Balloon type percutaneous gastrostomy tube for ultrasonic guidance

Abstract

The invention relates to the field of medical instruments, and discloses an ultrasound-guided balloon type percutaneous gastrostomy tube which comprises a tube body, the tube body comprises an inner-layer tube, a balloon part is arranged on the outer wall of one end of the tube body, the balloon part is communicated with a filling channel and used for injecting liquid into the balloon part through the filling channel, and after the balloon part is filled and expanded, the balloon part is filled with liquid and then is communicated with the inner-layer tube. The balloon part is arranged at one end of the tube body, the edge of the balloon part exceeds the end part of the tube body, the balloon part is used for preventing the tube end of the tube body from stabbing the stomach wall, an injection part is arranged at one end, far away from the balloon part, of the tube body, the injection part is used for injecting liquid into the filling channel, the tube body further comprises an outer-layer tube, and the outer-layer tube is used for preventing the filled balloon part from extruding the inner-layer tube to narrow the flow channel to cause blockage. After the balloon part is filled and expanded, the edge of the balloon part exceeds the end of the tube body, the effect of preventing the tube end of the tube body from stabbing the stomach wall is achieved, the filled balloon part can be prevented from extruding the inner-layer tube through the arranged outer-layer tube, and blockage caused by narrowing of a flow channel is avoided.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a balloon percutaneous gastrostomy tube for ultrasound guidance. BACKGROUND

[0002] For patients who have lost the ability to swallow but have normal gastrointestinal digestion and absorption function, percutaneous gastrostomy tube is a common method of enteral nutrition support. Percutaneous gastrostomy tube includes balloon type, pipeline type and airbag type. Among them, the balloon percutaneous gastrostomy tube is the most common one.

[0003] The balloon percutaneous gastrostomy tube is a method of realizing enteral nutrition support through the connection of skin and stomach wall. During the operation, the doctor will make a small hole on the abdominal skin, then insert a balloon catheter into the stomach, and then connect the other end to the nutrition infusion device outside the stomach. The balloon expands in the stomach to form a channel, so that the nutrient solution can enter the stomach through the catheter, and then be digested and absorbed through the gastrointestinal tract.

[0004] The existing balloon percutaneous gastrostomy tube is mostly made of a single thermoset material, such as natural latex, silicone rubber, etc. The existing balloon percutaneous gastrostomy tube made of natural latex has good tensile strength, soft and elastic tube body, and is widely used in clinical practice. However, due to the material problem, the balloon percutaneous gastrostomy tube made of this material usually has the problem that when the balloon is filled, the tube body at the balloon site will be stretched, causing the nutrient material flow channel at this site to become smaller, affecting the flow rate when the liquid enters. SUMMARY

[0005] In view of the deficiencies of the prior art, the present application provides a balloon percutaneous gastrostomy tube for ultrasound guidance, which solves the problem of the conventional balloon percutaneous gastrostomy tube that when the balloon is filled, the tube body at the balloon site will be stretched, causing the nutrient material flow channel at this site to become smaller, affecting the flow rate when the liquid enters.

[0006] To achieve the above purpose, the present application realizes the following technical scheme: a balloon percutaneous gastrostomy tube for ultrasound guidance, comprising a tube body, the tube body comprising an inner layer tube, the inner layer tube having a flow channel arranged in the middle part, the inner layer tube having a filling channel arranged inside, the tube body having a balloon part arranged on the outer wall of one end part, the balloon part being in communication with the filling channel for injecting liquid into the balloon part through the filling channel, the balloon part being inflated and expanded after being filled, the edge of the balloon part exceeding the end part of the tube body to prevent the tube end from injuring the stomach wall, the tube body having an injection part arranged at one end away from the balloon part, the injection part being used for injecting liquid into the filling channel, the tube body further comprising an outer layer tube arranged outside the inner layer tube, the outer layer tube being used for preventing the inflated balloon part from extruding the inner layer tube to narrow the flow channel and cause blockage.

[0007] Preferably, the balloon part is fixedly connected outside the tube body by a fixing clamp, one side of the filling channel is provided with a liquid injection opening, and the filling channel communicates with the balloon part through the liquid injection opening.

[0008] Preferably, the filling channel is provided with a plug at one end away from the balloon part.

