Drug delivery device

Abstract

The utility model is suitable for the technical field of blood vessel treatment, and provides a medicine delivery device which comprises a medicine delivery assembly and a driving assembly, the medicine delivery assembly and the driving assembly are fixedly connected, the driving assembly is used for driving liquid medicine to enter the medicine delivery assembly, and the medicine delivery assembly is used for delivering the liquid medicine to a preset position; the medicine mixing assembly is used for providing medicine; the medicine mixing assembly is located between the medicine conveying assembly and the driving assembly and comprises a medicine mixer and a puncture outfit, one end of the puncture outfit is connected with the driving assembly, and the other end of the puncture outfit is detachably connected with the medicine mixer. By means of the medicine conveying device, medicine supplement and medicine type replacement can be conducted in time, and the application flexibility of the device is improved.

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] In current technologies, drug-eluting balloons are commonly used to treat atherosclerotic diseases. Drug-eluting balloons involve coating an anti-proliferative drug onto the surface of a balloon after 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 to the balloon at a time. When the required amount of drug is insufficient, the delivery device must be removed from the body and replaced, causing surgical interruption, patient discomfort, and limiting the flexibility of drug administration. Utility Model Content

[0003] 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:

[0004] This application provides a drug delivery device, including: a drug delivery component and a drive component, the drug delivery component and the drive component are fixedly connected, the drive component is used to drive the drug liquid into the drug delivery component, and the drug delivery component is used to deliver the drug liquid to a preset position;

[0005] A drug mixing assembly for delivering a drug; the drug mixing assembly is located between the drug delivery assembly and the drive assembly, and the drug mixing assembly includes a drug mixer and a puncture device, one end of the puncture device being connected to the drive assembly and the other end being detachably connected to the drug mixer.

[0006] To further improve the implementation of this application, the following configuration structure is specifically adopted: the puncture device includes a receiving member and a puncture member; the receiving member has a receiving cavity, and the puncture member is installed at the bottom of the receiving cavity.

[0007] To further improve the implementation of this application, the following structure is specifically adopted: the puncture member can be inserted into the mixing device, and the outer peripheral surface of the puncture member has at least one through hole, which communicates with the mixing device.

[0008] To further improve the implementation of this application, the following configuration is adopted: the puncture member has a tip, and the width of the puncture member increases in the direction away from the tip.

[0009] To further improve the implementation of this application, the following structure is specifically adopted: a snap-fit ​​groove is provided on the cavity wall of the receiving cavity, which is used to snap-fit ​​with the open end of the mixing device.

[0010] To further improve the implementation of this application, the following structure is specifically adopted: at least two clearance grooves are provided on the outer wall of the receiving member, the clearance grooves extend along the axial direction of the receiving member and penetrate through the top of the receiving member.

[0011] To further improve the implementation of this application, the following structure is specifically adopted: at least one interference protrusion is provided on the wall of the receiving cavity, and the interference protrusion is arranged on the path of the mixing device being inserted into the receiving cavity, so as to make the mixing device and the puncture device interference fit.

[0012] To further improve the implementation of this application, the following configuration structure is adopted: the drive assembly includes a first connector, a drug storage body, and a control valve. One end of the drug storage body is detachably connected to the first connector, and the other end of the drug storage body is integrally connected to the control valve. The control valve is connected to the drug delivery assembly and the drug mixing assembly respectively.

[0013] 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 storage body through the insertion groove.

[0014] 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.

[0015] This application has at least the following technical advantages over the prior art:

[0016] The drug delivery device of this application includes a drug mixing component, which is located between the drug delivery component and the drive component. The drug mixing component includes a drug mixer and a puncture device, which are detachably connected. During surgery using the drug delivery device, if the amount of drug is insufficient, the drug mixer can be promptly detached from the puncture device and replaced with a new one containing the required amount of drug. This timely replenishment of the drug delivery device ensures the smooth progress of the surgery without the need to remove the entire drug delivery device from the patient, thus reducing surgical time and preventing secondary harm to the patient.

[0017] With the drug delivery device of this application, if a new situation arises during the operation and different drugs are required, the drug mixer installed on the trocar can be replaced in time to transport different types of drugs to the required location, avoiding the problem that the drug delivery device can only transport one type of drug, and ensuring the flexibility of drug use during the operation. Attached Figure Description

[0018] 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.

