Peritoneal dialysis solution sterilization temperature monitoring probe bag

By setting an integrated molded infusion tube and sealable exhaust pipe in the peritoneal dialysate sterilization temperature monitoring probe bag, the problem of uneven sterilization temperature caused by the difference in interlayer gas volume is solved, and the stability of the sterilization effect and the convenience of operation are achieved.

CN223068866UActive Publication Date: 2025-07-08HUAREN PHARMA (RIZHAO) CO LTD
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Patent Information

Application Number
CN202421649198.1
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-07-12
Publication Date
2025-07-08
Estimated Expiration
2034-07-12

AI Technical Summary

Technical Problem

The amount of interlayer gas in the existing peritoneal dialysate sterilization temperature monitoring probe bags varies greatly, resulting in uneven sterilization temperature, affecting product quality stability and operation convenience.

Method used

A peritoneal dialysate sterilization temperature monitoring probe bag is designed, and the medicine liquid bag, drainage bag and three-way valve are placed in the outer bag. An integrated infusion pipe and a sealable exhaust pipe are installed. The interlayer gas is discharged through the air pump to ensure that the amount of medicine liquid and interlayer air in each probe bag is consistent. The combined cover and sealing plug are used to ensure air tightness.

Benefits of technology

The uniformity and stability of sterilization temperature are achieved, the consistency of product quality is improved, and the operation is convenient, ensuring the uniformity of sterilization effect and the convenience of use.

✦ Generated by Eureka AI based on patent content.

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Abstract

The utility model belongs to the field of peritoneal dialysis solution production, and particularly relates to a peritoneal dialysis solution sterilization temperature monitoring probe bag which is characterized in that a liquid medicine bag, a drainage bag, a three-way valve and corresponding infusion tubes are all placed in an outer bag, and the liquid medicine bag is provided with a first infusion tube which is integrally formed; the end, located outside the liquid medicine bag, of the first infusion tube is provided with an infusion plug, the outer bag is provided with a first connector opposite to the infusion plug, the position of the first connector corresponds to the infusion plug and the first infusion tube, the end, located outside the outer bag, of the first connector is provided with a combined cover, and the outer bag is provided with a sealable exhaust pipe. The outer bag is connected with a sucking pump through an exhaust pipe; after the structure is adopted, the liquid medicine amount of each sterilization temperature monitoring probe bag and the residual air amount between the sterilization temperature monitoring probe bags and the outer bag interlayer are the same, so that the product sterilization effect at the cold point of the sterilization cabinet is uniform and stable, the temperature in the sterilization heating and cooling process is uniform, and the operation is convenient.
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Description

Technical Field

[0001] The utility model belongs to the field of peritoneal dialysis fluid production, and in particular relates to a peritoneal dialysis fluid sterilization temperature monitoring probe bag. Background Art

[0002] Peritoneal dialysis is a treatment technique that uses the human peritoneum as a semipermeable membrane and the abdominal cavity as an exchange space to remove excess water, metabolites and toxins from the body through diffusion and convection, thereby purifying the blood and replacing kidney function. Peritoneal dialysis is one of the effective renal replacement therapies for acute kidney injury and chronic renal failure, and peritoneal dialysis fluid is an important component of peritoneal dialysis, which consists of liquid medicine, liquid medicine bags (including three-layer co-extruded infusion membranes, three-layer co-extruded infusion tubes, polycarbonate easy-to-fold plugs for injections, and drug-added plugs for infusion bags), drainage bags and outer bags.

[0003] The temperature and other sterilization parameters obtained during the production process of each batch of peritoneal dialysis fluid are obtained by inserting the sterilization temperature monitoring probe that comes with the sterilization cabinet into the peritoneal dialysis fluid at the cold spot position verified by the sterilization test (the cold spot is generally at the front, middle, and back position of the bottom of the sterilization vehicle). The sterilization temperature monitoring probe bag currently made by pharmaceutical manufacturers first pours the sterilized liquid into the liquid bag in the sterilization temperature monitoring probe bag, and then inserts the temperature probe through the outer bag and inserts it into the drug plug (infusion plug) to reach the center of the liquid bag, and seals the puncture port of the outer bag with high-temperature resistant waterproof tape. After running the sterilization program, the sterilization temperature and other parameters are obtained. Since the peritoneal dialysis fluid is first wrapped in an outer bag and sealed outside the liquid bag and then sterilized, the puncture of the probe into the outer bag will affect the air tightness of the outer bag, resulting in a large difference in the sterilization temperature of the product at the cold spot position. How to solve the above problems has become one of the problems that technicians in this field need to solve. Utility Model Content

