Multifunctional catheter

Abstract

A multifunctional catheter comprises a catheter body (1) with a whistle-shaped guide head (13) at the front end, a thermoplastic tube (4) sleeved at the front end of the catheter body (1), a balloon (42) with the front end connected with the catheter body (1) and a Y-shaped tube (3) communicated with the rear end of the catheter body (1), and is technically characterized in that a urine excretion channel (31), an injection flushing channel (32) and a water injection channel (33) are arranged in the catheter body (1), and the injection flushing channel (32) and the water injection channel (33) are arranged on two sides of the urine excretion channel (31). The outlet ends of the urine discharge channel (31), the injection flushing channel (32) and the water injection channel (33) are positioned on the Y-shaped pipe (3); a plurality of intermittent linear grooves (11) in the same direction are formed in the tube body (1) in the circumferential direction, and urine overflow holes (411) communicated with the urine discharge channel (31) are formed in the rear ends of the intermittent linear grooves (11). The medicine has the advantages of being convenient to use, high in patient compliance, moderate in flexibility and the like.

Description

Technical Field

[0001] The invention relates to medical instruments, in particular to a multifunctional urinary catheter. Background Art

[0002] At present, domestic and foreign market catheters all complain that they have too few functions (only bladder urine excretion function, bladder flushing function, and balloon water injection function), and have the following defects: After the catheter is inserted into the human urethra, the urethra itself will produce secretions and will be discharged from the body along the wall of the catheter. The urethral secretions discharged from the body are very likely to cause bacterial infection and reproduction. Bacterial reflux can easily cause urethral infection and even primary septicemia. To prevent infection, silicone urinary catheters must be replaced within 28 days, and antibiotics must be injected intravenously at the same time. Medical staff also scrub and disinfect the secretions on the tube wall several times a day.

[0003] For infected urethra, prostate, bladder, and to prevent postoperative infection of urethra, prostate, and bladder, antibiotics cannot be directly injected, and only oral medication and perfusion therapy can be used. Perfusion is to inject antibiotics directly into the urethra with a syringe at the urethral opening. However, this method is not only complicated and time-consuming, but also extremely painful for the patient.

[0004] During the time when the catheter is in the body, about 15% to 25% of the residual urine in the bladder will be retained in the bladder and cannot be discharged. Because the residual urine is retained in the bladder for a long time, it will cause bacteria to multiply. It is the main cause of postoperative bladder infection. In order to prevent postoperative bladder infection, antibiotics are usually injected into the bladder for flushing. However, because the antibiotics are mixed with the residual urine, the infection cannot actually be stopped. The number of patients with postoperative bladder infection accounts for about 40%. The infection can cause surgical failure or complications. Because the residual urine is retained in the bladder for a long time, it is very easy to cause bladder stones for patients with high uric acid.

[0005] Blood clots generated after bladder surgery can easily block the urine drainage hole of the urinary catheter. Once blocked, the urine in the bladder cannot be discharged. If not discovered and treated in time, the bladder may burst and threaten the patient's life. After the urinary catheter is inserted into the urethra, it may sometimes cause bladder spasm. During spasm, the bladder contracts rapidly, causing strong pressure on the urine. The pressure will force the urine into the space between the urethra and the urinary catheter and prevent it from being discharged from the body for a long time. For patients with high uric acid, urethral stones will occur.

[0006] The flushing port of the catheter is located on the side. When the bladder is flushed, most of the antibiotics are flushed to the lower side of the bladder wall or in the residual urine, resulting in poor anti-inflammatory effect on the wound after bladder surgery. After catheterization, a large amount of urethral secretions cannot be discharged from the body, and the secretions are retained between the urethral wall and the urethral tube for a long time. A small amount of urethral secretions discharged from the body cause urethral infection.

[0007] The two front and rear holes for urinary bladder urine excretion of the urinary catheter are designed on one cross section, which weakens the strength of the part. During the catheterization process, folding may occur at the part, making the catheter body unable to be inserted or causing pain to the patient.

