Implantable urinary device

Abstract

This invention relates to the field of urological disease technology and provides an implantable urination device, including a valve that can be placed in the obstructed bladder outflow tract, a drive wire that can be partially placed in the urinary tract and partially placed in the scrotum, and a control unit that can be placed in the scrotum. The control unit controls the drive wire to open or close the valve. This implantable urination device, for patients with chronic urinary retention caused by long-term bladder outflow tract obstruction, allows for minimally invasive, simple, and non-exposed treatment by implanting a valve in the bladder outflow tract and placing a control unit in the scrotum that can control the drive wire to open or close the valve. This improves the patient's quality of life, regulates their psychological state, and promotes their physical and mental health.

Description

Technical Field

[0001] This invention relates to the field of urological disease technology, specifically to an implantable urination device. Background Technology

[0002] Urinary retention can be classified as acute or chronic. Causes include impaired bladder contractility, bladder outflow obstruction, detrusor-sphincter dyssynergia (asynchronous bladder contraction and sphincter relaxation), or a combination of these factors. Urinary retention is common in men with prostatic abnormalities or urethral strictures leading to outflow obstruction. Regardless of sex, urinary retention can be caused by medications (especially those with anticholinergic effects, including many over-the-counter medications), severe fecal impaction (increasing pressure in the bladder trigone), or neurogenic bladder in patients with diabetes, multiple sclerosis, Parkinson's disease, or previous pelvic surgery resulting in bladder denervation. Urinary retention may be asymptomatic or cause urinary frequency, incomplete emptying, urgency, or overflow incontinence. It may cause abdominal distension and pain. Pain may be absent when urinary retention progresses slowly. Long-term urinary retention increases the risk of urinary tract infections and can also cause obstructive urethral disease due to increased bladder pressure. Relief of acute urinary retention requires urethral catheterization. Subsequent treatment targets the underlying cause. In men with benign prostatic hyperplasia (BPH), medication (usually alpha-adrenergic blockers or 5-alpha-reductase inhibitors) or surgery can help reduce bladder outlet obstruction. There is no effective treatment for impaired bladder contractility; however, using alpha-adrenergic blockers to reduce outlet resistance may increase bladder emptying. Intermittent self-catheterization or indwelling catheterization is often necessary. Suprapubic catheterization or urethral diversion is a last resort.

[0003] Common treatments include home catheterization, long-term indwelling catheters, oral medications, prostatectomy, and suprapubic cystostomy. Among these, home catheterization and long-term indwelling catheters can severely impact patients' quality of life and cause significant psychological burden; oral medications have limited effectiveness for a large number of patients and long-term use can lead to side effects; prostatectomy may cause a series of complications such as urinary incontinence and infection; and suprapubic cystostomy involves a long-term fistula bag, which severely affects patients' quality of life. Summary of the Invention

[0004] The purpose of this invention is to provide an implantable urination device that can at least solve some of the defects in the prior art.

[0005] To achieve the above objectives, the present invention provides the following technical solution: an implantable urination device, comprising a valve that can be disposed in an obstructed bladder outflow tract, a drive line that can be partially disposed in the urinary tract and partially disposed in the scrotum, and a control unit that can be disposed in the scrotum, wherein the control unit controls the drive line to drive the valve to open or close.

[0006] Furthermore, the valve includes a valve body and two valve discs disposed within the valve body, each valve disc having an active part and a passive part; when the positions of the two active parts remain unchanged and the two passive parts are in close contact, the valve is in a closed state; when the position of at least one active part changes and the two passive parts move away from each other, the valve is in an open state.

[0007] Furthermore, at least one of the valve discs also has a fulcrum portion located between the active portion and the passive portion. When the position of the active portion changes, the valve disc rotates around the fulcrum portion to move the two passive portions away from each other.

[0008] Furthermore, at least one of the valve disc and the fixed part of the valve body, the valve body, and the drive line is made of nickel-cobalt-titanium-molybdenum alloy.

