Artificial urinary sphincter

Abstract

The application provides an artificial urethral sphincter, comprising: a positioning member configured to be positioned at a bladder neck and internally forming a first channel; a balloon configured to be arranged in a urethra and connected to the positioning member, an inside of the balloon forming a second channel communicated with the first channel, and comprising a first liquid storage cavity surrounding the second channel, the balloon comprising a first state of closing the second channel when the first liquid storage cavity is filled, and a second state of opening the second channel when the first liquid storage cavity is depressurized; a liquid storage balloon comprising a second liquid storage cavity; a catheter communicated between the first liquid storage cavity and the second liquid storage cavity; and a control valve configured to block liquid in the first liquid storage cavity from flowing into the second liquid storage cavity when in a closed state, and allow liquid in the first liquid storage cavity to flow into the second liquid storage cavity when in an open state. The artificial urethral sphincter does not damage the urethra and is not prone to urethral complications.

Description

Technical Field

[0001] This application relates to the field of medical device technology, specifically to an artificial urethral sphincter. Background Technology

[0002] Stress urinary incontinence refers to the involuntary leakage of urine from the urethra when abdominal pressure increases. Urodynamic testing shows involuntary leakage during a full bladder manometry test, occurring even with increased abdominal pressure and no detrusor muscle contraction. This condition causes significant disruption to patients' daily lives and social interactions. Currently, there are two main treatment methods: one involves inserting a catheter and connecting it to a collection bag. However, because a relatively large catheter is used, it disrupts the natural closure of the urethra, easily leading to urinary tract infections and unpleasant odors, and does not address the root cause of the problem.

[0003] Another treatment method is the implantation of an artificial urinary sphincter. One existing type of artificial sphincter mainly consists of a cuff, a control valve, and a catheter, with a water-filled balloon inside the cuff. The cuff wraps around the perineal section of the urethra, and the control valve is implanted into the scrotum in men or the labia in women. The balloon and control valve are connected via a catheter. In use, the balloon is filled with fluid, which compresses the urethra through the cuff to prevent leakage. When urination is needed, the control valve is operated, allowing the fluid in the balloon to flow out and opening the urethra. This artificial sphincter is implanted as a whole and has the advantage of reducing the risk of urinary tract infections. However, the long-term pressure on the urethra during use can lead to urethral atrophy and erosion, increasing the risk of complications. Furthermore, the control valve and balloon are easily damaged; according to foreign studies, they generally need to be removed after three years, which does not solve the fundamental problem.

[0004] It should be noted that the information disclosed in the background section above is only used to enhance the understanding of the background of this application, and therefore may include information that does not constitute prior art known to those skilled in the art.

[0005] Application content

[0006] In view of the problems in the prior art, the purpose of this application is to provide an artificial urethral sphincter that does not damage the urethra and is less likely to cause urethral complications.

[0007] This application provides an artificial urethral sphincter, comprising:

[0008] A positioning element is configured to be positioned at the bladder neck, and a first channel is formed inside the positioning element;

[0009] A balloon is configured to be placed in the urethra, the balloon is connected to the positioning member, the interior of the balloon forms a second channel, the second channel is connected to the first channel, and the balloon includes a first fluid reservoir surrounding the second channel. The balloon includes a first state in which the second channel is closed when the first fluid reservoir is inflated and a second state in which the second channel is opened when the first fluid reservoir is depressurized.

[0010] A reservoir, including a second reservoir chamber;

[0011] A conduit connects the first liquid storage chamber and the second liquid storage chamber;

[0012] The control valve is configured to prevent liquid in the first reservoir from flowing into the second reservoir when it is in a closed state, and to allow liquid in the first reservoir to flow into the second reservoir when it is in an open state.

[0013] By using this artificial urethral sphincter, a positioning device is used to position the artificial urethral sphincter in the human urethra, forming an artificial urethra inside the balloon. When the balloon is inflated, it closes the artificial urethra to prevent urine leakage. When urination is needed, the control valve is operated to depressurize the balloon and open the artificial urethra. This artificial urethral sphincter will not damage the human urethra, is less likely to cause urethral complications, is easy for patients to operate, and does not affect the patient's normal life.

