A urinary catheter with a special-shaped fixator

Abstract

The present application relates to the field of medical catheters and specifically discloses a urinary catheter with a special-shaped retainer. The urinary catheter includes a catheter body and a special-shaped retainer. The special-shaped retainer has good elasticity and is internally distributed with a shaped band and a bend and twist inducer. The urinary catheter provided by the present application uses a specially designed elastic chamber or corrugated pipe to support the elastically bent or twisted special-shaped retainer for positioning and fixation in the bladder. The deformation of the special-shaped retainer in the catheter head area can be changed according to usage needs, lowering the catheter port to adapt to the shape of the bladder, allowing urine in the bladder to be fully emptied through the catheter port along the conduction direction, reducing the probability of blockage inside the catheter, reducing the risk of damage and infection to the patient caused by frequent catheter changes, and increasing the safety and convenience of long-term indwelling catheterization.

Description

Technical Field

[0001] The present application relates to the field of medical catheters, and in particular to a urinary catheter with a special-shaped fixator. Background Art

[0002] For urinary incontinence and dysuria caused by physiological and medical factors, indwelling urinary catheters remain the primary means of alleviating urinary dysfunction and are increasingly used clinically. During this procedure, the catheter's anti-dislodgement balloon elevates the urinary opening, leading to difficulty emptying urine, concentrated urine crystals, increased endocrine secretions, and bacterial deposits, which can cause urinary tract infections and catheter blockage.

[0003] The current conventional solution to this problem is for doctors to instruct patients to drink more water and urinate more frequently to flush away sediment through urine, shorten the replacement cycle of long-term indwelling catheters, or flush the bladder regularly. These solutions are not based on the structure and usage of the catheter. Long-term indwelling catheters, due to their excessive length and deep penetration into the bladder, and the anti-detachment balloon elevating the position of the catheter port, can lead to incomplete urination. Even after some urinary stone surgeries, timely drainage of stone fragments and sediments is impossible, resulting in persistent obstruction and infection caused by residual urine, concentrated urine, crystals, bacteria, or stone deposits. Summary of the Invention

[0004] In order to improve the safety and convenience of long-term indwelling urinary catheterization, the present application provides a urinary catheter with a special-shaped fixator.

[0005] The present application provides a urinary catheter with a special-shaped fixator adopts the following technical solution:

[0006] A urinary catheter with a special-shaped fixator comprises a urinary catheter body and a special-shaped fixator arranged on the urinary catheter body;

[0007] Wherein, the urinary catheter body includes a main urinary catheterization channel and an air / liquid channel;

[0008] The special-shaped fixator comprises:

[0009] an elastic chamber located at the head and neck portion of the catheter body, the elastic chamber being connected to the inflation / liquid channel and sealed at the air / liquid inlet of the inflation / liquid channel;

[0010] a shaped belt fixed in the wall of the elastic chamber, wherein the elastic deformation of the shaped belt is smaller than the elastic deformation of the wall of the elastic chamber; and

[0011] The bending and twisting inducer is fixedly connected to the interior of the special-shaped fixator, and is used to guide the special-shaped fixator to elastically bend or twist to present a special shape after being filled with gas or liquid, and to control the degree and direction of deformation of the special-shaped fixator; the deformation of the special-shaped fixator causes the head and neck of the catheter body to bend and twist.

[0012] Furthermore, the elastic deformation of the bending-torsion inducer is smaller than the elastic deformation of the elastic chamber wall and the beam.

[0013] Furthermore, the wall surface of the elastic chamber is designed to be either a smooth annular tube or a corrugated tube or a combination of the two.

[0014] Furthermore, the cross-sectional waveform of the corrugated tube is any one of C-shape, U-shape, S-shape, square, Ω-shape, and stepped shape, or a combination of several of them.

[0015] Furthermore, the structure of the bundled belt is any one of vertical stripes, spirals, rings, diagonal stripes, and mesh stripes, or a combination of several of them.

