WO2020125542A1 - 球囊、球囊连接结构与球囊装置 - Google Patents

球囊、球囊连接结构与球囊装置 Download PDF

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Publication number
WO2020125542A1
WO2020125542A1 PCT/CN2019/124937 CN2019124937W WO2020125542A1 WO 2020125542 A1 WO2020125542 A1 WO 2020125542A1 CN 2019124937 W CN2019124937 W CN 2019124937W WO 2020125542 A1 WO2020125542 A1 WO 2020125542A1
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WIPO (PCT)
Prior art keywords
balloon
self
catheter
valve
inner catheter
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PCT/CN2019/124937
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English (en)
French (fr)
Inventor
贾婧玮
岳斌
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上海微创医疗器械（集团）有限公司
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Publication of WO2020125542A1 publication Critical patent/WO2020125542A1/zh

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    • 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
    • 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
    • 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
    • A61M25/10—Balloon catheters

Definitions

  • the invention relates to the field of medical equipment, in particular to a balloon, a balloon connection structure and a balloon device.
  • Obesity refers to excessive or abnormal distribution of fat in the body.
  • the standard commonly used to measure the body's fatness and thinness and whether it is healthy is the BMI index, that is, the height compared to the square of the body weight.
  • the BMI is evaluated as overweight when it is between 25-29, and it is considered to be obese when it exceeds 30.
  • the hazards of obesity are not only reflected in the accumulation of fat, affecting the appearance and daily life, but also cause a series of related physical and psychological complications, threatening human health. The most important and common complications include Type 2 diabetes and cardiovascular disease. Obesity and its complications have become one of the greatest threats to human health.
  • the basic principle of obesity treatment is to reduce food intake and increase energy consumption, in order to achieve a negative energy balance, and then promote the consumption of accumulated fat in the body.
  • the improvement of lifestyle depends on the patient's own willpower.
  • the effect is general in people with multiple complications and it is easy to repeat. It is often used as an auxiliary method in the treatment stage and it is difficult to cure obesity.
  • Orlistat is approved for the treatment of obesity in China. It has many contraindications and is likely to cause complications such as diarrhea, and the treatment effect is relatively general.
  • Surgical treatment is recognized as a long-term and effective method of treating obesity.
  • Gastric balloon is a purely physical treatment method. In recent years, Europe, America and other countries have successively approved related devices, which is expected to become a new hope for the treatment of obesity. Intragastric balloon surgery imitates the principle of gastric capacity limitation. Reducing stomach volume through the balloon causes a decrease in eating and induces a sense of fullness after eating. At the same time, it stimulates the mechanical and chemoreceptors of the stomach, changes the gastric emptying, and adjusts the level of gastric hormones to achieve the purpose of weight loss. Non-invasive is the biggest and most prominent advantage of the gastric balloon. It does not need to remove any gastrointestinal tract and does not change the anatomical structure of the human digestive tract. The operation is relatively simple.
  • An object of the present invention is to provide a balloon, a balloon connection structure, and a balloon device to solve one or more problems in the prior art.
  • the present invention provides a balloon connection structure for detachably connecting a balloon, the balloon includes a self-sealing structure, the balloon connection structure includes an outer catheter and a An inner catheter installed in the outer catheter;
  • one end of the outer conduit is used to connect with the outside of the self-closing structure, and when the outer conduit is subjected to the first external force, the outer conduit can be separated from the self-closing structure;
  • One end of the inner tube is used to connect with the interior of the self-closing structure, and when the inner tube is subjected to a second external force, the inner tube can be separated from the self-closing structure;
  • the inner catheter can move relative to the outer catheter.
  • the outer catheter is used for interference fit with the self-closing structure; or the outer catheter has a buckle for snapping with the outer periphery of the self-closing structure.
  • the inner catheter is used for interference fit with the interior of the self-closing structure; or the inner catheter has a buckle for snapping with the interior of the self-closing structure.
  • At least one through hole is provided on the side wall of one end of the inner catheter, and the through hole is used for the inner catheter to communicate with the balloon.
  • a needle structure is provided at one end of the inner catheter, and the needle structure is used for the inner catheter to communicate with the balloon.
  • the external conduit when the external conduit receives a force opposite to the direction of the first external force, the external conduit is used to maintain connection with the self-closing structure; when the external conduit receives the second external force When the force in the opposite direction is applied, the inner duct is used to maintain the connection with the interior of the self-closing structure.
  • the present invention provides a balloon for cooperating with the balloon connection structure as described above, which includes:
  • the balloon body has a contracted state and a filled state
  • a self-closing structure is connected to the balloon body.
  • the self-closing structure has a connecting body and a valve body.
  • the connecting body has a connecting hole for the inner catheter to pass through.
  • Connected to the outer catheter; the valve body is disposed in the connection body, and is used to selectively connect or disconnect the balloon body with the inner catheter.
  • annular protrusion is formed on the outer periphery of the connecting body, which is used to be engaged with a snap on one end of the outer catheter.
  • the balloon body has a double-layer structure
  • the outer layer of the balloon body is made of a degradable material
  • the inner layer of the balloon body is made of an acid-soluble material.
  • the outer layer of the balloon body is made of a mixture of at least two degradable materials.
  • the valve body is a one-way valve, including a spring and a valve, one end of the spring is connected to the distal end of the connecting body, the other end of the spring is connected to the valve, and the spring is used to The opening and closing of the valve is controlled by elastic force; the connecting body also has at least one channel for connecting the balloon body and the inner catheter when the valve is opened.
  • the valve has an engaging structure for connecting the inner catheter.
  • the valve body is a self-sealing valve, including a valve, and the valve has a structure with self-sealing characteristics.
  • the present invention provides a balloon device including the balloon connection structure as described above, and the balloon as described above, wherein one end of the outer catheter can be connected to the connection body External detachable connection, one end of the inner catheter can be detachably connected to the valve body or the connection hole; and the inner catheter can be connected to or disconnected from the balloon.
  • the balloon connection structure is used to detachably connect a balloon
  • the balloon connection structure includes an outer catheter and is movably installed in An inner tube in the outer tube, one end of the outer tube is used to connect with the outside of the self-closing structure, and when the outer tube is subjected to a first external force, the outer tube can The closed structure is separated; one end of the inner duct is used to connect with the interior of the self-enclosed structure, and when the inner duct is subjected to a second external force, the inner duct can be separated from the self-enclosed structure;
  • the inner catheter is used to selectively communicate with or disconnect from the balloon; by the action of the first external force and the second external force, after the balloon reaches the stomach, the balloon connection structure can be easily separated from the balloon .
