A device for precise dosing in clinical trials

Abstract

The application belongs to the technical field of medical devices, and particularly relates to a device for precise drug delivery in clinical trials, which comprises a kettle body, the upper end of the kettle body is threadedly connected with an extension pipe, the upper end of the extension pipe is provided with a medicine applying end, a plurality of annular through grooves and a plurality of liquid outlet holes are uniformly formed on the outer side of the medicine applying end, the annular through grooves and the liquid outlet holes are alternately distributed, a storage capsule is fixed in the annular through grooves, the kettle body is configured to store liquid medicine, and the storage capsule is configured to store paste medicine. The device can be changed from an initial state to a liquid state or a paste state through the cooperation of the first guide sliding groove, the second guide sliding groove and the guide pin rod to guide the anti-skid direction of the sleeve, liquid medicine or paste medicine can be delivered to the lesion inside the anorectal cavity through the device in different states, the device can simultaneously meet the drug delivery requirements of liquid medicine and paste medicine, and the practicability of the device is improved.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a device for precise drug delivery in clinical trials. Background Technology

[0002] Precision drug delivery is a crucial aspect of clinical trials and the treatment of anorectal diseases, directly impacting drug efficacy, the accuracy of trial data, and patient safety. In anorectal disease diagnosis and treatment, targeted drug delivery via the anus is a common method for local treatment, lesion intervention, and clinical efficacy evaluation, playing a significant role in improving drug bioavailability and reducing systemic adverse reactions. With the advancement of precision medicine and standardized clinical trials, clinicians are placing higher demands on the positioning accuracy, drug compatibility, and delivery effectiveness of drug delivery devices, urgently requiring stable, reliable, and multi-dosage-compatible precision drug delivery devices.

[0003] Currently, conventional rectal drug delivery devices have significant technical shortcomings in clinical trials and practical use, making it difficult to meet the needs of precise drug delivery. First, fecal secretions and other substances may remain on the rectal wall before drug delivery, which can block the contact between the drug and the lesion mucosa, preventing the drug from acting directly on the target site and affecting the treatment effect and the authenticity of the experimental data. Second, when delivering ointment-type drugs, the device is easily squeezed by the anal sphincter, causing the ointment to leak out prematurely and be unevenly distributed, failing to deliver it completely and effectively to the lesion area, resulting in low drug utilization. In addition, existing drug delivery devices have limited dosage form compatibility, mostly only compatible with either liquid or ointment-type drugs, making it difficult to meet the drug delivery needs of different experimental protocols and different drug forms, resulting in insufficient versatility and practicality.

[0004] The aforementioned problems collectively result in shortcomings in the accuracy, effectiveness, and versatility of existing anorectal drug delivery devices, which not only reduce the consistency of drug administration and the reliability of data in clinical trials, but also affect the local treatment effect. In order to meet the requirements of standardized treatment of anorectal diseases and high-quality clinical trials, there is an urgent need to develop a precise drug delivery device for clinical trials that can eliminate local interference, stably deliver drugs, and be compatible with multiple dosage forms, so as to solve the pain points of existing technologies. Summary of the Invention

[0005] The purpose of this invention is to provide a device for precise drug delivery in clinical trials. The device guides the anti-slip direction of the sleeve through the cooperation of a first guide groove, a second guide groove, and a guide pin, enabling the device to change from an initial state to a liquid state or an ointment state. By delivering liquid or ointment drugs to lesions inside the anorectal cavity through the device in different states, the device can simultaneously meet the drug delivery needs of both liquid and ointment drugs, significantly improving the versatility and practicality of the device.

