Self-breaking outer drainage tube

Abstract

The invention discloses a self-breaking outer drainage tube, and relates to the technical field of medical instruments, the self-breaking outer drainage tube comprises a tube body, and the tube body comprises a drainage part, a breaking part, a leading-out part and a puncture part; the drainage part and the fracture part are both made of degradable materials; the hole wall thickness of the circulation hole at the fracture part is smaller than the hole wall thickness of the circulation hole at the drainage part; during surgical operation, the degradable inner drainage part is placed in the pancreatic duct, the fracture part crosses the anastomotic stoma by 7-8 cm and crosses the biliary-intestinal anastomotic stoma, and the leading-out part walks in the enteric cavity to a proper position, penetrates out of the intestinal wall and is led out of the body through the abdominal wall. Cutting the puncture part to expose the outlet of the circulation hole, and discharging the body fluid through the circulation hole; after a certain period of time after the operation, the fracture part is automatically fractured under the action of pancreatic juice, the leading-out part is pulled out, the degradable drainage part continues to be degraded in the body and maintains the drainage function, and finally the drainage part is absorbed by the body or discharged out of the body without being taken out through the operation.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a self-rupturing external drainage tube. Background Technology

[0002] After intra-abdominal visceral surgery, drainage tubes are often placed to drain fluid and prevent complications. For example, pancreaticoduodenectomy (PD) is indicated for pancreatic head cancer, Vater's ampulla of Vater cancer, lower common bile duct cancer, and duodenal malignancies. The surgical procedure includes general exploration, trial dissection, resection of the lesion, and digestive tract reconstruction. Digestive tract reconstruction involves anastomosing the pancreas, gallbladder, stomach, and jejunum, and establishing drainage channels for pancreatic and bile fluids. Typically, a drainage tube is placed into the pancreatic duct or bile duct and introduced into the jejunum or externally through the anastomosis to establish internal or external drainage channels. Internal drainage involves placing the end of the drainage tube within the intestinal lumen, while external drainage requires passing the end of the drainage tube through the intestinal wall and exiting through an abdominal wall incision.

[0003] Clinical studies have shown that early external drainage after pancreatic drainage (PD) is beneficial for monitoring the characteristics of pancreatic drainage fluid and facilitating timely detection of postoperative pancreatic fistula. Simultaneously, early diversion of pancreatic juice to the outside effectively reduces intestinal pressure and the risk of pancreatic enzyme activation, thereby lowering the incidence of postoperative pancreatic fistula. However, long-term external drainage may impair pancreatic function, increase electrolyte imbalances and catheter complications, and increase the difficulty of nursing care. In comparison, internal drainage is more physiological, maintaining fluid circulation, reducing metabolic disorders and the risks associated with external catheters, and can reduce the difficulty of nursing care. However, it does not allow direct observation of the characteristics of pancreatic drainage fluid and carries risks such as stent blockage, displacement, or secondary pancreatitis. Long-term retention may also induce pancreatic duct stones and increase the risk of secondary surgery. Furthermore, currently used internal drainage stents typically rely on intestinal peristalsis for expulsion or removal during a secondary surgery. This can lead to broken stent fragments piercing the intestinal wall, causing intestinal fistula. If these fragments are not expelled for a long period, they may lead to complications such as pancreatic duct stones and pancreatitis, significantly impacting the patient's long-term quality of life and prognosis.

[0004] In view of this, there is an urgent need for a self-rupturing external drainage tube to solve the above problems. Summary of the Invention

[0005] To address the problems existing in the prior art, the present invention solves this problem using the following technical structure.

[0006] To achieve the above objectives, the present invention adopts the following technical solution: A self-rupturing external drainage tube includes: a tube body, the tube body including a drainage part, a rupture part, an outlet part and a puncture part, the drainage part, the rupture part, the outlet part and the puncture part being connected in sequence; The tube is provided with a flow hole, which extends from the suspension end of the drainage part to the end of the outlet part near the puncture part. Both the drainage portion and the fracture portion are made of biodegradable materials; The wall thickness of the flow hole at the fracture portion is less than the wall thickness of the flow hole at the drainage portion.

[0007] The puncture site is cone-shaped.

[0008] The outer diameter of the drainage section gradually decreases from the end closest to the fracture to the end furthest from the fracture.

[0009] The drainage portion is made of poly-ε-caprolactone or polylactic acid, and the length of the drainage portion is 100 mm to 150 mm.

[0010] The fractured portion is made of poly-ε-caprolactone or polylactic acid, and the length of the fractured portion is 3mm-5mm.

[0011] The lead-out part is made of polyvinyl chloride or polyurethane, and the length of the lead-out part is 500mm-550mm.

[0012] The drainage section is provided with a plurality of drainage holes in a circumferential direction, and all of the drainage holes are in communication with the flow hole.

[0013] The outlet is provided with an air hole, which communicates with the flow hole.

