Anti-reflux stomach tube

Abstract

This invention discloses an anti-reflux gastric tube, relating to the field of medical device technology. It includes a tube body, a connector connected to one end of the tube body, a tip located at the end furthest from the tube body and connector, with a spherical closed tip and side holes on its sidewalls, and a balloon assembly fitted onto the outside of the tube body, with one end fixedly connected to the tube body. The balloon assembly converges towards the center, its outer surface tightly adhering to the inner wall of the gastric tube. The advantages of this invention are: the radial expansion of the balloon assembly actively seals the micro-gaps around the tube, effectively blocking the reflux path of gastric contents; it is easy to operate, requiring only one hand to pull; during removal, the support portion contracts and punctures the inner wall, and after the gas is expelled, the folds wrap around the tip, avoiding damage to the esophageal mucosa, significantly improving clinical safety and ease of use.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an anti-reflux gastric tube. Background Technology

[0002] As a core device for enteral nutrition support and gastrointestinal decompression, nasogastric tubes have been widely used in clinical settings such as intensive care, neurosurgery, and geriatrics. However, reflux of gastric contents during nasogastric tube placement is a frequent occurrence. Refluxed material flows back from the esophagus to the pharynx, easily aspirated into the respiratory tract, leading to aspiration pneumonia, hypoxemia, or even suffocation. Studies have shown that the incidence of gastroesophageal reflux in patients with nasogastric tubes reaches 31%–38.5%, of which 15.2% progress to clinical overt aspiration, significantly increasing the mortality rate of ICU patients.

[0003] The occurrence of reflux problems is closely related to the structure of the gastric tube itself. Traditional gastric tubes mostly adopt a single-lumen straight tube design, with the tube body passing through the lower esophageal sphincter area, which continuously weakens the physiological anti-reflux barrier function. At the same time, there are inherent micro-gaps between the tube wall and the esophageal mucosa. Under the influence of positive pressure fluctuations in the stomach, the contents are prone to migrate backward along these gaps. In addition, the gastric tube has concentrated distal openings and a single distribution of side holes, which easily form local pressure eddies during perfusion, further aggravating the retention of contents and the upward trend.

[0004] In the prior art, further improvements have been made to the gastric tube to address the above problems by increasing the number of distal side holes or adjusting the hole distribution to disperse the intragastric pressure. However, the problem of sealing the gap around the tube has not been solved, and improper flow channel design may induce the contents to migrate proximally. Summary of the Invention

[0005] In view of the problems existing in or in the prior art, the present invention is proposed.

[0006] Therefore, the purpose of this invention is to provide an anti-reflux gastric tube, which solves the problem that current gastric tube designs cannot effectively seal the micro-gaps around the tube, resulting in a persistent risk of gastric contents reflux and easily causing aspiration complications.

[0007] To solve the above-mentioned technical problems, the present invention provides the following technical solution: an anti-reflux gastric tube, comprising a tube body, A connector that is connected to one end of the tube body; The head end is installed at the other end away from the tube body connector, and the top of the head end is spherically closed, with side holes opened on the side wall; An airbag assembly is fitted onto the outside of the tube body, and one end of the airbag assembly is fixedly connected to the tube body. The airbag assembly converges towards the center, and its outer surface fits tightly against the inner wall of the gastric tube.

[0008] As a preferred embodiment of the anti-reflux gastric tube of the present invention, a sliding area is formed on the side wall of the tube body near the tip, and the outer contour of the cross-section of the sliding area is completely within the cross-sectional contour of the tube body. The airbag assembly is installed in the sliding area and completely covers the outside of the sliding area. One end of the airbag assembly is fixedly connected to the tube body.

[0009] As a preferred embodiment of the anti-reflux gastric tube of the present invention, the balloon assembly includes a covering part, a supporting part and a connecting part, wherein the connecting part is fixedly connected to the tube body; The support portion has a closed cavity inside.

[0010] As a preferred embodiment of the anti-reflux gastric tube of the present invention, wherein: a guide tube is formed on the inner wall of the tube body, and one end of the guide tube is open in the sliding area; The connector has a wiring port on its side wall, and a conduit is inserted inside the wiring port, which connects the guide tube to the wiring port.

[0011] As a preferred embodiment of the anti-reflux gastric tube of the present invention, a pull rope is provided inside the guide tube; The pull cord includes a button that passes through the conduit and extends to its outer side, and a branch line that passes through the guide tube and connects to the airbag assembly; The number of branch lines is at least two sets, and the branch lines are connected to the covering part.

