Multi-mode fluid delivery device and tube thereof

Abstract

The utility model relates to the field of delivery for delivering drugs and vaccines, in particular to a multi-mode fluid delivery device, which comprises a tube for accommodating fluid, the tube is provided with a first end and a second end, and a self-sealing elastic part or a hole for distributing the fluid in the tube is arranged in the second end; the injection head is detachably connected with the tube, the injection head comprises one or more needle pieces, and the one or more needle pieces are configured to be in butt joint with a self-sealing elastic part in the second end or a hole used for distributing fluid in the tube in a removable mode; the power mechanism comprises a piston arranged in the first end of the pipe and capable of pushing the fluid or is connected with the piston in an operating mode so as to apply delivery pressure to the piston pushing the fluid. The utility model further provides a related tube, an injection head and a needle kit. According to the utility model, flexible switching among a needleless injection mode, a micro-needle injection mode and a needle injection mode is realized.

Description

Technical Field

[0001] The utility model relates to the field of medical devices, in particular to the application of multi-mode drug and vaccine delivery in the fields of human clinical medicine and animal health care, and in particular to a multi-mode fluid delivery device and its tube, injection head and needle kit. Background Art

[0002] In the current field of drug and vaccine delivery, needle, microneedle and needle-free injection are the three main delivery methods. Traditional needle injection is widely used for the delivery of various drugs and vaccines, but the drugs and vaccines that enter the body through needle injection are in an aggregated state, which is not conducive to drug absorption and metabolism, and needle injection is often accompanied by pain and infection risks for patients, which causes psychological and physical burdens on patients. For example, needle phobia is the main reason why vaccination is not popular in many countries around the world. Although microneedle injection technology can reduce pain and trauma, its delivery site is limited, and its efficiency and applicability are limited when delivering large molecule drugs or high-dose vaccines. Relatively speaking, needle-free injection technology greatly improves the diffusion of drugs after delivery into the body and reduces the risk of pain and infection. However, the application and popularization of pure needle-free injection technology in clinical and animal health fields still face challenges. The main reason is that needle-free injection requires the use of high-pressure liquid jets to break the skin, which greatly limits the area of ​​the delivered liquid jet and the delivered drug dose. In addition, there is insufficient scientific research on the penetration and precise delivery performance of needle-free injection, especially in terms of jet flow rate, drug chemical properties, drug diffusion mode, needle-free injection aperture design, and the impact of different biological media (such as the epidermis, subcutaneous tissue, muscle, etc. of the human body and animals) on drug delivery performance.

[0003] In actual applications, the restrictions on the injection aperture and the high requirements for skin adhesion of needle-free injection technology have limited its popularity. This technology is prone to drug leakage due to the presence of hair, and it is difficult to accurately control the injection position, depth and diffusion of the drug. Therefore, although needle-free injection technology has significant advantages in theory, there are still many challenges in actual clinical applications. In addition, the stimulation of drug metabolism and vaccine immunogenicity puts forward high standards for the three-dimensional diffusion and precise positioning of drugs and vaccines in the body. Existing needle-free injection technology still faces unsolvable difficulties in meeting these requirements. For example, increasing the diffusion requires increasing the area of ​​the liquid jet, but the increase in the area of ​​the liquid jet will greatly cause skin breaking difficulties, bleeding and injury.

[0004] A significant gap in current drug delivery technology is how to effectively combine the advantages of precise positioning and large-dose delivery of needle-based technology, the advantages of high diffusion of needle-free injection technology, and the advantages of multi-point delivery of microneedle injection technology to meet the specific needs of different drugs and vaccines. In particular, in seeking a solution that can flexibly switch between different injection modes according to clinical conditions, existing technologies have not yet provided a satisfactory answer.

[0005] 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

[0006] The purpose of the utility model is to provide a multi-mode fluid delivery device and related tubes, injection heads and needle kits, combining the advantages of needle-free delivery, needle delivery and microneedle delivery to solve the problems existing in the above three delivery methods, thereby improving the stability, accuracy and bioavailability of the delivery system.

[0007] The present invention provides a multi-mode fluid delivery device, which includes:

[0008] A tube for containing a fluid, the tube having a first end and a second end, the second end being provided with a self-closing elastic portion or a hole for dispensing the fluid in the tube;

[0009] an injection head detachably connected to the tube, the injection head comprising one or more needle members configured to removably engage with the self-sealing elastic portion in the second end or the hole for dispensing the fluid in the tube; and

[0010] A power mechanism includes a piston disposed in the first end of the tube and capable of pushing the fluid or is operatively connected to the piston to apply a delivery pressure to the piston pushing the fluid.

[0011] 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.

[0012] In some embodiments of the present invention, at least one of the one or more needle members has a hole diameter in the range of 0.06 mm to 1.50 mm;

[0013] At least one of the self-closing elastic portion or the hole for distributing the fluid in the tube has a diameter in the range of 0.06 mm to 1.50 mm.

[0014] In some embodiments of the present invention, the total fluid delivery area of ​​the plurality of needles or the plurality of holes for distributing the fluid in the tube is 0.009 mm 2The single hole area of ​​the needle or hole is 0.0028 to 0.035 mm 2 .

[0015] In some embodiments of the present invention, the plurality of needle members are arranged in a straight line or in a ring.

[0016] In some embodiments of the present invention, the plurality of needle members include a central needle member located at the center of the injection head and a plurality of peripheral needle members located around the central needle member.

[0017] In some embodiments of the present invention, the injection head comprises a supporting portion for supporting the needle member and a first needle portion located on a side of the supporting portion facing away from the tube.

[0018] In some embodiments of the present invention, the needle member comprises an interventional soft needle removably connected to the hole of the tube.

