A dedicated double-lumen catheter for selective transnasal gastrointestinal tract

Abstract

The present invention provides a special double-lumen catheter for selective transnasal gastrointestinal tract, which comprises a catheter body and a catheter seat connected to the end of the catheter body. The catheter body is a double-lumen catheter, including a main lumen tube with a larger inner diameter and a secondary lumen tube with a smaller inner diameter. The head end of the catheter body is made of a memory shaping material. Among them, the head end of the main lumen tube is bent and folded back into a loop shape, and the head end of the secondary lumen tube is located inside the main lumen tube and opens at the middle part of the loop-shaped part. The double-lumen catheter of the present invention can improve the problems existing in the current transnasal catheter placement treatment device, shorten the catheter placement time, and relieve the pain of patients.

Description

Technical Field

[0001] The present invention relates to the field of interventional medical devices, and particularly to a nasal-gastrointestinal double-lumen catheter. Background Art

[0002] At present, in the treatment of patients requiring enteral nutrition and patients with intestinal obstruction, the transnasal catheter placement therapy has been widely accepted and carried out clinically. Especially in the treatment of postoperative gastroparesis and adhesive intestinal obstruction, it is the preferred treatment method. The transnasal catheter placement therapy usually uses an enteral nutrition tube and an intestinal obstruction catheter inserted through the nose, which are medical devices related to interventional surgery specifically used for operations within the digestive tract. With the cooperation of a guide wire and a catheter, the catheter is driven to completely pass through the upper digestive tract through the nasal cavity and reach the small intestine where it is needed, so as to achieve the effects of direct enteral nutrition support and dredging the obstructed intestine.

[0003] There are two methods in the placement of the intestinal obstruction catheter: placement under gastroscopy and placement under X-ray. Each method has its own advantages and disadvantages. The indication for intubation under X-ray fluoroscopy monitoring is wide, patients can generally tolerate it, the complication rate is low, the technical success rate can reach more than 90%, and real-time intraoperative angiography can show the direction of the digestive tract. It is easy to pass through the obstructed part using a super-slippery guide wire, and the operation controllability is strong, which is the preferred placement method in clinical practice. However, the disadvantage is that the X-ray radiation has certain harm to the operator and the patient's body.

[0004] Usually, the transnasal catheter placement therapy under X-ray is operated by an interventional doctor: inserting a nutrition tube or an intestinal obstruction catheter equipped with a guide wire into the patient's one nasal cavity, passing through the esophagus to reach the stomach, and then guiding the catheter to the gastric antrum of the stomach under the guidance of the guide wire, selecting to enter the pyloric canal through the gastric antrum, and reaching the upper end of the jejunum through the duodenum, withdrawing the guide wire, and filling the water balloon at the front end of the catheter to complete the whole operation process.

[0005] In terms of the placement operation, the heads of the current clinically used intestinal obstruction catheters and jejunal nutrition tubes are both non-directional straight heads, and the catheter bodies are all soft structures, and they cannot be effectively supported and the direction cannot be selected in the stomach. The equipped guide wire is a rigid guide wire with a thickness of 1.24 mm (0.045"), although it has a good supporting effect, due to the special structure of the gastrointestinal tract, it is often difficult to select the direction when the two pass through the tortuous gastric antrum, pylorus and duodenal bulb. Summary of the Invention

[0006] In view of this, the purpose of the present invention is to overcome the disadvantages such as difficult direction selection within the digestive tract, complex surgical techniques, and excessive exposure of patients and operators to X-ray caused by the lack of a dedicated selective catheter for the intestine in the prior art, and provide a dedicated nasal-gastrointestinal double-lumen catheter device to improve the problems existing in the current transnasal catheter placement treatment device, shorten the catheter placement time, and relieve the pain of patients.

[0007] To achieve the above object, the present invention adopts the following technical solutions:

[0008] A special double-lumen catheter for selective transnasal gastrointestinal tract, comprising a catheter body and a catheter seat connected to the end of the catheter body. The catheter body is a double-lumen catheter, including a main lumen tube with a larger inner diameter and a secondary lumen tube with a smaller inner diameter. The head end of the catheter body is made of a memory shaping material. Among them, the head end of the main lumen tube is bent back into a loop shape, the head end of the secondary lumen tube is located inside the main lumen tube, and the opening is at the middle part of the loop-shaped part.

