CN108635092B

CN108635092B - Stomach divertor and alimentary canal support thereof

Info

Publication number: CN108635092B
Application number: CN201810326731.3A
Authority: CN
Inventors: 左玉星; 鲁艳
Original assignee: Hangzhou Tangji Medical Technology Co ltd
Current assignee: Hangzhou Tangji Medical Technology Co ltd
Priority date: 2018-04-12
Filing date: 2018-04-12
Publication date: 2020-06-16
Anticipated expiration: 2038-04-12
Also published as: CN108635092A

Abstract

The invention discloses a stomach fluid director and a digestive tract stent thereof, wherein the digestive tract stent has a pre-deployment shape and a post-deployment shape and comprises an upper stent, a lower stent and a connecting piece; under the shape after the expansion, the upper bracket top is equipped with first opening and the bottom is equipped with the second opening, the upper bracket below is located to the lower carriage, the lower carriage top is equipped with the third opening and the bottom is equipped with the fourth opening, connect through a plurality of connecting piece between upper bracket and the lower carriage, the membrane pipe is connected to the fourth opening of lower carriage, and, the upper bracket after the expansion and lower carriage all can't be through open stomach pylorus mouth, the connecting piece can pass through the stomach pylorus mouth or wear to establish in stomach pylorus mouth department. The bracket is divided into two parts to be fixed, one part is fixed at the pylorus opening of the stomach, the upper end of the membrane tube is firmly positioned in the alimentary canal when the alimentary canal wriggles, and the other part is fixed at the duodenal bulb part, so that the lower section of the membrane tube is prevented from extending to easily return to the stomach when the alimentary canal wriggles reversely, and food is prevented from flowing according to a designed channel.

Description

Stomach divertor and alimentary canal support thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to a gastric deflector and a digestive tract bracket thereof for treating endocrine diseases (such as diabetes, pancreatic islet dysfunction, obesity and the like) or lower digestive tract diseases (such as inflammation and the like).

Background

It is known that diabetes, which is a disease that has been highlighted in recent years, is one of the diseases of affluence, is a non-infectious epidemic disease that results from the increasing living standard of modern civilized society, and that is caused by the abundance of life, the excess of nutrition, and the reduction of activity, and specifically, it is a metabolic disease characterized by hyperglycemia. It is caused by a defect in insulin secretion or an impaired biological action thereof, or both. Diabetes can lead to chronic damage, dysfunction of various tissues, particularly the eye, kidney, heart, blood vessels, nerves. Diabetes mellitus is often accompanied by obesity and many complications, which pose a great threat to the health of people. The data show that in china alone, adults over 20 years of age, the incidence of diabetes is 9.7% and the patients develop about 1.5 billion of mouth. It is known that the common improvement of obesity and diabetes is diet control, exercise increase and certain medication assistance, which requires long-term patient adherence, and is liable to cause repetition and weight rebound once diet control and exercise are stopped, and long-term use of drugs or insulin also causes a heavy economic burden and inconvenience in life for the patient.

Another treatment is gastric bypass, which has very good effect on curing type ii diabetes and improving obesity, and in 2001, the international diabetes union has formally recommended metabolic surgery (including gastric bypass) as a treatment for obesity combined with type ii diabetes, however, gastric bypass as a surgical operation may cause wounds to the human body, and thus has many risks such as: death, intestinal obstruction, anastomotic leakage, pulmonary embolism, deep vein thrombosis, portal vein injury, respiratory system, and the like.

At present, diabetes is treated abroad by implanting a structure similar to a stomach fluid director in a gastrointestinal tract, however, the structure of the stomach fluid director is complex, a plurality of pull wires are usually needed to be operated simultaneously to realize the function of the stomach fluid director, professional guidance is needed before operation, misoperation is likely to occur without abundant experience, discomfort of patients is increased, operation is difficult, manufacturing cost is high, and large-scale popularization and application of the stomach fluid director in the country are difficult due to the problems of technical barriers, so how to provide a method for treating diabetes without much discomfort for patients during implementation becomes a problem to be solved urgently.

At present, some products similar to the stomach fluid director structure are implanted in the gastrointestinal tract at home and abroad to treat diabetes, a flexible catheter made of high polymer materials is implanted into the duodenum, and the flexible catheter is generally fixed on the duodenal bulb through a small metal bracket. However, the net-shaped stent made of the materials known at present is easy to proliferate and adhere if not covered, and is difficult to take out after being implanted for a period of time, and the covered stent is very easy to fall off.

The product of the American GI company which is on the market at present and the similar patent design in China are designed into a V shape, are provided with barbs and are fixed on a duodenal bulb part in the form of the barbs, the design has the advantage of being suitable for most patients, but has certain problems because the barbs are too long and can cause perforation of the digestive tract, and the barbs are too short and can easily fall off, and according to the clinical literature of the American GI company, the design has about 10 percent of falling-off rate clinically, and the design can cause tearing and bleeding of the digestive tract in a certain proportion under the conditions of accidental falling off, so that certain use risk exists. If the catheter is accidentally dropped into the distal duodenum, jejunum, or even colon, intestinal obstruction is easily caused. A better design is therefore needed to circumvent these risks.