[0008] The diameter of the internal channel of the catheter body is too small or designed incorrectly, resulting in the balloon water injection channel diameter being too small, requiring a larger thrust when injecting water, a smaller bladder flushing flow rate, and a smaller excretion volume even if the bladder urine excretion channel diameter is larger. Even if lubricant is applied to the catheter before insertion, the lubricant at the proximal end of the catheter is gradually scraped off due to the squeezing of the human urethra during the insertion of the catheter, and the lubricant loses its function. Secondly, the catheter is in close contact with the urethra (no air), and a vacuum negative pressure is generated between the catheter and the urethra wall during the insertion movement, which increases the friction several times.

[0009] If the guide head is designed to be hard (70-75 degrees Shore), although the friction resistance during insertion can be reduced, it is very easy to cause bladder spasm when the guide head hits the bladder wall, and it will penetrate the urethra or scratch the urethral mucosa; if the guide head is designed to be too soft, it can avoid bladder spasm when the guide head hits the bladder wall, and it will not penetrate the urethra or scratch the urethral mucosa, but it will greatly increase the friction resistance. Due to material selection and structural design issues, the balloon often bursts when it is under insufficient pressure, causing medical risks. When the catheter balloon is drained, the drainage port is often blocked, and the blockage makes it impossible to remove the catheter from the body. Special methods have to be taken to deal with it, which also brings pain to the patient. Because the capacity of the catheter balloon is too small (only 30mml), a slight leakage will cause the catheter to slip out of the body, and it needs to be replaced and inserted again, which also brings pain to the patient. Summary of the invention

[0010] The purpose of the present invention is to provide a multifunctional urinary catheter, which fundamentally solves the above problems and has the advantages of being easy to use, having strong patient compliance and having moderate flexibility.

[0011] To achieve the above-mentioned purpose, the present invention provides the following technical solutions: the multifunctional urinary catheter comprises a tube body with a whistle-shaped guide head at the proximal end, a heat shrink tube sleeved on the proximal end of the tube body, a balloon connected to the tube body at the proximal end, and a Y-shaped tube connected to the distal end of the tube body, and the technical key points are: a urine excretion channel, an injection and flushing channel and a water injection channel are arranged on both sides of the urine excretion channel in the tube body, and the outlet ends of the urine excretion channel, the injection and flushing channel, and the water injection channel are located on the Y-shaped tube; A plurality of discontinuous linear grooves in the same direction are arranged on the tube body along the circumferential direction, and a urine overflow hole connected to the urine excretion channel is arranged at the distal end of the discontinuous linear groove; A urine excretion hole is provided between the proximal end of the tube body and the whistle-shaped guide head, a heat shrink tube and a balloon connected to the tube body are provided at the distal end of the urine excretion hole, an annular groove is provided at the distal end of the heat shrink tube, and a urine overflow hole connected to the urine excretion channel is provided on the annular groove; An antibiotic overflow hole connected with the injection and flushing channel is arranged on the tube body at the far end of the heat shrink tube.

[0012] The beneficial effects of the present invention are as follows: when the urethra is infected, antibiotics can be directly injected into the urethra wall through the Y-shaped catheter without injecting antibiotics into the blood outside the body. The urethra catheter can also be retained in the human body for a long time; By providing an annular groove at the bottom of the balloon, the residual urine in the bladder can be completely discharged.

[0013] By setting up wire grooves and opening structures at different urination positions, the urine excretion holes can be prevented from being blocked by particles such as blood clots, and bladder stones and urethral stones will not be generated during catheterization.

[0014] By arranging an arc-shaped nozzle on the whistle-shaped guide head, the sprayed mist antibiotics can be sprayed to the entire inner surface of the bladder without causing postoperative bladder infection.

[0015] Through one-piece extrusion molding, the injection flushing channel and the water injection channel are separated on both sides of the urine excretion channel, which effectively increases the cross-sectional area of ​​the channels such as bladder flushing and balloon water injection, thereby greatly reducing the injection thrust.

