CN108294844B

CN108294844B - Auxiliary device for enhancing sphincter function

Info

Publication number: CN108294844B
Application number: CN201810058374.7A
Authority: CN
Inventors: 吕世文; 陈凯宾; 陈智敏; 邢宗江; 赵松辉
Original assignee: Ningbo Senscure Biotechnology Co ltd
Current assignee: Ningbo Senscure Biotechnology Co ltd
Priority date: 2018-01-23
Filing date: 2018-01-23
Publication date: 2020-02-21
Anticipated expiration: 2038-01-23
Also published as: CN108294844A

Abstract

The invention relates to an auxiliary device for enhancing the function of a sphincter, which comprises at least two magnetic devices capable of attracting each other, a buffer device arranged between the magnetic devices and a fixing piece for fixing the magnetic devices and the sphincter, wherein two ends of the buffer device can be respectively contacted with the adjacent magnetic devices, the magnetic devices are arranged on the outer side of the sphincter, when the sphincter is closed, the two magnetic devices attracted to each other are close to each other, and the buffer device is compressed to deform the buffer device; when the sphincter is expanded, the cushioning means can assist the two magnetic means, which attract each other, to move away. The invention not only assists the closing of the sphincter, but also does not influence the expansion of the sphincter, has good adaptability to the external side of the sphincter, is coordinated with the closing and expanding movement of the sphincter, has stable integral structure and ordered spatial arrangement, can realize fixation without wound, and has simple operation and high safety.

Description

Auxiliary device for enhancing sphincter function

Technical Field

The invention relates to the technical field of sphincter function reduction treatment, in particular to an auxiliary device for enhancing the sphincter function, which is embedded outside the sphincter in a human body and can replace the sphincter functions of cardia, pylorus, ileocecal, anal canal, urethra and the like, enhance or rebuild the sphincter ability of organs with weakened or lost sphincter strength, and control the normal flow direction and excretion of contents in the alimentary canal and the urinary tract.

Background

Sphincters are a type of circumflex muscle distributed across the walls of certain lumens of the human and animal body and are critical in controlling the normal flow of luminal contents. Sphincters in the human body are found in the digestive tract and urinary system. The sphincter can close the lumen when contracting, and can open the lumen when relaxing, and the sphincter is usually in a closed state. The lower esophageal sphincter at the gastroesophageal site is effective in preventing reflux of gastric contents to the esophagus. The pyloric sphincter at the exit of the stomach limits the amount of food that can be discharged per gastric peristalsis and prevents reflux of duodenal contents into the stomach. The ileum sphincter at the junction of the tail end of the ileum and the cecum can prevent ileum contents from being discharged to the cecum, prevent the ileum contents from entering the large intestine too quickly, prolong the retention time of chyme in the small intestine, facilitate the complete digestion and absorption of the small intestine contents and prevent the large intestine contents from flowing backwards to the ileum. The reduction or loss of sphincter function caused by various reasons can cause serious adverse clinical consequences, such as reflux esophagitis and Barrett esophagus caused by the reduction of the lower esophageal cardiac sphincter function; pyloric sphincter relaxes to cause bile reflux gastritis; urinary incontinence caused by urethral sphincter injury; anal sphincter injury causes fecal incontinence. How to restore and rebuild the sphincter function of the hollow organ has become a serious challenge for clinicians.

For example, gastroesophageal reflux. Gastroesophageal reflux disease is quite common in western countries, about 7% -15% of people have gastroesophageal reflux symptoms, the incidence increases with the age, the peak incidence age is 40-60 years old, the incidence of men and women is not different, but people with reflux esophagitis are more male than female (2: 1 to 3: 1). With the increasing improvement of the living standard of Chinese citizens and the continuous westernization of life style, the incidence rate of gastroesophageal reflux disease is increasing year by year, and the number of patients will increase year by year. Meanwhile, with the improvement of the living standard of people, the requirement on the living quality is continuously improved, and the requirement on radically curing the gastroesophageal reflux disease which affects the living quality for a long time is continuously expanded and improved. The Chinese medical society has the digestive disease society and statistics show that the gastroesophageal reflux prevalence rate in China is 5.77%. The prevalence rate of the disease in big cities is generally higher, 16.98 percent of Sichuan, 10.19 percent of Beijing, 7.7 percent of Shanghai and 7.28 percent of Zhejiang. At present, no good instrument is available for treating gastroesophageal reflux disease, and although three operations of treating gastroesophageal reflux disease, namely Nissen fundoplication, hiatus hernia repair and radio frequency treatment, are available, complications are often caused after the operations, the postoperative life is greatly influenced, and the operation treatment is not recommended.

Foreign countries have developed over the years and related products to overcome the above disadvantages, for example, U.S. patent No. US 7,695,427B 2 entitled "apparatus for treating esophageal sphincter" discloses an apparatus for treating gastroesophageal reflux disease, in which a string of magnetic beads is connected end to end by laparoscopic minimally invasive surgery into a closed loop that encircles the patient's lower esophageal sphincter. But the disadvantages are:

1. the materials contacted with the tissues are all metal materials, the formed ring is not round enough and cannot be well attached to the outer side of the lower esophageal sphincter, when a patient swallows food, the esophageal dilatation can rub with the production of instruments, discomfort can be caused to the patient, and even more, inflammation and other symptoms can be caused on the outer side of the lower esophageal sphincter of the patient;

2. the implantation instrument has no outward expansion capability, so that the sphincter is easy to expand unsmoothly;

3. the implantation instrument is not fixed with the sphincter, so that the position is easy to shift, and the use effect is influenced.

