Intragastric balloon recovery device and system for taking out intragastric balloon

Abstract

The invention discloses an intragastric balloon recovery device and a system for taking out an intragastric balloon, and relates to the technical field of medical instruments. By arranging the pushing assembly and the locking assembly, the locking assembly can control the pushing piece to move and be fixed in the outer sleeve, then the puncture needle at the far end is pushed out of the outer sleeve or fixed in the outer sleeve, the puncture needle can stretch out of the outer sleeve and puncture the intragastric balloon, and the fixed balloon is limited in the intragastric balloon; therefore, the medium in the intragastric balloon and the intragastric balloon body can be drawn out through a single instrument and single operation. The process is easy to operate, operation instruments do not need to be replaced frequently, and the suction process is stable; the design of the Y-shaped Luer taper ensures that the suction channel and the puncture structure of the pushing assembly are separated on the holding handle, so that the intragastric balloon recovery device provided by the invention can realize the suction function without completely extracting the needle out of the outer sleeve.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a gastric balloon recovery device and a system for gastric balloon removal. BACKGROUND

[0002] Obesity and overweight are important risk factors for chronic diseases such as cardiovascular disease, diabetes, etc. In recent decades, obesity has increased dramatically in prevalence worldwide, and is a major health problem that causes economic burden in contemporary society. Traditional treatment methods for obesity include dietary control, lifestyle intervention, and drug therapy, etc., but these means are rarely able to achieve long-term and significant weight loss. Surgical intervention is the only long-term effective method for weight loss and improvement of obesity-related comorbidities. However, the invasiveness, safety, and potential adverse reactions after surgery make the patients receiving surgical intervention less than 1% of the population suitable for obesity.

[0003] In recent years, some regions have gradually shifted the weight loss method to non-invasive weight loss. The existing non-invasive weight loss method is mainly gastric balloon. When the gastric balloon is implanted in the body, it can produce a feeling of satiety due to its expansion, which can provide excellent weight loss effect for the user. Generally, it is implanted in the body for 4-6 months, and the weight loss rate can reach 10-15%.

[0004] Currently, the gastric balloon is usually removed by an endoscope system. The injection needle is sent into the stomach through the endoscope system, the balloon is punctured, and then the foreign body forceps is used to remove it. This process is complex and requires multiple changes of operating instruments, and there is a risk of contamination of the endoscope lumen during the replacement process. In addition, some gastric balloons are gastric water balloons. The gastric water balloon is directly punctured in the stomach after being implanted in the body for a period of time. The water in the water balloon is sealed for a long time, which is inevitable to breed bacteria. When the water balloon is removed, the water in the water balloon is discharged into the gastrointestinal tract, which is easy to cause vomiting and diarrhea in patients.

[0005] In view of this, the present application is proposed. SUMMARY

[0006] The purpose of the present application is to provide a gastric balloon recovery device and a system for gastric balloon removal.

[0007] The present application is implemented as follows: In a first aspect, the present application provides a gastric balloon recovery device, comprising a sleeve assembly, a balloon fixing assembly, a puncture needle, a pushing assembly, a holding handle, and a locking assembly.

[0008] The sleeve assembly comprises an outer sleeve, one end of the outer sleeve being fixedly connected with the holding handle.

[0009] The push assembly comprises a push member accommodated in the inner cavity of the outer sleeve and selectively movable in the inner cavity of the outer sleeve, one end of the push member being fixedly connected with the puncture needle selectively accommodated in the inner cavity of the outer sleeve, the other end of the push member extending out of the outer sleeve being provided with the locking assembly.

[0010] The balloon fixing assembly comprises a fixing balloon and an inflation tube, the fixing balloon being sleeved on the end of the outer sleeve away from the holding handle and configured to be positioned in the stomach balloon after being inflated, the fixing balloon and the inflation tube being in communication, and the end of the inflation tube away from the fixing balloon being fixedly connected with the holding handle.

[0011] The holding handle comprises a Y-shaped luer joint, the Y-shaped luer joint comprising a suction joint and an inflation joint, the suction joint being in communication with the outer sleeve, and the inflation joint being in communication with the inflation tube.

[0012] In an optional embodiment, the push member comprises a straight pipe push member and a bent pipe push member connected in sequence, the bent pipe push member being fixedly connected with the puncture needle, the straight pipe push member being accommodated in the outer sleeve and sequentially passing through the holding handle and the locking assembly outside the outer sleeve.

[0013] Preferably, the bent pipe push member comprises any one of a steel wire rope, a soft plastic rod and a soft plastic tube.

[0014] Preferably, the straight pipe push member comprises any one of a push rod, a hard plastic rod and a hard plastic tube.

[0015] In an optional embodiment, the sleeve assembly further comprises a guide head located at the end of the outer sleeve away from the holding handle, the guide head being a hollow structure.

[0016] In an optional embodiment, the diameter of the end of the guide head away from the outer sleeve is smaller than the diameter of the end of the guide head close to the outer sleeve.