[0019] Figure 1 This is a schematic diagram of the drug delivery device in this application;

[0020] Figure 2 This is a schematic diagram showing the connection of the drug delivery component, drug mixing component, and drive component in this application;

[0021] Figure 3 This is a schematic diagram of the puncture device in this application;

[0022] Figure 4 This is an enlarged view of part A in this application;

[0023] Figure 5 This is a cross-sectional view of the drug mixture component in this application;

[0024] Figure 6 This is a schematic diagram of the structure of the driving component in this application;

[0025] Figure 7 This is a schematic diagram of the drive component along the axial direction in this application;

[0026] Figure 8 This is a schematic diagram of the control valve in this application;

[0027] Figure 9 This is a cross-sectional view of the drug delivery device in this application;

[0028] Figure 10 This is an enlarged view of part B in this application.

[0029] In the picture:

[0030] 100 - Drug delivery assembly; 110 - Outer tube; 120 - Inner tube; 130 - Delivery cavity; 150 - Expandable unit; 160 - Connecting tube;

[0031] 200-Drive assembly; 210-First connector; 211-Plug-in slot; 220-Drug reservoir; 230-Control valve; 231-Valve core; 232-Valve body;

[0032] 300-Mixing component; 310-Mixer; 320-Puncturer; 321-Receiving component; 3211-Receiving cavity; 3212-Snap-fit ​​groove; 322-Puncture component; 3221-Through hole; 3222-Tip; 323-Allowing groove. Detailed Implementation

[0033] 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 used to concisely illustrate this application and are merely examples, not intended to limit this application.

[0034] 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 used to concisely illustrate this application and are merely examples, not intended to limit this application.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] In current technologies, drug-eluting balloons are commonly used to treat atherosclerotic diseases. Drug-eluting balloons involve coating an anti-proliferative drug onto the surface of a balloon after 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 to the balloon at a time. When the required amount of drug to be delivered is insufficient, the delivery device must be removed from the body and replaced, causing surgical interruption and patient discomfort. Furthermore, the drug mixing unit can only provide one type of drug, limiting the flexibility of medication administration.

[0040] In view of this, this application provides a drug delivery device, such as... Figures 1-10 As shown, the device includes a drug delivery assembly 100 and a drive assembly 200. The drug delivery assembly 100 and the drive assembly 200 are fixedly connected, and the drive assembly 200 is sealed to the drug delivery assembly 100 to prevent external air from entering and contaminating the drug. The drive assembly 200 is used to drive the drug solution into the drug delivery assembly 100, and the drug delivery assembly 100 is used to drive the drive assembly 200 to deliver the drug solution to a preset position in the blood vessel.

[0041] A drug mixing assembly 300 is used to deliver medication. The drug mixing assembly 300 is located between the drug delivery assembly 100 and the drive assembly 200, and includes a drug mixer 310 and a puncture device 320. One end of the puncture device 320 is connected to the drive assembly 200, and the other end is detachably connected to the drug mixer 310. For example, the puncture device 320 can be connected to the drive assembly 200 and the drug mixer 310 respectively by means of threaded connection, snap-fit, or fastening.

[0042] The driving component 200 in this application can be a gas source, liquid source, etc. in the pressure source. After the drug solution is formed in the drug mixing component 300, the driving component 200 can drive the drug solution into the drug delivery component 100 by controlling the size of the gas source, liquid source, etc., until the drug delivery component 100 transports the drug to the preset position in the blood vessel.

[0043] In the above scheme, the mixing component 300 is pre-loaded with the required drug, such as photosensitizing compound powder. The photosensitizing compound powder can be stored in powder or granular form in the mixing component 300. The mixing component 300 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 the photosensitizer powder and drug powder into the mixing component 300, thereby forming a drug solution. The mixing device 310 in this application can be a container such as a vial that can be filled with different drugs. For example, the drug mixer 310 in the drug mixing assembly 300 is pre-filled with drugs to be transported to the blood vessel wall. When the drug mixer 310 is not connected to the puncture device 320, a solvent liquid is injected into the drug mixer 310 through a syringe to form a drug solution. Then the drug mixer 310 is connected to the puncture device 320 so that when the drug mixer 310 is punctured by the puncture device 320, the drug solution can directly enter the drive assembly 200 along the puncture device 320. The drive assembly 200 drives the drug solution to the drug delivery assembly 100 through a pressurization operation. The drug delivery assembly 100 delivers the drug solution to a preset position in the blood vessel.

