Artificial sphincter device

Abstract

The invention aims to provide an artificial sphincter device, the artificial sphincter device comprises a pressing unit, the pressing unit comprises a base, a pressing assembly and a fixing assembly, the fixing assembly is installed on the pubis and fixedly connected with the base, the base is used for bearing the pressing assembly, and the pressing assembly is fixedly connected with the fixing assembly. The pressing assembly is used for pressing the urethra; the control unit is used for controlling the pressure of the pressing assembly on the urethra. The control unit is matched with the base to drive the pressing assembly to move towards or away from the urethra, and the urine control effect is achieved. Compared with an artificial sphincter surrounding the periphery of the urethra in the prior art, the artificial sphincter does not need to be installed around the urethra after the urethra is completely dissociated, urination control is not carried out by narrowing and locking the urethra, and complications such as urethra ischemia, necrosis and stenosis are avoided.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an artificial sphincter device. Background Art

[0002] For the treatment of problems such as urinary leakage and urinary incontinence, surgical treatment and non-surgical treatment are generally available. Among them, surgical treatment includes urethral suspension and artificial urinary sphincter treatment, and non-surgical treatment includes setting a urethral compression device outside the human body. Existing artificial urinary sphincters generally achieve the purpose of urine control by squeezing around the periphery of the urethra. The artificial sphincter that surrounds the urethra will aggravate urethral compression and aggravate urethral ischemia, necrosis, and stenosis due to its long-term constriction. In addition, in order to set up an artificial sphincter around the periphery of the urethra, the urethra needs to be completely freed during the operation, which not only makes the operation difficult and complicated, but also destroys the blood supply to the urethra and causes urethral ischemia. Summary of the Invention

[0003] One purpose of the present application is to provide an artificial sphincter device, which eliminates the need to completely free the urethra and then install it around the urethra during surgery, and avoids surrounding compression of the urethra and aggravating urethral ischemia, necrosis, and stenosis.

[0004] According to one aspect of the present application, an artificial sphincter device is provided, comprising:

[0005] A pressing unit, comprising a base, a pressing assembly, and a fixing assembly, wherein the fixing assembly is mounted on the pubic bone, the fixing assembly is fixedly connected to the base, the base is used to carry the pressing assembly, and the pressing assembly is used to press the urethra;

[0006] A control unit is used to control the pressure of the pressing component on the urethra.

[0007] In some embodiments, the fixing assembly includes at least one pair of fixing members.

[0008] In some embodiments, the control unit includes a magnetoelectric control component, which includes a battery control component, a magnetic control component, a support component and a first pulling component; the magnetic control component is installed on the base, the support component is installed on the magnetic control component, and the pressing component is installed on the support component. The first pulling component connects the battery control component and the magnetic control component. The battery control component is used to control the on and off of the current, so that the first pulling component pulls the magnetic control component or gradually releases the pulling force on the magnetic control component. The first pulling component pulls the magnetic control component to move, and the magnetic control component drives the support component to move. The support component drives the pressing component to move away from the urethra. The first pulling component gradually releases the pulling force on the magnetic control component. The magnetic control component resets under the action of its own magnetic force, and the support component drives the pressing component to move toward the urethra.

[0009] In some embodiments, a first groove is provided on the base, the magnetic control component includes a first magnetic part and a second magnetic part, the first magnetic part and the second magnetic part are installed in the first groove, the first pulling component includes a first pulling part and a second pulling part, the magnetic poles of the first magnetic part and the second magnetic part close to each other are different, the end of the first magnetic part away from the second magnetic part is connected to one end of the first pulling part, and the other end of the first pulling part is connected to the battery control component, the end of the second magnetic part away from the first magnetic part is connected to one end of the second pulling part, and the other end of the second pulling part is connected to the battery control component.

[0010] In some embodiments, the first pulling component is made of a material including shape memory alloy.

[0011] In some embodiments, the pressing assembly includes a first pressing member, the supporting assembly includes a first supporting member, the first supporting member includes two supporting components, one end of the two supporting components are installed on the first pressing member, and the other ends of the two supporting components are respectively installed on the first magnetic member and the second magnetic member.

[0012] In some embodiments, the pressing assembly also includes one or more second pressing members, and the supporting assembly also includes one or more corresponding elastic second supporting members, each of the second pressing members is respectively installed on a second supporting member, and the one or more second supporting members are installed on the first magnetic member or the second magnetic member; the magnetoelectric control assembly also includes a second pulling assembly, and the second pulling assembly includes one or more third pulling members, each of the third pulling members is respectively connected to the battery control assembly and a second pressing member, and the battery control assembly controls the current on and off so that the one or more third pulling members respectively pull the corresponding second supporting member or gradually release the pulling force on the second supporting member. Each second supporting member is deformed under the pulling of the corresponding third pulling member, driving the corresponding second pressing member to move away from the urethra. After the pulling force of the corresponding third pulling member is gradually released, the second support member is reset under its own elastic force, driving the corresponding second pressing member to move toward the urethra.

[0013] In some embodiments, the support component is made of an elastic material.

[0014] In some embodiments, the battery control assembly includes a battery and a switch, and the switch includes a first elastic member with built-in switch contacts.

[0015] In some embodiments, the control unit includes a hydraulic control component; a first cavity is formed between the pressing component and the base; the hydraulic control component is used to control the discharge of fluid into or out of the first cavity, thereby pushing the pressing component to move toward or away from the urethra to change the pressure of the pressing component on the urethra.

[0016] In some embodiments, a second groove is provided on the base, and a first cavity is formed between the pressing component and the second groove. The part of the pressing component that cooperates with the second groove is elastic. The part of the pressing component that cooperates with the second groove is recessed toward the direction of the second groove when not subject to external force, and bulges away from the second groove when subjected to pressure from the fluid in the first cavity.

[0017] In some embodiments, the hydraulic control component includes a first connecting pipe, a first control component and a second control component. The first control component is connected to the first cavity through the first connecting pipe, and the second control component is connected to the first control component. The first control component is used to store fluid and control the fluid to flow unidirectionally from the first control component through the first connecting pipe into the first cavity. The second control component is used to control the fluid to flow from the first cavity back to the first control component through the first connecting pipe.

