WO2019196380A1 - 胃导流器及其消化道支架、释放方法 - Google Patents

胃导流器及其消化道支架、释放方法 Download PDF

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Publication number
WO2019196380A1
WO2019196380A1 PCT/CN2018/111746 CN2018111746W WO2019196380A1 WO 2019196380 A1 WO2019196380 A1 WO 2019196380A1 CN 2018111746 W CN2018111746 W CN 2018111746W WO 2019196380 A1 WO2019196380 A1 WO 2019196380A1
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WO
WIPO (PCT)
Prior art keywords
gastric
digestive tract
opening
tube
bracket
Prior art date
Application number
PCT/CN2018/111746
Other languages
English (en)
French (fr)
Inventor
左玉星
鲁艳
Original Assignee
杭州糖吉医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201810326731.3A external-priority patent/CN108635092B/zh
Priority claimed from CN201810336514.2A external-priority patent/CN108938163B/zh
Application filed by 杭州糖吉医疗科技有限公司 filed Critical 杭州糖吉医疗科技有限公司
Priority to PL18914681.4T priority Critical patent/PL3777784T3/pl
Priority to US16/981,322 priority patent/US11517461B2/en
Priority to ES18914681T priority patent/ES2934842T3/es
Priority to EP18914681.4A priority patent/EP3777784B1/en
Publication of WO2019196380A1 publication Critical patent/WO2019196380A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0036—Intragastrical devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
    • A61F5/0079—Pyloric or esophageal obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0089—Instruments for placement or removal

Definitions

  • the invention relates to the technical field of medical devices, in particular to a gastric diverter for treating endocrine diseases (such as diabetes, islet dysfunction, obesity, etc.) or lower gastrointestinal diseases (such as inflammation), and a digestive tract support thereof and a release method thereof .
  • endocrine diseases such as diabetes, islet dysfunction, obesity, etc.
  • lower gastrointestinal diseases such as inflammation
  • diabetes is a disease that has gradually been valued by people in recent years. It is one of the rich diseases. It is derived from the continuous improvement of living standards in modern civilized society. After people's lives are rich, they eat well and eat well. A non-infectious epidemic caused by overnutrition and reduced activity. Specifically, diabetes refers to a metabolic disease characterized by high blood sugar. It is caused by defects in insulin secretion or its biological effects, or both. Diabetes can cause chronic damage and dysfunction in various tissues, especially the eyes, kidneys, heart, blood vessels, and nerves. Diabetes is often accompanied by obesity and many complications, posing a great threat to people's health.
  • gastric bypass Another treatment is gastric bypass.
  • the use of gastric bypass has a very good effect on eradicating type 2 diabetes and improving obesity.
  • the International Diabetes Federation officially recommended metabolic surgery (including gastric bypass surgery).
  • gastric bypass surgery as a surgical procedure, can cause wounds in the human body, and thus has many risks such as death, intestinal obstruction, anastomotic leakage, pulmonary embolism, deep vein thrombosis, and portal vein. Injury, respiratory system, etc.
  • the products of the American GI company and the domestic similar patent design have designed the stent to be self-shaped, with barbs, and fixed in the duodenal bulb in the form of barbs.
  • the advantage of this design is that Adapted to most patients, but there are certain problems, because the barbed too long will cause the digestive tract perforation, too short is easy to fall off, according to the clinical literature of the US GI company, the design is about 10% clinically
  • the rate of shedding, as well as removal and implantation, as well as accidental shedding can cause a certain percentage of digestive tract tears and bleeding, and there is a certain risk of use. If the catheter accidentally falls into the distal part of the duodenum, the jejunum, and even the colon, it is easy to cause intestinal obstruction. Therefore a better design is needed to circumvent these risks.
  • Patent documents published as CN103298518, CN105263439, WO2017/052694, and the like disclose an intragastric device comprising: a porous structure comprising a top, a bottom and an inner portion and having a pre-expanded shape with a first volume and a band greater than a developed shape of the second volume of the first volume, wherein in the expanded shape, the porous structure includes at least one first opening adjacent the top and at least one second opening adjacent the bottom Passing food through the at least one first opening into the porous structure, through the interior, and exiting the porous structure through the at least one second opening; and a sleeve having a flexible elongated body having a proximal end of a third opening, a distal end having a fourth opening, and a cannula interior, wherein the cannula is coupled to the porous structure such that the at least one second is withdrawn
  • the porous structure (scaffold) is expanded into a cylinder, an ellipsoid, a sphere cube or a cuboid, occupying a considerable volume in the stomach and freely movable in the stomach.
  • the diameter of the porous structure is larger than the diameter of the open pylorus, and the bottom of the porous structure
  • the cannula membrane tube extends through the pylorus to the duodenum.
  • the intragastric device further includes an anti-migration component positioned at a junction of the porous structure and the sleeve and attached to the porous structure or the sleeve or both, wherein the migration prevention
  • the component includes a compressed pre-deployment configuration and an expanded post-expansion configuration and is designed to be adjacent to the patient's pylorus and prevent the porous structure from migrating to and through the pylorus.
  • the spherical stent is entirely in the stomach, outside the pylorus, and there is a cannula (membrane tube) in the pylorus.
  • the mechanism of action is mainly to implant a mesh-shaped spherical memory alloy braiding device in the stomach, and the spherical stent is coated.
  • the spherical stent has a certain volume in the stomach to form a feeling of satiety, and the food can be stored in the spherical stent for a certain period of time, thereby reducing the intake of food and functioning to treat metabolic diseases such as obesity and diabetes.
  • the membrane tube used for food drainage is its secondary functional structure.
  • the above intragastric device has the following problems: First, the memory alloy material having a self-expanding shape has a certain mechanical force and weight, and if the volume is large enough to occupy the stomach volume, there is a certain pressure on the stomach, and the implant is implanted. In the stomach, there will be pressure on the gastric mucosa, which is very likely to cause ulceration of the digestive tract. Second, the food stays in the balloon for a long time. Although it can slow the emptying of the stomach, it is easy to cause bacteria to breed and cause inflammation. Third, The device is not fixed in the pyloric or the duodenal bulb.
  • the lower stretched membrane tube is easily returned to the stomach due to the reverse motility of the digestive tract, causing the food to not flow according to the design channel.
  • the volume of the membrane tube at the pylorus is relatively small. Large, especially after the content of food, pyloric foreign body sensation is obvious and easy to cause pyloric closure, bile reflux and other diseases.
  • the patent documents disclosed in CN102335052, CN104382671, CN204671331, CN205359721, etc. disclose a digestive tract support, the main body is formed by a plurality of support units having a certain rigidity and support, and connecting parts which are easy to bend, and the two ends of the connecting parts are respectively Connected to the corresponding bracket unit, the main body is a straight cylindrical structure that is easy to bend or an easy-to-bend composite structure composed of a cylinder and a cone; the bracket unit is woven from a metal tube or is woven from a wire.
  • the structure of the connecting member is woven from a soft metal wire or a plastic wire, and the connecting wire is generally woven perpendicularly to the plane of the upper and lower brackets.
  • the stent is used for the treatment of stenosis or obstruction of the digestive tract, and functions as an expansion and support stenosis.
  • it is implanted into the digestive tract as an independent product, and is not connected to the membrane tube, and because of its high support strength and deformation, it is not easily deformed.
  • the object of the present invention is to provide a gastric diverter and a digestive tract support and a release method thereof.
  • the stent is composed of two parts, one part is fixed to the gastric pylorus and the other part is fixed to the duodenal bulb.
  • the stent can provide a certain supporting force, but has certain flexibility.
  • the stent can ensure that the upper segment of the extension membrane tube is fixed to the duodenal bulb, and can open and close with the opening and closing of the intestinal tract. Damage to the intestinal wall.
  • the extended membrane tube can treat metabolic diseases such as diabetes and obesity by isolating food.
  • the stent has good applicability, convenient manufacturing process, low cost and high production speed, and is used for the stent of the digestive tract, and the stent can also be connected with the implantable catheter.
  • the inventors of the present invention have carefully studied and designed a two-stage stent, which is woven using an elastic silk material and fixed by both the pyloric and duodenal bulbs.
  • Layer coating prevents tissue proliferation and can fully solve the problem that the stent and the membrane tube are easy to fall off or proliferate, and the outer edge is smooth and has no damage to human tissues.
  • the present invention has been completed.
  • the present invention employs the following technical solutions:
  • a digestive tract stent of a gastric diverter having a pre-deployed shape and a deployed shape, including an upper bracket, a lower bracket and a connecting member; in the unfolded shape, the upper bracket is first adjacent to the top thereof Opening and having a second opening adjacent to the bottom thereof, the lower bracket is disposed under the upper bracket, the lower bracket is provided with a third opening near the top thereof and a fourth opening is adjacent to the bottom thereof, and the upper bracket and the lower bracket pass A plurality of connecting members are connected, a fourth opening of the lower bracket is connected to the membrane tube, and the unfolded upper and lower brackets are unable to pass through the open gastric pylorus (ie, the outer diameter of the expanded upper and lower brackets is larger than Zhang
  • the connector can be passed through the stomach pylorus or worn at the stomach pylorus.
  • the stent is fixed in two parts, and a part (upper bracket) is fixed to the gastric pylorus.
  • a part upper bracket
  • the upper end of the membrane tube is firmly positioned in the digestive tract, and the other part (lower bracket) is fixed on the duodenal bulb.
  • the lower extension membrane tube is easily returned to the stomach, causing the food to not flow according to the design channel.
  • the stent can provide a certain supporting force, but has certain flexibility. The stent can ensure that the upper segment of the extension membrane tube is fixed to the duodenal bulb, and can open and close with the opening and closing of the intestinal tract. Damage to the intestinal wall.
  • the extended membrane tube can treat metabolic diseases such as diabetes and obesity by isolating food.
  • the stent has good applicability, convenient manufacturing process, low cost and high production speed, and is used for the stent of the digestive tract, and the stent can also be connected with the implantable catheter.
  • the connector is a connecting wire.
  • the connecting line can be linear or thin strip with a small cross-sectional area, so as to ensure the connection of the upper and lower brackets without affecting the flow of food.
  • the connecting member may also be a flexible film tube, an elastic tube of a mesh structure, a connecting strip or a connecting piece having flexibility or elasticity, etc., but these connecting pieces are still bulky even if they are reduced, which may cause gastric pyloric closure. It is not strict and the patient is uncomfortable, so the connecting line is preferred.
  • the connecting wire may be a wire, such as a nickel-titanium alloy, a 304 stainless steel, or the like, or a polymer material wire having good elasticity and fatigue resistance, such as polyethylene, nylon, or the like.
  • the connecting line is coated on the outside.
