Methods of administration and devices therefor

Abstract

A method for administering a medicament, the method comprising introducing a fluid into a container (100) containing the medicament, allowing the fluid to flow along a pressure relief channel (231) to an outlet of the container (100), and after the flow rate of the fluid has stabilized, closing the outlet and allowing the fluid to enter a pressure channel (232), flow along the pressure channel (232), exit the pressure channel (232) and push the medicament towards an outlet of the container (100). The method for administering the medicament can deliver the medicament in the container (100) in a more stable and sustained manner and in a more gentle form, effectively avoiding the sudden release of pressure which can cause the medicament to be pushed back by the target tissue and spread over the field of view of the endoscope, thereby allowing more accurate administration of the medicament (e.g. a hemostatic agent), improving the continuity of the endoscopic procedure, improving the hemostatic effect and reducing the time required for the procedure.

Description

Technical Field

[0001] This invention relates to a method of drug delivery, and more particularly to a method for delivering a drug in a container, and a delivery device, to facilitate the drug's therapeutic effect on target tissues. Background Technology

[0002] Compounds and polymers with therapeutic and preventative effects on diseases can only achieve good efficacy in the body when administered to patients using appropriate techniques. Oral administration is the most common technique for delivering compounds and polymers with therapeutic and preventative effects to patients. Other methods include injection, transdermal administration, pulmonary administration, and nasal administration. To prolong dosing intervals and improve patient compliance, techniques have been developed to chemically couple or encapsulate compounds or polymers, thereby improving drug bioavailability, maintaining them within the therapeutic window for a longer period, and reducing drug toxicity.

[0003] Compounds and polymers are dissolved in a solvent to form a solution, which is then administered to the patient via injection or by atomizing the solution into small droplets via a nebulizer for transpulmonary delivery. Alternatively, the drug solution can be applied to a dressing, which adheres to the tissue surface for transdermal administration. In some treatments, no medication is required; for example, in the treatment of bleeding from skin, body cavities, and internal wounds, hemostasis is typically achieved through pressure hemostasis, or a combination of sutures and pressure hemostasis.

[0004] The advent of hemostatic gels has improved wound hemostasis. However, for wounds with large amounts of bleeding, hemostatic gels are difficult to adhere to the wound in a short time, otherwise it is difficult to achieve the purpose of timely hemostasis.

[0005] There are also products on the market that spray medication onto the wound. The purpose of this spray method is to evenly distribute the powder; it is not a method of stopping bleeding. For example, Yunnan Baiyao aerosol is mainly used for sprains. For abrasions and cuts, it is still necessary to use powder to stop bleeding, and pressure must be applied to stop the bleeding (according to the aerosol's instructions).

[0006] Chinese utility model patent ZL201420372934.3 discloses a hemostatic device and its components for trauma treatment, including a container for holding a hemostatic agent, a valve for controlling the connection or disconnection of an external pressure source with the container, an action conduit with one end bent to form a bend, and a tee fitting connected to the container, valve, and action conduit respectively. This device can quickly stop bleeding in the target tissue; however, due to the instantaneous pressure relief at the moment the valve is opened—causing a sudden increase in the pressure of the ejected fluid—the hemostatic powder, driven by pressure, impacts the tissue. The reaction force generated at the site of action due to this impact causes the hemostatic powder to fill the field of view, making further observation impossible. Simultaneously, the surgical laparoscope is also obstructed by the hemostatic powder, hindering timely observation of the hemostatic effect and affecting the continuity of laparoscopic surgery. Summary of the Invention

[0007] One object of the present invention is to provide a method of drug delivery that uses a more stable fluid with a continuously balanced pressure to apply a continuous and balanced force to the drug, thereby promoting the delivery of the drug.

[0008] Another object of the present invention is to provide a method of drug delivery that makes the delivery of drugs using a pressurized fluid more controllable, avoids sudden effects on the drugs from the fluid, and ensures that the drugs are continuously and evenly propelled by the fluid.

[0009] Another object of the present invention is to provide a method of drug administration for the application of a continuous and balanced delivery of powdered pharmaceuticals.

[0010] Another object of the present invention is to provide a drug delivery device that is driven by a pressure source to deliver a drug to a target tissue so as to facilitate the drug to exert a therapeutic effect in the target tissue.

[0011] Another object of the present invention is to provide a drug delivery device that applies stable pressure to the drug within the device to avoid impacting and damaging the target tissue.

[0012] Another objective of this invention is to provide a drug delivery device that, driven by a pressure source, precisely delivers a hemostatic agent to the bleeding tissue, avoiding repeated hemostasis of the bleeding tissue and facilitating the effective hemostasis of an appropriate amount of hemostatic agent in the bleeding tissue.

