A slider-type artificial anal sphincter device capable of constantly clamping intestinal tissue

Abstract

This invention discloses a slider-type artificial anal sphincter device capable of constant-force clamping of intestinal tissue, comprising a base (1), connectors (2), constant-force clamping mechanisms (3), a control drive mechanism (4), and screws (5). The base (1) has six elliptical through slots and six sliding grooves, each of which is fitted with a connector (2), and the connectors (2) are connected to each other in a ring. A circular channel is provided at the center of the base (1) for fixing and accommodating the intestine. Each sliding groove is fitted with a constant-force clamping mechanism (3), and the constant-force clamping mechanism (3) has rectangular through holes that are connected to the connectors (2) to form a whole. This invention uses a motor-driven push rod to simultaneously displace the six constant-force clamping mechanisms, mimicking the circumferential contraction mechanism of the human sphincter, thus realizing the simulated opening and closing of an artificial sphincter.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a slider-type artificial anal sphincter device capable of clamping intestinal tissue with constant force. Background Technology

[0002] Fecal incontinence refers to the ability to prevent the leakage of solid, liquid, or gaseous feces under various conditions. Fecal incontinence (FI) refers to the loss of voluntary control over feces or gas for more than three months, and is a common clinical condition. Fecal incontinence can be classified into complete and incomplete incontinence based on severity. With the unhealthy lifestyles of modern people, the aging population, and increasing psychological stress, fecal incontinence has become a significant social problem.

[0003] There are various causes of anal incontinence, which can be categorized as follows: sphincter nerve or muscle injury or weakness. Sphincter injury caused by childbirth or surgery is the most common cause of anal incontinence. The causes of anal incontinence are complex, including rectal and anal tumors, nervous system diseases, perineal trauma, childbirth injuries, and congenital malformations. Understanding the causes allows for early prevention and treatment. Due to the complexity of the causes of anal incontinence and the significant individual differences among patients, it is difficult to provide uniform treatment for all cases. After clinical evaluation, doctors will adopt different treatment plans based on the cause and severity of anal incontinence.

[0004] Treatment for anal incontinence includes conservative and surgical approaches. Conservative treatment primarily includes dietary management, medication, biofeedback, and non-surgical electrical stimulation. If conservative treatment fails to address the patient's symptoms, surgical intervention may be considered, with the specific surgical plan depending on the patient's physical condition and the severity of incontinence. Surgical treatments mainly include sphincter transplantation, sphincter reconstruction, enterostomy, and artificial anal sphincter. Currently, enterostomy is the most common treatment for anal incontinence in clinical practice, but this method significantly impacts the psychological and physiological stress on patients, severely affecting their quality of life. Finding an alternative to enterostomy that can effectively address incontinence is a key focus and challenge in clinical research. The rise and development of interdisciplinary research in medicine and engineering, and the development of artificial anal sphincter based on the successful application of artificial urethral sphincter, offer a potential solution to this difficult problem of treating severe anal incontinence.

[0005] Addressing the shortcomings of existing artificial anal sphincter systems in clinical or experimental stages, this paper proposes a slider-type artificial anal sphincter device that can clamp intestinal tissue with constant force. By simulating the normal defecation mechanism of the human body, it helps patients achieve defecation control, providing a new approach to solving anal incontinence and offering possibilities for future clinical applications.

[0006] Therefore, those skilled in the art are dedicated to developing a slider-type artificial anal sphincter device that can clamp intestinal tissue with constant force to solve the above problems. Summary of the Invention

[0007] In view of the above-mentioned defects of the prior art, the technical problem to be solved by the present invention is that artificial anal sphincter devices are prone to defecation, have a high complication rate and a high mechanical failure rate.

