WO2019000704A1 - 胃导流器及其消化道抗菌导管 - Google Patents

胃导流器及其消化道抗菌导管 Download PDF

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Publication number
WO2019000704A1
WO2019000704A1 PCT/CN2017/105992 CN2017105992W WO2019000704A1 WO 2019000704 A1 WO2019000704 A1 WO 2019000704A1 CN 2017105992 W CN2017105992 W CN 2017105992W WO 2019000704 A1 WO2019000704 A1 WO 2019000704A1
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WO
WIPO (PCT)
Prior art keywords
tube
digestive tract
housing
catheter
gastric
Prior art date
Application number
PCT/CN2017/105992
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
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 EP17915783.9A priority Critical patent/EP3646827B1/en
Priority to PL17915783.9T priority patent/PL3646827T3/pl
Priority to US16/610,551 priority patent/US20200069910A1/en
Priority to JP2020515798A priority patent/JP6913825B2/ja
Priority to RU2019140670A priority patent/RU2745080C1/ru
Priority to ES17915783T priority patent/ES2956103T3/es
Priority to AU2017420550A priority patent/AU2017420550B2/en
Publication of WO2019000704A1 publication Critical patent/WO2019000704A1/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
    • A61F5/004—Intragastrical devices remotely adjustable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
    • 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
    • A61F5/003—Implantable devices or invasive measures inflatable
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0008—Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0056—Catheters; Hollow probes characterised by structural features provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0205—Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/04—General characteristics of the apparatus implanted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/32—General characteristics of the apparatus with radio-opaque indicia
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • the present invention relates to the field of medical device technology, and particularly relates to a method for treating endocrine diseases (such as diabetes, islet dysfunction, obesity, etc.) or lower gastrointestinal diseases (such as inflammation), gastric diverters and their digestive tract antibacterial catheter.
  • endocrine diseases such as diabetes, islet dysfunction, obesity, etc.
  • lower gastrointestinal diseases such as inflammation
  • gastric diverters and their digestive tract antibacterial catheter.
  • diabetes is a disease that has been gradually paid attention to by people in recent years. It is one of the rich diseases. It is derived from the continuous improvement of the living standards of modern civilized society. After people's lives are rich, they eat well. A non-infectious epidemic that produces fine, over-nutrition, 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 to various tissues, especially the eyes, kidneys, heart, blood vessels, nerves, and dysfunction. Diabetes is often accompanied by obesity and many complications, posing a great threat to people's health.
  • gastric bypass surgery has a very good effect on eradicating type 2 diabetes and improving obesity.
  • the International Diabetes Federation officially recommended metabolic surgery (including gastric transfer).
  • Flow surgery As a treatment for obesity and type 2 diabetes, gastric bypass surgery, as a surgical procedure, can cause wounds in the human body, and therefore has many risks such as: death, intestinal obstruction, anastomotic leakage, pulmonary embolism, deep vein Thrombosis, portal vein injury, respiratory system, etc.
  • the retrieved barb can easily damage the esophagus and cause the esophagus to tear. 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.
  • an object of the present invention is to provide a gastric diverter and an antibiotic antibiotic catheter thereof, which adopts a digestive tract isolation catheter made of an antibacterial material to minimize the occurrence of intestinal inflammation.
  • Improve the metabolism of human metabolic diseases avoid complications such as liver abscess and pancreatitis, and provide a safer and more effective medical device for treating metabolic diseases such as diabetes.
  • an antibacterial material such as nano silver ions, silver particles, nano silver, nano copper ions, copper in a membrane tube polymer material.
  • Granules, vanillin, ethyl vanillin or chitosan these materials are easy to add to polymer materials, do not affect the physical properties of the material, and do not harm the human body.
  • the present invention adopts the following technical solutions:
  • a digestive tract antibacterial catheter of a gastric diverter comprising: a membrane tube (31), one end of the membrane tube (31) is connected to a stent (32), and the membrane tube (31) is made of an antibacterial material Outside the membrane tube (31)
  • the membrane tube (31) has a wall thickness of 0.001 mm to 0.3 mm, and the membrane tube (31) and the stent (32) are fixedly connected by suturing, hot pressing, ultrasonic welding or laser welding.
  • the film tube comprises a polymer material, an antibacterial material and a developing material, and the raw materials are uniformly mixed and then formed into a film or a tubular film by blow molding, extrusion, molding or hot press forming.
  • the film tube is coated with an antibacterial material on the outer surface of a film made of a polymer material, a tubular film or a thin-walled tube.
  • the polymer material has good biocompatibility and can be retained in the human body for a long period of time without adversely affecting the human body.
  • the long-term retention means that it can stay in the digestive tract of the human body for three months or longer.
  • the polymer material must be sufficiently soft to not cause adverse stimulation to the mucosa of the digestive tract, and the patient does not feel uncomfortable after implantation, even if the individual has slight discomfort, and is also in the short sputum. Can disappear by itself.
  • the polymer material must have good chemical and biological stability, and under the influence of various strong acids, alkalis and biological enzymes in the digestive tract, chemical changes should not occur, and dissolution substances unfavorable to the human body are generated. .
  • the polymer material must have good processing properties and can be processed into a film or a tubular film having a thickness of 0.001 to 0.3 mm.
  • the polymer material may be any one or a combination of polyethylene, fluoropolymer, polyurethane, silica gel, TPU, or the like, which is a polymer material satisfying the above requirements.
  • the antibacterial material has good biocompatibility, is non-toxic and environmentally friendly to the human body.
  • the antibacterial material must have an obvious antibacterial inhibitory effect on pathogenic microorganisms, and can maintain antibacterial properties in a long day.
  • the antibacterial material must have excellent physical properties and have a certain strength and flexibility in human tissues.
  • the antibacterial material has self-cleaning and environmental protection, is convenient to use, and preferably has a certain self-degrading ability.
  • the antibacterial material may be one or more of nano silver ions, silver particles, nano silver, nano copper ions, copper particles, vanillin, ethyl vanillin compound or chitosan.
  • Composite material Preferably, a developing material may be added to the digestive tract implant catheter to determine the position of the digestive tract implant catheter in the human body, whether it is twisted and knotted, and the like.
  • the developing material must have good biocompatibility, is harmless to the human body, and does not affect the physical shape of the digestive tract implant after the proper amount is added, and the catheter can remain soft.
  • the developing material may be one or more of barium sulfate, barium carbonate, and tungsten compound.
  • the polymer material, the antibacterial material, and the developing material are uniformly mixed with each other, and can be processed into a film-like tubular material by a well-known polymer processing process such as blow molding, extrusion, molding, or the like.
  • the film has a thickness of 0.001 to 0.3 mm, and the tube has a diameter of 10 to 35 mm.
  • the digestive tract antibacterial catheter can be implanted into the digestive tract.
  • the digestive tract includes the esophagus, stomach, duodenum, jejunum, ileum, etc., such that the different positions of the implantable catheter may correspond to the esophagus, stomach, duodenum, jejunum, ileum, and the like, respectively. Since the catheters have different functions at different locations, different effects can be exerted on different parts of the digestive tract.
  • the bracket (32) is a mesh tube made of a braided wire (103), and the braided wire is a biocompatible elastic yarn, which may be a wire or a polymer material wire. Or a filament of degradable material.
  • the bracket (32) comprises a bracket upper section (101) and a bracket lower section (102), and the upper section of the bracket upper section (101) has an outer diameter larger than the lower bracket section (102) by 5 to 15 mm.
  • the bracket (32) is provided with a developing ring (106).
  • the scaffold (32) is provided with a recovery line (105).
  • a gastric flow guide comprising: a housing, a release body, a push assembly, and a digestive tract antibacterial catheter as described above, wherein the housing (1) is tubular, the housing ( 1) has a first port (11) at one end and a second port (13) at the other end, a duct in a folded state to be released is disposed in the housing (1), and the release body (2) is disposed At the first port (11) and connected to one end of the membrane tube (31), the release body (2) is made of a material that can be absorbed or dissolved by the human intestinal tract; the push assembly
  • the inner tube (41), the middle tube (42) and the outer tube (43) are sequentially sleeved and movable relative to each other, and a part of the inner tube (41) is located in the housing (1) and
  • the release body (2) is connected; one end of the middle tube (42) extends into the housing through the second port (13) (1) inside, and the end of the middle tube (42) is fixedly provided with a stopper piston (12) in the housing (1) for pushing
  • the film tube (31) is pulled out from the housing and spread out, and released at a specified position in the human intestinal tract.
  • the digestive tract antibacterial catheter can be implanted into the digestive tract for treating endocrine diseases, such as diabetes, islet dysfunction, obesity, etc., or lower gastrointestinal diseases, such as inflammation, etc. .
  • the catheter of the present invention has a certain antibacterial effect, and can effectively prevent or reduce the occurrence of gastrointestinal inflammation, such as liver abscess, pancreatitis and the like.
