Drug delivery device

Abstract

The utility model is suitable for the technical field of vascular treatment, and provides a medicine delivery device which comprises a medicine mixing assembly and a medicine delivery assembly, the medicine mixing assembly and the medicine delivery assembly are fixedly connected, the medicine mixing assembly is used for mixing liquid and medicine to form medicine liquid, and the medicine delivery assembly is used for delivering the medicine liquid formed in the medicine mixing assembly to a preset position. Wherein the medicine mixing assembly comprises a first connector, a medicine mixing body and a control valve, one end of the medicine mixing body is detachably connected with the first connector, the other end of the medicine mixing body is partially and integrally connected with the control valve, and one end of the control valve is connected with the medicine conveying assembly. By means of the medicine conveying device, medicine can be supplemented into the medicine mixing assembly in time, and smooth operation is guaranteed.

Description

Technical Field

[0001] This application relates to the field of vascular treatment technology, and in particular to a drug delivery device. Background Technology

[0002] Atherosclerosis (AS) is a major cause of coronary heart disease, cerebral infarction, and peripheral artery disease. For example, intracranial atherosclerotic disease (ICAD) is a major cause of ischemic stroke, accounting for approximately 17%-35% of ischemic cerebrovascular events in Asians. Peripheral artery disease (PAD) is a global health burden affecting 20% ​​of the population aged 80 and over, and it is showing a trend towards affecting younger people, placing a heavy health and economic burden on people and society.

[0003] Percutaneous angioplasty and percutaneous stenting are revolutionary technologies for treating vascular stenosis, greatly improving treatment outcomes for patients with atherosclerotic diseases. However, drug-eluting stents still face risks such as in-stent restenosis and late-stage stent thrombosis. Furthermore, due to their rigid metal structure and susceptibility to breakage, drug-eluting stents remain less effective for treating tortuous intracranial vessels and lower extremity vessels.

[0004] To address the drawbacks of drug-eluting stents, "interventional non-implantable" drug-eluting balloons were invented and used to treat atherosclerotic diseases. Drug-eluting balloons involve coating an anti-proliferative drug onto the surface of a balloon during balloon angioplasty, delivering it to the target lesion site via a balloon catheter. After balloon inflatation, the anti-proliferative drug is transferred to the blood vessel wall, thereby persistently inhibiting the proliferation of vascular smooth muscle, reducing vascular stenosis, and achieving a therapeutic effect. However, current drug delivery devices can only deliver a fixed amount of drug at a time to the balloon. When the required amount of drug to be delivered is insufficient, the drug delivery device must be removed from the body and replaced, causing surgical interruption and patient discomfort. Utility Model Content

[0005] The purpose of this application is to provide a drug delivery device to solve the aforementioned technical problems existing in the prior art, mainly including the following:

[0006] This application provides a drug delivery device, comprising: a drug mixing component and a drug delivery component, wherein the drug mixing component and the drug delivery component are fixedly connected, the drug mixing component is used to mix liquid and drug to form a drug solution, and the drug delivery component is used to deliver the drug solution formed in the drug mixing component to a preset position, wherein:

[0007] The drug mixing assembly includes a first connector, a mixing body, and a control valve. One end of the mixing body is detachably connected to the first connector, and the other end of the mixing body is integrally connected to the control valve. One end of the control valve is connected to the drug delivery assembly.

[0008] To further improve the implementation of this application, the following structure is specifically adopted: the distal end of the first connector is provided with a insertion groove, and the first connector is inserted into the proximal end of the drug mixture through the insertion groove.

[0009] To further improve the implementation of this application, the following structure is specifically adopted: the first connector includes a main body and a first limiting part. The first limiting part is provided with a receiving cavity along the axial direction. A through hole is opened at the bottom of the receiving cavity. The main body passes through the through hole, and the cavity wall of the receiving cavity and the outer wall of the main body define an insertion groove.

[0010] To further improve the implementation of this application, the following structure is specifically adopted: the drug mixture has a mixing cavity extending axially, the distal end of the first connector can be partially inserted into the mixing cavity, and at least one interference protrusion is provided on the cavity wall of the mixing cavity. The interference protrusion is arranged on the insertion path of the first connector into the drug mixture, so as to make the first connector and the drug mixture have an interference fit.

[0011] To further improve the implementation of this application, the following structure is specifically adopted: a first sealing element is embedded in the insertion groove, and the first sealing element is sealed to the proximal end of the drug mixture.

