A quick-install artificial urinary sphincter system

Abstract

The invention discloses a quick-install artificial urethral sphincter system, comprising an extrusion assembly arranged on the urethra. The quick-install artificial urethral sphincter system locks and unlocks the first locking block and the second locking block in the locking component, so that the urethra is placed in the cavity formed by the shell, two telescopic tubes and the locking component, and the urethra is squeezed by the extrusion assembly to close the urine and release the pressure to urinate. The whole process does not require the urethra to be cut off to achieve the installation of the extrusion assembly, which is convenient and fast, and reduces the difficulty of the operation; through the cooperation between the internal control assembly and the external controller, the patient can urinate by himself; and the patient can adjust the pressure value of the extrusion assembly squeezing the urethra according to his own situation, and set the pressure value through the external controller to achieve a good effect of closing the urine, and prevent excessive compression of the urethra and accelerate urethral atrophy.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to a quick-install artificial urethral sphincter system. Background Art

[0002] A sphincter is a circular muscle distributed in the walls of certain lumens in humans and animals, and is often particularly thickened. The human body's sphincters are commonly found in the digestive tract and urinary system, and they maintain the body's normal functions and control the opening and closing of the lumens mainly through contraction and relaxation. The internal urethral sphincter is located at the junction of the urethra and the bladder. When it contracts, it can close the internal urethral opening to prevent urine from leaking out. The membranous part of the urethra (urogenital diaphragm) has a urethral sphincter, which is composed of striated muscle and is controlled by consciousness.

[0003] For the treatment of urinary incontinence, bladder training, Kegel training, electrical stimulation and drugs are often used clinically. Bladder training requires patients to change their habits of fluid intake and urination in order to achieve the purpose of regular urination. It is difficult for patients to persist in training and it is difficult to achieve the expected treatment effect. The problem of urinary incontinence is not fundamentally solved. Kegel training and electrical stimulation require regular pelvic muscle training under the guidance of a doctor. The treatment cycle is long and the cure rate is low. Drug treatment is only suitable for patients with mild urinary incontinence. Oxybutynin and tolterodine are commonly used, both of which are anticholinergic and antimuscarinic drugs. In addition, the administration method of oxybutynin is controversial, and its mechanism of action in relaxing smooth muscles is still unclear, and it also has side effects on the human body. In addition to the above methods, the AMS 800 artificial urinary sphincter system has become the gold standard for treating various moderate to severe urinary incontinence and true urinary incontinence caused by various sphincter dysfunction. However, due to its fixed cuff size, it has poor matching with the patient's urethra; the pressure of the balloon and cuff is certain before use, and the risk of atrophy or necrosis of the urethra due to long-term compression cannot be avoided. Summary of the invention

[0004] The purpose of the present invention is to solve the problems raised in the background technology and to provide a quick-install artificial urinary sphincter system.

[0005] To achieve the above object, the technical solution adopted by the present invention is:

[0006] The present invention provides a quick-install artificial urinary sphincter system, comprising an extrusion assembly arranged on the urethra, wherein:

[0007] The squeezing assembly includes a shell, a driving assembly, a traction rope, a locking component and two telescopic tubes, and a spring arranged on the outside of each telescopic tube. The driving assembly is arranged in the shell, the top end of each telescopic tube is fixedly connected to the bottom of the shell, and the bottom end is connected to the locking component. The traction rope is arranged on the driving assembly, and the two ends respectively pass through the two telescopic tubes and are connected to the locking component. Each spring has an elastic force to extend toward the two ends, so that the urethra is placed in a cavity formed by the shell, the two telescopic tubes and the locking component. The traction rope is tightly wound by the driving assembly, and the locking component is driven to move in a direction close to the shell under the action of the contraction of the telescopic tube, so as to apply pressure to the urethra to achieve urine retention. The traction rope is released by the driving assembly, and the locking component is driven to move in a direction away from the shell under the action of the spring, so as to release the pressure on the urethra to urinate.

[0008] Preferably, the driving assembly includes a motor and a drum, the base of the motor is connected to the inner wall of the shell, one end of the drum is installed to the output end of the motor, and the other end is rotatably connected to the inner wall of the shell, and the side wall of the drum is provided with a first channel along the cross-sectional direction. After the traction rope passes through the first channel, the two ends respectively pass through two telescopic tubes and are connected to the locking component.

[0009] Preferably, two support blocks are provided inside the shell, and each of the support blocks and the shell is provided with an avoidance channel. After the traction rope passes through the first channel, both ends pass through the corresponding avoidance channel and telescopic tube respectively, and then are connected to the locking component.

[0010] Preferably, the telescopic tube comprises a first guide cylinder, a second guide cylinder and a third guide cylinder which are arranged in sequence, the first guide cylinder is slidably inserted in the second guide cylinder, and the top end of the first guide cylinder is fixedly connected to the bottom of the shell, the second guide cylinder is slidably inserted in the third guide cylinder, and the bottom end of the third guide cylinder is connected to the locking component;

[0011] The bottom of the first guide cylinder and the second guide cylinder are both provided with a limit block, the top of the second guide cylinder and the third guide cylinder are both provided with a stop wall, and the limit block on the first guide cylinder cooperates with the stop wall on the second guide cylinder to prevent the first guide cylinder from detaching from the second guide cylinder, and the limit block on the second guide cylinder cooperates with the stop wall on the third guide cylinder to prevent the second guide cylinder from detaching from the third guide cylinder.

[0012] Preferably, the extrusion assembly also includes a limiting cylinder, the top end of which is fixedly connected to the bottom of the shell, and after the top end of the spring is inserted into the limiting cylinder, it abuts against the bottom of the shell, and the bottom end of the spring abuts against the top of the third guide cylinder.

