Drainage devices

Abstract

The present disclosure relates to a drainage device, comprising: a drainage tube body (1); an airbag assembly (2), which is arranged on the drainage tube body (1) and comprises a plurality of first airbags (21) and a plurality of second airbags (22), wherein the plurality of first airbags (21) and the plurality of second airbags (22) are arranged along the circumference of the drainage tube body (1), and the process of filling and releasing working fluid into and out of the plurality of first airbags (21) and the process of filling and releasing working fluid into and out of the plurality of second airbags (22) are independent of each other.

Description

Technical Field

[0001] The present disclosure relates to the field of medical equipment, and in particular to a drainage device. Background Art

[0002] Anastomotic leakage is one of the serious complications after colorectal surgery, which can cause severe intra-abdominal infection, thereby increasing the patient's pain, prolonging hospitalization time, and increasing treatment costs. In severe cases, it can lead to the patient's death. In addition, anastomotic leakage after colorectal surgery may also cause long-term complications such as anastomotic stenosis and defecation dysfunction, thereby reducing the patient's survival rate and affecting the quality of life.

[0003] The occurrence of anastomotic leakage after colorectal surgery is related to the patient's nutritional status, anastomotic tension, intestinal pressure, and anastomotic blood supply. Evidence shows that continuous decompression and drainage in the rectum after surgery to reduce intestinal pressure can significantly reduce the occurrence of anastomotic leakage. Effective decompression and drainage in the rectum and fixation of decompression drainage are prerequisites for success. Summary of the invention

[0004] In one aspect of the present disclosure, there is provided a drainage device, comprising:

[0005] Drainage tube body;

[0006] The airbag assembly is arranged on the drainage tube body and includes a plurality of first airbags and a plurality of second airbags. The plurality of first airbags and the plurality of second airbags are arranged along the circumference of the drainage tube body, and the process of filling and releasing the working fluid of the plurality of first airbags is independent of the process of filling and releasing the working fluid of the plurality of second airbags.

[0007] In some embodiments, the first airbags and the second airbags are alternately arranged along the circumference of the drainage tube body.

[0008] In some embodiments, the airbag assembly is located at the end of the drainage tube body along the first axial side, the adjacent first airbag and the second airbag are tightly attached to each other in the expanded state, and a groove located on the first side is formed between the first airbag and the second airbag.

[0009] In some embodiments, the drainage device further comprises:

[0010] a first fluid-filling tube, located in the tube wall of the drainage tube body, the first fluid-filling tube comprising a first annular tube section and a first straight tube section, the first annular tube section being respectively connected to the plurality of first airbags, the first straight tube section being connected to the first annular tube section and extending along the axial direction of the drainage tube body;

[0011] The second fluid-filling tube is located in the tube wall of the drainage tube body. The second fluid-filling tube includes a second annular tube segment and a second straight tube segment. The second annular tube segment is respectively connected to the multiple second airbags. The second straight tube segment is connected to the second annular tube segment and extends along the axial direction of the drainage tube body.

[0012] In some embodiments, the drainage device further comprises:

[0013] The external fixing seat is arranged on the drainage tube body and is configured to fix and limit the drainage tube body along the axial direction of the drainage tube body together with the airbag assembly at the outside and inside of the cavity opening of the human body when the drainage tube body is inserted into the human body cavity.

[0014] In some embodiments, the drainage device further comprises:

[0015] A first filling tube, located in the tube wall of the drainage tube body and connected to the plurality of first airbags respectively;

[0016] A second filling tube is located in the tube wall of the drainage tube body and is respectively connected to the plurality of second air bags;

[0017] a third fluid-filling tube, comprising a first portion located in the outer fixing seat and connected to the first fluid-filling tube, and a second portion connected to the first portion and led outward from the outer fixing seat;

[0018] The fourth filling tube comprises a third portion located in the outer fixing seat and connected to the second filling tube, and a fourth portion connected to the third portion and led out from the outer fixing seat.

[0019] In some embodiments, the drainage device further comprises:

[0020] a first pressure measuring airbag in communication with the second portion of the third filling tube and configured to inject working fluid into the plurality of first airbags via the third filling tube and the first filling tube;

[0021] The second pressure measuring airbag is communicated with the fourth portion of the fourth filling tube and is configured to inject working fluid into the plurality of second airbags via the fourth filling tube and the second filling tube.

[0022] In some embodiments, the drainage device further comprises:

[0023] The fluid guiding device is connected to the second portion of the third filling tube and the fourth portion of the fourth filling tube respectively, and is configured to guide the working fluid to flow into the plurality of first airbags and the plurality of second airbags alternately at a preset cycle according to a set program.

[0024] In some embodiments, the drainage device further comprises:

[0025] The drainage container is located on a side of the external fixing seat away from the airbag assembly and is detachably connected to an end of the drainage tube body away from the airbag assembly.

[0026] In some embodiments, the drainage container comprises a flexible drainage bag.

[0027] In some embodiments, the drainage container has a docking port for plugging with an end of the drainage tube body away from the airbag assembly, and the cross-sectional area of ​​the bottom of the drainage container is larger than the cross-sectional area of ​​the docking port.

[0028] In some embodiments, the external mount comprises:

[0029] A tube body connecting portion, connected to the drainage tube body;

[0030] The first fixing portion and the second fixing portion are respectively connected to two sides of the tube body connecting portion in the longitudinal direction, and the transverse width of the first fixing portion is greater than the transverse width of the second fixing portion.

[0031] In some embodiments, the lateral width of the outer fixing seat gradually decreases along the direction from the first fixing portion to the second fixing portion, and the end of the first fixing portion away from the tube body connecting portion and the end of the second fixing portion away from the tube body connecting portion are arc-shaped.

[0032] In some embodiments, surfaces of the first fixing portion and the second fixing portion adjacent to a side of the airbag assembly are concave arc surfaces relative to the airbag assembly.