Disclosure of Invention

The invention aims to solve the problems in the prior art and provide an auxiliary device which not only assists the closing of the sphincter but also does not influence the expansion of the sphincter, and the invention aims to be realized by the following technical scheme:

an assistive device for enhancing sphincter function, comprising: at least two magnetic devices capable of attracting each other and a buffer device disposed between the two magnetic devices, and a fixing member for fixing the magnetic devices to the sphincter, both ends of the buffer device being capable of contacting the adjacent magnetic devices, respectively, the magnetic devices being disposed on the outside of the sphincter, when the sphincter is closed, the two magnetic devices attracting each other approach each other to compress the buffer device, thereby deforming the buffer device; the cushioning means can assist the two magnetic means attracting each other to move away when the sphincter is dilated.

The aim of the invention is further realized by the following preferred technical scheme:

preferably, the buffer device further comprises a limiting device, and two ends of the limiting device are connected with the adjacent magnetic devices so as to limit the maximum distance for pulling apart the two magnetic devices which attract each other. .

Preferably, the damping device further comprises a coaxial holder.

Preferably, the buffer device is one or more constant-diameter or variable-diameter springs.

More preferably, the damping means is composed of a plurality of springs, and axes of the plurality of springs are parallel to each other.

Preferably, the damping means is made of an elastic material.

Preferably, the buffer device is a net structure or a sac structure or a tubular structure or a porous structure made of an elastic material, and the net structure or the sac structure or the tubular structure or the porous structure can be deformed under the action of the magnetic device, and can be restored under the condition of no stress.

Preferably, the fixing member includes an inner connecting member and an outer connecting member.

More preferably, the inner connecting member has higher elasticity than the outer connecting member.

More preferably, the outer connecting member and the inner connecting member are soft and inelastic, and the outer connecting member is fitted to the outside of the sphincter in the sphincter closed state.

Preferably, the fixing member is one or a combination of more of a linear structure, a filiform structure, a rod-shaped structure, a strip-shaped structure, a wave-shaped structure, a net-shaped structure, an anchor hook and a rivet made of high molecular materials or metal materials.

Preferably, the magnetic device includes a magnetic element and a protective element disposed outside the magnetic element.

Preferably, the magnetic element is composed of one or more magnets, or the magnetic element is composed of magnetic beads/particles.

Compared with the prior art, the invention has the following beneficial effects:

1. the invention is provided with a buffer device. Firstly, on the basis that the magnetic device plays a role in assisting the expansion and contraction of the sphincter, the buffer device is arranged, so that the fatal defect that the swallowing difficulty is caused by the fact that the expansion resistance of the sphincter is increased and the expansion function is influenced due to the fact that only the magnetic element is arranged in the prior art is avoided; secondly, as a buffer device between the two magnetic devices, the total length of the buffer device when the buffer device is compressed to the limit is adjusted, the value of the attraction force F1 when the sphincter is closed to the limit position can be adjusted to a proper value, and the sphincter expansion function is not influenced on the premise of ensuring the maximization of the auxiliary sphincter closing function;

2. the buffer device provided by the invention is provided with the limiting device and the coaxial retaining piece, so that the buffer device is favorably clung to the surface of the sphincter, and the efficacy of the buffer device is exerted to the maximum extent; the device can be positioned on a given plane for a long time, and the working disorder of the device caused by the dislocation attraction of the magnetic device is avoided, so that the device can continuously play the preset function.

3. The invention is provided with a fixing part which can fix the device and the sphincter together, and the design ensures that the device can not cause the deviation of the device after being implanted, so that the device can be fixed at the implantation position for a long time.

Drawings

FIG. 1a is a schematic view of the sphincter-enhancing auxiliary device of this invention and its placement outside the lower esophageal sphincter;

FIG. 1b is a schematic view of the sphincter enhancing auxiliary device of the present invention in a first embodiment and its placement outside the sphincter;

FIG. 2a is a schematic view showing the state of two magnetic devices and a buffer device therebetween when the sphincter muscle is expanded to the limit;

FIG. 2b is a schematic view of the state in which the buffer device just contacts the active surfaces of the two magnetic devices during sphincter closure;

FIG. 2c is a schematic view showing a state in which the buffer device is compressed to deform and generate a certain rebound force during the sphincter closing process;

FIG. 2d is a schematic view showing the state of the two magnetic devices and the buffer device when the buffer device is closed to the limit during the closing process of the sphincter;

FIG. 3a is a schematic view of a magnetic device having a rectangular or near rectangular cross-section in position on the outside of the sphincter;

FIG. 3b is a schematic view of a magnetic device with a circular or near circular cross-section on the outside of the sphincter;

FIG. 3c is a schematic view of a magnetic device with an elliptical or near elliptical cross-section on the outside of the sphincter;

FIG. 3d is a schematic view of the magnetic device in a tile-shaped cross-section on the outside of the sphincter;

FIG. 4a is a schematic view of a configuration in which the anchor is a suture, and FIG. 4b is a schematic view of a configuration in which the anchor is a fluke;

FIG. 5a is a schematic view of an auxiliary device for enhancing the function of a sphincter and its placement outside the sphincter according to the present invention in a second embodiment;

FIG. 5b is a schematic view of FIG. 5a showing only the magnetic device and the buffer device;

