Anti-sticking and anti-drag catheter with bionic fixing device

Abstract

The invention relates to the field of medical catheters, and particularly discloses an anti-sticking and anti-drag catheter with a bionic fixing device, the bionic fixing device is tightly attached to the middle section of the urethra by combining a bulged uneven surface with a micron-sized adhesion bulge structure on the outer wall surface and simulating an turbulent frog foot, and the anti-sticking and anti-drag catheter with the bionic fixing device is fixed on the middle section of the urethra. Part of patients can exert the urination control function of the sphincter in the bladder and the urethra, the operation of inserting into the bladder and the stimulation of foreign matters to the bladder are reduced, and urine is fully drained from a low position; when the fixing device is in contact and fixed with the urethra, the urethral catheter is effectively prevented from jumping off, the situation of urine leakage caused by incompatibility of a thin urethral catheter is reduced, and the friction injury and infection risk caused by frequent replacement of a thick urethral catheter to the urethra are reduced; meanwhile, a bionic anti-sticking and resistance-reducing structure is arranged on the inner wall of the urine flow channel of the bionic catheter, so that the adhesion of the inner wall to urine, calculus, blood and bacteria is reduced, the conditions of adhesion scaling, calculus deposition and blockage infection caused by long-term soaking of the catheter inner tube in the urine are reduced, and the safety and convenience of long-term retention catheterization are improved.

Description

Technical Field

[0001] The present application relates to the field of medical catheters, and in particular to an anti-adhesion and drag-reducing urinary catheter with a bionic fixator. Background Art

[0002] For problems such as urination difficulties caused by physiological and disease factors, indwelling urinary catheters are still the main means to alleviate urination disorders, and their clinical application is becoming more and more widespread. However, this operation is invasive. During the insertion, removal and retention of thick catheters, large areas of friction between the bladder and urethra occur, which can easily damage the patient's mucosa and cause bladder or urethral infection. On the other hand, the length of the catheter that penetrates deep into the bladder is too large, and the catheter opening is easily blocked by crystals due to long-term immersion in urine. At the same time, patients who use bladder-fixated catheters for a long time are at high risk of bladder atrophy. In order to prevent urine leakage, they need to use thicker catheters, which seriously affects the patient's experience.

[0003] At present, there are some catheters with super-lubricating hydrophilic coatings on the market. When the super-lubricating hydrophilic coating comes into contact with water, a lubricating film is formed between the surface of the catheter and the fragile urethral tissue, which can reduce the friction and irritation of the outer wall of the catheter on the urethral tissue, reducing the risk of damage and infection. However, the problem of the catheter penetrating deep into the bladder and rubbing the urethra during long-term indwelling still exists. The patient's urination control system basically cannot function, and it is very easy to form a reflux infection of urine contents into the bladder. The replacement and thickening of the catheter body increases the risk of urethral damage and infection. Summary of the invention

[0004] In order to improve the safety and convenience of long-term indwelling catheterization, the present application provides an anti-adhesive and drag-reducing catheter with a bionic fixator.

[0005] The present application provides an anti-adhesive and drag-reducing catheter with a bionic fixator, which adopts the following technical solution: An anti-adhesive and drag-reducing urinary catheter with a bionic fixator comprises a urinary catheter body and a bionic fixator arranged on the urinary catheter body; The catheter body includes a main catheterization channel and an air / liquid channel; the inner wall of the main catheterization channel is provided with a bionic anti-viscosity and drag reduction structure to reduce the viscosity and friction of urine on the inner wall of the main catheterization channel; The bionic fixator comprises an elastic pipe and a micron-scale adhesive protrusion structure; Wherein, the elastic pipe is located at the head and neck of the catheter body, the cavity between the elastic pipe and the catheter body is connected to the inflation / liquid channel, and is sealed at the air / liquid inlet of the inflation / liquid channel; The micron-scale adhesive protrusion structure comprises a plurality of micron-scale adhesive protrusion units arranged in an array on the outer wall of the elastic pipe; When the elastic tube bulges and deforms, the micron-scale adhesion protrusion structure on the outer wall is propped up, so that the bionic fixator is in contact and adhesion with the urethra.

[0006] The fixation site of the bionic fixator provided by the present application is the urethra, which allows some patients to continue to exert the urination control function of the bladder and the internal urethral sphincter, reducing the risk of bladder atrophy in patients. Since the operation of inserting the bladder is avoided and the insertion length is short, the foreign body stimulation to the bladder is reduced, which helps to prevent urine reflux infection; at the same time, the urine is fully discharged from a position below the bladder, which reduces the probability of blockage caused by the catheter port being immersed in the urine of the bladder for a long time, and improves the safety and convenience of long-term indwelling catheterization.

