A device for administering a radioactive inhalation preparation for a human body substance balance experiment

Abstract

The utility model discloses a kind of dosing devices of radioactive inhalation preparation for human body material balance experiment, comprising: dosing box, its first side is provided with transparent side plate, and the second side opposite to first side is sealedly connected with flexible sealing cover;Dosing mask is sealedly connected in the middle of flexible sealing cover, and dosing mask is provided with dosing port that is communicated with the inside of dosing box;Dosing device, to provide radioactive inhalation preparation;And dosing glove, it is sealedly connected with glove hole in the middle of transparent side plate, dosing glove is inserted into the inside of dosing box to operate spray dosing device and release radioactive inhalation preparation, so that subject is inhaled radioactive inhalation preparation through oral cavity and nose by oral cavity and nose adhering dosing mask.The utility model can realize accurate oral cavity and nose dosing of radioactive inhalation preparation under sealed condition, can avoid radioactive drug overflow pollution environment in dosing process, also can avoid cross influence between different subjects when dosing.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, and in particular to a delivery device for a radioactive inhalation preparation used in human body material balance experiments. Background Technology

[0002] Human body mass balance studies, as an important component of clinical pharmacology research for innovative drugs, are primarily used to quantitatively and comprehensively describe the absorption, distribution, metabolism, and excretion characteristics of drugs in the human body. They elucidate the elimination pathways and contributions of drugs within the body, support confirmatory clinical study designs, and provide crucial evidence for evaluating the safety and efficacy of innovative drugs in clinical use. Mass balance studies can be conducted using radioactive isotope labeling tracer methods or other suitable methods. Among these, radioactive isotopes (usually...) are used... 14 C or 3 H) labeling and tracing methods for studying human body material balance are currently the most commonly used methods to comprehensively and directly obtain information on drug absorption, distribution, metabolism, and excretion in the human body.

[0003] Innovative drug formulations come in various forms, including common oral and injectable formulations, as well as increasingly emerging inhaled formulations. These drugs must undergo thorough clinical pharmacological evaluation before being marketed, and if systemic exposure is suspected, human material balance studies are required. Material balance research on such formulations in China is still in its early stages. How to administer radioactive inhaled formulations and how to assess their transformation process in vivo are areas that urgently need improvement and exploration. To address these issues and meet the needs of radioactive inhaled formulation administration, this invention provides a closed-loop radioactive inhaled formulation delivery device. This device ensures accurate administration of such formulations while preventing radionuclide leakage and cross-contamination during administration, and ensures that radioactive drugs not inhaled by the patient do not pollute the environment. Utility Model Content

[0004] The technical problem to be solved by this utility model is to provide a drug delivery device for a radioactive inhalation preparation used in human body material balance experiments, addressing the shortcomings of the prior art.

[0005] To solve the above-mentioned technical problems, the technical solution adopted by this utility model is: a drug delivery device for a radioactive inhalation preparation used in human body mass balance experiments, comprising:

[0006] The drug delivery box has a transparent side panel on its first side and a flexible sealing cover sealed to the second side opposite to the first side.

[0007] The drug delivery mask is sealed to the middle of a flexible sealing cover, and the drug delivery mask has a drug delivery port that communicates with the inside of the drug delivery box.

[0008] A drug delivery device disposed inside the drug delivery box for delivering a radioactive inhalation formulation;

[0009] And a drug delivery glove, which is sealed to a glove hole in the middle of a transparent side panel. The drug delivery glove is inserted into the drug delivery box to operate the spray drug delivery device to release the radioactive inhalation agent, so that the subject with the mouth and nose covered by the drug delivery mask can inhale the radioactive inhalation agent through the mouth and nose.

[0010] The remaining sides of the dosing box can also be made of transparent material to allow good light penetration inside, facilitating the operation of the spray dosing device. For example, the entire dosing box can be made of transparent acrylic material. In an optional embodiment, a lighting device can also be installed inside the dosing box.