FIG. 5c is a schematic diagram showing the structure of another embodiment of the magnetic device and the buffer device;

FIG. 5d is a schematic view showing the structure of still another embodiment of the magnetic device and the buffer device;

FIG. 5e is a schematic structural diagram of the buffering device in FIG. 5 d;

fig. 6a to 6c are schematic views of a buffering device composed of different spring structures and a limiting device;

FIGS. 7a and 7b are schematic views of a third embodiment of a cushioning device comprising a net structure and a position-limiting device, wherein FIG. 7b is a schematic view of the net structure of FIG. 7a deformed by pressure;

FIG. 7c is a schematic view of a third embodiment of a cushioning device comprising a bladder structure and a stop;

FIGS. 7d and 7e are schematic views of a buffer device composed of a tubular structure and a position-limiting device in a third embodiment, wherein FIG. 7e is a schematic view of the tubular structure of FIG. 7d being deformed by pressure;

FIG. 7f is a schematic view of a third embodiment of a cushioning device comprising a porous structure and a spacing device;

FIG. 8 is a schematic view of an auxiliary device for enhancing the function of a sphincter and a device placed outside the sphincter according to the present invention in a fifth embodiment;

FIG. 9 is a schematic view of another embodiment of an auxiliary device for enhancing the sphincter function in the fifth embodiment;

FIG. 10 is a schematic view of a sphincter enhancing auxiliary device of the present invention in a sixth embodiment and its placement outside the sphincter;

FIG. 11 is a schematic view of another embodiment of an auxiliary device for sphincter enhancement in accordance with the sixth embodiment;

FIG. 12 is a schematic view of an auxiliary device for enhancing the function of a sphincter and a device placed outside the sphincter in accordance with a seventh embodiment of the present invention;

FIG. 13 is a schematic view of another embodiment of an auxiliary device for sphincter enhancement in function according to the seventh embodiment;

fig. 14 is a schematic view of still another embodiment of the sphincter function enhancement assisting device of the seventh embodiment.

Wherein: 1 is stomach, 11 is lower gastroesophageal sphincter, 13 is external sphincter, 12 is gastric juice, 2 is magnetic device, 21 is magnetic element, 211 is guide slot, 212 is magnet, 213 is magnetic bead/magnetic powder, 22 is protective element, 222 is fixed slot, 23 is spacer, 3 is buffer, 31 is spring, 311 is coaxial retainer, 32 is position limiter, 321 is limit piece, 322 is limit line, 33 is parallel spring connecting rod, 34 is spring connecting piece, 4 is fixed piece, 41 is internal connecting piece, 42 is external connecting piece, 422 is network structure, 423 is waveform structure, 43 is positioning piece.

Detailed Description

In order to clearly understand the technical features and the intended effects of the present invention, embodiments of the present invention will be described in detail with reference to the accompanying drawings.

The first embodiment:

the first embodiment of the auxiliary device for enhancing sphincter function (hereinafter referred to as device) provided by the present invention is shown in fig. 1b, and is placed outside the sphincter (fig. 1a is a schematic view of the lower gastro-esophageal sphincter, which can also be used in the body's sphincter such as the urethra sphincter and the anal sphincter), and comprises two magnetic devices 2 that can attract each other, a buffer device 3 placed between the two magnetic devices 2, and a fixing member 4 for fixing the two magnetic devices 2 to the sphincter, wherein both ends of the buffer device 3 can be respectively contacted with the adjacent magnetic devices 2, the magnetic devices 2 are placed on the outside of the sphincter, and when the sphincter is closed, the two magnetic devices 2 that attract each other approach each other, and the buffer device 3 is compressed to deform the buffer device 3; the damping means 3 can assist the two magnetic means 2, which attract each other, to move away when the sphincter is dilated. The fixing element 4 comprises an outer connecting element 42 for connecting the non-active surfaces of the two magnetic means 2 and an inner connecting element 41 arranged in the damping device 3 for connecting the active surfaces of the two magnetic means 2. The two magnetic means 2 and the damping means 3, as well as the external connection 42, are arranged on the sphincter and wrapped around the outside of the sphincter. Preferably, both the magnetic means 2 and the cushioning means 3 are placed in the external region of the sphincter.

Both magnetic means 2 of the device, the damping means 3, are placed in the external surface area of the sphincter. The two magnetic devices 2 are connected with the external connecting member 42, and the head and tail ends of the external connecting member 42 are fixed on the surface of the sphincter, so that the two magnetic devices 2 of the device and the external connecting member 42 are always attached to the outside of the sphincter. The two magnetic devices 2, which attract each other, can generate a force F1 of mutual attraction, which F1, with the help of the external connection 42, acts on the external sphincter, providing a "pinching force" towards the inside of the sphincter, so that the two magnetic devices 2 act as an aid in the sphincter closure, controlling the normal flow of the contents of the sphincter lumen.