[0007] The uneven deformation of the bulging surface of the bionic holdfast, combined with the micron-scale adhesive protrusion structure on the outer wall of the elastic tube that imitates the feet of a frog, achieves double fixation, prevents the bionic holdfast from slipping, and reduces urine leakage due to the mismatch of thin catheters; the fixation of the catheter in the urethra does not depend on the diameter of the catheter body, which helps to avoid damage to the urethra and the risk of infection caused by frequent replacement of thick catheters.

[0008] Furthermore, the elastic pipe is a band ring pipe or an inner hole pipe, wherein: The band ring tube is a smooth ring tube with a band inside the wall, the band is elastic and has smaller elastic deformation than the smooth ring tube; the cavity between the inner wall of the band ring tube and the outer wall of the catheter body is a closed chamber connected to the inflation / liquid channel; A bundle-shaped channel is arranged inside the wall surface of the inner bore pipe, and the bundle-shaped channel is connected to the gas / liquid channel.

[0009] Furthermore, the unfolded structure of the tie belt includes any one of vertical stripes, spiral stripes, ring stripes, twill stripes, and mesh stripes, or a combination of several of them.

[0010] Furthermore, the bundle-shaped channels include channels of any one of vertical stripes, spirals, rings, diagonal stripes, and mesh stripes, or a combination of several of the channels that are interconnected.

[0011] Furthermore, after the bionic fixator is filled with gas or liquid, the presence of the bundle-shaped belt or the bundle-shaped channel causes the elastic pipe to deform with an uneven surface.

[0012] Furthermore, the micron-sized adhesion protrusion unit is a polygonal column, and the height of the micron-sized adhesion protrusion unit is 0.1-2.0 times the diameter of the circumscribed circle of the bottom surface of the polygonal column.

[0013] Furthermore, the center distance between adjacent micrometer-scale adhesion protrusion units is 1.0-2.0 times the diameter of the circumscribed circle of the bottom surface of the polygonal column.

[0014] The principle of the bionic holdfast using the micron-sized adhesive protrusion structure on the surface that imitates the frog's feet to achieve fixation is as follows: the microchannels formed between the micron-sized adhesive protrusion units can accommodate liquid. On the one hand, the microchannels help the liquid to diffuse to the entire surface of the bionic holdfast so as to discharge the gas between the surface of the bionic holdfast and the urethra wall that reduces the adhesion; on the other hand, under humid conditions, the microchannels help to discharge excess liquid between the surface of the bionic holdfast and the urethra wall, thereby effectively increasing solid-solid contact to improve adhesion.

[0015] The micron-scale adhesion protrusion units are set with appropriate size and spacing to form negative pressure between the bionic fixator and the urethra wall, restricting the flow of liquid to enhance the adhesion effect.

[0016] The micron-scale adhesive protrusion unit can also enhance the adhesive effect by setting a suitable protrusion height. Since the gap between the micron-scale adhesive protrusion units is very small, if the protrusion height is large, the micron-scale adhesive protrusion units are easy to bend and aggregate, reducing the effective contact area between the micron-scale adhesive protrusion unit and the urethra wall, resulting in reduced adhesion; if the protrusion height is small, the depth of the microchannel between the micron-scale adhesive protrusion units is small, affecting the wet adhesion effect.

[0017] Preferably, the length of the elastic tube is 20-30 mm.

[0018] Preferably, the base material of the bionic fixator includes any one or a combination of elastic latex, silicone, and polyurethane materials.

[0019] Preferably, the material of the catheter body includes any one or a combination of latex, rubber, polyvinyl chloride and polyurethane.

[0020] Furthermore, the bionic anti-viscosity and drag reduction structure comprises: A wedge-shaped protrusion structure, comprising a plurality of wedge-shaped protrusion units arranged in an array on the inner wall of the main urinary catheterization channel, each of the wedge-shaped protrusion units comprising one or more main inclined surfaces with an angle of less than 10° with the flow channel wall, the main inclined surfaces facing the flow direction of urine; The corrugated protrusion structure comprises a plurality of corrugated protrusion units arranged in an array on the main inclined surface, wherein the sizes of the corrugated protrusion units and the wedge-shaped protrusion units are both in the micrometer level; The hydrophobic super-slip coating is arranged on the inner wall of the main urinary catheterization channel.

