WO2020238844A1 - 球囊组件 - Google Patents

球囊组件 Download PDF

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Publication number
WO2020238844A1
WO2020238844A1 PCT/CN2020/092059 CN2020092059W WO2020238844A1 WO 2020238844 A1 WO2020238844 A1 WO 2020238844A1 CN 2020092059 W CN2020092059 W CN 2020092059W WO 2020238844 A1 WO2020238844 A1 WO 2020238844A1
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WO
WIPO (PCT)
Prior art keywords
balloon
sealing
interface
catheter
sealing film
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PCT/CN2020/092059
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English (en)
French (fr)
Inventor
岳斌
季晓飞
刘琛
姚映忠
Original Assignee
上海竞捷医疗科技有限公司
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Application filed by 上海竞捷医疗科技有限公司 filed Critical 上海竞捷医疗科技有限公司
Publication of WO2020238844A1 publication Critical patent/WO2020238844A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/562—Implants for placement in joint gaps without restricting joint motion, e.g. to reduce arthritic pain

Definitions

  • This application relates to the field of medical devices, and in particular to a balloon assembly.
  • the joint capsule is a kind of connective tissue, which is distributed in the joint cavity, which can firmly connect the two adjacent bones, and at the same time play a lubricating effect, reducing the wear and tear of the joint movement.
  • Injury to the joint will weaken or even lose the support for bones and the transmission of joint motion.
  • the injury of the rotator cuff will weaken or even lose the function of maintaining the fulcrum of the humeral head and glenoid, seriously affecting the normal function of the shoulder joint.
  • the main function of the joint balloon is to be implanted in the joint cavity to support and lubricate. By replacing the damaged joint capsule or providing temporary support, it can ensure smooth and frictionless movement between the bones, thereby helping the organism to restore the joints. Characteristics.
  • the implantable balloon is folded in the puncture cannula and positioned and released under the direct vision of the arthroscopy.
  • the balloon is filled by injecting physiological saline through the catheter, and then the catheter is separated from the balloon and then withdrawn. seal. Therefore, the design of the catheter needs to ensure that the balloon can be disconnected in time after the balloon is filled and that the balloon does not leak after the catheter is withdrawn.
  • the plug is usually inserted into the opening of the balloon body with external force after the catheter is withdrawn to realize the sealing of the implantable balloon.
  • Implantable balloons have been widely used to achieve specific medical purposes due to their small initial volume, small trauma to patients caused by surgical operations and quick recovery.
  • a common sealing method is used, on the one hand, the withdrawal of the catheter and the sealing of the balloon cannot be carried out at the same time, which is likely to cause leakage of the filling liquid; on the other hand, when the plug is used for sealing, the plug at the seal is sealed Not strong enough, it is easy to loosen under the action of external force, and more importantly, it is easy to cause the plug to wear when it is inserted into the balloon opening. If debris enters the body, such as blood vessels, it will bring more health Hidden dangers.
  • a balloon assembly is provided for the problems of balloon sealing and catheter withdrawal.
  • a balloon assembly comprising: a balloon body, the balloon body is provided with a balloon body opening; a balloon interface, the balloon interface is provided at the opening of the balloon body for the passage of fillers And enters the inner cavity of the balloon body; a sealing body, the sealing body is arranged at the opening of the balloon body and/or the balloon interface, the sealing body includes preventing the filling from passing
  • the balloon interface is a sealing membrane flowing out of the balloon body; an outer catheter, the outer catheter is detachably connected to the balloon interface, and the filler can enter the balloon through the outer catheter The inner cavity of the body.
  • the balloon assembly further includes an inner catheter, the inner catheter passes through the outer catheter, a gap for the filler to pass is formed between the inner catheter and the outer catheter, and the inner catheter One end of the catheter extends into the balloon interface and is connected to an inflatable inner balloon; the sealing film covers at least part of the surface of the inner balloon, and the inner balloon is under the action of the fluid flowing in the inner catheter Filling and expanding and pressing the sealing membrane to engage with the inner wall of the balloon body and/or the inner wall of the balloon interface, thereby sealing the inner cavity of the balloon.
  • the sealing film and the covered area of the inner capsule have a U-shaped profile in a longitudinal section along the axial direction of the inner catheter.
  • the balloon assembly is simple in structure and safe in operation, and can realize the sealing of the balloon when the catheter is withdrawn after the balloon is filled.
  • the sealing body is arranged in the inner cavity of the balloon body, and at least a part of the edge of the sealing body is engaged with the inner wall of the balloon body; the sealing body has an open position and a closed position.
  • the sealing body When the filler is filled into the inner cavity of the balloon body, the sealing body is in an open position; when the filler is filled with the balloon body, the sealing body is in a closed position.
  • the sealing body When the balloon body is filled, the sealing body can be pushed away under the action of external force to be in an open position, thereby opening the balloon body opening, so that the filler can smoothly enter the balloon body. With the continuous increase of the filling material in the balloon body, the internal pressure gradually increases. At the same time, after the external force acting on the sealing body is withdrawn, the sealing body will be in a closed position under the pressure inside the balloon body, passing The sealing film is joined with the inner wall of the balloon body to seal the opening of the balloon body, thereby realizing the sealing of the opening of the balloon body.
  • the balloon sealing operation under this scheme is simpler, and the filling and sealing can be realized simultaneously.
  • the balloon body and the sealing body can be integrated into an integrated structure, and the structure is simple, which can effectively reduce the manufacturing cost.
  • the balloon assembly is simple in structure and safe in operation, and can realize the sealing of the balloon when the catheter is withdrawn after the balloon is filled.
  • the outer tube is adapted to abut against the sealing body so that the sealing body is in an open position.
  • the balloon assembly further includes an inner tube sheathed in the outer tube, a space for the filler to pass is formed between the inner tube and the outer tube, and one end of the inner tube is suitable for It extends into the balloon interface to abut the sealing body, so that the sealing body is in an open position.
  • the sealing body is arranged in the balloon body;
  • the balloon assembly further includes an auxiliary tube detachably connected with the sealing body, the auxiliary tube is sleeved in the outer catheter, and the A space for the filler to pass is formed between the auxiliary tube and the outer catheter, and the auxiliary tube is used to preset the sealing body at the opening of the balloon body.
  • the outer periphery of the sealing film is suitable for sealing engagement with the inner wall of the balloon body and/or the inner wall of the balloon interface, and the sealing film includes an incision penetrating the sealing film.
  • the sealing membrane in this solution is preset in the balloon interface, and can be integrated with the balloon interface to seal the balloon body. It includes an incision that penetrates the sealing membrane and can communicate with the balloon body. With the characteristics of the sealing film's own material, the cuts can be tightly bonded together without external force.
  • the sealing film includes a cross-shaped incision.
  • the opposite edges of the incision respectively include lips, and the lips are closed simultaneously when the incision is closed.
