A drainage device with a bypass sampling interface and a sampling method

Abstract

The drainage device with a bypass sampling interface comprises a tee pipe, a valve, a liquid collecting bag and a self-sealing unit, the tee pipe comprises a first conduit, a second conduit and a third conduit which are communicated with each other, the valve comprises a first valve, a second valve and a third valve, the first valve is arranged in the first conduit, the second valve and the liquid collecting bag are arranged in the second conduit in sequence in the direction away from the first valve, the self-sealing unit and the third valve are arranged in the third conduit, and the third valve is closer to the first conduit than the self-sealing unit. The present application can prevent the drainage liquid from flowing back to the body, prevent the drainage liquid in the liquid collecting bag from flowing back to the sampling channel, prevent the drainage liquid in the sampling channel from flowing back, and further realize the prevention of body infection and the prevention of detection sample pollution. In addition, the present application realizes the whole sampling process in a closed system through the arrangement of the self-sealing unit and the sample pipe structure, avoids the contact with the environment air, improves the anti-infection reliability. At the same time, the present application can realize the instant sampling of the sample and the reliable reaction of the instant sample state.

Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to a drainage device and sampling method with a bypass sampling interface. Background Technology

[0002] Drainage bags are mainly used for the drainage and collection of urine and postoperative wound fluids, and are the most commonly used medical consumables in clinical practice. Existing drainage bags have a simple structure, mainly including a drainage interface, a collection bag, and a drain outlet. Clinically, there are often medical orders to collect drainage fluid samples for testing, but there are few in-depth and reasonable designs for drainage bags. The common clinical procedures are: (1) Medical staff disinfect the drain outlet with a cotton swab, take a sterile container to collect the drainage fluid from the drain outlet, and then use a syringe to draw the drainage fluid into a sterile culture bottle / closed container; (2) Medical staff disinfect the catheter with a cotton swab, use a sterile syringe to pierce the catheter to draw the drainage fluid into a sterile culture bottle / closed container. Both of the above common methods have the risk of increasing the infection of the drainage bag, which usually requires increasing the frequency of drainage bag replacement, increasing the workload of medical staff, the amount of drainage bags used and discarded, and the medical expenses and discomfort of patients. In addition, the above two procedures inevitably expose the collected samples to air, increasing the risk of contamination of the test samples. For example, postoperatively, patients in general surgery and hepatobiliary departments require the collection of peritoneal and pelvic fluid for culture to determine the presence of infection and the appropriate antibiotic regimen. If the samples are contaminated during collection, the culture results will be distorted, interfering with clinical diagnosis and treatment. Furthermore, the method suffers from the problem that the composition of accumulated body fluids varies, failing to reflect the immediate state of the sample.

[0003] Chinese patent ZL 201821896770.9 discloses a disposable drainage bag for easy specimen collection, which avoids multiple punctures by adding a sampling port to the drainage interface, collection bag, and drain port. Chinese patent ZL202211425064.7 discloses a neurosurgical lumbar cistern drainage device, which adds a sampling tube with a rotary valve to the front end of the collection bag. Although these patents add an extra sampling port, the problem of sampling contamination cannot be effectively avoided.

[0004] The invention of a drainage bag with a simple and reasonable structure, convenient operation, effective reduction of sampling contamination and drainage bag infection, reduced replacement frequency, and the ability to collect immediate drainage fluid has important clinical application value. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a drainage device with a bypass sampling interface and its usage method, which solves the problems of easy infection when sampling with drainage bags, frequent replacement of drainage bags after multiple samplings, heavy workload of medical staff, large amount of discarded drainage bags, high medical costs for patients, and inability of sampling to reflect the real-time sample status.

[0006] The first aspect of the present invention provides a drainage device with a bypass sampling interface, comprising a three-way tube, a valve, a collection bag, and a self-sealing unit. The three-way tube includes a first conduit, a second conduit, and a third conduit that are interconnected. The valve includes a first valve, a second valve, and a third valve. The first valve is disposed on the first conduit. The second valve and the collection bag are sequentially disposed on the second conduit in a direction away from the first valve. The self-sealing unit and the third valve are disposed on the third conduit. The third valve is closer to the first conduit than the self-sealing unit.

