A urodynamic data acquisition device, delivery device and detection system

Abstract

This application provides a urodynamic data acquisition device, delivery device, and detection system, including: an in-body device for placement in the bladder and an external device for fixation to the skin outside the body; the external device is electrically connected to the in-body device via a cord, allowing the in-body device to be removed from the bladder by pulling the cord; the external device includes a power source for powering the in-body device; the in-body device includes a sensing unit comprising one or more sensors configured to acquire electrical signals within the bladder; the external device includes: a processor communicating with the sensors for generating urodynamic data based on the electrical signals; and a memory configured to store the generated urodynamic data. This application addresses or improves upon the problem in related technologies where the unreasonable placement or structural arrangement of components in the data acquisition device of a catheter-free urodynamic detection system leads to inconvenience in urodynamic data detection and use.

Description

Technical Field

[0001] This application belongs to the field of urodynamic testing technology, and more specifically, relates to a urodynamic data acquisition device, a delivery device, and a testing system. Background Technology

[0002] Routine urodynamic testing involves instilling saline solution into the bladder through a catheter to simulate bladder filling and voiding, measuring bladder compliance and stability, bladder contractility, urethral closure pressure, and other indicators to understand lower urinary tract function and diagnose voiding dysfunction. It is considered the "gold standard" for diagnosing voiding dysfunction. However, conventional urodynamic testing equipment is bulky and requires multiple components. The entire procedure must be performed in an operating room, often lasting several hours. During the examination, the patient usually needs to lie still, requiring constant reminders from the operator to assist with various movements to advance the test. The complexity of routine urodynamic testing also means that the accuracy of the results is often unsatisfactory.

[0003] Based on this, a catheter-free urodynamic testing system has been developed in related technologies. This system can realize the flexibility of urodynamic examination, make urodynamic assessment more accurate and efficient, and also make the assessment process more comfortable for patients.

[0004] However, unreasonable placement or structural design of components in the data acquisition device of catheter-free urodynamic testing systems in related technologies leads to inconvenience in urodynamic data detection and use, such as excessively large size of the implantable device, difficulty in removing the implantable device from the body, unstable signal transmission of the implantable device, and easy loss of detection data. Utility Model Content

[0005] To address or improve the problem of inconvenience in urodynamic data detection and use caused by unreasonable placement or structural arrangement of components in the data acquisition device of catheter-free urodynamic testing systems in related technologies, this application provides a urodynamic data acquisition device, a delivery device, and a detection system.

[0006] To achieve the above objectives, in a first aspect, embodiments of this application provide a urodynamic data acquisition device, comprising: an in-body device for placement in the bladder and an external device for fixation to the external skin; the external device is electrically connected to the in-body device via a cord, so that the in-body device can be removed from the bladder by pulling the cord; the external device includes a power source for powering the in-body device.

[0007] The implantable device includes a sensing unit: the sensing unit includes one or more sensors, and the one or more sensors are configured to collect electrical signals within the bladder;

[0008] External devices include:

[0009] The processor communicates with the sensor to generate urodynamic data based on the electrical signals;

[0010] And a memory configured to store the generated urodynamic data.

[0011] Furthermore, the implantation device also includes a deformable part for preventing it from slipping out of the bladder. The deformable part is connected to one or both ends of the sensing part. During the process of the implantation device entering the bladder, the axis of the deformable part and the axis of the sensing part remain in the same straight line or parallel. After the implantation device enters the bladder, the deformable part deforms into a curled state or an expanded state to prevent the implantation device from slipping out of the bladder.

[0012] Furthermore, the urodynamic data include at least one of the following: (i) the volume of urine in the bladder, (ii) the rate at which urine is expelled from the bladder, (iii) the pressure in the bladder, (iv) the volume of the bladder, (v) bladder abnormalities, and (vi) the chemical composition of the urine in the bladder.

[0013] Furthermore, the deformable part includes a shape memory elastic element, which is insulated from and connected to the sensing part.

[0014] Furthermore, when the deformable portion is connected to one end of the sensing portion, the deformable portion includes one or more deformation lines, and one or more of the deformation lines are connected to the sensing portion at one end and extend around the sensing portion; when the deformable portion is connected to both ends of the sensing portion, the deformable portion includes a plurality of expansion deformation lines arranged around the sensing portion.

[0015] Furthermore, one end of the sensing unit is fixedly connected to one end of the deformable part containing the plurality of expansion deformation lines; the other end of the sensing unit is slidably connected to the other end of the deformable part containing the plurality of expansion deformation lines.