  • the two can be connected again when needed, so as to adjust the volume of the balloon.
  • the balloon body of the balloon has a double-layer structure, the outer layer of the balloon body is made of a degradable material, the inner layer of the balloon body is made of an acid-soluble material, and the balloon body After a certain period of time, it can be automatically degraded and discharged normally with the metabolism in the body, eliminating the use of endoscopes and reducing the risk of use.
  • FIG. 1 is a schematic view of the use of a balloon device provided by an embodiment of the present invention.
  • FIG. 2 is a schematic diagram of the overall structure of a balloon device provided by a preferred embodiment of the present invention, wherein the self-closing structure is a one-way valve;
  • FIG. 3 is a partial enlarged view of the balloon device provided in FIG. 2;
  • FIG. 4 is a schematic diagram of the overall structure of a balloon device provided by a preferred embodiment of the present invention, wherein the self-sealing structure is a self-sealing valve;
  • FIG. 5 is a partial enlarged view of the balloon device provided in FIG. 4.
  • the singular forms “a”, “an”, and “the” include plural objects unless the content clearly dictates otherwise.
  • the term “or” is generally used to include the meaning of “and/or”, unless the content clearly indicates otherwise, the term “proximal” is usually close to the term At one end of the patient, the term “distal” is usually the end close to the patient's lesion.
  • an embodiment of the present invention provides a balloon device, which can enter the stomach by swallowing or the like.
  • the balloon device includes a balloon 100 and a balloon connection structure 200, wherein the balloon 100 includes a balloon body 120 and a self-closing structure 110.
  • the balloon connection structure 200 includes an inner catheter 210 and an outer catheter 220.
  • the inner catheter 210 is movably penetrated in the outer catheter 220, and is preferably configured coaxially.
  • the balloon body 120 has a contracted state and a filled state, and can change its own volume according to the amount of the contained content, and occupy a part of the stomach internal volume with its own volume, so as to achieve the purpose of reducing food intake .
  • the self-closing structure 110 is connected to the balloon body 120, specifically to the proximal end of the balloon body 120.
  • the self-closing structure 110 includes a connection body 112 and a valve body (a check valve 111 in FIG. 3), a valve
  • the main body is a device that can be automatically closed, that is, when there is no external force or external component acting on it, it is in a closed state, which can close the inner cavity of the balloon body 120, so that the inner cavity of the balloon body 120 is not in communication with the outside ;
  • the valve body is disposed in the connecting body 112 for making the balloon 100 selectively communicate with or disconnect from the inner catheter 210.
  • the connecting body 112 preferably has a connecting hole for the inner tube 210 to pass through; and the outer portion of the connecting body 112 is used for fixing with the outer tube 220.
  • one end of the outer tube 220 is fixed to the outside of the self-closing structure 110, and when the outer tube 220 is subjected to the first external force, the outer tube 220 is separated from the self-closing structure 110; the inner tube 210 One end of is fixed to the inside of the self-closing structure 110 (valve body or connecting hole), and when the inner tube 210 is subjected to a second external force, the inner tube 210 is separated from the self-closing structure 110.
  • the inner catheter 210 is used to selectively communicate with or disconnect from the balloon 100: when the inner catheter 210 is fixed to the self-closing structure 110, the valve body can be conducted under the action of the inner catheter 210 to make the inner The catheter 210 is in communication with the balloon 100; when the inner catheter 210 is separated from the self-closing structure 110, the valve body is closed, disconnecting the inner catheter 210 from the balloon 100.
  • the valve body When one end of the inner catheter 210 is connected to the valve body of the self-closing structure 110 (at this time, the valve body can be in a closed state), it can be applied by the operator to the valve body after entering the human stomach An external force causes the valve body to open and inject liquid into the balloon 100 through the inner catheter 210 and the valve body.
  • the inner catheter 210 may apply an external force to the valve body before entering the human body, so that the valve body opens, that is, the balloon Before and after the connection structure 200 enters the human body, the valve body remains open until the inner catheter 210 is removed and the valve body closes.
  • first external force when the balloon 100 abuts against the stomach wall, when a force (first external force) is applied to the outer catheter 220 away from the self-closing structure 110 in the axial direction, the outer catheter 220 is detached from the self-closing structure 110, and then Further, a force (second external force) is applied to the inner catheter 210 away from the self-closing structure 110 in the axial direction, so that the inner catheter 210 can be separated from the self-closing structure 110, and then the entire balloon connection structure 200 is withdrawn.
  • first external force first external force
  • second external force is applied to the inner catheter 210 away from the self-closing structure 110 in the axial direction
  • the balloon connection structure 200 can be easily separated from the balloon 100, and the self-sealing structure 110 can be automatically closed; and the balloon connection structure 200 can be separated from the balloon 100 After that, when necessary, the two can be connected again, so that the volume of the balloon 100 can be adjusted again through the balloon connection structure 200.
  • the position of the balloon 100 can be defined with the help of a gastroscope, and then a force (that is, a force opposite to the second external force) in the axial direction toward the self-closing structure 110 is applied to the inner catheter 210, and the inner catheter After the connecting holes of 210 and the self-closing structure 110 are aligned and inserted into the connecting holes, the inner tube 210 and the inside of the self-closing structure 110 can be fixedly connected again.
  • a force that is, a force opposite to the second external force
  • a force is applied to the outer catheter 220 in the axial direction toward the self-closing structure 110 (that is, a force opposite to the first external force) to fix the outer catheter 220 to the outside of the self-closing structure 110, so that the balloon can be connected Both the structure 200 and the balloon 100 are connected again.
  • another balloon connection structure 200 can also be used to connect with the balloon 100, which is not limited in the present invention.
  • the balloon device provided in this embodiment has a simple structure and is convenient to use, and can separate and reconnect both the balloon connection structure 200 and the balloon 100 in a simple manner.
  • the outer tube 220 is used for interference fit with the self-closing structure 110; or the outer tube 220 has a buckle 221 for clamping with the outer periphery of the self-closing structure 110.
  • the outer tube 220 may have a buckle 221 (preferably L-shaped), and the outer periphery of the connecting body 112 of the self-closing structure 110 is formed with an annular protrusion 114, and the buckle 221 may be It engages with the protrusion 114.