[0018] In some embodiments, the first control component includes a second elastic member and an opening and closing member, and a second cavity, a third cavity and a first channel are provided in the second elastic member. The second cavity is connected to the first cavity through the first connecting tube, and the third cavity is connected to the second cavity through the first channel. The opening and closing member is used to open or close the first channel, and the second control component is used to control the opening and closing member to open the first channel.

[0019] In some embodiments, the second control component includes a second connecting tube, a third elastic member and a fourth pulling member, one end of the second connecting tube is connected to the third elastic member, the other end of the second connecting tube is connected to the second cavity, one end of the fourth pulling member is connected to the third elastic member, and the other end of the fourth pulling member passes through the second connecting tube and is connected to the opening and closing member.

[0020] In some embodiments, the opening and closing member is conical, the tip of the opening and closing member is facing and located in the first channel, the fourth pulling member is connected to the end of the opening and closing member where the cross-section gradually increases, and the part with the largest cross-section of the opening and closing member can completely cover the end face of the end of the first channel connected to the second cavity. After the second control component controls the opening and closing member to open the first channel, the tip of the opening and closing member is still located in the first channel.

[0021] In some embodiments, a partition is provided in the second cavity, and a through hole is provided on the partition. The central axis of the through hole coincides with the center of the end face of one end of the first channel connected to the second cavity, and the fourth pulling member passes through the second connecting tube and the through hole in sequence and is connected to the center of the end of the opening and closing member whose cross-section gradually increases.

[0022] In some embodiments, the hydraulic control assembly includes a third connecting pipe, a control box and a third control assembly, the third connecting pipe connects the control box and the first cavity, the third control assembly is arranged on the control box, a fifth cavity with a variable volume is arranged in the third control assembly, a fourth cavity with a variable volume is arranged in the control box, the bottom of the fourth cavity includes a retractable part, the volume of the fourth cavity is changed by the retracting of the retractable part, and the control box is further provided with a second channel, a third channel and a fourth channel; a first one-way valve is provided in the second channel, and the second channel is connected to The fifth cavity and the third connecting tube, the first one-way valve is used to control the fluid to flow only to the fifth cavity; the second one-way valve is installed in the third channel, the third channel connects the fourth cavity and the fifth cavity, the second one-way valve is used to control the fluid to flow only to the fourth cavity; the fourth channel connects the fourth cavity and the third connecting tube; the third control component controls the flow of fluid in the first cavity, the fourth cavity, the fifth cavity, the third connecting tube, the second channel, the third channel, and the fourth channel, thereby controlling the pressure of the pressing component on the urethra.

[0023] In some embodiments, the pressing component is made of silicone.

[0024] Compared with the prior art, the artificial sphincter device provided in the present application includes a pressing unit, which includes a base, a pressing assembly and a fixing assembly, wherein the fixing assembly is installed on the pubic bone, the fixing assembly is fixedly connected to the base, the base is used to support the pressing assembly, and the pressing assembly is used to press the urethra; a control unit, the control unit is used to control the pressure of the pressing assembly on the urethra. The control unit is used in conjunction with the base to drive the pressing assembly to move toward or away from the urethra to achieve the effect of controlling urine. Compared with the artificial sphincter that surrounds the periphery of the urethra in the prior art, the present application does not require the urethra to be completely freed and then installed around the urethra, nor does it control urine by narrowing and locking the urethra, thereby avoiding complications such as urethral ischemia, necrosis, and stenosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Other features, objects and advantages of the present application will become more apparent upon reading the detailed description of non-limiting embodiments made with reference to the following drawings:

[0026] Figure 1 FIG1 shows a schematic structural diagram of an artificial sphincter device according to one embodiment of the present application;

[0027] Figure 2 FIG1 shows a schematic structural diagram of an artificial sphincter device according to one embodiment of the present application;

[0028] Figure 3 A schematic structural diagram of a base and a fixing assembly according to an embodiment of the present application is shown;

[0029] Figure 4 A schematic structural diagram of a base and a fixing assembly according to an embodiment of the present application is shown;

[0030] Figure 5 A schematic diagram showing the coordination of a base, a magnetic control assembly, a support assembly, and a pressing assembly according to one embodiment of the present application is shown;

[0031] Figure 6 FIG1 shows a schematic structural diagram of an artificial sphincter device according to one embodiment of the present application;

[0032] Figure 7 A schematic diagram showing the coordination of a base, a magnetic control assembly, a first pulling assembly, a second pulling assembly, a supporting assembly, and a pressing assembly according to one embodiment of the present application is shown, wherein the urethra is closed;

[0033] Figure 8 A schematic diagram showing the coordination of a base, a magnetic control assembly, a first pulling assembly, a second pulling assembly, a supporting assembly, and a pressing assembly according to one embodiment of the present application is shown, wherein the urethra is opened;

[0034] Figure 9 A schematic diagram of a switch structure according to an embodiment of the present application is shown, wherein the switch is disconnected;

[0035] Figure 10 A schematic diagram of a switch structure according to an embodiment of the present application is shown, wherein the switch is turned on;

[0036] Figure 11 A schematic diagram showing the cooperation between a pressing assembly and a base according to one embodiment of the present application is shown, wherein the urethra is closed;

[0037] Figure 12 A schematic structural diagram of a base and a fixing assembly according to an embodiment of the present application is shown;

[0038] Figure 13 A schematic diagram showing the cooperation between a pressing assembly and a base according to one embodiment of the present application is shown, wherein the urethra is open;

[0039] Figure 14 FIG1 shows a schematic structural diagram of an artificial sphincter device according to one embodiment of the present application;

[0040] Figure 15 A schematic diagram of the structure of a hydraulic control assembly according to one embodiment of the present application is shown, wherein the first channel is open;

[0041] Figure 16 A schematic diagram of the structure of a hydraulic control assembly according to one embodiment of the present application is shown, wherein the first channel is closed;

[0042] Figure 17 FIG1 shows a schematic structural diagram of an artificial sphincter device according to one embodiment of the present application;

[0043] Figure 18 A schematic structural diagram of a hydraulic control assembly according to an embodiment of the present application is shown;

[0044] Figure 19 A schematic diagram showing the flow of fluid in a hydraulic control assembly according to one embodiment of the present application is shown;

[0045] Figure 20 A schematic diagram showing the flow of fluid in a hydraulic control assembly according to one embodiment of the present application is shown;

[0046] Figure 21 A schematic diagram of fluid flow in a hydraulic control assembly according to an embodiment of the present application is shown.