[0013] Preferably, the locking component includes a first locking block, a second locking block and a clamping column, the bottom ends of the two third guide cylinders are respectively fixedly connected to the first locking block and the second locking block, and the two ends of the traction rope are respectively connected to the first locking block and the second locking block after passing through the telescopic tube, the first locking block is provided with a wedge block, the second locking block is provided with a through groove corresponding to the wedge block, and the first locking block is provided with a second channel, the second locking block is provided with a third channel connected to the through groove, and the clamping column is slidably inserted in the second channel and the third channel.

[0014] Preferably, the thickness of the side of the wedge block away from the first locking block is greater than the thickness of the side of the wedge block close to the first locking block, and the shape of the through groove corresponds to the shape of the wedge block.

[0015] Preferably, a silicone sleeve is sleeved between the outer wall of the limiting cylinder and the third guide cylinder, and a silicone pad is provided at the bottom of the shell and the top of the second locking block.

[0016] Preferably, a permanent magnet and a rotation sensor are provided on the reel, and a pressure sensor is provided at the bottom of the shell corresponding to the urethra.

[0017] Preferably, the quick-install artificial urinary sphincter system further comprises an in-vivo control component and an in-vivo controller, wherein the in-vivo control component comprises a wireless communication module, a signal processing module, a motor control module, a rotation module and a pressure module, and the quick-install artificial urinary sphincter system controls the pressure value of the urethra during urine closure through the in-vivo control component and the in-vivo controller, and is executed according to the following steps:

[0018] S1. The external controller sets a preset pressure value of the urethra and transmits it to the signal processing module through the wireless communication module;

[0019] S2, the signal processing module calculates the preset angle that the motor needs to rotate from the preset initial position according to the preset pressure value;

[0020] S3, the signal processing module obtains a first angle by subtracting the preset angle from the current angle of the motor relative to the preset initial position, and controls the motor to rotate to a corresponding angle through the motor control module according to the first angle; wherein the signal processing module is further used to memorize the angle of each rotation of the motor and calculate the current angle of the motor relative to the preset initial position;

[0021] S4, after the motor rotates, the signal processing module obtains the actual angle of the motor rotation monitored by the rotation sensor through the rotation module, calculates the current angle of the motor relative to the preset initial position, and determines whether the current angle of the motor relative to the preset initial position is equal to the preset angle. If not, repeat S3-S4 until the current angle of the motor relative to the preset initial position is equal to the preset angle;

[0022] S5. If the current angle of the motor relative to the preset initial position is equal to the preset angle, the signal processing module obtains the actual pressure value of the urethra monitored by the pressure sensor through the pressure module, and determines whether the actual pressure value is equal to the preset pressure value. If they are equal, the control of the urethra pressure value is completed;

[0023] S6, if the actual pressure value is not equal to the preset pressure value, the signal processing module calculates the second angle that the motor needs to rotate according to the difference between the actual pressure value and the preset pressure value, and controls the motor to rotate a corresponding angle through the motor control module according to the second angle, and then repeats S4-S6 until the actual pressure value is equal to the preset pressure value, thereby completing the control of the urethral pressure value;

[0024] The signal processing module calculates the preset angle that the motor needs to rotate from the preset initial position according to the preset pressure value, and the signal processing module calculates the angle that the motor needs to rotate according to the difference between the actual pressure value and the preset pressure value. The calculation formula is as follows:

[0025] ;

[0026] in, , and All represent preset coefficients. When the preset pressure value is When calculating the preset angle that the motor needs to rotate from the preset initial position, Indicates the preset pressure value, Indicates the preset angle. When the angle that the motor needs to rotate is calculated based on the difference between the actual pressure value and the preset pressure value, Indicates the difference between the actual pressure value and the preset pressure value. Indicates the second angle that the motor needs to rotate.

[0027] Compared with the prior art, the present invention has the following beneficial effects:

[0028] 1. The quick-install artificial urinary sphincter system locks and unlocks the first locking block and the second locking block in the locking component, so that the urethra is placed in the cavity formed by the housing, the two telescopic tubes and the locking component, and the urethra is squeezed by the squeezing component to close the urine and release the pressure to urinate. The whole process does not require the urethra to be cut off to achieve the installation of the squeezing component, which is convenient and fast, and reduces the difficulty of the operation;

[0029] 2. This quick-install artificial urinary sphincter system enables patients to urinate on their own through the cooperation between the internal control components and the external controller; and the patient can adjust the pressure value of the squeezing component to squeeze the urethra according to his own situation, and set the pressure value through the external controller to achieve a good urine retention effect and prevent excessive compression of the urethra and accelerate urethral atrophy. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 It is a schematic diagram of the combination of the quick-install artificial urinary sphincter system of the present invention and the urethra;

[0031] Figure 2 It is a schematic diagram of the structure of the extrusion assembly of the present invention;

[0032] Figure 3 is a cross-sectional view of an extrusion assembly of the present invention;

[0033] Figure 4 It is a schematic diagram of the structure of the driving assembly of the present invention;

[0034] Figure 5 It is a partial schematic diagram of the extrusion assembly of the present invention;

[0035] Figure 6 It is a structural schematic diagram of the locking component of the present invention;

[0036] Figure 7 is a cross-sectional view of the locking component of the present invention;

[0037] Figure 8 is a module block diagram of the in vivo control component of the present invention;

[0038] Fig. 9 This is a schematic diagram of the urethra-closing state of the squeezing assembly of the present invention;

[0039] Fig.10 It is a schematic diagram of the state in which the squeezing assembly of the present invention enables the urethra to urinate.

