An artificial anal sphincter device imitating the puborectalis muscle type flexible clamping

Abstract

The present invention relates to an artificial anal sphincter device with flexible clamping imitating puborectalis muscle, comprising a frame, an upper support ring, a flexible sleeve, a lower support ring, a control drive and a flexible rope, wherein an upper support frame and a lower support frame are horizontally arranged one above the other, a pair of fixed brackets are vertically arranged at intervals on the sides of the upper support frame and the lower support frame, the upper support frame and the lower support frame are respectively used to install the upper support ring and the lower support ring, the support ring comprises a left part and a right part of the support ring respectively arranged on the left and the right, the left part and the right part of the support ring are closed by buckles to form an arch, a channel for accommodating a supporting intestinal tube is formed between the support rings, the flexible sleeve is horizontally placed between the upper support ring and the lower support ring, and is installed by a fixed bracket, and the flexible rope connects the rotating shaft, the support ring and the flexible sleeve respectively. Compared with the prior art, the present invention realizes the structural design imitating puborectalis muscle and the flexible clamping of the intestinal tube tissue, avoids the complex mechanical structure design, and ensures the effectiveness and safety of the device.

Description

Technical Field

[0001] The invention relates to the technical field of medical instruments, in particular to an artificial anal sphincter device with puborectalis muscle-like flexible clamping. Background Art

[0002] Fecal incontinence (FI), also known as anal incontinence, refers to the disorder of anal self-control caused by various reasons, which makes it impossible to sense and control the discharge of liquid, gaseous and solid intestinal contents. It is a common clinical disease. Although it is medically believed that anal incontinence will not endanger the patient's life, it is easy to cause a variety of complications, which not only brings great pain to the patient's body and mind, but also brings many difficulties to nursing work.

[0003] Anal incontinence can be divided into complete incontinence and incomplete incontinence. Complete incontinence refers to the loss of the body's ability to control gas or feces, while incomplete incontinence refers to the ability to control the discharge of dry stools but lose the ability to control gas or loose stools. Anal incontinence is caused by many factors, the main causes of which include sphincter damage, pelvic diseases, diseases that affect rectal capacity or perception, central nervous system diseases, mental illness or behavioral disorders, and intestinal disorders.

[0004] Anal incontinence has a significant impact on people's quality of life. There are various treatments for FI, but currently only one-third of patients can receive treatment. Conservative treatment can be adopted for mild patients, and better results can be achieved through diet adjustment, lifestyle adjustment, drug therapy and biofeedback therapy. For patients with severe anal incontinence such as congenital, neurogenic anal incontinence and colorectal cancer, when conservative treatment cannot effectively treat the patient's condition, surgical treatments such as sphincter reconstruction, sphincteroplasty, colostomy and sacral nerve stimulation can be used.

[0005] Traditional surgical treatments for anal incontinence are complicated, difficult, and prone to recurrence after surgery. With the continuous development of interdisciplinary medicine and engineering, the emergence of artificial anal sphincter systems provides a new idea for solving anal incontinence and provides a possibility for solving anal incontinence. Artificial anal sphincter refers to an artificial sphincter prosthesis that simulates the physiological function of the normal external anal sphincter to control defecation and treat fecal incontinence. Artificial anal sphincter is an innovative therapy that can effectively treat fecal incontinence, and devices developed abroad have been used clinically. However, there are still problems in fecal control ability, safety, comfort, control method and defecation perception. The development of an artificial anal sphincter that is comfortable, safe and stable, has good defecation control, convenient energy supply and can realize defecation perception function will be a great blessing for many FI patients. Summary of the invention

[0006] Aiming at the problems of complex mechanical structure, large implanted prosthesis volume and high mechanical failure rate of existing artificial anal sphincter devices, the present invention adopts a puborectalis muscle imitation structure design and utilizes flexible rope transmission to provide a bionic, small, light and flexible transmission puborectalis muscle imitation flexible clamping artificial anal sphincter device.

