Magnetic drive alternate clamping type artificial anal sphincter prosthesis

Abstract

The invention provides a magnetic force driven alternate clamping type artificial anal sphincter prosthesis, which comprises an upper clamping device, a lower clamping device, an upper clamping device and a lower clamping device, wherein the upper clamping device is used for clamping a first part of an intestinal tract and can be opened or closed through magnetic force driving; the lower clamping device is used for clamping a second part of the intestinal tract and can be opened or closed through magnetic force driving, and the magnetic force threshold value of the lower clamping device is larger than that of the upper clamping device; the linkage part is connected with the upper clamping device and the lower clamping device and enables the upper clamping device and the lower clamping device to be in linkage. According to the artificial anal sphincter device, a magnetic force driving mode is adopted, the upper clamping device and the lower clamping device are used for alternately clamping an intestinal canal, clamping is carried out in a large-area plane, an excrement temporary storage stage is preset, an intestinal pressure monitor is matched for defecation early warning, and manual operation is not needed; the artificial anal sphincter prosthesis can effectively reduce the risk of injury and infection caused by the fact that the intestinal tract is in a clamping state for a long time, and is safe, stable, good in excrement control and convenient in energy supply.

Description

Technical Field

[0001] This invention relates to a technology in the field of medical devices, specifically a magnetically driven alternating clamping artificial anal sphincter prosthesis. Background Technology

[0002] Fecal incontinence is clinically characterized by the loss of voluntary control over feces. While not strictly defined as a clinical disease in medicine, fecal incontinence results in frequent leakage of feces due to the inability of the anus to close completely. Severe cases may even experience leakage due to minor disturbances in daily life, significantly impacting the patient's daily life and mental and physical health. Current medical treatments for fecal incontinence mainly include sphincter repair surgery, colostomy, and sacral nerve stimulation. These surgeries are technically challenging and can lead to a series of complications, resulting in less than ideal clinical outcomes.

[0003] In recent years, with the development of interdisciplinary medical engineering, artificial anal sphincter prostheses have provided a new approach to treating fecal incontinence. Artificial anal sphincter prostheses aim to achieve renewed control of feces by mimicking the physiological processes of normal bowel control and defecation, thereby treating fecal incontinence. Currently, artificial anal sphincter devices developed by companies such as the Austrian company Agency for Medical Innovations are being used clinically. These devices utilize an external, manually operated micro-pump to adjust hydraulic pressure, thereby controlling the diameter of the intestinal tract and achieving circumferential clamping. However, such devices have issues with bowel control ability, control methods, clamping methods, reliability, and comfort. Furthermore, other existing artificial anal sphincter devices generally suffer from complex mechanical structures, high mechanical failure rates, complex drive mechanisms, and high operational difficulty. Therefore, there is currently a lack of a safe, stable, well-controlled, and conveniently powered artificial anal sphincter prosthesis to address these problems. Summary of the Invention

[0004] This invention addresses the problems of complex mechanical structure, high mechanical failure rate, complex driving method, and high operation difficulty of existing artificial anal sphincter devices. The aim is to provide an artificial anal sphincter prosthesis that uses magnetic drive, alternately clamps the intestinal tract with upper and lower clamping devices, clamps with a large area plane, has a preset fecal buffer stage, and is equipped with an intestinal pressure monitor for early defecation warning. It requires no manual operation and can effectively reduce the risk of intestinal damage and infection caused by prolonged clamping. It is a safe, stable, well-controlled, and conveniently energy-supply artificial anal sphincter prosthesis.

[0005] This invention provides a magnetically driven alternating clamping artificial anal sphincter prosthesis, characterized by: an upper clamping device for clamping a first part of the intestine, which can be opened or closed by magnetic force; a lower clamping device for clamping a second part of the intestine, which can also be opened or closed by magnetic force, wherein the magnetic force threshold of the lower clamping device is greater than that of the upper clamping device; and a linkage unit connecting the upper clamping device and the lower clamping device and linking the upper and lower clamping devices together, wherein when the upper clamping device is in a closed state, the lower clamping device is in an open state, and when the upper clamping device is in an open state, the lower clamping device is in a closed state, wherein the first part of the intestine is located upstream of the second part of the intestine.

