A composite catheter kit and a method of making a catheter therefrom

Abstract

The application discloses a composite catheter kit and a catheter preparation method thereof, and belongs to the field of medical treatment. The composite catheter kit comprises a catheter, a fixed patch, a punching tool, a particle pushing guide wire and a particle fixing wire. The catheter comprises a catheter head end, a catheter middle section and a catheter tail end. A drainage cavity is arranged in the catheter. A plurality of treatment cavities parallel to the drainage cavity are arranged in the catheter middle section. A catheter seat and a luer joint are fixedly connected to the catheter head end. A fixed pull wire penetrating through the drainage cavity is fixedly connected to one side of the catheter seat. A sheath in sliding connection is arranged on a particle warehouse opening of the treatment cavity close to the catheter seat. The catheter further comprises a plurality of holes of drainage holes and exhaust holes. The application covers the requirements of internal and external drainage treatment operations. The microneedle type exhaust hole design can exhaust air when particles are sent into the treatment cavity, reduces resistance, realizes the parallel of the double functions of catheter drainage and radiotherapy, and the catheter preparation method is simple, easy to operate and easy to mass produce.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to a composite catheter kit and its catheter preparation method. Background Technology

[0002] A healthy digestive system relies heavily on the gallbladder. A recent study published in the journal *Cancer*, titled "2017 Global Burden of Disease Study," indicates that between 1990 and 2017, the global incidence of gallbladder and bile duct cancer increased by 76%, and the mortality rate increased by 65%. The global incidence of gallbladder and bile duct cancer has been rising for nearly 30 years, with an 80% increase in incidence over that period.

[0003] The human bile duct has a simple structure, but it is narrow, complex in location, and rich in connective tissue. Even small tumors within the bile duct can cause obstruction, often presenting with malignant symptoms. Typically, the surgical resection rate for malignant bile duct obstruction is around 20%, with a 5-year survival rate below 5%. Malignant obstructive jaundice is a common disease among Asians, people of East Asian descent, and the elderly, with numerous causes, primarily due to bile duct cancer, gallbladder cancer, liver cancer, and metastatic cancer in the hilar region invading or compressing the bile duct, leading to obstruction of bile excretion. Once jaundice develops, liver function deteriorates rapidly, eventually leading to liver failure and death. Clinical data confirms that over 85% of bile duct cancers are well-differentiated adenocarcinomas. Chemotherapy is ineffective against well-differentiated adenocarcinomas, and radiotherapy is also not very effective. Resection is the traditional radical treatment, but it requires advanced techniques, has a long recovery period, and its clinical application is limited. Many elderly patients cannot undergo surgical treatment for various reasons. In addition, biliary stenting is the preferred palliative treatment for malignant obstructive jaundice. However, due to the growth of malignant tumors within the stent and granulation tissue proliferation, more than 50% of patients will experience re-obstruction within 6 months. There is an urgent clinical need for minimally invasive and highly effective treatment options.

[0004] With the continuous improvement of various treatment methods, the rapid development of imaging technology, and the rise of the multidisciplinary comprehensive treatment concept, minimally invasive interventional therapy plays an increasingly important role in the treatment of malignant tumors. In particular, radioactive particle therapy has significant advantages and unique characteristics in current tumor treatment. In November 2009, the General Office of the former Ministry of Health issued a notice on the "Management Standards for Radioactive Particle Implantation Therapy Technology (Trial Implementation)." This was an encouragement to those engaged in particle therapy and a standardization of the industry. Gaining recognition from government authorities allows "small" particles to play a "big" role. Statistics show that the average annual increase in hospitals with nuclear medicine departments nationwide is 12.5%. For example, those capable of continuously emitting gamma rays... 125 I-type radioactive particles have a half-life of 59.6 days and an effective radiation range of 1.7 cm, making them ideal for narrow bile duct structures. They can leverage the dosimetric advantage of rapid radiation uptake and downtake to achieve the dual goals of tumor radiotherapy and protection of surrounding normal tissues. Patients can be discharged and recuperate after particle implantation, greatly saving medical costs.

[0005] Currently, none of the commercially available catheters can achieve the dual function of drainage and particle transport. In clinical studies, there are often clinical scenarios involving catheter binding, stent compression of the particle chain, and parallel operation of a separate particle chain and drainage tube, but each has its drawbacks and is very unfavorable for clinical operation.

[0006] The composite catheter kit described in this invention achieves both internal and external drainage functions through percutaneous transhepatic biliary drainage (PTCD) and also enables particle radiation therapy. For example, it allows for insertion into the side cavity of the catheter body. 125 Class I radioactive particles can solve the problem of increased bile duct pressure caused by bile duct obstruction and stenosis due to malignant tumors such as bile duct cancer, pancreatic head cancer, and ampullary cancer. Of course, this invention can also solve the problem of simple external drainage of thoracic and abdominal cavities, pus cavities, or other lesions that require drainage and brachytherapy.