[0040] Description of reference numerals:

[0041] 1. Urethra; 2. Extrusion assembly; 21. Shell; 22. Drive assembly; 221. Motor; 222. Reel; 223. First channel; 23. Traction rope; 24. Locking component; 241. First locking block; 242. Second locking block; 243. Clamping column; 244. Wedge block; 245. Through groove; 246. Second channel; 247. Third channel; 25. Telescopic tube; 251. First guide cylinder; 252. Second guide cylinder; 253. Third guide cylinder; 254. Limit block; 255. Retaining wall; 26. Spring; 27. Support block; 28. Limit cylinder; 3. Silicone sleeve; 4. Silicone pad; 5. In-vivo control assembly; 6. In-vivo controller; 7. Bladder; 8. Human skin; 9. Wireless charger. DETAILED DESCRIPTION

[0042] In order to make the purpose, technical solution and advantages of the present application more clearly understood, the present application is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and are not used to limit the present application.

[0043] like Figure 1-Figure 10 As shown, a quick-install artificial urinary sphincter system is provided, comprising an extrusion assembly 2 arranged on a urethra 1, wherein:

[0044] The squeezing assembly 2 comprises a shell 21, a driving assembly 22, a traction rope 23, a locking component 24 and two telescopic tubes 25, and a spring 26 arranged on the outside of each telescopic tube 25. The driving assembly 22 is arranged in the shell 21, the top end of each telescopic tube 25 is fixedly connected to the bottom of the shell 21, and the bottom end is connected to the locking component 24. The traction rope 23 is arranged on the driving assembly 22, and the two ends respectively pass through the two telescopic tubes 25 and are connected to the locking component 24, and each spring 26 has an elastic force to extend toward the two ends, so that the urethra 1 is placed in a cavity formed by the shell 21, the two telescopic tubes 25 and the locking component 24. The traction rope 23 is tightly wound by the driving assembly 22, and the locking component 24 is driven to move in a direction close to the shell 21 under the action of the contraction of the telescopic tube 25, so as to apply pressure to the urethra 1 to achieve urine retention, and the traction rope 23 is released by the driving assembly 22, and the locking component 24 is driven to move in a direction away from the shell 21 under the action of the spring 26, so as to release the pressure on the urethra 1 to urinate.

[0045] like Figure 1 , Figure 3 and Figure 5 As shown, it should be noted that, in this embodiment, the shell 21 and the locking component 24 are both implant-grade titanium alloy / stainless steel shells, the shell 21 includes an upper shell and a base, the two can be fixed by laser welding, the driving component 22 is installed on the base, the top ends of the two telescopic tubes 25 are fixedly connected to the bottom of the base, and the bottom ends of the two telescopic tubes 25 are fixedly connected to the locking component 24, the traction rope 23 is arranged on the driving component 22, and the two ends respectively pass through the two telescopic tubes 25 and are fixedly connected to the locking component 24, the spring 26 is in a compressed state, and by opening the locking component 24, the traction rope 23 is fixedly connected to the locking component 24. The urethra 1 is placed in the cavity formed by the housing 21, two telescopic tubes 25 and the locking component 24. The traction rope 23 is wound tightly by the driving component 22. Under the action of the contraction of the telescopic tube 25 (the spring 26 is further compressed at this time), the locking component 24 is driven to move in the direction close to the housing 21 (i.e., upward movement), and pressure is applied to the urethra 1 to achieve urine retention. The traction rope 23 is released by the driving component 22, and the locking component 24 is driven to move in the direction away from the housing 21 (i.e., downward movement) under the action of the restoring force of the spring 26, and the pressure on the urethra 1 is released to urinate. Figure 1The example is only for the convenience of description and is not limited to a specific position. The telescopic tube 25 is hollow and has a through hole.

[0046] like Figure 4 As shown, in one embodiment, the driving assembly 22 includes a motor 221 and a reel 222. The base of the motor 221 is connected to the inner wall of the housing 21. One end of the reel 222 is mounted to the output end of the motor 221, and the other end is rotatably connected to the inner wall of the housing 21. A first channel 223 is provided on the side wall of the reel 222 along the cross-sectional direction. After the traction rope 23 passes through the first channel 223, the two ends of the traction rope respectively pass through two telescopic tubes 25 and are connected to the locking component 24.

[0047] Two support blocks 27 are provided inside the shell 21 , and each support block 27 and the shell 21 are provided with an escape channel. After the traction rope 23 passes through the first channel 223 , both ends pass through the corresponding escape channel and the telescopic tube 25 respectively, and then are connected to the locking component 24 .

[0048] It should be noted that the base of the motor 221 is fixedly connected to the base of the housing 21, one end of the reel 222 is fixedly connected to the output end of the motor 221, and the other end of the reel 222 is rotatably connected to the side wall of the housing 21 (can be matched by a bearing), and two support blocks 27 are fixedly connected to the base of the housing 21 and are located on both sides of the reel 222. In this embodiment, the support block 27 is triangular in shape, but other forms of support blocks 27 can also be used. The support block 27 and the base of the housing 21 are both provided with avoidance channels for the traction rope 23 to pass through, wherein there are two avoidance channels on the base, corresponding to the two extension channels on the base. The parts of the contraction tube 25 are all provided with avoidance channels, the traction rope 23 passes through the first channel 223 (roughly the middle part of the traction rope 23 is located in the first channel 223), and then the two ends of the traction rope 23 respectively pass through the avoidance channels on the two support blocks 27 one by one, and then pass through the avoidance channels on the base and the inside of the telescopic tube 25 one by one, and then are fixedly connected with the locking component 24; wherein, a hose is also fixedly installed in the first channel 223, and the traction rope 23 passes through the hose in the first channel 223, thereby isolating the traction rope 23 from direct contact with the edge of the hole of the first channel 223, thereby preventing the traction rope 23 from wearing too quickly and causing breakage.

