A device for measuring the permeability of medical protective clothing against chemotherapy drugs.

Abstract

This application provides a device for measuring the permeability of medical protective equipment against chemotherapy drugs, relating to the field of materials testing. It includes a collection chamber and a drug chamber, each with a flange-like interface on its opposite side and an annular sealing gasket on the outside of the interface. Connecting plates are fitted onto the connection points between the collection chamber and the drug chamber and their corresponding interfaces. The two connecting plates are connected by multiple detachable connectors. An upwardly extending sampling port is provided at the end of the collection chamber away from the drug chamber; an upwardly extending drug inlet is provided at the end of the drug chamber away from the collection chamber. Sealing caps are provided at both the sampling port and the drug inlet. This device has good sealing performance, can accurately measure permeability, and is easy to disassemble, clean, and highly practical.

Description

Technical Field

[0001] This utility model relates to the field of materials testing, and in particular to a device for measuring the penetration performance of medical protective products against chemotherapy drugs. Background Technology

[0002] ASTM D6978, published by the American Society for Testing and Materials (ASTM), describes a standard practice for evaluating the resistance of medical glove materials to the penetration of potentially hazardous cancer chemotherapy drugs under continuous contact conditions. The conditions used in this test method are designed to approximate worst-case clinical use. The standard specifies testing requirements for at least nine chemotherapy drugs, seven of which are mandatory, with two additional drugs added from the list of chemotherapy drugs. These drugs work by damaging cancer cell DNA, altering parts of cancer cell DNA, disrupting enzymes within cancer cells, or inhibiting cancer cell proliferation. They can cause greater side effects in healthy individuals, making the use of gloves with high resistance to chemotherapy drug penetration crucial for protecting the health of healthcare workers.

[0003] However, there is currently a lack of a device for measuring the permeability of medical protective equipment against chemotherapy drugs that is well-sealed, easy to disassemble and assemble, and easy to clean and disinfect. Utility Model Content

[0004] In view of the above problems, this utility model embodiment is proposed to provide a device for measuring the penetration performance of antichemotherapy drugs in medical protective products that overcomes or at least partially solves the above problems.

[0005] A device for measuring the penetration performance of chemotherapy drugs in medical protective equipment includes a collection chamber and a drug chamber that are connected to each other. Each of the collection chamber and the drug chamber has a flange-like interface on its opposite side and an annular sealing gasket on the outside of the interface. The connection parts of the collection chamber and the drug chamber with the corresponding interface are respectively fitted with connecting plates. The two connecting plates are connected by multiple detachable connectors.

[0006] The collection chamber has an upward-extending sampling port at the end furthest from the drug chamber; the drug chamber has an upward-extending drug inlet at the end furthest from the collection chamber; and the sampling port and the drug inlet are each equipped with a sealing cap.

[0007] Preferably, the connecting plate is horseshoe-shaped with its opening facing downwards.

[0008] Preferably, a buffer gasket is also fitted onto the flange neck of the collection chamber / drug chamber; the buffer gasket abuts between the connecting plate and the collection chamber / drug chamber.

[0009] Preferably, the buffer pad is made of polytetrafluoroethylene.

[0010] Preferably, the mating surfaces of the collection chamber and the drug chamber are both frosted surfaces.

[0011] Preferably, the sealing gasket abuts against the interface, is made of silicone, and its surface is covered with a polytetrafluoroethylene film.

[0012] Preferably, both the collection chamber and the drug chamber are made of high borosilicate transparent glass.

[0013] Preferably, the connector includes a bolt and a nut; the bolt passes between two opposing connecting plates and is locked by the nut; wherein the nut is located on one side of the drug chamber; both the bolt head and the nut are provided with anti-slip stripes.

[0014] Preferably, the sampling port extends upward from the top of the collection chamber, and its axis is perpendicular to the axis of the collection chamber; the drug delivery port extends upward in an arc shape from the end of the drug chamber.

[0015] Preferably, the sampling port and the dosing port are respectively provided with external threads, and the sealing cap is threadedly sealed to the sampling port / dosing port.