[0019] In some embodiments of the present invention, the multi-mode fluid delivery device further comprises a needle kit, wherein the needle kit comprises a needle sleeve for removably surrounding the first needle head of the needle member.

[0020] In some embodiments of the present invention, the height of the needle sleeve of the needle kit is less than or equal to the first needle head of the needle member, thereby partially surrounding the first needle head, so that the first needle head extends from the front end of the needle sleeve to form an insertion portion.

[0021] In some embodiments of the present invention, the needle kit comprises a first needle kit, wherein the height of the needle sleeve of the first needle kit is greater than the first needle head of the needle member, thereby completely surrounding the first needle head to protect the first needle head.

[0022] In some embodiments of the present invention, the injection head further comprises a needle sleeve portion sleeved on the needle member and a rotating member operatively connected to the needle member or the needle sleeve portion, wherein the rotating member is configured to adjust the axial position of the needle member and the needle sleeve portion by rotation so as to adjust the exposed length of the needle member relative to the needle sleeve portion.

[0023] In some embodiments of the present invention, a tube for a multi-mode fluid delivery device is also provided, the tube having a first end and a second end, wherein the first end is configured to accommodate a piston for pushing the fluid in the tube, and the second end is provided with a self-closing elastic portion or a plurality of holes for distributing the fluid in the tube.

[0024] In some embodiments of the present invention, an injection head for a multi-mode fluid delivery device is further provided, the injection head comprising one or more needle members and a supporting portion for supporting the needle members.

[0025] In some embodiments of the present invention, the needle kit comprises one or more needle sleeves, wherein the needle sleeve is configured to removably surround the first needle portion of the needle member.

[0026] 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

[0027] 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:

[0028] Figure 1 A schematic structural diagram showing a multi-mode fluid delivery device according to an embodiment of the present utility model;

[0029] Figure 2 A schematic structural diagram showing a multi-mode fluid delivery device according to an embodiment of the present utility model;

[0030] Figure 3 A schematic needle arrangement diagram of a multi-mode fluid delivery device according to an embodiment of the present invention is shown;

[0031] Figure 4 A schematic needle arrangement diagram of a multi-mode fluid delivery device according to an embodiment of the present invention is shown;

[0032] Figure 5 A schematic needle arrangement diagram of a multi-mode fluid delivery device according to an embodiment of the present invention is shown;

[0033] Figure 6 A schematic needle arrangement diagram of a multi-mode fluid delivery device according to an embodiment of the present invention is shown;

[0034] Figure 7 A schematic diagram showing a schematic needle member of a multi-mode fluid delivery device according to an embodiment of the present invention;

[0035] Figure 8 A schematic diagram showing a schematic needle member of a multi-mode fluid delivery device according to an embodiment of the present invention;

[0036] Fig. 9 A schematic diagram showing a linear arrangement of needle components of a multi-mode fluid delivery device according to an embodiment of the present utility model;

[0037] Fig.10 A schematic diagram showing a linear arrangement of needle components of a multi-mode fluid delivery device according to an embodiment of the present utility model;

[0038] Fig.11 A schematic diagram showing a linear arrangement of needle components of a multi-mode fluid delivery device according to an embodiment of the present utility model;

[0039] Fig.12 A schematic diagram showing a linear arrangement of needle components of a multi-mode fluid delivery device according to the present invention;

[0040] Fig.13 A schematic diagram showing the arrangement of the needle array of the multi-mode fluid delivery device according to the present invention;

[0041] Fig.14A A schematic diagram showing a schematic arrangement of needle components of a multi-mode fluid delivery device according to an embodiment of the present invention;

[0042] Fig. 14B A schematic diagram showing a schematic arrangement of needle components of a multi-mode fluid delivery device according to an embodiment of the present invention;

[0043] Fig.15 A schematic diagram showing the arrangement of needle components with different needle hole diameters of a multi-mode fluid delivery device according to an embodiment of the present utility model;

[0044] Fig.16 A schematic diagram showing the arrangement of needle components with different needle hole diameters of a multi-mode fluid delivery device according to an embodiment of the present utility model;

[0045] Fig.17 A schematic diagram showing the arrangement of needle components with different needle hole diameters of a multi-mode fluid delivery device according to an embodiment of the present utility model;

[0046] Fig.18 A schematic diagram showing the arrangement of needle components with different needle hole diameters of a multi-mode fluid delivery device according to an embodiment of the present utility model;

[0047] Fig.19 A schematic diagram showing the annular arrangement of needle components of a multi-mode fluid delivery device according to an embodiment of the present utility model;

[0048] Fig. 20 A schematic diagram showing the annular arrangement of needle components of a multi-mode fluid delivery device according to an embodiment of the present utility model;

[0049] Fig.21 A schematic diagram showing the coaxial annular arrangement of multiple groups of needle members of a multi-mode fluid delivery device according to an embodiment of the present utility model;

[0050] Fig. 22 A schematic diagram showing the coaxial annular arrangement of multiple groups of needle members of a multi-mode fluid delivery device according to an embodiment of the present utility model;

[0051] Fig.23A schematic diagram showing a plurality of coaxial ring-shaped needle components of a multi-mode fluid delivery device according to an embodiment of the present invention;

[0052] Fig.24 A schematic diagram showing the arrangement of the central needle member and the peripheral needle members of the multi-mode fluid delivery device according to an embodiment of the present invention;

[0053] Fig.25 A schematic diagram showing the arrangement of the central needle member and the peripheral needle members of the multi-mode fluid delivery device according to an embodiment of the present invention;

[0054] Fig.26 A schematic diagram showing the arrangement of the central needle member and the peripheral needle members of the multi-mode fluid delivery device according to an embodiment of the present invention;