[0012] To further improve the implementation of this application, the following configuration structure is adopted: the control valve includes a valve core and a valve body, the valve core portion can be inserted into the valve body, and the valve core can rotate relative to the valve body.

[0013] To further improve the implementation of this application, the following structure is specifically adopted: the outer wall of the valve core is provided with a snap-fit ​​groove, and the corresponding position of the inner wall of the valve body is provided with a snap-fit ​​protrusion, wherein the snap-fit ​​groove and the snap-fit ​​protrusion are engaged in a limiting fit.

[0014] To further improve the implementation of this application, the following structure is specifically adopted: the valve body is integrally formed with the drug mixture and the drug delivery assembly.

[0015] To further improve the implementation of this application, the following configuration structure is specifically adopted: when the valve core rotates relative to the valve body, the valve core has at least a first state and a second state, wherein:

[0016] In the first state, the valve core is connected to the drug supply assembly, which allows the drug in the drug supply assembly to enter the drug mixture.

[0017] In the second state, the valve core is connected to the drug delivery assembly, and is used to allow the liquid medicine in the drug mixture to flow into the drug delivery assembly, thereby delivering the liquid medicine to a preset position.

[0018] To further improve the implementation of this application, the following configuration structure is specifically adopted: In the first state, the first channel of the valve core is connected to the third cavity of the valve body, the second channel of the valve core is connected to the first cavity of the valve body, and the first channel is connected to the second channel. The drug of the drug supply component enters the drug mixture sequentially through the third cavity, the second cavity, and the first cavity.

[0019] When the valve core switches from the first state to the second state, the first cavity, the first channel, and the second cavity are connected, and the liquid medicine in the mixture flows sequentially along the first cavity, the first channel, and the second cavity to the preset position.

[0020] This application has at least the following technical advantages over the prior art:

[0021] The drug delivery device provided in this application includes a drug mixing component and a drug delivery component, which are fixedly connected. The drug mixing component is used to mix liquid and drug to form a drug solution, and the drug delivery component is used to deliver the drug solution formed in the drug mixing component to a preset position. The proximal end of the drug mixture in the drug mixing component is detachably connected to a first connector, facilitating the loading of drug into the drug mixture. When the drug delivery device has entered the blood vessel for surgery, if the drug in the drug mixture is insufficient during delivery, the first connector can be promptly detached from the proximal end of the drug mixture to replenish the drug. This eliminates the need to remove the drug delivery device from the body, avoids interrupting the surgery, reduces surgical time, and prevents secondary harm to the patient. Attached Figure Description

[0022] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the description of the embodiments of this application or the prior art 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.

[0023] Figure 1 This is a schematic diagram of the drug delivery device in this application;

[0024] Figure 2 This is a cross-sectional view of the drug delivery device in this application along the axial direction;

[0025] Figure 3 yes Figure 2 Enlarged view of section A in the middle;

[0026] Figure 4 This is a schematic diagram of the structure of the drug mixing component in this application;

[0027] Figure 5 This is a cross-sectional view along the axial direction after the first connector and the drug mixture are connected in this application;

[0028] Figure 6 This is a schematic diagram of the structure of the first connector in this application;

[0029] Figure 7 This is a schematic diagram of the control valve in this application;

[0030] Figure 8 This is a schematic diagram of the valve core and valve body in this application;

[0031] Figure 9 This is a sectional view of the control valve along the axial direction in this application;

[0032] Figure 10 This is a cross-sectional view of the valve core and valve body in the first state of the control valve assembly.

[0033] Figure 11 This is a cross-sectional view of the valve core and valve body assembled in the second state of the control valve.

[0034] In the picture:

[0035] 100-Mixing assembly; 10-First connector; 11-Insertion groove; 12-Main body; 13-First limiting part; 20-Mixing body; 21-Mixing chamber; 30-Control valve; 31-Valve core; 311-Snap-fit ​​groove; 312-First channel; 313-Second channel; 32-Valve body; 321-Snap-fit ​​protrusion; 322-First cavity; 323-Second cavity; 324-Third cavity;

[0036] 200-Drug delivery assembly; 210-Outer tube; 220-Inner tube; 230-Delivery cavity; 250-Expandable unit; 251-Micropore; 260-Connecting tube. Detailed Implementation

[0037] The following description provides many different embodiments or examples for implementing various features of this application. The elements and arrangements described in the specific examples below are only for concise expression of this application and are merely examples, not intended to limit this application.

