Novel jejunum nutrient canal

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a novel jejunum nutrient canal. The novel jejunum nutrition tube comprises a tube body, a tubular inner cavity is limited by the tube body, and the tube body comprises a first tube section and a second tube section which are attached to each other and are in smooth transition; the axial length of the first pipe section ranges from 40 cm to 80 cm, and the axial length of the second pipe section ranges from 30 cm to 50 cm. The first pipe section has a first bending modulus of 8000-26000 psi, and the second pipe section has a second bending modulus of 2000-10000 psi; the single-cavity tube can be easily placed into the jejunum, the tube diameter is large, a nutrient solution can conveniently pass through the tube, and the pipeline blocking risk is reduced.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a novel jejunal feeding tube. Background Technology

[0002] A jejunal feeding tube is a medical device that provides enteral nutritional support to critically ill patients. When patients are unable to eat orally, the jejunal feeding tube can be inserted through the nose into the jejunum, bypassing the stomach to deliver nutrients directly and ensure nutritional supply. Currently, jejunal feeding tubes have a dual-lumen structure, with one lumen for the guidewire and the other for the nutrient solution / irrigation fluid. This structure has two main drawbacks: First, tube insertion is difficult. The physiological path and anatomical structure from the nasal cavity to the jejunum are complex and tortuous, especially the "S" bend at the pylorus, which increases the resistance to tube insertion. A guidewire alone cannot efficiently guide the feeding tube to the jejunum, and the stress on the tube poses a risk of damaging the gastrointestinal wall muscles. Blind insertion or X-ray fluoroscopy procedures increase the burden on both doctors and patients. Second, the presence of the guidewire channel encroaches on the space for the nutrient solution / irrigation fluid, and viscous nutrient solutions are prone to clogging in the narrow and tortuous tube. Summary of the Invention

[0003] The purpose of this invention is to provide an easily insertable single-lumen jejunal feeding tube.

[0004] To achieve the above objectives, the technical solution adopted by the present invention is as follows: A novel jejunal feeding tube includes a tube body defining a tubular lumen. The tube body is configured to be positioned within a patient's gastrointestinal tract, extending through the pylorus of the stomach, with its distal end located in the jejunum. To accommodate the physiological characteristics and anatomical structure of the gastrointestinal system, the tube body has an axial length of 60–130 cm, an outer diameter of 8–16 Fr, and an inner diameter of 6–14 Fr.

[0005] The tube body includes a first segment extending from the outside to the stomach and a second segment extending from the stomach to the jejunum, with the first and second segments attached to each other and smoothly transitioning. The axial length of the first segment is 40-80 cm, and the axial length of the second segment is 30-50 cm. The first and second segments maintain a substantially consistent wall thickness in the axial direction.

[0006] The first tube segment has a first flexural modulus of 8,000–26,000 psi, and the second tube segment has a second flexural modulus of 2,000–10,000 psi. This differentiated flexural modulus design allows the second tube segment to bend more easily than the first when the tube is subjected to stress. This ensures that the second tube segment passes more easily through the stomach, duodenum, and jejunum, while maintaining the stiffness of the first tube segment, providing sufficient resistance to kinking to allow unimpeded flow of the nutrient solution. By using different stiffness distributions, the insertion requirements of different sections of the jejunal feeding tube can be matched to the patient's anatomical structure.

[0007] The stiffness of a tube varies with its shape, wall thickness, and material. Therefore, a specific stiffness distribution along the tube's axial length can be produced by adjusting the shape, wall thickness, and material.

[0008] Preferably, the first pipe section is a single-layer structure, and the material is selected from at least one or a combination of two or more of polyethylene, polypropylene, polyurethane, polycarbonate and Pebax.

