Needleless delivery device and needleless needle tube

Abstract

The utility model relates to the field of human body clinical medical treatment and animal health care, and provides a needleless delivery device which comprises a tube used for containing fluid and provided with a first end and a second end, and a plurality of holes used for distributing the fluid in the tube are formed in the second end. The power mechanism comprises a piston arranged in the first end of the pipe and capable of pushing the fluid, or the power mechanism is in operation connection with the piston so as to apply delivery pressure to the piston pushing the fluid. According to the needleless delivery device, through the arrangement of the multiple holes, the control over the number of the holes and the optimization of the size and distribution of the hole diameters, the delivery amount of drugs and vaccines is remarkably increased while skin injury is not caused. The utility model further provides a needleless needle tube used for the needleless delivery device.

Description

Technical Field

[0001] The utility model relates to the field of medical devices, in particular to a needle-free delivery device and a needle-free needle tube. Background Art

[0002] Needle-free injection technology has many advantages over traditional needle injection. Although there are many needle-free injection devices on the market, the clinical application of needle-free injection in human clinical and animal health care fields is basically not popularized. The main reason is that there is still insufficient scientific research on the penetration and delivery performance of needle-free injection, especially on the jet flow rate, drug chemical properties, needle-free injection aperture design, and the effects of human and animal epidermis, subcutaneous, muscle and other media on drug penetration and delivery performance. Existing needle-free syringes mostly use single-hole injection, and the research and application of truly effective multi-hole injection technology is still blank. In the field of vaccine delivery, needle-free injection has been clinically studied in the fields of inactivated vaccines, attenuated vaccines, recombinant protein vaccines, nucleic acid (mRNA) vaccines, and DNA vaccines, but because of unreliable effectiveness, it has not been popularized in practical applications. In practical applications, needle-free delivery devices have high requirements for skin fit, are prone to leakage due to hair, and are difficult to accurately control the injection position, depth and diffusion of the drug solution. Because high-pressure jets have strong destructive power, the jet aperture of needle-free injection devices on the market is generally 0.15mm, so when a large dose of drug delivery is required, the current needle-free injection technology has limitations. In addition, drug metabolism and vaccine immunogenicity stimulation have high requirements for the three-dimensional diffusion and precise positioning of drugs and vaccines in the body, and the research and application of needle-free injection technology in this area is still blank.

[0003] The content of this background technology description is only for facilitating understanding of the relevant technology in this field and is not regarded as an admission of the prior art. Utility Model Content

[0004] Therefore, in view of the above-mentioned defects of needle-free injection, the embodiment of the present invention intends to provide a needle-free delivery device to at least partially solve the problems existing in the existing needle-free injection. The embodiment of the present invention also provides a needle-free needle tube for the needle-free delivery device.

[0005] The present invention provides a needle-free delivery device, comprising:

[0006] a tube for containing a fluid, the tube having a first end and a second end, the second end having a plurality of holes disposed therein for distributing the fluid in the tube; and

[0007] A power mechanism includes a piston disposed in the first end of the tube and capable of pushing the fluid, or the power mechanism is operatively connected to the piston to apply a delivery pressure to the piston pushing the fluid.

[0008] In some embodiments of the present invention, the power mechanism is any one of compressed gas drive, spring drive, electromagnetic drive, or a combination of the above drive modes.

[0009] In some embodiments of the present invention, the total fluid delivery area of ​​the plurality of holes is 0.009 mm 2 The single hole area of ​​the hole is 0.0028~0.035mm 2 .

[0010] In some embodiments of the present invention, the plurality of holes are arranged along a diameter or a midline of the second end, and one of the plurality of holes arranged along a diameter or a midline of the second end is located at the center of the circle or the center of the second end.

[0011] In some embodiments of the present invention, the diameter of the hole located at the center of the circle or the center of the second end is different from the diameters of the other holes of the plurality of holes.

[0012] In some embodiments of the present invention, the plurality of holes are arranged in a ring shape with the center of the second end as the center.

[0013] In some embodiments of the present invention, at least one of the plurality of holes arranged in an annular manner has a hole diameter different from that of the other holes.

[0014] In some embodiments of the present invention, the plurality of holes include a central hole located at the center of the circle or center of the second end and a plurality of peripheral holes located around the central hole, and the plurality of peripheral holes are arranged in a ring shape.

[0015] In some embodiments of the present invention, the diameter of the central hole is different from the diameters of the plurality of peripheral holes.

[0016] In some embodiments of the present invention, a needle-free needle tube for a needle-free delivery device is also provided, comprising:

[0017] A tube for containing a fluid, the tube having a first end and a second end, wherein the first end is configured to accommodate a piston for pushing the fluid, and the second end has a plurality of holes for dispensing the fluid in the tube.

[0018] The needle-free delivery device of the embodiment of the utility model is configured with the needle-free delivery device of the utility model, the components of the needle-free delivery device, and the multiple holes with different numbers, diameters and arrangements. Compared with the traditional single-hole needle-free injection, it can achieve a significant increase in the delivery amount of the delivery object without causing damage to the skin, especially increasing the single delivery amount of drugs and vaccines, and has a delivery efficiency far higher than the existing single-hole needle-free delivery, which can meet a wider range of application scenarios.

[0019] Other optional features and technical effects of the embodiments of the present utility model are partially described below, and partially can be understood by reading this document. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Hereinafter, embodiments of the present utility model will be described in detail with reference to the accompanying drawings. The elements shown are not limited by the proportions shown in the accompanying drawings. The same or similar reference numerals in the accompanying drawings represent the same or similar elements, wherein:

[0021] Figure 1 A schematic structural diagram of a needle-free delivery device according to an embodiment of the present invention is shown;

[0022] Figure 2 A schematic structural diagram of a needle-free delivery device according to an embodiment of the present invention is shown;

[0023] Figure 3 A schematic diagram of a multi-hole arrangement of a needle-free delivery device according to an embodiment of the present invention is shown;

[0024] Figure 4 A schematic diagram of a multi-hole arrangement of a needle-free delivery device according to an embodiment of the present invention is shown;

[0025] Figure 5 A schematic diagram of a multi-hole arrangement of a needle-free delivery device according to an embodiment of the present invention is shown;

[0026] Figure 6 A schematic diagram of a multi-hole arrangement of a needle-free delivery device according to an embodiment of the present invention is shown;

[0027] Figure 7 A schematic diagram showing a linear arrangement of multiple holes in a needle-free delivery device according to an embodiment of the present invention is shown;

[0028] Figure 8 A schematic diagram showing a linear arrangement of multiple holes in a needle-free delivery device according to an embodiment of the present invention is shown;

[0029] Fig. 9 A schematic diagram showing a linear arrangement of multiple holes in a needle-free delivery device according to an embodiment of the present invention is shown;

[0030] Fig.10 A schematic diagram showing a linear arrangement of multiple holes in a needle-free delivery device according to an embodiment of the present invention is shown;

[0031] Fig.11 A schematic diagram showing the arrangement of a porous array of a needle-free delivery device according to an embodiment of the present utility model is shown;

[0032] Fig.12 A schematic diagram showing a multi-hole arrangement with different pore sizes of a needle-free delivery device according to an embodiment of the present invention;

[0033] Fig.13 A schematic diagram showing a multi-hole arrangement with different pore sizes of a needle-free delivery device according to an embodiment of the present invention;

[0034] Fig.14 A schematic diagram showing a multi-hole arrangement with different pore sizes of a needle-free delivery device according to an embodiment of the present invention;