[0055] Fig. 27 A schematic diagram showing the arrangement of the central needle member and the peripheral needle members of the multi-mode fluid delivery device according to an embodiment of the present invention;

[0056] Fig.28 A schematic diagram showing the arrangement of the central needle member and the peripheral needle members of the multi-mode fluid delivery device according to an embodiment of the present invention;

[0057] Fig.29 A schematic diagram showing the arrangement of the central needle member and the peripheral needle members of the multi-mode fluid delivery device according to an embodiment of the present invention;

[0058] Fig.30 A schematic diagram showing the arrangement of the central needle member and the peripheral needle members of the multi-mode fluid delivery device according to an embodiment of the present invention;

[0059] Fig.31 A schematic diagram showing the arrangement of the central needle member and the peripheral needle members of the multi-mode fluid delivery device according to an embodiment of the present invention;

[0060] Fig.32 A schematic diagram showing the arrangement of the central needle member and the peripheral needle members of the multi-mode fluid delivery device according to an embodiment of the present invention;

[0061] Fig.33 A schematic diagram showing a schematic injection head of a multi-mode fluid delivery device according to an embodiment of the present invention;

[0062] Fig.34 A schematic diagram showing a schematic injection head of a multi-mode fluid delivery device according to an embodiment of the present invention;

[0063] Fig.35 A schematic diagram showing a schematic needle kit of a multi-mode fluid delivery device according to an embodiment of the present invention;

[0064] Fig.36 A schematic diagram showing a schematic needle kit of a multi-mode fluid delivery device according to an embodiment of the present invention;

[0065] Fig.37 A schematic diagram showing a schematic needle kit of a multi-mode fluid delivery device according to an embodiment of the present invention;

[0066] Fig.38 A schematic diagram showing a needle-free needle tube of a multi-mode fluid delivery device according to an embodiment of the present invention;

[0067] Fig.39 A schematic diagram showing a needle-free needle tube of a multi-mode fluid delivery device according to an embodiment of the present invention;

[0068] Fig.40 A schematic diagram showing the arrangement of needle components of a multi-mode fluid delivery device according to an embodiment of the present utility model;

[0069] Fig.41 A schematic diagram of the second end structure of the multi-mode fluid delivery device according to an embodiment of the present utility model is shown. DETAILED DESCRIPTION

[0070] 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 conjunction 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 intended to limit the utility model.

[0071] 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.

[0072] In multiple embodiments of the present invention, Figure 1 and Figure 2 As shown, a multi-mode fluid delivery device is provided, in particular, a multi-mode fluid delivery device for drugs and vaccines, which may include a tube 100 for containing a fluid, wherein the tube 100 has a first end 110 and a second end 120. Figure 1 As shown, the second end 120 may be provided with a hole 121 for distributing the fluid in the tube. Figure 2As shown, a self-closing elastic portion 122 may be disposed in the second end 120 .

[0073] The multi-mode fluid delivery device may further include an injection head 200 detachably connected to the tube 100, the injection head 200 including one or more needle members 210. The one or more needle members 210 are configured to removably dock with the self-enclosed elastic portion 122 in the second end 120 or the hole 121 for dispensing the fluid 130 in the tube 100.

[0074] The multi-mode fluid delivery device may further include a power mechanism 300 including a piston 310 disposed in the first end 110 of the tube 100 and capable of pushing the fluid 130 or operatively connected to the piston 310 to apply delivery pressure to the piston 310 pushing the fluid 130 .

[0075] In some embodiments of the present invention, Figure 2 As shown, three self-closing elastic parts 122 are provided in the second end 120, and the three needle parts 210 are configured to be removably connected to the self-closing elastic part 122 in the second end 120. Specifically, the three needle parts 210 are configured to be inserted into the three self-closing elastic parts 122 provided in the corresponding second end 120.

[0076] In some embodiments of the present invention, the self-closing elastic portion 122 is formed by filling silicone in a hole 121 provided in the second end 120 for distributing the fluid in the tube. The specific composition of the silicone is not limited herein. Similarly, the hole 121 may be filled with a material other than silicone that is suitable for being inserted by the multiple needle members 210, which is not limited herein.

[0077] In some embodiments of the present invention, Figure 1 and Figure 2 As shown, the piston 310 may be provided as an independent component, and the power mechanism 300 is configured to be operatively connected to the piston 310 to apply delivery pressure to the piston 310. It is also conceivable that in other embodiments of the present invention, the power mechanism 300 may be integrated with the piston 310.

[0078] In some embodiments of the utility model, the driving mode of the power mechanism 300 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 300 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.

[0079] 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 310 of the multi-mode fluid 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 310 when pushing the fluid 130 is 0.05 m / s to 0.50 m / s, preferably 0.09 m / s to 0.25 m / s, and more preferably 0.14 to 0.20 m / s.

[0080] In some embodiments of the present invention, compared to manual needle injection (the outlet jet velocity of the fluid ejected from the needle is about 2 m / s), the outlet jet velocity of the fluid 130 of the multi-mode fluid delivery device of the present invention embodiment when being pushed away from the multiple holes 121 in the second end 120 or the one or more needle parts 210 of the injection head 200 by the piston 310 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.

[0081] In some embodiments of the present invention, at least one of the one or more needle members 210 is substantially inserted into the human or animal body.

[0082] In some embodiments of the present invention, at least one of the one or more needle members is substantially inserted into a human or animal body;

[0083] In some embodiments of the present invention, at least one of the one or more needle members has a hole diameter in the range of 0.06 mm to 1.50 mm, further preferably in the range of 0.11 mm to 1.00 mm, and further preferably in the range of 0.11 mm to 0.50 mm;

[0084] In some embodiments of the present invention, at least one of the self-closing elastic portion or the hole for distributing the fluid in the tube has a diameter in the range of 0.06 mm to 1.50 mm, further preferably in the range of 0.11 mm to 1.00 mm, and even more preferably in the range of 0.11 mm to 0.50 mm.