[0006] The magnetically driven alternating clamping artificial anal sphincter prosthesis provided by this invention may also have the following features: the linkage part includes at least a rotatably configured movable rocker arm, which connects the upper clamping device and the lower clamping device. When the upper clamping device is in the closed state, it clamps and closes the first part of the intestine, while the lower clamping device is in the open state. When the pressure inside the intestine is greater than the magnetic threshold of the upper clamping device, the upper clamping device moves from the closed state to the open state, thereby driving the movable rocker arm to rotate and driving the lower clamping device to move from the open state to the closed state. This stage is the fecal buffering stage. When the feces in the intestine further accumulate and the pressure inside the intestine reaches the magnetic threshold of the lower clamping device, the lower clamping device moves from the closed state to the open state, thereby driving the movable rocker arm to rotate and driving the upper clamping device to move from the open state to the closed state, returning to the defecation suppression stage. Thus, the artificial anal sphincter prosthesis completes one complete defecation suppression and defecation cycle.

[0007] The magnetically driven alternating clamping artificial anal sphincter prosthesis provided by the present invention may also have the following features: the linkage part further includes a central limiting ring for being fitted onto the intestine to fix the intestine; a movable rocker arm is fitted onto the central limiting ring and can rotate relative to the central limiting ring within a certain range of angles, the rotation angle being θ, where θ is 35°; the upper end of the movable rocker arm is connected to the upper clamping device and the lower end is connected to the lower clamping device.

[0008] The magnetically driven alternating clamping artificial anal sphincter prosthesis provided by the present invention may also have the following features: both the upper clamping device and the lower clamping device include two clamping ends, and a magnet is installed in the clamping end. The magnets of the two clamping ends have opposite magnetic properties. The closing of the corresponding clamping device is achieved by the attraction of the two magnets. The movable rocker is arranged in two symmetrical positions. The upper end of each movable rocker is connected to the clamping end of the upper clamping device, and the lower end is connected to the clamping end of the lower clamping device.

[0009] The magnetically driven alternating clamping artificial anal sphincter prosthesis provided by the present invention may also have the following features: the clamping end includes a first cover plate and a second cover plate, a magnet is installed in the first cover plate, the first cover plate is provided with four first mounting holes, the four first mounting holes are arranged in a manner of two at the top and two at the bottom, the second cover plate is provided with four second mounting holes, the positions of the four second mounting holes correspond to the positions of the four first mounting holes respectively, and the second cover plate and the first cover plate are detachably connected by inserting fastening components into the second mounting holes and the first mounting holes.

[0010] The magnetically driven alternating clamping artificial anal sphincter prosthesis provided by the present invention may also have the following features: a central hole is provided in the middle of the movable rocker arm, a rotating bearing is provided in the central hole, and a central limiting ring is connected to the rotating bearing to form a closed ring.

[0011] The magnetically driven alternating clamping artificial anal sphincter prosthesis provided by the present invention may also have the following features: the upper and lower ends of the movable rocker are respectively provided with first positioning holes, and the clamping end is provided with a second positioning hole. The second positioning hole penetrates the first cover plate and the second cover plate. The fastening assembly is fastened by the cooperation between the second positioning hole and the first positioning hole, so that the upper end of the movable rocker is connected to the clamping end of the upper clamping device and the lower end is connected to the clamping end of the lower clamping device.

[0012] The magnetically driven alternating clamping artificial anal sphincter prosthesis provided by the present invention may also have the following features: wherein the central limiting ring includes a first ring body and a second ring body, the first ring body is provided with protrusions at both ends, and the second ring body is provided with assembly cavities adapted to the protrusions at both ends. The protrusions are inserted into the assembly cavities, and the first ring body and the second ring body are detachably spliced ​​by fastening components through the first fixing hole on the protrusion and the second fixing hole on the assembly cavity.

[0013] The magnetically driven alternating clamping artificial anal sphincter prosthesis provided by the present invention may also have the following feature: an intestinal pressure monitor is installed on the clamping end of the lower clamping device.

[0014] The magnetically driven alternating clamping artificial anal sphincter prosthesis provided by the present invention may also have the following features: wherein the magnetic force threshold of the upper clamping device is A, A is 4.5 Newtons (N), and the difference between the magnetic force threshold of the lower clamping device and the magnetic force threshold of the upper clamping device is B, B is 4.9 Newtons (N).