[0035] Fig.15 A schematic diagram showing a multi-hole arrangement with different pore sizes of a needle-free delivery device according to an embodiment of the present invention;

[0036] Fig.16 A schematic diagram showing a multi-hole annular arrangement of a needle-free delivery device according to an embodiment of the present utility model;

[0037] Fig.17 A schematic diagram showing a multi-hole annular arrangement of a needle-free delivery device according to an embodiment of the present utility model;

[0038] Fig.18 A schematic diagram showing a coaxial annular arrangement of multiple groups of holes of a needle-free delivery device according to an embodiment of the present utility model is shown;

[0039] Fig.19 A schematic diagram showing a coaxial annular arrangement of multiple groups of holes of a needle-free delivery device according to an embodiment of the present utility model is shown;

[0040] Fig. 20 A schematic diagram showing a plurality of coaxial ring-shaped groups of holes of a needle-free delivery device according to an embodiment of the present invention is shown;

[0041] Fig.21 A schematic diagram showing a multi-hole arrangement of the central hole and the peripheral holes of the needle-free delivery device according to an embodiment of the present utility model;

[0042] Fig. 22 A schematic diagram showing a multi-hole arrangement of the central hole and the peripheral holes of the needle-free delivery device according to an embodiment of the present utility model;

[0043] Fig.23 A schematic diagram showing a multi-hole arrangement of the central hole and the peripheral holes of the needle-free delivery device according to an embodiment of the present utility model;

[0044] Fig.24 A schematic diagram showing a multi-hole arrangement of the central hole and the peripheral holes of the needle-free delivery device according to an embodiment of the present utility model;

[0045] Fig.25 A schematic diagram showing a multi-hole arrangement of the central hole and the peripheral holes of the needle-free delivery device according to an embodiment of the present utility model;

[0046] Fig.26 A schematic diagram showing a multi-hole arrangement of the central hole and the peripheral holes of the needle-free delivery device according to an embodiment of the present utility model;

[0047] Fig. 27 A schematic diagram showing a multi-hole arrangement of the central hole and the peripheral holes of the needle-free delivery device according to an embodiment of the present utility model;

[0048] Fig.28 A schematic diagram showing a multi-hole arrangement of a needle-free delivery device according to an embodiment of the present invention is shown;

[0049] Fig.29 A schematic diagram showing a multi-hole arrangement of a needle-free delivery device according to an embodiment of the present invention is shown;

[0050] Fig.30 A schematic structural diagram of a needle-free delivery device according to an embodiment of the present invention is shown;

[0051] Fig.31 A schematic structural diagram of a needle-free delivery device according to an embodiment of the present invention is shown. DETAILED DESCRIPTION

[0052] In order to make the purpose, technical solution and advantages of the utility model more clear, the utility model is further described in detail below in combination with specific implementation methods and drawings. Here, the schematic implementation methods and descriptions of the utility model are used to explain the utility model, but are not used as limitations of the utility model.

[0053] As used herein, the term "including" and its variations mean open inclusion, i.e., "including but not limited to". Unless otherwise stated, the term "or" means "and / or". The term "based on" means "based at least in part on". The terms "an example embodiment" and "an embodiment" mean "at least one example embodiment". The term "another embodiment" means "at least one additional embodiment". The terms "first", "second", etc. may refer to different or the same objects. Other explicit and implicit definitions may also be included below.

[0054] In multiple embodiments of the present invention, Figure 1 As shown, a needle-free delivery device is provided, especially a needle-free delivery device for drugs and vaccines, the needle-free delivery device may include a tube 100 and a power mechanism 200 not specifically depicted, wherein the tube 100 is suitable for containing a fluid 130 and has a first end 110 and a second end 120, wherein a piston 210 for pushing the fluid 130 in the tube is arranged in the first end 110, and a plurality of holes 121 are arranged on the second end 120.

[0055] In some embodiments of the present invention, Figure 2As shown, the second end 120 of the needle-free delivery device may further have a narrowing section 122 that gradually narrows from the tube 100 axially toward the distal end, and a plurality of holes 121 are provided on an end surface 123 of the narrowing section 122 , wherein the end surface 123 is configured to be circular.

[0056] In some embodiments of the present invention, Figure 1 as well as Figure 2 As shown, the piston 210 may be provided as an independent component, and the power mechanism 200 is configured to be suitable for being operatively connected to the piston 210 to apply delivery pressure to the piston 210. It is also conceivable that in other embodiments of the present invention, the power mechanism 200 may be integrated with the piston 210.

[0057] In some embodiments of the utility model, the driving mode of the power mechanism 200 may include any one of compressed gas driving, spring driving, electromagnetic driving, or a combination of the above driving modes. For example, in some embodiments, the power mechanism 200 may be driven by compressed gas, such as compressed nitrogen or compressed carbon dioxide gas, or may be driven by a compressed mechanical spring, or may be driven by a piezoelectric actuator, without limitation herein.

[0058] In some embodiments of the present invention, a plurality of holes 121 may be provided in the second end 120, that is, the number of the plurality of holes 121 is greater than or equal to 2, for example Figures 3 to 5 2, 3 and 4 holes 121 are provided on the second end 120. It can be understood that Figure 6 As shown, a plurality of holes 121 may be similarly arranged on the end surface 123 , and the number of the plurality of holes 121 is greater than or equal to 2. The following embodiments of the present invention will all take the arrangement of the second end 120 as an example.

[0059] In some embodiments of the present invention, the total area of ​​the plurality of holes is 0.009 mm 2 Above, preferably 0.020mm 2 More preferably 0.053 mm 2 The single hole area of ​​the hole is 0.0028~0.035mm 2 , preferably 0.0028 to 0.020 mm 2 , more preferably 0.0028 to 0.009 mm 2 .

[0060] In the embodiment of the utility model, the needle-free delivery device of the utility model can deliver 0.3 mm at a time without causing skin damage. 3 The volume of the drug or vaccine (pre-delivery volume) is preferably 1.0 mm3 The volume of the drug or vaccine (pre-delivery volume) is more preferably 5.0 mm 3 In some embodiments, the volume of medicine or vaccine delivered by the needle-free delivery device of the present invention at one time (the volume before delivery) can reach 14.0 mm 3 In a further embodiment, the volume of medicine or vaccine delivered by the needle-free delivery device of the utility model at one time (volume before delivery) can reach 46.0 mm 3 .

[0061] In some embodiments of the present invention, compared to manual needle injection (the pushing speed of the piston inside the needle tube is about 0.01 m / s), the piston speed of the piston 210 of the needle-free delivery device of the present invention embodiment when pushing the fluid 130 in the tube 100 is greater than or equal to 10 times the piston speed of manual needle injection, and the piston speed of the piston 210 when pushing the fluid 130 is 0.05 m / s to 0.50 m / s, preferably 0.13 m / s to 0.15 m / s, and more preferably 0.14 m / s to 0.20 m / s.

[0062] In some embodiments of the present invention, compared to manual needle injection (the outlet jet velocity of the fluid ejected from the needle tip is about 2 m / s), the outlet jet velocity of the fluid 130 in the needle-free delivery device of the present invention when being pushed away from the plurality of holes 121 in the second end 120 by the piston 210 is greater than or equal to 10 m / s, preferably greater than or equal to 50 m / s, more preferably greater than or equal to 100 m / s, and more preferably greater than or equal to 150 m / s.

