Mediastinal drain for median sternotomy cardiac surgery

Abstract

The application discloses a mediastinal drainage tube for median incision heart surgery, and belongs to the field of medical devices.The drainage tube comprises a drainage tube main body, a groove type head end, side holes and a connecting joint; the total length of the drainage tube main body is 40 cm, the head end is provided with an inwardly recessed U-shaped or V-shaped groove with a depth of 2-3 mm; the side holes are arranged in a cross-symmetrical manner every 3 cm from the head end to a position 15 cm away from the head end, thereby forming a multidirectional drainage network.The groove type head end can reduce the damage caused by implantation and provide a standby drainage channel, and the cross-symmetrical arrangement of the side holes can eliminate the drainage blind area, thereby effectively solving the problems of easy blockage and incomplete drainage of the mediastinal drainage tube, and the drainage tube is mainly used for postoperative mediastinal and pericardial cavity drainage.

Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to a disposable drainage tube device for postoperative drainage in cardiothoracic surgery, and more particularly to a special drainage tube for mediastinal drainage after cardiac surgery with a midline thoracic incision. Background Technology

[0002] The median sternotomy is the most classic and widely used approach in cardiac surgery, extensively applied in coronary artery bypass grafting, heart valve replacement or repair, congenital heart disease correction, and great vessel surgery. This approach, by longitudinally splitting the sternum, provides the surgeon with a clear and wide surgical field, facilitating exposure of the heart and great vessel structures. However, median sternotomy is a relatively invasive procedure, and postoperative effusion or blood clots often form in the mediastinum and pericardial cavity due to bleeding and fluid accumulation. If drainage is inadequate, serious complications such as cardiac tamponade, mediastinal infection, and poor sternal healing can occur, directly affecting the patient's postoperative recovery and long-term surgical outcomes.

[0003] Currently, devices used clinically for mediastinal drainage after cardiac surgery mainly include traditional silicone drainage tubes, drainage tubes with side holes, flat drainage tubes, and negative pressure drainage systems. Traditional drainage tubes are mostly single-lumen circular tubes, primarily made of medical-grade silicone or polyvinyl chloride, with several side holes to increase the drainage area. Some drainage tubes have beveled or tapered ends for easy insertion into the mediastinal cavity. In addition, negative pressure suction devices are often used in conjunction with these tubes to promote the drainage of accumulated blood through continuous or intermittent negative pressure. In recent years, some new drainage tubes have also adopted improvements such as spiral grooves, multi-lumen designs, or anticoagulant coatings to improve drainage efficiency and reduce the risk of blockage.

[0004] The basic structure of existing mediastinal drainage tubes typically includes: the tube body (lumen), side holes, a distal opening, a connecting connector, and a fixing device. The tube body is a hollow tube of a certain length and flexibility, usually made of medical-grade silicone rubber or soft polyvinyl chloride, which has good biocompatibility and plasticity. Multiple side holes are opened at the proximal end of the tube (i.e., the end placed in the mediastinum). These side holes are elliptical or circular, arranged alternately along the circumference and longitudinal direction of the tube wall to increase the drainage area and reduce the probability of blockage in a single channel. The distal end of the tube is connected to a drainage bag or negative pressure suction device via a standard connector to form a closed drainage loop.

[0005] In terms of working principle, postoperative mediastinal blood or effusion, under the influence of gravity and changes in intrathoracic pressure, enters the lumen through the side hole of the drainage tube, and then drains outward through the lumen to the external drainage collection device. When combined with negative pressure suction, negative pressure is applied to the distal end of the drainage tube, creating a pressure gradient within the lumen that is lower than that within the intrathoracic cavity, thereby actively attracting the blood to flow into the lumen and accelerating the drainage process. The drainage tube is usually left in place for several days to a week, and is removed after the drainage volume decreases below clinical standards.