Patent documents with publication numbers CN103298518, CN105263439, WO2017/052694, etc. disclose an intragastric device comprising: a porous structure comprising a top, a bottom, and an interior and having a pre-deployment shape with a first volume and a post-deployment shape with a second volume greater than the first volume, wherein in the post-deployment shape, the porous structure comprises at least one first opening adjacent the top and at least one second opening adjacent the bottom such that food enters the porous structure through the at least one first opening, passes through the interior, and exits the porous structure through the at least one second opening; and a sleeve having a flexible elongate body, a proximal end having a third opening, a distal end having a fourth opening, and a sleeve interior, wherein the sleeve is coupled to the porous structure such that food exiting the at least one second opening enters the sleeve through the third opening, passes through the sleeve interior, and exits the sleeve through the fourth opening. The porous structure (stent) is a cylinder, an ellipsoid, a spherical cube or a cuboid after expansion, occupies a considerable volume in the stomach and can freely move in the stomach, the diameter of the porous structure is larger than that of an opened pylorus, and a sleeve (membrane tube) at the bottom of the porous structure penetrates the pylorus and extends to the duodenum. The intragastric device further comprises an anti-migration component positioned at the junction of the porous structure and the sleeve and attached to either the porous structure or the sleeve or both, wherein the anti-migration component comprises a compressed pre-deployment configuration and an expanded post-deployment configuration and is designed to be adjacent to a pylorus of a patient and prevent migration of the porous structure to and through the pylorus. Among the above-mentioned structure, the ball support is all in the stomach, outside the pylorus, has sleeve pipe (membranous tube) in the pylorus, and the mechanism of action is mainly that a netted spherical memory alloy is implanted and is woven the device in the stomach, and this ball support tectorial membrane, this ball support occupy certain volume in the stomach can form a satiety to food can store certain time in ball support, thereby reduce the intake of food, play the effect of metabolic diseases such as treatment obesity and diabetes, and the membranous tube that is used for food drainage is next important functional structure. However, the intragastric device described above has the following problems: firstly, the memory alloy material with self-expansion shape has certain mechanical force and weight, and when the memory alloy material is large enough to occupy the volume in the stomach, the memory alloy material has certain oppression on the stomach, and the memory alloy material implanted in the stomach can oppress the gastric mucosa, thereby easily causing the ulcer of the digestive tract; secondly, the food stays in the saccule for a long time, and although the emptying of the stomach can be slowed down, the bacteria are easy to breed to cause inflammatory reaction; thirdly, the device is not fixed in the pylorus or the duodenal bulb, and the lower section of the extension membrane tube is easy to return to the stomach due to the reverse peristalsis of the digestive tract, so that food does not flow according to the designed channel; fourthly, the membrane tube positioned at the pylorus opening has larger volume, and the pylorus is obviously sensed by foreign matters and easily causes symptoms such as untight pylorus closure, bile reflux and the like particularly after food is contained.

Patent documents CN102335052, CN104382671, CN204671331, CN205359721 and the like disclose an alimentary canal stent, wherein a main body is formed by connecting a plurality of stent units with certain rigidity and supporting function and connecting parts which are easy to bend, two ends of each connecting part are respectively connected with the corresponding stent units, and the main body is in a straight cylinder structure which is easy to bend or an easily bent composite structure consisting of a cylinder and a cone; the support unit is of an integral structure formed by engraving metal pipes or a structure formed by weaving wire materials, the connecting part is formed by weaving metal wires or plastic wires with good flexibility, and the connecting wires are generally vertically woven with the upper support plane and the lower support plane. The stent is used for treating the stenosis or obstruction of the alimentary canal, plays a role in expanding and supporting the stenosis, is generally implanted into the alimentary canal as an independent product, is not connected with a membrane tube, cannot be used for the pyloric opening in the stomach because of high supporting strength and difficult deformation, and cannot be used as a gastric fluid director.

Disclosure of Invention

In order to solve the technical problems, the invention aims to provide a stomach fluid director and a digestive tract bracket thereof, wherein the bracket consists of two parts, one part is fixed at a stomach pylorus opening, and the other part is fixed at a duodenum bulb. This support can provide certain holding power, but has certain compliance, and this support can guarantee that extension section membrane tube upper segment opening is fixed in the duodenum ball portion, can open and close along with the switching of intestinal, can not harm the intestinal wall. The extended membrane tube can treat metabolic diseases such as diabetes, obesity and the like by isolating food. The stent has good applicability, convenient manufacturing process, low cost and high production speed, is used for a stent of the alimentary canal, and can be connected with an implantable catheter.

Aiming at the problems in the prior art, the inventor of the invention designs a two-section type stent through careful research, and the two-section type stent is woven by using elastic silk materials, the two sides of the pyloric opening and the duodenal bulbus are fixed, the outer layer is coated with a film to prevent tissue proliferation, the problem that the stent and the film tube are easy to fall off or proliferate can be fully solved, the outer edge is smooth, and the injury to human tissues is avoided. Thus, the present invention has been completed.

Specifically, the invention adopts the following technical scheme:

a digestive tract stent of a gastric deflector, which has a pre-deployment shape and a post-deployment shape, is characterized by comprising an upper stent (1), a lower stent (2) and a connecting piece (3); under the shape after the expansion, upper bracket (1) is being equipped with first opening and being equipped with the second opening near its bottom near its top near its, upper bracket (1) below is located in lower carriage (2), lower carriage (2) are being equipped with the third opening near its top and are being equipped with the fourth opening near its bottom near its, connect through a plurality of connecting piece (3) between upper bracket (1) and lower carriage (2), the fourth opening of lower carriage (2) is connected membrane pipe (7), and, upper bracket (1) and lower carriage (2) after the expansion all can't be greater than open stomach pylorus mouth external diameter through open stomach pylorus mouth (namely the external diameter of upper bracket (1) and lower carriage (2) after the expansion), connecting piece (3) can be through stomach pylorus mouth or wear to establish in stomach pylorus mouth department. Therefore, the bracket is divided into two parts to be fixed, one part (the upper bracket) is fixed at the pylorus opening of the stomach, the upper end of the membrane tube is firmly positioned in the alimentary canal when the alimentary canal wriggles, and the other part (the lower bracket) is fixed at the duodenal bulb part, so that the situation that food does not flow according to the designed channel because the lower section of the extending membrane tube easily returns to the stomach is avoided when the alimentary canal wriggles reversely. This support can provide certain holding power, but has certain compliance, and this support can guarantee that extension section membrane tube upper segment opening is fixed in the duodenum ball portion, can open and close along with the switching of intestinal, can not harm the intestinal wall. The extended membrane tube can treat metabolic diseases such as diabetes, obesity and the like by isolating food. The stent has good applicability, convenient manufacturing process, low cost and high production speed, is used for a stent of the alimentary canal, and can be connected with an implantable catheter.

Preferably, the connecting piece (3) is a connecting line. The connecting line can be linear or thin strip with smaller cross section, thus not only ensuring the connection of the upper bracket and the lower bracket, but also not influencing the flow of food. In addition, in other embodiments, the connecting member may be a flexible membrane tube, a mesh-structured elastic tube, a flexible or elastic connecting band or sheet, etc., but the connecting member is still bulky even after being reduced, which may cause the stomach pylorus to be not tightly closed and discomfort to the patient, so the connecting wire is preferred. The connecting wire can be a metal wire such as nitinol, 304 stainless steel, etc., or a high polymer material wire with good elasticity and fatigue resistance such as polyethylene, nylon, etc.