[0014] In some embodiments, the positioning element includes a guide portion and a locking portion, the guide portion being located at the front end of the locking portion, and the guide portion having a conical structure, which can better guide the artificial urethral sphincter to be implanted into the human body.

[0015] In some embodiments, the positioning element is made of a flexible material that will not damage the bladder neck and urethra when the artificial urethral sphincter is implanted, and will not cause permanent damage to the urethra even if pulled forcefully.

[0016] In some embodiments, the reservoir is made of a flexible material that deforms when pressed, squeezing the liquid in the second reservoir outward, and returns to its initial state when the pressure is released.

[0017] In some embodiments, the positioning element includes a ribbed structure composed of multiple ribs.

[0018] In some embodiments, the outer diameter of the catheter is less than or equal to 2 mm, which does not affect the natural closure tendency of the human urethra and greatly reduces the probability of urethritis.

[0019] In some embodiments, a one-way valve is further included in the liquid flow path between the first liquid reservoir and the second liquid reservoir, the one-way valve being configured to prevent liquid from flowing back into the second liquid reservoir when liquid is injected from the second liquid reservoir into the first liquid reservoir.

[0020] In some embodiments, a valve body is provided between the conduit and the reservoir, and the valve body has a first path and a second path inside. The one-way valve is located in the first path, and the control valve is located in the second path. The one-way valve is in a one-way open state, and the control valve is normally closed when not operated, but can open the second path when operated.

[0021] In some embodiments, both the control valve and the reservoir are configured to be externally located for easy hand operation by the patient.

[0022] In some embodiments, the balloon is provided with a silicone tube inside, and the inside of the silicone tube forms the second channel. When the second channel is open, urine enters the human urethra in sequence through the first channel and the second channel, and is then discharged outward.

[0023] In some embodiments, the positioning element, the balloon, and / or the catheter are made of a polymer material. Attached Figure Description

[0024] Other features, objects, and advantages of this application will become more apparent from the following detailed description of non-limiting embodiments with reference to the accompanying drawings.

[0025] Figure 1 This is a schematic diagram of the structure of an artificial urethral sphincter according to an embodiment of this application;

[0026] Figure 2 This is a front view of an artificial urethral sphincter according to an embodiment of this application;

[0027] Figure 3 This is a schematic diagram of the structure of an artificial urethral sphincter in use according to an embodiment of this application;

[0028] Figure 4 yes Figure 2 A magnified view of region A during artificial urethral closure;

[0029] Figure 5 yes Figure 2 A magnified view of region A during the opening of the artificial urethra;

[0030] Figure 6 This is a schematic diagram of the structure of a valve assembly according to an embodiment of this application;

[0031] Figure 7 and Figure 8This is a partial cross-sectional view of a valve body according to an embodiment of this application;

[0032] Figure 9 This is a schematic diagram of the liquid flow direction when the valve body is in operation according to an embodiment of this application.

[0033] Figure label:

[0034] 10 Artificial urethral sphincter; 5 Control valves

[0035] 1. Positioning component 51. Pressing part

[0036] 11 Edge 52 Blocking part

[0037] 12 First Channel 53 Second Spring

[0038] 13 Guiding section 6 Reservoir

[0039] 14. Card slot 7. Saline solution

[0040] 2. Balloon 81 connector

[0041] 21 Second Channel 82 Valve Body

[0042] 22 silicone tubes, 91 bladder

[0043] 3. Catheter 92, bladder neck.

[0044] 4. One-way valve 93. Prostate

[0045] 41 First spring S1 First path

[0046] 42. Blocking element S2-S3, second path Detailed Implementation

[0047] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this application will be thorough and complete, and will fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and therefore repeated descriptions of them will be omitted. The words “or” and “or” in the specification may mean “and” or “or”. Although the terms “upper,” “lower,” “between,” etc., may be used in this specification to describe different exemplary features and elements of this application, these terms are used herein only for convenience, such as the orientation according to the examples described in the accompanying drawings. Nothing in this specification should be construed as requiring a specific three-dimensional orientation of the structure to fall within the scope of this application. Although “first” or “second,” etc., are used in this specification to denote certain features, they are merely indicative of function and not as a limitation on the number or importance of specific features.