  • the material used in the invention has the advantages of simple structure, convenient manufacturing 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.
  • FIG. 1 is a cross-sectional view showing the structure of an embodiment of the present invention.
  • FIG. 2 is a schematic overall structural view of an 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.
  • FIG. 4 is a cross-sectional view of a release body of another structure according to an embodiment of the present invention.
  • FIG. 5 is a schematic structural view of an implantable catheter of the present invention.
  • FIG. 6 is a schematic structural view of an embodiment of a stent of the present invention.
  • FIG. 7 is a schematic structural view of another embodiment of a stent of the present invention.
  • FIG. 8 is a schematic structural view of still another embodiment of the stent 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 explicitly or implicitly include one or more of the features. In the description of the present invention, “multiple” means two or more unless otherwise specifically defined.
  • the terms “installation”, “connected”, “connected”, “fixed” and the like should be understood broadly, and may be, for example, a fixed connection or a Removable connection, or integral connection; can be mechanical connection or electrical connection; it can be directly connected or indirectly connected through an intermediate medium, which can be the internal communication between the two components.
  • installation should be understood broadly, and may be, for example, a fixed connection or a Removable connection, or integral connection; can be mechanical connection or electrical connection; it can be directly connected or indirectly connected through an intermediate medium, which can be the internal communication between the two components.
  • the first feature may be included in the “on” or “under” the second feature, and may include the first and second features, respectively, and may include the first
  • the second feature is not in direct contact but through additional features between them.
  • the first feature "aboves”, “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 includes the first feature below the second feature, "below” and "below” The feature is directly below and below the second feature, or merely indicates that the first feature is less than the second feature
  • a gastric deflector as shown in FIG. 1 includes a housing, a release body, a push assembly, and an implantable catheter, wherein the housing 1 has a tubular shape, and one end of the housing 1 has a first a fistula 11 having a second fistula 13 at the other end, wherein the housing 1 is provided with an implantable catheter in a folded state to be released, and the release body 2 is disposed at the first fistula 11 and One end of the membrane tube 31 is connected, and the release body 2 is made of a material that can be absorbed or dissolved by the human intestinal tract;
  • the push assembly includes an inner tube 41, which is sequentially sleeved and can move relative to each other, in the middle a tube 42 and an outer tube 43, a portion 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 through the second port 13 1 , and the end of the middle tube 42 is fixedly provided with a stopper piston 12
  • the movement of the inner tube 41 drives the release body 2 to move, thereby pulling the membrane tube 31 to gradually expand the membrane tube 31, and the middle tube 42 moves along the axial direction thereof and drives the
  • the stopper piston 12 pushes against the film tube 31 (i.e., pushes against the end of the film tube 31 that is not connected to the release body 2), and pushes the film tube 31 out of the casing 1.
  • a protrusion is disposed outside the second port 13 of the housing 1 , and a screw 14 is screwed on the boss, and the outer tube 43 passes through the nut 14 and the The second port 13 of the housing 1 is fixedly connected.
  • the fixed connection between the outer tube 43 and the second port 13 may be heat-shrinking or other means.
  • each part of the housing 1 and the push assembly may be made of one or more composite materials of polyurethane, polyethylene, and fluoropolymer, and has good supportability and pushability. With good toughness and smooth surface, it can be well pushed under the endoscope or the natural cavity of the human body, it is not easy to be discounted, and it has good handling.
  • the gastric deflector of the embodiment uses a fistula, a guide wire is inserted into the inner tube 41, and the operator extends the entire device from the mouth of the human body, and then cooperates with the gastroscope through the guide wire.
  • the housing 1 is guided to the duodenum and/or the upper part of the gastric pylorus in the human body close to the gastric pylorus, wherein the guide wire guides and supports the push assembly to help the inner tube 41 move in the esophagus and gastrointestinal tract of the human body. Thereby guiding the casing 1 and the membrane tube 31 to arrive smoothly At the specified location.
  • the middle tube 42 and the inner tube 41 in the push assembly are operated to release the membrane tube 31 in the housing 1 into the human intestinal tract, and the inner tube 41 is operated to pull the release body 2 to move, so that the folded film tube 31 is expanded.
  • the release body 2 made of a material that can be digested and absorbed by the human intestinal tract enters the intestinal tract of the human body, encounters the digestive tract liquid or water can be dissolved or decomposed in the short sputum, and finally is digested by the human intestinal tract.
  • the release body 2 is composed of a material that is biosafe for human body, can be digested by the human body or can be decomposed in the body, and has no toxic side effects on the human body, for example, may be an edible gelling agent, soy protein powder, starch. And one or more compounds such as a polysaccharide compound, glycerin, branched or amylopectin.
  • the release body 2 can also be made of a material which can be dissolved in the human body and is not absorbed at all, but is completely excreted from the body, without any toxic side effects on the human body.
  • the release body 2 includes an inner core 22 and a casing 23, and the inner core 22 has a main body portion 22 and a membrane tube connecting portion 221 formed by the main body portion 222.
  • the film tube connecting portion 221 is fixedly connected to one end of the film tube 31; the outer casing 23 is wrapped around the main body portion 222, and the outer casing 23 is connected to the first port 11 and is easily fracture.
  • the surface of the main body portion 222 of the inner core 22 and the direction in which the outer casing 23 is released toward the film tube 31 are all smooth surfaces, and such a structure is easier to release the body. 2 Movement in the human intestines.
  • the outer wheel of the main body portion 222 is approximately spherical or hemispherical, and the outer contour of the outer casing 23 is shaped to match the outer contour of the main body portion 222 and is covered.
  • the outer contour of the main body portion 222 is approximately hemispherical, and the outer contour of the outer casing 23 is approximately hemispherical.
  • the main body portion 222 and the outer casing The shape of 23 may also be a shape that is close to a sphere or a near hemisphere.
  • the outer contour of the main body portion 222 is hemispherical
  • the membrane tube connecting portion 21 is connected to the planar portion of the main body portion 222
  • the outer casing 23 is hemispherical.
  • an annular step 231 is formed on the outer edge of the end surface of the hemispherical outer casing 23, the ring The step 231 abuts against the second port 13 of the housing 1.
  • connection manner between the inner core 22 and the outer casing 23 may be screwed or snapped.
  • FIG. 3 shows the screw.
  • connection between the inner core 22 and the outer casing 23 may be not limited to screwing or snapping, but may also be a taper fit or other connection.
  • the outer casing 23 and the inner core 22 are mated by a taper. Other similar structures are not described here.
  • one end of the inner tube 41 sequentially passes through the membrane tube connecting portion 221 of the inner core 22, the main body portion 222, and the outer casing 23, and from the first cornice 11 Extend.
  • the endoscope examines the human intestine from the extended end of the inner tube 41.
  • the inner tube 41 and the membrane tube connecting portion 221 of the inner core 22, the main body portion 222 and the outer casing 23 are tightly fitted or interference-connected, so that the inner tube 41 can drive the inner tube 41.
  • the same movement of the release body 2 toward the release direction of the film tube 31 affects the film tube 31 and protrudes out of the housing 1.
  • the film tube connection portion 221, the main body portion 222 and the outer casing 23 are The inner tubes 41 can be connected in a number of different ways.
  • the inner tube 41 is provided with a damper tube 411 through a portion of the inner core 22, and in the embodiment, the inner tube 41 and the inner tube 41 are A tight fit is formed between the inner cores 22, and the damper tube 411 is used to increase the sliding friction between the release body 2 and the inner tube 41, thereby improving the movement of the inner tube 41 to move the release body 2. ability.
  • the damper tube 411 may be made of one or more elastic materials such as polyurethane, silica gel, TPE, etc., and the surface may be physically or chemically treated to increase the friction force, thereby making the film Before the tube 31 is released, the damper tube 411 maintains a relatively static state between the release body 2 and the inner tube 41.
  • the other end of the film tube 31 is fixedly connected to the bracket 32.
  • the bracket 32 is an elastic memory alloy braided bracket 32 and has a mesh tubular shape.
  • the bracket 32 can be made of nickel-titanium alloy, stainless steel or other elastic metal, or other qualified memory alloy, and the material meets the requirements of biocompatibility, and can be suitable for long-term implantation in the human body; the bracket 32 has a rhombus shape and a hexagonal shape. Or a honeycomb or other shape structure regularly arranged, placed with the human duodenal bulb, the stent has a certain elasticity It can be deformed with intestinal peristalsis, and has the same supporting force and can be fixed in the duodenal bulb.
  • the middle tube 42 drives the movement of the stopper piston 12 to push the bracket 32 and the diaphragm tube 31 outward from the housing 1, and the housing needs to be observed through the endoscope.
  • the bracket 32 in the body 1 should stop operating the middle tube 42 when the foremost end of the bracket 32 has to be separated from the housing 1. Therefore, the position of the housing 1 needs to be adjusted so that the bracket 32 can be fixed to the duodenal bulb in the human body.
