A misaligned hydraulic bladder structure for anal sphincter dilation

Abstract

The application discloses a misaligned liquid dynamic sac petal structure for anal sphincter expansion and contraction. The misaligned liquid dynamic sac petal structure comprises a liquid sac installed in a shell, and liquid dynamic sac petals are arranged on the inner side of the outer wall of the liquid sac in a circumferential interval and form a single-layer sac petal structure. The outer wall of the liquid sac is embedded with a sterile liquid path connected with each liquid dynamic sac petal, which is in communication with a liquid path control unit for controlling fluid pumping in and out, realizing independent expansion and contraction of each flexible liquid sac, adapting to the requirement of gradual change of pressure in the anal canal, avoiding sharp increase and decrease of pressure in the expansion and contraction process, and simultaneously having the overflow safety ability to cope with excessive pressure. Sensors are arranged on the surface of the tissue connection part to dynamically identify whether defecation and exhaust are needed, and the expansion and contraction of the liquid sac is changed through the liquid path control unit. The overall coupling structure formed by the liquid sac and the liquid dynamic branch is easy to implant and replace, and the misaligned arrangement of the liquid dynamic sac petals in the structure can realize effective sealing of the liquid sac.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, specifically relating to a misaligned, hydrodynamic valve structure for the expansion and contraction of the anal sphincter. Background Technology

[0002] Enterostomy, as one of the most frequently performed surgical procedures, aims to address postoperative bowel movement difficulties and prolong the survival of rectal cancer patients. However, patients undergoing enterostomy, especially permanent enterostomies, face decreased bowel movement convenience or a series of problems caused by the stoma. Therefore, designing novel structural instruments to replace the expansion and contraction of the anal sphincter, thereby improving individual bowel movement convenience and enhancing implantation and replacement efficiency, is of significant research importance.

[0003] Using artificial structures to replace the original sphincter function is another treatment option. Existing artificial sphincter structures include the implantable sphincter assist device with deformable elements designed by Michael D. Craggs, as described in US Patent 20220257257A1[P]. 2022-02-28. This device is designed for patients with reflux esophagitis caused by relaxation of the upper gastric sphincter, and uses a magnetic-elastic composite structure to assist sphincter activity. The design consists of multiple beads connected by elastic chains, each bead consisting of a pair of shells and an internal permanent magnet. The magnetic attraction between the permanent magnets biases the device towards a radially contracted state. However, for this patent, a strong magnetic field environment, especially magnetic resonance imaging (MRI), is an absolute contraindication or high-risk factor for such devices. Strong static magnetic fields can cause unpredictable displacement or malfunction of equipment, while gradient fields and radio frequency fields can induce heating. Besides external disturbances, the long-term biocompatibility of elastic casings or springs remains critical. Material degradation or creep can alter their mechanical properties, causing the closing force to weaken over time.

[0004] Current research on the long-term functional maintenance and precise fluid control of traditional artificial sphincters is as follows:

[0005] US Patent (Banik M S. Electroactive polymer based artificial sphincters and artificial muscle patches: US8100819B2[P / OL]. 2012-01-24[2025-10-28].) proposes a method for artificial sphincters and artificial muscle patches based on electroactive polymers (EAP), which supports implantation through multiple physiological channels (urethra, intestine and lower esophageal sphincters, etc.) and promotes the design of electronic and biocompatible implantable devices, but it focuses on a single activation mode driven by electro-actuation.

[0006] A study by the Faculty of Medicine at the University of Lille, France (Lallemant M, Bartolo S, Ghesquiere L, et al. Midterm complications after primary obstetrical anal sphincter injury repair in France[J]. BMC Pregnancy and Childbirth, 2024, 24(1): 539.) emphasizes that the integrity of the sphincter structure and the valve layout are closely related to long-term functional recovery and abdominal emptying. However, the study is mainly based on clinical epidemiological data analysis and lacks specific technical solutions and engineering implementation paths for structural design.

