WO2019120072A1 - 一种用于球囊系统的连接和释放结构 - Google Patents

一种用于球囊系统的连接和释放结构 Download PDF

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Publication number
WO2019120072A1
WO2019120072A1 PCT/CN2018/119123 CN2018119123W WO2019120072A1 WO 2019120072 A1 WO2019120072 A1 WO 2019120072A1 CN 2018119123 W CN2018119123 W CN 2018119123W WO 2019120072 A1 WO2019120072 A1 WO 2019120072A1
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WO
WIPO (PCT)
Prior art keywords
balloon
self
closing valve
upper layer
lower layer
Prior art date
Application number
PCT/CN2018/119123
Other languages
English (en)
French (fr)
Inventor
石秀凤
张强
Original Assignee
常州至善医疗科技有限公司
上海盼达医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 常州至善医疗科技有限公司, 上海盼达医疗科技有限公司 filed Critical 常州至善医疗科技有限公司
Priority to US16/765,119 priority Critical patent/US11931280B2/en
Priority to EP18893124.0A priority patent/EP3730099A4/en
Publication of WO2019120072A1 publication Critical patent/WO2019120072A1/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
    • A61F5/0089—Instruments for placement or removal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0036—Intragastrical devices
    • A61F5/004—Intragastrical devices remotely adjustable
    • A61F5/0043—Intragastrical devices remotely adjustable using injection ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/003—Implantable devices or invasive measures inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0036—Intragastrical devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10184—Means for controlling or monitoring inflation or deflation
    • A61M25/10185—Valves
    • 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
    • A61M25/1027—Making of balloon catheters
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • 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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1054—Balloon catheters with special features or adapted for special applications having detachable or disposable balloons
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1088—Balloon catheters with special features or adapted for special applications having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/1053—Stomach