  • the stent has a certain elasticity and can be deformed along with the peristalsis of the intestine.
  • the support can be fixed in the duodenal bulb.
  • the specific structure of the operation of the tube 42 and the inner tube 41 includes: the middle tube 42 has a first protruding end 421 protruding from the other end of the outer tube 43.
  • the first protruding end 421 is connected with a first handle 44, and the first handle 44 is provided with a luer connector 45 that communicates with the inside of the middle tube 42.
  • the inner tube 41 has the first A second protruding end 412 protrudes from the protruding end 421, and a second handle 46 is connected to the second protruding end 412.
  • the tube 42 and the inner tube 41 are moved to release the membrane tube 31, and a certain amount of water or physiological saline may be injected into the luer connector 45, and the water or physiological saline passes through the middle tube 42 and the inner tube 42.
  • the gap between the tubes 41 enters the inside of the membrane tube 31, accelerates the release of the membrane tube 31 in the duodenum, and also accelerates the dissolution or decomposition of the released body 2.
  • the membrane tube 31 and the release body 2 peristrate from the duodenum to the jejunum as the intestinal tract creeps, and the daytime is about 1-10 minutes.
  • the saline flows along the gap between the inner tube 41 and the middle tube 42 toward the membrane tube 31, which also accelerates 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 may contain a developing material such as barium sulfate, barium carbonate or tungsten, etc., which may be developed under X-rays, and the release body 2 may also contain a developing material, which can accurately show the release body 2 under X-rays. The location is convenient for the operator to operate.
  • the present invention can adopt the following operation mode.
  • the middle tube 42 is operated to drive the movement of the stopper piston 12, and the stopper piston 12 pushes the other end of the membrane tube 31 located in the housing 1.
  • Bracket 32 thereby pushing the entire membrane tube 31 out of the housing 1, here
  • the stopper piston 12 is pushed against the bracket 32 to move to the position of the first port 11 of the casing 1 (the membrane tube 31 is about to be completely released)
  • the intestine also reaches the designated release position (specifically, the proper position of the stomach of the human stomach near the duodenum and/or the upper part of the pylorus), and then pushes the second handle 46 away from the operator, allowing The bracket 32 is completely disengaged from the housing 1 to fix the bracket 32 to the bulbus of the human body.
  • the bracket has a certain elasticity, can be deformed along with the peristalsis of the intestine, and has a certain supporting force and can be fixed.
  • the membrane tube 31 in the duodenal bulb stretch state may be placed in the digestive tract of the human body for 1-12 months, and is adjusted according to the improvement of the condition or the actual situation.
  • another operation mode that can be employed is the same operation of the tube 42 and the inner tube 41, so that the stopper piston 12 is pushed against one end of the membrane tube 31 located in the housing 1 to the membrane tube 31.
  • the same casing of the casing 1 is pushed out, the movement of the inner tube 41 moves the release body 2, and the release body 2 pulls the bracket 32 at the other end of the membrane tube 31, so that the same duct of the membrane tube 31 is extended from the casing 1.
  • the entire membrane tube 31 is finally pushed out of the housing 1 at a designated release position of the human intestinal tract.
  • the implantable catheter as shown in FIG. 5, comprises a membrane tube (31), and one end of the membrane tube (31) is connected to the stent
  • the film tube (31) is made of an antibacterial material, the outer diameter of the film tube (31) is 10 mm to 35 mm, and the wall thickness of the film tube (31) is 0.01 mm to 0.1 mm.
  • the film tube (31) and the bracket (32) are fixedly connected by stitching, hot pressing, ultrasonic welding or laser welding.
  • the catheter comprises a polymer material, an antibacterial material and a developing material, and the raw material is uniformly mixed and then blown, extruded, or molded into a film or a tubular film.
  • the polymer material is any one or more of polyethylene, fluoropolymer, polyurethane, and silica gel.
  • the antibacterial material is one or more of nano silver, nano copper, vanillin, ethyl vanillin compound or chitosan.
  • the developing material is one or more of barium sulfate, barium carbonate, and tungsten compound.
  • the outer diameter of the membrane tube according to the present invention may be from 10 mm to 40 mm, preferably from 15 mm to 35 mm, more preferably from 15 mm to 30 mm. Within this range, it can be fully applied to the human digestive tract without causing damage to human tissues.
  • the membrane tube according to the invention may have a length of from 200 mm to 1500
  • Mm preferably from 200 mm to 1300 mm, more preferably from 300 mm to 1200 mm.
  • the catheter according to the invention is placed anywhere in the digestive tract and defines the active location.
  • the membrane tube according to the present invention may have a wall thickness of 0.001 mm to 0.3
  • Mm is preferably from 0.005 mm to 0.05 mm, more preferably from 0.01 mm to 0.03 mm. Within this range, the flexibility of the catheter according to the present invention can be sufficiently ensured and sufficient strength can be maintained.
  • the implantable catheter can be implanted into the digestive tract.
  • the digestive tract includes the esophagus, the stomach, the duodenum, the jejunum, the ileum, and the like, such that the different positions of the implantable catheter may correspond to the esophagus, stomach, duodenum, jejunum, ileum, and the like, respectively. Since the catheters have different functions at different locations, different effects can be exerted on different parts of the digestive tract.
  • the implantable catheter can play the role of isolating food in the intestinal tract, changing the physiological flow direction of the food. After implantation for a period of time, the insulin resistance of the patient body is eliminated, and the food flow can promote the patient's body.
  • the implantable catheter has a tensile modulus of more than 250 MP and an elongation of more than 230%.
  • the material is soft, 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 and the like.
  • the implantable catheter of the invention has the advantages of simple structure, good structure applicability, convenient manufacturing process, low cost, fast production speed, guaranteed quality and convenient manufacture, and is implanted. After the comfort, compliance, and will not cause damage to human tissue.
  • the implantable catheter of the present invention comprises barium sulphate having characteristics such as visible under the X-ray. Furthermore, the implantable catheter of the present invention can be coupled to a stent. When the bracket is attached, the stimulation of the digestive tract can be reduced, and the lifting adjustment or recovery of the stent can be made safer and more convenient.
  • nano silver is selected as an antibacterial material
  • the nano silver powder is added to the powder of the polytetrafluoroethylene material in a ratio of one ten thousandth to one thousandth of a weight percent.
  • Adding alcohol and other additives to mix the two materials thoroughly put the above mixture into special equipment, and first make the tube blank by heating and pressing, and the heating temperature is about 300 °C; then put it into the design.
  • Good extrusion die do tube over-molding; put the tube blank into the designed iron bar, put it in a ventilated heating furnace, volatilize the solvent such as alcohol, and solidify the tube blank;
  • the catheter is placed in a heat treatment furnace for shaping.
  • the obtained catheter has a diameter of 10-40 mm, the wall thickness of the thin wall tube is 0.01-0.1 mm, the catheter is soft, and has It has good biocompatibility and can be retained in the human body for a long time without adversely affecting the human body.
  • the long-term retention means that it can stay in the digestive tract of the human body for three months or longer.
  • the developing material may also be added to the material to facilitate the determination of the position of the implanted catheter in clinical use, and whether there is a kinking or the like.
  • the implanted catheter must have good chemical and biological stability, and under the influence of various strong acid and alkali and biological enzymes in the digestive tract, no chemical changes should occur, and an unfavorable dissolution product is generated. .
  • the catheter has an obvious antibacterial inhibitory effect on pathogenic microorganisms, maintains antibacterial properties in a long sputum, and is non-toxic and environmentally friendly to the human body.
  • the catheter has excellent physical properties and has a certain strength and flexibility in human tissues.
  • chitosan is selected as an antibacterial material, and chitosan is added to the PE masterbatch at a ratio of 5-25% by weight to prepare chitosan-containing PE masterbatch; select linear low-density polyethylene (LLDPE) as the base material, add chitosan-containing PE masterbatch to LLDPE plastic particles and mix evenly; use thin-wall tube for extrusion process, the processing temperature is preferably 100- At 130 ° C, the pressure is controlled during the extrusion process to maintain a stable inner diameter.
  • LLDPE linear low-density polyethylene
  • the obtained catheter made of antibacterial material has a soft texture, and the wall thickness of the thin-walled tube is 0.01-0.1 mm, and the diameter of the catheter is 10-40 mm, which does not adversely affect the digestive tract and has a good antibacterial effect.
  • a developing material may also be added to the material to determine the position of the catheter within the digestive tract of the human body.
  • the developing material is barium sulfate, and the specific addition amount is 10-35% by weight.
  • the gastrointestinal antibacterial catheter prepared by using the above-mentioned embodiment of the present invention is subjected to a bacteriostatic test, and the same material (but no bacteriostatic material) is used to form a film-like catheter of the same size, and a strip of 15 mm*30 mm is taken.
