Non-negative pressure drainage device

Abstract

The application discloses a non-negative pressure drainage device, which comprises a preformed water-permeable soft pad with a waterproof material coated on a bottom surface and a drainage tube inserted into the water-permeable soft pad; the top surface of the water-permeable soft pad is a flat surface, and the bottom surface has a downward protruding structure; the drainage tube is inserted into the protruding structure, and a drainage groove is arranged on the pipe wall of the pipe section part of the drainage tube located in the water-permeable soft pad. The application is particularly suitable for microvascular / neural anastomosis in the vascularization / neuralization of free skin flap transplantation of head and neck tumor and deformity surgery.

Description

TECHNICAL FIELD

[0001] The present application relates to a non-negative pressure drainage device, in particular to a non-negative pressure drainage device for head and neck vascular anastomosis. BACKGROUND

[0002] In the head and neck tumor and deformity surgery, free flap transplantation is often needed, and the key link is microvascular or nerve anastomosis. Heparin sodium and physiological saline are needed for anastomosis, which will cause a large amount of effusion or blood accumulation in the operation area and affect the anastomosis. At present, the most commonly used method is to use a general negative pressure aspirator to suck away the effusion after the effusion reaches a certain degree. This not only affects the progress of the operation, but also causes a lateral pulling force on the surrounding vascular pedicle or nerve tissue due to the strong negative pressure, which leads to anastomotic site displacement or rupture, and even the free nerve is sucked into the negative pressure aspirator, further affecting the progress of the operation and prolonging the operation time. In order to prevent the free nerve from being sucked into the negative pressure aspirator, the conventional method is to wrap a layer of gauze on the surface of the negative pressure aspirator or to aspirate in the area away from the vascular pedicle, but both methods have the problems of time-consuming and difficult to aspirate completely.

[0003] The utility model with publication number CN209984318U discloses a vascular anastomosis fixing and supporting device. The device drains excess liquid by setting multiple overflow holes. However, the device is mainly used for brain vascular anastomosis and serves as a stent. It cannot fit some concave parts of the human body, such as the deep neck part from the lower jaw to the head and neck. Therefore, the device is not suitable for head and neck vascular / nerve anastomosis.

[0004] Therefore, the skilled in the art is committed to developing a non-negative pressure drainage device that can adapt to the special structure of the operation site and is easy to use. SUMMARY

[0005] To achieve the above-mentioned purpose, the present application provides a non-negative pressure drainage device, which comprises a pre-formed water-permeable soft pad coated with waterproof material on the bottom surface and a drainage tube inserted into the water-permeable soft pad; the top surface of the water-permeable soft pad is a flat surface, and the bottom surface has a downward protruding structure; the drainage tube is inserted into the protruding structure, and the drainage groove is arranged on the pipe wall of the pipe segment part of the drainage tube located in the water-permeable soft pad.

[0006] Further, the drainage groove is a hollowing on the pipe wall, which can be linear, wavy, etc., and can be designed horizontally, vertically or obliquely, and the number is multiple; preferably, the drainage groove is a linear hollowing designed along the axial direction, and the number is 5-8, which are evenly arranged along the circumference of the pipe wall.

[0007] In a preferred embodiment of the present application, the top surface of the water-permeable soft pad is rectangular, and the bottom surface has a raised structure extending axially along the drainage tube, and the drainage tube is close to and parallel to the bottom line of the raised structure. Further, the cross section of the water-permeable soft pad perpendicular to the drainage tube is uniform. The bottom line refers to the connecting line of the lowest part of the structure.

[0008] Preferably, the distance between the closest point of the drainage tube to the bottom line and the bottom line is not more than 1 cm.

[0009] Preferably, the axial length of the water-permeable soft pad is 6-10 cm, and the transverse length is 4-7 cm. In this context, the axial direction of the water-permeable soft pad refers to the axial direction of the drainage tube, and the transverse direction refers to the direction perpendicular to the axial direction of the drainage tube.

[0010] Preferably, the base thickness (thickness excluding the raised structure) of the water-permeable soft pad is 0.5-1 cm.

[0011] Preferably, the height of the highest point of the raised structure is 2-5 cm.