Preferably, the connecting wire is coated with a film. Therefore, the connecting line is isolated from the digestive tract tissue, the friction injury is reduced, and the probability of gastric ulcer is reduced. The connecting wire is coated with a film elastic material to prevent the connecting wire from being too sharp to damage the pyloric ring. Preferably, the coated film-like elastic material may be one or more materials such as silicone rubber, polyurethane, and the like.

Preferably, the connecting piece (3) comprises a plurality of connecting lines, the upper ends of the connecting lines are respectively connected with the upper support (1), and the lower ends of the connecting lines are respectively connected with the lower support (2). Therefore, the upper bracket and the lower bracket are connected up and down by the connecting wires, so that the stress distribution is more uniform and the fixation is more reliable.

Preferably, the connecting member (3) is elastically deformed to conform to the curvature of the pyloric opening of the human body or to reduce the outer diameter thereof in a natural state at a position corresponding to the pyloric opening of the stomach. Like this, the connecting piece is through the design processing, and when human stomach pylorus was in basic closed state, the natural extension appearance of connecting piece can be complied with human pylorus mouth and the structure of lower part, can not strut the pylorus, causes the damage to the pylorus structure, can extend when upper or lower receiving pulling force, nevertheless has shape memory function, can resume original shape when upper or lower pulling force disappears.

Preferably, the upper bracket (1) is in a cone cylinder shape, an inverted cone cylinder shape, a straight cylinder shape or a straw hat shape. Therefore, the longitudinal section view of the upper bracket is rectangular or trapezoidal, or the two sides of the upper bracket are arc-shaped rectangle-like or trapezoid-like, and the first opening, the second opening and the exposed corners of the upper bracket can be chamfered so as to avoid damaging tissues. Of course, in other embodiments, the upper bracket may have a spherical shape or other shapes.

Preferably, the second opening outer diameter of the upper bracket (1) is larger than the first opening outer diameter. Like this, the characteristics of upper bracket are that the lower extreme opening is bigger, can block in the pylorus mouth and do not harm the pylorus tissue, have two openings from top to bottom, and food can pass through, but does not possess the function of storing food. The upper bracket is used for being clamped at the pylorus to pull the lower bracket, so as to indirectly pull the membrane tube in the duodenum and prevent the membrane tube from moving downwards or even being discharged in the peristalsis process of the digestive tract. The upper support lower opening support is larger than the diameter of the pyloric opening, and the diameter is preferably 20-50 mm. The diameter of the upper opening is preferably 20-30 mm. The height of the upper layer support 1 is preferably 5-15 mm.

Preferably, the lower bracket has a cylindrical structure. The lower frame structure is located inside the pyloric opening, specifically the duodenal bulb, and its main function is to provide an opening for the extended membranous canal through which food can enter the canal; secondly, in order to prevent the membrane tube from turning into the stomach from the duodenum, the position of the membrane tube is fixed in correspondence with the upper bracket; and thirdly, the upper bracket and the lower bracket are respectively limited inside and outside the pylorus opening of the stomach, so that the upper bracket cannot freely move in the stomach and is connected with the lower bracket and the membrane tube, and the upper bracket only has a small amount of displacement at the pylorus opening, thereby avoiding discomfort. The outer diameter of the upper opening (third opening) and the outer diameter of the lower opening (fourth opening) of the lower support are preferably the same, so that the lower support is in a straight cylinder shape, the longitudinal section view of the lower support is a rectangle or a rounded rectangle, and the upper part and the lower part of the lower support can be slightly rounded, mainly for preventing tissues from being damaged. However, the outer diameter of the upper opening (third opening) and the outer diameter of the lower opening (fourth opening) of the lower stent may be different, i.e., the side wall of the lower stent may have a certain taper or curvature to adapt to the duodenal bulb structure and facilitate the connection of the membranous tube.

Preferably, the diameter of the lower bracket is 15-25 cm, the lower bracket is matched with the diameter of a human duodenal bulb, and the height of the lower bracket is 5-20 mm. Preferably 10mm, which is as small as possible to achieve the maximum comfort of the human body while satisfying the above functions.

The distance between the lower end of the upper support and the upper end of the lower support is 20-60mm, the optimal size is selected according to different anatomical structures of human bodies, the principle is that the height of the upper support is larger than that of a pyloric ring, and the lower end of the lower support avoids the duodenal papilla.

The upper and lower supports are of a mesh structure and can be processed by a weaving or cutting process, and the mesh structure can be in various shapes such as a diamond shape, a honeycomb shape, a Z shape and the like. The structure enables the stent to be freely compressed and expanded in the transverse direction and the longitudinal direction, and has good elasticity. Preferably, the upper support (1) and the lower support (2) are both woven by elastic wires (4), the outer surfaces of the elastic wires (4) are coated, or the whole outer surfaces of the upper support (1) and the lower support (2) are respectively coated. Therefore, the contact between the stent wire and tissues in the stomach can be isolated, the friction injury is reduced, the probability of gastric ulcer occurrence is reduced, the tissue hyperplasia is prevented, and the high polymer material film can be one or more of medical materials such as silica gel, TPU, TPE and the like. The braided wire is elastic wire conforming to biocompatibility and can be metal wire, high polymer material wire or degradable material wire.

The lower support is fixedly connected with the membrane tube through sewing, hot pressing, ultrasonic welding or laser welding.

Preferably, the upper end of the connecting line is fixedly connected with the position, close to the first opening, of the top of the upper support (1), and the lower end of the connecting line is fixedly connected with the position, close to the third opening, of the top of the lower support (2). The bottom of the upper support is contracted to influence fixation when the alimentary canal support bears up-and-down tension in the preferable mode, and the bottom of the upper support is in contact with and supported by the elastic surface outside the pylorus opening, so that the damage of the alimentary canal tissue caused by connecting lines and the upper support can be reduced or avoided.

Preferably, the upper end of the connecting line is fixedly connected with the position, close to the first opening, of the top of the upper support (1), and after the connecting line is wound through the middle of the upper support (1) to weave meshes, the lower end of the connecting line is fixedly connected with the position, close to the third opening, of the top of the lower support (2). Therefore, the further preferable mode can prevent the upper bracket from overturning up and down when the digestive tract bracket bears the up-and-down pulling force, thereby influencing the fixation, and the upper bracket is in contact support with the elastic surface outside the pylorus opening of the stomach, thereby reducing or avoiding the damage of the digestive tract tissue.

Preferably, the upper bracket (1) and the lower bracket (2) are provided with developing rings (6), the brackets can be positioned under X-rays, and the developing rings are preferably platinum, gold, tantalum or the like.