[0063] In some embodiments of the present invention, the needle-free delivery device is configured so that the fluid jets passing through the multiple holes 121 have different in vivo diffusion degrees; preferably, the apertures d of the multiple holes 121 of the needle-free delivery device are configured so that the fluid jets passing through the multiple holes 121 have different in vivo diffusion degrees; preferably, the fluid jet velocities v passing through the multiple holes 121 of the needle-free delivery device are configured so that the fluid jets passing through the multiple holes 121 have different in vivo diffusion degrees.

[0064] In some embodiments of the present invention, compared to existing artificial needle injections (in which the injected fluid hardly diffuses in the body), the needle-free delivery device of the embodiments of the present invention enables the fluid 130 in the multiple holes 121 in the second end 120 pushed away by the piston 210 to have different diffusion in the body and different diffusion degrees.

[0065] In the embodiment of the present invention, the diffusivity refers to a comprehensive concept describing the distribution characteristics of a fluid in the body. Specifically, the diffusivity may include the fluid's diffusion volume ratio, diffusion depth, diffusion center, and edge liquid distribution density.

[0066] In some embodiments of the present invention, the diffusion volume ratio refers to the ratio of the diffusion area volume of the fluid delivered by the needle-free delivery device in the body to the original volume of the fluid not delivered, that is:

[0067]

[0068] In other embodiments of the present invention, the diffusion volume ratio may also refer to the ratio of the diffusion volume of the fluid delivered by the needle-free delivery device of the present invention to the diffusion volume of the fluid delivered by artificial needle injection, that is:

[0069]

[0070] Among them, the diffusion volume of the delivery fluid can be calculated in a variety of ways, which are not limited here. For example, in some embodiments of the present invention, fluorescent markers can be added to the drug or vaccine in advance, and then scanned by medical imaging technology and image analysis software can be used to calculate the volume of the diffusion area, such as calculating the envelope diagram of the diffusion area to estimate the volume of the diffusion area.

[0071] In some embodiments of the present invention, the diffusion depth refers to the farthest distance from the body surface to the diffusion area of ​​the fluid injected without needle; the diffusion center refers to the three-dimensional center of the diffusion area formed in the body by the fluid injected without needle, such as the centroid of the three-dimensional area, which is not limited here.

[0072] In some embodiments of the present invention, the needle-free delivery device is configured so that the diffusion volume of the fluid 130 in the body is greater than the non-delivered fluid volume or the needle-delivered fluid volume. Preferably, the diffusion volume of the fluid in the body is more than 1.50 times the non-delivered volume, preferably more than 1.80 times, further preferably more than 2.40 times, more preferably more than 3.00 times, and even more preferably more than 3.60 times.

[0073] It is understandable that when the delivery fluid enters the body through the needle-free delivery device, the three-dimensional spatial area of ​​its distribution becomes larger due to the diffusion of the fluid in the body. This diffusion process will increase the surface area of ​​contact between the fluid, especially the drug or vaccine, and the body's tissues, thereby improving the bioavailability and efficacy of the drug.

[0074] It is understandable that, under the guidance of the embodiments of the utility model, those skilled in the art can confirm the corresponding diffusion degrees of the dermis, epidermis, subcutaneous layer, muscle and human organs in the body of the inoculated object according to the needle-free delivery inoculated object, including but not limited to different types of animals or patients with different physical conditions.

[0075] In some embodiments of the present invention, the plurality of holes includes a first hole.

[0076] In a preferred embodiment, the first hole has a first aperture, and the size of the first aperture is configured to allow the fluid jet through the first hole to diffuse in at least one of the dermis, epidermis, subcutaneous tissue, muscle and human organs. Preferably, multiple holes have the same aperture, such as the first aperture.

[0077] In a preferred embodiment, the first hole has a first outlet jet velocity, and the first outlet jet velocity is configured to make the fluid jet through the first hole diffuse in at least one of the dermis, epidermis, subcutaneous tissue, muscle and human organs. Preferably, multiple holes have the same outlet jet velocity, such as the first outlet jet velocity.

[0078] In other embodiments of the present invention, the plurality of holes include a first hole and a second hole.

[0079] In a preferred embodiment, the first hole has a first aperture, the size of which is configured so that the fluid jet passing through the first hole diffuses in at least one of the dermis, epidermis, subcutaneous tissue, muscle and human organs; the second hole has a second aperture, the size of which is configured so that the fluid jet passing through the second hole diffuses in at least one of the dermis, epidermis, subcutaneous tissue, muscle and human organs. Preferably, the apertures of the plurality of holes may be configured to be unequal, for example, the plurality of holes may include a first hole and at least one second hole, wherein the first hole has a first aperture d1, and the second hole has a second aperture d2, wherein d1≠d2.

[0080] In a preferred embodiment, the first hole has a first outlet jet velocity, and the first outlet jet velocity is configured so that the fluid jet through the first hole diffuses in at least one of the dermis, epidermis, subcutaneous tissue, muscle, and human organs; the second hole has a second outlet jet velocity, and the second outlet jet velocity is configured so that the fluid jet through the second hole diffuses in at least the same or another of the dermis, epidermis, subcutaneous tissue, muscle, and human organs. Preferably, the jet velocities of the fluid 130 through the multiple holes can also be configured to be unequal, for example, the first hole has a first outlet jet velocity v1, and the second hole has a second outlet jet velocity v2, wherein v1≠v2.

[0081] In some embodiments of the present invention, the plurality of holes 121 may have different arrangements.

[0082] like Figures 7 to 9 As shown, the plurality of holes 121 are arranged along a straight line.

[0083] like Figures 7 to 9 As shown, the plurality of holes 121 are arranged along the diameter or midline of the second end 120, preferably, one of the plurality of holes 121 arranged along the diameter or midline of the second end 120 is located at the center of the circle or the center of the second end;

[0084] In one embodiment of the present invention, Figure 8 As shown, three holes 121 are arranged in a straight line along the diameter (midline) of the second end 120 , including a hole 121 ′ located at the center (center) of the second end 120 .

[0085] In some embodiments of the present invention, preferably, the plurality of holes 121 arranged along a straight line are arranged at equal intervals.

[0086] In one embodiment of the present invention, Figure 8 As shown, a plurality of holes 121 are arranged on the second end 120 along a diameter straight line of the second end 120 , wherein the plurality of holes 121 are arranged at equal intervals.

[0087] In some embodiments of the present invention, preferably, Figures 7 to 9 As shown, the plurality of holes 121 arranged along a straight line are mirror-symmetrical with respect to a diameter or a center line of the second end 120 .

[0088] In some embodiments of the present invention, preferably, the holes 121 have multiple groups, and each group of holes 121 is arranged along a straight line. Preferably, each group of holes 121 is arranged along a diameter or a center line of the second end 120 .

[0089] In one embodiment of the present invention, Fig.10 As shown, three groups of holes 121, namely group A, group B and group C, are arranged on the second end 120, wherein group A and group C each include two holes 121 arranged in a straight line, and group B includes three holes 121 arranged in a straight line.

[0090] In some embodiments of the present invention, the plurality of holes 121 are arranged in an array. Preferably, the plurality of holes 121 arranged in an array are mirror-symmetrical with respect to first and second diameters or midlines perpendicular to each other of the second end 120 .

[0091] In one embodiment of the present invention, Fig.11As shown, four holes 121 are arranged in an array on the second end 120 , and the four holes 121 are mirror-symmetrical with respect to the first and second diameters (center lines) of the second end 120 which are perpendicular to each other.