[0007] Preferably, the collection bag further includes a drain outlet, which is located at the end of the collection bag away from the second valve;

[0008] And / or, the collection bag is provided with graduations.

[0009] Preferably, the valve is a Tesla valve;

[0010] And / or, the drain outlet includes a rotary valve and a fourth valve, the rotary valve being connected to one end of the collection bag distal to the second conduit, and the fourth valve being connected to the rotary valve;

[0011] And / or, it also includes a first water-stop clamp, the first water-stop clamp being disposed on the second conduit, and the first water-stop clamp being closer to the first conduit than the collection bag;

[0012] And / or, it also includes a second water-stop clamp, which is disposed on the third conduit and is closer to the first conduit than the third valve.

[0013] Preferably, the first valve and / or the second valve each include a first inner tube and a plurality of first valve cores, the first inner tube is connected to the first conduit, and the first valve cores are disposed on the outer wall of the first inner tube and penetrate the first inner tube;

[0014] And / or, the third valve includes a second outer tube, a second inner tube and a plurality of second valve cores, wherein the second outer tube is sleeved on the outer wall of the second valve cores and the second valve cores are disposed on the outer wall of the second inner tube and communicate with the second inner tube;

[0015] And / or, it also includes a sample tube disposed at the end of the self-sealing unit away from the second valve;

[0016] And / or, the fourth valve is a Tesla valve.

[0017] Preferably, the second outer tube and / or the second valve core are elastic;

[0018] And / or, the first valve core and the second valve core are hollow.

[0019] Preferably, the self-sealing unit includes a first self-sealing part and a second self-sealing part. The first self-sealing part includes a connector, a first fixing member, and a first elastic valve. The connector communicates with the end of the third conduit away from the first conduit. The first elastic valve is located at the end of the connector away from the first conduit and has a first hole inside the connector. The second self-sealing part includes a second elastic valve and a second fixing member. The second elastic valve is located at the end of the sample tube near the first elastic valve and has a second hole inside the sample tube. The first fixing member matches the second fixing member, and the first elastic valve matches the second elastic valve.

[0020] Preferably, the first and second fixing members are movably connected, preferably by a threaded connection or a snap-fit ​​connection;

[0021] And / or, the connector includes a first extension, the first extension being disposed on the connector distal to the first conduit end and extending toward the center of the connector;

[0022] And / or, the sample tube includes a second extension, which is disposed near the first conduit end of the sample tube and extends toward the center of the sample tube;

[0023] And / or, the first resilient valve is movably connected to the connecting member;

[0024] And / or, the second resilient valve is movably connected to the sample tube.

[0025] Preferably, the first elastic valve includes a first plug body and a first plug cap. The first plug body is hollow, and the first plug body and the first plug cap are connected through the first hole. The first plug body is located on the side of the first extension member close to the sample tube, and the first plug cap is located on the side of the first extension member away from the sample tube.

[0026] And / or, the second resilient valve includes a second plug body and a second plug cap, the second plug body is hollow, the second plug body and the second plug cap are connected through the second hole, the second plug body is disposed on the side of the second extension member close to the connector, and the second plug cap is disposed on the side of the second extension member away from the connector.

[0027] Preferably, the first plug and / or the second plug are provided with springs;

[0028] And / or, the outer wall of the connector is provided with a first sealing member, and when the first elastic valve is connected to the second elastic valve, the first sealing member is connected to the first elastic valve;

[0029] And / or, a second sealing element is provided on the outer wall of the sample tube, and when the first elastic valve is connected to the second elastic valve, the second sealing element is connected to the second elastic valve.

[0030] A second aspect of the present invention provides a sampling method that uses the aforementioned diversion device with a bypass sampling interface for sampling.

[0031] The present invention has at least one of the following beneficial technical effects:

[0032] (1) This invention prevents the drainage fluid from flowing back into the body, the drainage fluid in the collection bag from flowing back into the sampling channel, and the drainage fluid in the sampling channel from flowing back into the body by setting a three-way tube combined with a Tesla valve, thereby preventing infection in the body and preventing contamination of the test sample. At the same time, it can realize real-time sample sampling and reliably reflect the real-time sample status.