[0009] Preferably, the second tube segment comprises an inner layer and an outer layer concentrically arranged and thermally fused together, with a reinforcing layer formed between the inner and outer layers; these layers extend along the axial length of the tube body, with the outer layer surrounding the reinforcing layer and the reinforcing layer surrounding the inner layer. The combination of the inner layer, reinforcing layer, and outer layer provides structural stability to the tube body and allows the jejunal feeding tube to withstand bending stress during insertion into the patient's gastrointestinal system (especially near the pylorus), making the tube body easy to bend and preventing kinking.

[0010] Preferably, the inner layer is made of polytetrafluoroethylene (PTFE), the reinforcing layer is a spiral nickel-titanium alloy wire, and the outer layer is made of polyurethane. The nickel-titanium alloy wire reinforcement enhances the tube's resistance to kinking; the spiral geometry makes the tube flexible; PTFE provides sufficient lubrication for guide wire passage and sufficient chemical stability to withstand nutrient solutions of different compositions and pH levels. The polyurethane ensures the tube's flexibility and biocompatibility, preventing mechanical damage to the gastrointestinal lining. The second section employs a balanced geometric and material design, ensuring the jejunal feeding tube's ability to navigate the tortuous gastrointestinal system.

[0011] Preferably, the radial thickness ratio of the inner layer, reinforcing layer, and outer layer is 1:(0.05~0.2):(0.4~1). The wall thickness of the second pipe section is generally 1~3Fr, with the outer and inner layers providing the main radial thickness. Through processes such as thermoforming, the connection strength can be improved, ensuring the reliability of the pipe structure. Preferably, when the outer layer wall thickness is slightly thinner than the inner layer, it facilitates a rapid response to the force of the helical spring tube and improves the bending performance of the pipe. The reinforcing layer is formed using nickel-titanium alloy wire with a diameter of 0.01~0.1mm, has a relatively thin thickness, and is integrally formed with the inner and outer layers. This differentiated wall thickness design comprehensively ensures the structural stability and bending capability of the pipe.

[0012] Preferably, the reinforcing layer has a constant pitch length.

[0013] Preferably, the reinforcing layer has a variable pitch length, wherein the pitch length of the distal reinforcing layer is shorter than that of the proximal reinforcing layer, making the stiffness of the distal side of the tube greater than that of the proximal side. When the tube is inserted into the jejunum, the stress on the distal end is borne earlier and more concentrated, and the differentiated pitch design makes the structure of the distal tube more robust and stable.

[0014] Preferably, the end of the second tube segment is provided with a guide tip, the axial length of which is 0.2 to 2 cm, and the outer diameter gradually transitions from 8 to 16 Fr on the proximal side to 6 to 14 Fr on the distal side. The tapered tube design with a smaller distal end and a larger proximal end makes it easier for the guide tip to pass through the gastrointestinal system.

[0015] Preferably, the guide tip is connected to the lumen of the second pipe section and has a basically the same inner diameter, ensuring that nutrient solutions of different viscosities can flow out of the pipe body quickly.

[0016] Preferably, the flow guide tip includes a metal layer, which is formed of stainless steel or a hyaluronic acid tube, snake tube, or spring tube disposed between the inner and outer polymers. That is, the flow guide tip can be entirely formed of stainless steel. In this embodiment, the stainless steel tube body is welded to the reinforcing layer in the second tube segment. Preferably, the inner and / or outer surfaces of the stainless steel tube body near its end are provided with steps to facilitate connection with the inner and / or outer layers of the second tube segment, for example, by adhesive bonding. In another embodiment, the flow guide tip is formed of a hyaluronic acid tube, snake tube, or spring tube disposed between the inner and outer polymers. The hyaluronic acid tube, snake tube, or spring tube can be welded to the reinforcing layer in the second tube segment to ensure connection strength. The inner polymer is polytetrafluoroethylene (PTFE), and the outer polymer is polyurethane, maintaining consistent material properties with the second tube segment for easy molding and connection.

[0017] Preferably, the guide tip has a smoothly transitioned end and inner and outer tube walls. More preferably, the arithmetic mean roughness (Ra) of the guide tip is ≤0.5μm, and the end of the guide tip is rounded to avoid damage to the gastrointestinal lining tissue when the tube is inserted.

