CN107158546A - Stomach air deflector and its implantable conduit - Google Patents

Stomach air deflector and its implantable conduit Download PDF

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Publication number
CN107158546A
CN107158546A CN201710499355.3A CN201710499355A CN107158546A CN 107158546 A CN107158546 A CN 107158546A CN 201710499355 A CN201710499355 A CN 201710499355A CN 107158546 A CN107158546 A CN 107158546A
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CN
China
Prior art keywords
membrane tube
housing
support
air deflector
tube
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
CN201710499355.3A
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Chinese (zh)
Other versions
CN107158546B (en
Inventor
左玉星
鲁艳
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Hangzhou Sugar Medical Technology Co Ltd
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Hangzhou Sugar Medical Technology Co Ltd
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Publication date
Application filed by Hangzhou Sugar Medical Technology Co Ltd filed Critical Hangzhou Sugar Medical Technology Co Ltd
Priority to CN201710499355.3A priority Critical patent/CN107158546B/en
Publication of CN107158546A publication Critical patent/CN107158546A/en
Application granted granted Critical
Publication of CN107158546B publication Critical patent/CN107158546B/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0113Mechanical advancing means, e.g. catheter dispensers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0177Introducing, guiding, advancing, emplacing or holding catheters having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/02General characteristics of the apparatus characterised by a particular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/1042Alimentary tract
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/1042Alimentary tract
    • A61M2210/1053Stomach

Abstract

The invention discloses a kind of stomach air deflector and its implantable conduit, including membrane tube, one end connecting bracket of membrane tube, the membrane tube includes the parts by weight of high density polyethylene (HDPE) 0.5~1.5, the parts by weight of low density polyethylene (LDPE) 4, the parts by weight of LLDPE 4 and the parts by weight of barium sulfate 0.5~1.5, blows and forms after proportionally mixing.The implantable conduit of this programme is using more soft comfortable, human body rejection be lower, fanout free region membrane tube material makes, and manufacture craft is convenient, cost is low, speed of production is fast, is chronically implanted available for human body alimentary canal.

Description

Stomach air deflector and its implantable conduit
Technical field
It is especially a kind of to be used to treat endocrine system disease (such as diabetes, pancreas islet the present invention relates to technical field of medical instruments Dysfunction, obesity etc.) or disease of lower digestive tract (such as inflammation) stomach air deflector and its implantable conduit.
Background technology
, it is known that diabetes are a kind of diseases being gradually valued by the people in recent years, it is one kind in rich man's disease, is source Improved constantly in the living standard of modern civilization society, after being well off of people, eat good things, eat smart, overnutrition, activity Amount is reduced, so that the non-infectious epidemic disease produced, specifically, diabetes refer to the metabolic disease being characterized with hyperglycaemia Disease.It is due to that defect of insulin secretion or its biological agent are impaired, or both have concurrently caused by.Diabetes can cause various Tissue, particularly eye, kidney, heart, blood vessel, the chronic lesion of nerve, dysfunction.Diabetes are generally along with obesity and very Many complication, greatly threat is caused to the healthy of people.Data display, it is only Chinese, in the adult of more than 20 years old, glycosuria The incidence of disease of disease is 9.7%, population about 1.5 hundred million of falling ill., it is known that it is to keep on a diet that common obesity and diabetes, which improve mode, Increase motion, and certain drug therapy is aided in, this needs the long-term of patient to adhere to, and once stops diet control and motion Easily cause afterwards repeatedly and weight gain, the use of long-term medicine or insulin also brings heavy financial burden to patient With the inconvenience of life.
Another cure is Gastric bypass, is had very for radical cure type-II diabetes and improvement obesity using Gastric bypass Good effect, IDF the surgical operation of formal recommendation metabolism (including the operation of stomach turn of tidal stream) conduct in 2001 Obesity merges the treatment method of type-II diabetes, but Gastric bypass is as a kind of surgical operation, can cause wound to human body, because This has many risks such as:Death, intestinal obstruction, anastomotic leakage, pulmonary embolism, DVT, injury of portal vein, respiratory system Deng.
At present, the external structure treatment diabetes also having by being implanted into similar stomach air deflector etc. in the gastrointestinal tract, however, should Stomach air deflector it is complicated, it usually needs many bracing wires operated simultaneously can just realize needed before its function, operation through Specialized guidance is crossed, does not possess rich experiences and operational error probably occurs, increase sufferer is uncomfortable, operates and is more stranded Difficulty, manufacturing cost is higher in addition, the problem of adding technology barriers, and it is difficult home to carry out large-scale popularization and application to cause it, A kind of method that patient does not have the treatment diabetes of more sense of discomfort when therefore how to provide implementation, or a kind of structure is provided Simply, easy to operate, the equipment for the treatment of diabetes with low cost becomes urgent problem to be solved.
In addition, the critical piece of stomach air deflector is fluoroplastics using material in the prior art, processing characteristics is poor, processing It is extremely difficult into large diameter thin wall pipe, that is, enable that to process cost also very high.The performance of fluoroplastics determines that the material is inclined Firmly, comfort level is poor after implantation, poor compliance, situations such as patient easily Nausea and vomiting occurs after implantation, and human body may be made Into injury.