[0007] A European patent (Polyak M. Implantable artificial sphincter system: EP0409592B1 [P / OL]. 1994-05-18 [2025-10-28]) proposes an implantable artificial sphincter system that achieves a multi-cavity and membrane layer layout of a sac-sac-control tube. It achieves organ fluid control and leakage prevention by minimizing the number of components and using pressure-responsive valve control technology. However, its rigid structure design based on traditional hydraulic control has limitations in terms of physiological adaptability and dynamic flexible adjustment, making it difficult to achieve precise pressure distribution and optimized configuration of staggered inner wall arrangement. Summary of the Invention

[0008] In order to address the problems and needs existing in the background art, the present invention provides a staggered arrangement of hydrodynamic sac flaps for the expansion and contraction of the anal sphincter.

[0009] The technical solution adopted in this invention is:

[0010] The liquid bladder is installed inside the housing and is connected to the liquid circuit control unit, which is used to control the expansion and contraction of the liquid bladder.

[0011] The staggered arrangement of the hydraulic valve structure also includes a sensor assembly for detecting status signals at the tissue connection portion of the outer shell.

[0012] A sealing ring is also provided between the outer shell and the liquid bladder.

[0013] The outer shell includes an outer shell body, a tissue connection part, and an inner shell connection part; a liquid bladder is disposed inside the outer shell body, and a tissue connection part is disposed at one end of the outer shell body for connecting with tissue; a sensor assembly is installed on the inner sidewall of the tissue connection part; and an inner shell connection part is disposed at the other end of the outer shell body for engaging with the end of the liquid bladder.

[0014] The tissue connection portion includes a first tissue connection portion and a second tissue connection portion. One end of both the first tissue connection portion and the second tissue connection portion is connected to the end of the outer shell body, and the other end of both the first tissue connection portion and the second tissue connection portion extends outward from the outer shell body. The other ends of the first tissue connection portion and the second tissue connection portion are arranged at intervals.

[0015] The liquid bladder includes a hydraulically movable bladder flap, a liquid bladder outer wall, and a shell connecting part; the liquid bladder outer wall is disposed inside the shell; a plurality of hydraulically movable bladder flaps are installed inside the liquid bladder outer wall, and all hydraulically movable bladder flaps have independent liquid channels connected to the liquid channel control unit; a shell connecting part is provided at one end of the liquid bladder outer wall for engaging with the end of the shell.

[0016] The liquid bladder includes a hydraulically movable bladder flap, a liquid bladder outer wall, and a shell connecting part; the liquid bladder outer wall is disposed inside the shell; one end of the liquid bladder outer wall is provided with a shell connecting part for engaging with the end of the shell; several hydraulically movable bladder flaps are installed inside the liquid bladder outer wall, and an independent liquid path connecting each hydraulically movable bladder flap is embedded between the liquid bladder outer wall and the hydraulically movable bladder flaps. All liquid paths are connected to the liquid path control unit, making the liquid bladder an integrated coupling structure that integrates external connection, internal deformation, and liquid path delivery.

[0017] Several of the aforementioned hydraulic valves are arranged circumferentially at intervals on the inner side of the outer wall of the fluid bladder, forming a single-layer valve structure.

[0018] The hydraulic valves are divided into multiple groups, and several hydraulic valves in each group are arranged at intervals along the circumference on the inner side of the outer wall of the liquid bladder to form a single-layer valve structure; different layers of valve structures are arranged vertically, and in two adjacent layers of valve structures, the upper and lower hydraulic valves are arranged alternately.

[0019] In the two adjacent sac flap structures, the line connecting the center points formed when the two single-layer sac flap structures are in a fully expanded state forms an angle with the axis of the fluid sac.