[0014] The extraction portion and the puncture portion are bonded together with epoxy adhesive.

[0015] The fractured portion is formed by a groove that is recessed inward from the outer side of the tube or recessed outward from the inner side of the tube.

[0016] The following beneficial effects can be achieved by using the structure described above in this invention: During the surgical procedure, a biodegradable internal drainage device is inserted into the pancreatic duct. The broken portion crosses the anastomosis 7-8 cm and passes over the choledochoenterostomy. The drainage portion runs within the intestinal lumen, exiting through the intestinal wall at a suitable location and being drained out through the abdominal wall. The puncture site is then trimmed to expose the drainage orifice, through which body fluids are drained. After a certain period post-surgery, the broken portion automatically breaks off under the action of pancreatic juice, allowing the drainage device to be removed. The biodegradable drainage device continues to degrade within the body, maintaining its drainage function, and is eventually absorbed or excreted by the body without the need for surgical removal. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the structure of this embodiment; Figure 2 This is a structural schematic diagram from another perspective of this embodiment.

[0018] In the diagram: 1. Drainage section; 11. Drainage hole; 2. Fracture section; 3. Outlet section; 31. Air hole; 4. Puncture section; 5. Flow hole. Detailed Implementation

[0019] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of the present invention.

[0020] It should be noted that the terms "comprising" and "having" and any variations thereof in the specification, claims and accompanying drawings of this invention are intended to cover non-exclusive inclusion. For example, a process, method, apparatus, product or device that includes a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such process, method, product or device.

[0021] The following is in conjunction with the appendix Figures 1-2 This application will be described in further detail.

[0022] refer to Figures 1-2 The self-rupture external drainage tube shown includes: a tube body, which includes a drainage part 1, a rupture part 2, an outlet part 3 and a puncture part 4, and the drainage part 1, the rupture part 2, the outlet part 3 and the puncture part 4 are connected in sequence. The tube body is provided with a flow hole 5, which extends from the suspension end of the drainage part 1 to the end of the outlet part 3 near the puncture part 4. Both the drainage section 1 and the fracture section 2 are made of biodegradable materials; The wall thickness of the flow hole 5 at the fracture part 2 is less than the wall thickness of the flow hole 5 at the drainage part 1.

[0023] Based on the above structure, during the surgical procedure, the biodegradable internal drainage part 1 is inserted into the pancreatic duct (the drainage part 1 can be trimmed as needed). The fractured part 2 crosses the anastomosis 7-8 cm and passes over the choledochoenterostomy. The drainage part 3 runs within the intestinal lumen, exits the intestinal wall at a suitable location, and is drained out through the abdominal wall. Then, the puncture part 4 is trimmed to expose the outlet of the flow hole 5, through which body fluids are drained. After a certain period of time (approximately 14 days) postoperatively, the fractured part 2 automatically breaks under the action of pancreatic juice, and the drainage part 3 is removed. The biodegradable drainage part 1 continues to degrade in the body and maintain its drainage function, eventually being absorbed or excreted by the body without the need for surgical removal.

[0024] like Figure 2As shown, the puncture part 4 is conical and made of medical-grade metal materials, such as nickel-coated aluminum alloy and stainless steel. During use, it plays the role of puncture. The exit part 3 and the puncture part 4 are bonded together with epoxy glue so that the puncture part 4 can be easily separated from the exit part 3 after the application is installed.

[0025] like Figure 1 As shown, the outer diameter of the drainage portion 1 gradually decreases from the end near the fracture portion 2 to the end away from the fracture portion 2, thereby reducing the volume of the drainage portion 1. Furthermore, the drainage portion 1 is integrally molded from a biodegradable material, including but not limited to poly-ε-caprolactone (PCL) or polylactic acid (PLA). In this embodiment, the drainage portion 1 is made of poly-ε-caprolactone with a weight-average molecular weight of 50,000. The length of the drainage portion 1 is 100 mm to 150 mm (e.g., 100 mm, 1...). The wall thickness of the flow hole 4 at the drainage part 1 is 0.5mm-1.5mm (e.g., 0.5mm, 1mm or 1.5mm), and the suspension end of the drainage part 1 is set as a round head. 6-10 drainage holes 11 with a diameter of 1mm are evenly opened on the drainage part 1 by laser drilling (the drainage holes 11 are connected to the flow hole 5). A drainage hole 11 is set every 10mm to facilitate the drainage of bodily fluids through the drainage holes 11.

[0026] Further optimization involves making the fracture portion 2 from a biodegradable material, including but not limited to poly-ε-caprolactone or polylactic acid. In this embodiment, the fracture portion 2 is made of poly-ε-caprolactone with a weight-average molecular weight of 50,000. The length of the fracture portion 2 is 3mm-5mm (e.g., 3mm, 4mm, or 5mm), and the wall thickness of the flow hole 4 at the fracture portion 2 is 0.2mm-0.5mm (e.g., 0.2mm, 0.3mm, or 0.5mm). The fracture portion 2 is formed by a precision molding process (mold temperature 65°C, pressure 0.5MPa, pressure holding for 30 seconds). The fracture portion 2 is formed by a groove that is recessed inward from the outer side of the tube or recessed outward from the inner side of the tube. Through the design of the groove, the wall thickness of the fracture portion 2 is thinner, allowing it to dissolve in a faster time.