[0017] In an optional embodiment, the shape of the guide head comprises any one of a conical shape, a hemispherical shape and an aerodynamic shape.

[0018] In an optional embodiment, the diameter of the puncture needle is 0.7-1.4 mm, preferably 0.9-1.3 mm, and more preferably 0.9-1.0 mm.

[0019] And / or, the inner diameter of the outer sleeve is 1.7-2.1 mm, preferably 1.8-2.0 mm, and more preferably 1.9-2.0 mm.

[0020] And / or, the diameter d of the puncture needle and the inner diameter D of the outer sleeve satisfy D-d≥0.9 mm.

[0021] In an optional embodiment, the locking assembly comprises a locking handle, a locking seat, and a locking seal, the locking seat is internally provided with a hollow channel, and the channel is provided with a recessed locking area at one end, the locking seal is arranged in the locking area, the locking seal is sleeved on the surface of the pushing member, and the locking handle and the locking seat are movably connected in the locking area to realize the compression and unlocking of the locking seal.

[0022] Preferably, the connection mode of the locking handle and the locking seat comprises any one of threaded connection, glue bonding, ultrasonic welding, and heating fusion.

[0023] Preferably, the locking seat is integrally formed with the holding handle, and the locking handle is located on the side of the holding handle away from the outer sleeve.

[0024] In an optional embodiment, the diameter of the fixed balloon after inflation is greater than the outer diameter of the outer sleeve and less than the inner diameter of the endoscope channel.

[0025] Preferably, the inflation tube is sleeved on the surface of the outer sleeve.

[0026] In an optional embodiment, the pushing assembly further comprises a push-pull handle arranged at the end of the pushing member away from the puncture needle.

[0027] In a second aspect, the present application provides a system for removing a gastric balloon, comprising a suction device, an inflation device, an endoscope system, and a device according to any one of the preceding embodiments, the suction device is in communication with the suction connector, the inflation device is in communication with the inflation connector, the endoscope system comprises an endoscope channel, the puncture needle, the pushing assembly located in the outer sleeve, the outer sleeve, and the inflation tube can be selectively accommodated in the endoscope channel.

[0028] The present application has the following beneficial effects: The present application provides a gastric balloon recovery device and a system for removing a gastric balloon, by arranging a pushing assembly and a locking assembly, the locking assembly can control the movement and fixation of the pushing member in the outer sleeve, and then push the puncture needle at the distal end out of the outer sleeve or fix it in the outer sleeve, the puncture needle can be extended out of the outer sleeve and pierce the gastric balloon, and the fixed balloon is limited in the gastric balloon to realize that the medium in the gastric balloon and the gastric balloon body can be extracted through a single instrument and a single operation. The process is simple to operate, the operation instrument does not need to be frequently replaced, and the suction process is stable; the design of the Y-shaped luer connector ensures that the suction channel and the puncture structure of the pushing assembly are separated on the holding handle, so that the gastric balloon recovery device provided by the present application can realize the suction function without completely extracting the needle out of the outer sleeve. BRIEF DESCRIPTION OF DRAWINGS

[0029] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed to be used in the embodiments will be briefly introduced as follows. It should be understood that the following drawings only show some of the embodiments of the present application, and therefore should not be regarded as a limitation to the scope, and other related drawings can also be obtained by those of ordinary skill in the art without any creative effort, based on these drawings.

[0030] Figure 1 The structure schematic diagram of the gastric balloon recovery device provided by the embodiments of the present application is shown in the figure. Figure 2 The sleeve assembly and the connection structure schematic diagram thereof provided by the embodiments of the present application are shown in the figure. Figure 3 The puncture needle and the push assembly connection structure schematic diagram provided by the embodiments of the present application are shown in the figure. Figure 4 The connection structure schematic diagram of the holding handle and the locking assembly provided by the embodiments of the present application is shown in the figure. Figure 5 The balloon fixing assembly and the connection structure schematic diagram thereof provided by the embodiments of the present application are shown in the figure. Figure 6 The enlarged view of the A area in the figure is shown in the figure. Figure 1 The enlarged view of the B area in the figure is shown in the figure. Figure 7 The enlarged view of the A area in the figure is shown in the figure. Figure 1 The enlarged view of the B area in the figure is shown in the figure. Figure 8 The gastric balloon recovery device provided by the embodiments of the present application in the initial state is shown in the figure. Figure 1 The enlarged view of the A area structure in the figure is shown in the figure. Figure 9 The gastric balloon recovery device provided by the embodiments of the present application in the puncture state is shown in the figure. Figure 1 The enlarged view of the A area structure in the figure is shown in the figure. Figure 10 The gastric balloon recovery device provided by the embodiments of the present application in the suction state is shown in the figure. Figure 1 The enlarged view of the A area structure in the figure is shown in the figure. Figure 11 The cross-sectional structure schematic diagram of the outer sleeve and the puncture needle of the gastric balloon recovery device provided by the embodiments of the present application is shown in the figure. Figure 12 The initial structure diagram of the gastric balloon used in the effect verification experiment process of the present application is shown in the figure. Figure 13 The structure diagram of the gastric balloon after being punctured and the suction being finished in the effect verification experiment process of the present application is shown in the figure.