  • the buckle 221 may be provided at the end of the outer tube 220 or at a position near the end, and the position of the protrusion 114 matches the position of the buckle 221.
  • the buckle 221 is clamped It is held between the balloon body 120 and the protrusion 114.
  • the distal end of the buckle 221 may be a slope, and the normal direction of the slope is toward the axis of the outer catheter 220, that is, the slope is gradually expanded from the proximal end to the distal end, so that the buckle 221 forms an inverted triangle.
  • the buckle 221 can be easily engaged with the protrusion 114.
  • the outer tube 220 may also be connected to the outer periphery of the connecting body 112 by an interference fit, that is, the inner diameter of the outer tube 220 is slightly smaller than the outer diameter of the connecting body 112.
  • the inner tube 210 can be fitted with the connecting body 112 (connecting hole) of the self-closing structure 110 through an interference fit, that is, the outer diameter of the inner tube 210 is slightly larger than the inner diameter of the connecting hole.
  • a protruding buckle may be provided on the outer periphery of the inner tube 210, and a groove matching the buckle may be provided on the inner wall of the connecting hole, so that the inner tube 210 and the connecting hole.
  • the outer tube 220 and the inner tube 210 are connected to the self-closing structure 110 by the clip, or the outer tube 220 and the inner tube 210 are connected to the self-closing structure 110 by interference fit, etc. This is not limited.
  • the valve body is a one-way valve 111, which includes a spring and a valve, one end of the spring is connected to the distal end of the connecting body 112, and the other end is connected to the valve.
  • the connecting body 112 In order to control the opening and closing of the valve by elastic force; the connecting body 112 further has at least one channel 115 for communicating the balloon 100 and the inner catheter 210 when the valve is opened.
  • one end of the inner catheter 210 abuts the valve of the one-way valve 111 (that is, the inner catheter 210 is located relative to the connecting body 112 First position), pressure is applied to the spring, so that the one-way valve 111 is in a conducting state, and then the inside of the balloon body 120 communicates with the inner catheter 210. Further, please refer to FIG.
  • the other end of the inner catheter 210 is connected with a standard Luer connector 230 through which the liquid can be injected into the inner catheter 210, such as saline, etc., the liquid can pass through
  • the conducting one-way valve 111 enters the balloon body 120 so that the balloon body 120 is in a filled state, and the liquid can be drawn outward through the luer connector 230 to shrink the volume of the balloon body 120.
  • the valve of the one-way valve 111 is closed under the action of the spring, closing the liquid in the balloon body 120.
  • a through hole 121 is provided at the distal end of the inner catheter 210, so that when one end of the inner catheter 210 abuts on the valve of the check valve 111, the inside of the balloon body 120 passes through the through hole 121 and The channel 115 connecting the body 112 communicates with the inner tube 210.
  • the valve body is a self-sealing valve 113, and there is no need to provide a channel on the connecting body 112 to communicate the balloon 100 and the inner catheter 210.
  • the self-sealing valve 113 is disposed at the distal end of the connecting body 112 and seals the balloon 100 together with the connecting body 112.
  • the self-sealing valve 113 is a structure with self-sealing characteristics such as a silicone sheet or a rubber sheet.
  • the self-sealing feature refers to the resistance to needle puncture and tear resistance. After the needle is penetrated, it can form a seal around the needle hole. After the needle is pulled out, the original sealing structure can be restored by itself.
  • An end of the inner catheter 210 connected to the self-closing structure 110 is provided with a needle structure.
  • the needle structure is inserted and passed through the The self-sealing valve 113 (that is, the inner tube 210 is located at a first position relative to the connecting body 112).
  • the inside of the balloon body 120 and the inner catheter 210 communicate with each other through the needle structure.
  • the other end of the inner catheter 210 is connected to a standard Luer connector 230.
  • the balloon body 120 can also be injected or withdrawn through the Luer connector 230 to make the balloon body 120 The volume changes.
  • the self-sealing valve 113 closes the hole left by the needle structure through its own deformation and is in a closed state, closing the balloon Liquid in the body 120.
  • the balloon body 120 has a double-layer structure, and the outer layer of the balloon body 120 is made of a degradable material to ensure that the balloon degrades after a certain period of time (for example, 6 months or 12 months).
  • the inner layer of the balloon body 120 is made of an acid-soluble material to ensure that the inner layer of the balloon body 120 also dissolves after the outer layer of the balloon body 120 is degraded, thereby achieving the purpose of quickly releasing the filling liquid.
  • the balloon body 120 with a double-layer structure can prevent the balloon body 120 from rupturing during the filling process, and after a certain period of time, the liquid in the balloon body 120 can be quickly discharged.
  • the balloon body 120 is formed from inner and outer double layers, and then assembled.
  • the double-layer structure of the balloon body 120 can be manufactured by co-extrusion, surface grafting, interfacial polymerization, or by adding a layer on the outer surface of the inner layer of the balloon body 120
  • the outer layer of the balloon body 120 is prepared by using one or more layers of degradable materials.
  • the additional means may include surface spraying, electrospinning, filter deposition, self-assembly, etc., which is not limited in the present invention.
  • One end of the balloon body 120 is connected to the self-closing structure 110 and encapsulated into a swallowable capsule shell that can be quickly dissolved in stomach acid.
  • the distal end of the double-layer catheter that is, the inner catheter 210 and the outer catheter 220 formed around the balloon catheter 200
  • the capsule shell quickly dissolves in gastric acid to release the balloon, and a certain volume of saline is injected into the balloon body 120 through the proximal Luer connector 230.
  • the catheter 220 is separated from the self-closing structure 110, exposing the connection between the inner catheter 210 and the self-closing structure 110, and then applying a force through the distal end of the inner catheter 210 to separate the inner catheter 210 from the self-closing structure 110.
  • the double-layer catheter is withdrawn, the self-sealing structure 110 is closed, and the balloon body 120 is closed, so that the balloon body 120 can maintain the volume and occupy the stomach volume, so as to limit the stomach volume.
  • the outer layer of the balloon body 120 degrades, exposing the inner layer of the balloon body 120 to gastric acid and dissolves immediately, quickly releasing the liquid (physiological saline) inside the balloon body 120 ), and then the residual material of the balloon 100 is normally excreted with the metabolism in the body. If the patient is pregnant or traumatized, the balloon body 120 can be punctured by gastroscope operation. After the liquid is released, the residual material of the balloon 100 can be removed to restore the stomach volume to increase the amount of food.