[0013] Another objective of this invention is to provide a drug delivery device that avoids the impact and reaction force of the drug delivered to the target tissue on the site and tissue, causing atomization of the field of view and causing hemostatic powder to adhere to the instrument surface (e.g., the laparoscope mirror), thus affecting observation.

[0014] A method for administering medication involves introducing a fluid into a container holding the medication, allowing the fluid to flow along a pressure relief channel until it is discharged through a pressure relief orifice in the container. Once the fluid flow rate stabilizes, the pressure relief orifice is closed before use, allowing the fluid to enter a pressure-receiving channel, flow along the pressure-receiving channel, and be discharged from the outlet of the pressure-receiving channel, thus propelling the medication toward the container outlet.

[0015] Another method of drug delivery involves introducing fluid into a container holding the drug, allowing the fluid to flow along a pressure relief channel until it is discharged through a pressure relief orifice in the container. Once the fluid flow rate stabilizes, the pressure relief orifice is closed before use. After the fluid enters the pressure-receiving channel, its flow direction changes at least twice before flowing toward the outlet of the pressure-receiving channel. After being discharged at the outlet of the pressure-receiving channel, it propels the drug toward the container outlet.

[0016] The drug administration method provided by this invention uses a powder form of the drug. More than 90% of the powder particles have a particle size ≤100μm, such as more than 90% of the powder particles having a particle size ≤50μm.

[0017] The drug delivery method provided by this invention involves a fluid entering a pressurized cavity, during which the fluid's flow direction changes at least once by 90° to 180°, such as, but not limited to, two, three, four, or more times.

[0018] The drug delivery method provided by this invention has an inner cavity volume of 10 cm³. 3 ~200cm 3 For ease of operation (e.g., handheld), a 10cm size is preferred. 3 ~100cm 3 Especially 30cm 3 ~80cm 3 For example, but not limited to 40cm 3 41cm 3 42cm 3 43cm 3 44cm 3 45cm 3 46cm 3 47cm 3 48cm 3 49cm 3 50cm 3 51em 3 52cm 3 53cm 3 54cm 3 55cm 3 56cm 3 57cm 3 58cm 3 59cm 3 60cm 3 61cm3 62cm 3 63cm 3 64cm 3 65cm 3 66cm 3 67cm 3 68cm 3 69cm 3 70cm 3 71cm 3 72cm 3 73cm 3 74cm 3 75cm 3 76cm 3 77cm 3 78cm 3 79cm 3 and 80cm 3 .

[0019] The drug delivery method provided by this invention uses a fluid flow rate of 0.3 L / min to 7 L / min, preferably 0.5 L / min to 4 L / min. The effective cross-sectional area of ​​the fluid at the outlet of the pressurized cavity is 10 mm². 2 ~200mm 2 To enable fluid delivery of the agent, a 10cm depth is preferred. 2 ~100cm 2 Especially 30cm 2 ~80cm 2 For example, but not limited to 40cm 2 41cm 2 42cm 2 43cm 2 44cm 2 45cm 2 46cm 2 47cm 2 48cm 2 49cm 2 50cm 2 51cm 2 52cm 2 53cm 2 54cm 2 55cm 2 56cm 2 57cm 2 58cm 2 59cm 2 60cm 2 61cm 2 62cm 263cm 2 64cm 2 65cm 2 66cm 2 67cm 2 68cm 2 69cm 2 70cm 2 71em 2 72cm 2 73cm 2 74cm 2 75cm 2 76cm 2 77cm 2 78cm 2 79cm 2 and 80cm 2 .

[0020] A device for delivering a drug, including

[0021] Containers used to hold medicines;

[0022] The cavity includes a cavity channel, a cavity inlet, and a cavity outlet, with the cavity outlet facing the bottom of the container;

[0023] The valve body divides the cavity into a pressure relief cavity and a pressure receiving cavity. The pressure relief cavity is connected to the cavity inlet, and the pressure receiving cavity is connected to the cavity outlet.

[0024] An interface is provided on the container to facilitate connection to a pressure source, allowing pressurized fluid to be introduced into the cavity.

[0025] Another device, including

[0026] Containers used to hold medicines;

[0027] An interface, located on the container, is used to connect to a pressure source;

[0028] A cavity, which is located inside a container, includes a cavity channel, a cavity inlet, and a cavity outlet. The cavity inlet is connected to an interface, and the cavity outlet faces the bottom of the container.

[0029] The valve body is placed inside the cavity, dividing the cavity into a pressure relief cavity and a pressure receiving cavity. The pressure relief cavity is connected to the cavity inlet, and the pressure receiving cavity is connected to the cavity outlet.