Definitions

  • the present application relates to implant systems and, in particular, to a connection and release structure for implanting a balloon system.
  • the main treatment methods for obesity include: diet control, life intervention, drug treatment and surgical treatment.
  • simple diet control, life intervention and drug treatment are difficult to achieve satisfactory weight loss; although the effect of weight loss surgery is obvious, it is difficult for patients to accept due to cultural, medical level and surgical complications.
  • intragastric balloon there are several types of intragastric balloon in foreign countries, especially the intragastric balloon that does not need to be swallowed by gastroscope. It is the direction of future weight loss measures.
  • the swallowing intragastric balloon is wrapped in a capsule prior to action and is attached to a longer catheter with one end attached to the self-closing valve on the intragastric balloon and the other end remaining outside the capsule and mouth.
  • the balloon and part of the catheter wrapped in the capsule are swallowed into the stomach of the patient, and the capsule is rapidly degraded in the stomach acid environment, and the filler is transported from the outer end of the catheter remaining outside the patient's mouth to the balloon.
  • the initial compressed state expands to an expanded state.
  • the disadvantage of this structure is that if the cross-sectional circumference of the catheter is greater than or equal to the cross-sectional circumference of the channel 1020, the two-layer self-closing valve 1110 is easily taken out of the balloon when the catheter 1100 is fully filled, thereby causing leakage of the filler; On the one hand, if the cross-sectional circumference of the catheter 1100 is smaller than the cross-sectional circumference of the channel 1020, the filling will easily flow out of the balloon from the gap between the catheter 1100 and the channel 1020 during filling, failing to achieve self-closing action.
  • the present application provides a novel catheter-to-balloon connection and release structure that allows the catheter to be well in the process of transporting the filler and after the catheter is withdrawn from the balloon.
  • the sealing effect prevents the filler from leaking.
  • connection and release structure for a balloon system for connection and release of a catheter to a balloon
  • the connection and release structure comprising positioning on the ball a self-closing valve on the capsule, the self-closing valve including a conduit connection port, the conduit passing through the conduit connection port and sealingly connected to the self-closing valve, wherein the self-closing valve is fixed on the inner wall of the balloon on.
  • the self-closing valve includes a passage cavity located inside the balloon, the first end of the self-closing valve being sealingly coupled to an opening in the balloon, the conduit entering the self-closing valve from the first end and It is pierced from the catheter connection port and enters the inside of the balloon.
  • the conduit connection port is an aperture disposed in a sidewall of the self-sealing valve, the aperture having a circumference that is no greater than an outer diameter of the conduit.
  • the distal end of the self-closing valve is bonded to the inner wall of the balloon.
  • the side of the self-closing valve that does not contain the small holes is all bonded to the inner wall of the balloon.
  • the balloon includes an upper layer of the balloon and a lower layer of the balloon, the upper layer of the balloon is provided with a flip hole;
  • the self-closing valve includes a self-closing valve upper layer and a joint with the upper layer of the balloon
  • the lower layer of the self-closing valve connected to the lower layer of the balloon, wherein the upper layer of the self-closing valve is provided with a small hole, the circumference of the small hole is not larger than the outer diameter of the catheter; the upper layer of the balloon and the upper layer of the self-closing valve and the ball
  • the lower layer of the capsule and the lower layer of the self-closing valve are combined at the edge to form a unitary structure.
  • the upper end of the self-closing valve and/or the distal end of the self-closing valve is bonded to the inner wall of the balloon.
  • the lower layer of the self-closing valve is entirely bonded to the inner wall of the balloon.
  • the lower layer of the self-closing valve and the lower layer of the balloon are integrally formed of the same material or are joined together by different materials by bonding or welding.
  • a method of making the above-described attachment and release structure for a balloon system comprising the steps of providing an upper layer of the balloon, a lower layer of the balloon, a self-closing valve upper layer coupled to the upper layer of the balloon, and a lower layer of the self-closing valve connected to the lower layer of the balloon, wherein the upper layer of the balloon is provided with a reversing hole, and an upper hole is formed on the upper layer of the self-closing valve, and the circumference of the small hole is not larger than the outer diameter of the catheter
  • the upper layer of the balloon and the upper layer of the self-closing valve are combined with the lower layer of the balloon and the lower layer of the self-closing valve at the edge to form a unitary structure.
  • the upper layer of the balloon and the lower layer of the balloon are inverted by the inverting hole on the upper layer of the balloon.
  • Forming a balloon forming a self-closing valve inside the balloon from the upper layer of the closing valve and the lower layer of the self-closing valve; fixing the self-closing valve on the inner wall of the balloon; and closing the turning hole on the upper layer of the balloon through the patch.
  • the upper layer of the balloon and the upper layer of the self-closing valve are combined with the lower layer of the balloon and the lower layer of the self-closing valve at the edges by bonding or welding.
  • the upper end of the self-closing valve and/or the distal end of the self-closing valve is bonded to the inner wall of the balloon.
  • the lower layer of the self-sealing valve is fully bonded to the inner wall of the balloon.
  • the self-closing valve is attached to the balloon by bonding or welding.
  • the conduit connection port is an opening formed from a second end of the distal end of the closure valve, the circumference of the opening being no greater than the outer diameter of the conduit.
  • all of the distal end or one side of the self-sealing valve is bonded to the inner wall of the balloon.
  • sections of the cross-section of the self-closing valve may be different, gradually becoming smaller or stepped from the first end to the second end, facilitating the penetration and extraction of the catheter.
  • the second end face of the self-closing valve is not flush.
  • the balloon includes an upper layer of the balloon and a lower layer of the balloon, and the upper layer of the balloon is provided with a reversing hole;
  • the self-closing valve includes an upper layer of the self-closing valve connected to the upper layer of the balloon and the ball
  • the lower layer of the self-closing valve connected to the lower layer of the capsule, the upper layer of the balloon and the upper layer of the self-closing valve are combined with the lower layer of the balloon and the lower layer of the self-closing valve at the edge to form a unitary structure, but the head end of the upper layer of the self-closing valve and the head of the lower layer of the self-closing valve The end is not connected, and the opening circumference formed from the head end of the upper layer of the closing valve and the head end of the lower layer of the self-closing valve is not larger than the outer diameter of the catheter; after the combination is completed, the opening is reversed through the flip hole on the upper layer of the balloon, and the upper layer of the balloon Forming
  • distal end or the entire upper layer of the self-closing valve is adhered to the inner wall of the balloon, or the distal end or the entire lower layer of the self-closing valve is bonded to the inner wall of the balloon.
  • the head end of the upper layer of the closing valve and the head end of the lower layer of the self-closing valve are smaller in size relative to the end connected to the balloon, forming a self-closing valve having a tapered shape.
  • the upper layer of the self-closing valve and the upper layer of the balloon are integrally formed of the same material or are joined by different materials by bonding or welding.
  • the lower layer of the self-closing valve and the lower layer of the balloon are integrally formed of the same material or are joined together by different materials by bonding or welding.
  • a lower layer of the self-closing valve connected to the lower layer of the balloon, wherein the upper layer of the balloon is provided with a reversing hole; the upper layer of the balloon and the upper layer of the self-closing valve are combined with the lower layer of the balloon and the lower layer of the self-closing valve at the edge to form a whole