[0038] The following description provides many different embodiments or examples for implementing various features of this application. The elements and arrangements described in the specific examples below are only for concise expression of this application and are merely examples, not intended to limit this application.

[0039] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, not all of them. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application. Therefore, the following detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely to represent selected embodiments of this application.

[0040] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances. Furthermore, the terms "first," "second," "third," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance.

[0041] In this application, unless otherwise expressly specified and limited, "above or below" a first feature may include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on" a first feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" a first feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0042] In addition, in this application, "proximal end" and "distal end" refer to the near and far positions of the structure relative to the surgeon in the usage environment, so as to facilitate the description of the positional relationship between the components and to facilitate understanding; for the same component, "proximal end" and "distal end" are the relative positional relationship of the component, not absolute; therefore, they should be understood from the perspective of implementing the principle of this application, and should not deviate from the essence of this application.

[0043] A "non-implantable" drug-eluting balloon has been invented and used to treat atherosclerotic diseases. The drug-eluting balloon involves coating the surface of a balloon with an anti-proliferative drug, which is then delivered to the target lesion site via a balloon catheter. After balloon inflatation, the anti-proliferative drug is transferred to the blood vessel wall, thereby persistently inhibiting the proliferation of vascular smooth muscle, reducing vascular stenosis, and achieving a therapeutic effect. However, current drug delivery devices can only deliver a fixed amount of drug at a time to the balloon. When the required amount of drug is insufficient, the delivery device must be removed from the body and replaced, which can interrupt the procedure and cause patient discomfort.

[0044] In view of this, this application provides a drug delivery device, such as... Figures 1-11 As shown, the system includes a drug mixing assembly 100 and a drug delivery assembly 200. The drug mixing assembly 100 and the drug delivery assembly 200 are fixedly connected and sealed to prevent external air from entering and contaminating the drug. The drug mixing assembly 100 is used to mix liquid and drug to form a drug solution, and the drug delivery assembly 200 is used to deliver the drug solution formed in the drug mixing assembly 100 to a preset location. For example, the drug mixing assembly 100 may be pre-loaded with a drug, such as a photosensitizing compound powder. The photosensitizing compound powder may be stored in powder or granular form in the drug mixing assembly 100, or it may be a film-forming coating applied to the inner wall of the drug mixing assembly 100. The drug mixing assembly 100 can be connected to a syringe containing any one of physiological saline, purified water, contrast agent, or a mixture thereof to inject a solvent liquid that dissolves or disperses photosensitizer powder and drug powder into the drug mixing assembly 100, thereby forming a drug solution. The drug mixing component 100 is connected to the drug delivery component 200. The drug solution in the drug mixing component 100 is first delivered to the drug delivery component 200, and then the drug delivery component 200 delivers the drug solution to the preset blood vessel wall position in the patient's body.

[0045] Wherein: the drug mixing assembly 100 includes a first connector 10, a drug mixing body 20, and a control valve 30. One end of the drug mixing body 20 is detachably connected to the first connector 10, and the other end of the drug mixing body 20 is partially integrally connected to the control valve 30. One end of the control valve 30 is connected to the drug delivery assembly 200.

[0046] For example, the proximal end of the drug mixture 20 is detachably connected to the first connector 10. Specifically, the proximal end of the drug mixture 20 can be connected to the first connector 10 by means of snap-fit, fastening, threaded connection, insertion, etc. In this application, the drug mixture 20 and the first connector are made detachable to facilitate the loading of drugs into the drug mixture 20. In some optional embodiments, when the drug delivery device has not entered the blood vessel or has already entered the blood vessel, a certain amount of drug can be loaded into the drug mixture 20 simply by disassembling the first connector 10. The amount of drug is sufficient for the current operation, and it is not necessary to disassemble the drug mixture 20 and the control valve 30 to load the drug from the distal end of the drug mixture 20. This ensures the sealing between the drug mixture 20 and the control valve 30 and also improves the efficiency of drug loading. In some optional embodiments, when the drug delivery device enters the blood vessel, if the drug in the drug mixture 20 is insufficient during delivery, the first connector 10 can be promptly detached from the proximal end of the drug mixture 20 to replenish the drug in the drug mixture 20. This way, the drug delivery device does not need to be removed from the body, the surgery does not need to be stopped, the operation time is reduced, and secondary harm to the patient is avoided.