[0033] In some embodiments, the first fixing portion is configured to abut against the perineum of the human body and the skin from the perineum to the anus when the drainage tube body is inserted into the rectum, and the second fixing portion is configured to abut against the tip of the coccyx of the human body and the skin from the tip of the coccyx to the anus when the drainage tube body is inserted into the rectum.

[0034] In some embodiments, the drainage device further comprises:

[0035] a first flushing and injection tube, at least partially located in the tube wall of the drainage tube body, the first flushing and injection tube comprising a third annular tube section and a third straight tube section, the third annular tube section is located on a side of the drainage tube body away from the external fixing seat, the third straight tube section is connected to the third annular tube section, and extends along the axial direction of the drainage tube body;

[0036] A second flushing and injection tube, comprising a fifth portion located in the outer fixing seat and connected to the first flushing and injection tube, and a sixth portion connected to the fifth portion and led out from the outer fixing seat;

[0037] The third annular pipe section is provided with a plurality of openings along the circumferential direction, and the plurality of openings are configured to spray flushing liquid or medical liquid outward.

[0038] In some embodiments, the external fixing seat includes: a tube body connecting portion connected to the drainage tube body, and a first fixing portion and a second fixing portion respectively connected to both sides of the tube body connecting portion in the longitudinal direction, and the second flushing and injection tube, the second filling tube and the fourth filling tube are all led outward at the end of the first fixing portion on the side away from the tube body connecting portion.

[0039] In some embodiments, the position of the external fixing seat relative to the drainage tube body in the axial direction of the drainage tube body is adjustable.

[0040] In some embodiments, the length of the drainage tube is 50-60 mm, and / or the inner diameter of the drainage tube is 15 mm, and / or the wall thickness of the drainage tube is 1.5 mm.

[0041] In some embodiments, the airbag assembly is located at the end of the drainage tube body along the first axial side, and the airbag assembly is flush with or exceeds the end of the drainage tube body at least in the expanded state.

[0042] In some embodiments, the external fixing seat is located at the end of the drainage tube body along the second side in the axial direction, and the second side end of the drainage tube body does not extend axially beyond the farthest end of the side of the external fixing seat away from the airbag assembly.

[0043] In some embodiments, the material of the outer mount is transparent. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] The accompanying drawings, which constitute a part of the specification, illustrate embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

[0045] The present disclosure may be more clearly understood from the following detailed description with reference to the accompanying drawings, in which:

[0046] Figure 1 is a schematic diagram of the three-dimensional structure of some embodiments of the drainage device disclosed herein;

[0047] Figure 2 and Figure 3 They are schematic diagrams of structures of some embodiments of the drainage device disclosed in the present invention at different viewing angles;

[0048] Figure 4 is a perspective schematic diagram of the internal structure of some embodiments of the drainage device according to the present disclosure;

[0049] Figure 5 It is a schematic diagram of the structure of the first filling tube, the second filling tube and the first flushing and injection tube in some embodiments of the rectal drainage device disclosed in the present invention.

[0050] It should be understood that the size of each part shown in the accompanying drawings is not drawn according to the actual proportional relationship. In addition, the same or similar reference numerals represent the same or similar components. DETAILED DESCRIPTION

[0051] Various exemplary embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings. The description of the exemplary embodiments is merely illustrative and is in no way intended to limit the present disclosure and its application or use. The present disclosure can be implemented in many different forms and is not limited to the embodiments described herein. These embodiments are provided to make the present disclosure thorough and complete and to fully express the scope of the present disclosure to those skilled in the art. It should be noted that unless otherwise specifically stated, the relative arrangement of the components and steps, the composition of the materials, the numerical expressions and the numerical values ​​set forth in these embodiments should be interpreted as being merely exemplary and not as limiting.

[0052] The words "first", "second" and similar words used in this disclosure do not indicate any order, quantity or importance, but are only used to distinguish different parts. The words "include" or "comprise" and similar words mean that the elements before the word include the elements listed after the word, and do not exclude the possibility of including other elements. "Up", "down", "left", "right" and the like are only used to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0053] In the present disclosure, when a specific device is described as being located between a first device and a second device, there may or may not be an intermediate device between the specific device and the first device or the second device. When a specific device is described as being connected to other devices, the specific device may be directly connected to the other device without an intermediate device, or may not be directly connected to the other device but have an intermediate device.

[0054] All terms (including technical terms or scientific terms) used in the present disclosure have the same meanings as those understood by ordinary technicians in the field to which the present disclosure belongs, unless otherwise specifically defined. It should also be understood that terms defined in general dictionaries, such as general dictionaries, should be interpreted as having meanings consistent with their meanings in the context of the relevant technology, and should not be interpreted in an idealized or extremely formal sense, unless explicitly defined herein.

[0055] Technologies, methods, and equipment known to ordinary technicians in the relevant art may not be discussed in detail, but where appropriate, the technologies, methods, and equipment should be considered as part of the specification.

[0056] Among the related technologies, the following rectal decompression and drainage methods are mainly used:

[0057] 1. After colorectal surgery, doctors manually perform anal dilation repeatedly to reduce rectal pressure and achieve tension-free defecation. Studies have found that this method is poorly accepted by patients, increases the workload of doctors, and the operation site is close to the surgical site, which limits the operation and has a limited effect on reducing rectal pressure.

[0058] 2. Fix the balloon in the rectal cavity. This method requires the use of a catheter with a balloon, an endotracheal tube, or other devices. Studies have shown that the balloon causes continuous compression of the rectal mucosa, affects the blood flow of the rectal wall, and can cause damage to the rectal mucosa. On the other hand, the decompression drainage tube in this balloon-equipped device has an exposed part outside the anus, which restricts the patient's activities and body position. In addition, the exposed part of the decompression drainage tube cannot be accurately fixed, so its position may change, affecting the position of the balloon in the rectal cavity, which inevitably pulls and displaces the rectal wall and affects the healing of the surgical site.