[0030] The device provided by the present invention causes the fluid moving in the pressurized cavity to change direction at least once, such as, but not limited to, two, three, four or more times.

[0031] The device provided by the present invention further includes a first reversing element in the valve body, which is disposed in the pressurized cavity, so that the fluid moving in the pressurized cavity undergoes a first change in the direction of movement.

[0032] The device provided by the present invention further includes a second reversing element in the valve body, which is disposed in the pressurized cavity, so that the fluid moving in the pressurized cavity undergoes a second change in the direction of movement.

[0033] The device provided by the present invention allows the fluid moving in the pressurized cavity to change direction at least twice after the valve body causes the fluid in the pressurized cavity to move toward the cavity outlet.

[0034] The device provided by the present invention provides a pressure source that provides a fluid at the desired pressure, such as a gas or liquid, with a preference for gases, such as, but not limited to, air, N2, O2, CO2, or inert gases.

[0035] Another type of device also includes a pharmaceutical preparation, which is placed in a container in powder form. More than 90% of the powder particles have a particle size ≤100μm, such as more than 90% of the powder particles having a particle size ≤50μm.

[0036] The medicine is acted upon by substances exiting from the cavity outlet and is discharged from the container outlet.

[0037] To facilitate direct application of the drug to the target tissue, a catheter with an inner diameter of, for example, 2.2 mm is provided at the outlet of the container. This catheter is combined with the drug delivery device provided by this invention. The catheter guides the drug delivery path, facilitating the application of the drug to the target tissue close to it. The catheter length ranges from 13 cm to 45 cm. The catheter length needs to be adjusted for different target tissues; for example, a 13 cm catheter is used for nasal tissue, while a 38 cm catheter is used for abdominal tissue. The drug delivery device is integrally formed with the device provided by this invention using molding or 3D printing.

[0038] The present invention provides a drug delivery device, including a device for delivering a drug and a conduit.

[0039] To facilitate laparoscopic surgery and avoid the adverse effects of medication delivered to the target tissue on the surgical area and tissues, which could cause the medication to spread throughout the laparoscopic field of view and affect observation, this invention also provides a pressure regulating component combined with the medication delivery device provided by this invention. The pressure regulating component, the catheter, and the device provided by this invention are integrally molded into a drug delivery device using molding or 3D printing.

[0040] Another drug delivery device includes a device for delivering the drug, a conduit, and a pressure regulating component.

[0041] The present invention provides a voltage regulating component, comprising:

[0042] The pressure regulating chamber has one end open and connected to the conduit, and the angle between the chamber wall at the other end and the axis of the pressure regulating chamber is 3° to 10°.

[0043] The drug exits from the other end of the opening and acts directly on the target tissue.

[0044] To further improve the pressure applied to the target tissue, another pressure regulating component includes...

[0045] The pressure regulating chamber has its pressure regulating inlet connected to the conduit, and the angle between the chamber wall of the pressure regulating outlet and the axis of the pressure regulating chamber is 10° to 12.5°.

[0046] The ejection chamber has an ejection inlet that is assembled with a pressure regulating outlet. The angle between the cavity wall of the ejection outlet and the axial direction of the ejection chamber is 5° to 6°.

[0047] Several grooves are provided on the wall of the pressure regulating cavity along the radial direction of the pressure regulating cavity.

[0048] The diameter of the injection inlet is the same as that of the pressure regulating outlet. A buffer chamber is also provided between the injection inlet and the injection outlet, with an axial length of 0.5mm to 2mm, especially 0.5mm to 1.5mm.

[0049] The drug exits from the other end of the opening and acts directly on the target tissue.

[0050] The various devices, catheters, and pressure regulating components provided by this invention are assembled together, or manufactured as a single unit through 3D printing or molding to deliver medications. These devices are all disposable medical consumables, facilitating manufacturing and use.

[0051] The beneficial effects of this invention are:

[0052] The method provided by this invention can deliver the agent in the container to the bleeding tissue in a more stable and continuous manner, thereby avoiding multiple hemostasis attempts and allowing the appropriate amount of hemostatic agent to play a hemostatic role in the bleeding tissue.

[0053] The method provided by this invention can deliver the drug in the container more gently in a more stable and continuous and balanced manner, effectively avoiding the drug from being affected by the reaction of the target tissue and filling the laparoscopic field of view, thus improving the continuity of laparoscopic surgery.

[0054] The method provided by this invention allows pressure-driven agents to act more concentratedly on target tissues. Especially for bleeding tissues, it provides more precise control over the hemostatic drug delivery area, confining over 75% of the agent within an area of ​​0.5cm to 1.5cm radius.