[0006] Despite the important role existing mediastinal drainage tubes play in clinical applications, several problems remain to be addressed. Firstly, blockage is a significant issue. Post-cardiac surgery mediastinal drainage fluid is rich in fibrin, blood cells, and tissue debris, easily forming blood clots or fibrin clots in the side holes or lumen of the drainage tube, leading to blockage. Once blockage occurs, drainage function is lost, and blood accumulation in the mediastinum cannot be drained in time, potentially causing rapid cardiac tamponade and endangering the patient's life. Secondly, incomplete drainage is a problem. Traditional round drainage tubes have limited contact area with tissues in the mediastinum, and the fixed distribution of side holes makes it difficult to cover the entire mediastinal cavity, especially in low-lying areas such as behind the sternum and at the base of the pericardium, often resulting in drainage blind spots. Thirdly, the tube removal process is uncomfortable and risky. During tube placement, adhesions can occur between the tube and surrounding tissues, requiring a certain amount of pulling force during removal, often causing significant pain for the patient and potentially leading to tissue tearing or bleeding. Fourthly, there is a lack of targeted structural design. Most existing drainage tubes are of a general design and do not fully consider the characteristics of the mediastinal anatomy after a midline thoracic incision. This makes it difficult for the drainage tube to reach the optimal drainage position after placement, thus limiting drainage efficiency. Summary of the Invention

[0007] The purpose of this invention is to provide a mediastinal drainage tube for cardiac surgery via a midline thoracic incision, in order to solve the problems of existing mediastinal drainage tubes such as easy blockage, incomplete drainage, large insertion damage, and poor structural adaptability.

[0008] To achieve the above objectives, the technical solution adopted by the present invention is as follows: A mediastinal drainage tube for median thoracic incision cardiac surgery includes a drainage tube body, a grooved head end, side holes, and a connecting connector. The drainage tube body is a flexible tube with a total length of 40 cm. The grooved head end is located at the head end of the drainage tube body, and its end has an inwardly recessed groove with a U-shaped or V-shaped structure and a depth of 2-3 mm. The side holes are arranged symmetrically every 3 cm along the axial direction of the tube body, starting from the head end, and extending to 15 cm from the head end. The connecting connector is located at the tail end of the drainage tube body and connects to the tube body through a tapered transition section.

[0009] The side holes are arranged in a symmetrical manner as follows: the first side hole is opened at 0 degrees on the pipe wall, the second side hole is opened at 180 degrees on the pipe wall, and they are arranged alternately to form a comprehensive, multi-angle drainage network.

[0010] The side hole is elliptical, with a major axis of 8-12mm and a minor axis of 4-6mm. The edges of the side hole are chamfered or rounded.

[0011] The main body of the drainage tube is made of medical-grade silicone or polyurethane material, with an outer diameter of 10mm, an inner diameter of 8mm, and a wall thickness of 1mm.

[0012] The connector is equipped with a standard interface ring for connecting to a drainage bag or a negative pressure suction device.

[0013] The beneficial effects of this invention are as follows: (1) The grooved tip design can gently push away the anterior tissue during insertion, reducing the risk of damage and bleeding to fragile tissues such as the pericardium, thymus or mediastinal fat; at the same time, during the drainage process, even if the tip is partially blocked by blood clots, the groove itself can still serve as an independent drainage channel, effectively preventing the tip from being completely blocked.

[0014] (2) The cross-symmetrical side hole layout ensures that the drainage tube forms a uniform, multi-directional drainage network in the mediastinal cavity, effectively covering the traditional drainage blind areas such as the back of the sternum and the bottom of the pericardium, achieving more thorough drainage and reducing residual blood accumulation.

[0015] (3) The total length of 40cm fully considers the anatomical depth of the mediastinum and the needs of external connection, ensuring that the end of the drainage tube can be reliably placed in the mediastinal drainage area, while leaving enough length to connect with the drainage bag or negative pressure device.