  • the structure is not connected at the head end of the upper layer of the self-closing valve and the head end of the lower layer of the self-closing valve, and the opening circumference formed from the head end of the upper layer of the closing valve and the head end of the lower layer of the self-closing valve is not larger than the outer diameter of the duct
  • the self-closing valve is fixed to the inner wall of the balloon by bonding the distal end or the entire upper layer of the self-closing valve to the inner wall of the balloon, or by bonding the distal or all of the lower layer of the self-closing valve to the balloon.
  • the inner wall is fixed to the inner wall of the balloon.
  • the upper layer of the balloon and the upper layer of the self-closing valve are combined with the lower layer of the balloon and the lower layer of the self-closing valve at the edges by bonding or welding.
  • the self-closing valve is attached to the balloon by bonding or welding.
  • a balloon system comprising a connection and release structure as described above.
  • the balloon system is an intragastric balloon system.
  • the balloon system is a skin-expanding balloon.
  • the self-closing valve is completely or partially bonded to the inner wall of the balloon, and the self-closing valve is not taken out of the balloon when the filler is withdrawn from the catheter, thereby preventing leakage of the filler.
  • the circumference of the small hole of the side wall of the self-closing valve or the circumference of the distal end section is not larger than the outer diameter of the catheter, the filler does not leak when filled.
  • the sections of the cross-section of the self-closing valve may be different, gradually increasing from the far side or stepwise, facilitating the penetration and extraction of the catheter.
  • Figure 1 is a schematic illustration of a balloon closure structure in accordance with the prior art
  • FIG. 2 is a schematic structural view of a balloon system according to an embodiment of the present application.
  • FIG. 3 is a balloon, a self-closing valve, and an exploded view thereof according to an embodiment of the present application;
  • Figure 4 is a plan view showing the assembly of the catheter and the self-closing valve shown in Figure 3;
  • Figure 5 is a side elevational view of the catheter assembled with the self-closing valve of Figure 3;
  • Figure 6 is a side view of the balloon after the catheter is withdrawn from the self-closing valve shown in Figure 3;
  • Figure 7 is a balloon, self-closing valve and its exploded view according to another embodiment of the present application.
  • Figure 8 is a plan view showing the assembly of the catheter and the self-closing valve shown in Figure 7;
  • Figure 10 is a side view of the balloon after the catheter has been withdrawn from the self-closing valve shown in Figure 7.
  • a schematic block diagram of a balloon system including a connection and release structure in accordance with one embodiment of the present application is shown.
  • the balloon system is implanted in vivo into a balloon system, such as an intragastric balloon system, and those skilled in the art will readily appreciate that the balloon system of the present application may be a balloon system for other purposes, such as a skin expansion balloon. Wait.
  • the in vivo implanted balloon system includes a balloon 100, a catheter 200, a capsule and a filler (not shown), and the balloon 100 contains a self-sealing valve 300 therein.
  • the balloon 100 is wrapped in a capsule prior to swallowing, one end of the catheter 200 (ie, the internal end) is connected to the self-sealing valve 300 on the balloon 100, and the other end (ie, the extracorporeal end) is left outside the capsule.
  • the catheter 200 is of a length such that the extracorporeal end remains outside the mouth when in use.
  • Both the balloon and the self-closing valve according to the present application are made of a flexible material.
  • FIG. 3-6 illustrate an in vivo implanted balloon system in accordance with an embodiment of the present application.
  • the structure and manufacturing method of the balloon system of this embodiment will be described in detail below with reference to Figs. 3-6.
  • the in vivo implanted balloon system is specifically an intragastric balloon system. Referring to FIG.
  • the balloon 100, the self-closing valve 300, and an exploded view thereof are illustrated, wherein the self-closing valve 300 has a sidewall opening;
  • the balloon 100 includes a balloon upper layer 110 and a balloon lower layer 120, the ball A flip hole 2 is disposed on the upper layer 110 of the capsule;
  • the self-closing valve 300 includes a self-closing valve upper layer 310 connected to the balloon upper layer 110 and a self-closing valve lower layer 320 connected to the balloon lower layer 120, wherein the self-closing valve
  • the upper layer 310 is provided with a small hole 311 whose circumference is not larger than the outer diameter of the catheter 200.
  • the balloon upper layer 110 and the balloon lower layer 120 form a balloon 100, which forms a self-sealing valve 300 from the closed valve upper layer 310 and the self-closing valve lower layer 320, which enters the interior of the balloon 100.
  • the distal end or all of the self-closing valve upper layer 310 and the self-closing valve lower layer 320 are bonded to the inner wall of the balloon 100 as shown in FIG.
  • the inverting hole 2 on the upper layer 110 of the balloon is closed with a patch.
  • the use of the intragastric balloon according to the present embodiment is as follows: after the patient swallows the capsule containing the balloon 100 and a portion of the catheter 200, the capsule dissolves rapidly in the gastric environment and is transported through the outer end of the catheter 200 into the balloon 100. The filling, the balloon 100 is changed from the initial compressed state to the expanded state. Since the diameter of the small hole 311 is not larger than the outer diameter of the catheter 200, the gap between the catheter 200 and the small hole 311 is tightly fitted without gaps, ensuring the ball when the filling is carried. The overall sealing of the bladder 100 and the self-closing valve, the filling will not leak.
  • FIG. 7 shows the balloon 100, the self-closing valve 300 and an exploded view thereof, the balloon 100 includes a balloon upper layer 140 and a balloon lower layer 150, and the balloon upper layer 140 is also provided with a turning hole 2;
  • the self-sealing valve 300 includes a self-closing valve upper layer 330 coupled to the balloon upper layer 140 and a self-closing valve lower layer 340 coupled to the balloon lower layer 150, and is self-closing valve upper layer 330 and self-closing valve lower layer 340.
  • the taper i.e., the head end 331 (or free end) of the self-closing valve upper layer 330 and the head end 341 of the self-closing valve lower layer 340 are smaller in size relative to the end to which the balloon is attached.
  • the self-closing valve upper layer 330 and the balloon upper layer 140 are integrally formed of the same material, and may also be joined together by different materials by bonding or welding.
  • the self-closing valve lower layer 340 and the balloon lower layer 150 are integrally formed of the same material, and may also be joined together by different materials by bonding or welding.
  • the balloon upper layer 140 and the self-closing valve upper layer 330 are combined with the balloon lower layer 150 and the self-closing valve lower layer 340 at the rim 1 by bonding or welding, but at the head end 331 of the self-closing valve upper layer 330 and the lower self-closing valve layer.
  • the head end 341 of the 340 is not bonded, and the opening perimeter formed from the head end 331 of the upper layer 330 of the closing valve and the head end 341 of the lower layer 340 of the closing valve is not larger than the outer diameter of the catheter 200.
  • FIG. 8 shows a plan view of the self-closing valve assembly of the catheter with the balloon shown in FIG. 7, and FIG. 9 shows a side view of the self-closing valve assembly of the catheter with the balloon shown in FIG. .
  • the catheter 200 is threaded from the outside of the balloon 100 into the channel cavity 160 between the self-closing valve upper layer 330 and the self-closing valve lower layer 340, and is formed from the head end 331 of the self-closing valve upper layer 330 and the head end 341 of the self-closing valve lower layer 340.
  • the opening is pierced and enters the inside of the balloon 100.
  • the use of the intragastric balloon according to the present embodiment is as follows: after the patient swallows the capsule containing the balloon 100 and a portion of the catheter 200, the capsule dissolves rapidly in the gastric environment and is transported through the outer end of the catheter 200 into the balloon 100.

