Turnover catheter device for ileum fistulization

Abstract

The utility model relates to the technical field of medical instruments, in particular to an ileum fistulization bypass catheter device. The ileum fistulization bypass catheter device comprises a first catheter body, the front end of the first catheter body is of an open structure, a plurality of first through holes are formed in the side portion of the first catheter body, and an air bag assembly is arranged on the rear section of each first through hole; a connecting port is formed in the tube tail of the first tube body, and a drainage bag is detachably connected to the outer side of the connecting port; a first branch tube communicated with the air bag assembly is arranged on one side of the tube tail of the first tube body, and an air injection valve used for injecting air into the air bag assembly or exhausting air from the air bag assembly is installed on the first branch tube, so that the function of cutting off an enteric cavity (namely air bag intestinal obstruction) is achieved, intestinal contents can be transferred through a catheter, and the risk of leakage of an anastomotic stoma is reduced. The nursing bed is easy to operate, convenient to nurse and easy to accept by patients and family members, and pain caused by treatment of the patients is greatly reduced.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to an ileostomy diversion catheter device. Background Technology

[0002] Colorectal cancer is one of the most common malignant tumors of the digestive tract, characterized by high incidence and mortality rates. Despite significant advancements in surgical techniques and related theories for colorectal cancer in recent years, anastomotic leakage remains one of the most prevalent and serious complications of sphincter-preserving surgery for rectal cancer. It not only increases the risk of secondary surgery, prolongs hospital stays, and increases hospital costs, but also potentially delays treatment, increasing the risk of tumor development and patient death. According to relevant literature, the incidence of anastomotic leakage ranges from 2.4% to 27%, with a mortality rate as high as 18%.

[0003] Currently, prophylactic ileostomy remains the primary measure for preventing anastomotic leakage. The main method for prophylactic bypass surgery is traditional open ileostomy at the terminal ileum. Therefore, while prophylactic ileostomy increases surgical safety and prevents anastomotic leakage to some extent, even mitigating the risks associated with it, it also increases the corresponding risks and complications. Statistics show that the complication rate of traditional ileostomy is over 30%, or even higher, causing immense physical and psychological suffering for patients. Follow-up studies have revealed that 100% of patients experience embarrassment and helplessness due to ostomy bag dislodgement.

[0004] Meanwhile, clinical observations have revealed that postoperative anastomotic leakage often occurs in the early stages (2-8 days), mostly around the fourth day after surgery. Therefore, to prevent the risk of anastomotic leakage within about a week, patients need to live with a stoma for three months. In some cases, the fistula may never be closed, which is a huge harm to patients and a source of great helplessness for them.

[0005] Therefore, there is an urgent need to design a special catheter for preventing diversion during rectal cancer anal-preserving surgery. Utility Model Content

[0006] The purpose of this utility model is to at least solve one of the technical problems existing in the prior art and to provide an ileostomy diversion catheter device.

[0007] To achieve the above objectives, the technical solution adopted by this utility model is as follows: an ileostomy diversion catheter device includes a first tube body, the front end of the first tube body has an open structure, and the side is provided with a plurality of first through holes, and the rear section of the first through holes is provided with an air bag assembly; the tail end of the first tube body is provided with a connection port, and a drainage bag is detachably connected to the outside of the connection port; a first branch tube is provided on one side of the tail end of the first tube body, which is connected to the air bag assembly, and an injection valve for injecting or depressing air into the air bag assembly is installed on the first branch tube.

[0008] Furthermore, several of the first through holes are elliptical in shape and are staggered and intersecting with each other.

[0009] Furthermore, the airbag assembly includes a first airbag and a second airbag, which are arranged adjacent to each other.

[0010] Furthermore, the first branch tube comprises two parts, and the two first branch tubes are respectively connected to the first airbag and the second airbag.

[0011] Furthermore, a second branch pipe is provided on the other side of the first pipe body, and a cap is threaded onto the second branch pipe.

[0012] Furthermore, it also includes a second pipe body, which penetrates the first pipe body through the second branch pipe and extends outward.

[0013] Furthermore, the outer diameter of the second pipe is smaller than the inner diameter of the first pipe, and equal to the inner diameter of the second branch pipe.

[0014] Furthermore, the front end of the second tube is blunt and solid, and the side is provided with several second through holes, which are elliptical and staggered and crisscrossed; the tail end of the second tube is provided with several connection ports, including a flushing port, a negative pressure port, and a pressure regulating port.

[0015] Furthermore, a negative pressure drain is connected to the negative pressure port, and a one-way control valve is installed on the pressure regulating port.

