CN114099064A

CN114099064A - Internal artificial urethra sphincter device

Info

Publication number: CN114099064A
Application number: CN202111495237.8A
Authority: CN
Inventors: 张耀光; 王建业; 刘晓东
Original assignee: Beijing Hospital
Current assignee: Beijing Hospital
Priority date: 2021-12-09
Filing date: 2021-12-09
Publication date: 2022-03-01

Abstract

The invention discloses an in-vivo artificial urethral sphincter device which is relatively simple in structure, mainly comprises three parts, a liquid controller, a sealing connecting piece and a locking piece, has no redundant device, is relatively small in volume and has small operation wound.

Description

Internal artificial urethra sphincter device

Technical Field

The invention relates to an in-vivo artificial urethral sphincter device, which is used for controlling the relaxation and contraction of urethra and belongs to the field of medical instruments.

Background

Urinary incontinence is a common disease of middle-aged and elderly people, and many patients have to wear diapers or paper diapers for a long time, which seriously affects the quality of life of the patients. At present, the implantation of the artificial urethral sphincter is the gold standard for treating the severe urinary incontinence in men, but the artificial urethral sphincter has a complex structure and high cost, and the artificial urethral sphincter is easy to cause infection, rejection and the like when remaining in a human body. Other treatments, such as the common penile clamp, require complete bundling of the entire penis, which can lead to chronic injuries such as penile tumors over time. The invention discloses a urethral control device which is relatively simple in structure, mainly comprises three parts, a liquid controller, a sealing connecting piece and a locking piece, is free of redundant devices, is relatively small in size, can simplify surgical operation and is less in wound.

Disclosure of Invention

The invention provides an in vivo artificial urethral sphincter device, which is characterized by comprising three parts, a first part liquid controller, a second part sealing connecting piece and a third part locking piece; the sealing connecting piece is a pipeline for connecting the liquid controller and the locking piece; the locking piece comprises a hard shell and an elastic bag; the sealing connecting piece is connected to the elastic bag of the locking piece; the liquid controller can control the volume change of the internal water under the action of external force, thereby controlling the pressure in the elastic bag; the liquid controller comprises a liquid storage cavity, a push rod spring and a manual pressing part; the manual pressing portion controls the movement of the push rod by the force of the hand, thereby controlling the volume of water inside the fluid controller.

According to a preferred embodiment, the fluid controller comprises a fluid storage chamber, an intermediate chamber, a piston, a push rod spring, a push rod, an auxiliary stop block, an elastic shell and a tail end; wherein the push rod spring surrounds the push rod; the push rod is fixedly connected with the tail end.

According to a preferred embodiment, an intermediate baffle is further included for providing support for the pusher spring.

According to a preferred embodiment, the push rod has a raised portion and the intermediate baffle has a corresponding notch.

According to a preferred embodiment, the pusher spring is located in the intermediate chamber.

According to a preferred embodiment, the piston is adapted to push liquid in the reservoir chamber; one end of the push rod is connected with the piston, and the other end of the push rod is connected with the tail end and used for controlling the piston to move.

According to a preferred embodiment, when rotating the tail end, the push rod rotates; through rotation, the protrusion on the push rod passes through the notch on the middle baffle plate to clamp the push rod.

According to a preferred embodiment, a rubber sealing plug is also included on the housing of the fluid controller for adding fluid.

According to a preferred embodiment, the retaining member comprises a rigid outer shell and an elastic bladder. One side of the elastic bag is tightly connected with the hard shell, and the hard shell provides tension required for fixing and deforming the elastic bag.

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.

According to the preferred embodiment, the hard shell has strong deformability, and the two ends of the hard shell are provided with fixed interfaces so as to be connected end to form a ring shape; the hard shell and the connecting piece are combined together to form an L shape;

according to a preferred embodiment, the hard shell is provided with an end-to-end fixing device, the end-to-end fixing can be realized by biological glue or mechanical fixing, a preferred circular or elliptical fixing hole and a fixing piece are provided, the maximum diameter of the fixing hole is 0.2-0.5 cm, the fixing piece is in a cylindrical or elliptical cylindrical shape or other shapes, protrudes out of the surface of the hard shell, the height is 0.2-0.5 cm, and the diameter is consistent with the fixing hole.

According to a preferred embodiment, the elastic bag has strong deformation capacity, and the urethra can be contracted and expanded to 0-70cmH₂The pressure of O varies, thereby controlling the closing and opening of the urethra.