[0008] To achieve the above objectives, the present invention provides a slider-type artificial anal sphincter device capable of constant force clamping of intestinal tissue, characterized in that it includes a chassis (1), a connector (2), a constant force clamping mechanism (3), a control drive mechanism (4), and screws (5); the chassis (1) is provided with 6 elliptical through slots and 6 sliding slots, each of the elliptical through slots is equipped with the connector (2), and the connectors (2) are connected to each other to form a ring; a circular channel is provided at the center of the chassis (1) for fixing and accommodating the intestine; each of the sliding slots is equipped with the constant force clamping mechanism (3), the constant force clamping mechanism (3) includes a slider (301), the slider (301) is provided with a rectangular through hole, and each slider (301) is connected to the connector (2) to form a whole;

[0009] The lower ends of the connectors (2) are respectively engaged with the elliptical through slots. The upper ends of the connectors (2) pass through the constant force clamping mechanism (3) and are connected to each other. The upper ends of the connectors (2) are divided into two parts with alternating heights. The six connectors (2) with alternating heights can form a spatially variable ring around the rotation center of the chassis (1). As the connectors (2) move on the elliptical through slots, the size of the ring formed by the connectors (2) can change. When the connectors (2) are close to the rotation center of the chassis (1), the annular space formed by the connectors (2) becomes smaller, and vice versa. The connectors (2) pass through the constant force clamping mechanism (3) and can drive the constant force clamping mechanism (3) to move simultaneously.

[0010] The control drive mechanism (4) includes a push rod sleeve (401), a push rod (402), a micro motor (403), and a push rod base (404); the push rod sleeve (401) is located at the upper end of the push rod base (404), one end of the push rod sleeve (401) is designed with a round hole, and is engaged with the push rod base (404) by the screw (5), and the other end of the push rod base (404) is fixedly connected to the base (1); one end of the push rod (402) is connected to the micro motor (403), and the other end of the push rod (402) is fixedly connected to the constant force clamping mechanism (3); the micro motor (403) is placed inside the push rod sleeve (401) and can drive the push rod (402) to extend or retract from the push rod sleeve (401);

[0011] When the micro motor (403) rotates forward, the push rod (402) extends from the push rod sleeve (401). The push rod (402) drives the constant force clamping mechanism (3) to approach the intestinal tract. The constant force clamping mechanism (3), which is fixed to the push rod (402), causes the annular space formed by the connector (2) to contract. The connector (2) drives the other five constant force clamping mechanisms (3) to simultaneously approach the intestine and apply pressure to the intestine, ultimately preventing the intestinal contents from exiting the intestine. Discharge; when the micro motor (403) reverses, the push rod (402) retracts from the push rod sleeve (401), the push rod (402) drives the constant force clamping mechanism (3) to release the clamping of the intestine, the constant force clamping mechanism (3) fixed with the push rod (402) drives the annular space formed by the connector (2) to expand, the connector (2) drives the other 5 constant force clamping mechanisms (3) to move away from the intestine at the same time, and finally the intestinal contents are discharged from the intestine.

[0012] Furthermore, the constant force clamping mechanism (3) includes a slider (301), a superelastic shape memory alloy sheet (302), and a clamping slider (303); the slider (301) is provided with a rectangular through hole, and each slider (301) is connected to each of the connectors (2); the superelastic shape memory alloy sheet (302) is made of titanium-nickel alloy; the clamping slider (303) is designed to be concave because it is in direct contact with the intestine, and this structure design reduces damage to the intestinal tissue during the clamping process; when the annular space formed by the connector (2) shrinks, the constant force clamping mechanism (3) simultaneously contracts radially under the drive of the connector (2), and when the annular space formed by the connector (2) expands, the constant force clamping mechanism (3) simultaneously expands radially outward under the drive of the connector (2).

[0013] Furthermore, the six elliptical through slots and the six sliding grooves are evenly distributed around the rotation center of the chassis (1), wherein the elliptical through slots cooperate with the connector (2) and the sliding grooves cooperate with the constant force clamping mechanism (3).

[0014] Furthermore, the six elliptical through slots on the chassis (1) serve as limiting points, restricting the size of the annular space formed by the connector (2) and the compression range of the intestine by the constant force clamping mechanism (3).

[0015] Furthermore, the circular channel at the center of the chassis (1) is used to fix the intestine.

