Artificial pneumatic-assisted urination system

Abstract

The present invention belongs to the field of medical devices. Specifically, disclosed is an artificial pneumatic-assisted urination system, which comprises a bladder wrapping member. The bladder wrapping member comprises a curved front shell and a curved rear shell; and an end surface of the curved front shell and an end surface of the curved rear shell are connected in a butt-joint manner. The curved rear shell is provided with a ureter wrapping shell, the ureter wrapping shell is provided with a ureter outer opening and a ureter inner opening, and a ureter passes through the ureter outer opening and the ureter inner opening into the interior of the curved rear shell. A bladder neck opening is provided. An inner layer is provided on the inner side of the curved front shell, the inner layer is made of a flexible and stretchable material, and the inner layer is connected near the edge of the inner side of the curved front shell. A sealed cavity is formed between the inner layer and the curved front shell. The curved front shell is provided with a communication member, and when a medium is injected into the sealed cavity, increasing the pressure, the inner layer is squeezed. The bladder wrapping member is of a modular assembly type, and the wrapping shell is provided with a hole and a slot, which ensures tight wrapping of the bladder while guaranteeing the blood supply to the bladder and the patency of the ureter and the bladder neck opening, thereby facilitating urine drainage and preventing the formation of bladder hernia.

Description

An artificial pneumatic assisted urination system Technical Field

[0001] This invention belongs to the field of medical device technology, and in particular relates to an artificial pneumatic assisted urination system. Background Technology

[0002] Urine is produced by the kidneys, flows down the ureters, and is stored in the bladder. When the bladder reaches a certain volume, a nerve reflex causes the bladder to contract and expel the urine through the urethra. Damage to urination-related nerves and poor long-term blood sugar control in diabetes can lead to neurogenic bladder. Simply put, neurogenic bladder means the bladder cannot properly store and expel urine. In the late stages of diabetic neurogenic bladder, patients lack the awareness to urinate, the bladder does not contract, leading to bladder overdistension, urine retention, further causing infection, ureteral obstruction and reflux, and further kidney damage, seriously affecting the patient's health. With the aging population, the diabetic population is rapidly increasing, and the number of patients with neurogenic bladder is also rapidly increasing. Currently, clinical treatment for diabetic-related neurogenic bladder is only a last resort (clean catheterization and cystostomy). Clean catheterization requires a high level of patient compliance and needs to be performed several times a day, causing considerable pain for the patient. With cystostomy, patients need to have a urinary catheter inserted into their abdomen and a urine bag attached for life. Because the stoma is directly connected to the inside of the bladder, urinary leakage and bladder infection are almost inevitable, resulting in a very poor quality of life for patients.

[0003] In addition, the standard treatment for mid-to-late stage bladder cancer is to remove the bladder. In order to maintain the patient's quality of life, a section of intestine can be removed to make a urinary allantoic and anastomosed with the ureter and urethra to replace the original bladder. However, the intestine does not contract to urinate like the bladder. In other words, the intestinal replacement bladder is similar to an artificial neurogenic bladder. After the operation, the patient will still face the problem of difficulty in urinating.

[0004] Based on the above problems, many domestic scholars have devoted themselves to developing bladder-assisted voiding devices. Ideally, such devices should meet the following basic requirements: 1. Non-toxic to organisms; 2. Emptying urine as much as possible; 3. Preventing reflux of urine from the bladder into the ureters during voiding; 4. Avoiding serious damage to the bladder, mainly including rupture, poor blood supply, and bladder hernia; 5. Long-term stable function of the device. Currently, the related devices disclosed all fall short of these requirements to varying degrees, and there has been no significant breakthrough in the treatment of neurogenic bladder. Summary of the Invention

[0005] In view of the shortcomings of the existing technology, the purpose of this invention is to provide an artificial pneumatic assisted urination system that, while tightly wrapping the bladder, can ensure the blood supply to the bladder and the unobstructed flow of the ureters and bladder neck, further facilitating the emptying of urine, and at least solves one of the problems in the background technology.

[0006] This invention provides the following technical solution:

[0007] An artificial pneumatic assisted urination system includes a bladder enclosure, which includes a curved front shell and a curved rear shell;

[0008] The end faces of the curved front shell and the end faces of the curved rear shell are mated and connected;

[0009] The curved rear shell is provided with a ureter wrapping shell, which has an outer ureter hole and an inner ureter hole. The ureter passes through the outer ureter hole and the inner ureter hole to enter the interior of the curved rear shell.