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

According to a preferred embodiment, the sealing connecting piece of the artificial urethral sphincter device is a cylindrical hollow pipeline, and has certain deformation capacity and the main functions of guiding the free flow of liquid between the first part of liquid controller and the third part of locking piece and ensuring the liquid sealing; the sealing connecting pieces with different lengths are selected according to the physical parameters and the operation style of the patient. The length of the sealing connecting piece is 5-30cm, and the preferable length is 8-20 cm.

The invention discloses an artificial urethral sphincter device, in particular to an artificial internal urethral canal control device which is used for controlling the opening and closing of a urethra. The device mainly comprises three parts, a fluid controller, a sealing connecting piece and a locking piece. Compared with the current artificial urethral sphincter, the water storage device of the large-volume balloon type is not additionally included. This patent simple structure, the wound that causes in the operation is littleer, is favorable to the recovery of postoperative.

Drawings

FIG. 1 is a schematic view of a fluid controller;

figure 2. urethral control device schematic;

FIG. 3 is a structure diagram of an improved push rod;

FIG. 4 is a view of a modified baffle;

FIG. 5 is a schematic view of an improved fluid controller;

fig. 6 is a schematic view of a push rod and push rod connector.

Detailed Description

In the description of the present invention, it is to be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", "vertical", etc., indicate orientations or positional relationships based on those shown in the drawings, and are used merely for convenience of description and for simplicity of description, but do not indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be considered as limiting the present invention. Furthermore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the feature. In the description of the present invention, "a plurality" means two or more unless otherwise specified.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; may be a mechanical connection; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

The urethral control device designed in the present invention is a device for use in the human body. In particular, the device is surgically implanted within the body of the respective patient. The device is a manual control working mode, avoids the complex design of an electric device, and does not need to be charged. By way of manual compression, the overall pressure within the device can be controlled, thereby controlling the opening and closing of the urethra.

The invention provides an artificial urethral sphincter device, which is characterized by comprising three parts, namely a first part liquid controller, a second part sealing connecting piece and a third part locking piece; the sealing connecting piece is a pipeline for connecting the liquid controller and the locking piece; the locking piece comprises a hard shell and an elastic bag; the sealing connecting piece is connected to the elastic bag of the locking piece; the liquid controller can control the volume change of the internal water under the action of external force, thereby controlling the pressure in the elastic bag; the liquid controller comprises a liquid storage cavity, a push rod spring and a manual pressing part; the manual pressing portion controls the movement of the push rod by the force of the hand, thereby controlling the volume of water inside the fluid controller.

The fluid controller is used for controlling the fluid, and the locking piece is contracted or expanded through pressing and the like in a manual mode. Also, the fluid controller may preferably be designed to

In the invention, the pressure of the device is controlled to be 40-70cm of water pressure by controlling the liquid quantity. The pressure refers to the relative pressure. The degree of thickness of the urethra varies from person to person and the usual locking elements generally need to retain a greater margin for better control of urination.

The locking member of the present invention may also be referred to as a locking device, or locker, for compressing the urethra to close it, thereby controlling urinary incontinence.

The fluid controller comprises a rubber sealing port and a pressure adjusting chamber. Wherein the sealing port is of a rubber material from which fluid can be injected with a syringe into the fluid controller and automatically forms a permanent seal after the syringe needle is withdrawn. The pressure regulating chamber is used for regulating the overall pressure of the control device.

The fluid controller is a water-containing capsule-like object of flat structure, which is used for controlling the water pressure. The most important part in the fluid controller is the part that controls the volume of water.

Example 1

An alternative design is provided. As shown in fig. 1:

wherein, part 101 is the interface pipeline part that links to each other with sealing connection spare, 102 is the stock solution cavity, 103 is middle cavity, 104 is the piston, 105 is the push rod spring, 106 is the push rod, 107 is the auxiliary stop, 108 is the elasticity shell, 109 is the tail end.

101 is intended to be connected to a sealed connection and will communicate with the stored liquid.

102 serve to store sterile saline solution.

103 is used for providing a push rod spring moving space.

104 are intended to move along the chamber formed by the housing and to maintain the seal.

105 is to provide a spring force.

106 are for connection to the piston.

107 to provide hand support so that when the hand is pushed down, the tail end moves in the direction to the right in the figure.

108 are resilient shells that deform and maintain a seal when a force is applied.

109 is the tail end and also fixes the position of the push rod 106.

110 is an intermediate baffle.

When the finger presses the position 108, the shape of 108 changes along the auxiliary block 109 under the action of the finger, so that the chamber becomes larger, and the tail end 109 moves towards the right side of fig. 4 along the force direction, so that the push rod 106 connected with the tail end 109 moves towards the right. Since the push rod 106 is connected to the piston 104, the piston moves to the right, causing the reservoir chamber 102 to become larger and the fluid in the entire fluid control device to flow inwardly 102.

