CN108210137B

CN108210137B - Auxiliary contraction device

Info

Publication number: CN108210137B
Application number: CN201810160559.9A
Authority: CN
Inventors: 吕世文; 陈凯宾; 陈智敏; 赵松辉
Original assignee: Ningbo Senscure Biotechnology Co ltd
Current assignee: Ningbo Senscure Biotechnology Co ltd
Priority date: 2018-02-27
Filing date: 2018-02-27
Publication date: 2024-03-15
Anticipated expiration: 2038-02-27
Also published as: CN108210137A

Abstract

The invention relates to an auxiliary retraction device comprising at least two mutually attractive implant assemblies which are implanted in or arranged around a body lumen, the implant assemblies comprising a magnet and a capsule which can be compressed into and detachably connected to an injection system, the magnet being able to be injected into the capsule by the injection system. The device is injected into human body lumen tissues under a minimally invasive endoscope, has the advantages of small wound, quick recovery of patients, stable overall structure, ordered spatial arrangement, integration with the human body lumen tissues, no influence on peripheral tissues of the human body lumen, simple operation and high safety.

Description

Auxiliary contraction device

Technical Field

The invention relates to the technical field of treatment for weakening the contraction function of human body lumen tissues, in particular to an auxiliary contraction device.

Background

Human body lumen tissue widely exists in human body organs, such as smooth muscle is mainly composed of smooth muscle fibers to form a tubular structure or hollow organ, and is widely distributed in human digestive tract, respiratory tract, blood vessels, urinary system, reproduction system and other systems; functionally, the organ can be moved and deformed by shortening and generating tension, and can also be continuously contracted or tensed contracted, so that the organ can keep the original shape against the applied load, the former can be used for treating stomach and intestines, and the latter can be used for treating arterial blood vessels, human body lumens and the like.

Taking smooth muscle as an example, smooth muscle is a kind of annular muscle distributed on some lumen walls of human and animal bodies, and has a critical effect on controlling the normal flow direction of lumen contents. The lumen of the human body is found in the digestive tract and urinary system. The lumen can be closed when the lumen of the human body is contracted, and is opened when the lumen is relaxed, and is always in a closed state at ordinary times. The lower esophageal lumen at the gastroesophageal site effectively prevents reflux of gastric contents to the esophagus. The pyloric lumen at the gastric outlet limits the amount of food that is expelled each time the stomach peristalsis occurs and prevents reflux of duodenal contents into the stomach. The ileum terminal and cecum juncture ileocecum human lumen can prevent ileum content from discharging to cecum, prevent ileum content from entering large intestine too fast, prolong chyme residence time in small intestine, facilitate complete digestion and absorption of small intestine content, and prevent large intestine content from flowing back to ileum. The reduced or lost lumen function of the human body caused by various reasons can cause clinically serious adverse effects, such as reflux esophagitis and Barrett esophagus caused by reduced lumen function of the lower cardiac esophagus; bile reflux gastritis caused by the relaxation of the lumen of a pylorus human body; urinary incontinence is caused by damage to the lumen of the urinary tract; anal human body lumen injury causes fecal incontinence. How to restore and reconstruct the function of the human lumen has become a serious challenge for clinicians.

In abroad, related products have been developed to treat the weakening or failure of the lumen function of the human body under the esophagus, for example, U.S. Pat. No. 7,695,427 B2 entitled "apparatus for treating the lumen of the human body under the esophagus" discloses an apparatus for treating gastroesophageal reflux disease, a string of magnetic bead chains, the head and tail ends of which are connected into a closed loop, which is looped around the outside of the lumen of the human body under the esophagus of a patient by laparoscopic minimally invasive surgery. But has the disadvantages that:

1. minimally invasive implantation cannot be performed, implantation of an open abdomen or laparoscopic surgery is required to be completed, the trauma to a patient is large, postoperative recovery is slow, and complications exist in or after the operation;

2. is only suitable for treating gastric reflux diseases, but cannot treat the weakening or failure of all the human lumen contraction functions;

3. because the device is made of metal materials, the device has certain friction to the wall of the human body lumen and peripheral tissues in the process of expanding and contracting the human body lumen, so that the wall of the human body lumen and the peripheral tissues can be inflamed, damaged and other symptoms.

4. The device is connected end to end, and the ring is placed outside human lumen, after implantation, each magnetic bead is wrapped by fibrous tissue easily, can influence the expansion of device, causes patient's complication such as dysphagia.

Disclosure of Invention

In view of the above, the invention aims to provide an auxiliary contraction device for treating the weakening of the contraction function of human body lumen tissue, so as to solve the problems of difficult operation, large trauma to a patient, high risk, easy expansion obstruction and the like in the process of treating the human body lumen tissue with the contraction function in the prior art, thereby effectively assisting the contraction of the human body lumen tissue on the premise of not influencing the expansion of the human body lumen tissue.