[0020] The liquid circuit control unit includes a reversing valve, a drive pump assembly, and a liquid reservoir; the liquid reservoir is connected to the drive pump assembly through the reversing valve, and the drive pump assembly is connected to the liquid reservoir; the drive pump assembly includes an overflow safety valve.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] (1) The staggered arrangement of the hydraulic bladder structure proposed in this invention can achieve effective sealing of the bladder, adapt to the needs of gradual pressure changes in the anal canal, and avoid a sudden increase or decrease in pressure during the expansion and contraction process.

[0023] (2) This invention proposes to independently control different hydraulic valves through sensors and hydraulic circuit design to achieve intelligent control of artificial sphincter, while having the ability to cope with overflow safety when pressure is too high.

[0024] (3) The present invention proposes an artificial sphincter structure with integral coupling function, which is easy to implant and replace, improving the convenience of use. Attached Figure Description

[0025] Figure 1 This is a structural diagram of the staggered arrangement of the hydraulic valves.

[0026] Figure 2 This is a schematic diagram of the liquid bladder structure.

[0027] Figure 3 This is a schematic diagram of the outer shell.

[0028] Figure 4 This diagram illustrates the unlocking principle of the snap-fit ​​structure.

[0029] Figure 5 The diagram shows the fluid circuit connection of the liquid bladder, where (a) is a schematic diagram of fluid pumping in and (b) is a schematic diagram of fluid pumping out.

[0030] Figure 6 This is a schematic diagram of the control fluid circuit.

[0031] Figure 7 The simulation diagrams show the expansion and contraction of a single-layer liquid bladder with two hydrodynamic flaps. (a) is the image of the single-layer liquid bladder before expansion, (b) is the image of the single-layer liquid bladder after expansion, and (c) is the image obtained after recognizing the image of the single-layer liquid bladder after expansion.

[0032] Figure 8 The simulation diagrams show the expansion and contraction of a single-layer liquid bladder with three hydrodynamic flaps. (a) is the image of the single-layer liquid bladder before expansion, (b) is the image of the single-layer liquid bladder after expansion, and (c) is the image obtained after recognizing the image of the single-layer liquid bladder after expansion.

[0033] Figure 9The simulation diagrams show the expansion and contraction of a single-layer liquid bladder with four hydrodynamic flaps. (a) is the image of the single-layer liquid bladder before expansion, (b) is the image of the single-layer liquid bladder after expansion, and (c) is the image obtained after recognizing the image of the single-layer liquid bladder after expansion.

[0034] Figure 10 The simulation diagrams show the expansion and contraction of a single-layer liquid bladder with 5 hydrodynamic flaps; (a) is the image of the single-layer liquid bladder before expansion, (b) is the image of the single-layer liquid bladder after expansion, and (c) is the image obtained after recognizing the image of the single-layer liquid bladder after expansion.

[0035] Figure 11 Images of a single-layered liquid bladder with three hydrodynamic valves, showing the expansion of the bladder with different valve sizes. (a) shows the expansion after adding one valve size, (b) shows the expansion after the same valve size, (c) shows the expansion after reducing one valve size, (d) shows the image obtained after recognizing the expansion after adding one valve size, (e) shows the image obtained after recognizing the expansion after the same valve size, and (f) shows the image obtained after recognizing the expansion after reducing one valve size.

[0036] Figure 12 The diagram shows the double-layered staggered arrangement of the liquid bladder; where (a) is the top view of the liquid bladder, (b) is the side view of the liquid bladder, (c) is the AA section view of the liquid bladder, and (d) is the BB section view of the liquid bladder.

[0037] Figure 13 The following are the finite element simulation results of the deformation of the double-layered liquid bladder: (a) is a complete structural schematic diagram of the double-layered liquid bladder before expansion, (b) is a cross-sectional view of the double-layered liquid bladder before expansion, (c) is the finite element simulation deformation result of the double-layered liquid bladder before expansion, (d) is a complete structural schematic diagram of the double-layered liquid bladder during expansion, (e) is a cross-sectional view of the double-layered liquid bladder during expansion, (f) is the finite element simulation deformation result of the double-layered liquid bladder during expansion, (g) is a complete structural schematic diagram of the double-layered liquid bladder after expansion, (h) is a cross-sectional view of the double-layered liquid bladder after expansion, and (i) is the finite element simulation deformation result of the double-layered liquid bladder after expansion.