[0006] The specific technical solution adopted by this invention is as follows: A device for precise drug delivery in clinical trials includes a pot body, an extension tube threaded to the upper end of the pot body, a drug application end at the upper end of the extension tube, and multiple annular grooves and multiple liquid outlet holes evenly distributed on the outer side of the drug application end, with the annular grooves and liquid outlet holes alternately distributed. A storage sac is fixed inside the annular grooves. The pot body is configured to store liquid drugs, and the storage sac is configured to store ointment drugs. The device also includes: Operating condition switching component, wherein the operating condition switching component is mounted on the outside of the extension tube; When the operating condition switching component is operated, the device can switch between an initial state, a paste state, and a liquid state. The device in the paste state is configured to deliver paste medicine; the device in the liquid state is configured to deliver liquid medicine; and the device in the initial state is configured to seal the paste medicine. The operating condition switching component can also cover the liquid outlet and the storage bladder.

[0007] In a preferred embodiment, the storage capsule is made of any one of the following materials: medical silicone, medical RPE, medical TPU, or other flexible materials with elastic properties.

[0008] In a preferred embodiment, the operating condition switching component includes a sleeve and multiple baffles. The sleeve is slidably connected to the outside of the extension tube, and the multiple baffles are movably snapped into the upper end of the sleeve. The application end and the baffles are slidably connected. The baffles are adapted to the liquid outlet. When the device is in the initial state or the ointment state, the baffles block the liquid outlet, and the inside of the pot and the extension tube forms a sealed chamber. When the device is in the liquid state, the baffles release the blockage of the liquid outlet.

[0009] In a preferred embodiment, the inside of the application end is fixed with multiple guide rails, and the multiple guide rails and multiple liquid outlet holes, as well as the multiple baffles and multiple guide rails, are all adapted to each other. The baffles and the application end are slidably connected through the guide rails.

[0010] In a preferred embodiment, the lower end of the outer side of the sleeve is provided with a first guide groove, a second guide groove, and a reversing transverse groove. The extension direction of the first guide groove and the second guide groove is the same as the direction of the central axis of the sleeve, and the first guide groove and the second guide groove are interconnected through the reversing transverse groove. The first guide groove, the second guide groove, and the reversing transverse groove form a U-shaped guide groove. The lower end of the outer side of the extension tube is fixed with a guide pin, and the guide pin is adapted to the U-shaped guide groove.

[0011] In a preferred embodiment, a limiting groove is provided at the upper end of the interior of the reversing transverse groove, and the limiting groove is adapted to the guide pin. In the initial state of the device, the guide pin and the limiting groove are in contact.

[0012] In a preferred embodiment, the upper end of the sleeve is provided with a plurality of first linkage slots, and the lower end of the baffle is provided with a second linkage slot. The first linkage slots and the second linkage slots are adapted to each other. When the device is in the initial state or the liquid state, the first linkage slots and the second linkage slots are in contact with each other. When the device is in the ointment state, the first linkage slots and the second linkage slots are disengaged from each other.

[0013] In a preferred embodiment, a plurality of collection grooves are provided at the upper end of the outer side of the sleeve, the upper end of the collection grooves extends through the sleeve to form an open end, and the lower end of the collection grooves is integrally closed by the material of the sleeve to form a closed end.

[0014] In a preferred embodiment, the lower end of the outer side of the sleeve is provided with multiple anti-slip grooves.

[0015] In a preferred embodiment, a sealing element is fitted between the baffle plate and the application end.