The invention aims at realizing the following technical scheme:

an auxiliary retraction device comprising at least two mutually attractive implant assemblies, the implant assemblies being implanted in or disposed around a body lumen, the implant assemblies comprising a magnet and a balloon compressible into and detachably connectable with an injection system through which the magnet can be injected into the balloon.

The aim of the invention can be further realized by the following technical scheme:

preferably, the magnet is composed of a plurality of nano-scale, sub-micron scale, micron scale or millimeter scale magnetic particles.

More preferably, the maximum size of the magnetic particles is less than or equal to 2mm.

More preferably, the magnet is provided with a protective layer.

More preferably, the protective layer is a shell structure or the protective layer is a coating coated on the surface of the magnetic particles.

Preferably, the capsule is of an inflatable porous structure.

Preferably, the balloon is an inflatable balloon structure.

Preferably, the capsule body is provided with an injection connecting piece.

More preferably, the injection connector is provided with a blocking device to prevent the magnet from flowing out of the capsule body in a reverse direction.

More preferably, the injection connector is provided with an injection port facilitating multiple injections of the magnet.

Preferably, the capsule body is provided with one or more capsule body inner cavities.

More preferably, the capsule body comprises a capsule body front inner cavity, a capsule body rear inner cavity and a capsule body concave cambered surface connected between the capsule body front inner cavity and the capsule body rear inner cavity. More preferably, the back cavity of the bag body is arranged in a C shape around the lumen of the human body after being unfolded.

More preferably, the balloon is provided with a plurality of balloon lumens, which are independently separated. More preferably, the inner cavities of the plurality of capsules are arranged in a propeller type.

More preferably, the implant assembly is injected into the human body lumen tissue by an injection system comprising a puncture tube and an injection inner tube disposed in the puncture tube, the injection inner tube being detachably connected with the injection connector.

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

1. the auxiliary contraction device is embedded in the expandable and contractile lumen tissue (such as a lumen of a human body) and can provide auxiliary force to change the closing pressure of the lumen of the human body so that the closing pressure of the lumen of the human body reaches a normal value to strengthen or reconstruct the weakened or lost lumen contraction function and maintain the original efficacy of the lumen contraction function.

2. The magnet of the auxiliary contraction device is arranged in the capsule body, the magnet consists of a plurality of magnetic particles with nano-scale, submicron-scale, micron-scale or millimeter-scale, the sizes of the magnetic particles are tiny, and the magnetic force among the magnetic particles is weaker, so the design has the advantages that: 1) All the magnetic particles in the magnet are tiny in size and good in magnetic particle dispersibility, so that the magnet has certain fluidity, can be accumulated and injected into the capsule body one by one or in a small number in a dispersed state, and can be injected into human body lumen tissues through minimally invasive intervention operation by selecting an injection catheter with a size of a few millimeters, thereby realizing the advantages of less trauma to a patient, faster operation recovery time, more reliable and safe operation and the like; 2) The capsule body can be self-expanded and has a variable shape, so that when the implantation assembly is subjected to the extrusion force of the lumen of a human body, the positions among the magnetic particles in the capsule body can still relatively move, and the implantation assembly formed by the method has the advantage of variable shape, so that the implantation assembly can adapt to different lumen tissues in the human body, and the implantation assembly provided by the invention has a wide application range.

3. The magnet of the auxiliary contraction device is externally provided with a protective layer. Firstly, the direct contact between the magnet with poor biocompatibility and human tissues can be effectively avoided, so that the implant component is ensured to have good biocompatibility; secondly, the protective layer is used as a spacer between the two magnets, so that collision caused by magnet attraction is avoided, micro cracks or macro cracks or direct fragmentation of the magnets are prevented, and the attraction force of the magnets is ensured to continuously play a role in assisting muscle closure.

4. The implantation component of the auxiliary contraction device comprises the bag body with the containing function, firstly, the bag has the isolating function, and the direct contact between the magnet with poor biocompatibility and human tissues is more effectively avoided, so that the implantation component is ensured to have good biocompatibility; secondly, the capsule body can be partially or completely placed on the outer surface of the human body lumen tissue, so that the placement space of the implantation assembly is enlarged, the placement quantity of the magnets is increased, the implantation assembly has stronger magnetism, and the contraction capacity of the human body lumen tissue is obviously increased; then, after the capsule body enters the human body lumen tissue, the magnet is placed in the space formed by the capsule body, under the extrusion of the human body lumen peripheral tissue, the capsule body can conform to the whole outline formed by the magnet, fully fit with the outline, and tightly fit with the human body lumen tissue at the periphery of the capsule body, and finally the implanted assembly and the human body lumen tissue are fused into a whole, so that the device can not cause complications such as inflammation, damage and the like of the human body lumen tissue and the peripheral tissue, and can not cause any influence on the expansion of the human body lumen after implantation; finally, the injection connecting piece is arranged on the sac, and the magnet can be injected into the human body lumen for many times under the action of the injection connecting piece, so that the attractive force between the implanted components can be timely and timely adjusted and micro-adjusted along with the number of the implanted magnets in the operation process, and further, the invention can play a role in assisting the contraction of the human body lumen tissue.