[0012] Further, the water-permeable soft pad is made of porous material, which can be sponge, high molecular porous material, etc.; preferably, the water-permeable soft pad is made of medical PVA sponge.

[0013] Further, the waterproof material can be a detachable or non-detachable outer wrapping layer, or a waterproof coating.

[0014] Preferably, the top surface of the water-permeable soft pad has a color that can be clearly distinguished from human blood, tissue, and bone, such as yellow, light green, or light blue. The color should be light to avoid reflection under a microscope.

[0015] Preferably, the water-permeable soft pad can be 3D printed.

[0016] Preferably, the other end of the drainage tube (the end outside the water-permeable soft pad) is connected with a puncture needle, which can penetrate through the nearby muscle tissue, thereby helping to fix the drainage device.

[0017] In a preferred embodiment of the present application, the water-permeable soft pad and the drainage tube are separable, and after the anastomosis of the blood vessels / nerves is completed, the drainage tube can be pulled out of the water-permeable soft pad. The drainage tube can be left in the surgical position to play a long-term drainage role.

[0018] In another preferred embodiment of the present application, the drainage tube is provided with an interface at the inner and outer junction of the water-permeable soft pad, so that the inner and outer tube segments of the drainage tube can be separated. After the anastomosis of the blood vessels / nerves is completed, the water-permeable soft pad and the internal drainage tube segment can be removed, and the external drainage tube can be left to continue to play a drainage role.

[0019] Further, the application also provides a water-permeable soft pad and a drainage tube for the above-mentioned non-negative pressure drainage device.

[0020] The non-negative pressure drainage device provided by the application can be designed according to the anatomical concave of the human body, the bottom raised structure, the upper water-permeable soft pad for transferring the blood and water generated in the operation to the periphery of the low-positioned drainage tube, and the drainage groove for flowing into the drainage tube, so as to remove the blood and water, thereby overcoming the problems of the original negative pressure aspirator, such as the strong negative pressure, the easy displacement or rupture of the anastomotic stoma, and the suction of free nerves and blood vessels; the blood and water are automatically transferred away during the anastomosis, so that the operation does not need to be stopped to wait for the suction, the smoothness of the operation is improved, and the operation time is shortened; the water-permeable soft pad can be removed alone after the operation, and the drainage tube can be reserved as a postoperative drainage tube; in addition, the non-negative pressure drainage device has the advantages of simple structure, convenient manufacturing and use, can be designed according to the actual anatomical structure of the anastomosis, and then obtained by 3D printing, or can be manufactured into a unified specification, and then cut according to the needs during actual use.

[0021] The non-negative pressure drainage device is particularly suitable for the use of patients with head and neck tumor, deformity surgery, and vascularized / neurovascularized free flap transplantation, and is used for the key link of microvascular / neurovascular anastomosis of vascular / neurovascular transplantation.

[0022] The concept, specific structure and generated technical effects of the application will be further described below with reference to the drawings, so as to fully understand the purpose, features and effects of the application. BRIEF DESCRIPTION OF DRAWINGS

[0023] Figure 1 is a structural schematic diagram of a preferred embodiment of the application;

[0024] Figure 2 is a design diagram of the drainage groove on the drainage tube in the application;

[0025] Figure 3 is a structural schematic diagram of another preferred embodiment of the application and the use mode thereof in vascular / neurovascular anastomosis;

[0026] Figure 4 is a schematic diagram of the placement position of the preferred embodiment of the application when used in the lower jaw part;

[0027] 1, the water-permeable soft pad, 2, the waterproof layer, 3, the drainage tube, 4, the drainage groove, 5, the puncture needle, 6, the anastomosis blood vessels / neurovascular of the donor area, 7, the anastomosis blood vessels / neurovascular of the recipient area. DETAILED DESCRIPTION

[0028] Embodiments of the present application are described below in detail with reference to the accompanying drawings, wherein the same or similar components are denoted by the same reference numerals throughout the drawings. The embodiments described below by reference to the drawings are exemplary and are intended to explain the present application, and should not be understood as limiting the present application.