[0009] Preferably, the injection part comprises an injection tube arranged on one side of the tube body away from the balloon part, the injection tube communicates with the filling channel, the injection tube is provided with an injection head at one end away from the tube body, and a head rubber plug is fixedly connected to the end of the injection tube on the inner side of the injection head.

[0010] Preferably, the outer tube comprises the following components in terms of weight percentage: 65%-75% of polyurethane elastomer, 5%-15% of crosslinking agent, 3%-7% of filler, 2%-4% of reaction promoter, 1%-3% of anti-aging agent and 5%-10% of softening agent.

[0011] Preferably, the crosslinking agent is one of diisocyanate, diphenyl phenol peroxide and dimethyl sulfoxide.

[0012] Preferably, the filler is one of silicon dioxide, aluminum oxide and silicate.

[0013] Preferably, the softening agent is one of phthalate, polysiloxane and polypropylene glycol.

[0014] Preferably, the reaction promoter comprises active agent, catalyst and initiator.

[0015] Preferably, the anti-aging agent is one of phenol and dimethyl phenol.

[0016] The application provides a preparation method of the outer tube, comprising the following steps: S1. Heating a specified amount of polyurethane elastomer to a flowable liquid state at a temperature of 60-100 DEG C in a heating container; S2. Adding a specified amount of crosslinking agent to the polyurethane elastomer and stirring at high speed for 1-2 hours; S3. Continuously adding a specified amount of filler, reaction promoter, anti-aging agent and softening agent and continuously stirring and mixing to fully and uniformly mix all the components; S4. Placing the mixture into an extruder for one-time extrusion to obtain the outer tube; S5. Connecting the inner tube with the outer tube after treating the inner tube by plasma wind or corona process to obtain the tube body.

[0017] The application provides a balloon type percutaneous gastrostomy tube for ultrasound guidance, which has the following beneficial effects: 1. The balloon part set by the application can prevent the tube end from scratching the stomach wall after inflation, and the outer tube can prevent the inflated balloon part from extruding the inner tube, so as to avoid the flow channel from being narrowed and blocked, and the liquid or nutrient can smoothly enter the flow channel from the injection part and reach the stomach of the patient through the flow channel, ensuring smooth delivery.

[0018] 2. The outer tube of the application is made of elastic polyurethane material, which has good flexibility and elastic recovery ability. When the balloon part is inflated, the outer tube can withstand a certain pressure and disperse the pressure to the surrounding through its elastic recovery ability, reducing the extrusion force on the inner tube, so that the balloon percutaneous gastrostomy tube can better realize the delivery and absorption of nutrient substances, thereby improving the treatment effect. Patients can obtain the required nutritional supplements to promote physical recovery and health. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 is a schematic diagram of the overall structure of the application; Figure 2 is a schematic diagram of the tube cross section of the application; Figure 3 is a schematic diagram of the balloon part installation of the application; Figure 4 is a schematic diagram of the injection part installation of the application.

[0020] Wherein, 10, tube; 11, inner tube; 12, outer tube; 13, flow channel; 14, filling channel; 141, liquid injection opening; 142, plug; 20, balloon part; 21, fixed clamp; 30, injection part; 31, injection tube; 32, injection head; 33, head rubber plug. DETAILED DESCRIPTION

[0021] The technical solutions in the embodiments of the application will be described in detail below with reference to the drawings of the application specification. Obviously, the described embodiments are only a part of the embodiments of the application, not all. Based on the embodiments in the application, all other embodiments obtained by those skilled in the art without creative labor are within the scope of protection of the application.

[0022] Please refer to the drawings of the application specification Figure 1 - the drawings of the application specification Figure 4 The embodiments of the application provide a balloon percutaneous gastrostomy tube for ultrasound guidance, which aims to prevent the tube end from scratching the stomach wall during the extension of the gastrostomy tube into the stomach. And prevent the tube segment at the balloon from being extruded after the balloon is inflated, so as to prevent the flow channel from being too small to facilitate the delivery of nutrient substances.

