Simple rectum leakage test capsule tube
By designing a simple rectal leak test balloon tube, which uses an air balloon to seal the upper rectum, injects gas or diluent into the inner catheter, and adjusts the pressure with a pressure relief valve in the middle, the risks of airtightness and damage in existing testing methods are solved, and a safe and efficient rectal leak test is achieved.
Patent Information
- Application Number
- CN202423048279.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-10
- Publication Date
- 2026-01-23
- Estimated Expiration
- 2034-12-10
AI Technical Summary
Existing rectal leakage testing methods, which involve directly injecting air with a syringe, have issues such as the inability to completely seal the upper part of the intestine, the risk of intestinal damage, and gas reflux.
A simple rectal leakage test balloon tube was designed, including an outer catheter, a balloon, a first connector, a central pressure relief valve, and an inner catheter. The balloon is used to block the upper part of the rectum, and the inner catheter injects gas or diluent into the rectum. The central pressure relief valve adjusts the pressure of the balloon to prevent overpressure.
It enables effective sealing of the upper intestinal segment in rectal leakage tests, reduces the amount of gas or diluent used, protects the upper intestinal segment, prevents balloon rupture, and improves test safety and accuracy.
Smart Images

Figure CN223817547U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to a simple rectal leakage test capsule, belonging to the field of rectal leakage test technology. Background Technology
[0002] The rectal leak test is a method used to assess the integrity of anastomoses after intestinal surgery, commonly used to detect leaks at the anastomosis site after rectal or colonic surgery. This test can promptly identify postoperative anastomotic defects, preventing serious infections or peritonitis. Current testing methods involve inflating the rectum with air or instilling diluted methylene blue solution through the anus. The methylene blue instillation test is more effective; it involves instilling a diluted methylene blue solution into the rectum and closely observing for any blue liquid leaking into the abdominal cavity or other areas. If there is a problem with the anastomosis or a leak, the blue solution will seep out from the leak site, allowing observation to determine if fluid has appeared in the abdominal cavity.
[0003] Currently, air is often injected directly into the anus using a syringe, but this method has many drawbacks. First, it requires pressing on the intestines within the abdominal cavity, especially under laparoscopy, which often fails to completely seal the upper intestinal segment, causing air to flow into the upper intestinal segment and making it impossible to complete the rectal leakage test. Second, if too much gas is injected into the upper intestinal segment during this process, there is a risk of intestinal damage. Third, because the syringe needs to be withdrawn from the anus and re-injected multiple times, gas can reflux.
[0004] Therefore, a simple rectal leakage test balloon tube was designed. It can block air or methylene blue dilution in the rectal segment through the set balloon, while the air or methylene blue dilution remains in the rectal segment. This can not only complete the rectal leakage test, but also protect the upper part of the intestine from damage. Summary of the Invention
[0005] The technical problem to be solved by this utility model is to provide a simple rectal leakage test capsule, which solves the problems existing in the current rectal leakage test by directly using a syringe.
[0006] The technical problem to be solved by this utility model is achieved by the following technical solution:
[0007] A simple rectal leakage test balloon tube includes an outer catheter, a balloon sealed and fixed at the proximal end of the outer catheter, an air inlet for inflating the balloon at the proximal end of the outer catheter, and also includes a first connector, a central pressure relief valve, a second connector, and an inner catheter.
[0008] The first connector is connected to the distal end of the external catheter via a trachea and a central pressure relief valve in sequence.
[0009] The central pressure relief valve consists of a cylindrical shell, a hollow valve stem, a valve core, a spring, and a hollow adjusting knob.
[0010] The cylindrical shell has a sealed end at one end and an open end at the other. The sealed end has a connecting pipe in the middle that communicates with the distal end of the external conduit. The sealed end also has an exhaust hole that surrounds the connecting pipe and communicates with the outside. A valve core is fixed at one end of the hollow valve stem. The valve core is inserted into the cylindrical shell from the opening and completely seals the connecting pipe opening and the exhaust hole. A spring is sleeved on the valve stem. By screwing the hollow adjustment knob into the cylindrical shell, the spring is compressed, and the valve core is tightly closed with the connecting pipe opening and the exhaust hole. The hollow part of the hollow valve stem connects the first one-way valve and the connecting pipe.