  • each of the lips respectively extends from the sealing film toward the inner cavity of the balloon body.
  • the outer catheter includes a needle-shaped head that can pass through the incision into the inner cavity of the balloon body for injecting the filler into the balloon body In the lumen.
  • the sealing film is made of elastic material.
  • the needle-shaped head of the outer catheter can be inserted into the inner cavity of the balloon body through the incision to inject the filler. After the filling is completed, the outer catheter is withdrawn. Due to the characteristics of its own material, the sealing film The pressure of the biological tissue fluid on the periphery of the balloon interface enables the incisions on the sealing membrane to be tightly combined, thereby sealing the balloon body.
  • the sealing membrane In the balloon assembly of this scheme, by pouring the sealing membrane in the balloon interface, the sealing membrane itself forms a sealed body. There is no special requirement for the internal structure of the balloon body, so it is easier to process and manufacture in production, and the cost is lower.
  • the balloon body can be sealed while meeting the withdrawal of the outer catheter, thus having a wider market effect.
  • constituent materials of the balloon body, the balloon interface and/or the sealing film include polyamide, polyester, polyurethane, polyamide polyether block copolymer, polyethylene, polypropylene, polyamide Imine, cross-linked polyethylene, cross-linked polyurethane, ionomer, PCL (polycaprolactone), PLA (polylactic acid), PLGA (polylactic acid-glycolic acid copolymer), PLCL (lactide-caprolactone) Copolymers), plastic starch materials, polyionic composites or copolymerized or blended materials of multiple materials.
  • the role of the implantable balloon is to support and replace the organs in the body, such as the joint capsule, a material with biocompatibility is preferred. If the role of the implantable balloon is to provide short-term support in the recovery of the body, such as the healing period after a muscle tear at the joint, it is preferably a biodegradable material. This type of implantable balloon will follow The recovery of the organism is gradually absorbed by the organism.
  • the sealing film is an adhesive sealing film.
  • connection between the outer catheter and the balloon interface includes, but is not limited to, an interference connection, a threaded connection, or a snap connection.
  • the outer wall of the outer catheter has a protrusion
  • the inner wall of the balloon interface has When the outer catheter is extended into the balloon interface with the matching recess, the protrusions and depressions can cooperate to clamp the outer catheter on the balloon interface.
  • the function of the outer catheter is to fill the balloon body with the filler. Therefore, the connection between the outer catheter and the balloon interface should be tight to ensure that no leakage occurs during the filling process.
  • a balloon assembly comprising: a balloon body, the balloon body is provided with a balloon body opening; a balloon interface, the balloon interface is provided at the opening of the balloon body for the passage of fillers And enters the inner cavity of the balloon body; a sealing body, the sealing body is arranged at the opening of the balloon body and/or the balloon interface, the sealing body includes a body suitable for and the ball
  • the sealing film joined with the inner wall of the balloon body and/or the inner wall of the balloon interface enables the sealing body to prevent the filler from flowing out of the balloon body through the balloon interface.
  • the outer edge of the sealing film is in sealing engagement with the inner wall of the balloon interface; or, the sealing body is arranged in the inner cavity of the balloon body, and at least part of the edge of the sealing body is connected to the inner wall of the balloon interface.
  • the inner wall of the balloon body is joined; the sealing body has an open position and a closed position.
  • the sealing body When the filling is filled into the inner cavity of the balloon body, the sealing body is in the open position; when the filling is completed When the balloon body is filled, the sealing body is in the closed position; all or part of the contact surface of the sealing body and the balloon body is covered by the sealing film; or, the outer periphery of the sealing film is The inner wall of the balloon body and/or the inner wall of the balloon interface are sealingly joined, and the sealing film includes an incision penetrating the sealing film.
  • FIG. 1 is a schematic cross-sectional view of a balloon assembly provided in Example 1 of the application in a first state;
  • Example 2 is a schematic cross-sectional view of the balloon assembly provided in Example 1 of the application in a second state;
  • Example 3 is a schematic cross-sectional view of the balloon assembly provided in Example 1 of the application in a third state;
  • Example 4 is a schematic cross-sectional view of the balloon assembly provided in Example 2 of the application in the first state;
  • Example 5 is a schematic cross-sectional view of the balloon assembly provided in Example 2 of the application in the second state;
  • Example 6 is a schematic cross-sectional view of the balloon assembly provided in Example 3 of the application in the first state;
  • FIG. 7 is a schematic cross-sectional view of the balloon assembly provided in Embodiment 4 of the application in the first state;
  • FIG. 8 is a schematic cross-sectional view of the sealing film provided in Embodiment 5 of the application.
  • FIG. 9 is a side view of the sealing film provided in Embodiment 5 of the application.
  • Example 10 is a schematic cross-sectional view of the balloon assembly provided in Example 5 of this application.
  • Example 11 is a schematic cross-sectional view of the sealing film provided in Example 6 of this application.
  • the first state mentioned in this application refers to the state before the balloon filling starts.
  • the outer catheter 4 and the balloon interface 2 are detachably connected, the inner catheter 6 is inserted into the outer catheter 4, and an annular gap is formed between the inner catheter 6 and the outer catheter 4 for the filler to pass through.
  • the inner balloon 5 is connected to one end of the inner catheter 6 extending into the balloon interface 2, and the inner balloon 5 is generally disposed in the balloon interface 2.
  • the filler can enter the inner cavity of the balloon body 1 through the aforementioned annular gap and the gap between the inner balloon 5 and the balloon interface 2.
  • the inner tube 6 is a hollow tube and communicates with the inner balloon 5. Fluid (such as gas, liquid, etc.) can enter the inner balloon 5 or flow out from the inner balloon 5 through the inner tube 6, so that the inner balloon 5 is expanded or returned. Shrink.
  • the sealing film 3 itself can form the entire sealing body, and the sealing film 3 covers at least part of the surface of the inner bag 5.
  • the sealing film 3 is used to engage with the inner wall of the balloon body 1 and/or the inner wall of the balloon interface 2, so that the sealing body can prevent the filler from flowing out of the inner cavity of the balloon body 1 through the balloon interface 2.
  • the sealing body may include a sealing film 3 and other elements that are joined to the sealing film 3 and can be adhered to the inner bag 5.
  • the filler is filled into the inner cavity of the balloon body 1 through the annular gap between the inner catheter 6 and the outer catheter 4.
  • the inner balloon 5 is inflated under the action of the fluid flowing in the inner catheter 6 and presses the sealing membrane 3 on its surface to gradually close and join the inner wall of the balloon interface 2 and/or the ball On the inner wall of the capsule body 1.
  • the outer edge of the sealing membrane 3 is in sealing engagement with the inner wall of the balloon interface 2, thereby sealing the inner cavity of the balloon body 1, so that the filler injected into the inner cavity of the balloon body 1 will not pass through the balloon interface 2 Leaked.
  • the outer edge of the sealing film 3 and the inner wall of the balloon body 1 are sealingly combined.