[0007] The artificial anal sphincter device with puborectalis muscle-imitation flexible clamping provided by the present invention has its parts in direct contact with the intestinal tract wrapped with soft and biocompatible medical silicone material, which can effectively reduce the stress between the device and the intestinal tract and achieve good biocompatibility, and can solve the safety and effectiveness problems faced by the clinical application of artificial sphincters. The device has the advantages of simple operation, compact structure and constant force clamping.

[0008] The purpose of the present invention is achieved through the following technical solutions:

[0009] An artificial anal sphincter device imitating the puborectalis muscle type flexible clamping comprises a frame, an upper support ring, a flexible sleeve, a lower support ring, a relaxation rope, a rotating shaft, a contraction rope, a reducer and a micro motor.

[0010] The frame includes a supporting mainboard, an upper supporting frame and a lower supporting frame are fixed on one side of the supporting mainboard, a fixed bracket connects the upper supporting frame and the lower supporting frame, an upper supporting ring is connected to the upper supporting frame, a lower supporting ring is connected to the lower supporting frame, and a flexible sleeve is arranged between the upper supporting ring and the lower supporting ring through a fixed bracket;

[0011] A motor bracket is fixed on the other side of the supporting main board, the micro motor is connected to the motor bracket, the rotating shaft is connected to the reducer through a coupling, and the reducer and the micro motor are assembled together;

[0012] One end of the contraction rope is wound around the rotating shaft, and the other end is fixed to the flexible sleeve; one end of the expansion rope is wound around the rotating shaft, and the other end is fixed to the upper support ring, and passes through the support main board, the lower support frame, the lower support ring and the flexible sleeve in sequence;

[0013] When the micromotor rotates forward, the relaxation rope relaxes and the contraction rope winds, at which time the flexible sleeve contracts, pulling the intestinal tube toward the support mainboard of the rack; when the micromotor rotates reversely, the relaxation rope winds and the contraction rope relaxes, at which time the flexible sleeve relaxes, relaxing the intestinal tube toward the support mainboard away from the rack.

[0014] In one embodiment of the present invention, the upper support ring and the lower support ring are both composed of detachable components, and the surface is covered with medical silicone film. The upper support ring and the lower support ring have the same structure, and the double arch structure formed by the two is used to support the upper and lower parts of the intestinal tract respectively.

[0015] In one embodiment of the present invention, the upper support ring is composed of a detachable upper support ring left part and an upper support ring right part, and the upper support ring left part and the upper support ring right part are connected to the upper support frame.

[0016] In one embodiment of the present invention, the lower support ring is composed of a detachable lower support ring left part and a lower support ring right part, and the lower support ring left part and the lower support ring right part are connected to the lower support frame.

[0017] In one embodiment of the present invention, the frame is the main force-bearing member, and the support mainboard, upper support frame, lower support frame, fixed support frame, and motor support are made of polyetheretherketone (PEEK) material. PEEK is a good substitute for bone or cartilage, and has been applied in medical fields such as spinal surgery and orthopedics, and has good mechanical properties and biocompatibility.

[0018] In one embodiment of the present invention, the supporting main board is provided with two through slots for installing the expansion rope and the contraction rope, and the middle position of the fixing bracket is provided with a through slot for installing the flexible sleeve.

[0019] In one embodiment of the present invention, the upper support ring and the lower support ring are made of polyetheretherketone (PEEK) material, and are both wrapped with medical silicone film on the outside. Because the upper support ring and the lower support ring are in contact with the intestinal tract, considering biocompatibility, the upper support ring and the lower support ring are both wrapped with medical silicone film.