[0016] The technical effects achieved by this invention are as follows: After the device is delivered to the lesion site, the present invention rotates the sleeve, and the residue on the inner wall of the anorectal cavity can be cleaned and collected through the collection groove opened on the sleeve. This avoids the residue from blocking the contact between the drug and the lesion mucosa, ensuring that the drug can directly act on the target site, and improving the accuracy of drug use, the accuracy of data and the reliability of treatment effect in clinical trials. The present invention can limit the device in its initial state by means of the cooperation of the guide pin and the limiting slot. During the delivery of the drug, the sleeve covers the ointment inside the storage bag, which effectively avoids the ointment from overflowing prematurely due to the squeezing of the anal sphincter during the delivery process, and also prevents external contaminants from entering the device and contaminating the drug. This invention guides the anti-slip direction of the sleeve through the cooperation of the first guide groove, the second guide groove, and the guide pin, enabling the device to change from an initial state to a liquid state or an ointment state. By delivering liquid or ointment drugs to lesions inside the anorectal cavity through the device in different states, the device can simultaneously meet the drug delivery needs of both liquid and ointment drugs, significantly improving the versatility and practicality of the device, and effectively solving the technical deficiency of the single dosage form adaptability of existing drug delivery devices. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the overall structure of the present invention; Figure 2 This is a cross-sectional view of the overall structure of the present invention; Figure 3 This is the present invention. Figure 2 A magnified view of a portion of point A in the middle; Figure 4 This is an exploded view of the overall structure of the present invention; Figure 5 This is a schematic diagram of the structure of the storage capsule of the present invention; Figure 6 This is a schematic diagram of the structure of the upper end of the sleeve of the present invention; Figure 7 This is a schematic diagram of the structure of the lower outer end of the sleeve of the present invention; Figure 8 This is a schematic diagram of the structure of the flow-blocking plate and guide rail of the present invention; Figure 9 This is a schematic diagram of the sleeve and flow baffle plate of the device of the present invention when it is in the liquid state; Figure 10 This is a schematic diagram of the sleeve and flow baffle plate in the initial state of the device of the present invention; Figure 11 This is a schematic diagram of the sleeve and flow baffle plate of the device of the present invention when it is in the ointment state.

[0018] The attached diagram lists the components represented by each number as follows: 10. Pot body; 11. Extension tube; 12. Application end; 13. Annular groove; 14. Dispensing hole; 15. Storage bag; 16. Guide pin; 20. Operating condition switching component; 21. Sleeve; 211. Collection trough; 22. Baffle plate; 221. Sealing element; 23. Guide slide rail; 24. First guide slide groove; 25. Second guide slide groove; 26. Reversing transverse groove; 27. Limiting slot; 28. First linkage slot; 29. ​​Second linkage slot. Detailed Implementation

[0019] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0020] Many specific details are set forth in the following description in order to provide a full understanding of the invention. However, the invention may also be practiced in other ways different from those described herein, and those skilled in the art can make similar extensions without departing from the spirit of the invention. Therefore, the invention is not limited to the specific embodiments disclosed below.

[0021] Secondly, the term "an embodiment" or "embodiment" as used herein refers to a specific feature, structure, or characteristic that may be included in at least one implementation of the present invention. The phrase "in a preferred embodiment" appearing in different places throughout this specification does not necessarily refer to the same embodiment, nor is it a single or selective embodiment that mutually excludes other embodiments.

[0022] Secondly, the present invention is described in detail with reference to the schematic diagrams. When detailing the embodiments of the present invention, for ease of explanation, the cross-sectional views illustrating the device structure may be partially enlarged, not according to the usual scale. Furthermore, the schematic diagrams are merely examples and should not limit the scope of protection of the present invention. In addition, actual fabrication should include the three-dimensional spatial dimensions of length, width, and depth.

[0023] Please see the appendix Figures 1 to 5 As shown, this is the first embodiment of the present invention. This embodiment provides a device for precise drug delivery in clinical trials, including a pot body 10 configured to store liquid medication. An extension tube 11 is threadedly connected to the upper end of the pot body 10. An application end 12 is provided at the upper end of the extension tube 11. Multiple annular grooves 13 and multiple liquid outlet holes 14 are evenly distributed on the outer side of the application end 12, and the annular grooves 13 and liquid outlet holes 14 are alternately distributed. A storage sac 15 is fixed inside the annular grooves 13. The pot body 10 is configured to store liquid medication, and the storage sac 15 is configured to store ointment medication. The device also includes: Operating condition switching component 20 is mounted on the outside of extension tube 11; The device is equipped with an operating condition switching component 20, which can switch between an initial state, a paste state, and a liquid state. The device in the paste state is configured to deliver paste medicine; the device in the liquid state is configured to deliver liquid medicine; and the device in the initial state is configured to seal the paste medicine. The operating condition switching component 20 can also cover the liquid outlet 14 and the storage bladder 15.