[0029] In the description of the present application, it should be understood that the terms "transverse", "vertical", "axial", "length", "height", "thickness", "upper", "lower", "front", "rear", "left", "right", "top", "bottom", "inner", "outer" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be understood as limiting the present application. In the description of the present application, the meaning of "a plurality of" is two or more, unless otherwise explicitly and specifically limited.

[0030] Figure 1 A preferred embodiment of the non-negative pressure drainage device of the present application is shown, which includes a pre-formed water-permeable soft pad 1 and a drainage tube 3 inserted therein. In this embodiment, the water-permeable soft pad 1 is made of medical PVA sponge, and its lower surface (bottom surface) is coated with a waterproof layer 2, which is water-impermeable and can prevent blood and water from flowing out from the bottom. The upper surface (top surface) of the water-permeable soft pad 1 is a flat surface, and the lower surface has a raised structure 11 extending from one end of the water-permeable soft pad 1 to the other end, with a constant height of the raised structure 11, and the line connecting the top points of the raised structure is the bottom line of the soft pad. The drainage tube 3 is inserted into the raised structure 11 and located at the lower part near the bottom line, and the raised structure 11 is designed to be inserted into the concave part of the human body to fix the drainage device. Figure 1 As can be seen, the raised structure is located at the center axis of the water-permeable soft pad 1, and the lower surface of the water-permeable soft pad 1 extends to each side from the bottom line to an upward curve, resembling a pair of wings spread open. Such a design helps to fix the drainage device by inserting the raised structure into the concave part of the human body. However, the raised structure in the present application is not unique, and its cross-sectional shape can also be triangular, circular, buckle-shaped, etc., and its length can also be shorter than the length of the upper surface, and its position does not have to be at the center axis, as long as it can be inserted into the concave part of the human body. The shape can be designed according to the requirements of different parts of the operation. However, regardless of the changes in the raised structure, the position of the drainage tube 3 should be set at the lower part of the raised structure, so that it can utilize the principle of gravity to drain blood and water without negative pressure suction. In this embodiment, the porous sponge soft pad allows excess blood and water during the operation to flow downward from the pores to the surrounding of the drainage tube 3. The part of the drainage tube 3 inside the sponge pad has a plurality of drainage grooves 4 on the tube wall. The number, position and shape of the drainage grooves can be designed as needed, and the shape can be selected from, for example, Figure 2The straight line, diagonal line and wave shape, etc. The drainage tube 3 in the embodiment is provided with an interface 31 at the inner and outer joint of the water-permeable soft pad. The interface 31 in the figure is located outside the soft pad. In other embodiments, the interface can also be located inside the soft pad. The existence of the interface makes the water-permeable soft pad and the drainage tube inside it be able to be taken out together. The remaining drainage tube can be retained at the surgical site as a postoperative drainage tube. The waterproof layer 2 in the embodiment can be a detachable waterproof material or a waterproof polymer coating. In addition, the waterproof layer 2 can further wrap the side surface of the water-permeable soft pad 1, which can better prevent blood and water from flowing out from the periphery of the water-permeable soft pad.

[0031] Figure 3 Another preferred embodiment of the present application is slightly different from the foregoing embodiments. In the figure, the drainage tube 3 is connected with a puncture needle 5 at the other end outside the water-permeable soft pad 1. The puncture needle can help the fixation of the device by puncturing the adjacent muscle tissue and can be connected with the intraoperative negative pressure suction device. In addition, the drainage tube 3 in the embodiment is not provided with an interface, and the drainage tube 3 itself cannot be taken out. However, the water-permeable soft pad 1 can be separated from the drainage tube 3. After anastomosis is completed, the drainage tube 3 can be directly taken out from the water-permeable soft pad 1. The drainage tube 3 can be retained as a postoperative drainage tube. Figure 3 As can be seen from the figure, the operation of blood vessel / nerve anastomosis is carried out on the upper surface of the water-permeable soft pad 1. The two ends are respectively introduced into the donor anastomosis blood vessel / nerve 6 and the recipient anastomosis blood vessel / nerve 7. The color of the soft pad upper surface for surgical operation should be greatly different from the color of the surrounding blood, blood vessels and tissues in order to identify the blood vessel / nerve. When the non-negative pressure drainage device in the embodiment is used for head and neck surgery, its size can be set as follows: the length L of the upper surface is 10 cm, the width D is 6 cm, the basic thickness T of the soft pad is 0.5 cm, and the height H of the raised structure is 2 cm. The size can be modified according to the actual surgical needs to produce products. In addition, since the material of the water-permeable soft pad is easy to trim, it can also be trimmed on the basis of products of uniform size. The use of the drainage device in the blood vessel / nerve anastomosis,