[0085] In some embodiments of the present invention, the total fluid delivery area of ​​the plurality of needles or the plurality of holes for distributing the fluid in the tube is 0.009 mm 2 Above, preferably 0.020mm 2 More preferably 0.053 mm 2 More preferably 0.28 mm 2 The single hole area of ​​the needle or hole is 0.0028 to 0.035 mm 2, preferably 0.0028 to 0.020 mm 2 , more preferably 0.0028 to 0.009 mm 2 , wherein the single hole area of ​​the needle member refers to the single hole area calculated from the inner diameter of the needle of the needle member.

[0086] In the embodiment of the present invention, the multi-mode fluid delivery device of the present invention can deliver 0.3 mm at a time. 3 The volume of the drug or vaccine (pre-delivery volume) is preferably 1.0 mm 3 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 multi-mode fluid delivery device of the present invention at one time (pre-delivery volume) can reach 14.0 mm 3 In a further embodiment, the volume of medicine or vaccine delivered by the multi-mode fluid delivery device of the present invention at one time (pre-delivery volume) can reach 46.0 mm 3 .

[0087] In some embodiments of the present invention, the one or more needle members 210 have different adjustable skin insertion depths.

[0088] In some embodiments of the present invention, at least one of the one or more needle members 210 has an insertion depth that is not substantially inserted but forms a close contact with the human or animal skin.

[0089] In some embodiments of the present invention, at least one of the one or more needle members 210 has an insertion depth that is substantially inserted into the inner layer of human or animal skin.

[0090] In some embodiments of the present invention, at least one of the one or more needle members 210 has an insertion depth that is substantially inserted into the subcutaneous layer of a human or animal.

[0091] In some embodiments of the present invention, at least one of the one or more needle members 210 has an insertion depth that is substantially inserted into the muscle layer of a human body or an animal.

[0092] In some embodiments of the present invention, at least one of the one or more needle members 210 has an insertion depth sufficient to be inserted into an organ in a human or animal body.

[0093] In some embodiments of the present invention, at least one of the one or more needle members 210 has an adjustable insertion depth.

[0094] In some embodiments of the present invention, the multimodal fluid delivery device is configured so that the diffusion volume of the fluid 130 in the body is greater than the undelivered volume. Preferably, the diffusion volume of the fluid in the body is more than 1.50 times the undelivered 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.

[0095] 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 multi-mode fluid delivery device in the body to the original volume of the fluid not delivered, that is:

[0096]

[0097] 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 multi-mode fluid delivery device of the present invention to the diffusion volume of the fluid delivered by artificial needle injection, that is:

[0098]

[0099] 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.

[0100] It is understandable that when the delivery fluid enters the body through the multimodal fluid 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.

[0101] 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.

[0102] In some embodiments of the present invention, Figures 3 to 6As shown, the needle aperture d of the one or more needle members 210 can be configured so that the fluid jet passing through the one or more needle members 210 has a variety of different in vivo diffusion degrees, that is, different diffusion volume ratios, diffusion depths or diffusion breadths; thus, in some embodiments of the present invention, the needle apertures of the one or more needle members 210 may be equal and have a first needle aperture d1, and the size of the first needle aperture d1 is configured so that the fluid jet passing through the one or more needle members 210 has different diffusion degrees, preferably, different diffusion depths, so that the fluid jet diffuses in at least one of the dermis, epidermis, subcutaneous layer, muscle and human organs.

[0103] In some embodiments of the present invention, the outlet jet velocity v of the one or more needle members 210 can be configured so that the fluid jet passing through the one or more needle members 210 has a plurality of different in vivo diffusion degrees, i.e., different diffusion volume ratios, diffusion depths or diffusion breadths; thus, in some embodiments of the present invention, the outlet jet velocity v of the one or more needle members 210 can be equal and have a first outlet jet velocity v1, and the size of the first outlet jet velocity v1 is configured so that the fluid jet passing through the one or more needle members 210 has different diffusion degrees, preferably, different diffusion depths, so that the fluid jet diffuses in at least one of the dermis, epidermis, subcutaneous layer, muscle and human organs.

[0104] In some embodiments of the present invention, the plurality of needle members include a first needle member and a second needle member.

[0105] In some embodiments of the present invention, the first needle member has a first skin insertion depth located in one of the dermis, epidermis, subcutaneous layer, muscle and human organs, and the second needle member has a second skin insertion depth located in another of the dermis, epidermis, subcutaneous layer, muscle and human organs. Figure 7 As shown, the skin insertion depths of the one or more needle members 210 may be configured to be unequal, the first needle member 210 having a first skin insertion depth L1, and the second needle member 210' having a second skin insertion depth L2, wherein L1≠L2.

[0106] In some embodiments of the present invention, the first needle member has a first needle aperture, the size of which is configured so that the fluid jet passing through the first needle member diffuses in at least one of the dermis, epidermis, subcutaneous tissue, muscle, and human organs; the second needle member has a second needle aperture, the size of which is configured so that the fluid jet passing through the second needle member diffuses in at least another of the dermis, epidermis, subcutaneous tissue, muscle, and human organs. For example, Figure 8As shown, the first needle member 210 has a first needle hole diameter d1, and the second needle member 210' has a second needle hole diameter d2, wherein d1≠d2.

[0107] In some embodiments of the present invention, the first needle member has a first outlet jet velocity, and the first outlet jet velocity is configured so that the fluid jet passing through the first needle member diffuses in at least one of the dermis, epidermis, subcutaneous tissue, muscle, and human organs; the second needle member has a second outlet jet velocity, and the second outlet jet velocity is configured so that the fluid jet passing through the second needle member diffuses in at least another of the dermis, epidermis, subcutaneous tissue, muscle, and human organs. For example, the first needle member 210 may have a first outlet jet velocity v1, and the second needle member 210' may have a second outlet jet velocity v2, wherein v1≠v2.