[0020] In one embodiment of the present invention, the flexible sleeve is a soft belt-like structure, a limiting device is attached to the flexible sleeve, and a contraction rope is connected to the flexible sleeve. When the contraction rope is tightened by rotating the rotating shaft, the closed cross-sectional area formed by the flexible sleeve is reduced, which is used to tighten the intestinal tube; when the motor is reversed, the contraction rope is reset by rotating the rotating shaft, and the closed cross-sectional area formed by the flexible sleeve is increased, which is used to relax the intestinal tube.

[0021] In one embodiment of the present invention, the limiting device is a protrusion provided on the surface of the flexible sleeve. During the traction and contraction of the flexible sleeve, the length of the distal flexible sleeve will be reduced from 100 mm to about 40 mm, and a protrusion is provided at the corresponding position of the flexible sleeve, and the protrusion cannot pass through the through slot of the fixing frame, thereby realizing the limiting function, preventing the traction distance from being too long, resulting in excessive local stress of the flexible sleeve on the rectum, and protecting the intestinal tract.

[0022] In one embodiment of the present invention, the flexible sleeve material is thermoplastic polyurethane material, which passes through the through groove in the middle of the fixing frame. When the flexible sleeve contracts and pulls the intestinal tube, the contact area between the flexible sleeve and the intestinal tube remains unchanged. The process of squeezing the intestinal tube by the flexible sleeve is approximately flat pressure rather than radial squeezing, thereby reducing the stress concentration on the intestinal tube. The traction method of the flexible sleeve simulates the action of the puborectalis muscle, and the intestinal tube forms an anorectal angle at the traction site, thereby preventing the leakage of gaseous and liquid excrement.

[0023] In one embodiment of the present invention, the surfaces of the relaxation rope and the contraction rope are coated with a biocompatible coating material.

[0024] When the present invention is used, the micro motor driven by the control first rotates forward, so that the rotating shaft works at a set speed under the action of the reducer. At this time, the relaxation rope wound on the rotating shaft will relax, the contraction rope will be wound and tightened, and the flexible sleeve will move horizontally when the contraction rope is tightened, and the flexible sleeve will horizontally pull the intestinal tube to the direction of the frame main board, thereby forming a simulated anorectal angle. At this time, the device is in a closed state, which plays a restraining role on the intestinal tube. When the motor is reversed, the relaxation rope wound on the rotating shaft will be wound and tightened, and the contraction rope will relax. At this time, the flexible sleeve is reset as the contraction rope is relaxed, and the intestinal tube is in a laxative state. The present invention is driven by a motor, and the flexible rope mechanism drives the flexible sleeve to move, imitates the action mechanism of the human puborectalis muscle, and realizes the opening and closing of the simulated artificial sphincter. The present invention realizes the flexible clamping of the intestinal tissue by designing a flexible rope mechanism imitating the puborectalis muscle, and effectively solves the problems of ischemic necrosis of the intestinal tissue caused by the mismatch between the sphincter device and the intestinal tissue mechanics.

[0025] The flexible rope mechanism designed in the present invention realizes flexible clamping of the intestinal tube by controlling the rotation of the motor, and has the following significant advantages compared with the existing artificial anal sphincter technology:

[0026] (1) The present invention is easy to operate. The opening and closing of the artificial anal sphincter can be achieved by controlling the rotation of the motor. The degree of opening and closing can be controlled by the rotation of the motor. The overall execution process is smooth and simple.

[0027] (2) The present invention has an ingenious structure and adopts flexible rope transmission. The device is small in size and light in weight. The flexible sleeve traction mechanism can effectively avoid the clamping and compression damage of the intestinal tissue, thereby improving the safety of the artificial sphincter.