[0016] By setting discontinuous linear grooves and selecting organic materials with better toughness, the friction coefficient is greatly reduced while ensuring the strength of the cannula. In addition, by setting discontinuous linear grooves, urethral secretions can be naturally discharged from the body. With the organic materials with higher flexibility, the cannula can be left in place for a long time while preventing the risk of urethral bacterial infection, alleviating the pain of repeated insertion and removal. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a schematic diagram of the main structure of the present invention.

[0018] Figure 2 for Figure 1 Schematic diagram of the cross-sectional structure along line AA.

[0019] Figure 3 for Figure 1 Schematic diagram of the cross-sectional structure along line BB.

[0020] Figure 4 for Figure 1 Schematic diagram of the cross-sectional structure along line CC.

[0021] Figure 5 for Figure 1 Schematic diagram of the local enlarged structure of part D in the middle.

[0022] Figure 6 for Figure 5 Schematic diagram of the structure.

[0023] Figure 7 This is a reference diagram of the use status of the present invention.

[0024] Figure 8 This is a reference diagram for cleaning the inner wall of the bladder according to the present invention.

[0025] Fig. 9 A schematic diagram of an extrusion method of the present invention. DETAILED DESCRIPTION

[0026] The following combination Figures 1 to 9 , the specific contents of the present invention are described in detail through specific embodiments. Example

[0027] like Figure 1 As shown, the multifunctional urinary catheter comprises a tube body 1 with a whistle-shaped guide head 13 at the proximal end, a heat shrink tube 4 sleeved on the proximal end of the tube body 1, and a Y-shaped tube 3 connected to the distal end of the tube body 1; The Y-shaped tube 3 includes a urine excretion channel 31, an injection and flushing channel 32 and a water injection channel 33 in the same direction as the tube body 1. The end openings of the injection and flushing channel 32 and the water injection channel 33 are supported on both sides of the end of the urine excretion channel 31 through the Y-shaped tube 3. The tube body 1 is provided with an intermittent linear groove 11, and a tissue excretion hole 111 is provided at the distal end of the intermittent linear groove 11. The tube body 1 is provided with an antibiotic overflow hole 12; in order to avoid the antibiotics being injected into the urethra, the antibiotic pressure at the overflow port is too high, which may damage the urethral mucosa or even perforate the urethra. The circular hole of the antibiotic overflow hole 12 is changed into a cutting gap of about 8 mm in length, thereby completely dispersing the pressure.

[0028] The heat shrink tube 4 is provided with an annular groove 41 and a balloon 42. The proximal end of the balloon 42 is connected and fixed to the proximal end of the heat shrink tube 4. The annular groove 41 is set at the connection position between the balloon 42 and the heat shrink tube 4. The annular groove 41 is provided with a urine overflow hole 411. The proximal end of the heat shrink tube 4 is provided with a whistle-type guide head 13; the tube body 1 between the whistle-type guide head 13 and the heat shrink tube 4 is provided with a urine excretion hole 14.

[0029] Since silicone material cannot be ground, the annular groove on the catheter body cannot be formed by grinding. If a sleeve is used to form the annular groove, the thickness of the sleeve is limited to 0.5 mm, and the R angle of 0.3 mm on both sides of the annular groove is also difficult to form, and two sleeves are required. Therefore, the balloon 42 with the annular groove 41 is directly integrally formed.

[0030] like Figure 2As shown, the injection and flushing channel 32 and the water injection channel 33 are arranged outside the urine excretion channel 31 and are arranged in parallel in the same direction in the tube body 1. The most proximal end of the urine excretion channel 31 is a whistle-shaped guide head 13. The whistle-shaped guide head 13 is provided with a urine excretion hole 14 connected to the urine excretion channel 31 at the proximal end of the balloon 42. The distal end of the balloon 42 is provided with a water injection hole 421 connected to the water injection channel 33. The distal end of the intermittent linear groove 11 is provided with a tissue excretion hole 111 connected to the urine excretion channel 31. Further, as Figure 6 As shown, the urine excretion holes 14 are arranged on both sides of the whistle-type guide head 13 in an asymmetrical manner. Specifically, the central axes of the urine excretion holes 14 on both sides are arranged non-collinearly.