Drawings

FIG. 1a is a schematic view of the structure of the auxiliary contracting device of the present invention when the human body lumen is expanded after the auxiliary contracting device is implanted in the human body lumen;

FIG. 1b is a schematic view of the structure of the auxiliary contracting device of the present invention after being implanted in a human lumen, when the human lumen is contracted;

FIG. 1c is a schematic diagram showing the structure of the capsule body according to the present invention, wherein the shape of the capsule body changes with the position change between the magnetic particles;

FIG. 1d is a schematic view of a structure of a magnet with a protective layer according to the first embodiment;

FIG. 2a is a schematic view of an unreleased structure of the injection system of the present invention; FIG. 2b is a schematic representation of the results of the injection system of the present invention after release;

FIG. 3 is a schematic view showing a structure in which a magnet according to the first embodiment is injected into a capsule body to form an implant assembly by an injection system;

FIG. 4a is a schematic structural view of a bladder according to the first embodiment;

FIGS. 4b, 4c and 4d are schematic views showing the structure of different plugging devices on the balloon according to the first embodiment;

FIG. 5a is a schematic structural view of a balloon having a front lumen and a rear lumen according to the second embodiment;

FIGS. 5b and 5c are schematic structural views of various embodiments of a balloon having a front lumen and a rear lumen;

FIG. 5d is a schematic view of a balloon having a front lumen and a rear lumen, the rear lumen being C-shaped around a body lumen after deployment;

FIG. 6a is a schematic structural view of a balloon having multiple lumens;

FIG. 6b is a schematic side view of a balloon having multiple lumens implanted within a body lumen;

FIG. 6c is a schematic top view of a balloon having multiple lumens implanted within a body lumen;

FIGS. 7a, 7b and 7c are schematic structural views of three different embodiments of the implant assembly of the third embodiment implanted in a body lumen;

FIG. 7d is a schematic view of a third embodiment in which multiple implant sets are implanted in a body lumen;

fig. 8a and 8b are schematic structural views of porous structures in which the capsule body has two different pore structures in the fourth embodiment, respectively.

Wherein: 1 is a human body lumen, 2 is an implantation component, 21 is a magnet, 22 is a balloon, 210 is a protective layer, 221 is a balloon inner cavity, 222 is a balloon port, 223 is an injection connecting piece, 2231 is an injection port, 2232 is a plugging device, 2233 is a connecting channel, 2234 is an elastic sealing ring, 2235 is a one-way valve, 2236 is a magnetic block, 224 is a balloon front cavity, 225 is a balloon rear cavity, 226 is a balloon inner concave cambered surface, 227 is a fixed section, 2271 is a through hole, 228 is a porous structure, 3 is an injection system, 31 is a protective sheath, 32 is an injection catheter, 33 is a puncture tube, and 34 is an injection inner tube.

Detailed Description

For a clearer understanding of technical features and objects of the present invention, specific embodiments of the present invention will be described in detail with reference to the accompanying drawings.

Embodiment one:

the invention provides an auxiliary contraction device (hereinafter referred to as the device) which is implanted in a human body lumen 1, the device comprises two implantation components 2 which can attract each other, the two implantation components 2 are implanted in the human body lumen 1, the implantation components 2 comprise a magnet 21 and a capsule 22 which can be compressed into an injection system 3 and is detachably connected with the injection system 3, and the magnet 21 can be injected into the capsule 22 through the injection system 3. When the human body lumen 1 is contracted, the two implant assemblies 2 attracted to each other approach each other, so that the contraction pressure of the human body lumen 1 is enhanced, as shown in fig. 1 b; when the body lumen 1 is subjected to external stimulus or autonomous reaction of the body, the reflectability causes the body lumen 1 to expand, so that the two implant components 2 attracted to each other are away from each other, as shown in fig. 1 a. In the present embodiment, the two implant components 2 are all implanted into the wall of the human body lumen 1, which is advantageous in that the implant components 2 are completely embedded inside the human body lumen 1, can contact with human body lumen tissues as much as possible, and improves the long-term effectiveness of fixation of the implant components 2 with the human body lumen tissues. In a preferred embodiment, the two implant components 2 are symmetrically arranged, so that the mutual attractive force F generated by the two implant components 2 is beneficial to the uniformity and symmetry of the contraction force generated by the human body lumen 1 during contraction, the contraction capacity of the human body lumen 1 is enhanced, the contraction function of the damaged or invalid human body lumen 1 is normalized, and the mutual attractive force F does not obstruct the normal expansion of the human body lumen 1, so that the device can control the normal contraction and expansion functions of the human body lumen 1.