Also there are some to be implanted into the product of similar stomach flow-guiding device structure to treat diabetes by intestines and stomach both at home and abroad at present, The soft conduit of a piece high polymer material is implanted to duodenum, and the soft conduit typically all passes through a micro metal branch Frame is fixed on duodenal bulb.The current product is produced by GI Company Inc. of the U.S., and has been used for clinic, and the country also has many similar Design.The support is a kind of V-shape or wavy shaped configuration, and duodenal bulb is fixed on by hangnail.The risk of the design It is that hangnail is pierced into duodenum, certain damage is produced to human body alimentary canal, hangnail can easily damage oesophagus when taking-up, cause Oesophagus is torn.Such as the conduit falls into distal duodenum, jejunum, or even colon accidentally, easily causes intestinal obstruction.Therefore one is needed These risks are evaded in individual more preferable design.
The content of the invention
In order to solve above-mentioned technical problem, it is an object of the invention to provide a kind of stomach air deflector and its implantable conduit, The implantable conduit uses more soft, more comfortable, and human body rejection is lower after implantation, to the membrane tube material system of human body fanout free region Make, manufacture craft is convenient, cost is low, speed of production is fast, is chronically implanted available for human body alimentary canal.The stomach air deflector passes through gastroscope Guiding, then by seal wire, enteron aisle is entered close to gastropyloric duodenum and/or stomach pylorus top from human oral cavity, The partial enteral inwall is isolated with the food in stomach, to improve human insulin secretion, so that diabetes are preferably treated, Wound will not be produced to human body.
For above-mentioned the problems of the prior art, the present inventor is by carefully studying, and discovery uses polyethylene Class material can fully overcome existing implantable conduit cost is high, hardness is big etc. as the material for making large diameter thin wall conduit Problem, while inventor uses the high density polyethylene (HDPE) and low density polyethylene (LDPE) of different proportion, and adds the materials such as barium sulfate, again The conduit various functions are imparted, so as to complete the present invention.
Specifically, present invention employs following technical scheme:
A kind of implantable conduit of stomach air deflector, it is characterised in that including membrane tube (31), one end connection branch of membrane tube (31) Frame (32), the membrane tube (31) includes parts by weight of high density polyethylene (HDPE) 0.5~1.5, parts by weight of low density polyethylene (LDPE) 4, linear low close The parts by weight of polyethylene 4 and the parts by weight of barium sulfate 0.5~1.5 are spent, blows and forms after proportionally mixing;The high density polyethylene (HDPE) Refer to density in 0.940~0.976g/cm3In the range of, thermoplastic resin of the modulus of elasticity in 800~1200MPa;It is described low close Degree polyethylene refers to density in 0.910~0.940g/cm3In the range of, modulus of elasticity 200~500MPa thermoplastic resin, Melt index is in 0.2~0.5g/min;The LLDPE refers to density in 0.915~0.935g/cm3Scope It is interior, thermoplastic resin of the modulus of elasticity in 100~400MPa.
Preferably, the external diameter of the membrane tube (31) is 10mm to 40mm.
Preferably, the length of the membrane tube (31) is 200mm to 1500mm.
Preferably, the wall thickness of the membrane tube (31) is 0.001mm to 0.3mm.
Preferably, the membrane tube (31) and support (32) are solid by suture, hot pressing, ultrasonic bonding or laser welding Fixed connection.
Preferably, the support (32) is the netted pipe being compiled into by braided wires (103), described braided wires are to meet The elastic yarn of biocompatibility, can be wire, high polymer material silk either degradation material silk.
Preferably, the support (32) includes support epimere (101) and support hypomere (102), support epimere (101) is outside Footpath is more than support hypomere (102) external diameter.
Preferably, the support (32) is provided with developing ring (106).
Preferably, the support (32) is provided with exhausting line (105).
A kind of stomach air deflector, it is characterised in that including housing, releaser, push component and as described above implantable Conduit, wherein, in a tubular form, one end of the housing (1) has the first opening (11) to the housing (1), and the other end has second It is open (13), the implantable conduit in folded state to be released is set in the housing (1), the releaser (2) is arranged on First opening (11) place is simultaneously connected with one end of the membrane tube (31), and the releaser (2) by human body intestinal canal by that can be disappeared Change the material for absorbing or dissolving to be made;The component that pushes includes being arranged and being each other capable of the inner tube of relative motion successively (41), middle pipe (42) and outer tube (43), said inner tube (41) part be located at the housing (1) in and with the releaser (2) Connection;One end of the middle pipe (42) is stretched into the housing (1) through the described second opening (13), and the middle pipe (42) should End is fixed with the block piston (12) for being used in the housing (1) pushing against the membrane tube (31);The outer tube (43) Positioned at the housing (1) outside and its one end be fixedly connected on it is described second opening (13) on;Wherein, said inner tube (41) is along its axle To being moved towards operator so that the releaser (2) is disengaged with the housing (1), inner tube (41) and middle pipe (42) drive institute State membrane tube (31) to deviate from and deploy out of housing, and discharged in the specified location of human body intestinal canal.
