技术领域technical field
本发明涉及医疗器械装置技术领域，具体是一种胃镜辅助的胃减容装置。The invention relates to the technical field of medical devices, in particular to a gastric volume reduction device assisted by a gastroscope.
背景技术Background technique
植入胃减容球囊作为物理治疗肥胖的一种方法，其作用原理是具有一定体积的球囊占据了胃内空间，减少了胃的容量，使患者少量进食即产生饱胀感，从而通过控制进食量达到控制和改善体重的目的。但是目前使用的减肥球囊均为单纯以生理盐水等液体为填充物，在使用过程中，由于球囊填充物质量较大等原因，部份患者会出现胃下垂、胃部不适等症状，影响患者健康，降低生活质量；另外，目前使用的减肥球囊均为单层球囊，存在着球囊破裂后进入肠道造成肠梗阻的风险；同时由于填充液的充入量较大，在球囊取出时，也会造成填充液的抽取过程较为繁琐。Implantation of gastric volume reduction balloons is a method of physical therapy for obesity. The principle of action is that the balloon with a certain volume occupies the space in the stomach, reduces the capacity of the stomach, and makes the patient feel full after eating a small amount. Control food intake to control and improve body weight. However, the weight loss balloons currently used are all filled with normal saline and other liquids. During use, due to the large weight of the balloon filling, some patients will experience symptoms such as gastroptosis and stomach discomfort, which will affect the patient. health and reduce the quality of life; in addition, currently used weight loss balloons are all single-layer balloons, and there is a risk of intestinal obstruction after the balloon ruptures; at the same time, due to the large amount of filling fluid, the When taking it out, it will also cause the extraction process of the filling liquid to be relatively cumbersome.
发明内容Contents of the invention
为了减少胃减容球囊在使用过程中患者出现胃下垂和胃部不适及球囊破裂造成肠梗阻等风险，本发明提供一种双囊型胃减容装置。In order to reduce the risk of gastroptosis, stomach discomfort and intestinal obstruction caused by balloon rupture during the use of the gastric volume reduction balloon, the present invention provides a double-capsule gastric volume reduction device.
本发明采用的技术方案是：一种双囊型胃减容装置，包括球囊部分和管路部分，球囊部分包括液体囊(1)、气体囊(2)和三腔管(3)，管路部分包括外套膜(11)、接头(12)、导管(13)，所述液体囊(1)包裹气体囊(2)，三腔管(3)末端通过接头(12)与导管(13)连接，球囊部分与接头(12)和导管(13)相通。The technical solution adopted in the present invention is: a double-bag gastric volume reduction device, including a balloon part and a pipeline part, the balloon part includes a liquid bag (1), a gas bag (2) and a three-lumen tube (3), The pipeline part includes a mantle (11), a joint (12), and a catheter (13). The liquid bag (1) wraps the gas bag (2), and the end of the three-lumen tube (3) passes through the joint (12) and the catheter (13). ) connection, the balloon part communicates with the joint (12) and the catheter (13).
所述三腔管(3)由高分子材料制成，3个管腔分别为充液腔(6)、充气腔(8)以及导丝腔(7)。The three-lumen tube (3) is made of polymer material, and the three lumens are respectively a fluid-filled cavity (6), an air-filled cavity (8) and a guide wire cavity (7).
所述液体囊(1)采用硅橡胶材料制成，壁厚0.2～1mm；气体囊(2)由硅橡胶或者其他高弹性的高分子材料制成，壁厚0.2～1mm。The liquid capsule (1) is made of silicon rubber material with a wall thickness of 0.2-1 mm; the gas capsule (2) is made of silicon rubber or other high-elastic polymer materials with a wall thickness of 0.2-1 mm.