[0007] This invention aims to realize a minimally invasive and highly efficient dual-function catheter, bringing hope to patients with malignant obstructive jaundice and providing them with an authentic and original lifestyle. Summary of the Invention

[0008] Based on this, and in view of the shortcomings of the existing technology, a composite catheter kit and its catheter preparation method are technical problems that need to be solved by those skilled in the art.

[0009] To overcome the above-mentioned technical defects, the present invention adopts the following technical solution: A composite catheter kit includes a catheter 6 with a micro-elliptical or circular structure, a fixing patch, a punching fixture, a particle pushing guidewire printed with graduations, and a particle fixing wire that can be cut and adjusted to hold the particles. The catheter includes a catheter tip, a catheter middle section, and a catheter tail. The catheter 6 has a drainage cavity inside. The catheter middle section has several treatment cavities parallel to the drainage cavity. The catheter tip is fixedly connected to a catheter seat 9 and a Luer connector 10. A fixing pull wire 3 that passes through the drainage cavity is fixedly connected to one side of the catheter seat 9. A slidably connected sheath 7 is fitted outside the particle chamber opening 8 of the treatment cavity near the catheter seat. A first drainage hole 4 and a second drainage hole 1 are sequentially opened on the outside of the p-shaped structure from the sheath to the catheter tail. The first drainage hole 4 and the second drainage hole 1 are respectively connected to the drainage cavity but not to the treatment cavity. Several vent holes 2 are distributed on the protruding part of the p-shaped structure. It also includes a radiopaque section 5 fitted on the catheter middle section.

[0010] Furthermore, the ρ-shaped structure is a single-cavity structure integrally fused and formed, and the single-cavity structure is connected to the drainage cavity.

[0011] Furthermore, the tip angle of the ρ-type structure is 10°-40°.

[0012] Furthermore, the catheter 6 is 6F-16F in size and has a length of 0.2m-1.8m.

[0013] Furthermore, the catheter 6 can adopt a micro-elliptical or circular structure.

[0014] Furthermore, the radial section of the middle segment of the catheter has a multi-lumen structure, which includes a drainage lumen and a treatment lumen.

[0015] Furthermore, the multi-cavity structure can be any one of a dual-cavity structure, a triple-cavity structure, or a quadruple-cavity structure.

[0016] Furthermore, the outer portion of the middle section of the catheter includes at least two rows of the first drainage holes 4, the centerlines of the first drainage holes 4 forming an angle α, where the angle α is 20°≤α≤270°. Furthermore, the included angle α of the dual-cavity structure can be 180°, and the included angle α of the triple-cavity structure can be 120°.

[0017] Furthermore, when applicable to internal and external drainage, the total number of openings of the first drainage hole 4, the second drainage hole 1, and the exhaust hole 2 shall be no less than 34 holes, and the second drainage hole 1 shall have at least 6 holes.

[0018] Furthermore, the diameter of the exhaust hole 2 is smaller than the diameters of the first drainage hole 4 and the second drainage hole 1.

[0019] Furthermore, the diameters of the first drainage hole 4 and the second drainage hole 1 are 0.3mm-2.2mm.

[0020] Furthermore, the interval scale of the particle pusher wire printing can be 10mm.

[0021] Furthermore, the volume of the treatment cavity is smaller than the volume of the drainage cavity.

[0022] Furthermore, the drilling fixture includes a drilling tool, which includes an arc-shaped groove for placing the conduit. The arc-shaped groove has an outer cavity for mounting a button battery 204 and an LED 203. An observation end is provided at the connection point between the cavity and the arc-shaped groove for observing the position of the conduit's inner cavity illuminated by the LED. The drilling tool can be used for manually drilling holes in any of the aforementioned conduits.