[0016] Furthermore, both ends of the sensor are provided with rigid or semi-rigid end caps, which are made of metal, plastic or rubber.

[0017] Furthermore, the power source is a battery.

[0018] Furthermore, the cord comprises:

[0019] Flexible outer skin;

[0020] A signal line, located within the flexible outer sheath, is used to transmit signals between the sensor and the processor;

[0021] A power cord is located inside the flexible outer sheath and is used to form a current loop between each component and the power source.

[0022] And a reinforcing line, located inside the flexible outer sheath, is used to increase the tensile strength of the rope.

[0023] Furthermore, the sensing unit includes:

[0024] A closed shell with a membrane chamber;

[0025] The sensor and its circuit are housed within the enclosed housing, and the wire is connected to the circuit.

[0026] The sensor is located inside the soft membrane cavity; the soft membrane cavity is filled with an insulating liquid filler.

[0027] Furthermore, the cord is connected to the external device via a quick-connect structure; and / or, the outer surface of the outer skin is coated with a hydrophilic antibacterial coating.

[0028] Furthermore, one or more of the sensors are configured to detect the volume and level of urine in the bladder using one or more of the following: (a) one or more shock waves or pressure pulses, (b) one or more light waves, (c) one or more lasers, (d) one or more sound signals, (e) ultrasound, (f) conductivity, and (g) pressure.

[0029] Secondly, this application provides a delivery device for delivering the intubation device of the urodynamic data acquisition device to a designated location, comprising:

[0030] An outer tube is used to accommodate the implantable device, and the front part of the outer tube can be inserted into the bladder along the urethra;

[0031] The inner tube is slidably fitted inside the outer tube, and the inner tube can be pushed forward along the axis of the outer tube in order to push the intubation device out of the outer tube.

[0032] Thirdly, this application provides a urodynamic data detection system, comprising:

[0033] The urodynamic data acquisition device;

[0034] A data terminal for communicating with the processor of the data acquisition device, the data terminal including software that, through the processor, can view, analyze, store, and record the results of one or more bladder filling and emptying cycles; or the software can configure the processor to overlay two or more filling / emptying cycles to help identify trends.

[0035] Furthermore, the software configures the processor to use artificial intelligence / machine learning algorithms to detect trends, which include at least one of the following: detrusor insufficiency, detrusor overactivity, urinary incontinence, bladder distension, storage dysfunction, and voiding dysfunction.

[0036] The urodynamic data acquisition device, delivery device, and detection system of this application embodiment, by placing the power supply, processor, and memory on an external device, allows the external device to communicate with the sensor through the processor to store the generated urodynamic data into the memory. The internal device can be easily adjusted in position or removed in the bladder by pulling the internal device with a string. Thus, the embodiments of this application, to a certain extent, solve or improve the problem of inconvenience in urodynamic data detection and use caused by unreasonable placement or structural setting of various components of the data acquisition device in the catheter-free urodynamic detection system of related technologies. Attached Figure Description

[0037] To more clearly illustrate the technical solutions in the embodiments of this application, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0038] Figure 1 This is a schematic diagram of the overall structure of a urodynamic data acquisition device according to an embodiment of this application.

[0039] Figure 2 This is a schematic diagram of a urodynamic data acquisition device.

[0040] Figure 3 for Figure 1 A schematic diagram of the structure of the central sensing unit.

[0041] Figure 4 This is a schematic diagram showing the connection between the external device and the quick-connect cable structure.

[0042] Figure 5 for Figure 1 A schematic diagram of the cross-sectional structure of the rope.

[0043] Figure 6 This is a schematic diagram of the structure of the deformable part before insertion into the body, according to an embodiment of this application.

[0044] Figure 7 This is a schematic diagram of the deformable part after insertion into the body, according to one embodiment of this application.

[0045] Figure 8 This is a schematic diagram of the structure of the deformed part before insertion into the body, which is another embodiment of this application.

[0046] Figure 9 This is a schematic diagram of the deformable part after insertion into the body, representing another embodiment of this application.

[0047] Figure 10 This is a schematic diagram of the structure of a conveying device according to an embodiment of this application.

[0048] Figure 11 This is a schematic diagram of the structure of a urodynamic data detection system according to an embodiment of this application.