[0016] Furthermore, the second tube is provided with a spiral cap for fixing the second tube to the first tube.

[0017] Compared with the prior art, the technical solution of this application has the following beneficial effects:

[0018] 1. The ileostomy diversion catheter device of this application serves to "cut off" the intestinal lumen (i.e., balloon-induced intestinal obstruction) by setting an air balloon assembly, a drainage bag, and an air injection valve for injecting or depressing air into the air balloon assembly on the first tube body, so as to divert intestinal contents through the catheter.

[0019] 2. The airbag assembly of this application includes two airbags, which can dynamically adjust the degree of "truncation" to achieve complete treatment.

[0020] 3. This application creates a negative pressure drainage environment before the first tube is depressurized and drained by installing a second tube inside the first tube and setting a negative pressure drain at the tail end of the second tube. This reduces the pressure that accumulates at the cut-off point of the balloon by extending the negative pressure depressurization, preventing contents from flowing from between the balloon and the intestinal wall to the distal end, thus avoiding incomplete diversion and reducing the risk of anastomotic leakage.

[0021] 4. The ileostomy bypass catheter device of this application is simple to operate, convenient to care for, and easy for patients and their families to accept, greatly reducing the pain caused to patients by rectal cancer sphincter-preserving surgery. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the ileostomy diversion catheter device in Example 1;

[0023] Figure 2 This is a schematic diagram of the ileostomy diversion catheter device in Example 2;

[0024] Figure 3 This is a schematic diagram of the structure of the second tube in this utility model.

[0025] Reference numerals: 1. First tube body; 2. First through hole; 3. Airbag assembly; 301. First airbag; 302. Second airbag; 4. Connection port; 5. Cover cap; 6. First branch pipe; 7. Second branch pipe; 8. Sealing cap; 9. Second tube body; 10. Second through hole; 11. Flushing port; 12. Negative pressure port; 13. One-way control valve. Detailed Implementation

[0026] The technical solutions of this utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments of this utility model. Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments.

[0027] Example 1

[0028] Reference Figure 1 As shown in the preferred embodiment of this utility model, an ileostomy diversion catheter device includes a first tube body 1. The front end of the first tube body 1 has an open structure, and the side is provided with several first through holes 2. The rear section of the first through holes 2 is provided with a balloon assembly 3, thereby facilitating the collection of intestinal contents. The tail end of the first tube body 1 is provided with a connection port 4, and a drainage bag is detachably connected to the outside of the connection port 4 to facilitate drainage. A first branch tube 6 is provided on one side of the tail end of the first tube body 1, which communicates with the balloon assembly 3. An inflation valve for inflating or deflating the balloon assembly 3 is installed on the first branch tube 6, thereby "cutting off" the intestinal lumen (i.e., balloon-induced intestinal obstruction) so that the catheter can divert intestinal contents and reduce the risk of anastomotic leakage. This utility model is simple to operate, convenient to care for, easy for patients and their families to accept, and greatly reduces the pain of patient treatment.

[0029] As a preferred embodiment of this utility model, it may also have the following additional technical features: a plurality of the first through holes 2 are elliptical in shape and are staggered and intersecting each other. The first through holes are located 10cm from the front section (also the functional section) of the first tube body, and there are 5 of them, with a major diameter of 1.0cm × minor diameter of 0.5cm, so as to facilitate the collection of intestinal contents.

[0030] In this embodiment, the balloon assembly 3 includes a first balloon 301 and a second balloon 302, which are arranged adjacent to each other. The balloon assembly is located 10-18 cm from the functional section of the first tube, with the first balloon at the front and the second balloon at the rear. The second balloon is a functional balloon; after inflation, it secures the first tube to prevent prolapse and simultaneously acts as a "cut-off" of the intestinal lumen (i.e., balloon-induced intestinal obstruction), allowing the catheter to drain intestinal contents. The minimum inflation volume of this balloon is 60 ml; typically, an inflation volume of 30 ml and a balloon diameter of 5 cm are sufficient. The first balloon is a backup balloon, activated when the second balloon fails due to unforeseen circumstances, thus allowing for dynamic adjustment of the "cut-off" degree to achieve complete treatment.

[0031] In this embodiment, the first branch tube 6 includes two tubes, which are respectively connected to the first airbag 301 and the second airbag 302. That is, each of the tube walls in the two airbags has an independent ventilation hole, which is connected to the tube wall channel and the air injection valve at the tail end. By injecting or depressurizing the airbag through the air injection valve, the first tube body is depressurized and drained to expel intestinal contents.