Further, when the sphincter is expanded to the limit (i.e. the sphincter diameter becomes maximum) and ready to start the systolic closure, the spacing between the two magnetic means 2 is maximum and the value of the force F1 is minimum, as shown in fig. 2 a; as the sphincter is constantly contracted, the spacing between the two magnetic means 2 becomes smaller, the value of F1 gradually increasing; when the distance between two magnetic devices 2 is reduced to be the same as the length of the buffer device 2 in the natural state (i.e. the distance between the two ends a and B of the buffer device 2), both ends a and B of the buffer device 2 will contact with the adjacent magnetic device 2, as shown in fig. 2B, and since the value of the force F1 is greater than 0 and the two magnetic devices 1 have inertia in moving close to each other, the buffer device 2 will be compressed and thus deformed; then, the sphincter is further contracted and closed, the distance between the two magnetic devices 2 is further reduced, and the value of the force F1 is further increased, while the buffer device 3 is compressed and deformed and generates a rebound force F2 opposite to the direction of F1, as shown in fig. 2c, but because F1 > F2, the effect of the two magnetic devices 2 to assist the contraction and closure of the sphincter is not hindered; when the sphincter contraction process is at the end of contraction or at the limit of contraction (i.e. the sphincter diameter is minimized), as shown in fig. 2d, the deformation of the damping device 3 is maximized and the repulsive force F2 is maximized, which partially counteracts the attractive force F1, the force of the attractive force F1 to reduce the repulsive force F2 is greater than the normal sphincter closing force, and the sphincter expansion capability can be enhanced by the repulsive force F2 while the sphincter is normally expanded, and the sphincter closing capability can be enhanced in the sphincter closing state. In short, the design of arranging the buffer device 3 between the two magnetic devices 2 can avoid the reduction of the sphincter expansion capability caused by only arranging a magnetic element in the prior art and the influence on the normal operation of the sphincter function on the basis that the magnetic devices 2 play a role of assisting the sphincter contraction. In addition, this design has a number of advantages, including: 1. the buffer device is used as a spacer between the two magnetic devices 2, and the total length of the buffer device 3 when the buffer device is compressed to the limit can be adjusted, so that the value of the attraction force F1 when the sphincter muscle contracts to the limit position can be adjusted to a proper value, and the sphincter muscle expansion function is not influenced on the premise of ensuring the maximization of the sphincter muscle contraction assisting function; 2. since the two magnetic devices 2 are bound to collide with each other, micro cracks or macro cracks or cracks are likely to be formed, and the buffer device 3 is introduced to play a role in buffering or damping, so that the risk is greatly reduced.

For the present embodiment, in one embodiment, the damping device 3 is a constant diameter spring 31, as shown in fig. 5a, the damping device 3 may also be a variable diameter spring, and the spring structure is selected as the damping device 3 because the spring has the advantages of easy deformation, large elasticity, adjustable elastic coefficient, and the like. Preferably, the spring 31 is a compression spring having a spiral structure capable of withstanding a biasing force, and may be an air spring or a carbon nano spring. The shape of the spring 31 includes, but is not limited to, a cylinder, a cone, a truncated cone, an elliptic cylinder, a cuboid, a saddle, a convexity and a concavity, the cross section of the material for making the spring includes, but is not limited to, a circle, a rectangle, a sector and a bow, the material for making the spring includes, but is not limited to, titanium and its alloy, metal materials such as 316L stainless steel, nickel-titanium alloy, cobalt-chromium alloy, tantalum, tungsten and platinum-iridium alloy, etc., and the polymer material with high elastic modulus, and the process for making the spring includes heat treatment and shaping after surrounding a wire winding mandrel mould with a metal wire or a polymer wire, laser cutting with a metal tube or a polymer tube according to a pre-designed pattern, injection molding with polymer plastic in a mould, etc. Adjusting one or more parameters of the spring 31, including the spacing between the coils, the overall length of the spring, the cross-sectional area of the material used for the spring, the overall diameter of the spring, the type and state of the material of the spring, and the overall shape of the spring, can adjust the resilience force F2 of the spring 31 to a suitable value. In addition, the surface of the spring 31 may be coated or coated with a thin layer having good biocompatibility, and the selected materials are polymer materials such as polyvinylpyrrolidone, polytetrafluoroethylene, polyethylene terephthalate, polyester, polypropylene, parylene, polycarbonate, polyurethane, fluorinated ethylene propylene copolymer, silicone, polyamide, polyolefin, polyvinyl alcohol, silica gel, silicon-containing, and the like, so as to improve the safety of the spring 31, particularly long-term corrosion resistance and fatigue fracture resistance.

In another embodiment, the cushioning device 3 is an elastic cushioning device made of an elastic material, and alternative elastic materials include, but are not limited to, silicone, rubber, gel, thermoplastic elastomer, and polymer materials containing a porous structure. The elastic buffer device is made of an elastic material with the elastic modulus of more than 0.5KPa and less than or equal to 9.5GPa, or made of an elastic material with the compression ratio within the range of 0.1-0.95. The elastic modulus is defined as follows: a thin rod is subjected to a pulling force F divided by the cross-sectional area S of the rod, referred to as "linear stress", and the elongation dL of the rod divided by the original length L, referred to as "linear strain". The linear stress divided by the linear strain equals the young' S modulus E ═ F/S)/(dL/L. The compression ratio is defined as the ratio of the length of the elastic material in the compressed state to the length in the natural state. In addition, the buffer device 2 is also provided with a hole, a bulge and other structures, so that the fixing piece 4 can be conveniently and fixedly connected with the sphincter.