[0047] The same or similar reference numerals in the drawings represent the same or similar components.

[0048] Reference numerals

[0049] 100 Pressing unit, 110 Base, 111 First groove, 111' Second groove, 120 Pressing assembly, 121 First pressing member, 122 Second pressing member, a First cavity, 130 Fixing assembly, 131 Fixing member, 200 Control unit, 210 Magnetoelectric control assembly, 211 Battery control assembly, 211a Battery, 211b Switch, 212 Magnetic control assembly, 212a First magnetic member, 212b Second magnetic member, 213 Support assembly, 213a First support member, 213b Second support member, 214 First pulling assembly, 214a First pulling member, 214b Second pulling member, 215 Second pulling assembly Component, 215a third pulling member, 220 hydraulic control component, 221 first connecting pipe, 222 first control component, 222a second elastic member, b second cavity, b1 partition, c third cavity, d first channel, 222b opening and closing member, 223 second control component, 223a second connecting pipe, 223b third elastic member, 223c fourth pulling member, 224 third connecting pipe, 225 control box, e fourth cavity, e1 retractable member, f second channel, f1 first one-way valve, g third channel, g1 second one-way valve, h fourth channel, 226 third control component, i fifth cavity, 300 pubic bone, 400 urethra. DETAILED DESCRIPTION

[0050] The present application is described in further detail below with reference to the accompanying drawings.

[0051] In the description of this application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this application.

[0052] Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature defined as "first," "second," etc., may explicitly or implicitly include one or more of such features. Throughout the description of this application, "plurality" means two or more, unless otherwise specifically defined.

[0053] In this application, unless otherwise specified or limited, the terms "mounted," "connected," "connect," "fixed," etc. should be understood in a broad sense. For example, they can refer to fixed connection, detachable connection, or integral connection; mechanical connection or electrical connection; direct connection or indirect connection through an intermediate medium; or internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on specific circumstances.

[0054] In this application, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may include the first and second features being in direct contact, or may include the first and second features being in contact not directly but through another feature between them. Furthermore, a first feature being "above," "above," and "above" a second feature may include the first feature being directly above and obliquely above the second feature, or may simply mean that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature may include the first feature being directly above and obliquely above the second feature, or may simply mean that the first feature is lower in level than the second feature.

[0055] In the description of the present application, “plurality” means two or more, unless otherwise clearly defined.

[0056] refer to Figure 1 、 Figure 2The figure shows a schematic diagram of the structure of an artificial sphincter device. The artificial sphincter device includes a pressing unit 100, and the pressing unit 100 includes a base 110, a pressing assembly 120, and a fixing assembly 130, wherein the fixing assembly 130 is mounted on the pubic bone 300, and the fixing assembly 130 is fixedly connected to the base 110, and the base 110 is used to support the pressing assembly 120, and the pressing assembly 120 is used to press the urethra 400; a control unit 200, and the control unit 200 is used to control the pressure of the pressing assembly 120 on the urethra 400. The control unit 200 controls the pressing assembly 120 to move toward or away from the urethra 400, thereby changing the pressure of the pressing assembly 120 on the urethra 400 and closing the urethra (refer to FIG. 1 ). Figure 7 、 Figure 11 ) or open (refer to Figure 8 、 Figure 13 ) to achieve urinary control or urination. Compared to the existing artificial sphincter that surrounds the urethra, which requires the urethra to be completely freed during installation and can easily cause urethral ischemia, necrosis, and stenosis, the artificial sphincter device described in this solution does not surround the urethra and does not require the urethra to be completely freed during surgery, making the surgical procedure simpler and preventing complications such as urethral ischemia, necrosis, and stenosis.

[0057] In some embodiments, the long side of the base 110 can be designed to be curved, and the length and curvature of the long side can be determined based on the surface width and curvature of the urethra 400, so that the base 110 can fit the urethra 400. In some embodiments, the base can be made of titanium alloy or other materials with good tissue compatibility, light texture, and non-deformable properties.

[0058] In some embodiments, the fixing assembly 130 includes at least one pair of fixing members 131, for example, Figure 3 A pair of fixing members 131 are provided at both ends of the base 110, and one end of the fixing member 131 not connected to the base 110 is mounted on the user's pubic bone, thereby ensuring that the base 110 does not move, loosen or twist. Figure 4 In order to further enhance the fixing stability, multiple pairs of fixing members 131 may be provided at both ends of the base 110. In some embodiments, the fixing assembly 130 and the base 110 may be integrally formed or separately formed.