  • the doctor determines that the volume of the balloon body 120 needs to be adjusted (released or increased) according to the patient's condition, it can be assisted by a balloon connection structure 200 and the balloon 100 again with the assistance of the gastroscope Connect and draw or inject liquid into the balloon body 120 to adjust the volume of the balloon body 120.
  • the outer layer material of the balloon body 120 may be a medical degradable material.
  • one of polylactic acid, polycaprolactone, polyglycolide, lactic acid/glycolic acid copolymer, chitosan, collagen, silk protein, etc., or two or more of these can be selected A mixture or composite of materials.
  • the choice and combination of materials determine the degradation time of the outer layer of the balloon body 120, and the doctor can freely choose the degradation time according to the patient's condition.
  • the inner layer material of the balloon body 120 may be a medical acid-soluble material. Generally, one of the materials such as chitosan and acid-soluble protein, or a mixture or composite material of chitosan and acid-soluble protein can be selected.
  • the capsule shell is selected from medical water-soluble/acid-soluble polymer materials.
  • materials such as gelatin and polyvinyl alcohol, or a mixture or composite material of shell gelatin and polyvinyl alcohol can be selected.
  • the material of the double-layer catheter can be medical polymer material or medical silicone material.
  • one of nylon, Pebax, polyurethane, polyethylene, polypropylene and other materials can be selected, or a mixture or composite material of two or more of these materials can be selected.
  • the double-layer structure of the balloon body 120 is connected to a self-closing structure 110, is connected to the double-layer catheter through the self-closing structure 110, and is encapsulated into the shell of the gelatin capsule. In the in vitro simulation test, the capsule shell can smoothly enter the stomach through the esophagus and dissolve in the stomach acid, releasing the balloon 100.
  • the outer catheter 220 is moved to expose the connection between the inner catheter 210 and the self-sealing structure 110, and the inner catheter 210 is separated from the self-sealing structure 110 by applying a force to the distal end of the inner catheter 210 , And then withdraw the double-layer catheter.
  • the outer layer of the balloon body 120 degrades at 6 months, and the inner layer of the balloon body 120 dissolves when exposed to gastric acid, the liquid in the balloon body 120 is released, and the remaining portion of the balloon 100 Normally excreted from the body.
  • the balloon connection structure includes an outer catheter and an inner catheter movably disposed in the outer catheter, the outer catheter One end of is used to fix with the outside of the self-closing structure, and when the outer conduit is subjected to the first external force, the outer conduit is separated from the self-closing structure; one end of the inner conduit is used to The inner part of the self-closing structure is fixed, and when the outer tube is subjected to a second external force, the inner tube is separated from the self-closing structure.