[0108] In some embodiments of the present invention, the plurality of needle members further comprises a third needle member;

[0109] In some embodiments of the present invention, the third needle member has a third skin insertion depth located in one of the dermis, epidermis, subcutaneous layer, muscle and human organ;

[0110] In some embodiments of the present invention, the third needle member has a third needle aperture, and the size of the third needle aperture is configured so that the fluid jet passing through the third needle member diffuses in at least one of the dermis, epidermis, subcutaneous tissue, muscle, and dermis, epidermis, or subcutaneous tissue of a human organ;

[0111] In some embodiments of the present invention, the third needle member has a third outlet jet velocity, and the third outlet jet velocity is configured to allow the fluid jet passing through the third needle member to diffuse in at least one of the dermis, epidermis, subcutaneous tissue, muscle, and human organs.

[0112] In some embodiments of the present invention, Figures 9 to 11 As shown, the one or more needle members 210 may be arranged along a straight line.

[0113] In some embodiments of the present invention, the one or more needle components 210 are arranged along the diameter or midline of the injection head 200, and one of the one or more needle components 210 arranged along the diameter or midline of the injection head 200 is located at the center of the injection head 200.

[0114] In one embodiment of the present invention, Fig.10 As shown, three needle components 210 are arranged in a straight line along the diameter (center line) of the injection head 200 , including a needle component 210 ′ located at the center (center) of the injection head 200 .

[0115] In some embodiments of the present invention, the plurality of needle members 210 arranged along a straight line are arranged at equal intervals.

[0116] In one embodiment of the present invention, Figure 10 to Figure 11 As shown, a plurality of needle members 210 are arranged in a straight line along the diameter (center line) of the injection head 200 on the injection head 200 , wherein the plurality of needle members 210 are arranged at equal intervals.

[0117] In some embodiments of the present invention, Figures 9 to 11 As shown, the plurality of needle members 210 arranged along a straight line are mirror-symmetrical with respect to another diameter or center line of the injection head 200 different from the straight line.

[0118] In some embodiments of the present invention, the needle members 210 may be in multiple groups, and each group of needle members 210 is arranged along a straight line, and each group of needle members 210 is arranged along a diameter or a center line of the injection head 200 .

[0119] In one embodiment of the present invention, Fig.12 As shown, the injection head 200 is provided with three groups of needle components 210 (group A, group B and group C) (in Fig.12 And in the subsequent figures, the same group of needle members 210 are shown by dotted lines, wherein the group A and the group C each include two needle members 210 arranged along a straight line, and the group B includes three needle members 210 arranged along a straight line.

[0120] In some embodiments of the present invention, the plurality of needle members 210 are arranged in an array; the plurality of needle members 210 arranged in an array are mirror-symmetrical with respect to the mutually perpendicular first and second diameters or midlines of the injection head 200 .

[0121] In one embodiment of the present invention, Fig.13 As shown, the injection head 200 is provided with four needle members 210 arranged in an array (in Fig.13 The array arrangement relationship of the four needle components 210 is shown by mutually perpendicular dotted lines in the figure), and the four needle components 210 are mirror-symmetrical with respect to the mutually perpendicular first and second diameters (center lines) of the injection head 200.

[0122] In some embodiments of the present invention, the skin insertion depth L′ of the needle member 210 ′ located at the center or center of the injection head 200 is different from the skin insertion depth L of other needle members 210 of the plurality of needle members 210 .

[0123] In one embodiment of the present invention, Figure 7As shown, three needle members 210 are arranged in a straight line along the diameter (midline) of the injection head 200, including a needle member 210' located at the center (center) of the injection head 200. The skin insertion depth L' of the needle member 210' is different from the skin insertion depth L of other needle members 210 of the plurality of needle members 210. Figure 7 In the configuration shown, L'>L. It is understandable that in another configuration, L'<L may also be configured.

[0124] In some embodiments of the present invention, the skin insertion depth L' of at least one group of needle members 210' among the multiple groups of needle members 210 is different from the skin insertion depth L of the other groups of needle members 210;

[0125] In one embodiment of the present invention, Fig.14A As shown, the injection head 200 has two groups of needles 210, group A and group B, arranged in a straight line, wherein the group A and the group B are arranged in a straight line, wherein the skin insertion depth of the two needles 210' included in the group B is L', and the skin insertion depth of the two needles 210 included in the group A is L, wherein L'≠L, Fig.14A In the configuration shown, L'<L. It is to be understood that in another configuration, L'>L may also be configured.

[0126] In some embodiments of the present invention, the needle hole diameter d′ of the needle member 210 ′ located at the center of the injection head 200 is different from the needle hole diameters d of other needle members 210 of the plurality of needle members 210 .

[0127] In one embodiment of the present invention, Fig.15 and Fig.16 As shown, the injection head 200 is provided with three needle members 210 arranged in a straight line, including a needle member 210' with a needle hole diameter d' located at the center or center of the injection head 200, and the remaining two needle members 210 with needle hole diameters d, wherein d'≠d. Fig.15 In the configuration shown, d'<d, in Figure 8 as well as Fig.16 In the configuration shown, d'>d.

[0128] In some embodiments of the present invention, the needle hole diameter d2 of at least one group of needle members 210 among the multiple groups of needle members 210 is different from the needle hole diameter d1 of the other groups of needle members 210 .

