titanium support segment (1) is knurled by using a knurling machine to form a knurled segment structure (2), the specification of the knurled segment structure (2) is set to a knurling depth of 80-120 μm and a pitch of 0.8-1.2 mm, and the nickel-titanium support segment (1) is coated with a coating on the outside, which is an antibacterial layer of 7% nano-silver chitosan.

4. The novel urinary guidewire according to claim 1, characterized in that: A transition zone with a taper slope of 1:5 is provided between the pointed silicone soft head (4) and the nickel-titanium support section (1), and the transition zone is coated with an elastic polyurethane intermediate layer with a Shore hardness of 45A.

5. The novel urinary guidewire according to claim 1, characterized in that: The length of the pointed silicone soft head (4) is set to 3 mm, the diameter is set to 1.2 mm, and the pointed silicone soft head (4) is formed by injection molding using LSR material with a Shore hardness of 30A.

6. The novel urinary guidewire according to claim 1, characterized in that: A nickel-titanium core shaft with a diameter of 0.8 mm is provided inside the pointed silicone soft head (4), and the nickel-titanium core shaft and the pointed silicone soft head (4) are fixed by welding.

7. The novel urinary guidewire according to claim 1, characterized in that: The pointed silicone soft head (4) is provided with a coating, and the surface of the knurled section structure (2) is specially treated and coated with an ultra-soft PVP hydrogel lubricating layer, and the coating thickness is between 5 μm and 8 μm, so that the friction coefficient is less than 0.

06.

8. A method for preparing a novel urinary guidewire, applied to any one of the novel urinary guidewires according to claims 1-6, characterized in that: The following steps are involved: S1. Use a high-precision optical projector and a ring light source to eliminate surface reflection interference. Clamp the support segment vertically on the rotating fixture and rotate it 360° at 15° intervals. The projector automatically collects axial profile data to detect the straightness and performance of the nickel-titanium support segment (1). Keep the coaxiality of the nickel-titanium support segment (1) less than or equal to 0.1 mm. S2. Use a double-cavity injection mold. The mold needs to be preheated to 60°C to avoid condensation of silicone. The injection molding machine is driven by a servo motor. The pressure fluctuation range is ≤±2bar, the temperature control accuracy is ±1°C, and the injection molding parameters are set. Injection pressure: 80±3bar; Mold temperature: 120±2℃; Curing time: 30±2 seconds; This completes the injection molding of the tip silicone soft head (4); S3. Use laser welding equipment; perform circular scanning along the joint between the nickel-titanium support section (1) and the tip silicone soft head (4) during welding. Use an infrared thermometer to monitor the joint temperature to avoid performance degradation caused by phase change of nickel-titanium alloy. After welding, perform an appearance inspection. The weld surface must be smooth and continuous without cracks, pores or melt-through defects. Then perform a tensile test: apply an axial load along the welding direction, and the breaking force must be ≥5N. S4. Slowly add PVP to 40°C preheated water and stir until completely dissolved; cool to 25°C, add glycerol, continue stirring for 1 hour, and sterilize through a 0.22μm filter membrane; Set environmental conditions and parameters: The coating tank temperature is kept constant at 4±0.5℃ and the humidity is ≤40% to reduce water evaporation; Dipping time: 20±1 seconds; After dipping, the soft tip is left to stand horizontally at room temperature for 30 minutes to allow the solvent to evaporate naturally, thereby forming an ultra-soft lubricating layer with a thickness of 5-8 μm on the surface of the tip silicone soft tip (4); S5, using a knurling machine to perform knurling on the nickel-titanium support segment (1) to form a knurled segment structure (2), and then using a high concentration of 7% HAg-01 to dip-coat for 15 seconds at room temperature to form an antibacterial layer on the outside of the nickel-titanium support segment (1); S6. For the transition area between the nickel-titanium support section (1) and the knurled section structure (2), an elastic polyurethane intermediate layer with a Shore hardness of 45A is dip-coated for 10 seconds to form a protective layer with a thickness of 3 μm in the transition area.

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