Pre-encapsulation catheter flusher

Abstract

The invention discloses a pre-potting catheter flusher, which is a flushing device which is produced by adopting a blowing, potting and sealing integrated forming technology and contains a pre-potting solution, and can be used as a balloon filling device, a medical catheter flusher and the pre-potting solution. The prefilled catheter flusher comprises a liquid storage part, a connecting part and a sealing part, sterile and pyrogen-free cleaning liquid or other cleaning liquid is stored in the liquid storage part, the sealing part is connected to the end, away from the liquid storage part, of the connecting part, and the sealing part comprises a liquid outlet pipe and an easy-to-tear opening structure connected to a liquid outlet of the liquid outlet pipe. And the periphery of the liquid outlet pipe has taper so as to form a male Luer taper structure. The pre-potting catheter flusher is of a full-sealed structure produced through the blowing potting technology, and is resistant to high temperature and high pressure, sterile, free of pyrogen and low in production cost; after the easy-to-tear opening structure of the liquid outlet pipe is torn off, the appearance and the taper size characteristic of the liquid outlet pipe meet the requirements of a male Luer taper, the liquid outlet pipe can be in butt joint with various medical pipelines, catheter cleaning and pipeline perfusion operation can be conducted, and operation is easy.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a pre-filled catheter flusher. Background Art

[0002] Pre-filled saline catheter flushers, balloon inflators for in-vivo catheters, and pre-filled sealing solutions for intravenous indwelling needles are widely used in clinical practice. In order to maintain the patency and sterility of the catheter, the catheter needs to be flushed with sterile saline; it can also be used to inflate in-vivo catheter balloons, such as ureteral balloon inflation; indwelling needles are widely used by patients during intravenous infusions, and pre-filled sterile saline can be used as sealing solution during the indwelling period.

[0003] At present, the pre-filled solution with a syringe structure is generally used for catheter flushing, balloon inflation, etc. The process is as follows:

[0004] 1. Prepare cleaning solution: Use sterile saline or other specified cleaning solution as needed.

[0005] 2. Connection: Open the Luer connector cap of the syringe infusion port and connect it to the external Luer connector of the medical catheter. Make sure the connection is tight to avoid leakage.

[0006] 3. For flushing the catheter: Connect the Brewer connector on the outside of the medical catheter, use the push-in structure of the syringe, and slowly push the catheter to clean it.

[0007] 4. Used to inflate the cannula balloon: connect the Luer connector on the outside of the cannula, use a syringe to push the pre-filled saline solution into the balloon inside the cannula, and inflate the balloon to expand and fix it in the human body to prevent the cannula from accidentally falling out.

[0008] 5. Pre-filled sealing liquid for indwelling needles: Use sterile, pyrogen-free pre-filled saline injection, which can be used as the sealing liquid for the infusion tube during the retention of the intravenous indwelling needle. When in use, connect the Luer connector of the indwelling needle tube and slowly push it into the infusion tube of the indwelling needle.

[0009] 6. Remove the syringe: After flushing is complete, carefully remove the syringe to avoid pulling out the catheter.

[0010] 7. Records: Record the date, time, type of liquid and flushing results.

[0011] However, there are the following problems in flushing the catheter in the above manner. During the production process, the cavity of the syringe, the push-pull rod, the piston sealing gasket, and the infusion port sealing screw cap involve different production processes and multiple production and assembly processes. After the cleaning solution is filled, it is sealed with a plastic screw cap, and there are a lot of process contamination possibilities in the production. During the storage process, the temperature changes and a pressure difference occurs, and the packaging integrity of the product will be challenged. The screw cap sealing method is difficult to withstand the pressure difference and temperature difference. The final product cannot be effectively sterilized, and the sterility level is difficult to ensure. There have been a large number of clinical adverse data and product recall incidents at home and abroad for many years, showing that products with this type of syringe structure and screw cap sealing method have potential biological contamination risks. Summary of the invention