[0023] The present invention also provides a method for preparing the catheter used in the above-described scheme, comprising the following steps: S1: Dry the catheter material and the developing material required for catheter preparation at 80-130℃ for 1-6 hours to obtain a material with a water content of less than 0.5% for later use; S2: The material dried in S1 is placed in an extruder with the temperature set at 170-210℃ and extruded to form conduit I; S3: Suspend and shape the extruded tube I from S2 and cut it to obtain tube II; S4: Place the flared end of conduit II obtained in S3 into the flaring mold. Use a heating device to heat the flared end in the mold to a molten state. Then push the exposed part of the conduit into the mold cavity so that the molten material in the mold cavity is fully filled. After filling, wait 1-5 seconds and then stop heating. Then blow compressed air at room temperature and ≤0.5MPa directly onto the outer surface of the mold for 10-20 seconds and wait for the mold to cool. After cooling, take out the conduit. At this time, the conduit flaring is completed, and conduit III is obtained. S5: Place the other end of conduit III in S4, i.e. the unprocessed end, into the tip forming mold. Use a heating device to heat one end of the conduit in the forming mold to a molten state. Then push the exposed part of the conduit into the mold cavity so that the molten material in the mold cavity is fully filled. After filling, wait 1-5 seconds and then stop heating. Then blow compressed air at room temperature and ≤0.5MPa directly onto the outer surface of the forming mold for 8-15 seconds and wait for the mold to cool. After cooling, remove the conduit. At this time, the conduit tip forming is completed, and conduit IV is obtained. S6: Using a semi-automatic drilling machine, several holes are drilled 20-40mm from the flared end of guide tube III in S4 or guide tube IV in S5 to serve as particle chamber openings. A drilling machine is used to automatically drill holes 10-30mm from the guide tube marking and development section to the tail end of the guide tube, obtaining the first hole of the first drainage hole. Then, holes are drilled sequentially from the first hole to the tail end of the guide tube. A drilling machine is used to automatically drill holes 60-90mm from the tail end to the head end of the guide tube, obtaining the head hole of the second drainage hole and several vent holes spaced apart from the head hole. Then, holes are drilled sequentially from the head hole to the tail end of the guide tube to obtain all the second drainage holes. After all the drilling is completed, guide tube V is obtained. S7: Place the end of the tube V after the hole is opened in S6 into the cavity mold and heat and cool it to shape it, so as to obtain a ρ-shaped structure. Then, a developing part is fitted on the middle section of the tube to obtain tube VI. S8: Apply a coating to the surface of catheter VI after S7 shaping and cure it to obtain catheter VII; S9: Assemble and clean the conduit VII after S8 coating curing to obtain the conduit 6.

[0024] Furthermore, the conduit material is any one or more of polyurethane, polytetrafluoroethylene, fluorinated ethylene propylene copolymer, nylon, polypropylene, polyethylene, and polyvinyl chloride.

[0025] Furthermore, the developing material is at least one of tungsten powder, bismuth subcarbonate, barium sulfate, iodine compounds, bismuth trioxide, and calcium tungstate.

[0026] Furthermore, the required suspension and shaping conditions in S3 are: temperature: 20-28℃, suspension and shaping humidity: 45-65%RH, and suspension and shaping time: 2-16 days.

[0027] Furthermore, regarding the heating conditions of the heating device in S4 or S5: the diameter of the copper wire can be 0.1-0.2mm, and the length of the heating coil wound from it can be 10mm, the inner diameter can be 12mm, and the number of layers can be 2-4.

[0028] Furthermore, the drilling equipment in S6 has a cutting tool diameter of 0.4mm-2.6mm, a cutting tool rotation speed greater than 2000rpm / min, and a feed rate of 0.1-150mm / min.

[0029] Furthermore, the S8 coating includes at least one of a lubricating coating, an anticoagulant coating, an antibacterial coating, and a drug-loaded coating.

[0030] Furthermore, the associated lubricating coating sequentially includes a cured base layer and a super-slippery layer, wherein the curing can be any one of LED lamp curing, mercury lamp curing, ultraviolet curing, and thermal curing.

[0031] The beneficial effects achieved by this invention are as follows: 1. The composite catheter kit brought by the present invention includes a catheter, a fixing patch, a punching tool, a particle pushing guidewire and a particle fixing wire, covering the needs of internal and external drainage treatment operations. The catheter tip is provided with several independent treatment chambers and their corresponding particle compartments, which greatly facilitates the delivery of particles into the treatment chambers. The catheter tail is designed with a micro-needle vent hole to expel air when the particles are delivered into the treatment chambers, reducing resistance and realizing the dual functions of catheter drainage and radiotherapy in parallel. 2. The particle fixing line and the particle pushing guide wire printing scale line configuration in the composite catheter kit of the present invention are as follows: the particle fixing line is used to adjust and fix the particles in the particle treatment cavity to avoid the treatment being greatly reduced due to their displacement or fall off; the scale line is used to cut and measure the particle fixing line when adjusting the particle position to accurately locate the position of the particle in the particle cavity and achieve precise treatment. 3. The snap-on sheath design in this invention effectively protects the particle chamber opening and particle fixing line to avoid unnecessary contact and pulling during surgery, which is more conducive to achieving precise treatment of lesions and makes the catheter safer to use; 4. The catheter body in the composite catheter kit of the present invention adopts a micro-elliptical or circular design, and the surface can be coated with hydrophilic, antibacterial and other coatings. The catheter tail end has a ρ-shaped structure design. The design of the tube body shape, ρ-shaped structure and coating design greatly reduces the catheter puncture force, which is very conducive to catheter puncture and reduces the patient's puncture discomfort. 5. The multi-porous design of different drainage holes and venting holes on the surface of the catheter in the composite catheter kit of the present invention, as well as the multi-lumen structure design to make the irradiation energy of the particle-carrying material more uniform, all enable the catheter to have both drainage and treatment functions, and will not weaken the implementation effect of the other function due to one function. 6. The composite catheter kit of the present invention also provides a manual punching tool. In clinical use, the operator can use the punching tool to increase the number of holes required for the catheter, so that the multi-hole structure such as drainage holes is not limited to the 34-hole design required for radiotherapy of biliary tract cancer, but can also be applied to the treatment of other lesions that require drainage and brachytherapy. 7. The catheter fixation patch and body surface fixation patch provided in the composite catheter kit of the present invention can avoid the need for body surface suturing when fixing the catheter, reducing patient injury; 8. The catheter preparation method matching the composite catheter kit of the present invention is simple and easy to operate, and is mostly automated, which greatly saves manpower and is easy to mass-produce. Attached Figure Description