[0010] Bladder neck foramen;

[0011] The curved front shell has an inner layer on its inner side, which is made of a flexible and stretchable material. The inner layer is connected to the inner side of the curved front shell near the edge, forming a sealed cavity between the inner layer and the curved front shell. The curved front shell has a connecting piece. When the sealed cavity is filled with a medium, the increased pressure compresses the inner layer.

[0012] Preferably, the medium inside the sealed cavity is air; the connecting part on the curved front shell is an air hole or air nozzle, and the connecting part connects the air supply component and the sealed cavity.

[0013] Preferably, the curved rear shell is an integral structure or a split structure; the split structure includes two symmetrically arranged curved surfaces, which are assembled together to form the curved rear shell; two ureter wrapping shells are symmetrically arranged on the curved rear shell, and a protrusion is provided on the side of the ureter wrapping shell closer to the curved rear shell, and an anti-reflux airbag is provided on the side of the ureter wrapping shell away from the curved rear shell. The protrusion and the anti-reflux airbag are arranged correspondingly, and the anti-reflux airbag and the protrusion cooperate to compress the ureter.

[0014] Preferably, the bladder neck opening is located on the curved rear shell or at the junction of the curved front shell and the curved rear shell. The bladder neck opening is formed by an arc-shaped defect in the curved rear shell, or by both an arc-shaped defect in the curved rear shell and an arc-shaped defect in the curved front shell.

[0015] Preferably, the ureter enclosure includes a fixed module and a movable module, with the movable module rotatably connected to the fixed module on one side and engaged on the other side; the fixed module is connected to the curved rear shell, the inner hole of the ureter is located on the curved rear shell, and the outer hole of the ureter is located on the fixed module, the movable module, or adjacent to the fixed module and the movable module; when the outer hole of the ureter is located adjacent to the fixed module and the movable module, it is formed by the arc-shaped defect on the fixed module and the arc-shaped defect on the movable module; the inner hole of the ureter is located above the bladder neck foramen, and a first vascular groove is provided between the inner hole of the ureter and the bladder neck foramen, the first vascular groove being a through groove.

[0016] Preferably, the inner layer is made of a single or multiple layers of flexible material, and the inner layer is fitted inside the anterior middle part of the bladder. The sealed cavity between the inner layer and the curved outer shell can change volume as gas enters and exits the air supply component, squeezing the inner layer to push the bladder to urinate.

[0017] Preferably, the curved front shell end face is provided with multiple slots, and the curved rear shell end face is provided with multiple inserts. The inserts are inserted into the slots in a corresponding manner. The outer side walls of the curved front shell and the curved rear shell are provided with fixing protrusions, which can be secured by cable ties.

[0018] Preferably, the adjacent ends of the curved anterior shell and the curved posterior shell are provided with a plurality of second vascular grooves. The second vascular grooves are located on the curved anterior shell or the curved posterior shell, or are formed by the defects of the curved anterior shell and the curved posterior shell.

[0019] Preferably, the curved posterior shell has multiple fixing holes through which sutures are threaded to fix the bladder to the inner side of the curved posterior shell. During surgery, the bladder is sutured and fixed to the inner layer of the curved posterior shell through the fixing holes. The curved anterior shell has a fixing block with a through hole. A strap or hook is provided in the through hole to fix the bladder package to the human pelvis. The strap and hook are made of titanium alloy or zirconia ceramic.

[0020] Preferably, the air supply component includes an inflation mechanism and an air guiding mechanism. The inflation mechanism includes an air bladder with knobs at both ends. Both ends of the air bladder are connected to filters via the knobs. The air bladder has a built-in one-way valve, supplying air unidirectionally to the air guiding mechanism. An air tube is connected to the air outlet of the air bladder, and the air tube is connected to the air guiding mechanism. A filter is located at the end of the air tube near the air bladder, and a knob is located on one side of the filter, which is connected to the air outlet of the air bladder. The air guiding mechanism includes a main pipe, which is connected to the filter of the air bladder via the knobs. The main pipe is connected to three tubing, one of which is connected to a connecting piece, and the other two tubing are respectively connected to two anti-reflux air bladders inside the ureteral casing. When in use, the air supply component consists of separate air inflator and air delivery mechanisms connected by a knob and thread. The air delivery mechanism's air tube end is exposed outside the body and is equipped with a filter that filters airborne bacteria and viruses to prevent infection. When urination is needed, the air bladder is connected to the air tube, and the air bladder is squeezed, increasing the volume of the sealed cavity and compressing the inner layer and bladder to achieve urination. The filter membrane is made of one or more of polyethersulfone (PES), nylon, and polytetrafluoroethylene, with a pore size of 0.22μm-0.45μm, effectively filtering airborne bacteria and viruses and preventing them from entering the bladder and causing infection, thus improving safety.