[0018] Preferably, the guide tip has a gradually decreasing inner diameter. Specifically, the guide tip has a flange arranged circumferentially along the circumferential wall and protruding into the cavity. The flange has a flow-receiving surface for receiving fluid and a flow-guiding surface for guiding the fluid flow, with a smooth transition between the flow-receiving surface and the flow-guiding surface. The flange design helps to provide more efficient fluid delivery at the outlet end.

[0019] Preferably, the flange defines the minimum inner diameter of the guide tip, which is 3 to 9 Fr.

[0020] Preferably, the axial cross-sectional profile of the flange is a Bézier curve, with a profile shape such as a semicircle or a bullet. This design helps to constrain the outflow posture of the nutrient solution and reduce energy loss caused by fluid turbulence or wall shear stress.

[0021] Preferably, the flange is located at or near the end of the guide tip.

[0022] Preferably, the interfaces of the first pipe segment, the second pipe segment, and the guide tip are provided with interlocking stepped structures, wedge-shaped structures, or concave-convex structures. This design helps to improve the connection strength at the pipe body interfaces and prevent pipe body separation.

[0023] Preferably, the novel jejunal feeding tube further includes a temperature control element. The temperature control element and the signal line connecting the control console and the temperature control element are disposed in the tube wall, for example, in the first tube section and / or the second tube section. The temperature control element can sense the temperature of the nutrient solution in real time and heat / cool the nutrient solution through heat exchange according to a preset temperature target, ensuring that the temperature of the nutrient solution when it reaches the jejunum is suitable for the patient's nutrient absorption.

[0024] Preferably, at least the outer peripheral surface of the second tube segment is provided with a hydrophilic coating. More preferably, the outer peripheral surfaces of the first tube segment, the second tube segment, and the guide tip are all provided with a hydrophilic coating. The hydrophilic coating is applied to the tube body, for example, by a wetting or coating process, which can improve the lubricity of the tube body and its permeability in the gastrointestinal system.

[0025] Preferably, the thickness of the hydrophilic coating is ≤30µm.

[0026] Preferably, the hydrophilic coating is made of polyvinylpyrrolidone.

[0027] Preferably, it also includes a handle assembly disposed at the proximal end of the tube body, and a traction line embedded in the tube body is connected to the guide tip and the handle assembly respectively. The handle assembly is configured to control the direction of the guide tip through the traction line.

[0028] Preferably, the device also includes a Y-shaped tube integrated into the handle assembly. The Y-shaped tube comprises a main tube and a branch tube. The main tube is coaxially arranged with the tube body, and the branch tube forms a certain angle with the main tube, for example, 20–60°. The proximal end of the tube body is connected to the IV drip via the Y-shaped tube. The nutrient solution or flushing solution in the IV drip is driven by a peristaltic pump to enter the tube body at a controlled flow rate and flow into the jejunum. The guidewire and nutrient solution share a common cavity, entering the tube body from the main tube. If a blockage is encountered, the flushing solution enters the tube body from the branch tube and performs flushing.

[0029] The main beneficial effects of adopting the above technical solution are as follows: 1. The novel jejunal feeding tube of the present invention has a single-lumen structure, without a separate guide wire lumen, and a large diameter, which facilitates the passage of nutrient solution and reduces the risk of tube blockage.

[0030] 2. The tube body features a differentiated stiffness design, making the distal tube body easier to bend and control while having sufficient anti-twisting capacity, thus allowing the tube body to easily pass through the pylorus and reach the jejunum.