[0011] The spray delivery device stores the radioactive inhalation preparation required for the experiment. A person using a medication glove can operate the device to release the radioactive inhalation preparation in a spray form, allowing the subject to inhale it through the mouth and nose. For example, in an optional embodiment, the spray delivery device is a conventional press-type spray bottle, which releases the stored radioactive inhalation preparation in a spray form by pressing.

[0012] Preferably, the outer edge of the drug delivery mask has a smooth curved surface that fits in contact with the mouth and nose area of ​​the human face.

[0013] Preferably, the outer edge of the drug delivery mask is sealed with a hollow sealing bladder, and the hollow sealing bladder has an inhalation port in the middle that matches the shape of the mouth and nose of the human face.

[0014] Preferably, the drug delivery mask is equipped with an inflation sealing assembly for inflating air into the hollow sealed bladder. The inflation sealing assembly includes an inflation conduit communicating with the cavity inside the hollow sealed bladder, an inflation ball connected to the end of the inflation conduit, an inlet one-way valve on the inflation ball, an outlet one-way valve connecting the end of the inflation conduit and the inflation ball, and an exhaust valve on the inflation conduit. The inlet one-way valve only allows gas from the external environment to enter the inflation ball, and the outlet one-way valve only allows gas from the inflation ball to enter the inflation conduit. The exhaust valve is located on the inflation conduit between the outlet one-way valve and the hollow sealed bladder. The exhaust valve is a conventional knob valve, which can be easily opened manually to release the air inflated into the hollow sealed bladder.

[0015] Preferably, a silicone sealing strip is provided around the inlet on the outer surface of the hollow sealed bladder. The silicone sealing strip is preferably made of conventional medical-grade silicone.

[0016] Preferably, the drug delivery mask is provided with a fixing strap. The fixing strap can be an elastic strap with an adjustable length; it can also be an adjustable-length strap with a buckle or Velcro structure. After the drug delivery mask is fitted to the subject's mouth and nose, the fixing strap is wrapped around the subject's head and fixed to ensure that the drug delivery mask fits snugly against the subject's mouth and nose.

[0017] The hollow sealing sac and inflatable sealing assembly cooperate with the drug delivery mask and its silicone sealing strip to ensure a better seal and prevent leakage of the radioactive inhaled preparation during administration. In an optional embodiment, the administration process is as follows:

[0018] The drug delivery mask is placed over the subject's mouth and nose, and the fastening straps are wrapped around the subject's head and secured tightly so that the edge of the drug delivery mask fits snugly against the subject's mouth and nose. Then, the inflation ball is repeatedly squeezed to inflate the hollow sealed bladder.

[0019] During this process, the exhaust valve remains closed. External air enters the inflation ball through the intake one-way valve, and then enters the hollow sealing bladder through the exhaust one-way valve and the inflation tube. After the hollow sealing bladder inflates, it squeezes the silicone sealing strip between the hollow sealing bladder and the subject's mouth and nose, causing the silicone sealing strip to further press against the skin of the subject's mouth and nose, thereby achieving a better seal. At the same time, other parts of the hollow sealing bladder (the parts on the outer periphery of the silicone sealing strip) will also adhere to the skin of the subject's mouth and nose due to the inflation, thereby forming a seal on the outer periphery of the silicone sealing strip, further improving the sealing effect.

[0020] The operator then puts their hand into the drug delivery glove and operates the spray delivery device to release the radioactive inhalation agent for the subject to inhale, thus completing the drug delivery.

[0021] Preferably, the flexible sealing cover has a connection port in the middle, and the drug delivery mask is sealed to the connection port through its outer periphery. In a preferred embodiment, the flexible sealing cover is made of conventional plastic material, such as polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), etc., which is flexible and can maintain a good seal.

[0022] The connection points between the flexible sealing cover and the drug delivery box, the connection points between the drug delivery mask and the flexible sealing cover, the connection points between the drug delivery gloves and the transparent side panels, and other parts of the drug delivery box are all sealed to prevent leakage of radioactive inhalation agents.