[0004] In order to solve the problems existing in the prior art, such as large difference in gas volume in the interlayer between each sterilization temperature monitoring probe bag, large temperature difference in multiple probe bags at the same time, unstable sterilization effect and product quality, and inconvenient operation, the utility model provides a peritoneal dialysis fluid sterilization temperature monitoring probe bag, wherein a medicine bag, a drainage bag, a three-way valve and a corresponding infusion tube are all placed in an outer bag, an integrally formed first infusion tube is arranged on the medicine bag, an infusion plug is arranged on one end of the first infusion tube located outside the medicine bag, a first interface is arranged on the outer bag opposite to the infusion plug, the position of the first interface corresponds to the infusion plug and the first infusion tube, a combination cover is arranged on one end of the first interface outside the outer bag, a sealable exhaust pipe is arranged on the outer bag, and the outer bag is connected to an air pump through the exhaust pipe; after adopting this structure, the amount of medicine in each sterilization temperature monitoring probe bag and the residual amount of air between the interlayer and the outer bag can be ensured to be the same, so that the sterilization effect of the product at the cold point of the sterilization cabinet is uniform and stable, and the temperature of the sterilization heating and cooling process is ensured to be uniform, which is convenient for operation.

[0005] The sterilization temperature monitoring probe bag for peritoneal dialysis solution has the following specific technical solutions:

[0006] A sterilization temperature monitoring probe bag for peritoneal dialysis solution, comprising an outer bag, a liquid medicine bag, a drainage bag and a three-way valve. The liquid medicine bag, the drainage bag, the three-way valve and the corresponding infusion tubes are all placed in the outer bag. The liquid medicine bag is provided with an integrally formed first infusion tube and a second infusion tube. An infusion plug is provided at one end of the first infusion tube located outside the liquid medicine bag. A first interface is provided on the outer bag opposite to the infusion plug. The position of the first interface corresponds to the infusion plug and the first infusion tube. A combined cover is provided at one end of the first interface outside the outer bag, and a sealing plug is fixed inside the first interface. The outer bag is also provided with a sealable exhaust pipe, and the outer bag is connected to an air pump through the exhaust pipe.

[0007] Wherein the bag body of the liquid medicine bag, the first infusion tube and the second infusion tube are all prepared by a three-layer co-extrusion process and integrally formed. After the liquid medicine bag is made, it can be loaded with liquid medicine.

[0008] Further, the drainage bag is provided with a second interface, and a dialysis waste liquid tube is connected to the second interface. An easy-break plug is connected to one end of the second infusion tube located outside the liquid medicine bag, and a third infusion tube is connected to the other end of the easy-break plug opposite to the second infusion tube.

[0009] Furthermore, the third infusion tube and the dialysis waste liquid tube are connected to two interfaces of the three-way valve, and a sealing cap is provided on the other interface of the three-way valve. Preferably, infusion clamps are provided on the third infusion tube and the dialysis waste liquid tube.

[0010] Furthermore, the above-mentioned air pump has a pressure monitoring function and can monitor the pressure and vacuum degree while discharging the gas in the outer bag sandwich. The air pump can use a circulating water type vacuum pump or other air pumps that can monitor the pressure or vacuum degree.

[0011] During actual drainage operation, the liquid medicine in the liquid medicine bag can be introduced into the patient's abdominal cavity through the third infusion tube for dialysis, and the dialyzed waste liquid can be introduced into the drainage bag through the dialysis waste liquid tube. During actual drainage, infusion clamps can be provided on the third infusion tube and the dialysis waste liquid tube as needed for control.

[0012] The outer bag can be connected to the air pump through the exhaust pipe. When the exhaust pipe and the air pump are opened, the gas in the inner sandwich of the outer bag can be discharged through the air pump. After the gas is discharged, the exhaust pipe can be sealed and the connection between the outer bag and the air pump can be removed.