For the present embodiment, the implant assembly 2 comprises a magnet 21 and a capsule 22 that can be compressed into the injection system 3 and detachably connected to the injection system 3, the magnet 21 being capable of being injected into the capsule 22 by the injection system 3. The magnet 21 is composed of a plurality of magnetic grains having a size of nano-scale, submicron-scale, micron-scale or millimeter-scale, and the maximum size of each magnetic grain is usually not more than 2mm. Since each of the magnetic particles of the magnet 21 is small in size, the magnetic force between the magnetic particles is weak, and the magnetic particles are good in dispersibility, the magnet has a certain fluidity, which makes: 1) The magnetic particles can be accumulated and injected into the capsule body one by one or in a small number in a scattered state, an injection catheter with a size of a few millimeters can be selected to inject the implantation assembly into the human body lumen tissue through the minimally invasive intervention operation, and the advantages of less trauma to a patient, faster operation recovery time, more reliable and safe operation and the like are realized; 2) After the first implantation component 2 is implanted, in the injection process of the second implantation component 2, as the magnetic particles are continuously injected into another symmetrical target position in the human body lumen 1, the magnetic particles newly entering the position can be oriented according to the magnetic field generated by the first implantation component 2 and attracted by the first implantation component 2, so that the newly entering magnetic particles are oriented towards the first implantation component 2, and the magnetic particles subsequently entering the position can be influenced by the magnetic field generated by all the magnetic particles previously injected into the position, thereby ensuring that the two implantation components 2 can be attracted to each other; 3) The combined capsule body 22 has the advantages of being capable of being compressed into the injection system 3, being capable of being expanded, being variable in shape and the like, after a plurality of tiny magnetic particles enter an inner space formed by the capsule body 22, the implant assembly 2 is subjected to extrusion force of human body lumen tissues, so that positions among the magnetic particles can still move relatively, the capsule body 22 can follow the shape change along with the movement of the magnetic particles, as shown in fig. 1c, the formed implant assembly 2 also has the advantage of being variable in shape, and finally, the implant assembly 2 can adapt to different human body lumen tissues in a human body, and therefore, the implant assembly 2 provided by the invention has a wide application range.

The magnet 21 is a magnetic material capable of attracting iron, cobalt, nickel, or other substances, and optional magnetic materials include, but are not limited to, neodymium-iron-boron alloys, samarium-cobalt alloys, alnico (and alloys with other elements such as cobalt), iron-chromium (and alloys with other elements such as cobalt and molybdenum), iron-aluminum-carbon alloys, iron-cobalt (and alloys with other elements such as vanadium and tungsten), alloys of rare earth elements and cobalt, alloys of rare earth elements and iron, platinum-cobalt alloys, cupro-nickel-iron alloys, other alloys containing iron, cobalt, or nickel, manganese-aluminum-carbon alloys, alnico alloys, ferrites, intermetallic compounds, and the like, and naturally also include some functionalization or modification of the above materials, such as carboxylation, streptavidin modification, polylysine modification, amination, polyethyleneimine modification, oleic acid modification, silica modification, polystyrene modification, polyethylene glycol modification, fluorescein modification, avidin coating, and the like, thereby forming nano-magnetic microspheres, nano-magnetic particles, bio-magnetic particles, and the like.