[0033] (2) This invention enables the entire sampling process to be carried out in a closed system by setting a self-sealing unit and sample tube structure, avoiding contact with ambient air and improving the reliability of infection prevention; the device has a simple and ingenious structure, strong practicality, outstanding anti-pollution performance, and is convenient for multiple sampling without contamination, which can effectively control the occurrence of nosocomial infections; thus, it can significantly reduce the amount of disposable drainage bags used in existing clinical practice, alleviate patient pain, save physicians' labor, reduce medical costs, and has important value in clinical promotion and application. Attached Figure Description

[0034] Figure 1 This is a schematic diagram of the drainage bag with a bypass sampling interface.

[0035] Figure 2 This is a cross-sectional view of the first self-sealing part, the second self-sealing part, and the sample tube of the present invention before they are connected.

[0036] Figure 3 This is a cross-sectional view showing the first self-sealing part, the second self-sealing part, and the sample tube of the present invention before they are fully connected.

[0037] Figure 4 This is a schematic diagram of the structure of the first valve and the second valve of the present invention.

[0038] Figure 5 This is a schematic diagram of the structure of the third valve of the present invention.

[0039] Figure 6 This is a schematic diagram of the fluid velocity within the valve structure of the present invention.

[0040] Explanation of icon numbers:

[0041] 1. Liquid collection bag;

[0042] 2. Self-sealing unit;

[0043] 21. The First Self-Proclaimed Department;

[0044] 211. Connecting parts;

[0045] 212. First fastener;

[0046] 213. First resilient valve;

[0047] 2131. First plug body;

[0048] 2132. First cap;

[0049] 22. The Second Self-Proclaimed Department;

[0050] 221. Second resilient valve;

[0051] 2211. Second plug body;

[0052] 2212, Second cap;

[0053] 222. Second fastener;

[0054] 3. First catheter;

[0055] 4. Second catheter;

[0056] 5. Third catheter;

[0057] 6. First valve;

[0058] 7. Second valve;

[0059] 8. Third valve;

[0060] 9. Drainage port;

[0061] 10. First water-stop clamp;

[0062] 11. Second waterstop clamp;

[0063] 12. Second outer tube;

[0064] 13. Second valve core;

[0065] 14. Sample tubes;

[0066] 15. First hole;

[0067] 16. Second hole;

[0068] 17. First extension component;

[0069] 18. Second extension piece;

[0070] 19. First sealing component;

[0071] 20. Second sealing component;

[0072] 25. First inner tube;

[0073] 23. First valve core;

[0074] 24. Second inner tube. Detailed Implementation

[0075] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0076] It should be noted that the process equipment or apparatus not specifically mentioned in the following embodiments are all conventional equipment or apparatus in the art.

[0077] like Figure 1-6 The described drainage device with a bypass sampling interface includes a three-way pipe, a valve, a collection bag 1, and a self-sealing unit 2. The three-way pipe includes a first conduit 3, a second conduit 4, and a third conduit 5 that are interconnected. The valve includes a first valve 6, a second valve 7, and a third valve 8. The first valve 6 is located on the first conduit 3. The second valve 7 and the collection bag 1 are sequentially located on the second conduit 4 in a direction away from the first valve 6. The self-sealing unit 2 and the third valve are located on the third conduit 5. The third valve 8 is closer to the first conduit 3 than the self-sealing unit 2.

[0078] In a preferred embodiment, the collection bag 1 further includes a drain port 9, which is located at the end of the collection bag 1 away from the second valve 7. The drain port 9 includes a rotary valve and a fourth valve. The rotary valve is connected to the end of the collection bag 1 away from the second conduit 4, and the fourth valve is connected to the rotary valve. The fourth valve is a Tesla valve. The collection bag 1 is marked with graduations. The collection bag 1 is used to continuously receive large volumes of drainage fluid. The drain port 9 is used to drain fluid when the collection bag 1 is full or when drainage is necessary as prescribed by the doctor, following the principle of minimizing the number of drainages.