[0021] Preferably, the slot provided on the end face of the curved front shell and the insert provided on the end face of the curved rear shell constitute a mortise and tenon structure.

[0022] Preferably, the movable module and the fixed module of the ureteral enclosure are provided with a hinge on one side, which is connected by rotation through the hinge, and the other side is closed and fixed by a fixed protrusion binding strap.

[0023] Preferably, the active module has a connection hole through which a catheter passes and connects to the anti-reflux balloon. The catheter supplies air to the anti-reflux balloon. When the balloon is squeezed to expel urine from the bladder, the pressure inside the anti-reflux balloon increases. The anti-reflux balloon and the protrusion work together to squeeze the ureter, preventing urine in the bladder from flowing back into the kidney through the ureter and causing kidney damage.

[0024] Preferably, the curved rear shell adopts an integral structure or a split structure. The split structure consists of two arc-shaped surfaces, and the split structure makes installation easier. A vascular groove is provided between the bladder orifice and the ureteral orifice for placing blood vessels connecting to the bladder.

[0025] Preferably, when using an intestinal neobladder, since the vascular structure of the intestinal neobladder is different from that of the original bladder, it should be understood that the blood vessels of the intestinal neobladder have a ring-shaped structure along the periphery of the intestinal neobladder. Therefore, in order to use an intestinal neobladder, multiple second vascular grooves are provided at the adjacent ends of the curved anterior shell and the curved posterior shell. Blood vessels are placed along the periphery through multiple second vascular grooves to supply blood to the intestinal neobladder.

[0026] Preferably, the catheter is provided with a fixing plate, which can be sutured under the skin to fix the catheter.

[0027] Preferably, a positive electrode and a negative electrode are located near the air vent on the inner wall of the curved front shell. The positive and negative electrodes are tightly attached to the inner wall of the curved front shell and are formed by overlapping and pressing. The positive and negative electrodes are elastic and made of titanium alloy. When there is little urine in the bladder, the positive and negative electrodes are not in contact. When the bladder is full, the inner layer compresses the positive and negative electrodes, causing them to contact and form a conductive path. Both the positive and negative electrodes are connected to wires that extend to the outside of the body via a conduit. A buzzer or flashing light can be connected to the positive and negative electrodes via these wires, with the positive electrode connected to the power source and the negative electrode connected to the negative terminal of the power source. As the bladder gradually fills with urine, the inner and outer layers of the curved front shell come into contact, connecting the positive and negative electrodes. The external buzzer sounds or the flashing light illuminates, alerting the patient to assisted urination.

[0028] Compared with the prior art, the present invention has the following beneficial effects:

[0029] This invention discloses an artificial pneumatic assisted urination system. The bladder wrapping component is modularly assembled, and the wrapping shell has holes and grooves. While tightly wrapping the bladder, it can ensure the blood supply to the bladder and the unobstructed flow of the ureter and bladder neck, which further facilitates the emptying of urine without causing the formation of bladder hernia (bladder diverticulum).

[0030] Using a pneumatic system to power urination eliminates the need for an internal water balloon and pump, reducing discomfort and complications associated with water balloons. The pneumatic system has a simple structure and is less prone to failure compared to pump-powered systems. It also features multi-stage filters to ensure that the gas entering the urination air chamber and anti-reflux balloon is sterile, preventing infection. Attached Figure Description

[0031] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained from these drawings without creative effort.

[0032] Figure 1 is a schematic diagram of the overall structure of the present invention.

[0033] Figure 2 is a top view of the structure of the present invention.

[0034] Figure 3 is a bottom view of the structure of the present invention.

[0035] Figure 4 is a schematic diagram of the bladder wrapping structure of the present invention.