[0016] Furthermore, one or more bending and torsion inducers divide the interior of the special-shaped fixator into one or more elastic chambers, and each elastic chamber is connected to an independent air / liquid channel.

[0017] Preferably, the bending and twisting inducer is parallel or spiral along the catheter, guiding the special-shaped fixator to bend or twist elastically during operation.

[0018] Preferably, when one or more elastic chambers are filled with gas or liquid, the bending and twisting inducer guides the special-shaped fixator to bend and twist in the corresponding direction, thereby achieving control over the degree and direction of the bending and twisting of the special-shaped fixator.

[0019] Furthermore, the catheter body is provided with a plurality of catheter openings, all of which are connected to the main catheterization channel, wherein at least one of the catheter openings is located at the end of the catheter body, and at least one of the catheter openings is located near the special-shaped fixator.

[0020] Preferably, the length of the special-shaped fixator is 20-50 mm.

[0021] Preferably, the base material of the catheter body is any one of latex, rubber, polyvinyl chloride and polyurethane, or a combination of several of them.

[0022] Preferably, the wall surface of the elastic chamber, the beam and the bending and torsion inducer are made of any one or a combination of latex, rubber and polyurethane materials.

[0023] The elastic deformation of the bending and torsion inducer is smaller than that of the elastic chamber wall and the bundle band, and can play a good guiding and supporting role in the deformation of the elastic chamber wall, guiding the control of the degree and direction of bending and torsion of the special-shaped fixator after it is filled with gas or liquid.

[0024] The ties constrain the deformation of the elastic chamber wall, thereby restricting the deformed shape of the fixator and preventing stress concentration and wall damage. Choosing the appropriate number, width, and spacing of ties helps ensure smooth bending and twisting of the elastic chamber after it is filled with gas or liquid, creating the appropriate curvature.

[0025] By inflating the elastic chamber of the shaped fixator with gas or liquid through the inflation / liquid channel, the elastic chamber bulges under the constraints of the shaped band and the bend-torsion inducer, forcing the catheter to bend or twist elastically. This expanded volume secures the shaped fixator within the bladder. Furthermore, the elastic deformation of the shaped band is minimal, limiting deformation of the elastic chamber wall. This creates an uneven surface on the bulging shaped fixator, facilitating its stable fixation within the bladder.

[0026] The head of the catheter body bends and twists along with the special-shaped retainer, thereby lowering the catheter port and adapting to the shape of the bladder, so that the urine and sediment in the bladder can be completely emptied along the conduction direction, reducing the chance of blockage in the catheter lumen, reducing the risk of damage and infection to the patient caused by frequent catheter changes, and increasing the safety and convenience of long-term indwelling catheterization.

[0027] The present application also provides a method for using the above-mentioned urinary catheter with a special-shaped fixator, comprising the following steps:

[0028] Insert the urethra through the catheter to allow the fixed device to reach the bladder.

[0029] After the elastic chamber is filled with gas or liquid through the inflation / liquid channel, it is sealed immediately, causing the wall of the elastic chamber to bulge and bend and twist into a special-shaped fixed state under the constraint and guidance of the restraint band and the bending and twisting inducer, thereby fixing the urinary catheter in the bladder and at the same time lowering the position of the catheter port to discharge urine and sediment from a low position.

[0030] Furthermore, the method further comprises the following steps: changing the degree of bulging and bending of the special-shaped fixator by controlling the amount of gas or liquid filled into the elastic chamber.

[0031] Furthermore, the method further comprises the following steps: filling gas or liquid into different elastic chambers to bend and twist the special-shaped fixator in different directions.

[0032] Preferably, the method further includes the following steps: before inserting the catheter into the urethra, applying a lubricant 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 special-shaped fixator do not react with the selected lubricant such as swelling.

[0033] In summary, this application includes at least one of the following beneficial technical effects:

[0034] 1. The shaped fixator provided herein achieves gas- or liquid-driven expansion and bending and twisting of the shaped fixator through the structural constraints and differential elastic deformation between the elastic chamber, the shaped band, and the bending and twisting inducer. By controlling the amount of gas or liquid injected, the degree of bulging, bending, and twisting of the shaped fixator can be varied. By injecting gas or liquid into different elastic chambers, the shaped fixator can be bent and twisted in different directions to accommodate different usage requirements.