[0016] This application specifically includes the following advantages:

[0017] In the embodiments of this application, a collection chamber and a drug chamber are provided, each with a flange-shaped interface on its opposite side and an annular sealing gasket on the outside of the interface; a connecting plate is fitted onto the connection part between the collection chamber and the drug chamber and the corresponding interface; the two connecting plates are connected by multiple detachable connectors; an upwardly extending sampling port is provided at the end of the collection chamber away from the drug chamber; an upwardly extending drug inlet is provided at the end of the drug chamber away from the collection chamber; and a sealing cap is provided on the sampling port and the drug inlet respectively. By setting up opposing collection chambers and drug chambers connected by an interface, the collection chamber is used to collect the medium for sampling and testing, and the drug chamber is used to hold the drug solution. A drug addition port in the drug chamber facilitates the addition of the drug solution, while a sampling port in the collection chamber facilitates operations such as adding liquid, sampling, and stirring. Sealing caps are installed at both the sampling port and the drug addition port to seal the two chambers and facilitate disassembly. Annular sealing gaskets are installed at the interface between the collection chamber and the drug chamber to hold medical protective equipment and to seal the collection chamber and drug chamber respectively, preventing media leakage. During the measurement process, the two chambers are pressed together, allowing the sealing gaskets to directly contact the interface, making them easy to remove for replacement or cleaning. The collection chamber and drug chamber are flange-shaped, with connecting plates fitted onto their flange necks. These connecting plates are then connected and fixed using detachable connectors, allowing for easy removal, replacement, or cleaning. The measuring device of this application has good sealing performance, can accurately measure permeability, and is easy to disassemble, clean, and is highly practical. Attached Figure Description

[0018] To more clearly illustrate the technical solution of this application, the drawings used in the description of this application will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 A front view of the measuring device provided in an embodiment of this utility model;

[0020] Figure 2 Top view of the measuring device provided in the embodiment of this utility model;

[0021] Figure 3 Left view of the measuring device provided in an embodiment of this utility model;

[0022] Figure 4 Right view of the measuring device provided in an embodiment of this utility model.

[0023] Reference numerals: 1. Collection chamber; 11. Sampling port; 2. Drug chamber; 21. Drug dosing port; 3. Interface; 4. Sealing gasket; 5. Connecting plate; 6. Connector; 61. Bolt; 62. Nut; 7. Buffer gasket; 8. Sample. Detailed Implementation

[0024] To make the objectives, features, and advantages of this application more apparent and understandable, the application will be further described in detail below with reference to the accompanying drawings and specific embodiments. Obviously, the described embodiments are only some, not all, of the embodiments of this application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0025] Through analysis of existing technologies, the inventors discovered that the implementation scheme most similar to this application includes:

[0026] 1. The permeation tank design described in the attached drawings of ASTM F 739-20, which is referenced by American standard ASTM D6978, is similar to that of this application. However, the external design, internal structure, detailed design, tank components, assembly components, flanges, and bolts of the design described in this standard are different.

[0027] 2. The device pool scheme described in the attached drawings of the pharmaceutical industry standard YY / T 0616.5-2019 is similar to that of this application, but the external design, internal structure, detailed design, pool components, combined components, flanges, and bolts of the scheme described in this standard are different.

[0028] ASTM D6978 provides a suitable permeation device, but it is not a standardized device and is extremely rare on the market. Very few manufacturers currently produce this device, and the few foreign manufacturers that do offer it are very expensive, deterring most customers. Based on my experience using the device I have purchased, I summarize as follows:

[0029] 1. The glass surfaces at the joint between the two pools were not treated and were rough and uneven. Although a sealing gasket was used, the gasket may deform over time, which could lead to poor sealing.

[0030] 2. The feed inlet uses a ground glass stopper, which has insufficient sealing and stability. Especially when immersed in a water bath, the glass stopper is prone to falling off, causing water to enter the permeation tank or leakage.

[0031] 3. When in use, the device pool cannot be placed upright and stably on the table while the feeding port is kept vertically upward. This is because the device uses a triangular arc-edged aluminum flange, which must be supported by external supports to be placed stably, making operation very inconvenient.

