An in-vivo artificial urinary sphincter device

Abstract

The invention discloses an in vivo artificial urethral sphincter device, which has a relatively simple structure and is mainly divided into three parts: a liquid controller, a sealing connector, and a locking member. It has no redundant devices, is relatively small in size, and has little surgical trauma.

Description

Technical Field

[0001] The invention relates to an in-vivo artificial urethral sphincter device, which is used for controlling the expansion and contraction of the urethra and belongs to the field of medical devices. Background Art

[0002] Urinary incontinence is a common disease among middle-aged and elderly people. Many patients have to wear diapers or disposable diapers for a long time, which seriously affects the quality of life of patients. At present, artificial urinary sphincter implantation is the gold standard for treating moderate to severe urinary incontinence in men, but the artificial urinary sphincter has a complex structure and is very expensive. It is easy to cause infection and rejection when it remains in the human body. Other treatment methods, such as the common penis clamp, require the entire penis to be completely tied up. Long-term use can cause chronic damage such as penile tumors. The present invention discloses a urethral control device with a relatively simple structure. It is mainly divided into three parts: a liquid controller, a sealing connector, and a locking member. There are no redundant devices, and the volume is relatively small, the surgical operation can be simplified, and the trauma is less. Summary of the invention

[0003] The present invention provides an in vivo artificial urinary sphincter device, characterized in that it comprises three parts, a first part, a liquid controller, a second part, a sealing connector, and a third part, a locking member; wherein the sealing connector is a pipeline connecting the liquid controller and the locking member; the locking member comprises a hard shell and an elastic bag; the sealing connector is connected to the elastic bag of the locking member; the liquid controller can control the volume change of internal water under the action of external force, thereby controlling the pressure in the elastic bag; the liquid controller comprises a liquid storage chamber, a push rod, a push rod spring, and a manual pressing part; the manual pressing part controls the movement of the push rod through the force of the hand, thereby controlling the volume of water inside the liquid controller.

[0004] According to a preferred embodiment, the liquid controller includes a liquid storage chamber, an intermediate chamber, a piston, a push rod spring, a push rod, an auxiliary stopper, an elastic shell, and a tail end; wherein the push rod spring surrounds the push rod; and the push rod is fixedly connected to the tail end.

[0005] According to a preferred embodiment, an intermediate baffle is further included to provide support for the push rod spring.

[0006] According to a preferred embodiment, the push rod has a protruding portion, and the middle baffle has a corresponding notch.

[0007] According to a preferred embodiment, the push rod spring is located in the intermediate chamber.

[0008] According to a preferred embodiment, the piston is used to push the liquid in the liquid storage chamber; one end of the push rod is connected to the piston, and the other end is connected to the tail end, so as to control the movement of the piston.

[0009] According to a preferred embodiment, when the tail end is rotated, the push rod rotates; through the rotation, the protrusion on the push rod passes through the notch on the middle baffle plate and clamps the push rod.

[0010] According to a preferred embodiment, a rubber sealing plug is further included, which is located on the housing of the liquid controller and is used for adding liquid.

[0011] According to a preferred embodiment, the locking member comprises a hard shell and an elastic bag. One side of the elastic bag is tightly connected to the hard shell, and the hard shell provides the elastic bag with the tension required for fixation and deformation.

[0012] According to a preferred embodiment, the width of the hard shell is 0.5-4 cm, preferably 0.5-2.5 cm; the length of the hard shell is 2-11 cm, preferably 3-8 cm; the thickness of the hard shell is 0.05-0.5 cm, preferably 0.1-0.3 cm.

[0013] According to a preferred embodiment, the hard shell has a strong deformation ability, and there are fixed interfaces at both ends to connect the head and tail to form a ring; the hard shell and the connecting piece are combined together to form an L shape;

[0014] According to a preferred embodiment, the hard shell should have head and tail fixing devices, which can be fixed by biological glue or mechanical fixation, preferably circular or elliptical fixing holes and fixing parts, the maximum diameter of the fixing holes is 0.2-0.5 cm, the fixing parts are cylindrical or elliptical or other shapes protruding from the surface of the hard shell, with a height of 0.2-0.5 cm and a diameter consistent with the fixing holes.

[0015] According to a preferred embodiment, the elastic bladder has a strong deformation ability, and the contraction and expansion of the elastic bladder can produce a pressure change of 0-70cmH2O on the urethra, thereby controlling the closing and opening of the urethra.

[0016] According to a preferred embodiment, the elastic bag is an elastic silicone rubber cuboid tightly connected to the hard shell, with a length of 0.9-9 cm, a width of 0.3-3 cm, and a thickness of 0.15-1.2 cm; preferably, the length is 2.5-8.5 cm, the width is 0.4-2 cm, and the thickness is 0.2-1 cm.