Technical scheme of the present invention as a result of more than, the conduit can be comprising high density polyethylene (HDPE) (HDPE), low close Spend polyethylene (LDPE), LLDPE (LLDPE).The implantable conduit is used to treat alimentary canal and endocrine system disease Deng.Compared with prior art, implantable conduit of the present invention, with simple in construction, structure applicability is good, manufacture craft side Just, cost is low, speed of production is fast, have the advantages that quality assurance and easily manufactured, and comfortableness, compliance after implantation It is good, tissue will not be damaged.Stomach flow-guiding device structure of the present invention is simple, and part compares less, is manufactured into This is low;Wound will not be produced in human body intestinal canal when being implanted into human body, operation risk is small, and the pain that patient is subjected to is few, postoperative extensive It is multiple fast, it is safe, only need simply push action just to complete operation, therefore, just can be with by very simple training Left-hand seat is operated, without needing complicated bracing wire as like product, error or failure can energy rate it is extremely low.According to the stomach of the present invention Air deflector can be used for the stretching, extension for aiding in soft conduit and gastroenteritic power observation, and implant releaser is gradually disintegrated after the implantation, And by digestive juice exploded rear point by absorption of human body, barium sulfate is excreted via enteron aisle, and damage will not be caused to human body, because This uses safety.The disease such as type-II diabetes and improvement obesity can thoroughly be reversed by being inserted by the stomach air deflector of the present invention after human body Shape, it is not necessary to keep on a diet again, improves the quality of life of patient.
Brief description of the drawings
Fig. 1 is the structure sectional view of the embodiment of the present invention;
Fig. 2 is the overall structure diagram of the embodiment of the present invention;
Fig. 3 is a kind of sectional view of the releaser of structure of the embodiment of the present invention;
Fig. 4 is the sectional view of the releaser of another structure of the embodiment of the present invention;
Fig. 5 is the structural representation of implantable conduit of the invention;
Fig. 6 is a kind of structural representation of embodiment of support of the present invention;
Fig. 7 is the structural representation of the another embodiment of support of the present invention;
Fig. 8 is the structural representation of the another embodiment of support of the present invention.
Description of reference numerals:
The opening 12- block pistons of 1- housings 11- first 13- the second opening 14- nut 2- releaser 22- inner cores 221- membrane tube connecting portion 222- main part 23- shell 231- ring-shaped step 31- membrane tube 32- support 41- inner tubes 411- hinders The first external parts of pipe 421- 43- outer tube 44- first handle 45- female Luers in Buddhist nun's pipe the second external parts of 412- 42- 46- second handles;The 104- number 105- exhausting lines 106- developments of 101- support epimere 102- support hypomeres 103- braided wires Ring.
Embodiment
Embodiments of the invention are described below in detail, the example of the embodiment is shown in the drawings, wherein from beginning to end Same or similar label represents same or similar element or the member with same or like function
Part.The embodiments described below with reference to the accompanying drawings are exemplary, it is intended to for explaining the present invention, and can not manage Solve as limitation of the present invention.
In the description of the invention, it is to be understood that term " " center ", " longitudinal direction ", " transverse direction ", " length ", " width ", " thickness ", " on ", " under ", "front", "rear", "left", "right", " vertical ", " level ", " top ", " bottom " " interior ", " clockwise ", " inverse The orientation or position relationship of the instructions such as hour hands " are, based on orientation shown in the drawings or position relationship, to be for only for ease of description originally Invention and simplified description, rather than instruction or the signified device of hint or element must be with specific orientation, with specific square Position construction and operation, therefore be not considered as limiting the invention.
In addition, term " first ", " second " are only used for describing purpose, and it is not intended that indicating or implying relative importance Or the implicit quantity for indicating indicated technical characteristic.Thus, define " first ", the feature of " second " can express or Implicitly include one or more this feature.In the description of the invention, unless otherwise indicated, " multiple " are meant that two Individual or two or more, unless otherwise clear and definite restriction.
In the present invention, unless otherwise clearly defined and limited, term " installation ", " connected ", " connection ", " fixation " etc. Term should be interpreted broadly, for example, it may be being fixedly connected or being detachably connected, or be integrally connected;It can be machine Tool is connected or electrically connected;Can be joined directly together, can also be indirectly connected to by intermediary, can be two members Connection inside part.For the ordinary skill in the art, above-mentioned term can be understood in this hair as the case may be Concrete meaning in bright.
In the present invention, unless otherwise clearly defined and limited, fisrt feature second feature it " on " or it " under " Can directly it be contacted including the first and second features, it is not direct contact but by it that can also include the first and second features Between other characterisation contact.Moreover, fisrt feature second feature " on ", " top " and " above " to include first special Levy directly over second feature and oblique upper, or be merely representative of fisrt feature level height higher than second feature.Fisrt feature exists Second feature " under ", " lower section " and " following " fisrt feature that includes are immediately below second feature and obliquely downward, or be merely representative of Fisrt feature level height is less than second feature.
A kind of stomach air deflector as shown in Figure 1, including housing, releaser, push component and implantable conduit, wherein, In a tubular form, one end of the housing 1 has the first opening 11 to the housing 1, and the other end has the second opening 13, the housing 1 It is middle that the implantable conduit in folded state to be released is set, the releaser 2 be arranged on described first be open at 11 and with institute One end connection of membrane tube 31 is stated, the releaser 2 by the material that human body intestinal canal is digested and assimilated or is dissolved by that can be made;It is described to push away Sending component includes inner tube 41, middle pipe 42 and the outer tube 43 for being arranged and being capable of each other relative motion successively, said inner tube 41 A part is located in the housing 1 and is connected with the releaser 2;One end of the middle pipe 42 is stretched into through the described second opening 13 In the housing 1, and the end of the middle pipe 42 is fixed with the gear for pushing against the membrane tube 31 in the housing 1 Block piston 12;The outer tube 43 is located at outside the housing 1 and its one end is fixedly connected in second opening 13;Wherein, institute State inner tube 41 and be axially facing operator along it and move so that the releaser 2 is disengaged with the housing 1, inner tube 41 and middle pipe 42 Drive the membrane tube 31 to deviate from and deploy out of housing, and discharged in the specified location of human body intestinal canal.