[0031] like Figure 3 As shown, the urine excretion channel 31 is located in the middle of the tube body 1 , the injection and flushing channel 32 and the water injection channel 33 are respectively arranged on the outside thereof, and the antibiotic overflow hole 12 is connected to the injection and flushing channel 32 .

[0032] like Figure 4 As shown, the urine excretion channel 31 is located in the middle of the tube body 1, the injection and flushing channel 32 and the water injection channel 33 are arranged on the outside thereof, and the intermittent linear grooves 11 are arranged on the outside of the tube body 1 and are connected to the urine excretion channel 31 through the tissue excretion hole 111.

[0033] like Figure 5 As shown, the proximal end of the tube body 1 is a whistle-type guide head 13, and a urine excretion hole 14 connected to the urine excretion channel 31 is provided at the distal end of the whistle-type guide head 13. The tube body 1 is connected to the proximal ends of the heat shrink tube 4 and the balloon 42 on the rear side of the urine excretion hole 14. The distal end of the balloon 42 is provided with an annular groove 41, and the annular groove 41 is provided with a urine overflow hole 411 connected to the urine excretion channel 31.

[0034] like Figures 6 and 7 As shown, when in use, after the tube body 1 is inserted into the human urethra, the secretions produced by the urethra are squeezed into the intermittent linear grooves 11, flow along the intermittent linear grooves 11, enter the urine excretion channel 31 through the tissue excretion holes 111, and finally enter the urine recovery bag 5 outside the body, thereby realizing tissue recovery. The urethral secretions are prevented from flowing onto the tube body 1 outside the body, and there is no need to disinfect and scrub the urethral tube outside the body. The tube body 1 can stay in the human urethra for a long time, avoiding frequent intubation and removal of the tube.

[0035] An annular groove 41 is provided at a distance of 6 mm from the root of the balloon 42 of the catheter. A plurality of (two in this embodiment) urine overflow holes 411 are provided in the annular groove 41 . The urine overflow holes 411 are connected to the urine excretion channel 31 .

[0036] When in use, antibiotics are directly injected through the port of the injection and flushing channel 32. A portion of the antibiotics seep out through the antibiotic overflow hole 12 onto the inner wall of the urethra to kill bacteria and reduce inflammation, and the other portion of the antibiotics is sprayed onto the inner wall of the bladder through the whistle-shaped guide head 13.

[0037] In addition, by intermittently injecting antibiotics at the port of the injection and flushing channel 32, a clean environment of the urethra and bladder can be ensured without the need for intravenous injection of antibiotics.

[0038] By providing an annular groove 41 with a urine overflow hole 411 at the end of the balloon 42, all the residual urine in the bladder can be discharged, avoiding urine or washing liquid residue. Of course, no urine in the bladder will not produce bladder stones. After intubation, the residual urine in the bladder will slowly penetrate into the annular groove 41 along the 6mm urine infiltration section, then enter the urine overflow hole 411, and then pass through the urine excretion channel 31 to be discharged from the body. A linear groove (not marked in the figure) is provided on the bladder urine excretion hole 14 and is provided at the bottom of the linear groove.

[0039] By providing the intermittent linear grooves 11, the urethral secretions can be excreted into the urine recovery bag 5 in an organized manner, while preventing small particles such as bladder stones, urethral stones, and blood clots from blocking the urine excretion hole 14. Specifically, when the blood clot blocks the urine excretion hole 14, the urine will still flow into the urine excretion channel 31 along the linear grooves on both sides of the urine excretion hole 14. The urine entering from both ends will also cause the blood clot to swell under the impact of convection, thereby effectively preventing particles from blocking the urine excretion hole 14.

[0040] By setting up the whistle-type guide head 13, the antibiotics can be flushed to the entire inner surface of the bladder through the injection and flushing channel 32, and the aperture of the catheter balloon 42 for water injection, bladder flushing and urine excretion can be guaranteed to be unobstructed. Specifically, the whistle-type guide head 13 made of polyurethane self-skinning can reduce its Shore hardness to 45 degrees without increasing the friction coefficient. The Shore hardness of the outer epidermis (about 1mm thick) can reach more than 70, while the inner Shore hardness can be controlled below 40~45. Secondly, the epidermis is made of high brightness. The balloon 42 on the intermittent linear groove 11 catheter is formed by liquid silicone injection technology, so that the bonding surfaces on both sides of the balloon 42 are integrated with the tube body 1 to avoid leakage.