[0017] According to a preferred embodiment, the sealing connector of the artificial urinary sphincter device is a cylindrical hollow pipe, and the sealing connector has a certain deformation ability, and its main function is to guide the free flow of liquid between the first part of the liquid controller and the third part of the locking member, and ensure the liquid seal; different lengths of the sealing connector are selected according to the patient's physical parameters and the surgical procedure. The length of the sealing connector is 5-30cm, and the preferred length is 8-20cm.

[0018] The present invention discloses an artificial urethral sphincter device, which is also an artificial internal urethral tube control device for controlling the switch of the urethra. It mainly includes three parts, a liquid controller, a sealing connector and a locking member. Compared with the current artificial urethral sphincter, it no longer includes an additional large-volume balloon-type water storage device. The patent has a simple structure, and the wound caused during surgery is smaller, which is conducive to postoperative recovery. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 .Schematic diagram of liquid controller;

[0020] Figure 2 .Schematic diagram of urethral control device;

[0021] Figure 3 .Improved push rod structure diagram;

[0022] Figure 4 .Improved baffle structure diagram;

[0023] Figure 5 .Schematic diagram of improved liquid controller;

[0024] Figure 6 .Schematic diagram of the push rod and push rod connector. DETAILED DESCRIPTION

[0025] In the description of the present invention, 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", "axial", "radial", "circumferential", "vertical", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying 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 the present invention. In addition, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, unless otherwise specified, "multiple" means two or more.

[0026] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0027] The urethra control device designed in the present invention is a device for use in the human body. Specifically, the device is implanted in the body of a corresponding patient through surgery. The device is manually controlled, avoiding the complex design of an electric device and does not require charging. By manually pressing, the overall pressure in the device can be controlled, thereby controlling the opening and closing of the urethra.

[0028] The present invention provides an artificial urethral sphincter device, characterized in that it includes three parts, a first part, a liquid controller, a second part, a sealing connector, and a third part, a locking member; wherein the sealing connector is a pipeline connecting the liquid controller and the locking member; the locking member includes a hard shell and an elastic bag; the sealing connector is connected to the elastic bag of the locking member; the liquid controller can control the volume change of internal water under the action of external force, thereby controlling the pressure in the elastic bag; the liquid controller includes a liquid storage chamber, a push rod, a push rod spring, and a manual pressing part; the manual pressing part controls the movement of the push rod through the force of the hand, thereby controlling the volume of water inside the liquid controller.

[0029] The function of the liquid controller is to control the liquid by manually pressing or other operations to make the locking member contract or expand.

[0030] In the present invention, the pressure of the device is controlled within the range of 40-70 cm water pressure by controlling the amount of liquid. The pressure refers to relative pressure. The thickness of the urethra of different people is different. In order to better control urination, the conventional locking member generally needs to retain a larger margin.

[0031] The locking member in the present invention may also be referred to as a locking device or a locking apparatus, which is used to compress the urethra to close the urethra, thereby controlling urinary incontinence.

[0032] The liquid controller includes a rubber sealing port and a pressure regulating chamber. The sealing port is made of rubber material, and liquid can be injected into the liquid controller through the port with a syringe, and a permanent seal is automatically formed after the syringe needle is pulled out. The pressure regulating chamber is used to adjust the overall pressure of the control device.

[0033] The liquid controller is a flat structured capsule-shaped object that holds water and is used to control water pressure. The most important part of a liquid controller is the part that controls the water volume.

[0034] Example 1

[0035] Provide another design method. Figure 1 As shown:

[0036] Among them, part 101 is the interface pipeline part connected to the sealing connector, 102 is the liquid storage chamber, 103 is the intermediate chamber, 104 is the piston, 105 is the push rod spring, 106 is the push rod, 107 is the auxiliary stopper, 108 is the elastic shell, and 109 is the tail end.

[0037] The interface pipe part 101 connected to the sealing connector is used to connect to the sealing connector and communicate the stored liquid.

[0038] The liquid storage chamber 102 is used to store sterile physiological saline solution.

[0039] The function of the middle chamber 103 is to provide a space for the push rod spring to move.

[0040] The function of the piston 104 is to move along the chamber formed by the housing and maintain a seal.

[0041] The function of the push rod spring 105 is to provide elastic force.

[0042] The push rod 106 serves to connect to the piston.

[0043] The auxiliary stopper 107 is used to provide support for hand pressure, so that when the hand is pressed down, the tail end moves toward the right side in the figure.

[0044] When a force is applied, the elastic housing 108 will deform and maintain a seal.

[0045] The tail end 109 is where the push rod 106 is fixed.

[0046] The middle baffle 110 is a middle baffle.