[0021] The bionic anti-adhesion and drag reduction structure uses a wedge-shaped convex structure to imitate the characteristics of silver carp scales, and a corrugated convex structure to imitate the kelp skirt. The micron-level bionic anti-adhesion and drag reduction structure is combined with the nano-level hydrophobic super-slip coating to achieve synergistic anti-adhesion and drag reduction. The specific principles are as follows: Grooves are formed between the micron-sized wedge-shaped protrusion units, which are low in front and high in the back. When the fluid flows through the tail of the wedge-shaped protrusion unit, the fluid swirls to generate vortices, causing part of the fluid near the wedge-shaped protrusion unit to produce a non-zero initial velocity, promptly washing away the settled impurities and viscous fluid, and reducing the viscous resistance in the flow of urine.

[0022] The wedge-shaped protrusion unit with a low front and a high back maintains a relatively high fluid contact angle front. At the same time, the corrugated protrusion structure increases the roughness of the inclined surface of the wedge-shaped protrusion unit. Combined with the hydrophobic effect of the hydrophobic coating, it further reduces the direct contact and viscosity between urine and impurities and the inner wall of the main catheterization channel. It can not only reduce the residue, adhesion or backflow of urine on the inner wall of the main catheterization channel, but also reduce adhesion friction, thereby reducing the energy loss of the fluid vortex, which is conducive to maintaining a stable fluid vortex and further enhancing the anti-viscosity and drag reduction effect.

[0023] Furthermore, the center distance between the front and rear adjacent wedge-shaped protrusion units is 1.0-2.0 times the length of the wall-adhering surface of the wedge-shaped protrusion unit along the fluid flow direction. Preferably, the protrusion height of the wedge-shaped protrusion unit is 0.02-0.2 times the length of the wall-adhering surface shape.

[0024] Preferably, the protrusion height of the wedge-shaped protrusion unit is less than 0.5 mm.

[0025] Preferably, the shape of the wall-adhering surface of the wedge-shaped protrusion unit includes one or a combination of polygon, circle, ellipse or sector, wherein the polygon includes triangle, quadrilateral and pentagon.

[0026] Preferably, a plurality of the wedge-shaped protrusion units form a planar array on the wall surface of the flow channel, and the arrangement of the array includes any one or a combination of square, rhombus, hexagonal and irregular arrays.

[0027] Preferably, the length of the wedge-shaped protrusion unit along the fluid flow direction is 0.5-5.0 mm, and the width along the circumference of the flow channel wall is 0.1-1.0 mm.

[0028] When the size of the wedge-shaped protrusion unit is too large, the inward convergence and internal rotation of the fluid by the previous wedge-shaped protrusion unit cannot continue to the next adjacent wedge-shaped protrusion unit, and it is impossible to maintain a stable vortex to achieve anti-viscosity drag reduction, resulting in an excessively large fluid boundary layer and increased resistance. When the distance between adjacent wedge-shaped protrusion units is too large, it is also impossible to maintain a stable fluid vortex to wash away heavier impurities. The wedge-shaped protrusion cannot be used to adjust the flow field distribution and reduce the thickness of the turbulent layer, making it difficult to promptly wash away the settled impurities and viscous fluid. Setting a suitable angle between the inclined surface and the flow channel wall is also conducive to maintaining a stable fluid vortex.

[0029] Preferably, the waveform of the corrugated protrusion unit includes any one or a combination of C-shape, U-shape, S-shape, sawtooth shape, sine waveform or attenuated waveform.

[0030] Preferably, the wave path of the corrugated protrusion unit occupies 0.5-100 wavelengths.

[0031] Preferably, the height of the corrugated protrusion unit is 0.1-10 times the wavelength of the corrugated protrusion unit.

[0032] Preferably, one or more of the corrugated protrusion units form the corrugated protrusion structure that is arranged horizontally, vertically or staggered at an oblique angle.

[0033] Preferably, the interval between adjacent corrugated protrusion units is 0.1-2 times of the protrusion height of the corrugated protrusion unit, and the size is in micrometer order.

[0034] Preferably, the hydrophobic coating is a biocompatible hydrophobic flexible polymer molecular brush coating, and the thickness of the hydrophobic coating is 5-100 nm.

[0035] Preferably, the hydrophobic flexible polymer is selected from any one of polydimethylsiloxane, perfluoropolyether, polyisobutylene and their derivatives.