[0024] In this embodiment, when applying medication to the lesion inside the patient's rectum, if the medication is liquid, the extension tube 11 is rotated to separate the pot 10 from the extension tube 11, the liquid medication is injected into the pot 10, and then the extension tube 11 is reconnected to the pot 10. If the medication is ointment, the operating condition switching component 20 is operated to change the device from the initial state to the ointment state, the ointment is injected into the storage sac 15, and then the operating condition switching component 20 is reversed to return the device to the initial state. At this time, the operating condition switching component 20 can control the liquid outlet. 14. The storage pouch 15 and the ointment form a protective cover, effectively preventing the ointment from being squeezed by the anal sphincter and causing premature leakage when the device is inserted into the anus. After the medication is assembled inside the device, the applicator 12 is delivered from the anus to the lesion by holding the pot 10. Holding the pot 10 drives the extension tube 11 and the operating condition switching component 20 to rotate synchronously. The operating condition switching component 20 cleans and collects the residue on the anal wall. Operating the operating condition switching component 20 changes the device from the initial state to the ointment state or liquid state. Squeezing the pot 10 allows the medication to be applied to the lesion. The medication is applied to the lesion site. When the medication is liquid, the operating condition switching component 20 is activated, changing the device from its initial state to a liquid state. The component 20 is then removed from the liquid outlet 14 and storage sac 15, and the container 10 is squeezed, allowing the liquid medication inside to flow from the liquid outlet 14 to the lesion site. When the medication is an ointment, the operating condition switching component 20 is activated, changing the device from its initial state to an ointment state. The component 20 is then removed from the liquid outlet 14 and storage sac 15, and the container 10 is squeezed, allowing the liquid medication inside to flow from the liquid outlet 14 to the lesion site. The increased air pressure squeezes the storage sac 15, causing it to flip outwards towards the application end 12. This squeezes out the ointment stored inside the storage sac 15 and applies it to the lesion surface. The operating condition switching component 20 drives the device to switch between the initial state, liquid state, and ointment state. This allows the device to not only clean the residue on the anorectal wall but also simultaneously meet the delivery needs of both liquid and ointment medications. At the same time, it ensures the device's airtightness before application, effectively preventing medication leakage and avoiding external contaminants from entering the device and contaminating the medication.

[0025] In a preferred embodiment, the storage pouch 15 is made of any one of the following materials: medical silicone, medical RPE, medical TPU or other flexible materials with elastic properties. In this embodiment, the storage pouch 15 is preferably made of medical silicone.

[0026] In this embodiment, the storage sac 15 made of medical-grade silicone has good biocompatibility and elasticity. When the device is in its initial state, the storage sac 15 maintains its initial state under its own elasticity, and the ointment can be stored inside the storage sac 15. When the device switches to the ointment state and is squeezed by the air pressure inside the pot 10, the storage sac 15 can be smoothly folded outward to the application end 12 to ensure that the ointment is completely squeezed out. After the medication is administered, the storage sac 15 can return to its initial shape due to its rebound properties, which facilitates the cleaning and reuse of the device. At the same time, the flexible material can avoid mechanical damage to the anal wall and improve the safety of use.

[0027] Secondly, please refer to the following as well. Figures 1 to 4 The working condition switching component 20 includes a sleeve 21 and multiple baffles 22. The sleeve 21 is slidably connected to the outside of the extension tube 11. The multiple baffles 22 are movably snapped into the upper end of the sleeve 21. The application end 12 is slidably connected to the baffles 22. The baffles 22 are adapted to the liquid outlet 14. When the device is in the initial state or the ointment state, the baffles 22 block the liquid outlet 14, and the inside of the pot body 10 and the extension tube 11 forms a sealed chamber. When the device is in the liquid state, the baffles 22 release the blockage of the liquid outlet 14.