[0059] 3. External anal suture fixation. Studies have found that this method of fixation is not accurate and can easily cause the drainage tube to bend or fall out. The position change of the exposed decompression drainage tube can affect the position of the decompression drainage tube in the rectal cavity, causing traction and displacement of the rectal wall. In addition, the tubular structure in the rectal cavity can cause obvious pain and may cause infection at the suture fixation site.

[0060] 4. Fixation with external fixators on the anus. Studies have shown that this method does not conform to the human anatomy and requires other fixators, such as fixation ropes and waist loops, which makes the patient less comfortable. In addition, the connections between external fixators are complex, the fixation is not accurate, the exposed parts outside the anus are large, which restricts the patient's position, and the position of the exposed parts will indirectly affect the position of the internal parts of the rectum, causing traction on the rectal wall or anastomosis, thereby affecting the healing of the anastomosis.

[0061] In view of this, an embodiment of the present disclosure provides a drainage device that can reduce the pressure of the airbag component on the mucous membrane of the human body cavity.

[0062] like Figure 1 , which is a schematic diagram of the three-dimensional structure of some embodiments of the drainage device according to the present disclosure. Figure 1 , and combined with Figure 2-Figure 5As shown in the structural diagram, in some embodiments, the drainage device includes: a drainage tube body 1 and an airbag assembly 2. The airbag assembly 2 is arranged on the drainage tube body 1 and includes a plurality of first airbags 21 and a plurality of second airbags 22.

[0063] In some embodiments, the airbag assembly 2 may be made of a flexible, waterproof, and airtight material, such as polyvinyl chloride (PVC). The airbag assembly 2 includes a plurality of first airbags 21 and a plurality of second airbags 22 arranged along the circumference of the drainage tube body 1. Figure 1 In the embodiment, a plurality of first airbags 21 and a plurality of second airbags 22 are radially arranged relative to the drainage tube body 1 along the radial outer side of the drainage tube body 1, similar to the shape of petals. The plurality of first airbags 21 and the plurality of second airbags 22 can expand radially as the volume of the internal working fluid increases, and contract radially as the volume of the internal working fluid decreases. The airbag assembly 2 can be filled with or released with liquid or gaseous working fluids, such as air, water, oil, etc. Taking air as an example, by filling air into part or all of the airbags of the airbag assembly 2 to change the inflation volume and air pressure in the airbag assembly 2, part or all of the airbags can be expanded or contracted radially. The airbag assembly 2 in a contracted state can easily enter the human body cavity (for example, enter the rectum through the anus) together with the drainage tube body 1, while the airbag assembly 2 in an expanded state can support the cavity wall of the human body cavity (for example, the cavity wall of the rectal cavity). In some application scenarios (such as rectal decompression and drainage after or during surgery), the first airbag and the second airbag can be expanded to different degrees to form discontinuous local compression on the rectal cavity mucosa. In other application scenarios (such as local compression treatment of distal rectal bleeding or conservative treatment of colorectal injury), all airbags in the airbag assembly 2 can be expanded to the same degree to inhibit distal rectal bleeding.

[0064] In order to facilitate independent control of the expansion degree of the first airbag and the second airbag, in some embodiments, the process of filling and releasing the working fluid of the plurality of first airbags 21 can be made independent of the process of filling and releasing the working fluid of the plurality of second airbags 22. For example, the plurality of first airbags 21 and the plurality of second airbags 22 are not connected to each other.

[0065] Compared with some related technologies in which multiple annular airbags are arranged axially along the drainage tube body and are alternately inflated, in this embodiment, multiple first airbags and multiple second airbags are arranged circumferentially along the drainage tube body, and the charging and discharging processes of the working fluid are independent of each other. On the one hand, by alternately filling and releasing the working fluid into the first airbags and the second airbags, continuous local compression on the cavity wall mucosa can be avoided when supporting the human body cavity. On the other hand, by circumferentially arranging multiple airbags, there is no need to use a longer drainage tube body, thereby reducing or avoiding the risk of damage to the cavity wall by the longer part of the drainage tube body located in the human body cavity.

[0066] exist Figure 1 In the embodiment, the plurality of first airbags 21 and the plurality of second airbags 22 are all located at the same position in the axial direction of the drainage tube body 1. In addition, the number of the first airbags 21 may be the same as or different from the number of the second airbags 22, for example, both are 6.

[0067] In order to ensure the uniformity of the local support of the airbag assembly 2 to the human body cavity, the first airbag 21 (i.e. Figure 1 The white airbag in the middle) and the second airbag 22 (i.e. Figure 1 The gray airbags in the figure) are alternately arranged along the circumference of the drainage tube body 1, that is, the multiple airbags are sequentially arranged along a circumferential direction (clockwise or counterclockwise) as the first airbag 21, the second airbag 22, the first airbag 21, the second airbag 22, ...

[0068] By setting the process of filling and releasing the working fluid of the multiple first airbags 21 and the process of filling and releasing the working fluid of the multiple second airbags 22 to be independent of each other, mutual interference between the flow or pressure control of the working fluid inside the first airbags 21 and the second airbags 22 can be effectively avoided.

[0069] refer to Figure 1 and Figure 3 In some embodiments, the airbag assembly 2 is located at the end of the drainage tube body 1 along the first side in the axial direction, and the adjacent first airbag 21 and the second airbag 22 are closely attached to each other in the expanded state, and a groove 27 located on the first side is formed between the first airbag 21 and the second airbag 22. Figure 1 In the embodiment, each group of adjacent first airbags 21 and second airbags 22 along the circumferential direction can form a concave groove 27. The groove 27 can effectively guide the contents of the human body cavity to flow to the tube opening of the drainage tube body located in the center, thereby improving the drainage effect.