[0027] Further optimization involves making the lead-out portion 3 from a non-degradable material, including but not limited to polyvinyl chloride (PVC) or polyurethane (TPU). In this embodiment, the lead-out portion 3 is made of soft polyvinyl chloride, manufactured through a melt extrusion process. The length of the lead-out portion 3 is 500mm-550mm (e.g., 500mm, 525mm, or 550mm). One end of the broken portion is connected to the lead-out portion 3 by hot-melt welding (temperature 80°C, pressure 0.3 MPa, time 10 seconds) to ensure a firm seal. Figure 1 and Figure 2As shown, an air hole 31 is provided on the side of the outlet 3 near the puncture part 4. The purpose of providing the air hole 31 is to discharge excess gas in the flow hole 5 when using this application.

[0028] Further optimization involves providing linear development marks within the flow hole walls of the flow section 1, the fracture section 2, and the outlet section 3. The development marks are composed of barium. Through a co-extrusion process, 10% barium sulfate is embedded within the hole walls of the flow section 1, the fracture section 2, and the outlet section 3 to achieve linear development.

[0029] This application innovatively introduces a fracture section 2 structure, achieving controllable fracture time of the drainage tube (the fracture section 2 is set with a corresponding hole wall thickness according to the degradation rate of the biodegradable material). Medical staff can flexibly choose the timing of removal of the drainage section based on the patient's postoperative recovery, allowing the drainage tube to perform external drainage function in the early stage, facilitating real-time monitoring of the nature and amount of drainage fluid and timely detection of complications; later, it can be converted to internal drainage to maintain body fluid circulation and reduce the risks associated with external catheters. The biodegradable internal drainage section is made of biodegradable polymer material, which has good biocompatibility and a controllable degradation rate, avoiding complications such as pancreatitis and pancreatic duct stones caused by long-term retention of the internal drainage section in the pancreatic duct. The drainage section 3 is made of soft, non-absorbable material, which facilitates smooth removal after surgery, reduces tissue damage, lowers nursing difficulty, and improves patient comfort and postoperative recovery quality.

[0030] The above are merely preferred embodiments of this application, and the present invention is not limited to the above embodiments. It is understood that other improvements and variations that are directly derived or conceived by those skilled in the art without departing from the spirit and concept of the present invention should be considered to be included within the protection scope of the present invention.

Claims

1. A self-segmenting external drainage tube, characterized in that, include: The tube body includes a drainage section (1), a fracture section (2), an outlet section (3), and a puncture section (4), which are connected in sequence. The tube body is provided with a flow hole (5), which extends from the suspension end of the drainage part (1) to the end of the outlet part (3) near the puncture part (4). Both the drainage part (1) and the fracture part (2) are made of biodegradable materials; The wall thickness of the flow hole (5) at the fracture part (2) is less than the wall thickness of the flow hole (5) at the drainage part (1).

2. A self-segmenting external drainage tube according to claim 1, wherein: The puncture site (4) is conical.

3. The self-rupturing external drainage tube according to claim 2, characterized in that: The outer diameter of the drainage section (1) gradually decreases from the end closest to the fracture section (2) to the end furthest from the fracture section (2).

4. The self-rupturing external drainage tube according to claim 1, characterized in that: The drainage section (1) is made of poly-ε-caprolactone or polylactic acid, and the length of the drainage section (1) is 100 mm to 150 mm.

5. A self-rupturing external drainage tube according to claim 4, characterized in that: The fractured portion (2) is made of poly-ε-caprolactone or polylactic acid, and the length of the fractured portion (2) is 3mm-5mm.

6. The self-rupturing external drainage tube according to claim 5, characterized in that: The lead-out part (3) is made of polyvinyl chloride or polyurethane, and the length of the lead-out part (3) is 500mm-550mm.

7. A self-rupturing external drainage tube according to any one of claims 1-6, characterized in that: The drainage section (1) is provided with a plurality of drainage holes (11) in the circumferential direction, and the plurality of drainage holes (11) are all connected to the flow hole (5).

8. A self-rupturing external drainage tube according to any one of claims 1-6, characterized in that: The outlet (3) is provided with an air hole (31), which is connected to the flow hole (5).

9. A self-rupturing external drainage tube according to any one of claims 1-6, characterized in that: The lead-out portion (3) and the puncture portion (4) are bonded together with epoxy adhesive.

10. A self-rupturing external drainage tube according to any one of claims 1-6, characterized in that: The fractured part (2) is formed by a groove that is recessed inward from the outer side of the tube or recessed outward from the inner side of the tube.

Images