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Abstract

本申请提供一种用于球囊系统的连接和释放结构、包括该连接和释放结构的球囊系统及其制作方法。所述连接和释放结构用于导管与球囊的连接和释放，所述连接和释放结构包括定位在所述球囊上的自封闭阀，所述自封闭阀包括导管连接口，所述导管穿过该导管连接口并与自封闭阀密封性地相连，该自封闭阀全部或部分地粘接到球囊内壁上，在输送完填充物拔出导管时自封闭阀不会被带出球囊外，可防止填充物泄漏；另一方面，因自封闭阀侧壁小孔的周长或远端截面的周长不大于导管的外径，填充物充盈时也不会泄漏。此外，自封闭阀的截面周长各段可以不相同，由远向近逐渐增大或呈阶梯式增大，有助于导管的穿进和拔出。

Description

一种用于球囊系统的连接和释放结构 技术领域
本申请涉及植入系统，具体地说，涉及一种用于植入球囊系统的连接和释放结构。
背景技术
在过去的20年间，全球范围内肥胖症，包括成年人肥胖症、老年人肥胖症以及青少年儿童的肥胖症的发病率都在飙升。根据世界卫生组织统计，2014年全世界就有15％的成年女性及11％的成年男性肥胖，这意味着，在2014年全世界就有近十亿成年人肥胖。不容乐观的是中国的肥胖人口已赶超美国，2016年中国有8960万肥胖人口(美国肥胖人口为8780万人)，其中男性占4320万人，女性占4640万人。肥胖通常伴发有高血压、II型糖尿病、缺血性心脏病、血脂异常、关节退行变、睡呼吸暂停及某些肿瘤等，因此，如何有效的控制体重，预防和控制并发症的发生是备受关注的话题。
目前肥胖症的主要治疗方式包括：饮食控制、生活干预、药物治疗及手术治疗。然而单纯的饮食控制、生活干预及药物治疗很难达到满意的减重效果；虽然减重手术效果明显，但是由于文化、医疗水平及手术并发症等原因很难为患者所接受。植入式医疗器械减肥，模拟外科手术治疗肥胖症的机理，包括胃内球囊，这些年刚刚兴起，因为安全、简便、有效、可复原，因而受到广泛的关注，且会成为未来减肥的主要有效手段。
目前国外已经有几类胃内球囊上市，尤其是不需要经过胃镜送入而自行吞咽的胃内球囊，是未来减肥手段的方向。吞咽式胃内球囊在作用前被包裹在胶囊中，并连有一根较长的导管，导管一端与胃内球囊上的自封闭阀相连，另一端留在胶囊和口腔外。通过吞咽方式将包裹在胶囊中的球囊及部分导管送入患者胃内，胶囊在胃酸环境下迅速降解，从留在患者口腔外的导管的体外端向球囊内输送填充物，球囊由初始的压缩状态膨胀为扩张态。填充物输送完毕后从患者体内拔出导 管，球囊上与导管形成流体通道的自封闭阀自动关闭，以防填充物外泄。美国专利US8974483B2即公开了这样一种导管与球囊的连接和释放结构，具体参见图1。
美国专利US8974483B2公开的这种导管与球囊连接和释放结构包括导管1100和沿边缘密封的两层自封闭阀1110。自封闭阀1110可以定位在球囊上部1014或下部1016材料表面的孔中，或在上部1014和下部1016的接缝1004的开口中。导管1100从球囊外穿过两层自封闭阀1110之间的通道1020进入球囊，向球囊内输送完填充材料后拔出导管1100，两层自封闭阀1110之间的通道1020自动封闭，防止球囊内填充物外泄。
这种结构的缺点是如果导管的截面周长大于等于通道1020的截面周长，则导管1100充盈完毕拔出时容易将两层自封闭阀1110带出球囊外，造成填充物外泄；另一方面如果导管1100的截面周长小于通道1020的截面周长，则充盈时填充物容易从导管1100与通道1020的间隙处流出球囊外，达不到自封闭的作用。
因此，如何设计一种封闭性能较好的自封闭结构是本领域急需解决的问题，使得导管在输送填充物的过程中及导管从球囊上拔出后都有很好的封闭效果，防止填充物泄漏。
发明内容
为了解决上述技术问题，本申请提供了一种新型的导管与球囊连接和释放结构，该连接和释放结构使得导管在输送填充物的过程中及导管从球囊上拔出后都有很好的封闭效果，防止填充物泄漏。
根据本申请的一方面，提供一种用于球囊系统的连接和释放结构，所述连接和释放结构用于导管与球囊的连接和释放，所述连接和释放结构包括定位在所述球囊上的自封闭阀，所述自封闭阀包括导管连接口，所述导管穿过该导管连接口并与自封闭阀密封性地相连，其特征在于：所述自封闭阀固定在球囊内壁上。
进一步，所述自封闭阀包括位于球囊内部的通道腔，所述自封闭阀的第一端与球囊上的开口密封连接，所述导管从所述第一端进入所述自封闭阀并从所述导管连接口穿出，进入球囊内部。
在一个实施例中，所述导管连接口为设置在所述自封闭阀侧壁上的小孔，该小孔的周长不大于导管的外径。
进一步，所述自封闭阀的远端粘接在球囊的内壁上。
可选地，所述自封闭阀上不含小孔的一侧全部粘接在球囊的内壁上。
在一个实施例中，所述球囊包括球囊上层和球囊下层，所述球囊上层上设置翻转孔；所述自封闭阀包括与所述球囊上层连接的自封闭阀上层和与所述球囊下层连接的自封闭阀下层，其中自封闭阀上层上开有小孔，所述小孔的周长不大于所述导管的外径；所述球囊上层和自封闭阀上层与球囊下层和自封闭阀下层在边沿连接组合成整体结构，组合完成后通过球囊上层上的翻转孔进行翻转，球囊上层和球囊下层形成球囊，自封闭阀上层和自封闭阀下层形成位于球囊内部的自封闭阀，所述自封闭阀固定在球囊内壁上，球囊上层上的翻转孔通过补片封闭。
进一步，所述自封闭阀上层和/或所述自封闭阀下层的远端粘接在球囊的内壁上。
可选地，所述自封闭阀下层全部粘接在球囊的内壁上。
进一步，所述自封闭阀上层与所述球囊上层由同一种材料整体形成或者由不同的材料通过粘接或焊接的方式连接在一起。
进一步，所述自封闭阀下层与所述球囊下层由同一种材料整体形成或者由不同的材料通过粘接或焊接的方式连接在一起。