[0031] 3. The guide tip features a tapered design, making it easier for the tube to pass through the pylorus and reducing damage to the gastrointestinal lining. The tip also has an internal flange design, which helps the nutrient solution flow out in a controlled manner, reducing shear stress (the impact of the nutrient solution on the intestinal wall) and energy loss, making the nutrient solution flow more safely and efficiently. Attached Figure Description

[0032] Figure 1 This is a schematic diagram illustrating the usage state of an embodiment of the present invention; Figure 2 This is a schematic diagram of the combined state of the tube body and guide wire according to an embodiment of the present invention; Figure 3 This is a schematic diagram of the tube body in an embodiment of the present invention and the tube body combined with the guide wire, handle assembly, and Y-shaped tube in an embodiment of the present invention; Figure 4 This is a schematic diagram of the axial cross-sectional structure of the tube body and the Y-shaped tube in the combined state according to an embodiment of the present invention (the guide tip is a layered design). Figure 5 This is a schematic diagram of the axial cross-sectional structure of the tube body and the Y-shaped tube in the combined state according to an embodiment of the present invention (the flow guide tip is a single-layer design). Figure 6 This is a schematic diagram of the axial cross-sectional structure of the tube body according to an embodiment of the present invention (the flow guide tip has a layered design). Figure 7 This is a schematic diagram of the axial cross-sectional structure of the pipe body according to an embodiment of the present invention. Figure 8 This is a schematic diagram of the radial cross-sectional structure of the first pipe section according to an embodiment of the present invention; Figure 9 This is a schematic diagram of the radial cross-sectional structure of the second pipe section according to an embodiment of the present invention; Figure 10 This is a schematic diagram of the structure of the guidewire in an embodiment of the present invention. Detailed Implementation

[0033] The technical solutions disclosed in this invention will be further described below with reference to the embodiments.

[0034] In this invention, the proximal end A is defined as the side closer to the surgeon, and the distal end B is defined as the side farther away from the surgeon.

[0035] See Figure 1-9 A novel jejunal feeding tube is disclosed. The tube body 100 defines a tubular lumen 101 suitable for visualization of a guidewire 200 and the passage of nutrient solution. Guided by the guidewire 200, the tube body 100 is configured to be positioned within the patient's gastrointestinal tract, extending through the pylorus of the stomach, with the distal end of the tube body located in the jejunum. The tube body 100 includes a first segment 10 and a second segment 20 that are smoothly connected to each other. The first segment 10 extends externally through the esophagus to the stomach, and the second segment 20 extends from the stomach to the jejunum. The first segment 10 and the second segment 20 maintain substantially the same wall thickness along their axial length. A guide tip 30 is provided at the end of the second segment 20. A temperature control element 40 is provided within the tube body 100, and a handle assembly 50 is provided proximal to the tube body 100, integrating a Y-shaped tube 60.

[0036] The axial length of the tube 100 is 80–130 cm, the outer diameter is 8–16 Fr, and the inner diameter is 6–14 Fr. For example, the axial length of the tube 100 is 80 cm, 85 cm, 90 cm, 95 cm, 100 cm, 105 cm, 110 cm, 115 cm, 120 cm, 125 cm, or 130 cm, and the outer diameter is 8 Fr, 8.5 Fr, 9 Fr, 9.5 Fr, 10 Fr, 10.5 Fr, 11 Fr, 11.5 Fr, 12 Fr, 12.5 Fr, or 1... 3Fr, 13.5Fr, 14Fr, 14.5Fr, 15Fr, 15.5Fr, 16Fr, with inner diameters of 6Fr, 6.5Fr, 7Fr, 7.5Fr, 8Fr, 8.5Fr, 9Fr, 9.5Fr, 10Fr, 10.5Fr, 11Fr, 11.5Fr, 12Fr, 12.5Fr, 13Fr, 13.5Fr, 14Fr.

[0037] The axial length of the first pipe section 10 is 40-80cm, and the axial length of the second pipe section 20 is 30-50cm; for example, the axial length of the first pipe section 10 is 40cm, 45cm, 50cm, 55cm, 60cm, 65cm, 70cm, 75cm, 80cm, and the axial length of the second pipe section 20 is 30cm, 35cm, 40cm, 45cm, 50cm.