[0049] like Figure 3 As shown, in one embodiment, the telescopic tube 25 includes a first guide cylinder 251, a second guide cylinder 252 and a third guide cylinder 253 which are sequentially arranged, the first guide cylinder 251 is slidably inserted in the second guide cylinder 252, and the top end of the first guide cylinder 251 is fixedly connected to the bottom of the housing 21, the second guide cylinder 252 is slidably inserted in the third guide cylinder 253, and the bottom end of the third guide cylinder 253 is connected to the locking component 24;

[0050] The bottom of the first guide cylinder 251 and the second guide cylinder 252 are both provided with a limit block 254, and the top of the second guide cylinder 252 and the third guide cylinder 253 are both provided with a stop wall 255, and the limit block 254 on the first guide cylinder 251 cooperates with the stop wall 255 on the second guide cylinder 252 to prevent the first guide cylinder 251 from separating from the second guide cylinder 252, and the limit block 254 on the second guide cylinder 252 cooperates with the stop wall 255 on the third guide cylinder 253 to prevent the second guide cylinder 252 from separating from the third guide cylinder 253.

[0051] It should be noted that the top of the first guide cylinder 251 is fixedly connected to the bottom of the base of the shell 21, and the bottom of the third guide cylinder 253 is fixedly connected to the locking component 24. The first guide cylinder 251, the second guide cylinder 252 and the third guide cylinder 253 are all hollow. The first guide cylinder 251 and the second guide cylinder 252 slide relatively, and the second guide cylinder 252 and the third guide cylinder 253 slide relatively. The limit blocks 254 at the bottom of the first guide cylinder 251 and the second guide cylinder 252 are integrally formed with the corresponding guide cylinder, and the width of each limit block 254 is greater than the width of the corresponding guide cylinder (that is, the width of the limit block 254 at the bottom of the first guide cylinder 251 is greater than the width of the first guide cylinder 251, and the limit block 254 at the bottom of the second guide cylinder 252 is greater than the width of the first guide cylinder 251). 54 is greater than the width of the second guide cylinder 252), both side walls of the second guide cylinder 252 (or the third guide cylinder 253) are provided with a straight-line retaining wall 255, and each retaining wall 255 is integrally formed with the inner wall of the second guide cylinder 252 (or the third guide cylinder 253) and points to the inside of the second guide cylinder 252 (or the third guide cylinder 253). During the relative sliding process between the first guide cylinder 251 and the second guide cylinder 252, specifically, the side wall of the first guide cylinder 251 and the two retaining walls 255 on the second guide cylinder 252 slide relative to each other, and during the relative sliding process between the second guide cylinder 252 and the third guide cylinder 253, specifically, the side wall of the second guide cylinder 252 and the two retaining walls 255 on the third guide cylinder 253 slide relative to each other.

[0052] In one embodiment, the quick-install artificial urinary sphincter system also includes a limiting cylinder 28, the top of which is fixedly connected to the bottom of the shell 21. After the top of the spring 26 is inserted into the limiting cylinder 28, it abuts against the bottom of the shell 21, and the bottom end of the spring 26 abuts against the top of the third guide cylinder 253.

[0053] It should be noted that the top end of the limiting cylinder 28 is fixedly connected to the bottom of the base of the shell 21, the spring 26 is sleeved on the outside of the three guide cylinders, and the top end of the spring 26 is against the bottom of the base of the shell 21, and the bottom end of the spring 26 is against the top of the third guide cylinder 253 (specifically, the retaining wall 255 of the third guide cylinder 253). After installation, the spring 26 is in a compressed state, and the limiting cylinder 28 is located on the outside of the spring 26, and is used to limit the spring 26 in the left and right directions.

[0054] When the motor 221 rotates to wind the traction rope 23, the traction rope 23 pulls the locking component 24 to move upward, and while the locking component 24 moves upward, the first guide cylinder 251 and the second guide cylinder 252 slide relative to each other, and the second guide cylinder 252 and the third guide cylinder 253 slide relative to each other, so that the entire telescopic tube 25 shortens upward, and the spring 26 is further compressed, and the locking component 24 and the base of the shell 21 squeeze the urethra 1 to achieve urine retention; when the motor 221 rotates to release the traction rope 23, under the action of the restoring force of the spring 26, the first guide cylinder 251 and the second guide cylinder 252 slide relative to each other, and the second guide cylinder 252 and the third guide cylinder 253 slide relative to each other, so that the entire telescopic tube 25 extends downward, and the locking component 24 moves downward, and the locking component 24 and the base of the shell 21 release the pressure on the urethra 1 to achieve urination.

[0055] like Figure 6-Figure 7 As shown, in one embodiment, the locking component 24 includes a first locking block 241, a second locking block 242 and a clamping column 243, the bottom ends of the two third guide cylinders 253 are respectively fixedly connected to the first locking block 241 and the second locking block 242, and the two ends of the traction rope 23 are respectively connected to the first locking block 241 and the second locking block 242 after passing through the telescopic tube 25, the first locking block 241 is provided with a wedge block 244, the second locking block 242 is provided with a through groove 245 corresponding to the wedge block 244, and the first locking block 241 is provided with a second channel 246, and the second locking block 242 is provided with a third channel 247 connected with the through groove 245, and the clamping column 243 is slidably inserted in the second channel 246 and the third channel 247;

[0056] The thickness of the side of the wedge block 244 away from the first locking block 241 is greater than the thickness of the side of the wedge block 244 close to the first locking block 241 , and the shape of the through slot 245 corresponds to the shape of the wedge block 244 .