[0009] Furthermore, the valve is provided with a fixed outer sheath, and the fixed outer sheath is provided with a barbed structure.

[0010] Furthermore, at least one of the fixed outer sheath, the valve disc of the valve, and the housing of the drive line is made of silicone.

[0011] Furthermore, the control unit includes a deformable balloon, one end of which is implanted in the balloon; when the balloon is squeezed, it deforms and is stretched, and the drive line is pulled to drive the valve to open.

[0012] Furthermore, the balloon is a silicone balloon.

[0013] Furthermore, the balloon is filled with physiological saline.

[0014] Furthermore, the control unit has a first interface, and the housing of the drive line is provided with a second interface, and the first interface and the second interface are detachably connected.

[0015] Compared with the prior art, the beneficial effects of the present invention are: an implantable urination device for patients with chronic urinary retention caused by long-term bladder outflow tract obstruction, by implanting a valve in their bladder outflow tract and setting a control unit in the scrotum that can control the drive line to drive the valve to open or close, can achieve minimally invasive, simple and non-exposed treatment, can improve the patient's quality of life, regulate the patient's psychological emotions, and promote the patient's physical and mental health. Attached Figure Description

[0016] Figure 1 A vertical cross-sectional view of the valve of an implantable urination device provided in an embodiment of the present invention (the valve is in a closed state);

[0017] Figure 2A top view schematic diagram of the valve of an implantable urination device provided in an embodiment of the present invention;

[0018] Figure 3 A schematic diagram of the valve of an implantable urination device provided in an embodiment of the present invention, viewed from below;

[0019] Figure 4 A schematic diagram of a drive wire implanted in the balloon of a valve in an implantable urination device according to an embodiment of the present invention;

[0020] Figure 5 A schematic diagram of the valve of an implantable urination device after compression, provided in an embodiment of the present invention;

[0021] Figure 6 A vertical cross-sectional schematic diagram of the fixing outer sheath of an implantable urination device provided in an embodiment of the present invention;

[0022] Figure 7 A schematic diagram of the fixed outer sheath of an implantable urination device provided in an embodiment of the present invention;

[0023] Figure 8 for Figure 1 A diagram showing the valve in its open state;

[0024] Figure 9 This is a schematic diagram of an implantable urination device implanted in the body, according to an embodiment of the present invention.

[0025] In the attached figures, the following are the reference numerals: 1-valve; 10-valve body; 11-valve disc; 12-active part; 13-passive part; 14-fulcrum part; 2-drive line; 3-control unit; 30-balloon; 4-fixed outer sheath; 40-barbed structure; A-bladder; B-urinary tract; C-scrotum. Detailed Implementation

[0026] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0027] Please see Figures 1 to 9This invention provides an implantable urination device, comprising a valve 1 that can be disposed in an obstructed bladder outflow tract, a drive line 2 that can be partially disposed in the urinary tract B and partially disposed in the scrotum C, and a control unit 3 that can be disposed in the scrotum C. The control unit 3 controls the drive line 2 to actuate and drive the valve 1 to open or close. In this embodiment, this device can be implanted to relieve symptoms in patients with chronic urinary retention caused by long-term outflow tract obstruction, whose detrusor muscle and nerve reflex functions are good and whose renal function is normal. Specifically, the valve 1 is implanted in the bladder outflow tract, and then the drive line 2 and control unit 3 are disposed thereon. When the valve 1 is opened, a channel can be opened for the obstructed outflow tract, so that urine formed in the bladder A can flow into the urinary tract B through this channel to complete urination. Specifically, the drive line 2 is controlled by the control unit 3, which in turn drives the valve 1 to open or close. Since the valve 1, drive line 2, and control unit 3 are all located within the body, there is no external exposure. Furthermore, because this part of the body is relatively small, these components can be made very small, thus achieving a minimally invasive effect. In use, the control unit 3 can be designed near the outer wall of the scrotum C. Therefore, only the control unit 3 within the scrotum C needs to be activated to control the drive line 2, thereby opening the valve 1 to facilitate urine drainage. The specific operation method will be detailed in the following embodiments after further explanation of each component.