根据本申请的另一方面，提供一种制作上述用于球囊系统的连接和释放结构的方法，包括如下步骤：提供球囊上层、球囊下层、与球囊上层连接的自封闭阀上层和与所述球囊下层连接的自封闭阀下层，所述球囊上层上设置翻转孔、所述自封闭阀上层上开有小孔，所述小孔的周长不大于所述导管的外径；将所述球囊上层和自封闭阀上层与球囊下层和自封闭阀下层在边沿连接组合成整体结构，组合完成后通过球囊上层上的翻转孔进行翻转，球囊上层和球囊下层形成球囊，自封闭阀上层和自封闭阀下层形成位于球囊内部的自封闭阀；将所述自封闭阀固定在球囊内壁上；再将球囊上层上的翻转孔通过补片封闭。
进一步，球囊上层和自封闭阀上层与球囊下层和自封闭阀下层在边沿通过粘接或焊接方式组合在一起。
进一步，将自封闭阀上层和/或自封闭阀下层的远端粘接在球囊的内壁上。
可选地，将自封闭阀下层全部粘接在球囊的内壁上。
进一步，所述自封闭阀通过粘接或焊接连接到所述球囊上。
在另一个实施例中，所述导管连接口为自封闭阀远端的第二端形成的开口，该开口的周长不大于导管的外径。
进一步，所述自封闭阀的远端或一侧的全部粘接在球囊的内壁上。
进一步，自封闭阀的截面周长各段可以不相同，由第一端向第二端逐渐变小或呈阶梯式变小，便于导管的穿入和拔出。
进一步地，自封闭阀可以是由两边密封的两层材料组成，也可以是无接缝的管材；
进一步地，自封闭阀的第二端面不平齐。
在一个实施例中，所述球囊包括球囊上层和球囊下层，球囊上层上设置翻转孔；所述自封闭阀包括与所述球囊上层连接的自封闭阀上层和与所述球囊下层连接的自封闭阀下层，球囊上层和自封闭阀上层与球囊下层和自封闭阀下层在边沿连接组合成整体结构，但在自封闭阀上层的头端和自封闭阀下层的头端处不连接，且自封闭阀上层的头端和自封闭阀下层的头端形成的开口周长不大于导管的外径；组合完成后通过球囊上层上的翻转孔进行翻转，球囊上层和球囊下层形成球囊，自封闭阀上层和自封闭阀下层形成位于球囊内部的自封闭阀；所述自封闭阀固定在球囊内壁上；球囊上层上的翻转孔用补片封闭。
进一步，所述自封闭阀上层的远端或全部粘接在球囊的内壁上，或者所述自封闭阀下层的远端或全部粘接在球囊的内壁上。
进一步，所述封闭阀上层的头端和自封闭阀下层的头端的尺寸相对于与球囊相连的一端而言较小，形成呈锥形的自封闭阀。
进一步，所述自封闭阀上层与球囊上层由同一种材料整体形成或者由不同的材料通过粘接或焊接的方式连接在一起。
进一步，所述自封闭阀下层与球囊下层由同一种材料整体形成或者由不同的材料通过粘接或焊接的方式连接在一起。
根据本申请的另一方面，提供另一种制作上述用于球囊系统的连接和释放结构的方法，包括如下步骤：提供球囊上层、球囊下层、与球囊上层连接的自封闭阀上层和与所述球囊下层连接的自封闭阀下层，所述球囊上层上设置翻转孔；将所述球囊上层和自封闭阀上层与球囊下层和自封闭阀下层在边沿连接组合成整体结构，但在自封闭阀上层的头端和自封闭阀下层的头端处不连接，且自封闭阀上层的头端和自封闭阀下层的头端形成的开口周长不大于导管的外径；组合完成后通过球囊上层上的翻转孔进行翻转，球囊上层和球囊下层形成球囊，自封闭阀上层和自封闭阀下层形成位于球囊内部的自封闭阀；将所述自封闭阀固定在球囊 内壁上；球囊上层上的翻转孔用补片封闭。
进一步，通过将自封闭阀上层的远端或全部粘接在球囊的内壁上实现自封闭阀与球囊内壁的固定，或者通过将自封闭阀下层的远端或全部粘接在球囊的内壁上实现自封闭阀与球囊内壁的固定。
进一步，球囊上层和自封闭阀上层与球囊下层和自封闭阀下层在边沿通过粘接或焊接方式组合在一起。
进一步，所述自封闭阀通过粘接或焊接连接到所述球囊上。
根据本申请的另一方面，提供一种球囊系统，包括如上所述的连接和释放结构。
在一个实施方式中，所述球囊系统为胃内球囊系统。
在另一个实施方式中，所述球囊系统为皮肤扩张球囊。
根据本申请的连接和释放结构，自封闭阀全部或部分地粘接到球囊内壁上，在输送完填充物拔出导管时自封闭阀不会被带出球囊外，可防止填充物泄漏；另一方面，因自封闭阀侧壁小孔的周长或远端截面的周长不大于导管的外径，填充物充盈时也不会泄漏。此外，自封闭阀的截面周长各段可以不相同，由远向近逐渐增大或呈阶梯式增大，有助于导管的穿进和拔出。
附图说明
图1为根据现有技术的球囊封闭结构的示意图；
图2为根据本申请一个实施方式的球囊系统的结构示意图；
图3为根据本申请一个实施方式的球囊、自封闭阀及其分解图；
图4为导管与图3所示的自封闭阀装配的俯视图；
图5为导管与图3所示的自封闭阀装配的侧视图；
图6为导管从图3所示的自封闭阀拔出后球囊侧视图；
图7根据本申请另一个实施方式的球囊、自封闭阀及其分解图；
图8为导管与图7所示的自封闭阀装配的俯视图；
图9为导管与图7所示的自封闭阀装配的侧视图；
图10为导管从图7所示的自封闭阀拔出后球囊侧视图。
具体实施方式
下面将对本申请的实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请的实施例，本领域普通技术人员在没有作出创造性劳动的前提下所获得的所有其他实施例，都属于本申请保护的范围。
参见附图2，示出根据本申请一个实施方式的包含连接和释放结构的球囊系统的结构示意图。优选地，该球囊系统为体内植入球囊系统，例如为胃内球囊系统，本领域技术人员容易想到本申请的球囊系统可以是用于其他目的球囊系统，如皮肤扩张球囊等。所述体内植入球囊系统包括：球囊100、导管200、胶囊和填充物(图中未显示)，所述球囊100内含有自封闭阀300。所述球囊100在吞咽前被包裹在胶囊中，所述导管200一端(即体内端)与球囊100上的自封闭阀300相连，另一端(即体外端)留在胶囊外，所述导管200具有一定的长度使得在使用时体外端留在口腔外。根据本申请的球囊及自封闭阀均由柔性材料制成。