[0044] In some optional embodiments, the drug mixer 310 in the drug mixing assembly 300 is pre-filled with a drug intended for transport to the blood vessel wall. The drug mixer 310 is then connected to a puncture device 320, which punctures the drug mixer 310. By controlling the control components in the drug delivery device, a solvent such as saline solution can be allowed to enter the drug mixer 310 through the puncture device 320. This arrangement allows the drug to dissolve only when the drug delivery device is in use or after some components have entered the body, increasing the drug's timeliness.

[0045] Therefore, the drug delivery device of this application includes a drug mixing assembly 300, which is positioned between the drug delivery assembly 100 and the drive assembly 200. The drug mixing assembly 300 includes a drug mixer 310 and a puncture device 320, which are detachably connected. During surgery using the drug delivery device, if the amount of drug is insufficient, the drug mixer 310 can be promptly detached from the puncture device 320 and replaced with a new drug mixer 310 containing the required amount of drug. This timely replenishment of the drug delivery device ensures the smooth progress of the surgery. It eliminates the need to remove the entire drug delivery device from the patient, allowing the surgery to continue without interruption, reducing surgical time and preventing secondary harm to the patient.

[0046] In some optional embodiments, the drug delivery device of this application allows for timely replacement of the drug mixer 310 mounted on the puncture device 320 when a new situation arises during surgery and different drugs are required. This transports drugs of different types to the required location, avoiding the problem that the drug delivery device can only transport one type of drug and ensuring the flexibility of drug use during surgery.

[0047] The drug delivery assembly 100 includes an outer tube 110, an inner tube 120, and an expandable unit 150. The distal end of the inner tube 120 is connected to the expandable unit 150. The inner tube 120 is used to guide the expandable unit 150 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 150 has a plurality of micropores 151 on its peripheral wall. When the expandable unit 150 is filled with a drug solution, the external volume of the expandable unit 150 can increase with the increase of the volume of the drug solution inside the expandable unit 150 (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 150 increases to the upper limit of volume expansion. At this time, the expandable unit 150 abuts against the inner wall of the blood vessel or maintains a preset gap between the expandable unit 150 and the inner wall of the blood vessel, and the drug solution can flow out from the micropores 151 as the volume of the expandable unit 150 increases.

[0048] The outer tube 110 is sleeved on the inner tube 120, and the gap between the outer tube 110 and the inner tube 120 forms a delivery channel 130. The distal end of the delivery channel 130 is connected to the expandable unit 150. The drug solution flows from the drug mixing component 300 to the delivery channel 130 under the action of the driving component 200, allowing the drug solution to flow from the delivery channel 130 to the interior of the expandable unit 150. It is then sprayed onto the inner wall of the blood vessel through the micropore 151. 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 110 is sealed to the proximal end of the inner tube 120 to ensure that the drug solution can stably flow along the delivery channel 130 to the expandable unit 150.

[0049] According to some alternative embodiments, the puncture device 320 includes a receiving member 321 and a puncture member 322; the receiving member 321 has a receiving cavity 3211, and the puncture member 322 is mounted at the bottom of the receiving cavity 3211.

[0050] In the above scheme, the receiving member 321 is cylindrical, with an opening at its proximal end. The receiving member 321 has a hollow structure, forming a receiving cavity 3211. The opening of the mixing device 310 can be installed into the receiving cavity 3211 through the opening of the receiving member 321. The puncture member 322 is installed at the bottom of the receiving cavity 3211 away from the mixing device 310. The puncture member 322 can be connected to the receiving member 321 by adhesive bonding, integral molding, or snap-fit. In some optional embodiments, the puncture member 322 and the receiving member 321 are detachable. Before installing different mixing devices 310 into the puncture device 320, the corresponding puncture members 322 can be installed in the receiving member 321. This allows the mixing device 310 to be quickly punctured by the puncture member 322 when it is installed into the puncture device 320.

[0051] According to some optional embodiments, the puncture member 322 can be inserted into the mixing device 310, and the outer peripheral surface of the puncture member 322 has at least one through hole 3221, and the through hole 3221 communicates with the mixing device 310.