Wherein, the motion of said inner tube 41 drives the releaser 2 to move, so as to affect the membrane tube 31, make membrane tube 31 by Gradually deploy, the middle pipe 42, which is axially moved along it and drives the block piston 12 to push against the membrane tube 31, (pushes against membrane tube 31 The one end not being connected with releaser 2), the membrane tube 31 is released into housing 1.
Outer being provided with boss, the boss for protrusion of the second opening 13 of the housing 1 is bolted with nut 14, described outer Pipe 43 is open through described the second of the nut 14 and the housing 1 and 13 is fixedly connected, specifically, the outer tube 43 with it is described The mode that is fixedly connected of second opening 13 can be bonding pyrocondensation or other modes.
In the present embodiment, the housing 1, each several part of push component can be used in polyurethane, polyethylene, fluoropolymer One or more composites be made, with good supportive, pushability and good toughness, surface is smooth, Ke Yi Under scope or human body natural's cavity completes good push, it is difficult to give a discount, and with good handling.
Specifically, the stomach air deflector of the present embodiment in said inner tube 41 in use, be passed through seal wire, operator will entirely fill Put from the oral area of human body and stretch into, then coordinated by seal wire and gastroscope and guide housing 1 to human body close to gastropyloric 12 Duodenum 12 and/or stomach pylorus top, wherein, seal wire to push component rise guiding and supporting function, help inner tube 41 people esophagus, Movement in intestines and stomach, so that guide housing 1 and membrane tube 31 smoothly reach specified location.Then during operation is pushed in component Pipe 42 and inner tube 41 are so as to which the membrane tube 31 in housing 1 is discharged into human body intestinal canal, while operating inner tube 41 to affect releaser 2 Motion, the membrane tube 31 of folded state is deployed, also, the releaser being made up of the material that can be digested and assimilated by human body intestinal canal 2 after human body intestinal canal is entered, and running into alimentary canal liquid or water can dissolve or decompose in a short time, finally by human body intestinal canal Digest and assimilate, so as to complete the release process of membrane tube 31, with this in the conduction pipe of human body intestinal canal inwall formation film-form, prevent And slow down absorption of the nutrient in enteron aisle, the secretion of digestive ferment is adjusted, so as to play the work of regulation blood glucose, blood fat and control body weight With, and then avoid the generation of diabetes.The releaser 2 by meeting human biosafety, can be by human consumption or can Decompose in vivo, and do not have to human body any toxic side effect material constitute, for example, it may be by edible gelling agent, Soyabean protein powder, starch, compound of polysaccharide, glycerine, side chain or amylopectin etc. one or more compound groups into.In formula When add one of the above or multiple compounds, then hydrous water, liposoluble substance etc., solidify in corresponding mould, form hard Hard solid structure.Meanwhile, the releaser 2, which can also be used, to be dissolved and not absorbed completely in human body, but entirely The material that portion is normally excreted is made, without any side effects to human body.
As shown in Figure 3 to Figure 4, the releaser 2 include inner core 22, shell 23, the inner core 22 have main part 222 with And the membrane tube connecting portion 221 formed, the membrane tube connecting portion 221 and one end of the membrane tube 31 are extended by the main part 222 It is fixedly connected;The shell 23 is coated on outside the main part 222, the shell 23 with described first opening 11 be connected and by Power easy fracture.
It is preferred that, reference picture 3, Fig. 4, the main part 222 and the shell 23 of the inner core 22 are towards the membrane tube 31 The surface in the direction of release is smooth surface, and such structure is easier to motion of the releaser 2 in the enteron aisle of human body.
Specifically, reference picture 3, Fig. 4, the foreign steamer of the main part 222 is in almost spherical or hemispherical, the shell 23 Outline is in the shape matched with the outline of the main part 222 and is coated on outside the main part 222;In the present embodiment, The outline of the main part 222 is near hemispherical, and the outline of the shell 23 is near hemispherical, certainly, the master The shape of body portion 222 and the shell 23 can also be profile close to spheroid or nearly hemispheroidal shape.
It is preferred that, reference picture 3, Fig. 4, the outline of the main part 222 are hemispherical, the membrane tube connecting portion 221 with The planar section connection of the main part 222, the shell 23 is hemispherical and is coated on the land portions of the main part 222 Outside, ring-shaped step 231 is formed in the outer rim of the end face of hemispheric shell 23, the ring-shaped step 231 is connected to the housing 1 Second opening 13 at.
Specifically, in reference picture 3, Fig. 4, above-described embodiment, the connected mode between the inner core 22 and the shell 23 Can be spirally connected or clamping, specifically, Fig. 3 shows the inner core 22 and shell 23 for the state of being spirally connected, wherein, inner core 22 and shell 23 Include the position that profile is the position of almost spherical and profile is cylinder, intermeshing screw thread is arranged on the inner core 22 And the profile of shell 23 is on the position of cylinder, Fig. 4 shows the inner core 22 and shell 23 of clamped condition, wherein, inner core 22 The inwall of outer surface and shell 23 sets the buckle structure for being capable of mutual clamping, it is necessary to illustrate, the inner core 22 with it is described Connected mode between shell 23 can be not limited only to be spirally connected or clamping, it would however also be possible to employ taper fit or other connection sides Formula, for example, shell 23 and inner core 22 are coordinated by taper form.Other similar structures are not repeated one by one herein.