[0079] In a preferred embodiment, the valve is a Tesla valve. The first valve 6 and the second valve 7 each include a first inner tube 25 and a plurality of first valve cores 23. The first inner tube 25 communicates with the first conduit 3. The first valve cores 23 are disposed on the outer wall of the first inner tube 25 and penetrate the first inner tube 25. The distance between the first valve cores 23 and the first inner tube 25 gradually decreases along the direction of fluid flow. The plurality of first valve cores 23 are cyclically disposed on the first inner tube 25. Figure 6As shown, when fluid flows forward through the Tesla valve, it splits into two paths at each return port, and then the two paths converge at the next junction, achieving acceleration. Conversely, if fluid flows backward into the Tesla valve, it also splits into two paths at the first junction and converges again at the second junction. The difference is that when flowing backward, the two paths flow in opposite directions, creating significant resistance. Therefore, the Tesla valve can only allow forward flow and makes reverse flow difficult, thus preventing backflow of the drainage fluid in the sampling channel.

[0080] In a preferred embodiment, the third valve 8 includes a second outer tube 12, a second inner tube 24, and a plurality of second valve cores 13. The second outer tube 12 is sleeved on the outer wall of the second valve cores 13, and the second valve cores 13 are disposed on the outer wall of the second inner tube 24 and communicate with the second inner tube 24. The distance between the second valve cores 13 and the second inner tube 24 gradually decreases along the direction of fluid flow. The second outer tube 12 and / or the second valve cores 13 are elastic. The second outer tube 12 is made of rubber. When squeezed from the end with a large cross-sectional area to the end with a small cross-sectional area, all the internal liquid can be squeezed out. When the squeezing is removed, it returns to its original shape. The second valve cores 13 are symmetrically distributed about the second inner tube 24 as an axis of symmetry. The second valve cores 13 are hollow. The second valve cores 13 are circulated in the second outer tube 12. The number of valve cores 13 in circulation, the diameter of the second outer tube 12, and the bending angle of the second valve cores 13 can be flexibly designed to adapt to different drainage scenarios. The Tesla valve does not deform under pressure during normal use and can ensure unidirectional fluid movement.

[0081] In a preferred embodiment, the system further includes a first water-stop clamp 10, which is disposed on the second conduit 4 and is closer to the first conduit 3 than the collection bag 1. The system also includes a second water-stop clamp 11, which is disposed on the third conduit 5 and is closer to the first conduit 3 than the third valve 8. The first water-stop clamp 10 and the second water-stop clamp 11 are used to flexibly control the complete opening or complete closing of the conduit channel.

[0082] In a preferred embodiment, a sample tube 14 is also included, which is located at the end of the self-sealing unit 2 away from the second valve 7, and the sample tube 14 has a cavity inside.

[0083] In a preferred embodiment, the self-sealing unit 2 includes a first self-sealing part 21 and a second self-sealing part 22. The first self-sealing part 21 includes a connector 211, a first fixing member 212, and a first elastic valve 213. The connector 211 communicates with the end of the third conduit 5 away from the first conduit 3. The first elastic valve 213 is provided at the end of the connector 211 away from the first conduit 3. The first elastic valve 213 is provided with a first hole 15, and the first hole 15 is located inside the connector 211. The second self-sealing part 22 includes a second elastic valve 221 and a second fixing member 222. The second elastic valve 221 is located at one end of the sample tube 14 near the first elastic valve 213. The second elastic valve 221 is provided with a second hole 16, and the second hole 16 is located inside the sample tube 14. The first fixing member 212 matches the second fixing member 222, and the first elastic valve 213 matches the second elastic valve 221. The matching refers to the corresponding shape, size, and positional relationship.

[0084] In a preferred embodiment, the first fixing member 212 and the second fixing member 222 are movably connected, preferably by a threaded connection or a snap-fit ​​connection, the first elastic valve 213 is movably connected to the connecting member 211, and the second elastic valve 221 is movably connected to the sample tube 14.

[0085] In a preferred embodiment, the connector 211 includes a first extension 17, which is disposed at the end of the connector 211 away from the first catheter 3 and extends toward the center of the connector 211, and the sample tube 14 includes a second extension 18, which is disposed at the end of the sample tube 14 near the first catheter 3 and extends toward the center of the sample tube 14.