  • the outer wire is covered with a film-like elastic material to prevent the connecting wire from being too sharp and damage the pyloric ring.
  • the coated film-based elastic material may be one or more materials such as silica gel, polyurethane, and the like.
  • the connecting member comprises a plurality of connecting lines, the upper ends of the plurality of connecting lines are respectively connected to the upper bracket, and the lower ends of the plurality of connecting lines are respectively connected to the lower bracket.
  • the upper and lower brackets are connected by a plurality of connecting wires, and the force distribution is more uniform, and the fixing is more reliable.
  • the position of the connecting member corresponding to the pyloric port of the stomach is naturally deformed in conformity with the bending or narrowing of the outer diameter of the pyloric port of the human body.
  • the connecting member is shaped, and when the human gastric pylorus is in a substantially closed state, the natural extended shape of the connecting member can conform to the structure of the pyloric port and the lower part of the human body, and does not open the pylorus, causing damage to the pylorus structure, above or below. It can be stretched when it is pulled, but it has a shape memory function, and it can restore its original shape when the upper or lower pull force disappears.
  • the upper bracket has a tapered cylindrical shape, an inverted cone shape, a straight cylindrical shape or a straw hat shape.
  • the longitudinal cross-sectional view of the upper bracket is rectangular, trapezoidal, or a rectangular-like, trapezoid-like shape with curved sides, and the first opening, the second opening, and the exposed corners of the upper bracket can be rounded to avoid Damage to tissue.
  • the upper bracket may also be spherical or other shape.
  • the outer diameter of the second opening of the upper bracket is larger than the outer diameter of the first opening.
  • the upper bracket is characterized by a relatively large opening at the lower end, which can be stuck in the pyloric port without damaging the pyloric tissue, and has two openings on the upper and lower sides, and the food can pass, but does not have the function of storing food.
  • the function of the upper bracket is to pull the lower bracket at the pyloric port and indirectly pull the membrane tube in the duodenum to prevent the membrane tube from moving down or even discharging during the peristalsis of the digestive tract.
  • the upper bracket lower mouth bracket is larger than the pyloric port diameter, and the diameter is preferably 20-50 mm.
  • the upper mouth diameter is preferably 20-30 mm.
  • the height of the upper shelf 1 is preferably 5-15 mm.
  • the lower bracket is a cylindrical structure.
  • the lower stent structure is located inside the pylorus, specifically the duodenal bulb.
  • the main function of the structure is that the membrane tube has an opening for the extension, and the food can enter the membrane tube through the opening; the second is to prevent the membrane tube from The duodenum is turned into the stomach and echoes with the upper bracket to fix the position of the membrane tube.
  • the upper and lower brackets are respectively limited to the inside and outside of the gastric pylorus, so that the upper stent cannot move freely in the stomach, and the lower stent and the membrane tube Connected, the upper bracket has only a small amount of displacement at the pyloric port to avoid discomfort.
  • the outer diameter of the upper opening (third opening) of the lower bracket and the outer diameter of the lower opening (fourth opening) are preferably the same, such that the lower bracket has a straight cylindrical shape, and the longitudinal cross-sectional view of the lower bracket is rectangular or rounded rectangular, and the upper and lower sides may have A little rounding is mainly to prevent damage to the tissue.
  • the outer diameter of the upper opening (third opening) of the lower bracket and the outer diameter of the lower opening (fourth opening) may also be different, that is, the side wall of the lower bracket may have a certain taper or curvature to accommodate the duodenal bulb. Structure and easy connection of the membrane tube.
  • the lower stent has a diameter of 15 to 25 cm, which matches the diameter of the duodenal bulb of the human body, and the height of the lower stent is 5-20 mm. Preferably, 10 mm, the height is as small as possible to meet the above functions, to achieve the maximum comfort limit of the human body.
  • the distance between the lower end of the upper bracket and the upper end of the lower bracket is 20-60 mm, and the appropriate size is preferred according to different anatomical structures of the human body.
  • the principle is to be greater than the height of the pyloric ring, and the lower end of the lower bracket should avoid the duodenal papilla.
  • the upper and lower brackets are mesh-shaped structures, which can be processed by a weaving or cutting process, and the mesh structure can be various shapes such as a diamond shape, a honeycomb shape, and a zigzag shape.
  • This structure allows the stent to be freely compressed and expanded in the lateral and longitudinal directions, and has good elasticity.
  • the upper bracket and the lower bracket are both made of elastic yarn, the outer surface of the elastic filament is coated, or the outer outer surfaces of the upper bracket and the lower bracket are respectively coated. This can isolate the contact between the stent wire and the tissue in the stomach, reduce friction damage, reduce the probability of gastric ulcer, and prevent tissue proliferation.
  • the polymer material membrane can be one or more of medical materials such as silica gel, TPU, and TPE.
  • the braided wire is a biocompatible elastic yarn, which may be a wire, a polymer material wire or a degradable material wire.
  • the lower bracket is fixedly connected to the film tube by stitching, hot pressing, ultrasonic welding or laser welding.
  • the upper end of the connecting wire is fixedly connected to the top of the upper bracket near the first opening, and the lower end of the connecting wire is fixedly connected to the top of the lower bracket near the third opening.
  • Such a preferred manner can prevent the bottom contraction of the upper stent from being affected by the upper and lower force of the digestive tract support, and the bottom of the upper stent is in contact with the outer surface of the gastric pylorus, which can reduce or avoid damage to the digestive tract tissue by the connecting line and the upper bracket.
  • the upper end of the connecting wire is fixedly connected to the top of the upper bracket near the first opening, and the connecting wire is fixedly connected to the top of the lower bracket near the third opening after the mesh is formed through the middle of the upper bracket.
  • Such a further preferred manner can prevent the upper stent from being upside down and affecting the fixation when the gastrointestinal stent is subjected to the pull-up force, and the upper stent is in contact with the outer surface of the gastric pylorus, which can reduce or avoid damage to the digestive tract tissue.
  • the upper bracket and the lower bracket are provided with a developing ring for positioning the bracket under X-rays, and the developing ring is preferably platinum, gold or tantalum or the like.
  • the upper bracket is provided with an upper bracket recovery line
  • the lower bracket is provided with a lower bracket recovery line. This allows the digestive tract stent and the membrane tube to be removed by a special collector or endoscope grasping forceps.
  • a gastric flow guide comprising a digestive tract support as described above.
  • a gastric flow guide comprising a receiving tube shell, a releasing body and a pushing assembly, wherein the receiving tube shell has a tubular shape, and both ends of the receiving tube shell are open, and the receiving tube shell is arranged to be released a membrane tube in a folded state and a digestive tract stent as described above, the release body being disposed at a distal opening of the housing tube and connected to one end of the membrane tube, the release body being capable of being intestine Made of a material that is digested or dissolved;
  • the push assembly includes an inner tube, a middle tube, and an outer tube that are sequentially sleeved and movable relative to each other, the inner tube being partially located in the housing tube and being Disconnecting the body; one end of the middle tube extends into the receiving tube through the proximal opening of the receiving tube, and the end of the middle tube is fixedly disposed in the receiving tube for pushing a push block of the film tube; the outer tube is located outside the receiving tube case and one end thereof is directly or
  • the receiving tube case is provided with a marking line which is 2 to 5 cm away from the distal opening of the housing tube. This facilitates the release of the upper and lower brackets inside and outside the pyloric port.
  • the release body comprises a release body shell and a release inner core
  • the release body shell is disposed at a distal opening of the housing tube
  • the release body core is connected to the inner tube
  • the release body shell is wrapped around the core of the release body.
  • a method of releasing a gastric deflector comprising a gastric deflector as described above, and the steps of:
  • the upper bracket of the digestive tract stent can be fixed in the pyloric port, and the lower stent can be fixed on the duodenal bulb, ensuring that the membrane tube can be stably fixed in the duodenum for a long time, and Will not damage human tissue.
  • the outer layer of the stent has a film, which can reduce the friction between the stent and the tissue, avoid tissue proliferation caused by long-term implantation, and facilitate the later extraction.
  • the upper bracket fixed to the pylorus mouth is open at the pyloric port at one end, and the other end is open in the stomach, which can also delay the emptying time of the stomach, compared with the traditional gastric diverter or the duodenal cannula. It has a better therapeutic effect on metabolic diseases such as diabetes and obesity.
  • the bracket has good applicability, convenient manufacturing process, low cost and fast production speed.
  • the stent of the present invention can be implanted into the digestive tract for the treatment of endocrine diseases such as diabetes, islet dysfunction, obesity, etc., or lower gastrointestinal diseases such as inflammation.
  • the stent of the invention can effectively prevent the proliferation of the tissue after implantation, and can be fixed at the pyloric and duodenal nipples for a long time without causing damage to the human digestive tract.
  • the utility model has the advantages of good structural applicability, convenient production process, low cost, fast production speed, guaranteed quality and convenient manufacture, and has good comfort and compliance after implantation, and does not cause damage to human tissues.
  • the stent can be connected to the implantable membrane tube, and the membrane tube can be connected to reduce the stimulation of the digestive tract, and the lifting adjustment or recovery stent is safer and more convenient.
  • Figure 1 is a schematic view showing the structure of a gastric deflector of the present invention
  • FIG. 2 is a schematic enlarged view of the distal end of the gastric deflector of the present invention
  • Figure 3 is a side view of the unfolded structure of the digestive tract stent of the present invention (single-line straw hat type bracket);
  • Figure 4 is a front view of the unfolded structure of the digestive tract stent of the present invention (single-line straw hat type bracket);
  • Figure 5 is a side view of the expanded structure of the digestive tract stent of the present invention (two-line straw hat type bracket);
  • Figure 6 is a front view of the unfolded structure of the digestive tract stent of the present invention (two-line straw hat type bracket);
  • Figure 7 is a side view of the expanded structure of the digestive tract stent of the present invention (three-line trapezoidal stent);
  • Figure 8 is a front elevational view (three-line trapezoidal bracket) of the expanded structure of the digestive tract stent of the present invention.
  • Figure 9 is a side view of the expanded structure of the digestive tract stent of the present invention (two-line inverted trapezoidal stent);
  • Figure 10 is a side view of the expanded structure of the digestive tract stent of the present invention (two-line trapezoidal stent);
  • Figure 11 is a side view of the expanded structure of the digestive tract stent of the present invention (two-line circular arc-shaped bracket);
  • Figure 12 is a schematic exploded view showing the structure of the membrane tube and the digestive tract stent of the present invention.
  • Figure 13 is a schematic view showing the placement of the membrane tube and the digestive tract stent in the human digestive tract of the present invention.
  • first and second are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, features defining “first” and “second” may include one or more of the features either explicitly or implicitly. In the description of the present invention, "a plurality” means two or more unless otherwise specifically defined.