It is preferred that, reference picture 2, one end of said inner tube 41 sequentially passes through the membrane tube connecting portion 221 of the inner core 22, main body Portion 222 and the shell 23, and stretched out from the described first opening 11.Endoscope inspects human body intestinal canal from the external part of inner tube 41. In the present embodiment, it is between membrane tube connecting portion 221, main part 222 and the shell 23 of said inner tube 41 and the inner core 22 Tight fit or interference connection so that inner tube 41 can drive the releaser 2 towards membrane tube 31 release direction motion while Affect membrane tube 31 to deploy and stretch out the housing 1, certainly, the membrane tube connecting portion 221, main part 222 and the shell 23 with It can be connected between said inner tube 41 by various ways.
It is preferred that, reference picture 2, said inner tube 41 sets damper tube 411, the present embodiment through the part overcoat of the inner core 22 In, cause to form tight fit between said inner tube 41 and the inner core 22 by the damper tube 411, the damper tube 411 is used In increasing the force of sliding friction between the releaser 2 and said inner tube 41, so that improving said inner tube 41 affects the release The ability that body 2 is moved.
In the present embodiment, the damper tube 411 can be by one or more elastomeric materials in polyurethane, silica gel, TPE etc. It is made, surface can pass through physical or chemical treatment, to increase frictional force, so that before the release of membrane tube 31, damper tube 411 makes to release Put and keep relative static conditions between body 2 and inner tube 41.
It is preferred that, shown in reference picture 2, the other end of the membrane tube 31 is fixedly connected with support 32, and the support 32 is elasticity Memorial alloy braided support 32, and with the profile in grid duct shape, specifically, support 32 can use Nitinol, it is stainless Steel or other elastic metallics, or other qualified memorial alloys are made, and material meets biocompatibility requirement, can be suitable Human body is chronically implanted;The support 32 is with rhombus, and hexagon or the shape and structure aligned transfer such as cellular are placed and human body 12 Duodenum 12 bulb, support has certain elasticity, can be deformed upon with intestines peristalsis, while there is certain support force, can To be fixed on duodenal bulb.
Specifically, when pipe 42 in operation, middle pipe 42 drive block piston 12 move by support 32 together with membrane tube 31 from Pushed out in housing 1 to now needing by the support 32 in endoscopic observation housing 1, when support 32 foremost will be from When being left in housing 1, middle pipe 42 should be stopped operation.Now need to make support 32 leave shell by adjusting the position of housing 1 Human body duodenal bulb can be fixed on during body 1, support has certain elasticity, can be deformed upon with intestines peristalsis, There is certain support force simultaneously, duodenal bulb can be fixed on.
Specifically, in above-described embodiment, the concrete structure that pipe 42, inner tube 41 are moved in operation includes:The middle pipe 42 has There is the first external part 421 of the other end for stretching out the outer tube 43, first external part 421 is connected with first handle 44, institute State and set the extraneous female Luer 45 connected with the middle inside of pipe 42 on first handle 44, said inner tube 41 has from described The second external part 412 that first external part 421 stretches out, second external part 412 is connected with second handle 46.
Specifically, pipe 42, the motion of inner tube 41 are so that can also be to female Luer during discharging membrane tube 31 in operation 45 a certain amount of water of injection or physiological saline, water or physiological saline enter membrane tube by the gap between middle pipe 42 and inner tube 41 Inside 31, accelerate release of the membrane tube 31 in duodenum, also accelerate the dissolving or decomposition of releaser 2.Specifically, in release During membrane tube 31, the membrane tube 31 and releaser 2 are wriggled with the wriggling of human body intestinal canal from duodenum to jejunum direction, this Time is about 1-10 minutes.During this, physiological saline can flow along gap between inner tube 41 and middle pipe 42 to membrane tube 31 Dynamic, this can also accelerate the wriggling of membrane tube 31 and releaser 2 to jejunum direction, so as to accelerate the release of membrane tube 31.The membrane tube 31 Developing material can be contained, such as barium sulfate, waltherite or tungsten, can be developed under X-ray, the releaser 2 can also contain aobvious Shadow material, the position of releaser 2 can be accurately shown under X-ray, is easy to operator to operate.