  • the sealing film 3 and the inner capsule 5 are used in combination.
  • the sealing film 3 and the area of the inner capsule 5 covered by the sealing film 3 have a U-shaped profile in the longitudinal section along the axial direction of the inner catheter 6
  • this is not the entire combination of the sealing film 3 and the inner capsule 5, and other combinations are allowed as long as the above-mentioned sealing structure can be achieved.
  • the fluid in the inner catheter 6 is drawn back, the inner bladder 5 can retract and release the sealing film 3 due to its own elasticity, and the sealing film 3 can maintain a tight fit with the inner wall of the balloon interface 2 due to its material properties Status, as shown in Figure 3.
  • the outer catheter 4 is removed, and the body can be withdrawn together with the inner catheter 6 and the inner capsule 5 connected to it.
  • the balloon assembly is used in a complete set, wherein the sealing assembly is pre-set in the balloon interface 2 in advance, and after the balloon body 1 is filled, pressure is applied to the sealing membrane 3, and the sealing membrane 3 is pressed together Or it can be glued to the inner wall of the balloon interface 2, which is easy to operate. After sealing, the sealing membrane 3 can remain stable under internal and external pressures. At the same time, there will be no wear and tear during the entire sealing process, and it will not bring other hidden dangers to the biological body. Have better application prospects.
  • Figure 4 shows a schematic cross-sectional view of the balloon assembly provided in Example 2 of the present application in the first state, including a balloon body 7 and a balloon interface 8 connected to the balloon body 7, and the sealing body 9 is located in the balloon In the inner cavity of the body 7, at least part of the edge of the sealing body 9 is engaged with the inner wall of the balloon body.
  • the sealing body 9 can be integrally formed with the balloon body 7.
  • the sealing body 9 extends from the inner wall of the balloon body 7, and at least part of the edge of the sealing body 9 is not connected to the inner wall of the balloon body 7.
  • the sealing body 9 covers the opening of the balloon body 7, and the sealing body 9 has an open position and a closed position.
  • the outer catheter 10 abuts against the sealing body 9, and the sealing body 9 is pushed away under the action of the outer catheter 10 to be in an open position, so that the filler can enter the inner cavity of the balloon body 7.
  • the material of the sealing body 9 may be different from the material of the balloon body 7, and the two may not be integrally formed, but may be bonded together by bonding, welding or other methods.
  • the rigidity of the sealing body 9 is greater than the rigidity of the balloon body 7, so the sealing body 9 is easier to detach from the inner surface of the balloon body 7 under the action of the outer catheter 10, so that the filler can enter the balloon body 7.
  • Figure 5 shows a schematic diagram of the balloon assembly of Embodiment 2 in the second state, that is, the sealed state diagram of the balloon assembly after the filling is completed.
  • the sealing body 9 is gradually covered by the increasing amount of filling in the balloon body 7 Extrusion fits on the inner wall of the balloon body 7. Since the surface area of the sealing body 9 is larger than the opening area of the balloon body 7, it can completely cover the opening of the balloon body 7, and the outer catheter 10 is gradually withdrawn after the filling is completed. , The sealing body 9 can automatically fit the inner wall of the balloon body 7 under the action of the internal pressure of the balloon body 7, so that the sealing body 9 is in the closed position, so that the retraction of the outer catheter 10 and the sealing of the balloon body 7 can be synchronized get on.
  • the outer catheter 10 may have another alternative, including a sleeved outer catheter 10 and The inner tube 11, one end of the outer tube 10 is detachably connected to the balloon interface 8; the inner tube 11 passes through the outer tube 10 and forms a ring allowing the filler to pass through with the outer tube 10 ⁇ gap.
  • the inner tube 11 can move axially relative to the outer tube 10.
  • the outer catheter 10 is connected to the balloon interface 8, but there is no need to require the outer catheter 10 to act on the sealing body 9 to open the balloon body 7.
  • one end of the inner tube 11 When filling, one end of the inner tube 11 is extended into the balloon interface And push the balloon body 7 along the axial direction, and press one end of the inner tube 11 against the sealing body 9, thereby pressing the sealing body 9 in the balloon body 7 to open; and after the filling is completed, the inner tube 11 and the outer catheter 10 are together Withdrawal, the sealing body 9 is automatically attached to the inner surface of the balloon body 7 under the pressure of the balloon body 7, and the balloon body 7 and/or the balloon interface 8 can be sealed.
  • FIG. 7 shows a schematic cross-sectional view of the balloon assembly provided in Example 4 of the present application in the first state.
  • the sealing assembly includes a sealing body 9 built in the balloon body 7 and detachably connected to the sealing body 9
  • the auxiliary tube 11 is inserted through the outer tube 10, and a space for the filler to pass is formed between the auxiliary tube 11 and the outer tube 10.
  • the auxiliary tube 11 can position and cover the sealing body 9 on the balloon interface 8.
  • the auxiliary tube 11 can move axially relative to the outer tube 10, and the sealing body 9 may have a protrusion for connecting with the auxiliary tube 11.
  • the auxiliary tube 11 is connected to the sealing body 9 in advance, and then the outer catheter 10 is connected to the balloon interface 8.
  • the auxiliary tube 11 is pushed to push the sealing body 9 to open the cavity of the balloon body 7, and the balloon body 7 is filled through the annular gap between the outer catheter 10 and the auxiliary tube 11.
  • the sealing body 9 is attached to the opening of the balloon body 7 under the pressure inside the balloon body 7.
  • the outer catheter 10 and the auxiliary tube 11 are removed and the birth is removed, and the balloon body 7 can be sealed at the same time.
  • the surface of the sealing body 9 in contact with the balloon body 7 may be completely or partially covered by a sealing film, which at least completely covers the surface of the balloon body 7
  • the opening or the sealing film completely surrounds the opening of the balloon body 7 to prevent the filler from leaking from the inner cavity of the balloon body 7.
  • the sealing body 9 is pre-arranged in the balloon body 7, and the sealing is completed by the pressure in the balloon body 7 and/or the material characteristics of the sealing body 9.
  • An outer catheter 10 is arranged outside the balloon for filling, and the outer catheter 10 can be sealed at the same time as the outer catheter 10 is retracted.
  • the structure is simple and the manufacturing cost is low, which can well improve the requirement of simultaneous sealing and withdrawal of this type of product.
  • the sealing film 14 is located at the balloon interface 13, the outer periphery of the sealing film 14 is suitable for sealing engagement with the inner wall of the balloon interface 13 and/or the inner wall of the balloon body.
  • the sealing film 14 is provided with an incision 15.
  • the sealing film 14 has a certain thickness, the sealing film 14 itself can form the entire sealing body, and the cut 15 penetrates the entire sealing film 14 in the thickness direction of the sealing film 14 to communicate with the inner cavity of the balloon body 12.
  • the incision 15 is a cross-shaped incision.
