Novel medical developing catheter, developing mark as well as preparation method and application of novel medical developing catheter and developing mark

Abstract

The invention belongs to the technical field of implantation medical instruments, and relates to a novel medical developing catheter, a developing mark and a preparation method and application of the novel medical developing catheter and the developing mark. The developing mark is obtained by taking 10 parts of a high polymer material and 3-6 parts of a developing aid as raw materials through blending granulation, secondary melt extrusion, sample aging and cutting; the developing mark is fixedly mounted on the medical catheter body through a welding, rheology or bonding process, the combination process is simple, the combination firmness is high, and the problem that the developing mark and the catheter body shift and fall off when the medical catheter passes through a narrow cavity of a human body is solved. The high polymer material comprises polyurethane, a nylon elastomer or polyvinyl chloride; the developing aid comprises tungsten powder, barium powder or bismuth powder with the particle size of 0.01-0.05 mu m. Under the detection of X-rays or other imaging technologies, the developing effect of the developing mark is equivalent to that of a metal developing ring, the developing mark can replace the existing metal developing ring, and the material cost and the processing application difficulty are reduced. The novel medical developing catheter provided by the invention has developing, hydrophilic and lubricating functions.

Description

Technical Field

[0001] The present invention belongs to the technical field of implantable medical devices, and relates to a novel medical imaging catheter, an imaging marker, and a preparation method and application thereof. Background Art

[0002] Medical catheters are indispensable tools in modern medicine and are widely used in various diagnostic and therapeutic processes to establish temporary or permanent channels between the inside and outside of the human body. They are widely used in a variety of medical scenarios, such as infusion, drainage, monitoring, drug administration, etc. For example, vascular catheters can be used for cardiovascular interventional procedures, such as coronary angiography, stent implantation, etc. Biliary drainage catheters can be used for diagnosis and treatment of the hepatobiliary system, such as PTCD (percutaneous transhepatic cholangiography and drainage). Urinary catheters can be used for drainage and monitoring of the urinary system. Endotracheal intubation can be used for respiratory support and anesthesia management, etc.

[0003] Medical catheters, especially implantable ones, require doctors to accurately determine the position of the catheter in the body during use to ensure the success of the operation and the safety of the patient. The imaging marker (also called the imaging ring or imaging mark) is a mark visible through X-ray or other imaging technology, which helps doctors accurately locate the position of the catheter during surgery, plays a role in navigation in complex anatomical structures, and can monitor the position changes of the catheter in real time to ensure the safety of the operation.

[0004] Commonly used development marking materials mainly include precious metals (such as platinum, gold, etc.) and certain heavy metal alloys (such as platinum-iridium alloy). These materials have good development effects, but there are some obvious limitations, such as the high price of precious metals, which increases the cost of medical equipment. The size of the precious metal development ring is difficult to adjust during the molding process, and the processing precision is high, which makes the processing difficult. Hydrophilic coating is a special surface treatment technology that is widely used in medical devices, biomaterials and other fields. The main feature of this coating is that it can attract and retain moisture, thereby changing the physical and chemical properties of the material surface, improving the lubricity of the coated object, and reducing friction. There is a material interface between the precious metal development ring and the main material of the medical catheter (such as polyurethane, nylon elastomer, etc.), which makes the hydrophilic coating easy to break when it is left in the body for a long time, affecting the surgical effect. Existing metal development rings are usually fixed to the catheter by bonding or crimping, which is easy to loosen or shift under the influence of tissue fluid in the body, resulting in misjudgment of position and increasing surgical risks. Summary of the invention

[0005] Based on this, the purpose of the present invention is to provide a new type of medical catheter developing marker to replace the existing metal developing ring, thereby reducing material costs and processing and application difficulties.

[0006] The present invention also provides a preparation method and application of the novel medical catheter developing mark, and a medical developing catheter containing the novel medical catheter developing mark.

[0007] To achieve the above object, the present invention adopts the following technical solutions: The invention provides a novel medical catheter developing mark, which is prepared by taking 10 parts of polymer materials and 3-6 parts of developing auxiliary agents as raw materials; the components are calculated by weight.

[0008] Furthermore, the polymer material includes polyurethane, nylon elastomer or polyvinyl chloride; the developing aid includes tungsten powder, barium powder or bismuth powder with a particle size of 0.01-0.05 μm.

[0009] Furthermore, the development mark is in the shape of a ring, the inner diameter of the ring is 3.9±0.02 mm, the wall thickness is 0.01~0.03 mm, and the width is 1~3 mm.