[0023] After each subject's use, the drug delivery mask must be replaced or disinfected and cleaned to maintain cleanliness. In an optional embodiment, the flexible sealing cover and the drug delivery box adopt a conventional detachable connection structure, and / or the drug delivery mask and the flexible sealing cover adopt a conventional detachable connection structure; this facilitates the replacement or cleaning of the drug delivery mask; it also facilitates the placement and removal of the spray delivery device from the drug delivery box. Furthermore, the connection structure between the drug delivery mask and the flexible sealing cover is a standard component, and the drug delivery mask can be provided in several different sizes (e.g., large, medium, and small) according to age, thereby taking into account the differences among different subjects, facilitating use by people of different ages, and improving its applicability.

[0024] Preferably, the drug delivery box is also provided with air inlet pipes and air outlet pipes that are all connected to the inside of the drug delivery box.

[0025] Preferably, the end of the exhaust pipe is sequentially connected to a waste exhaust valve, a blower, and a waste gas collection bag. The air intake pipe is equipped with an air intake valve. Both the air intake valve and the waste exhaust valve are one-way valves. The air intake valve only allows external air to enter the dosing box, and the waste exhaust valve only allows gas inside the dosing box to enter the waste gas collection bag through the exhaust pipe.

[0026] After each administration, the exhaust fan is turned on to extract the gas containing the radioactive inhalation agent from inside the administration box through the exhaust pipe. The gas is then collected in the waste gas collection bag. After that, the exhaust valve is opened to release the gas from the hollow sealed bag. Then, the fixing straps are removed from the subject's head, and finally, the administration mask is removed from the subject's mouth and nose.

[0027] Preferably, the side length of the drug delivery box is 20-40cm, and the height is 20-40cm. This allows a normal person to insert their face into the drug delivery box and have it fit snugly against the drug delivery mask.

[0028] The number of administration gloves can be set to one or two, depending on the operational requirements of the aerosol delivery device. For example, if the aerosol delivery device is a conventional press-type spray bottle that can be operated with one hand to release the radioactive inhalation agent, then one administration glove is sufficient. Alternatively, two administration gloves can be set, spaced horizontally on the transparent side panel, which makes operating the aerosol delivery device more convenient.

[0029] In use, multiple drug delivery devices of the present invention can be used to administer drugs to multiple subjects simultaneously, thereby enabling better application in human material balance experiments.

[0030] The beneficial effects of this utility model are:

[0031] This invention provides a drug delivery device for a radioactive inhalation preparation used in human material balance experiments. It enables precise oral and nasal delivery of the radioactive inhalation preparation under sealed conditions, avoiding radioactive drug spillage and environmental pollution during drug delivery, and also avoiding cross-influence between different subjects during drug delivery.

[0032] In this invention, by combining the hollow sealing bladder, the inflatable sealing assembly, and the drug delivery mask and its silicone sealing strip, a better seal can be maintained during drug delivery, preventing leakage of the radioactive inhalation agent. During drug delivery, the inflatable sealing assembly inflates the hollow sealing bladder. After the hollow sealing bladder inflates, it squeezes the silicone sealing strip located between the hollow sealing bladder and the subject's mouth and nose, causing the silicone sealing strip to further press against the skin of the subject's mouth and nose, thereby achieving a better seal. At the same time, other parts of the hollow sealing bladder (the parts on the periphery of the silicone sealing strip) will also fit tightly against the skin of the subject's mouth and nose due to inflation, thus forming a seal on the periphery of the silicone sealing strip, further improving the sealing effect. Attached Figure Description

[0033] Figure 1 This is a schematic diagram of the administration device for the radioactive inhalation preparation used in the human body mass balance experiment in Example 1.

[0034] Figure 2 This is a schematic diagram of the drug delivery mask and the inflatable sealing assembly in Example 1;

[0035] Figure 3 This is a schematic diagram of the drug delivery mask in Example 1;

[0036] Figure 4 This is a cross-sectional view of the drug delivery mask in the thickness direction in Example 1;

[0037] Figure 5 This is a schematic diagram of the drug delivery device in Example 1 for use by a subject.