  • the terms “installation”, “connected”, “connected”, “fixed” and the like shall be understood broadly, and may be either a fixed connection or a detachable connection, unless explicitly stated and defined otherwise. , or connected integrally; may be mechanical connection or electrical connection; may be directly connected, or may be indirectly connected through an intermediate medium, and may be internal communication between the two elements.
  • installation shall be understood broadly, and may be either a fixed connection or a detachable connection, unless explicitly stated and defined otherwise.
  • , or connected integrally may be mechanical connection or electrical connection; may be directly connected, or may be indirectly connected through an intermediate medium, and may be internal communication between the two elements.
  • the specific meanings of the above terms in the present invention can be understood on a case-by-case basis.
  • the first feature "on” or “under” the second feature may include direct contact of the first and second features, and may also include first and second features, unless otherwise specifically defined and defined. It is not in direct contact but through additional features between them.
  • the first feature "above”, “above” and “above” the second feature includes the first feature directly above and above the second feature, or merely indicating that the first feature level is higher than the second feature.
  • the first feature “below”, “below” and “below” the second feature includes the first feature directly below and below the second feature, or merely the first feature level being less than the second feature.
  • a gastric deflector includes a receiving tube casing 13, a releasing body, and a pushing assembly.
  • the receiving tube casing 13 has a tubular shape, and both ends of the receiving tube casing 13 are open.
  • a film tube 7 and a digestive tract support in a folded state to be released are disposed in the accommodating case 13, and the release body is disposed at a distal opening of the accommodating case 13 and connected to one end of the film tube 7,
  • the release body is made of a material that can be absorbed or dissolved by the human intestinal tract;
  • the push assembly includes an inner tube 18, a middle tube 17 and an outer tube 16 that are sequentially sleeved and movable relative to each other, the inner tube 18 a portion is located in the receiving tube casing 13 and connected to the release body; one end of the middle tube 17 extends into the receiving tube casing 13 through the proximal opening of the receiving tube casing 13, and the middle tube 17 The end is fixedly provided with a push block 14 in the receiving tube casing 13 for
  • the receiving tube case 13 is provided with a marking line 25 which is 2 to 5 cm away from the distal opening of the housing tube 13.
  • the release body includes a release body casing 11 and a release body core 12, the release body casing 11 is disposed at a distal opening of the accommodation tube casing 13, and the release body core 12 is connected to the inner tube 18, and the release body casing 11 is covered in the release body. Outside the core 12.
  • a digestive tract stent of a gastric diverter having a pre-deployed shape and a deployed shape, including an upper bracket 1, a lower bracket 2, and a connecting member 3;
  • the upper bracket 1 is provided with a first opening near its top and a second opening near its bottom, the lower bracket 2 is disposed below the upper bracket 1, and the lower bracket 2 is provided with a third opening near its top and adjacent to it
  • the bottom is provided with a fourth opening, the upper bracket 1 and the lower bracket 2 are connected by a plurality of connecting members 3, the fourth opening of the lower bracket 2 is connected to the membrane tube 7, and the unfolded upper bracket 1 and lower bracket 2 are unable to Through the open gastric pylorus (i.e., the outer diameter of the deployed upper and lower stents 1 and 2 is larger than the outer diameter of the open gastric pylorus), the connector 3 can be passed through the gastric pylorus or through the gastric pylorus.
  • the stent is fixed in two parts, and a part (upper bracket) is fixed to the gastric pylorus.
  • a part upper bracket
  • the upper end of the membrane tube is firmly positioned in the digestive tract, and the other part (lower bracket) is fixed on the duodenal bulb.
  • the lower extension membrane tube is easily returned to the stomach, causing the food to not flow according to the design channel.
  • the stent can provide a certain supporting force, but has certain flexibility. The stent can ensure that the upper segment of the extension membrane tube is fixed to the duodenal bulb, and can open and close with the opening and closing of the intestinal tract. Damage to the intestinal wall.
  • the extended membrane tube can treat metabolic diseases such as diabetes and obesity by isolating food.
  • the stent has good applicability, convenient manufacturing process, low cost and high production speed, and is used for the stent of the digestive tract, and the stent can also be connected with the implantable catheter.
  • the connector 3 is a connecting line.
  • the connecting line can be linear or thin strip with a small cross-sectional area, so as to ensure the connection of the upper and lower brackets without affecting the flow of food.
  • the connecting member may also be a flexible film tube, an elastic tube of a mesh structure, a connecting strip or a connecting piece having flexibility or elasticity, etc., but these connecting pieces are still bulky even if they are reduced, which may cause gastric pyloric closure. It is not strict and the patient is uncomfortable, so the connecting line is preferred.
  • the connecting wire may be a wire, such as a nickel-titanium alloy, a 304 stainless steel, or the like, or a polymer material wire having good elasticity and fatigue resistance, such as polyethylene, nylon, or the like.
  • the connecting line is covered on the outside. In this way, the contact between the connecting line and the digestive tract tissue is reduced, the frictional damage is reduced, and the probability of occurrence of gastric ulcer is reduced.
  • the outer wire is covered with a film-like elastic material to prevent the connecting wire from being too sharp and damage the pyloric ring.
  • the coated film-based elastic material may be one or more materials such as silica gel, polyurethane, and the like.
  • the connecting member 3 includes a plurality of connecting wires.
  • the upper ends of the plurality of connecting wires are respectively connected to the upper bracket 1
  • the lower ends of the plurality of connecting wires are respectively connected to the lower bracket 2 .
  • the upper and lower brackets are connected by a plurality of connecting wires, and the force distribution is more uniform, and the fixing is more reliable.
  • the position of the connecting member 3 corresponding to the pyloric port of the stomach is naturally deformed in conformity with the bending or narrowing of the outer diameter of the pyloric port of the human body.
  • the connecting member is shaped, and when the human gastric pylorus is in a substantially closed state, the natural extended shape of the connecting member can conform to the structure of the pyloric port and the lower part of the human body, and does not open the pylorus, causing damage to the pylorus structure, above or below. It can be stretched when it is pulled, but it has a shape memory function, and it can restore its original shape when the upper or lower pull force disappears.
  • the upper bracket 1 has a tapered cylindrical shape, an inverted cone cylindrical shape, a straight cylindrical shape or a straw hat shape.
  • the longitudinal cross-sectional view of the upper bracket is rectangular, trapezoidal, or a rectangular-like, trapezoid-like shape with curved sides, and the first opening, the second opening, and the exposed corners of the upper bracket can be rounded to avoid Damage to tissue.
  • the upper bracket may also be spherical or other shape.
  • the outer diameter of the second opening of the upper bracket 1 is larger than the outer diameter of the first opening.
  • the upper bracket is characterized by a relatively large opening at the lower end, which can be stuck in the pyloric port without damaging the pyloric tissue, and has two openings on the upper and lower sides, and the food can pass, but does not have the function of storing food.
  • the function of the upper bracket is to pull the lower bracket at the pyloric port and indirectly pull the membrane tube in the duodenum to prevent the membrane tube from moving down or even discharging during the peristalsis of the digestive tract.
  • the upper bracket lower mouth bracket is larger than the pyloric port diameter, and the diameter is preferably 20-50 mm.
  • the upper mouth diameter is preferably 20-30 mm.
  • the height of the upper shelf 1 is preferably 5-15 mm.
  • the lower bracket is a cylindrical structure.
  • the lower stent structure is located inside the pylorus, specifically the duodenal bulb.
  • the main function of the structure is that the membrane tube has an opening for the extension, and the food can enter the membrane tube through the opening; the second is to prevent the membrane tube from The duodenum is turned into the stomach and echoes with the upper bracket to fix the position of the membrane tube.
  • the upper and lower brackets are respectively limited to the inside and outside of the gastric pylorus, so that the upper stent cannot move freely in the stomach, and the lower stent and the membrane tube Connected, the upper bracket has only a small amount of displacement at the pyloric port to avoid discomfort.
  • the outer diameter of the upper opening (third opening) of the lower bracket and the outer diameter of the lower opening (fourth opening) are preferably the same, such that the lower bracket has a straight cylindrical shape, and the longitudinal cross-sectional view of the lower bracket is rectangular or rounded rectangular, and the upper and lower sides may have A little rounding is mainly to prevent damage to the tissue.
  • the outer diameter of the upper opening (third opening) of the lower bracket and the outer diameter of the lower opening (fourth opening) may also be different, that is, the side wall of the lower bracket may have a certain taper or curvature to accommodate the duodenal bulb. Structure and easy connection of the membrane tube.
  • the diameter of the lower bracket is 15-25 cm, which matches the diameter of the duodenal bulb of the human body, and the height of the lower stent is 5-20 mm. Preferably, 10 mm, the height is as small as possible to meet the above functions, to achieve the maximum comfort limit of the human body.
  • the upper end of the connecting wire is fixedly connected to the top of the upper bracket 1 near the first opening, and the lower end of the connecting wire is fixedly connected to the top of the lower bracket 2 near the third opening.
  • Such a preferred manner can prevent the bottom contraction of the upper stent from being affected by the upper and lower force of the digestive tract support, and the bottom of the upper stent is in contact with the outer surface of the gastric pylorus, which can reduce or avoid damage to the digestive tract tissue by the connecting line and the upper bracket.
  • the upper end of the connecting wire is fixedly connected to the top of the upper bracket 1 near the first opening.
  • the lower end of the connecting line is fixedly connected to the top of the lower bracket 2 near the third opening.
  • the distance between the lower end of the upper bracket and the upper end of the lower bracket is 20-60 mm, and the appropriate size is preferred according to different anatomical structures of the human body.
  • the principle is to be greater than the height of the pyloric ring, and the lower end of the lower bracket should avoid the duodenal papilla.
  • the upper and lower brackets are mesh-shaped structures, which can be processed by a weaving or cutting process, and the mesh structure can be various shapes such as a diamond shape, a honeycomb shape, and a zigzag shape.
  • This structure allows the stent to be freely compressed and expanded in the lateral and longitudinal directions, and has good elasticity.
  • the upper bracket 1 and the lower bracket 2 are both formed of the elastic wires 4, the outer surface of the elastic wires 4 is coated, or the outer outer surfaces of the upper bracket 1 and the lower bracket 2 are respectively coated. This can isolate the contact between the stent wire and the tissue in the stomach, reduce friction damage, reduce the probability of gastric ulcer, and prevent tissue proliferation.
  • the polymer material membrane can be one or more of medical materials such as silica gel, TPU, and TPE.
  • the braided wire is a biocompatible elastic yarn, which may be a wire, a polymer material wire or a degradable material wire.
  • the lower bracket and the membrane tube are fixedly connected by one or more of hot melt, hot pressing, ultrasonic welding, high frequency welding, stitching or laser welding.