[0028] It should be noted that when the device is in liquid state or initial state, the baffle plate 22 and the sleeve 21 are connected to each other; when the device is in paste state, the baffle plate 22 and the sleeve 21 are disconnected from each other.

[0029] Furthermore, the outer side of the sleeve 21 is provided with multiple scale markings, which can be used to determine the position of the medication application end 12 inside the anus and rectum. In this embodiment, the scale markings are digital scale markings.

[0030] Furthermore, a limiting groove is provided at the lower end of the application end 12, and the flow baffle 22 is slidably connected to the inside of the limiting groove.

[0031] In this embodiment, when delivering medication into the patient's rectum, the applicator 12 is delivered through the anus to the lesion by holding the pot body 10. The pot body 10 is held while the extension tube 11 and the operating mode switching component 20 rotate synchronously. Residual substances on the rectal wall are cleaned and collected through the upper outer end of the sleeve 21. After cleaning, the pot body 10 is held while the extension tube 11 remains stationary. If the medication is liquid, the sleeve 21 is rotated forward and pulled towards the pot body 10. The sleeve 21 and the baffle plate 22 are snapped together. The sleeve 21 drives the baffle plate 22 to move synchronously, changing the device from its initial state to a liquid state. After the baffle plate 22 disengages from the liquid outlet 14, the baffle plate 22 releases its blockage of the liquid outlet 14, squeezing the pot body 10. This allows the liquid medicine inside the pot body 10 to flow sequentially through the extension tube 11 and the inside of the liquid outlet 14 to the lesion location. If the medicine is a paste, the sleeve 21 is rotated in the opposite direction and pulled towards the pot body 10. The cover formed by the sleeve 21 on the storage sac 15 is removed, and the jar body 10 is squeezed, so that the gas inside the jar body 10 flows into the extension tube 11 and squeezes the storage sac 15, causing the storage sac 15 to deform and squeeze out the ointment inside the storage sac 15 and apply it to the surface of the lesion. This allows the device to not only clean the residue on the inner wall of the anus and rectum, but also to meet the delivery needs of liquid and ointment drugs at the same time.

[0032] It should be noted that in this embodiment, rotating the sleeve 21 in the forward direction and rotating the sleeve 21 in the reverse direction only indicate that the rotation direction of the sleeve 21 is different, and does not constitute a specific limitation on the rotation direction.

[0033] Secondly, please refer to it again. Figure 3 and Figure 8 Multiple guide rails 23 are fixed inside the application end 12, and the multiple guide rails 23 and multiple liquid outlet holes 14, as well as the multiple baffles 22 and multiple guide rails 23 are all adapted to each other. The baffles 22 and the application end 12 are slidably connected through the guide rails 23.

[0034] In this embodiment, during the state switching process of the device, the guide rail 23 can guide the baffle plate 22 to prevent the baffle plate 22 from deviating during its movement, thus ensuring good stability of the device during the process.

[0035] Please refer to it again. Figure 7The lower end of the outer side of the sleeve 21 is provided with a first guide groove 24, a second guide groove 25 and a reversing transverse groove 26. The extension direction of the first guide groove 24 and the second guide groove 25 is the same as the direction of the central axis of the sleeve 21, and the first guide groove 24 and the second guide groove 25 are interconnected through the reversing transverse groove 26. The first guide groove 24, the second guide groove 25 and the reversing transverse groove 26 form a U-shaped guide groove. The lower end of the outer side of the extension tube 11 is fixed with a guide pin 16, and the guide pin 16 is compatible with the U-shaped guide groove.