  • the materials were placed in agar medium and placed in two culture dishes, and cultured for 48 hours under the same culture conditions, the samples cultured using the digestive tract catheter used in the present invention were found, and the total number of colonies was less than that of the bacteriostatic material. The sample will be less than 50%.
  • the film tube 31 is connected to one end of the bracket 32, and the connection may be one or a combination of stitching, hot pressing, ultrasonic welding, or laser welding.
  • the embodiment provides a digestive tract support 32 divided into two parts, an upper section 101 and a lower section 102.
  • the diameter of the upper section 101 is preferably 25 to 40 mm, which is larger than the diameter of the duodenal bulb. , the straightness of the lower section 102
  • the diameter is preferably 15 to 25 cm, which is close to or slightly larger than the diameter of the duodenum.
  • the diameter of the upper section 101 is larger than the diameter of the lower section 102.
  • the diameter of the upper section 101 is 5 to 15 mm larger than the diameter of the lower section 102.
  • the bracket may be of the funnel shape of FIG. 6, that is, the upper section 101 has an inverted trapezoidal shape, and the upper section 101 has a diameter larger than the diameter of the lower section 102.
  • the upper section 101 has a diameter of 25 to 40 mm and a diameter greater than twelve.
  • the upper part of the intestine, the lower section 102 has a diameter of 15 to 25 cm, which is equivalent to the diameter of the upper part of the duodenum, and the diameter of the upper section 101 is 5 to 15 mm larger than the lower section 102.
  • the upper section 101 has a rounded rectangle fixed to the duodenal bulb.
  • the inverted trapezoidal design can achieve smooth over-extension, maximally avoiding long-term implantation to cause damage to the digestive tract wall, and providing maximum support force.
  • the lower segment is connected to the membrane tube and the membrane tube. 31 extended to the lower part of the duodenum or the upper part of the jejunum.
  • the bracket 32 may also be of the spherical shape of FIG. 7, that is, the upper section 101 has an elliptical shape, and the upper section 101 has a diameter larger than the diameter of the lower section 102.
  • the upper section 101 has a diameter of 25 to 40 mm and a diameter larger than the twelve fingers.
  • the diameter of the lower part 102 is 15 ⁇ 25cm, which is equivalent to the diameter of the duodenum, and the diameter of the upper part 101 is 5 ⁇ 15mm larger than the lower part.
  • the upper 101 ball is fixed on the duodenal bulb.
  • the arc-shaped design can avoid the long-term implantation to cause damage to the digestive tract wall.
  • the arc-shaped excessive can provide good supporting force.
  • the lower segment 102 connects the membrane tube 31.
  • the membrane tube 31 is extended to the lower part of the duodenum or the upper part of the jejunum.
  • the bracket may be of the wine cup type of FIG. 8, that is, the upper section 101 has a rounded rectangle, and the upper section 101 has a diameter larger than the diameter of the lower section 102.
  • the upper section 101 has a diameter of 25 to 40 mm and a diameter larger than the upper part of the duodenum.
  • the lower section 102 has a diameter of 15 to 25 cm, which is equivalent to the diameter of the upper part of the duodenum, and the diameter of the upper section 101 is 5 to 15 mm larger than that of the lower section 102.
  • the upper section 101 rounded rectangle is fixed on the duodenal bulb.
  • the rounded rectangle design maximizes the contact area between the stent and the duodenal bulb, which can avoid the long-term implantation to damage the digestive tract wall.
  • Tube the membrane tube is extended to the lower part of the duodenum or the upper part of the jejunum.
  • the upper portion 101 of the bracket 32 has a height of 5 to 15 mm, and the height of the lower portion 102 is also 5 to 15 mm.
  • the specific height can be appropriately adjusted according to the specific physiological anatomy of the human body.
  • the bracket 32 is arranged in a rhombus, hexagonal or honeycomb shape, and is placed on the duodenal bulb of the human body.
  • the bracket 32 has a certain elasticity and can be deformed along with the intestinal peristalsis. With a certain supporting force, it can be fixed in the duodenal bulb to prevent slipping.
  • the braided wire 103 of the bracket 32 may be a metal material, a polymer material, or a degradable material.
  • the wire material may be stainless steel wire or nickel titanium alloy wire
  • the polymer material may be a polymer material such as PE.
  • PE polyethylene
  • PU polyurethane
  • PTFE polytetrafluoroethylene
  • degradable materials can be PPDO (poly-p-dioxanone), PLLA (polylactic acid), PGA (polyethylene glycol) Acid) and so on.
  • 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 slippage.
  • the braided wire 103 is selected from a nickel-titanium alloy, and the nickel-titanium alloy wire is preferably a nickel-titanium alloy satisfying long-term implantation requirements, and the preferred austenite transformation point is 0 to 10 degrees.
  • the bracket 32 is woven on the mold by a wire, and then heat-set and shaped, and the shaped product may be the structure shown in FIG. 6 to FIG. 8 or a similar structure conforming to human physiological anatomy. It has a certain supporting force and compressive force in both the horizontal and vertical directions. It can be deformed with the human intestinal peristalsis, has a uniform supporting force, is fixed in the duodenal bulb and can be restored to a heat-set shape, fixed at ten.
  • the duodenal bulb 113 is woven on the mold by a wire, and then heat-set and shaped, and the shaped product may be the structure shown in FIG. 6 to FIG. 8 or a similar structure conforming to human physiological anatomy. It has a certain supporting force and compressive force in both the horizontal and vertical directions. It can be deformed with the human intestinal peristalsis, has a uniform supporting force, is fixed in the duodenal bulb and can be restored to a heat-set shape, fixed at ten.
  • the braided wire of the bracket 32 is in the shape of a swivel that rotates about the central axis.
  • the direction of rotation of the revolving body may be a direction of rotation of the boring pin or a direction of rotation of the tweezer from the head end portion.
  • the bracket 32 has a recovery line 105, and the recovery line 105 is sewn to the outermost circumference of the upper section 101 of the bracket 32, and the bracket can be taken out from the body by a special collector or grasping forceps. And recycling.
  • the recovery line is pulled in, the holder 32 is retracted as a whole and enters the endoscope transparent cap or a specific recovery device as the endoscope is removed from the human digestive tract.
  • the recovery line 105 may be a material that meets biocompatibility requirements such as PE, nylon, and polyester.
  • the surface of the bracket 32 may be coated to facilitate later removal.
  • the film may be various biocompatible biomaterials such as silica gel, fluoroplastic, PE, and TPU.
  • the film has a thickness of 0.01 to 0.2 mm.
  • the bracket 32 is woven by a single wire.
  • the number of the heads 104 of the bracket 32 may be preferably 10-30 heads, less preferably 15-25 heads, and most preferably 18-24 heads.
  • the bracket 32 is provided with a developing ring 106, which can be clearly positioned under X-rays.
  • the developing ring 106 can be a heavy metal material that is harmless to the human body such as platinum, gold or enamel.