[0012] In order to overcome the shortcomings of the prior art, the present invention provides a prefilled catheter flusher, which no longer uses a syringe plus a screw-on cap sealing structure, but uses a novel blow-fill-seal integrated technology to manufacture a prefilled liquid container with a spring bottle, and at the same time has a liquid outlet with a Luer connector structure. The Luer connector is used to facilitate accurate docking of the catheter, and the operation is simple. The blow-fill-seal integrated molding technology is used for production, and the aseptic process is used for production. Compared with products using a syringe structure, there is no need to produce accessories for reassembly, filling with liquid, and screwing on the cap for packaging, which greatly reduces the probability of process contamination. The product uses a broken cap opening method, is in a fully sealed state before use, is resistant to high temperature and high pressure, and can use the final product sterilization method to ensure the sterility of the product, thereby greatly improving the product safety.

[0013] The technical solution adopted by the present invention to solve its technical problem is:

[0014] A prefilled catheter flusher is made by a blow-fill-seal process, comprising a liquid storage part, a connecting part and a sealing part, wherein the liquid storage part stores sterile pyrogen-free cleaning liquid, the sealing part is connected to an end of the connecting part away from the liquid storage part, the sealing part comprises a liquid outlet pipe and an easy-tear structure connected to the liquid outlet of the liquid outlet pipe, and the outer periphery of the liquid outlet pipe has a taper to form a male Luer joint structure.

[0015] As a further improvement of the above technical solution, the easy-tear structure includes a connecting head and a breaking cap, the connecting head is connected to the liquid outlet, and the diameter of the connecting head is larger than the diameter of the liquid outlet pipe, the connection between the connecting head and the liquid outlet pipe is a fracture position, a fracture line is provided at the fracture position, and the breaking cap is connected to the outer periphery of the connecting head.

[0016] As a further improvement of the above technical solution, the liquid storage portion includes an elastic liquid storage bottle, and the cleaning liquid can be discharged from the elastic liquid storage bottle when the elastic liquid storage bottle is squeezed.

[0017] As a further improvement of the above technical solution, the elastic liquid storage bottle is a spring bottle.

[0018] As a further improvement of the above technical solution, the connecting portion includes a connecting tube, one end of which is connected to the elastic liquid storage bottle, and the other end of which is connected to the liquid outlet tube.

[0019] As a further improvement of the above technical solution, a tapered tube is provided at one end of the connecting tube close to the liquid outlet tube, and the diameter of the tapered tube gradually decreases along the direction from the connecting tube to the liquid outlet tube.

[0020] As a further improvement of the above technical solution, a hand-held portion is provided between the connecting tube and the elastic liquid storage bottle.

[0021] As a further improvement of the above technical solution, the hand-held part includes an annular groove.

[0022] As a further improvement of the above technical solution, the volume of the cleaning liquid in the elastic liquid storage bottle is less than half of the volume of the elastic liquid storage bottle.

[0023] As a further improvement of the above technical solution, the liquid storage part, the connecting part and the sealing part are made of polypropylene or polyethylene, and the cleaning liquid is physiological saline.

[0024] The beneficial effects of the present invention are:

[0025] 1. The present invention provides a pre-filled catheter flusher for medical use, which contains a sterile, pyrogen-free cleaning solution and adopts a blow-fill-seal integrated molding method to form a fully sealed product with complete packaging, thereby preventing the cleaning solution from being contaminated during the production process, thereby ensuring the sterility of the catheter when flushing the catheter. In addition, polyethylene or polypropylene is used as the main production material of the pre-filled catheter flusher, which is non-toxic and harmless, and can be sterilized in the final product, and the sterility level can reach 10-6 (SAL=10 -6 ), the product is safer, the raw materials are single, the process is simple, and the product price is greatly reduced.