[0129] In one embodiment of the present invention, Figure 17 to Figure 18As shown, the injection head 200 is provided with three groups of needle components 210, namely, group A, group B and group C, wherein group A and group C each include two needle components 210 arranged in a straight line, and group B includes three needle components 210' arranged in a straight line, wherein the needle aperture diameter of the three needle components 210' included in group B is d', and the needle aperture diameter of the needle components 210 included in group A and group B is d, wherein d'≠d.

[0130] In some embodiments of the present invention, the outlet jet velocity v' of the needle member 210 ' located at the center or center of the injection head 200 is different from the outlet jet velocity v of other needle members 210 of the plurality of needle members 210 .

[0131] In some embodiments of the present invention, the outlet jet velocity v2 of at least one group of needle members 210 among the multiple groups of needle members 210 is different from the outlet jet velocity v1 of the other groups of needle members 210 .

[0132] In one embodiment of the present invention, Fig.17 and Fig.18 As shown, three groups of needle members 210, namely Group A, Group B and Group C, are arranged on the injection head 200, wherein Group A and Group C each include two needle members 210 arranged in a straight line, and Group B includes three needle members 210' arranged in a straight line, wherein the outlet jet velocity v2 of the three needle members 210' included in Group B, and the outlet jet velocity v1 of the needle members 210 included in Group A and Group C, wherein v2≠v1.

[0133] In some embodiments of the present invention, the multiple needle members 210 on the injection head 200 are arranged in a ring shape; the multiple needle members 210 are arranged in a ring shape with the center of the injection head 200 as the center.

[0134] In one embodiment of the present invention, Fig.19 and Fig. 20 As shown, for example, Fig.19 The injection head 200 is shown to have three needle members 210 arranged thereon. The three needle members 210 are arranged in a ring with the center O of the injection head 200 as the center. Fig. 20 It is shown that four needle components 210 are arranged on the injection head 200, and the four needle components 210 are arranged in a ring with the circle O of the injection head 200 as the center.

[0135] In some embodiments of the present invention, the needle members 210 are provided in multiple groups, each group of needle members 210 is arranged in a ring shape, and the multiple groups of needle members 210 are arranged in a coaxial ring shape with each other.

[0136] In one embodiment of the present invention, Fig.21 As shown, two groups of needle components 210, namely group A and group B, are arranged on the injection head 200, wherein both group A and group B are arranged in a circular shape and are coaxially arranged in a circular shape with the center O of the injection head 200 as the center.

[0137] In some embodiments of the present invention, at least one of the plurality of needle members 210 arranged in an annular manner has a skin insertion depth L′ different from that of the other needle members 210 .

[0138] In some embodiments of the present invention, the skin insertion depth L of at least one group of needle members 210 among the plurality of groups of needle members 210 arranged in an annular manner is different from the skin insertion depth L of the other groups of needle members 210 .

[0139] In one embodiment of the present invention, Fig. 14B as well as Fig.23 As shown, the injection head 200 is provided with two groups of needle components 210, namely, group A and group B, wherein group A and group B each include three needle components 210. Fig. 14B for Fig.23 The cross-sectional view of the configuration along the axial direction of the tube 100 shows the skin insertion depth of the plurality of needle members 210 arranged in a ring on the injection head, wherein the skin insertion depth of the three needle members 210 included in the A group is L', and the skin insertion depth of the three needle members 210 included in the B group is L, wherein L'≠L, Fig. 14B In the configuration shown, L'>L; it is understandable that in other configurations, L'<L may also be set.

[0140] In some embodiments of the present invention, the skin insertion depths L of the multiple groups of needle members 210 coaxially arranged in an annular shape decrease or increase radially.

[0141] In one embodiment of the present invention, again referring to Fig. 14B as well as Fig.23 , which shows the skin insertion depth of the multiple needle members 210 arranged in a ring on the injection head, wherein the skin insertion depth of the three needle members 210 included in the A group is L', and the skin insertion depth of the three needle members 210 included in the B group is L, and the skin insertion depth L of the needle members 210 in the A group and the B group increases radially outward, that is, L'>L; it can be understood that in other configurations, the skin insertion depth L of the needle members 210 in the A group and the B group can also be set to decrease radially outward, that is, L'<L.

[0142] In one embodiment of the present invention, again referring to Fig. 14B as well as Fig.23, two groups of needle members 210, namely group A and group B, are arranged on the injection head 200, wherein the group A and the group B are arranged in a ring and coaxially arranged in a ring with the center of the injection head 200 as the center, wherein the skin insertion depth of the three needle members 210' included in the group A is L', and the skin insertion depth of the needle members 210 included in the group B is L, wherein L'≠L; and in one configuration, the skin insertion depths of the needle members 210' of group A and the needle members 210 of group B, which are coaxially arranged in a ring with each other, increase radially outward, that is: L'>L; it can be understood that in another configuration, the skin insertion depths of the needle members 210' of group A and the needle members 210 of group B can also be set to decrease radially outward, that is: L'<L.

[0143] In some embodiments of the present invention, at least one of the plurality of needle members 210 arranged in an annular manner has a needle hole diameter d' different from that of the other needle members 210;

[0144] In some embodiments of the present invention, the needle hole diameter d' of at least one group of needle members 210 of the plurality of groups of needle members 210 is different from the needle hole diameter d of the other groups of needle members 210;

[0145] In some embodiments of the present invention, the needle apertures d of the plurality of groups of needle members 210 coaxially arranged in an annular manner decrease or increase in the radial direction.