[0031] Main component symbol explanation: 100-gastric balloon recovery device; 110-cannula assembly; 111-outer cannula; 112-guide head; 120-piercing needle; 130-pushing assembly; 131-pushing member; 1311-steel wire rope; 1312-pushing rod; 132-pushing and pulling handle; 140-holding handle; 141-Y type luer joint; 1411-cannula joint; 1412-suction joint; 1413-inflation joint; 150-locking assembly; 151-locking handle; 152-locking seat; 153-locking sealing member; 154-locking area; 160-balloon fixing assembly; 161-fixed balloon; 162-inflation tube; 200-gastric balloon. DETAILED DESCRIPTION

[0032] In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the following will be a clear and complete description of the technical solutions in the embodiments of the present application with reference to the drawings. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. The components of the embodiments of the present application described and shown in the drawings can be arranged and designed in various different configurations.

[0033] Therefore, the following detailed description of the embodiments of the present application provided in the drawings is not intended to limit the scope of the claimed application, but only represents selected embodiments of the present application. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in the present application without creative labor are within the scope of protection of the present application.

[0034] It should be noted that: similar reference numerals and letters represent similar items in the following drawings, therefore, once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings.

[0035] In the description of the present application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship when the product of the present application is usually placed, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the indicated device or element must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application. In addition, the terms "first", "second", "third" and the like are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0036] In addition, the terms "horizontal", "vertical", and the like do not mean that the components must be absolutely horizontal or vertical, but can be slightly inclined. For example, "horizontal" only means that it is more horizontal than "vertical", and does not mean that the structure must be completely horizontal, but can be slightly inclined.

[0037] In the description of the present application, it should be noted that, unless otherwise specified and limited, the terms "arrangement", "installation", "connection", "connection" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0038] First embodiment Please refer to Figures 1-5 The present embodiment provides a gastric balloon recovery device 100, which comprises a sleeve assembly 110, a puncture needle 120, a pushing assembly 130, a holding handle 140, a locking assembly 150 and a balloon fixing assembly 160.

[0039] Among them, the gastric balloon 200 can be a gastric water balloon. The commonly used gastric balloon 200 is a gastric water balloon. Because the water in the gastric water balloon is sealed for a long time, bacteria are easy to breed. When the gastric balloon 200 needs to be taken out, if the water balloon is directly punctured and the water is discharged into the stomach, it is easy to cause gastrointestinal reactions such as vomiting and diarrhea.

[0040] The gastric balloon recovery device 100 provided by the present application can directly suck the medium filled in the gastric balloon 200 to the outside of the body, and the gastric balloon 200 and the gastric balloon recovery device 100 are stably connected during the suction process, so as to avoid gastrointestinal reactions caused by accidental leakage of the medium such as water in the gastric balloon 200, and the recovery process of the gastric balloon 200 is safe and reliable; at the same time, the device is simple to operate, does not need to frequently replace the instrument in the endoscope lumen, the position of the puncture needle 120 is controllable, which can effectively protect the needle and effectively puncture the gastric balloon 200, and also can improve the convenience of placing the gastric balloon recovery device 100 into the endoscope lumen, thereby providing a safer, more reliable and stable operation device for the recovery of the gastric balloon 200.

[0041] Specifically, please refer to Figure 1 and Figure 2 The sleeve assembly 110 comprises an outer sleeve 111, one end of the outer sleeve 111 is fixedly connected with the holding handle 140, and the connection mode can be any one of glue bonding, hot melt connection or ultrasonic welding, as long as it can ensure that one end of the outer sleeve 111 is fixedly connected with the holding handle 140.

[0042] Please refer to Figure 6 In the embodiment, the sleeve assembly 110 further comprises a guide head 112, which is located at the end of the outer sleeve 111 away from the holding handle 140 and is fixedly connected with the outer sleeve 111, for example, by means of glue bonding or heat shrinkage process.

[0043] Please refer to Figure 1 , Figure 3 and Figure 6 The puncture needle 120 is connected with the pushing assembly 130, and the puncture needle 120 is configured to puncture the intragastrical balloon 200 so as to facilitate the intragastrical balloon recovery device 100 to suck the medium filled in the intragastrical balloon 200. The structure of the puncture needle 120 and part of the pushing assembly 130 can be selectively accommodated in the outer sleeve 111. In order to ensure that the puncture needle 120 can smoothly extend to realize the function of puncturing the intragastrical balloon 200, the guide head 112 is a hollow structure. That is, the internal cavities of the guide head 112 and the outer sleeve 111 provide a movable accommodation space for the puncture needle 120 and the pushing assembly 130.