[0070] refer to Figure 1-Figure 5 In some embodiments, the drainage device further comprises an external fixing seat 3. The external fixing seat 3 is arranged on the drainage tube body 1, and can fix and limit the drainage tube body 1 along the axial direction of the drainage tube body 1 together with the airbag assembly 2 at the outside and inside of the cavity opening of the human body cavity when the drainage tube body 1 is inserted into the human body cavity.

[0071] For example, when the drainage device is used for rectal drainage, the drainage tube body 1 is inserted into the lower end of the rectum through the anus, and the airbag assembly 2 and the external fixing seat 3 can respectively fix and limit the drainage tube body 1 along the axial direction of the drainage tube body 1 on the inside and outside of the anus, thereby achieving dual fixation inside the rectal cavity and outside the anus, making the fixation more accurate, more in line with the human anatomical structure and physiological function, making the patient more comfortable, and reducing the workload of clinical medical staff. In addition, other auxiliary fixing devices can also be omitted, so that the stability and fixed position of the drainage device are not easily affected by the patient's limb activities, nor are they easily affected by the patient's limb activities and body position.

[0072] In some embodiments, the drainage tube body 1 can be made of polyurethane material. This material has good human tolerance and can withstand the extrusion of the cavity openings of some human cavities without obvious deformation, thereby ensuring that the lumen of the drainage tube body 1 remains unobstructed. For example, when used for rectal drainage, the drainage tube body 1 can be under the pressure of the internal and external anal sphincters without obvious deformation, effectively reducing the pressure in the rectal cavity, creating a low-pressure environment for colorectal surgery, promoting the healing of the anastomosis, and reducing the probability of anastomotic fistula.

[0073] The drainage tube body 1 can be retained at the distal end of the human body cavity (i.e., the end adjacent to the cavity opening), such as the lower end of the rectum adjacent to the anus, when in use. By fixing the airbag assembly in the human body cavity, the tubular structure at the proximal end of the human body cavity (i.e., the end away from the cavity opening) can be omitted. Thus, in some embodiments, the tubular structure is not provided at the proximal end of the drainage tube body 1 located in the human body cavity, thereby making the drainage tube body shorter, reducing the drainage resistance, and not causing damage to the surgical site in the human body cavity by pulling and shifting.

[0074] refer to Figure 2 In some embodiments, the airbag assembly 2 is located at the end of the drainage tube body 1 along the first side in the axial direction, and the airbag assembly 2 is at least flush with the end of the drainage tube body 1 or exceeds the end of the drainage tube body 1 in the expanded state. Figure 2 In the z-axis direction, the highest position of the airbag assembly 2 in the expanded state is not lower than the upper end of the drainage tube body 1. This can effectively prevent the tubular structure above the airbag assembly 2 from damaging the cavity wall mucosa.

[0075] exist Figure 2 In the embodiment, the external fixing seat 3 can be arranged at the end of the drainage tube body 1 along the second axial side, that is, Figure 2The lower end of the drainage tube body 1 along the z-axis direction. Moreover, the second side end of the drainage tube body 1 does not extend axially beyond the farthest end of the side of the external fixing seat 3 away from the airbag assembly 2. In other words, the lowest position of the external fixing seat 3 is not lower than the lower end of the drainage tube body 1. In this way, the drainage device of this embodiment has no tubular structure outside the cavity opening, so that the patient can move freely without affecting the stability and fixed position of the drainage device. In other embodiments, the lower end of the drainage tube body 1 may protrude slightly downward relative to the lowest end of the external fixing seat 3.

[0076] Taking rectal surgery as an example, since the anal canal lengths of different patients are different, medical personnel can determine the anal canal length by finger examination or by instrument, and select a drainage device with a corresponding specification of the appropriate drainage tube length. In some embodiments, the length of the drainage tube 1 can be selected to be 50-60 mm to meet the needs of rectal drainage.

[0077] In some embodiments, the fixed position between the external fixing seat 3 and the drainage tube body 1 is adjustable in the axial direction of the drainage tube body 1. For example, a plurality of gears are set on the drainage tube body 1, and the external fixing seat 3 can be moved along the axial direction of the drainage tube body 1, and fixedly connected with the drainage tube body 1 at the corresponding gear by means of clamping, screw connection, etc. Correspondingly, a recognizable scale can be set on the drainage tube body 1.

[0078] In some embodiments, the inner diameter of the drainage tube body 1 is 10-20 mm, and can be 15 mm, which can not only make the drainage smoother through the wider inner diameter of the tube cavity, but also reduce the discomfort of the patient when using the drainage device. In order to accommodate, for example, a filling tube or a flushing and injection tube in the tube wall, in some embodiments, the tube wall thickness of the drainage tube body 1 can be set to 1-2 mm, and can be 1.5 mm.

[0079] refer to Figure 3 In some embodiments, the maximum diameter D of the airbag assembly 2 in the expanded state is 28-38 mm. Figure 2 In some embodiments, the height H of the airbag component 2 along the axial direction of the drainage tube body 1 is 6-12 mm, and can be 10 mm. In addition, in some embodiments, the airbag component 2 is flush with or higher than the end of the drainage tube body 1 at least in the expanded state. For example, Figure 4 The highest position of the airbag assembly 2 in the middle expansion state is flush with the top end of the drainage tube body 1, so that the drainage tube body 1 does not have a tubular structure located above the airbag assembly.

[0080] refer to Figure 4 and Figure 5In some embodiments, the drainage device further includes: a first fluid-filling tube 23 and a second fluid-filling tube 24. The first fluid-filling tube 23 and the second fluid-filling tube 24 are located in the tube wall of the drainage tube body 1. The first fluid-filling tube 23 includes a first annular tube segment 23a and a first straight tube segment 23b, the first annular tube segment 23a is respectively connected to the plurality of first airbags 21, the first straight tube segment 23b is connected to the first annular tube segment 23a, and extends along the axial direction of the drainage tube body 1. The second fluid-filling tube 24 includes a second annular tube segment 24a and a second straight tube segment 24b, the second annular tube segment 24a is respectively connected to the plurality of second airbags 22, the second straight tube segment 24b is connected to the second annular tube segment 24a, and extends along the axial direction of the drainage tube body 1.