[0047] In this application, the distal end of the drug mixture 20 is integrally connected to the control valve 30, reducing the installation steps of the drug mixing assembly 100 and increasing the sealing performance of the drug mixing assembly 100. The control valve 30 controls the drug mixture 20 to be connected to a syringe containing any one of physiological saline, purified water, contrast agent, or a mixture thereof, to inject a solvent liquid for dissolving or dispersing photosensitizer powder and drug powder into the drug mixing assembly 100, thus forming a drug solution; it also controls the smooth entry of the drug solution in the drug mixture 20 into the drug delivery assembly 200.

[0048] The drug delivery assembly 200 includes an outer tube 210, an inner tube 220, and an expandable unit 250. The distal end of the inner tube 220 is connected to the expandable unit 250. The inner tube 220 is used to guide the expandable unit 250 into the lesion area of ​​the patient's artery, vein, lacrimal duct, airway, nasal cavity, esophagus, bile duct, urethra, or other vascular or non-vascular cavities through a guidewire. The expandable unit 250 has a plurality of micropores 251 on its peripheral wall. When the expandable unit 250 is filled with a drug solution, the external volume of the expandable unit 250 can increase with the increase of the volume of the drug solution inside the expandable unit 250 (in this embodiment, the drug solution is a therapeutic drug, which can be one of gas, liquid, solid or at least a combination of two, preferably liquid) until the volume of the expandable unit 250 increases to the upper limit of volume expansion. At this time, the expandable unit 250 abuts against the inner wall of the blood vessel or maintains a preset gap between the expandable unit 250 and the inner wall of the blood vessel, and the drug solution can flow out from the micropores 251 as the volume of the expandable unit 250 increases.

[0049] The outer tube 210 is fitted onto the inner tube 220, and the gap between the outer tube 210 and the inner tube 220 forms a delivery channel 230. The distal end of the delivery channel 230 is connected to the expandable unit 250. The drug solution flows from the drug mixing component 100 to the delivery channel 230, allowing the drug solution to flow from the delivery channel 230 into the interior of the expandable unit 250. It is then sprayed onto the inner wall of the blood vessel through the micropores 251. Under laser excitation, the photosensitive cross-linking agent in the therapeutic drug causes the elastin in the therapeutic drug to rapidly combine with the collagen in the blood vessel wall, forming a scaffold in situ, thereby achieving the healing and repair of the blood vessel and achieving the therapeutic effect. The proximal end of the outer tube 210 is sealed to the proximal end of the inner tube 220 to ensure that the drug solution can flow stably along the delivery channel 230 to the expandable unit 250.

[0050] When the drug mixing component 100 needs to drive the flow of the drug solution to the expandable unit 250, its proximal end can be connected to a pressure source. The pressure source generates driving pressure, creating a pressure difference between the proximal end of the drug mixing component 100 and the micropore 251. Under the action of the pressure difference, the drug solution is forced to flow between the drug mixing component 100, the delivery channel 230, the expandable unit 250, and the micropore 251 to the inner wall of the blood vessel, allowing the drug solution to be sprayed directly onto the inner wall of the blood vessel. With reasonable control of the driving pressure of the pressure source, the drug solution sprayed from the micropore 251 can force the inner wall of the blood vessel to expand when it comes into contact with the inner wall of the blood vessel, allowing the drug solution to more easily pass through the inner layer of the inner wall of the blood vessel and enter the middle layer and even the outer layer of the inner wall of the blood vessel. When the drug solution is a therapeutic drug, the therapeutic drug can reach the middle and outer layers of the inner wall of the blood vessel and combine with the collagen in the middle and outer layers to form a scaffold, thereby further improving the stability and safety of the scaffold structure and improving the therapeutic effect. It should be noted that the pressure source can be a gas source or a liquid source, with liquid source pressurization being preferred to avoid the risk of forming an air embolism.

[0051] According to some alternative embodiments, the distal end of the first connector 10 is provided with a insertion groove 11, and the first connector 10 is inserted into the proximal end of the drug mixture 20 through the insertion groove 11.

[0052] In the above scheme, a insertion groove 11 is provided on the distal end surface of the first connector 10. The insertion groove 11 extends along the axial direction of the first connector 10, so that the proximal end of the drug mixture 20 can be smoothly inserted into the insertion groove 11, thereby realizing the disassembly and connection of the first connector 10 and the drug mixture 20.