[0023] The balloon type percutaneous gastrostomy tube includes a tube body 10, which is composed of an inner tube 11 and an outer tube 12. The inner tube 11 is provided with a flow channel 13 in the middle for guiding the flow of liquid from one end of the tube body into the stomach. The inner tube 11 is also provided with an inflation channel 14 inside for inflating and expanding the balloon part 20 by liquid injection. The outer wall of one end of the tube body 10 is provided with a balloon part 20, which communicates with the inflation channel 14, and the inflation channel 14 can be used to inject liquid into the balloon part 20. After the balloon part 20 is inflated and expanded, its edge exceeds the end of the tube body 10, which plays a role in preventing the tube end of the tube body 10 from injuring the stomach wall. The other end of the tube body 10 is provided with an injection part 30 away from the balloon part 20, which is used to inject liquid into the inflation channel 14. The outer tube 12 is arranged outside the inner tube 11 to prevent the inflated balloon part 20 from pressing the inner tube 11, so as to avoid the flow channel 13 being narrowed and blocked.

[0024] The principle of the balloon type percutaneous gastrostomy tube is to accurately place the tube body 10 into the stomach through the ultrasonic guidance technology. During the operation, the doctor places an ultrasonic probe on the surface of the patient's body, and determines the position and direction of the tube body 10 by observing the ultrasonic image. Then, the doctor uses a puncture needle to insert the tube body 10 into the patient's skin and abdominal wall, and guides it into the stomach. Once the tube body 10 is correctly placed, the doctor can inject liquid into the inflation channel 14 through the injection part 30 to inflate and expand the balloon part 20. After the balloon part 20 is inflated, its edge exceeds the end of the tube body 10, which plays a role in protecting the stomach wall. At the same time, the outer tube 12 prevents the inflated balloon part 20 from pressing the inner tube 11, ensuring that the flow channel 13 remains unobstructed.

[0025] As an embodiment of the present application, the balloon part 20 is fixedly connected to the outer side of the tube body 10 through a fixed clamp 21, and the inflation channel 14 is provided with a liquid injection opening 141 on one side, and the inflation channel 14 communicates with the balloon part 20 through the liquid injection opening 141.

[0026] Specifically, the balloon part 20 is fixedly connected to the outer side of the tube body 10 through the fixed clamp 21. This fixing method can ensure that the balloon part 20 is firmly connected to the tube body 10, preventing the balloon part 20 from accidentally falling off or shifting. The fixed clamp 21 is designed to consider stability and durability to ensure that the balloon part 20 remains stable during use. The inflation channel 14 is provided with a liquid injection opening 141 on one side, and the inflation channel 14 communicates with the balloon part 20 through the liquid injection opening 141. The purpose of this design is to facilitate the injection of liquid into the balloon part 20 to achieve the inflation and expansion of the balloon. The liquid injection opening 141 should have good sealing performance to ensure that no leakage occurs during liquid injection.

[0027] In general, by the design of the inflation channel 14 and the injection opening 141, the physician can inject an appropriate amount of liquid into the balloon portion 20 to inflate and expand it, thereby protecting the stomach wall. When the balloon portion 20 is inflated, its edge extends beyond the end of the tube 10, preventing the end of the tube 10 from injuring the stomach wall. This design can improve the safety of the operation and reduce the discomfort of the patient after the operation.

[0028] As an embodiment of the present application, the inflation channel 14 is provided with a plug 142 at the end away from the balloon portion 20.

[0029] Specifically, the inflation channel 14 is provided with a plug 142 at the end away from the balloon portion 20. The role of the plug 142 is to prevent the liquid in the inflation channel 14 from leaking or accidentally losing. The plug 142 should have good sealing performance to ensure that the liquid in the inflation channel 14 does not overflow during injection.

[0030] As an embodiment of the present application, the injection portion 30 includes an injection tube 31, which is arranged on the side of the tube 10 away from the balloon portion 20, and is in communication with the inflation channel 14. The injection tube 31 is provided with an injection head 32 at the end away from the tube 10, and the inside of the injection head 32 is fixedly connected with a head rubber plug 33 at the end of the injection tube 31.

[0031] Specifically, the injection portion 30 is the part used to inject liquid into the inflation channel 14 and the balloon portion 20. The injection portion 30 includes an injection tube 31, which is arranged on the side of the tube 10 away from the balloon portion 20, and is in communication with the inflation channel 14. The purpose of this design is to facilitate the physician to inject liquid into the inflation channel 14 and the balloon portion 20 through the injection tube 31. The injection tube 31 should have appropriate length and diameter so that the physician can easily perform the injection operation. The injection tube 31 is provided with an injection head 32 at the end away from the tube 10, and the inside of the injection head 32 is fixedly connected with a head rubber plug 33 at the end of the injection tube 31. The injection head 32 is part of the injection portion 30, which controls the flow of injection liquid and prevents leakage. The head rubber plug 33 is fixedly connected at the end of the injection tube 31, which can provide sealing to ensure that the injection liquid can only enter the inflation channel 14 and the balloon portion 20 through the predetermined channel.

