CN107126306A - Stomach air deflector and its support - Google Patents

Abstract

The invention discloses a gastric deflector and a bracket thereof. The bracket is a mesh tube made of braided silk, and comprises an upper section of the bracket and a lower section of the bracket. The outer diameter of the upper section of the bracket is larger than the outer diameter of the lower section of the bracket. This program can provide good support and fix it in the duodenum. The bracket has good compliance and fatigue resistance, has a certain supporting force, but also has a certain degree of flexibility, and can be stably fixed to the duodenum for a long time. move without damaging the bowel wall. And it can be connected with duodenal membrane tubes, and can be used for treating metabolic diseases such as diabetes and obesity. The stent has good applicability, convenient manufacturing process, low cost and fast production speed, and is used for the stent of the digestive tract, and the stent can also be connected with an implantable catheter.

Description

Gastric diverter and its holder

technical field

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

Background technique

It is known that diabetes is a disease that has gradually been paid attention to by people in recent years. It is one of the diseases of the rich and the rich. It is derived from the continuous improvement of living standards in modern civilized society. , overnutrition, reduced activity, resulting in a non-infectious epidemic, specifically, diabetes refers to a metabolic disease characterized by high blood sugar. It results from defective insulin secretion or impaired biological action, or both. Diabetes can lead to chronic damage and dysfunction of various tissues, especially eyes, kidneys, heart, blood vessels, and nerves. Diabetes is usually accompanied by obesity and many complications, which pose a great threat to people's health. Data show that in China alone, among adults over 20 years old, the incidence of diabetes is 9.7%, and the incidence population is about 150 million. It is known that the common way to improve obesity and diabetes is to control diet, increase exercise, and assist certain drug treatment, which requires long-term persistence of the patient, and once the diet control and exercise are stopped, it is easy to cause recurrence and weight rebound. Long-term drugs or The use of insulin also brings heavy economic burden and inconvenience to patients.

Another treatment method is gastric bypass surgery, which has a very good effect on eradicating type 2 diabetes and improving obesity. In 2001, the International Diabetes Federation officially recommended metabolic surgery (including gastric bypass surgery) As a treatment for obesity with type 2 diabetes, gastric bypass surgery, as a surgical operation, will cause wounds to the human body, so there are many risks such as: death, intestinal obstruction, anastomotic leakage, pulmonary embolism, deep vein thrombosis, portal vein injury, respiratory system, etc.

At present, foreign countries also treat diabetes by implanting a structure similar to a gastric diverter in the gastrointestinal tract. However, the structure of the gastric diverter is complicated, and usually requires multiple pull wires to be operated at the same time to realize its function. After professional guidance, without rich experience, it is very likely that there will be operational errors, which will increase the discomfort of patients and make it difficult to operate. In addition, the high manufacturing cost and technical barriers make it difficult to carry out large-scale promotion in the country. Therefore, how to provide a method for treating diabetes that the patient will not have more discomfort during implementation, or provide a device for treating diabetes with simple structure, easy operation, and low cost has become an urgent problem to be solved.

In addition, the main components of the gastric diverter in the prior art are made of fluoroplastics, which have relatively poor processing performance, and it is very difficult to process them into large-diameter thin-walled tubes, and even if they can be processed, the cost is very high. The performance of fluoroplastics determines that the material is relatively hard, and the comfort and compliance after implantation are poor. After implantation, patients are prone to nausea and vomiting, and may cause harm to the human body.

At present, there are also some products at home and abroad that treat diabetes by implanting a product similar to a gastric deflector structure in the gastrointestinal tract. A flexible catheter made of polymer material is implanted into the duodenum, and the flexible catheter is generally passed A small metal stent is attached to the duodenal bulb. At present, this product is produced by American GI Company and has been used clinically, and there are many similar designs in China. The stent is a V-shaped or wave-shaped structure, which is fixed to the duodenal bulb through barbs. The risk of this design is that the barb penetrates the duodenum, causing certain damage to the human digestive tract. When the barb is taken out, the barb will easily damage the esophagus and cause the esophagus to tear. If the catheter accidentally falls into the distal duodenum, jejunum, or even the colon, it is likely to cause intestinal obstruction. Therefore a better design is needed to avoid these risks.

Contents of the invention

In order to solve the above technical problems, the object of the present invention is to provide a gastric deflector and its bracket, which can provide good supporting force and be fixed to the duodenum. The bracket has good compliance and fatigue resistance, has a certain supporting force, but also has a certain degree of flexibility, and can be stably fixed to the duodenum for a long time. move without damaging the bowel wall. And it can be connected with duodenal membrane tubes, and can be used for treating metabolic diseases such as diabetes and obesity. The stent has good applicability, convenient manufacturing process, low cost and fast production speed, and is used for the stent of the digestive tract, and the stent can also be connected with an implantable catheter.