[0032] Figure 1 This is a schematic diagram of the catheter structure of the present invention; Figure 2 This is a schematic diagram of the punching fixture structure of the present invention; Figure 3 This is a structural diagram of the ρ-type molding die of the present invention; Figure 4 This is a comparison diagram of the tip angle of the ρ-type structure of the present invention; Figure 5 This is a schematic diagram of the included angle of the multi-cavity structure of the present invention; Figure 6 This is an energy distribution diagram of the dual-cavity structure of the present invention; Figure 7 This is an energy distribution diagram of the three-cavity structure of the present invention; Figure 8 This is a process flow diagram of the catheter preparation method of the present invention.

[0033] In the diagram: 1 is the second drainage hole, 2 is the vent hole, 3 is the fixing cable, 4 is the first drainage hole, 5 is the developing section, 6 is the guide tube, 7 is the sheath, 8 is the particle chamber opening, 9 is the guide tube seat, 10 is the Luer connector, 100 is the upper jaw, 200 is the lower jaw, 300 is the support spring, 101 is the upper handle, 102 is the hollow opening knife, 201 is the lower handle, 202 is the observation end, 203 is the LED, and 204 is the button battery. Implementation

[0034] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0035] This invention provides a composite catheter kit, such as Figure 1 As shown, the device includes a catheter 6 with a micro-elliptical or circular structure, a fixing patch, a punching fixture, a particle pushing guide wire printed with graduations, and a particle fixing wire that can be cut and adjusted to hold the particles. The catheter includes a catheter head, a catheter middle section, and a catheter tail. The catheter 6 has a drainage cavity inside. The catheter middle section has several treatment cavities parallel to the drainage cavity. The catheter head is fixedly connected to a catheter seat 9 and a Luer connector 10. A fixing pull wire 3 that passes through the drainage cavity is fixedly connected to one side of the catheter seat 9. A slidingly connected sheath 7 is fitted outside the particle chamber opening 8 of the treatment cavity near the catheter seat. The sheath 7 and the p-shaped structure at the catheter tail end have staggered first drainage holes 4 and second drainage holes 1 sequentially opened on the outside. The first drainage holes 4 and the second drainage holes 1 are respectively connected to the drainage cavity but not to the treatment cavity. The protruding part of the p-shaped structure is provided with several vent holes 2. The device also includes a radiopaque section 5 fitted inside the catheter middle section.

[0036] The present invention preferably uses catheters of model / specification 6F-16F with a length of 0.2m-1.8m. Furthermore, the tube body of the catheter 6 can adopt a micro-elliptical or circular structure depending on the tube body size.

[0037] Furthermore, the radial section of the middle section of the catheter 6 has a multi-lumen structure, which includes a drainage lumen and a treatment lumen.

[0038] Preferably, the multi-cavity structure of this invention can be any one of a dual-cavity structure, a triple-cavity structure, or a quadruple-cavity structure. Figure 6 , Figure 7 As shown, the preferred dual-cavity and triple-cavity structures have more uniform particle radiation energy, making them easier to treat with radiotherapy.

[0039] As an embodiment of the present invention, the total number of openings of the first drainage hole 4, the second drainage hole 1, and the exhaust hole 2 is at least 34, wherein the number of second drainage holes 1 is at least 6. Depending on the location of the bile duct lesion, the drainage holes need to cross the lesion during drainage. To avoid blockage during long-term placement and reduce the incidence of complications, a larger number of drainage holes is more suitable for long-term placement. The design of a larger number of drainage holes is the result of calculations and multiple experiments. A total of 34 openings represents the minimum limit for simultaneously achieving both internal and external drainage functions. When only external drainage is required during treatment, the total number of openings can be appropriately reduced according to the actual situation to suit the condition; the total number of openings can be 6, 8, 18, or 20.

[0040] As an embodiment of the present invention, the first drainage hole 4, the second drainage hole 1 and the exhaust hole 2 may be in a slightly elliptical or circular shape.