[0012] As a preferred embodiment of the anti-reflux gastric tube of the present invention, the movement trajectory of the pull rope is completely separated from the interior of the tube body.

[0013] As a preferred embodiment of the anti-reflux gastric tube of the present invention, a clamping member is provided at the opening position of the end of the catheter, and the clamping member can restrict the movement of the pull rope towards the connector.

[0014] As a preferred embodiment of the anti-reflux gastric tube of the present invention, the inner side of the support portion is provided with at least one puncture element.

[0015] As a preferred embodiment of the anti-reflux gastric tube of the present invention, wherein: the branch line pulls the covering part to move towards the end closer to the connecting part, the supporting part is compressed and expands radially, and its side wall abuts against the inner wall of the gastric tube.

[0016] In a preferred embodiment of the anti-reflux gastric tube of the present invention, the tip of the puncture member penetrates the inner wall of the air bladder assembly, thereby causing the support portion to deflate.

[0017] The beneficial effects of this invention are as follows: This invention actively seals the micro-gaps around the tube by radially expanding the airbag assembly, effectively blocking the reflux path of gastric contents; it is easy to operate and can be completed by pulling with one hand; when removed, the support part contracts and punctures the inner wall, and after the gas is released, the folds wrap around the tip, avoiding damage to the esophageal mucosa, significantly improving clinical safety and ease of use. Attached Figure Description

[0018] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 This is a schematic diagram of the airbag assembly of the present invention in a flat state.

[0020] Figure 2 This is a schematic diagram of the radial deformation of the airbag assembly of the present invention.

[0021] Figure 3 This is a schematic diagram of the connector and pull rope connection structure of the present invention.

[0022] Figure 4 This is a schematic diagram of the connection structure between the puncture component and the airbag assembly of the present invention.

[0023] Figure 5 This is a schematic diagram showing the installation position of the puncture component of the present invention. Detailed Implementation

[0024] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0025] Many specific details are set forth in the following description in order to provide a full understanding of the invention. However, the invention may also be practiced in other ways different from those described herein, and those skilled in the art can make similar extensions without departing from the spirit of the invention. Therefore, the invention is not limited to the specific embodiments disclosed below.

[0026] Secondly, the term "an embodiment" or "embodiment" as used herein refers to a specific feature, structure, or characteristic that may be included in at least one implementation of the present invention. The phrase "in one embodiment" appearing in different places throughout this specification does not necessarily refer to the same embodiment, nor is it a single embodiment or an embodiment selectively excluded from other embodiments.

[0027] Reference Figures 1-5This embodiment provides an anti-reflux gastric tube, including a tube body 1, a connector 2 connected to one end of the tube body 1, a head end 4 installed at the other end away from the tube body 1 and the connector 2, and the top of the head end 4 is spherically closed, with a side hole on the side wall; an air bladder assembly 3 sleeved on the outside of the tube body 1, and one end of the air bladder assembly 3 is fixedly connected to the tube body 1; wherein, the air bladder assembly 3 is drawn towards the center, and its outer surface is tightly attached to the inner wall of the gastric tube.

[0028] In this embodiment, the main problem is that there is a gap between the gastric tube and the esophagus, which makes it easy for gastric contents to reflux into the respiratory tract. To address this problem, this embodiment provides a movable airbag assembly 3 on the outside of the tube body 1. By inflating the airbag assembly 3 towards the center, the sidewall of the airbag assembly 3 can be made to make close contact with the inner wall of the esophagus, thereby preventing the reflux of gastric contents.

[0029] It should be noted that the tube body 1 is a hollow cylindrical flexible catheter made of medical-grade silicone; both ends of the tube body 1 are provided with annular flanges to enhance the fixation strength with the connector 2 or the tip 4; the surface of the tube body 1 is plasma treated to reduce the coefficient of friction and facilitate insertion; the elastic modulus of the tube body 1 is 0.8–1.2 MPa to ensure structural stability under gastric pressure fluctuations and to avoid mechanical damage to the esophageal mucosa.

[0030] Connector 2 has a tapered joint structure. One end is firmly connected to the annular flange near the end of tube 1 through a hot-melt welding process. The other end is a standard Luer cone interface, which is compatible with the interfaces of conventional infusion sets and syringes. The inner cavity of connector 2 is equipped with a flow guide groove to guide the nutrient solution or medicine to flow smoothly into tube 1 and reduce turbulence. The connection interface between connector 2 and tube 1 is ultrasonically cleaned and sterilized to ensure no leakage risk. After connection, the overall tensile strength reaches 25N, which meets the requirements for clinical use.