[0038] Explanation of reference numerals in the attached figures:

[0039] 1—Dosing box body; 11—Transparent side panel; 111—Glove hole; 12—Flexible sealing cover; 13—Connection port; 14—Air inlet pipe; 15—Air inlet valve; 16—Exhaust pipe; 17—Waste exhaust valve; 18—Exhaust fan; 19—Waste gas collection bag;

[0040] 2—Medication mask; 21—Medication port; 22—Smooth curved surface; 23—Hollow sealed capsule; 231—Cavity; 24—Inhalation port;

[0041] 25—Inflation sealing assembly; 251—Inflation conduit; 252—Inflation ball; 253—Inlet check valve; 254—Outlet check valve; 255—Exhaust valve;

[0042] 26—Silicone sealing strip;

[0043] 27—Securing straps;

[0044] 3—Drug delivery device;

[0045] 4—Administration gloves. Detailed Implementation

[0046] The present invention will be further described in detail below with reference to the embodiments, so that those skilled in the art can implement it based on the description.

[0047] It should be understood that terms such as “having,” “comprising,” and “including” as used herein do not exclude the presence or addition of one or more other elements or combinations thereof.

[0048] Example 1

[0049] Reference Figure 1-4 This embodiment provides a delivery device for a radioactive inhalation preparation used in human mass balance experiments, comprising:

[0050] The drug delivery box 1 has a transparent side panel 11 on its first side and a flexible sealing cover 12 sealed to the second side opposite to the first side.

[0051] The administration port 21 cover 2 is sealed and connected to the middle of the flexible sealing cover 12. The administration port 21 cover 2 has an administration port 21 that communicates with the inside of the administration box 1.

[0052] The drug delivery device 3 is disposed inside the drug delivery box 1 to provide a radioactive inhalation preparation;

[0053] And the drug delivery glove 4, which is sealed to the glove hole 111 in the middle of the transparent side plate 11. The drug delivery glove 4 is inserted into the drug delivery box 1 to operate the spray drug delivery device 3 to release the radioactive inhalation agent, so that the subject with the mouth and nose in contact with the drug delivery mask 21 can inhale the radioactive inhalation agent through the mouth and nose.

[0054] In this embodiment, the entire drug delivery box 1 is made of conventional transparent acrylic material to ensure good light transmission inside.

[0055] In this embodiment, the spray drug delivery device 3 is a conventional press-type spray bottle, which stores the radioactive inhalation preparation required for the experiment. The stored radioactive inhalation preparation can be released in the form of a spray by manually pressing the bottle.

[0056] The outer edge of the administration port 21 cover 2 has a smooth curved surface 22 that conforms to the mouth and nose area of ​​the human face. A hollow sealing bladder 23 is sealed to the inner circumference of the outer edge of the administration port 21 cover 2, and an inhalation port 24 matching the shape of the mouth and nose area of ​​the human face is opened in the middle of the hollow sealing bladder 23. An inflation sealing assembly 25 for filling the hollow sealing bladder 23 with air is provided on the administration port 21 cover 2. The inflation sealing assembly 25 includes an inflation conduit 251 communicating with the cavity 231 inside the hollow sealing bladder 23, an inflation ball 252 connected to the end of the inflation conduit 251, an inlet one-way valve 253 provided on the inflation ball 252, an outlet one-way valve 254 connected between the end of the inflation conduit 251 and the inflation ball 252, and an exhaust valve 255 provided on the inflation conduit 251.

[0057] The inlet check valve 253 allows gas to enter the inflation ball 252 only from the external environment, while the outlet check valve 254 allows gas to enter the inflation conduit 251 only from the inflation ball 252. The exhaust valve 255 is located on the inflation conduit 251 between the outlet check valve 254 and the hollow sealed bladder 23. The exhaust valve 255 is a conventional knob valve, which can be easily opened manually to release the air that has been filled into the hollow sealed bladder 23.