[0032] As an embodiment of the present application, the outer tube 12 includes the following components by weight percentage: 65%-75% of polyurethane elastomer 5%-15% of crosslinking agent 3%-7% of filler 2%-4% of reaction promoter 1%-3% of anti-aging agent 5%-10% of softener The cross-linking agent can be one of diisocyanate, diphenyl peroxide, dimethyl sulfoxide. The cross-linking agent functions to form cross-linking structure in the polyurethane elastomer, improving its mechanical properties and durability.

[0033] The filler can be one of silicon dioxide, aluminum oxide, silicate. The filler functions to increase the hardness, strength and stability of the material.

[0034] The softening agent can be one of phthalate, polysiloxane, polypropylene glycol. The softening agent functions to increase the softness and plasticity of the material, improving its bending and deformation ability.

[0035] The reaction accelerator includes active agent, catalyst, initiator, etc. They can accelerate the reaction of the cross-linking agent, speeding up the curing and formation of the material.

[0036] The anti-aging agent can be one of phenol, dimethyl phenol. The anti-aging agent functions to delay the aging and degradation process of the material, improving its durability and service life.

[0037] Specifically, in the balloon-type percutaneous gastrostomy tube, the flow channel 13 plays an important role in transporting nutrients. When the doctor injects liquid or nutrients, these substances will enter the flow channel 13 through the injection part 30, and then pass through the flow channel 13 to supply the patient's stomach.

[0038] However, due to the filling and expansion of the balloon part 20, as well as the pressure of the surrounding tissue and other factors, the flow channel 13 can be squeezed and narrowed. If the flow channel 13 is narrowed or blocked, the delivery of liquid or nutrients will be affected, resulting in a decline in treatment effect or normal operation.

[0039] However, by setting the outer tube 12 between the balloon part 20 and the inner tube 11, the squeezing and narrowing of the flow channel 13 can be effectively prevented. The outer tube 12 is made of elastic polyurethane material, which has good flexibility and elastic recovery ability. When the balloon part 20 expands, the outer tube 12 can withstand a certain pressure and disperse the pressure to the surrounding through its elastic recovery ability, reducing the squeezing force on the inner tube 11.

[0040] The presence of the outer tube 12 can maintain the patency of the flow channel 13, prevent it from being narrowed or blocked due to the squeezing of the inner tube 11, and maintain the patency of the flow channel 13 through its elastic recovery ability. In this way, liquid or nutrients can smoothly enter the flow channel 13 from the injection part 30, and pass through the flow channel 13 to the patient's stomach, ensuring smooth delivery.

[0041] As an embodiment of the present application, the preparation method of the outer tube 12 includes the following steps: S1: First, a predetermined amount of polyurethane elastomer is heated to a temperature range of 60°C to 100°C in a heated container to make it a flowing liquid state.

[0042] S2: Then, a predetermined amount of cross-linking agent is added to the polyurethane elastomer and stirred using a high-speed stirrer for 1 to 2 hours. The purpose of this step is to uniformly disperse the cross-linking agent in the polyurethane elastomer.

[0043] S3: Next, a predetermined amount of filler, reaction accelerator, anti-aging agent, and softening agent is continuously added and mixed while stirring to ensure that all ingredients are thoroughly mixed. The filler can increase the strength and durability of the outer tube, the reaction accelerator can accelerate the cross-linking reaction, the anti-aging agent can extend the service life of the outer tube, and the softening agent can increase the flexibility of the outer tube.

[0044] S4: The mixture is placed in an extruder and extruded into an outer tube 12 in one pass. The extruder extrudes the polyurethane mixture through a die into the desired tubular shape, forming the outer tube.

[0045] S5: Finally, the inner tube 11 is treated with a plasma wind or corona process and connected to the outer tube 12. This step can enhance the adhesion and connection strength between the inner tube and the outer tube, thereby forming a complete tube.