The entire fluid controller may be in the form of a somewhat flattened elongated or oval cylinder, preferably a somewhat flattened elongated shape, and may be manually pressed against a portion of the flexible housing to provide pressure to cause a change in the volume of stored fluid within the entire system, resulting in the flow of stored fluid out or in.

An overall schematic view of the urethral control device is shown in figure 2. Wherein, 10 is a liquid controller, 11 is a sealing connecting piece, 12 is a hard shell, and 13 is an elastic bag. Wherein the rigid shell 12 in combination with the resilient bladder 13 forms a locking member. The hard shell 12 is tightly connected with the elastic bag 13. Fluid controller 10 is used to control the fluid. The sealing connection 11 is used to connect the fluid controller to the elastomeric bladder 13. When the pressure in the fluid controller is reduced, fluid flows from the elastomeric bladder 13 into the fluid controller. When the pressure in the fluid controller rises, fluid flows from the fluid controller into the elastomeric bladder 13, causing the elastomeric bladder to expand. The elastic bag 13 is of an annular or nearly annular structure, and a urethral canal is arranged in the middle of the elastic bag, and the opening and closing of the urethral canal are controlled through a filling state or a vacant state.

Example 2

An improved fluid controller design is provided. The fluid controller of example 1. In actual clinical practice, particularly in the early stage of surgery, the elastic balloon of the urethral control device is required to be in a void state so as to maintain the urethra in an open state. In the case of such a practical need, the elastic bag 13 of the fluid controller is in a non-pressurized or weakly pressurized state for a long time. The present embodiment provides a design for adjusting the state of a fluid controller. See fig. 3 and 4. Fig. 3 is a modified state of the push rod 106, and fig. 4 is a modified state of the intermediate baffle 110. In fig. 4, on the push rod, there is a protruding portion for engaging the intermediate barrier control push rod. In fig. 4, the intermediate baffle has a notch corresponding to the protrusion of the push rod. The upper protruding portion may pass through the intermediate barrier when the push rod is moved in the correct direction. After the push rod passes through the middle baffle, the push rod can be clamped and cannot move leftwards only by rotating a certain angle.

In a further improvement, the middle baffle plate may be provided with a groove at the right side of the notch, and the protruding part in fig. 3 is clamped in the groove or protrudes. Easy slipping of the push rod is avoided, resulting in the push rod returning to its original position and unintended closing of the urethra.

The design position of the protruding part on the push rod is determined according to the pressure and the whole system. Applying the configurations of FIGS. 3 and 4 to the fluid controller of FIG. 1; wherein, the volume of the liquid storage chamber 102 is 2-5 ml, and the movement limit length of the push rod is 1-3.5 cm. The device 102 has a length of 3.5-6.5 cm, a thickness of 1-2 cm, and a width of 1-2 cm. More preferably, the overall device has a length of 3.8 cm, a thickness of 1.5 cm and a width of 2 cm.

Example 3

The fluid controller of embodiment 1 or embodiment 2. In the actual clinical setting, it is necessary to easily add a certain amount of fluid, typically sterile physiological saline, to the fluid controller. Then a certain amount of liquid is required to be added into the water storage elastic body in the embodiment 1 or the liquid storage chamber in the embodiment 2 according to requirements. A common design is to provide a rubber seal in the housing in the region of the appropriate connection to the reservoir. The rubber sealing device is elastic rubber. The needle of the syringe can be inserted out of the rubber sealing device to inject water. When the needle of the syringe is pulled out, the rubber sealing device can seal the hole formed by the needle due to the self elasticity. The rubber sealing device is a rubber sealing plug. The whole device is sealed, and liquid cannot permeate into the device or flow out of the device.

Example 4

The structure of another embodiment of the fluid controller is shown in FIG. 5.

The part 201 is an interface pipeline part connected with the outside, 202 is a water storage elastic body, 203 is a sliding track, 204 is a push plate, 205 is a push rod spring, 206 is a push rod, 207 is a push rod connector, 208 is an elastic shell, and 209 is a tail end.

201 is intended to be connected to the outside and will communicate with the stored liquid.

202 function to seal, contain stored liquid, and provide a deformable bladder.

At 203 is a sliding track that provides a track for the push rod.

204 is a push plate for pressing the water-storing elastic body 202.

205 is a push rod spring providing a pushing force.

206 is a pusher for coupling to the pusher plate 204.

207 is a push rod connector that cooperates with the push rod 206 to move the position of the push plate 204 along the slide track 203.

208 is a resilient shell that deforms when a force is applied.