[0036] It should be noted that a first mark and a second mark are provided on the outer side of the sleeve 21, and the first mark is adapted to the first guide groove 24, and the second mark is adapted to the second guide groove 25. In this embodiment, the first mark is "ointment" and the second mark is "liquid". The setting of the first mark and the second mark facilitates the staff to conveniently adjust the state of the device.

[0037] In this embodiment, when delivering medication into the patient's rectum, if the medication is a liquid, rotate the sleeve 21 until the guide pin 16 moves into the first guide groove 24. At this time, the sleeve 21 and the baffle plate 22 are engaged with each other. Then pull the sleeve 21 towards the body 10. The sleeve 21 drives the baffle plate 22 to move synchronously, so that the baffle plate 22 releases the blockage of the liquid outlet 14, changing the device from the initial state to the liquid state. Squeezing the body 10 allows the liquid medication inside the body 10 to flow through the liquid outlet 14 to the lesion surface. If the medication is a paste, rotate the sleeve... The sleeve 21 is pulled until the guide pin 16 moves into the second guide groove 25. At this time, the sleeve 21 and the baffle plate 22 are separated from each other. The baffle plate 22 still keeps the liquid outlet hole 14 blocked, and the inside of the pot body 10 and the extension tube 11 is still a closed chamber. Pull the sleeve 21 towards the pot body 10 to release the cover of the storage bag 15 by the sleeve 21, so that the device changes from the initial state to the ointment state. Squeeze the pot body 10 to make the medium inside the pot body 10 flow and squeeze the storage bag 15, so that the storage bag 15 deforms and squeezes out the ointment inside, so that the ointment is applied to the surface of the lesion.

[0038] Please refer to it again. Figure 7 A limiting slot 27 is provided at the upper end of the interior of the reversing transverse groove 26, and the limiting slot 27 is adapted to the guide pin 16. When the device is in the initial state, the guide pin 16 and the limiting slot 27 are in contact.

[0039] In this embodiment, when delivering the medication to the patient's rectum, the device is in its initial state. At this time, the guide pin 16 and the limiting groove 27 are in contact with each other. The guide pin 16 limits the sleeve 21. Through the cooperation of the limiting groove 27 and the guide pin 16, the relative rotation or movement of the sleeve 21 and the extension tube 11 can be avoided. This ensures that the ointment will not be squeezed by the anal sphincter before the medication application end 12 reaches the lesion, thus preventing the ointment from overflowing.

[0040] Please refer to it again. Figure 6 as well as Figures 8 to 11 The upper end of the sleeve 21 is provided with multiple first linkage slots 28, and the lower end of the baffle plate 22 is provided with a second linkage slot 29. The first linkage slots 28 and the second linkage slots 29 are compatible with each other. When the device is in the initial state or liquid state, the first linkage slots 28 and the second linkage slots 29 are in contact with each other. When the device is in the ointment state, the first linkage slots 28 and the second linkage slots 29 are disengaged from each other.

[0041] In this embodiment, when the device is in the initial state or liquid state, the sleeve 21 and the baffle plate 22 are engaged by the cooperation of the first linkage slot 28 and the second linkage slot 29, so that when the liquid medicine is delivered to the patient, the baffle plate 22 can move synchronously with the sleeve 21 and release the blockage of the liquid outlet 14. When the device is in the ointment state, the sleeve 21 and the baffle plate 22 are disengaged, and the baffle plate 22 keeps the liquid outlet 14 blocked, so that the sealed chamber formed inside the pot 10 and the extension tube 11 has good sealing performance. Then, after squeezing the pot 10, the medium (such as air) inside the pot 10 can squeeze the storage bladder 15, thereby squeezing out the ointment medicine.

[0042] Please refer to it again. Figure 4 and Figure 6 Multiple collection grooves 211 are provided on the upper end of the outer side of the sleeve 21. The upper end of the collection groove 211 extends through the sleeve 21 to form an open end, and the lower end of the collection groove 211 is closed by the material of the sleeve 21 to form a closed end.