[0038] The first pipe segment 10 has a first flexural modulus of 8000–26000 psi, and the second pipe segment 10 has a second flexural modulus of 2000–10000 psi; for example, the first flexural modulus of the first pipe segment 10 is 8000 psi, 8500 psi, 9000 psi, 9500 psi, 10000 psi, 10500 psi, 11000 psi, 11500 psi, 12000 psi, 12500 psi, 13000 psi, 13500 psi, 14000 psi, 14500 psi, 15000 psi, 15500 psi, 16000 psi, 16500 psi, 17000 psi, 17500 psi, 18000 psi, 18500 psi, or 19000 psi. i. 19500psi, 20000psi, 20500psi, 21000psi, 21500psi, 22000psi, 22500psi, 23000psi, 23500psi, 24000psi, 24500psi, 25000psi, 25500psi, 26000psi, and the second bending modulus of the second pipe section 20 is 2000psi, 2500psi, 3000psi, 3500psi, 4000psi, 4500psi, 5000psi, 5500psi, 6000psi, 6500psi, 7000psi, 7500psi, 8000psi, 8500psi, 9000psi, 9500psi, 10000psi.

[0039] The first pipe section 10 is a single-layer structure, and the material is selected from at least one or a combination of two or more of polyethylene, polypropylene, polyurethane, polycarbonate and Pebax. For example, the material used for the first pipe section 10 is medical-grade low-density polyethylene, high-density polyethylene, ultra-high molecular weight polyethylene, polypropylene, thermoplastic polyurethane (Lubrizol Pellethane® series), polycarbonate and Pebax.

[0040] The wall thickness of the second pipe section 20 is 1 to 3 Fr, for example, 1 Fr, 1.5 Fr, 2 Fr, 2.5 Fr, or 3 Fr; it includes an inner layer 21 and an outer layer 23 that are concentrically arranged and thermally fused together, and a reinforcing layer 22 is formed between the inner layer 21 and the outer layer 23; these layers extend along the axial length of the pipe body, with the outer layer 23 surrounding the reinforcing layer 22 and the reinforcing layer 22 surrounding the inner layer 21. The inner layer 21 is made of polytetrafluoroethylene (PTFE), and the reinforcing layer 22 is formed into a spiral shape using nickel-titanium alloy wire with a diameter of 0.01–0.1 mm. The wire diameter is, for example, 0.01 mm, 0.02 mm, 0.03 mm, 0.04 mm, 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, or 0.1 mm. The outer layer 23 is made of polyurethane, for example, a mixture of polyurethane (PELLETHANE manufactured by Dow Chemical, Shore D hardness: 65) and polyurethane (PELLETHANE manufactured by Dow Chemical, Shore D hardness: 75) in a 1:1 or 2:1 ratio. Nylon may be added to increase hardness. The reinforcing layer 22 has a constant pitch length or a variable pitch length. For example, the pitch length on the distal side of the reinforcing layer 22 is shorter than that on the proximal side. The radial thickness ratio of the inner layer 21, the reinforcing layer 22, and the outer layer 23 is 1:(0.05~0.2):(0.4~1); for example, the radial thickness ratio of the inner layer 21, the reinforcing layer 22, and the outer layer 23 is 1:0.05:0.4, 1:0.05:0.5, 1:0.05:0.6, 1:0.05:0.7, 1:0.05:0.8, 1:0.05:0.9, 1:0.05:1, 1:0.1:0.4, 1:0.1:0.5, 1:0.1:0.6, 1:0 1:0.7, 1:0.1:0.8, 1:0.1:0.9, 1:0.1:1, 1:0.15:0.4, 1:0.15:0.5, 1:0.15:0.6, 1:0.15:0.7, 1:0.15:0.8, 1:0.15:0.9, 1:0.15:1, 1:0.2:0.4, 1:0.2:0.5, 1:0.2:0.6, 1:0.2:0.7, 1:0.2:0.8, 1:0.2:0.9, 1:0.2:1.