Preferably, an upper support recovery line (8) is arranged on the upper support (1), and a lower support recovery line (9) is arranged on the lower support (2). So that the digestive tract stent and the membranous tube can be taken out by a specially-made recoverer or a grasper for an endoscope.

A gastric drainage apparatus comprising a digestive tract stent as described above.

A stomach deflector comprises a containing shell (13), a releasing body and a pushing assembly, and is characterized in that the containing shell (13) is tubular, two ends of the containing shell (13) are provided with openings, a membrane tube (7) to be released and in a folded state and a digestive tract stent are arranged in the containing shell (13), the releasing body is arranged at the opening at the far end of the containing shell (13) and is connected with one end of the membrane tube (7), and the releasing body is made of a material which can be digested, absorbed or dissolved by intestinal tracts of a human body; the pushing assembly comprises an inner pipe (18), a middle pipe (17) and an outer pipe (16) which are sequentially sleeved and can move relative to each other, and one part of the inner pipe (18) is positioned in the containing pipe shell (13) and is connected with the releasing body; one end of the middle pipe (17) extends into the containing pipe shell (13) through the near-end opening of the containing pipe shell (13), and a push block (14) which is positioned in the containing pipe shell (13) and used for pushing the membrane pipe (7) is fixedly arranged at the end of the middle pipe (17); the outer tube (16) is positioned outside the containing shell (13) and one end of the outer tube is directly or indirectly fixedly connected to the proximal opening of the containing shell (13); the inner pipe (18) moves towards an operator along the axial direction of the inner pipe so as to enable the releasing body to be separated from the containing pipe shell (13), and the inner pipe (18) and the middle pipe (17) drive the membrane pipe (7) to be separated from the containing pipe shell (13) and spread and release.

Preferably, the housing case (13) is provided with a marking line (25) which is 2 to 5cm away from the distal opening of the housing case (13). Thus, the upper bracket and the lower bracket can be respectively released inside and outside the pylorus hole.

Preferably, the releaser comprises a releaser outer shell (11) and a releaser inner core (12), the releaser outer shell (11) is arranged at the distal opening of the containing tube shell (13), the releaser inner core (12) is connected with the inner tube (18), and the releaser outer shell (11) is covered outside the releaser inner core (12).

A method of releasing a gastric deflector, comprising a gastric deflector as described above, and the steps of:

1) the folded membrane tube and the digestive tract bracket are arranged in a containing tube shell (13), and the containing tube shell (13)

Is closed by the release body;

2) under the guidance of the guide wire, the releaser at the far end of the containing tube shell (13) is sent into the duodenum, and then the releaser and the membrane tube are pushed out of the containing tube shell;

3) withdrawing the containing tube shell until the marking line reaches the pylorus opening, pushing the lower bracket out of the containing tube shell, and leaving the lower bracket on the duodenal bulb;

4) and withdrawing the containing tube shell, pushing the upper bracket out of the containing tube shell, and allowing the upper bracket to stay outside the pylorus hole to complete the release.

By adopting the technical scheme, the upper bracket of the alimentary canal bracket can be fixed at the pylorus opening, and the lower bracket can be fixed at the duodenal bulb, so that the membrane tube can be stably fixed in the duodenum for a long time without damaging human tissues. And the outer layer of the bracket is provided with the covering film, so that the friction between the bracket and the tissue can be reduced, the tissue hyperplasia caused by long-term implantation can be avoided, and the later-stage taking out is convenient. And one end of the upper bracket fixed at the pylorus opening is arranged at the pylorus opening, and the other end is arranged in the stomach, the emptying time of the stomach can be delayed. The support has the advantages of good applicability, convenient manufacturing process, low cost and high production speed. Is connected with the alimentary canal membrane tube. The stent of the invention can be implanted into the digestive tract to treat endocrine diseases, such as diabetes, pancreatic islet dysfunction, obesity and the like, or lower digestive tract diseases, such as inflammation and the like. Compared with the prior art, the bracket of the invention can effectively prevent the hyperplasia of the implanted tissues, can be fixed at the pyloric opening and the duodenal papilla for a long time, and can not cause damage to the digestive tract of a human body. The implant has the advantages of good structural applicability, convenient manufacturing process, low cost, high production speed, guaranteed quality, convenient manufacturing and the like, is comfortable and compliant after being implanted, and cannot damage human tissues. In addition, the stent can be connected with an implantable membrane tube, so that the stimulation to the digestive tract can be reduced after the membrane tube is connected, and the lifting adjustment or the recovery of the stent is safer and more convenient.

Drawings

FIG. 1 is a schematic structural view of a gastric deflector of the present invention;

FIG. 2 is an enlarged schematic view of the distal end of the gastric deflector of the present invention;

FIG. 3 is a side view of a deployed configuration of example 1 of the digestive tract stent of the present invention (single line straw hat type stent);

FIG. 4 is a front view showing a deployed structure of example 1 of the digestive tract stent of the present invention (single-line straw hat type stent);

FIG. 5 is a side view of an unfolded structure of the digestive tract stent of example 2 of the present invention (a double-line straw hat type stent);

FIG. 6 is a front view showing a deployed configuration of example 2 of the digestive tract stent of the present invention (a double-lined straw hat type stent);

FIG. 7 is a side view of a deployed structure (three-wire trapezoidal stent) of example 3 of the digestive tract stent of the present invention;

FIG. 8 is a front view showing a deployed structure of example 3 of the digestive tract stent of the present invention (three-wire trapezoidal stent);

FIG. 9 is a side view of the deployed configuration of example 4 of the digestive tract stent of the present invention (double-line inverted trapezoid stent);

FIG. 10 is a side view of an unfolded configuration of the digestive tract stent of example 5 of the present invention (double-line trapezoidal stent);

FIG. 11 is a side view showing a developed structure of a digestive tract stent of example 6 of the present invention (double-line circular arc stent);

FIG. 12 is a schematic view showing the developed structure of the membrane tube and the digestive tract stent of the present invention;

FIG. 13 is a schematic view of the placement of the inventive membrane tube and digestive tract stent within the human digestive tract.