[0043] In this embodiment, after holding the pot body 10 and delivering the medication end 12 to the lesion site through the anus, holding the pot body 10 drives the extension tube 11 and the sleeve 21 to rotate synchronously, causing the collection tank 211 to rotate synchronously. The collection tank 211 cleans and collects the residue on the anal wall, thereby effectively... To prevent residues from interfering with the contact between the medication and the lesion and to ensure the effectiveness of the medication, the open end is designed to allow residues to enter the collection tank 211 smoothly, while the closed end is designed to prevent or reduce the overflow of residues collected inside the collection tank 211.

[0044] In a preferred embodiment, the lower end of the outer side of the sleeve 21 is provided with multiple anti-slip grooves.

[0045] In this embodiment, the anti-slip texture increases the friction between the sleeve 21 and the user's hand, thereby making it easier for the user to apply force.

[0046] Please refer to it again. Figure 8 A sealing element 221 is assembled between the flow deflector 22 and the application end 12.

[0047] In this embodiment, when the treatment is in the form of a paste, the sealing element 221 can improve the sealing performance of the sealed chamber formed by the pot body 10 and the extension tube 11, and prevent air leakage.

[0048] In a preferred embodiment, a first frustum is formed at the upper end of the outer side of the application end 12, and a second frustum is formed at the upper end of the outer side of the sleeve 21. When the device is in the initial state, the first frustum and the second frustum form a smooth transition surface.

[0049] The working principle of this invention is as follows: When applying medication to the lesion inside the patient's rectum, if the medication is liquid, rotate the extension tube 11 to separate the pot 10 from the extension tube 11, inject the liquid medication into the pot 10, and then reconnect the extension tube 11 to the pot 10. If the medication is ointment, rotate the sleeve 21 to rotate the guide pin 16 into the second guide groove 25 and pull the sleeve 21 towards the pot 10 to remove the sleeve 21 from covering the storage sac 15. After placing the ointment medication into the storage sac 15, return the device to its initial state. After the medication is assembled into the device, hold the pot 10 and deliver the application end 12 from the anus to the lesion. Hold the extension tube 11 and the sleeve 21 and rotate them synchronously. The collection groove 211 at the end of the sleeve 21 cleans and collects the residue on the anorectal wall. Rotate and pull the sleeve 21 towards the pot 10 to change the device from the initial state to the ointment state or liquid state. Squeeze the pot 10 to apply the medication to the lesion. When the medication is liquid, rotate the sleeve 21 until the guide pin 16 is in the first guide position. Pull the sleeve 21 further into the groove 24 and closer to the vessel body 10. Simultaneously, the sleeve 21 moves the baffle plate 22, releasing the baffle plate's blockage of the outlet hole 14. This changes the device from its initial state to a liquid state, releasing the sleeve 21's cover over the outlet hole 14 and storage sac 15. Squeezing the vessel body 10 allows the liquid medicine inside to flow from the outlet hole 14 to the lesion. When the medicine is a paste, rotate the sleeve 21 until the guide pin 16 is inside the second guide groove 25, allowing the sleeve to... The tube 21 and the baffle plate 22 are separated from each other. Then, the sleeve 21 is pulled towards the pot body 10, so that the device changes from the initial state to the ointment state. The sleeve 21 is removed from covering the liquid outlet 14 and the storage bladder 15. The pot body 10 is squeezed, the air pressure inside the pot body 10 increases, and the storage bladder 15 is squeezed, so that the storage bladder 15 flips outward towards the application end 12, thereby squeezing out the ointment stored inside the storage bladder 15 and applying it to the surface of the lesion, thus completing the delivery of the ointment. After the drug delivery is completed, the entire device can be removed by holding the pot body 10.

[0050] The above are merely preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention. Structures, devices, and operating methods not specifically described or explained in this invention are implemented according to conventional methods in the art unless otherwise specified or limited.