[0035] 2. When the urinary catheter is fixed in the bladder, the head and neck of the urinary catheter are elastically bent or twisted by the bulging, twisting and deforming special-shaped fixator, and the urinary catheter port of the urinary catheter is depressed by the special-shaped fixator. At the same time, the deformation of the special-shaped fixator conforms to the shape of the bladder, which is conducive to the emptying of urine and sediment in the bladder, reducing the risk of obstruction and infection caused by urine residue, concentration, crystallization, bacteria or stone deposition, and increasing the safety and convenience of long-term indwelling catheterization. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 This is a schematic structural diagram of a urinary catheter with a special-shaped fixator according to an embodiment of the present application;

[0037] Figure 2 1 is a diagram showing the expansion of the elastic chamber of the special-shaped fixator and the schematic diagram of the shaped belt and the bending and torsion inducer in the embodiment of the present application, wherein:

[0038] (a) is a schematic diagram of an elastic chamber wall using a smooth annular tube, (a-1) and (a-2) are schematic diagrams of a combination of a diagonal beam and a bend-torsion inducer parallel to the tube, (a-3) is a schematic diagram of a combination of a reticular beam and a bend-torsion inducer parallel to the tube, and (a-4) is a schematic diagram of a combination of a diagonal beam and a helical bend-torsion inducer along the tube.

[0039] (b) is a schematic diagram of the elastic chamber wall using a bellows, (b-1) is a schematic diagram of the use of two cross-bending and torsion inducers, (b-2) is a schematic diagram of the beam with vertical stripes, (b-3) is a schematic diagram of the beam with diagonal stripes, and (b-4) is a schematic diagram of the use of two bending and torsion inducers to separate the elastic chamber into two independent chambers;

[0040] (c-1)-(c-6) are schematic diagrams of the bellows cross-section waveforms of C-shape, U-shape, S-shape, square shape, Ω shape, and step shape respectively;

[0041] Figure 3 : These are working effect diagrams of the special-shaped fixator in the embodiments of the present application, wherein (a) is a schematic diagram of the elastic chamber wall using a smooth annular tube, (b) is a schematic diagram of the elastic chamber wall using a corrugated tube, and (c) is a schematic diagram of the special-shaped fixator fixed in the bladder when the elastic chamber wall adopts a smooth annular tube design.

[0042] Figure numerals: 1. Special-shaped fixator; 1-1. Elastic chamber; 1-2. Tie band; 1-3. Bending and twisting inducer; 2. 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. DETAILED DESCRIPTION

[0043] The following is combined with Figure 1-3 This application is described in further detail.

[0044] The present application embodiment discloses a urinary catheter with a special-shaped fixator. Figure 1 The urinary catheter includes a urinary catheter body 2 and a special-shaped fixator 1.

[0045] Among them, reference Figure 1 The catheter body 2 includes a main catheterization channel 2-1, with a urine inlet 2-4 and a urine outlet 2-7 at either end. During use, urine enters the main catheterization channel 2-1 through the urine inlet 2-4 and is then discharged through the urine outlet 2-7. The base material of the catheter body 2 can be any one of rubber, polyvinyl chloride, and polyurethane, or a combination thereof.

[0046] Reference Figure 1 The two sides of the main catheterization channel 2-1 are respectively provided with a flushing and injection channel 2-3 and an inflation / liquid channel 2-2, the two ends of the flushing and injection channel 2-3 are respectively provided with a flushing and injection inlet 2-9 and a flushing and injection outlet 2-6, and the two ends of the inflation / liquid channel 2-2 are respectively provided with an inflation / liquid inlet 2-8 and an inflation / liquid outlet 2-5.