[0038] In the diagram: 2. First check valve; 3. Second check valve; 4. Overflow safety valve; 5. First drive pump; 6. Second drive pump; 7. Flow control valve; 8. Two-position four-way directional valve; 9. First pressure regulating valve; 10. Second pressure regulating valve; 11. Third pressure regulating valve; 13. Shell texture; 14. Sensor assembly; 15. Keyway; 16. First tissue connection part; 17. Second tissue connection part; 18. Check valve; 19. Claw; 20. Hydraulic bladder flap; 21. Outer wall of the liquid bladder; 22. Key; 23. Shell; 24. Liquid bladder; 25. First sealing ring; 26. Second sealing ring; 27. Liquid circuit; 28. Liquid circuit control unit; 29. ​​Drive pump assembly; 30. Liquid reservoir. Detailed Implementation

[0039] To more intuitively describe the principles and advantages of this invention, the specific implementation methods will be described in detail below with reference to the above-mentioned accompanying drawings. The directional terms used below, such as "up," "down," "left," and "right," refer only to the directions shown in the figures.

[0040] like Figure 1 As shown, the present invention proposes a staggered arrangement of hydrodynamic valves for the expansion and contraction of the anal sphincter, comprising a hydrodynamic sac 24 installed within a housing 23. The hydrodynamic sac 24 is connected to a fluid control unit 28, which controls the expansion and contraction of the hydrodynamic sac 24. The housing 23 is hollow and open at both ends. The tissue connection portion of the housing 23 is connected to the anal canal or intestinal tract of the human body. The staggered arrangement of hydrodynamic valves proposed in this invention serves as an artificial sphincter.

[0041] The staggered arrangement of the hydraulic valve structure also includes a sensor assembly 14, which is used to detect the status signal at the tissue connection part of the outer shell 23 and send the status signal to the controller for controlling the fluid circuit control unit 28. The controller sends control signals to the regulating valves such as the reversing valve according to the received status signal.

[0042] In one feasible implementation, the sensor assembly 14 includes a gas sensor and a pressure sensor. The gas sensor is used to monitor intestinal gas, and the pressure sensor is used to monitor intestinal pressure, thereby enabling the monitoring of intestinal data and determining whether excretion is necessary.

[0043] A sealing ring is also provided between the outer shell 23 and the liquid bladder 24. Optionally, the sealing ring includes a first sealing ring 25 and a second sealing ring 26, which are respectively disposed at both ends of the liquid bladder 24. When the liquid bladder 24 is assembled with the outer shell, the sealing ring is compressed and deformed, and the sealing ring tightly fills the assembly gap, thereby achieving a seal.

[0044] like Figure 3As shown, the outer shell 23 includes an outer shell body, a tissue connecting portion, and an inner shell connecting portion; the outer shell body is hollow and open at both ends. A liquid bladder 24 is disposed within the outer shell body. One end of the outer shell body has a tissue connecting portion for connecting with tissue; the other end of the outer shell body has one or more inner shell connecting portions for engaging with the end of the liquid bladder 24. The liquid bladder 24 is pushed from the inner shell connecting portion of the outer shell body into the outer shell body. After pushing, the outer shell connecting portion of the liquid bladder 24 engages with the inner shell connecting portion of the outer shell body, completing the installation of the liquid bladder 24.

[0045] In one feasible implementation, the outer shell body is provided with shell texture 13. This texturing treatment can increase the contact area between the device and surrounding tissues, providing physical guidance and support for tissue attachment, making it easier for human tissues to firmly attach and integrate. External contaminants cannot enter the human body through the gap between the tissue and the outer shell to cause pollution and inflammation.