所述液体囊(1)和气体囊(2)固定在三腔管(3)上，三腔管(3)管壁上开有两个侧孔(9)，使充液腔(6)与液体囊(1)连通，充气腔(8)与气体囊(2)连通；侧孔(9)处包覆有弹性良好的薄壁管(4)，薄壁管(4)的一端与三腔管(3)粘结，其余部分紧紧包围管壁，可以实现腔体与球囊内液体或气体的单向流通。The liquid bag (1) and the gas bag (2) are fixed on the three-cavity tube (3), and two side holes (9) are opened on the tube wall of the three-cavity tube (3), so that the liquid-filled cavity (6) and The liquid bag (1) is connected, and the inflatable chamber (8) is connected with the gas bag (2); the side hole (9) is covered with a thin-walled tube (4) with good elasticity, and one end of the thin-walled tube (4) is connected to the three-chamber The tube (3) is bonded, and the remaining part tightly surrounds the tube wall, so that the one-way communication between the cavity and the liquid or gas in the balloon can be realized.
所述三腔管(3)的末端设有止逆塞(10)，采用弹性高分子材料制成，在植入胃减容球时可以对接头起到防脱作用；植入后止逆塞(10)的缝隙可自动闭合，防止三腔管内充液腔或充气腔的液体或气体流出。The end of the three-lumen tube (3) is provided with a non-return plug (10), which is made of an elastic polymer material, and can prevent the joint from falling off when the gastric volume reduction ball is implanted; The slit of (10) can be automatically closed to prevent the liquid or gas from flowing out of the liquid-filled cavity or the gas-filled cavity in the three-cavity tube.
所述三腔管(3)的前端进行圆滑处理，充气腔(6)和充液腔(8)前端被封堵，导丝腔(7)前端未封堵，保持敞开状态，末端通过止逆塞(10)可与接头(12)的中心孔对接。The front end of the three-lumen tube (3) is smoothed, the front ends of the air-filled chamber (6) and the liquid-filled chamber (8) are blocked, the front end of the guide wire chamber (7) is not blocked, and remains open, and the end passes through the non-return The plug (10) can be docked with the central hole of the joint (12).
在所述止逆塞(10)的外周安装有取出环(5)，该环为柔性细线，优选医用缝合线，利用该环可方便地取出球囊。A take-out ring (5) is installed on the outer periphery of the non-return plug (10), and the ring is a flexible thread, preferably a medical suture thread, and the balloon can be easily taken out by using the ring.
所述管路部分，接头(12)前端为两个分叉的塔状插接头，可从三腔管(3)末端插入，分别与充液腔(6)、充气腔(8)连通，接头的中央有中心孔，可容导丝通过；接头(12)的末端与导管(13)连接并相通。In the pipeline part, the front end of the joint (12) is two bifurcated tower-shaped plug joints, which can be inserted from the end of the three-chamber tube (3), and communicate with the liquid-filled chamber (6) and the air-filled chamber (8) respectively. There is a central hole in the center of the tube, which can accommodate the passage of the guide wire; the end of the joint (12) is connected and communicated with the catheter (13).
所述管路部分，导管(13)为三腔软管，其尺寸、结构与球囊部分三腔管(3)的三个对应腔道相同，并可通过接头分别连通；导管的末端，还分别有充液管(14)、充液座(15)与充液腔连通，充气管(16)、充气座(17)与充气腔连通。The pipeline part, the catheter (13) is a three-lumen flexible pipe, the size and structure of which are the same as the three corresponding lumens of the three-lumen tube (3) of the balloon part, and can be connected respectively through joints; the end of the catheter is also The liquid filling pipe (14), the liquid filling seat (15) are respectively communicated with the liquid filling cavity, and the gas charging tube (16), the gas filling seat (17) are communicated with the gas filling cavity.
所述管路部分，外套膜(11)是一个柔软的薄壁管，由弹性高分子材料制成，优选硅橡胶材料，薄壁管(11)一端收口与导管(13)前端粘结，其余部分平直，壁厚0.2～1mm，外套膜沿纵向均布4～8个切口，切口长2～6mm。In the pipeline part, the mantle (11) is a soft thin-walled tube made of elastic polymer material, preferably silicone rubber material. One end of the thin-walled tube (11) is bonded to the front end of the catheter (13), and the rest The part is straight, the wall thickness is 0.2-1mm, and the mantle is evenly distributed along the longitudinal direction with 4-8 incisions, and the incision length is 2-6mm.