[0052] In the above scheme, the opening of the mixing device 310 is installed into the puncture device 320, and the end of the puncture member 322 away from the receiving cavity 3211 can puncture the opening of the mixing device 310 and enter into the mixing device. In this application, the puncture member 322 has a hollow structure, which forms an inlet and outlet liquid channel. At least one through hole 3221 is opened on the outer peripheral surface of the puncture member 3222. The number of through holes 3221 can be one, two, three, or more, and the through holes 3221 are connected to the inlet and outlet liquid channel. One end of the puncture device 320 is connected to the mixing device 310 and punctures the opening of the mixing device 310, so that the solvent liquid enters into the mixing device 310 through the through hole 3221 along the inlet and outlet liquid channel of the puncture member 3222, dissolving the drug in the mixing device 310 into a drug solution. At the same time, when the medicine is formed in the mixing device 310, the puncture member 322 punctures the opening of the mixing device 310, and the medicine flows into the inlet and outlet channel through the through hole 3221 on the outer peripheral surface of the puncture member 322. Under the pressure of the drive component 200, the medicine flows into the delivery component 100.

[0053] In this application, the inlet / outlet channels and through holes 3221 provided in the puncture member 322 are respectively connected to the drive assembly 200 and the drug delivery assembly 100. On the one hand, they are used to allow the solvent liquid to enter into the drug mixer 310, so that the drug inside can form a drug solution; on the other hand, they are used to allow the drug solution in the drug mixer 310 to flow smoothly into the drug delivery assembly 100 and the drive assembly.

[0054] According to some alternative embodiments, the puncture member 322 has a tip 3222, and the width of the puncture member 322 increases in a direction away from the tip 3222.

[0055] In the above scheme, the end of the puncture member 322 that contacts the mixing device 310 is set as a tip 3222. When the mixing device 310 is installed on the puncture device 320, the tip 3222 of the puncture member 322 can smoothly and quickly puncture the opening of the mixing device 310. In this application, the width of the puncture member 322 is increased in its axial direction away from the tip 3222, such as the puncture member 322 being conical. This arrangement allows the puncture member 322 to puncture the opening of the mixing device 310 through the tip 3222, and the remaining part enters into the mixing device 310 along with the tip 3222. Furthermore, the puncture opening of the mixing device 310 gradually increases, avoiding the situation where the puncture member 322 initially requires a large force to puncture the opening of the mixing device 310, which is time-consuming.

[0056] According to some optional embodiments, the cavity wall of the receiving cavity 3211 is provided with a snap-fit ​​groove 3212, which is used to snap-fit ​​with the open end of the mixing device 310.

[0057] In the above scheme, by setting a snap-fit ​​groove 3212 on the cavity wall of the receiving cavity 3211, when the open end of the mixing device 310 is installed in the puncture device 320, after the open end snaps into the snap-fit ​​groove 3212, it indicates that the mixing device 310 is axially installed in the puncture device 320, and the installation status of the mixing device 310 can be understood in a timely manner.

[0058] According to some optional embodiments, at least two clearance grooves 323 are formed on the outer wall of the receiving member 321. The clearance grooves 323 extend along the axial direction of the receiving member 321 and penetrate through the top of the receiving member 321.

[0059] In the above solution, when the receiving component 321 needs to dock with the mixing device 310 with a larger opening, the width of the clearance groove 323 can be increased accordingly, and the receiving component 321 can dock with the mixing device 310. The clearance groove 323 provided on the receiving component 321 in this application allows the receiving component 321 to be adapted to mixing devices 310 of different sizes, without limiting the size of the mixing device 310 connected to the receiving component 321. Furthermore, the clearance groove 323 provided on the receiving component 321 in this application means that the receiving component 321 does not need to be replaced when connecting mixing devices 310 of different sizes, ensuring the smooth progress of the surgery and expanding the applicability of the drug delivery device.

[0060] According to some optional embodiments, at least one interference protrusion is provided on the cavity wall of the receiving cavity 3211. The interference protrusion is arranged on the path of the mixing device 310 being inserted into the receiving cavity 3211, so as to make the mixing device 310 and the puncture device 320 interference fit.