[0013] Preferably, the first infusion tube is located at the central position of the liquid medicine bag to ensure that the probe can reach the center of the liquid medicine bag after the temperature monitoring probe is inserted. When assembling the temperature monitoring probe into the peritoneal dialysis solution sterilization temperature monitoring probe bag, the outer bag is integrally sealed, the first interface and the exhaust pipe have been sealed, the positions of the first interface and the first infusion tube correspond to each other, the temperature monitoring probe passes through the combined cover, passes through the infusion plug after passing through the first interface, and reaches the center inside the liquid medicine bag after passing through the first infusion tube.

[0014] When inputting liquid medicine into the liquid medicine bag, a graduated tube can be used for adding liquid. The graduated tube is provided with graduations, and a pipeline corresponding to the size of the first infusion tube is connected to the bottom. It should be ensured that the pipeline at the bottom of the graduated tube can be placed inside the first infusion tube. An infusion clamp is provided on the pipeline at the bottom of the graduated tube to open and close the pipeline. When liquid medicine needs to be input, first close the infusion clamp to seal the pipeline, place the pipeline in the corresponding position, then add liquid to the graduated tube to the corresponding graduation, and then open the infusion clamp.

[0015] During use, the temperature monitoring probe passes through the combined cover, passes through the infusion plug after passing through the first interface, enters the inside of the liquid medicine bag from the first infusion tube, reaches the center of the liquid medicine bag, and monitors the temperature of the liquid medicine inside the liquid medicine bag.

[0016] The peritoneal dialysis solution sterilization temperature monitoring probe bag can achieve the following technical effects:

[0017] 1) It can ensure that the liquid medicine volume of each sterilization temperature monitoring probe bag and the residual air volume between the outer bag interlayer are the same, making the sterilization effect of the products at the cold point of the sterilization cabinet uniform and stable, ensuring uniform temperature during the sterilization heating and cooling processes, being convenient for operation. The sealing plug fixed inside the combined cover interface and the sealable exhaust port ensure the airtightness during probe puncture, and there is no need to use adhesive tape to seal the puncture port;

[0018] 2) The bag body is provided with a preset probe channel, a liquid medicine introduction channel, and a sealable air extraction tube. An easy-to-break plug is provided between the liquid medicine bag and the drainage bag, and the operations during the overall production of the probe bag, temperature monitoring, and actual use for drainage are convenient and efficient. Description of the Drawings

[0019] Figure 1 It is a schematic diagram of the overall structure of the peritoneal dialysis solution sterilization temperature monitoring probe bag;

[0020] Figure 2 For Figure 1 The enlarged view of part A in

[0021] Figure 3 It is a side view of the peritoneal dialysis solution sterilization temperature monitoring probe bag;

[0022] Figure 4 It is a schematic diagram of the peritoneal dialysis solution sterilization temperature monitoring probe bag when loading the temperature measurement probe;

[0023] Figure 5 Schematic diagram of the graduated tube

[0024] Wherein: 1 is the liquid medicine bag; 2 is the drainage bag; 3 is the outer bag; 4 is the first interface; 5 is the combined cap; 6 is the infusion plug; 7 is the first infusion tube; 8 is the second infusion tube; 9 is the frangible plug; 10 is the third infusion tube; 11 is the dialysis waste liquid tube; 12 is the second interface; 13 is the three-way valve; 14 is the sealing cap; 15 is the exhaust pipe; 16 is the air extraction pump; 17 is the temperature monitoring probe; 18 is the graduated tube; 19 is the infusion clamp. Specific embodiments

[0025] The technical solution of the present utility model will be further described below in conjunction with specific embodiments. These embodiments are only used to more specifically describe the technical solution of the present utility model and should not be construed as limiting the protection scope of the present utility model.

[0026] Embodiment 1

[0027] As Figures 1 - 3 shown, the peritoneal dialysis solution sterilization temperature monitoring probe bag includes a liquid medicine bag 1, a first infusion tube 7 and a second infusion tube 8 integrally formed with the liquid medicine bag 1. Preferably, the bag body of the liquid medicine bag 1, the first infusion tube 7 and the second infusion tube 8 are all prepared by a three-layer co-extrusion process and integrally formed. After the liquid medicine bag 1 is made, it can be loaded with liquid medicine.

[0028] The peritoneal dialysis solution temperature monitoring probe bag further includes a drainage bag 2 and an outer bag 3. The drainage bag 2 is provided with a second interface 12, and a dialysis waste liquid tube 11 is connected to the second interface 12.

[0029] One end of the first infusion tube 7 located outside the liquid medicine bag 1 is provided with an infusion plug 6, and the first infusion tube 7 can be opened and sealed through the infusion plug 6.