[0049] The markings in the diagram are:

[0050] 1-Insertion device, 100-Sensor, 101-Sensing unit, 102-First deformable part, 101a-Support circuit, 101b-Pressure sensor, 101c-Soft membrane chamber, 101d-Insulating liquid filler, 111-Front cover, 112-Expansion deformation line, 113-Rear cover, 2-External device, 21-Outer shell, 22-Adhesive tape, 3-Wire, 31-Power cord, 32-Signal line, 33-Reinforcing wire, 34-Flexible outer skin, 35-Coating, 41-Outer tube, 42-Inner tube, 51- Quick-connect plug, 52-Quick-connect interface, 1001-Battery voltage detection module, 1002-Lithium battery, 1003-Charge and discharge protection module, 1004-Power switch, 1005-LED indicator, 1006-Storage module, 1007-Processor, 1008-Bluetooth module, 1009-Host computer, 1010-Urethra pressure sensor, 1011-Electromyographic sensor, 1012-Bladder pressure sensor, 1013-Atmospheric pressure sensor, 200-Power supply, 201-Processor, 202-Memory. Detailed Implementation

[0051] To make the technical problems, technical solutions, and beneficial effects to be solved by this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and are not intended to limit the scope of this application.

[0052] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on or indirectly on that other component. When a component is referred to as being "connected to" another component, it can be directly connected to or indirectly connected to that other component.

[0053] It should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0054] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0055] To address or improve the inconvenience of urodynamic data detection and use caused by unreasonable component placement or structural design in catheter-free urodynamic testing systems, this application provides a urodynamic data acquisition device. (See attached document.) Figure 1 As shown, the device includes an in-body device 1, a cord 3, and an external device 2. The in-body device 1 is connected to the external device 2 via the cord 3. Optionally, the cord 3 includes a wire. The in-body device 1 and the external device 2 are electrically connected via a power cord in the cord 3. The in-body device 1 is used to be placed in the bladder; the external device 2 is used to be fixed to external skin, such as the skin on the inner thigh or the skin on the abdomen.

[0056] See Figure 2 As shown, the acquisition device includes a power supply 200 located in the external device 2, which supplies power to the electrical components in the external device and the electrical components in the in-body device.

[0057] In some embodiments, the acquisition device includes a sensing unit disposed in the in-body device 1. The sensing unit may include one or more sensors 100, and electrical signals in the bladder can be acquired through the one or more sensors 100 of the sensing unit.

[0058] See Figure 2 As shown, based on one or more sensors 100 in the above-mentioned in-body device, the data acquisition device also includes a processor 201 and a memory 202 in the external device 2; the processor 201 communicates with all of the above-mentioned sensors 100 and generates urodynamic data according to the above-mentioned electrical signals; the generated urodynamic data is stored in the above-mentioned memory 202.

[0059] By adopting the above method, the number of components in the implantable device is greatly reduced, thereby significantly reducing the size of the implantable device. When it is necessary to remove the implantable device from the bladder, it can be easily removed by pulling the string.

[0060] By transmitting the electrical signals collected by sensors within the bladder to a processor and memory in an external device for processing and storage, data loss due to device malfunction is avoided. Furthermore, the less stringent size requirements of the external device allow for the configuration of the processor and memory based on processing and storage needs, enabling the use of a larger memory unit. This facilitates the processor's processing and storage of the electrical signals collected by the sensors within the bladder. Additionally, placing the processor and memory externally promotes stable operation of the processor and memory, as well as stable data processing.

[0061] To further reduce the size of the external device and improve the portability of the urodynamic data acquisition device, the power source can be a battery.

[0062] During use, the intravesical device is delivered into the patient's bladder via the urethra using a delivery device and remains inside the bladder throughout the procedure. After use, it can be removed from the bladder by pulling a cord through the urethra. The external device remains outside the patient's body and can be attached to a specific area of ​​the patient's thigh using adhesive tape. One end of the cord connects to the intravesical device, and the other end connects to the external device, enabling power supply and signal transmission between the two. The cord is partially inside the bladder, partially in the urethra, and partially outside the body. After use, the intravesical device can be removed by pulling the cord through the urethra from the patient's bladder.