[0036] Figure 5 is a schematic diagram of the split structure of the bladder wrapping component of the present invention.

[0037] Figure 6 is a schematic diagram of the bladder wrapping structure of the present invention.

[0038] Figure 7 is a schematic diagram of the cross-sectional structure of the bladder wrapping component of the present invention.

[0039] Figure 8 is a front view of the bladder wrapping component of the present invention.

[0040] Figure 9 is a schematic diagram of the single-leaf curved surface rear shell structure of the present invention. Detailed Implementation

[0041] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, not all of them. Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to represent selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0042] Furthermore, in this invention, the use of terms such as "first" and "second" is for descriptive purposes only and does not specifically refer to any order or sequence, nor is it intended to limit the invention. They are merely used to distinguish components or operations described using the same technical terms and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Therefore, a feature defined with "first" or "second" may explicitly or implicitly include at least one of those features. Additionally, the technical solutions and features of the various embodiments can be combined with each other, but this must be based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or impossible to implement, such a combination should be considered non-existent and not within the scope of protection claimed by this invention. Example

[0043] Referring to Figures 1-8, an artificial pneumatic assisted urination system includes a bladder enclosure, which comprises a curved front shell 1 and a curved rear shell 2. The end faces of the curved front shell 1 and the curved rear shell 2 are connected to each other. A ureter enclosure 3 is provided on the curved rear shell 2. The ureter enclosure 3 has an external ureter hole 18 and an internal ureter hole 7. The ureter passes through the external ureter hole 18 and the internal ureter hole 7 and enters the interior of the curved rear shell 2. There is also a bladder neck orifice. An inner layer 17 is provided on the inner side of the curved front shell 1. The inner layer 17 is made of a flexible and elastic material and is connected to the inner side of the curved front shell 1 near the edge. A sealed cavity 27 is formed between the inner layer 17 and the curved front shell 1. The curved front shell 1 has a connecting piece 21. When the sealed cavity 27 is filled with a medium, the increased pressure compresses the inner layer 17. The inner layer has a double-layer structure. The layer near the curved rear shell is made of polyurethane material, which has good elasticity, strong toughness and good sealing performance. The layer near the bladder is made of PDMS material, which is non-toxic and has no side effects. The curved front shell and curved rear shell are made of titanium alloy or PETISO material.

[0044] The medium inside the sealed cavity 27 is air; the connecting part 21 on the curved front shell 1 is an air hole or air nozzle, and the connecting part 21 connects the air supply component and the sealed cavity 27.

[0045] The curved rear shell 2 can be an integral structure or a split structure; the split structure includes two symmetrically arranged curved surfaces, which are assembled together to form the curved rear shell 2; two ureter wrapping shells 3 are symmetrically arranged on the curved rear shell 2, and a protrusion 13 is provided on the side of the ureter wrapping shell 3 near the curved rear shell 2, and an anti-reflux balloon 6 is provided on the side of the ureter wrapping shell 3 away from the curved rear shell 2. The anti-reflux balloon 6 is connected to a catheter 22, and the protrusion 13 is correspondingly arranged with the anti-reflux balloon. The anti-reflux balloon and the protrusion 13 cooperate to compress the ureter.

[0046] The bladder neck opening is located on the curved posterior shell 2 or at the adjacent position of the curved anterior shell 1 and the curved posterior shell 2. The bladder neck opening is formed by the arc-shaped defect of the curved posterior shell 2, or by the arc-shaped defect of the curved posterior shell 2 and the arc-shaped defect of the curved anterior shell 1.

[0047] The ureteral enclosure 3 includes a fixed module 4 and a movable module 5. The movable module 5 is rotatably connected to the fixed module 4 on one side and engaged on the other side. The fixed module 4 is connected to the curved rear shell 2. The ureteral inner hole 7 is located on the curved rear shell 2, and the ureteral outer hole 18 is located on the fixed module 4, the movable module 5, or at the junction of the fixed module 4 and the movable module 5. When the ureteral outer hole 18 is located at the junction of the fixed module 4 and the movable module 5, it is formed by the arc-shaped defects on the fixed module 4 and the movable module 5. The ureteral inner hole 7 is located above the bladder neck orifice, and a first vascular groove 9 is provided between the ureteral inner hole 7 and the bladder neck orifice. The first vascular groove 9 is a through groove. During installation, when the curved front shell and the curved rear shell are engaged, the ureter, bladder neck, and blood vessel can be placed in the corresponding ureteral outer hole, bladder neck orifice, and first vascular groove, respectively. Then, the engagement is completed, and the posteroinferior wall of the bladder portion is sutured and fixed to the curved rear shell through the fixing hole. This bladder wrapping device completely encloses the bladder while ensuring the patency of bladder blood vessels, ureters, and bladder neck, thus facilitating the emptying of urine as much as possible and preventing the formation of bladder hernia.