[0057] It should be noted that the two ends of the traction rope 23 are fixedly connected to the first locking block 241 and the second locking block 242 respectively, the wedge block 244 is fixed to the right side of the first locking block 241 (the two can be integrally formed or designed in a split manner), and a through groove 245 is provided on the left side of the second locking block 242. The shape of the through groove 245 corresponds to the shape of the wedge block 244, and the specific shape is not limited. The thickness of the right side of the wedge block 244 is greater than the thickness of the left side, then the thickness of the right side of the through groove 245 is greater than the thickness of the left side, and a second channel 246 is provided in the first locking block 241 (the second channel 246 extends from the first locking block 241 to the wedge block 244), and a third channel 247 is provided in the second locking block 242 (the third channel 247 is connected to the through groove 245), and the clamping column 243 is inserted into the second channel 246 and the third channel 247 from the outside in sequence. When the first locking block 241 and the second locking block 242 need to be locked, the wedge block 244 is first inserted into the through slot 245 along the front-to-back direction (the wedge block 244 is slidably connected with the through slot 245) to limit the first locking block 241 and the second locking block 242 in the up-and-down direction, and then the clamping column 243 is inserted into the second channel 246 and the third channel 247 in sequence to limit the first locking block 241 and the second locking block 242 in the front-to-back direction, thereby locking the first locking block 241 and the second locking block 242; when the first locking block 241 and the second locking block 242 need to be unlocked, the clamping column 243 is first pulled out from each channel, and then the wedge block 244 and the through slot 245 are slid away from each other along the front-to-back direction, thereby unlocking the first locking block 241 and the second locking block 242. In order to facilitate the operation of the clamping column 243, an auxiliary hole is provided at the right end of the clamping column 243, so that the clamping column 243 can be inserted into or removed from the channel by connecting the auxiliary hole with the help of a tool.

[0058] By locking or unlocking the first locking block 241 and the second locking block 242, the urethra 1 can be conveniently placed in the cavity formed by the shell 21, the two telescopic tubes 25 and the locking component 24. During the operation, the urethra 1 does not need to be cut off to achieve the installation of the extrusion assembly 2, which is convenient and quick.

[0059] In one embodiment, a silicone sleeve 3 is sleeved between the limiting cylinder 28 and the outer wall of the third guide cylinder 253 , and a silicone pad 4 is provided at the bottom of the shell 21 and the top of the second locking block 242 .

[0060] It should be noted that the silicone sleeve 3 is fixedly installed between the outer wall of the limiting cylinder 28 and the third guide cylinder 253, and the bottom of the base of the shell 21 and the top of the second locking block 242 are fixedly installed with a silicone pad 4. The silicone sleeve 3 and the silicone pad 4 are both made of materials that can be implanted in the human body and are elastic and soft. The silicone sleeve 3 and the silicone pad 4 can be deformed accordingly according to the extrusion force to avoid excessive compressive damage to the urethra 1.

[0061] In one embodiment, a permanent magnet and a rotation sensor are provided on the reel 222 , and a pressure sensor is provided at the bottom of the housing 21 corresponding to the urethra 1 .

[0062] It should be noted that a circular hole is provided at one end of the reel 222 away from the motor 221 for installing a permanent magnet, and a rotation sensor is installed at the end surface of the reel 222 where the circular hole is located. The rotation sensor monitors the rotation angle of the reel 222 through the change of the magnetic field of the permanent magnet. The pressure sensor is installed at the bottom of the base of the shell 21 and corresponds to the position of the urethra 1. The silicone pad 4 covers the bottom of the pressure sensor, and the pressure value of the urethra 1 is detected by the pressure sensor.

[0063] like Figure 8 As shown, in one embodiment, the quick-install artificial urinary sphincter system further includes an in-vivo control component 5 and an in-vivo controller 6, the in-vivo control component 5 includes a wireless communication module, a signal processing module (single-chip processor), a motor control module, a rotation module and a pressure module (the in-vivo controller 6 and the wireless communication module are wirelessly connected via Bluetooth or WiFi), the quick-install artificial urinary sphincter system controls the pressure value of the urethra 1 during urine retention through the in-vivo control component 5 and the in-vivo controller 6, and executes according to the following steps:

[0064] S1. The external controller 6 sets a preset pressure value of the urethra 1 (the patient sets the corresponding pressure value according to different states, such as resting, walking, exercising, etc., so that the pressure value of the squeezing component 2 squeezing the urethra 1 is adjusted to achieve a good urine retention effect and reduce the pressure on the urethra 1), and transmits it to the signal processing module through the wireless communication module;

[0065] S2, the signal processing module calculates the preset angle that the motor 221 needs to rotate from the preset initial position according to the preset pressure value (the preset initial position is when the locking component 24 is farthest from the housing 21, that is, the locking component 24 is at the lowest point, and the corresponding angle position of the motor is the initial position);

[0066] S3, the signal processing module obtains a first angle by subtracting the preset angle from the current angle of the motor 221 relative to the preset initial position, and controls the motor 221 to rotate a corresponding angle through the motor control module according to the first angle; wherein the signal processing module is further used to memorize the angle of each rotation of the motor 221, and calculate the current angle of the motor 221 relative to the preset initial position (that is, each time the motor 221 rotates, the signal processing module memorizes the current rotation angle of the motor 221, and calculates the current angle of the motor 221 relative to the preset initial position);