In one embodiment, a protective layer 210 is disposed on the magnet 21, and preferably, the protective layer 210 is a coating layer having a lubricating function coated on the surface of each magnetic particle, so that the design advantage is that: 1. the safety of the magnet 21, in particular the long-term corrosion resistance, is improved, ensuring good biocompatibility thereof; 2. this facilitates the injection of the magnetic particles into the inner tube 34, which has a lumen size of only a few millimeters, and into the capsule 22. In another embodiment, the protective layer 210 is a shell structure. As shown in fig. 1d, the magnet 21 is provided with a protective layer 210 of a shell structure, each protective layer 210 is coated with a plurality of magnetic particles, and of course, the protective layer 210 may be provided on each magnetic particle. This design not only achieves good biocompatibility with the coatings mentioned above, but also has a number of advantages, including: 1. the defect that the materials used by the magnetic particles are almost difficult to process into any ideal shape at present is avoided, the production and processing requirements on the magnetic particles are reduced, and the magnetic particles are convenient to manufacture; 2. because the relative position between the magnetic particles in each implantation assembly is not fixed, the possibility of mutual friction exists, micro cracks or direct fragmentation of the formed magnetic particles are easy to occur, the magnetic field direction and the magnetic field strength formed by the implantation assembly are influenced, the effect of the device for assisting the contraction of the human body lumen is further influenced, and the adverse condition can be effectively avoided by the design. To achieve the above object, the protective layer 210 is made of a metal material including but not limited to titanium and its alloy, 316L stainless steel, nickel titanium alloy, etc., or a polymer material or an organic material including polyvinylpyrrolidone, polytetrafluoroethylene, polyethylene terephthalate, polyester, polypropylene, parylene, polycarbonate, polyurethane, fluorinated ethylene propylene copolymer, silicone, polyamide, polyvinyl alcohol, silicon-containing, heparin, polyvinyl chloride, ultra-high molecular weight polyethylene, polyolefin elastomer, silicone rubber, glucose, etc., or an inorganic material including silicon dioxide, titanium nitride, etc. Of course, metallic materials with or added with visualization capabilities, such as cobalt chrome, tantalum, tungsten, platinum iridium, or compounds such as barium sulfate, bismuth oxide, etc., may also be used to enhance visualization of the present device during and after surgery.

As shown in fig. 2a, the capsule 22 of the present invention can be compressed into the injection system 3, that is, the capsule 22 can be directly compressed into the puncture tube 33 with an inner cavity size of only several millimeters or in a certain folded and compressed state, so that the implantation of the capsule 22 into the human lumen 1 is possible by the minimally invasive endoscopic intervention operation, and finally the implantation of the implantation assembly 2 into the human lumen 1 is realized by the minimally invasive endoscopic intervention operation. For this embodiment, as shown in fig. 2b, the balloon 22 is of an inflatable sac structure, and when the puncture tube 33 and the protective sheath 31 are retracted, the balloon 22 is self-inflated, which is advantageous in that the magnet 21, which is generally poor in biocompatibility, can be effectively prevented from directly contacting with human tissues, including interstitial fluid, fibrous tissues, etc. in and outside the lumen of the human body, so as to ensure good biocompatibility of the implant assembly 2. Because the balloon in the prior art is pressed by human body lumen tissue from the contact of the target position and the balloon or the periphery thereof after entering a certain target position in the human body lumen, the balloon is always in a compressed state, so that the subsequent process of injecting the magnet into the balloon 22 becomes difficult, and the design can enable the interior of the balloon 22 to form a certain inner cavity before the injection, thereby facilitating the easy and convenient injection of the subsequent magnet 21. To achieve the above object, the capsule 22 should be made of a high molecular material including, but not limited to, polyester, polytetrafluoroethylene, polyurethane, polypropylene, polyvinyl chloride, polyamide, ultra-high molecular weight polyethylene, polyolefin elastomer, silicone rubber, etc., and a material having a developing function selected from barium sulfate, bismuth oxide, etc., or a metal material such as cobalt chrome, tantalum, tungsten, platinum iridium alloy, etc., may be added or additionally used to enhance visualization of the capsule 22 during and after the operation. Preferably, the capsule 22 is made of a material with compliance or semi-compliance or good elasticity, such as polyurethane, silicone rubber, polyolefin elastomer, etc., so as to give the capsule 22 the characteristics of softness and good deformability, so that the internal space formed by the capsule 22 is variable, after the capsule 22 enters a certain target position in the human lumen 1, the magnet 21 is placed in the space formed by the capsule 22 again, under the extrusion of the peripheral human lumen tissue, the capsule 22 can conform to the whole outline formed by the magnet 21, in particular, the uneven outline as shown in fig. 1c, and is fully adhered to the outline, and is tightly adhered to the human lumen tissue around the capsule 22, and finally the implantation assembly 2 is fused with the human lumen tissue into a whole, so that compared with the prior art, the device does not cause complications such as inflammation, damage and the like of the human lumen tissue and peripheral tissue, and at the same time, after implantation, does not cause any influence on the expansion of the human lumen. The definition of "elastic" herein is as follows: the material deforms under the action of external force, and the original size and shape can be restored after the external force is removed. The capsule 22 can be made into any desired structure and shape according to the manufacturing requirements or clinical requirements (such as the fixation requirements of the human body lumen 1 and the adaptability requirements of fitting the human body lumen 1).