[0058] Among them, a silicone sealing strip 26 is provided around the suction port 24 on the outer surface of the hollow sealing bladder 23, and the silicone sealing strip 26 is preferably made of conventional medical silicone.

[0059] The administration port 21 cover 2 is provided with a fixing strap 27, which is an elastic strap.

[0060] The flexible sealing cover 12 has a connection port 13 in the middle, and the drug delivery port 21 cover 2 is sealed to the connection port 13 through its outer periphery.

[0061] The connection between the flexible sealing cover 12 and the drug delivery box 1, the connection between the drug delivery port 21 cover 2 and the flexible sealing cover 12, the connection between the drug delivery glove 4 and the transparent side plate 11, and other parts of the drug delivery box 1 are all sealed to prevent leakage of the radioactive inhalation preparation.

[0062] The administration port 21 cover 2 and the flexible sealing cover 12 adopt a conventional detachable connection structure, which allows for easy removal of the administration port 21 cover 2. The flexible sealing cover 12 and the administration box 1 also adopt a conventional detachable connection structure.

[0063] The drug delivery box 1 is also equipped with air inlet pipes 14 and exhaust pipes 16, both of which are connected to the interior of the drug delivery box 1. Air inlet pipes 14 and exhaust pipes 16 are respectively equipped with air intake valves 15 and waste exhaust valves 17. The end of the air intake pipe 14 is connected to a blower, and the end of the exhaust pipe 16 is connected to a waste gas collection bladder 19. Both the air intake valve 15 and the waste exhaust valve 17 are one-way valves. The air intake valve 15 only allows external air to enter the interior of the drug delivery box 1, and the waste exhaust valve 17 only allows gas from inside the drug delivery box 1 to enter the waste gas collection bladder 19 via the exhaust pipe 16.

[0064] The quantity of the drug delivery gloves 4 is one.

[0065] In this embodiment, the dimensions of the drug delivery box 1 provided as an example are: a cube shape with a side length of 24cm.

[0066] The procedure for using the radioactive inhalation preparation delivery device for human body mass balance experiments in this embodiment is as follows:

[0067] 1. Administration of medication:

[0068] The aerosol delivery device 3, containing the radioactive inhalation preparation required for the experiment, is placed at the bottom of the box beforehand;

[0069] The administration port 21 cover 2 is placed over the subject's mouth and nose. The fixing strap 27 is wrapped around the subject's head and secured tightly, so that the edge of the administration port 21 cover 2 is in close contact with the subject's mouth and nose. The exhaust valve 255 is kept closed. Then, the inflation ball 252 is repeatedly squeezed to inflate the hollow sealing bladder 23. The squeezing of the hollow sealing bladder 23 causes the silicone sealing strip 26 between the hollow sealing bladder 23 and the subject's mouth and nose to press against the skin of the subject's mouth and nose, thereby maintaining a good seal. At the same time, the part of the hollow sealing bladder 23 located on the periphery of the silicone sealing strip 26 will also adhere to the skin of the subject's mouth and nose due to the inflation, thereby forming a seal around the silicone sealing strip 26, further improving the sealing effect.

[0070] The operator puts their hand into the drug delivery glove 4 and operates the press spray delivery device 3 to release the radioactive inhalation preparation for the subject to inhale, thus achieving drug delivery.

[0071] Reference Figure 5 This is a schematic diagram of a drug delivery device for use by a subject.

[0072] 2. Cleaning:

[0073] After the required administration time is reached, first turn on the exhaust fan 18 to extract the gas containing the radioactive inhalation agent inside the administration box 1 through the exhaust pipe 16 (the extraction time is selected according to actual needs). Then, the gas enters the waste gas collection bag 19 for collection (subsequent centralized filtration and purification). Then, manually open the exhaust valve 255 to release the gas in the hollow sealed bag 23. Then, remove the fixing strap 27 from the subject's head and finally remove the administration port 21 mask 2 from the subject's mouth and nose.