The present invention stomach air deflector can use following mode of operation, first, operator to close to operator direction When pulling inner tube 41 so that the second opening 13 of housing 1 extrudes shell 23, fracture makes releaser at the ring-shaped step 231 of shell 23 2 disengage with housing 1, then, and operation said inner tube 41 makes the releaser 2 be moved to away from operator (i.e. in patient body), from And one end of membrane tube 31 is stretched out from housing 1 and drive the membrane tube 31, deploy membrane tube 31, at this moment, then operate it is described in Pipe 42 drives block piston 12 to move, and block piston 12 promotes the support 32 of the other end for the membrane tube 31 being located in housing 1, from And released membrane tube 31 is overall from housing 1, it is noted herein that, when membrane tube 31 has been unfolded completely, and block piston (membrane tube 31 will discharge completely) is, it is necessary to ensure support 32 when 12 pushing and pressing supports 32 move to the first 11 position of opening of housing 1 The off-position specified also is reached in human body intestinal canal and (refers specifically to the close gastropyloric duodenum and/or stomach of human stomach The appropriate location on pylorus top), second handle 46 now is promoted to the direction away from operator again, allows support 32 completely from described Deviate from housing 1, support 32 is fixed on human body duodenal bulb, support has certain elasticity, can be compacted with enteron aisle It is dynamic to deform upon, while having certain support force, the membrane tube 31 of duodenal bulb extended position can be fixed in human body The time placed in alimentary canal can be 1-12 months, be adjusted according to the improvement situation or actual conditions of the state of an illness.
In the present embodiment, another mode of operation that can be used makes block live for pipe 42 and inner tube 41 operate simultaneously in While membrane tube 31 is released housing 1 by one end that the pushing and pressing of plug 12 are located at the membrane tube 31 in housing 1, the motion drive of said inner tube 41 is released Put body 2 to move, releaser 2 affects the support 32 of the other end of membrane tube 31, membrane tube 31 is stretched out while expansion from housing 1, It is final to release the entirety of membrane tube 31 from housing 1 in the off-position specified of human body intestinal canal.
The implantable conduit, as shown in figure 5, including membrane tube (31), one end connecting bracket (32) of membrane tube (31), the film Manage (31) and include high density polyethylene (HDPE) (HDPE), low density polyethylene (LDPE) (LDPE), LLDPE (LLDPE), sulfuric acid Barium etc..Wherein, the high density polyethylene (HDPE) (HDPE), also known as low-pressure polyethylene, refer to density in 0.940~0.976g/cm3Model In enclosing, thermoplastic resin of the modulus of elasticity in 800-1200MPa.Wherein, the low density polyethylene (LDPE) (LDPE) is also known as high pressure and gathered Ethene, refers to density in 0.910~0.940g/cm3In the range of, modulus of elasticity is in 200-500MPa thermoplastic resin, melting Index is in 0.2-0.5g/min.Wherein, the LLDPE (LLDPE) refers to density in 0.915~0.935g/ cm3In the range of, thermoplastic resin of the modulus of elasticity in 100-400MPa.
Preferably, the weight ratio of the high density polyethylene (HDPE), low density polyethylene (LDPE), LLDPE and barium sulfate Can be 1.5:4:4:0.5, preferably 1:4:4:1, more preferably 0.5:4:4:1.5.Within this range, availability is excellent Implantable conduit.
Preferably, can be 10mm to 40mm according to the external diameter of the membrane tube of the present invention, preferably 15mm is to 35mm, more preferably 15mm to 30mm.Within this range, human body alimentary canal can be fully adapted to, tissue will not be damaged.
Preferably, according to the present invention membrane tube length can be 200mm to 1500mm, preferably 200mm to 1300mm, more Preferably 300mm to 1200mm.Within this range, gastral any position can will be inserted according to the conduit of the present invention, and limited Surely the position worked.
Preferably, can be 0.001mm to 0.3mm according to the wall thickness of the membrane tube of the present invention, preferably 0.005mm is extremely 0.05mm, more preferably 0.01mm are to 0.03mm.Within this range, the flexibility of the conduit according to the present invention can be fully ensured that, And keep enough intensity.
The preparation method of the membrane tube is, by high density polyethylene (HDPE), low density polyethylene (LDPE), LLDPE and sulphur Sour barium is mixed according to above-mentioned constant weight ratio, and blowing is formed.
The implantable conduit can be implanted alimentary canal.The alimentary canal includes esophagus, Stomach duodenum, jejunum, ileum Deng so that the diverse location of the implantable conduit can correspond respectively to esophagus, Stomach duodenum, jejunum, ileum etc..By There are different functions in the conduit in diverse location, so as to produce different effects to gastral different piece.Institute The implantable conduit stated can play a part of isolating food in enteron aisle, change the physiology flow direction of food, after implantation a period of time, The Insulin resistance of patient body is eliminated, and the food stream can also promote insulin secretion in patient's body through mode, subtract Few Intra-islet Apoptosis simultaneously is allowed to rise in value, and islet function recovers, and the metabolic disease such as diabetes, obesity is cured.Described The stretch modulus of implantable conduit is more than 250MP, and elongation percentage is more than 230%, and material softness is disliked caused by after being implanted into vivo The heart, vomitting the phenomenons such as stomachache can substantially reduce.
According to the implantable alimentary canal of implantable conduit of the present invention, for treatment endocrine system disease, such as diabetes, pancreas Island dysfunction, obesity etc., or disease of lower digestive tract, such as inflammation.Compared with prior art, it is of the present invention implantable Conduit, with simple in construction, structure applicability is good, manufacture craft convenient, cost is low, speed of production is fast, quality it is guaranteed with And it is easily manufactured the advantages of, and comfortableness, compliance are good after being implanted into, and tissue will not be damaged.
In addition, the barium sulfate that implantable conduit of the present invention is included has the characteristic such as visible under x-ray.In addition, this The described implantable conduit of invention can be connected with support.Can be reduced after connecting bracket stimulates gastral, and adjusts lifting Whole or recovery support is more conveniently, safely.