[0032] 4. Careful observation and analysis of the device revealed that the flange on one side of the collection chamber must be fixed to the tank body during production. This is because the length of the feed inlet branch pipe extending out of the tank exceeds the inner diameter of the flange, making it impossible to insert into the flange later. Therefore, this flange is permanently fixed to the tank body, essentially becoming an integral part of it. Later, if the flange corrodes or is damaged, it cannot be replaced. Furthermore, the gasket between the flange and the tank body often sticks together under pressure after use, becoming difficult to separate and accumulating dirt and grime, leading to contamination and making cleaning challenging.

[0033] 5. The flange of this device uses ordinary hexagonal nuts and screws, which can only be tightened with a wrench. This is inconvenient and inefficient. Changing test materials is very time-consuming. At the same time, the use of metal wrenches can easily cause the glass device to be accidentally damaged, resulting in its scrapping.

[0034] The device's instruction manual indicates that it was primarily designed for open-loop testing. While it is well-suited for open-loop testing, it is limited for closed-loop testing. When used for closed-loop testing, the device has extra components that affect operation and can easily lead to test failures.

[0035] Reference Figures 1-4 This invention discloses a device for measuring the penetration performance of antichemotherapy drugs in medical protective equipment, comprising a collection chamber 1 and a drug chamber 2 that are connected to each other. Each of the collection chamber 1 and the drug chamber 2 has a flange-shaped interface 3 on its opposite side, and an annular sealing gasket 4 is provided on the outside of each interface 3. Connecting plates 5 are respectively fitted onto the connection portions of the collection chamber 1 and the drug chamber 2 with their corresponding interfaces 3. The two connecting plates 5 are connected by multiple detachable connectors 6.

[0036] The collection chamber 1 is provided with an upwardly extending sampling port 11 at the end away from the drug chamber 2; the drug chamber 2 is provided with an upwardly extending drug inlet 21 at the end away from the collection chamber 1; the sampling port 11 and the drug inlet 21 are respectively provided with sealing caps.

[0037] In the embodiments of this application, a collection chamber 1 and a drug chamber 2 are provided, each with a flange-shaped interface 3 on its opposite side and an annular sealing gasket 4 on the outside of the interface 3; a connecting plate 5 is fitted onto the connecting parts of the collection chamber 1 and the drug chamber 2 with the corresponding interface 3; the two connecting plates 5 are connected by a plurality of detachable connectors 6; a sampling port 11 extending upward is provided at the end of the collection chamber 1 away from the drug chamber 2; a drug addition port 21 extending upward is provided at the end of the drug chamber 2 away from the collection chamber 1; a sealing cap is provided on the sampling port 11 and the drug addition port 21 respectively. The system consists of a collection chamber 1 and a drug chamber 2 connected by an interface 3. Collection chamber 1 is used to collect the collection medium for sampling and testing, while drug chamber 2 is used to hold the drug solution. A drug inlet 21 in drug chamber 2 facilitates the addition of the drug solution, while a sampling inlet 11 in collection chamber 1 facilitates operations such as adding liquid, sampling, and stirring. Sealing caps are installed at both the sampling inlet 11 and the drug inlet 21 to seal the two chambers and facilitate assembly and disassembly. Annular sealing gaskets 4 are installed at the interface 3 between collection chamber 1 and drug chamber 2 to hold medical protective equipment. The device provides a seal for the collection chamber 1 and the drug chamber 2, preventing media leakage. During the measurement process, the two chambers are pressed together, allowing the sealing gasket 4 to directly abut against the interface 3 of the two chambers, facilitating removal, replacement, or cleaning. By framing the collection chamber 1 and drug chamber 2 with flanges and fitting connecting plates 5 onto their flange necks, and then connecting and fixing the two connecting plates 5 with detachable connectors 6, the collection chamber 1 and drug chamber 2 can be securely connected. Both the detachable connectors 6 and the fitted connecting plates 5 can be disassembled, removed, replaced, or cleaned. This measuring device offers excellent sealing performance, accurately measures permeability, and is easy to disassemble, clean, and highly practical.

[0038] The apparatus for measuring the penetration performance of antichemotherapy drugs in traditional Chinese medicine protective products, as described in this exemplary embodiment, will now be further explained.