[0041] Furthermore, the diameter of the exhaust hole 2 is smaller than the diameters of the first drainage hole 4 and the second drainage hole 1.

[0042] Furthermore, in order to ensure the connection strength of the pipe body while maximizing the drainage efficiency, the diameters of the first drainage hole 4 and the second drainage hole 1 are 0.3mm-2.2mm.

[0043] As an embodiment of the present invention, further, the outer side of the middle section of the catheter includes at least two rows of the first drainage holes, the centerlines of the first drainage holes forming an angle α, the angle α being 20°≤α≤270°. To ensure the drainage effect at the distal end of the catheter 6, the drainage holes at the distal end of the catheter 6 are often symmetrically opened. In catheters 6 having two or more lumens, such as... Figure 5 As shown in (a) and (b), the included angle of the double-lumen structure can be 180°, the included angle of the triple-lumen structure can be 120°, and so on. Specifically, in a catheter with only one treatment lumen 8, such as... Figure 5 As shown in (c) and (d), the included angle is 160°≤α≤270°. If the angle is too large or too small, the distance between the two rows of openings will be too close. This choice is to avoid multiple cavities from crossing each other during the opening process, so that the openings can be better distributed evenly and the drainage effect during use can be enhanced.

[0044] As an embodiment of the present invention, the p-shaped structure at the tail end of the catheter 6 is a single-lumen structure integrally fused and formed, and the single-lumen structure is connected to the drainage cavity. A fusion-forming process is used to make the tail end of the catheter 6 a p-shaped structure while keeping the catheter body straight or in a micro-spiral state. The micro-spiral p-shaped structure allows for a more uniform energy distribution when the particles in the treatment cavity are used to treat the lesion at close range. Furthermore, the preoperative particle delivery guidewire effectively pushes and precisely positions the particles through the particle chamber opening 8, and the particle fixing line seals the empty particle spaces in the cavity and fixes the existing particles, making the particle distribution in the treatment cavity more adaptable to the condition. This dual design is more beneficial for treatment.

[0045] like Figure 3 , Figure 4 As shown, the smaller the melting angle of the catheter tip (tail end), the longer its actual length; conversely, the larger the melting angle, the shorter its actual length. Puncture simulation experiments demonstrate that increasing the angle increases instantaneous puncture resistance, but a smaller taper makes processing more difficult. Taking a catheter with an outer diameter of 4.0 mm, an inner diameter of 3.0 mm, and a tip inner diameter of 0.66 mm as an example, the puncture resistance under different tip angle conditions is shown in Table 1. Specifically, to reduce puncture resistance so that the catheter can enter the narrow obstructed cavity, improve the medical experience, and reduce operational difficulty, as an embodiment of the present invention, the preferred tip angle of the ρ-shaped structure is 10°-40°. Fusion head equipment parameter selection: heating power is set to 60-80% of the equipment's capacity, heating time range is (400-500) × 0.01 s, and advancement time range is (750-850) × 0.01 s.

[0046]

[0047] Table 1: Comparison of catheter tip length and puncture resistance for catheters with an outer diameter of 4.0 mm, an inner diameter of 3.0 mm, and a tip inner diameter of 0.66 mm. As an embodiment of the present invention, the volume of the treatment cavity is smaller than the volume of the drainage cavity.

[0048] As an embodiment of the present invention, the interval of the particle pusher wire printing is preferably 10 mm.

[0049] As an embodiment of the present invention, the punching fixture further includes a punching tool, such as... Figure 2As shown, the drilling tool includes an arc-shaped groove for placing the conduit 6. The arc-shaped groove extends outwards to form a cavity for installing a button battery 204 and an LED 203. An observation end 202 is provided at the connection point between the cavity and the arc-shaped groove to observe the position of the conduit 6's inner cavity illuminated by the LED 203. The observation end 202 allows control over the position of the LED 203 illuminating the inner wall of the conduit 6's cavity. During operation, the portion of the conduit 6 to be drilled is smoothly placed into the arc-shaped groove of the drilling tool. The upper clamp handle 101 and the lower clamp handle 201 are held. The lower clamp handle 201 and the lower clamp handle 101, through the compression of the support spring 300, cause the lower jaw 200 and the upper jaw 100 to press against each other, thereby pushing the hollow drilling cutter 102 to cut into the portion of the conduit 6 to be drilled. The operator needs to continuously check the observation end 202 to avoid manual drilling that could interfere with the cavity. This tool is simple and quick to operate and can effectively meet the drilling needs of different conduits.