[0047] When in use, the finger presses the position of the elastic shell 108, and under the force of the finger, the shape of the elastic shell 108 changes along the auxiliary stopper 107, so that the cavity where the auxiliary stopper 107 is located becomes larger, and the tail end 109 moves along the direction of the force. Figure 1 The push rod 106 connected to the tail end 109 moves to the right, causing the push rod 106 connected to the tail end 109 to move to the right. Since the push rod 106 is connected to the piston 104, the piston 104 moves to the right, causing the liquid storage chamber 102 to become larger, and the liquid in the entire liquid control device flows toward the liquid storage chamber 102.

[0048] The entire liquid controller can be in the shape of a long, slightly flat strip or an elliptical cylinder, preferably a long, slightly flat strip. In the elastic shell 108, pressure can be provided by pressing by hand to change the volume of the stored liquid inside the entire system, thereby causing the stored liquid to flow out or in.

[0049] The overall schematic diagram of the urethral control device is shown in Figure 2. Among them, 10 is a liquid controller, 11 is a sealing connector, 12 is a hard shell, and 13 is an elastic sac. Among them, the hard shell 12 and the elastic sac 13 are combined to form a locking member. The hard shell 12 and the elastic sac 13 are tightly connected. The liquid controller 10 is used to control liquid. The sealing connector 11 is used to connect the liquid controller 10 and the elastic sac 13. When the pressure in the liquid controller 10 increases, the liquid flows from the elastic sac 13 to the liquid controller 10. When the pressure in the liquid controller 10 decreases, the liquid flows from the liquid controller 10 to the elastic sac 13, causing the elastic sac 13 to expand. The elastic sac 13 is an annular or nearly annular structure, with a urethral tube in the middle, and the opening and closing of the urethral tube are controlled by the filled or empty state.

[0050] Example 2

[0051] Provided is an improved design of a liquid controller. According to the liquid controller described in Example 1. In actual clinical practice, especially in the early stage of surgery, the elastic bag of the urethral control device is required to be in an empty state to keep the urethra in an open state. Under such actual demand, the elastic bag 13 of the liquid controller is in a state of no pressure or weak pressure for a long time. This embodiment provides a design for adjusting the state of the liquid controller. See Figure 3 and Figure 4 . Figure 3 is an improved state of the push rod 106, Figure 4 It is an improved state of the middle baffle 110 . Figure 3 In the embodiment, there is a protruding portion on the push rod 106 , which is used to cooperate with the middle baffle 110 to control the push rod 106 . Figure 4 In the middle baffle 110, there is a notch adapted to the protruding portion of the push rod 106. When the push rod moves in the correct direction, the protruding portion above can pass through the middle baffle 110. After the push rod 106 passes through the middle baffle 110, it only needs to rotate a certain angle to make the push rod 106 stuck and unable to move to the left.

[0052] For further improvement, the middle baffle 110 can be designed with a groove on the right side of the notch. Figure 3 The middle protrusion is stuck in the recess, or protrudes, to prevent the push rod 106 from sliding easily, causing the push rod 106 to return to its original position instead of closing the urethra as planned.

[0053] The design position of the protrusion on the push rod 106 is determined according to the pressure and the overall system. Figure 3 and Figure 4 The structure in is used for Figure 1The liquid controller in the embodiment of the present invention; wherein the volume of the liquid storage chamber 102 is 2-5 ml, and the movement limit length of the push rod 106 is 1-3.5 cm. The size of the liquid storage chamber 102 device is 3.5-6.5 cm in length, 1-2 cm in thickness, and 1-2 cm in width. More preferably, the length of the entire device is 3.8 cm, the thickness is 1.5 cm, and the width is 2 cm.

[0054] Example 3

[0055] According to the liquid controller described in Example 1 or Example 2. In actual clinical practice, it is necessary to easily add a certain amount of liquid to the liquid controller, generally sterile saline. Then it is necessary to add a certain amount of liquid to the water storage elastomer of Example 1 or the liquid storage chamber of Example 2 according to the needs. A common design method is to pre-set a rubber sealing device in the outer shell of a suitable area connected to the liquid storage chamber. The rubber sealing device is elastic rubber. The needle of the syringe can be inserted from the rubber sealing device to inject water. When the needle of the syringe is pulled out, the rubber sealing device will seal the hole formed by the needle due to its own elastic force. The rubber sealing device is a rubber sealing plug. The overall device is sealed, and liquid will not penetrate or flow out.

[0056] Example 4

[0057] Another solution of the structure of the liquid controller is shown in Figure 5 .

[0058] Among them, part 201 is the interface pipe part connected to the outside, 202 is the water storage elastomer, 203 is the sliding track, 204 is the push plate, 205 is the push rod spring, 206 is the push rod, 207 is the push rod connector, 208 is the elastic shell, and 209 is the tail end.