[0086] In a preferred embodiment, the first elastic valve 213 includes a first plug 2131 and a first plug cap 2132. The first plug 2131 is hollow, and the first plug 2131 and the first plug cap 2132 are connected through the first hole 15. The first plug 2131 is located on the side of the first extension 17 near the sample tube 14, and the first plug cap 2132 is located on the side of the first extension 17 away from the sample tube 14. The second elastic valve 221 includes a second plug 2211 and a second plug cap 2212. The second plug 2211 is hollow, and the second plug 2211 and the second plug cap 2212 are connected through the second hole 16. The second plug 2211 is located on the side of the second extension 18 near the connector 211, and the second plug cap 2212 is located on the side of the second extension 18 away from the connector 211.

[0087] In a preferred embodiment, the first plug 2131 and / or the second plug 2211 are provided with springs;

[0088] In a preferred embodiment, the outer wall of the connector 211 is provided with a first sealing member 19. When the first elastic valve 213 is connected to the second elastic valve 221, the first sealing member 19 is connected to the first elastic valve 213. The outer wall of the sample tube 14 is provided with a second sealing member 20. When the first elastic valve 213 is connected to the second elastic valve 221, the second sealing member 20 is connected to the second elastic valve 221.

[0089] Example 1

[0090] The method for sampling using the diversion device with bypass sampling interface of the present invention includes the following steps:

[0091] (1) In the initial state, the first water-stopping clamp 10 and the second water-stopping clamp 11 completely close the channel, the first self-sealing part 21 and the second self-sealing part 22 are not connected, there is no air in the liquid collection bag 1 and the first conduit 3, the second conduit 4 and the third conduit 5, and the whole device is kept under negative pressure.

[0092] (2) Connect the first catheter 3 to the patient's bladder, open the first stop clamp 10, and the drainage fluid enters the collection bag 1 through the first valve 6 and the second valve 7;

[0093] (3) At the designated time when clinical sampling is required, close the first stop clamp 10 and open the second stop clamp 11 to allow about 20 mL of drainage fluid to enter the third catheter 5;

[0094] (4) Close the second water-stop clamp 11 and open the first water-stop clamp 10;

[0095] (5) Disinfect the self-sealing unit 2 and sample tube 14 with alcohol respectively;

[0096] (6) Tighten and connect the first self-sealing part 21 and the second self-sealing part 22;

[0097] (7) Manually squeeze the drainage fluid in the third conduit 5 in step (3) along the third valve 8 towards the first conduit 3 and away from the first conduit 3 so that all the drainage fluid completely enters the sample tube 14;

[0098] (8) Separate the first self-sealing part 21 and the second self-sealing part 22 to complete one sample collection;

[0099] (9) Continue to take samples at the designated time when clinical sampling is required, take a new sample tube 14, and repeat steps (3) to (8).

[0100] The above embodiments are merely illustrative of the principles and effects of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in the present invention should still be covered by the claims of the present invention.

Claims

1. A drainage device with a bypass sampling interface, characterized in that, The device includes a three-way pipe, a valve, a collection bag (1), and a self-sealing unit (2). The three-way pipe includes a first conduit (3), a second conduit (4), and a third conduit (5) that are interconnected. The valve includes a first valve (6), a second valve (7), and a third valve (8). The first valve (6) is located on the first conduit (3). The second valve (7) and the collection bag (1) are sequentially located on the second conduit (4) in a direction away from the first valve (6). The third valve (8) and the self-sealing unit (2) are located on the third conduit (5). The third valve (8) is closer to the first conduit (3) than the self-sealing unit (2). The third valve (8) includes a second outer tube (12), a second inner tube (24) and a plurality of second valve cores (13). The second outer tube (12) is sleeved on the outer wall of the second valve core (13), and the second valve core (13) is disposed on the outer wall of the second inner tube (24) and communicates with the second inner tube (24). It also includes a sample tube (14), which is located at the end of the self-sealing unit (2) away from the third valve (8); The third valve (8) can push the drainage fluid in the third conduit (5) into the sample tube (14) by external force. The self-sealing unit (2) includes a first self-sealing part (21) and a second self-sealing part (22). The first self-sealing part (21) includes a connector (211), a first fixing part (212), and a first elastic valve (213). The connector (211) is connected to the end of the third conduit (5) away from the first conduit (3). The first elastic valve (213) is located at the end of the connector (211) away from the first conduit (3). The first elastic valve (213) has a first hole (15), and the first hole (15) is located on the connector. (211) Inside, the second self-sealing part (22) includes a second elastic valve (221) and a second fixing member (222). The second elastic valve (221) is located at one end of the sample tube (14) near the first elastic valve (213). The second elastic valve (221) is provided with a second hole (16). The second hole (16) is located inside the sample tube (14). The first fixing member (212) matches the second fixing member (222). The first elastic valve (213) matches the second elastic valve (221).