[0046] In one feasible implementation, an axial keyway 15 is provided on the inner wall of the outer shell body, which is used to cooperate with the key 22 on the outer wall of the liquid bladder 24 to restrict the mutual rotation between the outer shell and the liquid bladder around the axis, and also to achieve the positioning of the liquid bladder 24.

[0047] Optionally, there may be one or more keyways 15. Multiple keyways 15 are arranged at equal intervals along the circumference on the inner wall of the housing. Optionally, both the keyways 15 and the keys 22 may have three sections.

[0048] The installation of an artificial sphincter at the end of the rectum presents significant anatomical and functional requirements. Firstly, its upper end is located near the abdominal cavity, adjacent to two key tissues: the intestine (specifically the end of the rectum) and the pelvic floor muscles that form the pelvic floor support structure. In one feasible embodiment, the tissue connection includes a first tissue connection 16 and a second tissue connection 17. One end of both the first and second tissue connection portions 16 and 17 is connected to the end of the outer shell, while the other ends of both extend outward from the outer shell. The other ends of the first and second tissue connection portions 16 and 17 are spaced apart. In practical use, the first tissue connection portion 16 serves as the inner layer of the outer shell and is sutured to the end of the intestine. Healing and sealing are promoted using sutures, bio-adhesive, or tissue engineering techniques. Therefore, a strong and airtight connection is established between the inner layer of the outer shell and the intestine, ensuring that human excrement can only be discharged through the internal space of the artificial sphincter, preventing abdominal infection caused by leakage from the junction of the device and the intestine. The second tissue connection part 17 serves as the outer layer of the shell. It is stably sutured to the pelvic floor muscle tissue to maintain the integrity of the pelvic floor structure, ensure abdominal pressure, thereby sealing the pelvic outlet and preventing the prolapse of abdominal organs such as the small intestine, thus achieving a double sealing and connection function.

[0049] In one feasible implementation, the inner shell connection includes a backstop 18. Optionally, as... Figure 3 As shown, the backstop 18 specifically has a downward-opening mounting chamber at the end of the outer shell body. This mounting chamber is used to house the corresponding claw 19 of the liquid bladder 24. A first groove is also provided on the outer side of the end of the outer shell body, communicating with the mounting chamber. The lower surface of the first groove serves as the locking surface of the claw 19. After the claw 19 enters the mounting chamber from the bottom of the outer shell body, the protruding head of the claw 19 engages with the lower surface of the first groove, achieving mutual engagement and fixation between the claw 19 and the backstop 18. When the liquid bladder 24 needs to be replaced, a sharp external object can pass through the first groove and act on the claw 19 in the mounting chamber. The protruding head of the claw 19 moves inward and disengages from the locking surface of the backstop 18. Then, by pulling down the liquid bladder 24, the claw 19 disengages from the mounting chamber, separating the liquid bladder 24 from the outer shell 23, i.e., unlocking. Figure 4 As shown.

[0050] like Figure 2 As shown, the liquid bladder 24 includes hydraulically movable flaps 20, a liquid bladder outer wall 21, and a shell connecting portion. The liquid bladder outer wall 21 is disposed within the shell body of the shell 23, and is coaxially arranged with the shell body. A plurality of hydraulically movable flaps 20 are installed within the liquid bladder outer wall 21, and the bottoms of all hydraulically movable flaps 20 are connected to the liquid passage control unit 28 via a liquid passage 27. A shell connecting portion is provided at one end of the liquid bladder outer wall 21 for engaging with the end of the shell body of the shell 23. Optionally, the shell connecting portion includes a claw 19.