[0010] The present invention further provides a method for preparing a novel medical catheter developing mark, comprising the following steps: S1, mixing a polymer material and a developing aid in proportion and then drying to obtain a raw material A; S2, extruding the raw material A through an extruder to form a granule and then drying to obtain a granule B; S3, extruding the granule B through an extruder to form, placing it for aging, to obtain a sample tube C; S4, cutting the sample tube C to obtain the result.

[0011] Furthermore, the moisture content of the raw material A and the granular material B after drying is ≤0.02, and the drying can be carried out by hot air drying, the hot air drying temperature is 80-110°C, and the drying is carried out for 3-6 hours; the aging process is: first at a temperature of 100-120°C, for 6-10 hours, and then at room temperature for 5-7 days, and the room temperature is 25±5°C.

[0012] Furthermore, the extrusion granulation parameters described in S2 are: zone one 90°C~120°C, zone two 100°C~140°C, zone three 120°C~140°C, zone four 130°C~150°C, flange 130°C~170°C, die head and mold 150°C~180°C.

[0013] Furthermore, the extrusion molding parameters described in S3 are: zone 1 100℃~130℃, zone 2 130℃~150℃, zone 3 140℃~160℃, zone 4 150℃~170℃, flange 160℃~190℃, head and mold 170℃~210℃; extrusion speed 1~6rpm, pulling speed 5~10m / min.

[0014] The present invention further provides an application of a novel medical catheter developing marker. After the developing marker is sleeved on a designated position on the outer surface of the medical catheter body, the developing marker is fixedly installed on the medical catheter body by welding, rheology or bonding technology to obtain a novel medical catheter body.

[0015] Furthermore, the developing mark is combined with the medical catheter body in an interference fit manner, and the inner diameter of the developing mark is 0.05-0.1 mm smaller than the outer diameter of the medical catheter body.

[0016] Furthermore, the welding process is: welding power 60~100hz, time 2-8s, pressure 0.1~0.5Mpa.

[0017] Furthermore, the rheological process is: a heat shrink tube is covered on the outer cover of the medical catheter body with the developing mark, and then the heat shrink tube is removed after being sent to the rheometer for processing; the temperature of the rheometer is 160°C~210°C, and the moving speed of the heating ring is 0.1~1mm / s.

[0018] Furthermore, the bonding process is: injecting epoxy resin glue or cyclohexanone glue into the gap between the developing mark and the medical catheter body, initially curing for 2-6 hours, and completely curing for 24-48 hours.

[0019] The present invention further provides a novel medical imaging catheter, comprising a novel medical catheter imaging marker.

[0020] Furthermore, the material of the tube body of the novel medical imaging catheter corresponds to the material of the novel medical catheter imaging mark, which is a polymer material, including polyurethane, nylon elastomer or polyvinyl chloride.

[0021] Furthermore, the structure of the new medical imaging catheter tube body includes single-lumen, double-lumen, triple-lumen and above, and its outer contour is generally a circle, which is obtained by an extrusion process.

[0022] Furthermore, the surface of the tube body of the medical imaging catheter contains a hydrophilic coating with a thickness of 1-10 μm.

[0023] The beneficial effects of the present invention are: 1. The present invention provides a new type of medical catheter imaging marker, which has a development effect comparable to that of a metal imaging ring under the detection of X-ray or other imaging techniques, and has a lower cost. The same material as the medical catheter body is used as the matrix, and inorganic powders such as tungsten, barium, and bismuth are added as a developing aid. The imaging marker and the medical catheter are made of the same material, and the material compatibility is stronger.

[0024] 2. The present invention provides a novel method for preparing a medical catheter developing mark, the process is easy to control and can be mass-produced. The production equipment is non-dedicated, the size adjustment is flexible and easy to control, and the processing cost is lower.

[0025] 3. The present invention provides a novel application of a medical catheter developing marker, wherein the developing marker is fixedly installed on the medical catheter body by welding, rheological or bonding processes, wherein during the welding or rheological process, due to the supporting effect of the core shaft inside the catheter body, or directly using the bonding process, the developing marker will not compress the medical catheter, causing the catheter size to be reduced and affecting the surgical effect.

[0026] 4. The present invention provides a new application of a medical catheter developing mark. The combination process of the new medical catheter developing mark and the medical catheter body is simple and the combination is strong, which avoids the problem of displacement and falling off of the developing mark and the catheter body when the catheter passes through a narrow cavity of the human body. There is no material interface after the two are combined, and the effect is better after the hydrophilic coating; at the same time, there is no problem of compressing the size of the medical catheter, which avoids the surgical risks caused by the compression of the catheter size.