  • the inner catheter is used to selectively communicate with or disconnect from the balloon; by the action of the first external force and the second external force, after the balloon reaches the stomach, the balloon connection structure can be conveniently connected to the balloon Separate.
  • the two can be connected again when needed, so as to adjust the volume of the balloon.
  • the balloon body of the balloon has a double-layer structure, the outer layer of the balloon body is made of a degradable material, the inner layer of the balloon body is made of an acid-soluble material, and the balloon body After a certain period of time, it can be automatically degraded and discharged normally with the metabolism in the body, eliminating the use of endoscopes and reducing the risk of use.
  • the balloon, balloon connection structure and balloon device provided by the present invention can be used not only as a gastric balloon, but also other balloons used in other parts of the human body, such as a rotator cuff balloon, a vertebral body balloon, and a uterus Balloons, etc.

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Abstract

一种球囊（100）、球囊连接结构（200）与球囊装置，球囊连接结构（200）用于可拆卸地连接一球囊（100），球囊连接结构（200）包括外导管（220）以及内导管（210），外导管（220）的一端用于与自封闭结构（110）的外部相连接，且当外导管（220）受到第一外力作用时，外导管（220）能够与自封闭结构（110）分离；内导管（210）的一端用于与自封闭结构（110）的内部相连接，且当内导管（210）受到第二外力作用时，内导管（210）能够与自封闭结构（110）分离；通过第一外力与第二外力的作用，在球囊（100）到达胃部后，球囊连接结构（200）可方便地与球囊（100）分离；当外导管（220）或内导管（210）处于与自封闭结构（110）分离的状态时，内导管（210）可活动地穿设在外导管（220）内。优选的，在球囊连接结构（200）与球囊（100）分离后，在需要的时候，可再次将两者连接起来，以便于调整球囊（100）的容积。

Description

球囊、球囊连接结构与球囊装置 技术领域
本发明涉及医疗器械领域，特别涉及一种球囊、球囊连接结构与球囊装置。
背景技术
肥胖是指人体内脂肪的过多或者异常分布。目前国际上常用的衡量人体胖瘦程度以及是否健康的标准为BMI指数，即身高比上体重的平方，BMI在25-29之间时评价为超重，超过30时即认为肥胖。作为一种代谢性疾病，肥胖的危害不仅体现在堆积脂肪、影响外观和日常生活上，更会引起一系列相关的躯体和心理并发症，威胁人体健康，其中最重要、最常见的并发症包括2型糖尿病和心血管疾病等。肥胖及其并发症已经成为人类健康最大的威胁之一。2017年发表在新英格兰医学杂志上的一项研究表明，世界三分之一的人口，大约为22亿，超重，10％的人口，大约为7.12亿，肥胖。在成年肥胖与肥胖儿童人数统计中，中国分别位列第一与第二，肥胖总人口已超7000万，其中超过20％为儿童，临床上对于安全有效的肥胖治疗方式仍有着十分巨大的需求。
肥胖治疗的基本原则是减少食物摄入和增加能量消耗，以达到能量的负平衡，进而促进对体内蓄积脂肪的消耗。目前治疗肥胖的主要方式有以下三种，生活方式改善多取决于患者自身意志力，在有多并发症的人群中效果一般，且容易反复，多作为治疗阶段的辅助手段，难以根治肥胖。药物治疗方面，目前国内批准可用于治疗肥胖的药物只有奥利司他一种，其禁忌症较多且容易引起腹泻等并发症，治疗效果也比较一般。而外科手术治疗是公认可长期有效治疗肥胖的方法，目前临床上较为成熟，应用广泛的手术方法主要有四种：胃旁路术、胃袖状切除术、胃束带折叠术及胆胰分流并十二指肠转位术，但是无论是何种手术，对机体均有一定程度的损伤，并导致术后生理结构改变，不可避免地存在一系列近期和远期并发症，极大地限制了外科手术的应用。
胃球囊是一种纯物理作用的治疗方式，近年来欧美等国相继批准了相关器械，有望成为肥胖治疗的新希望。胃内球囊术是模仿胃容量限制的原理，通过球囊减少胃容积引起进食减少及诱发进食后饱胀感。同时刺激胃的机械及化学感受器，改变胃排空，调节胃激素水平从而达到减重的目的。无创是胃球囊最大最突出的优点，它不需切除任何胃肠道，不改变人体消化道的解剖结构，操作相对比较简便。文献报道其围手术期并发症远低于其他手术，手术死亡率为零，除早期的恶心呕吐症状很少有严重并发症发生。由于胃球囊不影响胃肠道对营养素的吸收，不会造成术后腹泻及营养不良。如果遇到创伤、怀孕等营养需要量增加的情况，胃球囊可随时取出。
在目前胃球囊治疗中，如何将胃球囊输送到人体中并将输送装置与胃球囊脱离仍是一个有待解决的问题，现有技术中的输送装置结构复杂，给加工制造带来很大困难，同时，在与胃球囊脱离的操作上，也非常不便；另一方面，在将胃球囊植入人体后，可能需要再次对胃球囊的体积进行调整，而目前尚未发现能有效进行该操作的技术；再一方面，胃球囊的球囊部件多采用硅胶等弹性体材质，这种材料的选择有利于实现球囊在胃部的体积扩充，以达到限制胃容量的目的。然而这些材料多为不可降解，导致其无法自发释放体积，取出时仍需内窥镜操作，增加了手术的风险。另外，植入方式上，大部分胃球囊也需要通过胃镜等内窥镜手段，这也增加了食道穿孔，肠梗塞等内径相关并发症发生的风险。
基于现有技术中存在的问题，有必要开发一种新型胃球囊，以更好地满足临床应用需求。
发明内容
本发明的目的在于提供一种球囊、球囊连接结构与球囊装置，以解决现有技术中存在的一个或多个问题。