[0074] Remove the administration port 21 cover 2 from the flexible sealing cover 12 and replace it with a new administration port 21 cover 2, or clean, disinfect and reuse it; after a period of use, the flexible sealing cover 12 can be removed from the administration box 1, and then the inside of the administration box 1 can be cleaned before reuse.

[0075] It should be understood that the above usage process is merely a routine working step based on the structure of this utility model, and this utility model has not made any methodological improvements.

[0076] In the description of this utility model, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this utility model and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model.

[0077] Although the embodiments of this utility model have been disclosed above, they are not limited to the applications listed in the specification and embodiments. They can be applied to various fields suitable for this utility model. For those skilled in the art, other modifications can be easily made. Therefore, without departing from the general concept defined by the claims and their equivalents, this utility model is not limited to the specific details.

Claims

1. A delivery device for a radioactive inhalation preparation used in human body mass balance experiments, characterized in that, include: The drug delivery box has a transparent side panel on its first side and a flexible sealing cover sealed to the second side opposite to the first side. The drug delivery mask is sealed to the middle of a flexible sealing cover, and the drug delivery mask has a drug delivery port that communicates with the inside of the drug delivery box. A drug delivery device disposed inside the drug delivery box for delivering a radioactive inhalation formulation; And a drug delivery glove, which is sealed to a glove hole in the middle of a transparent side panel. The drug delivery glove is inserted into the drug delivery box to operate the spray drug delivery device to release the radioactive inhalation agent, so that the subject with the mouth and nose covered by the drug delivery mask can inhale the radioactive inhalation agent through the mouth and nose.

2. The drug delivery device for a radioactive inhalation preparation used in human body mass balance experiments according to claim 1, characterized in that, The outer edge of the drug delivery mask has a smooth curved surface that fits snugly against the mouth and nose area of ​​the human face.

3. The drug delivery device for a radioactive inhalation preparation used in human body mass balance experiments according to claim 2, characterized in that, The outer edge of the drug delivery mask is sealed with a hollow sealing bladder, and the center of the hollow sealing bladder has an inhalation port that matches the shape of the mouth and nose of the human face.

4. The drug delivery device for a radioactive inhalation preparation used in human body mass balance experiments according to claim 3, characterized in that, The drug delivery mask is provided with an inflatable sealing assembly for filling the hollow sealed bladder with air. The inflatable sealing assembly includes an inflation conduit communicating with the cavity inside the hollow sealed bladder, an inflation ball connected to the end of the inflation conduit, an inlet one-way valve provided on the inflation ball, an outlet one-way valve connected between the end of the inflation conduit and the inflation ball, and an exhaust valve provided on the inflation conduit.

5. The drug delivery device for a radioactive inhalation preparation used in human body mass balance experiments according to claim 4, characterized in that, A silicone sealing strip is provided around the inlet on the outer surface of the hollow sealed bladder.

6. The drug delivery device for a radioactive inhalation preparation used in human body mass balance experiments according to claim 4, characterized in that, The drug delivery mask is equipped with a fixing strap.

7. The drug delivery device for a radioactive inhalation preparation used in human body mass balance experiments according to claim 1, characterized in that, The flexible sealing cover has a connection port in the middle, and the drug delivery mask is sealed to the connection port through its outer periphery.

8. The drug delivery device for a radioactive inhalation preparation used in human body mass balance experiments according to claim 1, characterized in that, The drug delivery box is also equipped with air inlet pipes and exhaust pipes that are connected to the inside of the drug delivery box at intervals.

9. The drug delivery device for a radioactive inhalation preparation used in human body mass balance experiments according to claim 8, characterized in that, The exhaust pipe is connected in sequence to a waste exhaust valve, a blower and a waste gas collection bag. The intake pipe is equipped with an air intake valve. Both the air intake valve and the waste exhaust valve are one-way valves.

10. The administration device for a radioactive inhalation preparation for human body mass balance experiments according to claim 9, characterized in that, The side length of the drug delivery box is 20-40cm, and the height is 20-40cm.

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