Controllable catheter

Abstract

The invention discloses a controllable catheter which comprises an in-vivo implantation unit, an in-vitro control unit and an external auxiliary assembly. The in-vivo implantation unit is a medical silicon rubber hollow tube body and has seven specifications of 3.5-6.5 cm, a petal-shaped fixing part close to the bladder end can be unfolded and anchored on the bladder wall, and a magnetic drive pump valve assembly is arranged in the middle of the in-vivo implantation unit; the in-vitro control unit drives the spiral impeller to conduct negative pressure drainage through magnetic coupling, and the key controls opening and closing of the one-way valve. The size adaptation assembly comprises a urethra measurer and a push rod. The petal-shaped fixing part is coated with an antibacterial coating, the magnetic coupling efficiency between the inner magnet and the outer magnet is larger than or equal to 85%, and magnetic field leakage is controllable. The in-vitro unit integrates pressure monitoring and alarming functions and supports wireless charging and disinfection. And protein adsorption is reduced through in-vivo unit surface treatment, and the sealing of the joint reaches the IP67 standard. The device realizes autonomous urination control through magnetic driving, precise adaptation and antibacterial design, reduces the infection risk, improves the autonomy of patients, and is suitable for patients with urination dysfunction.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a controllable urinary catheter, which is particularly suitable for patients with urinary dysfunction such as neurogenic bladder and benign prostatic hyperplasia. Background Technology

[0002] In recent years, with the increasing number of patients with urinary system diseases, the clinical demand for urinary catheterization devices has become increasingly prominent. Traditional urinary catheters rely on frequent manual insertion, which not only causes great pain to patients but also increases the risk of urinary tract infection due to repeated mucosal damage. Statistics show that the incidence of urinary tract infection in patients with indwelling catheters is as high as 75%-80%, and long-term indwelling can easily lead to bladder function degeneration, seriously affecting patients' quality of life. In addition, traditional devices lack a self-control mechanism and require reliance on urine drainage bags, which restricts patients' activities and causes a heavy psychological burden; approximately 65% ​​of long-term catheterized patients experience varying degrees of social impairment.

[0003] While existing intelligent catheterization technologies attempt to incorporate innovative mechanisms such as magnetic actuation, they generally suffer from problems such as low magnetic coupling efficiency and poor size adaptability. For example, the magnetic drive structure of some devices may interfere with medical devices such as pacemakers due to magnetic field leakage. Furthermore, a single-size tube cannot accommodate the varying urethral lengths of different patients (the urethral length of adult women is approximately 3-5 cm, with significant individual differences), leading to device displacement or excessive insertion in 15%-20% of patients. Simultaneously, uneven release of the antibacterial coating makes it difficult to maintain infection control effects for long periods; the antibacterial rate of traditional silver ion coatings often drops below 80% after two weeks.

[0004] This invention aims to address the core problems of insufficient autonomous control, high infection risk, and poor individual adaptability in existing technologies. Through an innovative combination of magnetic coupling drive, multi-level antibacterial design, and precise size adaptation, it provides a safe, efficient, and convenient controllable urinary catheter to meet the urgent clinical demand for long-lasting indwelling catheterization technology with low complications. Summary of the Invention

[0005] The purpose of this invention is to overcome the shortcomings of existing technologies and to propose a controllable urinary catheter, comprising an implantable unit, an external control unit, and an external auxiliary device: The implantable unit is a hollow tubular structure that can be placed in the urethra. It is made of medical-grade silicone rubber and is available in various lengths. The proximal end of the tube has a petal-shaped fixing part made of flexible silicone with an integrated elastic support structure. It unfolds to form an anchoring structure by a push rod. The middle of the tube has a built-in magnetic pump valve assembly, which includes a drive magnet, a spiral impeller, and a one-way closing valve. The external control unit is a handheld magnetic control device, consisting of an external magnet, a control circuit board, a rechargeable battery, and a status indicator light. It is linked with the internal magnet through the principle of magnetic coupling, driving the spiral impeller to rotate and generate negative pressure to drain urine. When the control button is released, the one-way closing valve automatically closes. The external auxiliary device includes a urethral measuring device for measuring the length of the urethra to match the specifications of the implanted unit. The measuring device is sterile packaged and has scale markings and positioning structure.