[0050] like Figure 8 As shown, the present invention also provides a method for preparing the catheter used in the above scheme, comprising the following preparation steps: S1: Dry the catheter material and the developing material required for catheter preparation at 80-130℃ for 1-6 hours to obtain a material with a water content of less than 0.5% for later use; S2: The material dried in S1 is placed in an extruder with the temperature set at 170-210℃ and extruded to form conduit I; S3: Suspend and shape the extruded tube I from S2 and cut it to obtain tube II; As an embodiment of the present invention, the conduit material is further selected from any one or more of polyurethane, polytetrafluoroethylene, fluorinated ethylene propylene copolymer, nylon, polypropylene, polyethylene, and polyvinyl chloride. Since conduit materials such as polyurethane are thermoplastic elastomers, the surfaces of the tubes will adhere to each other immediately after extrusion, and the internal molecular chains cannot be fully fixed within 48 hours due to the influence of ambient temperature and humidity. This results in a discrepancy between the dimensions of the freshly extruded conduit and the product after suspension and shaping. The product after suspension and shaping has more stable dimensions and a better appearance.

[0051] S4: Place the flared end of conduit II obtained in S3 into the flaring mold. Use a heating device to heat the flared end in the mold to a molten state. Then push the exposed part of the conduit into the mold cavity so that the molten material in the mold cavity can fully fill the mold cavity. After filling, wait 1-5 seconds and then stop heating. Then blow compressed air at room temperature and ≤0.5MPa directly onto the outer surface of the mold for 10-20 seconds and wait for the mold to cool. After cooling, take out the conduit. At this time, the conduit flaring is completed, and conduit III is obtained. S5: Place the other end of conduit III in S4, i.e. the unprocessed end, into the tip forming mold. Use a heating device to heat one end of the conduit in the forming mold to a molten state. Then push the exposed part of the conduit into the mold cavity so that the molten material in the mold cavity can fully fill the mold cavity. After filling, wait 1-5 seconds and then stop heating. Then blow compressed air at room temperature and ≤0.5MPa directly onto the outer surface of the forming mold for 8-15 seconds and wait for the mold to cool. After cooling, take out the conduit. At this time, the conduit tip forming is completed, and conduit IV is obtained. S6: Using a semi-automatic drilling machine, several holes are drilled 20-40mm from the flared end of guide tube III in S4 or guide tube IV in S5 to serve as particle chamber openings. A drilling machine is used to automatically drill holes 10-30mm from the guide tube marking and development section to the tail end of the guide tube, obtaining the first hole of the first drainage hole. Then, holes are drilled sequentially from the first hole to the tail end of the guide tube. A drilling machine is used to automatically drill holes 60-90mm from the tail end to the head end of the guide tube, obtaining the head hole of the second drainage hole and several vent holes spaced apart from the head hole. Then, holes are drilled sequentially from the head hole to the tail end of the guide tube to obtain all the second drainage holes. After all the drilling is completed, guide tube V is obtained. S7: Place the guide tube tip (after S6 opening) into the mold with a special cavity. See details. Figure 3 The mold is made of sheet metal, with a groove on one side resembling a ρ-shape, the groove size being slightly larger than the conduit size by 0.1-0.7 mm. During use, the tip of the conduit prepared in S4 is used as the head end, and the conduits are sequentially placed into the groove along the head end. After placement, the conduits are heated, typically at 80-140℃ for 4-10 minutes. After heating, the mold and conduits are cooled together using purified water at room temperature through immersion or spraying. After cooling, the conduits are removed, and the conduits are shaped into a ρ-shape. A developing section 5 is then fitted onto the middle section of the conduit, resulting in conduit VI. The developing function of the developing section 5 here is to further determine the position of the first drainage hole 4, and does not conflict with the developing function of the conduit prepared with the developing material. S8: Apply a coating layer to the surface of catheter VI after S7 shaping and cure it to obtain catheter VII; S9: Clean the catheter VII after S8 coating curing, and assemble it with particle fixing wire, particle push guide wire, catheter seat 9 and Luer connector 10 to obtain the catheter 6.

[0052] As an embodiment of the present invention, the imaging material is further selected from at least one of tungsten powder, bismuth subcarbonate, barium sulfate, iodine compounds, bismuth trioxide, and calcium tungstate. The X-ray-proof properties of the catheter facilitate accurate identification of catheter advancement within the body during clinical procedures.

[0053] As an embodiment of the present invention, the required hanging and shaping conditions in S3 are further as follows: temperature: 20-28℃, hanging and shaping humidity: 45-65%RH, and hanging and shaping time: 2-16 days.

[0054] As an embodiment of the present invention, further, the preferred working principle of the heating device in S4 or S5 is as follows: The industrial frequency alternating current is converted into a higher frequency alternating current, which is then passed through a coil wound with copper wire. Utilizing the principle of electromagnetic induction, the current is converted into a magnetic field of the same frequency by the inductor coil, which then acts on a metal body within this magnetic field. Utilizing the eddy current effect, an induced rotating current (eddy current) proportional to the magnetic field strength is generated in the metal object. This rotating current is converted into heat energy by the resistance within the metal object. The heating coil, wound with copper wire of 0.1-0.2 mm diameter, has a length of 10 mm, an inner diameter of 12 mm, and 2-4 layers. The heating can be achieved using a high-frequency heating device with copper wire of 0.1-0.2 mm diameter and a heating coil of 10 mm length, an inner diameter of 12 mm, and 2-4 layers.