  • the sealing film 14 is preferably made of an elastic material or any material suitable for sealing.
  • the incision 15 can be closed or glued together at the incision when there is no external force, so that the balloon body 12 can be bonded together. Seal. It should be noted that, in other embodiments, the sealing body may include the sealing film 14 and other elements joined to the sealing film 14.
  • FIG. 10 shows a balloon assembly provided in Example 5 of the present application.
  • the outer catheter 16 is detachably connected to the balloon interface 13. Further, one end of the outer catheter 16 has a needle-shaped head 17 that can pass through The cross-shaped incision 15 extends into the balloon body 12 to fill it. After the filling is completed, the outer catheter 16 is withdrawn. The cross-shaped incision 15 can be attached together to seal the balloon body 12, as shown in Fig. 8 , As shown in Figure 9.
  • FIG. 11 shows a cross-sectional view of the sealing film provided in Example 6 of the present application.
  • the incision 15 of the sealing film 14 is a straight incision, and the opposite edges of the incision 15 respectively include lips 151.
  • the upper and lower lips 151 fit, so as to better realize the alignment.
  • the balloon body 12 is sealed.
  • Each lip portion 151 respectively extends from the sealing film 14 toward the inner cavity of the balloon body 7.
  • the shape of the incision 15 on the sealing film 14 in Examples 5 and 6 of the present application is preferably a linear shape, but other shapes of incision 15 are also applicable, such as a curved shape, a broken line shape, etc., as long as the The sealing film 14 can seal the balloon body 12 under the action of external force.
  • the sealing film 14 can be directly poured into the cavity of the balloon interface 13 and sealed, and an incision 15 penetrating the sealing film 14 is provided on the sealing film 14 .
  • the outer tube 16 matched with the sealing assembly is used for filling, and the outer tube 16 can be withdrawn after the filling is completed. Therefore, this kind of sealing structure is simple, easy to process and manufacture, and market applications will be more common.
  • the constituent materials of the balloon body, balloon interface, sealing body and/or sealing film listed in the above embodiments include but are not limited to polyamide, polyester, polyurethane, polyamide polyether block copolymer, polyethylene, polypropylene , Polyimide, cross-linked polyethylene, cross-linked polyurethane, ionomer, PCL (polycaprolactone), PLA (polylactic acid), PLGA (polylactic acid-glycolic acid copolymer), PLCL (lactide- Caprolactone copolymers), plastic starch materials, polyionic complexes, or copolymerized or blended materials of multiple materials.
  • the sealing film can be attached to the balloon interface or the inner wall of the balloon body to achieve sealing by means of biological binding force, such as hydrogen bonding, electrostatic attraction, van der Waals attraction, and hydrophobic force.
  • the material of the sealing film is preferably PLCL (lactide-caprolactone copolymer), PLA (polylactic acid), plastic starch material, polyion composite and the like.
  • the aforementioned materials refer to biocompatible or biodegradable materials.