[0011] The second connector is connected to the distal end of the inner catheter;
[0012] The inner catheter is inserted into the outer catheter, and the distal ends of the inner and outer catheters are sealed and fixed. The proximal end of the inner catheter passes through the wall of the outer catheter and communicates with the inside of the rectum.
[0013] In one embodiment of this application, a semi-circular end cap is sealed and fixed at the proximal end of the external catheter.
[0014] In one embodiment of this application, a first check valve is connected between the first connector and the central pressure relief valve. The first check valve only allows external fluid to enter from the first connector toward the central pressure relief valve.
[0015] In one embodiment of this application, the distal end of the internal catheter is connected to a second one-way valve, which only allows fluid to flow from the second connector toward the inside of the rectum.
[0016] In one embodiment of this application, the outer wall of the hollow adjustment knob is provided with a scale indicating the pressure relief value.
[0017] In one embodiment of this application, the valve core is a rubber valve core.
[0018] In one embodiment of this application, both the outer and inner catheters are made of flexible transparent plastic tubing.
[0019] The beneficial effects of this invention are as follows: the inflatable airbag can block the upper part of the rectum, and air or methylene blue dilution can be injected into the rectum through an internal catheter. The airbag can prevent the air or methylene blue dilution from flowing upward, and the rectal leakage test can be completed with less air or methylene blue dilution. The central pressure relief valve can adjust the pressure value of the airbag, preventing blind inflation of the airbag, which could cause the airbag to explode and rupture, damaging the rectum. After the test is completed, the central pressure relief valve can be manually deflated quickly, shrinking the airbag and retracting it. Attached Figure Description
[0020] Figure 1 This is a schematic diagram of the structure of one embodiment of the present utility model;
[0021] Figure 2 This is a schematic diagram of another embodiment of the present invention;
[0022] Figure 3 This is a schematic diagram of the external structure of the first connector, air pipe, first one-way valve, and central pressure relief valve;
[0023] Figure 4 This is a schematic diagram of the internal structure of the first connector, air pipe, first check valve, and central pressure relief valve.
[0024] Figure 5 This is a schematic diagram of one embodiment of a quick-plug structure.
[0025] In the diagram: 1. Rectum; 101. Anus; 2. External catheter; 201. Air inlet; 202. Semi-circular end cap; 3. Airbag; 4. First connector; 5. Central pressure relief valve; 501. Cylindrical shell; 502. Hollow valve stem; 503. Valve core; 504. Spring; 505. Hollow adjustment knob; 506. Connecting pipe; 507. Exhaust port; 508. Scale; 509. Hollow part; 6. Second connector; 7. Internal catheter; 701. Proximal port; 8. First one-way valve; 9. Second one-way valve; 10. Annular toothed groove; 11. Inner sleeve; 12. Outer sleeve; 13. Trachea. Detailed Implementation
[0026] To facilitate a clear understanding of the technical means, creative features, objectives, and effects of this utility model, the following description, in conjunction with specific illustrations, further elaborates on this utility model.
[0027] In this article, "proximal" refers to the end closer to the body, and "distal" refers to the end farther from the body. Specifically, the proximal end refers to the end inserted into the rectum 1, and the distal end refers to the end operated on by medical personnel.
[0028] like Figure 1 As shown, this simplified rectal leakage test balloon includes an outer catheter 2, which is made of medical-grade plastic tubing. An air bladder 3 is sealed and fixed to the proximal end of the outer catheter 2. An air inlet 201 for inflating the air bladder 3 is located at the proximal end of the outer catheter 2. It also includes a first connector 4, a central pressure relief valve 5, a second connector 6, and an inner catheter 7. The first connector 4 is sequentially connected to the distal end of the outer catheter 2 via a trachea 13 and the central pressure relief valve 5. The outer catheter 2, inner catheter 7, and trachea 13 are all made of flexible plastic tubing, such as polyvinyl chloride (PVC), polyurethane (PU), or silicone rubber. The first connector 4 and the second connector 6 use a quick-connect structure compatible with commercially available syringe syringe connectors.