一方面，为解决上述技术问题，本发明提供一种球囊连接结构，用于可拆卸地连接一球囊，所述球囊包括有自封闭结构，所述球囊连接结构包括外导管以及能够穿设在所述外导管内的内导管；
其中，所述外导管的一端用于与所述自封闭结构的外部相连接，且当所述外导管受到第一外力作用时，所述外导管能够与所述自封闭结构分离；
所述内导管的一端用于与所述自封闭结构的内部相连接，且当所述内导管受到第二外力作用时，所述内导管能够与所述自封闭结构分离；
当所述外导管或所述内导管处于与所述自封闭结构分离的状态时，所述内导管能够相对所述外导管活动。
可选的，所述外导管用于与所述自封闭结构过盈配合；或所述外导管具有卡扣，用于与所述自封闭结构的外周卡接。
可选的，所述内导管用于与所述自封闭结构的内部过盈配合；或所述内导管具有卡扣，用于与所述自封闭结构的内部卡接。
可选的，所述内导管的一端的侧壁上设置有至少一个通孔，所述通孔用于所述内导管与所述球囊连通。
可选的，所述内导管一端设有一针头结构，所述针头结构用于所述内导管与所述球囊连通。
可选的，当所述外导管受到与所述第一外力方向相反的作用力时，所述外导管用于与所述自封闭结构保持连接；当所述外导管受到与所述第二外力方向相反的作用力时，所述内导管用于与所述自封闭结构的内部保持连接。
另一方面，为解决上述技术问题，本发明提供一种球囊，用于与如上所述的球囊连接结构相配合，其包括：
球囊本体，具有收缩状态与充盈状态；
自封闭结构，与所述球囊本体连接，所述自封闭结构具有连接本体和阀主体，所述连接本体具有一连接孔，用于供所述内导管穿过，所述连接本体的外部用于与所述外导管相连接；所述阀主体设置在所述连接本体内，用于使得所述球囊本体选择性地与所述内导管连通或断开。
可选的，所述连接本体的外周形成有环状的凸起部，用于与所述外导管之一端的卡扣相卡接。
可选的，所述球囊本体为双层结构，所述球囊本体的外层由可降解材料制成，所述球囊本体的内层由可酸溶材料制成。
可选的，所述球囊本体的外层由至少两种可降解材料混合的材料制成。
可选的，所述阀主体为单向阀，包括弹簧和阀门，所述弹簧的一端连接所述连接本体的远端端部，所述弹簧的另一端连接所述阀门，所述弹簧用以通过弹力控制所述阀门的开启和关闭；所述连接本体还具有至少一通道，用于在所述阀门开启时，连通所述球囊本体和所述内导管。
可选的，所述阀门上具有卡合结构，用于连接所述内导管。
可选的，所述阀主体为自封阀，包括一阀门，所述阀门为具有自封闭特性的结构。
再一方面，为解决上述技术问题，本发明提供一种球囊装置，包括如上所述的球囊连接结构，以及如上所述的球囊，其中所述外导管的一端能够与所述连接本体的外部可拆卸连接，所述内导管的一端能够与所述阀主体或所述连接孔可拆卸连接；且所述内导管能够与所述球囊连通或断开。
在本发明提供的球囊、球囊连接结构与球囊装置中，所述球囊连接结构用于可拆卸地连接一球囊，所述球囊连接结构包括外导管以及可活动地穿设在所述外导管内的内导管，所述外导管的一端用于与所述自封闭结构的外部相连接，且当所述外导管受到第一外力作用时，所述外导管能够与所述自封闭结构分离；所述内导管的一端用于与所述自封闭结构的内部相连接，且当所述内导管受到第二外力作用时，所述内导管能够与所述自封闭结构分离；所述内导管用于选择性地与所述球囊连通或断开；通过第一外力与第二外力的作用，在球囊到达胃部后，所述球囊连接结构可方便地与球囊分离。优选的，在所述球囊连接结构与所述球囊分离后，在需要的时候，可再次将两者连接起来，以便于调整球囊的容积。进一步地，所述球囊的球囊本体为双层结构，所述球囊本体的外层由可降解材料制成，所述球囊本体的内层由可酸溶材料制成，球囊本体在一定时间后能自动降解，并随体内代谢正常排出体外，免除内窥镜的使用，降低使用风险。
附图说明
本领域的普通技术人员将会理解，提供的附图用于更好地理解本发明， 而不对本发明的范围构成任何限定。其中：
图1是本发明一实施例提供的球囊装置的使用示意图；
图2是本发明一优选实施例提供的球囊装置的整体结构的示意图，其中自封闭结构为单向阀；
图3是图2提供的球囊装置的局部放大图；
图4是本发明一优选实施例提供的球囊装置的整体结构的示意图，其中自封闭结构为自封阀；
图5是图4提供的球囊装置的局部放大图。
附图中：
100-球囊；110-自封闭结构；111-单向阀；112-连接本体；113-自封阀；114-凸起部；115-通道；120-球囊本体；121-通孔；200-球囊连接结构；210-内导管；220-外导管；230-鲁尔接头。
具体实施方式
为使本发明的目的、优点和特征更加清楚，以下结合附图和具体实施例对本发明作进一步详细说明。需说明的是，附图均采用非常简化的形式且未按比例绘制，仅用以方便、明晰地辅助说明本发明实施例的目的。此外，附图所展示的结构往往是实际结构的一部分。特别的，各附图需要展示的侧重点不同，有时会采用不同的比例。
如在本说明书和所附权利要求书中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，除非内容另外明确指出外。如在本说明书和所附权利要求中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外，术语“近端”通常是靠近术者的一端，术语“远端”通常是靠近患者病变部位的一端。
请参考图2和图3，本发明实施例提供一种球囊装置，该球囊装置可通过吞咽等方式进入胃部。所述球囊装置包括一球囊100和一球囊连接结构200，其中，球囊100包括球囊本体120以及自封闭结构110。所述球囊连接结构200包括内导管210和外导管220，所述内导管210可活动地穿设在所述外导 管220内，优选配置为同轴。所述球囊本体120具有收缩状态与充盈状态，可根据所容置的容置物的量而改变自身的体积，并以其自身的体积占据一部分胃内容积，以达到减少食物摄入量的目的。所述自封闭结构110与所述球囊本体120连接，具体与球囊本体120的近端连接，该自封闭结构110包括连接本体112和阀主体(图3中为单向阀111)，阀主体为可自动关闭的装置，即当无外力或无外部构件对其施加作用时，其自身处于关闭状态，能封闭球囊本体120的内腔，使球囊本体120的内腔与外部不连通；阀主体设置在所述连接本体112内，用于使得所述球囊100选择性地与内导管210连通或断开。而当阀主体受到外力或外部构件对其施加作用时，其可使球囊本体120的内腔与外部连通。其中，所述连接本体112优选具有一连接孔，用于供所述内导管210穿设；而连接本体112的外部用于与所述外导管220相固定。实际装配时，外导管220的一端与自封闭结构110的外部相固定，且当所述外导管220受到第一外力作用时，所述外导管220与所述自封闭结构110分离；内导管210的一端与所述自封闭结构110的内部(阀主体或连接孔)相固定，且当所述内导管210受到第二外力作用时，所述内导管210与所述自封闭结构110分离。
所述内导管210用于选择性地与所述球囊100连通或断开：当内导管210与自封闭结构110相固定时，阀主体可在内导管210的作用下而导通，使内导管210与球囊100连通；当内导管210与自封闭结构110相分离时，阀主体即关闭，使内导管210与球囊100断开。当内导管210的一端与所述自封闭结构110的阀主体相连接时(此时阀主体可处于关闭状态)，其可在进入人体胃部后，由操作者操作内导管210对阀主体施加一个外力，使得阀主体打开，进而通过内导管210和阀主体向球囊100内部注射液体。在另外一些实施例中，当内导管210的一端与连接本体112上的连接孔相固定时，可使得内导管210在进入人体前即对阀主体施加一个外力，使得阀主体打开，即球囊连接结构200进入人体前后，阀主体均保持打开，直至撤去内导管210，阀主体关闭。