Aiming at the above-mentioned problems in the prior art, the inventors of the present invention, after careful study, found that the elastic wire is used to weave a tubular stent with varying diameters, and the weaving route is helical around the central axis, and the supporting force is provided by elastic elasticity and structure , can sufficiently solve the above problems, thus completing the present invention.

Specifically, the present invention adopts the following technical solutions:

A bracket for a gastric deflector, characterized in that the bracket is a mesh tube made of braided wire (103), including a bracket upper section (101) and a bracket lower section (102), and the outer diameter of the bracket upper section (101) is greater than Support lower section (102) outer diameter.

Preferably, the braided wire is a biocompatible elastic wire, which may be a metal wire, a polymer material wire or a degradable material wire.

As a preference, a developing ring (106) is provided on the upper section (101) or lower section (102) of the bracket, which can position the bracket under X-rays, and the developing ring is preferably platinum, gold or tantalum.

Preferably, a recovery line (105) is provided on the upper section (101) of the bracket. It can be removed under the endoscope through a special retriever or endoscope grasping forceps.

As a preference, the diameter of the upper section of the stent (101) is 25 to 40 mm, which is larger than the upper section of the duodenum. The diameter of the lower section of the stent (102) is preferably 15 to 25 cm, which is equivalent to the diameter of the upper section of the duodenum. The diameter of the upper section of the stent (101) is 5-15mm larger than the bracket lower section (102).

Preferably, the mesh tube is braided by one wire, spiraling clockwise or counterclockwise.

Preferably, the number of the mesh tubes is 10-30.

Preferably, the bracket upper section (101) is in the shape of an inverted trapezoid, a sphere, an ellipse or a rectangle with rounded corners.

Preferably, the bracket is fixedly connected to the membrane tube (31) by suturing, heat pressing, ultrasonic welding or laser welding.

A gastric deflector, characterized in that it includes a housing, a release body and a pushing assembly, wherein the housing (1) is tubular, and one end of the housing (1) has a first opening (11), The other end has a second opening (13), and the housing (1) is provided with a folded film tube (31) to be released and a support (32) as described above, and the release body (2) is arranged on At the first opening (11) and connected to one end of the membrane tube (31), the release body (2) is made of a material that can be digested, absorbed or dissolved by the human intestine; the push assembly includes sequentially An inner tube (41), a middle tube (42) and an outer tube (43) that are sheathed and can move relative to each other, a part of the inner tube (41) is located in the housing (1) and is connected to the release body (2); one end of the middle tube (42) extends into the housing (1) through the second opening (13), and this end of the middle tube (42) is fixedly located at The block piston (12) used to push against the membrane tube (31) in the housing (1); the outer tube (43) is located outside the housing (1) and one end thereof is fixedly connected to On the second opening (13); wherein, the inner tube (41) moves toward the operator along its axial direction so that the release body (2) is disengaged from the housing (1), and the inner tube ( 41) and the middle tube (42) drive the membrane tube (31) to escape from the casing and unfold, and release it at a designated position in the human intestinal tract.

Because the present invention adopts the above technical scheme, the bracket has good compliance and fatigue resistance, has a certain supporting force, but also has a certain flexibility, and can be stably fixed to the duodenum for a long time. It moves with the movement of the duodenum and will not damage the intestinal wall. Moreover, the bracket has good applicability, convenient manufacturing process, low cost and fast production speed. It is connected with the membrane tube of the digestive tract and implanted into the digestive tract, and can be used to treat metabolic diseases such as diabetes and obesity. The stent of the present invention can be implanted in the digestive tract to treat endocrine diseases, such as diabetes, pancreatic islet dysfunction, obesity, etc., or lower digestive tract diseases, such as inflammation. Compared with the prior art, the stent of the present invention can effectively reduce the risk of damage to the digestive tract mucosa, easy tearing of the esophagus, and intestinal obstruction caused by existing products and designs. And it has the advantages of good structural applicability, convenient manufacturing process, low cost, fast production speed, guaranteed quality, convenient manufacturing, etc., and has good comfort and compliance after implantation, and will not cause damage to human tissues. In addition, the stent can also be connected with an implantable membrane tube, which can reduce the irritation to the digestive tract after connecting the membrane tube, and make lifting adjustment or recovering the stent safer and more convenient.

Description of drawings

Fig. 1 is a structural sectional view of an embodiment of the present invention;

Fig. 2 is the overall structure schematic diagram of the embodiment of the present invention;

Fig. 3 is a cross-sectional view of a release body of a structure according to an embodiment of the present invention;

4 is a cross-sectional view of another structure of the release body of the embodiment of the present invention;

Figure 5 is a schematic structural view of the implantable catheter of the present invention;

Figure 6 is a schematic structural view of an embodiment of the stent of the present invention;

Figure 7 is a schematic structural view of another embodiment of the stent of the present invention;

Fig. 8 is a schematic structural view of another embodiment of the stent of the present invention.