[0031] The head end 4 is a spherical closed structure, and the head end 4 is installed at the distal end of the tube body 1 (the distal end refers to the end that is farther away from the staff during use). The top end is hemispherical, with a smooth surface and rounded corners to reduce irritation to the esophageal mucosa. Multiple circular side holes are evenly distributed on the side wall of the head end 4 at 120° to ensure uniform fluid distribution. The edges of the side holes are chamfered to avoid sharp edges scratching the tissue.

[0032] The balloon assembly 3 is fitted on the outside of the tube body 1, and is located at a certain distance from the tip 4 in the distal region of the tube body 1, so as to ensure that the tip 4 enters the stomach while the balloon assembly 3 is stuck inside the esophagus; one end of the balloon assembly 3 is fixed to the outer wall of the tube body 1 by hot melt bonding (the adhesive is medical grade polyurethane glue, and the curing temperature is 60 degrees).

[0033] The free end of the balloon assembly 3 on the side away from the tube body 1 is movable. By pulling the rope, the free end of the balloon assembly 3 is moved towards the middle position. The balloon assembly 3 expands in the radial direction, so that the outer wall of the balloon assembly 3 touches the inner wall of the esophagus, thereby effectively preventing the gap between the gastric tube and the esophagus from being filled and avoiding the reflux of gastric contents.

[0034] During intubation, the patient is placed in a right lateral decubitus position with their head slightly tilted forward. The gastric tube is slowly advanced along the nasal cavity to the pharynx, and the patient is instructed to swallow. The tube is then advanced to the predetermined length. Once the gastric tube is confirmed to be in the stomach, the proximal end of the tube is secured to the nasal ala and cheek with sterile adhesive tape. Then, the free end of the balloon assembly is located and pulled to radially inflate the balloon, causing the outer surface of the balloon to fit tightly against the inner wall of the gastric tube, effectively sealing the micro-gaps between the esophagus and the gastric tube and blocking the reflux path of gastric contents.

[0035] Reference Figures 1-5 As an optional embodiment, a sliding area 11 is formed on the side wall of the tube body 1 near the head end 4, and the outer contour of the cross-section of the sliding area 11 is completely within the cross-sectional contour of the tube body 1; an airbag assembly 3 is installed in the sliding area 11, and the airbag assembly 3 completely covers the outside of the sliding area 11, and one end of the airbag assembly 3 is fixedly connected to the tube body 1.

[0036] This embodiment mainly overcomes the problem that the balloon assembly 3 protrudes outside the tube body 1, causing discomfort to the patient during the gastric tube insertion process. To solve the above problem, a sliding area 11 is provided on the side wall of the tube body 1, and the balloon assembly 3 is sleeved on the outside of the sliding area 11, with its two ends matching the two ends of the sliding area 11, to ensure a smooth transition at the connection between the balloon assembly 3 and the tube body 1.

[0037] The cross-sectional profile of the sliding area 11 is completely located inside the cross-sectional profile of the tube body 1, and one end of the sliding area 11 is stepped, while the other end is a smooth slope; and the axial length of the sliding area 11 is adapted to the length of the airbag assembly 3.

[0038] Furthermore, the airbag assembly 3 includes a covering part 31, a support part 32 and a connecting part 33, the connecting part 33 being fixedly connected to the tube body 1; the support part 32 has a closed chamber inside.

[0039] It should be noted that the end face of the connecting part 33 overlaps with the end face of the sliding area 11 in a stepped manner, and the connecting part 33 is firmly connected to the tube body 1 by fixing the thermal gel; the connection is smooth and smooth, ensuring that there are no sharp edges that damage the esophageal mucosa during the insertion of the gastric tube; the end of the covering part 31 is flared and fits tightly with the sliding area 11, effectively preventing the end of the covering part 31 from lifting up, further ensuring the smooth insertion of the gastric tube.

[0040] Furthermore, the inner wall of the support part 32 forms an independent closed space, and an air inlet is provided on the inner wall near the sliding area 11. The air inlet is a one-way valve structure, which can only satisfy the requirement of filling the support part 32 with gas.

[0041] Reference Figures 1-5 In one embodiment provided in this application, a guide tube 12 is formed on the inner wall of the tube body 1, and one end of the guide tube 12 is opened in the sliding area 11; a wiring port is formed on the side wall of the connector 2, and a conduit 6 is passed through the wiring port, and the conduit 6 connects the guide tube 12 to the wiring port.

[0042] It should be noted that the tube body 1 protrudes from its inner wall to form a guide tube 12 with an independent channel, and one end of the guide tube 12 opens through the side wall of the sliding area 11 and extends to its outer side.