[0026] 2. The pre-filled catheter flusher adopts an easy-tear design for easy operation. After opening the easy-tear design, the front end of the pre-filled catheter flusher exposes the liquid outlet, and the size characteristics of the front end of the pre-filled catheter flusher can match the Luer connector structure of medical devices, which is convenient for precise alignment of the catheter to be flushed. The operation is simple, avoiding catheter damage or liquid overflow, and can also prevent air from entering and contaminating the cleaning fluid during flushing.

[0027] 3. The pre-filled catheter flusher has a spring bottle structure, which is easy to squeeze, and a hand-held part is provided between the spring bottle and the connecting tube, so the product can be used with one hand to flush the catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The present invention is further described below in conjunction with the accompanying drawings and embodiments.

[0029] Figure 1 is a schematic structural diagram of the prefilled catheter flusher in Example 1 of the present invention;

[0030] Figure 2 1 is a schematic diagram of the structure of the pre-filled catheter flusher after the easy-tear opening is opened in Example 1 of the present invention;

[0031] Figure 3 yes Figure 1 Front view of the medium prefilled catheter flusher;

[0032] Figure 4 yes Figure 1 Side view of the medium prefilled catheter flusher;

[0033] Figure 5 It is a schematic diagram of the states of the pre-filled catheter flusher before and after the easy tearing opening is opened in Example 2 of the present invention.

[0034] Figure numerals: 1, liquid storage part; 2, connecting part; 3, sealing part; 4, hand-held part; 11, spring bottle; 21, connecting tube; 22, conical tube; 31, liquid outlet tube; 32, connecting head; 33, break-off cap. DETAILED DESCRIPTION

[0035] The following will be combined with the embodiments and drawings to clearly and completely describe the concept, specific structure and technical effects of the present invention, so as to fully understand the purpose, characteristics and effects of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, other embodiments obtained by technicians in this field without creative work belong to the scope of protection of the present invention. In addition, all the connection / connection relationships involved in the patent do not refer to the direct connection of components, but refer to the fact that a better connection structure can be formed by adding or reducing connection accessories according to the specific implementation situation. For example, fixed connection / fixed installation can be selected according to the needs of screw connection, bolt connection, pin connection, key connection, bonding, mortise and tenon connection, welding, riveting and other methods. For example, detachable connection can be selected according to the needs of screw connection, bolt connection, threaded connection, snap connection, mortise and tenon connection, Velcro connection and other methods. The various technical features in the invention can be combined interactively without conflicting with each other.

[0036] Reference Figure 1-Figure 4Embodiment 1 of the present invention provides a prefilled catheter flusher for medical use, which can be used as a prefilled sealing liquid for flushing a catheter, inflating a catheter balloon, or for indwelling a needle. The prefilled catheter flusher comprises a liquid storage portion 1, a connecting portion 2, and a sealing portion 3. The liquid storage portion 1 stores a sterile, pyrogen-free cleaning liquid. The sealing portion 3 is connected to an end of the connecting portion 2 away from the liquid storage portion 1. The sealing portion 3 comprises a liquid outlet tube 31 and an easy-tear structure connected to the liquid outlet of the liquid outlet tube 31. The outer periphery of the liquid outlet tube 31 has a taper to form a male Luer connector structure.

[0037] Specifically, the pre-filled catheter flusher is a fully packaged product made by the blow-fill-seal integrated molding process. It is produced by the blow-fill-seal integrated molding technology and the aseptic process. Compared with the product using the syringe structure, it does not need to produce accessories for reassembly, fill liquid and screw cap packaging, which greatly reduces the probability of process contamination, thereby ensuring the sterility of the catheter when flushing the catheter. The packaging material of the pre-filled catheter flusher (i.e., the spring bottle 11, the connecting tube 21, the liquid outlet tube 31, the connector 32 and the break cap 33) is PP (polypropylene) or PE (polyethylene). The use of PP or PE is non-toxic and harmless to the human body. At the same time, the raw materials are single, the process is simple, and the production cost is low, which can reduce the product price, thereby having a sales advantage. The cleaning solution mainly uses physiological saline, and other solutions that are isotonic with human blood can also be used. The cleaning solution is sterile and pyrogen-free to flush the catheter, which is used to keep the catheter clean and sterile to prevent catheter-related complications.