[0028] As an optimized solution for an embodiment of the present invention, please refer to Figure 1 , Figure 2 , Figure 3 and Figure 8 The valve 1 includes a valve body 10 and two valve discs 11 disposed within the valve body 10. Each valve disc 11 has an active part 12 and a passive part 13. When the positions of the two active parts 12 remain unchanged and the two passive parts 13 are in close contact, the valve 1 is in a closed state. When the position of at least one active part 12 changes and the two passive parts 13 move away from each other, the valve 1 is in an open state. In this embodiment, the structure of the valve 1 is refined, including a valve body 10 and valve discs 11. The valve body 10 can be cylindrical, for example, it can be designed as a cylindrical structure to fit the shape of the outlet channel, such as... Figure 1As shown, a movable valve disc 11 is then provided within the valve body 10. The movement of the valve disc 11 enables the two valve discs 11 to engage and maintain a gap between them. Each valve disc 11 can be further divided into an active part 12 and a passive part 13. Thus, when the active part 12 of one valve disc 11 moves, the passive part 13 of that valve disc 11 will move, for example, moving away from the other passive part 13. At this time, there is a gap between the two passive parts 13, indicating the valve 1 is open. Of course, this result can also be caused by the simultaneous movement of both active parts 12. As shown in this embodiment, both active parts 12 of the valve discs 11 move, resulting in... Figure 8 As shown, the two passive parts 13 have a larger gap, improving urination efficiency. Of course, it is also feasible to activate only the active part 12 of one valve disc 11, and both can achieve the purpose of urination. Of course, in addition to the form of valve 1 shown in this embodiment, other existing forms of valve 1 are also feasible, as long as they are easy to control and easy to implant in the human body. This embodiment does not limit this.

[0029] For further optimization of the above solution, please refer to [link / reference]. Figure 1 , Figure 2 , Figure 3 and Figure 8 At least one of the valve discs 11 also has a fulcrum portion 14, which is located between the active part 12 and the passive part 13. When the position of the active part 12 changes, the valve disc 11 rotates around the fulcrum portion 14 to move the two passive parts 13 away from each other. In this embodiment, by refining the movement trajectory of the valve disc 11, a fulcrum portion 14 can be defined. Thus, the movement of the valve disc 11 can be a rotation around the fulcrum portion 14, and the interval between the two passive parts 13 is obtained by rotation. Preferably, the valve disc 11 and the valve body 10 have a fixed part at the fulcrum portion 14 to limit the position of the fulcrum portion 14, ensuring that the position of the fulcrum portion 14 cannot move. Thus, when closure is required, only the control force of the control unit 3 needs to be removed. At this time, the two valve discs 11 will no longer be driven by the drive line 2, and under the action of gravity, the passive parts 13 will naturally sink from... Figure 8 The state was restored to Figure 1 The state, and in Figure 8In this design, since urine flows from top to bottom, the two valve discs 11 can be pressed down with the help of the urine. The two valve discs 11 then rotate around the fulcrum 14, causing the passive parts 13 of the two valve discs 11 to re-adhere, thereby automatically closing the valve 1. It is evident that the ingenuity of this structure lies in utilizing the weight of the valve discs 11 themselves and the assistance of urine to conveniently close the valve 1 without requiring a separate valve 1 closing mechanism. From this perspective, it also reduces the risk of injury to the human body from wounds or the cost and unreliability associated with more complex structures. In another embodiment, the structural features of this valve disc 11 also facilitate the rapid resolution of emergencies. For example, if the drive line 2 breaks or the valve disc 11 cannot be opened smoothly, since this valve 1 has no direct locking device and its structure is very simple, a catheter can be inserted normally, passing between the valve discs 11 to open the valve discs 11, and the catheter can still smoothly enter the bladder A for urination. Furthermore, if a patient cannot tolerate the implantation of the urinary tract B valve 1, since the valve 1 is mainly fixed to the outer sheath 4 by friction without any rigid connection, the urinary tract B valve 1 can be removed first using a cystoscope (A), followed by the outer sheath 4. Finally, the above components and the control unit 3 can be removed through a small incision in the scrotum (C), without causing significant harm to the patient. Of course, in the above embodiment, besides rotating around the fulcrum to create a gap between the two passive parts 13, other action methods can also be used. For example, the valve disc 11 can be moved directly downwards, i.e., a channel is designed in the valve body 10 for the active part 12 to move up and down, and the valve disc 11 is pulled into the channel. Using this approach to open the valve 1 is also feasible, and this embodiment does not limit this.