Explanation of reference signs:

1-housing 11-first opening 12-block piston 13-second opening 14-nut 2-release body 22-inner core 221-membrane tube connection part 222-main body 23-outer shell 231-annular step 31- Membrane tube 32-support 41-inner tube 411-damping tube 412-second extension 42-middle tube 421-first extension 43-outer tube 44-first handle 45-Luer connector 46-second handle ; 101-stent upper section 102-stent lower section 103-braided silk 104-number of heads 105-recycling line 106-developing ring.

detailed description

Embodiments of the present invention are described in detail below, examples of which are shown in the drawings, wherein the same or similar reference numerals designate the same or similar elements or elements having the same or similar functions throughout. The embodiments described below by referring to the figures are exemplary and are intended to explain the present invention and should not be construed as limiting the present invention.

In describing the present invention, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", " The orientations or positional relationships indicated by "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "clockwise", "counterclockwise" are based on the attached The orientation or positional relationship shown in the figure is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be construed as a reference to this invention. Invention Limitations.

In addition, the terms "first" and "second" are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features. Thus, a feature defined as "first" and "second" may explicitly or implicitly include one or more of these features. In the description of the present invention, unless otherwise specified, "plurality" means two or more, unless otherwise clearly defined.

In the present invention, unless otherwise clearly specified and limited, terms such as "installation", "connection", "connection" and "fixation" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection , or integrally connected; it may be mechanically connected or electrically connected; it may be directly connected or indirectly connected through an intermediary, and it may be the internal communication of two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.

In the present invention, unless otherwise clearly specified and limited, a first feature being "on" or "under" a second feature may include direct contact between the first and second features, and may also include the first and second features Not in direct contact but through another characteristic contact between them. Moreover, "above", "above" and "above" the first feature on the second feature include that the first feature is directly above and obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. "Below", "beneath" and "under" the first feature to the second feature include that the first feature is directly below and obliquely below the second feature, or simply means that the first feature has a lower level than the second feature.

A gastric deflector as shown in FIG. 1 includes a housing, a release body, a pushing assembly and an implantable catheter, wherein the housing 1 is tubular, and one end of the housing 1 has a first opening 11 , the other end has a second opening 13, the implantable catheter in a folded state to be released is set in the housing 1, the release body 2 is set at the first opening 11 and is connected with the membrane tube 31 Connected at one end, the release body 2 is made of materials that can be digested and absorbed or dissolved by the human intestine; the push assembly includes an inner tube 41, a middle tube 42 and an outer tube 43 that are sheathed in sequence and can move relative to each other A part of the inner tube 41 is located in the housing 1 and connected to the release body 2; one end of the middle tube 42 extends into the housing 1 through the second opening 13, and the middle This end of the tube 42 is fixedly provided with a stopper piston 12 for pushing against the membrane tube 31 in the housing 1; the outer tube 43 is located outside the housing 1 and one end thereof is fixedly connected to the above the second opening 13; wherein, the inner tube 41 moves toward the operator along its axial direction so that the release body 2 is disengaged from the housing 1, and the inner tube 41 and the middle tube 42 drive the membrane tube 31 escapes from the casing and unfolds, and releases at a designated position in the human intestinal tract.

Wherein, the movement of the inner tube 41 drives the movement of the release body 2, thereby affecting the membrane tube 31, so that the membrane tube 31 is gradually expanded, and the middle tube 42 moves along its axial direction and drives the stopper piston 12 to push Press against the film tube 31 (that is, push against the end of the film tube 31 not connected to the release body 2 ), and push the film tube 31 out of the casing 1 .

The second opening 13 of the housing 1 is protrudingly provided with a boss, the nut 14 is screwed on the boss, and the outer tube 43 passes through the nut 14 and the joint of the housing 1. The second opening 13 is fixedly connected. Specifically, the fixed connection method between the outer tube 43 and the second opening 13 may be adhesive heat shrink or other methods.

In this embodiment, each part of the housing 1 and the push assembly can be made of one or more composite materials of polyurethane, polyethylene, and fluoropolymer, which have good support, pushability, and good Toughness, smooth surface, can be pushed well under the endoscope or the natural cavity of the human body, not easy to discount, and has good maneuverability.

