Implantable urination device

Abstract

The invention relates to the technical field of urinary diseases, and provides an implantable urination device which comprises a valve capable of being arranged in an obstructed bladder outflow tract, a driving line capable of being partially arranged in a urinary tract and partially arranged in a scrotum, and a control unit capable of being arranged in the scrotum. The control unit controls the driving wire to act so as to drive the valve to be opened or closed. According to the implantable urination device, for a patient suffering from chronic urinary retention caused by long-term bladder outflow tract obstruction, the valve is implanted into the bladder outflow tract of the patient, and the control unit capable of controlling the driving line to drive the valve to be opened or closed is arranged in the scrotum, so that minimally invasive, simple and convenient treatment without exposed objects can be achieved; the life quality of a patient can be improved, psychological mood of the patient is adjusted, and physical and psychological health of the patient is promoted.

Description

Technical Field

[0001] The present invention relates to the technical field of urinary diseases, in particular to an implantable urination device. Background Art

[0002] Urinary retention can be acute or chronic. Causes include impaired bladder contractility, bladder outlet obstruction, detrusor-sphincter dyssynergia (asynchronous bladder contraction and sphincter relaxation), or a combination of these. Urinary retention is common in men with prostatic abnormalities or urethral strictures that cause outlet obstruction. In either sex, urinary retention may be due to medications (particularly those with anticholinergic effects, including many over-the-counter medications), severe fecal impaction (which increases pressure in the trigone), or neurogenic bladder in patients with diabetes, multiple sclerosis, Parkinson's disease, or previous pelvic surgery that resulted in bladder denervation. Urinary retention may be asymptomatic or may cause urinary frequency, incomplete urination, urgency, or overflow incontinence. Abdominal distension and pain may result. Pain may be absent when urinary retention develops slowly. Chronic urinary retention predisposes to urinary tract infections and can also cause increased bladder pressure leading to obstructive uropathy. Urethral catheterization is required for relief of acute urinary retention. Subsequent treatment is directed at the cause. In men with benign prostatic hyperplasia, drugs (usually alpha-adrenergic blockers or 5alpha-reductase inhibitors) or surgery can help reduce bladder outlet obstruction. There is no effective treatment for impaired bladder contractility; however, use of alpha-adrenergic blockers to reduce outlet resistance may increase bladder emptying. Intermittent self-catheterization or indwelling catheterization is often required. Suprapubic catheterization or urethral diversion is a last resort.

[0003] Common treatment methods include home clean catheterization, long-term indwelling urinary catheter, oral medication, prostatectomy and suprapubic cystostomy. Among them, home clean catheterization and long-term indwelling urinary catheter will seriously affect the patient's quality of life and cause serious psychological burden; oral medication has limited therapeutic effect on a large number of patients and long-term medication will have side effects; prostatectomy may cause a series of complications such as urinary incontinence and infection; suprapubic cystostomy requires long-term carrying of the fistula bag, which seriously affects the patient's quality of life. Summary of the invention

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

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

[0006] Furthermore, the valve includes a valve body and two valve flaps arranged in the valve body, each of the valve flaps 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 of the active parts changes and the two passive parts are separated from each other, the valve is in an open state.

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

[0008] Furthermore, at least one of a fixing portion between the valve flap and the valve body, the valve body and the drive line is made of a nickel-cobalt-titanium-molybdenum alloy.

[0009] Furthermore, a fixed outer sheath is disposed outside the valve, and a barb structure is disposed on the fixed outer sheath.

[0010] Furthermore, at least one of the fixed outer sheath, the valve flap of the valve, and the outer shell of the driving line is made of silicone material.

[0011] Furthermore, the control unit includes a deformable balloon, and one end of the driving wire is implanted in the balloon; when the balloon is squeezed, the balloon is deformed and stretched, and the driving wire 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 driving 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 outlet obstruction, by implanting a valve in the bladder outlet 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. BRIEF DESCRIPTION OF THE DRAWINGS

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

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

[0018] Figure 3 A schematic diagram of a valve of an implantable urination device provided by an embodiment of the present invention from a bottom-up perspective;

[0019] Figure 4 A schematic diagram of implanting a driving wire in a balloon of a valve of an implantable urination device provided by an embodiment of the present invention;

[0020] Figure 5 A schematic diagram of a valve of an implantable urination device after being squeezed according to an embodiment of the present invention;