[0030] One end of the second infusion tube 8 located outside the liquid medicine bag 1 is connected to a frangible plug 9, and the other end of the frangible plug relative to the second infusion tube 8 is connected to a third infusion tube 10.

[0031] The third infusion tube 10 and the dialysis waste liquid tube 11 are connected to two interfaces of the three-way valve 13. The other interface of the three-way valve 13 is provided with a sealing cap 14, which can open and seal the interface of the three-way valve 13 not connected to the third infusion tube 10 and the dialysis waste liquid tube 11.

[0032] During the actual drainage operation, the liquid medicine in the liquid medicine bag 1 can be introduced into the patient's abdominal cavity through the third infusion tube 10 for dialysis, and the waste liquid after dialysis can be introduced into the drainage bag 2 through the dialysis waste liquid tube 11. Infusion clamps can be set on the third infusion tube 10 and the dialysis waste liquid tube 11 as needed during the actual drainage.

[0033] The liquid medicine bag 1, the drainage bag 2, the three-way valve 13 and the corresponding infusion tubes are all placed in the outer bag 3. The body of the outer bag 3 is sealed. A first interface 4 is provided on the outer bag 3 opposite to the infusion plug 6. The position of the first interface 4 corresponds to the infusion plug 6 and the first infusion tube 7. A combination cover 5 is provided at one end of the first interface 4 outside the outer bag 3 to seal the first interface 4. Preferably, a sealing plug is fixed inside the first interface 4.

[0034] A sealable exhaust pipe 15 is also provided on the outer bag 3. The outer bag 3 can be connected to the air pump 16 through the exhaust pipe 15. When the exhaust pipe 15 and the air pump 16 are opened, the air in the inner layer of the outer bag 3 can be discharged through the air pump 16. After the air is discharged, the exhaust pipe 15 can be sealed and the connection between the outer bag 3 and the air pump 16 can be removed.

[0035] It should be noted that the air pump 16 has a pressure monitoring function and can monitor the pressure and vacuum degree while discharging the air in the inner layer of the outer bag 3. Preferably, a circulating water type vacuum pump can be used for the air pump 16, but the selection of the air pump 16 is not limited to the circulating water type air pump. Any air pump that can monitor the pressure or vacuum degree can be used.

[0036] At the same time, as Figures 1 - 3 shown, the first infusion tube 7 is located at the central position of the liquid medicine bag 1 to ensure that the temperature monitoring probe 17 can reach the center of the liquid medicine bag 1 after being inserted.

[0037] Figure 4 Shown is a schematic diagram of assembling the temperature monitoring probe 17 into the peritoneal dialysis solution sterilization temperature monitoring probe bag. At this time, the whole outer bag 3 is sealed, the first interface 4 and the exhaust pipe 15 have been sealed, the positions of the first interface 4 and the first infusion tube 7 correspond, the temperature monitoring probe 17 passes through the combination cover 5, passes through the infusion plug 6 after passing through the first interface 4, and reaches the center inside the liquid medicine bag 1 after passing through the first infusion tube 7.

[0038] It should be noted that since the volumes of the outer bag 3 and the liquid medicine bag 1 are close, the volume of the liquid medicine bag 1 expands after introducing the liquid medicine. And because the combination cover 5 is located at the central position of the outer bag 3 and the first infusion tube 7 is located at the central position of the liquid medicine bag 1, this makes the combination cover 5 and the first infusion tube 7 correspond in the vertical direction, so that the probe 17 can smoothly puncture the infusion plug 6 of the combination cover 5 and the first infusion tube 7.

[0039] When inputting the liquid medicine into the liquid medicine bag 1, it can be carried out as Figure 5Add liquid to the graduated tube 18 as shown. There are graduations on the graduated tube 18, and a tube with a size corresponding to the first infusion tube 7 is connected to the bottom. It should be ensured that the bottom tube of the graduated tube 18 can be placed inside the first infusion tube 7. An infusion clamp 19 is provided on the bottom tube of the graduated tube 18 to open and close the tube. When it is necessary to input the liquid medicine, first close the infusion clamp 19 to seal the tube. After placing the tube in the corresponding position, add liquid to the graduated tube until it reaches the corresponding graduation, and then open the infusion clamp 19.