[0059] refer to Figure 1 、 Figure 5-7In some embodiments, the control unit includes a magnetoelectric control component 210, which includes a battery control component 211, a magnetic control component 212, a support component 213 and a first pulling component 214; the magnetic control component 212 is installed on the base 110, the support component 213 is installed on the magnetic control component 212, and the pressing component 120 is installed on the support component 213. The first pulling component 214 connects the battery control component 211 and the magnetic control component 212. The battery control component 211 is used to control the on and off of current, so that the first pulling component 214 pulls the magnetic control component 212 or gradually releases the pulling force on the magnetic control component 212. The first pulling component 214 pulls the magnetic control component 214 to move, and the magnetic control component 214 drives the support component 213 to move, and the support component 213 drives the pressing component 120 to move away from the urethra; the first pulling component 214 gradually releases the pulling force on the magnetic control component 212, and the magnetic control component 212 returns to its original position under the action of its own magnetic force, and the support component 213 drives the pressing component 120 to move toward the urethra. Since the process of releasing the pulling force of the first pulling component 214 is gradual, that is, the pulling force of the first pulling component 214 on the magnetic control component 212 does not disappear suddenly, the process of returning the magnetic control component 212 is also gradually restored, so that the pressing of the urethra by the pressing component 120 is relatively gentle. For example, when the battery control component 211 controls the flow of current, the first pulling component 214 deforms and contracts, pulling the magnetic control component 212 apart, causing the support component 213 mounted on the magnetic control component 212 to move. The support component 213 drives the pressing component 120 away from the urethra 400, reducing pressure on the urethra 400 and inducing urination. When the battery control component 211 controls the flow of current, the first pulling component returns to its original state, gradually releasing the pulling force on the magnetic control component 212. The magnetic control component 212 returns to its original position under its own magnetic attraction, causing the support component 213 mounted on the magnetic control component 212 to return to its original position. The support component 213 drives the pressing component 120 toward the urethra 400, increasing pressure on the urethra 400 and squeezing the urethra 400 to achieve urinary control.

[0060] refer to Figure 5-8In some embodiments, a first groove 111 is provided on the base 110, and the magnetic control component 212 includes a first magnetic member 212a and a second magnetic member 212b, and the first magnetic member 212a and the second magnetic member 212b are installed in the first groove 111, and the first pulling component 214 includes a first pulling member 214a and a second pulling member 214b, and the magnetic poles of the ends of the first magnetic member 212a and the second magnetic member 212b that are close to each other are different, and the end of the first magnetic member 212a away from the second magnetic member 212b is connected to one end of the first pulling member 214a, and the other end of the first pulling member 214a is connected to the battery control component 211, and the end of the second magnetic member 212b away from the first magnetic member 212a is connected to one end of the second pulling member 214b, and the other end of the second pulling member 214b is connected to the battery control component 211.

[0061] In some embodiments, the first groove 111 opens toward the urethra 400 , and the first groove 111 accommodates the magnetic control component 212 , the first pulling component 214 , etc., thereby improving the stability of the coordination of the components.

[0062] In some embodiments, the first pulling component 214 is made of a shape memory alloy. Made of this shape memory alloy (SMA), the first pulling component 214 deforms and contracts when heated to a certain temperature, then returns to its pre-heating shape upon cooling, thereby pulling the magnetic control component 212 apart. This embodiment utilizes the thermal effect of current. The battery control component 211 controls the on / off current flow to cause the first pulling component 214 to deform, pulling or releasing the magnetic control component 212, causing it to separate or reposition. This in turn drives the movement of the support component 213 and the pressing component 120, thereby adjusting the pressure exerted by the pressing component 120 on the urethra 400. Furthermore, the first pulling component 214 gradually recovers its pre-heating shape upon cooling. That is, the pulling force exerted by the first pulling component 214 on the magnetic control component 212 does not disappear suddenly. Therefore, the magnetic control component 212 also gradually returns to its original shape, resulting in a gentler pressure from the pressing component 120 on the urethra.

[0063] refer to Figure 5 In some embodiments, the pressing assembly 120 includes a first pressing member 121, the supporting assembly 213 includes a first supporting member 213a, the first supporting member 213a includes two supporting members, one end of the two supporting members are installed on the first pressing member 121, and the other ends of the two supporting members are respectively installed on the first magnetic member 212a and the second magnetic member 212b.

[0064] In some embodiments, the urethra 400 may be pressed only by the first pressing member 121, which may be a single protrusion type (see FIG. Figure 7 The first pressing member 121 shown in FIG. 1 may also be a multi-protrusion type (see FIG. Figure 5 The first pressing member 121 shown in the figure may also be any other shape suitable for urethra pressing.

[0065] refer to Figure 8 When urination is required, the battery control component 211 controls the current to flow through the first pulling member 214a and the second pulling member 214b. Due to the thermal effect of the current, the first pulling member 214a and the second pulling member 214b will continue to heat up. When a certain temperature is reached, the first pulling member 214a and the second pulling member 214b will deform and shrink, pulling the first magnetic member 212a and the second magnetic member 212b toward the two ends of the base 110 respectively, so that the first magnetic member 212a and the second magnetic member 212b that are attracted to each other are separated, and the angle formed by the end of the two supporting members connected to the first pressing member 121 becomes larger, and the distance from the first pressing member 121 to the base 110 becomes smaller, that is, the first pressing member 121 is away from the urethra 400, and the pressure on the urethra 400 is reduced, and the urethra is in an open state for urination. Reference Figure 7 When the urine control state is restored, the battery control component 211 is used to control the disconnection of the current, so that the temperature at the first pulling member 214a and the second pulling member 214b is reduced, and the first pulling member 214a and the second pulling member 214b are restored to their original length, and the pulling force on the first magnetic member 212a and the second magnetic member 212b is gradually released. The first magnetic member 212a and the second magnetic member 212b are attracted to each other under the action of their own magnetic force, so that the angle formed by the two supporting members and one end connected to the first pressing member 121 becomes smaller, driving the first pressing member 121 to move toward the urethra 400, increasing the pressing pressure of the first pressing member 121 on the urethra 400, and achieving the purpose of urine control.

[0066] refer to Figure 7 、 Figure 8In some embodiments, the pressing component 120 also includes one or more second pressing members 122, and the supporting component also includes one or more corresponding elastic second supporting members 213b, each of the second pressing members 122 is respectively installed on a second supporting member 213b, and the one or more second supporting members 213b are installed on the first magnetic member 212a or the second magnetic member 212b; the magnetoelectric control component 210 also includes a second pulling component 215, and the second pulling component includes one or more third pulling members 215a, and each of the third pulling members 215a is respectively connected to the battery control component 211 and a second pressing member 122.