As shown in figure 5, the membrane tube 31 is connected with one end of support 32, connected mode can be suture, hot pressing, ultrasound Wave soldering connect or laser welding in one or several kinds be combined.
As shown in Figure 6 to 8, a kind of alimentary stent 32 of the present embodiment offer is divided into epimere 101 and hypomere 102 two Point, the diameter of epimere 101 is preferably 25~40mm, more than the diameter of duodenal bulb, and the diameter preferably 15 of hypomere 102~ 25cm, is approached with duodenum or slightly larger than duodenal diameter.The diameter of epimere 101 is greater than the diameter of hypomere 102, makees For preferred, diameter big 5~15mm of the diameter compared with hypomere 102 of epimere 101.
Preferably, described support can be Fig. 6 infundibulate type, i.e. epimere 101 is in inverted trapezoidal, and epimere 101 Diameter is more than the diameter of hypomere 102, preferably, a diameter of 25~40mm of epimere 101, diameter is more than duodenum epimere, hypomere 102 a diameter of 15~25cm, suitable with duodenum epimere diameter, the diameter diameter of epimere 101 is than the big 5~15mm of hypomere 102.On 101 round rectangles of section are fixed on duodenal bulb, and inverted trapezoidal design can be achieved smooth excessiveness, substantially avoid being chronically implanted Cause damage to digestive tract wall, and maximum support force, hypomere connection membrane tube be provided, membrane tube 31 extend to duodenum hypomere or Jejunum epimere.
Preferably, support 32 can also be Fig. 7 ball-shaped, i.e., epimere 101 is oval, and the diameter of epimere 101 More than the diameter of hypomere 102, preferably, a diameter of 25~40mm of epimere 101, diameter is more than duodenum epimere, hypomere 102 is straight Footpath is 15~25cm, epimere 101 diameter than hypomere bigger 5~15mm suitable with duodenum diameter.The ball of epimere 101 is fixed on Duodenal bulb, avoids being chronically implanted arc-shaped design maximizing and causes damage to digestive tract wall, circular arc excessively may be used To provide good support force, the connection membrane tube 31 of hypomere 102, membrane tube 31 extends to duodenum hypomere or jejunum epimere.
Preferably, support can be Fig. 8 wine glass-shaped, i.e. the rounded rectangle of epimere 101, and the diameter of epimere 101 is big In the diameter of hypomere 102, preferably, a diameter of 25~40mm of epimere 101, diameter is more than duodenum epimere, the diameter of hypomere 102 For 15~25cm, suitable with duodenum epimere diameter, the diameter diameter of epimere 101 is than the big 5~15mm of hypomere 102.Epimere 101 is justified Angular moment shape is fixed on duodenal bulb, and round rectangle design makes support maximum with duodenal bulb contact area, can be maximum Avoid with changing being chronically implanted and cause damage to digestive tract wall, the connection membrane tube of hypomere 102, membrane tube extends to duodenum hypomere or sky Intestines epimere.
Preferably, the described height of 32 epimere of support 101 is 5~15mm, the height of hypomere 102 is also 5~15mm, tool The height of body can slightly be appropriately adjusted according to the specific physiological anatomic architecture of human body.
The support 32 is with rhombus, and hexagon or the shape and structure aligned transfer such as cellular are placed and human body duodenum Bulb, support 32 has certain elasticity, can be deformed upon with intestines peristalsis, while have certain support force, can be with Duodenal bulb is fixed on, prevents from gliding.
The braided wires 103 of described support 32 can be metal material, high polymer material or degradation material.Metal Wire material can be stainless steel wire, nitinol alloy wire, and high polymer material can be that high polymer material such as PE (polyethylene), PU are (poly- Carbamate), PTFE (polytetrafluoroethylene (PTFE)), degradation material can be PPDO (PPDO), PLLA (poly- breasts Acid), PGA (polyglycolic acid) etc..Described material meets biocompatibility requirement, can be chronically implanted in human body, and have Good toughness and elasticity, there is certain support force in alimentary canal, is connected with membrane tube 31, can prevent from gliding.
Preferably, the described selection Nitinol of braided wires 103, described nitinol alloy wire is preferably to meet long-term plant Enter the Nitinol of requirement, _ s of Austenite preferably is 0-10 degree.
Described support 32 is woven by wire rod on mould, then by heat treatment shaping, the product after sizing can be Structure shown in Fig. 6 to Fig. 8 or the similar structure for meeting Human Physiology dissection.There is certain support force horizontal and vertical And compression stress, it can wriggle and deform upon with human body intestinal canal, have uniform support force, be fixed on duodenal bulb and can To return to the shape of thermal finalization, duodenal bulb 113 is fixed on.
Specifically the braiding circuit of the support 32 is in the revolution shape around middle shaft rotation.The direction of rotation of the revolution Can be, turn clockwise direction or rotate counterclockwise direction when being overlooked from the head portion.
As shown in fig. 7, the support 32 has exhausting line 105, described exhausting line 105 is sutured in the epimere 101 of support 32 Outmost turns, support can be taken out and be reclaimed from vivo by special recover or nipper.When drawing in exhausting line, The overall retraction of support 32, into scope hyaline cap or specific retracting device, as endoscope takes out out of human body alimentary canal. Described exhausting line 105 can be the material that PE, nylon, terylene etc. meet biocompatibility requirement.