  • the upper end of the connecting wire is fixedly connected to the top of the upper bracket 1 near the first opening, and the lower end of the connecting wire is fixedly connected to the top of the lower bracket 2 at a position close to the third opening.
  • Such a preferred manner can prevent the bottom contraction of the upper stent from being affected by the upper and lower force of the digestive tract support, and the bottom of the upper stent is in contact with the outer surface of the gastric pylorus, which can reduce or avoid damage to the digestive tract tissue by the connecting line and the upper bracket.
  • the upper end of the connecting wire is fixedly connected with the top of the upper bracket 1 near the first opening, and the connecting wire is fixed around the middle of the upper bracket 1 , and the lower end of the connecting line and the top of the lower bracket 2 are fixed near the third opening. connection.
  • Such a further preferred manner can prevent the upper stent from being upside down and affecting the fixation when the gastrointestinal stent is subjected to the pull-up force, and the upper stent is in contact with the outer surface of the gastric pylorus, which can reduce or avoid damage to the digestive tract tissue.
  • the gastric deflector includes a conveyor and a built-in sleeve.
  • the conveyor consists of a handle and a delivery catheter, and the internal cannula consists of a digestive tract stent and a membrane tube.
  • the built-in sleeve enters the body through the conveyor and remains in the duodenum.
  • the digestive tract stent is composed of an upper stent 1 and a lower stent 2, and a connecting line 3 is connected in the middle.
  • the upper bracket 1 and the lower bracket 2 may be made of elastic wire material or cut of a tubular material, and the material may be a medical implantable material, such as nickel titanium alloy, 316 stainless steel, polyurethane, aluminum magnesium alloy, etc. Materials.
  • the bracket is woven or cut into a mesh structure, and the mesh opening can be various structures such as a rhombus shape and a hexagonal shape.
  • the bracket can be freely stretched and compressed in the horizontal and vertical directions, and can spontaneously return to a predetermined shape and size.
  • the upper bracket 1 may be fixed at the pyloric port, and the diameter of the lower end opening is larger than the maximum diameter of the pyloric opening.
  • the shape includes, but is not limited to, various types of FIG. 3, FIG. 5, FIG. 7, FIG. 9, FIG. 10 and FIG.
  • the shape, the principle can be fixed outside the pyloric mouth, does not fall into the pylorus, but does not affect the normal function of the stomach and pylorus, will not damage the digestive tract wall. Clinically, different stents can be selected according to actual needs.
  • the lower bracket 1 of the upper bracket 1 is larger than the diameter of the pyloric port, and preferably 20-50 mm in diameter.
  • the upper mouth diameter is preferably 20-30 mm.
  • the height of the upper shelf 1 is preferably 5-15 mm.
  • the main function of the lower bracket 2 is to connect with the membrane tube, and the upper end of the membrane tube is kept open after the ball is opened, ensuring that the chyme can enter the membrane tube and is isolated from the wall of the digestive tract.
  • the shape of the lower bracket 2 is mainly designed to match the size of the duodenal bulb and is slightly larger than the diameter of the bulb.
  • the diameter of the lower mouth of the lower bracket 2 is larger than the diameter of the pyloric port, and the diameter is preferably 20-30 mm.
  • the upper mouth diameter is preferably 20-30 mm. Slightly larger than the diameter of the human duodenal bulb.
  • the height of the upper support 2 is preferably 5-15 mm.
  • the function of the connecting line is to connect the upper bracket 1 and the lower bracket 2, and the number of connecting lines may be one, two, three or more as described in FIGS. 3 to 8.
  • the main function is to connect the upper bracket 1 and the lower bracket 2, and when the lower bracket 2 moves downward with the diaphragm tube 7, the upper bracket 1 can be clamped by the upper bracket 1 through the connecting line 3, and the upper bracket 1 can pass when it is floating upward.
  • the connecting wire 3 is next to the lower bracket 2.
  • the connecting wire 3 may be composed of a material that satisfies the requirements for human body implantation, and may preferably be one or more materials such as nickel titanium alloy, 316 stainless steel, polyurethane, silica gel, aluminum magnesium alloy, and the like.
  • the outer layer of the connecting wire 3 is coated with a biocompatible soft material.
  • the covering material may be one or more of silica gel, polyurethane, polyethylene, etc. material.
  • both the upper stent 1 and the lower stent 2 are covered with a protective film 5.
  • the protective film must be a material that meets the requirements for human body implantation.
  • the material of the film may be one or more materials such as silica gel, polyurethane, polyethylene, and the like.
  • the upper bracket 1 and the lower bracket 2 have a certain distance therebetween.
  • the distance between the lower end of the upper bracket 1 and the upper bracket 2 is 20-60 mm.
  • a suitable size is preferred.
  • the lower end of the lower stent 2 is to avoid the duodenal papilla 104.
  • the upper bracket 1 and the lower bracket 2 have a developing ring 6 which can be clearly positioned under X-rays, and the developing ring can be a heavy metal material which is harmless to the human body such as platinum, gold or enamel.
  • the upper end of the upper bracket 1 and the lower bracket 2 respectively have a recovery line 8 and a recovery line 9, and the recovery lines 8 and 9 are respectively sewn to the outermost circumferences of the upper bracket 1 and the lower bracket 2, through a special recycler or The gripper can remove the scaffold from the body and recover it.
  • the recovery line is pulled in, the upper support 1 and the lower support 2 are respectively retracted into the endoscope transparent cap or a specific recovery device, and the endoscope is taken out from the human digestive tract.
  • the recycling lines 8 and 9 may be materials conforming to biocompatibility requirements such as PE, nylon, and polyester.
  • a method of releasing a gastric deflector comprising a gastric deflector as described above, and the steps of:
  • the membrane tube and digestive tract stent Prior to use, the membrane tube and digestive tract stent are compressed and received in the containment housing 13 and the distal end is closed by the release body housing 11 and the inner core 12.
  • the distal release body enters the duodenum of the human body under the guidance of the guide wire.
  • the middle tube 17 is unlocked, the middle handle 22 is pushed, the first stage push is completed, the release body and the film tube 7 are pushed out of the storage tube case 13, and the storage tube case 13 is retracted until the marking line 25 reaches.
  • the pylorus port pushes the lower bracket 2 out of the receiving tube casing 13 to complete the second stage pushing, the lower bracket 2 remains in the duodenal bulb portion 103, and then pushes the upper bracket 1 out of the receiving tube casing 13 to allow the upper bracket 1 Stay at the pyloric port 102 and complete the release.
  • the limit ball head 23 is first rotated from the “0” position to the “1” position, the middle tube 17 is unlocked, and the middle handle 22 is slowly pushed until the resistance cannot be pushed, and the first stage push is completed.
  • the release body casing 11 and the membrane tube 7 are pushed out of the storage tube casing 13, and the storage tube casing 13 is retracted until the marking line 25 reaches the pyloric port, and the rotation limit ball head 23 is rotated from the "1" position to the "2" position, again
  • the middle tube 17 is unlocked, and the middle handle 22 is slowly pushed until the resistance cannot be pushed.
  • the second stage push is completed, the lower bracket 2 is pushed out from the receiving tube casing 13, and the lower bracket 2 is left in the duodenal ball portion 103, and is rotated again.
  • the limit ball head 23 is rotated from the "2" position to the "3" position, the middle tube 17 is unlocked, the middle handle 22 is pressed, the front handle 24 is pulled back, and the upper bracket 1 is pushed out from the storage tube casing 13 to allow the upper bracket 1 Stay at the pyloric port 102 and complete the release.
  • the membrane tube 7 reaches the upper part of the jejunum as the intestinal peristal moves, at which time the core 12 is released and dissolved automatically, and the release body shell 11 and the membrane tube 7 are automatically disengaged to complete the release process.
  • the conveyor is withdrawn from the mouth and the built-in sleeve remains in the body to isolate the food.
  • the implantable catheter can play the role of isolating food in the intestinal tract, changing the physiological flow direction of the food. After the implantation for a period of time, the insulin resistance of the patient's body is eliminated, and the food flow can also promote the insulin in the patient. Secretion, reducing islet cell apoptosis and increasing its value, islet function recovery, diabetes, obesity and other metabolic diseases are cured.
  • the implantable catheter has a tensile modulus of more than 250 MP, an elongation of more than 230%, a soft material, and 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 into the digestive tract for the treatment of endocrine diseases such as diabetes, islet dysfunction, obesity, etc., or lower gastrointestinal diseases such as inflammation.
  • the implantable catheter of the invention has the advantages of simple structure, good structure applicability, convenient manufacturing process, low cost, fast production speed, quality assurance and convenient manufacture, and is implanted. After the comfort, compliance, and will not cause damage to human tissue.
  • the upper bracket of the invention is fixed on the pyloric port, and the lower bracket is fixed on the duodenal bulb and connected to the membrane tube. Both brackets are not free to move, only a small range of displacement, specifically the upper bracket will not enter the pylorus, the lower bracket will not enter the pylorus, and there is a connecting line in the middle, the displacement range will not exceed the range of the connecting line.
  • the height of the upper and lower bracket joints is 1-8cm.
  • the upper bracket is located outside the pylorus, the lower bracket is located in the duodenal bulb, and the lower end of the lower bracket does not reach the duodenal papilla.
  • the principle of action of the invention is to implant a membrane tube in the duodenum and extend it to the distal end of the digestive tract, and to isolate the food through the membrane tube, thereby changing the metabolic mechanism and functioning to treat metabolic diseases such as obesity and diabetes.
  • the role of the stent is mainly to fix the membrane tube and to open the membrane tube so that food can enter the implanted membrane tube.
  • the extended membrane tube (sleeve) of the present invention has a length of 600 mm to 1600 mm and is a main functional structure.
  • the upper bracket is relatively small and does not cause pressure on the stomach.
  • the small and large structure under the digestive tract stent is easy to empty, and the food is not easily retained.
  • the pylorus has a bracket fixed, the upper and lower echoes, and the position of the membrane tube is not easily displaced.
  • a digestive tract stent is disclosed.
  • the present invention not only has different functional functions, but also has different structures: in the present invention, the upper and lower brackets have different shapes; the connecting line is an arc. Shape, need to conform to the anatomy of the pylorus; the connection line is generally more than two to connect firmly; for the fixation of the pylorus, specifically to fix a intestinal isolation membrane tube, the specific application of the product is to treat diabetes and obesity and other metabolism disease.
  • the lower stent needs to be connected to a soft membrane tube for therapeutic purposes.