[0027] 5. The present invention provides a novel medical imaging catheter, which can also be coated with a hydrophilic coating on its surface so that it has both the imaging function and the hydrophilic lubrication function. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the technical solution of the present invention, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0029] Attached Figure 1 This is a front view of the new medical imaging catheter tube body of the present invention; Attached Figure 2 A cross-sectional view of the tube body of the novel medical imaging catheter in the present invention; Attached Figure 3 It is a schematic diagram of the welding process of the novel medical catheter developing mark and the medical catheter body in the present invention; Attached Figure 4 It is a schematic diagram of the rheological combination process of the novel medical catheter developing mark and the medical catheter body in the present invention; Attached Figure 5 This is a test chart of the development effect of the new medical development mark in the present invention; In the figure, 1 is a new type of medical catheter development mark, 2 is a medical catheter body, 3 is a core shaft, 4 is a heat shrink tube, and 5 is a precious metal development mark. DETAILED DESCRIPTION

[0030] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. The embodiments mentioned are all implemented on the premise of the technical solutions of the present invention, and detailed implementation processes are given, but it should be stated that the protection scope of the present invention is not limited to the following embodiments.

[0031] In the preparation of the novel medical catheter developing mark in the embodiment of the present invention, 10 parts by weight of high molecular weight polyurethane, nylon elastomer or polyvinyl chloride material is used, and 3-6 parts by weight of developing aid is added thereto, and the developing aid is selected as tungsten powder, barium powder or bismuth powder with a particle size of 0.01-0.05 μm. After the raw materials are fully mixed, they are subjected to hot air drying treatment, the hot air drying temperature is 80-110°C, and the drying is carried out for 3-6 hours. During this period, the moisture content of the raw materials is tested by a moisture tester, and the drying is stopped when the measured value is ≤0.02.

[0032] The dried raw materials are blended and granulated using a twin-screw granulator. The blending temperature is set to 90℃~120℃ in zone 1, 100℃~140℃ in zone 2, 120℃~140℃ in zone 3, 130℃~150℃ in zone 4, 130℃~170℃ in flange, and 150℃~180℃ in die and mold. When setting the blending temperature, the maximum should not exceed 180℃, and the high temperature section is near the die and mold end, and the low temperature section is near the barrel end. The temperature difference between each section is 5~15℃ as the best. The pellets obtained by extrusion are dried with hot air at a temperature of 80~110℃ for 3~6 hours. During this period, the moisture content of the raw materials is tested with a moisture tester. When the measured value is ≤0.02, the drying is stopped.

[0033] The double closed-loop precision extruder is used for secondary melt extrusion of pellets. The extruder should include forced feeding, melt pressure control and feedback, precision mold, online detection and data feedback system. Set the extrusion temperature of the extruder, zone 1 100℃~130℃, zone 2 130℃~150℃, zone 3 140℃~160℃, zone 4 150℃~170℃, flange 160℃~190℃, head and mold 170℃~210℃. Some extruders may have only 3~4 heating zones. When setting the extrusion temperature, the maximum does not exceed 210℃, and the high temperature section is close to the head and the mold end, and the low temperature section is the barrel end. The temperature difference between each zone is 5~15℃ as the best. The wall thickness of the new medical catheter development mark is 0.01~0.03mm, which is controlled by adjusting the extrusion amount of the extruder and the traction speed of the traction machine. Taking the extruder in Example 30# as an example, the extrusion speed is 1~6rpm and the traction speed is 5~10m / min. The new medical catheter development mark made of polyurethane and nylon elastomer has poor elasticity and strength due to insufficient reaction of internal substances, and further aging treatment is required. The sample is first placed at a temperature of 100-120°C for 6-10 hours, and then placed at room temperature (25±5°C) for 5-7 days. After the material stress is fully released, a sample with stable dimensions and smooth surface is obtained. The sample aging verification process in the embodiment of the present invention is as follows: after the new medical catheter development mark tube body is extruded, a measurement mark point is made on the tube body at intervals of 5cm, and a total of 6 marks are set. The inner diameter and wall thickness of the tube body at each mark point on each tube body are measured and the average value is taken as the inner diameter and wall thickness of the tube body. During the aging period, the inner diameter and wall thickness of the tube body at the mark point are measured every day until the final inner diameter and wall thickness values ​​are stabilized at an inner diameter of 3.9±0.02mm and a wall thickness of 0.01~0.03mm, and the aging process is terminated. For each example, 10 tubes are taken, and the average values ​​of the inner diameters and wall thicknesses of the 10 tubes are recorded as the inner diameters and wall thicknesses of the novel medical catheter development marking of the example. The sample (or the aged sample) is cut into novel medical catheter development marking products with a width of 1-3 mm.