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

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

[0023] Figure 8 for Figure 1 Schematic diagram of valve opening state;

[0024] Fig. 9 A schematic diagram of an implantable urination device provided by an embodiment of the present invention being implanted in the body;

[0025] In the accompanying drawings: 1-valve; 10-valve body; 11-valve flap; 12-active part; 13-passive part; 14-fulcrum part; 2-driving line; 3-control unit; 30-balloon; 4-fixed outer sheath; 40-barb structure; A-bladder; B-urinary tract; C-scrotum. DETAILED DESCRIPTION

[0026] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0027] See also Figures 1 to 9, an embodiment of the present invention provides an implantable urination device, including a valve 1 that can be arranged in the obstructed bladder outflow tract, a drive line 2 that can be partially arranged in the urinary tract B and partially arranged in the scrotum C, and a control unit 3 that can be arranged in the scrotum C, wherein the control unit 3 controls the action of the drive line 2 to drive the valve 1 to open or close. In this embodiment, for patients with chronic urinary retention caused by long-term outflow tract obstruction, whose detrusor muscle and nerve reflex function are good and whose renal function is normal, the device can be implanted to relieve symptoms. Specifically, the valve 1 is implanted in the bladder outflow tract, and then the drive line 2 and the control unit 3 are arranged. When the valve 1 is opened, a channel can be opened for the obstructed outflow tract, so that the urine formed in the bladder A can flow from the channel into the urinary tract B to complete urination. Specifically, the control unit 3 is used to control the action of the driving wire 2, and the action of the driving wire 2 drives the valve 1 to open or close. Since the valve 1, the driving wire 2 and the control unit 3 are all arranged in the body, no external objects can be exposed, and since this part of the human body is not large, the volume of these components can also be made very small, so as to achieve a minimally invasive effect. When in use, the control unit 3 can be designed to be close to the outer wall of the scrotum C, so that only the control unit 3 in the scrotum C needs to be driven to control the action of the driving wire 2, thereby realizing the opening of the valve 1 to complete the discharge of urine. As for the specific operation method, the following embodiments will be detailed after each component is refined.

[0028] As an optimization solution of the 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 flaps 11 disposed in the valve body 10, each of the valve flaps 11 having an active portion 12 and a passive portion 13; when the positions of the two active portions 12 remain unchanged and the two passive portions 13 are in close contact, the valve 1 is in a closed state; when the position of at least one of the active portions 12 changes and the two passive portions 13 are separated from each other, the valve 1 is in an open state. In this embodiment, the structure of the valve 1 is refined, which includes a valve body 10 and a valve flap 11. The valve body 10 can be columnar, for example, in order to fit the shape of the outflow channel, it can be designed as a cylindrical structure, such as Figure 1As shown, a movable valve flap 11 is then provided in the valve body 10, and the movement of the two valve flaps 11 fitting together and the movement of the two valve flaps 11 being spaced apart from each other are completed by driving the movement of the valve flap 11. We can refine the two ends of each valve flap 11 into an active portion 12 and a passive portion 13, respectively. In this way, when the active portion 12 of one of the valve flaps 11 moves, the result reflected may be that the passive portion 13 of the valve flap 11 moves, for example, moves away from the other passive portion 13. At this time, there is a space between the two passive portions 13, which is the open state of the valve 1. Of course, this result may also be brought about by the movement of the two active portions 12 together. For example, in this embodiment, the active portions 12 of the two valve flaps 11 both move, and then it will be as follows Figure 8 As shown, there is a larger interval between the two passive parts 13, which improves the urination efficiency. Of course, the solution of moving only the active part 12 of one valve flap 11 is also feasible, and both can achieve the purpose of urination. Of course, in addition to the form of the valve 1 shown in this embodiment, other existing forms of valves 1 are also feasible, as long as they can be easily controlled and easily implanted in the human body, and this embodiment does not limit this.