[0063] Therefore, the above technical solution rationally arranges the position and structure of each component in the intravesical device by placing the power supply 200, processor 201, and memory 202 in the external device and connecting the external device 2 and the intravesical device 1 with a cord. Using the power supply 200 located in the external device to power the intravesical device improves the stability of power supply within the intravesical device. Placing the processor and memory in the external device facilitates the stable transmission of collected urodynamic data to the processor and memory in the external device for processing and storage. Because the power supply, processor, and memory are located in the external device, the size of the intravesical device is reduced. Combined with the pulling of the cord 3, the intravesical device can be easily removed from the bladder. Thus, the above technical solution, while facilitating the detection and storage of urodynamic data, reduces the size of the intravesical device and makes it easier to remove from the bladder. This solves or improves the problem of inconvenient urodynamic data detection and use caused by unreasonable placement or structural arrangement of components in the data acquisition device of catheter-free urodynamic detection systems in related technologies. Placing the power supply externally is safer than placing it internally.

[0064] In some embodiments, based on various electrical signals within the bladder acquired by one or more of the aforementioned sensors, the processor can generate more comprehensive urodynamic data, including: (i) the volume of urine in the bladder, (ii) the rate at which urine is expelled from the bladder, (iii) the pressure within the bladder, (iv) the volume of the bladder, (v) bladder abnormalities, and (vi) the chemical composition of the urine in the bladder.

[0065] In order to obtain more comprehensive electrical signals about the volume and level of urine in the bladder, one or more sensors in the above-mentioned sensing unit can detect the volume and level of urine in the bladder using the following methods or devices: (a) one or more shock waves or pressure pulses, (b) one or more light waves, (c) one or more lasers, (d) one or more sound signals, (e) ultrasound, (f) conductivity, and (g) pressure.

[0066] To facilitate the sensor unit's acquisition of various electrical signals within the bladder, please refer to... Figure 3 and 4 As shown, in some embodiments, the sensing unit 101 includes a closed housing and a sensing component disposed within the closed housing; the closed housing has a tubular structure; optionally, the closed housing includes a soft membrane chamber 101c, which encloses the sensing component within the soft membrane chamber 101c; optionally, the soft membrane chamber is made of a polyurethane film.

[0067] The sensing component includes one or more pressure sensors 101b and a support circuit 101a; each pressure sensor 101b is connected to the support circuit 101a, and the support circuit 101a is connected to the processor 201 of the external device 2. The soft membrane chamber 101c is filled with an insulating liquid filler 101d. The insulating liquid filler 101d enhances the sensitivity of the pressure sensors 101b to external stimuli. Optionally, the insulating liquid filler is silicone oil or other mineral oil. Using a soft membrane chamber allows for better skin-friendly comfort when the enclosed shell comes into contact with the body; optionally, the insulating liquid filler is silicone oil.

[0068] Understandably, the sensing components may also include temperature sensors or other sensors such as electromyography (EMG) sensors.

[0069] For easy assembly, disassembly, and securing of the urodynamic data acquisition device, please refer to... Figure 4 As shown, optionally, the external device 2 includes a housing 21, which houses the aforementioned processor, memory, and power supply. For ease of attachment, the housing 21 has adhesive tape 22, which can be adhered to the skin near the patient's urethral opening during use. In some embodiments, a cord is connected to the external device via a quick-connect structure. See also... Figure 4 As shown, the cord is connected to a quick-connect plug 51, and the external device is equipped with a quick-connect interface 52. The quick-connect plug 51 connects to the external device through the quick-connect interface 52. The cord can be quickly connected and disconnected through the quick-connect structure. It is understood that the quick-connect plug 51 and quick-connect interface 52 can achieve both electrical connection between the cord 3 and the external device 2, and also a physically detachable and fixed connection between the cord 3 and the external device 2. This quick-connect structure includes not only physical connection, but also electrical and signal connection. To improve the cord's toughness and tensile strength after repeated use, a reinforcing wire 33 is provided in the cord. For details, please refer to... Figure 5 As shown, the cord 3 includes: a power cord 31, a signal cord 32, a reinforcing cord 33, and a flexible outer sheath 34; the flexible outer sheath 34 wraps the signal cord 32, the power cord 31, and the reinforcing cord 33 within the hollow space of the flexible outer sheath.

[0070] To minimize irritation to living tissues and reduce the risk of infection when the cord is inserted into the body, a coating 35 is provided on the outer side of the flexible outer skin. Optionally, the coating 35 is a hydrophilic and antibacterial biocompatible material coating. For example, the material of the coating is polyvinylpyrrolidone, fucoidan, chitosan, fucoidan, or a modified product of chitosan.