[0048] The inner layer 17 is made of a single or multiple layers of flexible material, and the anterior middle part of the bladder is nestled inside the inner layer 17. The sealed cavity 27 between the inner layer 17 and the curved outer shell can change volume with the gas entering and exiting the air supply component, squeezing the inner layer 17 to push the bladder to urinate. The end face of the curved front shell 1 is provided with multiple slots 16, and the end face of the curved rear shell 2 is provided with multiple inserts 15. The inserts 15 are inserted into the slots 16 respectively. The outer side walls of the curved front shell 1 and the curved rear shell 2 are provided with fixing protrusions 14, which can be tightened by cable ties.

[0049] Multiple second vascular grooves 12 are provided at the adjacent ends of the curved anterior shell 1 and the curved posterior shell 2. The second vascular grooves 12 are located on the curved anterior shell 1 or the curved posterior shell 2, or are formed by defects in both the curved anterior shell 1 and the curved posterior shell 2. The curved posterior shell 2 has multiple fixation holes 10 through which sutures are passed to fix the bladder to the inner side of the curved posterior shell 2. The curved anterior shell 1 has a fixation block 11 with a through hole. A zip tie or hook is installed in the through hole to fix the bladder package to the human pelvis. The fixation block on the anterolateral side of the outer layer of the curved anterior shell has hooks, which can be used to fix the bladder package system to the pelvis to prevent displacement of the bladder package and compression of important pelvic organs and tissues.

[0050] The air supply assembly includes an inflation mechanism and an air guiding mechanism. The inflation mechanism includes an air bladder with knobs at both ends. Filters are connected to both ends of the air bladder via the knobs. The air bladder has a built-in one-way valve, supplying air unidirectionally to the air guiding mechanism. An air tube is connected to the air outlet of the air bladder, and the air tube is connected to the air guiding mechanism. A filter is located at the end of the air tube near the air bladder, and a knob is located on one side of the filter, connecting to the air outlet of the air bladder via the knob. The air guiding mechanism includes a main pipe, which is connected to the filter of the air bladder via the knob. The main pipe is connected to three tubing, one of which is connected to a connecting piece, and the other two tubing are respectively connected to two anti-reflux air bladders inside the ureteral casing. In use, the air supply assembly features a separate inflator and air guide mechanism connected by a knob and threads. The air tube end of the air guide mechanism is exposed outside the body and equipped with a filter to filter bacteria and viruses from the air, preventing infection. When urination is needed, the inflator is connected to the air tube, and squeezing the air tube increases the volume of the sealed cavity, compressing the inner layer and bladder to facilitate urination. The filter membrane is made of one or more of polyethersulfone (PES), nylon, and polytetrafluoroethylene, with a pore size of 0.22μm-0.45μm, effectively filtering bacteria and viruses from the air and preventing them from entering the bladder and causing infection, thus improving safety. The slot 16 on the end face of the curved front shell 1 and the insert 15 on the end face of the curved rear shell 2 form a mortise and tenon structure.

[0051] The movable module 5 of the ureter enclosure 3 and the fixed module 4 are connected by a hinge 20 on one side, and are rotated together by the hinge 20. The other side is closed and fixed by a fixing protrusion 14 and a cable tie. The movable module 5 has a connection hole 19, through which a catheter 22 passes and connects to the anti-reflux balloon 6. Air is supplied to the anti-reflux balloon 6. When the balloon 24 is squeezed to expel urine from the bladder, the pressure inside the anti-reflux balloon 6 increases. The anti-reflux balloon 6 and the protrusion 13 work together to squeeze the ureter, preventing urine in the bladder from flowing back into the kidney and causing kidney damage.

[0052] The split structure consists of two arc-shaped surfaces, making installation easier. A vascular groove is provided between the bladder orifice 8 and the ureteral orifice 7 to accommodate the blood vessels connecting to the bladder.

