WO2020048029A1 - 一种可自然降解的植入物 - Google Patents

一种可自然降解的植入物 Download PDF

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Publication number
WO2020048029A1
WO2020048029A1 PCT/CN2018/119122 CN2018119122W WO2020048029A1 WO 2020048029 A1 WO2020048029 A1 WO 2020048029A1 CN 2018119122 W CN2018119122 W CN 2018119122W WO 2020048029 A1 WO2020048029 A1 WO 2020048029A1
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Prior art keywords
balloon
degradable material
naturally degradable
implant according
naturally
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PCT/CN2018/119122
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English (en)
French (fr)
Inventor
陈珊珊
石秀凤
张强
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常州至善医疗科技有限公司
上海盼达医疗科技有限公司
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Publication of WO2020048029A1 publication Critical patent/WO2020048029A1/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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/02—Devices for expanding tissue, e.g. skin tissue
    • 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

Definitions

  • the present application relates to implants, and in particular, to a naturally degradable implant.
  • the main treatments for obesity include: diet control, life intervention, medication and surgery.
  • diet control life intervention
  • medication medication
  • surgery it is difficult to achieve satisfactory weight loss by simple diet control, life intervention and drug treatment.
  • weight loss surgery is obvious, it is difficult to be accepted by patients due to cultural, medical standards and surgical complications.
  • Implantable medical devices for weight loss, simulation of the mechanism of surgical treatment of obesity, including intragastric balloons, have just risen in recent years. Because of their safety, simplicity, effectiveness, and resilience, they have received widespread attention and will become the main reason for future weight loss. Effective means.
  • intragastric balloons there are several types of intragastric balloons on the market, especially intragastric balloons that do not need to be fed through the endoscope, which is the direction of future weight loss methods.
  • the swallowing intragastric balloon is wrapped in a capsule before action, and is connected with a longer catheter.
  • One end of the catheter is connected to the self-closing valve on the intragastric balloon, and the other end is left outside the capsule and the mouth.
  • the balloon and part of the catheter wrapped in the capsule are swallowed into the patient's stomach by swallowing.
  • the capsule rapidly degrades in the acid environment of the stomach, and the fluid is delivered from the external end of the catheter left outside the patient's mouth into the balloon.
  • the compressed state expands to the expanded state.
  • the US patent US8974483B2 discloses an implanted balloon including a hydrogel filler 108 previously placed in the balloon. After the fluid is delivered into the balloon 100 through the catheter 200, the filler 108 expands to compress the balloon. The sac 100 is expanded. The degradable material 106 inside the balloon seals the release channel in a mechanical form, and the degradable material 106 is degraded under the action of the filler or other external substances, and the release channel is opened.
  • the disadvantage of this structure is that the initial volume of the balloon 108 increases the initial volume of the balloon, which is not conducive to swallowing by the patient.
  • the degradation of degradable materials requires the aid of fillers or other external substances, and the operation is complicated. Therefore, how to design an implant that does not need to place a filler in advance, and at the same time, the degradable material can be naturally degraded is an urgent problem in the art.
  • the present application provides a new type of naturally degradable implant.
  • the implant does not have a filler in advance, and the degradable material can be degraded by itself without the need of an external substance.
  • the application provides a naturally degradable implant for occupying the internal space of a patient's body.
  • the implant includes a balloon body, a degradable material, and a fluid-delivery accessory, wherein the fluid-delivery accessory includes a self-closing valve and a catheter fixed on the balloon, and fluid is injected into the balloon through the catheter, and the degradable material is degraded
  • the release channel is opened afterwards, and the fluid is discharged from the balloon, which is characterized in that the degradable material is a naturally degradable material, and the naturally degradable material is located on the surface of the main body of the balloon or the bonding portion of the upper and lower layers of the balloon.
  • the naturally degradable material is a polylactic acid-based copolymer, and preferably, the naturally degradable material is a polylactic acid-caprolactone copolymer or a polylactic acid-trimethylene carbonate copolymer.
  • the naturally degradable material may also be polyparadioxanone.
  • the balloon body includes at least one release channel, and the release channel is sealed by a naturally degradable material.
  • the naturally degradable material is bonded to the surface of the balloon body in the form of a patch.
  • the shape of the naturally degradable material can be oval, similar to the cross-sectional shape of the capsule used, to avoid damage caused by excessive folding of the naturally degradable material in the folded state.
  • the outer periphery and the outer peripheral surface of the naturally degradable material are covered with a covering layer made of at least one layer of the balloon body material or other liquid-impermeable material, so as to control the separation time of the naturally degradable material from the balloon body.
  • the balloon in another embodiment, includes a balloon upper layer and a balloon lower layer, and the balloon upper layer and the balloon lower layer are connected at the edges to form an integrated structure.
  • the bonding methods between the naturally degradable materials and the natural degradable material and the balloon body include bonding or welding.
  • the implant of the present application can be used as an intragastric balloon or as a skin expansion balloon.
  • the naturally degradable implant of the present application no filler is placed in the balloon in advance, which ensures that the balloon can be folded to a small volume, which is convenient for patients to swallow.