[0081] exist Figure 5 The first annular tube segment 23a is provided with a plurality of openings along the circumferential direction, and can be communicated with a plurality of first airbags 21 arranged at intervals in the circumferential direction through the plurality of openings. The second annular tube segment 24a is provided with a plurality of openings along the circumferential direction, and can be communicated with a plurality of second airbags 22 arranged at intervals in the circumferential direction through the plurality of openings. The first annular tube segment 23a and the second annular tube segment 24a can be located at different axial positions of the drainage tube body 1.

[0082] refer to Figure 4 In some embodiments, the drainage device further includes: a third filling tube 25 and a fourth filling tube 26. The third filling tube 25 has a first portion 25a located in the external fixing seat 3 and communicating with the first filling tube 23, and a second portion 25b communicating with the first portion 25a and leading out from the external fixing seat 3. The fourth filling tube 26 has a third portion 26a located in the external fixing seat 3 and communicating with the second filling tube 24, and a fourth portion 26b communicating with the third portion 26a and leading out from the external fixing seat 3.

[0083] exist Figure 4 In the embodiment, the first straight pipe section 23b of the first filling pipe 23 is connected to the first portion 25a of the third filling pipe 25. In some embodiments, the first filling pipe 23 and the third filling pipe 25 can be made in one piece. Figure 4 In the embodiment, the second straight tube section 24b of the second fluid-filling tube 24 is connected to the third portion 26a of the fourth fluid-filling tube 26. In some embodiments, the second fluid-filling tube 24 and the fourth fluid-filling tube 26 can be made in one piece.

[0084] The lengths of the second portion 25b and the fourth portion 26b of the third filling tube 25 and the fourth filling tube 26 respectively extending outward from the external fixing seat 3 can be set as required, for example, set to a length extending to the patient's abdomen to facilitate operation by medical personnel. The working fluid can enter the first airbag 21 through the third filling tube 25 and the first filling tube 23, and enter the second airbag 22 through the fourth filling tube 25 and the second filling tube 24. The driving of the working fluid can be completed at the second portion 25b and the fourth portion 26b of the third filling tube 25 and the fourth filling tube 26 respectively extending outward from the external fixing seat 3.

[0085] refer to Figure 1-Figure 4 In some embodiments, the drainage device further includes: a first pressure-measuring airbag 29 and a second pressure-measuring airbag 28. The first pressure-measuring airbag 29 is connected to the second portion 25b of the third filling tube 25, and can inject working fluid into the multiple first airbags 21 via the third filling tube 25 and the first filling tube 23. The second pressure-measuring airbag 28 is connected to the fourth portion 26b of the fourth filling tube 26, and can inject working fluid into the multiple second airbags 22 via the fourth filling tube 26 and the second filling tube 24. Here, the first pressure-measuring airbag 29 and the second pressure-measuring airbag 28 act as driving devices for the working fluid and can realize the charging operation of the working fluid. The operator can manually squeeze the first pressure-measuring airbag 29 or the second pressure-measuring airbag 28 to realize the operation of filling the fluid.

[0086] Sealing heads can be respectively provided on the first pressure-measuring airbag and the second pressure-measuring airbag to maintain the working fluid pressure in the first airbag and the second airbag. When the sealing head of any one of the first pressure-measuring airbag and the second pressure-measuring airbag is opened, the working fluid in the corresponding first airbag or the second airbag can be released. In addition, the first pressure-measuring airbag and the second pressure-measuring airbag can measure the pressure of the working fluid, thereby more accurately controlling the charging and discharging of the working fluid in the first airbag and the second airbag, and better estimating the expansion degree of the airbag assembly.

[0087] In order to simplify manual operation and improve the automation and convenience of the drainage device, in some embodiments, the drainage device may further include: a fluid guiding device. The fluid guiding device is respectively connected to the second portion 25b of the third filling tube 25 and the fourth portion 26b of the fourth filling tube 26, and is configured to guide the working fluid to flow into the plurality of first airbags 21 and the plurality of second airbags 22 alternately according to a preset cycle according to a set program.

[0088] In some embodiments, the fluid guiding device may include an air pump, an air valve, and a microprocessor or controller, and the air valve and the air pump are controlled by the microprocessor or controller to realize the alternating charging and discharging operation of the plurality of first airbags 21 and the plurality of second airbags 22 according to a preset cycle. The fluid guiding device is used to automatically fill the first airbag and / or the second airbag with working fluid or release the working fluid in the first airbag and / or the second airbag, and the working parameters of the working fluid, such as pressure, flow, etc., can be detected.

[0089] refer to Figure 1 and Figure 2 In some embodiments, the drainage device further comprises a drainage container 4. The drainage container 4 is located on a side of the external fixing seat 3 away from the airbag assembly 2, and is detachably connected to an end of the drainage tube body 1 away from the airbag assembly 2. The drainage container 4 is connected to the drainage tube body 1 to conveniently collect rectal internal fluid, such as the contents in the rectal intestinal cavity or the liquid medicine after flushing the intestinal wall.

[0090] In some embodiments, the drainage container 4 includes a flexible drainage bag made of a flexible material (such as plastic or silicone, etc.) so as not to affect the patient's body position (such as sitting or upright position, etc.).

[0091] refer to Figure 2 In some embodiments, the drainage container 4 has a docking port for plugging into the end of the drainage tube body 1 away from the airbag assembly 2. The docking port may adopt an annular plug-in structure, and its outer diameter may be less than or equal to the inner diameter of the drainage tube body 1 so as to be inserted into the lower end of the drainage tube body 1. The length of the docking port may be 10 to 30 mm, for example, 20 mm, so as to form a stable and reliable connection with the drainage tube body 1. The cross-sectional area of ​​the bottom of the drainage container 4 is larger than the cross-sectional area of ​​the docking port. Figure 2 It can be seen that the bottom width W5 of the drainage container 4 is greater than the width W4 of the connecting port. This gradually widening structure of the drainage container can effectively reduce the resistance of the decompression drainage.

