Newborn tracheoesophageal fistula plugging device

Abstract

The utility model provides a neonatal tracheoesophageal fistula plugging device, which relates to the technical field of medical instruments, and comprises a catheter, a plugging balloon and a balloon inflation device, the two ends of the catheter are respectively a handheld section and an insertion section, the insertion section is provided with an insertion section bend angle, the angle of the insertion section bend angle is 160-180 degrees, and the balloon inflation device is connected with the handheld section. The angle conforms to the structure that the upper trachea and the esophagus are closely adjacent to each other, the balloon is conveniently placed in and blocks the orificium fistulae, the indwelling catheter efficiency is improved, the blocking balloon is installed at the position of the insertion section, the blocking balloon is the balloon with at least two wave structures, the effective blocking diameter range is large, and the blocking balloon can adapt to orificium fistulae of different shapes and sizes and wave crests on the two sides of the balloon. After being inflated, the device is supported on two sides of the orificium fistulae, so that leakage and displacement risks can be effectively reduced.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a neonatal tracheoesophageal fistula occluder. Background Technology

[0002] Congenital tracheoesophageal fistula is a neonatal malformation, classified into five types. Three of these involve a fistula connecting the lower esophagus to the trachea. In newborns requiring mechanical ventilation, the fistula must be sealed before ventilation to prevent air leakage into the stomach. Currently, there are no specific instruments for sealing these fistulas. Clinically, a small-sized bronchial occluder is used, but these methods have significant drawbacks.

[0003] The following is a solution for sealing fistulas using a small-sized bronchial occluder:

[0004] Small-sized bronchial occlusion device protocol: After correct endotracheal intubation, a small-sized occlusion endotracheal tube and endoscope are inserted externally through the endotracheal tube. When a tracheoesophageal fistula is reached, the occlusion balloon is inflated to seal the fistula, and mechanical ventilation is then initiated through the endotracheal tube. In neonatal tracheal stenosis, the outer diameter of endotracheal tubes used clinically for newborns is generally 4.2-4.9 mm, and the inner diameter is 3.0-3.5 mm. The smallest endoscope commonly available clinically has an outer diameter of 2.2 mm, and the smallest occlusion endotracheal tube clinically is 5Fr (outer diameter 1.66 mm). Since the endoscope and occlusion tube cannot be simultaneously inserted through the endotracheal tube lumen, they must be inserted externally. However, the neonatal tracheal mucosa is fragile, and external insertion causes significant irritation and damage to the airway mucosa. Furthermore, the anesthesia is shallow, easily leading to premature awakening, increasing the difficulty of anesthesia and surgery.

[0005] Occlusion catheters are generally used to close one lung. Their balloons have a short effective length and a complex and heavy handpiece structure, making them prone to displacement. The occlusion diameter is designed according to the bronchial diameter, making it difficult to effectively close fistulas with various shapes.

[0006] The esophageal wall and tracheal wall are in close contact at a small angle. Existing occlusion catheters with a 155° bend at the insertion end and those without an angle do not match the angle of the insertion segment with the fistula opening, making insertion difficult.

[0007] Because newborns have narrow tracheas, they are prone to injury when the occluder is removed;

[0008] This application is filed to address the aforementioned deficiencies. Utility Model Content

[0009] The purpose of this invention is to provide a neonatal tracheoesophageal fistula occluder, used to seal the fistula opening during mechanical ventilation of newborns with a fistula connecting the lower esophagus to the trachea, preventing air leakage into the stomach. It uses a new balloon structure, is suitable for sealing fistulas of various shapes, improves tube placement efficiency, reduces the probability of balloon displacement, and minimizes harm to the patient when the occluder is withdrawn.

[0010] To address the aforementioned problems, this utility model provides a neonatal tracheoesophageal fistula occluder, comprising a catheter, an occlusion balloon, and a balloon inflation device. The catheter has a handheld section and an insertion section at its two ends. The insertion section has an insertion section bend with an angle of 160°~180°. This angle conforms to the anatomical structure of the trachea and esophagus being closely adjacent, facilitating balloon insertion and occlusion of the fistula, thus improving insertion efficiency. The occlusion balloon is installed at the insertion section position, behind the insertion section bend, i.e., relative to the insertion section... The bend is closer to the distal end. The occlusion balloon is a balloon with at least two wave structures, which has a large effective occlusion diameter range and can adapt to fistulas of different shapes and sizes. The wave peaks on both sides of the balloon support the fistula after inflation, which can effectively reduce the risk of leakage and displacement. At least one end of the occlusion balloon is connected to the catheter in a twisted manner, so that the balloon fits tightly against the catheter after contraction, allowing the occluder to be withdrawn smoothly and reducing the damage during withdrawal. The balloon inflation device is connected to the occlusion balloon and is used to inflate and deflate the occlusion balloon.