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Abstract

一种胃导流器及其消化道支架、释放方法，消化道支架具有展开前形状和展开后形状，包括上支架（1）、下支架（2）和连接件（3）；在展开后形状下，上支架（1）顶部设有第一开口并且底部设有第二开口，下支架（2）设于上支架（1）下方，下支架（2）顶部设有第三开口并且底部设有第四开口，上支架（1）和下支架（2）之间通过若干个连接件（3）连接，下支架（2）的第四开口连接膜管（7），展开后的上支架（1）和下支架（2）均无法通过张开的胃幽门口，连接件（3）可以通过胃幽门口或穿设在胃幽门口处。

Description

胃导流器及其消化道支架、释放方法 技术领域
本发明涉及医疗器械技术领域，尤其指一种用于治疗内分泌疾病（如糖尿病、胰岛功能紊乱、肥胖等）或下消化道疾病（如炎症等）胃导流器及其消化道支架、释放方法。
 背景技术
已知，糖尿病是一种近年来逐渐被人们所重视的疾病，其是富贵病中的一种，是源于现代文明社会的生活水平不断提高，人们的生活富裕后，吃得好、吃得精，营养过剩，活动量减少，从而产生的非传染性的流行病，具体的，糖尿病是指以高血糖为特征的代谢性疾病。其是由于胰岛素分泌缺陷或其生物作用受损，或两者兼有引起的。糖尿病可以导致各种组织，特别是眼、肾、心脏、血管、神经的慢性损害、功能障碍。糖尿病通常伴随着肥胖以及很多并发症，对人们的健康的造成极大的威胁。数据显示，仅中国，20岁以上的成年人中，糖尿病的发病率为9.7%，发病人口约1.5亿。已知，常见的肥胖及糖尿病改善方式是控制饮食，增加运动，并辅助一定的药物治疗，这需要病人的长期坚持，并且一旦停止饮食控制和运动后容易引起反复和体重反弹，长期的药物或者胰岛素的使用也给病人带来沉重的经济负担和生活的不便。
另一种治疗法为胃转流术，采用胃转流术对于根治二型糖尿病和改善肥胖有非常良好的效果，在2001年，国际糖尿病联盟已正式推荐代谢外科手术（包括胃转流手术）作为肥胖合并二型糖尿病的治疗方法，然而胃转流术作为一种外科手术，会对人体造成创口，因此具有很多风险如：死亡、肠梗阻、吻合口漏、肺栓塞、深静脉血栓、门静脉损伤、呼吸系统等。
目前，国外也有通过在胃肠道中植入类似胃导流器等的结构治疗糖尿病，然而，该胃导流器的结构复杂，通常需要多根拉线同时进行操作才可以实现其功能，操作前需要经过专业指导，不具备丰富经验很有可能会出现操作失误，增加病患不适，操作起来较为困难，另外制造成本偏高，加上技术壁垒的问题，造成其很难在本国进行大范围的推广应用，因此如何提供一种实施时病人不会有较多不适感的治疗糖尿病的方法，或者提供一种结构简单，操作方便，成本低廉的治疗糖尿病的设备成为了亟待解决的问题。
目前国内外也有一些通过胃肠道内植入类似胃导流器结构的产品来治疗糖尿病，将一根高分子材料的软性导管植入到十二指肠，而该软性导管一般都通过一个小型金属支架固定于十二指肠球部。但是由于目前所知材料制成的网状支架如果不覆膜的话，容易发生增生和黏连，植入一段时间以后就难以取出，而覆膜的支架，则非常容易脱落。
目前已经上市的美国GI公司的产品和国内的同类专利设计，将支架设计成V自字型，带倒刺，以倒刺的形式，固定于十二指肠球部，该设计的优势是可以适应于多数的患者，但是也存在一定的问题，因为倒刺太长会对造成消化道穿孔，太短则容易脱落，根据美国GI公司的临床文献来看，该设计在临床上有10%左右的脱落率，而且取出和植入，以及意外脱落的情况下会造成一定比例的消化道撕裂和出血，存在一定的使用风险。如该导管不慎跌入十二指肠远端，空肠，甚至结肠，容易造成肠梗阻。因此需要一个更好的设计来规避这些风险。
公开号为CN103298518、CN105263439、WO2017/052694等专利文献公开了一种胃内装置，包括：多孔性结构，该多孔性结构包括顶部、底部和内部并且具有带第一体积的展开前形状和带大于所述第一体积的第二体积的展开后形状，其中在所述展开后形状下，所述多孔性结构包括临近所述顶部的至少一个第一开口和临近所述底部的至少一个第二开口以使得食物穿过所述至少一个第一开口进入所述多孔性结构，穿过所述内部，并且穿过所述至少一个第二开口退出所述多孔性结构；以及套管，该套管具有柔性的伸长主体，具有第三开口的近端，具有第四开口的远端，以及套管内部，其中所述套管被耦连到所述多孔性结构以使得退出所述至少一个第二开口的食物穿过所述第三开口进入所述套管，穿过所述套管内部，以及穿过所述第四开口退出所述套管。多孔性结构（支架）扩张后呈圆柱体、椭圆体、球体立方体或长方体，占据胃内相当大容积且可在胃内自由活动，多孔性结构的直径大于打开的幽门的直径，多孔性结构底部的套管（膜管）穿过幽门延伸到十二指肠。所述胃内装置进一步包括定位在所述多孔性结构与所述套管的接合处并且被附连到所述多孔性结构或者所述套管或者两个的防迁移部件，其中所述防迁移部件包括压缩的展开前构造和张开的展开后构造并且被设计成临近病人的幽门并防止所述多孔性结构迁移到和穿过所述幽门。上述结构中，球状支架全在胃内、幽门外，幽门内有套管（膜管），作用机理主要是在胃内植入一个网状球形的记忆合金编织的装置，该球状支架覆膜，该球状支架在胃内占有一定的体积可以形成一种饱腹感，并且食物可以在球状支架内储存一定的时间，从而降低食物的摄入量，起到治疗肥胖和糖尿病等代谢疾病的作用，而用于食物引流的膜管为其次要功能结构。但是，上述胃内装置存在下述问题：一是，具有自膨胀形的记忆合金材料具有一定的机械力和重量，体积大到能占有胃内容积的话，对胃内有一定的压迫，植入在胃内会对胃粘膜有压迫，非常容易造成消化道溃疡；二是，食物在球囊内停留时间长，虽能减缓胃的排空，但容易造成细菌滋生，引起炎症反应；三是，该装置在幽门口内或十二指肠球部没有固定，下段延伸膜管极易因为消化道逆蠕动而返回胃内，造成食物不按照设计通道进行流动；四是位于幽门口的膜管体积较大，尤其是内容食物后，幽门异物感明显并容易造成幽门闭合不严、胆汁反流等病症。
公开号为CN102335052、CN104382671、CN204671331、CN205359721等专利文献公开了一种消化道支架，主体由多个具有一定刚性和支撑作用的支架单元和易于弯曲的连接部件连接而成，连接部件的两端分别与对应的支架单元相连，主体呈易于弯曲的直圆柱体结构或由圆柱体和锥体组成的易于弯曲的复合体结构；支架单元由金属管材镂刻而成的整体结构或由丝材编织而成的结构，连接部件由柔软性好的金属线材或塑料线材编织而成，连接线一般与上下支架平面垂直编织。该支架用于消化道的狭窄或梗阻治疗，起到扩张和支撑狭窄的作用，一般作为一款独立的产品植入到消化道内，不连接膜管，并且因为其支撑强度高、不易变形，所以无法用于胃内幽门口，不能作为胃导流器使用。
 技术问题
本发明的目的是提供一种胃导流器及其消化道支架、释放方法，该支架由两部分组成，一部分固定于胃幽门口，一部分固定于十二指肠球部。该支架可以提供一定的支撑力，但又有一定的柔顺性，该支架可以保证延伸段膜管上段开口固定于十二指肠球部，能随着肠道的开闭而开闭，不会损伤肠壁。延伸的膜管通过隔离食物可以治疗糖尿病、肥胖等代谢性疾病。该支架适用性好，制作工艺方便、成本低、生产速度快，用于消化道的支架，该支架还可与可植入导管相连接。
 技术解决方案
针对上述的现有技术中的问题，本发明的发明人经过仔细研究，设计了两段式的支架，并使用弹性丝材料编织而成，通过幽门口和十二指肠球部两边固定，外层覆膜，防止组织增生，可以充分解决支架及膜管易脱落或者易增生的问题，而且外缘光滑，对人体组织无损伤。从而完成本发明。
具体地说，本发明采用了以下的技术方案：
一种胃导流器的消化道支架，该消化道支架具有展开前形状和展开后形状，包括上支架、下支架和连接件；在展开后形状下，上支架在临近其顶部设有第一开口并且在临近其底部设有第二开口，下支架设于上支架下方，下支架在临近其顶部设有第三开口并且在临近其底部设有第四开口，上支架和下支架之间通过若干个连接件连接，下支架的第四开口连接膜管，并且，展开后的上支架和下支架均无法通过张开的胃幽门口（即展开后的上支架和下支架的外径大于张开的胃幽门口外径），连接件可以通过胃幽门口或穿设在胃幽门口处。这样，该支架分成两部分固定，一部分（上支架）固定于胃幽门口，在消化道蠕动时将膜管上端牢固定位在消化道内，另一部分（下支架）固定于十二指肠球部，在消化道逆蠕动时，避免下段延伸膜管极易返回胃内，造成食物不按照设计通道进行流动。该支架可以提供一定的支撑力，但又有一定的柔顺性，该支架可以保证延伸段膜管上段开口固定于十二指肠球部，能随着肠道的开闭而开闭，不会损伤肠壁。延伸的膜管通过隔离食物可以治疗糖尿病、肥胖等代谢性疾病。该支架适用性好，制作工艺方便、成本低、生产速度快，用于消化道的支架，该支架还可与可植入导管相连接。
作为优选，该连接件为连接线。该连接线可以是线状或者具有较小截面积的细条状，这样既能保证上下支架的连接，还不影响食物流动。此外，其他实施方式中，连接件还可以是柔性膜管、网孔结构的弹性管、具有柔性或弹性的连接带或连接片等，但是这些连接件即使缩小后仍旧体积较大会造成胃幽门闭合不严和患者不适，因此优选连接线。连接线可以是金属丝，如镍钛合金，304不锈钢等，也可以是有良好的弹性和耐疲劳性的高分子材料丝，如聚乙烯、尼龙等材料。
作为优选，该连接线外面覆膜。这样，隔离连接线与消化道组织的接触，减少摩擦损伤，降低胃溃疡发生的概率。连接线外包覆膜类弹性材料，防止连接丝过于锐利而损伤幽门环。作为优选，包覆的膜类弹性材料可以是硅胶，聚氨酯等一种或多种材料。
作为优选，该连接件包括多根连接线，多根连接线的上端分别连接上支架，多根连接线的下端分别连接下支架。这样，采用多根连接线上下连接上下支架，受力分布更加均匀，固定更加可靠。