Description of reference numerals: 1-upper support; 2-lower support; 3-connecting wires; 4-elastic yarns; 5, stent coating; 6-a developing ring; 7-a membrane tube; 8-upper bracket recovery line; 9-lower support recovery line; 11-a releaser housing; 12-a release body core; 13-containing shell; 14-a push block; 15-screw cap; 16-an outer tube; 17-middle tube; 18-an inner tube; 21-rear handle; 22-middle handle; 23 limiting ball heads; 24 a front handle; 25 marking a line; 101-stomach; 102-pyloric opening; 103-duodenal bulb; 104-duodenal papilla; 105-duodenum; 106-jejunum.

Detailed Description

Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the drawings are illustrative and intended to be illustrative of the invention and are not to be construed as limiting the invention.

In the description of the present invention, it is to be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "clockwise", "counterclockwise", and the like, indicate orientations and positional relationships based on those shown in the drawings, and are used only for convenience of description and simplicity of description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, are not to be considered as limiting the present invention.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present invention, unless otherwise specified, "a plurality" means two or more unless explicitly defined otherwise.

In the present invention, unless otherwise expressly specified or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In the present invention, unless otherwise expressly stated or limited, "above" or "below" a first feature means that the first and second features are in direct contact, or that the first and second features are not in direct contact but are in contact with each other via another feature therebetween. Also, the first feature being "on," "above" and "over" the second feature includes the first feature being directly on and obliquely above the second feature, or merely indicating that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature includes the first feature being directly under and obliquely below the second feature, or simply meaning that the first feature is at a lesser elevation than the second feature.

The stomach fluid director as shown in fig. 1 and fig. 2 comprises a containing shell 13, a releaser and a pushing assembly, wherein the containing shell 13 is tubular, two ends of the containing shell 13 are open, a membrane tube 7 and a digestive tract stent which are to be released and are in a folded state are arranged in the containing shell 13, the releaser is arranged at the opening of the far end of the containing shell 13 and is connected with one end of the membrane tube 7, and the releaser is made of a material which can be digested, absorbed or dissolved by the intestinal tract of a human body; the pushing assembly comprises an inner pipe 18, a middle pipe 17 and an outer pipe 16 which are sleeved in sequence and can move relative to each other, and a part of the inner pipe 18 is positioned in the containing pipe shell 13 and connected with the releasing body; one end of the middle pipe 17 extends into the containing pipe shell 13 through the near-end opening of the containing pipe shell 13, and a push block 14 which is positioned in the containing pipe shell 13 and used for pushing the membrane pipe 7 is fixedly arranged at the end of the middle pipe 17; the outer tube 16 is positioned outside the containing shell 13 and one end of the outer tube is directly or indirectly fixedly connected to the proximal opening of the containing shell 13; wherein the inner tube 18 moves towards the operator along the axial direction thereof to disengage the release body from the housing tube 13, and the inner tube 18 and the middle tube 17 drive the membrane tube 7 to be released from the housing tube 13 and spread and release.

The housing case 13 is provided with a marking line 25 which is 2 to 5cm away from the distal opening of the housing case 13. The releaser comprises a releaser shell 11 and a releaser inner core 12, wherein the releaser shell 11 is arranged at the opening at the far end of the containing tube shell 13, the releaser inner core 12 is connected with the inner tube 18, and the releaser shell 11 is covered outside the releaser inner core 12.

An digestive tract stent of a gastric deflector having a pre-deployment shape and a post-deployment shape, as shown in fig. 3-11, comprises an upper stent 1, a lower stent 2 and a connecting member 3; under the shape after the expansion, upper bracket 1 is being equipped with first opening and being equipped with the second opening near its bottom near its top near its, upper bracket 1 below is located to lower carriage 2, lower carriage 2 is being equipped with the third opening near its top and being equipped with the fourth opening near its bottom, connect through a plurality of connecting piece 3 between upper bracket 1 and the lower carriage 2, membrane pipe 7 is connected to the fourth opening of lower carriage 2, and, upper bracket 1 after the expansion and lower carriage 2 can't be through open stomach pylorus mouth (namely the external diameter of upper bracket 1 after the expansion and lower carriage 2 is greater than open stomach pylorus mouth external diameter), connecting piece 3 can pass through the stomach pylorus mouth or wear to establish in stomach pylorus mouth department. Therefore, the bracket is divided into two parts to be fixed, one part (the upper bracket) is fixed at the pylorus opening of the stomach, the upper end of the membrane tube is firmly positioned in the alimentary canal when the alimentary canal wriggles, and the other part (the lower bracket) is fixed at the duodenal bulb part, so that the situation that food does not flow according to the designed channel because the lower section of the extending membrane tube easily returns to the stomach is avoided when the alimentary canal wriggles reversely. This support can provide certain holding power, but has certain compliance, and this support can guarantee that extension section membrane tube upper segment opening is fixed in the duodenum ball portion, can open and close along with the switching of intestinal, can not harm the intestinal wall. The extended membrane tube can treat metabolic diseases such as diabetes, obesity and the like by isolating food. The stent has good applicability, convenient manufacturing process, low cost and high production speed, is used for a stent of the alimentary canal, and can be connected with an implantable catheter.

The connecting piece 3 is a connecting line. The connecting line can be linear or thin strip with smaller cross section, thus not only ensuring the connection of the upper bracket and the lower bracket, but also not influencing the flow of food. In addition, in other embodiments, the connecting member may be a flexible membrane tube, a mesh-structured elastic tube, a flexible or elastic connecting band or sheet, etc., but the connecting member is still bulky even after being reduced, which may cause the stomach pylorus to be not tightly closed and discomfort to the patient, so the connecting wire is preferred. The connecting wire can be a metal wire such as nitinol, 304 stainless steel, etc., or a high polymer material wire with good elasticity and fatigue resistance such as polyethylene, nylon, etc.

The connecting wire is coated with a film. Therefore, the connecting line is isolated from the digestive tract tissue, the friction injury is reduced, and the probability of gastric ulcer is reduced. The connecting wire is coated with a film elastic material to prevent the connecting wire from being too sharp to damage the pyloric ring. Preferably, the coated film-like elastic material may be one or more materials such as silicone rubber, polyurethane, and the like.

The connecting piece 3 comprises a plurality of connecting wires, the upper ends of the connecting wires are respectively connected with the upper support 1, and the lower ends of the connecting wires are respectively connected with the lower support 2. Therefore, the upper bracket and the lower bracket are connected up and down by the connecting wires, so that the stress distribution is more uniform and the fixation is more reliable.