具体的，当球囊100抵靠在胃壁上时，对外导管220施加一个沿轴向远 离自封闭结构110的力(第一外力)时，外导管220即与所述自封闭结构110脱离，而后，进一步对内导管210施加一个沿轴向远离自封闭结构110的力(第二外力)，可使内导管210与自封闭结构110分离，进而撤出整个球囊连接结构200。因此，在球囊100到达胃部后，可方便地将球囊连接结构200与球囊100分离，且自封闭结构110可自动关闭；而所述球囊连接结构200与所述球囊100分离后，在需要的时候，可再次将两者连接起来，以便于通过球囊连接结构200再次调整球囊100的容积。具体的，可在胃镜的帮助下将球囊100的位置限定，而后对内导管210施加一个沿轴向朝向自封闭结构110的力(即与第二外力相反的作用力)，并将内导管210与自封闭结构110的连接孔对准后插入连接孔内，内导管210与自封闭结构110的内部即可再次固定连接。而后对外导管220施加一个沿轴向朝向自封闭结构110的力(即与第一外力相反的作用力)，使外导管220与所述自封闭结构110的外部相固定，即可使球囊连接结构200与球囊100两者再次连接起来。当然，也可以使用另一个球囊连接结构200与球囊100连接，本发明对此不做限制。
相比现有的球囊装置，常因结构复杂而导致体积大，致使患者将球囊装置吞咽入胃部时产生困难。本实施例提供的球囊装置结构简单，使用方便，能通过简单的方式使球囊连接结构200与球囊100两者分离和再连接。
优选的，所述外导管220用于与所述自封闭结构110过盈配合；或所述外导管220具有卡扣221，用于与所述自封闭结构110的外周卡接。请参考图3，所述外导管220可具有卡扣221(优选L形)，而所述自封闭结构110之连接本体112的外周形成有环状的凸起部114，所述卡扣221可与所述凸起部114相卡接。这里卡扣221可设置于外导管220之端部，也可设置在靠近端部的部位，而凸起部114的设置与该卡扣221的位置相匹配，较佳地，卡扣221被夹持在球囊本体120与凸起部114之间。特别的，卡扣221的远端可以为斜面，该斜面的法向朝向外导管220之轴线方向，即该斜面由近端向远端为逐渐扩张的形态，使卡扣221形成一倒三角形，当对外导管220施加一个沿轴向朝向自封闭结构110的力，可使卡扣221方便地与凸起部114卡接在一起。当然，在其它一些实施例中，外导管220还可以与连接本体112的外周 通过过盈配合而连接，即外导管220的内径略小于连接本体112的外径。
进一步，内导管210可通过过盈配合与自封闭结构110的连接本体112(连接孔)相配合，即内导管210的外径略大于连接孔的内径。当然，在另一些实施例中，还可以在内导管210的外周设置凸起的卡扣，而连接孔的内壁上设置与所述卡扣相匹配的凹槽，使内导管210与连接孔两者通过卡接连接；或者外导管220与内导管210均通过卡接与自封闭结构110连接，又或者外导管220与内导管210均通过过盈配合与自封闭结构110连接等，本发明对此不作限定。
优选的，如图3所示，所述阀主体为单向阀111，包括弹簧和阀门，弹簧的一端连接所述连接本体112的远端端部，另一端连接所述阀门，所述弹簧用以通过弹力控制所述阀门的开启和关闭；所述连接本体112还具有至少一通道115，用于在所述阀门开启时，连通所述球囊100和所述内导管210。当所述球囊100与所述球囊连接结构200配合形成球囊装置时，内导管210的一端部抵靠于单向阀111的阀门上(即内导管210相对于所述连接本体112位于第一位置)，对弹簧施加压力，从而使单向阀111呈导通状态，进而球囊本体120的内部与内导管210相连通。进一步的，请参考图2，所述内导管210的另一个端部连接有一标准鲁尔接头230，可通过该鲁尔接头230向内导管210注射液体，如生理盐水等，所述液体可通过导通的单向阀111进入球囊本体120而使球囊本体120呈充盈状态，也可通过所述鲁尔接头230向外抽取液体，而使球囊本体120的体积收缩。当内导管210被移除时(即内导管210相对于所述连接本体112位于第二位置)，单向阀111的阀门在弹簧的作用下呈关闭状态，封闭球囊本体120内的液体。
在本实施例中，在内导管210的远端设置通孔121，从而使得内导管210的一端部抵靠于单向阀111的阀门上时，球囊本体120的内部通过该通孔121以及连接本体112的通道115与内导管210相连通。
在另一实施例中，如图5所示，所述阀主体为自封阀113，连接本体112上无需再设置通道用于连通所述球囊100和所述内导管210。在本实施例中，自封阀113设置于连接本体112的远端，与连接本体112一同对球囊100进行 密封。自封阀113是如硅胶片或橡胶片等制成的具有自封闭特性的结构，自封闭特征是指具有耐针刺和抗撕裂特性，经针刺入后能够在针孔周围形成密封，当针拔出后，能自行恢复原有的密封结构。内导管210用于与自封闭结构110连接的一端部设有一针头结构，当所述球囊100与所述球囊连接结构200配合形成球囊装置时，所述针头结构插入并穿过所述自封阀113(即内导管210相对于所述连接本体112位于第一位置)。此时，球囊本体120的内部与内导管210通过该针头结构相连通。同样的，所述内导管210的另一个端部连接有一标准鲁尔接头230，如图4所示，亦可通过鲁尔接头230对球囊本体120内部注射或抽取液体，使球囊本体120的体积改变。当内导管210被移除时(即内导管210相对于所述连接本体112位于第二位置)，自封阀113通过自身的形变封闭所述针头结构留下的孔而呈关闭状态，封闭球囊本体120内的液体。
进一步，所述球囊本体120为双层结构，所述球囊本体120的外层由可降解材料制成，保证球囊在一定时间(例如6个月或12个月)后降解，而所述球囊本体120的内层由可酸溶材料制成，保证球囊本体120的外层降解后球囊本体120的内层也随之溶解，从而达到快速释放充盈液体的目的。双层结构的球囊本体120可避免充盈过程中球囊本体120发生破裂，以及特定时间后，球囊本体120内液体可快速排出。优选的，所述球囊本体120由内外双层分别成型，然后组装而得。当然，在一些实施例中，所述球囊本体120的双层结构可采用共挤出、表面接枝，界面聚合等方式制得，或者通过在球囊本体120之内层的外表面附加一层或多层可降解材料而制得球囊本体120之外层，其中的附加手段可包括表面喷涂、静电纺丝、过滤沉积、自组装等，本发明对此不作限定。