[0011] According to one embodiment of the present invention, the diameter of the catheter is ≤1.2mm, which satisfies the requirement that the catheter and endoscope can be simultaneously inserted into the endotracheal tube of the newborn, and the airway pressure meets the requirements for newborn ventilation.

[0012] According to one embodiment of the present invention, the catheter has a polymer outer layer, the material of which is one of polyetheretherketone, polyamide, polyimide, polyethylene, and polypropylene, preferably polyetheretherketone. The catheter made of this material has excellent biocompatibility, causes little irritation to the mucosa, and reduces the risk of intraoperative awakening.

[0013] According to one embodiment of the present invention, the catheter is equipped with a conversion connector, which has a connector portion and an endoscope channel. The connector portion can be connected to an endotracheal tube and a breathing tube. The conversion connector is also equipped with a catheter fixing device to fix it on the catheter.

[0014] According to one embodiment of the present invention, the catheter is further provided with a polymer inner layer, the material of which is one of polyetheretherketone, polyamide, polyimide, and thermoplastic polyurethane elastomer, preferably a polyamide layer. The polyamide layer and the polyetheretherketone outer layer are made by double-layer co-extrusion. The catheter structure has excellent bending resistance and can provide sufficient axial support when the catheter is placed at the same time as the endoscope, and can be quickly placed to the occlusion position.

[0015] According to one embodiment of the present invention, the balloon inflation device is located at the handheld section, which is convenient for operation. The handheld section has no other devices, and the structure is simple and the weight is low.

[0016] Preferably, the angle of the bend in the insertion section is 170°.

[0017] According to one embodiment of the present invention, both ends of the occlusion balloon are connected to the catheter by a twisting method, which further improves the effect of tightly adhering to the catheter after contraction.

[0018] The beneficial effects of this invention are that by setting a suitable insertion segment bend angle, it conforms to the anatomical structure of the trachea and esophagus being closely adjacent, facilitating balloon placement and fistula sealing, thus improving the efficiency of catheter placement. By setting the sealing balloon to a wave-shaped structure, it can effectively seal a wide range of diameters, adapting to fistulas of different shapes and sizes. After inflation, it is supported on both sides of the fistula, effectively reducing the risk of leakage and displacement. Furthermore, by using a twisting method to connect the sealing balloon to the catheter, the balloon adheres tightly to the catheter after contraction, allowing the occluder to be smoothly withdrawn and reducing damage during withdrawal. Attached Figure Description

[0019] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0020] Figure 1 A schematic diagram of the overall structure of a neonatal tracheoesophageal fistula occluder.

[0021] Figure 2 This is a schematic diagram of the occlusion balloon.

[0022] Figure 3 This is a schematic diagram of sealing a Type 1 fistula.

[0023] Figure 4 This is a schematic diagram of sealing a type II fistula.

[0024] Figure 5 This is a schematic diagram of sealing a type III fistula. Detailed Implementation

[0025] The following description is only intended to disclose the present invention so that those skilled in the art can implement it. The embodiments in the following description are merely examples, and those skilled in the art will conceive of other obvious modifications. The basic principles of the present invention defined in the following description can be applied to other embodiments, modifications, improvements, equivalents, and other solutions that do not depart from the spirit and scope of the present invention.

[0026] A neonatal tracheoesophageal fistula occluder, such as Figure 1It includes a catheter 7, an occlusion balloon 3, a balloon inflation device 6, and a conversion connector 5. The balloon inflation device 6 is connected to the occlusion balloon 3 and is used to inflate and deflate the occlusion balloon 3. The conversion connector 5 is installed on the catheter 7 and has a connector part and an endoscope channel. The connector part can be connected to the endotracheal tube and the breathing circuit. The conversion connector 5 is also equipped with a catheter fixing device to fix it on the catheter 7.