[0015] The role and effect of invention

[0016] According to the present invention, the magnetically driven alternating clamping artificial anal sphincter prosthesis includes an upper clamping device, a lower clamping device, a linkage part, and an intestinal pressure monitor. The upper clamping device can clamp a first part of the intestine and open or close it by magnetic drive; the lower clamping device can clamp a second part of the intestine and open or close it by magnetic drive. The first part of the intestine is located upstream of the second part of the intestine. The linkage part connects the upper clamping device and the lower clamping device, so that the upper clamping device and the lower clamping device are linked. When the upper clamping device is in the closed state, it clamps and closes the first part of the intestine, while the lower clamping device is in the open state. When the pressure inside the intestine exceeds the magnetic threshold of the upper clamping device, the upper clamping device moves from the closed state to the open state, thereby driving the lower clamping device to move from the open state to the closed state. The magnetic threshold of the lower clamping device is greater than that of the upper clamping device. When feces accumulate further in the intestine and the pressure inside the intestine reaches the magnetic threshold of the lower clamping device, the lower clamping device moves from the closed state to the open state, thereby driving the upper clamping device to move from the open state to the closed state, thus completing one complete bowel suppression and defecation cycle.

[0017] Therefore, when the magnetically driven alternating clamping artificial anal sphincter prosthesis of the present invention is placed in the patient's body, it has the advantages of alternating clamping of the intestinal tract, planar clamping of the intestinal tract, large clamping area, fecal buffering stage, early warning of defecation, and no need for manual operation. It can effectively reduce the risk of damage and infection to the intestine due to long-term clamping. In addition, the present invention has a simple mechanical structure, good biocompatibility, novel concept, convenient installation, and no need for implantation of electronic components in the body, and can effectively control defecation. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the upper clamping device suppressing defecation and the lower clamping device discharging defecation in an embodiment of the present invention;

[0019] Figure 2 This is a schematic diagram of the upper clamping device being convenient and the lower clamping device being restrictive in an embodiment of the present invention;

[0020] Figure 3 This is an exploded view of a magnetically driven alternating clamping artificial anal sphincter prosthesis according to an embodiment of the present invention;

[0021] Figure 4 This is a schematic diagram of the structure of the clamping end of the upper clamping device in an embodiment of the present invention;

[0022] Figure 5 This is a schematic diagram of the structure of the clamping end of the lower clamping device in an embodiment of the present invention;

[0023] Figure 6 This is a schematic diagram of the structure of the movable rocker arm in an embodiment of the present invention;

[0024] Figure 7 This is a schematic diagram of the rotating bearing in an embodiment of the present invention;

[0025] Figure 8 This is a schematic diagram of the structure of the first ring body in an embodiment of the present invention; and

[0026] Figure 9 This is a schematic diagram of the structure of the second ring body in an embodiment of the present invention. Detailed Implementation

[0027] To make the technical means, creative features, objectives and effects of the present invention easy to understand, the following embodiments, in conjunction with the accompanying drawings, specifically illustrate the magnetically driven alternating clamping artificial anal sphincter prosthesis of the present invention.

[0028] Figure 1 This is a schematic diagram of the upper clamping device suppressing defecation and the lower clamping device discharging defecation in an embodiment of the present invention. Figure 2 This is a schematic diagram of the upper clamping device being convenient and the lower clamping device being restrictive in an embodiment of the present invention.

[0029] like Figure 1 , 2 As shown, this embodiment provides a magnetically driven alternating clamping artificial anal sphincter prosthesis 100, including an upper clamping device 10, a lower clamping device 20, a linkage part 30, and an intestinal pressure monitor. The intestinal pressure monitor is installed on the lower clamping device 20, which is not shown in the figure.

[0030] Figure 3 This is an exploded view of a magnetically driven alternating clamping artificial anal sphincter prosthesis according to an embodiment of the present invention. Figure 4 This is a schematic diagram of the structure of the clamping end of the upper clamping device in an embodiment of the present invention.

[0031] like Figure 3 , 4 As shown, the upper clamping device 10 includes two upper clamping ends 11. The two upper clamping ends 11 have similar structures, and one of them will be described in detail below.