[0016] Furthermore, the lower half of the connector (2) is a cylindrical thin rod, which is inserted into the corresponding elliptical through groove on the chassis (1); the upper end of the connector (2) consists of two parts with alternating high and low sections, and the high and low sections of the six connectors (2) are connected together to form a spatially variable ring around the rotation center of the chassis (1).

[0017] Furthermore, the driving chip of the micro motor (403) is the DRV9937 manufactured by TI, with a size of 2mm×2mm×0.8mm, a power supply voltage of 1.8V-7V, and a maximum driving current of 1.8A.

[0018] Furthermore, a flexible sensor is mounted on the surface of the clamping slider (303) for sensing intestinal pressure.

[0019] Furthermore, the clamping slider (303) that contacts the outer wall of the intestinal tract is wrapped with silicone rubber to meet the requirements of material biocompatibility.

[0020] Furthermore, the clamping slider (303) is made of polyetheretherketone (PEEK) material, and the superelastic shape memory alloy sheet (302) is made of titanium-nickel alloy.

[0021] Compared with traditional methods and apparatus, the present invention has the following advantages:

[0022] This invention uses a motor-driven push rod to simultaneously displace six constant-force clamping mechanisms, mimicking the circumferential contraction mechanism of the human sphincter to simulate the opening and closing of an artificial sphincter. By designing constant-force elements in the clamping mechanisms, this invention utilizes multi-slider synchronous radial expansion and contraction to achieve uniform circumferential loading of the intestinal tissue, and employs a superelastic shape memory alloy sheet to achieve constant-force clamping of the intestinal tissue. This avoids the negative effects caused by insufficient or excessive force on the intestinal tissue, effectively solving problems such as local ischemia and necrosis of the intestinal tissue due to mechanical mismatch between the artificial sphincter device and the intestinal tissue. All materials used in this invention are biocompatible medical materials, reducing the possibility of tissue rejection and various complications after implantation, ensuring the safety and effectiveness of the device. Compared with existing artificial anal sphincter technology, this invention has the following significant advantages:

[0023] (1) This invention mimics the sphincter contraction mechanism and uses multiple sliders to simultaneously radially stretch and extend the intestinal tract, thereby simulating the closed state of the intestinal tissue, avoiding complex mechanical structures and improving the effectiveness of artificial sphincter.

[0024] (2) The present invention utilizes the synchronous radial extension and retraction of multiple sliders to achieve uniform circumferential loading of intestinal tissue, thereby avoiding local ischemia and necrosis of intestinal tissue caused by uneven force.

[0025] (3) The present invention utilizes a superelastic shape memory alloy sheet to achieve constant force clamping of intestinal tissue, avoiding the failure of the device due to insufficient force applied to the intestinal tissue or the local ischemia and necrosis of the intestinal tissue due to excessive force applied to the intestinal tissue, thus ensuring the safety and effectiveness of the device.

[0026] (4) The present invention is easy to operate. By controlling the rotation of the micro motor, the artificial anal sphincter can be opened and closed. The degree of opening and closing can be controlled by the rotation of the motor. The overall execution process is smooth and simple.

[0027] (5) This invention is an implantable device. Considering long-term biocompatibility, the material used is medical-grade titanium alloy, which is lightweight and has good biocompatibility. The slider device that contacts the outer wall of the intestinal tract is wrapped with silicone rubber to meet the biocompatibility requirements of the material. All drive motors are waterproof and sealed, which improves the safety of the artificial sphincter.

[0028] The following will further explain the concept, specific structure, and technical effects of the present invention in conjunction with the accompanying drawings, so as to fully understand the purpose, features, and effects of the present invention. Attached Figure Description

[0029] Figure 1 This is a schematic diagram of a preferred embodiment of the slider-type artificial anal sphincter device capable of constant force clamping of intestinal tissue according to the present invention.

[0030] Figure 2 This is a schematic diagram of the chassis structure of a slider-type artificial anal sphincter device capable of constant force clamping of intestinal tissue according to a preferred embodiment of the present invention.