The position of the connecting member 3 corresponding to the gastric pyloric opening can generate elastic deformation conforming to the bending of the human body pyloric opening or reducing the outer diameter under the natural state. Like this, the connecting piece is through the design processing, and when human stomach pylorus was in basic closed state, the natural extension appearance of connecting piece can be complied with human pylorus mouth and the structure of lower part, can not strut the pylorus, causes the damage to the pylorus structure, can extend when upper or lower receiving pulling force, nevertheless has shape memory function, can resume original shape when upper or lower pulling force disappears.

The upper bracket 1 is in a cone cylinder shape, an inverted cone cylinder shape, a straight cylinder shape or a straw hat shape. Therefore, the longitudinal section view of the upper bracket is rectangular or trapezoidal, or the two sides of the upper bracket are arc-shaped rectangle-like or trapezoid-like, and the first opening, the second opening and the exposed corners of the upper bracket can be chamfered so as to avoid damaging tissues. Of course, in other embodiments, the upper bracket may have a spherical shape or other shapes.

The second opening outer diameter of the upper bracket 1 is larger than the first opening outer diameter. Like this, the characteristics of upper bracket are that the lower extreme opening is bigger, can block in the pylorus mouth and do not harm the pylorus tissue, have two openings from top to bottom, and food can pass through, but does not possess the function of storing food. The upper bracket is used for being clamped at the pylorus to pull the lower bracket, so as to indirectly pull the membrane tube in the duodenum and prevent the membrane tube from moving downwards or even being discharged in the peristalsis process of the digestive tract. The upper support lower opening support is larger than the diameter of the pyloric opening, and the diameter is preferably 20-50 mm. The diameter of the upper opening is preferred

20-30 mm. The height of the upper layer support 1 is preferably 5-15 mm.

The lower support is of a cylindrical structure. The lower frame structure is located inside the pyloric opening, specifically the duodenal bulb, and its main function is to provide an opening for the extended membranous canal through which food can enter the canal; secondly, in order to prevent the membrane tube from turning into the stomach from the duodenum, the position of the membrane tube is fixed in correspondence with the upper bracket; and thirdly, the upper bracket and the lower bracket are respectively limited inside and outside the pylorus opening of the stomach, so that the upper bracket cannot freely move in the stomach and is connected with the lower bracket and the membrane tube, and the upper bracket only has a small amount of displacement at the pylorus opening, thereby avoiding discomfort. The outer diameter of the upper opening (third opening) and the outer diameter of the lower opening (fourth opening) of the lower support are preferably the same, so that the lower support is in a straight cylinder shape, the longitudinal section view of the lower support is a rectangle or a rounded rectangle, and the upper part and the lower part of the lower support can be slightly rounded, mainly for preventing tissues from being damaged. However, the outer diameter of the upper opening (third opening) and the outer diameter of the lower opening (fourth opening) of the lower stent may be different, i.e., the side wall of the lower stent may have a certain taper or curvature to adapt to the duodenal bulb structure and facilitate the connection of the membranous tube.

The diameter of the lower support is 15-25 cm and is matched with the diameter of a human duodenal bulb, and the height of the lower support is 5-20 mm. Preferably 10mm, which is as small as possible to achieve the maximum comfort of the human body while satisfying the above functions.

The upper end of the connecting wire is fixedly connected with the top of the upper bracket 1 near the first opening, and the lower end of the connecting wire is fixedly connected with the top of the lower bracket 2 near the third opening. The bottom of the upper support is contracted to influence fixation when the alimentary canal support bears up-and-down tension in the preferable mode, and the bottom of the upper support is in contact with and supported by the elastic surface outside the pylorus opening, so that the damage of the alimentary canal tissue caused by connecting lines and the upper support can be reduced or avoided.

The upper end of the connecting wire is fixedly connected with the position, close to the first opening, of the top of the upper support 1, the connecting wire is wound through the mesh holes woven in the middle of the upper support 1, and the lower end of the connecting wire is fixedly connected with the position, close to the third opening, of the top of the lower support 2. Therefore, the further preferable mode can prevent the upper bracket from overturning up and down when the digestive tract bracket bears the up-and-down pulling force, thereby influencing the fixation, and the upper bracket is in contact support with the elastic surface outside the pylorus opening of the stomach, thereby reducing or avoiding the damage of the digestive tract tissue.

The upper and lower supports are of a mesh structure and can be processed by a weaving or cutting process, and the mesh structure can be in various shapes such as a diamond shape, a honeycomb shape, a Z shape and the like. The structure enables the stent to be freely compressed and expanded in the transverse direction and the longitudinal direction, and has good elasticity. Preferably, both the upper stent 1 and the lower stent 2 are knitted from elastic wires 4, and the outer surfaces of the elastic wires 4 are covered with a film, or the outer surfaces of the entire upper stent 1 and the entire lower stent 2 are covered with films. Therefore, the contact between the stent wire and tissues in the stomach can be isolated, the friction injury is reduced, the probability of gastric ulcer occurrence is reduced, the tissue hyperplasia is prevented, and the high polymer material film can be one or more of medical materials such as silica gel, TPU, TPE and the like. The braided wire is elastic wire conforming to biocompatibility and can be metal wire, high polymer material wire or degradable material wire.

The lower support and the membrane tube are fixedly connected through one or more of hot melting, hot pressing, ultrasonic welding, high-frequency welding, sewing or laser welding and the like.

Preferably, the upper end of the connecting wire is fixedly connected with the top of the upper bracket 1 near the first opening, and the lower end of the connecting wire is fixedly connected with the top of the lower bracket 2 near the third opening. The bottom of the upper support is contracted to influence fixation when the alimentary canal support bears up-and-down tension in the preferable mode, and the bottom of the upper support is in contact with and supported by the elastic surface outside the pylorus opening, so that the damage of the alimentary canal tissue caused by connecting lines and the upper support can be reduced or avoided.

Preferably, the upper end of the connecting wire is fixedly connected with the top of the upper support 1 close to the first opening, and after the connecting wire is wound through the middle of the upper support 1 to weave meshes, the lower end of the connecting wire is fixedly connected with the top of the lower support 2 close to the third opening. Therefore, the further preferable mode can prevent the upper bracket from overturning up and down when the digestive tract bracket bears the up-and-down pulling force, thereby influencing the fixation, and the upper bracket is in contact support with the elastic surface outside the pylorus opening of the stomach, thereby reducing or avoiding the damage of the digestive tract tissue.