  • the degradable materials on the surface of the balloon or between the upper and lower balloons are naturally degradable materials. After being implanted in the human body for a period of time, they degrade on their own and open the release channel without the need to use external magnetic fields, microwaves or changes in gastric pH to induce Degradation. After natural degradation, the balloon can be easily discharged from the body without surgery, which reduces the patient's pain.
  • FIG. 1 is a schematic diagram of a balloon structure according to the prior art
  • FIG. 2 is a schematic structural diagram of a balloon system according to an embodiment of the present application.
  • 3A is a top view of a balloon and a naturally degradable material
  • FIG. 3B is a schematic diagram of a peripheral and outer surface covering layer of a naturally degradable material
  • FIG. 4 is a balloon, a naturally degradable material, and an exploded view thereof according to another embodiment of the present application;
  • FIG. 5 is a top view of a balloon and a naturally degradable material assembled according to FIG. 4;
  • FIG. 6 is a side view of the natural degradable material and the upper and lower layers of the balloon.
  • the implant is a balloon system implanted in vivo, for example, an intragastric balloon system.
  • the balloon system of the present application may be a balloon system for other purposes, such as a skin expansion balloon. Wait.
  • the implantable balloon system includes a balloon 100, a catheter 200, and a capsule (not shown).
  • the balloon 100 is wrapped in a capsule before swallowing, and one end of the catheter 200 is connected to a self-closing valve on the balloon 100.
  • the balloon housing 102 is made of a flexible material such as silicone rubber or polyurethane.
  • the balloon has at least one opening as a release channel 103, and the naturally degradable material 104 seals the release channel in the form of a patch, and the naturally degradable material
  • the combination of 104 and balloon housing 102 includes bonding or welding.
  • the naturally degradable material may be a polylactic acid-based copolymer.
  • the naturally degradable material is a polylactic acid-caprolactone copolymer or a polylactic acid-trimethylene carbonate copolymer.
  • the thickness of the film is 10-100 micrometers.
  • the balloon surface seals the release channel.
  • the naturally degradable material is poly-p-dioxane.
  • Naturally degradable materials can be round, oval, square, or any other shape.
  • FIG. 3B shows that there is a cover layer 105 on the outer periphery and the outer edge surface of the naturally degradable material 104.
  • the cover layer 105 is a ring-shaped structure and is composed of a balloon main body material or other liquid-impermeable material.
  • the capsule shell 102 is bonded or welded, and the inner edge 1052 is bonded or welded with the naturally degradable material 104 to control the separation time of the naturally degradable material 104 from the balloon shell 102.
  • FIGS. 4-6 show a schematic structural diagram of a naturally degradable implant according to another embodiment of the present application. This embodiment is different from the embodiment shown in FIG. 3 in that the naturally degradable material is located in the upper and lower balloons. Of the binding site. The structure and manufacturing method of the balloon system of this embodiment are described in detail below with reference to FIGS. 4-6.
  • FIG. 4 shows the balloon 100, the naturally degradable material 104, and an exploded view thereof.
  • the balloon 100 includes an upper balloon layer 110 and a lower balloon layer 120, and a flip hole 2 is provided on the upper balloon layer 110;
  • the upper balloon layer 110, the lower balloon layer 120, and at least one layer of the naturally degradable material 104 are connected and combined at the edge 1 to form an integrated structure.
  • the naturally degradable material 104 is located in the middle of the joint between the upper layer of the balloon 110 and the lower layer of the balloon 120 to form a degradable release channel. After the combination is completed, it is flipped through the flip hole 2 in the upper layer 110 of the balloon. Finally, the flip hole 2 on the upper layer 110 of the balloon is closed with a patch to form a complete balloon, as shown in FIG. 5.
  • FIG. 6 shows a side view of the degradable material and the upper and lower balloons. As shown in FIG. 6, there is at least one layer of naturally degradable material 104 in the middle of the joint between the upper and lower balloons 110 and 120. 104 due to hydrolysis to form a release channel, the structural integrity of the balloon is destroyed, and the filling in the balloon flows out.
  • the use of the intragastric balloon according to the present application is as follows: After a patient swallows a capsule containing the balloon 100 and a portion of the catheter 200, the capsule dissolves rapidly in the gastric environment, and is delivered and filled into the balloon 100 through the outer end of the catheter 200
  • the filler may be a liquid or a gas.
  • the balloon 100 changes from an initially compressed state to an expanded state. After the filling is completed, the catheter 200 is pulled out, and under the pressure of the filling material inside the balloon 100, the self-closing valve is automatically closed to block the leakage of the filling material in the balloon.
  • the balloon 100 occupies the volume in the stomach to achieve weight loss.
  • the naturally degradable material 104 is hydrolyzed, the release channel is opened, the structural integrity of the balloon 100 is destroyed, and the filling in the balloon is discharged into the patient's stomach.
  • the empty balloon shell 102 eventually follows Gastrointestinal motility is naturally excluded from the body.
  • the naturally degradable implant of the present application no filler is placed in the balloon 100 in advance, which ensures that the balloon can be folded to a small volume, which is convenient for patients to swallow.
  • the degradable material 104 on the outside of the balloon is a naturally degradable material. It degrades itself after being implanted in the patient for a period of time.
  • the release channel is opened without the need to use external magnetic fields, microwaves, or changes in gastric pH to induce degradation.
  • the balloon shell 102 can be easily expelled from the body, and can be removed without surgery, reducing the patient's pain.