[0029] The second connector 6 is connected to the distal end of the inner catheter 7. The inner catheter 7 is inserted into the outer catheter 2, and the inner catheter 7 and the distal end of the outer catheter 2 are sealed and fixed. The proximal port 701 of the inner catheter 7 passes through the wall of the outer catheter 2 and communicates with the inside of the rectum 1. The wall of the outer catheter 2 has an opening that allows the proximal port 701 to be fixed. The proximal port 701 and the opening in the wall of the outer catheter 2 are sealed and fixed with adhesive. The opening of the proximal port 701 is exposed in the rectum 1, and methylene blue dilution is injected into the rectum 1 through the proximal port 701.
[0030] During use, position the patient's anus 101 slightly above the upper part of the rectum 1. Medical staff insert the proximal end of the external catheter 2 containing the balloon 3 into the upper part of the patient's rectum 1, and the patient's anus 101 clamps the external catheter 2. At this time, the first connector 4, the central pressure relief valve 5, and the second connector 6 are located outside the patient's anus 101. Medical staff use a syringe connected to the first connector 4 and the second connector 6 to inflate the balloon 3 and the rectum 1 with gas and methylene blue diluent, respectively. The methylene blue diluent is injected into the rectum 1 and the gas is expelled through the anus 101 until the rectum 1 is completely filled with methylene blue diluent. The methylene blue diluent will then be squeezed out from the patient's anus 101. If there is a leak at the rectal anastomosis, the blue methylene blue diluent solution will also seep out from the leak site. Observation can determine whether there is fluid in the abdominal cavity: if blue fluid seeps out, there is a leak in the rectum 1; if no blue fluid seeps out, it indicates that the anastomosis of the rectum 1 surgery is good.
[0031] The methylene blue solution mentioned in this article that was injected into the rectum 1 can also be replaced by gas (air). Observe whether air bubbles are generated at the anastomosis site: if there are air bubbles, it indicates a leak; if there are no air bubbles, it indicates that the anastomosis of the rectum 1 surgery is good.
[0032] In one embodiment, to facilitate smoother insertion of the balloon 3 into the rectum 1, a semi-circular end cap 202 is sealed and fixed at the proximal end of the external catheter 2. The semi-circular end cap 202 prevents damage to the inner wall of the rectum 1. Before insertion into the rectum 1, lubricant is applied to the semi-circular end cap 202, the outer wall of the balloon 3, and the external catheter 2.
[0033] like Figure 2 As shown, in order for the airbag 3 to provide stable support, a first one-way valve 8 is installed, allowing only inflow and no outflow. This way, once the airbag 3 is injected with the appropriate pressure, the first connector 4 can be disconnected.
[0034] In one embodiment, the first check valve 8 can be configured as follows:
[0035] A first check valve 8 is connected between the first connector 4 and the central pressure relief valve 5. The first check valve 8 only allows external fluid to enter from the first connector 4 towards the central pressure relief valve 5.
[0036] Connect the syringe to the first connector 4 and inflate the air bladder 3, causing it to gradually expand. If the syringe capacity is too small, disconnect the first connector 4 to allow the syringe to re-inflate. Once fully inflated, reconnect the syringe to the first connector 4 and inflate the air bladder 3. Repeat this process several times until the air bladder 3 reaches the appropriate pressure. During this process, due to the presence of the first one-way valve 8, when the syringe is disconnected from the first connector 4, the first one-way valve 8 blocks the outflow of gas from the air bladder 3.
[0037] like Figure 2 In order to prevent the methylene blue diluent from flowing back through the inner conduit 7 after the syringe is disconnected, a second one-way valve 9 is designed.
[0038] In one embodiment, the second check valve 9 can be configured as follows:
[0039] The distal end of the inner catheter 7 is connected to the second one-way valve 9, which only allows fluid to flow from the second connector 6 toward the inside of the rectum 1.