Claims

1. A device for precise drug delivery in clinical trials, characterized in that: The device includes a pot body (10), with an extension tube (11) threaded to the upper end of the pot body (10). An application end (12) is provided at the upper end of the extension tube (11). Multiple annular grooves (13) and multiple liquid outlet holes (14) are evenly distributed on the outer side of the application end (12), and these annular grooves (13) and liquid outlet holes (14) are alternately distributed. A storage sac (15) is fixed inside the annular grooves (13). The pot body (10) is configured to store liquid medicine, and the storage sac (15) is configured to store ointment medicine. The device also includes: Operating condition switching assembly (20), which is assembled on the outside of extension tube (11), includes a sleeve (21) and multiple baffles (22). The sleeve (21) is slidably connected to the outside of extension tube (11), and the multiple baffles (22) are snapped into the upper end inside the sleeve (21). The application end (12) is slidably connected to the baffles (22). When the device is in its initial or ointment state, the baffle plate (22) blocks the outlet (14) in accordance with the liquid outlet (14), and a sealed chamber is formed inside the vessel body (10) and the extension tube (11); when the device is in its liquid state, the baffle plate (22) releases the blockage of the outlet (14), and a first guide groove (24), a second guide groove (25), and a reversing crossbar are provided at the lower end of the outer side of the sleeve (21). The first guide groove (24) and the second guide groove (25) are connected to each other through the reversing transverse groove (26). The first guide groove (24), the second guide groove (25) and the reversing transverse groove (26) form a U-shaped guide groove. The lower end of the outer side of the extension tube (11) is fixed with a guide pin (16), and the guide pin (16) and the U-shaped guide groove are adapted to each other. The upper end of the sleeve (21) is provided with a plurality of first linkage slots (28), and the lower end of the baffle plate (22) is provided with a second linkage slot (29). The first linkage slots (28) and the second linkage slots (29) are adapted to each other. When the device is in the initial state or liquid state, the first linkage slots (28) and the second linkage slots (29) are in contact with each other. When the device is in the ointment state, the first linkage slots (28) and the second linkage slots (29) are disengaged from each other. When the operating condition switching component (20) is operated, the device can switch between an initial state, an ointment state, and a liquid state. The device in the ointment state is configured to deliver ointment medicine; the device in the liquid state is configured to deliver liquid medicine; and the device in the initial state is configured to seal ointment medicine. The operating condition switching component (20) can also cover the liquid outlet (14) and the storage sac (15).

2. The device for precise drug delivery in clinical trials according to claim 1, characterized in that: The storage capsule (15) is made of any one of the following materials: medical silicone, medical RPE, or medical TPU.

3. The device for precise drug delivery in clinical trials according to claim 1, characterized in that: The inside of the application end (12) is fixed with multiple guide rails (23), and the multiple guide rails (23) and multiple liquid outlet holes (14), as well as the multiple baffles (22) and multiple guide rails (23) are all adapted to each other. The baffles (22) and the application end (12) are slidably connected through the guide rails (23).

4. The device for precise drug delivery in clinical trials according to claim 1, characterized in that: The upper end of the reversing transverse groove (26) is provided with a limiting slot (27), and the limiting slot (27) and the guide pin (16) are adapted to each other. When the device is in the initial state, the guide pin (16) and the limiting slot (27) are in contact.

5. The device for precise drug delivery in clinical trials according to claim 1, characterized in that: The upper end of the outer side of the sleeve (21) is provided with multiple collection grooves (211). The upper end of the collection groove (211) extends through the sleeve (21) to form an open end. The lower end of the collection groove (211) is closed by the material of the sleeve (21) to form a closed end.

6. The device for precise drug delivery in clinical trials according to claim 1, characterized in that: The lower end of the outer side of the sleeve (21) is provided with multiple anti-slip textures.

7. The device for precise drug delivery in clinical trials according to claim 1, characterized in that: A sealing element (221) is fitted between the flow baffle (22) and the application end (12).

Images