  • the materials of each component can be optimized according to the application environment of the implantable balloon. For example, the implantable balloon needs to replace the organs in the body. It is preferable to use biocompatible materials. If the implantable balloon To provide an auxiliary effect in the recovery period after the organism is injured, it is preferable to use biodegradable materials.
  • the constituent materials of the sealing film also include a viscous sealing film, including but not limited to adding a viscous spray coating on the surface thereof to make the adhesion of the sealing film stronger.
  • the balloon body and the balloon interface can be integrally formed, or can be separately processed and connected together.
  • the connection methods include but are not limited to bonding.
  • the mating connection between the outer catheter and the balloon interface should be tight and leak-free.
  • the outer catheter can be detached from the balloon interface after the filling is completed. Therefore, the mating connection is a detachable tight connection, including but not limited to Clip connection, threaded connection, interference fit, etc.
  • the balloon assembly provided in the present application can be used to manufacture rotator cuff balloons, but can also be manufactured into other types of balloons, such as gastric balloons, according to different applicable parts or diseases.
  • the balloon assembly provided by the present application can simultaneously achieve the sealing of the balloon and the withdrawal of the catheter.
  • the sealing body can maintain a balance under the pressure inside and outside the balloon, and at the same time, no debris will be left during the sealing process, so that the entire
  • the sealing process is simple in operation and high in safety, effectively prolonging the service life of the implantable balloon.

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Abstract

本申请涉及一种球囊组件，包括球囊本体，所述球囊本体上设有球囊本体开口；球囊接口，所述球囊接口设置在所述球囊本体开口处，用以供填充物通过并进入到所述球囊本体的内腔中；密封体，所述密封体设置在所述球囊本体开口处和/或所述球囊接口处，所述密封体包括阻止所述填充物通过所述球囊接口从所述球囊本体中流出的密封膜；外导管，所述外导管与所述球囊接口可拆卸地连接，所述填充物能够通过所述外导管进入所述球囊本体的内腔。本申请能够同时实现球囊的密封和导管的回撤，密封体在球囊内外的压力下可以保持平衡，同时在密封的过程中不易留下残损物，使得整个密封过程操作简洁，安全性高，有效地延长了植入式球囊的使用寿命。

Description

球囊组件 技术领域
本申请涉及医疗器械领域，特别是涉及一种球囊组件。
背景技术
关节连接处附着大量的肌腱组织以及软骨组织，这些组织能够起到支撑关节，维持关节稳定性的作用，此外，这些组织对于关节的运动同样至关重要。关节囊是一种结缔组织，分布在关节腔体之中，能够将相邻的两个骨骼牢固的联系起来，同时起到润滑作用，减少关节运动时的摩损。关节处的损伤将减弱甚至丧失对骨骼的支撑作用和对关节运动的传递作用，例如，肩袖的损伤将减弱甚至丧失维持肱骨头与关节盂的支点功能，严重影响肩关节的正常功能。关节球囊的主要作用是植入在关节腔体中起到支撑和润滑作用，通过替代损伤的关节囊或者提供暂时性支撑，保证骨骼间的平滑和无摩擦运动，从而帮助生物体恢复关节处的特性。
植入式球囊通过折叠在穿刺套管内，在关节镜的直视下定位释放后，通过导管注入如生理盐水使球囊充盈，再将导管与球囊分离后撤出，同时对球囊进行密封。因此，导管的设计需要保证球囊充盈后能够及时断开连接并且在导管撤回后保证球囊不发生泄露。有关技术中为了解决以上问题，通常采用撤回导管后用外力将塞子塞入球囊本体开口处以实现对植入式球囊的密封。
植入式球囊由于初始体积小，手术操作导致的患者创伤小并且恢复快，开始被广泛应用以实现特定的医疗目的。然而，采用常见的密封方式时，一方面导管的撤回与球囊的密封不能够同时进行，容易造成填充液的泄漏；另一方面，当用塞子塞入的方式密封时，封口处的塞子密封不够牢固，外力作用下很容易松动，更重要的是，在将塞子塞入球囊开口处时容易造成塞子磨损，如有残损物进入生物体内，如血管中，将会带来更多的健康隐患。
发明内容
基于此，针对球囊的密封及导管回撤问题，提供一种球囊组件。
一种球囊组件，包括：球囊本体，所述球囊本体上设有球囊本体开口；球囊接口，所述球囊接口设置在所述球囊本体开口处，用以供填充物通过并进入到所述球囊本体的内腔中；密封体，所述密封体设置在所述球囊本体开口处和/或所述球囊接口处，所述密封体包括阻止所述 填充物通过所述球囊接口从所述球囊本体中流出的密封膜；外导管，所述外导管与所述球囊接口可拆卸地连接，所述填充物能够通过所述外导管进入所述球囊本体的内腔。
进一步地，所述球囊组件还包括内导管，所述内导管穿设在所述外导管中，所述内导管与所述外导管之间形成使所述填充物通过的间隙，所述内导管的一端伸入所述球囊接口中并连接可膨胀的内囊；所述密封膜覆盖于所述内囊的至少部分表面，所述内囊在所述内导管中流动的流体的作用下充盈膨胀并压迫所述密封膜与所述球囊本体的内壁和/或所述球囊接口的内壁接合，从而封闭所述球囊的内腔。