[0053] In some optional embodiments, a positioning groove may be provided on the groove wall of the insertion groove 11, and a positioning protrusion is provided on the outer wall of the drug mixture 20. The positioning protrusion can extend into the positioning groove to achieve a limiting fit, which is used to restrict the movement of the first connector 10 and the drug mixture 20 in the axial and circumferential directions, so that the first connector 10 and the drug mixture 20 are firmly connected.

[0054] According to some alternative embodiments, the first connector 10 includes a main body 12 and a first limiting part 13. The first limiting part 13 is provided with a receiving cavity along the axial direction. A through hole is opened at the bottom of the receiving cavity. The main body 12 passes through the through hole, and the cavity wall of the receiving cavity and the outer wall of the main body 12 define an insertion groove 11.

[0055] In the above scheme, the first limiting part 13 has an axially upward-facing cavity on the end face adjacent to the drug mixture 20. A through hole is formed on the bottom of the cavity, and the cavity and the through hole connect the first limiting part 13. The main body 12 enters the cavity through the through hole, and one end of the main body 12 can pass through the cavity and enter the drug mixture 20. The outer wall of the main body 12 in the cavity and the cavity wall of the cavity form an insertion groove 11. The proximal end of the drug mixture 20 can be inserted into the insertion groove 11 to achieve the connection between the drug mixture 11 and the first connector 10.

[0056] According to some optional embodiments, the drug mixture 20 has a mixing cavity 21 extending axially. The drug mixture 20 has a hollow structure, forming the mixing cavity 21. The mixing cavity 21 can be used to fill drugs, and physiological saline or the like can enter the mixing cavity 21 for drug mixing and dissolution. The distal end of the first connector 10 can be partially inserted into the mixing cavity 21, connecting the first connector 10 to the mixing cavity 21. At least one interference fit protrusion is provided on the cavity wall of the mixing cavity 21. The interference fit protrusion is arranged on the insertion path of the first connector 10 into the drug mixture 20, for interference fit between the first connector 10 and the drug mixture 20. Exemplarily, an interference fit protrusion is provided on the cavity wall at the proximal end of the mixing cavity 21. The interference fit protrusion can be one, two, three, etc., and is not limited here. By setting the interference protrusion, during the insertion process of the first connector 10 into the drug mixture 20, the groove wall of the insertion groove 11 abuts against the interference protrusion, thereby achieving a stable connection between the first connector 10 and the drug mixture 20 and increasing the sealing performance at the connection between the first connector 10 and the drug mixture 20.

[0057] According to some alternative embodiments, a first seal is embedded in the insertion slot 11, and the first seal is in a proximal sealing connection with the drug mixture 20.

[0058] In the above scheme, an installation groove is provided on the groove wall opposite to the drug mixture 20 in the insertion groove 11. The first sealing element is embedded in the installation groove. After the proximal end of the drug mixture 20 is inserted into the insertion groove 11, the proximal end of the drug mixture 20 will be tightly abutted against the first sealing element, ensuring good sealing performance after the first connector 10 and the drug mixture 20 are connected.

[0059] According to some alternative embodiments, the control valve 30 includes a valve core 31 and a valve body 32, wherein the valve core 31 is partially insertable into the valve body 32 and is rotatable relative to the valve body 32.

[0060] In the above scheme, the valve core 31 and valve body 32 of the control valve 30 are detachably connected. The lower end of the valve core 31 can be inserted into the valve body 32, and the valve core 31 controls the liquid medicine in the drug mixture 20 to enter the drug delivery assembly 200 by rotating relative to the valve body 32. For example, one end of the valve body 32 in this application is integrally connected to the drug mixture 20, and the other end is integrally connected to a portion of the drug delivery assembly 200. When assembling the drug delivery device, since the valve body 32 is integrally connected to both the drug mixture 20 and the drug delivery assembly 200, only the valve core 31 needs to be inserted into the valve body 32 to complete the overall installation. The detachable connection of the valve core 31 and valve body 32 in this application facilitates the assembly of the drug delivery device and improves assembly efficiency; it also enables the mixing and emptying of solid and liquid drugs by cooperating with the mixing chamber 21 in the drug mixture 20; and it facilitates the inspection and replacement of the valve core 31.