[0036] The present application also provides a method for using the above-mentioned anti-adhesion and drag-reducing catheter with a bionic fixator, comprising the following steps: Insert the catheter along the urethra to allow the bionic fixator to reach the urethra; Gas or liquid is filled into the cavity between the elastic tube and the main catheterization channel through the inflation / liquid channel, and the inflation / liquid inlet is sealed in time. The bionic fixator will swell and deform with an uneven surface, supporting the micron-scale adhesion protrusion structure of the outer wall of the elastic tube to contact and adhere to the inner wall of the urethra, thereby fixing the bionic fixator in the urethra.

[0037] Preferably, the method further includes the following steps: before inserting the catheter into the urethra, a lubricant is applied to the outside of the catheter, wherein the lubricant is any one or more of a silicone lubricant, a gel, a water-based lubricant and a polyvinyl alcohol lubricant, and the catheter body and the bionic fixator do not react with the selected lubricant such as swelling.

[0038] In summary, the present application includes at least one of the following beneficial technical effects: 1. The fixation site of the bionic fixator provided by the present application is the urethra, which allows some patients to continue to exert the urination control function of the bladder and the internal urethral sphincter, reducing the risk of bladder atrophy in patients; since the operation of inserting the bladder is avoided, the insertion length is short, which reduces the foreign body stimulation to the bladder and helps prevent urine reflux infection; at the same time, the urine is fully discharged from a position below the bladder, reducing the probability of blockage caused by the catheter port being immersed in the urine of the bladder for a long time, and improving the safety and convenience of long-term indwelling catheterization; 2. The bionic fixator provided by the present application has a bulging uneven surface, and cooperates with the micron-level adhesive protrusion structure of the outer wall surface that imitates the frog's feet to achieve double fixation, prevent the catheter from slipping, and reduce urine leakage due to the incompatibility of thin catheters; the fixation of the catheter in the urethra does not depend on the diameter of the catheter body, which helps to avoid damage to the urethra and infection risks caused by frequent replacement of thick catheters; 3. The present application sets a bionic anti-adhesion and drag-reducing structure on the inner wall of the main catheterization channel of the catheter, which fully imitates the surface characteristics of animals and plants such as silver carp and kelp that can swing with low resistance in seawater and are not easy to adhere to pollutants, and imitates a multi-level bionic anti-adhesion and drag-reducing structure that combines the structure and arrangement of silver carp scales, the corrugated structure of the kelp skirt and the anti-adhesion and super-slip flexible coating. First, the urine flow field characteristics are changed by the micron-scale wedge-shaped protrusion structure, and the grooves between adjacent wedge-shaped protrusion units are used to generate fluid vortices to propel the flow, thereby promptly washing away the settled impurities and viscous fluids, reducing the viscous resistance between the fluids, and accelerating the low-resistance flow of urine along the catheter; at the same time, the micron-scale corrugated protrusion structure and the nano-scale hydrophobic coating on the wedge-shaped protrusion structure exert a hydrophobic anti-viscosity and drag reduction effect, preventing the viscous deposition of urine, blood and stones, reducing the friction resistance of contact with the inner wall of the catheter, reducing the blockage and even infection of the catheter, effectively extending the service life of the catheter, reducing the risk of damage and infection to patients caused by frequent replacement of catheters, and increasing the safety and convenience of long-term indwelling catheterization. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 This is a schematic diagram of the overall structure of an anti-adhesive and drag-reducing urinary catheter with a bionic fixator according to an embodiment of the present application; Figure 2 : is a schematic diagram of the elastic pipeline of the bionic fixator in the embodiment of the present application, wherein: (a) is a schematic diagram of an elastic pipe using a smooth annular tube with a beam, (b) is a schematic diagram of an elastic pipe using an inner hole pipe, (c) is the unfolded shape of the beam and the beam channel, where the connection of the channel depends on multiple gas / liquid outlets, (c-1)-(c-4) are schematic diagrams of annular, spiral, twill, and reticular shapes respectively; Figure 3Schematic diagrams of the micron-scale adhesion protrusion structure on the outer wall of the biomimetic fixator in the embodiment of the present application, wherein (a) is a schematic diagram of the outer wall of the biomimetic fixator, (b) is a triangular prism adhesion protrusion structure array, (c) is a quadrangular prism adhesion protrusion structure array, (d) is a pentagonal prism adhesion protrusion structure array, and (e) is a hexagonal prism and triangular prism adhesion protrusion structure array; Figure 4 The present invention is mainly used to illustrate the arrangement of wedge-shaped protrusion units on the inner wall of the main urinary catheterization channel, wherein (a)-(c) are schematic diagrams of wedge-shaped protrusion units with triangular, quadrilateral, and pentagonal wall surfaces, respectively; Figure 5 It is a cross-sectional schematic diagram of the embodiment of the present application mainly used to show the arrangement of the wedge-shaped protrusion units on the inner wall of the main urinary catheterization channel; Figure 6 Schematic diagrams of structures of corrugated protrusion units of different shapes in the embodiments of the present application, wherein (a)-(f) are schematic diagrams of waveforms of C-shape, U-shape, S-shape, sawtooth shape, sine waveform or attenuated waveform respectively; Figure 7 This is a working effect diagram of the bionic fixator in the embodiment of the present application; Figure 8 It is a schematic diagram of the anti-viscosity and drag reduction mechanism of the bionic anti-viscosity and drag reduction structure in the embodiment of the present application.