[0071] Signal line 32 is connected to all sensors in the sensing unit to transmit signals between each sensor and the processor; each component in the in-body device is connected to the power supply in the external device via power line 31 to form an electrical circuit; optionally, the reinforcing line 33 is made of metal, such as iron, aluminum, copper or titanium.

[0072] To prevent the device from passively slipping out of the bladder, the device also includes a deformable part to prevent slippage from the bladder.

[0073] In one embodiment of this application, the deformable part is made of an elastic material or a shape memory material that can change shape between a straight line and a curve.

[0074] For example, see Figure 6 and Figure 7 As shown, the deformable portion can be a first deformable portion 102 covering the outside of the cord 3, and the first deformable portion 102 is made of an elastic material or a shape memory material. For example, the diameter of the closed shell is 2-10 mm and the length is 3 mm-15 mm, and the diameter of the cord 3 after covering the first deformable portion is 0.5-5 mm and the length is 30-200 mm.

[0075] See Figure 6 As shown, when the first deformable part 102 is in a straight line shape, the insertion part 301 can also be in a straight line shape; when the central axis of the first deformable part 102 is on the same straight line as the central axis of the closed shell, the insertion device 1 can be slowly inserted into the bladder. After the insertion device 1 enters the designated position in the bladder, the first deformable part 102 becomes a coiled shape, thereby preventing the insertion device 1 from passively sliding out of the bladder.

[0076] Optionally, the first deformable part 102 may be made of a metallic material with shape memory properties (such as nickel-titanium alloy (phase transformation point Af≤35℃)) or a polymeric material (such as polynorbornene, polyurethane, high trans polyisoprene, styrene, 7-butadiene copolymer, fluorinated resin, polycaprolactone or polyamide) or a material with good elasticity (such as 302 stainless steel).

[0077] Thus, during the process of the implantation device entering the bladder, the axis of the first deformable part 102 and the axis of the sensing part 101 remain in the same straight line or parallel. After the implantation device enters the bladder, the first deformable part 102 deforms and curls up to prevent the implantation device from sliding out of the bladder.

[0078] It is understood that the first deformable portion 102 includes a shape memory elastic element, which is insulated from the sensing portion. Optionally, the shape memory elastic element is made of a shape memory material. For example, the shape memory elastic element is made of a nickel-titanium alloy (phase transition point Af ≤ 35°C), which is linear at temperatures below or equal to 35°C.

[0079] In another embodiment of this application, the deformable portion may also be a second deformable portion, which includes a plurality of expansion deformation lines 112 disposed around the periphery of the sensing portion. See also Figure 8 and9 As shown, the upper end of each expansion deformation line 112 is connected to the upper end of the sensing unit, and the lower end of each expansion deformation line 112 can be connected to the lower end of the sensing unit.

[0080] See Figure 3 As shown, one or both ends of the sensing unit are provided with rigid or semi-rigid end caps, which are made of metal, plastic, or rubber. Optionally, the rigid or semi-rigid end cap includes a front cover 111 and a rear cover 113. The soft membrane chamber 101c encloses the sensing component within the soft membrane chamber 101c. The front cover 111 and the rear cover 113 are located at the upper and lower ends of the soft membrane chamber 101c, respectively, and at least one of the front cover 111 and the rear cover 113 is movably sleeved with the soft membrane chamber 101c.

[0081] By having at least one of the front cover 111 and the rear cover 113 movably sleeved with the soft membrane chamber 101c, it can be achieved that when the two ends of the deformable part and the sensing part are connected, one end of the sensing part is fixedly connected to one end of the deformable part containing multiple expansion deformation lines; and the other end of the sensing part is slidably connected to the other end of the deformable part containing multiple expansion deformation lines.

[0082] It is understood that the other end of the sensing unit is slidably connected to the other end of the deformed part containing multiple expansion deformation lines, and is not limited to being movably sleeved with the soft membrane chamber 101c by at least one of the front cover 111 and the rear cover 113. Other sliding connection methods can also be used, which are not limited here.

[0083] See Figure 8 and 9 As shown, all expansion deformation lines 112 are evenly distributed around the outer circumference of the closed shell. The upper end of each expansion deformation line 112 is insulated from and fixedly connected to the front cover 111, and the lower end of each expansion deformation line 112 is insulated from and fixedly connected to the rear cover 113.

[0084] Before the second deformed part enters the bladder, see [reference needed]. Figure 8 As shown, the axial direction of each expansion deformation line 112 is parallel to the axis of the soft membrane chamber.