[0044] Further, the pushing assembly 130 comprises a pushing piece 131, which is accommodated in the inner cavity of the outer sleeve 111 and is selectively movable in the inner cavity of the outer sleeve 111. One end of the pushing piece 131 is fixedly connected with the puncture needle 120, so that the puncture needle 120 can be selectively extended out of or accommodated in the inner cavity of the outer sleeve 111.

[0045] The end of the pushing piece 131 away from the puncture needle 120 extends out of the outer sleeve 111. Since the end of the outer sleeve 111 away from the guide head 112 has the holding handle 140, in the embodiment, the pushing piece 131 extends out of the outer sleeve 111, passes through the holding handle 140, and continues to pass through the locking assembly 150 at the end of the holding handle 140 away from the outer sleeve 111, so that the locking assembly 150 is arranged on the surface of the pushing piece 131 extending out of the outer sleeve 111.

[0046] Please refer to Figure 1 and Figure 2 The holding handle 140 comprises a Y-shaped luer joint 141, and the three interfaces of the Y-shaped luer joint 141 are respectively a sleeve joint 1411, a suction joint 1412 and an inflation joint 1413. Please refer to Figure 4 and Figure 7 The sleeve joint 1411 is fixedly connected with the outer sleeve 111 to fix the holding handle 140; the suction joint 1412 communicates with the inner cavity of the outer sleeve 111 and is used for sucking the medium in the intragastrical balloon 200; and the inflation joint 1413 is used for inflating the balloon fixing assembly 160.

[0047] Please refer to Figure 1 and Figure 5The balloon fixing assembly 160 comprises a fixing balloon 161 sleeved on the end of the outer sleeve 111 away from the holding handle 140 and an inflation pipe 162 in communication with the fixing balloon 161, and the end of the inflation pipe 162 away from the fixing balloon 161 is fixedly connected with the holding handle 140, and the inflation connector 1413 is in communication with the inflation pipe 162 to inflate the fixing balloon 161.

[0048] Please refer to Figure 1 and Figures 8-10 In the use process of the gastric balloon recovery device 100 provided by the embodiment, the unlocking of the locking assembly 150 enables the puncture needle 120 and the pushing piece 131 to move in the internal cavity of the guide head 112 and the outer sleeve 111, so that the puncture needle 120 extends out of the guide head 112 (as shown in Figures 8-9 ), to puncture the gastric balloon 200, and the guide head 112 drives part of the outer sleeve 111 and the fixing balloon 161 on the surface of the outer sleeve 111 to enter the gastric balloon 200, and then inflates the fixing balloon 161 through the inflation pipe 162, so that the fixing balloon 161 expands to block the puncture of the gastric balloon 200 (as shown in Figure 10 ), and the fixing balloon 161 is limited in the gastric balloon 200, which can ensure the stable connection between the gastric balloon recovery device 100 and the gastric balloon 200, avoid the accidental outflow of the medium in the gastric balloon 200 due to the disconnection between the gastric balloon recovery device 100 and the gastric balloon 200 during the suction process, and on the other hand, since the fixing balloon 161 is limited in the gastric balloon 200, after the medium in the gastric balloon 200 is suctioned, the deflated gastric balloon 200 can be directly taken out by the gastric balloon recovery device 100 under the limiting action of the fixing balloon 161, so that the single instrument and single operation of the instrument are realized, that is, the effect of discharging the medium in the gastric balloon 200 and discharging the gastric balloon body can be achieved, which greatly simplifies the operation complexity.

[0049] Therefore, the embodiment of the present application provides the guide head 112 which can assist part of the outer sleeve 111 and the fixing balloon 161 on the surface of the outer sleeve 111 to enter the puncture inside the gastric balloon 200 when the puncture needle 120 punctures the gastric balloon 200, so that the fixing balloon 161 can play a limiting role after being inflated, and realize the double recovery of the medium in the gastric balloon 200 and the gastric balloon body.

[0050] As shown in Figure 6 , in order to achieve the above-mentioned effect, the diameter of the end of the guide head 112 away from the outer sleeve 111 is smaller than the diameter of the end of the guide head 112 close to the outer sleeve 111, and specifically, the guide head 112 is conical in shape.

[0051] In other embodiments, the shape of the guide head 112 can also be any one of a pyramid, a hemisphere, an inverted trapezoid, and a streamline, as long as it can guide the outer sleeve 111 and the fixed balloon 161.

[0052] As shown in Figures 8-10 , in order to ensure the limiting effect of the fixed balloon 161, the diameter of the fixed balloon 161 after inflation is greater than the outer diameter of the outer sleeve 111 and less than the inner diameter of the endoscope channel.

[0053] In this embodiment, in order to simplify the structure of the gastric balloon recovery device 100, the inflation tube 162 is sleeved on the surface of the outer sleeve 111, and the inflation tube 162 is also fixedly connected with the holding handle 140. The inner cavity of the inflation tube 162 is in communication with the inflation connector 1413 on the holding handle 140.