[0040] Connect the syringe filled with diluted methylene blue solution to the second connector 6 and inject the diluted methylene blue solution into the rectum 1. If the syringe capacity is small, disconnect the second connector 6 to refill the syringe with diluted methylene blue solution. After refilling, reconnect the syringe to the second connector 6 and inject the diluted methylene blue solution into the rectum 1 again. Repeat this process several times until the rectum 1 is filled with diluted methylene blue solution. If there is a problem with the anastomosis or a leak during the rectal 1 surgery, the blue solution will seep out from the leak site. Observation can be used to determine whether there is fluid in the abdominal cavity. During this process, due to the presence of the second one-way valve 9, when the syringe is disconnected from the second connector 6, the second one-way valve 9 blocks the flow of diluted methylene blue solution from the internal catheter 7.
[0041] like Figure 3 , Figure 4 As shown, the central pressure relief valve 5 adopts a central structure, which connects the first connector 4 and the distal end of the outer conduit 2 at both ends of the central pressure relief valve 5. Specifically, in one embodiment, the following structure can be adopted:
[0042] The central pressure relief valve 5 consists of a cylindrical shell 501, a hollow valve stem 502, a valve core 503, a spring 504, and a hollow adjusting knob 505.
[0043] The cylindrical housing 501 has a sealed end at one end and an open end at the other. A connecting pipe 506, communicating with the distal end of the external conduit 2, is located in the middle of the sealed end. An exhaust port 507, surrounding the connecting pipe 506 and communicating with the outside, is also located on the sealed end. A valve core 503 is fixed to one end of the hollow valve stem 502. The valve core 503 is inserted into the cylindrical housing 501 through the opening and completely seals the opening of the connecting pipe 506 and the exhaust port 507. A spring 504 is fitted onto the valve stem. By screwing a hollow adjusting knob 505 into the cylindrical housing 501, the spring 504 is compressed, tightly sealing the valve core 503, the opening of the connecting pipe 506, and the exhaust port 507. The hollow portion 509 of the hollow valve stem 502 connects the first one-way valve 8 and the connecting pipe 506. The cylindrical housing 501 and the hollow valve stem 502 are made of rigid medical plastic. For example, polycarbonate (PC) and polystyrene (PS) materials. Valve core 503 is made of rubber.
[0044] The first connector 4 is connected to the first one-way valve 8 via the trachea 13. The first one-way valve 8 is connected to one end of the hollow valve stem 502, and the other end of the hollow valve stem 502 is connected to the connecting tube 506. At this time, gas is injected into the first connector 4 via a syringe. The gas passes sequentially through the first one-way valve 8, the central pressure relief valve 5, and the external catheter 2, entering the balloon 3 through the air inlet 201. The balloon 3 inflates and compresses the upper part of the rectum 1 until it is blocked. If the pressure of the balloon 3 causes discomfort to the patient, the pressure relief value of the balloon 3 can be reduced by rotating the hollow adjustment knob 505 outwards. Gas exceeding the pressure relief value will push the valve core 503 and be discharged from the exhaust port 507. When the gas in the balloon 3 drops to the set pressure relief value, the gas discharge automatically stops. After the test is completed, the connection between the trachea 13 and the hollow valve stem 502 can be disconnected, allowing the gas to be quickly discharged from the exhaust port 507.
[0045] To ensure more precise adjustment of the pressure relief value, a scale 508 indicating the pressure relief value is provided on the outer wall of the hollow adjustment knob 505. As medical personnel rotate the knob, the hollow adjustment knob 505 extends and retracts within the cylindrical housing 501. The current pressure relief value is marked on the end face of the cylindrical housing 501 where the hollow adjustment knob 505 is located. Users can determine the pressure relief value by observing the scale 508 on the end face of the cylindrical housing 501. If the pressure relief value is exceeded, the central pressure relief valve 5 will automatically release pressure to prevent patient discomfort or overpressure explosion and rupture of the airbag 3, ensuring greater patient safety and comfort.
[0046] The first connector 4, the first one-way valve 8, and the air tube 13 are sealed and fixed with glue, as are the second connector 6, the second one-way valve 9, and the inner tube 7. The air tube 13 and the central pressure relief valve 5, and the central pressure relief valve 5 and the distal end of the outer tube 2 are connected by a quick-connect structure. Specifically, the quick-connect structure adopts an inner sleeve 11 with annular grooves 10 and an outer sleeve 12. The outer sleeve 12 is pressed onto the inner sleeve 11 with annular grooves 10 using an interference fit. The connection strength and sealing strength are much greater than the maximum pressure relief value of the airbag 3.