[0048] This application provides an artificial urethral sphincter, including a positioning element, a balloon, a catheter, and a control valve. The positioning element is configured to be positioned at the bladder neck to locate the entire artificial urethral sphincter. A first channel is formed inside the positioning element for urine drainage. The balloon is configured to be disposed in the urethra. The balloon is connected to the positioning element, and a second channel is formed inside the balloon communicating with the first channel. The balloon includes a first fluid reservoir surrounding the second channel. The balloon includes a first state where the second channel is closed when the first fluid reservoir is inflated and a second state where the second channel is open when the first fluid reservoir is depressurized. The fluid reservoir includes a second fluid reservoir. The catheter communicates between the first fluid reservoir and the second fluid reservoir. The control valve is configured to prevent fluid in the first fluid reservoir from flowing into the second fluid reservoir when it is closed, and to allow fluid in the first fluid reservoir to flow into the second fluid reservoir when it is open.

[0049] By using this artificial urethral sphincter, a positioning device is used to position the artificial urethral sphincter in the human urethra, forming an artificial urethra inside the balloon. When the balloon is inflated, the artificial urethra is closed. When urination is needed, the control valve is operated to allow the fluid in the first reservoir to flow into the second reservoir, depressurizing the balloon and opening the artificial urethra. This method does not damage the human urethra, is less likely to cause urethral complications, is convenient for patients to operate, and does not affect their normal life.

[0050] The structure of an artificial urethral sphincter in one embodiment is described in detail below with reference to the accompanying drawings. It is understood that the drawings and the following description are merely illustrative and are not intended to limit the scope of protection of this invention.

[0051] Figure 1 and Figure 2The structure of the artificial urethral sphincter 10 of this embodiment is shown. Figure 3 The use of the artificial urethral sphincter 10 in a human body is illustrated. In this embodiment, the artificial urethral sphincter 10 includes a positioning element 1, a balloon 2, a catheter 3, and a control valve 5. Figure 3 In the diagram, 91 represents the bladder, 92 represents the bladder neck, 93 represents the prostate, and the portion of catheter 3 inside the body and the corresponding part of balloon 2 constitute the urethra. The positioning element 1 is configured to be positioned at the bladder neck 93 to locate the entire artificial urethral sphincter 10. A first channel 12 is formed inside the positioning element 1 to allow urine to drain.

[0052] The balloon 2 is configured to be placed in the urethra. The outer surface of the balloon 2 is cylindrical. The first end of the balloon 2 is connected to the positioning member 1. A thin-walled silicone tube 22 passes through the inside of the balloon 2, and a second channel 21 is formed inside the silicone tube 22, which communicates with the first channel 12. The second channel 21 serves as an artificial urethra, the length of which is only 1 / 5 of the male urethra and 1 / 2 of the female urethra, which can maximize the maintenance of the natural closure tendency of the human urethra. Specifically, the actual length of the artificial urethra can be selected and set as needed, and this application does not limit it. The balloon 2 includes a first fluid reservoir surrounding the second channel 21. The first fluid reservoir can be filled with liquid such as physiological saline 7 (shown in...). Figure 4 and Figure 5 The balloon 2 includes a first state where the second channel 21 is closed when the first fluid reservoir is inflated, and a second state where the second channel 21 is open when the first fluid reservoir is depressurized. When the balloon 2 is in the first state, the artificial urethra is closed, preventing urination. When the balloon 2 is in the second state, the artificial urethra is open, allowing urine to pass through the artificial urethra into the lower portion of the human urethra and be expelled from the body. This application changes the external pressure of the human urethra to internal pressure of the balloon 2 within the artificial urethra, reducing the pressure and minimizing the risk of complications such as urethral erosion and atrophy.

[0053] The reservoir 6 is configured externally for easy patient handling. The reservoir 6 includes a second reservoir chamber, which is the internal cavity of the reservoir 6, used to store liquids such as saline solution. The reservoir 6 is made of a flexible material; when pressed, it deforms, squeezing the liquid from the second reservoir chamber outwards; after releasing the pressure, the reservoir 6 returns to its initial state. The catheter 3 is a long, thin tube that connects the first and second reservoir chambers.