[0029] To further optimize the above solution, please refer to Figure 1 , Figure 2 , Figure 3 and Figure 8 At least one of the valve flaps 11 also has a fulcrum portion 14, and the fulcrum portion 14 is located between the active portion 12 and the passive portion 13. When the position of the active portion 12 changes, the valve flap 11 rotates around the fulcrum portion 14 to move the two passive portions 13 away from each other. In this embodiment, the movement trajectory of the valve flap 11 is refined to define a fulcrum portion 14, so that the movement of the valve flap 11 can be rotation around the fulcrum portion 14, and the interval between the two passive portions 13 is obtained by rotation. Preferably, the valve flap 11 and the valve body 10 are provided with a fixed portion 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, so that when closing is required, only the control force of the control unit 3 needs to be removed. At this time, the two valve flaps 11 will no longer be driven by the driving line 2, and the passive portion 13 will naturally sink under the action of gravity, thereby Figure 8 The status is restored to Figure 1 status, and in Figure 8In the embodiment, since urine flows from top to bottom, the two valve flaps 11 can be pressed down with the help of urine, and the two valve flaps 11 rotate around the fulcrum 14 to achieve the passive parts 13 of the two valve flaps 11 to fit together again, thereby automatically closing the valve 1. It can be seen that the cleverness of this structure lies in the use of the gravity of the valve flap 11 itself and the help of urine, and the closure of the valve 1 is completed conveniently without setting up a valve 1 closing mechanism. From this perspective, it also reduces the cost and unreliability caused by wound damage to the human body or more complex structures. In other embodiments, the structural features of the valve flap 11 also facilitate the rapid resolution of emergencies. For example, when the drive line 2 is broken or the valve flap 11 cannot be opened smoothly, since the valve 1 does not have any direct locking device, the structure is very simple. We can insert the catheter normally, pass through between the valve flaps 11 to open the valve flap 11, and the catheter can still smoothly enter the bladder A to urinate. Moreover, if the patient cannot tolerate the implantation of the urinary tract B valve 1, because the valve 1 and the fixed outer sheath 4 are fixed mainly by friction without any hard connection, the urinary tract B valve 1 can be first removed through the cystoscope A, and then the fixed outer sheath 4 can be removed, and finally the above components and the control unit 3 can be removed by making a small incision in the scrotum C, which will not cause great harm to the patient. Of course, in the above embodiments, in addition to rotating around the fulcrum to achieve a spacing between the two passive parts 13, other action modes can also be used, such as directly moving the valve flap 11 downward, that is, designing a channel in the valve body 10 for the active part 12 to move up and down, and the valve flap 11 is pulled into the channel. It is also feasible to open the valve 1 using this idea, and this embodiment does not limit this.

[0030] As an optimization solution of the embodiment of the present invention, at least one of the fixing part of the valve flap 11 and 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 increase the life of the product, and this material is not harmful to the human body. Preferably, all three are made of nickel-cobalt-titanium-molybdenum alloy.

[0031] As an optimization solution of the 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 outflow channel by the fixed outer sheath 4. Since the fixed outer sheath 4 has the barb structure 40, and since the valve 1 and the fixed outer sheath 4 are very small in size and light in weight, they can be stably arranged in the outflow channel. Preferably, the shape of the fixed outer sheath 4 can match the shape of the valve 1, for example, both adopt a cylindrical structure. Preferably, the barbs of the barb structure 40 are very small, and a plurality of barbs are fixed on the outflow channel in coordination, but they will not cause much damage to the flow channel.

[0032] To further optimize the above solution, at least one of the fixed outer sheath 4, the valve flap 11 of the valve 1, and the outer shell of the drive line 2 is made of silicone material. In this embodiment, a layer of outer shell is also provided outside the drive line 2 to prevent the nickel-cobalt-titanium-molybdenum alloy from directly contacting the human body. The use of silicone material can avoid harming the human body.

[0033] As an optimization solution of the embodiment of the present invention, please refer to Figures 1 to 8 The control unit 3 includes a deformable balloon 30, one end of the driving wire 2 is implanted in the balloon 30; when the balloon 30 is squeezed, the balloon 30 is deformed and stretched, and the driving wire 2 is pulled to drive the valve 1 to open. In this embodiment, the method of controlling the action of the driving wire 2 can use a balloon 30, which will deform when squeezed, thereby pulling the driving wire 2 fixed therein. When the driving wire 2 is pulled, Figure 1 and Figure 8 As shown, the active part 12 of the valve flap 11 will move downward, and the valve flap 11 can rotate around the fulcrum part 14, so that a distance is formed between the two passive parts 13. Preferably, the driving line 2 includes a traction rope, one end of which is installed on the valve 1, and the other end is installed on the control unit 3; the control unit 3 drives the traction rope to move to pull the valve 1, so that the valve 1 is opened. Preferably, the traction rope is provided with a shell.