[0092] In some embodiments of the present invention, the diameter of the hole 121 ′ located at the center or center of the second end 120 is different from the diameters of other holes in the plurality of holes 121 .

[0093] In one embodiment of the present invention, Figure 12 to Figure 13 As shown, the second end 120 is provided with three holes arranged along a straight line, including a hole 121 ′ with a hole diameter d′ located at the center or center of the second end 120 , and the other two holes 121 with a hole diameter d, wherein d′≠d.

[0094] In some embodiments of the present invention, preferably, the aperture d2 of at least one group of holes 121 among the plurality of groups of holes 121 is different from the aperture d1 of the other groups of holes 121 .

[0095] In one embodiment of the present invention, Figure 14 to Figure 15 As shown, three groups of holes 121, namely group A, group B and group C, are arranged on the second end 120, wherein group A and group C each include two holes 121 arranged in a straight line, and group B includes three holes 121' arranged in a straight line, wherein the aperture of the three holes 121' included in group B is d', and the aperture of the holes 121 included in group A and group B is d, wherein d'≠d.

[0096] In some embodiments of the present invention, Figure 8 , Fig.12 as well as Fig.13 As shown, the outlet jet velocity v′ of the hole 121 ′ located at the center or centre of the second end 120 is different from the outlet jet velocity v of the other holes 121 of the plurality of holes 121 .

[0097] In some embodiments of the present invention, preferably, the outlet jet velocity v2 of at least one group of holes in the plurality of groups of holes is different from the outlet jet velocity v1 of the other groups of holes.

[0098] In one embodiment of the present invention, Fig.14 as well as Fig.15 As shown, three groups of holes 121, namely Group A, Group B and Group C, are arranged on the second end 120, wherein Group A and Group C each include two holes 121 arranged in a straight line, and Group B includes three holes 121' arranged in a straight line, wherein the outlet jet velocity v2 of the three holes 121' included in Group B, and the outlet jet velocity v1 of the holes 121 included in Group A and Group B, wherein v2≠v1.

[0099] In some embodiments of the present invention, the plurality of holes 121 on the second end 120 are arranged in a ring shape; preferably, the plurality of holes 121 are arranged in a ring shape with the center of the second end 120 as the center.

[0100] In one embodiment of the present invention, Fig.16 as well as Fig.17 As shown, for example, Fig.16 It is shown that three holes 121 are arranged on the second end 120 , and the three holes 121 are arranged in a ring with the center O of the second end 120 as the center.

[0101] In some embodiments of the present invention, the holes 121 are arranged in a plurality of groups, and each group of holes 121 is arranged in a ring shape. Preferably, the plurality of groups of holes 121 are arranged in a coaxial ring shape.

[0102] In one embodiment of the present invention, Fig.18 As shown, two groups of holes 121, group A and group B, are arranged on the second end 120, wherein both group A and group B are arranged in a ring shape and are coaxially arranged in a ring shape with the center O of the second end 120 as the center.

[0103] In one embodiment of the present invention, Fig.19 and Fig. 20 As shown, the second end 120 is provided with two groups of holes 121, namely, group A and group B, wherein both the group A and the group B are arranged in a circular shape and are coaxially arranged in a circular shape with the center of the second end 120 as the center, wherein the aperture of the three holes 121' included in the group B is d', and the aperture of the holes 121 included in the group A is d, wherein d'≠d; and Fig.19 In the configuration shown, the diameters of the holes 121 of the A group and the B group, which are coaxially arranged in an annular manner, decrease radially outward, that is, d'>d. Fig. 20 In the configuration shown, the holes 121 of group A and group B increase radially outward, that is, d'<d.

[0104] In some embodiments of the present invention, preferably, at least one of the plurality of holes 121 arranged in an annular manner has an outlet jet velocity different from that of the other holes;

[0105] In some embodiments of the present invention, preferably, the outlet jet velocity of at least one group of holes 121 of the plurality of groups of holes 121 is different from the outlet jet velocity of the other groups of holes;

[0106] In some embodiments of the present invention, the outlet jet velocities of the multiple groups of holes 121 coaxially arranged in an annular manner increase or decrease in the radial direction.

[0107] In some embodiments of the present invention, the plurality of holes 121 include a central hole 121 ″ located at the center of the second end and a plurality of peripheral holes 121 located around the central hole.

[0108] In one embodiment of the present invention, Figure 21 to Figure 24 As shown, the second end 120 is provided with a central hole 121 ″ located at the center (center) of the second end and a plurality of peripheral holes 121 located around the central hole.

[0109] In one embodiment of the present invention, Fig.21 As shown, the second end 120 is provided with a central hole 121 ″ located at the center (center) of the second end and two peripheral holes 121 located around the central hole.

[0110] In some embodiments of the present invention, Figure 22 to Figure 24 As shown, the plurality of peripheral holes 121 are arranged in a ring shape.

[0111] In some embodiments of the present invention, Figure 22 to Figure 24 As shown, the plurality of peripheral holes 121 are arranged in a coaxial ring around the central hole 121 ″.

[0112] In some embodiments of the present invention, Fig.24 As shown, the peripheral holes 121 have multiple groups, and each group of peripheral holes 121 is arranged in a ring. Fig.24 As shown, the plurality of groups of peripheral holes 121 are arranged in a coaxial ring around the central hole 121 ″.

[0113] In one embodiment of the present invention, Fig.24 As shown, six peripheral holes 121 are provided on the second end 120, and the six peripheral holes 121 are divided into two groups A and B which are evenly arranged in a ring shape, wherein the two groups A and B each contain three peripheral holes 121, and the two groups of peripheral holes 121 are coaxially arranged in a ring shape around the central hole 121".

[0114] In some embodiments of the present invention, the diameter d” of the central hole 121 ″ is different from the diameter d of the plurality of peripheral holes 121 .

[0115] In one embodiment of the present invention, Figure 25 to Figure 26 As shown, the second end 120 is provided with a central hole 121" with a hole diameter d" and three peripheral holes 121 with a hole diameter d, wherein d"≠d. Fig.25 In the configuration shown, d"<d, while in Fig.26 In the configuration shown, d”>d.

[0116] In another embodiment of the present invention, Figure 27 to Figure 29 As shown, the second end 120 is provided with a central hole 121" with an aperture d" and six peripheral holes 121 with an aperture d, wherein d"≠d, and the six peripheral holes 121 are divided into two groups A and B that are evenly arranged in a ring shape, wherein the two groups A and B each contain three peripheral holes 121, and the two groups of peripheral holes 121 are coaxially arranged in a ring shape around the central hole 121".

[0117] In some embodiments of the present invention, the aperture d1 of at least one of the plurality of peripheral holes 121 is different from the aperture d2 of the other peripheral holes. In some embodiments of the present invention, the apertures of the plurality of coaxially annularly arranged holes 121 and the central hole 121" increase or decrease radially.

[0118] like Fig.28 and Fig.29 As shown, the aperture of the three peripheral holes 121 included in the group A is d1, and the aperture of the three peripheral holes 121 included in the group B is d2, and d1≠d2. Fig.28 In the configuration shown, d1>d2, while in Fig.29 In the configuration shown, d1 < d2. Fig.28 and Fig.29 As further shown, the aperture of the central hole 121" is d", the aperture of the three peripheral holes 121 included in the group A is d1, and the aperture of the three peripheral holes 121 included in the group B is d2, and d1≠d2; Fig.28 In the configuration shown, the diameters of the coaxially arranged A and B holes 121 and the central hole 121" decrease radially outward, that is, d">d1>d2. Fig.29 In the configuration shown, the diameters of the A and B holes 121 and the central hole 121 ″ which are coaxially arranged in an annular manner increase radially, that is, d″<d1<d2.