Specifically, when the gastric deflector of this embodiment is used, a guide wire is passed through the inner tube 41, and the operator inserts the whole device from the mouth of the human body, and then cooperates with the guide wire and the gastroscope to close the casing 1 Guide to the duodenum and/or the upper part of the gastric pylorus near the gastric pylorus in the human body, wherein the guide wire guides and supports the pushing component, helping the inner tube 41 to move in the human esophagus and gastrointestinal tract, thereby guiding the shell The body 1 and the membrane tube 31 arrive at the designated position smoothly. Then operate the middle tube 42 and the inner tube 41 in the pushing assembly to release the membrane tube 31 in the housing 1 into the intestinal tract of the human body, and at the same time operate the inner tube 41 to drive the movement of the release body 2 to unfold the folded membrane tube 31, Moreover, after entering the human intestinal tract, the release body 2 made of materials that can be digested and absorbed by the human intestinal tract can melt or decompose in a short time when encountering digestive tract liquid or water, and finally be digested and absorbed by the human intestinal tract, thereby Complete the release process of the membrane tube 31, so as to form a film-like diversion channel on the inner wall of the human intestinal tract, prevent and slow down the absorption of nutrients in the intestinal tract, adjust the secretion of digestive enzymes, and thus play a role in regulating blood sugar, blood lipids and controlling body weight role, thereby preventing the occurrence of diabetes. The release body 2 is composed of materials that meet the biological safety of the human body, can be digested by the human body or can be decomposed in the body, and have no toxic or side effects on the human body, for example, can be made of edible gelling agent, soybean protein powder, starch , polysaccharide compound, glycerol, amylopectin or amylopectin and other one or more compounds. When formulating, add one or more of the above compounds, together with water, fat-soluble substances, etc., and solidify in the corresponding mold to form a hard solid structure. At the same time, the release body 2 can also be made of materials that can be dissolved in the human body and not absorbed at all, but are completely excreted from the body without any toxic side effects on the human body.

As shown in Figures 3 to 4, the release body 2 includes an inner core 22 and an outer shell 23, the inner core 22 has a main body part 222 and a membrane tube connection part 221 formed by extending the main body part 222, the membrane The tube connecting portion 221 is fixedly connected to one end of the membrane tube 31 ; the shell 23 is wrapped around the main body portion 222 , and the shell 23 is connected to the first opening 11 and is easily broken under force.

Preferably, referring to Fig. 3 and Fig. 4, the surface of the main body 222 of the inner core 22 and the surface of the outer shell 23 facing the release direction of the membrane tube 31 are all smooth surfaces, such a structure is easier to release the body 2 in the human body. movements in the gut.

Specifically, referring to Fig. 3 and Fig. 4, the outer ring of the main body 222 is approximately spherical or hemispherical. outside the main body 222; in this embodiment, the outer contour of the main body 222 is approximately hemispherical, and the outer contour of the housing 23 is approximately hemispherical. Of course, the shapes of the main body 222 and the housing 23 are also It can be a shape close to a sphere or a nearly hemisphere.

Preferably, referring to Fig. 3 and Fig. 4, the outer contour of the main body part 222 is hemispherical, the membrane tube connection part 221 is connected to the plane part of the main body part 222, and the shell 23 is hemispherical and covers Outside the spherical portion of the main body 222 , an annular step 231 is formed on the outer edge of the end surface of the hemispherical shell 23 , and the annular step 231 abuts against the second opening 13 of the housing 1 .

Specifically, referring to Fig. 3 and Fig. 4, in the above-mentioned embodiment, the connection mode between the inner core 22 and the outer shell 23 can be screw connection or card connection. Specifically, Fig. 3 shows the screw connection state. The inner core 22 and the outer shell 23, wherein, the inner core 22 and the outer shell 23 both include a part with an approximate spherical profile and a part with a cylindrical profile, and the threads that engage with each other are arranged on the part where the inner core 22 and the outer shell 23 have a cylindrical profile Above, Fig. 4 shows the inner core 22 and the outer shell 23 in the clamping state, wherein, the outer surface of the inner core 22 and the inner wall of the outer shell 23 are provided with a snap-fit structure capable of engaging with each other. It should be noted that the inner core The connection between 22 and the outer shell 23 may not be limited to screw connection or clamping, but may also adopt taper fit or other connection means, for example, the outer shell 23 and the inner core 22 fit through a taper. Other similar structures are not described here one by one.

Preferably, referring to FIG. 2 , one end of the inner tube 41 passes through the membrane tube connection part 221 of the inner core 22 , the main body part 222 and the outer shell 23 in sequence, and protrudes from the first opening 11 . The endoscope inspects the human intestinal tract from the protruding end of the inner tube 41 . In this embodiment, the inner tube 41 and the membrane tube connection part 221 of the inner core 22, the main body part 222 and the outer shell 23 are in a tight fit or interference connection, so that the inner tube 41 can drive the When the releasing body 2 moves toward the release direction of the membrane tube 31, it pulls the membrane tube 31 to unfold and stretch out from the housing 1. Of course, the membrane tube connection part 221, the main body part 222 and the outer shell 23 are connected to the inner tube. 41 can be connected in many different ways.