[0054] Further, in order to effectively control the movement posture and position stability of the puncture needle 120 in the outer sleeve 111, prevent it from being difficult to conform to the curved path due to too high rigidity or being bent, deflected, even touching the inner wall of the outer sleeve 111 to cause jamming or damage during the pushing process of the outer sleeve 111, the pushing member 131 provided in this embodiment is specially designed as a combined structure including a straight tube pushing member and a bent tube pushing member connected in sequence. This structure not only ensures the axial thrust transmission efficiency during the pushing process, but also has appropriate flexibility, which can adapt to the complex anatomical path in the endoscope channel and the gastric cavity, and ensure that the puncture needle 120 accurately and stably reaches the target position.

[0055] Please refer to Figure 3 , specifically, the bent tube pushing member provided in this embodiment is a steel wire rope 1311, and the straight tube pushing member is a pushing rod 1312. The steel wire rope 1311 is fixedly connected with the puncture needle 120, and the connection mode can be welding or crimping, etc. The other end of the steel wire rope 1311 is fixedly connected with the pushing rod 1312, and the connection mode can be welding or crimping, etc.

[0056] Please refer to Figure 1 and Figure 7 , the pushing rod 1312 is contained in the outer sleeve 111 and extends out of the outer sleeve 111, sequentially passes through the holding handle 140 and the locking assembly 150, and controls the locking and unlocking of the pushing rod 1312 through the locking assembly 150. When the locking assembly 150 locks the pushing rod 1312, the pushing rod 1312, the steel wire rope 1311 and the puncture needle 120 cannot move in the outer sleeve 111; when the locking assembly 150 unlocks the pushing rod 1312, the pushing rod 1312, the steel wire rope 1311 and the puncture needle 120 can move in the outer sleeve 111, and the puncture needle 120 can extend out of the distal end of the outer sleeve 111.

[0057] In the embodiment, in order to facilitate the operation of the pushing assembly 130 and the position of the piercing needle 120 in the outer sleeve 111, the pushing assembly 130 further comprises a push-pull handle 132, which is arranged at the end of the pushing member 131 away from the piercing needle 120. That is, the pushing rod 1312 is accommodated in the outer sleeve 111 and extends out of the outer sleeve 111, passes through the holding handle 140 and the locking assembly 150, and is fixedly connected with the push-pull handle 132.

[0058] The connection between the pushing rod 1312 and the push-pull handle 132 can be, for example, glue bonding or injection molding of the pushing rod 1312 and the push-pull handle 132.

[0059] Please refer to Figure 1 and Figure 4 In the embodiment, the locking assembly 150 comprises a locking handle 151, a locking seat 152, and a locking seal 153.

[0060] The locking seat 152 is internally provided with a hollow channel so as to facilitate the passing of the pushing rod 1312 from the inside of the locking seat 152. One end of the channel of the locking seat 152 is provided with a recessed locking area 154, which surrounds the channel, and the locking seal 153 is arranged in the locking area 154. The pushing rod 1312 passes through the locking seal 153 and is then fixedly connected with the push-pull handle 132 through the locking handle 151. The locking handle 151 and the locking seat 152 are movably connected in the locking area 154 to realize the compression and unlocking of the locking seal 153.

[0061] When the locking handle 151 and the locking seat 152 are connected in the locking area 154, the locking handle 151 extrudes the locking seal 153, and the locking seal 153 extrudes the pushing rod 1312, thereby realizing the compression of the pushing rod 1312 and preventing the pushing rod 1312 from sliding in the outer sleeve 111. When the locking handle 151 is disengaged from the locking area 154, the locking seal 153 returns to the initial state, and the pushing rod 1312 can slide relative to the locking seal 153, realizing the unlocking of the pushing rod 1312 and the free movement of the piercing needle 120.

[0062] In the embodiment, the locking handle 151 and the locking seat 152 are connected by threads. In addition, in order to reduce the volume of the gastric balloon retrieval device 100, the locking seat 152 is integrally formed with the holding handle 140, that is, the locking area 154 can be arranged on the side of the holding handle 140 away from the outer sleeve 111, so that only the locking handle 151 and the locking seal 153 need to be additionally installed.

[0063] Further, the existing gastric balloon recovery device 100 also has the problem of long suction process time. The inventors have found that the recovery of the gastric balloon 200 is mainly dependent on the endoscope system, and the inner channel of the endoscope system is about 2.8-3.2 mm, which greatly limits the size of the injection needle that can enter the inner channel of the endoscope. The largest injection needle allowed in the inner channel of the endoscope is a 21G injection needle. However, the use of the 21G injection needle has the problems of easy separation of the injection needle from the gastric balloon 200, leading to suction failure, and slow suction efficiency due to the size of the injection needle, resulting in a long suction process time.