[0055] The method provided by this invention allows pressure-driven agents to act more concentratedly on target tissues, especially bleeding tissues, enabling more agents to act on the bleeding wound. The agents can achieve hemostasis within 20 seconds, significantly shortening the hemostasis time.

[0056] The device provided by this invention, when connected to a pressure source, can deliver the medication in the container more gently in a more stable and continuous balanced manner. This effectively avoids the medication from being affected by the reaction of the target tissue and spreading throughout the laparoscopic field of view or adhering to the surface of the laparoscopy, which would prevent timely observation of the medication's effect on the target tissue (especially the hemostatic effect of the hemostatic agent on the target tissue). This improves the continuity of laparoscopic surgery.

[0057] The device provided by this invention, in conjunction with a pressure regulating component, allows the pressure-driven agent to act more concentratedly on the target tissue. Especially for bleeding tissue, it provides more precise control over the hemostatic drug delivery area, confining over 75% of the agent within an area of ​​0.5cm to 1.5cm in radius.

[0058] The device provided by this invention allows the pressure-driven agent to act more concentratedly on the target tissue, especially the bleeding tissue, so that more agent can act on the bleeding wound. The agent can achieve hemostasis within 20 seconds, significantly shortening the hemostasis time and facilitating the appropriate amount of hemostatic agent to play a hemostatic role in the bleeding tissue.

[0059] Compared with the technical solution disclosed in Chinese Utility Model Patent ZL201420372934.3, the device provided by the present invention delivers hemostatic powder to the bleeding tissue, avoiding the reaction of the hemostatic powder causing atomization in the laparoscopic field of view, and also preventing it from adhering to the surface of the laparoscope, thus facilitating the laparoscopic surgical operation. It can implement more intuitive and precise hemostatic measures on the bleeding tissue and shorten the operation time. Attached Figure Description

[0060] Figure 1 This is a schematic diagram of a device for implementing the method of the present invention;

[0061] Figure 2 for Figure 1 A cross-sectional view of the device shown at one angle;

[0062] Figure 3 A cross-sectional schematic diagram of an embodiment of a conduit with a pressure regulating component mounted at one end;

[0063] Figure 4 This is a cross-sectional schematic diagram of an embodiment of the device of the present invention;

[0064] Figure 5 This is a cross-sectional schematic diagram of an embodiment of a voltage regulating component;

[0065] Figure 6This is a cross-sectional schematic diagram of another embodiment of the pressure regulating component;

[0066] Figure 7 A schematic diagram of an embodiment for delivering a drug to form an area of ​​action in target tissue using an existing device;

[0067] Figure 8 A schematic diagram of an embodiment of the device of the present invention for delivering a drug to a target tissue to form an area of ​​action;

[0068] Figure 9 A schematic diagram of another embodiment of the device of the present invention for delivering a drug to the target tissue to form an area of ​​action;

[0069] Figure 10 This is a cross-sectional schematic diagram of another embodiment of the device of the present invention. Detailed Implementation

[0070] The technical solution of the present invention will be described in detail below with reference to the accompanying drawings. The embodiments of the present invention are only used to illustrate the technical solution of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solution of the present invention without departing from the spirit and scope of the technical solution of the present invention, and all such modifications and substitutions should be covered within the scope of the claims of the present invention.

[0071] Figure 1 This is a schematic diagram of a device embodiment used to implement the method of the present invention. Figure 2 for Figure 1 A cross-sectional view of the device at one angle. Figure 1 and Figure 2 As shown, the device in this embodiment includes a container 100 and a cavity 200. An interface 300 is disposed on the container 100 for connecting a pressure source. In this embodiment, the pressure source provides a fluid at the desired pressure, such as a gas or liquid, preferably a gas, such as, but not limited to, air, N2, O2, CO2, or an inert gas. The interface 300 also communicates with the cavity 200 to introduce pressurized fluid into the cavity 200.

[0072] A cavity 200 is disposed within a container 100 and includes a channel 230, a cavity inlet 210, and a cavity outlet 220. The cavity inlet 210 communicates with an interface 300, and the cavity outlet 220 faces the bottom of the container. Pressurized fluid is introduced into the channel 230 from the cavity inlet 210, flows within the channel 230, and flows out of the cavity outlet 220, acting on the pharmaceutical agent within the container. The pharmaceutical agent is transported towards the container outlet by the pressure of the fluid.