[0067] The battery control assembly 211 controls the current flow, causing one or more third pulling members 215a to pull or gradually release the tension on the corresponding second support member 213b. Each second support member 213b deforms under the pull of its corresponding third pulling member 215a, driving the corresponding second pressing member 122 away from the urethra. After the tension of the corresponding third pulling member 215a is gradually released, the second support member 213b returns to its original position under its own elastic force, driving the corresponding second pressing member 122 to return to its original position, i.e., move toward the urethra. Because the third pulling member 215a releases its tension gradually, i.e., the tension on the second support member 213b does not disappear suddenly, the second support member 213b also gradually returns to its original position, thereby reducing the pressure of the second pressing member 122 on the urethra.

[0068] For example, to ensure effective compression of the urethra 400, one or more second pressing members 122 may be introduced to cooperate with the first pressing member 121 to compress the urethra 400. The second pressing member 122 may be a single-protrusion type, a multi-protrusion type, or any other shape suitable for urethral compression. The first pressing member 121 and the second pressing member 122 may have the same or different shapes.

[0069] In some embodiments, the second pulling component 215 is similar to the first pulling component 214, and is made of a material including a shape memory alloy. Figure 8 When urination is required, the battery control component 211 controls the current to flow through the third pulling member 215a. The third pulling member 215a also heats up due to the thermal effect of the current. When it reaches a certain temperature, it deforms and contracts, and cooperates with the first pulling component 214 to drive the magnetic control component 212 to move toward the two ends of the base 110, pulling the second pressing member 122 away from the urethra 400. Figure 7When the battery control assembly 211 disconnects the current, the third pulling member 215a returns to its original shape, gradually releasing the tension on the second pressing member 122. The second support member 213b returns to its original shape due to its own elasticity, causing the second pressing member 122 to press the urethra 400 again, thus entering the urine control state. Furthermore, the second pulling member 215 gradually recovers its pre-heating shape upon cooling. That is, the tension exerted by the second pulling member 215 on the second pressing member 122 does not disappear suddenly. Therefore, the second support member 213b also gradually returns to its original shape, resulting in a more moderate pressure on the urethra by the second pressing member 122.

[0070] In some embodiments, the support component 213 is made of elastic material to facilitate adaptation to deformation and restoration of the support component 213 after deformation.

[0071] refer to Figure 6 、 Figure 9 、 Figure 10 In some embodiments, the battery control component 211 includes a battery 211a and a switch 211b, and the switch 211b includes a first elastic member with built-in switch contacts. In some embodiments, the battery 211a can be buried in the subcutaneous tissue of the lower abdominal wall for easy installation and charging. The battery 211a includes a battery that can be repeatedly charged in a contactless manner. The current intensity output by the battery 211a can make the first traction component 214 and the second traction component 215 reach a certain temperature and deform and shrink. In some embodiments, the switch 211b can be buried in the user's scrotum. The switch 211b can be connected to the battery 211a and the corresponding first traction component 214 and second traction component 215 through a wire. Reference Figure 9 The initial state of the switch 211b is inflated, and its built-in switch contacts are not in contact. When the user needs to urinate, he presses the switch 211b, and the switch 211b is pressed and becomes Figure 10 As shown in the flat shape, the switch contacts are in contact, and power is applied at this time. The first pulling component 214 and the second pulling component 215 are heated and deformed due to the thermal effect of the current, prompting the pressing component 120 to move away from the urethra 400. After urination is completed, stop pressing the switch 211b, and the 211b moves away from the urethra 400. Figure 10 The flat shape shown is restored to Figure 9 As shown in the expanded state, the switch contacts are separated, the current is disconnected, the temperature of the first pulling component 214 and the second pulling component 215 decreases, and their lengths are restored, gradually releasing the pulling force on the first magnetic part 212a, the second magnetic part 212b and the second pressing part 122, prompting the pressing component 120 to move toward the urethra 400, increasing the pressure on the urethra 400, and entering the urine control state.

[0072] refer to Figure 2 、 Figure 11 In some embodiments, the control unit 200 includes a hydraulic control component 220; a first cavity a is formed between the pressing component 120 and the base 110; the hydraulic control component 220 is used to control the fluid to be discharged into or out of the first cavity a, thereby pushing the pressing component 120 to move toward or away from the urethra 400 to change the pressure of the pressing component 120 on the urethra 400. In some embodiments, the hydraulic control component 220 can be buried in the user's scrotum to facilitate user control. In some embodiments, the first cavity a can be formed by the cavity for accommodating fluid in the pressing component 120 and the side of the base 110 close to the urethra 400, or it can be formed by the groove provided in the base 110 and the side of the pressing component away from the urethra 400, or it can be a combination of the above two. Reference Figure 11 , the first cavity a is filled with fluid ( Figure 11 The wavy line in the first cavity a represents the fluid. The fluid in the first cavity a supports the pressing component 120 toward the urethra 400, so that the pressing component can fully squeeze the urethra 400 to achieve the purpose of urine control. After the hydraulic control component 220 controls the fluid to be discharged from the first cavity a, the pressing component 120 loses the support and naturally sinks toward the base 110. The pressure on the urethra 400 is reduced and enters the urination state. The pressing component 120 can be Figure 11 The multi-convex shape shown can also be any other shape suitable for pressing the urethra, which is not limited here.

[0073] refer to Figure 12 、 Figure 13 In some embodiments, a second groove 111' is provided on the base 110, and a first cavity a is formed between the pressing component 120 and the second groove 111'. The portion of the pressing component 120 that cooperates with the second groove 111' is elastic. The portion of the pressing component 120 that cooperates with the second groove 111' is recessed toward the second groove 111' when not subject to external force, and protrudes away from the second groove 111' when subjected to pressure from the fluid in the first cavity a. For example, the opening of the second groove 111' faces the urethra 400, and the portion of the pressing component 120 that cooperates with the second groove 111' covers the opening of the second groove 111', and together with the second groove 111', forms the first cavity a. When there is no fluid in the first cavity a, the portion of the pressing component 120 that cooperates with the second groove 111' sinks toward the second groove 111' (refer to Figure 13), driving the pressing component 120 to move away from the urethra 400; when there is fluid in the first cavity a, the portion of the pressing component 120 that cooperates with the second groove 111' expands toward the urethra 400 (refer to Figure 11 ), driving the pressing component 120 to move toward the urethra 400.