Preferably, referring to FIG. 2 , the part of the inner tube 41 that passes through the inner core 22 is covered with a damping tube 411 . In this embodiment, the inner tube 41 is connected to the inner core 22 through the damping tube 411 A tight fit is formed between them, and the damping tube 411 is used to increase the sliding friction force between the release body 2 and the inner tube 41 , thereby improving the ability of the inner tube 41 to pull the release body 2 to move.

In this embodiment, the damping tube 411 can be made of one or more elastic materials in polyurethane, silica gel, TPE, etc., and the surface can be physically or chemically treated to increase friction, so that the membrane tube 31 can release Before, the damping tube 411 keeps the release body 2 and the inner tube 41 in a relatively static state.

Preferably, as shown in FIG. 2 , the other end of the membrane tube 31 is fixedly connected to a bracket 32, the bracket 32 is an elastic memory alloy braided bracket 32, and has a net-like tubular profile. Specifically, the bracket 32 can be Made of nickel-titanium alloy, stainless steel or other elastic metals, or other qualified memory alloys, the material meets the requirements of biocompatibility and is suitable for long-term implantation in the human body; the bracket 32 is rhombus, hexagon or honeycomb Arranged regularly with equal shapes and structures, it is placed on the bulb of the duodenum of the human body. The bracket has certain elasticity and can be deformed with the peristalsis of the intestinal tract. At the same time, it has a certain supporting force and can be fixed on the bulb of the duodenum.

Specifically, when the middle tube 42 is operated, the middle tube 42 drives the stopper piston 12 to move the bracket 32 and the film tube 31 together from the housing 1 to push outward. For the bracket 32, when the front end of the bracket 32 is about to leave the housing 1, the operation of the middle tube 42 should be stopped. At this time, it is necessary to adjust the position of the housing 1 so that the bracket 32 can be fixed on the duodenal bulb of the human body when it leaves the housing 1. The bracket has a certain degree of elasticity and can be deformed with the peristalsis of the intestinal tract, and at the same time has a certain support Force, can be fixed in the duodenal bulb.

Specifically, in the above-mentioned embodiment, the specific structure of the movement of the middle pipe 42 and the inner pipe 41 includes: the middle pipe 42 has a first protruding end 421 protruding from the other end of the outer pipe 43, and the first The extension end 421 is connected with a first handle 44, and the first handle 44 is provided with a Luer connector 45 that communicates the outside world with the inside of the middle tube 42. The inner tube 41 has a The protruding second protruding end 412 is connected with the second handle 46 .

Specifically, during operation, the tube 42 and the inner tube 41 move to release the film tube 31. A certain amount of water or saline can also be injected into the Luer connector 45, and the water or saline passes through the gap between the middle tube 42 and the inner tube 41. The gap between them enters the inside of the membrane tube 31, which accelerates the release of the membrane tube 31 in the duodenum, and also accelerates the dissolution or decomposition of the release body 2. Specifically, when the film tube 31 is released, the film tube 31 and the release body 2 move from the duodenum to the jejunum along with the peristalsis of the human intestinal tract, and this time is about 1-10 minutes. During this process, the physiological saline will flow toward the membrane tube 31 along the gap between the inner tube 41 and the middle tube 42 , which will also accelerate the peristalsis of the membrane tube 31 and the release body 2 toward the jejunum, thereby accelerating the release of the membrane tube 31 . The film tube 31 can contain a developing material, such as barium sulfate, bismuth carbonate or tungsten, which can be developed under X-rays, and the release body 2 can also contain a developing material, which can accurately show the release body 2 under X-rays. The position is convenient for the operator to operate.

The gastric deflector of the present invention can be operated in the following manner. First, the operator pulls the inner tube 41 toward the operator so that when the second opening 13 of the casing 1 squeezes the casing 23, the ring-shaped step 231 of the casing 23 The release body 2 is disengaged from the casing 1 by fracture, and then the inner tube 41 is operated to move the release body 2 away from the operator (ie, in the patient's body), so that one end of the membrane tube 31 extends from the casing 1 out and drives the membrane tube 31 to expand the membrane tube 31, at this time, the middle tube 42 is operated to drive the stopper piston 12 to move, and the stopper piston 12 pushes the other end of the membrane tube 31 located in the housing 1 The bracket 32 is used to push the membrane tube 31 out of the casing 1 as a whole. It should be noted here that when the membrane tube 31 has been fully stretched and the stopper piston 12 pushes against the bracket 32 and moves to the first opening 11 of the casing 1 position (membrane tube 31 is about to be fully released), it is necessary to ensure that the stent 32 also reaches the designated release position in the human intestinal tract (specifically refers to the proper position of the duodenum near the gastric pylorus in the human stomach and/or the upper part of the gastric pylorus) , then push the second handle 46 away from the operator, so that the bracket 32 can be completely disengaged from the housing 1, so that the bracket 32 is fixed on the duodenal bulb of the human body. The bracket has certain elasticity and can be The membrane tube 31 that can be fixed in the stretched state of the duodenal bulb can be placed in the human digestive tract for 1-12 months, depending on the improvement of the condition or The actual situation is adjusted.