[0073] After the pressure source valve is opened, the fluid from the pressure source enters the cavity 200 and quickly flows out from the cavity outlet 220. This causes a sudden force to be applied to the agent at the cavity outlet 220, driving the agent to move rapidly towards the container outlet 110. When the agent with greater momentum acts on the target tissue, it is reacted by the target tissue, thus expanding the area of ​​action of the agent (see...). Figure 7 This disperses the medication, reducing its concentration in the target tissue. When used in laparoscopic surgery, the medication can spread throughout the entire field of view due to the reaction of the target tissue, making it impossible to continue the surgery. The endoscope must be removed and wiped clean before the procedure can proceed, affecting the continuity of the surgery and hindering its progress.

[0074] To avoid this situation, the device in this embodiment also includes a valve 400, which includes a first through hole 410 and a valve body 420. The first through hole 410 is connected to the cavity inlet 210 and the cavity outlet 220 respectively. The valve body 420 is placed in the cavity 200, dividing the cavity 230 into a pressure relief cavity 231 and a pressure receiving cavity 232.

[0075] After the pressure source valve is opened, the fluid from the pressure source enters the cavity 200 through the cavity inlet 210, then passes through the pressure relief channel 231, and exits through the first through hole 410. Once the fluid flow rate from the pressure source stabilizes, the first through hole 410 is sealed using the cover 500. This allows the fluid from the pressure source to enter the pressure-receiving cavity 232 and exit through the cavity outlet 220, acting on the agent placed at the bottom of the container. At this time, the fluid from the pressure source can act on the agent at a more stable flow rate, resulting in more uniform force on the agent. When the agent acts on the target tissue, it reduces the reaction force of the target tissue, making the agent more concentrated on the target tissue.

[0076] For laparoscopic surgery, the device in this embodiment reduces the reaction of the drug to the target tissue, and the drug no longer affects the field of vision of the laparoscope, enabling continuous surgery. The method of closing the first through-hole 410 can be selected according to the application scenario. For example, during surgery, the operator can close the first through-hole 410 by pressing the first through-hole 410 with their thumb, thereby guiding the fluid from the pressure source into the pressurized cavity 232 and discharging it from the cavity outlet 220, making the operation of the device more convenient. As another example, for product packaging, the cap 500 is used to close the first through-hole 410 to maintain the sterility of the product during transportation and storage.

[0077] In order to effectively control the flow rate of fluid from the pressure source, the incoming fluid can be adjusted by means of a flow meter or other device, and the pressure of the fluid can be pre-adjusted by means of preset flow rate.

[0078] In order to prevent the fluid from the pressure source from generating a momentary high momentum in the delivered drug when it first enters the cavity 230, the valve body 420 of this embodiment also includes a guide 423, which causes the pressure relief cavity 231 and the pressure receiving cavity 232 to extend toward the first through hole 410.

[0079] Verification has shown that changing the flow direction of the fluid from the pressure source can effectively address the issue of the agent experiencing instantaneous high momentum during the initial stage of fluid entry into cavity 230, resulting in a more stable and sustained force on the agent from the pressurized fluid. In this embodiment, the device incorporates a reversing element within the valve body 420, causing the fluid moving within the pressurized cavity to undergo at least one 90°–180° directional change, such as, but not limited to, two, three, four, or more times.

[0080] In this embodiment, the valve body 420 further includes a first reversing element 421, which is disposed within the pressure-receiving cavity 232, causing the fluid moving within the pressure-receiving cavity to undergo a first 180° change in its direction of movement. A second reversing element 422 is also disposed along the fluid flow path, within the pressure-receiving cavity 232, causing the substance moving within the pressure-receiving cavity to move towards the cavity outlet after a second 180° change in its direction of movement. The smaller the particle size of the agent, the more often the fluid flow direction can be changed by the reversing element, which helps to reduce the force exerted by the fluid upon initial contact with the agent, and avoids the target tissue experiencing a reaction from the agent with greater momentum, thus expanding the area affected by the agent (see [reference]). Figure 7 This disperses the drug and reduces its concentration in the target tissue.

[0081] The agent acting on the target tissue is in powder form, with over 90% of the powder particles having a particle size ≤100μm, such as over 90% having a particle size ≤50μm. Fluid exiting from the cavity outlet 220 pushes the agent towards the container outlet 110, allowing the agent to act on the target tissue.

[0082] To facilitate the direct application of the drug to the target tissue, a conduit is also provided at the outlet of the container, which is combined with the device of this embodiment. By installing the conduit to guide the delivery path of the drug from the container outlet, it is also beneficial to apply the drug to the target tissue in close proximity.

[0083] To facilitate laparoscopic surgery and further avoid the adverse effects of drugs delivered to the target tissue causing the drug to fill the entire laparoscopic field of view and affect laparoscopic observation, this embodiment also provides a pressure regulating component that is used in combination with the device and catheter of this embodiment.