The magnetic device 2 includes a magnetic element 21 and a protective element 22 provided outside the magnetic element 21. The magnetic element 21 is made of a magnetic material that can attract iron, cobalt, nickel, or the like. Generally, the height dimension of the magnetic means 2 should be greater than or equal to the height dimension of the buffer means 3 on the external side of the sphincter, so that the magnetic means 2 can come into end-face contact with the buffer means 3, so that the buffer means 3 performs its function. Alternative magnetic materials include, but are not limited to, neodymium-iron-boron alloys, samarium-cobalt alloys, aluminum-nickel (and with other elements such as cobalt), iron-chromium (and with other elements such as cobalt, molybdenum), iron-aluminum-carbon alloys, iron-cobalt (and with other elements such as vanadium, tungsten), alloys of rare earth elements with cobalt, alloys of rare earth elements with iron, platinum-cobalt alloys, copper-nickel-iron alloys, other iron-containing or cobalt-containing or nickel-containing alloys, manganese-aluminum-carbon alloys, aluminum-manganese-silver alloys, ferrites, intermetallics. The magnetic device 2 can be made into any desired configuration and shape, including but not limited to a full (or perforated or slotted) cuboid, cylinder, ellipsoid, semi-cylinder, according to manufacturing or clinical needs (e.g., fixation to the outside of the sphincter, adaptation to the outside of the sphincter), and the cross-section of the magnetic device 2 in a direction perpendicular to the attractive force F1 can be one or more of a full (or hollow or slotted) rectangle, circle, ellipse, semicircle, sector, trapezoid, ring, tile, i-shape, as shown in fig. 3a to 3 d. Of course, the contact surface between the magnetic device 2 and the buffer device 3 may be not only a plane but also a curved surface such as a round head or a concave convex-concave shape.

The provision of the protective element 22 outside the magnetic element 2 has the advantage that: 1. since the biocompatibility of the magnetic member 21 is generally poor, the protection member 22 provided outside the magnetic member 21 can effectively prevent the magnetic member 21 from being in direct contact with the human tissue, such as the external side of the sphincter, to ensure good biocompatibility; 2. since there is a lot of human tissue fluid outside the sphincter, the protective element 22 can overcome the corrosion caused by the direct contact between the magnetic element 21 and the tissue fluid, which eventually leads to the safety deterioration of the magnetic element 21; 3. as a spacer between the two magnetic devices 2, by varying the material and thickness of the protective element 22, the value of the attraction force F1 is adjusted to a suitable value, ensuring the maximum function of assisting the sphincter closure without affecting the sphincter dilation function; 4. since the magnetic elements 21 have the fatal disadvantage of being fragile in impact, the introduction of the protective element 22 prevents the direct impact between the magnetic elements 21 from causing microscopic cracks or fractures that impair the action of the attractive force F1 on assisting sphincter contractions, or from causing fragmentation into any tissue of the human body that could harm the patient's life.

The protective element 22 may be made of metallic materials including, but not limited to, titanium and its alloys, 316L stainless steel, nitinol, cobalt-chromium alloys, tantalum, tungsten, platinum-iridium alloys, or polymeric materials including, but not limited to, those mentioned above as being useful for thin layers of the surface of the spring 31, and metallic materials having a visualization function, such as cobalt-chromium alloys, tantalum, tungsten, platinum-iridium alloys, may also be used to enhance visualization of the intraoperative and postoperative follow-up devices. The protection member 22 can be made into any structure and shape according to the manufacturing or clinical requirements (such as the fixing requirement with the surface of the sphincter and the adaptability requirement with the surface of the sphincter), and fig. 5b shows that the protection member 22 is provided with a fixing groove 222 of the protection member so as to be fixed with the surface of the sphincter through the fixing member 4.

The outer connecting member 42 can be made in any desired configuration and shape, including but not limited to, threads, filaments (e.g., fig. 2), rods, strips, waves (fig. 10), nets (fig. 11-14), for manufacturing or clinical purposes (e.g., compliance with the sphincter surface), and materials including but not limited to polyester, polytetrafluoroethylene, polyurethane, polypropylene, polyvinyl chloride, polyamide, ultra high molecular weight polyethylene, polyolefin elastomers, silicone rubber, and the above-mentioned materials for spring fabrication, which materials and configuration and shape of the outer connecting member 42 should have moderate or low resiliency, good bending compliance, and good long term fatigue resistance, such that the outer connecting member 42 will conform to the outside of the sphincter throughout the entire movement of sphincter expansion closure, and the change range of the distance between the two magnetic devices 2 is as large as possible, so that the effects of assisting the sphincter to close and not influencing the expansion of the sphincter are fully exerted.

Considering that the device needs to be fixed to the sphincter after being implanted into the sphincter, the fixing member 4, such as a suture loop 424 formed by suturing the outer and

inner connectors

42 and 41 with a suture to the surface of the sphincter, an anchor hook 425 for mechanically anchoring the outer and

inner connectors

42 and 41 directly to the surface of the sphincter, etc., can be used to effectively fix to the surface of the sphincter after implantation, as shown in fig. 4a and 4 b; furthermore, the fixing device 4 further comprises a positioning member 43, and the buffer device 3 can be effectively fixed with the surface of the sphincter through the positioning member 43, which finally enables the device of the embodiment to be on a predetermined plane for a long time to ensure that the device continuously plays a predetermined role.

Second embodiment:

as shown in fig. 5a and 5b, the second embodiment is different from the first embodiment in that: the buffer device 3 further comprises a limiting device 32, and two ends of the limiting device 32 are connected with the adjacent magnetic devices 2 so as to limit the maximum distance for pulling apart the two magnetic devices 2 which attract each other. This design has the following benefits: 1. the device forms a closed loop, so that the device is more favorably clung to the outer side of the sphincter, and the efficacy of the device is exerted to the maximum extent; 2. the device can be positioned on a given plane for a long time, and the working disorder of the device caused by the dislocation attraction of other magnetic devices 2 is avoided, so that the device can further play a preset role continuously; 3. sphincter injuries and other high risks caused by the need to fix the damping device 3 on the outside of the sphincter using additional fixing elements 4 in the design of the first embodiment are avoided.