[0074] refer to Figure 14 In some embodiments, the hydraulic control assembly 220 includes a first connecting pipe 221, a first control assembly 222, and a second control assembly 223. The first control assembly 222 is connected to the first cavity a through the first connecting pipe 221, and the second control assembly 223 is connected to the first control assembly 222. The first control assembly 222 is used to store fluid and control the fluid to flow unidirectionally from the first control assembly 222 to the first cavity a through the first connecting pipe 221. The second control assembly 223 is used to control the fluid to flow from the first cavity a back to the first control assembly 222 through the first connecting pipe 221. Figure 11 One end of the base 110 is provided with a through hole, which is connected to the first connecting pipe 221 to form a channel for fluid to enter and exit the first cavity a.

[0075] In some embodiments, the first control component 222 includes a second elastic member 222a and an opening and closing member 222b, and the second elastic member 222a is provided with a second cavity b, a third cavity c and a first channel d, the second cavity b is connected to the first cavity a through the first connecting tube 221, and the third cavity c is connected to the second cavity b through the first channel d, the opening and closing member 222b is used to open or close the first channel d, and the second control component 223 is used to control the opening and closing member 222b to open the first channel d.

[0076] The third cavity c stores fluid. When a user presses the portion of the second elastic member 222a corresponding to the third cavity c, that portion deforms, reducing the volume of the third cavity c and causing the fluid in the third cavity to drain. This pushes the opening and closing member 222b toward the second cavity b, opening the first channel d and allowing the fluid in the third cavity c to enter the first cavity a through the first channel d, the second cavity b, and the first connecting tube 221. After the fluid has drained into the first cavity a, the user can stop pressing. At this point, the volume of the third cavity c is restored to a negative pressure state, and the opening and closing member 222b is attracted to close the first channel d, preventing the fluid in the first cavity a from flowing back into the third cavity c. This allows the first cavity a to remain filled, thereby maintaining the squeezing and urinary control effect of the pressing assembly 120 on the urethra 400. When urination is required, the second control component 223 controls the opening and closing member 222b to open the first channel d, so that the fluid is affected by the negative pressure of the third cavity c and is sucked out of the first cavity a and returns to the third cavity c.

[0077] In some embodiments, in order to ensure that the fluid is discharged into and out of the first cavity a more smoothly, the second cavity b can be arranged above the third cavity c, and the volume of the second cavity b is smaller than that of the third cavity c.

[0078] In some embodiments, the second control assembly 223 includes a second connecting tube 223a, a third elastic member 223b, and a fourth pulling member 223c. One end of the second connecting tube 223a is connected to the third elastic member 223b, while the other end communicates with the second cavity b. One end of the fourth pulling member 223c is connected to the third elastic member 223b, while the other end of the fourth pulling member 223c passes through the second connecting tube 223a and connects to the opening and closing member 222b. The third elastic member 223b may be a solid elastic member. The fourth pulling member 223c may comprise a rope with a certain tensile strength. The second connecting tube 223a is used to control the position of the fourth pulling member 223c. A user can press the third elastic member 223b, causing it to deform, which in turn causes the fourth pulling member 223c to pull the opening and closing member 222b, thereby opening the first channel d.

[0079] refer to Figure 15 、 Figure 16In some embodiments, the opening and closing member 222b is tapered, with the tip of the opening and closing member 222b facing and located within the first channel d. The fourth pulling member 223c is connected to the end of the opening and closing member 222b where the cross-section gradually increases. The portion of the opening and closing member 222b with the largest cross-section can completely cover the end surface of the first channel d connecting to the second cavity b. After the second control assembly 223 controls the opening and closing member 222b to open the first channel d, the tip of the opening and closing member 222b remains within the first channel d. In this embodiment, due to the tapered design, the first channel d can be opened and the fluid can be discharged into or out of the third cavity c by simply moving the portion of the opening and closing member 222b with the largest cross-section away from the connection between the first channel d and the second cavity b. This does not require the opening and closing member 222b to completely disengage from the first channel d, thus facilitating the opening and closing member 222b to re-block the first channel d.

[0080] In some embodiments, a partition b1 is provided in the second cavity b, and a through hole is provided on the partition b1. The central axis of the through hole coincides with the center of the end face of one end of the first channel d connected to the second cavity b, and the fourth pulling member 223c passes through the second connecting tube 223a and the through hole in sequence and is connected to the center of the end where the cross section of the opening and closing member 222b gradually increases. The partition is used to limit the position of the opening and closing member 222b without hindering the discharge of fluid, so as to prevent the opening and closing member 222b from moving to other positions with the fluid. In some embodiments, the diameter of the through hole is smaller than the maximum diameter of the opening and closing member 222b to prevent the opening and closing member 222b from passing through the through hole. The distance from the partition b1 to the interface between the first channel d and the second cavity b is smaller than the length of the opening and closing member 222b, so that the first channel d can be opened (such as Figure 15 ) or closed (as shown Figure 16 As shown), the tip of the second cavity b can always be located in the first channel d.

[0081] In some embodiments, the barrier b1 is a cross-shaped structure with four sides, and the through-hole is located at the intersection of the cross. Of course, the barrier b1 can also be a structure with three intersecting sides, as long as it can prevent the opening and closing member 222b from being completely pulled out of the first channel d and does not block the passage of fluid in the second cavity b.