[0084] Figure 3 This is a cross-sectional schematic diagram of an embodiment of a conduit with a pressure regulating component mounted at one end. Figure 5 This is a cross-sectional schematic diagram of one embodiment of the voltage regulating component. (In conjunction with...) Figure 3 ,like Figure 5 As shown, the pressure regulating component 700 in this embodiment includes a pressure regulating cavity 710, one end of which is connected to the conduit 600, and the cavity wall 711 at the other end of the opening forms an angle α with the axial direction of the pressure regulating cavity of 3° to 10°. The drug, guided by the conduit, exits from the opening at an angle α of 3° to 10° and acts directly on the target tissue. The action surface formed by the drug on the target tissue is shown in [reference needed]. Figure 8 .

[0085] Figure 6 This is a cross-sectional schematic diagram of another embodiment of the pressure regulating component. Figure 6 As shown, the pressure regulating component 700 of this embodiment includes a pressure regulating cavity 710, whose pressure regulating inlet 712 is connected to the conduit 600, and the axial angle b between the cavity wall 714 of the pressure regulating outlet 713 and the pressure regulating cavity is 10° to 12.5°. Along the radial direction of the pressure regulating cavity 710, a plurality of grooves 715 are provided on the cavity wall of the pressure regulating cavity.

[0086] An ejection chamber 720 is also provided at the front of the pressure regulating chamber 710. Its ejection inlet 721 is assembled with the pressure regulating outlet 713. The angle c between the wall of the ejection outlet 722 and the axial direction of the ejection chamber is 5°–6°. The drug, guided by the catheter, exits from the opening at angle c and acts directly on the target tissue. The action surface formed by the drug on the target tissue is described in [reference needed]. Figure 9 .

[0087] In this embodiment, the diameter of the ejection inlet 721 is the same as the diameter of the pressure regulating outlet 713. A buffer cavity 730 is also provided between the ejection inlet and the ejection outlet, with an axial length d of 0.5mm to 2mm, especially 0.5mm to 1.5mm.

[0088] Figure 4 This is a cross-sectional schematic diagram of an embodiment of the device of the present invention. (In conjunction with...) Figure 1 ,like Figure 4 As shown, in this embodiment, the pressure-reducing component 700 is assembled at one end of the catheter 600, and the other end of the catheter 600 is assembled with the device. A hemostatic agent (see ZL2015100443818) is loaded into the device of this embodiment, and a hemostasis test is performed on the bleeding tissue. The interface 300 is connected to a gas source, and pressurized gas is introduced. The catheter 600 is aligned with the bleeding target tissue, and the first through-hole 410 is pressed, allowing the pressurized gas to enter the pressurized cavity 232. After two 180° changes in direction, the gas moves towards the cavity outlet and meets the agent at the outlet. Driven by the gas, the agent at the bottom of the container 100 is discharged from the catheter outlet and acts on the bleeding wound. The gas flow rate is adjusted, and the hemostasis is observed.

[0089] Figure 10This is a cross-sectional schematic diagram of another embodiment of the device of the present invention, as shown below. Figure 10 As shown, the pressure-reducing component 700 of the device of the present invention (e.g. Figure 6 (As shown) It is assembled at one end of the conduit 600, and the other end of the conduit 600 is assembled with the device. The inner volume of the container used for the device is 15 cm³. 3 Pressurized gas is introduced into the pressure relief chamber 231. Once the gas flow stabilizes, the first through-hole 410 is pressed, allowing the pressurized gas to enter the pressure chamber 232. After a 90° directional change, the gas moves towards the chamber outlet and encounters the medication there. Driven by the gas, the medication at the bottom of container 100 is discharged through the catheter outlet and applied to the bleeding wound. The application surface of the medication on the target tissue is described in [reference needed]. Figure 9 .

[0090] The method and apparatus provided in this embodiment can deliver the drug in the container more gently in a more stable and continuous balanced manner, effectively avoiding the drug from being affected by the reaction of the target tissue and covering the laparoscopic field of view or adhering to the surface of the laparoscopy, which would prevent timely observation of the drug's effect on the target tissue (especially the hemostatic effect of the hemostatic agent on the target tissue), thus improving the continuity of laparoscopic surgical operations.

[0091] Postoperative bleeding was active in the middle lobe of the rat liver. In the model group, bleeding remained severe even after applying pressure with hemostatic gauze; only one case achieved complete hemostasis, while the rest experienced incomplete hemostasis, with relatively large amounts of bleeding and prolonged bleeding time. After administering the drug to the bleeding target tissue using the device described in this embodiment, the amount of liver bleeding significantly decreased, showing a significant difference compared to the model group (p < 0.001); the bleeding time in this group was also significantly reduced compared to the model group (p < 0.01). The results are shown in Table 1.