[0028] (3) The present invention imitates the action mechanism of the puborectalis muscle, so that the device forms an anorectal angle at the intestinal tract, simulates the closed state of the intestinal tissue, avoids complex mechanical structure, and improves the effectiveness of the artificial sphincter. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1It is a schematic structural diagram of an artificial anal sphincter device with puborectalis muscle-like flexible clamping in Example 1 of the present invention;

[0030] Figure 2 This is a schematic diagram of the frame structure of the artificial anal sphincter device imitating the puborectalis muscle-like flexible clamping in Example 1 of the present invention;

[0031] Figure 3 This is a schematic diagram of the support ring structure in the artificial anal sphincter device imitating the puborectalis muscle-like flexible clamping in Example 1 of the present invention;

[0032] Figure 4 It is a schematic diagram of the structure of the flexible sleeve in the artificial anal sphincter device imitating the puborectalis muscle-like flexible clamping in Example 1 of the present invention;

[0033] Figure 5 It is a schematic diagram of the structure of the rope being installed on the rotating shaft in the artificial anal sphincter device imitating the puborectalis muscle-type flexible clamping in Example 1 of the present invention;

[0034] The numbers in the figure show:

[0035] 1—frame, 101—upper support frame, 102—lower support frame, 103—fixed support, 104—motor support, 105—support main board, 2—upper support ring, 201—left part of upper support ring, 202—right part of upper support ring, 3—flexible sleeve, 301—limiting device, 4—lower support ring, 401—left part of lower support ring, 402—right part of lower support ring, 5—relaxation rope, 6—rotating shaft, 7—contraction rope, 8—reducer, 9—micro motor. DETAILED DESCRIPTION

[0036] The present invention is described in detail below with reference to the accompanying drawings and specific embodiments.

[0037] Example

[0038] refer to Figure 1 , 2 As shown in Figures 3, 4 and 5, an artificial anal sphincter device with flexible clamping imitating the puborectalis muscle includes a frame 1, an upper support ring 2, a flexible sleeve 3, a lower support ring 4, a relaxation rope 5, a rotating shaft 6, a contraction rope 7, a reducer 8 and a micro motor 9.

[0039] Continue to refer Figure 1 , 2 As shown in Figures 3, 4 and 5, the rack 1 includes a supporting mainboard 105, an upper supporting frame 101 and a lower supporting frame 102 are fixed to one side of the supporting mainboard 105, and a fixing bracket 103 connects the upper supporting frame 101 and the lower supporting frame 102.

[0040] The upper support ring 2 is composed of an upper support ring left portion 201 and an upper support ring right portion 202 , and the upper support ring left portion 201 and the upper support ring right portion 202 are connected to the upper support frame 101 .

[0041] The lower support ring 4 is composed of a lower support ring left portion 401 and a lower support ring right portion 402 , and the lower support ring left portion 401 and the lower support ring right portion 402 are connected to the lower support frame 102 .

[0042] The flexible sleeve 3 is arranged between the upper support ring 2 and the lower support ring 4 through a fixing bracket 103 .

[0043] A motor bracket 104 is fixed on the other side of the support main board 105, and a micro motor 9 is connected to the motor bracket 104. The rotating shaft 6 is connected to the reducer 8 through a coupling, and the reducer 8 is assembled with the micro motor 9. One end of the contraction rope 7 is wound around the rotating shaft 6, and the other end is fixed to the flexible sleeve 3. One end of the relaxation rope 5 is wound around the rotating shaft 6, and the other end is fixed to the upper support ring 2, and passes through the support main board 105, the lower support frame 102, the lower support ring 4 and the flexible sleeve 3 in sequence. The relaxation rope 5 and the contraction rope 7 are used to relax and tighten the flexible sleeve 3.

[0044] Further references Figure 1 , 2 3. The upper support ring 2 and the lower support ring 4 are both composed of detachable components, and the surface is covered with a medical silicone film. Take the lower support ring 4 as an example: the lower support ring 4 is symmetrically arranged by the detachable components of the lower support ring left part 401 and the lower support ring right part 402. One end of the lower support ring left part 401 and the lower support ring right part 402 are closed by buckles, and one end is provided with a through hole, which cooperates with the fixed axis of the lower support frame 102 to form a rotating pair. The upper support ring 2 has the same structure as the lower support ring 4, and the double arch structure formed by the two is used to support the upper and lower parts of the intestinal tube respectively.