209 is the trailing end and also fixes the position of the push rod connector 207.

The entire fluid controller may be in the form of a long, somewhat flattened, or oval cylinder, with pressure provided by hand pressure on a portion of the flexible housing, causing a change in the volume of stored fluid within the entire system, resulting in the flow of stored fluid out or in.

A schematic illustration of the push rod and push rod connector is shown in figure 6; wherein, the left side is a push rod, and the right side is a push rod connector. The push rod forms a tight connection with the push rod connector and allows the push rod to move in its axial direction. According to the fluid controller shown in fig. 5, when the elastic housing 208 is pressed by hand, the tail end 209 moves to the right side, the elastic force of the push rod spring 205 is reduced, the pressure applied to the water storage elastic body 202 is reduced, and the fluid flows in.

It will be appreciated by those skilled in the art that when the structures are close together, modifications or combinations of techniques can be made by those skilled in the art within the scope of the present disclosure. The components disclosed in the present invention should not be considered separately.

The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the appended claims.

Claims

1. An in vivo artificial urinary sphincter device, comprising three parts, a first part liquid controller, a second part sealing connecting piece and a third part locking piece; the sealing connecting piece is a pipeline for connecting the liquid controller and the locking piece; the locking piece comprises a hard shell and an elastic bag; the sealing connecting piece is connected to the elastic bag of the locking piece; the liquid controller can control the volume change of the internal water under the action of external force, thereby controlling the pressure in the elastic bag; the liquid controller comprises a liquid storage cavity, a push rod spring and a manual pressing part; the manual pressing portion controls the movement of the push rod by the force of the hand, thereby controlling the volume of water inside the fluid controller.

2. The artificial urinary sphincter device of claim 1, said fluid controller comprising a reservoir chamber, an intermediate chamber, a piston, a push rod spring, a push rod, an auxiliary stop, an elastic housing, a tail end; wherein the push rod spring surrounds the push rod; the push rod is fixedly connected with the tail end.

3. The artificial urinary sphincter apparatus of claim 1, further comprising an intermediate barrier for providing support for the push rod spring.

4. The artificial urinary sphincter apparatus of any one of claims 1-3, said push rod having a raised portion and said intermediate barrier having a corresponding notch.

5. The artificial urinary sphincter apparatus of any one of claims 1-4, the pushrod spring being located in the intermediate chamber.

6. The artificial urinary sphincter apparatus of any one of claims 1-5, said piston being adapted to push fluid in the reservoir chamber; one end of the push rod is connected with the piston, and the other end of the push rod is connected with the tail end and used for controlling the piston to move.

7. The artificial urinary sphincter apparatus of any of claims 1-6, wherein when rotating the trailing end, the push rod is rotated; through rotation, the protrusion on the push rod passes through the notch on the middle baffle plate to clamp the push rod.

8. The artificial urinary sphincter apparatus of claim 7, further comprising a rubber sealing plug located on the housing of the fluid controller for adding fluid.

9. The artificial urinary sphincter apparatus of claim 1, said retaining member comprising a rigid housing and an elastic balloon; the hard shell can be used for fixing the elastic bag, and the hard shell can be bent to enable the elastic bag to be annular, can maintain the tension of the elastic bag and can be connected with the connecting piece; the elastic sac is in direct contact with the urethra and controls opening and closing of the urethra through deformation.

10. The hard shell according to claim 9 is in a strip shape, the hard shell has strong deformability, and two ends of the hard shell are provided with fixed interfaces so as to be connected end to form a ring shape; the hard shell and the connecting piece are combined together to form an L/T shape.

11. The artificial urinary sphincter device clasp according to claim 9, said rigid shell being an elongated strip of woven composite material having a width of 0.5-4 cm, a thickness of 0.05-0.5 cm and a length of 2-11 cm; the hard shell is provided with a round or oval fixing hole, and the maximum diameter of the hole is 0.1-1 cm. The hard shell is provided with a fixing piece corresponding to the fixing hole, the fixing piece is cylindrical or elliptic cylindrical and protrudes out of the surface of the hard shell, the height is 0.2-1 cm, and the diameter or the maximum diameter is consistent with the fixing hole.

12. The artificial urinary sphincter device retaining member of claim 9, said flexible bladder being an elastic silicone rubber cuboid closely connected to the rigid shell, having a length of 0.9-9 cm, a width of 0.3-3 cm and a thickness of 0.15-1.2 cm.

13. The artificial urinary sphincter device sealing connection of claim 1 being in the form of a cylindrical hollow tube guiding the free flow of fluid between the first portion of fluid controller and the third portion of retaining member and ensuring a fluid seal.