In this embodiment, another operation mode that can be used is to operate the middle tube 42 and the inner tube 41 at the same time, so that the stopper piston 12 pushes against one end of the membrane tube 31 located in the housing 1 to push the membrane tube 31 out of the housing 1 At the same time, the movement of the inner tube 41 drives the release body 2 to move, and the release body 2 affects the bracket 32 at the other end of the membrane tube 31, so that the membrane tube 31 protrudes from the housing 1 while unfolding, and finally in the intestinal tract of the human body. The designated release position pushes the membrane tube 31 out of the housing 1 as a whole.

Described implantable conduit, as shown in Figure 5, comprises film tube (31), and one end of film tube (31) connects support (32), and this film tube (31) comprises high density polyethylene (HDPE), low density Polyethylene (LDPE), linear low-density polyethylene (LLDPE), barium sulfate, etc. Wherein, the high-density polyethylene (HDPE), also known as low-pressure polyethylene, refers to a thermoplastic resin with a density in the range of 0.940-0.976 g/cm ³ and an elastic modulus in the range of 800-1200 MPa. Wherein, the low-density polyethylene (LDPE), also known as high-pressure polyethylene, refers to a thermoplastic resin with a density in the range of 0.910-0.940 g/ ^cm3 , an elastic modulus of 200-500 MPa, and a melt index of 0.2-0.5 g/cm3. min. Wherein, the linear low-density polyethylene (LLDPE) refers to a thermoplastic resin with a density in the range of 0.915-0.935 g/cm ³ and an elastic modulus in the range of 100-400 MPa.

Preferably, the weight ratio of the high-density polyethylene, low-density polyethylene, linear low-density polyethylene and barium sulfate can be 1.5:4:4:0.5, preferably 1:4:4:1, more preferably 0.5 :4:4:1.5. Within this range, an implantable catheter with excellent performance can be obtained.

Preferably, the outer diameter of the membrane tube according to the invention may be 10 mm to 40 mm, preferably 15 mm to 35 mm, more preferably 15 mm to 30 mm. Within this range, it can be fully applied to the human digestive tract without causing damage to human tissues.

Preferably, the length of the membrane tube according to the invention may be from 200 mm to 1500 mm, preferably from 200 mm to 1300 mm, more preferably from 300 mm to 1200 mm. To the extent that the catheter according to the invention can be placed anywhere in the alimentary canal, the site of action can be defined.

Preferably, the membrane tube according to the invention may have a wall thickness of 0.001 mm to 0.1 mm, preferably 0.005 mm to 0.05 mm, more preferably 0.01 mm to 0.03 mm. Within this range, the catheter according to the present invention can sufficiently ensure flexibility and maintain sufficient strength.

The preparation method of the film tube is that high-density polyethylene, low-density polyethylene, linear low-density polyethylene and barium sulfate are mixed according to the above-mentioned certain weight ratio, and then blown.

The implantable catheter can be implanted in the digestive tract. The alimentary canal includes esophagus, stomach, duodenum, jejunum, ileum, etc., so that different positions of the implantable catheter can correspond to esophagus, stomach, duodenum, jejunum, ileum, etc., respectively. Since the catheter has different functions at different locations, it can act differently on different parts of the digestive tract. The implantable catheter can isolate food in the intestinal tract, change the physiological flow direction of food, and after a period of time after implantation, the phenomenon of insulin resistance in the patient's body will be eliminated, and the way that food flows through can also promote insulin resistance in the patient's body. secrete, reduce the apoptosis of islet cells and make them proliferate, restore the function of islets, and cure metabolic diseases such as diabetes and obesity. The tensile modulus of the implantable catheter is more than 250MP, the elongation rate is greater than 230%, the material is soft, and the nausea, vomiting and abdominal pain caused by implantation in the body can be significantly reduced.

The implantable catheter according to the present invention can be implanted in the alimentary canal to treat endocrine diseases, such as diabetes, pancreatic islet dysfunction, obesity, etc., or lower alimentary canal diseases, such as inflammation. Compared with the prior art, the implantable catheter of the present invention has the advantages of simple structure, good structural applicability, convenient manufacturing process, low cost, fast production speed, guaranteed quality and convenient manufacture, and is implantable The rear comfort and compliance are good, and it will not cause damage to human tissues.