[0051] To ensure the fluid bladder 24 can be disassembled and replaced after damage, the fluid path connected to the fluid path control unit 28 needs to be simplified. If the fluid paths of different hydraulic valves are connected to the fluid path control unit 28 from different locations, it will lead to difficulties in installation and disassembly. This invention independently embeds the fluid paths controlling different hydraulic valves between the hydraulic valves and the outer wall of the fluid bladder. The fluid paths controlling different hydraulic valves rotate around an axis to the same area before being integrated into a single output bundle, greatly reducing the difficulty of installation and disassembly between the fluid paths of different hydraulic valves and the external fluid path control unit 28. Figure 5 (a) and Figure 5 As shown in (b).

[0052] In one feasible implementation, a plurality of hydraulic flaps 20 are arranged circumferentially on the inner side of the outer wall 21 of the liquid bladder and form a single-layer flap structure, that is, the center height of all hydraulic flaps 20 is at the same horizontal plane.

[0053] In one feasible implementation, the hydraulic valves 20 are divided into multiple groups. Several hydraulic valves 20 in each group are arranged circumferentially on the inner side of the outer wall 21 of the liquid bladder, forming a single-layer valve structure. That is, the center height of all hydraulic valves 20 is at the same horizontal plane. Different layers of valve structures are arranged alternately or non-alternatingly. In two adjacent layers, the upper and lower hydraulic valves 20 are staggered, meaning the line connecting the center points of the upper and lower hydraulic valves 20 is not parallel to the axial direction, i.e., it forms an angle with the axial direction. In this embodiment, the hydraulic valves 20 are divided into two groups; therefore, the arrangement of the hydraulic valves 20 is a double-layer staggered arrangement.

[0054] In the two adjacent layers of flap structures, the line connecting the center point formed by the two single-layer flap structures when they are fully expanded (i.e., the center point of the cavity area formed after all the hydraulic flaps 20 in this layer are fully expanded) makes an angle with the axis of the liquid bladder 24; that is, the two are not parallel, and the connecting line is not axial. Specifically, the size of the hydraulic flaps 20 is adjusted so that the volumes of different hydraulic flaps 20 in a single layer are different after expansion. Therefore, after covering the internal space, the remaining gap is no longer located on the axis of the liquid bladder structure. Then, a double-layer staggered structure is used to seal the gap through which the two liquid bladders are no longer coaxial after expansion.

[0055] Optionally, in the single-layer flap structure, the number of hydrodynamic flaps 20 is three.

[0056] In one feasible implementation, one or more keys 22 are provided on the outer surface of the outer wall 21 of the liquid bladder.

[0057] One feasible implementation method is, for example Figure 6 As shown, the liquid circuit control unit 28 includes a reversing valve, a drive pump assembly 29, and a liquid reservoir 30. All the hydraulically actuated valves 20 in the liquid reservoir 24 are connected to the drive pump assembly 29 through the reversing valve, and the drive pump assembly 29 is connected to the liquid reservoir 30. The drive pump assembly 29 is used to drive the liquid in the hydraulically actuated valves 20 to pump in and out, realizing bidirectional flow of the liquid.

[0058] In one feasible implementation, two fluid paths are provided between the reversing valve and all the hydraulically actuated flaps 20 in the liquid bladder 24. One fluid path includes a pressure regulating valve, which connects to the outlet of the drive pump assembly 29 after passing through the pressure regulating valve and the reversing valve. The other fluid path does not include a pressure regulating valve and connects directly to the inlet of the drive pump assembly 29 via the reversing valve. The pressure regulating valve is used to adjust the fluid pressure pumped into the hydraulically actuated flaps 20, thereby regulating the pressure of the hydraulically actuated flaps 20. In one operating mode of the reversing valve, the hydraulically actuated flaps 20 are connected to the outlet of the drive pump assembly 29 via the pressure regulating valve, while the inlet of the drive pump assembly 29 is unused. In another operating mode of the reversing valve, the hydraulically actuated flaps 20 are directly connected to the inlet of the drive pump assembly 29, while the outlet of the drive pump assembly 29 is unused. Optionally, the reversing valve is a two-position four-way reversing valve 8. Figure 6The diagram shows three pressure regulating valves: the first pressure regulating valve 9, the second pressure regulating valve 10, and the third pressure regulating valve 11.