[0067] S4, after the motor 221 rotates, the signal processing module obtains the actual rotation angle of the motor 221 monitored by the rotation sensor through the rotation module, and calculates the current angle of the motor 221 relative to the preset initial position (calculates the current angle relative to the preset initial position according to the angle memory of each rotation of the motor 221), and determines whether the current angle of the motor 221 relative to the preset initial position is equal to the preset angle. If not, repeat S3-S4 until the current angle of the motor 221 relative to the preset initial position is equal to the preset angle;

[0068] S5. If the current angle of the motor 221 relative to the preset initial position is equal to the preset angle, the signal processing module obtains the actual pressure value of the urethra 1 monitored by the pressure sensor through the pressure module, and determines whether the actual pressure value is equal to the preset pressure value. If they are equal, the control of the pressure value of the urethra 1 is completed;

[0069] S6, if the actual pressure value is not equal to the preset pressure value, the signal processing module calculates the second angle that the motor 221 needs to rotate according to the difference between the actual pressure value and the preset pressure value, and controls the motor 221 to rotate a corresponding angle through the motor control module according to the second angle, and then repeats S4-S6 until the actual pressure value is equal to the preset pressure value, and the control of the pressure value of the urethra 1 is completed (to achieve a good effect of urine retention and reduce the pressure of the urethra 1);

[0070] The signal processing module calculates the preset angle that the motor 221 needs to rotate from the preset initial position according to the preset pressure value, and the signal processing module calculates the angle that the motor 221 needs to rotate according to the difference between the actual pressure value and the preset pressure value. The calculation formula is as follows:

[0071] (I);

[0072] in, , and All represent preset coefficients. When the preset pressure value is When calculating the preset angle that the motor needs to rotate from the preset initial position, Indicates the preset pressure value, represents the preset angle. When the angle that the motor 221 needs to rotate is calculated based on the difference between the actual pressure value and the preset pressure value, Indicates the difference between the actual pressure value and the preset pressure value. Indicates the second angle that the motor 221 needs to rotate, wherein, The unit is cow, The unit is radians.

[0073] It should be noted that formula (I) is obtained based on experimental simulation: In this embodiment, a simulated urethra (such as a hose) is placed in a cavity formed by the housing 21, two telescopic tubes 25 and the locking component 24 in the quick-install artificial urethral sphincter system, and the acquisition channels corresponding to the pressure sensor and the rotation sensor are initialized, and the sampling frequency is set to 200 times per second (i.e., once every 5 ms) to ensure that the changes in pressure and angle can be captured;

[0074] The motor is given a rotation angle, so that the locking component is driven to compress the simulated urethra, and then paused for 5 seconds. According to the given angle during compression, the motor is reversed to a corresponding angle to release the urethra. This is a cycle of motor compression-release of the urethra. The above cycle is repeated 100-200 times, and the pressure value and angle monitored by the pressure sensor and the rotation sensor after each cycle are recorded and stored in the computer;

[0075] Data processing is performed on the obtained pressure values ​​and angle data. First, the mean deviation and standard value of the pressure values ​​and angles are calculated respectively. By comparison, the abnormal data are removed. The processed pressure values ​​and angle data are plotted into a scatter plot. It can be seen that it is a nonlinear relationship. The quadratic polynomial is fitted to obtain the values ​​of each coefficient in formula (I).

[0076] The in-vivo control component 5 further includes a wireless charging module, a power management module, a battery and a temperature detection module. The wireless charging module, the power management module and the battery are electrically connected in sequence, and the wireless charging module is also connected to the external wireless charger 9. When the power management module detects that the battery power is too low, the power management module sends a low power signal to the signal processing module. The signal processing module informs the external controller 6 through the wireless communication module. The external controller 6 reminds the patient that the battery power in the body is too low. The patient uses the wireless charger 9 to charge the battery through the wireless charging module of the in-vivo control component 5 (the external controller 6 is provided with a Type-C charging port, which can be used with the wireless charger 9 to charge the in-vivo control component 5. The wireless charger 9 can be used The external controller 6 is powered by the Type-C interface, power adapter and mobile power supply, and can also be powered by a mobile phone with a reverse charging function to realize charging of the internal control component 5; the external controller 6 wirelessly connected to the internal control component 5 is used to monitor various parameters of the internal control component 5 (the values ​​monitored by the pressure sensor and the rotation sensor) and control the internal control component 5 to perform corresponding operations, and has the functions of system power on and off and setting buttons; the external controller 6 also has power monitoring management and battery charging management, and has a human-computer interaction interface for displaying various parameters of the internal control component 5; the external controller 6 can also be replaced by a smart phone equipped with relevant software, so that the mobile phone can directly control the internal control component 5).

[0077] At the same time, the battery also powers the pressure module, temperature detection module, rotation module and motor control module through the power management module.

[0078] The temperature detection module detects the temperature of the wireless charging module, and the temperature monitored by the temperature detection module is transmitted to the signal processing module. When the temperature is higher than the threshold, the signal processing module controls the wireless charging module not to work (the wireless charging module is also electrically connected to the signal processing module) to prevent the risk of reduced component life and damage due to excessive temperature.