图3-6示出根据本申请的一个实施方式的体内植入球囊系统。下面参照附图3-6详细描述该实施方式的球囊系统的结构及制作方法。该体内植入球囊系统具体为胃内球囊系统。参见图3，其示出所述球囊100、自封闭阀300及其分解图，其中自封闭阀300具有侧壁开孔；所述球囊100包括球囊上层110和球囊下层120，球囊上层110上设置翻转孔2；所述自封闭阀300包括与所述球囊上层110连接的自封闭阀上层310和与所述球囊下层120连接的自封闭阀下层320，其中自封闭阀上层310上开有小孔311，所述小孔311的周长不大于导管200的外径。自封闭阀上层310与球囊上层110可以由同一种材料整体形成，也可以由不同的材料通过粘接或焊接的方式连接在一起。同样地，自封闭阀下层320与球囊下层120可以由同一种材料整体形成，也可以由不同的材料通过粘接或焊接的方式连接在一起。球囊上层110和自封闭阀上层310与球囊下层120和自封闭阀下层320在边沿1通过粘接或焊接方式组合在一起，组合完成后通过球囊上层110上的翻转孔2进行翻转，球囊上层110和球囊下层120形成球囊100，自封闭阀上层310和自封闭阀下层320形成自封闭阀300，该自封闭阀300进入球囊100的内部。接着，将自封闭阀上层310和自封闭阀下层320的远端或全部粘接在球囊100的内壁上，如图4所示。最后将球囊上层110上的翻转孔2用补片封闭。
参见附图4、5，附图4示出导管与图3所示的球囊的自封闭阀装配的俯视图，图5示出导管与图3所示的球囊的自封闭阀装配的侧视图，导管200从球囊 100外穿入自封闭阀上层310和自封闭阀下层320之间的通道腔130，并从自封闭阀上层310上的小孔311穿出，进入球囊100内部。
根据本实施例的胃内球囊的使用情况如下：患者吞咽内含球囊100和部分导管200的胶囊后，胶囊在胃内环境下迅速溶解，通过导管200的体外端向球囊100内输送填充物，球囊100由初始的压缩态变为膨胀态，由于小孔311的直径不大于导管200的外径，导管200与小孔311之间为无间隙紧密配合，确保输送填充物时球囊100和自封闭阀的整体密封性，填充物不会外泄。填充完毕拔出导管200，在球囊100内部填充物的压力下，自封闭阀上层310和自封闭阀下层320紧贴在一起，阻挡球囊内填充物的泄漏，如图6所示。球囊100长期占据胃内体积，达到减重的目的。
图7-10示出根据本申请另外一个实施方式的包含连接和释放结构的球囊系统的结构示意图，该实施方式与图3-6所示的实施方式不同之处在于：自封闭阀上不设置小孔，而是设置远端开口作为导管连接口。下面参照附图7-10详细描述该实施方式的球囊系统的结构及制作方法。
具体而言，图7示出所述球囊100、自封闭阀300及其分解图，所述球囊100包括球囊上层140和球囊下层150，球囊上层140上同样设置翻转孔2；所述自封闭阀300包括与所述球囊上层140连接的自封闭阀上层330和与所述球囊下层150连接的自封闭阀下层340，且自封闭阀上层330和自封闭阀下层340呈锥形，即自封闭阀上层330的头端331(或称自由端)和自封闭阀下层340的头端341的尺寸相对于与球囊相连的一端而言较小。自封闭阀上层330与球囊上层140由同一种材料整体形成，也可以由不同的材料通过粘接或焊接的方式连接在一起。同样自封闭阀下层340与球囊下层150由同一种材料整体形成，也可以由不同的材料通过粘接或焊接的方式连接在一起。
球囊上层140和自封闭阀上层330与球囊下层150和自封闭阀下层340在边沿1通过粘接或焊接方式组合在一起，但在自封闭阀上层330的头端331和自封闭阀下层340的头端341处不粘接，且自封闭阀上层330的头端331和自封闭阀下层340的头端341形成的开口周长不大于导管200的外径。组合完成后通过球囊上层140上的翻转孔2进行翻转，球囊上层140和球囊下层150形成球囊100，自封闭阀上层330和自封闭阀下层340形成自封闭阀300，并进入球囊100的内部，参见附图8。将自封闭阀上层330的远端或全部粘接在球囊100的内壁上， 如图8、9所示。最后将球囊上层140上的翻转孔2用补片封闭。
参见附图8、9，附图8示出导管与图7所示的球囊的自封闭阀装配的俯视图，图9示出导管与图7所示的球囊的自封闭阀装配的侧视图。将导管200从球囊100外穿入自封闭阀上层330和自封闭阀下层340之间的通道腔160，并从自封闭阀上层330的头端331和自封闭阀下层340的头端341形成的开口处穿出，进入球囊100内部。
根据本实施例的胃内球囊的使用情况如下：患者吞咽内含球囊100和部分导管200的胶囊后，胶囊在胃内环境下迅速溶解，通过导管200的体外端向球囊100内输送填充物，球囊100由初始的压缩态变为膨胀态，由于自封闭阀上层330的头端331和自封闭阀下层340的头端341形成的开口周长不大于导管200的外径，导管200与自封闭阀上层330的头端331和自封闭阀下层340的头端341之间为无间隙紧密配合，确保输送填充物时球囊100和自封闭阀300的整体密封性，填充物不会外泄。填充完毕拔出导管200，在球囊100内部填充物的压力下，自封闭阀上层330和自封闭阀下层340紧贴在一起，阻挡球囊内填充物的泄漏，如图10所示。自封闭阀上层330和自封闭阀下层340呈锥形有助于导管200的穿入和拔出。球囊100长期占据胃内体积，达到减重的目的。
根据本申请的连接和释放结构，自封闭阀全部或部分地粘接到球囊内壁上，在输送完填充物拔出导管时自封闭阀不会被带出球囊外，可防止填充物泄漏；另一方面，因自封闭阀侧壁小孔的周长或远端截面的周长不大于导管的外径，填充物充盈时也不会泄漏。此外，自封闭阀的截面周长各段可以不相同，由远向近逐渐增大或呈阶梯式增大，有助于导管的穿进和拔出。