Further, the capsule 22 is detachably connected to the injection system 3. In this embodiment, the balloon 22 includes a balloon lumen 221, and a balloon port 222 fixedly connected to the balloon lumen 221, as shown in fig. 3. All of the magnets 21 are injected into the capsule body inner chamber 221. While the balloon port 222 serves as a connection channel with the injection tube 34 in the injection system 3, the balloon port 222 is detachably connected with the injection tube 34 of the injection system 3 so as to facilitate detachment of the balloon 22 from the injection system 3. In this embodiment, as shown in fig. 4a, an injection connector 223 is provided at the balloon port 222 of the balloon 22, and all injected magnets 21 are injected into the balloon inner cavity 221 through the injection connector 223. Injection connector 223 includes an injection port 2231 and an occlusion device 2232, and a connection channel 2233 connecting injection port 2231 and occlusion device 2232, injection port 2231 being sized to match injection inner tube 34, injection port 2231 being generally positioned outside the inner wall of body lumen 1. The injection port may be injection molded from a medical implant grade polymeric material or may be machined from a medical implant grade metallic material. The purpose of this is to: in the implantation process, when the attractive force F between the implanted implant components 2 is insufficient to enhance the contraction capability of the human body lumen 1, the injection inner tube 34 can be re-placed into the injection port 2331, and the number of the implanted magnets 21 can be timely adjusted so that the magnets can be injected into the human body lumen 1 for multiple times, so that the attractive force between the implant components 2 can be timely and timely adjusted and micro-adjusted along with the number of the implanted magnets in the operation process, thereby ensuring that the invention can play a role in effectively assisting the contraction function of the human body lumen 1. In one embodiment, the closure device 2232 is an elastomeric seal 2234, as shown in fig. 4 b. The elastic sealing ring 2234 has high elasticity, and the elastic sealing ring 2234 automatically contracts and closes under static state. The elastic sealing ring 2234 and the inner cavity 221 of the capsule body are fixedly connected by utilizing a welding or gluing process, the elastic sealing ring 2234 is sleeved at the far end of the injection inner tube 34 by utilizing an elastic retraction force, after the injection inner tube 34 conveys the magnet 21, the injection inner tube 34 is retracted to be separated from the elastic sealing ring 2234, the elastic sealing ring 2234 automatically contracts and closes, the magnet 21 is sealed in the capsule body 22, and the elastic sealing ring 2344 has the advantages that: the plugging device has the advantages of simple structure, good sealing effect, operation time saving and operation complications reduction. In yet another embodiment, the closure device 2232 is an anti-reflux valve 2235 having only one-way flow, as shown in fig. 4c, such an anti-reflux valve 2235 allows the magnet 21 to easily enter the balloon lumen 221 from the balloon port 222, but at the same time prevents the magnet 21 from leaking out of the balloon lumen 221 from the balloon port 222 after injection, as in the previous embodiment. In yet another embodiment, the plugging device 2232 is two magnetic blocks 2236 that are attracted to each other, and as shown in fig. 4d, the magnetic blocks 2236 have an arc shape, and when the injection tube 34 is retracted, the two magnetic blocks 2236 are attracted to each other, thereby achieving the same effect as the two previous embodiments. The connecting channel 2233 connects the injection port 2231 and the closure device 2232 together, and is fixedly connected using a welding or gluing process. The connecting channel 2233 may be made of the same materials as the balloon 22 described above, or any of the materials mentioned above for the balloon 22, which may be advantageous: may be closed with the occluding device 2232 or the connecting channel 2233 may be squeezed closed within the body lumen 1 to further increase the sealing effect of the balloon 22.

The implantation component 2 can be placed in the lumen 1 of a human body through minimally invasive endoscopic intervention. As shown in fig. 3, the present invention should be matched with a corresponding injection system 3, so that the implant assembly 2 enters the human body lumen 1 through the injection system 3. The injection system 3 comprises a protective sheath 31 and an injection catheter 32, said injection catheter 32 comprising a puncture tube 33 and an injection inner tube 34. When the injection system 3 reaches the appointed implantation position of the human body lumen 1 through the endoscope, the protective sheath 31 is retracted, the puncture tube 33 is punctured into the implantation position, the puncture tube 33 is retracted, the capsule body 22 is exposed out of the human body lumen 1, and a certain inner cavity can be formed in the capsule body 22 before the implantation assembly 2 is injected into the capsule body by utilizing the self-expansion capability of the capsule body 22, so that the subsequent magnet 21 can be easily injected into the capsule body. The protective sheath 31 has the function that when the injection system 3 enters the designated position of the human body lumen 1 from the natural lumen, the puncture outfit 33 is positioned in the protective sheath 31, so that the puncture outfit 33 is prevented from damaging human body tissues.

Embodiment two:

based on the first embodiment, the second embodiment is different from the first embodiment in that: in this embodiment, the capsule 22 includes a front cavity 224, a rear cavity 225, and a concave arc surface 226 connected therebetween, and after the injection of the magnet 21, the tissue of the human lumen 1 is embedded into the concave arc surface 226, so that the fixation of the implant assembly 2 and the human lumen 1 is more stable, and the long-term effectiveness of the fixation is achieved, as shown in fig. 5 a.