[0119] In some embodiments of the present invention, the outlet jet velocity v" of the central hole is different from the outlet jet velocity v of the plurality of peripheral holes.

[0120] In some embodiments of the present invention, the outlet jet velocity v1 of at least one group of peripheral holes 121 among the plurality of groups of peripheral holes 121 is different from the outlet jet velocity v2 of the other groups of peripheral holes 121 .

[0121] In some embodiments of the present invention, the outlet jet velocities of the multiple groups of holes 121 coaxially arranged in an annular pattern and the central hole 121 increase or decrease radially.

[0122] It is understandable that those skilled in the art can determine the aperture size and the number of the plurality of peripheral holes according to their needs, and no limitation is imposed herein.

[0123] In some embodiments of the present invention, the shapes of the holes 121 are cylindrical, conical or streamlined.

[0124] In some embodiments of the utility model, any needle-free delivery device in the above-mentioned embodiments of the utility model can also be used in combination with a triple vaccine for feline rhinotracheitis, calicivirus disease, and panleukopenia. Thus, the embodiments of the present application also provide corresponding drug-device combination products. In an embodiment of the utility model, the drug-device combination product may include or may be a drug delivery system. In an embodiment of the utility model, the triple vaccine is, for example, a cat triple vaccine.

[0125] In the utility model embodiment, the cat triple vaccine refers to an inactivated vaccine for preventing common infectious diseases of cats, which can prevent cat rhinotracheitis, feline calicivirus disease and feline panleukopenia, which are the most common infectious diseases of cats. The cat triple vaccine is developed by screening the dominant epidemic strains of the three infectious diseases of cats from a large number of clinical samples, so it has good safety, rapid antibody production, long immunity duration and one shot to prevent three diseases. It is suitable for cats over 8 weeks old, and generally needs to be vaccinated with three shots of basic immunity at 8 weeks, 12 weeks and 16 weeks of age. After completing basic immunity, a booster shot should be vaccinated every year to maintain the immune effect.

[0126] In some embodiments of the present invention, the second end 120 of the needle-free delivery device used in combination with a cat triple vaccine is provided with three holes 121 arranged in a circular pattern at equal intervals around the center of the second end 120 , and the three holes 121 are 1.25 mm±20% away from the center of the second end 120 .

[0127] In some embodiments of the present invention, the pushing speed of the piston 210 of the needle-free delivery device used in combination with the feline triple vaccine is configured to be 0.12 m / s±20%.

[0128] In some embodiments of the present invention, the needle-free delivery device used in combination with a feline triple vaccine is configured such that the outlet jet velocity of the feline triple vaccine when pushed away from the hole 121 in the second end 120 by the pushing element 210 is 150.00 m / s±20%.

[0129] In some embodiments of the present invention, the needle-free delivery device used in combination with the feline triple vaccine is configured so that the diffusion volume of the feline triple vaccine in the body is more than 1.5 times the non-delivery volume of the feline triple vaccine.

[0130] In some embodiments of the present invention, the needle-free delivery device used in combination with the feline triple vaccine is configured so that the average antibody titer of the feline triple vaccine 14 days after the second dose is more than 1.2 times the average antibody titer of needle injection, preferably more than 2.0 times, and more preferably more than 4.8 times.

[0131] In the embodiment of the utility model, the average antibody titer is an indicator of the strength of immune response, which is used to evaluate the level of antibodies produced by an organism to a specific antigen (such as a virus, bacteria or vaccine). It is expressed as the average value of the serum dilution multiples that can neutralize or bind a certain amount of antigen under specific conditions. In other words, the higher the average antibody titer, the stronger the ability of the antibodies produced by the organism to fight against specific pathogens.

[0132] In some embodiments of the present invention, the needle-free delivery device used in combination with the feline triple vaccine is configured so that the average antibody titer of the feline triple vaccine 30 days after the second dose is more than 1.2 times the average antibody titer of needle injection, preferably more than 2.0 times, and more preferably more than 3.7 times.

[0133] In some embodiments of the present invention, the needle-free delivery device used in combination with the feline triple vaccine is configured so that the average antibody titer of the feline triple vaccine 60 days after the second dose is more than 1.2 times, preferably more than 2.0 times, and more preferably more than 6.3 times the average antibody titer of needle injection.

[0134] In some embodiments of the present invention, the needle-free delivery device used in combination with the feline triple vaccine is configured so that the average antibody titer of the feline triple vaccine 60 days after the second dose of 60% vaccine dose is more than 1.1 times, preferably more than 1.5 times, and more preferably more than 2.0 times the average antibody titer produced by needle injection of 100% vaccine dose.

[0135] In some embodiments of the present invention, any needle-free delivery device in the above embodiments of the present invention can also be used in combination with a hepatitis B vaccine. Thus, the present application also provides a corresponding drug-device combination product. In the embodiments of the present invention, the drug-device combination product can include or can be a drug delivery system.

[0136] In the embodiment of the utility model, the hepatitis B vaccine refers to a hepatitis B recombinant yeast vaccine (Hansen yeast) for preventing hepatitis B (a viral liver disease), which is made by purifying the hepatitis B virus surface antigen (HBsAg) expressed by recombinant Hansen yeast and adding aluminum adjuvant, and the active ingredient is the hepatitis B virus surface antigen. The vaccine is suitable for people who are susceptible to hepatitis B, especially the following people: (1) newborns, especially those whose mothers are HBsAg and HBeAg positive, (2) people who are 16 years old and above who are susceptible to hepatitis B, (3) medical staff engaged in medical work and laboratory personnel who come into contact with blood. After vaccination, the immune system can be stimulated to produce protective antibodies, so that the human body has immunity to prevent hepatitis B, so as to achieve the purpose of preventing hepatitis B infection. The conventional immunization site is the deltoid muscle of the upper arm. The immunization program is 3 injections, which are given once at birth (0 months), 1-2 months of age, and 6-18 months of age. The first injection is given to newborns within 24 hours after birth, and each injection is 1 dose.

[0137] In some embodiments of the present invention, the second end 120 of the needle-free delivery device used in combination with the hepatitis B vaccine is provided with three holes 121 arranged in a circular pattern at equal intervals around the center of the second end 120 , and the three holes 121 are 1.25 mm±20% away from the center of the second end 120 .

[0138] In some embodiments of the present invention, the pushing speed of the piston 210 of the needle-free delivery device used in combination with the hepatitis B vaccine is configured to be 0.12 m / s±20%.

[0139] In some embodiments of the present invention, the needle-free delivery device used in combination with the hepatitis B vaccine is configured so that the outlet jet velocity of the hepatitis B vaccine when pushed away from the hole 121 in the second end 120 by the pushing element 210 is 150.00 m / s±20%.

[0140] In some embodiments of the present invention, the needle-free delivery device used in combination with the hepatitis B vaccine is configured so that the diffusion volume of the hepatitis B vaccine in the body is more than 1.5 times the non-delivery volume of the hepatitis B vaccine.

[0141] In some embodiments of the present invention, the needle-free delivery device used in combination with the hepatitis B vaccine is configured so that the average antibody titer of the hepatitis B vaccine 14 days after the second dose is more than 1.1 times, preferably more than 1.5 times, and more preferably more than 2.0 times the average antibody titer of needle injection.