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Abstract

一种胃导流器及其消化道抗菌导管，该导管包括膜管（31），膜管（31）的一端连接支架（32），该膜管（31）由抗菌材料制成，膜管（31）的外径为10mm至35mm，膜管（31）的壁厚为0.001mm至0.3mm，膜管（31）和支架（32）通过缝合、热压、超声波焊接或者激光焊接固定连接。该消化道抗菌导管采用抗菌材料制成，尽可能降低肠道炎症的发生，在改善人体代谢疾病的同时，避免例如肝脓肿、胰腺炎等并发症的发生，从而提供一种更安全、更有效的治疗如糖尿病等代谢疾病的医疗器械。

Description

胃导流器及其消化道抗菌导管 技术领域
[0001] 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抗 菌导管。
背景技术
[0002] 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。
[0003] 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。
[0004] 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吋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吋病人不会有 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。
[0005] 虽然现有技术中胃导流器产品在治疗和逆转糖尿病， 减肥等方面取得了非常良 好的效果， 但是也发现了少量的并发症， 例如肝脓肿就是一个相对比较严重的 并发症， 这也限制了该款革命性的产品广泛的临床应用。
[0006] 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。 目前该产品由美国 GI公司生产， 并已用 于临床， 国内也有很多同类设计。 该支架是一种 V字型或者波浪形结构， 通过倒 刺固定于十二指肠球部。 该设计的风险是倒刺刺入十二指肠， 对人体消化道产 生一定损伤， 取出的吋候倒刺会容易损伤食管， 造成食管撕裂。 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。
技术问题
[0007] 为了解决上述的技术问题， 本发明的目的是提供一种胃导流器及其消化道抗菌 导管， 采用抗菌材料制成的消化道隔离导管， 尽可能降低肠道炎症的发生， 在 改善人体代谢疾病的同吋， 避免例如肝脓肿、 胰腺炎等并发症的发生， 从而提 供一种更安全、 更有效的治疗如糖尿病等代谢疾病的医疗器械。
问题的解决方案
技术解决方案
[0008] 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， 采用在膜管高 分子材料中加入抗菌材料， 如纳米银离子、 银颗粒、 纳米银、 纳米铜离子、 铜 颗粒、 香草醛、 乙基香草醛类化合或者壳聚糖等， 这些材料特点是易于在高分 子材料中添加， 不会对材料物理性能产生影响， 且又不会对人体产生危害。
[0009] 具体地说， 本发明采用了以下的技术方案：
[0010] 一种胃导流器的消化道抗菌导管， 其特征在于， 包括膜管 （31) ， 膜管 （31) 的一端连接支架 （32) ， 该膜管 （31) 由抗菌材料制成， 所述膜管 （31) 的外 径为 10 mm至 35 mm， 所述膜管 （31) 的壁厚为 0.001 mm至 0.3 mm， 膜管 （31) 和支架 （32) 通过缝合、 热压、 超声波焊接或者激光焊接固定连接。
[0011] 作为优选， 所述膜管包含高分子材料、 抗菌材料和显影材料， 原材料混合均匀 后通过吹塑、 挤出、 模压或者热压成型为薄膜或管状薄膜。
[0012] 作为优选， 所述膜管是在高分子材料制成的薄膜、 管状薄膜或薄壁管的外表面 刷涂有抗菌材料。 作为优选， 所述的高分子材料必须具有良好的生物相容性， 可在人体内长期滞留， 且不对人体产生不良影响。 所述的长期滞留指可在人体 消化道内停留三个月或者更长的吋间。
[0013] 作为优选， 所述的高分子材料必须足够柔软， 不会对消化道黏膜产生不良刺激 ， 患者在植入后不会产生不适感， 即使个别人有轻微不适， 也在短吋间内可以 自行消失。
[0014] 作为优选， 所述的高分子材料必须有良好的化学及生物稳定性， 在消化道各种 强酸强碱及生物酶的影响下， 不应发生化学变化， 产生对人体不利的溶出物。
[0015] 作为优选， 所述的高分子材料必须具有良好的加工性能， 可以加工成薄膜或者 管状薄膜， 所述的薄膜厚度在 0.001-0.3mm。
[0016] 作为优选， 所述的高分子材料可以是聚乙烯、 氟聚合物、 聚氨酯、 硅胶、 TPU 等中的任何一种或几种复合的满足上述要求的高分子材料。
[0017] 作为优选， 所述的抗菌材料必须是具有良好的生物相容性， 对人体无毒无害、 对环境友好。
[0018] 作为优选， 所述的抗菌材料必须对致病微生物具有明显的抗菌抑制效果， 能在 较长吋间内保持抗菌性能。
[0019] 作为优选， 所述的抗菌材料必须具有优良的物理性能， 在人体组织中有一定的 强度和柔韧性。
[0020] 作为优选， 所述的抗菌材料必须具有自身清洁环保， 应用方便， 最好具有一定 的自降解能力。
[0021] 作为优选， 所述的抗菌材料可以是纳米银离子、 银颗粒、 纳米银、 纳米铜离子 、 铜颗粒、 香草醛、 乙基香草醛类化合或者壳聚糖等中的一种或多种复合材料 [0022] 作为优选， 可以在所述的消化道植入导管中添加显影材料， 以确定所述消化道 植入导管在人体中的停留位置， 有否扭曲打结等。
[0023] 作为优选， 所述的显影材料必须具有良好的生物相容性， 对人体五毒无害， 且 适量添加后不会对消化道植入管物理形状产生影响， 导管仍能保持柔软。
[0024] 作为优选， 所述的显影材料可以是硫酸钡， 碳酸铋、 钨化合物中的一种或多种
[0025] 作为优选， 所述的高分子材料、 抗菌材料、 显影材料相互混合均匀， 可以通过 吹塑、 挤出、 模压等熟知的高分子加工工艺被加工成薄膜状的管状材料， 所述 的薄膜厚度为 0.001-0.3mm， 所述的管材直径为 10-35mm。
[0026] 所述消化道抗菌导管可被植入消化道。 所述消化道包括食道、 胃、 十二指肠、 空肠、 回肠等， 从而所述可植入导管的不同位置可分别对应于食道、 胃、 十二 指肠、 空肠、 回肠等处。 由于所述导管在不同位置具有不同的功能， 从而可对 消化道的不同部分产生不同的作用。
[0027] 作为优选， 所述支架 （32) 是由编织丝 （103) 编制成的网状管， 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。
[0028] 作为优选， 所述支架 （32) 包括支架上段 （101) 和支架下段 （102) ， 支架上 段 （101) 外径比支架下段 （102) 大 5〜15mm。
[0029] 作为优选， 所述支架 （32) 上设有显影环 （106) 。
[0030] 作为优选， 所述支架 （32) 上设有回收线 （105) 。
[0031] 一种胃导流器， 其特征在于， 包括壳体、 释放体、 推送组件以及如上所述的消 化道抗菌导管， 其中， 所述壳体 （1) 呈管状， 所述壳体 （1) 的一端具有第一 幵口 （11) ， 另一端具有第二幵口 （13) ， 所述壳体 （1) 中设置待释放的呈折 叠状态的导管， 所述释放体 （2) 设置在所述第一幵口 （11) 处并与所述膜管 （ 31) 的一端连接， 所述释放体 （2) 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 （41) 、 中 管 （42) 和外管 （43) ， 所述内管 （41) 一部分位于所述壳体 （1) 内并与所述 释放体 （2) 连接； 所述中管 （42) 的一端经所述第二幵口 （13) 伸入所述壳体 (1) 内， 且所述中管 （42) 的该端固定设有位于所述壳体 （1) 中的用于推抵 所述膜管 （31) 的挡块活塞 （12) ； 所述外管 （43) 位于所述壳体 （1) 外且其 一端固定连接于所述第二幵口 （13) 上； 其中， 所述内管 （41) 沿其轴向朝向 操作者运动从而使所述释放体 （2) 与所述壳体 （1) 脱幵， 内管 （41) 和中管
(42) 带动所述膜管 （31) 从壳体内脱出并展幵， 并在人体肠道的指定位置释 放。
发明的有益效果
有益效果
[0032] 本发明由于采用了以上的技术方案， 该消化道抗菌导管可植入消化道， 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， 本发明所述的导管具有一定的抗菌效果， 可有效避 免或降低消化道炎症的发生， 例如肝脓肿、 胰腺炎等。 且本发明所用材料结构 简单， 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。
对附图的简要说明
附图说明
[0033] 图 1为本发明实施例的结构剖视图；
[0034] 图 2为本发明实施例的整体结构示意图；
[0035] 图 3为本发明实施例的一种结构的释放体的剖视图；
[0036] 图 4为本发明实施例的另一种结构的释放体的剖视图；