[0059] In one feasible embodiment, the drive pump assembly 29 includes a flow control valve 7, a first check valve 2, a second check valve 3, an overflow safety valve 4, a first drive pump 5, and a second drive pump 6; the reservoir 30 is connected to the inlet of the first drive pump 5, the outlet of the first drive pump 5 is connected to the first check valve 2, the reservoir 30 is also connected to the outlet of the second check valve 3, the inlet of the second check valve 3 is connected to the outlet of the second drive pump 6, the inlet of the second drive pump 6 is connected to the flow control valve 7, the inlet of the flow control valve 7 serves as the inlet of the drive pump assembly 29, and the outlet of the first check valve 2 serves as the outlet of the drive pump assembly 29; an overflow safety valve 4 is also provided in the liquid path between the first check valve 2 and the first drive pump 5 to limit the circuit pressure and prevent overload.

[0060] Optionally, the drive pump can be an automatic pump or a manual pump. A manual pump is a push-button pump.

[0061] Optionally, the controller for controlling the liquid circuit control unit 28 is housed within the casing of the liquid circuit control unit 28. Alternatively, the controller can be installed in a terminal to send control signals to the liquid circuit control unit 28 via Bluetooth or similar means.

[0062] The fluid control unit 28 proposed in this invention can realize individual control of different valves, and at the same time realize unidirectional flow of the fluid circuit, that is, ensure that the overall fluid circuit will not be overloaded or flow in reverse.

[0063] This invention uses the expansion and contraction of a liquid bladder composed of multiple hydraulically actuated valves to simulate the activity of the human anal sphincter. The hydraulically actuated valves are arranged circumferentially, and the liquid bladder and hydraulic branches form an integral coupling effect. For different numbers of single-layer hydraulically actuated valves, finite element analysis using a nonlinear strain measurement method is required to compare the sealing effect of different numbers.

[0064] In the finite element analysis, the 20 hydraulically movable valves in the single-layer valve structure, without expansion, all have an inner diameter of 20 mm and a wall thickness of 1 mm. A pressure of 0.5 MPa is applied to each hydraulically movable valve. The deformed model is obtained through finite element simulation. Projecting along the axial direction of the valve structure yields projected views of the deformation results under different numbers of hydraulically movable valves, as shown below. Figure 7 of (a), Figure 7 (b) Figure 7 (c) Figure 8 of (a), Figure 8 (b) Figure 8 (c) Figure 9 of (a), Figure 9 (b) Figure 9 (c) Figure 10 of (a), Figure 10 (b) and Figure 10 (c) As shown in the figure, after the hydraulic bladder wall fully expands, a void area (the white area in the binary image) is formed in the middle under different numbers of hydraulic bladder valves, which is the internal space not covered by the hydraulic bladder valves. By comparing the internal space not covered by different numbers of hydraulic bladder valves, it can be intuitively seen that the coverage of the internal space after deformation is the highest when the number is 3. Specifically, when the number of hydraulic bladder valves is 3 to 5, the expansion and filling rates of the hydraulic bladder valves are 99.97%, 99.43%, and 97.40%, respectively. The expansion and filling rate is the percentage of the area covered by the hydraulic bladder valves in the projection image to the area of ​​the internal space when it is not expanded in the projection image.

[0065] When the number of hydraulic valves is 3, gaps will still remain after the hydraulic valve wall is fully expanded, such as... Figure 11 of (a), Figure 11 (b) and Figure 11 As shown in (c). Therefore, the present invention adjusts the size of the single-layer liquid bladder flap to make the volume of the single-layer liquid bladder after expansion different. Thus, the remaining gap after covering the internal space is no longer located on the axis of the liquid bladder structure, as shown in (c). Figure 12 of (a), Figure 12 (b) Figure 12 (c) and Figure 12 As shown in (d); then, by using a double-layer staggered arrangement, the two liquid bladders expand to form a gap that is no longer coaxial, thereby achieving a seal, as shown in (d). Figure 13 of (a), Figure 13 (b) Figure 13 (c) Figure 13 (d) Figure 13 of (e) Figure 13 of (f), Figure 13 of (g), Figure 13 (h) and Figure 13 As shown in (i).