[0040] Figure numerals: 1. Bionic fixator; 1-1. Elastic pipe; 1-2. Micron-scale adhesion protrusion structure; 1-3. Bundle belt; 1-4. Sealed chamber; 1-5. Bundle channel; 2. Bionic catheter body; 2-1. Catheterization main channel; 2-2. Inflation / liquid channel; 2-3. Flushing and injection channel; 2-4. Catheterization port; 2-5. Inflation / liquid outlet; 2-6. Flushing and injection outlet; 2-7. Urine outlet; 2-8. Inflation / liquid inlet; 2-9. Flushing and injection inlet; 3. Bionic anti-adhesion and drag reduction structure; 3-1. Wedge-shaped protrusion structure; 3-2. Corrugated protrusion structure; 3-3. Hydrophobic super-slip coating. DETAILED DESCRIPTION

[0041] The following is combined with Figure 1-8 This application is described in further detail.

[0042] The present application embodiment discloses an anti-adhesive and drag-reducing urinary catheter with a bionic fixator. Figure 1 The urinary catheter comprises a urinary catheter body 2 and a bionic fixator 1. The urinary catheter body 2 comprises a urinary catheter main channel 2-1, and two ends of the urinary catheter main channel 2-1 are respectively provided with a urinary catheter port 2-4 and a urine outlet 2-7. When in use, urine enters the urinary catheter main channel 2-1 from the urinary catheter port 2-4 and then is discharged from the urine outlet 2-7.

[0043] Reference Figure 1A flushing and injection channel 2-3 and an inflation / liquid channel 2-2 are respectively arranged on both sides of the main catheterization channel 2-1, a flushing and injection inlet 2-9 and a flushing and injection outlet 2-6 are respectively arranged at both ends of the flushing and injection channel 2-3, and an inflation / liquid inlet 2-8 and an inflation / liquid outlet 2-5 are respectively arranged at both ends of the inflation / liquid channel 2-2.

[0044] Reference Figure 1 The bionic fixator 1 includes an elastic tube 1-1 and a micron-scale adhesive protrusion structure 1-2 arranged on the outer wall of the elastic tube 1-1. The inner diameter of the elastic tube 1-1 is 1 mm larger than the outer diameter of the catheter body 2. The elastic tube 1-1 is sleeved outside the catheter body 2 and is located at one end close to the catheter port 2-4. The inner walls of both ends of the elastic tube 1-1 are fixed to the outer wall of the catheter body 2, and bonding can be used to form a closed cavity between the elastic tube 1-1 and the catheter body 2. The gas / liquid outlet 2-5 is located in the closed cavity, so that the closed cavity is connected to the gas / liquid channel 2-2.

[0045] Reference Figure 2 The elastic pipe 1-1 can be an inner bore pipe or a smooth annular pipe with a tie band 1-3. Figure 2 As shown in (a), the shape belt 1-3 is arranged on the inner wall of the smooth ring tube or embedded in the wall surface of the smooth ring tube. The shape belt 1-3 includes a plurality of belts arranged in an array. The belt is elastic and its elastic deformation is smaller than that of the smooth ring tube. The cavity between the inner wall of the belt ring tube and the outer wall of the catheter body 2 is a closed chamber 1-4 connected to the inflation / liquid channel 2-2. Figure 2 As shown in (b), the wall of the inner bore pipe is provided with a bundle-shaped channel 1-5, and the bundle-shaped channel 1-5 is connected to the gas / liquid channel 2-2. Further, the shape of the bundle-shaped belt 1-3 or the bundle-shaped channel 1-5 can be any one of vertical stripes, spirals, rings, diagonal stripes, and mesh stripes, or a combination of several of them.