[0031] Figure 3 This is a schematic diagram of the connecting component structure of a slider-type artificial anal sphincter device capable of constant force clamping of intestinal tissue according to a preferred embodiment of the present invention.

[0032] Figure 4 This is a schematic diagram of the constant force clamping mechanism of a slider-type artificial anal sphincter device capable of constantly clamping intestinal tissue according to a preferred embodiment of the present invention.

[0033] Figure 5 This is a schematic diagram of the control drive mechanism of a slider-type artificial anal sphincter device capable of constant force clamping of intestinal tissue according to a preferred embodiment of the present invention.

[0034] Among them, 1-chassis, 2-connector, 3-constant force clamping mechanism, 301-slider, 302-super-elastic shape memory alloy sheet, 303-clamping slider, 4-control drive mechanism, 401-push rod sleeve, 402-push rod, 403-micro motor, 404-push rod chassis, 5-screw. Detailed Implementation

[0035] The following description, with reference to the accompanying drawings, illustrates several preferred embodiments of the present invention to make its technical content clearer and easier to understand. The present invention can be embodied in many different forms, and the scope of protection of the present invention is not limited to the embodiments mentioned herein.

[0036] In the accompanying drawings, components with the same structure are indicated by the same numerical designation, and components with similar structures or functions are indicated by similar numerical designations. The dimensions and thicknesses of each component shown in the drawings are arbitrary, and the present invention does not limit the dimensions and thicknesses of each component. To make the illustrations clearer, the thickness of some components has been appropriately exaggerated in the drawings.

[0037] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0038] In the description of this invention, it should be noted that the terms "middle", "upper", "lower", "left", "right", "horizontal", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting this invention.

[0039] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0040] refer to Figure 1 , 2 As shown in Figures 3, 4, and 5, a slider-type artificial anal sphincter device capable of constant force clamping of intestinal tissue includes a chassis 1, a connector 2, a constant force clamping mechanism 3, a control drive mechanism 4, and a screw 5.

[0041] Continue to refer to Figure 1 , 2 As shown in Figures 3, 4, and 5, the chassis 1 has six elliptical through slots and six sliding slots. The through slots are used for limiting the device. Each elliptical through slot is equipped with a connector 2. The connectors 2 are connected to each other to form a variable-sized annular space around the rotation center of the chassis 1. There is a circular channel at the center of the chassis 1 for fixing and accommodating the intestinal tube. Each sliding slot is equipped with a constant force clamping mechanism 3. The constant force clamping mechanism 3 has rectangular through holes that are connected to the connectors 2 to form a whole. One end of the push rod chassis 404 is designed with a circular hole and is assembled with the control drive mechanism 4 by screws 5. The other end of the push rod chassis 404 is fixed to the chassis 1.

[0042] Further reference Figure 3 The lower end of the connector 2 is divided into a round bar and a through groove on the chassis 1. The upper part of the connector 2 has two concave and convex parts, which are stepped. It passes through the constant force clamping mechanism 3 and is connected to each other to form a ring space with a defined range. During the movement of the connector 2 on the through groove, the size of the ring space formed by the connector 2 can change. When the connector 2 is close to the rotation center of the chassis 1, the range of the ring space formed by the connector 2 shrinks. Conversely, the range of the ring space formed by the connector 2 expands. The connector 2 passes through the constant force clamping mechanism 3 and drives all the constant force clamping mechanisms 3 to move radially at the same time.

[0043] Further reference Figure 4 The constant force clamping mechanism 3 comprises three parts: a slider 301, a super-elastic shape memory alloy sheet 302, and a clamping slider 303. The slider 301 has a rectangular through-hole. Connectors 2 connect all the constant force clamping mechanisms 3 together through this through-hole. The super-elastic shape memory alloy sheet 302 is made of titanium-nickel alloy. Because the clamping slider 303 is in direct contact with the intestine, it is designed with a concave shape. Flexible sensors are installed on the surface of each clamping slider 303 to sense intestinal pressure. When the annular space formed by the connector 2 shrinks, the constant force clamping mechanism 3 simultaneously expands and contracts radially under the action of the connector 2; conversely, the device releases its grip on the intestinal tract.