[0064] The gastric balloon recovery device 100 provided by the embodiment of the present application can timely limit the gastric balloon 200 after puncturing the gastric balloon 200 by the design of the fixed balloon 161 and the guide head 112, avoiding the problem of suction failure caused by the separation of the outer cannula 111 and the gastric balloon 200. In addition, since the holding handle 140 of the present application is provided with a Y-shaped luer joint 141, the suction channel of the gastric balloon recovery device 100 provided by the present application is the inner cavity of the outer cannula 111, which has a larger size and can quickly, efficiently and stably realize the suction of the internal medium of the gastric balloon 200. The suction channel does not conflict with the puncture structure composed of the puncture needle 120 and the pushing assembly 130, and the puncture needle 120 does not need to be completely removed during the suction of the internal medium of the gastric balloon 200, thereby improving the suction efficiency. In addition, the puncture needle 120 of the gastric balloon recovery device 100 provided by the present application does not directly contact the inner channel of the endoscope, which does not increase the risk of infection of the operator.

[0065] The diameter d of the puncture needle 120 provided by the embodiment is 0.9-1.0 mm, and the inner diameter D of the outer cannula 111 is 1.9-2.0 mm. The diameter d of the puncture needle 120 is the maximum diameter of the puncture needle 120, not the tip diameter.

[0066] It should be noted that the design principles of the diameter d of the puncture needle 120 and the inner diameter D of the outer cannula 111 are as follows: Firstly, since the inner cavity of the outer cannula 111 is used to suck out the internal medium of the gastric balloon 200, the larger the inner diameter of the outer cannula 111, the faster the suction rate. However, the inner diameter of the outer cannula 111 is limited by the size of the inner channel of the endoscope, and cannot be infinitely large. In order to ensure that the gastric balloon recovery device 100 provided by the present application can smoothly pass through the inner channel of the endoscope and enter the stomach, the inner diameter D of the outer cannula 111 is 1.9-2.0 mm, which is more appropriate.

[0067] With the inner diameter D of the outer tube 111 fixed, to improve the suction efficiency, the diameter d of the puncture needle 120 needs to be reduced as much as possible. However, if the diameter d of the puncture needle 120 is too small, it will affect the puncture effect. Therefore, the diameter d of the puncture needle 120 also needs to be balanced between suction efficiency and puncture strength.

[0068] like Figure 11 As shown, when the inner diameter D of the outer tube 111 is fixed, the diameter d of the puncture needle 120 increases, the cross-sectional area A1 of the puncture needle 120 increases, and the annular area A2 decreases. To ensure a sufficient fluid cross-sectional area, A1≤A2. After calculation, the diameter d of the puncture needle 120 is 1.3mm when A1 is at its maximum.

[0069] Furthermore, since the outer tube 111 of the gastric balloon retrieval device 100 has a large length-to-diameter ratio and is a long and narrow tube, the influence of fluid viscosity on the flow rate is relatively large, and the smaller the annular area A2, the greater the viscosity. Therefore, a fluid model was established, and the flow rate for puncture needles of different diameters was obtained through flow field simulation (boundary conditions: outlet pressure: -80 kPa; inlet pressure: 0 kPa; fluid type: physiological saline).

[0070] The analysis results are as follows: the flow rate is highest (1.757 ml / s) when the diameter d of the puncture needle 120 is between 0.9 and 1 mm, meaning that the time required to empty a 500 ml water balloon is 4 minutes and 45 seconds. Therefore, based on the above test and analysis results, setting the diameter d of the puncture needle 120 to 0.9–1.0 mm and the inner diameter D of the outer cannula 111 to 1.9–2.0 mm is beneficial to improving the aspiration efficiency of the gastric balloon retrieval device 100.

[0071] Second Embodiment This embodiment provides a system for removing a gastric balloon 200, including a suction device, an inflation device, an endoscope system, and a gastric balloon retrieval device 100 provided in the first embodiment. The suction device is connected to a suction connector 1412, the inflation device is connected to an inflation connector 1413, and the endoscope system includes an endoscope cavity.

[0072] When the gastric balloon 200 is being removed, the inflation tube 162 is located within the endoscopic cavity. When not performing the gastric balloon 200 removal procedure, the inflation tube 162 may or may not be located within the endoscopic cavity. That is, the outer sheath 111 within the inflation tube 162, the steel wire rope 1311 within the outer sheath 111, the push rod 1312, and the puncture needle 120 can all be selectively accommodated within the endoscopic cavity.

[0073] The operating principle of the gastric balloon retrieval device 100 and the system for removing the gastric balloon 200 provided in this embodiment of the invention is as follows: Please refer to Figures 1-10, the puncture needle 120, the steel wire 1311 and the push rod 1312 are sequentially fixed and connected (as shown in Figure 3 The puncture needle 120, the steel wire 1311 and the push rod 1312 are sent into the outer sleeve 111, and the length of the push rod 1312 exceeds the length of the outer sleeve 111 and extends out of the outer sleeve 111. The two ends of the outer sleeve 111 are fixedly connected with the guide head 112 and the holding handle 140 respectively, the puncture needle 120 is located at the side with the guide head 112, the push rod 1312 passes through the holding handle 140 and then passes through the locking handle 151, and the end surface is fixedly connected with the push-pull handle 132. The locking seal 153 is arranged in the locking area 154 of the end surface of the holding handle 140 away from the outer sleeve 111, and the push rod 1312 passes through the locking seal 153.