The gastric fluid director includes a transporter and an internal cannula. The conveyor consists of a handle and a conveying catheter, and the built-in sleeve consists of a digestive tract stent and a membrane tube. The built-in cannula is passed through the delivery device into the body and left in the duodenum. In the invention, the digestive tract stent consists of an upper stent 1 and a lower stent 2, and the middle parts of the upper stent and the lower stent are connected by a connecting line 3. The upper and

lower stents

1, 2 may be woven from a resilient wire material or cut from a tubular material, which may be a medical implantable material, such as one or more of nitinol, 316 stainless steel, polyurethane, almag, etc.

The stent is woven or cut into a net structure, the net openings can be in a diamond shape, a hexagonal shape and other structures, and the stent can be freely stretched and compressed in the transverse direction and the longitudinal direction and can spontaneously return to a preset shape and size.

The upper support 1 can be fixed at the pylorus opening, the diameter of the lower end opening is larger than the maximum diameter of the opening of the pylorus opening, the shape includes but is not limited to various shapes shown in figures 3, 5, 7, 9, 10 and 11, and the principle is that the upper support can be fixed outside the pylorus opening and cannot fall into the pylorus opening but cannot damage the alimentary canal wall without affecting the normal functions of the stomach and the pylorus. Different stents can be selected according to the actual requirement in clinic.

Preferably, the lower opening of the upper support 1 is larger than the diameter of the pyloric opening, and the diameter is preferably 20-50 mm. The diameter of the upper opening is preferably 20-30 mm. The height of the upper layer support 1 is preferably 5-15 mm.

The lower bracket 2 is mainly used for being connected with the membrane tube, and the upper end of the membrane tube is kept in an open state after the ball part is opened, so that chyme can enter the membrane tube and is isolated from the wall of the digestive tract. The shape of the lower bracket 2 is designed to be mainly in accordance with the size of the replaced duodenal bulb and to be slightly larger than the diameter of the bulb.

Preferably, the diameter of the lower opening of the lower support frame 2 is larger than the diameter of the pyloric opening, and the diameter is preferably 20-30 mm. The diameter of the upper opening is preferably 20-30 mm. Slightly larger than the diameter of human duodenal bulb. The height of the upper layer support 2 is preferably 5-15 mm.

The connecting lines are used for connecting the upper bracket 1 and the lower bracket 2, and the number of the connecting lines can be 1, 2, 3 or more as shown in fig. 3 to 8. The main function is to connect upper bracket 1 and lower carriage 2, can be dragged upper bracket by upper support 1 through connecting wire 3 when lower carriage 2 is along with membrane tube 7 downstream, can drag lower carriage 2 through connecting wire 3 when upper bracket 1 is toward the come-up.

The connecting wire 3 may be made of a material meeting the implantation requirements of a human body, and preferably may be made of one or more materials such as nickel-titanium alloy, 316 stainless steel, polyurethane, silica gel, aluminum-magnesium alloy and the like.

In order to protect the pylorus opening from being cut or injured by the connecting wire 3, the outer layer of the connecting wire 3 is covered with a biocompatible soft material, preferably, the covering material can be one or more materials such as silica gel, polyurethane, polyethylene and the like.

In order to prevent hyperplasia and reduce the damage of the bracket friction to the tissue, the upper bracket 1 and the lower bracket 2 are covered with a protective film 5. The protective film is a material which meets the requirement of human body implantation. Preferably, the material of the coating film may be one or more materials such as silica gel, polyurethane, polyethylene, and the like.

The upper support 1 and the lower support 2 are spaced from each other at a certain distance, preferably, the distance between the lower end of the upper support 1 and the upper section of the lower support 2 is 20-60mm, and the upper support is preferably of a proper size according to different anatomical structures of a human body, and is larger than the height of a pyloric ring in principle, and the lower end of the lower support 2 is required to avoid a duodenal papilla 104.

The upper bracket 1 and the lower bracket 2 are provided with developing rings 6 which can be clearly positioned under X-ray, and the developing rings can be made of heavy metal materials which are harmless to human bodies, such as platinum, gold, tantalum and the like.

The upper ends of the upper support 1 and the lower support 2 are respectively provided with a recovery line 8 and a recovery line 9, the

recovery lines

8 and 9 are respectively sewed on the outermost rings of the upper support 1 and the lower support 2, and the supports can be taken out of the body and recovered through a specially-made recoverer or a nipper. When the recovery line is pulled in, the upper layer bracket 1 and the lower layer bracket 2 respectively retract, enter the transparent cap of the endoscope or a specific recovery device, and are taken out from the alimentary canal of the human body along with the endoscope. The

recovery threads

8 and 9 can be made of PE, nylon, terylene and other materials meeting the biocompatibility requirement.

1) the folded membrane tube and the digestive tract stent are arranged in the containing tube shell 13, and the distal opening of the containing tube shell 13 is closed by the releasing body;

2) under the guidance of the guide wire, the releaser at the far end of the containing tube shell 13 is sent into the duodenum, and then the releaser and the membranous tube are pushed out of the containing tube shell;

Before use, the membrane tube and the digestive tract stent are compressed and housed in the housing tube 13, the distal end being closed by the releaser housing 11 and the inner core 12. When in use, the distal releasing body enters the duodenum of the human body under the guidance of the guide wire. After the releaser is unlocked, the middle pipe 17 is unlocked again, the middle handle 22 is pushed, the first-stage pushing is completed firstly, the releaser and the membrane pipe 7 are pushed out of the containing pipe shell 13, the containing pipe shell 13 is retracted again until the marking line 25 reaches the pylorus opening, the lower support 2 is pushed out of the containing pipe shell 13, the second-stage pushing is completed, the lower support 2 is left at the duodenal bulb part 103, the upper support 1 is pushed out of the containing pipe shell 13, and the upper support 1 is left at the pylorus opening 102 to complete the releasing. Specifically, when the handle is operated, the limiting ball 23 is rotated from the 0 position to the 1 position, the middle pipe 17 is unlocked, the middle handle 22 is slowly pushed until the middle handle is pushed until the middle handle cannot be pushed under the resistance, the first stage pushing is completed, the releaser shell 11 and the membrane tube 7 are pushed out of the containing tube shell 13, the containing tube shell 13 is withdrawn again until the marking line 25 reaches the pylorus opening, the limiting ball 23 is rotated from the 1 position to the 2 position, the middle pipe 17 is unlocked again, the middle handle 22 is slowly pushed until the middle handle cannot be pushed under the resistance, the second stage pushing is completed, the lower bracket 2 is pushed out of the containing tube shell 13, the lower bracket 2 is left in the duodenum part 103, the limiting ball 23 is rotated again from the 2 position to the 3 position, the middle pipe 17 is unlocked, the middle handle 22 is jacked against the middle handle 24, the front handle 24 is pulled backwards, the upper bracket 1 is pushed out of the containing tube shell 13, and the upper bracket 1 is left in the pylorus opening, the release is completed. ) The membrane tube 7 reaches the upper section of the jejunum along with the peristalsis of the intestinal tract, the inner core 12 of the releaser is automatically dissolved at the moment, the outer shell 11 of the releaser is automatically separated from the membrane tube 7, and the release process is finished. The conveyor withdraws the human body from the oral cavity, and the built-in sleeve is left in the human body to play a role in isolating food.