[0039] In this embodiment, the collection chamber 1 and the drug chamber 2 are cylindrical structures, each with a flange-shaped interface 3 on its opposite side. The interface 3 has a larger diameter and a flat mating surface. An annular sealing gasket 4 is provided on the outside of the interface 3 for both the collection chamber 1 and the drug chamber 2. The annular sealing gasket 4 can hold medical protective equipment, such as protective gloves, and also seal the collection chamber 1 and the drug chamber 2 to prevent leakage. Connecting plates 5 are fitted onto the connecting parts of the collection chamber 1 and the drug chamber 2 with their corresponding interfaces 3. Specifically, connecting plates 5 are fitted onto the end of the cylinder near the interface 3. The two connecting plates 5 are connected by multiple detachable connectors 6. The detachable connectors 6 allow the two connecting plates 5 to be separated, and the connecting plates 5 can be removed or installed from the collection chamber 1 or the drug chamber 2. During installation and removal, since the connecting plates 5 are fitted onto the outside of the smaller-diameter cylinder, they can simply pass through the corresponding cylinder, making them easy and quick to install and remove, whether for replacement or cleaning.

[0040] The collection chamber 1 is provided with an upwardly extending sampling port 11 at the end away from the drug chamber 2. The sampling port 11 can be used for adding the collection medium, sampling, or stirring. The drug chamber 2 is provided with an upwardly extending drug addition port 21 at the end away from the collection chamber 1. The drug addition port 21 is used for adding drug solution. The sampling port 11 and the drug addition port 21 are respectively provided with sealing caps, which can seal the collection chamber 1 and the drug chamber 2 respectively.

[0041] As an example, both the collection chamber 1 and the drug chamber 2 are made of high borosilicate transparent glass, which allows for easy observation of internal changes.

[0042] As an example, the connecting plate 5 is horseshoe-shaped with its opening facing downwards; it can also be described as a U-shaped open flange, preferably made of stainless steel. It is used to secure the left and right collection chambers 1 and drug chamber 2. One edge of the opening acts as a support, allowing the device to be placed stably on the table. In use, it is installed by simply slipping it onto the connected left and right chambers from one direction, similar to a saddle, without needing to insert the chambers into the flange holes as with traditional flanges.

[0043] As an example, the flange neck of the collection chamber 1 / the drug chamber 2 is also fitted with a buffer gasket 7; the buffer gasket 7 abuts between the connecting plate 5 and the collection chamber 1 / the drug chamber 2.

[0044] The buffer pad 7 is made of polytetrafluoroethylene and is installed between the connecting plate 5 and the corresponding chamber to increase the friction of the contact surface so that the components on both sides are firmly connected, while preventing the metal connecting plate 5 from damaging the glass chamber.

[0045] As an example, the mating surfaces of the collection chamber 1 and the drug chamber 2 are both frosted surfaces to enhance the sealing of the chamber installation.

[0046] As an example, the sealing gasket 4 abuts against the interface 3. It is made of silicone and its surface is covered with a polytetrafluoroethylene (PTFE) film. The sealing gasket 4 has a soft silicone body and a PTFE liner on its surface. The soft silicone body effectively enhances the sealing performance, while the PTFE liner is an inert, corrosion-resistant, and oil-resistant material that effectively prevents corrosion or chemical reactions.

[0047] As an example, the connector 6 includes a bolt 61 and a nut 62; the bolt 61 passes between two opposing connecting plates 5 and is locked by the nut 62; wherein the nut 62 is located on one side of the drug chamber 2; both the head of the bolt 61 and the nut 62 are provided with anti-slip stripes. The head of the bolt 61 has vertical lines or knurling, and the nut 62 also has vertical lines or knurling, all of which can be directly tightened by hand, without the need for tools such as wrenches to fix the flange.

[0048] As an example, the sampling port 11 extends upward from the top of the collection chamber 1, and its axis is perpendicular to the axis of the collection chamber 1. That is, the sampling port 11 is a straight pipe, which facilitates stirring and sampling. The dosing port 21 extends upward in an arc shape from the end of the drug chamber 2. The dosing port 21 is bent so that the opening faces upward. Because the drug chamber 2 on the right is smaller, due to the limitation of nut 62, there is not enough space above it, so the dosing port 21 cannot extend vertically upward from the top like the collection chamber 1. The bent pipe is designed to be installed on the side. In use, since the drug chamber 2 only needs to be fed through the dosing port 21, there is no need for stirring and sampling, so the bent pipe meets the requirements.