[0041] The flow guide tip 30 is formed of stainless steel or of a hyaluronic acid tube, a serpentine tube, or a spring tube disposed between the inner and outer polymers; the axial length of the flow guide tip 30 is 0.2–2 cm, and the outer diameter gradually transitions from 8–16 Fr on the proximal side to 6–14 Fr on the distal side. For example, the flow guide tip 30 is a stainless steel tube, or a hyaluronic acid tube embedded with inner and outer polymers, or a serpentine tube embedded with inner and outer polymers, or a spring tube embedded with inner and outer polymers, wherein the inner polymer is polytetrafluoroethylene and the outer polymer is polyurethane, and the flow guide tip 30 is connected to the lumen of the second pipe section 20 and has a substantially consistent inner diameter.

[0042] The axial length of the guide tip 30 is 0.2cm, 0.3cm, 0.4cm, 0.5cm, 0.6cm, 0.7cm, 0.8cm, 0.9cm, 1cm, 1.1cm, 1.2cm, 1.3cm, 1.4cm, 1.5cm, 1.6cm, 1.7cm, 1.8cm, 1.9cm, or 2cm; the proximal outer diameter of the guide tip 30 is 8Fr, 8.5Fr, 9Fr, 9.5Fr, 10Fr, 10.5Fr, or 1cm. 1Fr, 11.5Fr, 12Fr, 12.5Fr, 13Fr, 13.5Fr, 14Fr, 14.5Fr, 15Fr, 15.5Fr, 16Fr; the outer diameter of the distal side of the guide tip 30 is 6Fr, 6.5Fr, 7Fr, 7.5Fr, 8Fr, 8.5Fr, 9Fr, 9.5Fr, 10Fr, 10.5Fr, 11Fr, 11.5Fr, 12Fr, 12.5Fr, 13Fr, 13.5Fr, 14Fr.

[0043] The guide tip 30 has a smoothly transitioned end 33 and inner and outer tube walls. If the end 33 and tube body of the guide tip 30 are entirely made of stainless steel, and the stainless steel tube body is welded to the reinforcing layer in the second tube section 20, a step 25 is provided at the interface between the guide tip 30 and the second tube section 20 to facilitate connection with the inner layer 21 and / or outer layer 23 of the second tube section 20, for example, by adhesive bonding. If the guide tip 30 is formed by a hyaluronic acid tube, a serpentine tube, or a spring tube disposed between the inner and outer polymers, the hyaluronic acid tube, serpentine tube, or spring tube can be welded to the reinforcing layer in the second tube section 20, and the inner and outer polymers are integrally formed with the inner layer 21 and / or outer layer 23 of the second tube section 20, and the end 33 is formed by the inner polymer and / or outer polymer.

[0044] The arithmetic mean roughness (Ra) of the 30 circumferential surface of the guide tip is ≤0.5μm, for example, 0.1μm, 0.2μm, 0.3μm, 0.4μm, or 0.5μm.

[0045] The end 33 of the guide tip 30 is rounded, and the rounding radius matches the wall thickness of the guide tip 30.

[0046] The guide tip 30 has a gradually changing inner diameter. Specifically, the guide tip 30 is provided with a flange 31 protruding into the lumen. The flange 31 is located at or near the end 33 of the guide tip 30. The flange 31 defines the minimum inner diameter of the guide tip 30, which is 3 to 9 Fr, for example, 3 Fr, 3.5 Fr, 4 Fr, 4.5 Fr, 5 Fr, 5.5 Fr, 6 Fr, 6.5 Fr, 7 Fr, 7.5 Fr, 8 Fr, 8.5 Fr, or 9 Fr. The flange 31 has a flow-facing surface 311 for receiving fluid and a flow-guiding surface 312 for guiding the flow direction of fluid. The flow-facing surface 311 and the flow-guiding surface 312 have a smooth transition. The axial cross-sectional profile of the flange 31 is a Bézier curve, and the profile shape is, for example, a semi-circle or a bullet shape.

[0047] The interfaces of the first pipe section 10, the second pipe section 20 and the tip 30 are provided with interlocking stepped structures, wedge-shaped structures or concave-convex structures.