[0009] Further, the bent-back part of the loop-shaped part of the main lumen tube includes an arc-shaped bending part, a first extension part extending from the end of the bending part towards the catheter body, and a second extension part extending from the end of the first extension part away from the catheter body. The end of the secondary lumen tube opens at the transition between the bending part (111) and the first extension part (112).

[0010] Further, the body of the catheter body is made of a polyamide material with a supportive stainless steel braid.

[0011] Further, the head end of the catheter body is made of a memory shaping braided nylon body material with a tungsten material marker.

[0012] Further, alloy markers are provided at the end openings of both the main lumen tube and the secondary lumen tube.

[0013] Further, the outer diameter of the catheter body is 7Fr - 2.39 mm, the length is 130 - 170 cm, and a hydrophilic coating is attached inside and outside the lumen.

[0014] Further, the catheter seat is a Y-shaped connector. The main lumen catheter seat is a continuation of the main lumen tube body, and the angle of the secondary lumen catheter seat forms a 30° angle with the main lumen catheter seat.

[0015] Further, the catheter seat is made of vinyl acetate and polyamide materials.

[0016] Further, the catheter is also equipped with guide wires respectively matching the main lumen tube and the secondary lumen tube.

[0017] Further, the inner diameter of the main lumen tube is 1.24 mm, which is adapted to a 0.045” rigid guide wire; the inner diameter of the secondary lumen tube is 0.97 mm, which is adapted to a 0.035” hydrophilic guide wire.

[0018] The beneficial effects of the present invention are as follows:

[0019] 1) The present invention provides a double-lumen catheter structure. Since the upper digestive tract is not a tubular structure like blood vessels or ureters, it has wrinkled mucous membranes, as well as structures such as the cardia and pylorus. Repeated selection with a guide wire and a catheter is required. The double-lumen catheter can be combined with guide wires of different diameters. The 0.045” stiff guide wire in the thicker lumen plays a supporting role, and the 0.035” hydrophilic guide wire in the thinner lumen plays a selection role, thereby improving the ability to push the catheter and the guide wire into the duodenum and the proximal small intestine, and at the same time reducing the complex operation steps of exchanging the guide wire and the catheter.

[0020] 2) The present invention optimizes the shaping of the catheter tip to make it a loop-like structure. On the one hand, after the catheter tip is placed in the gastric antrum, it forms a loop in the gastric antrum according to the memory shaping of the catheter, and combines with the 0.045” stiff guide wire to support the gastric antrum, making it a foreign body fixed in the gastric antrum. Due to the peristaltic action of the gastrointestinal tract, the supported catheter is pushed by intestinal peristalsis to smoothly enter the pylorus and move deeper into the duodenum along the peristaltic direction.

[0021] 3) On the other hand, the present invention sets the outlets of the double-lumen catheter tip at different positions. The purpose is to form a loop-shaped catheter in the gastric antrum, and combine with the 0.045” stiff guide wire to support the gastric antrum in the main lumen of the catheter. Due to the easy deformation of the gastric relaxation function, the original three-dimensional spherical structure of the gastric antrum can be flattened into a two-dimensional flat funnel-like structure. Then, the 0.035” hydrophilic guide wire with a thin diameter is inserted into the secondary lumen and led out from the opening at the middle position of the loop. This guide wire can directly adhere to the gastric folds, and through the flat funnel-like gastric antrum, the pyloric canal and the duodenal bulb can be selected, and then the catheter is smoothly guided to move deeper into the duodenum.

[0022] 4) The present invention optimizes the length of the catheter itself to 150 cm. This design overcomes the problem that the existing catheters (usually 80 - 110 cm) are insufficient in length and do not match the length of the upper digestive tract; combined with the Y-shaped structure of the hub, it has a fixed directionality with the catheter tip, reducing the operation difficulty of unclear catheter tip orientation (front and rear positions of the catheter tip) under fluoroscopy, and enabling better control of the catheter to push it into the tortuous gastric antrum, pylorus and duodenal bulb. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a schematic structural diagram of an embodiment of the double-lumen catheter of the present invention.