[0046] Reference Figure 3 The micron-scale adhesive protrusion structure 1-2 includes a plurality of micron-scale adhesive protrusion units arranged in an array on the outer wall of the elastic tube 1-1. The micron-scale adhesive protrusion units are polyhedral prisms and are elastic. The polyhedral prisms can be any one or a combination of triangular prisms, quadrangular prisms, pentagonal prisms, hexagonal prisms, or a polyhedral prism with more prisms.

[0047] In this embodiment, the elastic tube 1-1 of the bionic fixator 1 can be a smooth ring tube with a beam, and the length of the elastic tube 1-1 is 20 mm. The beam 1-3 is a plurality of vertical stripes arranged in parallel, each of which has a width of 0.5 mm, and the parallel interval between two adjacent beams is 1 mm. The micron-scale adhesive protrusion unit 1-2 is a regular hexagonal prism with a protrusion height of 150 μm, a side length of the bottom of the regular hexagonal prism of 100 μm, a diameter of the circumscribed circle of the bottom of 200 μm, and a center distance between adjacent regular hexagonal prisms of 250 μm.

[0048] Due to the difference in elasticity between the binding band 1-3 and the smooth annular tube, or under the binding effect of the binding channel 1-5, the bionic fixator bulges with an uneven surface, and cooperates with the micron-level adhesive protrusion structure 1-2 on the outer wall of the elastic tube that imitates the feet of a frog, to achieve double fixation, prevent the bionic fixator from slipping, and reduce urine leakage due to the incompatibility of thin catheters; the fixation of the catheter in the urethra does not depend on the diameter of the catheter body, which helps to avoid damage to the urethra and the risk of infection caused by frequent replacement of thick catheters.

[0049] Reference Figure 1 , Figure 4 and Figure 5 The inner wall of the main urinary catheterization channel 2-1 is provided with a bionic anti-viscosity drag reduction structure 3, which includes a wedge-shaped protrusion structure 3-1, a corrugated protrusion structure 3-2 and a hydrophobic super-slip coating 3-3. The wedge-shaped protrusion structure 3-1 includes a plurality of wedge-shaped protrusion units arranged in an array on the inner wall of the main urinary catheterization channel 2-1, each wedge-shaped protrusion unit includes at least one main inclined surface with an angle of less than 10° with the flow channel wall and a wall-attached surface attached to the flow channel wall, and the main inclined surface faces the flow direction of the fluid.

[0050] Reference Figure 4 The wall-attached surface of the wedge-shaped protrusion unit is a polygon, which can be any one or a combination of triangles, quadrilaterals, pentagons, or other polygons. The wedge-shaped protrusion unit can be a polygonal pyramid or a polygonal prism obliquely cut along the vertex.

[0051] Reference Figure 4 and Figure 5 In the direction of fluid flow, multiple wedge-shaped protrusion units are arranged in a staggered manner on the wall of the flow channel in a fish scale-like manner, with low front and high back, and grooves are formed between adjacent wedge-shaped protrusion units.

[0052] Take a tetrahedral wedge-shaped protrusion unit design as an example. One side of the tetrahedral pyramid is the wall-adhering surface, and the side opposite to the wall-adhering surface is the inclined surface. The cross section of the tetrahedral pyramid along the direction parallel to the flow channel is a triangle with an inclination angle of 5°. The height of the wedge-shaped protrusion unit is 0.4 mm, the width of the wedge-shaped protrusion unit is 0.9 mm, and the length is 4 mm. The center distance between the two adjacent tetrahedral pyramids is about 6 mm. They are arranged in a fish scale-like manner, with the front low and the back high, and are staggered on the inner wall of the main urinary catheter channel. The arrangement method is referred to Figure 4 (a) in the figure.

[0053] Reference Figure 1 , Figure 4 and Figure 6 The corrugated protrusion structure 3-2 includes a plurality of corrugated protrusion units arranged in an array on an inclined surface, and the extension direction of the corrugated protrusion units is in the direction of the flow of the fluid. The waveform of the corrugated protrusion unit is any one of C-shape, U-shape, S-shape, sawtooth shape, sine waveform or attenuation waveform or a combination of several thereof.

[0054] As an example, S-shaped corrugated protrusion units with a wave path of 200-800 μm are uniformly distributed on the inclined surface of the wedge-shaped protrusion unit along the direction of urine flow, the spacing between adjacent corrugated protrusion units is 20 μm, and the height of the corrugated protrusion unit is 80 μm.