[0044] Further reference Figure 5 The control drive mechanism 4 includes four parts: push rod sleeve 401, push rod 402, micro motor 403, and push rod base 404. The push rod sleeve 401 is located at the upper end of the push rod base 404. One end of the push rod sleeve 401 is designed with a circular threaded hole and is installed together with the push rod base 404 by screws 5. The micro motor 403 is fixed to the push rod 401. The forward and reverse rotation of the micro motor 403 can drive the push rod 402 to extend or retract into the push rod sleeve 401. One end of the push rod 402 is connected to the micro motor 403, and the other end of the push rod 402 is fixed to the constant force clamping mechanism 3. The micro motor 403 is installed inside the push rod sleeve 401.

[0045] In this embodiment, the superelastic shape memory alloy sheet 302 is made of nickel-titanium alloy, the clamping slider 303 is made of polyetheretherketone (PEEK) material, and the other parts are made of medical titanium alloy material.

[0046] In this invention, directional terms such as "up," "down," "left," and "right" are used to describe the device according to the accompanying drawings, rather than referring to the actual location of the device in use.

[0047] The working process of the present invention is as follows: when the micro motor 403 rotates forward, the push rod 402 extends out from the push rod sleeve 401. The push rod 402 drives all the constant force clamping mechanisms 3 to move simultaneously towards the rotation center of the chassis 1, begin to approach the intestine, and apply pressure to the intestinal tissue, so that the intestinal contents cannot be discharged from the intestine. At this time, the device is in a closed state.

[0048] When the micro motor 403 reverses, the push rod 402 retracts from the push rod sleeve 401. The push rod 402 drives the constant force clamping mechanism 3 to release the clamping of the intestine. The constant force clamping mechanism 3, which is fixed to the push rod 402, drives the annular space formed by the connecting piece 2 to expand. The connecting piece 2 drives the other five constant force clamping mechanisms 3 to move away from the intestine at the same time. The device is reset, the intestinal tube is opened, and the intestine is in a smooth state.

[0049] The preferred embodiments of the present invention have been described in detail above. It should be understood that those skilled in the art can make numerous modifications and variations based on the concept of the present invention without creative effort. Therefore, all technical solutions that can be obtained by those skilled in the art based on the concept of the present invention through logical analysis, reasoning, or limited experimentation on the basis of existing technology should be within the scope of protection defined by the claims.