[0092] In some embodiments, the material of the external fixator 3 is transparent to facilitate medical staff to observe the inside of the human body cavity. For example, the external fixator 3 can be made of, but not limited to, transparent silicone. Transparent silicone is softer, which can increase the patient's acceptance and compliance, and facilitate the patient's free movement, thereby shortening the recovery time and reducing complications caused by long-term bed rest.

[0093] refer to Figure 1-Figure 4 In some embodiments, the external fixing seat 3 includes: a tube body connecting portion 31, a first fixing portion 32 and a second fixing portion 33. The tube body connecting portion 31 is connected to the drainage tube body 1. Figure 1-Figure 4, the z-axis is parallel to the axis of the drainage tube body, the x-axis and the y-axis are both parallel to the z-axis, and the x-axis is parallel to the y-axis. In some embodiments, the extension direction of the y-axis is perpendicular to the sagittal plane of the human body, the extension direction of the x-axis is perpendicular to the coronal plane of the human body, and the extension direction of the z-axis is perpendicular to the cross-section of the human body. Here, the extension direction of the x-axis is defined as the longitudinal direction of the external fixation seat 3, and the extension direction of the y-axis is defined as the transverse direction of the external fixation seat 3. The first fixing portion 32 and the second fixing portion 33 are respectively connected to both sides of the tube body connecting portion 31 along the longitudinal direction.

[0094] When the drainage device is used for rectal drainage, the first fixing portion 32 is configured to abut against the perineum of the human body and the skin from the perineum to the anus when the drainage tube body 1 is inserted into the rectum. The second fixing portion is configured to abut against the tip of the coccyx of the human body and the skin from the tip of the coccyx to the anus when the drainage tube body 1 is inserted into the rectum.

[0095] The first fixing part and the second fixing part are respectively fixed on the front and back sides of the human body, so that the drainage tube body is fixed more firmly. Figure 2 In order to better conform to the human anatomy and physiological structure, the surfaces of the first fixing portion 32 and the second fixing portion 33 adjacent to the airbag assembly 2 may be concave arc surfaces relative to the airbag assembly 2. Figure 1 and Figure 2 In the embodiment, the first fixing portion 32 and the second fixing portion 33 are bent toward the side of the airbag assembly 2 relative to the connection portion between the drainage tube body 1 and the tube body connecting portion 31. In this way, the external fixing seat 3 can present an anchor-like structure, thereby allowing the patient to move freely without affecting the stability and fixed position of the drainage device.

[0096] refer to Figure 3 In some embodiments, the transverse width W1 of the first fixing portion 32 is greater than the transverse width W2 of the second fixing portion 33. With reference to the above, this structure is more in line with the human anatomy and physiological structure, thereby better fixing and improving the comfort of the patient. Figure 3 In the embodiment, W1 is 30 mm, and W2 is 10 mm. The length of the external fixing base 3 in the second direction x can be 90 mm, and the thickness of the external fixing base 3 is 5 mm.

[0097] exist Figure 3In the figure, the lateral width of the external fixing seat 3 gradually decreases from the first fixing portion 32 to the second fixing portion 33, and the end of the first fixing portion 32 away from the tube body connecting portion 31 and the end of the second fixing portion 33 away from the tube body connecting portion 31 are both arc-shaped. This structure is not only more in line with the human anatomy and physiological structure, but also more comfortable for patients to use. In some application scenarios, it is necessary to introduce therapeutic liquid or cleaning liquid into the human body cavity, such as introducing liquid medicine into the rectum or flushing the inside of the rectum after surgery. Accordingly, refer to Figure 1-Figure 5 In some embodiments, the drainage device further includes a first flushing and injection tube 51 and a second flushing and injection tube 52. At least a portion of the first flushing and injection tube 51 is located in the tube wall of the drainage tube body 1. The first flushing and injection tube 51 includes a third annular tube segment 51a and a third straight tube segment 51b, wherein the third annular tube segment 51a is located on a side of the drainage tube body 1 away from the external fixing seat 3, and the third straight tube segment 51b is connected to the third annular tube segment 51a and extends along the axial direction of the drainage tube body 1.

[0098] The third annular pipe segment 51a is provided with a plurality of openings 54 along the circumferential direction, and the plurality of openings 54 are configured to spray outwardly a flushing liquid or a liquid medicine. In some embodiments, a nozzle may also be provided on each opening 54. The flushing and injection operation is performed by the plurality of openings 54 provided on the third annular pipe segment 51a, so that the flushing or injection of the human body cavity can be made more sufficient. The number of openings may be set as required, for example, 4 to 8 openings may be provided, and 6 openings may be selected. The plurality of openings 54 may be arranged at equal intervals along the circumferential direction. In other embodiments, the plurality of openings 54 may be arranged at non-equal intervals along the circumferential direction.

[0099] refer to Figure 2 In some embodiments, the third annular tube segment 51a is located axially outside the end of the drainage tube body 1, for example Figure 2 The top of the drainage tube 1 is above the top of the drainage tube 1. Figure 4 In other embodiments, the third annular pipe segment 51a is located inside the tube wall of the drainage tube body 1 and is located adjacent to the top of the drainage tube body 1, and a plurality of openings are also provided at the top of the drainage tube body 1, which are respectively aligned with the plurality of openings 54 of the third annular pipe segment 51a, so that the working fluid entering the third annular pipe segment 51a can be sprayed upward through the openings 54 and the opening at the top of the drainage tube body 1.