[0048] The outer and / or inner circumferential surfaces of the first pipe section 10, and / or the second pipe section 20, and / or the guide tip 30 are provided with a hydrophilic coating 24. The film thickness of the hydrophilic coating 24 is ≤30µm, for example, 30µm, 25µm, 20µm, 15µm, 10µm, or 5µm. The hydrophilic coating 24 is made of polyvinylpyrrolidone and is applied to the pipe body 100 by impregnation or coating process.

[0049] The tube body 100 has a temperature control element 40, which is, for example, a heating wire, a heating plate, or a cooling plate (Peltier effect). It is embedded in the tube wall of the first tube section 10 and / or the second tube section 20 by means of a buried method. The signal line connecting the control console (not shown in the figure) and the temperature control element 40 extends in the tube wall of the tube body 100.

[0050] The proximal end of the tube body 100 is provided with a handle assembly 50. One or more channels extending axially are provided in the wall of the tube body 100, and a traction wire 51 is provided in each channel. The handle assembly 50 is configured to control the direction of the guide tip 30 via the traction wire 51. For example, the two ends of the traction wire 51 are connected to the guide tip 30 and the handle assembly 50, respectively. The structure and principle of the handle assembly 50 controlling the direction of the guide tip 30 via the traction wire 51 can be implemented in known ways, as seen in existing products such as endoscopes and puncture sheaths.

[0051] The handle assembly 50 integrates a Y-shaped tube 60, which includes a main tube 61 and a branch tube 62. The main tube 61 is coaxially arranged with the tube body 100, and the branch tube 62 forms a certain angle with the main tube 61, for example, 20 to 40 degrees, such as 20 degrees, 25 degrees, 30 degrees, 35 degrees, and 40 degrees.

[0052] See Figure 10The visualization guidewire 200 and guidewire 220 are connected at their distal and proximal ends to the end unit 210 and the imaging mechanism 230, respectively. The end unit 210 integrates a light source 211 and a camera module 212. The guidewire 220 extends axially from its distal to proximal end into a hollow lumen. The light source 211 and camera module 212 are electrically connected to the external imaging mechanism 230 via a signal line 213 extending from the hollow lumen. The imaging mechanism 230 includes a CCD camera and a display screen. When the light source 211 is turned on, the camera module 212 acquires image information of the gastrointestinal system lumen. The CCD camera converts the light signal into an electrical signal and displays the image on the display screen. The communication connection between the CCD camera and the display screen can be wired or wireless.

[0053] In use, the visualization guidewire 200 enters the tube body 100 from the main tube 61. After the two are combined, it extends from the nose into the gastrointestinal system. The visualization guidewire 200 acquires intraluminal imaging information to guide the surgeon in adjusting the surgical operation. For example, the posture of the tube body 100 can be adjusted through the handle assembly 50 to make the tube body 100 move in a direction that is conducive to reaching the jejunum. After the distal end of the tube body 100 reaches the jejunum, the visualization guidewire 200 is withdrawn from the main tube 61. Then, the connection port of the IV bag (not shown) is screwed to the Y-shaped tube, so that the nutrient solution in the IV bag reaches the jejunum along the tubular lumen 101 under the drive of a peristaltic pump (not shown) and other power mechanisms.

Claims

1. A novel jejunal feeding tube, comprising a tube body (100) defining a tubular lumen (101), characterized in that: The tube body (100) includes a first tube segment (10) and a second tube segment (20) that are attached to each other and smoothly transition into each other; the axial length of the first tube segment (10) is 40 to 80 cm and the axial length of the second tube segment (20) is 30 to 50 cm; the first tube segment (10) has a first flexural modulus of 8,000 to 26,000 psi and the second tube segment (20) has a second flexural modulus of 2,000 to 10,000 psi.