[0055] Reference Figure 1 The bionic anti-viscosity drag reduction structure 3 also includes a hydrophobic coating 3-3 coated on the inner wall of the main urinary catheterization channel 2-1. The hydrophobic coating 3-3 is a biocompatible hydrophobic flexible polymer molecular brush coating with a thickness of 5-100 nm.

[0056] In this embodiment, the bionic fixator 1 is obtained by cutting after injecting latex material into a molding mold with a micron-level adhesive protrusion structure 1-2 and then molding. The catheter body 2 is made of silicone rubber material and manufactured by extrusion molding and injection molding. The mixed silicone raw material is injected into the outer mold of the catheter body 2, and then the inner mold with a bionic anti-adhesive drag reduction structure is inserted for extrusion molding, and the bionic anti-adhesive drag reduction structure is completely replicated to obtain the catheter body 2. The catheter body 2 is punched with a catheter port 2-4, an inflation / liquid outlet 2-5, and a flushing and injection outlet 2-6. The bionic fixator 1 is sleeved on the outside of the catheter body 2, and then the two ends of the elastic pipe 1-1 in the bionic fixator 1 are bonded to the outer wall of the catheter body 2.

[0057] After the surface of the catheter was pretreated with oxygen plasma, the inner and outer surfaces were dip-coated with a biocompatible hydrophobic polydimethylsiloxane solution for multiple times. A high-density hydrophobic polymer molecular brush coating with a thickness of 5-100 nm was grafted on the catheter through covalent bonds. The high flexibility of the polydimethylsiloxane molecular chain and the low chemical bond rotation energy maintained the super-slip properties of the surface (ultra-low dynamic contact hysteresis angle CAH or Δθ<5°), and gave the surface good lipophilic and hydrophobic properties (θ 油 <90°, θ 水 >90°).

[0058] When in use, first apply a proper amount of silicone oil lubricant on the outer wall of the catheter, then insert the catheter along the urethra, so that the bionic fixator 1 reaches the middle part of the urethra. Figure 7 As shown. An appropriate amount of air or sterile saline is injected into the closed cavity between the elastic tube 1-2 and the catheter body 2 through the inflation / liquid channel 2-2, and the elastic tube 1-2 bulges to form a shaped balloon with an uneven surface, so that the micron-level adhesion protrusion units on the outer wall of the elastic tube 1-2 are propped up and adhered to the inner wall of the urethra, thereby fixing the bionic fixator 1 in the urethra. In this way, not only can it control urination and reduce internal bladder infection to a certain extent through the bladder and the internal urethral sphincter, but it can also reduce the length of entry into the body through the good contact between the bionic fixator and the urethra, prevent patients from leaking urine and the movement of the catheter, and improve the safety and convenience of long-term indwelling catheterization.

[0059] The principle of the bionic anti-viscosity and drag reduction structure 3 on the inner wall of the main catheterization channel 2-1 is as follows: Figure 8 As shown, the details are as follows: Grooves are formed between the micron-sized wedge-shaped protrusion units, which are low in front and high in the back. When the fluid flows through the tail of the wedge-shaped protrusion unit, the fluid swirls to generate a vortex, which makes the part of the fluid near the wedge-shaped protrusion unit produce a non-zero initial velocity, and promptly washes away the settled impurities and viscous fluid, reducing the viscous resistance inside the fluid; at the same time, the wedge-shaped protrusion unit, which is low in front and high in the back, keeps the fluid at a relatively high contact angle front, and increases the roughness of the main inclined surface of the wedge-shaped protrusion unit through the micron-sized corrugated protrusion structure, and cooperates with the hydrophobic coating to further enhance the super-slip anti-stick characteristics, reduce the thickness of the fluid boundary layer, and reduce the direct contact and adhesion between the fluid and impurities and the flow channel wall, thereby reducing the friction resistance between the fluid and the wall. It can not only reduce the residue, adhesion or backflow of the fluid on the flow channel wall, and realize the anti-stickiness and drag reduction of the contact between the fluid and impurities and the flow channel wall, but also reduce the viscous friction, thereby reducing the energy loss of the fluid vortex, which is conducive to maintaining a stable fluid vortex and further enhancing the resistance and viscosity reduction effect.

[0060] The above are all preferred embodiments of the present application, and the protection scope of the present application is not limited thereto. Therefore, any equivalent changes made according to the structure, shape, and principle of the present application should be included in the protection scope of the present application.