球囊本体120的一端部与自封闭结构110相连接，并包封至可快速溶解于胃酸中的可吞咽胶囊外壳中。请参考图1，使用时，包裹着球囊100的胶囊外壳与球囊连接结构200的双层导管(即内导管210和外导管220套设后形成)的远端一同经食道吞咽至胃部，胶囊外壳在胃酸中快速溶解，释放球囊，通过近端的鲁尔接头230向球囊本体120内注射一定体积的生理盐水，待球 囊本体120达到所需体积后，施加作用力移动外导管220，使得其与自封闭结构110分离，暴露出内导管210与自封闭结构110的连接处，再通过内导管210的远端施加作用力，使内导管210与自封闭结构110分离，将双层导管撤出，自封闭结构110关闭，将球囊本体120封闭，使球囊本体120可保持体积，占据胃部容积，达到限制胃容量的目的。一定时间后(一般为6～12个月)，球囊本体120的外层降解，使球囊本体120的内层暴露至胃酸中并随即溶解，快速释放球囊本体120内部的液体(生理盐水)，随后球囊100的残余材料随体内代谢正常排出体外。而若遇到患者怀孕或受创伤等特殊情况，亦可通过胃镜下操作刺破球囊本体120，释放液体后将球囊100的残余材料取出，以使胃部恢复容积以增加食物量。此外，在球囊100植入胃部后，若医生判断根据患者情况需要调整球囊本体120的容积(释放或增加)，可在胃镜辅助下，再次通过一球囊连接结构200与球囊100连接并向球囊本体120抽取或注入液体，以调整球囊本体120的容积。
优选的，所述球囊本体120的外层材料可选用医用可降解材料。一般地，可以选择聚乳酸、聚己内酯、聚乙交酯、乳酸/羟基乙酸共聚物、壳聚糖、胶原蛋白、蚕丝蛋白等材料中的一种，或者选择两种或两种以上这些材料的混合物或复合材料。材料的选择及组合决定了球囊本体120之外层的降解时间，而医生可根据患者情况自由选择降解时间。所述球囊本体120的内层材料可选用医用酸溶材料。一般地，可以选择壳聚糖、酸溶蛋白等材料之一，或者壳聚糖与酸溶蛋白的混合物或复合材料等。所述胶囊外壳选用医用水溶/酸溶高分子材料。一般地，可以选择明胶、聚乙烯醇等材料，或者壳明胶与聚乙烯醇的混合物或复合材料等。而所述双层导管的材料可选用医用高分子材料或医用硅胶材料。一般地，可选择尼龙，Pebax，聚氨酯，聚乙烯，聚丙烯等材料之一，或者选择两种或两种以上这些材料的混合物或复合材料等。
在一个实施例中，球囊本体120之外层的材料选用聚乳酸/聚已内酯＝4/6的混合材料，球囊本体120之内层的材料选用酸溶壳聚糖。球囊本体120的双层结构共同连接在一自封闭结构110上，通过自封闭结构110与双层导管连接，并包封至明胶胶囊外壳内。在体外模拟测试中，所述胶囊外壳可顺利 通过食道进入胃部，并在胃酸中溶解，释放球囊100。通过X射线确认球囊100的位置后，使用注射器向内导管210之近端所连接的鲁尔接头230中注入500～700mL生理盐水，使球囊本体120充盈。待球囊本体120达到所需体积后，移动外导管220，暴露内导管210与自封闭结构110连接处，通过对内导管210的远端施加作用力，使内导管210与自封闭结构110分离，进而撤出双层导管。在模拟胃酸环境下，球囊本体120的外层在6个月时降解，球囊本体120的内层暴露在胃酸中随即溶解，球囊本体120中的液体释放，球囊100的残余部分随正常排泄排出体外。
综上，在本发明提供的球囊、球囊连接结构与球囊装置中，所述球囊连接结构包括外导管以及可活动地穿设在所述外导管内的内导管，所述外导管的一端用于与所述自封闭结构的外部相固定，且当所述外导管受到第一外力作用时，所述外导管与所述自封闭结构分离；所述内导管的一端用于与所述自封闭结构的内部相固定，且当所述外导管受到第二外力作用时，所述内导管与所述自封闭结构分离。所述内导管用于选择性地与所述球囊连通或断开；通过第一外力与第二外力的作用，在球囊到达胃部后，所述球囊连接结构可方便地与球囊分离。优选的，在所述球囊连接结构与所述球囊分离后，在需要的时候，可再次将两者连接起来，以便于调整球囊的容积。进一步地，所述球囊的球囊本体为双层结构，所述球囊本体的外层由可降解材料制成，所述球囊本体的内层由可酸溶材料制成，球囊本体在一定时间后能自动降解，并随体内代谢正常排出体外，免除内窥镜的使用，降低使用风险。
本发明所提供的球囊、球囊连接结构与球囊装置不仅仅可以用作胃球囊，还可以是用于人体其他部位的其他球囊，如肩袖球囊、椎体球囊、子宫球囊等。
上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于权利要求书的保护范围。

Claims (14)

  1. 一种球囊连接结构，用于可拆卸地连接一球囊，所述球囊包括有自封闭结构，其特征在于，所述球囊连接结构包括外导管以及能够穿设在所述外导管内的内导管；
    其中，所述外导管的一端用于与所述自封闭结构的外部相连接，且当所述外导管受到第一外力作用时，所述外导管能够与所述自封闭结构分离；
    所述内导管的一端用于与所述自封闭结构的内部相连接，且当所述内导管受到第二外力作用时，所述内导管能够与所述自封闭结构分离；
    当所述外导管或所述内导管处于与所述自封闭结构分离的状态时，所述内导管能够相对所述外导管活动。
  2. 根据权利要求1所述的球囊连接结构，其特征在于，所述外导管用于与所述自封闭结构过盈配合；或所述外导管具有卡扣，用于与所述自封闭结构的外周卡接。
  3. 根据权利要求1所述的球囊连接结构，其特征在于，所述内导管用于与所述自封闭结构的内部过盈配合；或所述内导管具有卡扣，用于与所述自封闭结构的内部卡接。
  4. 根据权利要求1所述的球囊连接结构，其特征在于，所述内导管的一端的侧壁上设置有至少一个通孔，所述通孔用于所述内导管与所述球囊连通。
  5. 根据权利要求1所述的球囊装置，其特征在于，所述内导管一端设有一针头结构，所述针头结构用于所述内导管与所述球囊连通。
  6. 根据权利要求1所述的球囊装置，其特征在于，当所述外导管受到与所述第一外力方向相反的作用力时，所述外导管用于与所述自封闭结构保持连接；当所述外导管受到与所述第二外力方向相反的作用力时，所述内导管用于与所述自封闭结构的内部保持连接。
  7. 一种球囊，用于与根据权利要求1-6中的任一项所述的球囊连接结构相配合，其特征在于，包括：
    球囊本体，具有收缩状态与充盈状态；
    自封闭结构，与所述球囊本体连接，所述自封闭结构具有连接本体和阀主体，所述连接本体具有一连接孔，用于供所述内导管穿过，所述连接本体的外部用于与所述外导管相连接；所述阀主体设置在所述连接本体内，用于使得所述球囊本体选择性地与所述内导管连通或断开。
  8. 根据权利要求7所述的球囊，其特征在于，所述连接本体的外周形成有环状的凸起部，用于与所述外导管之一端的卡扣相卡接。
  9. 根据权利要求7或8所述的球囊，其特征在于，所述球囊本体为双层结构，所述球囊本体的外层由可降解材料制成，所述球囊本体的内层由可酸溶材料制成。
  10. 根据权利要求9所述的球囊，其特征在于，所述球囊本体的外层由至少两种可降解材料混合的材料制成。
  11. 根据权利要求7或8所述的球囊，其特征在于，所述阀主体为单向阀，包括弹簧和阀门，所述弹簧的一端连接所述连接本体的远端端部，所述弹簧的另一端连接所述阀门，所述弹簧用以通过弹力控制所述阀门的开启和关闭；所述连接本体还具有至少一通道，用于在所述阀门开启时，连通所述球囊本体和所述内导管。
  12. 根据权利要求11所述的球囊，其特征在于，所述阀门上具有卡合结构，用于连接所述内导管。
  13. 根据权利要求7或8所述的球囊，其特征在于，所述阀主体为自封阀，包括一阀门，所述阀门为具有自封闭特性的结构。
  14. 一种球囊装置，其特征在于，包括根据权利要求1-6中的任一项所述的球囊连接结构，以及根据权利要求7-13中的任一项所述的球囊，其中所述外导管的一端能够与所述连接本体的外部可拆卸连接，所述内导管的一端能够与所述阀主体或所述连接孔可拆卸连接；且所述内导管能够与所述球囊连通或断开。
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