[0061] In the above scheme, an interference fit protrusion is provided on the cavity wall of the receiving cavity 3211. The interference fit protrusion can be arranged on the groove wall of the locking groove 3212 or on the cavity wall near the opening end of the receiving cavity 3211. One, two, or three interference fit protrusions can be arranged, and there is no limitation here. Through the setting of the interference fit protrusion, during the insertion process between the mixing device 310 and the puncture device 320, the outer wall of the mixing device 310 abuts against the interference fit protrusion, ensuring a stable connection between the mixing device 310 and the puncture device 320, increasing the sealing performance of the connection between the mixing device 310 and the puncture device 320, and also preventing the liquid medicine in the mixing device 310 from overflowing as it flows towards the puncture device 320.

[0062] According to some optional embodiments, the drive assembly 200 includes a first connector 210, a drug reservoir 220, and a control valve 230. One end of the drug reservoir 220 is detachably connected to the first connector 210, and the other end of the drug reservoir 220 is partially integrally connected to the control valve 230. The control valve 230 is connected to the drug delivery assembly 100 and the drug mixing assembly 300, respectively.

[0063] In the above scheme, the proximal end of the drug storage body 220 is detachably connected to the first connector 210. Specifically, the proximal end of the drug storage body 220 can be connected to the first connector 10 by means of snap-fit, fastening, threaded connection, insertion, etc.

[0064] The first connector 210 in the drive assembly 200 can be connected to a pressure source. The control valve 230 can control the syringe containing the solvent liquid to connect with the drug mixing assembly 300, so that the solvent liquid enters into the drug mixing assembly 300, and the drug in the drug mixing assembly 300 forms a drug solution. It can also control the drug solution in the drug mixing assembly 300 to enter the drug storage body 220; furthermore, it can control the drug solution in the drug storage body 220 to enter the drug delivery assembly 100.

[0065] For example, after the mixing device 310 is connected to the puncture device 320 and the puncture device 320 punctures the opening of the mixing device 310, the operating state of the control valve 230 is activated, allowing the syringe containing the solvent liquid to pass through the control valve 320, so that the solvent liquid enters the inlet / outlet channel of the puncture device 322 and flows into the mixing device 310 through the through hole 3221, so that the drug in the mixing device 310 forms a drug solution; then the operating state of the control valve 230 is switched, so that the drug storage body 220 is connected to the mixing device 310, and then the drug solution in the mixing device 310 flows into the drug storage body 220 under the action of negative pressure; then the operating state of the control valve 230 is switched, so that the drug storage body 220 is connected to the drug delivery assembly 100, and the drug solution in the drug storage body 200 flows into the expandable unit 150 in the drug delivery assembly 100 under the action of pressure.

[0066] During the above process, if the medication solution is insufficient, it can be replenished by replacing the mixing device 310 in a timely manner, depending on the surgical situation. In some optional embodiments, if the medication solution is insufficient, medication or medication solution can be added to the storage chamber 221 of the storage body 220 by disassembling only the first connector 210, thus replenishing the medication solution to the delivery assembly 100 in a timely manner. When medication is being added to the storage body 220, the state of the control valve 230 can be switched to allow the solvent liquid to enter the storage body 220 to form a medication solution. In some optional embodiments, if different medications need to be added according to the surgical situation, the mixing device 310 containing the corresponding medication can be replaced in a timely manner. With the settings of this application, when the medication is insufficient or needs to be changed, it is not necessary to replace the entire medication delivery device; only the mixing device 310 of different capacities needs to be replaced. This increases the applicability of the medication delivery device, reduces the surgical operation process, and alleviates patient discomfort.

[0067] According to some optional embodiments, the distal end of the first connector 210 is provided with a insertion groove 211, and the first connector 210 is inserted into the proximal end of the drug storage body 220 through the insertion groove 211.

[0068] In the above scheme, a insertion groove 211 is provided on the distal surface of the first connector 210. The insertion groove 211 extends along the axial direction of the first connector 210, so that the proximal end of the drug storage body 220 can be smoothly inserted into the insertion groove 11, thereby realizing the disassembly and connection of the first connector 210 and the drug storage body 220.

[0069] In some optional embodiments, a positioning groove may be provided on the groove wall of the insertion groove 211, and a positioning protrusion is provided on the outer wall of the drug storage body 220. 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 210 and the drug storage body 220 in the axial and circumferential directions, so that the first connector 210 and the drug storage body 220 are firmly connected.

[0070] According to some alternative embodiments, the control valve 230 includes a valve core 231 and a valve body 232, wherein the valve core 231 is partially insertable into the valve body 232 and the valve core 231 is rotatable relative to the valve body 232.