[0016] (4) The above structural features work together to significantly improve drainage efficiency, reduce the risk of serious complications such as cardiac tamponade and mediastinal infection, reduce pain and tissue damage during extubation, and improve the quality of postoperative recovery. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the overall structure of the drainage tube of the present invention; Figure 2 This is an enlarged structural diagram of the groove-shaped head end of the present invention; Figure 3 This is a cross-sectional view (AA section) of the drainage tube of the present invention. Figure 4 This is a schematic diagram showing the symmetrical arrangement of the side holes in this invention. Figure 5 This is a schematic diagram of the three-dimensional structure of the groove-shaped head end of the present invention; Figure 6This is an enlarged structural diagram of the connector of the present invention.

[0018] In the diagram: 1- Drainage tube body, 2- Groove-shaped head end, 3- Side hole, 4- Connecting connector, 5- Groove. Detailed Implementation

[0019] The present invention will now be described in further detail with reference to the accompanying drawings and specific embodiments.

[0020] like Figures 1 to 6 As shown, the present invention provides a mediastinal drainage tube for cardiac surgery via a midline thoracic incision, comprising a drainage tube body 1, a grooved head end 2, a side hole 3, a connecting connector 4, and a groove 5.

[0021] The main body 1 of the drainage tube is a flexible tube made of medical-grade silicone or polyurethane. This material has good biocompatibility and moderate rigidity, ensuring sufficient insertion force while minimizing irritation to the mediastinal tissue. The total length of the main body 1 is 40cm, determined through clinical anatomical data analysis and simulation. The mediastinal depth from the suprasternal notch to the lower edge of the xiphoid process is typically between 15 and 25cm. Adding the length required to pass through the skin incision and extend externally to connect with the drainage bag or negative pressure suction device, the total length of 40cm ensures that the end of the drainage tube is reliably placed at the deepest point of the mediastinal drainage area, while allowing sufficient slack externally for medical personnel to fix, connect, and observe the drainage fluid. The outer diameter of the main body 1 is 10mm, the inner diameter is 8mm, and the wall thickness is 1mm.

[0022] The grooved tip 2 is located at the tip of the drainage tube body 1, which is the end that first contacts the mediastinal tissue after insertion into the human body. This tip is not a traditional flat or rounded tip, but rather forms an inwardly recessed groove 5 at its end. The groove 5 has a U-shaped or V-shaped structure, a depth of approximately 2-3 mm, and a width matching the inner diameter of the drainage tube body 1. The edges of the groove 5 are smoothly rounded. During insertion, the smooth edges of the groove 5 gently push aside the tissue in front, rather than directly impacting or cutting the tissue like a flat-tipped tube, thus significantly reducing the risk of damage and bleeding to fragile tissues such as the pericardium, thymus, or mediastinal fat during insertion. During drainage, even if the tip of the drainage tube is partially blocked by blood clots or fibrin clots, the groove 5 itself can still function as an independent, open drainage channel, continuously draining surrounding fluid, effectively preventing the tip from being completely blocked and losing its drainage function.

[0023] Side holes 3 are precisely installed every 3 cm along the axial direction of the drainage tube body 1, starting from the head end. The side holes 3 are arranged in a symmetrical, cross-sectional pattern: the first side hole is located at 0 degrees on the tube wall, the second at 180 degrees, the third returns to 0 degrees, and the fourth returns to 180 degrees, alternating in this manner. This symmetrical arrangement ensures that the drainage tube forms a comprehensive, multi-angle drainage network within the mediastinal cavity. The side holes 3 are elliptical, with a major axis of 8-12 mm and a minor axis of 4-6 mm, ensuring drainage efficiency without compromising the structural strength of the tube wall due to excessively large hole diameters. The edges of the side holes 3 are chamfered or rounded to reduce friction and irritation to surrounding tissues. The setting range of the side hole 3 starts from the tube tip and extends to 15cm from the tip. This length range is designed according to the actual length and depth of the mediastinal drainage area, which can ensure that after the drainage tube is inserted, all parts of it located in the mediastinal cavity are equipped with side holes, thereby effectively covering the traditional drainage blind areas such as behind the sternum, the bottom of the pericardium, and in front of the aorta.