[0032] Figure 4The preferred position of the non-negative pressure drainage device of the present application is shown when used for head and neck blood vessel / nerve transplantation. In use, the drainage tube 3 is pierced with a puncture needle 5 from the deep surface of the sternocleidomastoid muscle, the post-auricular area under the mastoid process, and the water-permeable soft pad is placed at the level of the lower edge of the mandible. The water-permeable soft pad is trimmed to the upper area of the deep neck, so that the drainage device can be placed smoothly. The donor blood vessel / nerve 6 and the recipient blood vessel / nerve 7 are placed on the upper surface of the soft pad for anastomosis. The non-negative pressure drainage device in this embodiment can be designed or trimmed according to the anatomical depression after the neck dissection. The hydrophilic sponge soft pad on the surface is used to transfer the blood and water on the surface, as well as the heparin sodium and normal saline for flushing, to the lower part around the drainage tube, and the blood is removed by the drainage tube with a drainage groove. The drainage tube can also be placed slightly inclined to facilitate the outflow of liquid. After the anastomosis is completed, the water-permeable soft pad can be removed from the drainage tube, and the drainage tube remains in the neck as a postoperative drainage tube.

[0033] The preferred embodiments of the present application are described in detail above. It should be understood that those of ordinary skill in the art can make many modifications and changes without creative labor based on the concept of the present application. Therefore, any technical solution obtained by logical analysis, reasoning or limited experiment based on the prior art according to the concept of the present application should be within the protection scope defined by the claims.

Claims

1. A no negative pressure drainage device for use in anatomical recesses of the human body, characterized in that, The preformed water-permeable soft cushion coated with waterproof material on the bottom surface and a drainage tube inserted into the water-permeable soft cushion; the top surface of the water-permeable soft cushion is a flat surface, and the bottom surface has a downward protruding structure, which is located at the central axis of the water-permeable soft cushion, and the lower surface of the water-permeable soft cushion extends to each side from the bottom line upward, and the protruding structure is clamped into the concave part of the human body to fix the drainage device; the drainage tube is inserted into the protruding structure, and the tube wall of the tube segment part of the drainage tube in the water-permeable soft cushion is provided with a drainage groove; the top surface of the water-permeable soft cushion is rectangular, and the bottom surface has the protruding structure extending along the axial direction of the drainage tube, the drainage tube is close to and parallel to the bottom line of the protruding structure, the distance between the closest part of the drainage tube to the bottom line and the bottom line is not more than 1 cm, the basic thickness of the water-permeable soft cushion is 0.5-1 cm, and the height of the highest part of the protruding structure is 2-5 cm.

2. The no negative pressure drainage device for human anatomical recesses according to claim 1, characterized in that, The drainage groove is a hollow on the tube wall, and the number is multiple.

3. The no negative pressure drainage device for human anatomical recesses according to claim 1, characterized in that, The water-permeable soft cushion is made of porous material.

4. The no negative pressure drainage device for human anatomical recesses according to claim 1, characterized in that, The water-permeable soft cushion is 3D printed.

5. The no negative pressure drainage device for human anatomical recesses according to claim 1, characterized in that, The other end of the drainage tube is connected with a puncture needle.

6. The no negative pressure drainage device for human anatomical recesses according to claim 1, characterized in that, The water-permeable soft cushion and the drainage tube are separable.

7. The no negative pressure drainage device for human anatomical recesses according to claim 1, characterized in that, The drainage tube is provided with an interface at the inner and outer joints of the water-permeable soft cushion, so that the inner and outer tube segments of the drainage tube can be separated.

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