[0006] Preferably, the surface of the petal-shaped fixing part is coated with an antibacterial coating, and the edges have a serrated structure after unfolding, which significantly increases the contact area with the bladder neck mucosa, and keeps the radial pressure of the fixing part on the bladder neck within a safe range.

[0007] Preferably, the spiral impeller of the magnetic pump valve assembly can rotate to generate negative pressure to drain urine, and the one-way closing valve adopts a silicone diaphragm structure, which has a leak-proof function when closed.

[0008] Preferably, the drive magnet of the external control unit and the internal magnet achieve power transmission through magnetic coupling. The external magnetic field can penetrate human tissue and drive the internal components to work, and magnetic field leakage is effectively controlled.

[0009] Preferably, the external control unit integrates a pressure sensor and a flow monitoring module, which can collect bladder pressure and urine volume data and transmit them to a mobile terminal via wireless communication, triggering an alarm when abnormal pressure occurs.

[0010] Preferably, the rechargeable battery of the external control unit supports multiple uses, and the charging base supports wireless charging and sterilization functions.

[0011] Preferably, the surface of the implanted unit is treated to reduce protein adsorption, and the connection between the tube and the magnetic pump valve assembly has a sealing structure to prevent urine leakage.

[0012] Preferably, the external control unit is equipped with a safety locking mechanism, which automatically locks after a set number of consecutive misoperations. It can be unlocked by biometric identification or password. When not in use, it can be stored in a shielded structure to reduce external magnetic field interference.

[0013] Preferably, the urethral measuring device of the external auxiliary device adopts a sliding structure. After being inserted into the urethra, the length of the urethra is positioned by the sliding component, resulting in small measurement error and high fitting accuracy.

[0014] Preferably, the distal end of the implantable unit is provided with an annular positioning flange with a diameter larger than the inner diameter of the urethra to prevent excessive insertion, and the surface of the flange is provided with a textured structure to enhance the fixation effect.

[0015] Compared with existing technologies, the beneficial effects of this invention are: 1. This device achieves active drainage of urine from the bladder through a magnetic coupling drive mechanism of an external control unit. Compared to the passive drainage mode of traditional catheters that rely on gravity, the negative pressure generated by the rotation of the spiral impeller can adjust the urine flow rate according to the patient's needs, avoiding drainage obstruction caused by insufficient bladder pressure. At the same time, the one-way closing valve automatically closes when the control button is released, which can precisely control the start and stop of urination and prevent urine backflow. This solves the problem that traditional devices cannot block urine flow in real time, significantly improving the patient's ability to control the urination process.

[0016] The petal-shaped fixation part of the implantable unit is made of flexible silicone. After unfolding via a push rod, it forms a barbed anchoring structure, increasing the contact area with the bladder neck mucosa compared to smooth surfaces. Combined with the application of a silver ion antibacterial coating, this not only significantly reduces the risk of device displacement but also inhibits bacterial adhesion and biofilm formation. Furthermore, the plasma treatment of the implantable unit surface reduces protein adsorption, further minimizing infection risk and extending the indwelling period to 29 days, a significant improvement over traditional urinary catheter indwelling periods.

[0017] The external control unit integrates a pressure sensor and flow monitoring module, which can collect bladder pressure data in real time and transmit it to a mobile terminal via Bluetooth. When the bladder pressure exceeds a set threshold, an audible and visual alarm is triggered, effectively warning of the risk of urinary retention and preventing mucosal damage caused by overfilling of the bladder. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the overall structure of a controllable urinary catheter proposed in this invention; Figure 2 This is a schematic diagram of the structure of an implantable unit in a controllable urinary catheter proposed in this invention; Figure 3 This is a schematic diagram of the structure of an internal implantation unit and an external auxiliary device in a controllable urinary catheter proposed in this invention (state one). Figure 4 This is a schematic diagram of the structure of an internal implanted unit and an external auxiliary device in a controllable urinary catheter proposed in this invention (state two). Figure 5 This is a schematic diagram of the external control unit in a controllable urinary catheter proposed in this invention.