[0032] The upper clamping end 11 has a round-square structure, including an upper magnet 111, a first cover plate 112, and a second cover plate 113. The first cover plate 112 and the second cover plate 113 are made of carbon fiber, which has good biocompatibility. The first cover plate 112 faces the intestine, and the side facing the intestine is a smooth plane. The other side is provided with a groove to accommodate the upper magnet 111. The first cover plate 112 is provided with four first mounting holes 114, arranged in a top and bottom arrangement of two holes each. The second cover plate 113 is provided with four second mounting holes 115, the positions of which correspond to the positions of the four first mounting holes 114. By inserting countersunk screws 50 into the second mounting holes 115 and the first mounting holes 114, the second cover plate 113 and the first cover plate 112 are detachably connected, thereby fixing the upper magnet 111 inside the second cover plate 113 and the first cover plate 112.

[0033] The other upper clamping end 11 differs from the aforementioned upper clamping end 11 only in that the magnetism on the adjacent sides of the upper magnets 111 is opposite. Thus, these two upper clamping ends 11 can clamp the first part of the intestine through the attraction of the two upper magnets 111. The magnetic force threshold between the two upper clamping ends 11 is A, where A is 4.5 Newtons (N).

[0034] Figure 5 This is a schematic diagram of the structure of the clamping end of the lower clamping device in an embodiment of the present invention.

[0035] like Figure 3 and Figure 5 As shown, the lower clamping device 20 includes two lower clamping ends 21. The lower clamping ends 21 are structurally similar to the upper clamping ends 11, except that:

[0036] The lower clamping end 21 has a groove 211 on the side facing the intestinal tract for installing an intestinal pressure monitor. Simultaneously, a lower magnet 212 is installed inside the lower clamping end 21 and is positioned in the first cover plate 112 on the back of the groove 211. The two lower clamping ends 21 also clamp the second part of the intestine through two attracting lower magnets 212. The magnetic force threshold between the two lower clamping ends 21 is greater than the magnetic force threshold between the two upper clamping ends 11, and the difference in magnetic force thresholds is B, where B is 4.9 Newtons (N).

[0037] Apart from the differences mentioned above, the structure of the lower clamping end 21 is the same as that of the upper clamping end 11, and will not be described again here.

[0038] Figure 6 This is a schematic diagram of the structure of the movable rocker arm in an embodiment of the present invention. Figure 7 This is a schematic diagram of the rotating bearing in an embodiment of the present invention.

[0039] like Figure 3, Figure 6 and Figure 7 As shown, the linkage 30 includes a movable rocker arm 31, a rotating bearing 33, and a central limiting ring 32.

[0040] The movable rocker arm 31 has a cylindrical structure made of carbon fiber, which is biocompatible. The upper end of the movable rocker arm 31 is connected to the upper clamping end 11. Specifically, the upper clamping end 11 has a second positioning hole 313 that penetrates the first cover plate 112 and the second cover plate 113. The upper end of the movable rocker arm 31 is connected to the upper clamping end 11 by inserting the upper end of the movable rocker arm 31 into the second positioning hole 313.

[0041] Furthermore, the upper end of the movable rocker arm 31 is provided with a first positioning hole 312 that matches the second positioning hole 313. When the upper end of the movable rocker arm 31 is inserted into the second positioning hole 313, the upper end of the movable rocker arm 31 is fixedly connected to the upper clamping end 11 by inserting a countersunk screw into the second positioning hole 313 and the first positioning hole 312.

[0042] The lower end of the movable rocker arm 31 is connected to the lower clamping end 21, and the connection method is similar to that of the upper end and the upper clamping end 11. The only difference is that the second positioning hole 313 of the upper clamping end 11 is located at the lower center of the upper clamping end 11, and the second positioning hole 313 of the lower clamping end 21 is located at the upper center of the lower clamping end 21, which facilitates the movable rocker arm 31 to drive the upper clamping end 11 and the lower clamping end 21. Apart from this difference, the other connection methods are the same and will not be described in detail here.

[0043] Figure 8 This is a schematic diagram of the structure of the first ring body in an embodiment of the present invention. Figure 9 This is a schematic diagram of the structure of the second ring body in an embodiment of the present invention.

[0044] like Figure 3 , 8 As shown in Figure 9, the central limiting ring 32 is used to fit over the intestine to fix it in place. It includes a first ring body 321 and a second ring body 322. Both the first ring body 321 and the second ring body 322 are made of carbon fiber, which has good biocompatibility. The first ring body 321 has protrusions 3211 at both ends, and the second ring body 322 has assembly cavities 3221 at both ends that are adapted to the protrusions 3211. Inserting the protrusions 3211 into the assembly cavities 3221 allows the first ring body 321 and the second ring body 322 to form a complete ring structure.