In this case, in order to allow the spring 31 of the damper 3 to be deformed by being pressed by the two magnetic devices 2 and to exert its normal function, a guide groove 211 in which the stopper 32 of the damper 3 slides is provided in the direction of the force F1 inside or on the surface of the magnetic element 21. In order to keep the two ends of the limiting device 32 of the buffer device 3 always located inside the two magnetic devices 2 during the sphincter muscle expansion period, the two ends of the limiting device 32 are provided with the limiting parts 321, the magnetic element 21 is provided with the guide slots 211, meanwhile, the protection element 22 is provided with the limiting slots 221 at the action surface a or B, and the size of the limiting parts 321 is larger than that of the limiting slots 221 and smaller than that of the guide slots 211, so that the design can prevent the limiting parts 321 of the limiting device 32 from coming out of the two magnetic devices 2, and the limiting parts 321 can slide in the guide slots 211 of the magnetic element 21 without resistance. The position-limiting device 32 and the position-limiting member 321 can be integrally formed by the materials listed above for the protection component 22, or the position-limiting member 321 can be formed at two ends of the position-limiting device 32 by post-processing or connection processes, such as welding, preferably, the position-limiting member 321 is spherical, hemispherical or quasi-spherical, so that the contact manner with the guide groove 211 is point contact or line contact; in addition, the limiting member 321 may also be a flat structure, which can effectively reduce the distance between the magnetic device 2 and the external side of the sphincter, thereby facilitating the device to implement a flat design and improving the long-term effectiveness of the device.

In another embodiment, the position-limiting device 32 is a very flexible position-limiting wire 322, and the position-limiting wire 322 is connected to the two magnetic devices 2, as shown in fig. 5c, this design not only can play the role of the above embodiment, but also further enhances the fitting effect of the device to the external side of the sphincter because the position-limiting wire 322 is very flexible. The spacing wire 322 may be made of the material used for the outer connector 42. Preferably, the limiting wire 322 passes through the inside of the spring 31 and has good resilience, so that the central axis of the spring 31 is kept unchanged relative to the magnetic device 2 all the time when the device is in operation.

In another embodiment, the position-limiting device 32 is disposed at two ends of the spring 31, and is composed of two connecting rods 33 fixedly connected to two ends of the spring 31, respectively, and capable of transmitting pressure without deformation, and two position-limiting heads 331 fixedly connected to the other ends of the connecting rods 33 and located inside two magnetic devices 2, as shown in fig. 5d and 5e, correspondingly, a guide groove 211 for sliding the position-limiting heads 331 is disposed inside or on the surface of the magnetic devices 2 along the direction of the force F1, and in order to ensure that the position-limiting heads 331 are always located inside two magnetic devices 2, the magnetic devices 2, such as the position-limiting holes 221 for allowing the connecting rods 33 to slide freely and preventing the position-limiting heads 331 from falling out of the magnetic devices 2, are disposed on the protecting element 22. The design avoids the problem of poor bending compliance caused by the fact that the limiting device 32 is hard in the embodiment shown in fig. 5b to a certain extent, and the characteristic that the spring 31 is easy to bend on the central axis of the spring is utilized, so that the device is better in fit with the outer side of the sphincter and better in shape; in addition, the design of the limiting device and the buffering device can also use tubular metal materials with shape memory function, such as nickel-titanium alloy, cobalt-chromium alloy and the like, to be directly cut or shaped into the shape as shown in fig. 5e, so that the manufacturing is simple.

The third embodiment:

the third embodiment differs from the second embodiment in that, based on the second embodiment: the cushioning means 3 is a net structure 35 (as shown in fig. 7a and 7 b) or a bladder structure 36 (as shown in fig. 7 c) or a tubular structure 37 (as shown in fig. 7d and 7 e) or a porous structure 38 (as shown in fig. 7 f) made of an elastic material. Under the action of the two magnetic devices 2, the net-like structure 35 or the sac-like structure 36 or the porous structure 38 can be deformed, as shown in fig. 7b, and without being stressed, the net-like structure 35 or the sac-like structure 36 or the porous structure 38 can return to the original shape of fig. 7a or fig. 7c or fig. 7f, thereby exerting the effect similar to or the same as a spring. The net structure 35 may be woven from an elastic material or cut and shaped from a shape memory alloy tube. The porous structure 38 can be made of a high molecular elastic material by integral processing or by cutting and shaping a shape memory alloy tube. For the cushioning device 3 to be a bladder-like structure 36 made of a compliant material. The interior of the sac-like structure can be filled with a developable liquid, an inflatable body and a hole material, so that the sac-like structure generates elasticity and has the effect similar to the net-like structure 35. The tubular structure 37 is made of a polymer elastic material, and under the action of the two magnetic devices 2, the tubular structure 37 can be irregularly deformed, as shown in fig. 7e, and in the absence of a force, the tubular structure 37 can return to the original shape shown in fig. 7d, and can also exert an effect similar to the net-shaped structure 35. A stop 32 may also be provided in the mesh 35 or the bladder 36 or the tubular 37 or porous 38 structure.