[0059] The function of the interface pipe part 201 connected to the outside is to connect to the outside and communicate the stored liquid.

[0060] The water storage elastic body 202 has the functions of sealing, containing the stored liquid, and providing a deformable bladder.

[0061] The sliding track 203 provides a track for the push rod 206 .

[0062] The push plate 204 is used to squeeze the water storage elastic body 202 .

[0063] The push rod spring 205 provides the pushing force.

[0064] The push rod 206 is used to be connected to the push plate 204 .

[0065] The push rod connector 207 cooperates with the push rod 206 to move the push plate 204 along the sliding track 203 .

[0066] The elastic shell 208 will deform when a force is applied.

[0067] The tail end 209 is also the location where the push rod connector 207 is fixed.

[0068] The entire liquid controller can be in the shape of a slightly flattened strip, or an elliptical cylinder. In the elastic shell 208, pressure can be provided by pressing by hand to change the volume of the stored liquid inside the entire system, thereby causing the stored liquid to flow out or in.

[0069] The schematic diagram of the push rod 206 and the push rod connector 207 is shown in Figure 6 ; The left side is the push rod 206, and the right side is the push rod connector 207. The push rod 206 is tightly connected with the push rod connector 207, and the push rod 206 can move along its axial direction. Figure 5 In the liquid controller, when the elastic housing 208 is pressed by hand, the tail end 209 moves to the right, the elastic force of the push rod spring 205 decreases, resulting in a decrease in the pressure on the water storage elastic body 202, and liquid flows in.

[0070] Those skilled in the art can understand that when the structures are similar, those skilled in the art can make adjustments or technical combinations within the scope of the present invention. The components disclosed in the present invention should not be viewed separately.

[0071] The above is only a preferred specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the present invention should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention shall be based on the protection scope of the claims.

Claims

1. An in vivo artificial urinary sphincter device, characterized in that: include: Locking parts, sealing connections and liquid controllers; The locking member includes a hard shell and an elastic bag, wherein the hard shell is used to fix the elastic bag, and the hard shell is bent to make the elastic bag annular to maintain the tension of the elastic bag, and the elastic bag is used to directly contact the urethra to control the opening and closing of the urethra through deformation; The sealing connection piece is a cylindrical hollow pipe connecting the elastic bag of the liquid controller and the locking piece, and is used to guide the free flow of liquid between the liquid controller and the locking piece and ensure sealing; The liquid controller comprises a liquid storage chamber, a piston, a push rod, a tail end, an auxiliary stopper and an elastic shell. The liquid controller is used to control the volume change of the internal water under the action of an external force, thereby controlling the pressure in the elastic bag to contract or relax the locking member. The piston is used to push the liquid in the liquid storage chamber. When in use, the elastic shell is pressed by a finger. Under the force of the finger, the shape of the elastic shell changes along the auxiliary block, so that the chamber where the auxiliary block is located becomes larger, and the tail end moves to the right, causing the push rod connected to the tail end to move to the right, and the piston connected to the push rod moves to the right, and the liquid storage chamber becomes larger; The liquid controller further comprises an intermediate chamber, a push rod spring and an intermediate baffle, wherein the push rod spring is located in the intermediate chamber and surrounds the push rod, and the intermediate baffle is used to provide support for the push rod spring; When the tail end is rotated, the push rod rotates; through the rotation, the protrusion on the push rod passes through the notch on the middle baffle plate and clamps the push rod.

2. The artificial urinary sphincter device according to claim 1, characterized in that: Also includes: A rubber sealing plug is arranged on the outer shell in the area connected to the liquid storage chamber and is used for adding liquid into the liquid storage chamber.

3. The artificial urinary sphincter device according to claim 1, characterized in that: The hard shell is in the shape of an elongated strip and has the ability to be deformed. There are fixed interfaces at both ends to connect the ends to form a ring. The hard shell and the sealing connector are combined together to form an L shape.

4. The artificial urinary sphincter device according to claim 1, characterized in that: The hard shell is a long strip of woven composite material with a width of 0.5-4 cm, a thickness of 0.05 cm-0.5 cm, and a length of 2-11 cm. There are circular or elliptical fixing holes on the hard shell, and the maximum diameter of the holes is 0.1-1 cm. There are fixing parts corresponding to the fixing holes on the hard shell, and the fixing parts are cylindrical or elliptical protruding from the surface of the hard shell, with a height of 0.2-1 cm, and the diameter or maximum diameter is consistent with the fixing hole.

5. The artificial urinary sphincter device according to claim 1, characterized in that: The elastic bag is an elastic silicone rubber cuboid tightly connected to the hard shell, with a length of 0.9-9 cm, a width of 0.3-3 cm, and a thickness of 0.15-1.2 cm.

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