[0082] refer to Figure 17 、 Figure 18In some embodiments, the hydraulic control assembly 220 includes a third connecting pipe 224, a control box 225 and a third control assembly 226. The third connecting pipe 224 connects the control box 225 and the first cavity a. The third control assembly 226 is arranged on the control box 225. A fifth cavity i with a variable volume is provided in the third control assembly 226. A fourth cavity e with a variable volume is provided in the control box 225. The bottom of the fourth cavity e includes a retractable part e1. The volume of the fourth cavity e is changed by the extension and contraction of the retractable part e1. The control box 225 is also provided with a second channel f, a third channel g and a fourth channel h; the second channel f is provided with a first one-way valve f1, and the The second channel f connects the fifth cavity i and the third connecting tube 224, and the first one-way valve f1 is used to control the fluid to flow only to the fifth cavity i; the second one-way valve g1 is installed in the third channel g, and the third channel g connects the fourth cavity e and the fifth cavity i, and the second one-way valve g1 is used to control the fluid to flow only to the fourth cavity e; the fourth channel h connects the fourth cavity e and the third connecting tube 224; the third control component 226 controls the flow of fluid in the first cavity a, the fourth cavity e, the fifth cavity i, the third connecting tube 224, the second channel f, the third channel g, and the fourth channel h, thereby controlling the pressure of the pressing component 120 on the urethra.

[0083] Figure 18 A schematic diagram of the hydraulic control assembly 220 in the urine control state shows the first cavity a filled with fluid, and the pressing assembly 120 fully compresses the urethra 400. The fourth cavity e is at its minimum volume. The retractable element e1 is an elastic retractable element and is in its initial state. The fifth cavity i within the third control assembly 226 is also filled with fluid.

[0084] If the user needs to urinate, he or she can press the third control component 226. The third control component 226 is made of elastic material and deforms when pressed by the user. Figure 18 The raised state shown changes to Figure 19 The volume of the fifth cavity i decreases, which in turn reduces the volume of the fifth cavity i. The volume of the fifth cavity i decreases, which causes the fluid in the fifth cavity i to be discharged. Due to the limitation of the first one-way valve f1, the fluid discharged from the fifth cavity i can only be discharged according to Figure 19In the direction indicated by the red arrow, the fluid flows into the fourth cavity e through the third channel g. Due to the pressure of the user pressing the third control component 226 and the gravity of the fluid flowing into the fourth cavity e, the retractable member e1 is compressed, and the volume of the fourth cavity e increases, thereby facilitating the discharge of the fluid into the fourth cavity e. After the fluid in the fifth cavity i is completely discharged, the user stops pressing, and the third control component 226 returns to its original state (as shown in FIG. Figure 20 As shown in the convex state), the volume of the fifth cavity i is restored. At this time, the fifth cavity i is in a negative pressure state, and the fluid in the first cavity a is attracted. Figure 20 In the direction indicated by the red arrow, the fluid flows into the fifth cavity i through the third connecting tube 224 and the second channel f. At this time, the fluid in the first cavity a is discharged, the pressing assembly 120 is recessed toward the base 110, and the pressure on the urethra 400 is reduced, entering the urination state.

[0085] Then, urine control begins to recover. Since the user no longer presses and there is no fluid in the first cavity a, the gravity of the fluid in the fourth cavity e is less than the elastic force of the retractable member e1. The retractable member e1 begins to stretch to restore its initial state, and the volume of the fourth cavity e becomes smaller, prompting the fluid in the fourth cavity e to be discharged. Limited by the second one-way valve g1, and the presence of liquid in the fifth cavity i and the second channel f, the fluid discharged from the fourth cavity e can only be discharged according to Figure 21 The liquid flows in the direction indicated by the red arrow through the fourth channel h and the third connecting tube 224 and is discharged into the first cavity a. The first cavity a is filled with fluid again, and the urine enters the urine control state.

[0086] In some embodiments, the pressing component 120 is made of silicone.

[0087] In some embodiments, during urination, after the pressing component 120 moves the maximum distance away from the urethra, the pressing component 120 and the urethra are in a state of just contact (contact and no force) or slightly away from each other.

[0088] It is obvious to those skilled in the art that the present application is not limited to the details of the above-mentioned exemplary embodiments, and that the present application can be implemented in other specific forms without departing from the spirit or basic characteristics of the present application. Therefore, from any point of view, the embodiments should be regarded as exemplary and non-restrictive, and the scope of the present application is defined by the appended claims rather than the above description, and it is intended that all changes that fall within the meaning and scope of the equivalent elements of the claims are included in the present application. Any figure mark in the claims should not be regarded as limiting the claims involved. In addition, it is obvious that the word "comprising" does not exclude other units or steps, and the singular does not exclude the plural. Multiple units or devices stated in the device claim can also be implemented by one unit or device through software or hardware. Words such as "first" and "second" are used to indicate names and do not indicate any particular order.

Claims

1. An artificial sphincter device, characterized in that: The artificial sphincter device comprises: A pressing unit, comprising a base, a pressing assembly, and a fixing assembly, wherein the fixing assembly is mounted on the pubic bone, the fixing assembly is fixedly connected to the base, the base is used to carry the pressing assembly, and the pressing assembly is used to press the urethra; A control unit is used to control the pressure of the pressing component on the urethra.

2. The artificial sphincter device according to claim 1, wherein The fixing assembly includes at least one pair of fixing members.

3. The artificial sphincter device according to claim 1 or 2, characterized in that The control unit includes a magnetoelectric control component, which includes a battery control component, a magnetic control component, a support component and a first pulling component; The magnetic control component is mounted on the base, the support component is mounted on the magnetic control component, the pressing component is mounted on the support component, the first pulling component connects the battery control component and the magnetic control component, the battery control component is used to control the current on and off, so that the first pulling component pulls the magnetic control component or gradually releases the pulling force on the magnetic control component. The first pulling component pulls the magnetic control component to move, the magnetic control component drives the supporting component to move, and the supporting component drives the pressing component to move away from the urethra. The first pulling component gradually releases the pulling force on the magnetic control component, and the magnetic control component resets under the action of its own magnetic force, and the supporting component drives the pressing component to move toward the urethra.