[0024] Connector 4 is located at the tail end of the drainage tube body 1 and connects to the drainage tube body 1 via a tapered transition section. Connector 4 is equipped with a standard interface ring for connecting to a drainage bag or negative pressure suction device to form a closed drainage circuit. The tapered transition section design makes the transition from the tube body to the connector smoother and reduces stress concentration at the connection point.

[0025] The aforementioned structural features are not isolated but rather work synergistically to form a highly efficient drainage system. The grooved tip 2 protects the tissue during insertion and provides a backup channel in case of blockage; the symmetrically arranged side holes 3 ensure comprehensive drainage; and the total length of 40cm guarantees that the drainage tube can accurately reach and stably remain at the target location. When a patient develops a large amount of fibrin clots postoperatively due to coagulation dysfunction, some of the side holes 3 may become blocked. However, because the side holes 3 are symmetrically distributed, the unblocked side holes can still drain the accumulated fluid from different directions. At the same time, the grooved tip 2 can continue to function, thus greatly reducing the risk of complete drainage tube failure. This structural design gives the drainage tube extremely high tolerance and reliability in the complex mediastinal environment.

[0026] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Any simple modifications, equivalent changes, and alterations made to the above embodiments based on the technical essence of the present invention shall still fall within the scope of the present invention.

Claims

1. A mediastinal drainage tube for cardiac surgery via a midline thoracic incision, characterized in that, The device includes a drainage tube body (1), the head end of which is provided with a grooved head end (2), the tube wall of which is provided with multiple side holes (3) along the axial direction, and the tail end of which is provided with a connecting joint (4); the end of the grooved head end (2) is provided with an inwardly recessed groove (5), and the groove (5) is U-shaped or V-shaped.

2. The mediastinal drainage tube according to claim 1, characterized in that, The groove (5) has a depth of 2-3 mm and a width that matches the inner diameter of the drainage tube body (1). The edge of the groove (5) is rounded.

3. The mediastinal drainage tube according to claim 1, characterized in that, The side holes (3) are set every 3cm along the axial direction of the tube body (1) starting from the head end of the tube body, and are arranged in a cross-symmetrical manner. The distribution range of the side holes is from the head end of the tube to 15cm away from the head end.

4. The mediastinal drainage tube according to claim 3, characterized in that, The side holes (3) are arranged in a cross-symmetrical manner as follows: the first side hole is opened in the 0-degree direction of the pipe wall, the second side hole is opened in the 180-degree direction of the pipe wall, and the third side hole returns to the 0-degree direction, and so on alternately.

5. The mediastinal drainage tube according to claim 1, characterized in that, The total length of the main body of the drainage tube (1) is 40cm.

6. The mediastinal drainage tube according to claim 1, characterized in that, The side hole (3) is elliptical, with a major diameter of 8-12mm and a minor diameter of 4-6mm. The edges of the side hole are chamfered or rounded.

7. The mediastinal drainage tube according to claim 1, characterized in that, The main body (1) of the drainage tube is made of medical-grade silicone or polyurethane material, with an outer diameter of 10 mm, an inner diameter of 8 mm, and a wall thickness of 1 mm.

8. The mediastinal drainage tube according to claim 1, characterized in that, The connecting joint (4) is connected to the tail end of the drainage tube body (1) through a tapered transition section. The connecting joint (4) is provided with a standard interface ring for connecting to a drainage bag or a negative pressure suction device.

9. The mediastinal drainage tube according to claim 1, characterized in that, The grooved tip (2) is used to reduce damage to the mediastinal tissue during insertion and serves as an independent drainage channel during drainage to prevent the tip from being completely blocked by blood clots or fibrin clots.

10. The mediastinal drainage tube according to claim 1, characterized in that, The symmetrically arranged side holes (3) form a multi-directional drainage network in the mediastinal cavity, which is used to cover the drainage areas behind the sternum, at the bottom of the pericardium and in front of the aorta.

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