[0061] In some embodiments, a connecting tube 260 is also provided on the proximal end of the drug delivery assembly 200. One end of the connecting tube 260 is sealed to the outer tube 210, and the other end is integrally connected to the valve body 32 in the drug mixing assembly 100.

[0062] According to some optional embodiments, the outer wall of the valve core 31 is provided with a snap-fit ​​groove 311, and a corresponding snap-fit ​​protrusion 321 is provided on the inner wall of the valve body 32. The snap-fit ​​groove 311 and the snap-fit ​​protrusion 321 are engaged in a limiting fit. With this configuration, the valve core 31 can be quickly installed into the valve body 32 by snap-fit, and after the snap-fit ​​protrusion 321 extends into the snap-fit ​​groove 311 and completes the engagement, the valve core 31 will not move axially, thus preventing the valve core 31 from detaching from the valve body 32.

[0063] According to some alternative embodiments, the valve body 32 is integrally formed with the drug mixture 20 and the drug delivery assembly 200, respectively.

[0064] In the above-described scheme, one end of the valve body 32 is integrally connected to the drug mixture 20, and the other end is integrally connected to a portion of the drug delivery assembly 200. During the assembly of the drug delivery device, since the valve body 32 is integrally connected to both the drug mixture 20 and the drug delivery assembly 200, the entire installation can be completed simply by inserting the valve core 31 into the valve body 32. This design improves the assembly efficiency of the drug delivery device and ensures its sealing performance.

[0065] According to some optional embodiments, when the valve core 31 rotates relative to the valve body 32, the valve core 31 has at least a first state and a second state, wherein:

[0066] In the first state, the drug mixture 20 can be connected to the drug supply component, and only the drug mixture 20 is connected to the control valve 30, not to the drug delivery component 200. It is used to allow the drug in the drug supply component, which is a liquid, specifically, at least one of physiological saline, purified water, and contrast agent, to enter the drug mixture 20. After the liquid and the solid drug in the drug mixture 20 are mixed evenly, a drug solution is formed in the drug mixture 20.

[0067] When the valve core 31 is switched from the first state to the second state, the drug mixture 20 is connected to the drug delivery component 200, while the drug mixture 20 is not connected to the drug supply component. This is used to allow the liquid medicine formed in the drug mixture 20 to flow into the drug delivery component 200, and then deliver the liquid medicine to a preset position in the blood vessels of the body through the drug delivery component 200 to achieve the purpose of treatment.

[0068] According to some optional embodiments, when the valve core 31 is rotated, in the first state, the first channel 312 of the valve core 31 is connected to the third cavity 324 of the valve body 32, and the second channel 313 of the valve core 31 is connected to the first cavity 322 of the valve body 32. The first channel 312 and the second channel 313 are connected, and the first channel 312 and the second channel 313 have different directions of penetration in the valve core 31. The third cavity 324 is externally connected to a drug supply component. The liquid of the drug supply component (the liquid is at least one of physiological saline, purified water, and contrast agent) can sequentially enter the mixing chamber 21 of the drug mixture 20 through the third cavity 324, the first channel 312, the second channel 313, and the first cavity 322. The user can then inject the liquid into the mixing chamber 60, allowing the liquid and solid drug to mix evenly and form a mixture in the mixing chamber 60.

[0069] When the valve core 31 switches from the first state to the second state, the first cavity 322, the first channel 312, and the second cavity 323 are connected, and the negative pressure source is activated. This causes the liquid medicine in the drug mixture 20 to be delivered sequentially along the first cavity 322, the first channel 312, and the second cavity 323 to the expandable unit 250 under a preset pressure. This forces the expandable unit 250 to expand in volume, and the peripheral wall of the expandable unit 250 to come into close contact with the inner wall of the blood vessel. Then, the liquid medicine is sprayed from the micropore 251 onto the inner wall of the blood vessel, forming a scaffold on the inner wall of the blood vessel, thereby achieving the healing and repair of the blood vessel and achieving the therapeutic effect.

[0070] According to some optional embodiments, the drug delivery assembly 200 further includes an interface connected to the outer wall of the outer tube 210 and communicating with the delivery cavity 230. The interface can be connected to an external pressurizing device, which can expand and contract the expandable unit 250. The pressurizing device can be manually or electrically operated and contains a gas source or a liquid source.