[0053] In one embodiment, the catheter 22 is provided with a fixing plate 26, which can be sewn under the skin to fix the catheter 22.

[0054] In one embodiment, as shown in Figure 9, the curved posterior shell 2 adopts an integral structure, and the curved posterior shell is a single leaf, which can be selected according to the patient's pelvis, bladder shape, vascular plexus distribution and intestinal neobladder procedure.

[0055] In one embodiment, the inflator is an elastic balloon with one-way valves at both ends to control the direction of gas flow. Filters are connected to both ends of the inflator via knobs; these filters are removable and replaceable. A catheter originates from different air vents and converges into a single catheter, which bends at its outer end and connects to a knob. The knob is connected to a filter, which is also removable and replaceable. A fixing plate is located near the external end of the catheter; this plate can be sutured subcutaneously to secure the catheter. When urination is required, the patient can connect the inflator to the catheter system as needed. Inflating increases the pressure in the sealed cavity, compressing the inner layer to achieve urination. Simultaneously, the anti-reflux balloon inflates and compresses the ureter, preventing ureteral reflux. After urination, the inflator is removed, and the gas can freely escape from the urination chamber and the anti-reflux balloon. The bladder then receives urine from the ureter for storage. This pneumatic system has multiple filters to ensure the sterility of the air entering the body. The filters can be removed and replaced regularly to ensure long-term stable function of the device. In addition, this pneumatic device does not require batteries or pumps for power, making it reliable over a long period of time.

[0056] Storage period: As urine enters the bladder from the ureter, the bladder volume increases with the increase in urine volume. Because the sealed cavity of the catheter is connected to the outside through the catheter and filter, the bladder can push the inner layer to move, the gas in the sealed cavity is discharged, the volume of the sealed cavity shrinks, and the inner layer returns to its original position. When the bladder volume increases to a certain extent, because there are positive and negative electrodes near the air pores on the inner wall of the curved front shell, the positive and negative electrodes are closely attached to the inner wall of the curved front shell and are formed by overlapping and pressing. The positive and negative electrodes are elastic and made of titanium alloy. When there is little urine in the bladder, the positive and negative electrodes do not contact each other. When the bladder is full, the inner layer squeezes the positive and negative electrodes, and the two contact to form a conductive path. Both the positive and negative electrodes are connected to wires, and the wires extend to the outside of the body along with the catheter. The positive and negative electrodes can be connected to a buzzer or flashing light through the wires, and the positive electrode is connected to the power source. The negative electrode is connected to the negative terminal of the power supply. As the bladder gradually fills with urine, the inner layer of the curved front shell comes into contact with the outer shell, and the positive electrode and the negative electrode are connected. The external buzzer sounds or the light flashes to remind the patient to urinate.

[0057] It should be understood that in another embodiment, a conductive sheet is provided on the outer wall of the inner layer, and the positive electrode and the negative electrode can be connected through the conductive sheet of the inner layer to form a circuit.

[0058] Voiding phase: After connecting the air inflator and the catheter port, the air inflator is squeezed. Because there are one-way valves at both ends of the air inflator, the air is forced into the catheter system and filtered through multiple filters. The air entering the catheter system is sterile. The air further enters the voiding air chamber and the anti-reflux balloon, compressing the bladder and ureter to achieve spontaneous urination. At the same time, it can prevent urine reflux into the ureter. After urination, the air inflator and the catheter system are separated. The air in the anti-reflux balloon flows out of the catheter system, the ureter is relieved of pressure, and urine can flow from the ureter into the bladder, entering the urine storage phase again. This cycle continues.

[0059] In one embodiment, the specific shape of the bladder package can be adjusted according to the patient's pelvis, bladder shape, vascular plexus distribution, and intestinal replacement bladder procedure. The product can be manufactured by casting or 3D printing, and all parts in contact with human tissue are made of bio-inert materials.