[0034] like Figure 1 and 2 As shown, in the embodiment of the present invention, the novel medical catheter developing mark 1 is sleeved on a designated position on the outer surface of the medical catheter tube body 2, and then welded (such as Figure 3 ), rheology (e.g. Figure 4) or bonding process to fix the new medical catheter developing mark 1 on the medical catheter tube body 2 to obtain the new medical developing catheter tube body. The structure of the new medical developing catheter tube body includes single-lumen, double-lumen, triple-lumen and above, and its outer contour is generally round. It is made of polymer material and is obtained by extrusion process. The medical catheter tube body 2 and the new medical catheter developing mark 1 in the embodiment of the present invention are correspondingly selected from the same polymer material. The material of the new medical catheter developing mark 1 and the medical catheter tube body 2 in Examples 1, 4, and 5 is polyurethane, the material of the new medical catheter developing mark 1 and the medical catheter tube body 2 in Examples 2, 6, and 7 is nylon elastomer, and the material of the new medical catheter developing mark 1 and the medical catheter tube body 2 in Examples 3, 8, and 9 is polyvinyl chloride.

[0035] Figure 3 It is a schematic diagram of the welding process. Take a medical catheter body 2 with an outer diameter of 4.0mm, and put the new medical catheter development mark 1 on the designated position of the medical catheter body 2. Insert the core shaft 3 that matches the inner diameter of the medical catheter body 2 into the inside of the medical catheter body 2, and then send it to the welding mold. The position where the new medical catheter development mark 1 on the medical catheter body 2 is located should be sent to the middle position of the mold heating zone. Set the power of the welding equipment to 60~100hz, the time to 2-8s, and the pressure to 0.1~0.5Mpa. After the welding is completed, remove the medical catheter body 2 from the welding equipment, and pull out the core shaft 3 in the medical catheter body 2. At this time, the new medical catheter development mark 1 has been firmly fixed on the surface of the medical catheter body 2.

[0036] Figure 4 Schematic diagram of rheological process. Take a medical catheter body 2 with an outer diameter of 4.0 mm. Put the new medical catheter development mark 1 on the specified position of the medical catheter body 2. The medical catheter body 2 is covered with a heat shrink tube 4. The difference in inner diameter between the heat shrink tube 4 and the medical catheter body 2 is preferably 0.5~1.5 mm, and the heat shrink ratio of the heat shrink tube 4 is preferably 1.6. Insert the mandrel 3 matching the inner diameter of the medical catheter body 2 into the medical catheter body 2, and then send it to the rheometer, set the rheological parameters to 160℃~210℃, and the moving speed of the heating ring is 0.1~1mm / s. After the entire rheological process is completed, remove the heat shrink tube 4. At this time, the new medical catheter development mark 1 has been firmly fixed on the surface of the medical catheter body 2.

[0037] The process of the bonding process is as follows: take a medical catheter body 2 with an outer diameter of 4.0 mm. Put the new medical catheter developing mark 1 on the designated position of the medical catheter body 2. Inject the epoxy glue into the gap between the new medical catheter developing mark 1 and the medical catheter body 2 through the glue injection needle, and initially cure for about 2-6 hours, and completely cure for 24-48 hours. When the epoxy glue or cyclohexanone is fully solidified, the new medical catheter developing mark 1 is firmly fixed on the surface of the medical catheter body 2.

[0038] Finally, a hydrophilic coating with a thickness of 1-10 μm is coated on the surface of the new medical imaging catheter body by spraying or dipping, so that it has a hydrophilic lubricating function. The coating liquid can be directly selected from commercially available coating liquids. In the embodiment of the present invention, a hydrophilic coating is formed on the surface of the catheter by dipping, and the hydrophilic coating includes a bottom layer and a surface layer. The coating liquid includes a bottom layer coating liquid and a surface layer coating liquid, the bottom layer coating liquid mainly includes polyurethane (5%), water (20%) and ethanol (75%), and the surface layer coating liquid mainly includes polyvinyl pyrrolidone derivatives and polyacrylamide derivatives (2%), ethanol (40%) and water (58%), and each substance is a mass percentage. The coating process is: first immerse the catheter body in the bottom layer coating liquid for 10 seconds, then take it out at a speed of 10 mm / s, dry it for 30 seconds, and solidify it for 60 seconds to obtain the bottom layer. Then, the catheter body containing the bottom layer is immersed in the surface coating liquid for 10 seconds, then taken out at a speed of 5 mm / s, dried for 60 seconds, and cured for 270 seconds to obtain the surface layer.