[0079] The working principle of this quick-install artificial urinary sphincter system:

[0080] The in-vivo control component 5 is surgically implanted under the patient's skin (at Figure 1 In the figure, 7 represents the bladder, and 8 represents the human skin), so that the charging will not fail due to the distance from the wireless charger 9 outside the body, and during the operation, the extrusion assembly 2 is installed on the urethra 1, specifically, the first locking block 241 and the second locking block 242 are unlocked, and then the urethra 1 is placed in the cavity formed by the shell 21, the two telescopic tubes 25 and the locking component 24, and then the first locking block 241 and the second locking block 242 are locked to achieve the installation of the extrusion assembly 2, and then the installation of the extrusion assembly 2 is achieved without cutting off the urethra, which is convenient and fast, and reduces the difficulty of the operation;

[0081] The squeezing component 2 is initially in a urine-retaining state (eg Fig. 9 As shown in the figure, when the patient needs to urinate, he presses the control key on the external controller 6 twice in a row (with an interval of no more than 1s), and the external controller 6 sends a urination signal to the wireless communication module, and the wireless communication module sends the urination signal to the signal processing module. The signal processing module controls the motor 221 to rotate through the motor control module, so that the traction rope 23 is released, and the locking component 24 is driven to move away from the housing 21 (i.e., downward) under the action of the restoring force of the spring 26, so as to release the pressure on the urethra 1 to urinate (the urination state of the squeezing component 2 is shown in the figure). Fig.10 shown);

[0082] After urinating, the control key of the external controller 6 is pressed (or the preset time 40s countdown is waited, and the external controller 6 automatically sends a urine-stopping signal), and the external controller 6 sends the urine-stopping signal to the wireless communication module, and the wireless communication module sends the urine-stopping signal to the signal processing module, and the signal processing module controls the motor 221 to rotate through the motor control module, so that the traction rope 23 is wound tightly, and under the action of the contraction of the telescopic tube 25 and the spring 26, the locking component 24 is driven to move in the direction close to the housing 21 (i.e., upward movement), and pressure is applied to the urethra 1 to achieve urine-stopping;

[0083] When urination is needed again, the operation of the external controller 6 is repeated to enable the patient to urinate on his own.

[0084] For patients with neurogenic bladder who are aware of urination, they can manually operate the external controller 6 to urinate according to their own urination needs; for patients with neurogenic bladder or patients undergoing ileal cystotherapy for bladder cancer who are not aware of urination, they can control the external controller 6 at intervals to achieve urination;

[0085] The patient (a patient who is aware of urination or a patient who is not aware of urination) can adjust the pressure value of the squeezing component 2 squeezing the urethra 1 according to their own conditions (resting, walking, exercising, etc.), and set the pressure value through the external controller 6 to achieve a good urine retention effect and reduce the pressure on the urethra 1. The specific operation steps are as follows S1-S6.

[0086] The quick-install artificial urethral sphincter system locks and unlocks the first locking block and the second locking block in the locking component, so that the urethra is placed in the cavity formed by the shell, the two telescopic tubes and the locking component, and the urethra is squeezed by the squeezing component to close the urine and release the pressure to urinate. The whole process does not require the urethra to be cut off to achieve the installation of the squeezing component, which is convenient and fast, and reduces the difficulty of the operation. The quick-install artificial urethral sphincter system enables the patient to urinate on his own through the cooperation between the in-vivo control component and the in-vitro controller. The patient can adjust the pressure value of the squeezing component squeezing the urethra according to his own situation, and set the pressure value through the in-vitro controller to achieve a good urine closing effect and prevent excessive compression of the urethra and accelerated urethral atrophy.

[0087] The above-mentioned embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the attached claims.

Claims

1. A quick-install artificial urinary sphincter system, characterized in that: The quick-install artificial urinary sphincter system comprises an extrusion assembly (2) arranged on the urethra (1), wherein: The extrusion assembly (2) comprises a housing (21), a driving assembly (22), a traction rope (23), a locking component (24) and two telescopic tubes (25), and a spring (26) arranged on the outside of each telescopic tube (25). The driving assembly (22) is arranged in the housing (21), the top end of each telescopic tube (25) is fixedly connected to the bottom of the housing (21), and the bottom end is connected to the locking component (24). The traction rope (23) is arranged on the driving assembly (22), and the two ends respectively pass through the two telescopic tubes (25) and are connected to the locking component (24). The spring (26) The urethra (1) is placed in a cavity formed by a housing (21), two telescopic tubes (25) and a locking component (24) by means of an elastic force extending toward both ends. The traction rope (23) is wound tightly by means of a driving component (22). Under the action of the contraction of the telescopic tube (25), the locking component (24) is driven to move in a direction close to the housing (21), thereby applying pressure to the urethra (1) to achieve urine retention. The traction rope (23) is released by means of the driving component (22), and under the action of a spring (26), the locking component (24) is driven to move in a direction away from the housing (21), thereby releasing the pressure on the urethra (1) to allow urination. The telescopic tube (25) comprises a first guide cylinder (251), a second guide cylinder (252) and a third guide cylinder (253) which are arranged in sequence, the first guide cylinder (251) is slidably inserted in the second guide cylinder (252), and the top end of the first guide cylinder (251) is fixedly connected to the bottom of the housing (21), the second guide cylinder (252) is slidably inserted in the third guide cylinder (253), and the bottom end of the third guide cylinder (253) is connected to the locking component (24); The bottoms of the first guide cylinder (251) and the second guide cylinder (252) are both provided with a stop block (254); the tops of the second guide cylinder (252) and the third guide cylinder (253) are both provided with a stop wall (255); the stop block (254) on the first guide cylinder (251) cooperates with the stop wall (255) on the second guide cylinder (252) to prevent the first guide cylinder (251) from being separated from the second guide cylinder (252); the stop block (254) on the second guide cylinder (252) cooperates with the stop wall (255) on the third guide cylinder (253) to prevent the second guide cylinder (252) from being separated from the third guide cylinder (253); The locking component (24) comprises a first locking block (241), a second locking block (242) and a clamping column (243); the bottom ends of the two third guide cylinders (253) are respectively fixedly connected to the first locking block (241) and the second locking block (242); the two ends of the traction rope (23) are respectively connected to the first locking block (241) and the second locking block (242) after passing through the telescopic tube (25); the first locking block (241) is provided with a wedge block (244); the second locking block (242) is provided with a through groove (245) corresponding to the wedge block (244); the first locking block (241) is provided with a second channel (246); the second locking block (242) is provided with a third channel (247) connected to the through groove (245); the clamping column (243) is slidably inserted in the second channel (246) and the third channel (247).