[0071] In some optional embodiments, the light-emitting portion located at the distal end of the fiber optic assembly can be accessed into the expandable unit via an interface. After emitting light, the light-emitting portion can cover at least the area where the expandable unit 250 is located. The fiber optic assembly can be a cylindrical, loop, or spherical diffused fiber, preferably a cylindrical diffused fiber. Further, the light-emitting portion of the fiber optic assembly has its cladding removed, leaving only the fiber core, to uniformly distribute the laser onto the blood vessel wall. Further, after removing the cladding, the fiber core of the light-emitting portion of the fiber optic assembly is treated with frosted glass or loaded with a light-scattering agent to enhance the laser dispersion in all directions. The length of the cladding removal is controlled to match lesions of different lengths.

[0072] For example, after the photosensitizing crosslinking agent and the nanoparticles are delivered to the blood vessel wall, the photosensitizing crosslinking agent is triggered by laser to cause the silk fibroin on the surface of the nanoparticles to crosslink with the proteins in the nearby blood vessels, thereby anchoring and fixing the nanoparticles in the blood vessels and significantly reducing the risk of the nanoparticles being washed away from the blood vessel wall.

[0073] It should be noted that the drug is a pure drug or a nanomedicine formed with other components. The nanomedicine also contains a carrier. The therapeutic drug and silk fibroin are loaded on the carrier. The therapeutic drug is a pure drug or a nanomedicine particle formed with other components. The nanomedicine particles include micelles, liposomes, nanocrystals, dendritic molecular carriers, polymer nanoparticles, etc. In some embodiments, the medicament further includes an active pharmaceutical ingredient, said active pharmaceutical ingredient being rapamycin or a derivative thereof, ABT-578, zotamolimus, everolimus, biolimus A9, deforolimus (also known as rapamycin-42 (dimethylphospholipase)), temsirolimus, tacrolimus, pimcrolimus, nitric oxide synthase, C3 exoenzyme, RhoA inhibitor, tubulusin, A3 agonist, CB2 agonist, 17-AAG, Hsp90 antagonist, tyrosine phosphorylation inhibitor, cathepsin S inhibitor, paclitaxel or a derivative thereof, paclitaxel, docetaxel, corticosteroids, glucocorticoids, dexamethasone, ceramide, dimethylsphingosine, ether-linked diglycerides, ether-linked phosphatidic acids, dihydrosphingosine, estrogen, takil, or takil analogues. Analogs), Actinomycin D, prostaglandins, vitamin A, probucol, batimastat, statins, Trapidil, mitomycin C and cytochalasin B, cytotoxic substances, ethanol, chemotherapeutic agents, sclerosing agents, gene therapy agents, anti-angiogenic agents, antibodies, or any other agents considered effective in the treatment of tumors.

[0074] In some embodiments, when the pharmaceutical solution contains a photosensitizing compound, the photosensitizing compound is a single photosensitizer, crosslinker, and / or a combination with a carrier, and can be in any form. For example, it can be lyophilized, non-lyophilized, microencapsulated, nanoencapsulated (e.g., micelles, liposomes, nanocrystals, dendritic molecular carriers, polymer nanoparticles, etc.), protein-bound, freeze-dried, and / or can be provided in the form of tablets, gels, capsules, powders, pastes, creams, ointments, or solutions;

[0075] The photosensitive crosslinking agent is a naphthalimide compound and / or a naphthalimide hydrophilic derivative, camphorquinone and / or a camphorquinone hydrophilic derivative, riboflavin, riboflavin sodium phosphate, rose red, curcumin, or eosin Y.

[0076] Optionally, the photosensitizing compound may further include a photosensitizing synergist to enhance photoinitiation efficiency. The photosensitizing synergist includes, but is not limited to, diphenyliodonium hexafluorophosphate, ethyl p-dimethylaminobenzoate, potassium persulfate, sodium persulfate, and ammonium persulfate. The mass ratio of the photosensitizing synergist to the photosensitizer crosslinking agent is 5:1 to 0.02:1.

[0077] Furthermore, the drug delivery device of this embodiment targets tissue within a body cavity. This body cavity can be a vascular or non-vascular cavity such as an artery, vein, lacrimal duct, airway, prostate, nostril, sinus, ear canal, bile duct, or urethra, representing a diseased area. The drug delivery device of this application is also applicable to cancers located in other body cavities, delivering therapeutic agents from outside the tumor to the tumor site. For example, it has clinical applications in the treatment of cancers of the mouth, nose, pharynx, lungs, esophagus, stomach, intestines, colon, pancreas, rectum, cervix, uterus, and prostate.