使用前的胃减容装置以预装的形式提供，预装状态的球囊部分被抽空，沿三腔管(3)折叠整齐呈细长条状，接头(12)与三腔管末端插接，外套膜紧紧包裹住球囊。The gastric volume reduction device before use is provided in a pre-installed form, the pre-installed balloon part is evacuated, folded neatly along the three-lumen tube (3) into a slender strip, and the connector (12) is inserted into the end of the three-lumen tube , the mantle tightly wraps the balloon.
本发明的优点是：通过改变气体囊和液体囊的体积，可以调整整个球囊的比重，在不影响球囊体积的前提下改变球囊的重量，减轻球囊对胃壁的压迫，降低引起胃下垂的隐患；双球囊设计可以避免万一出现单层球囊破裂造成肠梗阻的风险；设计有导丝腔使球囊推送方便；设计有取出环使球囊易于取出。The advantages of the present invention are: by changing the volume of the gas capsule and the liquid capsule, the specific gravity of the entire balloon can be adjusted, the weight of the balloon can be changed without affecting the volume of the balloon, the pressure of the balloon on the stomach wall can be reduced, and gastroptosis can be reduced. hidden danger; the double-balloon design can avoid the risk of intestinal obstruction in case of rupture of the single-layer balloon; the design of the guide wire lumen makes the balloon push convenient; the design of the take-out ring makes the balloon easy to take out.
附图说明Description of drawings
图1双囊型球囊的构造图。Figure 1 Structural diagram of the double-capsule balloon.
图2管路部分示意图。Figure 2 is a schematic diagram of the pipeline.
图3预装的胃减容装置示意图。Figure 3 Schematic diagram of the pre-installed gastric volume reduction device.
图4球囊与接头连接示意图。Figure 4 Schematic diagram of the connection between the balloon and the joint.
图中：1.液体囊，2.气体囊，3.三腔管，4.薄壁管，5.取出环，6.充液腔，7.导丝腔，8.充气腔，9.侧孔，10.止逆塞，11.外套膜，12.接头，13.导管，14.充液管，15.充液座，16.充气管，17.充气座，A.球囊部分，B.管路部分。In the figure: 1. Liquid bladder, 2. Gas bladder, 3. Three-lumen tube, 4. Thin-walled tube, 5. Removal ring, 6. Fluid-filled cavity, 7. Guide wire cavity, 8. Inflatable cavity, 9. Side Hole, 10. Non-return plug, 11. Mantle, 12. Connector, 13. Catheter, 14. Liquid-filled tube, 15. Liquid-filled seat, 16. Inflatable tube, 17. Inflatable seat, A. Balloon part, B .Pipeline section.
具体实施方式detailed description
为了更好地理解本发明专利，下面结合附图和实施例作进一步描述。In order to better understand the patent of the present invention, the following will be further described in conjunction with the accompanying drawings and embodiments.
一种双囊型胃减容装置，包括球囊部分和管路部分。A double-bag gastric volume reduction device includes a balloon part and a pipeline part.
球囊部分如图1所示，球囊部分包括液体囊(1)、气体囊(2)和三腔管(3)。液体囊(1)和气体囊(2)固定在三腔管(3)上，液体囊(1)包裹着气体囊(2)。液体囊(1)采用硅橡胶材料制成，壁厚0.2～1mm；气体囊(2)由硅橡胶或者其他高弹性的高分子材料制成，壁厚0.2～1mm。液体囊(1)和气体囊(2)可通过注入量的不同来改变二者的体积。三腔管由高分子材料制成，三腔管(3)的3个管腔分别为充液腔(6)、充气腔(8)以及导丝腔(7)。三腔管(3)管壁上开有两个侧孔(9)，通过侧孔(9)，两个球囊分别与充液腔(6)、充气腔(8)连通；三腔管的侧孔处包覆有弹性良好的薄壁管(4)，薄壁管(4)的一端与三腔管(3)粘结，其余部分紧紧包围住三腔管管壁，可以实现腔体与球囊内液体或气体的单向流通。三腔管(3)的末端设有止逆塞(10)，采用弹性高分子材料制成，在植入胃减容球时可以对接头起到防脱作用；植入后止逆塞(10)的缝隙可自动闭合，防止三腔管(3)内充液腔或充气腔的液体或气体流出三腔管。在止逆塞(10)的外周安装有取出环(5)，该环为柔性细线(医用缝合线)，利用该环可方便地将球囊取出。三腔管(3)的前端进行圆滑处理，除导丝腔外，充气腔和充液腔被封堵。