优选地，所述密封膜及覆盖的所述内囊的区域在沿所述内导管轴向方向上的纵向截面上的轮廓呈U形形状。
在对所述球囊本体充盈结束后通过内导管向内囊注入气体、液体或者其他物质，随着内囊的膨胀扩大从而使其表面包裹的密封膜逐渐贴近并紧密结合在球囊接口的内壁表面上，最终实现对球囊本体的密封。该球囊组件结构简单且操作安全，在球囊充盈结束撤回导管的同时能够实现对球囊的密封。
进一步地，所述密封体设置在所述球囊本体的内腔中，所述密封体的至少部分边缘与所述球囊本体的内壁接合；所述密封体具有打开位置和封闭位置，当所述填充物往所述球囊本体的内腔填充时，所述密封体处于打开位置；当所述填充物完成对所述球囊本体的填充时，所述密封体处于封闭位置。
在对球囊本体进行充盈时，所述密封体能够在外力的作用下被推开而处于打开位置，从而打开所述球囊本体开口，因此填充物能够顺利进入到球囊本体之中。随着球囊本体内填充物的不断增多，其内部压力逐渐增大，同时，在撤出作用在密封体上的外力后，密封体将在球囊本体内部的压力作用下处于封闭位置，通过密封膜与球囊本体内壁的接合来封死球囊本体开口，从而实现其对球囊本体开口的密封。该方案下的球囊密封操作更为简单，可以实现填充和密封的同步进行，同时球囊本体及密封体可以成一体式结构，结构简单，能够有效地降低制造成本。该球囊组件结构简单且操作安全，在球囊充盈结束撤回导管的同时能够实现对球囊的密封。
进一步地，所述外导管适于抵靠所述密封体，使所述密封体处于打开位置。
进一步地，所述球囊组件还包括套设在所述外导管中的内管，所述内管与所述外导管之间形成使所述填充物通过的空间，所述内管的一端适于伸入所述球囊接口中以抵靠所述密封体，以使所述密封体处于打开位置。
进一步地，所述密封体设置在所述球囊本体内；所述球囊组件还包括与所述密封体可拆卸 连接的辅助管，所述辅助管套设在所述外导管中，所述辅助管与所述外导管之间形成供所述填充物通过的空间，所述辅助管用以将所述密封体预定位于所述球囊本体开口处。
进一步地，所述辅助管相对所述外导管轴向可移动地套设在所述外导管中；和/或，所述密封体具有用于和所述辅助管连接的突出部。
进一步地，所述密封体与所述球囊本体接触的表面的全部或部分由所述密封膜覆盖。
进一步地，所述密封膜的外周适于与所述球囊本体的内壁和/或所述球囊接口的内壁密封接合，所述密封膜上包括贯穿所述密封膜的切口。该方案中的密封膜预设在球囊接口中，与球囊接口可以成一体式结构，从而对球囊本体进行密封，其上包括有贯穿密封膜的切口，可以与球囊本体相通，由于密封膜自身材料的特性，在无外力作用下，切口可以紧密粘合在一起。
优选地，所述密封膜上包括十字形切口。
优选地，所述切口的相对的边缘上分别包括唇部，所述切口闭合时所述唇部同时闭合。
进一步地，各个所述唇部分别由所述密封膜朝向所述球囊本体的内腔方向延伸。
进一步地，所述外导管包括针状头部，所述针状头部可穿过所述切口至所述球囊本体的内腔中，用以将所述填充物注入到所述球囊本体的内腔中。
进一步地，所述密封膜由弹性材料制成。
所述外导管的针状头部可以通过所述切口伸入到球囊本体的内腔中从而注入填充物，在完成充盈后将外导管撤出，密封膜由于自身材料的特性，以及来自所述球囊接口外周生物体组织液的压力，使密封膜上的切口能够紧密的结合在一起，从而封堵住球囊本体。
该种方案的球囊组件，通过将密封膜浇筑在球囊接口中，密封膜本身即形成密封体，对于球囊本体的内部结构没有特殊要求，因此在生产中更易加工制造，成本较低，满足外导管回撤的同时能够实现对球囊本体进行密封，因而具有更广的市场效应。
进一步地，所述球囊本体、所述球囊接口和/或所述密封膜的构成材料包括聚酰胺、聚酯、聚氨酯、聚酰胺聚醚嵌段共聚物、聚乙烯、聚丙烯、聚酰亚胺、交联聚乙烯、交联聚氨酯、离聚物、PCL(聚已内酯)、PLA(聚乳酸)、PLGA(聚乳酸-羟基乙酸共聚物)、PLCL(丙交酯-己内酯共聚物)、可塑淀粉材料、聚离子复合物或以上材料中的多种材料的共聚或共混材料。
针对不同的应用环境，如果植入式球囊的作用是支撑并起到替代生物体内器官的作用，如关节囊，优选具有生物适合性的材质。如植入式球囊的作用是在机体恢复中做短暂的支撑作用，如关节处肌肉撕裂后的愈合期，则优选具有生物降解性材料，该种类型的植入式球囊会随着生物体的恢复逐步被机体吸收掉。
进一步地，所述密封膜为粘性密封膜。
进一步地，所述外导管与所述球囊接口之间的连接包括但不限于过盈连接、螺纹连接或卡接连接，如所述外导管外壁具有凸起部，所述球囊接口内壁具有与之配套的凹陷部，在将所述外导管伸入到所述球囊接口处时，该凸起和凹陷能够配合从而将所述外导管卡接在所述球囊接口上。外导管的作用是将填充物充盈到球囊本体之中，因此，外导管与球囊接口处的连接应该紧密，从而保证在填充的过程中不会发生泄漏。
一种球囊组件，包括：球囊本体，所述球囊本体上设有球囊本体开口；球囊接口，所述球囊接口设置在所述球囊本体开口处，用以供填充物通过并进入到所述球囊本体的内腔中；密封体，所述密封体设置在所述球囊本体开口处和/或所述球囊接口处，所述密封体包括适于和所述球囊本体的内壁和/或所述球囊接口的内壁接合的密封膜，使得所述密封体能够阻止所述填充物通过所述球囊接口从所述球囊本体中流出。
进一步地，所述密封膜的外缘与所述球囊接口的内壁密封接合；或者，所述密封体设置在所述球囊本体的内腔中，所述密封体的至少部分边缘与所述球囊本体的内壁接合；所述密封体具有打开位置和封闭位置，当所述填充物往所述球囊本体的内腔填充时，所述密封体处于打开位置；当所述填充物完成对所述球囊本体的填充时，所述密封体处于封闭位置；所述密封体与所述球囊本体接触的表面的全部或部分由所述密封膜覆盖；或者，所述密封膜的外周与所述球囊本体的内壁和/或所述球囊接口的内壁密封接合，所述密封膜上包括贯穿所述密封膜的切口。
附图说明
图1为本申请实施例1提供的球囊组件在第一状态下的剖面示意图；
图2为本申请实施例1提供的球囊组件在第二状态下的剖面示意图；
图3为本申请实施例1提供的球囊组件在第三状态下的剖面示意图；
图4为本申请实施例2提供的球囊组件在第一状态下的剖面示意图；
图5为本申请实施例2提供的球囊组件在第二状态下的剖面示意图；
图6为本申请实施例3提供的球囊组件第一状态下的剖面示意图；
图7为本申请实施例4提供的球囊组件第一状态下的剖面示意图；
图8为本申请实施例5提供的密封膜的剖面示意图；
图9为本申请实施例5提供的密封膜的侧视图；
图10为本申请实施例5提供的球囊组件的剖面示意图；
图11为本申请实施例6提供的密封膜的剖面示意图。
具体实施方式
下面将结合附图对本申请实施例中的技术方案做进一步清楚、完整的描述，但需要说明的是，以下实施例仅是本申请中的部分优选实施例，并不涉及本申请技术方案所涵盖的全部实施例。
如无特殊说明，本申请所述的第一状态均指球囊填充开始前的状态。
附图1-3显示的是本申请实施例1提供的球囊组件在不同工作状态下的示意图。如图1所示的球囊组件在第一状态下的剖面示意图，球囊组件包括球囊、密封体、外导管4、内导管6和可膨胀的内囊5。球囊包括一个球囊本体1和设置于球囊本体1开口处的一个球囊接口2，球囊接口2用于供填充物通过并进入到球囊本体1的内腔中。密封体包括密封膜3，密封体、内囊5和内导管6等用于密封球囊的组件可以统称为密封组件。密封组件设置在球囊本体1开口处和/或球囊接口2处。具体地，外导管4与球囊接口2可拆卸的连接，内导管6穿设在外导管4之中，在内导管6和外导管4之间形成一个使填充物通过的环状间隙。内囊5连接在内导管6伸入球囊接口2的一端，内囊5大体设置在球囊接口2之中。填充物能够通过上述环状间隙和内囊5与球囊接口2之间的空隙进入到球囊本体1的内腔之中。本实施例中，内导管6是中空管并与内囊5相通，流体(例如气体、液体等)可经过内导管6进入内囊5或者从内囊5流出，使得内囊5膨胀或者回缩。本实施例中，密封膜3自身即可以形成密封体整体，密封膜3覆盖在内囊5的至少部分表面上。密封膜3用于和球囊本体1的内壁和/或球囊接口2的内壁接合，从而使密封体能够阻止填充物通过球囊接口2从球囊本体1的内腔中流出。需要说明的是，在其他实施例中，密封体可以包括密封膜3以及其他与密封膜3接合并可以粘附在内囊5上的元件。