[0041] A nozzle (not marked in the figure) is provided at the upper side of the whistle-type guide head 13, and antibiotics are sprayed out in a mist form from the nozzle, which can be flushed onto all inner surfaces of the bladder to sterilize and disinfect the wound surface.

[0042] By providing the intermittent linear grooves 11 on the tube body 1, the friction resistance during insertion and removal is effectively reduced, and the flexibility of the tube body 1 is improved, and antibiotics can be directly injected into the inner wall of the urethra through the intermittent linear grooves 11. Specifically, after applying the lubricant, as the catheter is inserted, the lubricant and urethral secretions are squeezed into the intermittent linear grooves 11. During the use, the lubrication effect is always maintained as the intermittent linear grooves 11 are released. And because the intermittent linear grooves 11 are arranged along the length direction of the tube body 1, compared with the design of no grooves or annular grooves, and due to the self-deformability of the tube body 1, under the inward sliding and the squeezing effect of the inner wall of the urethra, the lubricant is always evenly distributed along the intermittent linear grooves 11. At the same time, the air in the intermittent linear grooves 11 isolates the tube body 1 from the inner wall of the urethra, thereby avoiding the generation of negative pressure, greatly reducing the friction resistance, and the friction coefficient is reduced by nearly 50% or more than that of the existing catheter.

[0043] If there is no special description in the text, the end where the whistle-shaped guide head 13 is installed is the proximal end, and the end where the Y-shaped tube 3 is installed is the distal end.

[0044] Regarding the preparation method of the urinary catheter in Example 1, it mainly comprises the following steps: Step S1, mixing the raw rubber and the modifier in proportion, cooperating with a shearing machine and a heating device to make the mixture uniform, so that the rubber molecular chain is broken and reorganized, thereby improving the physical properties and processing properties of the rubber. Modifiers, such as sulfur, diisopropylbenzene peroxide, benzoyl peroxide, organic amine compounds, melamine, dithiocarbamate accelerators, thiazole accelerators, guanidine accelerators, amine antioxidants, phenol antioxidants, organic sulfide antioxidants, etc., are used to modify the rubber to improve its processing properties.

[0045] Step S2, the refined rubber material is continuously extruded through a mold by an extruder (not shown in the figure) to obtain a tube body 1 with a consistent outer surface, which is used as the tube body 1 of the urinary catheter. The extruded tube body 1 needs to be cooled to prevent the tube body 1 from deforming during the cooling process. Usually, the tube body 1 is cooled to room temperature by water cooling, and then placed in the air for further cooling. After cooling, the tube body 1 is cut into the required length by a cutting device (such as a knife, laser or water knife).

[0046] like Fig. 9 As shown, when the discontinuous straight line groove 11 is used, the discontinuous straight line groove 11 is formed by embedding a slider that can float in the vertical direction relative to the horizontal tube body 1 in the middle of the outer sleeve of the extrusion die, and the slider is driven by a cylinder to slide inward or outward, and the cylinder is controlled by a numerical control system; However, the viscosity of the rubber compound after hot melting, the material cooling rate and other conditions limit the extrusion speed of the extruder. If the extrusion speed is too fast, the required tube body 1 with the intermittent linear grooves 11 cannot be formed as required. Under the influence of the above conditions, even if the slider is quickly pulled outward, the shortest length of the intermittent linear grooves 11 will still be ≥24mm. In practical applications, the total length of the catheter is usually fixed, and the length of the intermittent linear grooves 11 set on the tube body 1 should be ≤12mm. Under the premise of not changing the composition of the rubber compound, not changing the equipment and the extrusion speed, it can be cut into two at the corresponding position of the intermittent linear grooves 11 (the longest distance is 12mm).