[0045] Furthermore, the protrusion 3211 is provided with a first fixing hole 3212, and the assembly cavity 3221 is provided with a second fixing hole 3222 that matches the first fixing hole 3212. The pan head screw 50 is inserted into the second fixing hole 3222 and the first fixing hole 3212 in sequence, and the nut 60 is used to make the first ring body 321 and the second ring body 322 detachably fitted onto the intestine.

[0046] Two symmetrical rocker arms 31 are arranged. The upper ends of the two rocker arms 31 are connected to different upper clamping ends 11, and the lower ends are connected to different lower clamping ends 21. The middle part of the two rocker arms 31 is provided with a rocker arm center hole 311. The rocker arm center hole 311 is a circular hole. The rotating bearing 33 is provided at the rocker arm center hole 311, and the bearing center hole 331 is provided inside.

[0047] The two protrusions 3211 of the first ring body 321 are passed through the two bearing center holes 331 and the two rocker arm center holes 311, and finally inserted into the two assembly cavities 3221. The size of the first ring body 321 is adapted to the bearing center holes 331, so that the movable rocker arm 31 can be placed on the central limiting ring 32 and can rotate within a certain range of angles, the rotation angle being θ, where θ is 35°.

[0048] The magnetically driven alternating clamping artificial anal sphincter prosthesis 100 provided in this embodiment is to be implanted into the patient's body. Biocompatibility is an important consideration. Therefore, the first cover plate 112, the second cover plate 113, the first ring 321, the second ring 322 and the movable rocker 31 that constitute the upper clamping end 11 and the lower clamping end 21 are all made of carbon fiber material with extremely high biocompatibility, and the rest are covered by medical silicone rubber film.

[0049] In use, the middle limiting ring 32 is fitted onto the intestine. The upper clamping device 10 corresponds to the first part of the intestine, and the lower clamping device 20 corresponds to the second part of the intestine. The first part of the intestine is located upstream of the second part of the intestine. The working principle of the magnetically driven alternating clamping artificial anal sphincter prosthesis 100 is as follows:

[0050] (1) Upper clamping device 10 in the restraining state:

[0051] like Figure 1 As shown, the two upper clamping ends 11 of the upper clamping device 10 attract each other under the action of magnetic force through the internally installed upper magnet 111, which drives the first part of the intestinal tract to close. Since the upper clamping device 10 and the lower clamping device 20 are both fixed on the rotatable rocker arm 31, at this time, the two lower clamping ends 21 of the lower clamping device 20 rotate outward and are in the open state.

[0052] (2) Lower clamping device 20 in the restraining state:

[0053] When the pressure inside the intestine exceeds the magnetic force of the upper magnets 111 inside the two upper clamping ends 11 of the upper clamping device 10 attracting each other, the two upper clamping ends 11 of the upper clamping device 10 move outward to the open state, driving the movable rocker arm 31 to rotate, thereby driving the two lower clamping ends 21 of the lower clamping device 20 to move inward to the closed state, causing the second part of the clamped intestine to close. Figure 2 As shown, this stage is the fecal buffering stage. The magnetism of the lower magnets 212 inside the two lower clamping ends 21 of the lower clamping device 20 is slightly stronger than that of the upper magnets 111 inside the two upper clamping devices 10, which is intended to allow the patient time to prepare for defecation and achieve the effect of defecation warning. Thus, this invention can complete the transition from the upper clamping device defecation suppression state to the lower clamping device defecation suppression state without implanting any electronic devices inside the human body.

[0054] (3) Lower clamping device 20 in defecation state:

[0055] When feces accumulate further in the intestines, and the internal pressure reaches the magnetic threshold of the lower magnets 212 inside the two lower clamping ends 21 of the lower clamping device 20, the two lower clamping ends 21 move outward to the open state under the pressure of the intestinal tract, and drive the movable rocker arm 31 to rotate, thereby driving the two upper clamping ends 11 of the upper clamping device 10 to move inward to the closed state. At this time, the invention returns to the defecation-suppressing state of the upper clamping device 10.

[0056] Thus, the magnetically driven alternating clamping artificial anal sphincter prosthesis 100 of this embodiment of the invention has completed a complete bowel suppression and defecation process.