[0037] 图 5为本发明可植入导管的结构示意图；
[0038] 图 6为本发明支架的一种实施方式的结构示意图；
[0039] 图 7为本发明支架的另一种实施方式的结构示意图；
[0040] 图 8为本发明支架的再一种实施方式的结构示意图。
[0041] 附图标记说明：
[0042] 1-壳体 11-第一幵口 12-挡块活塞 13-第二幵口 14-螺帽 2-释放体 22-内芯 221-膜 管连接部 222-主体部 23-外壳 231-环形台阶 31-膜管 32-支架 41-内管
411-阻尼管 412-第二伸出端 42-中管 421-第一伸出端 43-外管 44-第一手柄 45-鲁尔 接头 46-第二手柄； 101-支架上段 102-支架下段 103-编织丝 104-头数 105-回收线 106-显影环。 。
实施该发明的最佳实施例
本发明的最佳实施方式
[0043] 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。
[0044] 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"、 "顺吋针"、 "逆吋针"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。
[0045] 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。
[0046] 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。
[0047] 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
[0048] 如图 1所示的一种胃导流器， 包括壳体、 释放体、 推送组件以及可植入导管， 其中， 所述壳体 1呈管状， 所述壳体 1的一端具有第一幵口 11， 另一端具有第二 幵口 13， 所述壳体 1中设置待释放的呈折叠状态的可植入导管， 所述释放体 2设 置在所述第一幵口 11处并与所述膜管 31的一端连接， 所述释放体 2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 41、 中管 42和外管 43， 所述内管 41一部分位于所述壳体 1内并 与所述释放体 2连接； 所述中管 42的一端经所述第二幵口 13伸入所述壳体 1内， 且所述中管 42的该端固定设有位于所述壳体 1中的用于推抵所述膜管 31的挡块活 塞 12; 所述外管 43位于所述壳体 1外且其一端固定连接于所述第二幵口 13上； 其 中， 所述内管 41沿其轴向朝向操作者运动从而使所述释放体 2与所述壳体 1脱幵 ， 内管 41和中管 42带动所述膜管 31从壳体内脱出并展幵， 并在人体肠道的指定 位置释放。
[0049] 其中， 所述内管 41运动带动所述释放体 2运动， 从而牵动所述膜管 31， 使膜管 3 1逐渐展幵， 所述中管 42沿其轴向运动并带动所述挡块活塞 12推抵所述膜管 31 ( 即推抵膜管 31未与释放体 2连接的一端） ， 将所述膜管 31推出壳体 1。
[0050] 所述壳体 1的第二幵口 13外凸出的设置有凸台， 所述凸台上螺接有螺帽 14， 所 述外管 43穿过所述螺帽 14与所述壳体 1的所述第二幵口 13固定连接， 具体的， 所 述外管 43与所述第二幵口 13的固定连接方式可以是粘接热缩或者其他方式。
[0051] 本实施例中， 所述壳体 1、 推送组件的各部分可以采用聚氨酯、 聚乙烯、 氟聚 合物中的一种或多种复合材料制成， 具有良好的支撑性、 推送性、 及良好的韧 性， 表面光滑， 可以在内镜下或人体自然腔道完成良好的推送， 不易打折， 且 具有良好的操控性。
[0052] 具体的， 本实施例的胃导流器使用吋， 在所述内管 41中通入导丝， 操作者将整 个装置从人体的口部伸入， 然后通过导丝与胃镜配合将壳体 1引导至人体内靠近 胃幽门的十二指肠和 /或胃幽门上部， 其中， 导丝对推送组件起引导及支持作用 ， 帮助内管 41在人的食道、 胃肠道中的移动， 从而引导壳体 1及膜管 31顺利到达 指定位置处。 然后操作推送组件中的中管 42及内管 41从而将壳体 1中的膜管 31释 放进入人体肠道中， 同吋操作内管 41牵动释放体 2运动， 以将折叠状态的膜管 31 展幵， 并且， 由能够被人体肠道消化吸收的材料制成的释放体 2在进入人体肠道 后， 遇到消化道液体或者水可在短吋间内溶化或者分解， 最后被人体肠道消化 吸收， 从而完成膜管 31的释放过程， 以此在人体肠道内壁形成薄膜状的导流管 道， 阻止及减缓营养素在肠道的吸收， 调整消化酶的分泌， 从而起到调节血糖 、 血脂和控制体重的作用， 进而避免糖尿病的发生。 所述释放体 2由符合人体生 物安全性、 能够被人体消化或者可在体内分解的， 并且对人体没有任何毒副作 用的材料组成， 例如,可以是由可食用胶凝剂、 大豆蛋白粉、 淀粉、 多糖化合物 、 甘油、 支链或支链淀粉等一种或多种化合物组成。 在配方的吋候加入以上一 种或多种化合物， 再配合水、 脂溶性物质等， 在相应的模具中固化， 形成坚硬 的固体结构。 同吋， 所述释放体 2也可以采用可在人体内溶解并且完全不被吸收 ， 而是全部正常排出体外的材料制成， 对人体无任何毒副作用。
[0053] 如图 3至图 4所示， 所述释放体 2包括内芯 22、 外壳 23， 所述内芯 22具有主体部 2 22以及由所述主体部 222延伸形成的膜管连接部 221， 所述膜管连接部 221与所述 膜管 31的一端固定连接； 所述外壳 23包覆在所述主体部 222外， 所述外壳 23与所 述第一幵口 11连接并且受力易断裂。
[0054] 优选的， 参照图 3、 图 4， 所述内芯 22的主体部 222以及所述外壳 23朝向所述膜 管 31释放的方向的表面均为圆滑表面， 这样的结构更易于释放体 2在人体的肠道 中的运动。
[0055] 具体的， 参照图 3、 图 4， 所述主体部 222的外轮呈近似球形或半球形， 所述外 壳 23的外轮廓呈与所述主体部 222的外轮廓匹配的形状并包覆在所述主体部 222 夕卜； 本实施例中， 所述主体部 222的外轮廓呈近似半球形， 所述外壳 23的外轮廓 呈近似半球形， 当然， 所述主体部 222与所述外壳 23的形状也可以是外形接近球 体或近半球体的形状。
[0056] 优选的， 参照图 3、 图 4， 所述主体部 222的外轮廓呈半球形， 所述膜管连接部 2 21与所述主体部 222的平面部分连接， 所述外壳 23呈半球形并包覆在所述主体部 222的球面部分外， 半球形的外壳 23的端面的外缘上形成环形台阶 231， 所述环 形台阶 231抵接于所述壳体 1的第二幵口 13处。
[0057] 具体的， 参照图 3、 图 4， 上述实施例中， 所述内芯 22与所述外壳 23之间的连接 方式可以是螺接或卡接， 具体的， 图 3示出了螺接状态的内芯 22与外壳 23， 其中 ， 内芯 22及外壳 23均包括轮廓为近似球形的部位以及轮廓为圆柱的部位， 相互 啮合的螺纹设置在所述内芯 22及外壳 23的轮廓为圆柱的部位上， 图 4示出了卡接 状态的内芯 22与外壳 23， 其中， 内芯 22的外表面与外壳 23的内壁设置能够相互 卡接的卡扣结构， 需要说明的是， 所述内芯 22与所述外壳 23之间的连接方式可 以不仅限于螺接或者卡接， 也可以采用锥度配合或其他连接方式， 例如， 外壳 2 3和内芯 22通过锥度形式配合。 其他类似的结构在此不一一赘述。
[0058] 优选的， 参照图 2， 所述内管 41的一端依次穿过所述内芯 22的膜管连接部 221、 主体部 222及所述外壳 23， 并从所述第一幵口 11伸出。 内窥镜从内管 41的伸出端 检视人体肠道。 本实施例中， 所述内管 41与所述内芯 22的膜管连接部 221、 主体 部 222及所述外壳 23之间为紧配合或过盈连接， 从而使内管 41可以带动所述释放 体 2朝膜管 31的释放方向运动的同吋牵动膜管 31展幵并伸出所述壳体 1， 当然， 所述膜管连接部 221、 主体部 222及所述外壳 23与所述内管 41之间可以通过多种 不同的方式连接。
[0059] 优选的， 参照图 2， 所述内管 41穿过所述内芯 22的部分外套设阻尼管 411， 本实 施例中， 通过所述阻尼管 411使得所述内管 41与所述内芯 22之间形成紧配合， 所 述阻尼管 411用于增加所述释放体 2与所述内管 41之间的滑动摩擦力， 从而提高 所述内管 41牵动所述释放体 2运动的能力。
[0060] 本实施例中， 所述阻尼管 411可以由聚氨酯、 硅胶、 TPE等中的一种或多种弹 性材料制成， 表面可经过物理或化学处理， 以增加摩擦力， 从而使在膜管 31释 放前， 阻尼管 411使释放体 2与内管 41之间保持相对静止状态。
[0061] 优选的， 参照图 2所示， 所述膜管 31的另一端固定连接支架 32， 所述支架 32为 弹性记忆合金编织支架 32， 并具有呈网状管形的轮廓， 具体的， 支架 32可以采 用镍钛合金， 不锈钢或其他的弹性金属， 或其他符合条件的记忆合金制成， 材 料符合生物相容性要求， 可适宜人体长期植入； 所述支架 32以菱形， 六边形或 蜂窝状等形状结构规律排列， 放置与人体十二指肠球部， 支架具有一定的弹性 ， 可以随着肠道蠕动发生形变， 同吋具有一定的支撑力， 可以固定在十二指肠 球部。