Claims

1. A slider-type artificial anal sphincter device capable of constantly clamping intestinal tissue, characterized in that, The system includes a chassis (1), connectors (2), a constant force clamping mechanism (3), a control drive mechanism (4), and screws (5). The chassis (1) has 6 elliptical through slots and 6 sliding slots. Each elliptical through slot is equipped with a connector (2), and the connectors (2) are connected to each other to form a ring. A circular channel is provided at the center of the chassis (1) for fixing and accommodating the intestine. Each sliding slot is equipped with a constant force clamping mechanism (3), which includes a slider (301). The slider (301) has a rectangular through hole, and each slider (301) is connected to the connector (2) to form a whole. The lower ends of the connectors (2) are respectively engaged with the elliptical through slots. The upper ends of the connectors (2) pass through the constant force clamping mechanism (3) and are connected to each other. The upper ends of the connectors (2) are divided into two parts with alternating heights. The six connectors (2) with alternating heights can form a spatially variable ring around the rotation center of the chassis (1). As the connectors (2) move on the elliptical through slots, the size of the ring formed by the connectors (2) can change. When the connectors (2) are close to the rotation center of the chassis (1), the annular space formed by the connectors (2) becomes smaller, and vice versa. The connectors (2) pass through the constant force clamping mechanism (3) and can drive the constant force clamping mechanism (3) to move simultaneously. The control drive mechanism (4) includes a push rod sleeve (401), a push rod (402), a micro motor (403), and a push rod base (404); the push rod sleeve (401) is located at the upper end of the push rod base (404), one end of the push rod sleeve (401) is designed with a round hole, and is engaged with the push rod base (404) by the screw (5), and the other end of the push rod base (404) is fixedly connected to the base (1); one end of the push rod (402) is connected to the micro motor (403), and the other end of the push rod (402) is fixedly connected to the constant force clamping mechanism (3); the micro motor (403) is placed inside the push rod sleeve (401) and can drive the push rod (402) to extend or retract from the push rod sleeve (401); When the micro motor (403) rotates forward, the push rod (402) extends from the push rod sleeve (401). The push rod (402) drives the constant force clamping mechanism (3) to approach the intestinal tract. The constant force clamping mechanism (3), which is fixed to the push rod (402), causes the annular space formed by the connector (2) to contract. The connector (2) drives the other five constant force clamping mechanisms (3) to simultaneously approach the intestine and apply pressure to the intestine, ultimately preventing the intestinal contents from exiting the intestine. Discharge; when the micro motor (403) reverses, the push rod (402) retracts from the push rod sleeve (401), the push rod (402) drives the constant force clamping mechanism (3) to release the clamping of the intestine, the constant force clamping mechanism (3) fixed with the push rod (402) drives the annular space formed by the connector (2) to expand, the connector (2) drives the other 5 constant force clamping mechanisms (3) to move away from the intestine at the same time, and finally the intestinal contents are discharged from the intestine.

2. The slider-type artificial anal sphincter device capable of constant force clamping of intestinal tissue as described in claim 1, characterized in that, The constant force clamping mechanism (3) also includes a superelastic shape memory alloy sheet (302) and a clamping slider (303); the superelastic shape memory alloy sheet (302) is made of titanium-nickel alloy; the clamping slider (303) is designed to be concave because it is in direct contact with the intestine. This design reduces damage to the intestinal tissue during the clamping process; when the annular space formed by the connector (2) shrinks, the constant force clamping mechanism (3) simultaneously contracts radially under the drive of the connector (2); when the annular space formed by the connector (2) expands, the constant force clamping mechanism (3) simultaneously expands radially outward under the drive of the connector (2).

3. The slider-type artificial anal sphincter device capable of constant force clamping of intestinal tissue as described in claim 1, characterized in that, The six elliptical through slots and six sliding grooves are evenly distributed around the rotation center of the chassis (1), wherein the elliptical through slots cooperate with the connector (2) and the sliding grooves cooperate with the constant force clamping mechanism (3).

4. The slider-type artificial anal sphincter device capable of constant force clamping of intestinal tissue as described in claim 1, characterized in that, The six elliptical through slots on the chassis (1) serve as limiting points, restricting the size of the annular space formed by the connector (2) and the compression range of the intestine by the constant force clamping mechanism (3).

5. The slider-type artificial anal sphincter device capable of constant force clamping of intestinal tissue as described in claim 1, characterized in that, The circular channel at the center of the chassis (1) is used to fix the intestine.

6. The slider-type artificial anal sphincter device capable of constant force clamping of intestinal tissue as described in claim 1, characterized in that, The lower half of the connector (2) is a cylindrical thin rod, which is inserted into the corresponding elliptical through groove on the chassis (1).

7. The slider-type artificial anal sphincter device capable of constant force clamping of intestinal tissue as described in claim 2, characterized in that, The surface of the clamping slider (303) is equipped with a flexible sensor for sensing intestinal pressure.

8. The slider-type artificial anal sphincter device capable of constant force clamping of intestinal tissue as described in claim 2, characterized in that, The clamping slider (303) is wrapped with silicone rubber to meet the biocompatibility requirements of the material.

9. The slider-type artificial anal sphincter device capable of constant force clamping of intestinal tissue as described in claim 8, characterized in that, The clamping slider (303) is made of polyetheretherketone (PEEK) material, and the superelastic shape memory alloy sheet (302) is made of titanium-nickel alloy.

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