[0027] Catheter 7 is made of polyetheretherketone-polyamide double-layer co-extrusion, with polyetheretherketone as the outer layer, which gives the catheter excellent biocompatibility, less irritation to the mucosa, and reduced risk of intraoperative awakening. The double-layer co-extruded catheter structure has excellent bending resistance and can provide sufficient axial support when placed in conjunction with the endoscope, allowing for rapid placement to the occlusion position.

[0028] The diameter of catheter 7 is ≤1.2mm, which allows the catheter and endoscope to be inserted simultaneously through the neonatal endotracheal tube, and the airway pressure meets the requirements for neonatal ventilation.

[0029] The catheter 7 has a handheld section 2 and an insertion section 1 on both sides. The end of the insertion section 1 is closed. The balloon inflation device 6 is located at the handheld section 2 for easy operation. The handheld section 2 has no other devices, has a simple structure and low weight. The insertion section 1 is provided with an insertion section bend 4. The angle of the insertion section bend 4 is 160°~180°, preferably 170°. This angle conforms to the anatomical structure of the trachea and esophagus being closely adjacent, which facilitates balloon placement and sealing of the fistula, and improves the efficiency of catheter placement.

[0030] The occlusion balloon 3 is installed at the insertion segment 1, behind the bend 4 of the insertion segment, that is, closer to the distal end than the bend 4. The occlusion balloon 3 is a double-wave balloon with two wave structures, offering a wide effective occlusion diameter range to accommodate fistulas 32 of different shapes and sizes. Figures 3-5 The three types of fistulas 32 are designed with the balloon's anterior and posterior peaks located at the esophageal 33 and tracheal 31 ends of the fistula 32, respectively. After inflation, the balloon is supported on both sides of the fistula 32, which can effectively reduce the risk of leakage and displacement.

[0031] During assembly of the occlusion balloon 3, the two ends of the occlusion balloon 3 are twisted at a slight angle and then bonded to the catheter 7, so that the balloon adheres tightly to the catheter after contraction, allowing the occluder to be withdrawn smoothly and reducing the damage during withdrawal.

[0032] Those skilled in the art should understand that the embodiments of the present invention described above and shown in the accompanying drawings are merely examples and do not limit the present invention. The purpose of the present invention has been fully and effectively achieved. The functional and structural principles of the present invention have been shown and explained in the embodiments. Without departing from the stated principles, the implementation of the present invention may have any variations and modifications.

Claims

1. A neonatal tracheoesophageal fistula occluder, characterized in that: The application relates to a catheter (7), a blocking balloon (3) and a balloon inflation device (6), wherein the catheter (7) is provided with a handheld section (2) and an insertion section (1) at two ends, the insertion section (1) is provided with an insertion section bending angle (4), the angle of the insertion section bending angle (4) is 160-180 degrees, the blocking balloon (3) is arranged at the position of the insertion section (1), the blocking balloon (3) is a balloon with at least two wave structures, at least one end of the blocking balloon (3) is connected to the catheter (7) in a twisting mode, and the balloon inflation device (6) is connected to the blocking balloon (3).

2. The neonatal tracheoesophageal fistula occluder of claim 1, wherein: The diameter of the catheter (7) is less than or equal to 1.2 mm.

3. The neonatal tracheoesophageal fistula occluder of claim 2, wherein: The catheter (7) is provided with a high-molecular outer layer, and the material is one of polyether ether ketone, polyamide, polyimide, polyethylene and polypropylene.

4. The neonatal Tracheoesophageal Fistula Occluder of claim 2 or 3, wherein: The catheter (7) is provided with a conversion joint (5), and the conversion joint (5) is provided with a joint part and an endoscope channel.

5. The neonatal tracheoesophageal fistula occluder of claim 4, wherein: The catheter (7) is further provided with a high-molecular inner layer, and the material is one of polyether ether ketone, polyamide, polyimide and thermoplastic polyurethane elastomer.

6. The neonatal tracheoesophageal fistula occluder of any one of claims 1-3, wherein: The balloon inflation device (6) is arranged at the handheld section (2).

7. The neonatal tracheoesophageal fistula occluder of claim 4, wherein: The angle of the insertion section bending angle (4) is 170 degrees.

8. The neonatal tracheoesophageal fistula occluder of claim 4, wherein: Both ends of the blocking balloon (3) are connected to the catheter (7) in a twisting mode.

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