[0030] As an optimized embodiment of the present invention, at least one of the valve disc 11 and the fixing part of the valve body 10, the valve body 10, and the drive line 2 is made of nickel-cobalt-titanium-molybdenum alloy. In this embodiment, the use of nickel-cobalt-titanium-molybdenum alloy can improve the product's lifespan, and this material is also harmless to the human body. Preferably, all three are made of nickel-cobalt-titanium-molybdenum alloy.

[0031] As an optimized solution for an embodiment of the present invention, please refer to Figure 6 and Figure 7 The valve 1 is provided with a fixed outer sheath 4, and the fixed outer sheath 4 is provided with a barb structure 40. In this embodiment, the valve 1 can be fixed in the outlet channel by the fixed outer sheath 4. Because the fixed outer sheath 4 has a barb structure 40, and because both the valve 1 and the fixed outer sheath 4 are very small in size and light in weight, they can be stably installed in the outlet channel. Preferably, the shape of the fixed outer sheath 4 can match the shape of the valve 1, for example, both can be cylindrical. Preferably, the barbs of the barb structure 40 are very small, and several barbs cooperate to fix it on the outlet channel, but will not cause great damage to the flow channel.

[0032] To further optimize the above solution, at least one of the fixed outer sheath 4, the valve disc 11 of the valve 1, and the outer shell of the drive line 2 is made of silicone. In this embodiment, the drive line 2 is also covered with an outer shell to prevent the nickel-cobalt-titanium-molybdenum alloy from directly contacting the human body. Using silicone material ensures that it will not harm the human body.

[0033] As an optimized solution for an embodiment of the present invention, please refer to Figures 1 to 8 The control unit 3 includes a deformable balloon 30, with one end of the drive line 2 implanted in the balloon 30. When the balloon 30 is squeezed, it deforms and stretches, pulling the drive line 2 to open the valve 1. In this embodiment, the balloon 30 can be used to control the movement of the drive line 2. The balloon 30 deforms when squeezed, thus pulling the drive line 2 fixed within it. When the drive line 2 is pulled, as... Figure 1 and Figure 8 As shown, the active part 12 of the valve disc 11 moves downward, allowing the valve disc 11 to rotate around the fulcrum part 14, thereby creating a gap between the two passive parts 13. Preferably, the drive line 2 includes a traction rope, one end of which is mounted on the valve 1, and the other end is mounted on the control unit 3; the control unit 3 drives the traction rope to pull the valve 1, causing the valve 1 to open. Preferably, the traction rope is covered with a shell.

[0034] For further optimization of the above solution, please refer to [link / reference]. Figures 1 to 8 The balloon 30 is a silicone balloon. Preferably, the balloon 30 is filled with saline solution. Both silicone and saline solution are very safe and will not harm the human body.