[0046] Through the above steps, the outer tube 12 can be prepared and connected to the inner tube 11 to obtain a tube for a balloon-type percutaneous gastrostomy tube. Such a tube has the elasticity, flexibility, and durability of polyurethane material, which can effectively prevent the narrowing and blockage of the flow passage 13 and ensure the smooth delivery of fluids and nutrients.

[0047] Although embodiments of the present application have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, alternatives, and variations can be made thereto without departing from the principles and spirit of the application, the scope of which is defined by the appended claims and their equivalents.

Claims

1. An ultrasound-guided balloon-type percutaneous gastrostomy tube comprising a tube body (10), characterized in that, The pipe body (10) comprises an inner layer pipe (11), a flow channel (13) is arranged in the middle of the inner layer pipe (11), a filling channel (14) is arranged inside the inner layer pipe (11), an outer wall of one end of the pipe body (10) is provided with a balloon part (20), the balloon part (20) is communicated with the filling channel (14), liquid is injected into the balloon part (20) through the filling channel (14), after the balloon part (20) is filled and expanded, the edge thereof exceeds the end of the pipe body (10), so as to prevent the pipe end of the pipe body (10) from hurting the stomach wall, an injection part (30) is arranged at one end of the pipe body (10) away from the balloon part (20), the injection part (30) is used for injecting liquid into the filling channel (14), the pipe body (10) further comprises an outer layer pipe (12), the outer layer pipe (12) is arranged outside the inner layer pipe (11), and the outer layer pipe (12) is used for preventing the balloon part (20) after being filled from extruding the inner layer pipe (11) to narrow the flow channel (13) and cause blockage.

2. The balloon catheter for percutaneous gastrostomy according to claim 1, wherein The balloon part (20) is fixedly connected outside the pipe body (10) through a fixing clamp (21), one side of the filling channel (14) is provided with a liquid injection opening (141), and the filling channel (14) is communicated with the balloon part (20) through the liquid injection opening (141).

3. The balloon catheter for percutaneous gastrostomy according to claim 1, wherein A plug (142) is arranged at one end of the filling channel (14) away from the balloon part (20).

4. The balloon catheter for percutaneous gastrostomy according to claim 1, wherein The injection part (30) comprises an injection pipe (31), the injection pipe (31) is arranged at one side of the pipe body (10) away from the balloon part (20), the injection pipe (31) is communicated with the filling channel (14), an injection end cover (32) is arranged at one end of the injection pipe (31) away from the pipe body (10), and an end cover rubber plug (33) is fixedly connected to the end of the injection pipe (31) inside the injection end cover (32).

5. The balloon catheter for percutaneous gastrostomy according to claim 1, wherein The outer layer pipe (12) comprises the following components in percentage by weight: 65%-75% of polyurethane elastomer, 5%-15% of crosslinking agent, 3%-7% of filling agent, 2%-4% of reaction promoter, 1%-3% of anti-aging agent and 5%-10% of softening agent.

6. The balloon catheter for percutaneous gastrostomy according to claim 5, wherein The crosslinking agent is one of diisocyanate, diphenyl peroxide and dimethyl sulfoxide.

7. The balloon catheter for percutaneous gastrostomy according to claim 5, wherein The filling agent is one of silicon dioxide, aluminum oxide and silicate.

8. The balloon catheter for percutaneous gastrostomy according to claim 5, wherein The softening agent is one of phthalate, polysiloxane and polypropylene glycol.

9. The balloon catheter for percutaneous gastrostomy according to claim 5, wherein The reaction promoter comprises active agent, catalyst and initiator; and the anti-aging agent is one of phenol and dimethyl phenol.

10. The balloon catheter for percutaneous gastrostomy according to any one of claims 5 to 9, wherein The preparation method of the outer layer pipe (12) comprises the following steps: S1, heating a specified amount of polyurethane elastomer to a flow liquid state at a temperature of 60-100 DEG C in a heating container; S2, adding a specified amount of crosslinking agent into the polyurethane elastomer and stirring at high speed for 1-2 h; S3, continuously adding a specified amount of filling agent, reaction promoter, anti-aging agent and softening agent and continuously stirring and mixing to fully and uniformly mix all components; S4, putting the mixture into an extruder for one-time extrusion to obtain the outer layer pipe (12); S5, connecting the inner layer pipe (11) with the outer layer pipe (12) after treating the inner layer pipe (11) through plasma wind or corona process to obtain the pipe body.

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