具体如图2所示，填充物通过内导管6和外导管4之间的环状间隙填充入球囊本体1的内腔中。在球囊本体1填充完毕后，内囊5在内导管6中流动的流体的作用下进行充盈膨胀并压迫其表面的密封膜3逐步贴紧并接合在球囊接口2的内壁和/或球囊本体1的内壁上。本实施例中，密封膜3的外缘与球囊接口2的内壁密封接合，从而封闭住球囊本体1的内腔，使注入球囊本体1内腔中的填充物不会通过球囊接口2泄露。其它实施例中，密封膜3的外缘与球囊本体1的内壁密封结合。其中，密封膜3与内囊5为组合使用，优选地，密封膜3及被密封膜3覆盖的内囊5的区域在沿内导管6的轴向方向的纵向截面上的轮廓呈U形形状，但这并不是 密封膜3和内囊5结合的全部样式，其他形式的组合只要能够实现以上密封的结构都是被允许的。
进一步地，回抽内导管6中的流体，内囊5由于自身的弹性能够回缩并释放密封膜3，密封膜3由于自身的材料特性而能够保持与球囊接口2的内壁紧密贴合的状态，具体如图3所示。之后卸下外导管4，连同内导管6及连接在其上的内囊5一起撤出生物体即可。
采用实施例1提供的技术方案，球囊组件成套使用，其中密封组件提前预置在球囊接口2内，完成对球囊本体1的充盈后对密封膜3施加压力，将密封膜3压合或者粘合在球囊接口2的内壁上，操作简单，密封后密封膜3在内外压力下能够保持稳定，同时整个密封过程中不会产生任何磨损，不会对生物机体带来其他隐患，因此具有更好的应用前景。
图4所示的是本申请实施例2提供的球囊组件在第一状态下的剖面示意图，包括一个球囊本体7及与球囊本体7连接的球囊接口8，密封体9位于球囊本体7的内腔中，密封体9的至少部分边缘与球囊本体的内壁接合。如图4所示，密封体9可以与球囊本体7一体成型，密封体9从球囊本体7的内壁延伸而出，密封体9的至少部分边缘未连接到球囊本体7的内壁上。密封体9覆盖在球囊本体7开口处，且密封体9具有打开位置和封闭位置。如图4所示，外导管10抵靠所述密封体9，在外导管10作用下密封体9被推开而处于打开位置，从而使填充物能够进入到球囊本体7的内腔中。
在其他实施例中，密封体9的材料可以与球囊本体7的材料不同，二者可以不是一体成型，而是采用粘合、焊接或其他方式结合在一起。密封体9的刚性大于球囊本体7的刚性，因此该密封体9更容易在外导管10作用下脱离球囊本体7的内表面，从而使填充物能够进入到球囊本体7中。
图5所示的是实施例2的球囊组件在第二状态下的示意图，即在填充完成后球囊组件的密封状态图，此时密封体9因球囊本体7内部填充物逐渐增多被挤压贴合在球囊本体7的内壁上，由于密封体9的表面积大于球囊本体7开口的面积，因此能够完全覆盖住球囊本体7的开口，在填充完毕后逐步撤出外导管10，密封体9能够在球囊本体7内部压力的作用下自动贴合球囊本体7的内壁，从而使得密封体9处于封闭位置，使得外导管10的回撤和球囊本体7的密封能够同步进行。
进一步地，如图6所示的本申请实施例3提供的球囊组件在第一状态下的剖面示意图，所述外导管10还可以有另一种替代方案，包括套接的外导管10和内管11，所述外导管10的一端与所述球囊接口8可拆卸连接；所述内管11穿设于所述外导管10内并与外导管10之间形 成允许填充物通过的环状间隙。优选地，内管11可相对于外导管10做轴向移动。此时，所述外导管10与球囊接口8连接但无需要求外导管10作用在密封体9上以打开球囊本体7，在进行填充时，将内管11的一端伸入球囊接口中并沿轴向推向球囊本体7，通过内管11的一端抵靠密封体9，从而压迫球囊本体7内的密封体9打开；而在填充结束后将内管11和外导管10一起撤出，密封体9在球囊本体7内部压力作用下自动贴合球囊本体7的内表面，即可实现对球囊本体7和/或球囊接口8的密封。
图7所示的是本申请实施例4提供的球囊组件在第一状态下的剖面示意图，其中，密封组件包括内置在球囊本体7之中的密封体9和与密封体9可拆卸连接的辅助管11。辅助管11穿设在外导管10中，辅助管11与外导管10之间形成供填充物通过的空间。辅助管11能够将密封体9定位并覆盖在球囊接口8上。优选地，辅助管11可相对于外导管10做轴向移动，密封体9可以具有用于和辅助管11连接的突出部。填充开始前，将辅助管11预先连接在密封体9上，之后再将外导管10连接在球囊接口8上。填充开始时，推动辅助管11从而推动密封体9打开球囊本体7的腔体，通过外导管10和辅助管11之间的环状间隙实现对球囊本体7的填充。在填充完毕后，密封体9受到球囊本体7内部的压力贴合在其开口处，此时卸下外导管10和辅助管11并撤出生物体，能够同时实现球囊本体7的密封。
进一步地,实施例2、3和4中涉及的球囊组件，密封体9与球囊本体7相接触的表面可以完全或部分由密封膜覆盖,所述密封膜至少完全覆盖球囊本体7的开口，或所述密封膜完全包围球囊本体7的开口，以避免填充物从球囊本体7的内腔向外泄露。
实施例2、3和4中涉及的球囊组件，密封体9预先设置在球囊本体7之中，密封时依靠球囊本体7内的压力和/或密封体9的材料特性完成，通过在球囊外部设置一个外导管10进行充盈，回撤外导管10的同时即可实现密封，结构简单，制造成本较低，能够很好地改进该类产品的密封与回撤能够同步进行的需求。
图8、图9显示的是本申请实施例5提供的密封膜的剖面图及侧视图。如图8所示，密封膜14位于球囊接口13处，密封膜14的外周适于与球囊接口13的内壁和/或球囊本体的内壁密封接合，密封膜14上开设有切口15。在一种实施例中，密封膜14具有一定厚度，密封膜14自身即可以形成密封体整体，切口15沿密封膜14的厚度方向贯穿整个密封膜14从而与球囊本体12的内腔相通。如图9所示，切口15为十字形切口。密封膜14优选地由弹性材料或者任何适于密封的材料制成，由于密封膜14的材料特性，切口15在无外力作用时其切口处能够闭合或者粘合在一起，实现对球囊本体12的密封。需要说明的是，在其他实施例中，密封 体可以包括密封膜14以及其他与密封膜14接合的元件。
图10所示的是本申请实施例5提供的一种球囊组件，外导管16与球囊接口13可拆卸地连接，进一步地，外导管16的一端具有针状头部17，能够穿过十字形切口15伸入到球囊本体12之中对其进行充盈，在充盈完成后撤回外导管16，十字形切口15能够贴合在一起，从而对球囊本体12实现密封，具体如图8、图9所示。
图11显示的是本申请实施例6提供的密封膜的剖面图。在该实施例中，密封膜14的切口15为一字型切口，并且切口15的相对的边缘上分别包括唇部151，切口15闭合时上下唇部151贴合，从而能够更好地实现对球囊本体12的密封。各个唇部151分别由密封膜14朝向球囊本体7的内腔方向延伸。
需要说明的是，本申请实施例5、6中密封膜14上的切口15形状优选为直线形，但其他形状的切口15也是能够适用的，例如曲线形、折线形等，只要能够保证在无外力作用下密封膜14能够对球囊本体12实现密封即可。
实施例5、6提供的密封组件，在制作工艺中，密封膜14可以直接浇筑在球囊接口13的腔体中并对其进行密封，并在密封膜14上开设贯穿密封膜14的切口15。在填充时，采用与密封组件配套的外导管16进行填充，充盈完成后撤出外导管16即可，因此，该种密封结构简单，加工制造容易，市场应用将更为普遍。