[0032] In this embodiment, a second branch pipe 7 is provided on the other side of the tail of the first tube 1, and a cap 8 is threaded onto the second branch pipe 7. This allows a 0.45cm drainage tube to be delivered through this channel to a position ≥30cm from the distal end of the first tube for negative pressure extension drainage when needed.

[0033] In this embodiment, the first tube (i.e., the outer tube) is a key component and can be used independently. The diameter of the outer tube is crucial, as it must balance drainage flow rate and fistula healing after tube removal. In vitro experiments showed that a 1cm inner diameter drainage tube achieves a full-bore drainage flow rate of 20ml / s, which is sufficient to achieve the desired effect. If the drainage tube is too thin, the drainage speed is too slow, resulting in poor decompression; if the drainage tube is too thick, although the drainage effect is good, the fistula healing after tube removal is slow, or delayed healing occurs, or intestinal fistula may form. Therefore, a balance must be struck between these two factors, ensuring both wound healing after tube removal and effective drainage. Therefore, in this embodiment, an outer tube with a length of 60cm, an outer diameter of 1.2cm, an inner diameter of 1.0cm, and a wall thickness of 0.1cm is selected.

[0034] Example 2

[0035] Reference Figure 1-3 As shown, the difference between this utility model and Embodiment 1 is that it also includes a second tube 9 (i.e., an inner sleeve), which passes through the first tube 1 via the second branch tube 7 and extends outward. This achieves negative pressure diversion, reducing the pressure that accumulates at the balloon cutoff point, preventing contents from flowing from between the balloon and the intestinal wall to the distal end, thus avoiding incomplete diversion and reducing the risk of anastomotic leakage.

[0036] In this embodiment, the outer diameter of the second pipe 9 is smaller than the inner diameter of the first pipe 1, and equal to the inner diameter of the second branch pipe 7.

[0037] When using a balloon decompression tube alone for ileal diversion, it was found that a small amount of contents was still expelled through the anus, indicating incomplete diversion. This may be because the small intestine transports contents rhythmically, intermittently, and progressively; occasionally, a large volume of contents is expelled rapidly, accompanied by a significant amount of gas, increasing the pressure within the intestinal lumen. This causes the contents to flow distally through the gap between the balloon and the intestinal wall, resulting in incomplete diversion.

[0038] Therefore, through the concept of "extended decompression and diversion," a thin tube with a diameter of 0.5 cm (half the inner diameter of the outer tube, following the principle of gastrointestinal decompression) is inserted inside the outer tube. The tail end is connected to a negative pressure drainage device, and the front end extends 30 cm forward from the front end of the outer tube. This creates a negative pressure drainage environment before the outer tube's decompression and drainage, allowing for the early drainage of each pushed-in small intestinal contents. When the remaining contents are pushed to the "balloon cutoff" point, both the volume and pressure decrease. The remaining contents are then collected through the side holes of the outer tube. There are 0.5 cm gaps on both sides between the inner and outer tubes, allowing for the diversion of the remaining contents, achieving complete or near-complete diversion of the intestinal contents. Therefore, in this embodiment, an inner tube with a length of 90 cm, an outer diameter of 0.5 cm, and an inner diameter of 0.4 cm is selected.

[0039] In this embodiment, the front end of the second tube 9 is blunt-tipped and solid, and the side is provided with several second through holes 10. These second through holes 10 are elliptical in shape and are staggered and intersecting. Six of these second through holes 10 are located 20cm from the front end of the second tube, with a major diameter of 0.4cm and a minor diameter of 0.2cm. The tail end of the second tube 9 is provided with several connection ports, including a flushing port 11, a negative pressure port 12, and a pressure regulating port. A negative pressure drainage device is connected to the negative pressure port 12, and a one-way control valve 13 is installed on the pressure regulating port. This achieves negative pressure diversion, reducing the pressure that accumulates at the balloon cutoff point, preventing contents from flowing from between the balloon and the intestinal wall to the distal end, thus avoiding incomplete diversion and reducing the risk of anastomotic leakage.

[0040] In this embodiment, the second tube 9 is provided with a spiral cap 5 for fixing the second tube to the first tube. This prevents leakage.