[0060] This device requires surgical installation for neurogenic bladder. Preoperatively, imaging techniques such as CT and MRI are needed to assess the patient's pelvic and bladder morphology and vascular plexus distribution to adjust the size, shape, openings, and slots of the wrapping device. The wrapping device is typically 3D printed or cast. During the surgery, two single-J stents are first placed into the ureter via ureteroscopy to drain urine from the kidneys. Simultaneously, an auxiliary balloon is inserted into the bladder via the urethra for later bladder inflation. Then, an extraperitoneal approach is used to separate the bladder dorsal wall from the peritoneum and the anterior bladder wall from the abdominal wall or pelvis. The ureteral segment near the bladder is freed. For male patients, the seminal vesicle is ligated and freed, while the bladder neck is preserved intact, and the lateral bladder ligaments are appropriately freed. The bladder wrapping device is then installed by placing the ureter, bladder neck, and vascular plexus into the corresponding external ureteral orifice, internal ureteral orifice, bladder neck foramen, and first vascular slot, respectively, and then apposition is completed. Inflate the bladder's auxiliary balloon to fill it, pushing the bladder against the curved posterior shell, ensuring the bladder's posterior wall adheres to the shell. The posteroinferior wall of the bladder is sutured and fixed to the curved posterior shell through the fixation hole. The ureter is placed inside the ureteral enclosure and passed upwards through the external ureteral orifice. The ureteral enclosure system is closed; the fixation protrusion can be connected via buckles or wrapped sutures. The catheter is combed and passed through a tunnel under the skin, with the fixation disc sutured subcutaneously to secure it. 7-10 days post-surgery, remove the bladder balloon and single-J stent. Connect the inflation device to the external opening of the catheter system. Repeatedly squeeze the balloon to induce urination. After urination, separate the inflation device from the catheter system to enter the storage phase. This cycle is repeated until spontaneous urination is achieved.

[0061] For intestinal neobladders, the size, shape, opening, and slot positions of the wrapping device are adjusted according to the different surgical procedures. The wrapping device is 3D printed or cast. Since the blood supply of the intestinal neobladder comes from the mesentery, the mesentery has a disordered structure and irregular blood vessel distribution. The vascular slots at the matching points of the wrapping slots can be elongated, circular, or other different shapes, and their sizes are not fixed. In addition, some intestinal neobladder procedures combine and anastomose the two ureters before implanting them into the neobladder. In this case, only one ureteral wrapping shell needs to be retained in the wrapping system. The bladder is removed, a single-J stent is placed in the ureter, and an intestinal neobladder is created. After anastomosing the neobladder to the ureter and urethra, a bladder wrapping device is installed. First, the ureter, urethral anastomosis, and vascular plexus are placed in the corresponding ureteral external orifice, ureteral internal orifice, bladder neck, and second vascular groove, respectively. Then, alignment is completed. The posteroinferior wall of the neobladder is sutured and fixed to the single-layer shell through fixation holes. The ureter is placed inside the ureteral wrapping shell, passing upwards through the ureteral external orifice. The ureteral wrapping system is closed, and the fixation protrusion is connected by buckles or, alternatively, by winding silk sutures. Hooks are located on the anterolateral side of the multi-layered curved anterior shell. These hooks are used to fix the bladder wrapping system to the pelvis to prevent displacement of the wrapping shell and compression of vital pelvic organs and tissues. The catheter is combed and passed through a tunnel under the skin. A fixation disc is sutured to the subcutaneous tissue to secure the catheter. 7-14 days after surgery, the single-J tube is removed, and the inflator is connected to the external opening of the catheter system. The balloon is repeatedly squeezed to induce urination. After urination, the inflator is disconnected from the catheter system to enter the urine storage period. This cycle is repeated until spontaneous urination can be achieved.

[0062] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention can have various modifications and variations; any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An artificial pneumatic assisted urination system, characterized in that, It includes a bladder package, which includes a curved front shell (1) and a curved rear shell (2); The end face of the curved front shell (1) and the end face of the curved rear shell (2) are mated and connected; The curved rear shell (2) is provided with a ureter wrapping shell (3), which is provided with an outer ureter hole (18) and an inner ureter hole (7). The ureter passes through the outer ureter hole (18) and the inner ureter hole (7) and enters the interior of the curved rear shell (2). Bladder neck foramen; The inner side of the curved front shell (1) is provided with an inner layer (17), which is made of a flexible and elastic material. The inner layer (17) is connected to the inner side of the curved front shell (1) near the edge. A sealed cavity (27) is formed between the inner layer (17) and the curved front shell (1). The curved front shell (1) is provided with a connecting piece (21). The pressure of the medium filling the sealed cavity (27) increases, which compresses the inner layer (17).