[0071] In the above scheme, the valve core 231 and valve body 232 of the control valve 230 are detachably connected. The lower end of the valve core 231 can be inserted into the valve body 232, and the valve core 231 controls the liquid medicine in the drug storage body 220 to enter the drug delivery assembly 100 by rotating relative to the valve body 232. For example, in this application, one end of the valve body 232 is integrally connected to the drug storage body 220, and the other end is integrally connected to a portion of the drug delivery assembly 100. When assembling the drug delivery device, since the valve body 232 is integrally connected to both the drug storage body 220 and the drug delivery assembly 100, only the valve core 231 needs to be inserted into the valve body 232 to complete the overall installation. The detachable connection of the valve core 231 and valve body 232 in this application facilitates the assembly of the drug delivery device and improves assembly efficiency; it also facilitates the inspection and replacement of the valve core 231.

[0072] In some embodiments, a connecting tube 160 is also provided on the proximal end of the drug delivery assembly 100. One end of the connecting tube 160 is sealed to the outer tube 110, and the other end is integrally connected to the valve body 232 in the drive assembly 200.

[0073] According to some optional embodiments, the drug delivery assembly 100 further includes an interface connected to the outer wall of the outer tube 110 and communicating with the delivery cavity 130. The interface can be connected to an external pressurizing device, which can expand and contract the expandable unit 150. The pressurizing device can be manually or electrically operated and contains a gas source or a liquid source.

[0074] 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.

[0075] 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.

[0076] 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.

[0077] 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;

[0078] 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] The above are merely preferred embodiments of this application and are 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 delivery assembly (100) and a drive assembly (200) are fixedly connected. The drive assembly (200) is used to drive the drug solution into the drug delivery assembly (100), and the drug delivery assembly (100) is used to deliver the drug solution to a preset position. A drug mixing assembly (300) for delivering a drug; the drug mixing assembly (300) is located between the drug delivery assembly (100) and the drive assembly (200), and the drug mixing assembly (300) includes a drug mixer (310) and a puncture device (320), one end of the puncture device (320) being connected to the drive assembly (200) and the other end being detachably connected to the drug mixer (310).

2. The drug delivery device as described in claim 1, characterized in that, The puncture device (320) includes a receiving member (321) and a puncture member (322); the receiving member (321) has a receiving cavity (3211), and the puncture member (322) is mounted at the bottom of the receiving cavity (3211).

3. The drug delivery device as described in claim 2, characterized in that, The puncture member (322) can be inserted into the mixing device (310). The outer peripheral surface of the puncture member (322) has at least one through hole (3221), and the through hole (3221) is connected to the mixing device (310).

4. The drug delivery device as described in claim 2, characterized in that, The puncture member (322) has a tip (3222), and the width of the puncture member (322) increases in the direction away from the tip (3222).

5. The drug delivery device as described in claim 2, characterized in that, The cavity wall of the receiving cavity (3211) is provided with a snap-fit ​​groove (3212), which is used to snap-fit ​​with the open end of the mixing device (310).

6. The drug delivery device as described in claim 2, characterized in that, At least two clearance grooves (323) are provided on the outer wall of the receiving member (321). The clearance grooves (323) extend along the axial direction of the receiving member (321) and penetrate the top of the receiving member (321).

7. The drug delivery device as described in claim 2, characterized in that, At least one interference protrusion is provided on the cavity wall of the receiving cavity (3211). The interference protrusion is arranged on the path of the mixing device (310) inserted into the receiving cavity (3211) to make the mixing device (310) and the puncture device (320) interference fit.

8. The drug delivery device as claimed in claim 1, characterized in that, The drive assembly (200) includes a first connector (210), a drug reservoir (220), and a control valve (230). One end of the drug reservoir (220) is detachably connected to the first connector (210), and the other end of the drug reservoir (220) is integrally connected to the control valve (230). The control valve (230) is connected to the drug delivery assembly (100) and the drug mixing assembly (300) respectively.

9. The drug delivery device as described in claim 8, characterized in that, The first connector (210) has a insertion groove (211) at its distal end, and the first connector (210) is inserted into the proximal end of the drug reservoir (220) through the insertion groove (211).

10. The drug delivery device as claimed in claim 8, characterized in that, The control valve (230) includes a valve core (231) and a valve body (232). The valve core (231) can be inserted into the valve body (232) and can rotate relative to the valve body (232).

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