[0049] As an example, the sampling port 11 and the dosing port 21 are each provided with external threads, and the sealing cap is threadedly sealed to the sampling port 11 / dosing port 21. Specifically, the threaded ports such as the sampling port 11 and the dosing port 21 are designed with GL45 threads, and the sampling port 11 and the dosing port 21 are equipped with plastic threaded caps. The caps are preferably made of PP material, and the cap gaskets are preferably fluorosilicone lined gaskets. After the threaded caps are tightened during use, leakage is prevented.

[0050] It should be noted that chemical permeation is the process by which chemical substances pass through a barrier. During the test, sample 8 is sandwiched between collection chamber 1 and drug chamber 2, with the drug on one side and the collection solution on the other. Continuous contact between the chemotherapy drug and sample 8 is maintained, ensuring that the drug solution can contact the surface of sample 8. Samples are taken from the inside of sample 8 at regular intervals, and the solution is analyzed using HPLC-DAD or LC-MS / MS to calculate the permeation rate and record the permeation resistance of sample 8. Permeation is considered to have occurred when the permeation rate reaches 0.01 μg / cm² / min. Monitoring is typically performed over 240 minutes.

[0051] The working principle of this embodiment is as follows: Before use, sample 8 is sandwiched between two fluorosilicone-lined sealing gaskets 4. Then, the sealing gasket 4 containing sample 8 is placed between the collection chamber 1 and the drug chamber 2, aligning the two chambers. Next, two U-shaped opening connecting plates 5 and a PTFE gasket for buffering between the glass and metal are installed at the necks of the two chambers and secured with three sets of hand-tightened bolts 61 and nuts 62. The collection medium is added through the sampling port 11, and the drug solution is added through the drug addition port 21. The sealing performance is tested by adjusting the tightness of the nuts 62 and the position of the sealing gaskets 4 until there is no leakage, at which point it can be used. During use, feeding, stirring, and sampling can be performed through the sampling port 11. The glass chamber allows for easy observation of internal changes. After use, the chamber is completely disassembled, all parts are cleaned, and the chambers are dried before reuse.

[0052] The beneficial effects of the embodiments of this application are as follows:

[0053] 1. The surface of the connection port 3 between the two pools is frosted to enhance the sealing of the chamber installation.

[0054] 2. The design incorporates a GL45 threaded port with a cap for feeding and sampling. The screw-on cap provides a good seal and greater stability, preventing the cap from falling off during testing. This also prevents the medium from leaking or evaporating and avoids water entering the device during a water bath, which could lead to test failure.

[0055] 3. The design uses stainless steel U-shaped open flanges, and the two flanges on one side form four legs, which can be placed stably on the table.

[0056] 4. The stainless steel U-shaped open flange is separate from the pool body and can be freely installed and removed, making replacement and cleaning very easy.

[0057] 5. The design uses high-head vertical-knurled or knurled stainless steel hand-tightening bolts 61 and nuts 62, which can be tightened by hand without the need for wrenches or other tools, making it convenient, quick, safe and reliable.

[0058] This solution is specifically designed for closed-loop testing as described in ASTM 6978. The tank does not contain any accessories for open-loop testing and does not adversely affect the closed-loop test.

[0059] The invention will be further described in detail below with reference to specific implementation examples, but this does not limit the invention to the scope of the described implementation examples. According to the scheme of this application, several devices were set up for use and testing, including the device for measuring the penetration performance of anti-chemotherapy drugs as described in this application, and a purchased device. Two types of nitrile gloves were tested, and the results of testing the same sample with the two different devices were consistent. The results are summarized as follows:

[0060] The test conditions are as follows:

[0061] Duration of contact: 4 hours

[0062] Temperature: 35℃±2℃;

[0063] Sampling site: wrist;

[0064] Collection system: closed loop;

[0065] Analytical method: Triple quadrupole liquid chromatography-mass spectrometry;

[0066] Parallel test quantity: 3 parallel tests.