[0043] A connector 2 is installed at the end of the tube body 1 away from the head end 4, and a wire hole is provided on the side wall of the connector 2, and a conduit 6 is provided inside the wire hole; one end of the conduit 6 passes through the connector 2 and extends to its outside, and the other end is connected to the port of the guide tube 12.

[0044] Furthermore, a pull cord 5 is provided inside the flow tube 12; the pull cord 5 includes a button 51 that passes through the conduit 6 and extends to its outer side, and a branch line 52 that passes through the flow tube 12 and connects to the airbag assembly 3; the number of branch lines 52 is at least two sets, and the branch lines 52 are connected to the covering part 31.

[0045] It should be noted that the pull rope 5 is inserted inside the guide tube 12, and the cooperation structure between the guide tube 6 and the guide tube 12 forms an independent channel, ensuring that the movement channel of the pull rope 5 is completely physically isolated from the nutrient solution flow channel, effectively preventing the nutrient solution from being contaminated.

[0046] To ensure uniform expansion and stable movement of the balloon assembly 3 outside the sliding area 11, the number of branch lines 52 is configured to be at least two sets. Multiple sets of branch lines 52 are distributed equidistantly in a circumferential array outside the sliding area 11 and are firmly connected to the covering part 31. When there are two sets of branch lines 52, they are symmetrically installed on both sides of the axis of the covering part 31, so that when the branch lines 52 are pulled, the balloon assembly 3 can be simultaneously subjected to force from both sides, achieving axial smooth movement. This effectively prevents the balloon assembly 3 from shifting or tilting during expansion, thereby ensuring that the outer surface of the balloon is tightly attached to the inner wall of the gastric tube, forming a continuous sealing ring and blocking the reflux path of gastric contents.

[0047] To further facilitate medical staff in operating the pull rope 5 to move the airbag assembly 3, a button 51 is provided at the end of the pull rope 5 that passes through the catheter 6. Holding the button 51 makes it easier for staff to operate the equipment.

[0048] Furthermore, the trajectory of the rope 5 is completely separated from the interior of the tube 1.

[0049] Furthermore, a clamping member 8 is provided at the opening position of the end of the conduit 6, which can restrict the movement of the pull rope 5 towards the connector 2.

[0050] Preferably, the pull rope 5 is made of medical-grade polyester fiber.

[0051] To precisely control the movement trajectory of the pull cord 5, an elastic clamping component 8 is integrated at the end of the conduit 6 away from the guide tube 12. The clamping component 8 has a hollow ring structure with annular protrusions on the inner wall, which can be embedded into the surface of the pull cord 5 to form a mechanical lock, effectively preventing the pull cord 5 from slipping accidentally. The bent part of the clamping component 8 is designed with an elastic flipping structure. When the pull cord 5 is pulled outward, the bent part is pressed and flips away from the pull cord 5, causing the opening of the clamping component 8 to expand, making it easier for the pull cord 5 to be pulled out smoothly. When the pull cord 5 stops being pulled, the clamping component 8 automatically closes under the elastic recovery action, and the end converges, firmly fixing the pull cord 5 in the current position and reliably restricting its inward retraction. This design, through a one-way mechanical locking mechanism, ensures that the movement trajectory of the airbag assembly 3 is stable during the inflation process, avoiding sealing failure caused by the displacement of the pull cord 5.

[0052] Reference Figures 1-5 In some embodiments, at least one puncture element 7 is provided inside the support portion 32.

[0053] Furthermore, the branch line 52 pulls the covering part 31 to move closer to the connecting part 33, and the supporting part 32 expands radially under pressure, with its side wall abutting the inner wall of the gastric tube.

[0054] To facilitate the safe removal of the gastric tube from the patient's esophagus, this embodiment integrates a piercing element 7 inside the support portion 32. In the initial state, the tip of the piercing element 7 maintains a preset gap with the inner wall of the support portion 32 to ensure no risk of accidental piercing. When the support portion 32 contracts and converges towards the center, the tip of the piercing element 7 gradually presses against the inner wall as it deforms until it pierces the inner wall of the support portion 32, releasing the internal gas. This effectively reduces the adhesion between the gastric tube and the esophageal mucosa, significantly simplifies the removal procedure, and avoids damage caused by forced tube removal due to mucosal adhesion.

[0055] Furthermore, the tip of the puncture component 7 penetrates the inner wall of the airbag assembly 3, thereby causing the support portion 32 to deflate.