以上实施例所列的球囊本体、球囊接口、密封体和/或密封膜的构成材料包括但不限于聚酰胺、聚酯、聚氨酯、聚酰胺聚醚嵌段共聚物、聚乙烯、聚丙烯、聚酰亚胺、交联聚乙烯、交联聚氨酯、离聚物、PCL(聚已内酯)、PLA(聚乳酸)、PLGA(聚乳酸-羟基乙酸共聚物)、PLCL(丙交酯-己内酯共聚物)、可塑淀粉材料、聚离子复合物或以上材料中的多种材料的共聚或共混材料。密封膜能够通过生物结合力方式，如氢键结合，静电引力，范德华引力，疏水作用力等，贴合在球囊接口或球囊本体内壁上，实现密封。密封膜的材料优选为PLCL(丙交酯-己内酯共聚物)、PLA(聚乳酸)、可塑淀粉材料、聚离子复合物等。前面所述的材料涉及生物适合性或可生物降解性材料。可以根据植入式球囊的应用环境的不同对各个组件的材料进行最优化搭配，如植入式球囊需要替代生物体内的器官，优选采用具有生物适合性的材料，如果植入式球囊是在生物体损伤后的恢复期提供辅助作用，则优选采用具有可生物降解性材料。
需要说明的是，为了进一步保证密封效果，密封膜的构成材料还包括粘性密封膜，包括但不限于在其表面添加粘性喷涂层，使得密封膜的粘接更牢固。
以上实施例所提供的球囊组件，球囊本体和球囊接口可以一体成型，也可以独自加工完成 后连接在一起，连接方式包括但不限于粘接。但需要说明的是，球囊本体和球囊接口连接后必须保证球囊本体的填充过程不会发生泄漏，同时能够满足球囊本体在不同应用环境下的使用性能。外导管与球囊接口之间的配合连接应该紧密无泄漏，同时在完成填充后又能够将外导管从球囊接口处拆卸下来，因此该种配合连接为可拆卸的紧密连接，包括但不限于卡接连接、螺纹连接、过盈配合等。
本申请所提供的球囊组件，除了可以用于制造肩袖球囊，还可以根据适用部位或病症的不同制造为其他类型的球囊，如胃球囊。
本申请所提供的球囊组件，能够同时实现球囊的密封和导管的回撤，密封体在球囊内外的压力下可以保持平衡，同时在密封的过程中不会留下残损物，使得整个密封过程操作简洁，安全性高，有效地延长了植入式球囊的使用寿命。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对申请专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若干变形和改进，这些都属于本申请的保护范围。因此，本申请专利的保护范围应以所附权利要求为准。

Claims (20)

  1. 一种球囊组件，其特征在于，包括：
    球囊本体，所述球囊本体上设有球囊本体开口；
    球囊接口，所述球囊接口设置在所述球囊本体开口处，用以供填充物通过并进入到所述球囊本体的内腔中；
    密封体，所述密封体设置在所述球囊本体开口处和/或所述球囊接口处，所述密封体包括阻止所述填充物通过所述球囊接口从所述球囊本体中流出的密封膜；
    外导管，所述外导管与所述球囊接口可拆卸地连接，所述填充物能够通过所述外导管进入所述球囊本体的内腔。
  2. 根据权利要求1所述的球囊组件，其特征在于，还包括内导管，所述内导管穿设在所述外导管中，所述内导管与所述外导管之间形成使所述填充物通过的间隙，所述内导管的一端伸入所述球囊接口中并连接可膨胀的内囊；
    所述密封膜覆盖于所述内囊的至少部分表面，所述内囊在所述内导管中流动的流体的作用下充盈膨胀并压迫所述密封膜与所述球囊本体的内壁和/或所述球囊接口的内壁接合，从而封闭所述球囊的内腔。
  3. 根据权利要求2所述的球囊组件，其特征在于，所述密封膜及覆盖的所述内囊的区域在沿所述内导管轴向方向上的纵向截面上的轮廓呈U形形状。
  4. 根据权利要求1所述的球囊组件，其特征在于，所述密封体设置在所述球囊本体的内腔中，所述密封体的至少部分边缘与所述球囊本体的内壁接合；所述密封体具有打开位置和封闭位置，当所述填充物往所述球囊本体的内腔填充时，所述密封体处于打开位置；当所述填充物完成对所述球囊本体的填充时，所述密封体处于封闭位置。
  5. 根据权利要求4所述的球囊组件，其特征在于，所述外导管适于抵靠所述密封体，使所述密封体处于打开位置。
  6. 根据权利要求4所述的球囊组件，其特征在于，所述球囊组件还包括套设在所述外导管中的内管，所述内管与所述外导管之间形成使所述填充物通过的空间，所述内管的一端适于伸入所述球囊接口中以抵靠所述密封体，以使所述密封体处于打开位置。
  7. 根据权利要求1所述的球囊组件，其特征在于，所述密封体设置在所述球囊本体内；所述球囊组件还包括与所述密封体可拆卸连接的辅助管，所述辅助管套设在所述外导管中，所述辅助管与所述外导管之间形成供所述填充物通过的空间，所述辅助管用以将所述密封体预定位于所述球囊本体开口处。
  8. 根据权利要求7所述的球囊组件，其特征在于，所述辅助管相对所述外导管轴向可移动地套设在所述外导管中；和/或，所述密封体具有用于和所述辅助管连接的突出部。
  9. 根据权利要求4至8中任一项所述的球囊组件，其特征在于，所述密封体与所述球囊本体接触的表面的全部或部分由所述密封膜覆盖。
  10. 根据权利要求1所述的球囊组件，其特征在于，所述密封膜的外周适于与所述球囊本体的内壁和/或所述球囊接口的内壁密封接合，所述密封膜上包括贯穿所述密封膜的切口。
  11. 根据权利要求10所述的球囊组件，其特征在于，所述密封膜上包括十字形切口。
  12. 根据权利要求10所述的球囊组件，其特征在于，所述切口的相对的边缘上分别包括唇部，所述切口闭合时所述唇部同时闭合。
  13. 根据权利要求12所述的球囊组件，其特征在于，各个所述唇部分别由所述密封膜朝向所述球囊本体的内腔方向延伸。
  14. 根据权利要求10所述的球囊组件，其特征在于，所述外导管包括针状头部，所述针状头部可穿过所述切口至所述球囊本体的内腔中，用以将所述填充物注入到所述球囊本体的内腔中。
  15. 根据权利要求10所述的球囊组件，其特征在于，所述密封膜由弹性材料制成。
  16. 根据权利要求1-14中任一项所述的球囊组件，其特征在于，所述球囊本体、所述球囊接口和/或所述密封膜的构成材料包括聚酰胺、聚酯、聚氨酯、聚酰胺聚醚嵌段共聚物、聚乙烯、聚丙烯、聚酰亚胺、交联聚乙烯、交联聚氨酯、离聚物、PCL、PLA、PLGA、PLCL、可塑淀粉材料、聚离子复合物或以上材料中的多种材料的共聚或共混材料。
  17. 根据权利要求1所述的球囊组件，其特征在于，所述密封膜为粘性密封膜。
  18. 根据权利要求1所述的球囊组件，其特征在于，所述外导管与所述球囊接口之间的连接包括过盈连接、螺纹连接或卡接连接。
  19. 一种球囊组件，其特征在于，包括：
    球囊本体，所述球囊本体上设有球囊本体开口；
    球囊接口，所述球囊接口设置在所述球囊本体开口处，用以供填充物通过并进入到所述球囊本体的内腔中；
    密封体，所述密封体设置在所述球囊本体开口处和/或所述球囊接口处，所述密封体包括适于和所述球囊本体的内壁和/或所述球囊接口的内壁接合的密封膜，使得所述密封体能够阻止所述填充物通过所述球囊接口从所述球囊本体中流出。
  20. 根据权利要求19所述的球囊组件，其特征在于，
    所述密封膜的外缘与所述球囊接口的内壁密封接合；
    或者，所述密封体设置在所述球囊本体的内腔中，所述密封体的至少部分边缘与所述球囊本体的内壁接合；所述密封体具有打开位置和封闭位置，当所述填充物往所述球囊本体的内腔填充时，所述密封体处于打开位置；当所述填充物完成对所述球囊本体的填充时，所述密封体处于封闭位置；所述密封体与所述球囊本体接触的表面的全部或部分由所述密封膜覆盖；
    或者，所述密封膜的外周与所述球囊本体的内壁和/或所述球囊接口的内壁密封接合，所述密封膜上包括贯穿所述密封膜的切口。
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CN110652350A (zh) * 2019-05-24 2020-01-07 上海竞捷医疗科技有限公司 球囊组件

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