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Abstract

本申请公开了一种可降解的植入物，用于占据患者身体内部空间，其包括球囊主体、可降解材料和流体输送附件，其中流体输送附件包括固定于球囊上的自封闭阀和导管，通过导管将流体注入球囊内部，可降解材料降解后开启释放通道，流体从球囊中排出，其中可降解材料为可以自然降解的材料，可自然降解材料位于球囊主体的表面或上下层球囊的结合部位。植入物植入人体一段时间后自行降解，打开释放通道，无需使用外加磁场、微波或改变胃内pH值等外力来诱导降解，降解后球囊可轻松排出体内，无需手术取出，减轻了患者的痛苦。

Description

一种可自然降解的植入物 技术领域
本申请涉及植入物，具体地说，涉及一种可自然降解的植入物。
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 外端向球囊内输送流体，球囊由初始的压缩状态膨胀为扩张态。流体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，以防流体外泄。美国专利US8974483B2即公开了这样一种植入球囊，具体参见图1。
如图1，美国专利US8974483B2公开的这种植入球囊包括在球囊中预先放置的水凝胶填充物108，流体通过导管200输送进球囊100后，填充物108膨胀，将压缩状态的球囊100扩张。位于球囊内部的可降解材料106以机械的形式将释放通道密封，可降解材料106在填充物或其他外加物质的作用下降解，开启释放通道。
这种结构的缺点是预先加入填充物108使球囊初始体积变大，不利于患者吞咽。同时可降解材料的降解需要借助填充物或其他外加物质，操作复杂。因此，如何设计一种不需要预先放置填充物，同时可降解材料可以自然降解的植入物是本领域急需解决的问题。
发明内容
为了解决现有技术存在的问题，本申请提供了一种新型的可自然降解的植入物，该植入物无预先放置填充物，可降解材料可以自行降解，无需借助外加物质。
本申请提供一种可自然降解的植入物，用于占据患者身体内部空间。植入物包括球囊主体、可降解材料和流体输送附件，其中流体输送附件包括固定于球囊上的自封闭阀和导管，通过所述导管将流体注入球囊内部，所述可降解材料降解后开启释放通道，流体从球囊中排出，其特征在于：可降解材料为可自然降解的材料，可自然降解材料位于球囊主体的表面或上下层球囊的结合部位。
在一个实施方式中，可自然降解材料为聚乳酸基共聚物，优选的，可自 然降解材料为聚乳酸-己内酯共聚物或聚乳酸-三亚甲基碳酸酯共聚物。可自然降解材料也可以是聚对二氧环己酮。
球囊主体上包括至少一个释放通道，释放通道被可自然降解材料密封。
优选的，可自然降解材料以补片的形式结合在球囊主体的表面。可自然降解材料的形状可以是椭圆形，与所用胶囊截面形状类似，避免折叠状态时对可自然降解材料的过度折叠而造成损伤。
优选的，在可自然降解材料的外周及外沿表面覆盖由至少一层球囊主体材料或其它液体不可渗透材料制成的覆盖层，以控制可自然降解材料与球囊主体的分离时间。
在另一种实施方式中，球囊包括球囊上层和球囊下层，球囊上层与球囊下层在边沿连接组合成整体结构。在球囊上层和球囊下层的结合部位中间具有至少一层可自然降解材料，形成可自然降解的释放通道。
可自然降解材料之间以及可自然降解材料与球囊主体的结合方式包括粘接或焊接。
本申请的植入物可以用作胃内球囊，也可以用作皮肤扩张球囊。
根据本申请的可自然降解的植入物，球囊内未预先放置填充物，保证了球囊可被折叠至较小体积，方便患者吞咽。球囊表面或上下层球囊之间的可降解材料为可自然降解的材料，植入人体一段时间后自行降解，打开释放通道，无需使用外加磁场、微波或改变胃内pH值等外力来诱导降解，自然降解后球囊可轻松排出体内，无需手术取出，减轻了患者的痛苦。
附图说明
附图用来提供对本申请的进一步理解，并且构成说明书的一部分，与本申请的具体实施方式一起用于解释本申请，并不构成对本申请的限制。
图1为根据现有技术的球囊结构的示意图；
图2为根据本申请一个实施方式的球囊***的结构示意图；
图3A为球囊及可自然降解材料的俯视图；
图3B为可自然降解材料的外周及外沿表面覆盖层示意图；
图4为根据本申请另一个实施方式的球囊、可自然降解材料及其分解图；
图5为根据图4装配的球囊和可自然降解材料的俯视图；
图6为可自然降解材料与球囊上下层的侧视图。