[0024] Figure 2 is Figure 1 A schematic cross-sectional view of the double-lumen catheter in the embodiment.

[0025] Figure 3 is Figure 1 A schematic axial view of the double-lumen catheter in the embodiment.

[0026] Figure 4The gastric antrum, pylorus, and duodenal bulb are imaged to show the anatomical structures.

[0027] Figure 5 This is the intubation method 1 (example) of the embodiment of the present invention.

[0028] Figure 6 This is the intubation method 2 (schematic diagram) of the embodiment of the present invention. Detailed implementation manners

[0029] To further understand the present invention, the preferred implementation manners of the present invention will be described below in conjunction with embodiments. However, it should be understood that these descriptions are only for further explaining the features and advantages of the present invention, rather than limiting the claims of the present invention.

[0030] Embodiment 1

[0031] As Figures 1 - 3 shown, the first embodiment of the present invention is a selective double-lumen catheter for the gastrointestinal tract via the nose, which includes a catheter body 1 and a catheter seat 2. The catheter seat 2 is connected to the end of the catheter body 1.

[0032] Among them, the catheter body 1 is a double-lumen catheter, and the tube body is made of polyamide material with a supportive stainless steel braid. It is internally provided with a main lumen tube 11 with a larger inner diameter and a secondary lumen tube 12 with a smaller inner diameter.

[0033] As a preferred implementation manner, in this embodiment, the outer diameter of the catheter body 1 is 7Fr - 2.39 mm, the length is 150 cm, and the inner and outer surfaces of the lumen are coated with a hydrophilic coating.

[0034] The head end portion 13 of the catheter body 1 is made of a memory-shaped braided nylon body material with a tungsten material marker. The head end portion of the main lumen tube 11 is bent back into a loop shape. The head end portion of the secondary lumen tube 12 is located inside the main lumen tube 11 and opens at the middle part of the loop-shaped portion.

[0035] As a preferred implementation manner, in this embodiment, the bent-back portion of the loop-shaped portion of the main lumen tube 11 includes a curved portion 111 in a 180° circular arc shape, a first extension portion 112 extending from the end of the curved portion 11 towards the catheter body, and a second extension portion 113 extending from the end of the first extension portion 112 away from the catheter body. The end of the secondary lumen tube 12 opens at the transition portion between the curved portion 111 and the first extension portion 112 of the main lumen tube.

[0036] As a preferred implementation manner, in this embodiment, a yellowish-white alloy marker 114 is provided at the end opening of the main lumen tube 11, and a yellowish-white alloy marker 121 is provided at the end opening of the secondary lumen tube 12.

[0037] In this embodiment, the catheter seat 2 is a Y-shaped connector made of vinyl acetate and polyamide materials. Among them, the main cavity catheter seat 21 is a continuation of the main cavity tube body, and the angle of the auxiliary cavity catheter seat 22 is 30° with respect to the main cavity catheter seat.

[0038] As a further implementation, the double-lumen catheter in this embodiment is also equipped with guide wires respectively matching the main cavity tube 11 and the auxiliary cavity tube 12.

[0039] As a preferred implementation, the inner diameter of the main cavity tube 11 is 1.24 mm, which is adapted to a 0.045" rigid guide wire; the inner diameter of the auxiliary cavity tube 12 is 0.97 mm, which is adapted to a 0.035" hydrophilic guide wire.

[0040] Embodiment 2

[0041] The second embodiment of the present invention is the first intubation method of the double-lumen catheter in Embodiment 1. Refer to Figure 4 and Figure 5 , Figure 4 , which show that the morphologies of the gastric antrum and duodenal bulb in different patients vary greatly, increasing the difficulty of inserting the catheter through the pylorus into the duodenum. As shown in Figure 5 , in this embodiment, by pushing forward with the blunt loop-shaped structure at the distal end of the catheter, without damaging the stomach and duodenum, the catheter can be smoothly pushed into the pylorus and moved deeper into the duodenum by directly relying on the peristaltic action of the gastrointestinal tract, completing the intubation of the gastric antrum, pylorus, and duodenal bulb, and the operation is simple and easy.