4. The artificial sphincter device according to claim 3, wherein: A first groove is provided on the base, and the magnetic control component includes a first magnetic part and a second magnetic part, and the first magnetic part and the second magnetic part are installed in the first groove. The first pulling component includes a first pulling part and a second pulling part, and the magnetic poles of the first magnetic part and the second magnetic part that are close to each other are different. The end of the first magnetic part away from the second magnetic part is connected to one end of the first pulling part, and the other end of the first pulling part is connected to the battery control component. The end of the second magnetic part away from the first magnetic part is connected to one end of the second pulling part, and the other end of the second pulling part is connected to the battery control component.

5. The artificial sphincter device according to claim 3 or 4, characterized in that: The first pulling component is made of a material including shape memory alloy.

6. The artificial sphincter device according to claim 4, wherein: The pressing assembly includes a first pressing member, the supporting assembly includes a first supporting member, the first supporting member includes two supporting components, one end of the two supporting components are installed on the first pressing member, and the other ends of the two supporting components are respectively installed on the first magnetic member and the second magnetic member.

7. The artificial sphincter device according to claim 6, wherein: The pressing assembly further includes one or more second pressing members, and the supporting assembly further includes one or more corresponding elastic second supporting members, each of the second pressing members is respectively mounted on one of the second supporting members, and the one or more second supporting members are mounted on the first magnetic member or the second magnetic member; The magnetoelectric control assembly further includes a second pulling assembly, which includes one or more third pulling members, each of which is connected to the battery control assembly and one of the second pressing members. The battery control assembly controls the on and off of current so that the one or more third pulling members respectively pull the corresponding second supporting member or gradually release the pulling force on the second supporting member. Each second support member is deformed under the pull of the corresponding third pulling member, driving the corresponding second pressing member to move away from the urethra. After the pulling force of the corresponding third pulling member is gradually released, the second support member is reset under its own elastic force, driving the corresponding second pressing member to move toward the urethra.

8. The artificial sphincter device according to any one of claims 3 to 7, characterized in that The supporting component is made of elastic material.

9. The artificial sphincter device according to any one of claims 3 to 8, characterized in that The battery control assembly includes a battery and a switch, and the switch includes a first elastic member with built-in switch contacts.

10. The artificial sphincter device according to claim 1 or 2, characterized in that The control unit includes a hydraulic control assembly; A first cavity is formed between the pressing assembly and the base; The hydraulic control component is used to control the fluid to be discharged into or out of the first cavity, thereby pushing the pressing component to move toward or away from the urethra to change the pressure of the pressing component on the urethra.

11. The artificial sphincter device according to claim 10, wherein: A second groove is provided on the base, and a first cavity is formed between the pressing component and the second groove. The part of the pressing component that cooperates with the second groove is elastic. The part of the pressing component that cooperates with the second groove is recessed toward the second groove when not subject to external force, and convex in the direction away from the second groove when subjected to pressure from the fluid in the first cavity.

12. The artificial sphincter device according to claim 10 or 11, characterized in that The hydraulic control component includes a first connecting pipe, a first control component and a second control component. The first control component is connected to the first cavity through the first connecting pipe, and the second control component is connected to the first control component. The first control component is used to store fluid and control the fluid to flow unidirectionally from the first control component through the first connecting pipe into the first cavity. The second control component is used to control the fluid to flow from the first cavity back to the first control component through the first connecting pipe.

13. The artificial sphincter device according to claim 12, wherein: The first control component includes a second elastic member and an opening and closing member. A second cavity, a third cavity and a first channel are provided in the second elastic member. The second cavity is connected to the first cavity through the first connecting pipe, and the third cavity is connected to the second cavity through the first channel. The opening and closing member is used to open or close the first channel, and the second control component is used to control the opening and closing member to open the first channel.

14. The artificial sphincter device according to claim 13, wherein: The second control component includes a second connecting tube, a third elastic member and a fourth pulling member, one end of the second connecting tube is connected to the third elastic member, the other end of the second connecting tube is communicated with the second cavity, one end of the fourth pulling member is connected to the third elastic member, and the other end of the fourth pulling member passes through the second connecting tube and is connected to the opening and closing member.

15. The artificial sphincter device according to claim 14, wherein: The opening and closing member is conical, and the tip of the opening and closing member is directed toward and located in the first channel. The fourth pulling member is connected to the end of the opening and closing member where the cross-section gradually increases. The part with the largest cross-section of the opening and closing member can completely cover the end face of the first channel connected to the second cavity. After the second control component controls the opening and closing member to open the first channel, the tip of the opening and closing member is still located in the first channel.

16. The artificial sphincter device according to claim 15, wherein: A partition is provided in the second cavity, and a through hole is provided on the partition. The central axis of the through hole coincides with the center of the end face of one end of the first channel connected to the second cavity. The fourth pulling member passes through the second connecting tube and the through hole in sequence and is connected to the center of the end of the opening and closing member whose cross section gradually becomes larger.

17. The artificial sphincter device according to claim 10 or 11, characterized in that The hydraulic control assembly includes a third connecting pipe, a control box, and a third control assembly. The third connecting pipe connects the control box and the first cavity. The third control assembly is disposed on the control box. A fifth cavity with a variable volume is disposed in the third control assembly. A fourth cavity with a variable volume is disposed in the control box. The bottom of the fourth cavity includes a retractable member. The volume of the fourth cavity is changed by retracting and retracting the retractable member. The control box also includes a second channel, a third channel, and a fourth channel. A first one-way valve is provided in the second channel, the second channel connects the fifth cavity and the third connecting pipe, and the first one-way valve is used to control the fluid to flow only into the fifth cavity; a second one-way valve is installed in the third channel, the third channel connects the fourth cavity and the fifth cavity, and the second one-way valve is used to control the fluid to flow only into the fourth cavity; the fourth channel connects the fourth cavity and the third connecting pipe; The third control component controls the flow of fluid in the first cavity, the fourth cavity, the fifth cavity, the third connecting tube, the second channel, the third channel, and the fourth channel, thereby controlling the pressure of the pressing component on the urethra.

18. The artificial sphincter device according to any one of claims 1 to 17, characterized in that The pressing component is made of silicone.

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