[0019] In the diagram: 11 - petal-shaped fixing part; 12 - driving magnet (inner magnet); 13 - spiral impeller; 14 - one-way closing valve; 21 - outer magnet; 22 - control circuit board; 23 - rechargeable battery; 24 - control button; 25 - status indicator light. Detailed Implementation

[0020] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0021] Referring to the figures, this embodiment provides a controllable urinary catheter, including an implantable unit 1, an external control unit 2, and an external auxiliary device 3: The implantable unit is a hollow tubular structure that can be placed in the urethra. It is made of medical-grade silicone rubber and comes in various lengths, ranging from 3.5 to 6.5 cm. The proximal end of the tube has a petal-shaped fixing part 11 made of flexible silicone with an integrated elastic support structure. It unfolds to form an anchoring structure under the control of the push rod 3. The middle of the tube has a built-in magnetic pump valve assembly, which includes a drive magnet 12, a spiral impeller 13, and a one-way closing valve 14. The external control unit 2 is a handheld magnetic control device, consisting of an external magnet 21, a control circuit board 22, a rechargeable battery 23, control buttons, and status indicator lights. It is linked with the internal magnet 12 through the principle of magnetic coupling, driving the spiral impeller 13 to rotate and generate negative pressure to drain urine. When the control button 24 is released, the one-way closing valve 14 automatically closes. The external auxiliary components include a urethral measuring device for measuring urethral length to match the specifications of the implanted unit. The measuring device is sterile packaged and features graduation markings and a positioning structure. It also includes a push rod 3 for pushing and opening the petal-shaped fixation part 11.

[0022] Furthermore, the surface of the petal-shaped fixing part 11 is coated with an antibacterial coating with an antibacterial rate of ≥99.9%; after unfolding, the edge has a serrated structure, which significantly increases the contact area with the bladder neck mucosa, and the radial pressure of the fixing part on the bladder neck is kept within a safe range, which is generally controlled at 10-15 mmHg.

[0023] Furthermore, the spiral impeller 13 of the magnetically driven pump valve assembly can rotate to generate negative pressure to drain urine, and the one-way closing valve 14 adopts a silicone diaphragm structure, which has a leak-proof function when closed. Here, the internal magnet and the one-way valve achieve coordinated control through the linkage of magnetic force and mechanical structure, and the specific relationship is as follows: Driven phase: The rotation of the inner magnet drives the one-way valve to open, and the magnetic coupling drives the outer magnet of the external control unit to rotate, generating a rotating magnetic field. Through magnetic coupling, the inner magnet (driving magnet 12) inside the body rotates synchronously. The inner magnet is fixedly connected to the spiral impeller 13, so when it rotates, it drives the spiral impeller to generate negative pressure to drain urine.

[0024] In addition, the magnetic field force drives the one-way valve to open. The one-way valve 14 (silicone diaphragm structure) integrates a sealing magnet, which forms a magnetic circuit with the inner magnet. When the inner magnet rotates, its magnetic field generates a magnetic pole repulsion force on the sealing magnet inside the one-way valve, pushing the one-way valve upward (away from the valve seat), thus opening the valve. Urine is then discharged from the urination port through the negative pressure of the spiral impeller.

[0025] Closure Phase: The inner magnet stops rotating, triggering the automatic closure of the one-way valve. After releasing control button 24 on the external control unit, the outer magnet stops rotating, and the inner magnet stops rotating due to the loss of magnetic driving force. At this point, the repulsive force between the inner magnet and the sealing magnet inside the one-way valve disappears. Mechanical reset achieves valve closure. The one-way valve relies on its own elasticity (the rebound force of the silicone diaphragm) or an additional spring structure to fall downwards after the magnetic force disappears, tightly fitting the valve seat and blocking urine flow. This process requires no additional power; automatic closure is achieved solely through magnetic linkage and mechanical reset, ensuring no urine leakage (leakage ≤ 0.5 ml / min).

[0026] Furthermore, the external magnet 21 and the internal magnet 12 of the external control unit achieve power transmission through magnetic coupling. Here, the magnetic coupling efficiency is ≥85%, the external magnetic field can penetrate human tissue and drive the internal components to work, and the magnetic field leakage is effectively controlled. Specifically, the attenuation rate of the external magnetic field penetrating human tissue is ≤0.5dB / cm, and the magnetic field leakage intensity is ≤5mT at 15cm from the surface of the device.

[0027] Furthermore, the external control unit integrates a pressure sensor and a flow monitoring module, which can collect bladder pressure and urine volume data in real time and transmit them to a mobile terminal via wireless communication. An alarm is triggered when there is abnormal pressure (e.g., abnormal pressure > 40 cmH2O).

[0028] Furthermore, the rechargeable battery of the external control unit supports multiple uses, and the charging base supports wireless charging and sterilization functions.