[0035] As an optimized embodiment of the present invention, the control unit 3 has a first interface, and the outer shell of the drive line 2 has a second interface, wherein the first interface and the second interface are detachably connected. In this embodiment, the connection between the control unit 3 and the drive line 2 can be a continuously connected interface connection. For example, the first interface can be designed at the end of the balloon 30 of the control unit 3, and the second interface can be designed on the outer shell. The two can be connected by means of threaded connection, snap-fit, binding, etc. Before implantation, the two can be spliced ​​together externally before implantation into the body.

[0036] At this point, the detailed structure of this device is complete. When using this device, if it is necessary to open the valve for urination, you can touch the control unit at the scrotum C with your finger and gently squeeze the balloon 30. At this time, the balloon 30 deforms, the drive line 2 is pulled, the active part 12 of the valve 11 moves down, and the valve 11 rotates under the action of the fulcrum part 14. The passive part 13 also moves accordingly, so that there is a gap between the two passive parts 13, thereby opening the obstructed outflow channel. Urine can flow out from the gap into the urinary tract B and be discharged from the body. During implantation of this device, the location of the urinary tract B stricture is first observed using a cystoscope to confirm the implantation position. A suitable diameter fixation sheath 4 is selected, and the fixation sheath 4 and valve 1 are assembled and their functionality verified externally. The assembled fixation sheath 4 and valve 1 are then inserted using a cystoscope. After implantation, the fixation sheath 4 and valve 1 are released. Due to the barbed structure 40 of the fixation sheath 4, valve 1 will automatically fix itself to the urinary tract. After confirming the implantation position, the opening status of valve 1 is observed externally using the control unit 3. After confirming that the function is intact, a hole is created at the weak point of the external urethra of the pubic symphysis to lead out the drive line 2. An incision is made on scrotum C to connect the drive line 2, which is led out from the urethra. The control unit 3 is then connected and placed into scrotum C. The operation of the control unit 3 and valve 1 is observed again using a cystoscope. After confirming that everything is correct, the surgery is completed.

[0037] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. An implantable urination device, characterized in that: The device includes a valve that can be placed in the outflow tract of an obstructed bladder, a drive wire that can be partially placed in the urinary tract and partially placed in the scrotum, and a control unit that can be placed in the scrotum. The control unit controls the drive wire to actuate and drive the valve to open or close. The control unit includes a deformable balloon, one end of which is implanted in the balloon. When the balloon is squeezed, it deforms and is stretched, pulling the drive wire to open the valve. The drive wire includes a traction rope, one end of which is attached to the valve and the other end to the control unit. The control unit actuates the traction rope to pull the valve, causing it to open.

2. The implantable urination device as described in claim 1, characterized in that: The valve includes a valve body and two valve discs disposed within the valve body. Each valve disc has an active part and a passive part. When the positions of the two active parts remain unchanged and the two passive parts are in close contact, the valve is in a closed state. When the position of at least one active part changes and the two passive parts move away from each other, the valve is in an open state.

3. An implantable urination device as described in claim 2, characterized in that: At least one of the valve discs also has a fulcrum portion located between the active portion and the passive portion. When the position of the active portion changes, the valve disc rotates about the fulcrum portion to move the two passive portions away from each other.

4. An implantable urination device as described in claim 2, characterized in that: At least one of the following components—the valve disc and the fixed part of the valve body, the valve body, and the drive line—is made of a nickel-cobalt-titanium-molybdenum alloy.

5. An implantable urination device as described in claim 1, characterized in that: The valve is provided with a fixed outer sheath, and the fixed outer sheath is provided with a barbed structure.

6. An implantable urination device as described in claim 5, characterized in that: At least one of the fixed outer sheath, the valve disc of the valve, and the housing of the drive line is made of silicone.

7. An implantable urination device as described in claim 1, characterized in that: The balloon is a silicone balloon.

8. An implantable urination device as described in claim 1, characterized in that: The balloon is filled with saline solution.

9. An implantable urination device as described in claim 1, characterized in that: The control unit has a first interface, and the housing of the drive line has a second interface, and the first interface and the second interface are detachably connected.

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