[0055] As an embodiment of the present invention, the drilling equipment of S6 may be a medical catheter side hole opening tool with patent number ZL202221739586.X.

[0056] As an embodiment of the present invention, further, the diameter of the drilling tool in S6 is 0.4mm-2.6mm, the rotation speed of the tool is greater than 2000rpm / min, and the feed rate is 0.1-150mm / min. The drilled hole is required to have smooth edges without burrs, and the hole dimensions for each model should meet the requirements. As an embodiment of the present invention, the S8 coating further includes at least one of a lubricating coating, an anticoagulant coating, an antibacterial coating, and a drug-loaded coating, wherein the lubricating coating comprises, in sequence, a cured base layer and a super-slippery layer.

[0057] As an embodiment of the present invention, the S8 coating curing can be any one of LED lamp curing, mercury lamp curing or ultraviolet curing, in order to achieve better adhesion of the conduit 6 tube body.

[0058] The method of using the composite catheter kit in this invention is as follows: Preoperative preparation: The operator removes the sterilized product from the packaging. After simple cleaning, the operator can slightly pull down the sheath 7 on the catheter 6 to expose the particle chamber opening 8. Using a clamping device, the particles are placed into the particle chamber opening 8 one by one. When placing the particles, the particle pusher wire can be used to adjust the position of the particles, and the particle fixing wire can be used to cut and fix the position of the particles. Then, the sheath 7 is fastened, and the catheter 6 loaded with particles is inserted into the human body using the Seldinger puncture method. Skin fixation tape is used to fix the skin contact point, and catheter fixation tape is used to fix the catheter 6. If further fixation of the inserted catheter 6 is required, the fixing pull wire on one side of the catheter seat 9 can be manipulated to perform micro-deformation fixation of the ρ-shaped structure at the end of the catheter. The proximal end of the catheter 6 can be connected to a drainage device or other treatment tools for the next treatment.

[0059] Finally, it should be noted that in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0060] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.

[0061] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily 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 invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A composite catheter kit, characterized in that, The composite catheter kit includes a catheter with a micro-elliptical or circular structure, a fixing patch, a punching fixture, a particle pusher wire printed with graduations, and a particle fixing wire that can be cut, adjusted, and used to fix the particles. The catheter includes a catheter tip, a catheter middle section, and a catheter tail. The catheter has a drainage cavity inside. The catheter middle section has several treatment cavities parallel to the drainage cavity. The catheter tip is fixedly connected to a catheter seat and a Luer connector. A fixing pull wire passing through the drainage cavity is fixedly connected to one side of the catheter seat. A slidably connected sheath is fitted over the particle chamber opening of the treatment cavity near the catheter seat. A staggered first drainage hole and a second drainage hole are sequentially opened on the outside of the p-shaped structure from the sheath to the catheter tail. The first drainage hole and the second drainage hole communicate with the drainage cavity but not with the treatment cavity. The protruding part of the p-shaped structure has several vent holes. The kit also includes a radiopaque section fitted over the catheter middle section. Wherein, the first drainage hole, the second drainage hole and the exhaust hole are micro-elliptical or circular structures, and the diameter of the exhaust hole is smaller than that of the first drainage hole and the second drainage hole; The ρ-shaped structure is a single-cavity structure integrally fused and formed, with a tip angle of 10°-40°, and the single-cavity structure is connected to the drainage cavity.

2. The composite catheter kit according to claim 1, characterized in that, The radial section of the middle segment of the catheter has a multi-lumen structure, which includes a drainage lumen and a treatment lumen. The multi-lumen structure includes any one of a dual-lumen structure, a triple-lumen structure, or a quadruple-lumen structure.

3. The composite catheter kit according to claim 1, characterized in that, The outer part of the middle section of the catheter includes at least two rows of the first drainage holes, the center lines of the first drainage holes forming an angle α, the angle α being 20°≤α≤270°.

4. The composite catheter kit according to claim 2, characterized in that, In the dual-cavity structure, the included angle α is: 160°≤α≤270°; in the multi-cavity structure with three or more cavities, the included angle α is: 20°≤α≤190°.

5. The composite catheter kit according to claim 1, characterized in that, When applicable to internal and external drainage, the total number of openings of the first drainage hole, the second drainage hole and the exhaust hole shall be no less than 34 holes, and the second drainage hole shall be at least 6.

6. The composite catheter kit according to claim 1, characterized in that, The diameters of the first drainage hole and the second drainage hole are 0.3mm-2.2mm.