[0029] Furthermore, the surface of the implanted unit is treated to reduce protein adsorption, with a protein adsorption rate reduction of over 80%; the connection between the tube and the magnetic pump valve assembly has a sealing structure with an IP67 sealing performance to prevent urine leakage.

[0030] Furthermore, the external control unit is equipped with a safety locking mechanism. It will automatically lock after a set number of consecutive misoperations and can be unlocked by biometric identification or password. When not in use, it can be stored in a shielded structure to reduce external magnetic field interference.

[0031] Furthermore, the urethral measuring device of the external auxiliary device adopts a sliding structure. After being inserted into the urethra, the length of the urethra is positioned by the sliding component, resulting in small measurement error and high fitting accuracy.

[0032] Furthermore, the distal end of the implantable unit is provided with an annular positioning flange with a diameter larger than the inner diameter of the urethra to prevent excessive insertion, and the surface of the flange is provided with a textured structure to enhance the fixation effect.

[0033] The controllable catheter described in the above embodiments achieves autonomous urination through the synergistic effect of magnetic coupling drive, mechanical anchoring, and intelligent control. The specific workflow is as follows: Use a urethral measuring device (with a double-tab sliding structure) to accurately measure the urethral length. Based on the measurement results, select the corresponding implantable unit (7 sizes from 3.5-6.5cm). After inserting the measuring device into the urethra, move the inner tab to locate the internal urethral orifice, with an error ≤ ±0.2cm. Ensure that the selected implantable unit length is slightly larger than the urethral measurement value to avoid insecure fixation due to being too short or damage to the bladder due to being too long.

[0034] The implanted unit is inserted into the urethra to the bladder neck via a push rod. Pushing the push rod triggers the internal elastic support structure, causing the proximal petal-shaped fixation part to unfold like a "flower blooming." The serrated edge structure of the flexible silicone fixation part fits tightly against the bladder neck mucosa, increasing the contact area by more than three times compared to a smooth surface. At the same time, it generates a radial pressure of 10-15 mmHg, forming a mechanical anchor and preventing the device from shifting.

[0035] Active urination phase: Hold the external control unit close to the pubic symphysis and press the control button. The internal rotating motor drives the urethral pump activator (ring permanent magnet) to rotate at high speed, generating a rotating magnetic field. This magnetic field penetrates human tissue and forms magnetic coupling with the drive magnet of the magnetic pump valve assembly in the middle of the implanted unit, driving the spiral impeller to rotate synchronously. The rotating impeller generates negative pressure, overcoming the pressure inside the bladder. Simultaneously, the sealing magnet inside the valve is lifted by the repulsion of its magnetic poles, allowing urine to be quickly discharged through the urinary outlet. During this process, the pressure sensor in the external control unit monitors the pressure inside the bladder in real time, ensuring that the drainage process is safe and controllable.

[0036] Safety Closure Phase: Releasing the control button eliminates the external magnetic field, stops the drive magnet from rotating, and the sealing valve closes under the action of the return spring, blocking urine flow. The one-way closure valve uses a silicone diaphragm structure, with a leakage rate ≤0.5ml / min when closed, effectively preventing urine reflux and infection.

[0037] Intelligent monitoring and feedback: The external control unit transmits real-time pressure data and urine output to a mobile terminal via Bluetooth 5.0. In case of abnormalities, an audible and visual alarm is triggered, prompting the patient or medical staff to intervene promptly. Simultaneously, the device features a multi-level safety locking mechanism, automatically locking after five consecutive misoperations, requiring fingerprint or password unlocking to prevent accidental activation by children or patients with cognitive impairments.

[0038] In the above embodiments and working principles, this device achieves active drainage of bladder urine through the magnetic coupling drive mechanism of the external control unit. Compared with the passive drainage mode of traditional urinary catheters that rely on gravity, the negative pressure generated by the rotation of the spiral impeller can adjust the urine flow rate according to the patient's needs, avoiding poor drainage due to insufficient bladder pressure. At the same time, the one-way closing valve automatically closes when the control button is released, which can precisely control the start and stop of urination, prevent urine backflow, solve the problem that traditional devices cannot block urine flow in real time, and significantly improve the patient's ability to control the urination process.