图中标号：1-边沿；2-翻转孔；100-球囊；102-球囊外壳；103-释放通道；104-可自然降解材料；105-覆盖层；1051-外沿；1052-内沿；106-可降解材料；108-填充物；110-球囊上层；120-球囊下层；200-导管。
具体实施方式
下面结合具体实施方式对本申请作进一步的说明，其中，附图仅用于示例性说明，表示的仅是示意图，而非实物图，不能理解为对本专利的限制，为了更好地说明本申请的具体实施方式，附图某些部件会有省略、放大或缩小，并不代表实际产品的尺寸，对本领域技术人员来说，附图中某些公知结构及其说明可能省略是可以理解的，基于本申请中的具体实施方式，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他具体实施方式，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可自然降解的植入物的结构示意图。优选地，该植入物为体内植入球囊***，例如为胃内球囊***，本领域技术人员容易想到本申请的球囊***可以是用于其他目的球囊***，如皮肤扩张球囊等。体内植入球囊***包括：球囊100、导管200和胶囊(图中未显示)。球囊100在吞咽前被包裹在胶囊中，所述导管200一端与球囊100上的自封闭阀相连。
下面参照附图详细描述该实施方式的球囊***的结构及制作方法。参见图3A，球囊外壳102由硅橡胶或聚氨酯等柔性材料制成，球囊上有至少一个开口作为释放通道103，可自然降解材料104以补片的形式将释放通道密封，可自然降解材料104与球囊外壳102的结合方式包括粘接或焊接。
可自然降解材料可以是聚乳酸基共聚物，优选地，可自然降解材料为聚乳酸-己内酯共聚物或聚乳酸-三亚甲基碳酸酯共聚物，薄膜厚度为10-100微米，结合在球囊表面对释放通道起密封作用。在另一些方式中，可自然降解材料为聚对二氧环己酮。可自然降解材料可以是圆形、椭圆形、方形、或其他任意形状。
图3B示出在可自然降解材料104的外周及外沿表面有一层覆盖层105，所述覆盖层105为环形结构，由球囊主体材料或其它液体不可渗透材料组成，其外沿1051与球囊外壳102粘接或焊接，内沿1052与可自然降解材料104粘接或焊接，以控制可自然降解材料104与球囊外壳102的分离时间。
图4-6示出根据本申请另外一个实施方式的可自然降解的植入物的结构示意图，该实施方式与图3所示的实施方式不同之处在于：可自然降解材料位于上下层球囊的结合部位。下面参照图4-6详细描述该实施方式的球囊***的结构及制作方法。
具体而言，图4示出所述球囊100、可自然降解材料104及其分解图，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；球囊上层110、球囊下层120和至少一层可自然降解材料104在边沿1通过粘接或焊接的方式连接组合成整体结构。可自然降解材料104位于球囊上层110和球囊下层120的结合部位中间，形成可降解的释放通道。组合完成后通过球囊上层110上的翻转孔2进行翻转。最后将球囊上层110上的翻转孔2用补片封闭，形成完整的球囊，如图5所示。
图6示出可降解材料与上下层球囊的侧视图，如图6所示，在上层球囊110和下层球囊120的结合部位中间有至少一层可自然降解材料104，可自然降解材料104因水解形成释放通道，球囊的结构完整性被破坏，球囊内的填充物流出。
根据本申请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，该填充物可以是液体，也可以是气体。球囊100由初始的压缩态变为膨胀态。填充完毕拔出导管200，在球囊100内部填充物的压力下，自封闭阀自动闭合，阻挡球囊内填充物的泄漏。球囊100占据胃内体积，达到减重的目的。植入人体一段时间后，可自然降解材料104水解，释放通道被打开，球囊100的结构完整性被破坏，球囊内填充物排出至患者胃中，排空后的球囊外壳102最终随胃肠蠕动自然排除体外。
根据本申请的可自然降解的植入物，球囊100内未预先放置填充物，保证了球囊可被折叠至较小体积，方便患者吞咽。球囊外部的可降解材料104为可自然降解的材料，植入患者体内一段时间后自行降解，打开释放通道，无需使用外加磁场、微波或改变胃内pH值等外力来诱导降解，自然降解后球囊外壳102可轻松排出体内，无需手术取出，减轻了患者的痛苦。
尽管已经示出和描述了本申请的具体实施方式，对于本领域的普通技术人员而言，可以理解在不脱离本申请的原理和精神的情况下，可以对这些具体实施方式进行多种变化、修改、替换和变型，本申请的范围由所附权利要求及其等同物限定。