[0062] 具体的， 当操作中管 42吋， 中管 42带动挡块活塞 12运动将支架 32与膜管 31—起 从壳体 1中向外推抵， 此吋需要通过内窥镜观察壳体 1中的支架 32， 当支架 32最 前端已经要从壳体 1中离幵吋， 应当停止操作中管 42。 此吋需要通过调整壳体 1 的位置使支架 32在离幵壳体 1吋能够固定在人体十二指肠球部， 支架具有一定的 弹性， 可以随着肠道蠕动发生形变， 同吋具有一定的支撑力， 可以固定在十二 指肠球部。
[0063] 具体的， 上述实施例中， 操作中管 42、 内管 41运动的具体结构包括： 所述中管 42具有伸出所述外管 43的另一端的第一伸出端 421， 所述第一伸出端 421连接有 第一手柄 44， 所述第一手柄 44上设置将外界与所述中管 42内部连通的鲁尔接头 4 5， 所述内管 41具有从所述第一伸出端 421伸出的第二伸出端 412， 所述第二伸出 端 412连接有第二手柄 46。
[0064] 具体的， 在操作中管 42、 内管 41运动从而释放膜管 31的过程中也可以向鲁尔接 头 45注入一定量的水或者生理盐水， 水或生理盐水通过中管 42与内管 41之间的 缝隙进入膜管 31内部， 加快膜管 31在十二指肠中的释放， 也加快了释放体 2的溶 解或分解。 具体的， 在释放膜管 31吋， 所述膜管 31和释放体 2随着人体肠道的蠕 动， 从十二指肠向空肠方向蠕动， 这个吋间大约是 1-10分钟。 这个过程中， 生理 盐水会沿着内管 41与中管 42之间缝隙向膜管 31流动， 这也会加快膜管 31和释放 体 2向空肠方向的蠕动， 从而加快膜管 31的释放。 所述膜管 31可以含有显影材料 ， 例如硫酸钡、 碳酸铋或钨等， 可在 X光下显影， 所述释放体 2也可以含显影材 料， 在 X光下可以准确的示出释放体 2的位置， 便于操作者操作。
[0065] 本发明可以采用如下的操作方式， 首先， 操作者向靠近操作者的方向拉动内管 41使得壳体 1的第二幵口 13挤压外壳 23吋， 外壳 23的环形台阶 231处断裂使释放 体 2与壳体 1脱幵， 然后， 操作所述内管 41使所述释放体 2向远离操作者 （即病人 体内） 运动， 从而使膜管 31的一端从壳体 1中伸出并带动所述膜管 31， 使膜管 31 展幵， 这吋， 再操作所述中管 42来带动挡块活塞 12运动， 挡块活塞 12推动位于 壳体 1内的膜管 31的另一端的支架 32， 从而将膜管 31整体从壳体 1中推出， 这里 需要注意的是， 当膜管 31已经完全舒展， 且挡块活塞 12推抵支架 32运动至壳体 1 的第一幵口 11位置吋 （膜管 31即将完全释放） ， 需要保证支架 32在人体肠道中 也到达指定的释放位置 （具体指人体胃部的靠近胃幽门的十二指肠和 /或胃幽门 上部的适当位置） ， 此吋再向远离操作者的方向推动第二手柄 46， 让支架 32完 全从所述壳体 1中脱出， 使支架 32固定在人体十二指肠球部， 支架具有一定的弹 性， 可以随着肠道蠕动发生形变， 同吋具有一定的支撑力， 可以固定在十二指 肠球部舒展状态的膜管 31在人体消化道内放置的吋间可以是 1-12个月， 根据病情 的改善情况或实际情况调整。
[0066] 本实施例中， 可以采用的另一种操作方式为同吋操作中管 42和内管 41， 使挡块 活塞 12推抵位于壳体 1内的膜管 31的一端将膜管 31推出壳体 1的同吋， 所述内管 4 1运动带动释放体 2运动， 释放体 2牵动膜管 31的另一端的支架 32， 使膜管 31展幵 的同吋从壳体 1中伸出， 最终在人体肠道的指定的释放位置将膜管 31整体从壳体 1中推出。
[0067] 所述可植入导管， 如图 5所示， 包括膜管 （31) ， 膜管 （31) 的一端连接支架
(32) ， 该膜管 （31) 由抗菌材料制成， 所述膜管 （31) 的外径为 10 mm至 35 mm, 所述膜管 （31) 的壁厚为 0.01 mm至 0.1 mm， 膜管 （31) 和支架 （32) 通 过缝合、 热压、 超声波焊接或者激光焊接固定连接。
[0068] 作为优选， 该导管包含高分子材料、 抗菌材料和显影材料， 原材料混合均匀后 通过吹塑、 挤出、 或者模压成型为薄膜或管状薄膜。 作为优选， 所述高分子材 料是聚乙烯、 氟聚合物、 聚氨酯、 硅胶中的任何一种或几种。 作为优选， 所述 抗菌材料是纳米银、 纳米铜、 香草醛、 乙基香草醛类化合或者壳聚糖中的一种 或多种。 作为优选， 所述显影材料是硫酸钡、 碳酸铋、 钨化合物中的一种或多 种。
[0069] 优选地， 根据本发明的膜管的外径可为 10 mm至 40 mm， 优选为 15mm至 35mm ， 更优选为 15mm至 30mm。 在此范围内， 可充分适用于人体消化道， 不会对人 体组织造成伤害。
[0070] 优选地， 根据本发明的膜管的长度可为 200 mm至 1500
mm, 优选为 200mm至 1300mm， 更优选为 300mm至 1200mm。 在此范围内， 可将 根据本发明的导管置入消化道的任何位置， 并限定起作用的位置。
[0071] 优选地， 根据本发明的膜管的壁厚可为 0.001 mm至 0.3
mm, 优选为 0.005mm至 0.05mm， 更优选为 0.01mm至 0.03mm。 在此范围内， 可 充分保证根据本发明的导管的柔软性， 并保持足够的强度。
[0072] 所述可植入导管可被植入消化道。 所述消化道包括食道、 胃、 十二指肠、 空肠 、 回肠等， 从而所述可植入导管的不同位置可分别对应于食道、 胃、 十二指肠 、 空肠、 回肠等处。 由于所述导管在不同位置具有不同的功能， 从而可对消化 道的不同部分产生不同的作用。 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， 植入一段吋间后， 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。
[0073] 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。
[0074] 此外， 本发明所述的可植入的导管包含的硫酸钡具有 X线下可见等特性。 此外 ， 本发明所述的可植入的导管可与支架连接。 连接支架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。
[0075] 在本发明导管的一种实施方式中， 选择纳米银作为抗菌材料， 将纳米银粉末添 加到聚四氟乙烯材料粉末中， 添加比例为万分之一到千分之一重量百分比， 加 入酒精等助剂， 使两种材料充分混匀， 将上述混合料放入到特制设备中， 通过 加热加压等工艺先做管坯， 加热的温度在 300°C左右； 然后再放入设计好的挤出 模具， 做导管二次成型； 将上述管坯放入到设计好的铁棒中， 放到带通风的加 热炉， 将酒精等溶剂挥发掉， 固化管坯； 再次将加工好的导管放入热处理炉中 定型。 获得的导管直径为 10-40mm， 薄壁管壁厚为 0.01-0.1mm， 导管柔软， 且具 有良好的生物相容性， 可在人体内长期滞留， 且不对人体产生不良影响。 所述 的长期滞留指可在人体消化道内停留三个月或者更长的吋间。
[0076] 作为优选， 还可以在材料中加入显影材料， 方便临床使用中确定植入导管的位 置， 以及是否有扭结等情况。
[0077] 作为优选， 所述的植入导管必须有良好的化学及生物稳定性， 在消化道各种强 酸强碱及生物酶的影响下， 不应发生化学变化， 产生对人体不利的溶出物。
[0078] 作为优选， 所述的导管对致病微生物具有明显的抗菌抑制效果， 能在较长吋间 内保持抗菌性能， 且对人体无毒无害、 对环境友好。
[0079] 作为优选， 所述的导管具有优良的物理性能， 在人体组织中有一定的强度和柔 韧性。
[0080] 在本发明的另一种实施方式中， 选择壳聚糖作为抗菌材料， 将壳聚糖添加到 PE 母粒中， 添加比例为 5-25%重量百分比， 制成含壳聚糖的 PE母粒； 选择线性低密 度聚乙烯 （LLDPE) 作为基料， 将含壳聚糖的 PE母粒添加到 LLDPE塑料粒子中 ， 混合均匀； 采用挤出工艺加工薄壁管， 加工温度优选 100-130°C， 挤出过程注 意控制气压， 以保持稳定的内径。 获得的抗菌材料制成的导管质地柔软， 薄壁 管壁厚为 0.01-0.1mm， 导管直径为 10-40mm， 不会对消化道产生不良影响， 而且 具有较好的抑菌作用。
[0081] 作为优选， 还可以在材料中加入显影材料， 以确定导管在人体消化道内的位置 。 作为优选， 所述的显影材料使用硫酸钡， 具体添加量为 10-35%重量百分比。
[0082] 用本发明上述实施方式制成的消化道抗菌导管进行抑菌实验， 使用同种材料 （ 但不添加抑菌材料） ， 制成同样尺寸的薄膜状导管， 取 15mm*30mm的条状材料 ， 放入琼脂培养基， 分别置入两个培养皿内， 在同样培养条件下， 培养 48h， 可 以发现使用本发明所用的消化道植入导管培养的样本， 菌落总数较不使用抑菌 材料的样品会少 50%以上。
[0083] 如图 5所示， 所述膜管 31与支架 32的一端相连接， 连接方式可以是缝合、 热压 、 超声波焊接、 或者激光焊接中的一种或者几种相结合。