[0100] The second flushing and injection tube 52 has a fifth portion 52a located in the outer fixing seat 3 and connected to the third straight pipe section 51b, and a sixth portion 52b connected to the fifth portion 52a and led outward from the outer fixing seat 3. In some embodiments, the second flushing and injection tube 52 and the first flushing and injection tube 51 can be made integrally.

[0101] The sixth portion 52b of the second flushing and drug injection tube 52 extending outward from the external fixing seat 3 can be connected to a device providing flushing liquid or drug solution so as to inject the flushing liquid or drug solution into the human body cavity.

[0102] refer to Figure 1 and Figure 4 In some embodiments, the second flushing and injection tube 52, the second filling tube 24 and the fourth filling tube 26 are all led outward at the end of the first fixing portion 32 away from the tube body connecting portion 31. To facilitate the operation of medical staff.

[0103] refer to Figure 4 and Figure 5 In some embodiments, at least a portion of the first flushing and injection tube 51 and the first filling tube 23 and the second filling tube 24 are disposed within the tube wall of the drainage tube body 1. Figure 5 In the embodiment, the third straight pipe section 51b of the first flushing and injection pipe 51 is arranged side by side and closely with the first straight pipe section 23b of the first filling pipe 23 and the second straight pipe section 24b of the second filling pipe 24 to simplify the manufacturing process. The third annular pipe section 51a is parallel to the first annular pipe section 23a and the second annular pipe section 24a, and is arranged at intervals along the axial direction of the drainage tube body 1. In other embodiments, the third straight pipe section 51b is located at different angular positions from the first straight pipe section 23b and the second straight pipe section 24b and is not closely attached.

[0104] With reference to the aforementioned embodiments of the drainage device disclosed herein, an example of applying the drainage device to post-rectal surgery will be described below.

[0105] Clinicians can first perform rectal digital examination to assess the length of the anal canal and use this to select a drainage device of appropriate specifications. The airbag component of the drainage device is inflated through a pressure measuring airbag to detect the inflation volume and expansion degree of the airbag component, and then the gas in the airbag component is evacuated.

[0106] The patient is placed in lithotomy position, the second fixing part of the external fixation seat is facing the position of the coccyx tip, the first fixing part is facing the position of the perineum, and the drainage tube body is inserted into the lower end of the rectum through the anus. The situation in the rectum and the retention position are observed through the lower end opening of the drainage tube body, and then one of the first airbag and the second airbag is inflated. After a period of time (for example, 12 hours), the other of the first airbag and the second airbag is inflated, and the previously inflated airbag is deflated. This alternating and repeated operation can improve the local compression of the rectal wall.

[0107] After the drainage device is fixed firmly, the flexible drainage bag is inserted into the opening at the lower end of the drainage tube body to receive the contents in the rectum. When the flexible drainage bag needs to be replaced, the connection port can be directly pulled out from the lower end opening of the drainage tube body and replaced with a new flexible drainage bag. When the drainage device needs to be removed, the gas in the airbag assembly is completely drained and then slowly removed from the outer edge of the anus.

[0108] When bleeding occurs at the distal end of the rectum, the first and second airbags can be inflated simultaneously to achieve pressurized hemostasis. When conservatively treating anastomotic fistulas of colorectal injuries, enema solutions and therapeutic drugs can be dripped through the flushing and injection tube, and the therapeutic effect can be evaluated by the properties of the drainage in the flexible drainage bag.

[0109] So far, various embodiments of the present disclosure have been described in detail. In order to avoid obscuring the concept of the present disclosure, some details known in the art are not described. Based on the above description, those skilled in the art can fully understand how to implement the technical solution disclosed here.

[0110] Although some specific embodiments of the present disclosure have been described in detail by way of examples, it should be understood by those skilled in the art that the above examples are for illustration only and are not intended to limit the scope of the present disclosure. It should be understood by those skilled in the art that the above embodiments may be modified or some technical features may be replaced by equivalents without departing from the scope and spirit of the present disclosure. The scope of the present disclosure is defined by the appended claims.

Claims

1. A drainage device, characterized in that: include: Drainage tube body (1); An airbag assembly (2) is arranged on the drainage tube body (1) and comprises a plurality of first airbags (21) and a plurality of second airbags (22), wherein the plurality of first airbags (21) and the plurality of second airbags (22) are arranged along the circumference of the drainage tube body (1), and the processes of filling and releasing the working fluid into and out of the plurality of first airbags (21) and the processes of filling and releasing the working fluid into and out of the plurality of second airbags (22) are independent of each other; and an external fixing seat (3) disposed on the drainage tube body (1) and configured to fix and limit the drainage tube body (1) along the axial direction of the drainage tube body (1) together with the airbag assembly (2) at the outside and inside of the cavity opening of the human body cavity when the drainage tube body (1) is inserted into the human body cavity; Wherein, the external fixing seat (3) comprises: A tube body connecting portion (31) connected to the drainage tube body (1); The first fixing portion (32) and the second fixing portion (33) are respectively connected to two sides of the tube body connecting portion (31) in the longitudinal direction, and the transverse width of the first fixing portion (32) is greater than the transverse width of the second fixing portion (33).

2. The drainage device according to claim 1, characterized in that: The first airbags (21) and the second airbags (22) are arranged alternately along the circumference of the drainage tube body (1).

3. The drainage device according to claim 2, characterized in that: The airbag assembly (2) is located at the end of the drainage tube body (1) along the first side in the axial direction, and the adjacent first airbag (21) and second airbag (22) are closely attached to each other in the expanded state, and a groove (27) located on the first side is formed between the first airbag (21) and the second airbag (22).

4. The drainage device according to claim 1, characterized in that: Also includes: a first fluid-filling tube (23) located in the tube wall of the drainage tube body (1), the first fluid-filling tube (23) comprising a first annular tube section (23a) and a first straight tube section (23b), the first annular tube section (23a) being connected to the plurality of first airbags (21) respectively, the first straight tube section (23b) being connected to the first annular tube section (23a) and extending along the axial direction of the drainage tube body (1); The second fluid-filling tube (24) is located inside the tube wall of the drainage tube body (1), and comprises a second annular tube section (24a) and a second straight tube section (24b). The second annular tube section (24a) is respectively connected to the plurality of second airbags (22), and the second straight tube section (24b) is connected to the second annular tube section (24a), and extends along the axial direction of the drainage tube body (1).