2. The artificial pneumatic assisted urination system according to claim 1, characterized in that, The medium inside the sealed cavity (27) is gas; the connecting part (21) on the curved front shell (1) is a vent or a nozzle, and the connecting part (21) connects the gas supply component and the sealed cavity (27).

3. The artificial pneumatic assisted urination system according to claim 1, characterized in that, The curved rear shell (2) is an integral structure or a split structure; the split structure includes two symmetrically arranged curved surfaces, which are assembled together to form the curved rear shell (2); two ureter wrapping shells (3) are symmetrically arranged on the curved rear shell (2), and a protrusion (13) is provided on the side of the ureter wrapping shell (3) close to the curved rear shell (2), and an anti-reflux balloon (6) is provided on the side of the ureter wrapping shell (3) away from the curved rear shell (2). The anti-reflux balloon (6) is connected to a catheter (22), and the protrusion (13) is correspondingly arranged with the anti-reflux balloon. The anti-reflux balloon and the protrusion (13) work together to squeeze the ureter.

4. The artificial pneumatic assisted urination system according to claim 1, characterized in that, The bladder neck orifice is located on the curved rear shell (2) or at the adjacent position of the curved front shell (1) and the curved rear shell (2). The bladder neck orifice is formed by the arc-shaped defect of the curved rear shell (2) or by the arc-shaped defect of the curved rear shell (2) and the arc-shaped defect of the curved front shell (1).

5. An artificial pneumatic assisted urination system according to any one of claims 1-3, characterized in that, The ureter enclosure (3) includes a fixed module (4) and a movable module (5). The movable module (5) is rotatably connected to the fixed module (4) on one side and engaged on the other side. The fixed module (4) is connected to the curved rear shell (2). The ureter inner hole (7) is located on the curved rear shell (2). The ureter outer hole (18) is located on the fixed module (4) or the movable module (5) or at the adjacent position of the fixed module (4) and the movable module (5). When the ureter outer hole (18) is located at the adjacent position of the fixed module (4) and the movable module (5), it is formed by the arc-shaped defect on the fixed module (4) and the arc-shaped defect on the movable module (5). The ureter inner hole (7) is located above the bladder neck foramen. A first vascular groove (9) is provided between the ureter inner hole (7) and the bladder neck foramen. The first vascular groove (9) is a through groove.

6. The artificial pneumatic assisted urination system according to claim 1, characterized in that, The inner layer (17) is made of a single or multiple layers of flexible material. The inner layer (17) is fitted inside the anterior middle part of the bladder. The sealed cavity (27) between the inner layer (17) and the curved outer shell can change volume with the gas entering and exiting the gas supply component, and squeeze the inner layer (17) to push the bladder to urinate.

7. The artificial pneumatic assisted urination system according to claim 1, characterized in that, The curved front shell (1) has multiple slots (16) on its end face, and the curved rear shell (2) has multiple inserts (15) on its end face. The inserts (15) are inserted into the slots (16) respectively. The outer side walls of the curved front shell (1) and the curved rear shell (2) are provided with fixing protrusions (14). The fixing protrusions (14) can be tightened by cable ties.

8. The artificial pneumatic assisted urination system according to claim 1, characterized in that, Multiple second vascular grooves (12) are provided at the adjacent ends of the curved front shell (1) and the curved rear shell (2). The second vascular grooves (12) are located on the curved front shell (1) or the curved rear shell (2), or are formed by the defects of the curved front shell (1) and the curved rear shell (2).

9. The artificial pneumatic assisted urination system according to claim 1, characterized in that, The curved rear shell (2) is provided with multiple fixing holes (10), through which sutures are passed to fix the bladder to the inside of the curved rear shell (2); the curved front shell (1) is provided with a fixing block (11), which is provided with a through hole, and a binding wire or hook is provided in the through hole to fix the bladder package to the human pelvis through the binding wire or hook.

10. The artificial pneumatic assisted urination system according to claim 1, characterized in that, The air supply assembly includes an air inflator and an air guiding mechanism. The air inflator includes an air inflator (24), and the air guiding mechanism includes a main pipe. The air inflator is connected to the main pipe, and the main pipe is connected to three tubes (22). One of the tubes (22) is connected to a connecting piece (21), and the other two tubes (22) are respectively connected to two anti-reflux air inflators inside the ureteral sheath (3).

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