2. The quick-install artificial urinary sphincter system according to claim 1, characterized in that: The driving assembly (22) comprises a motor (221) and a reel (222); a base of the motor (221) is connected to the inner wall of the housing (21); one end of the reel (222) is mounted to the output end of the motor (221), and the other end is rotatably connected to the inner wall of the housing (21); a first channel (223) is provided on the side wall of the reel (222) along the cross-sectional direction; after the traction rope (23) passes through the first channel (223), the two ends of the traction rope (23) respectively pass through two telescopic tubes (25) and are connected to the locking component (24).

3. The quick-install artificial urinary sphincter system according to claim 2, characterized in that: Two support blocks (27) are provided inside the housing (21), and each of the support blocks (27) and the housing (21) is provided with an escape channel. After the traction rope (23) passes through the first channel (223), both ends of the traction rope (23) pass through the corresponding escape channel and the telescopic tube (25) respectively, and then are connected to the locking component (24).

4. The quick-install artificial urinary sphincter system according to claim 1, characterized in that: The extrusion assembly (2) further comprises a limiting cylinder (28), the top end of the limiting cylinder (28) being fixedly connected to the bottom of the shell (21), the top end of the spring (26) being inserted into the limiting cylinder (28) and abutting against the bottom of the shell (21), and the bottom end of the spring (26) abutting against the top of the third guide cylinder (253).

5. The quick-install artificial urinary sphincter system according to claim 1, characterized in that: The thickness of the side of the wedge block (244) away from the first locking block (241) is greater than the thickness of the side of the wedge block (244) close to the first locking block (241), and the shape of the through groove (245) corresponds to the shape of the wedge block (244).

6. The quick-install artificial urinary sphincter system according to claim 4, characterized in that: A silicone sleeve (3) is sleeved between the outer walls of the limiting cylinder (28) and the third guide cylinder (253), and a silicone pad (4) is provided at the bottom of the housing (21) and the top of the second locking block (242).

7. The quick-install artificial urinary sphincter system according to claim 2, characterized in that: A permanent magnet and a rotation sensor are provided on the reel (222), and a pressure sensor is provided at the bottom of the housing (21) corresponding to the urethra (1).

8. The quick-install artificial urinary sphincter system according to claim 7, characterized in that: The quick-install artificial urinary sphincter system further comprises an in-vivo control component (5) and an in-vivo controller (6), wherein the in-vivo control component (5) comprises a wireless communication module, a signal processing module, a motor control module, a rotation module and a pressure module. The quick-install artificial urinary sphincter system controls the pressure value of the urethra (1) during urine retention through the in-vivo control component (5) and the in-vivo controller (6), and is executed according to the following steps: S1, the external controller (6) sets a preset pressure value of the urethra (1) and transmits it to the signal processing module via the wireless communication module; S2, the signal processing module calculates a preset angle that the motor (221) needs to rotate from a preset initial position according to a preset pressure value; S3, the signal processing module performs a subtraction between the preset angle and the current angle of the motor (221) relative to the preset initial position to obtain a first angle, and controls the motor (221) to rotate to a corresponding angle through the motor control module according to the first angle; wherein the signal processing module is further used to memorize each rotation angle of the motor (221) and calculate the current angle of the motor (221) relative to the preset initial position; S4, after the motor (221) rotates, the signal processing module obtains the actual rotation angle of the motor (221) monitored by the rotation sensor through the rotation module, calculates the current angle of the motor (221) relative to the preset initial position, and determines whether the current angle of the motor (221) relative to the preset initial position is equal to the preset angle; if not, repeat S3-S4 until the current angle of the motor (221) relative to the preset initial position is equal to the preset angle; S5, if the current angle of the motor (221) relative to the preset initial position is equal to the preset angle, the signal processing module obtains the actual pressure value of the urethra (1) monitored by the pressure sensor through the pressure module, and determines whether the actual pressure value is equal to the preset pressure value. If they are equal, the control of the pressure value of the urethra (1) is completed; S6, if the actual pressure value is not equal to the preset pressure value, the signal processing module calculates the second angle that the motor (221) needs to rotate according to the difference between the actual pressure value and the preset pressure value, and controls the motor (221) to rotate to a corresponding angle through the motor control module according to the second angle, and then repeats S4-S6 until the actual pressure value is equal to the preset pressure value, thereby completing the control of the pressure value of the urethra (1); The signal processing module calculates the preset angle that the motor (221) needs to rotate from the preset initial position according to the preset pressure value, and the signal processing module calculates the angle that the motor (221) needs to rotate according to the difference between the actual pressure value and the preset pressure value. The calculation formula is as follows: ； in, , and All represent preset coefficients. When the preset pressure value is When calculating the preset angle that the motor needs to rotate from the preset initial position, Indicates the preset pressure value, represents a preset angle. When the angle that the motor (221) needs to rotate is calculated based on the difference between the actual pressure value and the preset pressure value, Indicates the difference between the actual pressure value and the preset pressure value. Indicates the second angle that the motor (221) needs to rotate.

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