[0054] The control valve 5 is configured to be externally located for easy patient operation. The control valve 5 is situated in the communication path between the first and second fluid reservoirs, and is located close to the fluid reservoir 6. In this embodiment, the control valve 5 is a pressure relief valve, and its surface is provided with a pressing part 51 (shown in…). Figure 8 The balloon 2 is operated by the patient. The control valve 5 is configured to block the flow of liquid from the first reservoir into the second reservoir when closed, and to allow the flow of liquid from the first reservoir into the second reservoir when open. The patient can control the state switching of the balloon 2 by operating the press part 51 of the control valve 5. Therefore, when the balloon 2 is in the first state, it is inflated and closes the artificial urethra. When urination is needed, operating the control valve 5 allows liquid from the first reservoir to flow into the second reservoir, depressurizing the balloon 2 and opening the artificial urethra. This method does not damage the human urethra, reduces the risk of urethral complications, is convenient for the patient, and does not affect the patient's normal life.

[0055] like Figure 1 and Figure 2 As shown, the positioning element 1 includes a ridge structure composed of multiple ridges 11. In this embodiment, three ridges 11 are shown. In other embodiments, the number of ridges 11 can be increased or decreased as needed. The ridge structure includes a guide portion 13 and a locking portion 14. The guide portion 13 is located at the front end of the locking portion 14, and the guide portion 13 has a tapered structure to provide guidance when the positioning element 1 is implanted into the body.

[0056] The positioning element 1 is preferably made of a flexible material, such as silicone or other flexible polymer materials, but this application is not limited to this. By using a flexible positioning element 1, the bladder neck and urethra will not be damaged during the implantation of the artificial urethral sphincter, and even strong pulling will not cause permanent damage to the urethra. Furthermore, both the balloon 2 and the catheter 3 are made of polymer materials with a certain degree of flexibility. For example, the balloon 2 can be made of nylon or other polymer materials, which can avoid damage to the urethra. The outer diameter of the catheter 3 is preferably less than or equal to 2 mm, for example, it can be 1.5 mm, 1 mm, etc. Compared with the 3-7 mm outer diameter of traditional urinary catheters, this catheter 3 will not affect the natural closure tendency of the human urethra, greatly reducing the probability of urethritis. The range of outer diameter of the catheter 3 here is only an example. In other alternative embodiments, the catheter 3 can also use other outer diameter values, all of which are within the protection scope of this application.

[0057] The following is combined with Figure 1 , 6 Section 9 details the structure of the valve assembly described in this application. For example... Figure 1 , Figures 6-8As shown, a valve body 82 is provided between the conduit 3 and the reservoir 6, and the valve body 82 and the reservoir 6 together form a valve assembly. The control valve 5 is disposed on the valve body 82. The valve body 82 also has a one-way valve 4, which is disposed in the liquid flow path between the first reservoir and the second reservoir. The one-way valve 4 refers to a valve structure in which fluid can only flow in one direction and cannot flow back in the opposite direction. In this embodiment, the one-way valve 4 is configured to prevent liquid from flowing back into the second reservoir when liquid is injected from the second reservoir into the first reservoir. A connector 81 is provided at the top of the valve body 82 where it connects to the conduit 3. The connector 81 can be, for example, a Luer connector, which allows for tool-less disassembly, so that even if the valve body 82 is damaged and cannot be used, urination will not be impossible. However, the present invention is not limited to this. In other embodiments, the connector 81 can also be of other types, such as a plug connector, as long as it can achieve a conductive connection between the valve body 82 and the conduit 3.

[0058] like Figure 1 , 6 As shown in Figure 8, in this embodiment, the valve body 82 has two liquid flow paths inside: a first path and a second path. The one-way valve 4 is located in the first path, and the control valve 5 is located in the second path. Figure 7 In this diagram, the first path is exemplarily identified by S1, and the second paths are exemplarily identified by S2 and S3. The two ends of the first path S1 are respectively connected to the second liquid storage chamber of the conduit 3 and the liquid storage sac 6, and the two ends of the second paths S2 and S3 are also respectively connected to the second liquid storage chamber of the conduit 3 and the liquid storage sac 6. This is merely an example of two paths; in other embodiments, the first and second paths may adopt other shapes and extension methods.