[0045] Further references Figure 1 , 2 4. The flexible sleeve 3 is a soft belt-like structure, and a limiting device 301 is attached to the flexible sleeve 3. The contraction rope 7 is connected to the flexible sleeve 3. When the contraction rope 7 is tightened by the rotation of the rotating shaft 6, the closed cross-sectional area formed by the flexible sleeve 3 is reduced, which is used to tighten the intestinal tube; when the motor is reversed, the contraction rope 7 is reset by the rotation of the rotating shaft 6, and the closed cross-sectional area formed by the flexible sleeve 3 is increased, which is used to relax the intestinal tube.

[0046] Further references Figure 1 , 2, 5, through holes are opened at both ends of the rotating shaft 6, and the expansion rope 5 and the contraction rope 7 are wound around the rotating shaft 6 through the through holes. When the motor rotates forward, the expansion rope 5 is relaxed and the contraction rope 7 is wound, at which time the flexible sleeve contracts and pulls the intestinal tube toward the support main board 105 of the frame 1; when the motor rotates reversely, the expansion rope 5 is wound and the contraction rope 7 is relaxed, at which time the flexible sleeve expands and relaxes the intestinal tube to the direction away from the support main board 105 of the frame 1.

[0047] In this embodiment, the surfaces of the relaxation rope 5 and the contraction rope 7 are coated with a biocompatible coating material.

[0048] The directional terms such as “upper”, “lower”, “left” and “right” in the present invention are described according to the drawings, rather than the specific directions of the device in actual use.

[0049] The working process of the present invention is as follows: when the micro motor 9 rotates forward, it drives the rotating shaft 6 to rotate, the contraction rope 7 on the rotating shaft 6 is wound, the relaxation rope 5 is relaxed, the flexible sleeve 3 is tightened under the winding of the contraction rope 7, and the intestinal tube is pulled in to move toward the support main board 105 close to the frame 1, so as to achieve intestinal closure. When the intestinal tube is in the closed state, an anorectal angle is formed under the traction of the flexible sleeve 3.

[0050] When the micro motor 9 reverses, it drives the rotating shaft 6 to rotate, the expansion rope 5 on the rotating shaft 6 is wound, the contraction rope 7 is relaxed, and the flexible sleeve 3 expands under the relaxation of the expansion rope 5, pulling the intestinal tube into the direction away from the supporting main board 105 of the frame 1, so as to open the intestinal tube.

[0051] The above description of the embodiments is to facilitate the understanding and use of the invention by those skilled in the art. It is obvious that those skilled in the art can easily make various modifications to these embodiments and apply the general principles described herein to other embodiments without creative work. Therefore, the present invention is not limited to the above embodiments, and improvements and modifications made by those skilled in the art based on the disclosure of the present invention without departing from the scope of the present invention should be within the scope of protection of the present invention.