[0057] The role and effect of the embodiments

[0058] The magnetically driven alternating clamping artificial anal sphincter prosthesis according to the present invention comprises an upper clamping device, a lower clamping device, a linkage, and an intestinal pressure monitor. The upper clamping device can clamp a first portion of the intestine and open or close it by magnetic drive; the lower clamping device can clamp a second portion of the intestine and open or close it by magnetic drive. The first portion of the intestine is located upstream of the second portion of the intestine. The linkage connects the upper clamping device and the lower clamping device, enabling the upper and lower clamping devices to operate in conjunction. When the upper clamping device is in the closed state, it clamps and closes the first part of the intestine, while the lower clamping device is in the open state. When the internal intestinal pressure exceeds the magnetic threshold of the upper clamping device, it moves from the closed state to the open state, thereby causing the lower clamping device to move from the open state to the closed state. Since the magnetic threshold of the lower clamping device is greater than that of the upper clamping device, when feces accumulate further in the intestine and the internal intestinal pressure reaches the magnetic threshold of the lower clamping device, it moves from the closed state to the open state, thereby causing the upper clamping device to move from the open state to the closed state, thus completing one complete bowel movement suppression and defecation cycle. An intestinal pressure monitor is installed on the lower clamping device for intestinal monitoring and early warning, and it can also be used in conjunction with other monitoring devices to issue early defecation warnings to the patient.

[0059] Therefore, when the magnetically driven alternating clamping artificial anal sphincter prosthesis of the present invention is placed in the patient's body, it has the advantages of alternating clamping of the intestinal tract, planar clamping of the intestinal tract, large clamping area, fecal buffering stage, early warning of defecation, and no need for manual operation. It can effectively reduce the risk of damage and infection to the intestine due to long-term clamping. In addition, the present invention has a simple mechanical structure, good biocompatibility, novel concept, convenient installation, and no need for implantation of electronic components in the body, and can effectively control defecation.

[0060] Furthermore, the movable rocker arm connects the upper clamping device and the lower clamping device. When the upper clamping device is in the closed state, it clamps and closes the first part of the intestine, while the lower clamping device is in the open state. When the internal pressure of the intestine exceeds the magnetic threshold of the upper clamping device, the upper clamping device moves from the closed state to the open state, thereby rotating the movable rocker arm and causing the lower clamping device to move from the open state to the closed state. When the internal pressure of the intestine reaches the magnetic threshold of the lower clamping device, the lower clamping device moves from the closed state to the open state, thereby rotating the movable rocker arm and causing the upper clamping device to move from the open state to the closed state. This embodiment has an alternating clamping function, with the upper and lower clamping devices opening and closing alternately, reducing the adverse effects on the intestine caused by prolonged external clamping, such as mucosal damage, bleeding, infection, and intestinal necrosis.

[0061] Furthermore, the upper clamping end of the upper clamping device and the lower clamping end of the lower clamping device are two identical circular-square structures. With a large area of ​​planar support, the intestinal force-bearing area is larger, the intestinal pressure is smaller, and the force is more even compared with the existing artificial anal sphincter.

[0062] Furthermore, the lower clamping end of this embodiment is equipped with an intestinal pressure monitor, which has a preset fecal buffer stage for intestinal detection and early warning. It can be used in conjunction with other detection devices to issue defecation warning information to the patient in advance.

[0063] Furthermore, the central limiting ring is fitted onto the intestine to fix it in place, and it can also support the movable rocker arm, allowing the movable rocker arm to rotate within a certain range of angles relative to the central limiting ring.

[0064] Those skilled in the art should understand that this invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to this invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the invention as claimed. The scope of protection of this invention is defined by the appended claims and their equivalents.

Claims

1. A magnetically driven alternating clamping artificial anal sphincter prosthesis, characterized in that, include: The upper clamping device is used to clamp the first part of the intestine and can be opened or closed by magnetic force. The lower clamping device is used to clamp the second part of the intestine and can be opened or closed by magnetic force. The magnetic force threshold of the lower clamping device is greater than that of the upper clamping device. as well as The linkage unit connects the upper clamping device and the lower clamping device, and links the upper clamping device and the lower clamping device together. When the upper clamping device is in the closed state, the lower clamping device is in the open state; when the upper clamping device is in the open state, the lower clamping device is in the closed state. The first part of the intestine is located upstream of the second part of the intestine.