Claims

1. An anti-adhesive and drag-reducing urinary catheter with a bionic fixator, characterized in that: It includes a urinary catheter body and a bionic fixator arranged on the urinary catheter body; The catheter body includes a main catheterization channel and an air / liquid channel; the inner wall of the main catheterization channel is provided with a bionic anti-viscosity and drag reduction structure to reduce the viscosity and friction of urine on the inner wall of the main catheterization channel; The bionic fixator comprises an elastic pipe and a micron-scale adhesive protrusion structure; Wherein, the elastic pipe is located at the head and neck of the catheter body, the cavity between the elastic pipe and the catheter body is connected to the inflation / liquid channel, and is sealed at the air / liquid inlet of the inflation / liquid channel; The micron-scale adhesive protrusion structure comprises a plurality of micron-scale adhesive protrusion units arranged in an array on the outer wall of the elastic pipe; When the elastic tube bulges and deforms, the micron-scale adhesion protrusion structure on the outer wall is propped up, so that the bionic fixator is in contact and adhesion with the urethra.

2. The anti-adhesion and drag-reducing urinary catheter with a bionic fixator according to claim 1, characterized in that: The elastic pipe is a band ring pipe or an inner hole pipe, wherein: The band ring tube is a smooth ring tube with a band inside the wall, and the elastic deformation of the band is smaller than that of the smooth ring tube; the cavity between the inner wall of the band ring tube and the outer wall of the catheter body is a closed chamber connected to the inflation / liquid channel; A bundle-shaped channel is arranged inside the wall surface of the inner bore pipe, and the bundle-shaped channel is connected to the gas / liquid channel.

3. The anti-adhesion and drag-reducing urinary catheter with a bionic fixator according to claim 2, characterized in that: The unfolded structure of the tie belt includes any one of vertical stripes, spiral stripes, ring stripes, twill stripes, and mesh stripes, or a combination of several of them.

4. The anti-adhesion and drag-reducing urinary catheter with a bionic fixator according to claim 2, characterized in that: The bundle-shaped channels include channels in any one of vertical, spiral, annular, diagonal, and mesh shapes or a combination of several of the shapes and interconnected.

5. The anti-adhesion and drag-reducing urinary catheter with a bionic fixator according to claim 2, characterized in that: After the bionic fixator is filled with gas or liquid, the presence of the bundle-shaped belt or the bundle-shaped channel causes the elastic pipe to deform with an uneven surface.

6. The anti-adhesion and drag-reducing urinary catheter with a bionic fixator according to claim 1, characterized in that: The micron-scale adhesion protrusion unit is a polygonal column, and the height of the micron-scale adhesion protrusion unit is 0.1-2.0 times the diameter of the circumscribed circle of the bottom surface of the polygonal column.

7. The anti-adhesion and drag-reducing urinary catheter with a bionic fixator according to claim 6, characterized in that: The center spacing between adjacent micrometer-scale adhesion protrusion units is 1.0-2.0 times the diameter of the circumscribed circle of the bottom surface of the polygonal column.

8. The anti-adhesion and drag-reducing urinary catheter with a bionic fixator according to claim 1, characterized in that: The bionic anti-viscosity and drag reduction structure comprises: A wedge-shaped protrusion structure, comprising a plurality of wedge-shaped protrusion units arranged in an array and attached to the wall surface of the flow channel, each of the wedge-shaped protrusion units comprising one or more main inclined surfaces with an angle of less than 10° with the wall surface of the flow channel, the main inclined surfaces facing the flow direction of the fluid; The corrugated protrusion structure comprises a plurality of corrugated protrusion units arranged in an array on the main inclined surface, wherein the sizes of the corrugated protrusion units and the wedge-shaped protrusion units are both in the micrometer level; The hydrophobic super-slip coating is disposed on the wall surface of the flow channel.

9. The anti-adhesion and drag-reducing urinary catheter with a bionic fixator according to claim 8, characterized in that: The center distance between the front and rear adjacent wedge-shaped protrusion units is 1.0-2.0 times the length of the wall-adhering surface of the wedge-shaped protrusion unit along the fluid flow direction.

10. A method for using the anti-adhesive and drag-reducing urinary catheter with a bionic fixator according to any one of claims 1 to 9, characterized in that: The following steps are involved: Insert the catheter along the urethra to allow the bionic fixator to reach the urethra; After filling the bionic fixator with gas or liquid through the inflation / liquid inlet and sealing it in time, the bionic fixator bulges and deforms with uneven surface, and the micron-scale adhesion protrusion structure of the outer wall of the elastic tube contacts and adheres to the inner wall of the urethra, so that the bionic fixator is fixed in the urethra.

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