The balloon part is shown in Fig. 1, and the balloon part includes a liquid bag (1), a gas bag (2) and a three-lumen tube (3). The liquid bag (1) and the gas bag (2) are fixed on the three-lumen tube (3), and the liquid bag (1) wraps the gas bag (2). The liquid capsule (1) is made of silicon rubber material with a wall thickness of 0.2-1mm; the gas capsule (2) is made of silicon rubber or other high-elastic polymer materials with a wall thickness of 0.2-1mm. The volumes of the liquid capsule (1) and the gas capsule (2) can be changed by different injection volumes. The three-lumen tube is made of polymer material, and the three lumens of the three-lumen tube (3) are respectively a fluid-filled cavity (6), an air-filled cavity (8) and a guide wire cavity (7). Have two side holes (9) on the wall of the three-lumen tube (3), through the side holes (9), the two balloons communicate with the liquid-filled cavity (6) and the gas-filled cavity (8) respectively; The side hole is covered with a thin-walled tube (4) with good elasticity. One end of the thin-walled tube (4) is bonded to the three-lumen tube (3), and the rest of the tube tightly surrounds the wall of the three-lumen tube, so that the cavity can be realized One-way communication with liquid or gas inside the balloon. The end of the three-lumen tube (3) is provided with a non-return plug (10), which is made of elastic polymer material, and can prevent the joint from falling off when the gastric volume reduction ball is implanted; after implantation, the non-return plug (10) ) can be automatically closed to prevent the liquid or gas in the liquid-filled cavity or air-filled cavity in the three-lumen tube (3) from flowing out of the three-lumen tube. A take-out ring (5) is installed on the periphery of the non-return plug (10), which is a flexible thread (medical suture), and the balloon can be taken out easily by using the ring. The front end of the three-cavity tube (3) is processed smoothly, and except for the guide wire cavity, the air-filled cavity and the liquid-filled cavity are blocked.
管路部分如图2所示，管路部分包括外套膜(11)、接头(12)、导管(13)、充液管(14)、充液座(15)、充气管(16)、充气座(17)。接头前端的两个分叉为插接头，设计成塔状结构，与三腔管末端止逆塞(10)插接，分别与充液腔(6)、充气腔(8)连通，接头的中央有中心孔，可容导丝通过；接头的末端与导管连接。导管为三腔软管，导管的三个腔道的尺寸、结构与球囊部分三腔管的三个对应腔道相同，并通过接头分别连通；导管的末端，充液管、充液座与充液腔连通，充气管、充气座与充气腔连通。外套膜(11)是一个柔软的薄壁管，由弹性高分子材料制成，优选硅橡胶材料，一端收口与导管(13)前端粘结，其余部分平直，壁厚0.2～1mm，外套膜沿纵向均布4～8个切口，切口长2～6mm。The pipeline part is shown in Figure 2, and the pipeline part includes a mantle (11), a joint (12), a conduit (13), a liquid filling tube (14), a liquid filling seat (15), an inflation tube (16), an air seat (17). The two forks at the front end of the joint are plug joints, which are designed as a tower structure, and are inserted into the check plug (10) at the end of the three-cavity tube, and respectively communicated with the liquid-filled chamber (6) and the air-filled chamber (8). Has a central hole through which a guide wire can pass; the end of the connector is connected to the catheter. The catheter is a three-lumen hose. The size and structure of the three lumens of the catheter are the same as those of the three corresponding lumens of the three-lumen tube of the balloon part, and they are respectively connected through joints; the end of the catheter, the liquid filling tube, the liquid filling seat and the The liquid-filled cavity is connected, and the gas-filled tube and the gas-filled seat are connected with the gas-filled cavity. The mantle (11) is a soft thin-walled tube made of elastic polymer material, preferably silicone rubber material, one end of which is closed and bonded to the front end of the catheter (13), and the rest is straight, with a wall thickness of 0.2-1mm. 4 to 8 incisions are evenly distributed along the longitudinal direction, and the length of the incision is 2 to 6 mm.