[0047] Reference Figure 1 and Figure 2In (a), the shaped fixator 1 includes an elastic chamber 1-1, a shaped band 1-2, and a bend-torsion inducer 1-3. The shaped band 1-2 and the bend-torsion inducer 1-3 are all elastic, and the elastic deformation of the walls of the elastic chamber 1-1, the shaped band 1-2, and the bend-torsion inducer 1-3 decreases in sequence. The walls of the elastic chamber 1-1, the shaped band 1-2, and the bend-torsion inducer 1-3 can be made of any one or a combination of latex, rubber, or polyurethane, and should not undergo swelling reactions with the selected lubricant (any one or a combination of silicone lubricants, gels, water-based lubricants, and polyvinyl alcohol lubricants) that would affect their elastic properties.

[0048] Specifically, such as Figure 2 As shown in (a) and (b), the wall of the elastic chamber 1-1 is either a smooth annular tube or a bellows tube or a combination of the two, as shown in FIG. Figure 2 As shown in (c-1) to (c-6), the cross-sectional waveform of the bellows is any one of C-shape, U-shape, S-shape, square, Ω-shape, and stepped shape, or a combination of several of them.

[0049] Reference Figure 1 The elastic chamber 1-1 is sealed at the head and neck of the catheter body 2. The wall of the elastic chamber 1-1 is the wall of the catheter body or the elastic wall bonded to the outside of the catheter body 2. The inflation / liquid outlet 2-5 is provided in the elastic chamber and is connected to the inflation / liquid channel 2-2 on the catheter body 2 and is sealed at the inflation / liquid interface 2-8.

[0050] Reference Figure 1 and Figure 2 The shaped strap 1-2 comprises multiple straps fixed within the wall of the elastic chamber 1-1. Each strap extends circumferentially along the wall of the elastic chamber 1-1. The straps are arranged equidistantly along the axial direction of the elastic chamber 1-1. The shaped strap 1-2 may have any one of vertical, spiral, annular, diagonal, or reticular patterns, or a combination thereof.

[0051] Reference Figure 1 and Figure 2 One or more bending and twisting inducers 1-3 are provided, and the bending and twisting inducers 1-3 are fixed between the wall surface of the elastic chamber 1-1 and the outer wall of the catheter body 2, so that one or more elastic chambers 1-1 are formed between the special-shaped fixator 1 and the catheter body 2, and each elastic chamber 1-1 is respectively connected to an independent inflation / liquid channel 2-2.

[0052] After filling the elastic chamber 1-1 with gas or liquid through the inflation / liquid channel 2-2 and promptly sealing it, the shaped fixator 1, constrained by the shaped band 1-2 and the bend inducer 1-3, elastically bends and twists into a shaped balloon with an uneven surface, thereby securing the shaped fixator within the bladder. Simultaneously, the head and neck of the catheter body 2 bend and twist with the shaped fixator, thereby lowering the catheter port 2-4 and adapting to the shape of the bladder. This facilitates the emptying of urine and sediment within the bladder, reduces the risk of obstruction and infection caused by residual urine, concentrated urine, crystals, bacteria, or stone deposits, and reduces the risk of injury and infection to the patient caused by frequent catheter changes, thereby increasing the safety and convenience of long-term indwelling catheterization.

[0053] Reference Figure 1 and Figure 3 When the bend and twist inducer 1-3 is set to a line segment parallel to the catheter, the bend and twist inducer 1-3 and the catheter opening 2-4 at the end of the catheter body 2 are located on the same side of the catheter axis. When the special-shaped fixator 1 is directional-bent toward the side where the bend and twist inducer 1-3 is located, the head and neck of the catheter are bent, fixed and the position of the catheter opening 2-4 is lowered, so that urine in the bladder is discharged from a low position.

[0054] Reference Figure 1 and Figure 3 When the bending and twisting inducer 1-3 is set as a spiral line segment spiraling along the catheter, when the special-shaped fixator 1 is twisted toward the position where the bending and twisting inducer 1-3 is located, the head and neck of the catheter are twisted, fixed and the position of the catheter port 2-4 is lowered.