[0040] The manufacturing method of this product is as follows:

[0041] 1) Make an empty liquid medicine bag 1 from the membrane material, the first infusion tube 7 and the second infusion tube 8. After introducing the liquid medicine into the liquid medicine bag 1 through the first infusion tube 7, seal the first infusion tube 7 with the infusion plug 6. Connect the second infusion tube 8 of the liquid medicine bag 1 to the three-way valve 13 through the breakable plug 9 and the third infusion tube 10. Connect the second interface 12 of the drainage bag 2 to the three-way valve 13 through the dialysis waste liquid tube 11. Seal the last interface of the three-way valve 13 with the sealing cap 14.

[0042] 2) Place the liquid medicine bag 1, the drainage bag 2 and the corresponding three-way valve 13 into the outer bag 3 with a closed upper part and welded with the first interface 4 and closed on both sides and welded with an exhaust pipe 15 on one side from the bottom opening end. The position of the first interface 4 corresponds to the first infusion tube 7 and the infusion plug 6.

[0043] 3) Seal the first interface 4 with the combination cap 5 and weld and seal the bottom of the outer bag 3

[0044] 4) Connect the exhaust pipe 15 to the air extraction pump 16; turn on the air extraction pump 16 to extract air until the vacuum degree reading on the air extraction pump 16 reaches the specified reading (the vacuum degree on the air extraction pump 16 is the same when the air extraction of each outer bag 3 ends), then seal the air extraction port 15 and turn off the air extraction pump 16.

[0045] There are various ways to seal the air extraction port 15, as long as the sealing effect can be achieved. In this embodiment, the air extraction port 15 is sealed by tying it tightly with a cable tie.

[0046] When in use, as Figure 4 shown, pass the temperature monitoring probe 17 through the combination cap 5, through the first interface 4 and then through the infusion plug 6, and enter the inside of the liquid medicine bag 1 from the first infusion tube 7 to reach the center of the liquid medicine bag 1 to monitor the temperature of the liquid medicine inside the liquid medicine bag 1.

[0047] The above are only the preferred embodiments of the present invention and are not used to limit the present invention. Any equivalent replacement, modification, etc. made by those skilled in the art within the spirit and principle of the present invention without any creative labor shall be included in the protection scope of the present invention.

Claims

1. A peritoneal dialysis solution sterilization temperature monitoring probe bag, comprising an outer bag (3), a medicine solution bag (1), a drainage bag (2) and a three-way valve (13). The medicine solution bag (1), the drainage bag (2), the three-way valve (13) and the corresponding infusion tubes are all placed in the outer bag (3), and it is characterized in that: The liquid medicine bag (1) is provided with an integrally formed first infusion tube (7) and a second infusion tube (8). One end of the first infusion tube (7) located outside the liquid medicine bag (1) is provided with an infusion plug (6). A first interface (4) is provided on the outer bag (3) opposite to the infusion plug (6). The position of the first interface (4) corresponds to the infusion plug (6) and the first infusion tube (7). One end of the first interface (4) outside the outer bag (3) is provided with a combination cap (5), and a sealing plug is fixed inside the first interface (4); The outer bag (3) is further provided with a sealable exhaust pipe (15), and the outer bag (3) is connected to the air extraction pump (16) through the exhaust pipe (15).

2. The peritoneal dialysis solution sterilization temperature monitoring probe bag according to claim 1, characterized in that: The drainage bag (2) is provided with a second interface (12), and a dialysis waste liquid tube (11) is connected to the second interface (12).

3. The peritoneal dialysis solution sterilization temperature monitoring probe bag according to claim 1, wherein: One end of the second infusion tube (8) located outside the liquid medicine bag (1) is connected to an easy-break plug (9), and the other end of the easy-break plug (9) opposite to the second infusion tube (8) is connected to a third infusion tube (10).

4. The peritoneal dialysis solution sterilization temperature monitoring probe bag according to claim 3, characterized in that: The third infusion tube (10) and the dialysis waste liquid tube (11) are connected to two interfaces of a three-way valve (13), and a sealing cap (14) is provided on another interface of the three-way valve (13).

5. The peritoneal dialysis solution sterilization temperature monitoring probe bag according to claim 3, characterized in that: Infusion clamps are provided on the third infusion tube (10) and the dialysis waste liquid tube (11).

6. The peritoneal dialysis solution sterilization temperature monitoring probe bag according to claim 1, characterized in that: The air extraction pump (16) adopts a circulating water type vacuum pump.