[0146] In one embodiment of the present invention, Fig. 14B as well as Fig. 22 and Fig.23 As shown, the injection head 200 is provided with two groups of needle members 210, namely, group A and group B, wherein both group A and group B are arranged in a circular shape and are coaxially arranged in a circular shape with the center (center) of the injection head 200 as the center, wherein the needle aperture of the three needle members 210' included in group B is d', and the needle aperture of the needle member 210 included in group A is d, wherein d'≠d; and Fig. 22 In the configuration shown, the needle holes of the needle members 210 of group A and the needle members 210' of group B, which are coaxially arranged in an annular manner, decrease radially outward, that is, d'>d. Fig.23 In the configuration shown, the needle hole diameters of the needle members 210 of group A and the needle members 210 ′ of group B increase radially outward, that is, d′<d.

[0147] In some embodiments of the present invention, at least one of the circularly arranged needle members 210 has an outlet jet velocity v' different from that of the other holes;

[0148] In some embodiments of the present invention, the outlet jet velocity v' of at least one group of needle members 210 of the plurality of groups of needle members 210 is different from the outlet jet velocity v of the other groups of holes;

[0149] In some embodiments of the present invention, the outlet jet velocities v of the multiple groups of needle members 210 coaxially arranged in an annular manner increase or decrease radially.

[0150] In some embodiments of the present invention, the plurality of needle members 210 include a central needle member 210 ″ located at the center of the injection head 200 and a plurality of peripheral needle members 210 located around the central needle member 210 .

[0151] In one embodiment of the present invention, Fig.24 As shown, the injection head 200 is provided with a central needle component 210 ″ located at the center (center) of the injection head 200 and two peripheral needle components 210 located around the central needle component 210 .

[0152] In some embodiments of the present invention, the plurality of peripheral needle members 210 are arranged in a ring shape.

[0153] In some embodiments of the present invention, the plurality of peripheral needle members 210 are arranged in a coaxial ring around the central needle member 210 ″.

[0154] In one embodiment of the present invention, Figure 24 to Figure 26 As shown, the injection head 200 is provided with a central needle member 210" located at the center (center) of the injection head 200 and a plurality of peripheral needle members 210 located around the central needle member 210. For example, Fig.26 , a configuration in which four peripheral needle components 210 are arranged on the injection head 200 is shown.

[0155] In some embodiments of the present invention, the peripheral holes 121 have multiple groups, each group of peripheral needle members 210 is arranged in a ring shape, and the multiple groups of peripheral needle members 210 are arranged in a coaxial ring shape around the central needle member 210 ″.

[0156] In one embodiment of the present invention, Fig. 27 As shown, the injection head 200 is provided with 6 peripheral needle members 210, and the 6 peripheral needle members 210 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 3 peripheral needle members 210, and the two groups of peripheral needle members 210 are coaxially arranged in a ring shape around the central needle member 210".

[0157] In some embodiments of the present invention, the skin insertion depth L” of the central needle member 210 ″ is different from the skin insertion depths of the plurality of peripheral needle members 210 .

[0158] In one embodiment of the utility model, the injection head 200 is provided with a central needle component 210" with a skin insertion depth of L" and three peripheral needle components 210 with a skin insertion depth of L, wherein L"≠L, in one configuration L"<L, and in another configuration L">L.

[0159] In some embodiments of the present invention, the skin insertion depth L′ of at least one group of peripheral needle members 210 among the plurality of groups of peripheral needle members 210 is different from the skin insertion depth L of the other groups of peripheral needle members 210 .

[0160] In one embodiment of the present invention, the skin insertion depth of the three peripheral needle components 210 included in group A is L1, and the skin insertion depth of the three peripheral needle components 210 included in group B is L2, and L1≠L2, in one of the configurations shown, L1>L2, and in another configuration, L1<L2.

[0161] In some embodiments of the present invention, the skin insertion depths of the multiple groups of needle members 210 and the central needle member 210 ″ coaxially arranged in an annular manner decrease or increase radially.

[0162] In one embodiment of the utility model, the skin insertion depth of the one central needle member 210" is L", the skin insertion depth of the three peripheral needle members 210 included in the A group is L1, and the skin insertion depth of the three peripheral needle members 210 included in the B group is L2, and L1≠L2; in one configuration, the skin insertion depths of the needle members 210 of the A and B groups coaxially arranged in a ring and the central needle member 210" decrease radially outward, that is: L">L1>L2, and in another configuration, the skin insertion depths of the needle members 210 of the A and B groups coaxially arranged in a ring and the central needle member 210" increase radially, that is: L"<L1<L2.

[0163] In some embodiments of the present invention, the needle hole diameter d″ of the central needle member 210 ″ is different from the needle hole diameters d of the plurality of peripheral needle members 210 .

[0164] In one embodiment of the present invention, Figure 28 to Figure 29 As shown, the injection head 200 is provided with a central needle member 210" with a needle hole diameter d" and three peripheral needle members 210 with a needle hole diameter d, wherein d"≠d. Fig.28 In the configuration shown, d"<d, while in Fig.29In the configuration shown, d”>d.

[0165] In another embodiment of the present invention, Figure 30 to Figure 32 As shown, the injection head 200 is provided with a central needle component 210" with a needle aperture of d" and six peripheral needle components 210 with a needle aperture of d, wherein d"≠d, and the six peripheral needle components 210 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 needle components 210, and the two groups of peripheral needle components 210 are coaxially arranged in a ring shape around the central needle component 210".

[0166] In some embodiments of the present invention, the needle hole diameter d1 of at least one group of peripheral needle members 210 among the plurality of groups of peripheral needle members 210 is different from the needle hole diameter d2 of the other groups of peripheral needle members 210 .

[0167] In one embodiment of the present invention, Fig.31 and Fig.32 As shown, the needle hole diameter of the three peripheral needle parts 210 included in the group A is d1, and the needle hole diameter of the three peripheral needle parts 210 included in the group B is d2, and d1≠d2, Fig.31 In the configuration shown, d1>d2, while in Fig.32 In the configuration shown, d1 < d2.