[0085] Once the device is inserted into the bladder, refer to [the relevant documentation]. Figure 9 As shown, the deformation of each expansion deformation line 112 causes the expansion deformation line 112 to contract relative to the closed shell along the axial direction of the closed shell, presenting as... Figure 9 The expansion state shown can be a lantern-shaped structure.

[0086] Specifically, each expansion deformation line 112 can be an elastic filament (such as a nickel-titanium alloy wire). Multiple expansion deformation lines 112 form a lantern shape. The lantern shape, composed of multiple elastic filaments, a front cover, and a rear cover, is in an expanded state in its free state. When the multiple elastic filaments are compressed into the lantern shape, the lantern shape is forced into a compressed state, approximately an elongated cylindrical shape. During the compression deformation of the multiple elastic filaments, they slide along the outside of the sensing element to adapt to the deformation, without affecting or damaging the sensing element. Optionally, the outer diameter of the inserter in the approximately elongated cylindrical compressed state is 3-15 mm.

[0087] This application also provides a delivery device for delivering the in-body device of the above-mentioned urodynamic data acquisition device to a designated position, see reference. Figure 10 As shown, it includes an outer tube 41 and an inner tube 42; the outer tube 41 is used to receive the implantable device and the front part of the outer tube can be inserted into the bladder along the urethra; the inner tube 42 is slidably sleeved inside the outer tube and can be pushed forward along the axis of the outer tube to push the implantable device out of the outer tube.

[0088] The outer tube 42 is slidably fitted onto the outer surface of the inner tube 41 and can slide back and forth along the axis of the inner tube 41. The inner diameter of the outer tube 42 is slightly larger than the outer diameter of the sensing part of the implantation device. The inner diameter of the inner tube 41 is slightly larger than the outer diameter of the wire in the implantation module, but smaller than the outer diameter of the deformable part.

[0089] When the deformable part of the insertion device is the first deformable part 102, the insertion device can be formed as follows: Figure 7 The device is shown as an approximately circular ring (10-70 mm in diameter). Under external force, this approximately circular ring shape can be compressed into an approximately straight line shape. Once in this approximately straight line shape, the implant can be inserted into the delivery device. After the delivery device is implanted into the patient's bladder, the implant is pushed out of the delivery device and returns to its free state, restoring its approximately circular ring structure from its approximately straight line shape. This secures the implant in the patient's bladder, preventing it from slipping out of the urethra.

[0090] Therefore, the urodynamic data acquisition device can be conveniently inserted into a designated location in the bladder using the above method. Optionally, the outer wall of the outer tube is coated with a hydrophilic and antibacterial biocompatible material. For example, the coating material is polyvinylpyrrolidone, fucoidan, chitosan, fucoidan, or a modified product of chitosan.

[0091] When the deformable part of the insertion device is the second deformable part, refer to Figure 8 and 9 As shown, the second deformation section includes multiple expansion deformation lines 112, and all expansion deformation lines can produce, for example, when their shape changes. Figure 9The device, with its second deformable portion, is shown in an expanded shape. It can be permanently placed in the patient's bladder and will not automatically slip out of the urethra.

[0092] The implantation, operation, and removal process of the implantable device are described below using an implantable device having a first deformable portion 102. This process includes: disassembling the quick-connect structure at the connection between the cord 3 and the external device 2, separating the two. Under external force, the approximately circular structure formed by the first deformable portion 102 and the implantable device is compressed into an approximately straight shape and inserted into the front section of the delivery device, wherein the cord is located inside the inner tube 41, and the first deformable portion 102 and the implantable device are located inside the front section of the outer tube 42 and at the external front end of the inner tube 41. The front section of the delivery device is inserted into the bladder along the patient's urethra, fixing the position of the outer tube 42 relative to the patient's body, and then pushing the inner tube 41 forward along the axis of the outer tube 42, pushing the first deformable portion 102 and the implantable device out of the outer tube 42. When the first deformable portion 102 is pushed out of the outer tube 42, it returns to a coiled state, that is, immediately returns to an approximately circular structure, thereby fixing the implantable device in place in the patient's bladder and preventing it from slipping out of the urethra.

[0093] This application also provides a urodynamic data detection system, including: a urodynamic data acquisition device and a data terminal;

[0094] The data terminal is used to communicate with the processor of the data acquisition device. The data terminal contains software that can view, analyze, store, and record the results of one or more bladder filling and emptying cycles through the processor; or the software can configure the processor to overlay two or more filling / emptying cycles to help identify trends.