[0078] It should be noted that, in this document, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus 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 apparatus. 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 apparatus that includes that element. Furthermore, it should be noted that the scope of the methods and apparatuses in the embodiments of this application is not limited to performing functions in the order shown or discussed, but may also include performing functions substantially simultaneously or in the reverse order, depending on the functions involved. For example, the described methods may be performed in a different order than described, and various steps may be added, omitted, or combined. Additionally, features described with reference to certain examples may be combined in other examples.

[0079] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A drug delivery device, characterized in that, include: A drug mixing assembly (100) and a drug delivery assembly (200) are fixedly connected. The drug mixing assembly (100) is used to mix liquid and drug to form a drug solution, and the drug delivery assembly (200) is used to deliver the drug solution formed in the drug mixing assembly (100) to a preset position. The drug mixing assembly (100) includes a first connector (10), a drug mixing body (20), and a control valve (30). One end of the drug mixing body (20) is detachably connected to the first connector (10), and the other end of the drug mixing body (20) is integrally connected to the control valve (30). One end of the control valve (30) is connected to the drug delivery assembly (200).

2. The drug delivery device as described in claim 1, characterized in that, The first connector (10) has a insertion groove (11) at its distal end, and the first connector (10) is inserted into the proximal end of the drug mixture (20) through the insertion groove (11).

3. The drug delivery device as described in claim 2, characterized in that, The first connector (10) includes a main body (12) and a first limiting part (13). The first limiting part (13) is provided with a receiving cavity along the axial direction. A through hole is opened at the bottom of the receiving cavity. The main body (12) passes through the through hole, and the cavity wall of the receiving cavity and the outer wall of the main body (12) define an insertion groove (11).

4. The drug delivery device as described in claim 2, characterized in that, The drug mixture (20) has a mixing cavity (21) extending along the axial direction. The distal end of the first connector (10) can be partially inserted into the mixing cavity (21). At least one interference protrusion is provided on the cavity wall of the mixing cavity (21). The interference protrusion is arranged on the insertion path of the first connector (10) into the drug mixture (20) to make the first connector (10) and the drug mixture (20) fit together.

5. The drug delivery device as described in claim 2, characterized in that, A first sealing element is embedded in the insertion groove (11), and the first sealing element is sealed to the proximal end of the drug mixture (20).

6. The drug delivery device as described in claim 1, characterized in that, The control valve (30) includes a valve core (31) and a valve body (32). The valve core (31) can be inserted into the valve body (32) and can rotate relative to the valve body (32).

7. The drug delivery device as described in claim 6, characterized in that, The outer wall of the valve core (31) is provided with a snap-fit ​​groove (311), and the inner wall of the valve body (32) is provided with a snap-fit ​​protrusion (321) at the corresponding position. The snap-fit ​​groove (311) and the snap-fit ​​protrusion (321) are engaged in a limiting cooperation.

8. The drug delivery device as described in claim 6, characterized in that, The valve body (32) is integrally formed with the drug mixture (20) and the drug delivery assembly (200).

9. The drug delivery device as described in claim 6, characterized in that, When the valve core (31) rotates relative to the valve body (32), the valve core (31) has at least a first state and a second state, wherein: In the first state, the valve core (31) is connected to the drug supply assembly (20) so that the drug in the drug supply assembly enters the drug mixture (20). In the second state, the valve core (31) is connected to the drug mixture (20) and the drug delivery assembly (200) to allow the liquid medicine in the drug mixture (20) to flow into the drug delivery assembly (200), thereby delivering the liquid medicine to a preset position.

10. The drug delivery device as claimed in claim 9, characterized in that, In the first state, the first channel (312) of the valve core (31) is connected to the third cavity (324) of the valve body (32), the second channel (313) of the valve core (31) is connected to the first cavity (322) of the valve body (32), and the first channel (312) is connected to the second channel (313). The drug of the drug supply component enters the drug mixture (20) in sequence through the third cavity (324), the first channel (312), the second channel (313), and the first cavity (322). When the valve core (31) switches from the first state to the second state, the first cavity (322), the first channel (312), and the second cavity (323) are connected, and the liquid medicine in the mixture (20) flows into the preset position in sequence along the first cavity (322), the first channel (312), and the second cavity (323).

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