The implantable catheter can play a role in isolating food in the intestinal tract, change the physiological flow direction of the food, eliminate the insulin resistance phenomenon of the body of a patient after being implanted for a period of time, promote the insulin secretion in the body of the patient in a food flowing mode, reduce the apoptosis of islet cells and increase the islet cell proliferation, recover the islet function, and cure metabolic diseases such as diabetes, obesity and the like. The tensile modulus of the implantable catheter is more than 250MP, the elongation is more than 230 percent, the material is soft, and the phenomena of nausea, vomiting, abdominal pain and the like caused after the implantable catheter is implanted in vivo can be obviously reduced.

The implantable catheter according to the present invention may be implanted in the digestive tract for the treatment of endocrine diseases such as diabetes, pancreatic islet dysfunction, obesity, etc., or lower digestive tract diseases such as inflammation, etc. Compared with the prior art, the implantable catheter has the advantages of simple structure, good structural applicability, convenient manufacturing process, low cost, high production speed, guaranteed quality, convenient manufacturing and the like, is comfortable and compliant after being implanted, and does not cause damage to human tissues.

Compared with the prior art, the upper bracket is fixed at the pylorus opening, and the lower bracket is fixed at the duodenal bulb part and connected with the membrane tube. Two supports can not free activity, can only have the displacement of minim scope, and upper strata support can not get into the pylorus the inside particularly, and lower floor's support can not get into the pylorus outside to there is the connecting wire in the centre, and the displacement scope can not exceed the connecting wire scope. The height of the joint of the upper bracket and the lower bracket is 1-8cm, and the upper bracket and the lower bracket are different according to different human body structures, so that the upper bracket is positioned outside the pylorus, the lower bracket is positioned at the duodenal bulbar part, and the lowest end of the lower bracket can not reach the papilla part of the duodenum, and the normal function of the papilla is not influenced. The functional principle of the invention is that a membrane tube is implanted in the duodenum and is extended to the far end of the digestive tract, and food is isolated by the membrane tube, so that the metabolic mechanism is changed, and the invention has the function of treating metabolic diseases such as obesity, diabetes and the like. The stent mainly has the functions of fixing the membrane tube and opening the membrane tube to allow food to enter the implanted membrane tube. The length of the extended membrane tube (sleeve) is 600mm-1600mm, and the membrane tube (sleeve) is a main functional structure. The upper bracket is smaller, so that pressure can not be caused in the stomach, the structure with the small lower part and the large upper part of the digestive tract bracket is easy to empty, and food is not easy to be detained. The pylorus hole is fixed by a bracket, the upper part and the lower part correspond to each other, and the position of the membrane tube is not easy to displace.

Compared with the digestive tract stent disclosed in patent documents with publication numbers CN102335052, CN104382671, CN204671331, CN205359721 and the like, the present invention has different functions and structures: in the invention, the upper bracket and the lower bracket have different shapes; the connecting line is arc-shaped and needs to conform to the anatomical structure of the pylorus; the number of the connecting lines is generally more than two so as to be connected stably; the fixing device is used for fixing pyloric opening, in particular to an intestinal isolation membrane tube, and the product is particularly applied to treating metabolic diseases such as diabetes, obesity and the like. The lower bracket needs to be connected with a section of soft membrane tube to achieve the treatment purpose.

In the description herein, references to the description of the term "one embodiment," "some embodiments," "an example," "a specific example," or "some examples," etc., mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the terms used above do not necessarily refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention, and that variations, modifications, substitutions and alterations can be made in the above embodiments by those of ordinary skill in the art without departing from the principle and spirit of the present invention. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A digestive tract stent of a gastric deflector, which has a pre-deployment shape and a post-deployment shape, is characterized by comprising an upper stent (1), a lower stent (2) and a connecting piece (3); under the unfolded shape, the height of the upper support (1) is 5-15mm, a first opening is arranged on the upper support (1) close to the top of the upper support and a second opening is arranged on the lower support close to the bottom of the upper support, the lower support (2) is arranged below the upper support (1), a third opening is arranged on the lower support (2) close to the top of the lower support and a fourth opening is arranged on the lower support close to the bottom of the lower support, the upper support (1) and the lower support (2) are connected through a plurality of connecting pieces (3), the fourth opening of the lower support (2) is connected with a membrane tube (7), the unfolded upper support (1) and the unfolded lower support (2) cannot pass through an opened stomach pylorus opening, and the connecting pieces (3) can pass through the stomach pylorus opening or penetrate through the stomach pylorus opening; the connecting pieces (3) are a plurality of connecting lines; the upper ends of the connecting wires are respectively connected with the upper bracket (1), and the lower ends of the connecting wires are respectively connected with the lower bracket (2); the position of the connecting piece (3) corresponding to the gastric pyloric opening can generate elastic deformation which conforms to the bending of the human body pyloric opening or reduces the outer diameter in a natural state; the upper end of the connecting wire is fixedly connected with the position, close to the first opening, of the top of the upper support (1), the connecting wire is wound through the middle of the upper support (1) to weave meshes, and the lower end of the connecting wire is fixedly connected with the position, close to the third opening, of the top of the lower support (2).

2. The digestive tract stent of a gastric deflector of claim 1, wherein the connecting line is externally covered with a membrane.

3. The digestive tract stent of the gastric deflector according to claim 1, wherein the upper stent (1) is in the shape of a cone, an inverted cone, a straight cylinder or a straw hat.

4. The digestive tract stent of a gastric deflector according to claim 1, wherein the second opening outer diameter of the upper stent (1) is larger than the first opening outer diameter.

5. A gastric deflector comprising the digestive tract stent of any one of claims 1-4.