[0038] The pre-filled catheter flusher adopts an easy-tear structure, which is convenient for quickly opening the pre-filled catheter flusher. After opening the easy-tear structure (refer to Figure 2 ), exposing the liquid outlet at the front end of the liquid outlet tube 31, and the cleaning liquid is flushed out from the liquid outlet to flush the catheter, thereby improving the convenience of using the pre-filled catheter flusher.

[0039] In addition, the outer periphery of the liquid outlet tube 31 has a taper to form a male Luer connector structure, which can match the Luer connector of medical devices to connect various medical pipelines. In this way, the liquid outlet tube 31 of the pre-filled catheter flusher can be quickly matched and connected with the catheter to be flushed, which is simple to operate and realizes a seepage-free connection, avoids catheter damage or overflow of the cleaning liquid, and can also prevent air from entering the catheter during flushing to contaminate the cleaning liquid, thereby reducing the risk of infection.

[0040] In this embodiment, refer to Figure 1 , Figure 3 and Figure 4The easy-tear structure includes a connector 32 and a break cap 33. The connector 32 is connected to the liquid outlet and is used to seal the liquid outlet to ensure that the cleaning liquid inside the product will not be contaminated before the product is used. The connector is a spherical structure with a larger diameter (that is, the diameter of the connector is larger than the diameter of the liquid outlet pipe), and then it narrows in a large taper toward the liquid outlet pipe. The end of the liquid outlet also has a taper, that is, the connection between the connector and the liquid outlet pipe is the smallest diameter, and the smallest diameter is the fracture position with a clear fracture line. The wall here is thin and the diameter is the smallest. Such a structural setting can keep the fracture clear and neat when the connector is rotated and broken. The break cap 33 is connected to the outer periphery or outside of the connector 32. The break cap 33 increases the contact area, which makes it easier for the staff to quickly break the connector, and the waste material broken off from the plate is not easy to fall off, which is convenient for collection.

[0041] In this embodiment, refer to Figure 1-Figure 4 The liquid storage part 1 includes an elastic liquid storage bottle. When the elastic liquid storage bottle is squeezed, the cleaning liquid can be discharged from the elastic liquid storage bottle. Specifically, the elastic liquid storage bottle is a spring bottle 11. The spring bottle 11 is a container with a spring structure. When pressed, the bottle body can be folded and contracted, and its internal volume becomes smaller, so that the cleaning liquid is discharged.

[0042] Reference Figure 1-Figure 4 The connecting portion 2 includes a connecting tube 21, one end of which is connected to the spring bottle 11, and the other end of which is connected to the liquid outlet pipe 31. A conical tube 22 is provided at one end of the connecting tube 21 close to the liquid outlet pipe 31, and the diameter of the conical tube 22 gradually decreases along the direction from the connecting tube 21 to the liquid outlet pipe 31, so that when the spring bottle 11 is pressed to discharge the cleaning liquid, the setting of the conical tube 22 increases the fluid pressure when the cleaning liquid is discharged, so that the cleaning liquid has a certain impact when cleaning the catheter, ensuring the flushing effect of the catheter, preventing the catheter from being blocked, and maintaining the patency of the catheter.

[0043] Reference Figure 1-Figure 4 A hand-held portion 4 is provided between the connecting tube 21 and the spring bottle 11. Specifically, the hand-held portion 4 includes an annular groove, and the annular groove is used to accommodate fingers. When using the flusher of this embodiment, the staff's index finger and middle finger can clamp the annular groove, and the staff's thumb presses the bottom of the spring bottle 11. The thumb presses the spring bottle 11 to compress it, thereby discharging the flushing liquid. In this way, the pre-filled catheter flusher can be operated with one hand to realize the catheter flushing work, and the operation is simple and convenient.