[0066] Finally, it should be noted that the above embodiments and descriptions are only used to illustrate the technical solutions of the present invention and not to limit it. Those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the disclosure of the technical solutions of the present invention, and all such modifications and substitutions should be covered within the protection scope of the claims of the present invention.

Claims

1. A staggered arrangement of fluid-moving sac flaps for the expansion and contraction of the anal sphincter, characterized in that, include: A liquid bladder (24) is installed inside the outer casing (23). The liquid bladder (24) is connected to the liquid circuit control unit (28), which is used to control the expansion and contraction of the liquid bladder (24). The liquid bladder (24) includes a hydraulic valve (20), an outer wall (21) of the liquid bladder, and a shell connecting part; the outer wall (21) of the liquid bladder is disposed inside the shell (23); one end of the outer wall (21) of the liquid bladder is provided with a shell connecting part for coupling with the end of the shell (23); a plurality of hydraulic valves (20) are installed inside the outer wall (21) of the liquid bladder, and a liquid path that independently connects each hydraulic valve (20) is embedded between the outer wall (21) of the liquid bladder and the hydraulic valves (20), and all liquid paths are connected to the liquid path control unit (28); The fluid dynamic valve (20) is divided into multiple groups. Several fluid dynamic valves (20) in each group are arranged at intervals along the circumference on the inner side of the outer wall (21) of the fluid bladder to form a single-layer valve structure. Different layers of valve structures are arranged vertically. In two adjacent layers of valve structures, the two fluid dynamic valves (20) are arranged alternately. In the two adjacent sac flap structures, the line connecting the center points formed when the two single-layer sac flap structures are in a fully expanded state has an angle with the axis of the liquid sac (24).

2. The staggered arrangement of hydrodynamic flaps for anal sphincter expansion and contraction according to claim 1, characterized in that, The staggered arrangement of the hydraulic valve structure also includes a sensor assembly (14), which is used to detect the status signal at the tissue connection of the outer shell (23).

3. The staggered arrangement of hydrodynamic flaps for anal sphincter expansion and contraction according to claim 1, characterized in that, A sealing ring is also provided between the outer shell (23) and the liquid bladder (24).

4. The staggered arrangement of hydrodynamic flaps for anal sphincter expansion and contraction according to claim 1, characterized in that, The outer shell (23) includes an outer shell body, a tissue connection part and an inner shell connection part; a liquid sac (24) is provided inside the outer shell body, and a tissue connection part is provided at one end of the outer shell body for connecting with tissue; an inner shell connection part is provided at the other end of the outer shell body for coupling with the end of the liquid sac (24).

5. The staggered arrangement of hydrodynamic flaps for anal sphincter expansion and contraction according to claim 4, characterized in that, The tissue connection portion includes a first tissue connection portion (16) and a second tissue connection portion (17). One end of the first tissue connection portion (16) and the second tissue connection portion (17) are connected to the end of the outer shell body. The other end of the first tissue connection portion (16) and the second tissue connection portion (17) extend outward from the outer shell body. The other end of the first tissue connection portion (16) and the second tissue connection portion (17) are arranged at intervals.

6. The staggered arrangement of hydrodynamic flaps for anal sphincter expansion and contraction according to claim 1, characterized in that, The liquid circuit control unit (28) includes a reversing valve, a drive pump assembly (29) and a reservoir (30); the reservoir (24) is connected to the drive pump assembly (29) through the reversing valve, the drive pump assembly (29) is connected to the reservoir (30), and the drive pump assembly (29) includes an overflow safety valve.

Images