[0034] To further optimize the above solution, please refer to Figures 1 to 8 The balloon 30 is a silica gel balloon. Preferably, the balloon 30 is filled with saline. Both silica gel and saline are very safe and will not harm the human body.

[0035] As an optimization scheme of the embodiment of the present invention, the control unit 3 has a first interface, and the housing of the drive line 2 is provided with a second interface, and 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 connected by a sustainable interface connection, for example, the first interface is designed at the end of the balloon 30 of the control unit 3, and the second interface is designed on the housing, and the two are connected by threaded connection, clamping, binding, etc. Before implantation, the two can be spliced ​​externally and then implanted into the body.

[0036] At this point, the structure of the device has been refined. When using the device, if you need to open the valve to urinate, you can touch the control unit at the scrotum C with your fingers and gently pinch the balloon 30. At this time, the balloon 30 is deformed, the drive line 2 is pulled, and the active part 12 of the valve flap 11 moves downward. The valve flap 11 rotates under the action of the fulcrum part 14, and the passive part 13 also moves with it, so that there is a gap between the two passive parts 13, thereby opening the obstructed outflow tract, and urine can flow out of the gap to the urinary tract B and be discharged from the body. When implanting the device, first observe the stenosis position of the patient's urinary tract B through a cystoscope, confirm the implantation position, select a fixed outer sheath 4 with a suitable diameter, assemble the fixed outer sheath 4 and the valve 1, and verify in vitro that the functions are intact. Use the cystoscope again to clamp the assembled fixed outer sheath 4 and valve 1 for implantation. After implantation, release the fixed outer sheath 4 and the valve 1. Due to the barb structure 40 of the fixed outer sheath 4, the valve 1 can be fixed on the urinary tract by itself. After confirming the implantation position, use the control unit 3 in vitro to observe the opening of the valve 1. After confirming that the functions are intact, a hole can be made at the weak part of the pubic symphysis external urethra to lead out the drive line 2, an incision is made on the scrotum C to lead out the drive line 2 from the urethra, connect the control unit 3 and insert it into the scrotum C, use the cystoscope again to observe the working conditions of the control unit 3 and the valve 1, and end the operation after confirmation.

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

Claims

1. An implantable urination device, characterized in that: The invention comprises a valve which can be arranged in an obstructed bladder outflow tract, a driving wire which can be arranged partly in the urinary tract and partly in the scrotum, and a control unit which can be arranged in the scrotum, wherein the control unit controls the action of the driving wire to drive the valve to open or close.

2. An implantable urination device as claimed in claim 1, characterized in that: The valve includes a valve body and two valve flaps arranged in the valve body, each of the valve flaps 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 of the active parts changes and the two passive parts are separated from each other, the valve is in an open state.

3. An implantable urination device as claimed in claim 2, characterized in that: At least one of the valve flaps further has a fulcrum portion, and the fulcrum portion is located between the active portion and the passive portion. When the position of the active portion changes, the valve flap rotates around the fulcrum portion to move the two passive portions away from each other.

4. An implantable urination device as claimed in claim 2, characterized in that: At least one of the fixing portion between the valve flap and the valve body, the valve body and the drive line is made of nickel-cobalt-titanium-molybdenum alloy.

5. The implantable urination device according to claim 1, characterized in that: A fixed outer sheath is arranged outside the valve, and a barb structure is arranged on the fixed outer sheath.

6. An implantable urination device as claimed in claim 5, characterized in that: At least one of the fixed outer sheath, the valve flap of the valve, and the outer shell of the driving line is made of silicone material.

7. The implantable urination device according to claim 1, characterized in that: The control unit includes a deformable balloon, and one end of the driving wire is implanted in the balloon; when the balloon is squeezed, the balloon is deformed and stretched, and the driving wire is pulled to drive the valve to open.

8. An implantable urination device as claimed in claim 7, characterized in that: The balloon is a silica gel balloon.

9. An implantable urination device as claimed in claim 7, characterized in that: The balloon is filled with physiological saline.

10. The implantable urination device according to claim 1, characterized in that: The control unit has a first interface, and the housing of the driving line is provided with a second interface, and the first interface and the second interface are detachably connected.

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