The second difference is that: in the present embodiment, a part of the implant assembly 2 is implanted into the body lumen 1 and another part is at the outer surface of the body lumen 1, as shown in fig. 5 b. In this embodiment, the volume sizes of the front cavity 224 and the rear cavity 225 of the balloon are consistent, the front cavity 224 of the balloon is implanted into the human body lumen 1, the rear cavity 225 of the balloon is implanted into the outer surface of the human body lumen 1, and when the implantation is completed, the human body lumen 1 is clamped into the concave cambered surface 226 of the balloon, so that: 1. the injection number of the magnet 21 becomes large, enhancing the magnetic force of the implant assembly 2; 2. can be self-securing without fear of displacement of the implant assembly 2. More preferably, the volume of the back cavity 225 of the balloon is larger than the volume of the front cavity 224 of the balloon, as shown in fig. 5c, which is designed to fully utilize the outer surface of the body lumen 1 to implant more magnets 21 and increase the magnetic properties of the implant assembly 2. More preferably, the inner cavity 225 after the balloon is unfolded is arranged in a C-shape around the human body lumen 1, preferably, the C-shaped structure can be fitted with a half of the circumference of the outer surface of the human body lumen 1, so that the two implant components 2 can be implanted into the tissue of the human body lumen 1, and the outer surface of the human body lumen 1 can be surrounded by the two inner cavities 225 after the balloon, so that the contraction function of the human body lumen 1 is enhanced to the maximum. While this embodiment is suitable for body lumen tissue of thin wall thickness, preferably, such as sphincter tissue in the body (e.g., lower esophageal sphincter, urethral sphincter, anal sphincter, etc.), the number of magnets 21 injected in the sphincter is limited due to the thin muscle wall, so that the sphincter contraction function assisted by the implant assembly 2 is not obvious, in this embodiment, the limitation of the present device is solved, so that the implant assembly 2 can extend to the outer surface of the body lumen 1, the injection amount of the magnets 21 is increased, the magnetic force of the implant assembly 2 is effectively increased, and the contraction function of the sphincter tissue is enhanced.

In another embodiment, balloon 22 includes a plurality of balloon lumens 221, balloon ports 222, and a securing segment 237 fixedly connecting the two, as shown in fig. 6 a. A plurality of through holes 2271 are formed at one end of the fixing section 227, the plurality of through holes 2271 are symmetrically arranged in a ring shape, and the plurality of capsule inner cavities 221 are respectively connected with the plurality of through holes 2271, so that a plurality of independently dispersed capsule inner cavities 221 are formed in the capsule 22, and the plurality of capsule inner cavities 221 are arranged in a propeller shape. The other end of the fixing segment 227 is connected to the pouch port 222, and is fixedly connected by welding or gluing. The fixing section 227 may be made of the same material as the capsule 22 in the second embodiment, or may be made of any one of all the materials for preparing the capsule 22 mentioned in the second embodiment. The plurality of capsule inner cavities 221 in the capsule 22 are implanted to the outer surface of the human body lumen 1 through the injection system 3, the fixed section is implanted into the human body lumen 1, the magnet 21 is injected into the capsule 22 through the injection inner tube 34, and the magnet 21 can be respectively injected into the plurality of capsule inner cavities 221 through the plurality of through holes 2271 due to the certain fluidity of the magnet 21, so that the plurality of capsule inner cavities 231 are filled with the magnet 21, as shown in fig. 6b and 6c, and the design is such that: 1. the magnet 21 has certain fluidity, so that the magnet 21 can be filled with capsule structures of any shape; 2. more magnets 21 can be implanted by fully utilizing the outer surface of the human body lumen 1, so that the magnetism of the implantation assembly 2 is increased; 3. the contact area between the implantation assembly 2 and the human body lumen 1 can be increased, the magnetism of the implantation assembly 2 is maximized, and the contraction function of the human body lumen 1 is enhanced; 4. the fixing section 227 is implanted into the human body lumen 1, so that the plurality of capsule body lumens 221 can keep the positions for a long time without moving, and the fixing section 227 has good softness and deformability, and can be extruded and closed by the human body lumen 1 after the injection inner tube 34 is completely injected and evacuated, so that the capsule body 22 forms a closed space, and the magnetic property of the magnet 21 can be kept for a long time.