[0074] Firstly, the locking assembly 150 is in an unlocked state, the locking handle 151 is not screwed into the locking area 154 to press the locking seal 153, that is, the locking seal 153 is in a natural state (as shown in Figure 4 At this time, the puncture needle 120 and the push rod 1312 can freely move in the internal cavity of the guide head 112 and the outer sleeve 111, the puncture needle 120 is adjusted to be collected in the inner cavity of the outer sleeve 111 by the push-pull handle 132, then the locking handle 151 is screwed into the locking area 154 to press the locking seal 153, so that the puncture needle 120 is fixed in the inner cavity of the outer sleeve 111 (as shown in Figure 8 .

[0075] Then the side of the guide head 112 of the gastric balloon recovery device 100 is stretched into the endoscopic cavity until it is observed that the guide head 112 reaches the target area (near the gastric balloon 200), the locking handle 151 is unscrewed from the locking area 154 to loosen the locking seal 153, the puncture needle 120 is stretched out of the guide head 112 by the push-pull handle 132 (as shown in Figure 9 The position of the puncture needle 120 can be fixed again by the locking handle 151, and then the puncture needle 120 is pierced into the gastric balloon 200. As shown in Figure 10 The guide head 112 drives the front end of the outer sleeve 111 and the fixed balloon 161 into the gastric balloon 200, the fixed balloon 161 is inflated through the inflation tube 162, the fixed balloon 161 is inflated to block the hole of the gastric balloon 200, and the fixed balloon 161 is limited in the gastric balloon 200. In order to improve the pumping efficiency, the puncture needle 120 can be collected in the outer sleeve 111, and then fixed by the locking handle, and then the medium in the gastric balloon 200 is pumped out through the suction connector 1412. After the medium in the gastric balloon 200 is pumped out, the gastric balloon recovery device 100 in the endoscopic cavity is taken out, the fixed balloon 161 takes out the deflated gastric balloon 200 from the body together, and the rapid recovery of the gastric balloon 200 is completed.

[0076] Effect verification The difference between the gastric balloon recovery device 100 provided by the embodiment of the present application and the existing method of suction through injection needle is compared through animal experiments. Specifically, a water ball is placed in the stomach of a Bama pig, and the water ball contains 500 ml of normal saline. The water ball in the stomach of the Bama pig is recovered by using the gastric balloon recovery device 100 provided by the embodiment of the present application and the existing method of suction through injection needle respectively. The appearance of the gastric balloon 200 before being punctured is as shown in Figure 12 , and the appearance after being punctured and the suction being completed is as shown in Figure 13 .

[0077] The existing method of suction through injection needle includes: placing an injection needle and its traction structure in the endoscopic lumen, so that it reaches the target area (near the gastric balloon 200), and then controlling the traction structure to make the injection needle puncture the gastric balloon 200, placing the puncture needle 120 in the gastric balloon 200 for suction, until the normal saline is completely sucked out, then withdrawing the injection needle to the outside of the body, replacing the foreign body forceps into the target area (near the gastric balloon 200), and taking out the deflated gastric balloon 200 through the foreign body forceps.

[0078] The present application verifies the suction effect of 18G injection needle and 21G injection needle, and compares the suction effect of the gastric balloon recovery device 100 provided by the embodiment of the present application, to obtain the results shown in Table 1.

[0079] Table 1 Comparison table of gastric balloon 200 recovery effect

[0080] Among them, the total recovery time refers to the total time from the puncture of the puncture needle 120 / injection needle to the gastric balloon 200 to the time taken to take out the deflated gastric balloon 200 from the body.

[0081] From Table 1, it can be seen that the gastric balloon recovery device 100 of the embodiment of the present application has an average water pumping time of 6min5s, and an average total recovery time of 7min12s, compared with the commonly used injection needle for pumping water, the pumping efficiency and the recovery efficiency of the gastric balloon 200 are significantly improved.

[0082] And the gastric balloon recovery device 100 of the embodiment of the present application has fewer operation steps and higher operation convenience, and avoids cumbersome actions such as replacing instruments during surgery; in addition, the gastric balloon recovery device 100 of the embodiment of the present application has better suction process stability, and does not have the suction failure phenomenon caused by separation of the puncture needle 120 and the gastric balloon 200; the design of the locking assembly 150 not only ensures the stable puncture function of the puncture needle 120, but also can hide the needle head in the outer sleeve tube 111 before puncture to protect the needle head; through the design of the Y-shaped luer joint 141 and the locking sealing ring, the suction channel and the puncture structure (the puncture needle 120 + the pushing piece 131) are separated on the holding handle 140, so that the present application can realize the suction function without completely extracting the needle head from the outer sleeve tube 111, which ensures the suction efficiency and prevents water leakage; by designing the guide head 112 as a conical surface, it can be quickly guided into the inside of the gastric balloon 200; by setting the steel wire rope 1311, the gastric balloon recovery device 100 can have certain bending performance, and the gastric balloon recovery device 100 can have good pushing and puncture performance.