[0095] See Figure 8 As shown, in some embodiments, the urodynamic data detection system may include a battery voltage detection module 1001, a lithium battery 1002, a charge / discharge protection module 1003, a power switch 1004, an LED indicator 1005, a storage module 1006, a processor 1007, a Bluetooth module 1008, a host computer 1009, a urethral pressure sensor 1010, an electromyography sensor 1011, a bladder pressure sensor 1012, and an atmospheric pressure sensor 1013. The processor 1007 is connected to the battery voltage detection module 1001, the charge / discharge protection module 1003, the storage module 1006, the power switch 1004, the LED indicator 1005, the urethral pressure sensor 1010, the electromyography sensor 1011, the bladder pressure sensor 1012, and the atmospheric pressure sensor 1013, respectively; the processor 1007 is connected to the host computer 1009 via the Bluetooth module 1008.

[0096] The lithium battery 1002 provides power to all components. The processor 1007 receives electrical signals from each pressure sensor (via the signal lines in the cable) and performs related calculations, temporarily storing the processing results in the memory chip of the storage module 1006. The Bluetooth module 1008 sends the processing results from the memory chip to the application program (such as an app on a mobile phone) on the host computer receiving terminal. The LED indicator 1005 indicates the overall working status and can use different colors or flashing indicators to indicate different working states of the processor 1007.

[0097] The power switch 1004 is used to start or stop the processor. The external device can be waterproofed to prevent splashing of patient urine or other external liquids from causing malfunction.

[0098] The application (such as a mobile phone APP) located on the receiving terminal can process and analyze the data received from the Bluetooth module to obtain intuitive patient bladder pressure data. Its basic functions include: real-time bladder pressure data, historical bladder pressure data, charting of bladder pressure data, recording of patient drinking information, recording of urination information, recording of special symptoms, etc.

[0099] After the work is completed, turn off the power switch, and the urodynamic data monitoring system will stop working. Finally, tear off the adhesive tape 22, remove the external device from the patient's skin, and then pull the in-body device out of the patient's bladder through the urethra by pulling the string. Specifically, taking an in-body device with a first deformable part 102 as an example, during the removal of the in-body module, due to the compression of the narrow cavity around the patient's urethral wall, the first deformable part 102 will be compressed from a curled state into an approximately slender cylindrical state, and thus gradually pulled out of the patient's urethra under the pulling action of the string.

[0100] The software in this application embodiment can configure the processor to use artificial intelligence / machine learning algorithms to detect trends. Trends include detrusor insufficiency, detrusor overactivity, urinary incontinence, bladder distension, storage dysfunction, and voiding dysfunction. Therefore, this application embodiment can be combined with other products to perform more comprehensive parallel testing of patients. For example, it can be combined with a urinary flow meter to assist in testing the correlation between urine flow rate and bladder pressure during urination, providing doctors with more comprehensive data to assess the patient's condition.

[0101] The embodiments of this application have the following technical advantages compared with the prior art:

[0102] (1) The battery is located outside the body, ensuring high safety;

[0103] (2) The battery is located outside the body, and the long-term battery life of the entire system can be achieved by replacing the battery.

[0104] (3) The sensor module implanted in the body contains only a pressure sensor and necessary auxiliary structures, which greatly reduces the size, makes the implantation and removal operations easier, and makes the patient more comfortable to wear.

[0105] (4) The battery, data processing and signal transmission modules are located outside the body, and are not affected by bladder urine and human tissue (abdomen), so the signal transmission is stable;

[0106] (5) The battery, data processing and signal transmission module are located outside the body and have strong scalability. By adding sensors, the activity of pelvic floor muscles during urination can be monitored, and the electromyographic activity of the external urethral sphincter can be detected simultaneously, providing doctors with more comprehensive data for diagnosis.

[0107] (6) The entire bladder pressure monitoring system is compact in structure and has higher safety and comfort in use.

[0108] The above are merely preferred embodiments of this application and are not intended to limit this application. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A urodynamic data acquisition device, characterized in that, include: An in-body device for placement in the bladder and an external device for attachment to external skin; the external device is electrically connected to the in-body device via a cord to remove the in-body device from the bladder by pulling the cord; the external device includes a power source for powering the in-body device. The implantable device includes a sensing unit: the sensing unit includes one or more sensors, and the one or more sensors are configured to collect electrical signals within the bladder; The external device includes: a processor, which communicates with the sensor and is used to generate urodynamic data based on the electrical signal; And a memory configured to store the generated urodynamic data.