[0142] In some embodiments of the present invention, the needle-free delivery device used in combination with the hepatitis B vaccine is configured so that the average antibody titer of the hepatitis B vaccine 42 days after the second dose is more than 1.1 times the average antibody titer of needle injection, preferably more than 1.5 times, and more preferably more than 2.0 times.

[0143] In some embodiments of the present invention, the needle-free delivery device used in combination with the hepatitis B vaccine is configured so that the average antibody titer of the hepatitis B vaccine 42 days after the second dose of 60% vaccine dose is more than 1.1 times, preferably more than 1.3 times, and more preferably more than 1.5 times the average antibody titer produced by needle injection of 100% vaccine dose.

[0144] In some embodiments of the present invention, the needle-free delivery device used in combination with the hepatitis B vaccine is configured so that the T lymphocyte positive expression rate of the hepatitis B vaccine 42 days after the second dose is higher than that of needle injection by more than 10%, preferably more than 20%, and more preferably more than 50%.

[0145] In some embodiments of the present invention, any needle-free delivery device in the above embodiments of the present invention can also be used in combination with a pneumonia vaccine for humans to form a drug delivery system.

[0146] In the embodiment of the utility model, the pneumonia vaccine is mainly used to prevent pneumonia caused by pneumococcus, which can induce humoral immunity in the body. It is suitable for high-risk healthy people over 6 weeks old to prevent pneumococcal pneumonia and systemic pneumococcal infection caused by various serotypes contained in the vaccine, and can be injected subcutaneously or intramuscularly through the deltoid muscle on the outside of the upper arm, with 0.5 ml injected each time.

[0147] In some embodiments of the present invention, the second end 120 of the needle-free delivery device used in combination with a human pneumonia vaccine is provided with three holes 121 arranged in a circular pattern at equal intervals around the center of the second end 120 , and the three holes 121 are 1.25 mm±20% away from the center of the second end 120 .

[0148] In some embodiments of the present invention, the pushing speed of the piston 210 of the needle-free delivery device used in combination with a pneumonia vaccine for humans is configured to be 0.14 m / s±20%.

[0149] In some embodiments of the present invention, the needle-free delivery device used in combination with a pneumonia vaccine for humans is configured so that the exit jet velocity of the pneumonia vaccine for humans when pushed away from the hole 121 in the second end 120 by the pushing element 210 is 160.00 m / s±20%.

[0150] In some embodiments of the present invention, the needle-free delivery device used in combination with a pneumonia vaccine for humans is configured so that the diffusion volume of the pneumonia vaccine for humans in the body is more than 1.5 times the non-delivered volume of the pneumonia vaccine for humans.

[0151] In some embodiments of the present invention, the needle-free delivery device used in combination with a pneumonia vaccine for humans is configured so that the average antibody titer of the pneumonia vaccine for humans after vaccination is more than 1.1 times, preferably more than 1.5 times, and more preferably more than 2.0 times the average antibody titer of needle injection.

[0152] In some embodiments of the present invention, the needle-free delivery device used in combination with a pneumonia vaccine for humans is configured so that the average antibody titer of the pneumonia vaccine for humans 42 days after the second dose is more than 1.1 times, preferably more than 1.5 times, and more preferably more than 2.0 times the average antibody titer of needle injection.

[0153] In some embodiments of the present invention, the needle-free delivery device used in combination with a pneumonia vaccine for humans is configured so that the average antibody titer of the pneumonia vaccine after injection of 60% of the vaccine dose is more than 1.1 times, preferably more than 1.3 times, and more preferably more than 1.5 times the average antibody titer produced by injection of 100% of the vaccine dose with a needle.

[0154] In some embodiments of the present invention, any needle-free delivery device in the above embodiments of the present invention can also be used in combination with GLP-1 polypeptides. Therefore, the present application also provides a corresponding drug-device combination product. In the embodiments of the present invention, the drug-device combination product can include or can be a drug delivery system.

[0155] In some embodiments of the present invention, the second end 120 of the needle-free delivery device used in combination with the GLP-1 polypeptide is provided with three holes 121, which are arranged in a circular shape at equal intervals around the center of the second end 120, and the three holes are 1.25 mm ± 20% away from the center.

[0156] In some embodiments of the present invention, the pushing speed of the piston 210 of the needle-free delivery device used in combination with the GLP-1 polypeptide is 0.16 m / s ± 20%;

[0157] In some embodiments of the present invention, the needle-free delivery device used in combination with the GLP-1 polypeptide is configured so that the outlet jet velocity of the GLP-1 polypeptide when pushed away from the hole 121 in the second end 120 by the pushing element 210 is 170.00 m / s±20%.

[0158] In some embodiments of the present invention, the needle-free delivery device used in combination with the GLP-1 polypeptide is configured so that the diffusion volume of the GLP-1 polypeptide in the body is more than 1.5 times the non-delivery volume of the GLP-1 polypeptide.

[0159] In some embodiments of the present invention, the GLP-1 polypeptide includes semaglutide, and any needle-free delivery device in the above embodiments of the present invention can also be used in combination with semaglutide. Therefore, the embodiments of the present application also provide corresponding drug-device combination products. In embodiments of the present invention, the drug-device combination product may include or may be a drug delivery system.

[0160] In some embodiments of the present invention, the needle-free delivery device used in combination with semaglutide is configured such that the diffusion volume of the semaglutide in the body is more than 1.5 times the non-delivered volume of the semaglutide.

[0161] In some embodiments of the present invention, the needle-free delivery device used in combination with semaglutide is configured so that the weight-reducing effect of semaglutide on humans and animals is consistent with that of needle injection, and preferably the weight-reducing effect is increased by more than 2% over that of needle injection, further preferably by more than 5%, and even more preferably by more than 10%.

[0162] In some embodiments of the present invention, the needle-free delivery device used in combination with semaglutide is configured so that the weight loss endpoint of semaglutide in vivo is consistent with that of needle injection, preferably increased by more than 2%, more preferably increased by more than 5%, and more preferably increased by more than 10%.

[0163] In some embodiments of the present invention, the needle-free delivery device used in combination with semaglutide is configured so that the proportion of side effects such as nausea, vomiting, and bloating caused by semaglutide is consistent with that of needle injection, preferably reduced by more than 5%, further preferably reduced by more than 10%, and even more preferably reduced by more than 20%.

[0164] In some embodiments of the present invention, any needle-free delivery device in the embodiments of the present invention can also be used in combination with a drug preparation.

[0165] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a rabies vaccine for human use.

[0166] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a rabies vaccine for animals.

[0167] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a meningitis vaccine for human use.

[0168] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a hand, foot and mouth disease vaccine for animals.

[0169] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a new coronavirus vaccine for human use.

[0170] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a hepatitis A vaccine for human use.

[0171] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a hemorrhagic fever with renal syndrome vaccine for humans.

[0172] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a mumps vaccine for human use.

[0173] In some embodiments of the present invention, optionally, the pharmaceutical preparation is an HPV vaccine for humans.

[0174] In some embodiments of the present invention, optionally, the drug preparation is a tumor chemotherapy drug for human use.

[0175] In some embodiments of the present invention, optionally, the drug preparation is a tumor nuclear medicine for human treatment.

[0176] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a tumor vaccine for humans, including but not limited to polypeptide vaccines, mRNA vaccines, and DNA vaccines.