[0083] The above only describes the preferred embodiments of the present application and is not used to limit the present application. For those skilled in the art, the present application can have various changes and variations. Any modification, equivalent replacement, improvement, etc. within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. An intragastric balloon retrieval device, comprising: The device comprises a sleeve assembly, a balloon fixing assembly, a puncture needle, a pushing assembly, a holding handle and a locking assembly; The sleeve assembly comprises an outer sleeve, one end of which is fixedly connected with the holding handle; The pushing assembly comprises a pushing member, which is accommodated in the inner cavity of the outer sleeve and is selectively movable in the inner cavity of the outer sleeve, one end of the pushing member is fixedly connected with the puncture needle, and the puncture needle is selectively accommodated in the inner cavity of the outer sleeve; one end of the pushing member away from the puncture needle extends out of the outer sleeve, and the locking assembly is arranged on the surface of the pushing member extending out of the outer sleeve; The balloon fixing assembly comprises a fixing balloon and an inflation tube, the fixing balloon is sleeved on one end of the outer sleeve away from the holding handle, the fixing balloon and the inflation tube are in communication, and one end of the inflation tube away from the fixing balloon is fixedly connected with the holding handle; The holding handle comprises a Y-shaped luer joint, which comprises a suction joint and an inflation joint, the suction joint is in communication with the outer sleeve, and the inflation joint is in communication with the inflation tube.

2. The apparatus of claim 1, wherein, The pushing member comprises a straight tube pushing member and a bent tube pushing member connected in sequence, the bent tube pushing member is fixedly connected with the puncture needle, the straight tube pushing member is accommodated in the outer sleeve and sequentially passes through the holding handle and the locking assembly outside the outer sleeve; Preferably, the bent tube pushing member comprises any one of a steel wire rope, a soft plastic rod and a soft plastic tube; Preferably, the straight tube pushing member comprises any one of a pushing rod, a hard plastic rod and a hard plastic tube.

3. The apparatus of claim 1, wherein, The sleeve assembly further comprises a guide head, which is located at one end of the outer sleeve away from the holding handle, and the guide head is a hollow structure.

4. The apparatus of claim 3, wherein, The diameter of one end of the guide head away from the outer sleeve is smaller than the diameter of the other end of the guide head close to the outer sleeve.

5. The apparatus of claim 3 or 4, wherein, The shape of the guide head comprises any one of a conical shape, a hemispherical shape and a streamline shape.

6. The apparatus of claim 1, wherein, The diameter of the puncture needle is 0.7-1.4 mm, preferably 0.9-1.3 mm, and more preferably 0.9-1.0 mm; And / or, the inner diameter of the outer sleeve is 1.7-2.1 mm, preferably 1.8-2.0 mm, and more preferably 1.9-2.0 mm; And / or, the diameter d of the puncture needle and the inner diameter D of the outer sleeve satisfy D-d≥0.9 mm.

7. The apparatus of claim 1, wherein, The locking assembly comprises a locking handle, a locking seat and a locking sealing member, the inside of the locking seat is provided with a hollow channel, one end of the channel is provided with a recessed locking area, the locking sealing member is arranged in the locking area, the locking sealing member is sleeved on the surface of the pushing member, and the locking handle and the locking seat are movably connected in the locking area to realize the compression and unlocking of the locking sealing member; Preferably, the connection mode of the locking handle and the locking seat comprises any one of threaded connection, glue bonding, ultrasonic welding and heating fusion; Preferably, the locking seat is integrally formed with the holding handle, and the locking handle is located on the side of the holding handle away from the outer sleeve.

8. The apparatus of claim 1, wherein, The diameter of the fixed balloon after inflation is greater than the outer diameter of the outer sleeve and less than the inner diameter of the endoscope channel; Preferably, the inflation tube is sleeved on the surface of the outer sleeve.

9. The apparatus of claim 1, wherein, The push assembly further comprises a push-pull handle, which is arranged at the end of the push member away from the puncture needle.

10. A system for intragastric balloon retrieval, comprising: The device comprises a suction device, an inflation device, an endoscope system, and the device according to any one of claims 1-9, the suction device being in communication with the suction connector, the inflation device being in communication with the inflation connector, the endoscope system comprising an endoscope channel, the puncture needle, the push assembly located in the outer sleeve, the outer sleeve, and the inflation tube being selectively accommodated in the endoscope channel.

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