2. The magnetically driven alternating clamping artificial anal sphincter prosthesis according to claim 1, Its features are: in, The linkage includes at least a rotatable rocker arm, which connects the upper clamping device and the lower clamping device. When the upper clamping device is in the closed state, it clamps and closes the first part of the intestine, while the lower clamping device is in the open state. When the pressure inside the intestine is greater than the magnetic threshold of the upper clamping device, the upper clamping device moves from the closed state to the open state, thereby driving the movable rocker to rotate and driving the lower clamping device to move from the open state to the closed state. This stage is the fecal buffering stage. When feces accumulate further in the intestines and the internal pressure reaches the magnetic threshold of the lower clamping device, the lower clamping device moves from the closed state to the open state, thereby driving the movable rocker to rotate and driving the upper clamping device to move from the open state to the closed state, returning to the defecation suppression stage. At this point, the artificial anal sphincter prosthesis has completed a complete defecation suppression and defecation operation.

3. The magnetically driven alternating clamping artificial anal sphincter prosthesis according to claim 2, characterized in that: in, The linkage also includes a central limiting ring for fitting onto the intestine to fix it in place. The movable rocker arm is sleeved on the central limiting ring and can rotate within a certain range of angles relative to the central limiting ring. The rotation angle is θ, where θ is 35°. The upper end of the movable rocker arm is connected to the upper clamping device and the lower end is connected to the lower clamping device.

4. The magnetically driven alternating clamping artificial anal sphincter prosthesis according to claim 3, characterized in that: in, Both the upper and lower clamping devices include two clamping ends, and magnets are installed inside each clamping end. The magnets at the two clamping ends have opposite magnetic properties, and the clamping devices are closed by the attraction of the two magnets. The movable rocker arms are arranged in two symmetrical configurations, with the upper end of each movable rocker arm connected to the clamping end of the upper clamping device and the lower end connected to the clamping end of the lower clamping device.

5. The magnetically driven alternating clamping artificial anal sphincter prosthesis according to claim 4, characterized in that: in, The clamping end includes a first cover plate and a second cover plate, and the magnet is installed inside the first cover plate. The first cover plate is provided with four first mounting holes, arranged in a top-bottom configuration of two holes each. The second cover plate is provided with four second mounting holes, the positions of which correspond to the positions of the four first mounting holes. By inserting fastening components into the second mounting holes and the first mounting holes, the second cover plate and the first cover plate can be detachably connected.

6. The magnetically driven alternating clamping artificial anal sphincter prosthesis according to claim 5, characterized in that: in, The movable rocker arm has a central hole in its middle, and a rotating bearing is installed inside the central hole. The central limiting ring is connected to the rotating bearing, forming a closed loop.

7. The magnetically driven alternating clamping artificial anal sphincter prosthesis according to claim 6, characterized in that: in, The upper and lower ends of the movable rocker are respectively provided with first positioning holes, and the clamping end is provided with a second positioning hole. The second positioning hole passes through the first cover plate and the second cover plate. The fastening assembly is achieved by cooperating with the first positioning hole through the second positioning hole, so that the upper end of the movable rocker is connected to the clamping end of the upper clamping device and the lower end is connected to the clamping end of the lower clamping device.

8. The magnetically driven alternating clamping artificial anal sphincter prosthesis according to claim 7, characterized in that: in, The central limiting ring includes a first ring body and a second ring body. The first ring body has protrusions at both ends and a first fixing hole on each protrusion. The second ring body has assembly cavities at both ends that are adapted to the protrusions and a second fixing hole on each assembly cavity that is adapted to the first fixing hole. The protrusions are inserted into the assembly cavities, and the first and second fixing holes are used in conjunction with fastening components to achieve detachable splicing of the first and second ring bodies.

9. The magnetically driven alternating clamping artificial anal sphincter prosthesis according to claim 4, characterized in that: in, An intestinal pressure monitor is installed on the clamping end of the lower clamping device.

10. The magnetically driven alternating clamping artificial anal sphincter prosthesis according to claim 4, characterized in that: in, The magnetic force threshold of the upper clamping device is A, which is 4.5N. The difference between the magnetic force threshold of the lower clamping device and the magnetic force threshold of the upper clamping device is B, which is 4.9N.

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