[0059] The one-way valve 4 includes a first spring 41 and a blocking member 42. The blocking member 42 is, for example, a steel ball, or it may be a blocking component of other shapes and materials. The first spring 41 is, for example, a compression spring, which provides a downward biasing force to the blocking member 42. The control valve 5 includes a pressing part 51 and a blocking part 52. A second spring 53 is provided inside the pressing part 51. The second spring 53 is, for example, a compression spring, which provides an outward biasing force to the pressing part 51 and the blocking part 52. Figures 6-9 The structures of the control valve 5 and the check valve 4 shown are merely examples. In other embodiments, the control valve 5 and the check valve 4 may use other existing valve bodies. Other solutions that can also achieve the function of controlling the liquid flow direction between the balloon 2 and the reservoir 6 in this application are also within the protection scope of this application.

[0060] In this embodiment, the one-way valve 4 is in a one-way open state for a long time. When it is necessary to inject liquid from the reservoir 6 into the balloon 2, the reservoir 6 is pressed. The liquid in the reservoir 6 causes the blocking member 41 to rise without blocking the first path, and the liquid can enter the first reservoir chamber of the balloon 2 through the first path S1 (e.g., Figure 9 As shown by the white arrow in the first path S1, the balloon 2 is inflated. After the balloon 2 is fully inflated and enters the first state, because the pressure inside the balloon 2 is greater than the pressure inside the reservoir 6, under the combined action of the pressure and the first spring 41, the blocking member 42 closes the first path again, so that the liquid in the balloon 2 will not flow back into the reservoir 6, effectively maintaining the inflated state of the balloon 2 and achieving the purpose of maintaining urethral pressure without leakage.

[0061] In this embodiment, the control valve 5 is normally closed when not in operation, i.e., the second path is closed to prevent liquid in the balloon 2 from flowing into the reservoir 6 through the second path when urination is not needed. When urination is needed, the pressing part 51 needs to be pressed, causing the pressing part 51 to move inward, compressing the second spring 53 and driving the blocking part 52 to move. The blocking part 52 no longer blocks the second path, and the control valve 5 is in the open state. At this time, the balloon 2 is depressurized, and the liquid in the balloon 2 flows into the reservoir 6 through the S2 and S3 sections of the second path (e.g., Figure 9 (As shown by the black arrows in the second paths S2 and S3), balloon 2 enters the second state, the artificial urethra opens, and urination begins. Releasing the pressing part 51 causes the blocking part 52 and the pressing part 51 to move back to their initial positions under the biasing force of the second spring 53, and the control valve 5 returns to the closed state, closing the second path. After urination is complete, pressing the reservoir 6 again re-inflates balloon 2, closing the artificial urethra again.

[0062] The following is combined Figures 2-9 This article details the usage of the artificial urethral sphincter 10.

[0063] First, the artificial urethral sphincter 10 is implanted into the human body. Using a delivery device, the positioning element 1 is placed at the bladder neck. The conical guide 13 of the positioning element 1 allows it to enter the designated position more smoothly. The locking part 14 of the positioning element 1 locks into the bladder neck, thus positioning the artificial urethral sphincter. The balloon 2 is located in the urethra and is not inflated; the second channel 21 is open. The catheter 3 extends along the urethra, and the reservoir 6 remains outside the body. The second reservoir of the reservoir 6 stores saline solution. The control valve 5 is closed, and the second path is shut off.

[0064] Manually press the reservoir 6 so that the saline solution in the second reservoir chamber of the reservoir 6 enters the first reservoir chamber of the balloon 2 through the one-way valve 4, inflating the balloon 2 to the desired level. Figure 4In the first state shown, the outer diameter of balloon 2 is approximately 10 mm, forming a gourd shape with its tip. This not only secures the bladder neck, preventing slippage, but also seals the second channel 21 (i.e., the artificial urethra), minimizing leakage. Furthermore, because the pressure inside balloon 2 is greater than the pressure inside reservoir 6, and due to the one-way flow of the one-way valve 4, saline solution is prevented from flowing back from the first reservoir of balloon 2 into the second reservoir of reservoir 6. In this state, the artificial urethra is normally closed.