作为优选，所述连接件对应胃幽门口的位置在自然状态下会产生顺应人体幽门口的弯曲或缩小外径的弹性形变。这样，连接件经过定型处理，当人体胃幽门处于基本闭合状态时，连接件的自然延展外形能够顺应人体幽门口及下部的结构，不会撑开幽门，对幽门结构造成损伤，在上或下受到拉力的时候可以延展，但具有形状记忆功能，在上或下拉力消失的时候可以恢复原来的形状。
作为优选，所述上支架呈锥筒状、倒锥筒状、直筒状或草帽形状。这样，上支架的纵向截面视图呈矩形、梯形，或者两侧边为弧形的类矩形、类梯形，上支架的第一开口、第二开口以及外露边角处可以倒圆角处理，以避免损伤组织。当然在其他实施方式中，上支架也可以呈球状或其他形状。
作为优选，所述上支架的第二开口外径大于第一开口外径。这样，上支架的特点是下端开口比较大，可以卡在幽门口且不损伤幽门组织，上下具有两个开口，食物可以通过，但不具备储存食物的功能。上支架的作用是卡在幽门口拉住下支架，间接拉住十二指肠内的膜管，避免膜管在消化道蠕动过程中下移甚至排出。所述上支架下口支架大于幽门口直径，直径优选20-50mm。上口直径优选20-30mm。上层支架1的高度优选5-15mm。
作为优选，所述下支架为筒状结构。下支架结构位于幽门口内部，具体来说是十二指肠球部，该结构的主要功能是为了延伸的膜管有个开口，食物可以通过这个开口进入膜管；二是为了防止膜管从十二指肠翻入胃内，与上支架相呼应，将膜管位置固定；三是上下支架分别限位在胃幽门口内外，使得上支架不能在胃内自由移动，与下支架和膜管相连，上支架仅仅在幽门口有少量的位移，避免不适。下支架的上开口（第三开口）的外径和下开口（第四开口）的外径优选相同，这样下支架呈直筒状，下支架的纵向截面视图为矩形或者圆角矩形，上下可以有一点倒圆角，主要是为了防止损伤组织。但是下支架的上开口（第三开口）的外径和下开口（第四开口）的外径也可以不同，即下支架的侧壁可以有一定的锥度或者弧度，以适应十二指肠球部结构和便于连接膜管。
作为优选，所述下支架的直径为15～25cm，与人体的十二指肠球部直径相匹配，下支架高度为5-20mm。优选10mm，该高度在能满足以上功能的前提下尽可能小，以达到人体最大的舒适限度。
上支架的下端和下支架的上端距离为20-60mm，根据人体不同的解剖结构优选合适的尺寸，原则是要大于幽门环的高度，下支架的下端要避开十二指肠乳头。
上下支架为网状结构，可以由编织或者切割的工艺加工而成，网孔结构可以是菱形，蜂窝形，Z字形等多种形状。该结构使支架可以在横向和纵向自由压缩和膨胀，具有良好的弹性。作为优选，上支架和下支架都是由弹性丝编制成，弹性丝外表面覆膜，或者上支架、下支架的整体外表面分别覆膜。这样可以隔离支架丝材与胃内组织的接触，减少摩擦损伤，降低胃溃疡发生的概率，防止组织增生，高分子材料膜可以是硅胶，TPU,TPE等医用材料中的一种或几种。所述的编织丝为符合生物相容性的弹性丝，可以是金属丝、高分子材料丝或者是可降解材料丝。
下支架通过缝合、热压、超声波焊接或者激光焊接与膜管固定连接。
作为优选，连接线的上端与上支架顶部靠近第一开口的位置固定连接，连接线的下端与下支架顶部靠近第三开口的位置固定连接。这样的优选方式可以避免消化道支架承受上下拉力时上支架的底部收缩影响固定，并且上支架底部与胃幽门口外呈弹性面接触支撑，能够减少或避免连接线、上支架损伤消化道组织。
作为优选，连接线的上端与上支架顶部靠近第一开口的位置固定连接，连接线绕经上支架中部编制网孔后，连接线的下端与下支架顶部靠近第三开口的位置固定连接。这样进一步的优选方式可以避免消化道支架承受上下拉力时上支架产生上下翻转从而影响固定，并且上支架与胃幽门口外呈弹性面接触支撑，能够减少或避免消化道组织损伤。
作为优选，所述上支架和下支架上设有显影环，可在X射线下定位支架，所述的显影环优选铂、金或者钽等。
作为优选，所述上支架上设有上支架回收线，下支架上设有下支架回收线。这样可以通过特制的回收器或者内窥镜用抓钳取出消化道支架和膜管。
一种胃导流器，其特征在于，包括如上所述的消化道支架。
一种胃导流器，包括收纳管壳、释放体以及推送组件，其特征在于，所述收纳管壳呈管状，所述收纳管壳的两端为开口，所述收纳管壳中设置待释放的呈折叠状态的膜管和如上所述的消化道支架，所述释放体设置在收纳管壳的远端开口处并与所述膜管的一端连接，所述释放体由能够被人体肠道消化吸收或溶解的材料制成；所述推送组件包括依次套设并且相互之间能够相对运动的内管、中管和外管，所述内管一部分位于所述收纳管壳内并与所述释放体连接；所述中管的一端经收纳管壳的近端开口伸入所述收纳管壳内，且所述中管的该端固定设有位于所述收纳管壳中的用于推抵所述膜管的推块；所述外管位于所述收纳管壳外且其一端直接或间接固定连接于收纳管壳的近端开口上；其中，所述内管沿其轴向朝向操作者运动从而使所述释放体与所述收纳管壳脱开，内管和中管带动所述膜管从收纳管壳内脱出并展开释放。
作为优选，所述收纳管壳上设有标记线，该标记线距离收纳管壳的远端开口2至5cm。这样便于在幽门口内外分别释放上下两个支架。
作为优选，所述释放体包括释放体外壳和释放体内芯，释放体外壳设置在收纳管壳的远端开口处，释放体内芯与内管连接，释放体外壳包覆在释放体内芯外。
一种胃导流器的释放方法，包括如上所述的胃导流器，以及下述步骤：
1）呈折叠状态的膜管和消化道支架设置在收纳管壳内，收纳管壳的远端开口由释放体封闭；
2）在导丝的引导下，将收纳管壳远端的释放体送入十二指肠内，再将释放体和膜管推出收纳管壳；
3）再回撤收纳管壳，直至标记线到达幽门口，将下支架从收纳管壳中推出，下支架留在十二指肠球部；
4）再回撤收纳管壳，将上支架从收纳管壳中推出，让上支架留在幽门口外，完成释放。
 有益效果
本发明由于采用了以上技术方案，消化道支架的上支架可以固定在幽门口，下支架可以固定在十二指肠球部，确保该膜管可以长期稳定地固定在十二指肠内，而且不会损伤人体组织。而且该支架外层有覆膜，可以降低支架与组织的摩擦，避免长期植入而导致的组织增生，方便后期的取出。而且固定于幽门口的上支架一端开口于幽门口，另一端开口于胃内，还可以延缓胃的排空时间，与传统的胃导流器或者叫十二指肠套管相比，在治疗糖尿病、肥胖等代谢性疾病方面具有更好的疗效。该支架适用性好，制作工艺方便、成本低、生产速度快。与消化道膜管相连接。本发明支架可植入消化道，以用于治疗内分泌疾病，如糖尿病、胰岛功能紊乱、肥胖等，或者下消化道疾病，如炎症等。与现有技术相比，本发明的支架能有效防止植入后组织的增生，并能长期固定于幽门口和十二指肠乳头处，并且不会对人体消化道造成损伤。且具有结构适用性好，制作工艺方便、成本低、生产速度快、质量有保证以及制造方便等优点，并且植入后舒适性、顺应性好，不会对人体组织造成伤害。此外，该支架还可与可植入膜管相连接，连接膜管后可减少对消化道的刺激，且使提拉调整或回收支架更加安全、方便。
 附图说明
图1为本发明胃导流器的结构示意图；
图2为本发明胃导流器远端的放大结构示意图；
图3为本发明消化道支架实施例1的展开结构侧视图（单线草帽型支架）；
图4为本发明消化道支架实施例1的展开结构正视图（单线草帽型支架）；
图5为本发明消化道支架实施例2的展开结构侧视图（双线草帽型支架）；
图6为本发明消化道支架实施例2的展开结构正视图（双线草帽型支架）；
图7为本发明消化道支架实施例3的展开结构侧视图（三线梯形支架）；
图8为本发明消化道支架实施例3的展开结构正视图（三线梯形支架）；
图9为本发明消化道支架实施例4的展开结构侧视图（双线倒梯形支架）；
图10为本发明消化道支架实施例5的展开结构侧视图（双线梯形支架）；
图11为本发明消化道支架实施例6的展开结构侧视图（双线圆弧形支架）；
图12为本发明膜管和消化道支架的展开结构示意图；
图13为本发明膜管和消化道支架在人体消化道内放置的示意图。
附图标记说明：1-上支架；2-下支架；3-连接线；4-弹性丝；5-支架覆膜；6-显影环；7-膜管；8-上支架回收线；9-下支架回收线；11-释放体外壳；12-释放体内芯；13-收纳管壳；14-推块；15-螺帽；16-外管；17-中管；18-内管； 21-后手柄；22-中手柄； 23限位球头；24前手柄；25标记线；101-胃；102-幽门口；103-十二指肠球部；104-十二指肠乳头；105-十二指肠；106-空肠。
 本发明的最佳实施方式
下面详细描述本发明的实施例，所述实施例的示例在附图中示出，其中自始至终相同或类似的标号表示相同或类似的元件或具有相同或类似功能的元件。下面通过参考附图描述的实施例是示例性的，旨在用于解释本发明，而不能理解为对本发明的限制。
在本发明的描述中，需要理解的是，术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”“内”、“顺时针”、“逆时针”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。
此外，术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者更多个该特征。在本发明的描述中，除非另有说明，“多个”的含义是两个或两个以上，除非另有明确的限定。
在本发明中，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”、“固定”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。
在本发明中，除非另有明确的规定和限定，第一特征在第二特征之“上”或之“下”可以包括第一和第二特征直接接触，也可以包括第一和第二特征不是直接接触而是通过它们之间的另外的特征接触。而且，第一特征在第二特征“之上”、“上方”和“上面”包括第一特征在第二特征正上方和斜上方，或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之下”、“下方”和“下面”包括第一特征在第二特征正下方和斜下方，或仅仅表示第一特征水平高度小于第二特征。