7. The composite catheter kit according to claim 1, characterized in that, The graduation lines printed on the particle pusher wire are spaced 10 mm apart.

8. The composite catheter kit according to claim 1, characterized in that, The volume of the treatment cavity is smaller than the volume of the drainage cavity.

9. The composite catheter kit according to claim 1, characterized in that, The drilling fixture includes a drilling tool, which includes an arc-shaped groove for placing the conduit. The arc-shaped groove has a cavity portion for installing a button battery and an LED. An observation end for observing the position of the conduit cavity illuminated by the LED is provided at the connection between the cavity portion and the arc-shaped groove.

10. A preparation method for preparing the catheter in the composite catheter kit according to any one of claims 1 to 8, characterized in that, Includes the following steps: S1: Dry the catheter material and the developing material required for catheter preparation at 80-130℃ for 1-6 hours to obtain a material with a water content of less than 0.5% for later use; S2: The material dried in S1 is placed in an extruder with the temperature set at 170-210℃ and extruded to form conduit I; S3: Suspend and shape the extruded tube I from S2 and cut it to obtain tube II; S4: Place one end of the conduit II obtained in S3 into the flaring mold, heat it to a molten state using a heating device, and then push the protruding part of the conduit into the mold cavity so that the molten material in the mold cavity is fully filled. After filling, wait 1-5 seconds and then stop heating. Then blow compressed air at room temperature and ≤0.5MPa directly onto the outer surface of the mold for 10-20 seconds and wait for the mold to cool. After cooling, remove the conduit. At this time, the conduit flaring is completed, and conduit III is obtained. S5: Place the unprocessed end of conduit III from S4 into the tip forming mold. Use a heating device to heat one end of the conduit in the forming mold to a molten state. Then push the exposed part of the conduit into the mold cavity so that the molten material in the mold cavity is fully filled. After filling, wait 1-5 seconds and then stop heating. Then blow compressed air at room temperature and ≤0.5MPa directly onto the outer surface of the forming mold for 8-15 seconds and wait for the mold to cool. After cooling, remove the conduit. At this time, the conduit tip forming is completed, and conduit IV is obtained. S6: Use a semi-automatic hole-making machine to make several holes as particle chamber openings at a distance of 20-40mm from the flared end of the conduit III of S4 or the conduit IV of S5. Use a drilling equipment to position and automatically open holes 10-30mm from the position of the conduit marking development section to the end of the conduit to obtain the first hole of the first drainage hole. Then, open holes sequentially along the direction from the first hole to the end of the conduit. Using a drilling machine, a semi-automatic hole is drilled 60-90mm from the end of the catheter to the head of the catheter to obtain the head hole of the second drainage hole and several vent holes spaced apart from the head hole. Then, holes are drilled sequentially from the head hole to the end of the catheter to obtain all the second drainage holes. After the above drilling is completed, catheter V is obtained. S7: Place the end of the catheter V after the hole is opened in S6 into a cavity mold and heat and cool it to shape it, so as to obtain a ρ-shaped structure. Then, the above-mentioned developing part is sleeved in the middle section of the catheter to obtain catheter VI. S8: Apply a coating to the surface of catheter VI after S7 shaping and cure it to obtain catheter VII; S9: Assemble and clean the conduit VII after the S8 coating has been cured to obtain the conduit.

11. The preparation method according to claim 10, characterized in that, The catheter material is any one or more of polyurethane, polytetrafluoroethylene, fluorinated ethylene propylene copolymer, nylon, polypropylene, polyethylene, and polyvinyl chloride; the imaging material is at least one of tungsten powder, bismuth subcarbonate, barium sulfate, iodine compounds, bismuth trioxide, and calcium tungstate.

12. The preparation method according to claim 10, characterized in that, The required suspension and shaping conditions in S3 are: temperature: 20-28℃, suspension and shaping humidity: 45-65%RH, and suspension and shaping time: 2-16 days.

13. The preparation method according to claim 10, characterized in that, Regarding the heating conditions of the heating device in S4 or S5: the diameter of the copper wire is 0.1-0.2mm, and the length of the heating coil wound from it is 10mm, the inner diameter is 12mm, and the number of layers is 2-4.

14. The preparation method according to claim 10, characterized in that, The drilling equipment in S6 has a cutting tool diameter of 0.2mm-2.6mm, a cutting tool rotation speed greater than 2000rpm / min, and a feed rate of 0.1-150mm / min.

15. The preparation method according to any one of claims 11-14, characterized in that, The S8 coating includes at least one of a lubricating coating, an anticoagulant coating, an antibacterial coating, and a drug-loaded coating. The lubricating coating includes a cured base layer and a super-slippery layer. The curing is any one of LED lamp curing, mercury lamp curing, ultraviolet curing, and thermosetting.

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