5. The drainage device according to claim 1, characterized in that: Also includes: A first filling tube (23), located in the tube wall of the drainage tube body (1) and respectively connected to the plurality of first airbags (21); A second filling tube (24), located in the tube wall of the drainage tube body (1) and respectively connected to the plurality of second air bags (22); a third filling tube (25), comprising a first portion (25a) located in the outer fixing seat (3) and communicating with the first filling tube (23), and a second portion (25b) communicating with the first portion (25a) and leading outward from the outer fixing seat (3); The fourth filling tube (26) comprises a third portion (26a) located in the outer fixing seat (3) and connected to the second filling tube (24), and a fourth portion (26b) connected to the third portion (26a) and led outward from the outer fixing seat (3).

6. The drainage device according to claim 5, characterized in that: Also includes: a first pressure measuring airbag (29) connected to the second portion (25b) of the third filling tube (25) and configured to inject working fluid into the plurality of first airbags (21) via the third filling tube (25) and the first filling tube (23); The second pressure measuring airbag (28) is in communication with the fourth portion (26b) of the fourth filling tube (26) and is configured to inject working fluid into the plurality of second airbags (22) via the fourth filling tube (26) and the second filling tube (24).

7. The drainage device according to claim 5, characterized in that: Also includes: A fluid guiding device is respectively connected to the second portion (25b) of the third filling tube (25) and the fourth portion (26b) of the fourth filling tube (26), and is configured to guide the working fluid to flow into the plurality of first airbags (21) and the plurality of second airbags (22) alternately in accordance with a preset cycle according to a set program.

8. The drainage device according to claim 1, characterized in that: Also includes: The drainage container (4) is located on a side of the external fixing seat (3) away from the airbag assembly (2), and is detachably connected to an end of the drainage tube body (1) away from the airbag assembly (2).

9. The drainage device according to claim 8, characterized in that: The drainage container (4) comprises a flexible drainage bag.

10. The drainage device according to claim 8, characterized in that: The drainage container (4) has a connection port for plugging into an end of the drainage tube body (1) away from the airbag assembly (2), and the cross-sectional area of ​​the bottom of the drainage container (4) is larger than the cross-sectional area of ​​the connection port.

11. The drainage device according to claim 10, characterized in that: The transverse width of the outer fixing seat (3) gradually decreases along the direction from the first fixing portion (32) to the second fixing portion (33), and an end of the first fixing portion (32) away from the tube body connecting portion (31) and an end of the second fixing portion (33) away from the tube body connecting portion (31) are arc-shaped.

12. The drainage device according to claim 10, characterized in that: The surfaces of the first fixing portion (32) and the second fixing portion (33) adjacent to the airbag assembly (2) are concave arc surfaces relative to the airbag assembly (2).

13. The drainage device according to claim 10, characterized in that: The first fixing portion (32) is configured to abut against the perineum of a human body and the skin from the perineum to the anus when the drainage tube body (1) is inserted into the rectum, and the second fixing portion (33) is configured to abut against the tip of the coccyx of a human body and the skin from the tip of the coccyx to the anus when the drainage tube body (1) is inserted into the rectum.

14. The drainage device according to claim 5, characterized in that: Also includes: a first flushing and drug injection tube (51), at least partly located inside the tube wall of the drainage tube body (1), the first flushing and drug injection tube (51) comprising a third annular tube section (51a) and a third straight tube section (51b), the third annular tube section (51a) being located on a side of the drainage tube body (1) away from the external fixing seat (3), the third straight tube section (51b) being connected to the third annular tube section (51a) and extending along the axial direction of the drainage tube body (1); A second flushing and injection tube (52) comprising a fifth portion (52a) located inside the outer fixing seat (3) and connected to the third straight tube section (51b), and a sixth portion (52b) connected to the fifth portion (52a) and led outward from the outer fixing seat (3); The third annular pipe section (51a) is provided with a plurality of openings (54) along the circumferential direction, and the plurality of openings (54) are configured to spray flushing liquid or liquid medicine outward.

15. The drainage device according to claim 14, characterized in that: The external fixing seat (3) comprises: a tube body connecting portion (31) connected to the drainage tube body (1), and a first fixing portion (32) and a second fixing portion (33) respectively connected to both sides of the tube body connecting portion (31) in the longitudinal direction; the second flushing and injection tube (52), the second filling tube (24) and the fourth filling tube (26) are all led outward at an end of the first fixing portion (32) on a side away from the tube body connecting portion (31).

16. The drainage device according to claim 1, characterized in that: The position of the external fixing seat (3) relative to the drainage tube body (1) in the axial direction of the drainage tube body (1) is adjustable.

17. The drainage device according to claim 1, characterized in that: The length of the drainage tube body (1) is 50-60 mm, and / or the inner diameter of the drainage tube body (1) is 15 mm, and / or the wall thickness of the drainage tube body (1) is 1.5 mm.

18. The drainage device according to claim 1, characterized in that: The airbag assembly (2) is located at the end of the drainage tube body (1) along the first axial side, and the airbag assembly (2) is at least flush with the end of the drainage tube body (1) or exceeds the end of the drainage tube body (1) in an expanded state.

19. The drainage device according to claim 1, characterized in that: The external fixing seat (3) is located at the end of the drainage tube body (1) on the second side along the axial direction, and the second side end of the drainage tube body (1) does not extend beyond the farthest end of the side of the external fixing seat (3) away from the airbag assembly (2) along the axial direction.

20. The drainage device according to claim 1, characterized in that The material of the external fixing seat (3) is transparent.

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