如图1、图2所示的一种胃导流器，包括收纳管壳13、释放体以及推送组件，所述收纳管壳13呈管状，所述收纳管壳13的两端为开口，所述收纳管壳13中设置待释放的呈折叠状态的膜管7和消化道支架，所述释放体设置在收纳管壳13的远端开口处并与所述膜管7的一端连接，所述释放体由能够被人体肠道消化吸收或溶解的材料制成；所述推送组件包括依次套设并且相互之间能够相对运动的内管18、中管17和外管16，所述内管18一部分位于所述收纳管壳13内并与所述释放体连接；所述中管17的一端经收纳管壳13的近端开口伸入所述收纳管壳13内，且所述中管17的该端固定设有位于所述收纳管壳13中的用于推抵所述膜管7的推块14；所述外管16位于所述收纳管壳13外且其一端直接或间接固定连接于收纳管壳13的近端开口上；其中，所述内管18沿其轴向朝向操作者运动从而使所述释放体与所述收纳管壳13脱开，内管18和中管17带动所述膜管7从收纳管壳13内脱出并展开释放。
所述收纳管壳13上设有标记线25，该标记线距离收纳管壳13的远端开口2至5cm。所述释放体包括释放体外壳11和释放体内芯12，释放体外壳11设置在收纳管壳13的远端开口处，释放体内芯12与内管18连接，释放体外壳11包覆在释放体内芯12外。
如图3-11所示的一种胃导流器的消化道支架，该消化道支架具有展开前形状和展开后形状，包括上支架1、下支架2和连接件3；在展开后形状下，上支架1在临近其顶部设有第一开口并且在临近其底部设有第二开口，下支架2设于上支架1下方，下支架2在临近其顶部设有第三开口并且在临近其底部设有第四开口，上支架1和下支架2之间通过若干个连接件3连接，下支架2的第四开口连接膜管7，并且，展开后的上支架1和下支架2均无法通过张开的胃幽门口（即展开后的上支架1和下支架2的外径大于张开的胃幽门口外径），连接件3可以通过胃幽门口或穿设在胃幽门口处。这样，该支架分成两部分固定，一部分（上支架）固定于胃幽门口，在消化道蠕动时将膜管上端牢固定位在消化道内，另一部分（下支架）固定于十二指肠球部，在消化道逆蠕动时，避免下段延伸膜管极易返回胃内，造成食物不按照设计通道进行流动。该支架可以提供一定的支撑力，但又有一定的柔顺性，该支架可以保证延伸段膜管上段开口固定于十二指肠球部，能随着肠道的开闭而开闭，不会损伤肠壁。延伸的膜管通过隔离食物可以治疗糖尿病、肥胖等代谢性疾病。该支架适用性好，制作工艺方便、成本低、生产速度快，用于消化道的支架，该支架还可与可植入导管相连接。
该连接件3为连接线。该连接线可以是线状或者具有较小截面积的细条状，这样既能保证上下支架的连接，还不影响食物流动。此外，其他实施方式中，连接件还可以是柔性膜管、网孔结构的弹性管、具有柔性或弹性的连接带或连接片等，但是这些连接件即使缩小后仍旧体积较大会造成胃幽门闭合不严和患者不适，因此优选连接线。连接线可以是金属丝，如镍钛合金，304不锈钢等，也可以是有良好的弹性和耐疲劳性的高分子材料丝，如聚乙烯、尼龙等材料。
该连接线外面覆膜。这样，隔离连接线与消化道组织的接触，减少摩擦损伤，降低胃溃疡发生的概率。连接线外包覆膜类弹性材料，防止连接丝过于锐利而损伤幽门环。作为优选，包覆的膜类弹性材料可以是硅胶，聚氨酯等一种或多种材料。
该连接件3包括多根连接线，多根连接线的上端分别连接上支架1，多根连接线的下端分别连接下支架2。这样，采用多根连接线上下连接上下支架，受力分布更加均匀，固定更加可靠。
所述连接件3对应胃幽门口的位置在自然状态下会产生顺应人体幽门口的弯曲或缩小外径的弹性形变。这样，连接件经过定型处理，当人体胃幽门处于基本闭合状态时，连接件的自然延展外形能够顺应人体幽门口及下部的结构，不会撑开幽门，对幽门结构造成损伤，在上或下受到拉力的时候可以延展，但具有形状记忆功能，在上或下拉力消失的时候可以恢复原来的形状。
所述上支架1呈锥筒状、倒锥筒状、直筒状或草帽形状。这样，上支架的纵向截面视图呈矩形、梯形，或者两侧边为弧形的类矩形、类梯形，上支架的第一开口、第二开口以及外露边角处可以倒圆角处理，以避免损伤组织。当然在其他实施方式中，上支架也可以呈球状或其他形状。
所述上支架1的第二开口外径大于第一开口外径。这样，上支架的特点是下端开口比较大，可以卡在幽门口且不损伤幽门组织，上下具有两个开口，食物可以通过，但不具备储存食物的功能。上支架的作用是卡在幽门口拉住下支架，间接拉住十二指肠内的膜管，避免膜管在消化道蠕动过程中下移甚至排出。所述上支架下口支架大于幽门口直径，直径优选20-50mm。上口直径优选20-30mm。上层支架1的高度优选5-15mm。
所述下支架为筒状结构。下支架结构位于幽门口内部，具体来说是十二指肠球部，该结构的主要功能是为了延伸的膜管有个开口，食物可以通过这个开口进入膜管；二是为了防止膜管从十二指肠翻入胃内，与上支架相呼应，将膜管位置固定；三是上下支架分别限位在胃幽门口内外，使得上支架不能在胃内自由移动，与下支架和膜管相连，上支架仅仅在幽门口有少量的位移，避免不适。下支架的上开口（第三开口）的外径和下开口（第四开口）的外径优选相同，这样下支架呈直筒状，下支架的纵向截面视图为矩形或者圆角矩形，上下可以有一点倒圆角，主要是为了防止损伤组织。但是下支架的上开口（第三开口）的外径和下开口（第四开口）的外径也可以不同，即下支架的侧壁可以有一定的锥度或者弧度，以适应十二指肠球部结构和便于连接膜管。
所述下支架的直径为15～25cm，与人体的十二指肠球部直径相匹配，下支架高度为5-20mm。优选10mm，该高度在能满足以上功能的前提下尽可能小，以达到人体最大的舒适限度。
连接线的上端与上支架1顶部靠近第一开口的位置固定连接，连接线的下端与下支架2顶部靠近第三开口的位置固定连接。这样的优选方式可以避免消化道支架承受上下拉力时上支架的底部收缩影响固定，并且上支架底部与胃幽门口外呈弹性面接触支撑，能够减少或避免连接线、上支架损伤消化道组织。
连接线的上端与上支架1顶部靠近第一开口的位置固定连接，连接线绕经上支架1中部编制网孔后，连接线的下端与下支架2顶部靠近第三开口的位置固定连接。这样进一步的优选方式可以避免消化道支架承受上下拉力时上支架产生上下翻转从而影响固定，并且上支架与胃幽门口外呈弹性面接触支撑，能够减少或避免消化道组织损伤。
上支架的下端和下支架的上端距离为20-60mm，根据人体不同的解剖结构优选合适的尺寸，原则是要大于幽门环的高度，下支架的下端要避开十二指肠乳头。
上下支架为网状结构，可以由编织或者切割的工艺加工而成，网孔结构可以是菱形，蜂窝形，Z字形等多种形状。该结构使支架可以在横向和纵向自由压缩和膨胀，具有良好的弹性。作为优选，上支架1和下支架2都是由弹性丝4编制成，弹性丝4外表面覆膜，或者上支架1、下支架2的整体外表面分别覆膜。这样可以隔离支架丝材与胃内组织的接触，减少摩擦损伤，降低胃溃疡发生的概率，防止组织增生，高分子材料膜可以是硅胶，TPU,TPE等医用材料中的一种或几种。所述的编织丝为符合生物相容性的弹性丝，可以是金属丝、高分子材料丝或者是可降解材料丝。
下支架与膜管通过热熔、热压，超声波焊接、高频焊接、缝合或者激光焊接等一种或多种固定连接。
作为优选，连接线的上端与上支架1顶部靠近第一开口的位置固定连接，连接线的下端与下支架2顶部靠近第三开口的位置固定连接。这样的优选方式可以避免消化道支架承受上下拉力时上支架的底部收缩影响固定，并且上支架底部与胃幽门口外呈弹性面接触支撑，能够减少或避免连接线、上支架损伤消化道组织。
作为优选，连接线的上端与上支架1顶部靠近第一开口的位置固定连接，连接线绕经上支架1中部编制网孔后，连接线的下端与下支架2顶部靠近第三开口的位置固定连接。这样进一步的优选方式可以避免消化道支架承受上下拉力时上支架产生上下翻转从而影响固定，并且上支架与胃幽门口外呈弹性面接触支撑，能够减少或避免消化道组织损伤。
胃导流器包括输送器和内置套管。输送器由手柄和输送导管组成，内置套管由消化道支架和膜管组成。内置套管通过输送器进入人体，并留在十二指肠内。本发明中，消化道支架由上支架1和下支架2组成，中间有连接线3连接。上支架1和下支架2可以由弹性丝材料编制而成，或者管状材料切割而成，材料可以是医用可植入材料，例如镍钛合金，316不锈钢，聚氨酯，铝镁合金等一种或者多种材料。
所述的支架编织或者切割成网状结构，网口可以是菱形、六边形等多种结构，支架在横向和纵向可以被自由地拉伸和压缩，并可以自发回复成预定型的形状和尺寸。
所述的上支架1可以固定在幽门口，下端开口直径大于幽门口张开的最大直径，形状包括但不限于是图3，图5，图7、图9、图10和图11的各种形状，原则是可以固定于幽门口外，不掉入幽门口，但由不影响胃及幽门的正常功能，不会对消化道壁由损伤。临床根据实际需要可以选择不同的支架。
作为优选，所述上支架1下口支架大于幽门口直径，直径优选20-50mm。上口直径优选20-30mm。上层支架1的高度优选5-15mm。
所述的下支架2的主要作用是与膜管相连接，并使膜管上端在球部张开后保持开口状态，确保食糜可以进入膜管内，与消化道壁相隔绝。下支架2的形状设计主要是符合换着十二指肠球部的尺寸，且略大于球部的直径。
作为优选，所述下支架2下口直径大于幽门口直径，直径优选20-30mm。上口直径优选20-30mm。略大于人体十二指肠球部直径。上层支架2的高度优选5-15mm。
所述的连接线的功能是连接上支架1和下支架2，连接线的数量可以是如图3至图8所述的1根，2根，3根或者多根。主要的功能是连接上支架1和下支架2，当下支架2随着膜管7往下运动的时候可以由上层支架1通过连接线3拽住上支架，当上支架1往上浮的时候可以通过连接线3拽着下支架2。
所述的连接线3可以由满足人体植入要求的材料组成，作为优选可以是镍钛合金，316不锈钢，聚氨酯，硅胶，铝镁合金等一种或多种材料。