[0042] Embodiment 3

[0043] The third embodiment of the present invention is the second intubation method of the double-lumen catheter in Embodiment 1. Refer to the physical diagram in Figure 6 (a) and the schematic diagram in 6(b). For patients who have difficulty intubating using the method in Embodiment 2, form a loop of the catheter 1 in the gastric antrum 100, combine a 0.045" rigid guide wire 3 and the main cavity tube of the catheter to support the gastric antrum 100, so that the original three-dimensional spherical structure of the gastric antrum 100 is flattened into a two-dimensional flat funnel-like structure. Since the opening of the auxiliary cavity tube is located in the middle part of the loop-shaped part of the main cavity tube, insert a thinner 0.035" hydrophilic guide wire 4 into the auxiliary cavity tube and extend it from the opening, and its direction points to the distal end of the funnel. Therefore, the guide wire can directly adhere to the gastric folds, insert the guide wire into the pylorus and enter the duodenal bulb 200 along the funnel direction, and finally insert the catheter under the guidance of the guide wire to complete the intubation process.

[0044] The descriptions of the above embodiments are only used to help understand the method and its core idea of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and modifications can be made to the present invention, and these improvements and modifications also fall within the protection scope of the claims of the present invention.

Claims

1. A special double-lumen catheter for selective transnasal gastrointestinal tract, characterized in that, It includes a catheter tube body (1) and a catheter seat (2) connected to the end of the catheter tube body (1). The catheter tube body (1) is a double-lumen catheter, including a main lumen tube (11) with a larger inner diameter and an auxiliary lumen tube (12) with a smaller inner diameter. The head end portion (13) of the catheter tube body (1) is made of a memory shaping material. Among them, the head end portion of the main lumen tube (11) is bent back into a loop shape. The head end portion of the auxiliary lumen tube (12) is located inside the main lumen tube (11) and opens at the middle part of the loop-shaped portion. The bent-back portion of the loop-shaped portion of the main lumen tube (11) includes an arc-shaped bending portion (111), a first extension portion (112) extending from the end of the bending portion (111) towards the catheter tube body, and a second extension portion (113) extending from the end of the first extension portion (112) away from the catheter tube body. The end of the auxiliary lumen tube (12) opens at the transition between the bending portion (111) and the first extension portion (112). Alloy markers are provided at the end openings of both the main lumen tube (11) and the auxiliary lumen tube (12). The catheter is also equipped with guide wires respectively matching the main lumen tube (11) and the auxiliary lumen tube (12). The inner diameter of the main lumen tube (11) is 1.24 mm, which is suitable for a 0.045” rigid guide wire. The inner diameter of the auxiliary lumen tube (12) is 0.97 mm, which is suitable for a 0.035” hydrophilic guide wire.

2. The selective double-lumen catheter dedicated for transnasal gastrointestinal tract according to claim 1, characterized in that, The body of the catheter tube body (1) is made of a polyamide material with a supportive stainless steel braid.

3. The selective nasal-gastrointestinal tract dedicated double-lumen catheter according to claim 1, characterized in that, The head end portion (13) of the catheter tube body (1) is made of a memory shaping braided nylon body material with a tungsten material marker.

4. The selective double-lumen catheter dedicated to the transnasal gastrointestinal tract according to claim 1, characterized in that, The outer diameter of the catheter tube body (1) is 7Fr - 2.39 mm, and the length is 130 - 170 cm. A hydrophilic coating is attached inside and outside the lumen.

5. The selective nasal-gastrointestinal tract dedicated double-lumen catheter according to claim 1, characterized in that, The catheter seat (2) is a Y-shaped connector. The main lumen catheter seat (21) is a continuation of the main lumen tube body, and the angle of the auxiliary lumen catheter seat (22) is 30° with respect to the main lumen catheter seat.

6. The selective nasal-gastrointestinal tract dedicated double-lumen catheter according to claim 5, characterized in that, The catheter seat (2) is made of vinyl acetate and polyamide materials.

Images