[0084] 如图 6至图 8所示， 本实施例提供一种消化道支架 32分成上段 101和下段 102两部 分， 上段 101的直径优选为 25〜40mm， 大于十二指肠球部的直径， 下段 102的直 径优选 15〜25cm， 与十二指肠接近或略大于十二指肠的直径。 上段 101的直径要 大于下段 102的直径， 作为优选， 上段 101的直径较下段 102的直径要大 5〜15mm
[0085] 作为优选， 所述的支架可以是图 6的漏斗形型， 即上段 101呈倒梯形， 并且上段 101直径大于下段 102直径， 作为优选， 上段 101直径为 25〜40mm， 直径大于十 二指肠上段， 下段 102直径为 15〜25cm， 与十二指肠上段直径相当， 上段 101直 径直径比下段 102大 5〜15mm。 上段 101圆角矩形固定于十二指肠球部， 倒梯形 设计可实现平滑过度， 最大化地避免长期植入给消化道壁造成损伤， 且提供最 大的支撑力， 下段连接膜管， 膜管 31延长至十二指肠下段或空肠上段。
[0086] 作为优选， 支架 32也可以是图 7的圆球型， 即上段 101呈椭圆形， 并且上段 101 直径大于下段 102直径， 作为优选， 上段 101直径为 25〜40mm， 直径大于十二指 肠上段， 下段 102直径为 15〜25cm， 与十二指肠直径相当， 上段 101直径比下段 大 5〜15mm。 上段 101圆球固定于十二指肠球部， 圆弧状设计可最大化地避免长 期植入给消化道壁造成损伤， 圆弧形过度可以提供良好的支撑力， 下段 102连接 膜管 31， 膜管 31延长至十二指肠下段或空肠上段。
[0087] 作为优选， 支架可以是图 8的酒杯型， 即上段 101呈圆角矩形， 并且上段 101直 径大于下段 102直径， 作为优选， 上段 101直径为 25〜40mm， 直径大于十二指肠 上段， 下段 102直径为 15〜25cm， 与十二指肠上段直径相当， 上段 101直径直径 比下段 102大 5〜15mm。 上段 101圆角矩形固定于十二指肠球部， 圆角矩形设计 让支架与十二指肠球部接触面积最大， 可最大化地避免长期植入给消化道壁造 成损伤， 下段 102连接膜管， 膜管延长至十二指肠下段或空肠上段。
[0088] 作为优选， 所述的支架 32上段 101高度为 5〜15mm， 下段 102的高度也为 5〜15 mm, 具体的高度可根据人体具体生理解剖结构略作适当调整。
[0089] 所述支架 32以菱形， 六边形或蜂窝状等形状结构规律排列， 放置与人体十二指 肠球部， 支架 32具有一定的弹性， 可以随着肠道蠕动发生形变， 同吋具有一定 的支撑力， 可以固定在十二指肠球部， 防止下滑。
[0090] 所述的支架 32的编织丝 103可以是金属材料、 高分子材料、 或者可降解材料。
金属丝材料可以是不锈钢丝、 镍钛合金丝， 高分子材料可以是高分子材料如 PE (聚乙烯） 、 PU (聚氨基甲酸酯） 、 PTFE (聚四氟乙烯） ， 可降解材料可以是 PPDO (聚对二氧环己酮） 、 PLLA (聚乳酸） 、 PGA (聚乙二醇酸） 等。 所述 的材料符合生物相容性要求， 可在人体内长期植入， 且具有良好的韧性和弹性 ， 在消化道内有一定的支撑力， 与膜管 31相连接， 可以防止下滑。
[0091] 作为优选， 所述的编织丝 103选择镍钛合金， 所述的镍钛合金丝优选为满足长 期植入要求的镍钛合金， 优选的奥氏体相变点为 0-10度。
[0092] 所述的支架 32通过线材在模具上编织， 再经过热处理定型， 定型后的产品可以 是图 6至图 8所示结构或者类似的符合人体生理解剖的结构。 在横向和纵向都有 一定的支撑力和压缩力， 可以随着人体肠道蠕动发生形变， 有均匀的支撑力， 固定在十二指肠球部并且可以恢复到热定型的形状， 固定于十二指肠球部 113。
[0093] 具体地所述支架 32的编织线路呈绕中轴旋转的回旋体状。 所述回旋体的旋转方 向可为， 从所述头端部分俯视吋的顺吋针旋转方向或者逆吋针旋转方向。
[0094] 如图 7所示， 所述支架 32具有回收线 105， 所述的回收线 105缝合于支架 32上段 1 01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 回收线的吋候， 支架 32整体回缩， 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 105可以是 PE、 尼龙、 涤纶等符合生 物相容性要求的材料。
[0095] 作为优选， 所述的支架 32表面可以覆膜， 方便后期取出。 作为优选， 所述的膜 可以是硅胶、 氟塑料、 PE、 TPU等各种符合人体生物相容性的软性材料。 所述 的膜的厚度为 0.01-0.2mm。
[0096] 所述的支架 32,通过单根丝编织而成， 作为优选， 支架 32的头数 104可以是优选 1 0-30头， 次优选 15-25头， 最优选 18-24头。
[0097] 所述的支架 32上带有显影环 106， 可以在 X光下清晰定位， 所述的显影环 106可 以是铂金、 黄金、 钽等对人体无害的重金属材料。
[0098] 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。
[0099] 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。
本发明的实施方式
[0100] 在此处键入本发明的实施方式描述段落。
工业实用性
[0101] 在此处键入工业实用性描述段落。
序列表自由内容
[0102] 在此处键入序列表自由内容描述段落。

Claims

权利要求书
[权利要求 1] 一种胃导流器的消化道抗菌导管， 其特征在于， 包括膜管 （31) ， 膜 管 （31) 的一端连接支架 （32) ， 该膜管 （31) 由抗菌材料制成， 所 述膜管 （31) 的外径为 10 mm至 35
mm, 所述膜管 （31) 的壁厚为 0.001 mm至 0.3mm， 膜管 （31) 和支 架 （32) 通过缝合、 热压、 超声波焊接或者激光焊接固定连接。
[权利要求 2] 根据权利要求 1所述的一种胃导流器的消化道抗菌导管， 其特征在于 ， 所述膜管 （31) 包含高分子材料、 抗菌材料和显影材料， 原材料混 合均匀后通过吹塑、 挤出、 或者模压成型为薄膜、 管状薄膜或薄壁管
[权利要求 3] 根据权利要求 1所述的一种胃导流器的消化道抗菌导管， 其特征在于
， 所述膜管 （31) 是在高分子材料制成的薄膜、 管状薄膜或薄壁管的 外表面刷涂有抗菌材料。
[权利要求 4] 根据权利要求 1所述的一种胃导流器的消化道抗菌导管， 其特征在于
， 所述高分子材料是聚乙烯、 氟聚合物、 聚氨酯、 硅胶中的任何一种 或几种。
[权利要求 5] 根据权利要求 1所述的一种胃导流器的消化道抗菌导管， 其特征在于
， 所述抗菌材料是纳米银离子、 银颗粒、 纳米银、 纳米铜离子、 铜颗 粒、 香草醛、 乙基香草醛类化合或者壳聚糖中的一种或多种。
[权利要求 6] 根据权利要求 1所述的一种胃导流器的消化道抗菌导管， 其特征在于
， 所述显影材料是硫酸钡、 碳酸铋、 钨化合物中的一种或多种。
[权利要求 7] 根据权利要求 1所述的一种胃导流器的消化道抗菌导管， 其特征在于
， 所述支架 （32) 是由编织丝 （103) 编制成的网状管， 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。
[权利要求 8] 根据权利要求 6所述的一种胃导流器的消化道抗菌导管， 其特征在于
， 所述支架 （32) 包括支架上段 （101) 和支架下段 （102) ， 支架上 段 （101) 外径比支架下段 （102) 大 5〜15mm。
[权利要求 9] 根据权利要求 1所述的一种胃导流器的消化道抗菌导管， 其特征在于
， 所述支架 （32) 上设有显影环 （106) 和回收线 （105) 。
[权利要求 10] —种胃导流器， 其特征在于， 包括壳体、 释放体、 推送组件以及如权 利要求 1至 9中任一项所述的消化道抗菌导管， 其中， 所述壳体 （1) 呈管状， 所述壳体 （1) 的一端具有第一幵口 （11) ， 另一端具有第 二幵口 （13) ， 所述壳体 （1) 中设置待释放的呈折叠状态的导管， 所述释放体 （2) 设置在所述第一幵口 （11) 处并与所述膜管 （31) 的一端连接， 所述释放体 （2) 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 （41) 、 中管 （42) 和外管 （43) ， 所述内管 （41) 一部分位于 所述壳体 （1) 内并与所述释放体 （2) 连接； 所述中管 （42) 的一端 经所述第二幵口 （13) 伸入所述壳体 （1) 内， 且所述中管 （42) 的 该端固定设有位于所述壳体 （1) 中的用于推抵所述膜管 （31) 的挡 块活塞 （12) ； 所述外管 （43) 位于所述壳体 （1) 外且其一端固定 连接于所述第二幵口 （13) 上； 其中， 所述内管 （41) 沿其轴向朝向 操作者运动从而使所述释放体 （2) 与所述壳体 （1) 脱幵， 内管 （41 ) 和中管 （42) 带动所述膜管 （31) 从壳体内脱出并展幵， 并在人体 肠道的指定位置释放。
PCT/CN2017/105992 2017-06-27 2017-10-13 胃导流器及其消化道抗菌导管 WO2019000704A1 (zh)

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