2. The novel jejunal feeding tube according to claim 1, characterized in that: The second pipe section (20) includes an inner layer (21) and an outer layer (23) that are concentrically arranged and thermally fused together, and a reinforcing layer (22) is formed between the inner layer (21) and the outer layer (23); preferably, the radial thickness ratio of the inner layer (21), the reinforcing layer (22) and the outer layer (23) is 1:(0.05~0.2):(0.4~1); preferably, the inner layer (21) is made of polytetrafluoroethylene, the reinforcing layer (22) is a spiral nickel-titanium alloy wire, and the outer layer (23) is made of polyurethane; preferably, the reinforcing layer (22) has a constant pitch length; preferably, the reinforcing layer (22) has a variable pitch length, wherein the pitch length on the far end side of the reinforcing layer (22) is shorter than that on the near end side.

3. The novel jejunal feeding tube according to claim 1 or 2, characterized in that: The first pipe section (10) is a single-layer structure (11), and the material is selected from at least one or a combination of two or more of polyethylene, polypropylene, polyurethane, polycarbonate and Pebax.

4. The novel jejunal feeding tube according to any one of claims 1-3, characterized in that: The second pipe section (20) is provided with a flow guide tip (30) at its distal end. The axial length of the flow guide tip (30) is 0.2 to 2 cm, and the outer diameter gradually transitions from 8 to 16 Fr on the proximal side to 6 to 14 Fr on the distal side. Preferably, the flow guide tip (30) includes a metal layer (32), which is made of stainless steel or formed by a hyaluronic acid tube, a snake tube, or a spring tube disposed between the inner and outer polymers. Preferably, the arithmetic mean roughness (Ra) of the circumferential surface of the flow guide tip (30) is ≤0.5 μm, and the end (33) of the flow guide tip is rounded.

5. The novel jejunal feeding tube according to claim 4, characterized in that: The guide tip (30) has a gradually changing inner diameter. Preferably, the guide tip (30) is provided with a flange (31) arranged in a ring along the peripheral wall and protruding into the cavity. The flange (31) has a flow-facing surface (311) for receiving fluid and a flow-guiding surface (312) for guiding the flow direction of fluid. The flow-facing surface (311) and the flow-guiding surface (312) are smoothly transitioned. Preferably, the flange (31) is located at the end or near the end of the guide tip (30). The flange (31) defines the minimum inner diameter of the guide tip (30), which is 3 to 9 Fr. Preferably, the axial cross-sectional profile of the flange (31) is a Bezier curve, and the profile shape is, for example, a semi-circle or a bullet.

6. The novel jejunal feeding tube according to claim 4 or 5, characterized in that: The interface of the first pipe section (10), the second pipe section (20) and the guide tip (30) is provided with a stepped structure, wedge structure or concave-convex structure (25) that fits into each other.

7. The novel jejunal feeding tube according to any one of claims 1-6, characterized in that: At least the outer circumferential surface of the second pipe section (20) is provided with a hydrophilic coating (24), the film thickness of the hydrophilic coating (24) is ≤30µm, and the hydrophilic coating (24) is made of polyvinylpyrrolidone.

8. The novel jejunal feeding tube according to any one of claims 1-7, characterized in that: It also includes a temperature control element (40), and the temperature control element (40) and the signal line connecting the control console and the temperature control element (40) are located in the wall of the tube body (100).

9. The novel jejunal feeding tube according to any one of claims 1-8, characterized in that: It also includes a handle assembly (50) located at the proximal end (A) of the tube body (100), and a traction line (51) embedded in the tube body (100) is connected to the guide tip (30) and the handle assembly (50) respectively. The handle assembly (50) is configured to control the direction of the guide tip (30) through the traction line (51).

10. The novel jejunal feeding tube according to any one of claims 1-9, characterized in that: It also includes a Y-shaped tube (60) integrated in the handle assembly (50), the Y-shaped tube (60) including a main tube (61) and a branch tube (62), the main tube (61) being arranged coaxially with the tube body (100), and the branch tube (62) being at a certain angle to the main tube (61), for example, 20 to 60 degrees.

Images