为了保护幽门口避免被连接线3切开或者受伤，连接线3外层包覆生物相容性的软性材料，作为优选，包覆材料可以是硅胶，聚氨酯，聚乙烯等一种或者多种材料。
为了防止增生和降低支架摩擦对组织的损伤，所述的上支架1和下支架2都覆有保护膜5。所述的保护膜必须是符合人体植入要求的材料。作为优选，覆膜的材料可以是硅胶，聚氨酯，聚乙烯等一种或者多种材料。
所述的上支架1和下支架2中间有一定的距离，作为优选，上支架1的下端和下支架2的上段距离为20-60mm，根据人体不同的解剖结构优选合适的尺寸，原则是要大于幽门环的高度，下支架2的下端要避开十二指肠乳头104。
所述的上支架1和下支架2上有显影环6，可以在X光下清晰定位，所述的显影环可以是铂金、黄金、钽等对人体无害的重金属材料。
所述的上支架1和下支架2上端分别有回收线8和回收线9，所述的回收线8和9分别缝合于上支架1和下支架2的最外圈，通过特制的回收器或者抓钳可以将支架从体内取出并回收。拉进回收线的时候，上层支架1和下层支架2分别回缩，进入内镜透明帽或特定的回收装置中，随着内窥镜从人体消化道内取出。所述的回收线8和9可以是PE、尼龙、涤纶等符合生物相容性要求的材料。
一种胃导流器的释放方法，包括如上所述的胃导流器，以及下述步骤：
1）呈折叠状态的膜管和消化道支架设置在收纳管壳13内，收纳管壳13的远端开口由释放体封闭；
2）在导丝的引导下，将收纳管壳13远端的释放体送入十二指肠内，再将释放体和膜管推出收纳管壳；
3）再回撤收纳管壳，直至标记线到达幽门口，将下支架从收纳管壳中推出，下支架留在十二指肠球部；
4）再回撤收纳管壳，将上支架从收纳管壳中推出，让上支架留在幽门口外，完成释放。
使用前，膜管和消化道支架被压缩和收纳在收纳管壳13中，远端由释放体外壳11和内芯12所封闭。使用时，远端释放体在导丝的引导下进入人体十二指肠。通过解锁释放体后，再解锁中管17，推动中手柄22，先完成第一阶段推送，将释放体和膜管7推出收纳管壳13，再回撤收纳管壳13，直至标记线25到达幽门口，将下支架2从收纳管壳13中推出，完成第二阶段推送，下支架2留在十二指肠球部103，再将上支架1从收纳管壳13中推出，让上支架1留在幽门口102，完成释放。具体地说，手柄操作时，先将限位球头23由“0”档旋转到“1”档，解锁中管17，缓慢推动中手柄22，直到遇阻力不能推动，第一阶段推送完成，将释放体外壳11和膜管7推出收纳管壳13，再回撤收纳管壳13，直至标记线25到达幽门口，转动限位球头23由“1”档旋转到“2”档，再次解锁中管17，缓慢推动中手柄22，直到遇阻力不能推动，第二阶段推送完成，将下支架2从收纳管壳13中推出，下支架2留在十二指肠球部103，再次转动限位球头23由“2”档旋转到“3”档，解锁中管17，顶住中手柄22，向后拉前手柄24，将上支架1从收纳管壳13中推出，让上支架1留在幽门口102，完成释放。）膜管7随着肠道蠕动到达空肠上段，此时释放体内芯12自动溶解，释放体外壳11与膜管7自动脱开，完成释放过程。输送器从口腔撤出人体，而内置套管则留在体内，起到隔离食物的作用。
所述的可植入导管可在肠道内起到隔离食物的作用，改变食物的生理流向，植入一段时间后，患者身体的胰岛素抵抗现象消除，并且该食物流经方式还能促进患者体内胰岛素分泌，减少胰岛细胞凋亡并使之增值，胰岛功能恢复，糖尿病、肥胖等代谢性疾病得到治愈。所述的可植入导管的拉伸模量为250MP以上，延伸率大于230%，材料柔软，在体内植入后引起的恶心，呕吐腹痛等现象可以明显降低。
根据本发明的可植入的导管可植入消化道，以用于治疗内分泌疾病，如糖尿病、胰岛功能紊乱、肥胖等，或者下消化道疾病，如炎症等。与现有技术相比，本发明所述的可植入的导管，具有结构简单、结构适用性好、制作工艺方便、成本低、生产速度快、质量有保证以及制造方便等优点，并且植入后舒适性、顺应性好，不会对人体组织造成伤害。
    相对于现有技术来说，本发明上支架固定在幽门口，下支架固定在十二指肠球部，并连接膜管。两个支架都不能自由活动，只能有小范围的位移，具体来说上层支架不会进入幽门里面，下层支架不会进入幽门外面，并且中间有连接线，位移范围不会超过连接线范围。上下支架连接处高度为1-8cm，根据不同人体结构有不同，结果是使得上支架位于幽门外，下支架位于十二指肠球部，并且下支架的最下端不会到十二指肠乳头部，不影响乳头的正常功能。本发明作用原理主要是在十二指肠植入一个膜管，并延长到消化道的远端，通过膜管隔离食物，从而改变代谢机制，起到治疗肥胖和糖尿病等代谢疾病的作用。支架的作用主要为固定膜管，并撑开膜管，让食物可以进入植入的膜管。本发明延伸的膜管（套筒）长度为600mm-1600mm，为主要功能结构。上支架比较小，不会对胃内造成压力，消化道支架下小上大的结构容易排空，食物不易滞留。幽门口有支架固定，上下呼应，膜管位置不易位移。
    相对于公开号为CN102335052、CN104382671、CN204671331、CN205359721等专利文献公开了一种消化道支架来说，本发明不仅功能作用不同，而且结构也不同：本发明中，上下支架形状不同；连接线为弧形，需要顺应幽门口的解剖结构；连接线一般为两根以上以连接稳固；用于幽门口的固定，具体来说是固定一个肠道隔离膜管，产品具体应用为治疗糖尿病和肥胖等代谢疾病。下支架需要连接一段软性膜管，才能起到治疗目的。
 本发明的实施方式
在本说明书的描述中，参考术语“一个实施例”、“一些实施例”、“示例”、“具体示例”、或“一些示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中，对上述术语的示意性表述不一定指的是相同的实施例或示例。而且，描述的具体特征、结构、材料或者特点可以在任何的一个或多个实施例或示例中以合适的方式结合。
尽管上面已经示出和描述了本发明的实施例，可以理解的是，上述实施例是示例性的，不能理解为对本发明的限制，本领域的普通技术人员在不脱离本发明的原理和宗旨的情况下在本发明的范围内可以对上述实施例进行变化、修改、替换和变型。凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
 工业实用性
在此处键入工业实用性描述段落。
 序列表自由内容
在此处键入序列表自由内容描述段落。

Claims (13)

  1. 一种胃导流器的消化道支架，该消化道支架具有展开前形状和展开后形状，其特征在于，包括上支架（1）、下支架（2）和连接件（3）；在展开后形状下，上支架（1）在临近其顶部设有第一开口并且在临近其底部设有第二开口，下支架（2）设于上支架（1）下方，下支架（2）在临近其顶部设有第三开口并且在临近其底部设有第四开口，上支架（1）和下支架（2）之间通过若干个连接件（3）连接，下支架（2）的第四开口连接膜管（7），并且，展开后的上支架（1）和下支架（2）均无法通过张开的胃幽门口，连接件（3）可以通过胃幽门口或穿设在胃幽门口处。
  2. 根据权利要求1所述的一种胃导流器的消化道支架，其特征在于，该连接件（3）为连接线。
  3. 根据权利要求2所述的一种胃导流器的消化道支架，其特征在于，该连接线外面覆膜。
  4. 根据权利要求2所述的一种胃导流器的消化道支架，其特征在于，该连接件（3）包括多根连接线，多根连接线的上端分别连接上支架（1），多根连接线的下端分别连接下支架（2）。
  5. 根据权利要求1所述的一种胃导流器的消化道支架，其特征在于，所述连接件（3）对应胃幽门口的位置在自然状态下会产生顺应人体幽门口的弯曲或缩小外径的弹性形变。
  6. 根据权利要求1所述的一种胃导流器的消化道支架，其特征在于，所述上支架（1）呈锥筒状、倒锥筒状、直筒状或草帽形状。
  7. 根据权利要求1所述的一种胃导流器的消化道支架，其特征在于，所述上支架（1）的第二开口外径大于第一开口外径。
  8. 根据权利要求2所述的一种胃导流器的消化道支架，其特征在于，连接线的上端与上支架（1）顶部靠近第一开口的位置固定连接，连接线的下端与下支架（2）顶部靠近第三开口的位置固定连接。
  9. 根据权利要求2所述的一种胃导流器的消化道支架，其特征在于，连接线的上端与上支架（1）顶部靠近第一开口的位置固定连接，连接线绕经上支架（1）中部编制网孔后，连接线的下端与下支架（2）顶部靠近第三开口的位置固定连接。
  10. 一种胃导流器，其特征在于，包括如权利要求1至9中任一项所述的消化道支架。
  11. 一种胃导流器，包括收纳管壳（13）、释放体以及推送组件，所述收纳管壳（13）呈管状，所述收纳管壳（13）的两端为开口，所述收纳管壳（13）中设置待释放的呈折叠状态的膜管（7）和消化道支架，所述释放体设置在收纳管壳（13）的远端开口处并与所述膜管（7）的一端连接，所述释放体由能够被人体肠道消化吸收或溶解的材料制成；该消化道支架具有展开前形状和展开后形状，其特征在于，该消化道支架是权利要求1至9中任一项所述的消化道支架。
  12. 根据权利要求11所述的一种胃导流器，其特征在于，所述收纳管壳（13）上设有标记线（25）。
  13. 一种胃导流器的释放方法，包括如权利要求12所述的胃导流器，以及下述步骤：
    1）呈折叠状态的膜管和消化道支架设置在收纳管壳（13）内，收纳管壳（13）的远端开口由释放体封闭；
    2）在导丝的引导下，将收纳管壳（13）远端的释放体送入十二指肠内，再将释放体和膜管推出收纳管壳；
    3）再回撤收纳管壳，直至标记线到达幽门口，将下支架从收纳管壳中推出，下支架留在十二指肠球部；
    4）再回撤收纳管壳，将上支架从收纳管壳中推出，让上支架留在幽门口外，完成释放。
PCT/CN2018/111746 2018-04-12 2018-10-24 胃导流器及其消化道支架、释放方法 WO2019196380A1 (zh)

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