Claims (35)

  1. 一种用于球囊系统的连接和释放结构，所述连接和释放结构用于导管与球囊的连接和释放，所述连接和释放结构包括定位在所述球囊上的自封闭阀，所述自封闭阀包括导管连接口，所述导管穿过该导管连接口并与自封闭阀密封性地相连，其特征在于：所述自封闭阀全部或部分固定在所述球囊内壁上。
  2. 根据权利要求1所述的连接和释放结构，所述自封闭阀包括位于球囊内部的通道腔，所述自封闭阀的第一端与球囊上的开口密封连接，所述导管从所述第一端进入所述自封闭阀并从所述导管连接口穿出，进入球囊内部。
  3. 根据权利要求2所述的连接和释放结构，所述导管连接口为设置在所述自封闭阀侧壁上的小孔，该小孔的周长不大于导管的外径。
  4. 根据权利要求3所述的连接和释放结构，所述自封闭阀的远端粘接在球囊的内壁上。
  5. 根据权利要求3所述的连接和释放结构，所述自封闭阀上不含小孔的一侧全部粘接在球囊的内壁上。
  6. 根据权利要求3-5任一项所述的连接和释放结构，所述球囊包括球囊上层和球囊下层，所述球囊上层上设置翻转孔；所述自封闭阀包括与所述球囊上层连接的自封闭阀上层和与所述球囊下层连接的自封闭阀下层，其中自封闭阀上层上开有小孔，所述小孔的周长不大于所述导管的外径；所述球囊上层和自封闭阀上层与球囊下层和自封闭阀下层在边沿连接组合成整体结构，组合完成后通过球囊上层上的翻转孔进行翻转，球囊上层和球囊下层形成球囊，自封闭阀上层和自封闭阀下层形成位于球囊内部的自封闭阀，所述自封闭阀固定在球囊内壁上，球囊上层上的翻转孔通过补片封闭。
  7. 根据权利要求6所述的连接和释放结构，所述自封闭阀上层和/或所述自封闭阀下层的远端粘接在球囊的内壁上。
  8. 根据权利要求6所述的连接和释放结构，所述自封闭阀下层全部粘接在球囊的内壁上。
  9. 根据权利要求6所述的连接和释放结构，所述自封闭阀上层与所述球囊上层由同一种材料整体形成或者由不同的材料通过粘接或焊接的方式连接在一起。
  10. 根据权利要求6所述的连接和释放结构，所述自封闭阀下层与所述球囊下层由同一种材料整体形成或者由不同的材料通过粘接或焊接的方式连接在一起。
  11. 根据权利要求2所述的连接和释放结构，所述导管连接口为自封闭阀远端的第二端形成的开口，该开口的周长不大于导管的外径。
  12. 根据权利要求11所述的连接和释放结构，所述自封闭阀的远端或一侧的全部粘接在球囊的内壁上。
  13. 根据权利要求11所述的连接和释放结构，所述自封闭阀的截面周长由第一端向第二端逐渐变小或呈阶梯式变小，便于所述导管的穿入和拔出。
  14. 根据权利要求11-13任一项所述的连接和释放结构，所述自封闭阀由两边密封的两层材料组成或者为无接缝的管材。
  15. 根据权利要求11-13任一项所述的连接和释放结构，上述自封闭阀的第二端面不平齐。
  16. 根据权利要求11-13任一项所述的连接和释放结构，所述球囊包括球囊上层和球囊下层，球囊上层上设置翻转孔；所述自封闭阀包括与所述球囊上层连接的自封闭阀上层和与所述球囊下层连接的自封闭阀下层，球囊上层和自封闭阀上层与球囊下层和自封闭阀下层在边沿连接组合成整体结构，但在自封闭阀上层的头端和自封闭阀下层的头端处不连接，且自封闭阀上层的头端和自封闭阀下层的头端形成的开口周长不大于导管的外径；组合完成后通过球囊上层上的翻转孔进行翻转，球囊上层和球囊下层形成球囊，自封闭阀上层和自封闭阀下层形成位于球囊内部的自封闭阀；所述自封闭阀固定在球囊内壁上；球囊上层上的翻转孔用补片封闭。
  17. 根据权利要求16所述的连接和释放结构，所述自封闭阀上层的远端或全部粘接在球囊的内壁上。
  18. 根据权利要求16所述的连接和释放结构，所述自封闭阀下层的远端或全部粘接在球囊的内壁上。
  19. 根据权利要求17或18所述的连接和释放结构，所述自封闭阀通过粘接或焊接连接到所述球囊内壁上。
  20. 根据权利要求16所述的连接和释放结构，所述封闭阀上层的头端和自封 闭阀下层的头端的尺寸相对于与球囊相连的一端而言较小，形成呈锥形的自封闭阀。
  21. 根据权利要求16所述的连接和释放结构，所述自封闭阀上层与球囊上层由同一种材料整体形成或者由不同的材料通过粘接或焊接的方式连接在一起。
  22. 根据权利要求16所述的连接和释放结构，所述自封闭阀下层与球囊下层由同一种材料整体形成或者由不同的材料通过粘接或焊接的方式连接在一起。
  23. 一种制作权利要求3-6任一项所述用于球囊系统的连接和释放结构的方法，包括如下步骤：提供球囊上层、球囊下层、与球囊上层连接的自封闭阀上层和与所述球囊下层连接的自封闭阀下层，所述球囊上层上设置翻转孔、所述自封闭阀上层上开有小孔，所述小孔的周长不大于所述导管的外径；将所述球囊上层和自封闭阀上层与球囊下层和自封闭阀下层在边沿连接组合成整体结构，组合完成后通过球囊上层上的翻转孔进行翻转，球囊上层和球囊下层形成球囊，自封闭阀上层和自封闭阀下层形成位于球囊内部的自封闭阀；将自封闭阀上层和自封闭阀下层的远端或全部粘接在球囊的内壁上；再将球囊上层上的翻转孔通过补片封闭。
  24. 根据权利要求23所述的方法，球囊上层和自封闭阀上层与球囊下层和自封闭阀下层在边沿通过粘接或焊接方式组合在一起。
  25. 根据权利要求23所述的方法，将自封闭阀上层和/或自封闭阀下层的远端粘接在球囊的内壁上。
  26. 根据权利要求23所述的方法，将自封闭阀下层全部粘接在球囊的内壁上。
  27. 根据权利要求25或26所述的方法，所述自封闭阀通过粘接或焊接连接到所述球囊上。
  28. 一种制作权利要求11-16任一项所述用于球囊系统的连接和释放结构的方法，包括如下步骤：提供球囊上层、球囊下层、与球囊上层连接的自封闭阀上层和与所述球囊下层连接的自封闭阀下层，所述球囊上层上设置翻转孔；将所述球囊上层和自封闭阀上层与球囊下层和自封闭阀下层在边沿连接组合成整体结构，但在自封闭阀上层的头端和自封闭阀下层的头端处不连接，且自封闭阀上层的头端和自封闭阀下层的头端形成的开口周长不大于导管的外径；组合完成后通过球囊上层上的翻转孔进行翻转，球囊上层和球囊下层形成球囊，自封闭阀上层 和自封闭阀下层形成位于球囊内部的自封闭阀；将所述自封闭阀固定在球囊内壁上；球囊上层上的翻转孔用补片封闭。
  29. 根据权利要求28所述的方法，球囊上层和自封闭阀上层与球囊下层和自封闭阀下层在边沿通过粘接或焊接方式组合在一起。
  30. 根据权利要求28所述的方法，将自封闭阀上层的远端或全部粘接在球囊的内壁上。
  31. 根据权利要求28所述的方法，将自封闭阀下层的远端或全部粘接在球囊的内壁上。
  32. 根据权利要求30或31所述的方法，所述自封闭阀通过粘接或焊接连接到所述球囊上。
  33. 一种球囊系统，包括如权利要求1-22任一项所述的连接和释放结构。
  34. 根据权利要求33所述的球囊系统，所述球囊系统为胃内球囊系统。
  35. 根据权利要求33所述的球囊系统，所述球囊系统为皮肤扩张球囊。
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Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT201600084458A1 (it) * 2016-08-10 2018-02-10 Euromedical S R L Palloncino intragastrico e relativo metodo di fabbricazione
CN108158705B (zh) 2017-12-18 2024-05-28 常州至善医疗科技有限公司 一种用于球囊系统的连接和释放结构
CN108852578B (zh) * 2018-09-04 2024-05-28 常州至善医疗科技有限公司 一种可自然降解的植入物
CN113332014A (zh) * 2020-02-18 2021-09-03 上海微创医疗器械（集团）有限公司 胃球囊、胃球囊结构及胃球囊结构使用方法
CN114948368A (zh) * 2021-02-23 2022-08-30 常州至善医疗科技有限公司 一种植入球囊系统自封闭阀结构
WO2022188616A1 (zh) * 2021-03-09 2022-09-15 常州至善医疗科技有限公司 一种自封闭系统
CN115040300A (zh) * 2021-03-09 2022-09-13 常州至善医疗科技有限公司 一种体内植入物的封闭和释放结构
WO2022188617A1 (zh) * 2021-03-09 2022-09-15 常州至善医疗科技有限公司 一种体内植入物的封闭和释放结构
CN114129325A (zh) * 2021-12-02 2022-03-04 杭州糖吉医疗科技有限公司 可降解自密封阀及其制备方法、胃内植入球囊及其制备方法
CN116212124B (zh) * 2023-05-09 2023-08-18 杭州糖吉医疗科技有限公司 一种胃内球囊可降解自封闭阀及其制备方法和应用