双囊型胃减容装置使用前的预装状态如图3所示，双囊型胃减容装置包括球囊和管路两个部分组成，预装状态的球囊被抽空、沿三腔管折叠整齐呈细长条状，接头与三腔管末端插接，外套膜紧紧包裹住球囊。The pre-installed state of the double-bag gastric volume reduction device before use is shown in Figure 3. The double-bag gastric volume reduction device consists of two parts: a balloon and a tube. It is neatly folded into a slender strip, the connector is inserted into the end of the three-lumen tube, and the mantle tightly wraps the balloon.
临床使用时，通过胃镜将导丝送入患者胃内，然后退出胃镜使导丝前端留在胃部；导丝尾端穿入球囊导丝腔(7)，通过接头(12)从导管(13)的导丝腔穿出，然后在导丝的引导下把胃减容装置推送至胃内，确认球囊部分到达预定位置后，用注射器从充气座(17)向气体囊(1)充入定量气体，使气体囊充盈；然后用注射器从充液座(15)向液体囊(2)充入液体，使液体囊不断充盈膨胀达到所需的体积；球囊膨胀的时候会将外套膜(11)胀破，使球囊从外套膜中脱出(见图4)，轻拉导管(13)，接头(12)与球囊脱离开，继续抽拉导管， 将导丝、导管连同破的外套膜等全部管路部分通过食道从患者胃内抽拉出来。一般，球囊在胃内放置3～6月。治疗结束后将球囊取出时，先将球囊内的液体及气体在胃镜下用注射针穿刺抽出，然后用活检钳夹住取出环(5)，将胃镜和球囊一并取出体外。In clinical use, the guide wire is sent into the stomach of the patient through the gastroscope, and then withdrawn from the gastroscope so that the front end of the guide wire stays in the stomach; 13) through the guide wire cavity, and then push the gastric volume reduction device into the stomach under the guidance of the guide wire. After confirming that the balloon part has reached the predetermined position, use a syringe to inflate the gas bag (1) from the inflation seat (17). Inject a certain amount of gas to fill the gas bag; then use a syringe to fill the liquid bag (2) with liquid from the liquid filling seat (15), so that the liquid bag is continuously filled and expanded to reach the required volume; when the balloon is inflated, the mantle will be (11) Burst to make the balloon detach from the mantle (see Figure 4), lightly pull the catheter (13), the joint (12) is separated from the balloon, continue to pull the catheter, and pull the guide wire, catheter together with the damaged The entire tubing section, including the mantle, is pulled out of the patient's stomach through the esophagus. Generally, the balloon is placed in the stomach for 3 to 6 months. When the balloon is taken out after the treatment, the liquid and gas in the balloon are punctured out with an injection needle under the gastroscope, and then the extraction ring (5) is clamped with biopsy forceps, and the gastroscope and the balloon are taken out of the body together.
以上所述仅为本发明的较佳实施例，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。The above descriptions are only preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included in the protection of the present invention. within range.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610597015.XACN106073960B (en) | 2016-07-27 | 2016-07-27 | A double-capsule gastric volume reducing device |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610597015.XACN106073960B (en) | 2016-07-27 | 2016-07-27 | A double-capsule gastric volume reducing device |
| Publication Number | Publication Date |
|---|---|
| CN106073960Atrue CN106073960A (en) | 2016-11-09 |
| CN106073960B CN106073960B (en) | 2019-06-14 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610597015.XAExpired - Fee RelatedCN106073960B (en) | 2016-07-27 | 2016-07-27 | A double-capsule gastric volume reducing device |
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| CN (1) | CN106073960B (en) |
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| CN104507400A (en)* | 2012-08-02 | 2015-04-08 | W.L.戈尔及同仁股份有限公司 | space filling device |
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| CN205084182U (en)* | 2015-11-06 | 2016-03-16 | 中南大学湘雅医院 | Telescopic stomach tube with air bag |
| CN206167125U (en)* | 2016-07-27 | 2017-05-17 | 山东省药学科学院 | Bitunicate type stomach subtracts appearance and dress and puts |
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| Date | Code | Title | Description |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
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| CF01 | Termination of patent right due to non-payment of annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee | Granted publication date:20190614 Termination date:20200727 |