[0056] After the puncture device 7 punctures the support portion 32, the gas inside the support portion 32 is quickly discharged through the puncture hole. The medical elastic material of the support portion 32 undergoes controllable deformation due to the sudden drop in pressure, forming uniform wrinkles and tightly stacking. During the contraction of the support portion 32, this stacked structure naturally wraps around the tip of the puncture device 7, forming a gapless and dense protective layer, ensuring that the tip is completely covered by the material, and avoiding the risk of esophageal mucosal scratches or punctures caused by tip exposure during the gastric tube removal operation.

[0057] The specific operating procedure is as follows: The patient lies on their right side with their head slightly tilted forward. The tube is slowly pushed along the nasal cavity to the pharynx, and the patient is instructed to swallow. The tube is then pushed to the predetermined length. The patient is confirmed to be in the stomach (gastric fluid aspiration is acidic, and a gurgling sound can be heard upon auscultation). The end of the connector 2 is fixed to the nasal ala and cheek using sterile adhesive tape in a "U" shape. Then, the button 51 of the pull rope 5 is located. The button 51 is gently pulled with sterile forceps. The pull rope 5 drives the branch line 52 to simultaneously pull the covering part 31 of the airbag assembly 3, making the airbag assembly 3 radially uniform. The gastric tube expands uniformly, and its outer surface fits tightly against the inner wall of the tube, forming a continuous sealing ring that effectively seals the micro-gaps around the tube. When the gastric tube needs to be removed, the button 51 is pulled outward, driving the support part 32 of the balloon assembly 3 to converge and contract towards the center. The tip of the puncture piece 7 punctures the inner wall of the support part 32, and the gas inside the support part 32 is quickly discharged. The medical elastic material undergoes controllable deformation to form uniform wrinkles and tightly stacked, wrapping the tip of the puncture piece 7 to form a dense protective layer, avoiding scratches to the esophageal mucosa, thus safely and without damage completing the tube removal operation.

[0058] Importantly, the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. A reflux-preventing gastric tube, characterized in that: Includes tube body (1), Connector (2), which is connected to one end of the tube body (1); The head end (4) is installed at the other end of the tube body (1) away from the connector (2), and the top of the head end (4) is spherically closed, and the side wall is provided with a side hole; An airbag assembly (3) is fitted onto the outside of the tube body (1), and one end of the airbag assembly (3) is fixedly connected to the tube body (1). The airbag assembly (3) is drawn towards the center, and its outer surface is tightly attached to the inner wall of the esophagus; The tube body (1) has a sliding area (11) formed on the side wall near the head end (4), and the outer contour of the cross-section of the sliding area (11) is completely within the cross-sectional contour of the tube body (1). The airbag assembly (3) is installed on the sliding area (11) and the airbag assembly (3) completely covers the outside of the sliding area (11). One end of the airbag assembly (3) is fixedly connected to the tube body (1). The airbag assembly (3) includes a covering part (31), a supporting part (32) and a connecting part (33), wherein the connecting part (33) is fixedly connected to the tube body (1); The support portion (32) has a closed chamber inside; The inner wall of the tube (1) is formed with a guide tube (12), and one end of the guide tube (12) is open in the sliding area (11). The connector (2) has a wiring port on its side wall, and a conduit (6) is inserted inside the wiring port. The conduit (6) connects the guide tube (12) to the wiring port. The guide tube (12) is equipped with a pull rope (5); The pull cord (5) includes a button (51) that passes through the conduit (6) and extends to its outer side, and a branch line (52) that passes through the guide tube (12) and connects to the airbag assembly (3). The number of branch lines (52) is at least two sets, and the branch lines (52) are connected to the covering part (31).

2. The anti-reflux gastric tube as described in claim 1, characterized in that: The trajectory of the pull rope (5) is completely separated from the interior of the tube (1).

3. The anti-reflux gastric tube as described in claim 2, characterized in that: A clamp (8) is provided at the opening of the end of the conduit (6), and the clamp (8) can restrict the pull rope (5) from moving towards the connector (2).

4. The anti-reflux gastric tube as described in claim 3, characterized in that: At least one puncture element (7) is provided on the inner side of the support part (32).

5. The anti-reflux gastric tube as described in claim 4, characterized in that: The branch line (52) pulls the covering part (31) to move closer to the end of the connecting part (33), and the supporting part (32) expands radially under pressure, with its sidewalls abutting the inner wall of the esophagus.

6. The anti-reflux gastric tube as described in claim 5, characterized in that: The tip of the puncture member (7) penetrates the inner wall of the airbag assembly (3), thereby causing the support (32) to deflate.

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