In addition, the barium sulfate contained in the implantable catheter of the present invention has properties such as being visible under X-rays. Additionally, the implantable catheters of the present invention may be attached to stents. After the stent is connected, the irritation to the digestive tract can be reduced, and it is safer and more convenient to lift and adjust or recover the stent.

As shown in FIG. 5 , the membrane tube 31 is connected to one end of the bracket 32 by one or a combination of sewing, heat pressing, ultrasonic welding, or laser welding.

As shown in Figures 6 to 8, this embodiment provides a digestive tract stent 32 divided into two parts, an upper section 101 and a lower section 102. Its diameter is preferably 15 to 25 cm, which is close to or slightly larger than that of the duodenum. The diameter of the upper section 101 is greater than that of the lower section 102 , preferably, the diameter of the upper section 101 is 5-15 mm larger than that of the lower section 102 .

As a preference, the stent can be in the funnel shape of FIG. 6, that is, the upper section 101 is in an inverted trapezoidal shape, and the diameter of the upper section 101 is larger than that of the lower section 102. As a preference, the diameter of the upper section 101 is 25-40 mm, and the diameter is larger than that of the upper section of the duodenum. , the diameter of the lower section 102 is 15-25 cm, equivalent to the diameter of the upper duodenum, and the diameter of the upper section 101 is 5-15 mm larger than that of the lower section 102. The upper section 101 is fixed to the duodenal bulb with a rounded rectangle. The inverted trapezoidal design can achieve a smooth transition, maximize the avoidance of damage to the digestive tract wall caused by long-term implantation, and provide maximum support. The lower section is connected to the membrane tube, the membrane tube 31 Extended to the lower duodenum or upper jejunum.

Preferably, the stent 32 can also be spherical as shown in FIG. 7, that is, the upper section 101 is elliptical, and the diameter of the upper section 101 is larger than that of the lower section 102. As a preference, the diameter of the upper section 101 is 25-40 mm, and the diameter is larger than that of the upper section of the duodenum. The diameter of the lower section 102 is 15-25 cm, equivalent to that of the duodenum, and the diameter of the upper section 101 is 5-15 mm larger than that of the lower section. The ball in the upper section 101 is fixed on the duodenal bulb. The arc-shaped design can maximize the avoidance of damage to the digestive tract wall caused by long-term implantation. The excessive arc shape can provide good support. The lower section 102 is connected to the membrane tube 31. The membrane tube 31 extends to the lower part of the duodenum or the upper part of the jejunum.

Preferably, the stent can be in the shape of a wine glass as shown in Figure 8, that is, the upper section 101 is a rounded rectangle, and the diameter of the upper section 101 is larger than that of the lower section 102. The diameter is 15-25 cm, equivalent to the diameter of the upper duodenum, and the diameter of the upper segment 101 is 5-15 mm larger than that of the lower segment 102 . The upper section 101 is fixed to the duodenal bulb with a rounded rectangle. The rounded rectangular design maximizes the contact area between the stent and the duodenal bulb, which can maximize the avoidance of damage to the digestive tract wall caused by long-term implantation. The lower section 102 connects the membrane tube, the membranous tube extends to the lower duodenum or upper jejunum.

As a preference, the height of the upper section 101 of the bracket 32 is 5-15mm, and the height of the lower section 102 is also 5-15mm, and the specific height can be slightly adjusted according to the specific physiological and anatomical structure of the human body.

The bracket 32 is regularly arranged in the shape of rhombus, hexagon or honeycomb, and is placed on the duodenum bulb of the human body. The bracket 32 has certain elasticity and can deform with the peristalsis of the intestinal tract, and at the same time has a certain support Force, can be fixed in the duodenal bulb, to prevent sliding.

The braided wire 103 of the stent 32 may be made of metal material, polymer material, or degradable material. The metal wire material can be stainless steel wire, nickel-titanium alloy wire, the polymer material can be polymer material such as PE (polyethylene), PU (polyurethane), PTFE (polytetrafluoroethylene), and the degradable material can be PPDO (polydioxanone), PLLA (polylactic acid), PGA (polyglycolic acid) and the like. The material meets the requirements of biocompatibility, can be implanted in the human body for a long time, has good toughness and elasticity, has a certain supporting force in the digestive tract, and is connected with the membrane tube 31 to prevent sliding.

Preferably, the braided wire 103 is selected from nickel-titanium alloy, and the nickel-titanium alloy wire is preferably a nickel-titanium alloy that meets the requirements of long-term implantation, and the preferred austenite transformation point is 0-10 degrees.

The stent 32 is braided on the mold by wires, and then heat-treated and shaped. The shaped product can have the structure shown in FIGS. 6 to 8 or a similar structure that conforms to the physiological anatomy of the human body. It has a certain support force and compression force in the horizontal and vertical directions. It can be deformed with the peristalsis of the human intestinal tract. Duodenal bulb 113 .