Claims (15)

  1. 一种植入物，包括球囊主体、可降解材料和流体输送附件，其中所述流体输送附件包括固定于球囊主体上的自封闭阀和导管，通过所述导管将流体注入球囊主体内部，所述可降解材料降解后开启释放通道，流体从球囊主体中排出，其特征在于，可降解材料为可自然降解的材料。
  2. 根据权利要求1所述的植入物，其特征在于，所述可自然降解材料位于球囊主体的表面。
  3. 根据权利要求2所述的植入物，其特征在于，所述球囊主体上包括至少一个释放通道，所述释放通道被所述可自然降解材料密封。
  4. 根据权利要求3所述的植入物，其特征在于，所述可自然降解材料以补片的形式结合在球囊主体的表面。
  5. 根据权利要求4所述的植入物，其特征在于，所述可自然降解材料的外周及外沿表面覆盖由至少一层球囊主体材料或其它液体不可渗透材料制成的覆盖层，以控制可自然降解材料与球囊主体的分离时间。
  6. 根据权利要求5所述的植入物，其特征在于，所述覆盖层为环形，其外沿与球囊外壳粘接或焊接，内沿与可自然降解材料粘接或焊接。
  7. 根据权利要求1所述的植入物，其特征在于，所述球囊包括球囊上层和球囊下层，所述可自然降解材料位于上下层球囊的结合部位，形成可自然降解的释放通道。
  8. 根据权利要求7所述的植入物，其特征在于，所述球囊上层设置翻转孔，所述球囊下层和至少一层可自然降解材料在边沿连接组合成整体结构，组合完成后通过所述球囊上层上的所述翻转孔进行翻转，完成后将所述球囊上层上的所述翻转孔用补片封闭，形成完整的球囊主体。
  9. 根据权利要求2-8中任一项所述的植入物，其特征在于，可自然降解材料之间以及可自然降解材料与球囊主体的结合方式包括粘接或焊接。
  10. 根据权利要求1所述的植入物，其特征在于，所述可自然降解材料为 聚乳酸基共聚物。
  11. 根据权利要求10所述的植入物，其特征在于，所述可自然降解材料为聚乳酸-己内酯共聚物或聚乳酸-三亚甲基碳酸酯共聚物。
  12. 根据权利要求1所述的植入物，其特征在于，所述可自然降解材料为聚对二氧环己酮。
  13. 根据权利要求10-12任一项所述的植入物，其特征在于，所述可自然降解材料是厚度为10-100微米的薄膜。
  14. 根据权利要求2所述的植入物，其特征在于，所述可自然降解材料的形状可以是椭圆形，圆形，方形，或其他任意形状。
  15. 根据权利要求1任一项所述的植入物，所述植入物为胃内球囊或皮肤扩张球囊。
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