Preferably, the described surface of support 32 can facilitate the later stage to take out with overlay film.Preferably, described film can be with It is the various flexible materials for meeting human-body biological compatibility such as silica gel, fluoroplastics, PE, TPU.The thickness of described film is 0.01- 0.2mm。
Described support 32, is formed by individual thread braiding, preferably, the head number 104 of support 32 can be preferred 10- 30, most preferably less preferred 15-25 heads, 18-24 heads.
Developing ring 106 is carried on described support 32, can clearly be positioned under X-ray, described developing ring 106 can be The harmless heavy metal material such as platinum, gold, tantalum.
In the description of this specification, reference term " one embodiment ", " some embodiments ", " example ", " specifically show The description of example " or " some examples " etc. means to combine specific features, structure, material or the spy that the embodiment or example are described Point is contained at least one embodiment of the present invention or example.In this manual, to the schematic representation of above-mentioned term not Necessarily refer to identical embodiment or example.Moreover, specific features, structure, material or the feature of description can be any One or more embodiments or example in combine in an appropriate manner.
Although embodiments of the invention have been shown and described above, it is to be understood that above-described embodiment is example Property, it is impossible to limitation of the present invention is interpreted as, one of ordinary skill in the art is not departing from the principle and objective of the present invention In the case of above-described embodiment can be changed within the scope of the invention, change, replace and modification.It is all the present invention Within spirit and principle, any modification, equivalent substitution and improvements made etc. should be included in the scope of the protection.

Claims (10)

1. a kind of implantable conduit of stomach air deflector, it is characterised in that including membrane tube (31), one end connecting bracket of membrane tube (31) (32), the membrane tube (31) includes the parts by weight of high density polyethylene (HDPE) 0.5~1.5, the parts by weight of low density polyethylene (LDPE) 4, linea low density The parts by weight of polyethylene 4 and the parts by weight of barium sulfate 0.5~1.5, blow after proportionally mixing and form;The high density polyethylene (HDPE) is Refer to density in 0.940~0.976g/cm3In the range of, thermoplastic resin of the modulus of elasticity in 800~1200MPa;The low-density Polyethylene refers to density in 0.910~0.940g/cm3In the range of, modulus of elasticity melts in 200~500MPa thermoplastic resin Melt index in 0.2~0.5g/min;The LLDPE refers to density in 0.915~0.935g/cm3In the range of, Thermoplastic resin of the modulus of elasticity in 100~400MPa.
2. the implantable conduit of a kind of stomach air deflector according to claim 1, it is characterised in that outside the membrane tube (31) Footpath is 10mm to 40mm.
3. a kind of implantable conduit of stomach air deflector according to claim 1, it is characterised in that the length of the membrane tube (31) Spend for 200mm to 1500mm.
4. a kind of implantable conduit of stomach air deflector according to claim 1, it is characterised in that the wall of the membrane tube (31) Thickness is 0.001mm to 0.3mm.
5. the implantable conduit of a kind of stomach air deflector according to claim 1, it is characterised in that the membrane tube (31) and branch Frame (32) is fixedly connected by suture, hot pressing, ultrasonic bonding or laser welding.
6. a kind of implantable conduit of stomach air deflector according to claim 1, it is characterised in that the support (32) be by The netted pipe that braided wires (103) are compiled into, described braided wires are the elastic yarn for meeting biocompatibility, can be wire, High polymer material silk either degradation material silk.
7. the implantable conduit of a kind of stomach air deflector according to claim 6, it is characterised in that the support (32) includes Support epimere (101) and support hypomere (102), support epimere (101) external diameter are more than support hypomere (102) external diameter.
8. the implantable conduit of a kind of stomach air deflector according to claim 1, it is characterised in that set on the support (32) There is developing ring (106).
9. the implantable conduit of a kind of stomach air deflector according to claim 1, it is characterised in that set on the support (32) There is exhausting line (105).
10. a kind of stomach air deflector, it is characterised in that including housing, releaser, push component and as appointed in claim 1 to 9 Implantable conduit described in one, wherein, in a tubular form, one end of the housing (1) has the first opening to the housing (1) (11), the other end, which has in the second opening (13), the housing (1), sets the implantable conduit in folded state to be released, The releaser (2) is arranged on first opening (11) place and is connected with one end of the membrane tube (31), the releaser (2) By that can be made by the material that human body intestinal canal is digested and assimilated or is dissolved;The push component includes being arranged successively and each other It is capable of inner tube (41), middle pipe (42) and the outer tube (43) of relative motion, said inner tube (41) part is located in the housing (1) And be connected with the releaser (2);One end of the middle pipe (42) is stretched into the housing (1) through the described second opening (13), And the end of the middle pipe (42) is fixed with the block piston for pushing against the membrane tube (31) in the housing (1) (12);The outer tube (43) is located at the housing (1) outside and its one end is fixedly connected in second opening (13);Wherein, Said inner tube (41) is axially facing operator along it and moved so that the releaser (2) and the housing (1) disengagement, inner tube (41) deviate from and deploy out of housing with middle pipe (42) the drive membrane tube (31), and discharged in the specified location of human body intestinal canal.
CN201710499355.3A 2017-06-27 2017-06-27 Stomach air deflector Active CN107158546B (en)

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CN115670769A (en) * 2023-01-04 2023-02-03 杭州糖吉医疗科技有限公司 Alimentary canal membrane tube and preparation method thereof

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