[0065] When urination is needed, press the pressure part 51 of the control valve 5 to open the second path. The saline in the first reservoir of balloon 2 enters the reservoir 6 through the second path. Balloon 2 depressurizes and enters the reservoir 6. Figure 5 In the second state shown, the second channel 21 is open, allowing urine to enter the urethra at the lower end of the balloon 2 through the first channel 12 and the second channel 21, and then drain outwards along the urethra. Releasing the pressure point 51 closes the second path again, and the saline solution in the balloon 2 no longer flows outwards. Even in the second state, the balloon 2 is still partially filled with saline solution; therefore, the balloon 2 is not completely depressurized and maintains a certain pressure to preserve its shape and prevent displacement within the urethra.

[0066] After urination, pressing the reservoir 6 again will refill the first reservoir of the balloon 2 with saline solution through the first pathway, pressurizing the balloon 2 and closing the artificial urethra again. Under the combined action of the pressure of the balloon 2 and the one-way valve 4, the balloon 2 maintains the closed state of the artificial urethra, effectively maintaining the pressure inside the urethra and preventing urine leakage.

[0067] Therefore, this application provides an artificial urethra inside the balloon 2 installed at the bladder neck and controls its opening and closing, thus maximally maintaining the natural closing tendency of the human urethra. It replaces external pressure on the human urethra with pressure on the internal balloon 2 of the artificial urethra, reducing the pressure intensity and minimizing complications such as urethral erosion and atrophy. Furthermore, it is easy to replace and causes virtually no damage to the human body. Patients only need to operate the externally placed control valve 5 and the externally placed balloon 6 to control the state of the balloon 2, making operation convenient and not affecting the patient's normal life.

[0068] The above description, in conjunction with specific preferred embodiments, provides a further detailed explanation of this application and should not be construed as limiting the specific implementation of this application to these descriptions. For those skilled in the art, various simple deductions or substitutions can be made without departing from the concept of this application, and all such modifications or substitutions should be considered within the scope of protection of this application.

Claims

1. An artificial urethral sphincter, characterized in that, include: A positioning element configured to be positioned at the bladder neck, the positioning element having a first channel formed inside, the positioning element including a guide portion and a locking portion, the guide portion being located at the front end of the locking portion, the guide portion having a conical structure, and the positioning element being made of a flexible material; A balloon is configured to be placed in the urethra. The balloon is connected to the positioning member. The outer surface of the balloon is cylindrical. A silicone tube passes through the inside of the balloon. The inside of the silicone tube forms a second channel that communicates with the first channel. The second channel serves as an artificial urethra. The balloon includes a first fluid reservoir surrounding the second channel. The balloon includes a first state in which the second channel is closed when the first fluid reservoir is inflated and a second state in which the second channel is opened when the first fluid reservoir is depressurized. A reservoir, including a second reservoir chamber; A conduit connects the first liquid storage chamber and the second liquid storage chamber; The control valve is configured to prevent liquid in the first reservoir from flowing into the second reservoir when it is in a closed state, and to allow liquid in the first reservoir to flow into the second reservoir when it is in an open state.

2. The artificial urethral sphincter according to claim 1, characterized in that, The reservoir is made of a flexible material.

3. The artificial urethral sphincter according to claim 1, characterized in that, The positioning element includes a ribbed structure composed of multiple edges.

4. The artificial urethral sphincter according to claim 1, characterized in that, The outer diameter of the catheter is less than or equal to 2 mm.

5. The artificial urethral sphincter according to claim 1, characterized in that, It also includes a one-way valve disposed in the liquid flow path between the first liquid storage chamber and the second liquid storage chamber, the one-way valve being configured to prevent liquid from flowing back into the second liquid storage chamber when liquid is injected from the second liquid storage chamber into the first liquid storage chamber.

6. The artificial urethral sphincter according to claim 5, characterized in that, A valve body is provided between the conduit and the reservoir. The valve body has a first path and a second path inside. The one-way valve is located in the first path, and the control valve is located in the second path.

7. The artificial urethral sphincter according to claim 1, characterized in that, Both the control valve and the reservoir are configured to be located externally.

8. The artificial urethral sphincter according to claim 1, characterized in that, The positioning element, the balloon, and / or the catheter are made of polymer materials.

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