Specifically, the braided circuit of the stent 32 is in the shape of a cycloid rotating around the central axis. The rotation direction of the gyratory body may be a clockwise rotation direction or a counterclockwise rotation direction when viewed from the head end portion.

As shown in FIG. 7 , the stent 32 has a recovery line 105 , and the recovery line 105 is sutured to the outermost circle of the upper section 101 of the stent 32 , and the stent can be taken out of the body and recovered by a special recoverer or grasping forceps. When pulled into the recovery line, the bracket 32 retracts as a whole, enters the endoscope transparent cap or a specific recovery device, and is taken out from the human digestive tract along with the endoscope. The recycling thread 105 can be made of materials such as PE, nylon, polyester, etc. that meet biocompatibility requirements.

As a preference, the surface of the stent 32 can be covered with a film to facilitate later removal. Preferably, the membrane can be made of various soft materials such as silica gel, fluoroplastic, PE, TPU, etc. that meet the biocompatibility of the human body. The thickness of the film is 0.01-0.2mm.

The stent 32 is braided by a single wire, preferably, the number of ends 104 of the stent 32 may be preferably 10-30 ends, less preferably 15-25 ends, and most preferably 18-24 ends.

The bracket 32 is provided with a developing ring 106, which can be clearly positioned under X-rays. The developing ring 106 can be made of platinum, gold, tantalum and other heavy metal materials that are harmless to the human body.

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

Although the embodiments of the present invention have been shown and described above, it can be understood that the above embodiments are exemplary and cannot be construed as limitations to the present invention. Variations, modifications, substitutions, and modifications to the above-described embodiments are possible within the scope of the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included within the protection scope of the present invention.

Claims (10)

1. a kind of support of stomach air deflector, it is characterised in that the support is the netted pipe being compiled into by braided wires (103), including Support epimere (101) and support hypomere (102), support epimere (101) external diameter are more than support hypomere (102) external diameter.

2. the support of a kind of stomach air deflector according to claim 1, it is characterised in that described braided wires are to meet biology The elastic yarn of compatibility, can be wire, high polymer material silk either degradation material silk.

3. a kind of support of stomach air deflector according to claim 1, it is characterised in that the support epimere (101) or Support hypomere (102) is provided with developing ring (106).

4. the support of a kind of stomach air deflector according to claim 1, it is characterised in that set on the support epimere (101) There is exhausting line (105).

5. a kind of support of stomach air deflector according to claim 1, it is characterised in that support epimere (101) diameter For 25~40mm, diameter is more than duodenum epimere, support hypomere (102) diameter preferably 15~25cm, with duodenum epimere Quite, support epimere (101) diameter is than support hypomere (102) big 5~15mm for diameter.

6. the support of a kind of stomach air deflector according to claim 1, it is characterised in that described netted Guan Youyi roots silk is compiled Knit and form, in spiral clockwise or counterclockwise.

7. the support of a kind of stomach air deflector according to claim 1, it is characterised in that the head number of the netted pipe is 10- 30.

8. the support of a kind of stomach air deflector according to claim 1, it is characterised in that the support epimere (101) is in Trapezoidal, spheroidal, ellipse or round rectangle.

9. a kind of support of stomach air deflector according to claim 1, it is characterised in that the support passes through suture, hot pressing, super Sound wave is welded or laser welding is fixedly connected with membrane tube (31).

10. a kind of stomach air deflector, it is characterised in that including housing, releaser and push component, wherein, the housing (1) is in Tubulose, one end of the housing (1) has the first opening (11), and the other end, which has in the second opening (13), the housing (1), to be set Put the membrane tube (31) in folded state to be released and support as claimed in any one of claims 1-9 wherein (32), the release Body (2) is arranged on first opening and (11) place and is connected with one end of the membrane tube (31), and the releaser (2) is by can be by The material that human body intestinal canal is digested and assimilated or dissolved is made；The push component includes being arranged successively and each other can be relative Inner tube (41), middle pipe (42) and the outer tube (43) of motion, said inner tube (41) part be located at the housing (1) in and with it is described Releaser (2) is connected；One end of the middle pipe (42) is stretched into the housing (1) through the described second opening (13), and it is described in The end of pipe (42) is fixed with the block piston (12) for being used in the housing (1) pushing against the membrane tube (31)；Institute State outer tube (43) positioned at the housing (1) outside and its one end be fixedly connected on it is described second opening (13) on；Wherein, said inner tube (41) operator is axially facing along it to move so that the releaser (2) and the housing (1) disengagement, inner tube (41) and middle pipe (42) drive the membrane tube (31) to deviate from and deploy out of housing, and discharged in the specified location of human body intestinal canal.