[0177] In some embodiments of the present invention, the pharmaceutical preparation is a pig diarrhea bivalent vaccine. In some embodiments of the present invention, the pig diarrhea bivalent vaccine may include a pig transmissible gastroenteritis and porcine epidemic diarrhea bivalent live vaccine (HB08 strain + ZJ08 strain). In some embodiments of the present invention, the pig diarrhea bivalent vaccine may include a pig transmissible gastroenteritis and porcine epidemic diarrhea bivalent inactivated vaccine.

[0178] In some embodiments of the present invention, the pharmaceutical preparation is an inactivated blue ear vaccine. In some embodiments of the present invention, the inactivated blue ear vaccine may include an inactivated porcine reproductive and respiratory syndrome vaccine (CH-1a strain).

[0179] In some embodiments of the present invention, the pharmaceutical preparation is a foot-and-mouth disease vaccine. In some embodiments of the present invention, the foot-and-mouth disease vaccine can be used for pigs, cattle or sheep. In some embodiments of the present invention, the foot-and-mouth disease vaccine may include a pig foot-and-mouth disease O-type inactivated vaccine (O / Mya98 / XJ / 2010 strain + O / GX / 09-7 strain). In some embodiments of the present invention, the foot-and-mouth disease vaccine may include a pig foot-and-mouth disease O-type, A-type bivalent inactivated vaccine (Re-O / MYA98 / JSCZ / 2013 strain + Re-A / WH / 09 strain). In some embodiments of the present invention, the foot-and-mouth disease vaccine may include a foot-and-mouth disease O-type inactivated vaccine (OJMS strain), which can be used for cattle or sheep. In some embodiments of the present invention, the foot-and-mouth disease vaccine may include a foot-and-mouth disease O-type, A-type bivalent inactivated vaccine (O / HB / HK / 99 strain + AF / 72 strain, suspension culture), which can be used for cattle. In some embodiments of the present invention, the foot-and-mouth disease vaccine may include a bivalent inactivated foot-and-mouth disease type O and type A vaccine (O / MYA98 / BY / 2010 strain + Re-A / WH / 09 strain), which can be used for cattle or sheep.

[0180] In some embodiments of the present invention, the pharmaceutical preparation is a bovine bivalent vaccine. In some embodiments of the present invention, the bovine bivalent vaccine may include a bovine viral diarrhea / mucosal disease and infectious rhinotracheitis bivalent inactivated vaccine (NMG strain + LY strain).

[0181] In some embodiments of the present invention, the pharmaceutical preparation is a Pasteurella vaccine. In some embodiments of the present invention, the Pasteurella vaccine may include an inactivated vaccine for bovine Pasteurella multocida.

[0182] In some embodiments of the present invention, optionally, the drug preparation is insulin;

[0183] In some embodiments of the present invention, optionally, the drug preparation is a botulinum toxin cosmetic drug used for medical cosmetology.

[0184] In some embodiments of the present invention, there is also provided a use of the needle-free delivery device described in any one of the above embodiments of the present invention in the preparation of human clinical medical and animal health drugs for needle-free injection administration.

[0185] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a feline triple vaccine.

[0186] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a hepatitis B vaccine.

[0187] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a pneumonia vaccine for humans.

[0188] In some embodiments of the present invention, optionally, the pharmaceutical preparation is semaglutide.

[0189] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a rabies vaccine for human use.

[0190] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a rabies vaccine for animals.

[0191] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a meningitis vaccine for human use.

[0192] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a hand, foot and mouth disease vaccine for animals.

[0193] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a new coronavirus vaccine for human use.

[0194] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a hepatitis A vaccine for human use.

[0195] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a hemorrhagic fever with renal syndrome vaccine for humans.

[0196] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a mumps vaccine for human use.

[0197] In some embodiments of the present invention, optionally, the pharmaceutical preparation is an HPV vaccine for humans.

[0198] In some embodiments of the present invention, optionally, the drug preparation is a tumor chemotherapy drug for human use.

[0199] In some embodiments of the present invention, optionally, the drug preparation is a tumor nuclear medicine for human treatment.

[0200] In some embodiments of the present invention, optionally, the pharmaceutical preparation is a tumor vaccine for humans, including but not limited to polypeptide vaccines, mRNA vaccines, and DNA vaccines.

[0201] In some embodiments of the present invention, the pharmaceutical preparation is a swine diarrhea bivalent vaccine.

[0202] In some embodiments of the present invention, the pharmaceutical preparation is an inactivated blue ear vaccine.

[0203] In some embodiments of the present invention, the pharmaceutical preparation is a foot-and-mouth disease vaccine.

[0204] In some embodiments of the present invention, the pharmaceutical preparation is a bovine bivalent vaccine.

[0205] In some embodiments of the present invention, the pharmaceutical preparation is a Pasteurella vaccine.

[0206] In some embodiments of the present invention, optionally, the drug preparation is insulin.

[0207] In some embodiments of the present invention, optionally, the drug preparation is a botulinum toxin cosmetic drug used for medical cosmetology.

[0208] The present invention also provides a drug-device combination product, including a needle-free delivery device and a drug preparation 300. In the present invention, the drug-device combination product may include or may be a drug delivery system.

[0209] like Fig.30 and Fig.31 As shown, the needle-free delivery device comprises:

[0210] a tube 100 for containing a drug preparation 300, the tube 100 having a first end 110 and a second end 120, wherein the second end 120 is provided with a single hole 124 for dispensing the drug preparation 300 in the tube; and

[0211] A power mechanism 200, the power mechanism 200 comprising a piston 210 disposed in the first end 110 of the tube 100 and capable of pushing the drug preparation 300 or the power mechanism 200 is operatively connected to the piston 210 to apply a delivery pressure to the piston 210 pushing the drug preparation 300;

[0212] The needle-free delivery device is configured such that the diffusion volume of the drug preparation 300 in the body is more than 1.5 times the non-delivered volume.

[0213] In some embodiments of the present invention, Fig.31 As shown, the second end 120 of the needle-free delivery device may further have a narrowing section 122 that gradually narrows from the tube 100 axially to the distal end, and a single hole 124 is provided on the end surface 123 of the narrowing section 122. The end surface 123 is configured to be circular. The needle-free delivery device is configured so that the diffusion volume of the drug preparation 300 in the body is more than 1.50 times the non-delivered volume.

[0214] In some embodiments of the present invention, Fig.30 as well as Fig.31 As shown, the piston 210 may be provided as an independent component, and the power mechanism 200 is configured to be suitable for being operatively connected to the piston 210 to apply delivery pressure to the piston 210. It is also conceivable that in other embodiments of the present invention, the power mechanism 200 may be integrated with the piston 210 and apply delivery pressure to the piston 210.

[0215] In some embodiments of the utility model, the driving mode of the power mechanism 200 may include any one of compressed gas driving, spring driving, electromagnetic driving, or a combination of the above driving modes. For example, in some embodiments, the power mechanism 200 may be driven by compressed gas, such as compressed nitrogen or compressed carbon dioxide gas, or may be driven by a compressed mechanical spring, or may be driven by a piezoelectric actuator, without limitation herein.

[0216] In some embodiments of the present invention, the needle-free delivery device is configured such that the diffusion volume of the drug preparation 300 in the body is greater than the volume of the non-delivered drug preparation 300 or the volume of the drug preparation 300 delivered with a needle. Preferably, the diffusion volume of the drug preparation 300 in the body is more than 1.50 times the non-delivered volume, preferably more than 1.80 times, further preferably more than 2.40 times, more preferably more than 3.00 times, and even more preferably more than 3.60 times.