The fourth embodiment:

the fourth embodiment is different from the second embodiment in that, based on the second embodiment: the damping device 3 further comprises a coaxial holder 311 connected to the damping device 3 or the magnetic device 2. In one embodiment, as shown in fig. 5b and fig. 6b, the coaxial holder 311 is a fixing boss 222 disposed on one or two end faces of the magnetic device 2 capable of contacting with two ends of the buffer device 3 and located at the center of the end face, two end portions of the spring 31 are connected with the fixing boss 222, fig. 5b shows that the inner diameter of the spring 31 matches the outer peripheral dimension of the fixing boss 222, so as to avoid the fixed spring 31 from shaking in the circumferential direction relative to the magnetic device 2, and improve the working stability of the device.

In another embodiment, the coaxial holders 311 are provided at both end regions of the spring 31 as the buffer device 3, are fixedly connected to the spring 31, and are freely slidable on the stopper 32, as shown in fig. 6c, and can also achieve the same effect as the previous embodiment. In particular, the coaxial holder 311 is a small-diameter spring 312 with an outer diameter smaller than the inner diameter of the spring 31, the small-diameter spring 312 is arranged in the spring 31 and has a length smaller than or equal to the length of the spring 31, and the nested multiple spring structure design minimizes the total length of the whole buffer structure when the buffer structure is compressed to the limit, and ensures that the rebound capacity of the buffer device 3 is enhanced on the premise of maximizing the function of assisting sphincter contraction, and further assists the sphincter expansion function.

Fifth embodiment:

the fifth embodiment differs from the second embodiment in that, based on the second embodiment: one or more magnetic devices 2 and one or more buffer devices 3 are additionally arranged between the two magnetic devices 2, the buffer devices 3 are arranged between each two adjacent magnetic devices 2 and are connected through a limiting device 32, and all the magnetic devices 2 and the buffer devices 3 are connected in series end to end and form a closed loop together with an outer connecting piece 42. In the closed loop thus formed, the number of magnetic means 2 is m, the number of damping means 3 is n, and the relationship between the magnetic means 2 and the damping means 3 is: the design can make use of the superposition effect formed by the magnetic device and the buffer device to increase the functions of closing the auxiliary sphincter and not influencing the expansion.

Further, multiple sets of closed loops may be placed in different areas outside the sphincter, each set of closed loops being parallel to each other, and multiple outer connectors 42 of the multiple sets of closed loops may be distributed in parallel, as shown in fig. 8. Due to the spatial position and directional order of the device, in combination with the mutual interference of the magnetic fields of the magnetic elements 21, two magnetic elements 21 that are close to each other may be selected to be arranged in opposite directions in close closed loops, as shown in fig. 9. In addition, it is preferable that the plurality of outer connecting members 42 of the plurality of closed loops are connected to each other such that the plurality of outer connecting members 42 of the closed loops are integrally formed as shown in fig. 10 to 14, to enhance the structural stability of the device, and to reduce the number of the positioning members 43 used, such as only the proximal-most end surfaces and the distal-most end surfaces, to minimize the trauma to the surface of the sphincter.

Sixth embodiment:

the sixth embodiment differs from the fifth embodiment in a first point that: the number of the outer connecting members 42 is plural, and the plural outer connecting members 42 form a wave structure 423 shown in fig. 10 through a certain weaving process, such as wave weaving, and further, the wave structures are mutually inserted to realize movable connection or direct fixed connection to form a whole; a plurality of outer links 42 may also be woven in a cross-over fashion to form a mesh structure 422 as shown in fig. 11, ultimately forming a unitary body. The whole formed by the net-shaped structure 422 can not only adjust each knitting parameter, so that the net-shaped structure 422 has moderate or lower resilience, good adherence compliance with the outer side of the sphincter and good long-term fatigue resistance, fully exerts the effect of the magnetic device 2 for assisting the closing of the sphincter, but also is beneficial to being connected with the non-action surface of the magnetic device 2, and is simple to manufacture.

The second difference is that: the fixing member 4 further includes an inner connecting member 41 disposed in all the regions of the magnetic device 2 and having the same or similar material, structure and shape as the outer connecting member 42, so that all the magnetic devices 2 and the cushioning member 3 are connected as a whole, as shown in fig. 8 to 14, and further, the inner connecting member 41 can be connected with a net-like structure 422 formed by the outer connecting member 42 to form a complete whole, so that the structure of the device is more stable. The damping device 3 can be fixed to the inner connecting member 41 by means of sewing, bonding, snapping, hooking, wrapping or the like. It should be noted that the inner connecting member 41 should have a higher elasticity than the outer connecting member 42, so that the device can perform a larger function of assisting the sphincter closing and sphincter expansion.

In another embodiment, the external connection element 42 is soft and inelastic and fits outside the sphincter, and the internal connection element 41 is also soft and inelastic, but the length of the internal connection element 41 is greater than the maximum expansion of the adjacent magnetic means 2, so as to avoid any reduction in the sphincter expansion capacity due to the resilience of the elastic material.