Claims

1. An artificial anal sphincter device imitating the puborectalis muscle flexible clamping, characterized in that: The invention comprises a frame (1), an upper support ring (2), a flexible sleeve (3), a lower support ring (4), a relaxation rope (5), a rotating shaft (6), a contraction rope (7), a speed reducer (8) and a micro motor (9). The frame (1) comprises a supporting mainboard (105), an upper supporting frame (101) and a lower supporting frame (102) are fixed to one side of the supporting mainboard (105), a fixing bracket (103) is connected to the upper supporting frame (101) and the lower supporting frame (102), an upper supporting ring (2) is connected to the upper supporting frame (101), a lower supporting ring (4) is connected to the lower supporting frame (102), and a flexible sleeve (3) is arranged between the upper supporting ring (2) and the lower supporting ring (4) through the fixing bracket (103); A motor bracket (104) is fixed to the other side of the supporting main board (105), the micro motor (9) is connected to the motor bracket (104), the rotating shaft (6) is connected to the reducer (8) via a coupling, and the reducer (8) and the micro motor (9) are assembled together; One end of the contraction rope (7) is wound around the rotating shaft (6), and the other end is fixed to the flexible sleeve (3); one end of the expansion rope (5) is wound around the rotating shaft (6), and the other end is fixed to the upper support ring (2), and passes through the support main board (105), the lower support frame (102), the lower support ring (4) and the flexible sleeve (3) in sequence; When the micro motor (9) rotates forward, the relaxation rope (5) is relaxed and the contraction rope (7) is wound, and the flexible sleeve (3) is contracted, pulling the intestinal tube toward the support main board (105) of the frame (1); when the micro motor (9) rotates reversely, the relaxation rope (5) is wound and the contraction rope (7) is relaxed, and the flexible sleeve (3) is relaxed, relaxing the intestinal tube toward the support main board (105) away from the frame (1); The flexible sleeve (3) is a soft belt-like structure. A limiting device (301) is attached to the flexible sleeve (3). The contraction rope (7) is connected to the flexible sleeve (3). When the contraction rope (7) is tightened by rotating the rotating shaft (6), the closed cross-sectional area formed by the flexible sleeve (3) decreases, which is used to tighten the intestinal tube. When the motor is reversed, the contraction rope (7) is reset by rotating the rotating shaft (6), and the closed cross-sectional area formed by the flexible sleeve (3) increases, which is used to relax the intestinal tube.

2. The artificial anal sphincter device with puborectalis muscle-like flexible clamping according to claim 1, characterized in that: The upper support ring (2) and the lower support ring (4) are both composed of detachable components and their surfaces are covered with a medical silicone film. The upper support ring (2) and the lower support ring (4) have the same structure, and the double arch structure formed by the two is used to support the upper and lower parts of the intestinal tube respectively.

3. The artificial anal sphincter device with puborectalis muscle-like flexible clamping according to claim 2, characterized in that: The upper support ring (2) is composed of a detachable upper support ring left part (201) and an upper support ring right part (202), and the upper support ring left part (201) and the upper support ring right part (202) are connected to the upper support frame (101); The lower support ring (4) is composed of a detachable lower support ring left part (401) and a lower support ring right part (402), and the lower support ring left part (401) and the lower support ring right part (402) are connected to the lower support frame (102).

4. The artificial anal sphincter device with puborectalis muscle-like flexible clamping according to claim 1, characterized in that: The frame (1) is a main load-bearing component, and the material of the supporting mainboard (105), the upper supporting frame (101), the lower supporting frame (102), the fixing bracket (103), and the motor bracket (104) is polyetheretherketone material.

5. The artificial anal sphincter device with flexible clamping imitating puborectalis muscle according to claim 1, characterized in that: The supporting main board (105) is provided with two through slots for installing the expansion rope (5) and the contraction rope (7), and the fixing bracket (103) is provided with a through slot in the middle for installing the flexible sleeve (3).

6. The artificial anal sphincter device with puborectalis muscle-like flexible clamping according to claim 1, characterized in that: The upper support ring (2) and the lower support ring (4) are made of polyetheretherketone material, and the outer sides of the two are wrapped with a medical silicone film.

7. The artificial anal sphincter device with puborectalis muscle-like flexible clamping according to claim 1, characterized in that: The limiting device (301) is a protrusion arranged on the surface of the flexible sleeve (3).

8. The artificial anal sphincter device with flexible clamping imitating puborectalis muscle according to claim 1, characterized in that: The material of the flexible sleeve (3) is thermoplastic polyurethane material.

9. The artificial anal sphincter device with puborectalis muscle-like flexible clamping according to claim 1, characterized in that: The surfaces of the expansion rope (5) and the contraction rope (7) are both coated with a biocompatible coating material.

Images