2. The drainage device with a bypass sampling interface according to claim 1, characterized in that, The collection bag (1) also includes a drain port (9), which is located at the end of the collection bag (1) away from the second valve (7); The liquid collection bag (1) is marked with graduations.

3. The drainage device with a bypass sampling interface according to claim 2, characterized in that, The valve is a Tesla valve; The drain port (9) is provided with a rotary valve and a fourth valve. The rotary valve is connected to one end of the collection bag (1) far from the second conduit (4). The fourth valve is connected to the rotary valve. It also includes a first water-stop clamp (10), which is disposed on the second conduit (4), and the first water-stop clamp (10) is closer to the first conduit (3) than the collection bag (1); It also includes a second water-stop clamp (11), which is located on the third conduit (5) and is closer to the first conduit (3) than the third valve (8).

4. The drainage device with a bypass sampling interface according to claim 3, characterized in that, The first valve (6) and the second valve (7) respectively include a first inner tube (25) and a plurality of first valve cores (23). The first inner tube (25) is connected to the first conduit (3). The first valve cores (23) are disposed on the outer wall of the first inner tube (25) and penetrate the first inner tube (25).

5. The drainage device with a bypass sampling interface according to claim 3, characterized in that, The fourth valve is a Tesla valve.

6. The drainage device with a bypass sampling interface according to claim 4, characterized in that, The second outer tube (12) and the second valve core (13) are elastic; The first valve core (23) and the second valve core (13) are hollow.

7. The drainage device with a bypass sampling interface according to claim 1, characterized in that, The first fixing member (212) and the second fixing member (222) are threaded or snap-fitted; The connector (211) includes a first extension (17) which is located at the end of the connector (211) away from the first conduit (3) and extends toward the center of the connector (211); The sample tube (14) includes a second extension (18), which is located near the end of the first conduit (3) and extends toward the center of the sample tube (14). The first elastic valve (213) and the connecting member (211) are movably connected; The second elastic valve (221) is movably connected to the sample tube (14).

8. The drainage device with a bypass sampling interface according to claim 7, characterized in that, The first elastic valve (213) includes a first plug body (2131) and a first plug cap (2132). The first plug body (2131) is hollow. The first plug body (2131) and the first plug cap (2132) are connected through the first hole (15). The first plug body (2131) is located on the side of the first extension (17) close to the sample tube (14), and the first plug cap (2132) is located on the side of the first extension (17) away from the sample tube (14). The second elastic valve (221) includes a second plug body (2211) and a second plug cap (2212). The second plug body (2211) is hollow. The second plug body (2211) and the second plug cap (2212) are connected through the second hole (16). The second plug body (2211) is located on the side of the second extension (18) close to the connector (211), and the second plug cap (2212) is located on the side of the second extension (18) away from the connector (211).

9. The drainage device with a bypass sampling interface according to claim 8, characterized in that, Springs are provided inside the first plug (2131) and the second plug (2211); The outer wall of the connector (211) is provided with a first sealing member (19). When the first elastic valve (213) is connected to the second elastic valve (221), the first sealing member (19) is connected to the first elastic valve (213). The sample tube (14) is provided with a second sealing member (20) on its outer wall. When the first elastic valve (213) is connected to the second elastic valve (221), the second sealing member (20) is connected to the second elastic valve (221).

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