[0092] Table 1

[0093]

[0094] Note: Compared with the model group, "*" indicates p < 0.05, and "***" indicates p < 0.001.

[0095] Postoperative bleeding was active in rats after femoral artery incision. Even after absorbing blood with gauze and applying pressure, significant bleeding persisted in the model group, with hemostasis failing in 3 cases and incomplete hemostasis in the rest. Bleeding time was prolonged in this group. After administration using the device described in this embodiment, the amount of bleeding at the surgical site decreased (p < 0.05), and the bleeding time was significantly reduced, showing a highly statistically significant difference compared to the control group (p < 0.001). Incomplete hemostasis was observed in most animals in this group, as shown in Table 2.

[0096] Table 2

[0097]

Claims

1. An apparatus for implementing a method of delivering a powdered drug, avoiding fogging of the field of view, characterized in that... include: A container containing powdered medicine, including a pressure relief chamber, a pressure relief orifice, and a pressure receiving chamber; Fluid is introduced into the container and flows along the pressure relief channel until it is discharged through the pressure relief vent of the container. After the fluid flow rate stabilizes, the pressure relief vent is closed, and the fluid enters the pressure-receiving channel, flows along the pressure-receiving channel, and is discharged from the outlet of the pressure-receiving channel, thus pushing the powdered medicine to the outlet of the container. More than 90% of the powdered pharmaceutical agents have a particle size ≤100μm; By changing the flow direction of the fluid from the pressure source, the problem of the powdered drug generating instantaneous high momentum in the initial stage of fluid entering the cavity is solved, so that the powdered drug is subjected to a more stable and continuous force from the pressurized fluid.

2. An apparatus for implementing a method of delivering a powdered drug, avoiding fogging of the field of view, characterized in that... include: A container containing powdered medicine, including a pressure relief chamber, a pressure relief orifice, and a pressure receiving chamber; Fluid is introduced into the container and flows along the pressure relief channel until it is discharged through the pressure relief hole of the container. After the fluid flow rate stabilizes, the pressure relief hole is closed. After the fluid enters the pressure-receiving channel, its flow direction changes at least twice before flowing toward the outlet of the pressure-receiving channel. After being discharged at the outlet of the pressure-receiving channel, it pushes the powdered medicine toward the outlet of the container. By changing the flow direction of the fluid from the pressure source, the problem of the powdered drug generating instantaneous high momentum in the initial stage of fluid entering the cavity is solved, so that the powdered drug is subjected to a more stable and continuous force from the pressurized fluid.

3. The device according to claim 1 or 2, characterized in that... The internal volume of the container is 10 cm³. 3 ~200cm 3 .

4. The device according to claim 1 or 2, characterized in that... The internal volume of the container is 10 cm³. 3 ~100cm 3 .

5. The device according to claim 1 or 2, characterized in that... The internal volume of the container is 30 cm³. 3 ~80cm 3 .

6. The device according to claim 1 or 2, characterized in that... The internal volume of the container is 40 cm³. 3 41cm 3 42cm 3 43cm 3 44cm 3 45cm 3 46cm 3 47cm 3 48cm 3 49cm 3 50cm 3 51cm 3 52cm 3 53cm 3 54cm 3 55cm 3 56cm 3 57cm 3 58cm 3 59cm 3 60cm 3 61cm 3 62cm 3 63cm 3 64cm 3 65cm 3 66cm 3 67cm 3 68cm 3 69cm 3 70cm 3 71cm 3 72cm 3 73cm 3 74cm 3 75cm 3 76cm 3 77cm 3 78cm 3 79cm 3 Or 80cm 3 .

7. The device according to claim 1 or 2, characterized in that... The fluid flow rate is 0.3 L / min to 7 L / min.

8. The device according to claim 1 or 2, characterized in that... The fluid flow rate is 0.5 L / min to 4 L / min.

9. The device according to claim 1 or 2, characterized in that... The cross-sectional area of ​​the fluid acting at the outlet of the pressurized cavity is 10 mm². 2 ~200mm 2 .

10. The device according to claim 1 or 2, characterized in that... The cross-sectional area of ​​the fluid acting at the outlet of the pressurized cavity is 10 cm². 2 ~100cm 2 .

11. The device according to claim 1 or 2, characterized in that... The cross-sectional area of ​​the fluid at the outlet of the pressurized cavity is 30 cm². 2 ~80cm 2 .