Seventh embodiment:

the seventh embodiment differs from the sixth embodiment in the first place on the basis of the sixth embodiment in that: the damping device 3 is composed of a plurality of springs 31, the central axes of the plurality of springs 31 are parallel to each other and the direction of the acting force of the magnetic device 2, the adjacent springs 31 are connected by spring connectors 34 made of the same material as the springs 31 to form the parallel springs of fig. 12, and the number of the springs 31 is larger than or equal to the number of the magnets 21 in the magnetic device 2. Of course, each spring 31 can also be connected to the inner connection 41 or to the net structure formed by the inner connection 41 by means of the spring connection 34, as shown in fig. 13, thus forming a parallel spring, in which case the shape of the spring 31 is preferably an elliptic cylinder, a rectangular parallelepiped, a saddle, a convexity, a concavity, which avoids the spring 31 from rotating on its surface about its central axis. The springs connected in parallel can ensure that the central axes of the springs 31 are parallel in the processes of closing and expanding the sphincters, ensure the good shape of the springs in working, facilitate the fixation of the buffer device 3 on the device and avoid the phenomenon that two end surfaces of the springs 31 are tilted to cause the non-adhesion of the springs and the surfaces of the sphincters when the springs 31 keep the motion synchronism as a whole.

The second difference is that: the magnetic element 21 of the magnetic means 2 is not a magnet. In one embodiment, the magnetic elements 21 are a plurality of block magnets 212 as shown in fig. 10. A spacer 23 made of a non-magnetic material may be selectively disposed between two adjacent magnets 212, so that the magnets 212 are regularly arranged, which can serve to separate the magnets 212 and weaken or prevent magnetic fields generated between the magnets from interfering with each other.

In another embodiment, the magnetic element 21 is a plurality of magnetic beads/particles 213 as shown in fig. 14. The dimensions of the magnetic beads/particles are of the order of nanometers, or of the order of micrometers or millimeters (e.g. small beads), and accordingly the protective element 22 should be in the form of a bag, which has the following advantages: 1. in the flexible bag-shaped protection element 22, the filled plurality of tiny magnetic beads/particles 213 have good dispersibility, and on the premise of ensuring the acting force of the magnetic device 2, the height of the magnetic device 2 protruding from the external side of the sphincter can be reduced, so that the friction between the magnetic device 2 and the external tissue of the sphincter, such as the external tissue of the sphincter, can be effectively reduced or avoided, and the magnetic device also has good adherence with the external side of the sphincter; 2. the plurality of magnetic beads/magnetic powder particles 213 act as a whole to the outside, thereby effectively avoiding the phenomenon of dislocation and attraction which are easily caused by using the bulk magnet 212.

Finally, it should be understood that the above-mentioned embodiments are merely preferred embodiments of the present invention, and not intended to limit the present invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. An auxiliary device for enhancing sphincter function, comprising: at least two mutually attractive magnetic means (2) and a damping means (3) interposed between said two magnetic means (2), and a fixing means (4) for fixing said magnetic means (2) to the sphincter, the ends of said damping means (3) being able to come into contact with the adjacent magnetic means (2), respectively, said magnetic means (2) being arranged on the outside of the sphincter, when said sphincter is closed, the two magnetic means (2) attracting each other approach each other, compressing said damping means (3), deforming said damping means (3); when the sphincter is dilated, the damping means (3) can assist the distancing of the two magnetic means (2) that attract each other;

the buffer device (3) further comprises a limiting device (32), and two ends of the limiting device (32) are connected with the magnetic devices (2) so as to limit the maximum distance for pulling the two magnetic devices (2) which are attracted to each other;

two ends of the limiting device (32) are respectively connected with the outer ends of the adjacent magnetic devices (2), or two ends of the limiting device (32) are respectively arranged in the adjacent magnetic devices (2);

the fixing piece (4) comprises an inner connecting piece (41) and an outer connecting piece (42), the inner connecting piece (41) is arranged inside the buffer device (3) and is connected with an acting surface of the magnetic device (2), and the outer connecting piece (42) is connected with a non-acting surface of the magnetic device (2);

the damping device (3) further comprises a coaxial holder (311).

2. The sphincter enhancement assisting device according to claim 1, wherein: the buffer device (3) is one or more springs (31) with the same diameter or variable diameters.

3. The sphincter enhancement assisting device according to claim 2, wherein: the buffer device (3) is composed of a plurality of springs (31), and the axes of the springs (31) are parallel to each other.

4. The sphincter enhancement assisting device according to claim 1, wherein: the buffer device (3) is made of elastic material.

5. The sphincter enhancement assisting device according to claim 1, wherein: the buffer device (3) is a net-shaped structure or a sac-shaped structure or a tubular structure or a porous structure made of elastic materials, the net-shaped structure or the sac-shaped structure or the tubular structure or the porous structure can deform under the action of the magnetic device (2), and the net-shaped structure or the sac-shaped structure or the tubular structure or the porous structure can restore to the original shape under the condition of no stress.

6. The sphincter enhancement assisting device according to claim 1, wherein: the inner connecting member (41) is more elastic than the outer connecting member (42).

7. The sphincter enhancement assisting device according to claim 1, wherein: the outer connecting member (42) and the inner connecting member (41) are soft and inelastic, and the outer connecting member (42) is attached to the outside of the sphincter in a sphincter-closed state.

8. The sphincter functional enhancement auxiliary device according to claim 1 or 7, characterized in that: the fixing piece (4) is one or a combination of a plurality of linear structures, filiform structures, rod-shaped structures, strip-shaped structures, wave-shaped structures (423), net-shaped structures (422), anchor hooks or rivets made of high polymer or metal materials.

9. The sphincter enhancement assisting device according to claim 1, wherein: the magnetic device (2) comprises a magnetic element (21) and a protective element (22) arranged outside the magnetic element (21).

10. The sphincter enhancement assisting device according to claim 9, wherein: the magnetic element (21) consists of one or more magnets (212) or the magnetic element consists of magnetic beads/particles (213).