[0039] The main raw materials and process parameters of the following examples 1-3 are shown in the following table: 1. Raw materials Example Polymer Materials Development aid and particle size Drying temperature and time Example 1 10 parts polyurethane 3 parts tungsten powder (0.02μm) 100℃, 4 hours Example 2 10 parts nylon elastomer 4 parts barium powder (0.03 μm) 100℃, 4 hours Example 3 10 parts polyvinyl chloride 5 parts bismuth powder (0.04 μm No drying required 2. Blending granulation and secondary melt extrusion 3. Pulling speed, extrusion speed and specifications of new medical imaging marks 4. New medical catheter imaging markers (all 2mm wide) are fixedly installed on the medical catheter body Examples 4 and 5 correspond to Example 1, Examples 6 and 7 correspond to Example 2, and Examples 7 and 8 correspond to Example 3. The difference between Examples 4-9 and Examples 1-3 is that the way the developing mark is fixedly installed on the medical catheter body is different. The details are shown in the following table: The imaging performance test is performed on any one of the novel medical imaging catheter tube bodies in Examples 1-9 of the present invention. The test results are as follows: Figure 5 As shown in the figure, it can be seen that the development effect is equivalent to that of the precious metal development mark 5, and the new medical development in the present invention can be used to replace the existing metal development ring and be widely used in implantable medical devices with development function requirements.

[0040] The above description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A novel medical catheter development marker, characterized in that: The invention is prepared by taking 10 parts of polymer materials and 3-6 parts of developing aids as raw materials; the components are calculated by weight.

2. The novel medical catheter developing marker according to claim 1, characterized in that: The polymer material includes polyurethane, nylon elastomer or polyvinyl chloride; the developing auxiliary agent includes tungsten powder, barium powder or bismuth powder with a particle size of 0.01-0.05 μm.

3. The novel medical catheter developing marker according to claim 1, characterized in that: The developing mark is in the shape of a ring, the inner diameter of the ring is 3.9±0.02 mm, the wall thickness is 0.01-0.03 mm, and the width is 1-3 mm.

4. A method for preparing the novel medical catheter developing marker according to any one of claims 1 to 3, characterized in that: The method comprises the following steps: S1, mixing the polymer material and the developing aid in proportion and drying the mixture to obtain raw material A; S2, extruding the raw material A into granules through an extruder and drying the mixture to obtain granules B; S3, extruding the granules B through an extruder, placing them for aging, and obtaining sample tubes C; S4, cutting the sample tubes C.

5. The preparation method according to claim 4, characterized in that: The moisture content of the raw material A and the granular material B after drying is ≤0.02, and the aging process is: firstly placed at a temperature of 100-120° C. for 6-10 hours, and then placed at room temperature for 5-7 days.

6. The preparation method according to claim 4, characterized in that: The extrusion granulation parameters described in S2 are: 90℃~120℃ in zone 1, 100℃~140℃ in zone 2, 120℃~140℃ in zone 3, 130℃~150℃ in zone 4, 130℃~170℃ in flange, 150℃~180℃ in die head and die; the extrusion molding parameters described in S3 are: 100℃~130℃ in zone 1, 130℃~150℃ in zone 2, 140℃~160℃ in zone 3, 150℃~170℃ in zone 4, 160℃~190℃ in flange, 170℃~210℃ in die head and die; extrusion speed is 1~6rpm, and traction speed is 5~10m / min.

7. An application of the novel medical catheter developing marker according to any one of claims 1 to 3, characterized in that: After the developing mark is sleeved on a designated position on the outer surface of the medical catheter body, the developing mark is fixedly installed on the medical catheter body through welding, rheology or bonding process to obtain a novel medical developing catheter body.

8. The use according to claim 7, characterized in that The welding process is as follows: the welding power is 60-100 Hz, the welding time is 2-8 s, and the pressure is 0.1-0.5 MPa; the rheological process is as follows: the medical catheter body with the developing mark is covered with a heat shrink tube and then sent into the rheometer for processing and then the heat shrink tube is removed; the temperature of the rheometer is 160°C-210°C, and the moving speed of the heating ring is 0.1-1 mm / s; the bonding process is as follows: epoxy resin glue or cyclohexanone glue is injected into the gap between the developing mark and the medical catheter body, and cured for 24-48 hours.

9. A novel medical imaging catheter, characterized in that: A novel medical catheter developing marker comprising the novel medical catheter developing marker according to any one of claims 1 to 3.

10. The novel medical imaging catheter according to claim 9, characterized in that: The surface of the tube body of the medical imaging catheter contains a hydrophilic coating with a thickness of 1-10 μm.

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