[0041] The working principle of this invention is as follows: The outer tube is 60cm long, with an outer diameter of 1.2cm and an inner diameter of 1.0cm. The front 10cm has 5 side holes, and the 10-18cm section has two air bladders. The tail is a drainage port for connecting a disposable drainage bag (commonly used in clinical practice). One side of the tail has two ventilation valves connected to the air bladders, and the other side has an independent internal drainage tube channel covered by a cap. The inner tube is a disposable intestinal decompression catheter, 120cm long, with an outer diameter of 0.5cm and an inner diameter of 0.4cm. A cap is placed at 90cm of the tube, connecting to the drainage tube channel of the outer tube. The decompression drainage catheter is inserted through the internal drainage tube channel of the outer tube to 90cm, and the cap is tightened. The distal end of the drainage tube is connected to a disposable negative pressure drainage device (commonly used in clinical practice). Additionally, the accompanying components include a clinically commonly used disposable negative pressure drainage device and a disposable drainage bag.

[0042] Instructions for use: 1. Before use, pay attention to the production date on the seal. Do not use if it has expired. 2. After opening the packaging, rinse the operating table with sterile saline. 3. Inflate the balloon through the inflation valve and check for leaks. If there are no leaks, then remove the gas from the balloon. 4. Insert the internal drainage tube coated with paraffin oil through the internal drainage tube channel of the outer tube, and tighten the cap to ensure it is tight. If everything is normal, then remove the drainage tube for use. 5. Use this product when decompression and bypass are required after routine surgery.

[0043] Application: After rectal cancer resection and anastomosis, a balloon drainage tube is inserted through a puncture in the right lower abdomen or via the right main operating port of laparoscopic surgery. The tube is inserted through a puncture 20-30 cm from the terminal ileum. The balloon is inflated (filled with water) to 30 ml and pulled outwards. A purse-string suture is used to reinforce the embedding at the drainage tube opening in the intestinal wall. Then, the seromuscular layer around the drainage tube is sutured to the peritoneum around the drainage opening in the abdominal wall with 4-6 sutures for fixation, achieving the same decompression and diversion purpose as traditional stomas, reducing the risk of anastomotic leakage. This invention is simple to operate, convenient to care for, and easily accepted by patients and their families, greatly reducing the patient's suffering during treatment.

[0044] Without causing conflict, those skilled in the art can freely combine and use the above-mentioned additional technical features.

[0045] It is understood that this utility model has been described through some embodiments, and those skilled in the art will recognize that various changes or equivalent substitutions can be made to these features and embodiments without departing from the spirit and scope of this utility model. Furthermore, under the teachings of this utility model, these features and embodiments can be modified to adapt to specific situations and materials without departing from the spirit and scope of this utility model. Therefore, this utility model is not limited to the specific embodiments disclosed herein, and all embodiments falling within the scope of the claims of this application are within the protection scope of this utility model.

Claims

1. An ileostomy bypass catheter device, characterized in that: The device includes a first tube and a second tube. The first tube has an open front end and several first through holes on its side. An airbag assembly is located at the rear of each first through hole. The first tube has a connection port at its tail end, and a drainage bag is detachably connected to the outside of the connection port. A first branch tube communicating with the airbag assembly is located on one side of the tail end of the first tube. An inflation valve for inflating or deflating the airbag assembly is installed on the first branch tube. A second branch tube is located on the other side of the tail end of the first tube, and a cap is threaded onto the second branch tube. The second tube passes through the first tube via the second branch tube and extends outward.

2. The ileostomy bypass catheter device according to claim 1, characterized in that: Several of the first through holes are elliptical in shape and are staggered and intersecting with each other.

3. The ileostomy bypass catheter device according to claim 1, characterized in that: The airbag assembly includes a first airbag and a second airbag, which are arranged adjacent to each other.

4. The ileostomy bypass catheter device according to claim 3, characterized in that: The first branch tube comprises two parts, and the two first branch tubes are respectively connected to the first airbag and the second airbag.

5. The ileostomy bypass catheter device according to claim 1, characterized in that: The outer diameter of the second pipe is smaller than the inner diameter of the first pipe, and equal to the inner diameter of the second branch pipe.

6. The ileostomy bypass catheter device according to claim 1, characterized in that: The front end of the second tube is blunt and solid, and the side is provided with several second through holes. The several second through holes are elliptical and are staggered and crisscrossed. The tail end of the second tube is provided with several connection ports, including a flushing port, a negative pressure port, and a pressure regulating port.

7. The ileostomy bypass catheter device according to claim 6, characterized in that: A negative pressure drain is connected to the negative pressure port, and a one-way control valve is installed on the pressure regulating port.

8. The ileostomy bypass catheter device according to claim 1, characterized in that: The second tube is provided with a spiral cap for fixing the second tube to the first tube.

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