[0047] The simple central pressure relief valve 5 can be connected in series with the first connector 4 and the first one-way valve 8, which can reduce the number of interfaces required on the external catheter 2. When the airbag 3 is over-inflated and causes slight discomfort to the patient, the air pressure can be easily adjusted and reduced by rotating the hollow adjustment knob 505. When the position of the airbag 3 needs to be adjusted, the airbag 3 can be quickly deflated by pulling the hollow valve rod 502. The segmented series connection structure also facilitates the quick insertion and removal of the first connector 4, the first one-way valve 8, and the central pressure relief valve 5.
[0048] The upper part of the rectum 1 can be blocked using the balloon 3. Air or methylene blue dilution can be injected into the rectum 1 using the inner catheter 7. The balloon 3 can prevent the air or methylene blue dilution from flowing upward, so that less air or methylene blue dilution can be used to complete the rectal 1 leakage test, while also protecting the upper part of the rectum from damage. The central pressure relief valve 5 can adjust the maximum pressure value that the balloon 3 can withstand, preventing the balloon 3 from being blindly inflated, which could cause the balloon 3 to explode and rupture, damaging the rectum 1. After the test is completed, the central pressure relief valve 5 can be manually deflated quickly, shrinking the balloon 3 and retracting it.
[0049] The foregoing has shown and described the basic principles, main features, and advantages of this utility model. Those skilled in the art should understand that this utility model is not limited to the above embodiments. Various changes and modifications can be made to this utility model without departing from its spirit and scope, and all such changes and modifications fall within the scope of protection claimed by this utility model. The scope of protection of this utility model is defined by the appended claims and their equivalents.
Claims
1. A simplified rectal leakage test balloon tube, comprising an outer catheter, wherein a balloon is sealed and fixed at the proximal end of the outer catheter, and an air inlet is provided at the proximal end of the outer catheter for inflating the balloon, characterized in that, It also includes a first connector, a central pressure relief valve, a second connector, and an inner conduit; The first connector is connected to the distal end of the external catheter via a trachea and a central pressure relief valve in sequence. The central pressure relief valve consists of a cylindrical shell, a hollow valve stem, a valve core, a spring, and a hollow adjusting knob. The cylindrical shell has a sealed end at one end and an open end at the other. The sealed end has a connecting pipe in the middle that communicates with the distal end of the external conduit. The sealed end also has an exhaust hole that surrounds the connecting pipe and communicates with the outside. A valve core is fixed at one end of the hollow valve stem. The valve core is inserted into the cylindrical shell from the opening and completely seals the connecting pipe opening and the exhaust hole. A spring is sleeved on the valve stem. By screwing the hollow adjustment knob into the cylindrical shell, the spring is compressed, and the valve core is tightly closed with the connecting pipe opening and the exhaust hole. The hollow part of the hollow valve stem connects the first one-way valve and the connecting pipe. The second connector is connected to the distal end of the inner catheter; The inner catheter is inserted into the outer catheter, and the distal ends of the inner and outer catheters are sealed and fixed. The proximal end of the inner catheter passes through the wall of the outer catheter and communicates with the inside of the rectum.
2. The simplified rectal leakage test balloon tube according to claim 1, characterized in that, The proximal end of the external catheter is sealed and fixed with a semi-circular end cap.
3. The simplified rectal leakage test balloon tube according to claim 1, characterized in that, A first check valve is connected between the first connector and the central pressure relief valve. The first check valve only allows external fluid to enter from the first connector toward the central pressure relief valve.
4. The simplified rectal leakage test balloon tube according to claim 1, characterized in that, The distal end of the inner catheter is connected to a second one-way valve, which only allows fluid to flow from the second connector toward the inside of the rectum.
5. The simplified rectal leakage test balloon tube according to claim 1, characterized in that, The hollow adjustment knob has a scale on its outer wall indicating the pressure relief value.
6. The simplified rectal leakage test balloon tube according to claim 1, characterized in that, The valve core is made of rubber.
7. The simplified rectal leakage test balloon tube according to claim 1, characterized in that, Both the external and internal catheters are made of flexible, transparent plastic tubing.