[0055] When the bending and torsion inducers 1-3 are provided in multiple pieces, for example, two pieces are provided, such as Figure 2 As shown in (b-4), two bend and twist inducers 1-3 separate the space between the shaped fixator 1 and the catheter body 2 into two independent elastic chambers 1-1, symmetrically located on either side of the catheter body 2's axis. Accordingly, two air / liquid channels 2-2 are provided, each communicating with a corresponding elastic chamber 1-1. By introducing liquid or gas into different elastic chambers 1-1, the shaped fixator 1 can be bent in different directions.

[0056] The length of the special-shaped fixator 1 is 20-50 mm. In order to ensure that the special-shaped fixator 1 is smoothly bent and twisted and has a suitable curvature, the number of straps or the number of corrugations of the corrugated tube is not less than 10.

[0057] Further, there are multiple urinary catheter ports 2-4, as an example, refer to Figure 1 and Figure 3 There are two urinary catheter ports 2-4, one of which is located at the end of the urinary catheter body 2, and the other is located near the special-shaped fixator 1. Figure 3 As shown in (c), when the special-shaped fixator 1 is fixed in the bladder, the catheter opening 2-4 at the end of the catheter body 2 is depressed as the special-shaped fixator 1 is deformed; the catheter opening 2-4 located near the special-shaped fixator 1 remains at a low position in the bladder. The two catheter openings 2-4 work together to achieve a urinary catheterization effect, which is beneficial for the discharge of urine in the bladder from a low position.

[0058] The following is a description of the processing and use of a urinary catheter using specific examples:

[0059] Example 1

[0060] In this embodiment, the walls of the elastic chamber 1-1 are made of latex, while the sash 1-2 and the bend-torsion inducer 1-3 are made of silicone rubber with varying elasticity. The elasticity of the walls of the elastic chamber 1-1, the sash 1-2, and the bend-torsion inducer 1-3 decreases in sequence. During processing, the sash 1-2 is positioned in a mold, latex is injected, and the mold is formed. After cutting to a desired length, the elastic tube that secures the sash 1-2 within the wall is obtained.

[0061] The catheter body 2 is made of silicone rubber and manufactured using extrusion and injection molding processes. It features a catheter port 2-4, an air / liquid outlet 2-5, and an irrigation and injection outlet 2-6. The shaped retainer 1 is placed over the catheter body 2. The elastic tube with the shaped band 1-2 is then shaped through a bend inducer 1-3 and bonded to the outer wall of the catheter body 2, creating a specifically shaped elastic chamber 1-1 connected to the corresponding air / liquid channel 2-2, completing the design of the shaped retainer 1.

[0062] In this embodiment, the wall of the elastic chamber 1-1 is designed as a smooth annular tube, 50 mm long. The inner diameter of the smooth annular tube is 1 mm larger than the outer diameter of the catheter body 2. The shaped band 1-2 consists of multiple parallel vertical stripes, each 0.5 mm wide, with a 1 mm interval between adjacent parallel stripes. The bend and torsion inducer 1-3 is a line segment approximately 50 mm long, parallel to the catheter.

[0063] Using a urinary catheter involves the following steps:

[0064] Step 1: Apply a proper amount of silicone oil lubricant on the outer wall of the catheter, and insert the catheter along the urethra to allow the special-shaped fixator 1 to reach the bladder.

[0065] Step 2: Fill the elastic chamber 1-1 between the special-shaped fixator 1 and the urinary catheter body 2 with air or sterile saline through the air / liquid channel 2-2, so that the special-shaped fixator 1 swells and is directional-bent and twisted into a special shape (such as Figure 3As shown in a in the figure, the volume of the shaped fixator 1 after swelling is larger than the internal opening of the urethra, thereby fixing it in the bladder. When the shaped fixator 1 undergoes elastic bending and twisting deformation, the head and neck of the catheter are bent and twisted, and the catheter opening 2-4 is bent and twisted toward the side where the bending and twisting inducer 1-3 is located (as shown in a in the figure). Figure 3 As shown in c in the figure, the position of the urinary catheter 2-4 is pressed down to discharge the urine from the lower position.