12. The device according to claim 1 or 2, characterized in that... The cross-sectional area of ​​the fluid at the outlet of the pressurized cavity is 40 cm². 2 41cm 2 42cm 2 43cm 2 44cm 2 45cm 2 46cm 2 47cm 2 48cm 2 49cm 2 50cm 2 51cm 2 52cm 2 53cm 2 54cm 2 55cm 2 56cm 2 57cm 2 58cm 2 59cm 2 60cm 2 61cm 2 62cm 2 63cm 2 64cm 2 65cm 2 66cm 2 67cm 2 68cm 2 69cm 2 70cm 2 71cm 2 72cm 2 73cm 2 74cm 2 75cm 2 76cm 2 77cm 2 78cm 2 79cm 2 Or 80cm 2 .

13. The device according to claim 1 or 2, characterized in that... The powdered medicine has more than 90% of its particles with a particle size ≤50μm.

14. The device according to claim 1 or 2, characterized in that... After the fluid enters the pressurized cavity, its flow direction changes at least once between 90° and 180°.

15. The device according to claim 1 or 2, characterized in that... After the fluid enters the pressurized cavity, its flow direction changes by at least two 180° changes.

16. The device according to claim 1 or 2, characterized in that... More than 75% of the powdered medicine is confined to an area with a radius of 0.5cm to 1.5cm.

17. A device for conveying powder, avoiding fogging in the field of view, characterized in that... include A container used to hold medicines, in powder form; A cavity, comprising a cavity channel, a cavity inlet, and a cavity outlet, wherein the cavity outlet faces the bottom of the container; The valve body divides the cavity into a pressure relief cavity and a pressure receiving cavity, wherein the pressure relief cavity is connected to the cavity inlet and the pressure receiving cavity is connected to the cavity outlet; More than 90% of the powder has a particle size ≤100μm; The valve body changes the flow direction of the fluid from the pressure source, solving the problem of the powder in the conveying process generating instantaneous high momentum in the initial stage of the fluid entering the cavity, so that the powder is subjected to a more stable and continuous force from the pressurized fluid.

18. The device according to claim 17, characterized in that... It also includes an interface, which is disposed on the container for connecting a pressure source, and the cavity inlet is connected to the interface.

19. The device according to claim 17, characterized in that... The valve body causes the fluid moving within the pressurized cavity to change direction at least once.

20. The device according to claim 17, characterized in that... The valve body causes the fluid moving within the pressurized cavity to change direction at least twice.

21. The device according to claim 17, characterized in that... After the valve body causes the fluid moving in the pressurized cavity to change direction twice, the fluid in the pressurized cavity moves toward the cavity outlet.

22. The device according to claim 18, characterized in that... A pressurized fluid, which may be a gas or a liquid, flows within the cavity.

23. The device according to claim 18, characterized in that... More than 90% of the powder particles have a particle size ≤50μm.

24. A powder conveying assembly, characterized in that... Includes the device as described in any one of claims 17 to 23.

25. The component according to claim 24, characterized in that... It also includes a conduit, which is disposed at the outlet of the container.

26. The component according to claim 24, characterized in that It also includes a conduit and a pressure regulating component, wherein the conduit is disposed at the outlet of the container and the pressure regulating component is disposed at one end of the conduit.

27. A device for conveying powder, characterized in that... The device, conduit, and pressure regulating component according to any one of claims 17 to 23 are included. The pressure regulating component includes a pressure regulating cavity, one end of which is connected to the conduit, and the angle between the cavity wall at the other end and the axial direction of the pressure regulating cavity is 3° to 10°.

28. A device for conveying powder, characterized in that... The device, conduit, and pressure regulating component according to any one of claims 17 to 23 are included, wherein the pressure regulating component includes a pressure regulating cavity, the pressure regulating inlet of which is connected to the conduit, and the angle between the cavity wall of the pressure regulating outlet and the axial direction of the pressure regulating cavity is 10° to 12.5°.

29. The apparatus according to claim 28, characterized in that... The pressure regulating component also includes an ejection cavity, the ejection inlet of which is assembled with the pressure regulating outlet, and the angle between the cavity wall of the ejection outlet and the axial direction of the ejection cavity is 5°~6°.

30. The apparatus according to claim 28, characterized in that... Along the radial direction of the pressure regulating cavity, several grooves are provided on the cavity wall of the pressure regulating cavity.

31. The apparatus according to claim 30, characterized in that... The diameter of the injection inlet is the same as the diameter of the pressure regulating outlet.

32. The apparatus according to claim 31, characterized in that... A buffer chamber with an axial length of 0.5mm to 2mm is also provided between the ejection inlet and the ejection outlet.

33. The apparatus according to claim 31, characterized in that... A buffer chamber with an axial length of 0.5mm to 1.5mm is also provided between the ejection inlet and the ejection outlet.

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