[0039] The petal-shaped fixation part of the implantable unit is made of flexible silicone. After unfolding via a push rod, it forms a barbed anchoring structure, increasing the contact area with the bladder neck mucosa compared to smooth surfaces. Combined with the application of a silver ion antibacterial coating, this not only significantly reduces the risk of device displacement but also inhibits bacterial adhesion and biofilm formation. Furthermore, the plasma treatment of the implantable unit's surface reduces protein adsorption, further minimizing infection risk and extending the indwelling period to 29 days, a significant improvement over traditional urinary catheter indwelling periods.

[0040] The external control unit integrates a pressure sensor and a flow monitoring module, which can collect bladder pressure data in real time and transmit it to a mobile terminal via Bluetooth. When the bladder pressure exceeds a set threshold, an audible and visual alarm is triggered, effectively warning of the risk of urinary retention and preventing mucosal damage caused by overfilling of the bladder.

[0041] The above specific embodiments further illustrate the purpose, technical solution, and beneficial effects of the present invention. It should be understood that the above are merely specific embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the technical scope disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

[0042] Furthermore, it should be understood in the description of this invention that the terms indicating orientation or positional relationship are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this invention.

[0043] Furthermore, in this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

Claims

1. A controllable urinary catheter, characterized in that, Includes an implantable unit, an external control unit, and external auxiliary devices: The implantable unit is a hollow tubular structure that can be placed in the urethra. It is made of medical-grade silicone rubber and is available in various lengths. The proximal end of the tube has a petal-shaped fixing part made of flexible silicone with an integrated elastic support structure. It unfolds to form an anchoring structure by a push rod. The middle of the tube has a built-in magnetic pump valve assembly, which includes a drive magnet, a spiral impeller, and a one-way closing valve. The external control unit is a handheld magnetic control device, consisting of an external magnet, a control circuit board, a rechargeable battery, and a status indicator light. It is linked with the internal magnet through the principle of magnetic coupling, driving the spiral impeller to rotate and generate negative pressure to drain urine. When the control button is released, the one-way closing valve automatically closes. The external auxiliary device includes a urethral measuring device for measuring the length of the urethra to match the specifications of the implanted unit. The measuring device is sterile packaged and has scale markings and positioning structure.

2. The controllable urinary catheter according to claim 1, characterized in that, The petal-shaped fixing part is coated with an antibacterial coating. When unfolded, the edges have a serrated structure, which significantly increases the contact area with the bladder neck mucosa and keeps the radial pressure of the fixing part on the bladder neck within a safe range.

3. The controllable urinary catheter according to claim 1, characterized in that, The spiral impeller of the magnetic pump valve assembly can rotate to generate negative pressure to drain urine, and the one-way closing valve adopts a silicone diaphragm structure, which has a leak-proof function when closed.

4. The controllable urinary catheter according to claim 1, characterized in that, The external control unit's drive magnet and internal magnet achieve power transmission through magnetic coupling. The external magnetic field can penetrate human tissue and drive the internal components to work, and magnetic field leakage is effectively controlled.

5. The controllable urinary catheter according to claim 1, characterized in that, The external control unit integrates a pressure sensor and a flow monitoring module, which can collect data on bladder pressure and urine output, and transmit the data to a mobile terminal via wireless communication. An alarm is triggered when there is abnormal pressure.

6. The controllable urinary catheter according to claim 1, characterized in that, The rechargeable battery of the external control unit supports multiple uses, and the charging base supports wireless charging and sterilization functions.

7. The controllable urinary catheter according to claim 1, characterized in that, The surface of the implanted unit is treated to reduce protein adsorption, and the connection between the tube and the magnetic pump valve assembly has a sealing structure to prevent urine leakage.

8. The controllable urinary catheter according to claim 1, characterized in that, The external control unit is equipped with a safety locking mechanism. It will automatically lock after a set number of consecutive misoperations and can be unlocked by biometric identification or password. When not in use, it can be stored in a shielded structure to reduce external magnetic field interference.

9. The controllable urinary catheter according to claim 1, characterized in that, The external auxiliary device's urethral measuring instrument adopts a sliding structure. After being inserted into the urethra, the urethral length is positioned by the sliding component, resulting in small measurement error and high fitting accuracy.

10. The controllable urinary catheter according to claim 1, characterized in that, The implantable unit has an annular positioning flange at its distal end, with a diameter larger than the inner diameter of the urethra to prevent over-insertion. The flange surface has a textured structure to enhance the fixation effect.

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