[0067] Breakthrough detection time: The time from the start of the test until the permeation rate reaches exactly 0.01 μg / cm2 / min, in minutes.

[0068] First nitrile sleeve sample:

[0069] The results of the chemotherapy drug penetration performance test of disposable medical gloves are shown in Table 1:

[0070]

[0071] Second nitrile sleeve sample:

[0072] The results of the chemotherapy drug penetration performance test of disposable medical gloves are shown in Table 2:

[0073]

[0074] Although preferred embodiments of the present invention have been described, those skilled in the art, upon learning the basic inventive concept, can make other changes and modifications to these embodiments. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments as well as all changes and modifications falling within the scope of the present invention.

[0075] Finally, it should be noted that in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or terminal device that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or terminal device. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or terminal device that includes said element.

[0076] The above provides a detailed description of the device for measuring the penetration performance of antichemotherapy drugs in medical protective equipment. Specific examples have been used to illustrate the principle and implementation of this invention. The description of the above embodiments is only for the purpose of helping to understand the method and core idea of ​​this invention. At the same time, for those skilled in the art, there will be changes in the specific implementation and application scope based on the idea of ​​this invention. Therefore, the content of this specification should not be construed as a limitation of this invention.

Claims

1. A device for measuring the penetration performance of medical protective equipment against chemotherapy drugs, characterized in that, It includes a collection chamber and a drug chamber that are connected to each other. Each of the collection chamber and the drug chamber has a flange-like interface on its opposite side and an annular sealing gasket on the outside of the interface. The connection part between the collection chamber and the drug chamber and the corresponding interface is fitted with a connecting plate. The two connecting plates are connected by multiple detachable connectors. The collection chamber has an upward-extending sampling port at the end furthest from the drug chamber; the drug chamber has an upward-extending drug inlet at the end furthest from the collection chamber; and the sampling port and the drug inlet are each equipped with a sealing cap.

2. The apparatus for measuring the permeability of medical protective equipment to chemotherapy drugs according to claim 1, characterized in that, The connecting plate is horseshoe-shaped with its opening facing downwards.

3. The apparatus for measuring the permeability of medical protective equipment to chemotherapy drugs according to claim 1, characterized in that, The flange neck of the collection chamber / drug chamber is also fitted with a buffer gasket; the buffer gasket abuts between the connecting plate and the collection chamber / drug chamber.

4. The apparatus for measuring the permeability of medical protective equipment against chemotherapy drugs according to claim 3, characterized in that, The buffer pad is made of polytetrafluoroethylene.

5. The apparatus for measuring the permeability of medical protective equipment to chemotherapy drugs according to claim 1, characterized in that, The mating surfaces of the collection chamber and the drug chamber are both frosted surfaces.

6. The apparatus for measuring the permeability of medical protective equipment to chemotherapy drugs according to claim 5, characterized in that, The sealing gasket abuts against the interface. It is made of silicone and its surface is covered with a polytetrafluoroethylene film.

7. The apparatus for measuring the permeability of medical protective equipment to chemotherapy drugs according to claim 1, characterized in that, Both the collection chamber and the drug chamber are made of high borosilicate transparent glass.

8. The apparatus for measuring the permeability of medical protective equipment to chemotherapy drugs according to claim 1, characterized in that, The connector includes a bolt and a nut; the bolt passes between two opposing connecting plates and is locked by the nut; wherein the nut is located on one side of the drug chamber; both the bolt head and the nut are provided with anti-slip stripes.

9. The apparatus for measuring the permeability of medical protective equipment against chemotherapy drugs according to claim 1 or 8, characterized in that, The sampling port extends upward from the top of the collection chamber, and its axis is perpendicular to the axis of the collection chamber; the drug delivery port extends upward in an arc shape from the end of the drug chamber.

10. The apparatus for measuring the permeability of medical protective equipment against chemotherapy drugs according to claim 1, characterized in that, The sampling port and the dosing port are respectively provided with external threads, and the sealing cap is threadedly sealed to the sampling port / dosing port.

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