[0047] Step S3, punching holes (such as tissue excretion hole 111, antibiotic overflow hole 12, urine excretion hole 14, etc.) at corresponding positions of the intermittent linear grooves 11 on the tube body 1 after cooling and cutting in step S3, which can be done by punching, laser or other punching methods.

[0048] Step S4, the distal end of the tube body 1 with holes is nested in the Y-shaped tube 3, and the heat shrink tube 4 and the balloon 42 are sequentially mounted on the proximal end of the tube body 1.

[0049] Step S5, respectively gluing and bonding the sleeve joints of the tube body 1 and the heat shrink tube 4, and the sleeve joints of the balloon 42 and the heat shrink tube 4 to ensure that the components fit tightly together.

[0050] Step S6, use a heating spray gun to heat the heat shrink tube 4 so that it shrinks and fits tightly on the tube body 1. Seal the inflation hole of the balloon 42, inflate the balloon 42 through the inflation gas source, and detect and control it through the pressure sensor and controller to ensure that the balloon 42 expands within the correct pressure range. During the inflation process, monitor the pressure and volume changes of the balloon 42 in real time to ensure that no leakage occurs under the specified pressure conditions. After the air tightness test, put the tube body 1 into hot water for vulcanization treatment for 5min~30min to promote the cross-linking reaction of the rubber molecules, thereby improving the strength, elasticity and wear resistance of the rubber, and making it more resistant to high temperature, chemical corrosion and aging.

[0051] Step S7, after the vulcanization treatment is completed, the rear edge of the whistle-shaped guide head 13 is coated with glue and bonded to the proximal end of the tube body 1 where the urine excretion hole 14 is located. After the glue is dried, the inner wall of the tube body 1 is rinsed with hot water to remove the dirt and impurities remaining in the production process. After that, the tube body 1 is placed in hot water for secondary vulcanization treatment for 5min to 30min to improve its physical properties and bonding strength. The vulcanization is preferably carried out using a water tank or steam.

[0052] Step S8, installing prefabricated valve plugs, one-way valves, one-way valve jackets, etc. on the injection and flushing channel 32 and the water injection channel 33 of the Y-shaped tube 3. After assembly, they are cleaned, bagged, and sealed to obtain a finished product.

[0053] Description of reference numerals: 1 tube body, 11 intermittent linear grooves, 111 tissue excretion holes, 12 antibiotic overflow holes, 13 whistle-type guide head, 14 urine excretion holes; 3 Y-tube, 31 urine excretion channel, 32 injection and flushing channel, 33 water injection channel; 4 heat shrink tube, 41 annular groove, 411 urine overflow hole, 42 balloon, 421 water injection hole; 5 Urine recovery bag.

Claims

1. A multifunctional urinary catheter, comprising a tube body (1) with a whistle-shaped guide head (13) at the proximal end, a heat shrink tube (4) sleeved on the proximal end of the tube body (1), a balloon (42) connected to the tube body (1) at the proximal end, and a Y-shaped tube (3) connected to the distal end of the tube body (1), characterized in that: A urine excretion channel (31), an injection and flushing channel (32) and a water injection channel (33) are provided in the tube body (1); outlet ends of the urine excretion channel (31), the injection and flushing channel (32) and the water injection channel (33) are located on the Y-shaped tube (3); A plurality of discontinuous linear grooves (11) in the same direction are arranged on the tube body (1) along the circumference thereof, and a urine overflow hole (411) connected to the urine excretion channel (31) is arranged at the distal end of the discontinuous linear grooves (11); A urine discharge hole (14) is provided between the proximal end of the tube body (1) and the whistle-shaped guide head (13); a heat shrink tube (4) and a balloon (42) connected to the tube body (1) are provided at the distal end of the urine discharge hole (14); an annular groove (41) is provided at the distal end of the heat shrink tube (4); and a urine overflow hole (411) communicating with the urine discharge channel (31) is provided on the annular groove (41); An antibiotic overflow hole (12) communicating with the injection and flushing channel (32) is provided on the tube body (1) at the far end of the heat shrink tube (4).

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