Embodiment III:

based on the first embodiment, the third embodiment is different from the first embodiment in that: the device comprises a plurality of mutually attractive implant components 2, all implant components 2 are annularly arranged around the human body lumen 1, the design can exert the advantages of a magnet 21 formed by magnetic particles, particularly, for each implant component 2, each magnetic particle in the interior can sense the magnetic field generated by other magnetic particles in the magnet 21, and the magnetic fields generated by other implant components 2 can adjust the position and the magnetic field direction of the implant components to be optimal according to the comprehensive effect of the magnetic fields, so that the mutual attractive force among the implant components 2 can form a superposition effect, and the contraction function of the auxiliary human body lumen 1 exerted by the device is further increased. In one embodiment, all implant assemblies 2 are located entirely within the body lumen 1, as shown in fig. 7a, which provides the same advantages as in example one. In yet another embodiment, the implant assembly 2 is only partially positioned within the body lumen 1, with the remainder being implanted on the outer surface of the body lumen 1, as shown in fig. 7b. In another embodiment, the implant assembly 2 is entirely located on the outer surface of the body lumen 1, as shown in fig. 7 c.

Further, multiple sets of implant assemblies 2 may be placed in different areas of the body lumen 1, each set of implant assemblies 2 being arranged in a circular configuration and parallel to each other, as shown in fig. 7 d. The purpose of this is to further enhance the ability of the body lumen 1 to contract, and the implant assemblies 2 of adjacent groups are spaced apart from the body lumen 1 tissue, so that the implant assemblies 2 of each group do not interfere with each other during movement.

Embodiment four:

as shown in fig. 8a and 8b, the fourth embodiment is different from the first embodiment in that: the balloon 22 is not a balloon structure 220, but is an inflatable porous structure 223. The capsule 22 of this structure has a mesh structure as shown in fig. 8a, or a microporous structure as shown in fig. 8b, and the pore size of the mesh structure or the microporous structure should be reasonably designed, for example, the pore size is smaller than or equal to the size of the magnetic particles, in this case, the design can not only prevent the magnetic particles from leaking out of the pores and exert the function similar to the capsule structure 220, but also be beneficial to the growth of cells of the human body lumen tissue into the space formed by the capsule 22 after the capsule 22 is implanted into the human body lumen 1, so that the device and the human body lumen tissue are finally integrated, and the long-term effectiveness of the fixation of the implantation assembly 2 and the human body lumen 1 tissue is improved. Alternative materials for this embodiment include, but are not limited to, titanium and its alloys, 316L stainless steel, 304V stainless steel, 303 stainless steel, nickel titanium alloy, nickel chromium alloy, cobalt chromium alloy, tantalum, tungsten, platinum iridium alloy, or high polymer materials with higher elastic modulus, or the material described for the capsule 22 in embodiment one, the porous structure 223 may be woven and formed from elastic materials, or cut and formed from shape memory alloy tubes, or may be integrally formed or post-processed from high polymer materials.

Finally, it should be understood that the foregoing description is merely illustrative of the preferred embodiments of the present invention, and that no limitations are intended to the scope of the invention, as defined by the appended claims.

Claims

1. An auxiliary retraction device, characterized in that it comprises at least two mutually attractive implantation assemblies (2), said implantation assemblies (2) being implanted in a body lumen (1) or being arranged around the body lumen (1), said implantation assemblies (2) comprising a magnet (21) and a capsule (22) being compressible into an injection system (3) and being detachably connected to said injection system (3), said magnet (21) being capable of being injected into said capsule (22) by means of said injection system (3);

wherein the magnet (21) is composed of a plurality of nano-scale, submicron-scale, micron-scale or millimeter-scale magnetic particles;

the magnet (21) is provided with a protective layer (210);

an injection connecting piece (223) is arranged on the bag body (22).

2. The auxiliary retraction device according to claim 1, wherein: the balloon (22) is either an inflatable porous structure (228) or an inflatable bladder structure (220).

3. The auxiliary retraction device according to claim 1, wherein: the injection connector (223) is provided with a blocking device (2232) to prevent the magnet (21) from flowing out of the capsule (22) in a reverse direction.

4. The auxiliary retraction device according to claim 1, wherein: the injection connection (223) is provided with an injection port (2231) facilitating multiple injections of the magnet (21).

5. The auxiliary retraction device according to claim 1, wherein: the capsule (22) is provided with one or more capsule lumens (221).

6. The auxiliary retraction device according to claim 5 wherein: the capsule body (22) comprises a capsule body front inner cavity (224), a capsule body rear inner cavity (225) and a capsule body inner concave cambered surface (226) connected between the capsule body front inner cavity (224) and the capsule body rear inner cavity (225).

7. The auxiliary retraction device according to claim 1, wherein: the implantation assembly (2) is injected into the tissue of the human body lumen (1) through the injection system (3), the injection system (3) comprises a puncture tube (33) and an injection inner tube (34) arranged in the puncture tube (33), and the injection inner tube (34) is detachably connected with the injection connecting piece (223).