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130226219A1 (en) * 2011-01-21 2013-08-29 Obalon Therapeutics, Inc. Intragastric device
US8974483B2 (en) 2012-02-21 2015-03-10 Allurion Technologies, Inc. Methods and devices for deploying and releasing a temporary implant within the body
CN204890270U (zh) * 2015-09-01 2015-12-23 王东 可复式胃球囊
CN108158705A (zh) * 2017-12-18 2018-06-15 常州至善医疗科技有限公司 一种用于球囊系统的连接和释放结构

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL78883A0 (en) * 1986-05-23 1986-09-30 Omikron Scient Ltd Device and method for treating a patient for obesity
US5993473A (en) * 1997-11-19 1999-11-30 Chan; Yung C. Expandable body device for the gastric cavity and method
US6733512B2 (en) * 2002-03-07 2004-05-11 Mcghan Jim J. Self-deflating intragastric balloon
JP4777017B2 (ja) 2005-08-24 2011-09-21 オリンパスメディカルシステムズ株式会社 胃内留置用バルーン及びバルーン用媒体
WO2009059802A1 (en) * 2007-11-09 2009-05-14 Venera Khafizova Self-deflating gastric balloon device
AU2009241578B2 (en) * 2008-04-28 2014-01-23 Allergan, Inc. Flush patch for elastomeric implant shell
FR2983399B1 (fr) * 2011-12-01 2014-12-05 Life Partners Europ Dispositif intra-gastrique a volume variable
US10314714B2 (en) * 2014-11-04 2019-06-11 Spinal Stabilization Technologies Llc Percutaneous implantable nuclear prosthesis
CN107224342B (zh) * 2017-07-17 2023-09-08 赛克赛斯生物科技股份有限公司 一种单向阀、胃内球囊减肥装置及系统
CN208808762U (zh) * 2017-12-18 2019-05-03 常州至善医疗科技有限公司 一种球囊系统及其连接和释放结构

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130226219A1 (en) * 2011-01-21 2013-08-29 Obalon Therapeutics, Inc. Intragastric device
US8974483B2 (en) 2012-02-21 2015-03-10 Allurion Technologies, Inc. Methods and devices for deploying and releasing a temporary implant within the body
CN204890270U (zh) * 2015-09-01 2015-12-23 王东 可复式胃球囊
CN108158705A (zh) * 2017-12-18 2018-06-15 常州至善医疗科技有限公司 一种用于球囊系统的连接和释放结构

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP3730099A4

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