2. The urodynamic data acquisition device as described in claim 1, characterized in that, The implantation device also includes a deformable part for preventing it from slipping out of the bladder. The deformable part is connected to one or both ends of the sensing part. During the process of the implantation device entering the bladder, the axis of the deformable part and the axis of the sensing part remain in the same straight line or parallel. After the implantation device enters the bladder, the deformable part deforms into a curled state or an expanded state to prevent the implantation device from slipping out of the bladder.

3. The urodynamic data acquisition device as described in claim 1, characterized in that, The urodynamic data include at least one of the following: (i) the volume of urine in the bladder, (ii) the rate at which urine is expelled from the bladder, (iii) the pressure in the bladder, (iv) the volume of the bladder, (v) bladder abnormalities, and (vi) the chemical composition of the urine in the bladder.

4. The urodynamic data acquisition device as described in claim 2, characterized in that, The deformable part includes a shape memory elastic element, which is insulated from the sensing part.

5. The urodynamic data acquisition device as described in claim 4, characterized in that, When the deformable portion is connected to one end of the sensing portion, the deformable portion includes one or more deformation lines, and one or more of the deformation lines are connected to the sensing portion at one end and extend around the sensing portion; when the deformable portion is connected to both ends of the sensing portion, the deformable portion includes a plurality of expansion deformation lines arranged around the sensing portion.

6. The urodynamic data acquisition device as described in claim 5, characterized in that, When the deformable part is connected to both ends of the sensing part, one end of the sensing part is fixedly connected to one end of the deformable part containing multiple expansion deformation lines; the other end of the sensing part is slidably connected to the other end of the deformable part containing multiple expansion deformation lines.

7. The urodynamic data acquisition device as described in claim 6, characterized in that, One or both ends of the sensing unit are provided with rigid or semi-rigid end caps, which are made of metal, plastic or rubber.

8. The urodynamic data acquisition device as described in claim 1, characterized in that, The power source is a battery.

9. The urodynamic data acquisition device as described in claim 1, characterized in that, The cord includes: Flexible outer skin; A signal line, located within the flexible outer sheath, is used to transmit signals between the sensor and the processor; A power cord is located inside the flexible outer sheath and is used to form a current loop between each component and the power source. And a reinforcing line, located inside the flexible outer sheath, is used to increase the tensile strength of the rope.

10. The urodynamic data acquisition device according to any one of claims 1-9, characterized in that, The sensing unit includes: A closed shell with a membrane chamber; The sensor and its circuit are housed within the enclosed housing, and the wire is connected to the circuit. The sensor is located inside the soft membrane cavity; the soft membrane cavity is filled with an insulating liquid filler.

11. The urodynamic data acquisition device as described in claim 8, characterized in that, The cord is connected to the external device via a quick-connect structure; and / or, the outer surface of the outer skin is coated with a hydrophilic antibacterial coating.

12. The urodynamic data acquisition device as described in claim 1, characterized in that, One or more of the sensors are configured to detect the volume and level of urine in the bladder using one or more of the following: (a) one or more shock waves or pressure pulses, (b) one or more light waves, (c) one or more lasers, (d) one or more sound signals, (e) ultrasound, (f) conductivity, and (g) pressure.

13. A delivery device for delivering the intubation device of the urodynamic data acquisition device as described in any one of claims 1-12 to a designated position, characterized in that, include: An outer tube is used to accommodate the implantable device, and the front part of the outer tube can be inserted into the bladder along the urethra; The inner tube is slidably fitted inside the outer tube, and the inner tube can be pushed forward along the axis of the outer tube in order to push the intubation device out of the outer tube.

14. A urodynamic data detection system, characterized in that, include: The urodynamic data acquisition device according to any one of claims 1-12; A data terminal for communicating with the processor of the data acquisition device, the data terminal including software that, through the processor, can view, analyze, store, and record the results of one or more bladder filling and emptying cycles; or the software can configure the processor to overlay two or more filling / emptying cycles to help identify trends.

15. The urodynamic data detection system as described in claim 14, characterized in that, The software configures the processor to use artificial intelligence / machine learning algorithms to detect trends, which include at least one of the following: detrusor insufficiency, detrusor overactivity, urinary incontinence, bladder distension, storage dysfunction, and voiding dysfunction.

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