[0217] In some embodiments of the present invention, compared with manual needle injection (the pushing speed of the piston inside the needle tube is about 0.01 m / s), the piston speed of the piston 210 of the needle-free delivery device of the present invention embodiment when pushing the drug preparation 300 in the tube 100 is greater than or equal to more than 10 times the piston speed of manual needle injection, and the piston speed of the piston 210 when pushing the fluid 130 is 0.10 m / s to 0.20 m / s, preferably 0.13 m / s to 0.15 m / s, and more preferably 0.14 m / s.

[0218] In some embodiments of the present invention, the power mechanism is configured to apply different adjustable delivery pressures to the piston 210 that pushes the drug preparation 300 , and optionally, the delivery pressures include a first delivery pressure F1 and a second delivery pressure F2 ;

[0219] Preferably, the magnitude of the first delivery pressure F1 is configured such that the jet of the drug preparation 300 passing through the single hole 124 is diffused in at least one of the dermis, epidermis, subcutaneous layer, muscle and human organs; the magnitude of the second delivery pressure F2 is configured such that the jet of the drug preparation 300 passing through the single hole 124 is diffused in another of the dermis, epidermis, subcutaneous layer, muscle and human organs;

[0220] Preferably, the magnitude of the first delivery pressure F1 is configured so that the drug preparation jet passing through the single hole 124 has a first outlet jet velocity v1, and the first outlet jet velocity v1 is configured so that the drug preparation 300 jet passing through the single hole 124 is diffused in at least one of the dermis, epidermis, subcutaneous layer, muscle and human organ;

[0221] Preferably, the size of the second delivery pressure F2 is configured so that the drug preparation jet 300 passing through the single hole 124 has a second outlet jet velocity v2, and the second outlet jet velocity v2 is configured so that the drug preparation 300 jet passing through the single hole 124 diffuses in the dermis, epidermis, subcutaneous layer, muscle and at least another human organ.

[0222] In some embodiments of the present invention, optionally, the pharmaceutical preparation 300 is a cat triple vaccine;

[0223] In some embodiments of the present invention, optionally, the pharmaceutical preparation 300 is a hepatitis B vaccine;

[0224] In some embodiments of the present invention, optionally, the pharmaceutical preparation 300 is a pneumonia vaccine for human use;

[0225] In some embodiments of the present invention, optionally, the drug preparation 300 is semaglutide;

[0226] In some embodiments of the present invention, optionally, the drug preparation 300 is a tumor vaccine for human use, including but not limited to polypeptide vaccines, mRNA vaccines, and DNA vaccines.

[0227] The needle-free delivery device of the embodiment of the utility model solves or improves at least one of the following problems or achieves at least one of the following technical effects by configuring the needle-free delivery device of the utility model, the components of the needle-free delivery device and the related drug-machine combination device, and by controlling the flow rate, delivery depth and dispersion of the drug and vaccine jet:

[0228] (1) The needle-free delivery device of the embodiment of the utility model adopts multiple holes for needle-free delivery. Compared with the traditional single-hole needle-free injection, the utility model uses a multi-hole setting to achieve a significant increase in the delivery amount of the delivery object without causing damage to the skin, especially increasing the single delivery amount of drugs and vaccines. It has a delivery efficiency far higher than the existing single-hole needle-free delivery and can meet a wider range of application scenarios.

[0229] (2) The needle-free delivery device of the embodiment of the utility model adopts multiple holes for needle-free delivery. By optimizing the number and pore size of the multiple holes, the diffusion volume of the delivered substances, especially drugs and vaccines in the body is significantly increased, thereby increasing the contact effect between the delivered drugs and vaccines and the body tissues, and significantly improving the biological benefits of drugs and vaccines.

[0230] (3) The needle-free delivery device of the embodiment of the utility model achieves precise control of the delivery depth of the delivered drugs or vaccines by controlling the jet velocity of the delivery material ejected from the multiple holes, especially the jet velocity of the drug and vaccine jet, and achieves precise delivery of the drugs and vaccines to designated target locations within the skin, subcutaneous tissue, muscles or human organs through high-speed jets according to their characteristics.

[0231] (4) The needle-free delivery device of the embodiment of the utility model realizes the simultaneous and precise delivery of the delivery substance to at least one or more target locations or target areas within the skin, subcutaneous tissue, muscle or human organs by configuring the jet speeds of different holes in the multiple holes.

[0232] (5) The needle-free delivery device of the embodiment of the utility model achieves different diffusion effects of the delivered substance, especially drugs or vaccines, at the delivery position by controlling the aperture and arrangement of the multiple holes, especially achieving control of the diffusion volume ratio, diffusion width and diffusion center at the target position or target area, and can achieve specific diffusion effects according to different delivery requirements.

[0233] (6) The needle-free delivery device of the embodiment of the utility model is not limited to the site and receptor type of drug and vaccine delivery, and can be widely used in the delivery of drugs and vaccines for human and animal use.

[0234] On the basis of the above-mentioned problems solved and / or effects achieved, the present invention is also used in combination with cat triple vaccine, hepatitis B vaccine, human pneumonia vaccine, GLP-1 peptides, especially semaglutide, to achieve further technical effects as recorded in the embodiments of the present invention.

[0235] The above describes the implementation methods of the present invention. However, the present invention is not limited to the above implementation methods. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A needle-free delivery device, characterized in that include: A tube for containing a fluid, the tube having a first end and a second end, the second end being provided with a plurality of holes for distributing the fluid in the tube, the plurality of holes comprising a first hole and a second hole, the first hole having a first hole diameter, the second hole having a second hole diameter, the first hole diameter being different from the second hole diameter; as well as A power mechanism includes a piston disposed in the first end of the tube and capable of pushing the fluid, or the power mechanism is operatively connected to a piston to apply a delivery pressure to the piston pushing the fluid.

2. The needle-free delivery device according to claim 1, characterized in that The power mechanism is any one of compressed gas drive, spring drive, electromagnetic drive or a combination of the above drive modes.

3. The needle-free delivery device according to claim 1, characterized in that The total fluid delivery area of ​​the plurality of holes is 0.009 mm 2 The single hole area of ​​the hole is 0.0028~0.035mm 2 .

4. The needle-free delivery device according to claim 1, characterized in that The plurality of holes are arranged in a straight line along a diameter or a midline of the second end, and one of the plurality of holes arranged in a straight line along a diameter or a midline of the second end is located at the center or center of the second end.

5. The needle-free delivery device according to claim 4, characterized in that The hole located at the center or centre of the second end has a diameter different from the diameters of the other holes of the plurality of holes.

6. The delivery device according to claim 1, characterized in that The plurality of holes are arranged in a ring shape with the center or centre of the second end as the centre.

7. The needle-free delivery device according to claim 6, characterized in that At least one of the plurality of holes arranged in an annular pattern has a hole diameter different from that of the other holes.

8. The needle-free delivery device according to claim 1, wherein: The plurality of holes include a central hole located at the center of the second end and a plurality of peripheral holes located around the central hole, and the plurality of peripheral holes are arranged in a ring shape.

9. The needle-free delivery device according to claim 8, characterized in that The central hole has a diameter different from the diameters of the peripheral holes.

10. A needle-free needle cannula for a needle-free delivery device, characterized in that: include: A tube for containing fluid, the tube having a first end and a second end, wherein the first end is configured to accommodate a piston for pushing the fluid, and the second end has a plurality of holes for distributing the fluid in the tube, the plurality of holes including a first hole and a second hole, the first hole having a first aperture, the second hole having a second aperture, the first aperture being different from the second aperture.

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