[0066] Step 3: When the special-shaped fixator 1 needs to be removed from the bladder, the gas or liquid in the elastic chamber 1-1 is discharged from the gas / liquid inlet 2-8. The elastic chamber 1-1 contracts and becomes smaller due to the elasticity of its own wall surface. At the same time, the bend-twist inducer 1-3 returns to its straight position due to its own elasticity, thereby releasing the fixation of the special-shaped fixator 1 in the bladder.

[0067] Example 2

[0068] The difference from Example 1 is that the elastic chamber 1-1, the tie belt 1-2 and the bending and torsion inducer 1-3 in Example 2 are respectively made of silicone rubber with different elasticity, and the elastic deformation of the wall of the elastic chamber 1-1, the tie belt 1-2 and the bending and torsion inducer 1-3 decreases successively; the catheter body 2 is made of natural rubber.

[0069] The wall of the elastic chamber 1-1 is a 40 mm long bellows with a C-shaped cross-section. The inner diameter of the bellows is 2 mm larger than the outer diameter of the catheter body 2, and the number of corrugations is greater than 10. The sash 1-2 consists of multiple parallel vertical stripes, each 0.5 mm wide, with a 1 mm interval between adjacent strips. The bend and torsion inducer 1-3 is a spiral segment that winds along the catheter for nearly a full revolution.

[0070] The method of using the urinary catheter is the same as that in Example 1.

[0071] The above are all preferred embodiments of the present application, and are not intended to limit the scope of protection of the present application. Therefore, any equivalent changes made based on the structure, shape, and principle of the present application should be included in the scope of protection of the present application.

Claims

1. A urinary catheter with a special-shaped retainer, characterized in that: It includes a urinary catheter body and a special-shaped fixator arranged on the urinary catheter body; Wherein, the urinary catheter body includes a main urinary catheterization channel and an air / liquid channel; The special-shaped fixator comprises: an elastic chamber located at the head and neck portion of the catheter body, the elastic chamber being connected to the inflation / liquid channel and sealed at the air / liquid inlet of the inflation / liquid channel; a shaped belt fixed in the wall of the elastic chamber, wherein the elastic deformation of the shaped belt is smaller than the elastic deformation of the wall of the elastic chamber; and The bending and twisting inducer is fixedly connected to the interior of the special-shaped fixator, and is used to guide the special-shaped fixator to elastically bend or twist to present a special shape after being filled with gas or liquid, and to control the degree and direction of deformation of the special-shaped fixator; the deformation of the special-shaped fixator causes the head and neck of the catheter body to bend and twist.

2. The urinary catheter with a special-shaped fixator according to claim 1, characterized in that: The elastic deformation of the bending-torsion inducer is smaller than the elastic deformation of the elastic chamber wall and the beam.

3. The urinary catheter with a special-shaped fixator according to claim 2, characterized in that: The wall surface of the elastic chamber is designed to be either a smooth annular tube or a corrugated tube or a combination of the two.

4. The urinary catheter with a special-shaped fixator according to claim 3, characterized in that: The cross-sectional waveform of the corrugated tube is any one of C-shape, U-shape, S-shape, square, Ω-shape and stepped shape or a combination of several of them.

5. The urinary catheter with a special-shaped fixator according to claim 1, characterized in that: The structure of the bundled belt is any one of vertical stripes, spirals, rings, diagonal stripes, and mesh stripes, or a combination of several of them.

6. The urinary catheter with a special-shaped fixator according to claim 1, characterized in that: One or more bending and torsion inducers divide the interior of the special-shaped fixator into one or more elastic chambers, and each elastic chamber is connected to an independent air / liquid channel.

7. The urinary catheter with a special-shaped fixator according to claim 1, characterized in that: The catheter body is provided with a plurality of catheter openings, all of which are connected to the main catheterization channel, wherein at least one of the catheter openings is located at the end of the catheter body, and at least one of the catheter openings is located near the special-shaped fixator.

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