[0044] In a preferred embodiment, the volume of the cleaning liquid in the elastic liquid storage bottle is less than half of the volume of the elastic liquid storage bottle. More preferably, the volume of the cleaning liquid in the elastic liquid storage bottle is two-fifths of the volume of the spring bottle 11, and the rest of the spring bottle 11 is sterile air. In this way, all the flushing liquid can be easily discharged by pressing the spring bottle 11 once, and the catheter flushing work can be completed at one time, reducing the difficulty of catheter flushing.

[0045] In the present invention, the shape and size of the prefilled catheter flusher are not required and are considered to be within the protection scope of this product. For example, the prefilled catheter flusher provided in Example 2 is referred to as Figure 5 The spring bottle 11 in Example 2 is shorter but thicker than the spring bottle 11 in Example 1, and the spring bottle 11 is elliptical. In addition, the connecting tube 21 in Example 2 is also shorter than the connecting tube 21 in Example 1, and the outer wall is further provided with a pattern groove. However, in essence, the basic structure of Example 2 is the same as that of Example 1, and they are two products of the present invention for protecting the prefilled catheter flusher.

[0046] The above is a specific description of the preferred implementation of the present invention, but the invention is not limited to the embodiments. Those skilled in the art can make various equivalent modifications or substitutions without violating the spirit of the present invention. These equivalent modifications or substitutions are all included in the scope defined by the claims of this application.

Claims

1. A prefilled catheter flusher, made by a blow-fill-seal process, characterized in that: The invention comprises a liquid storage part, a connecting part and a sealing part, wherein the liquid storage part stores sterile pyrogen-free cleaning liquid, the sealing part is connected to one end of the connecting part away from the liquid storage part, the sealing part comprises a liquid outlet tube and an easy-tear structure connected to the liquid outlet of the liquid outlet tube, and the outer periphery of the liquid outlet tube has a taper to form a male Luer connector structure.

2. A prefilled catheter flusher according to claim 1, characterized in that: The easy-tear structure includes a connecting head and a breaking cap, the connecting head is connected to the liquid outlet, and the diameter of the connecting head is larger than the diameter of the liquid outlet pipe, the connection between the connecting head and the liquid outlet pipe is a fracture position, a fracture line is provided at the fracture position, and the breaking cap is connected to the outer periphery of the connecting head.

3. A prefilled catheter flusher according to claim 1, characterized in that: The liquid storage portion comprises an elastic liquid storage bottle, and the cleaning liquid can be discharged from the elastic liquid storage bottle when the elastic liquid storage bottle is squeezed.

4. A prefilled catheter flusher according to claim 3, characterized in that: The elastic liquid storage bottle is a spring bottle.

5. A prefilled catheter flusher according to claim 3, characterized in that: The connecting part comprises a connecting tube, one end of which is connected to the elastic liquid storage bottle, and the other end of which is connected to the liquid outlet tube.

6. A prefilled catheter flusher according to claim 5, characterized in that: A tapered tube is arranged at one end of the connecting tube close to the liquid outlet tube, and the diameter of the tapered tube gradually decreases along the direction from the connecting tube to the liquid outlet tube.

7. A prefilled catheter flusher according to claim 5, characterized in that: A hand-held portion is arranged between the connecting tube and the elastic liquid storage bottle.

8. A prefilled catheter flusher according to claim 7, characterized in that: The hand-held portion includes an annular groove.

9. A prefilled catheter flusher according to claim 3, characterized in that: The volume of the cleaning liquid in the elastic liquid storage bottle is less than half of the volume of the elastic liquid storage bottle.

10. The prefilled catheter flusher according to claim 1, characterized in that: The liquid storage part, the connecting part and the sealing part are made of polypropylene or polyethylene, and the cleaning liquid is physiological saline.

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