[0168] In some embodiments of the present invention, the needle apertures of the plurality of groups of needle members 210 and the central needle member 210 ″ coaxially arranged in an annular manner increase or decrease in radial direction.

[0169] In one embodiment of the present invention, Fig.31 and Fig.32 As shown, the needle hole diameter of the central needle member 210" is d", the needle hole diameters of the three peripheral needle members 210 included in group A are d1, and the needle hole diameters of the three peripheral needle members 210 included in group B are d2, and d1≠d2; Fig.31 In the configuration shown, the needle holes of the coaxially arranged A and B needle members 210 and the central needle member 210" decrease radially outward, that is, d">d1>d2, and in Fig.32 In the configuration shown, the needle apertures of the coaxially annularly arranged A and B needle members 210 and the central needle member 210" increase radially, that is, d" < d1 < d2.

[0170] In some embodiments of the present invention, the outlet jet velocity v” of the central needle member 210 ″ is different from the outlet jet velocity v of the plurality of peripheral needle members 210 .

[0171] In some embodiments of the present invention, the outlet jet velocity v1 of at least one group of peripheral needle members 210 among the plurality of groups of peripheral needle members 210 is different from the outlet jet velocity v2 of the other groups of peripheral needle members 210 .

[0172] In some embodiments of the present invention, the outlet jet velocities of the multiple groups of needle members 210 and the central needle member 210 ″ that are coaxially arranged in an annular manner increase or decrease radially.

[0173] In some embodiments of the present invention, Fig.33 and Fig.34 As shown, the injection head 200 includes a supporting portion 220 for supporting the needle member.

[0174] In some embodiments of the present invention, the support portion 220 is configured as a tubular wall extending toward one side of the needle tube 100; while in other embodiments of the present invention, the support portion 220 may be an independent component independent of the injection head 200 and used to connect the injection head 200 to the tube 100.

[0175] In some embodiments of the present invention, Fig.33 and Fig.34 As shown, the needle component 210 further includes a first needle portion 211 located on a side of the support portion 220 facing away from the needle tube 100 .

[0176] In some embodiments of the present invention, Fig.33 and Fig.34 As shown, the needle member 210 includes a fixing pad 230 located on the side of the support portion 220 facing the needle tube 100, and the fixing pad 230 is used to fix the needle member 210;

[0177] In some embodiments of the present invention, Fig.33 and Fig.34 As shown, the needle member 210 includes a second needle portion 212 located on the side of the support portion 220 facing the needle tube 100;

[0178] In some embodiments of the present invention, Fig.33 and Fig.34 Alternatively, the needle member 210 does not extend from the side of the support portion 220 facing away from the needle tube 100 , so that the needle member 210 forms a needle-free microhole 213 on the side of the support portion 220 facing away from the needle tube 100 .

[0179] In some embodiments of the present invention, the needle component 210 further comprises an interventional soft needle removably connected to the hole 210 .

[0180] In some embodiments of the present invention, Figure 35 to Figure 37 As shown, the multi-mode fluid delivery device further includes a needle kit 400 , and the needle kit 400 includes a needle sleeve 401 for removably surrounding the first needle portion 211 of the needle member 210 .

[0181] In some embodiments of the present invention, Figure 35 to Figure 37 As shown, the height h of the needle sleeve 401 of the needle kit 400 is greater than or equal to the first needle head 211 of the needle member 210, thereby completely surrounding the first needle head 211;

[0182] In some embodiments of the present invention, Figure 35 to Figure 37 As shown, optionally, the height h of the needle sleeve 410 of the needle kit 400 is smaller than the first needle head 211 of the needle member 210 , thereby partially surrounding the first needle head 211 , so that the first needle head 211 extends from the front end of the needle sleeve to form an insertion portion 214 .

[0183] In some embodiments of the present invention, Figure 35 to Figure 37 As shown, the needle kit 400 includes a first needle kit 410 , and the height of the needle sleeve 401 of the first needle kit 410 is greater than the first needle head 211 of the needle member, so as to completely surround the first needle head 211 to protect the first needle head 211 .

[0184] In some embodiments of the present invention, Figure 35 to Figure 37 As shown, the needle kit 400 is multiple, and the multiple needle kits 400 include a first needle kit 410 and a second needle kit 420.

[0185] The first needle kit 410 is configured so that the first needle head 211 is partially surrounded, the insertion portion is located in the dermis, the epidermis, the subcutaneous layer, the muscle or the human organ;

[0186] The second needle kit 420 is configured so that it surrounds the first needle head 211 and has another one of the states of being partially surrounded, the insertion portion being located in the dermis, the epidermis, subcutaneously, in the muscle, or in the human organ.

[0187] In some embodiments of the present invention, the needle kit 400 is multiple, and the multiple needle kits include a first needle kit 410, a second needle kit 420, a third needle kit 430, a fourth needle kit 440, a fifth needle kit 450 and a sixth needle kit 460;

[0188] The first needle kit 410 is configured so that it completely surrounds the first needle head 211;

[0189] The second needle kit 420 is configured such that the insertion portion 214 thereof surrounding the first needle head 211 is located in the dermis;

[0190] The third needle kit 430 is configured such that the insertion portion 214 surrounding the first needle head 211 is located in the epidermis;

[0191] The fourth needle kit 440 is configured such that the insertion portion 214 surrounding the first needle head 211 is located subcutaneously;

[0192] The fifth needle kit 450 is configured so that its insertion portion 214 surrounding the first needle head 211 is located in the muscle;

[0193] The sixth needle kit 460 is configured such that the insertion portion 214 thereof surrounding the first needle head 211 is located in a human organ.

[0194] In some embodiments of the present invention, the needle cover structure can be integrated on the injection head. In other embodiments of the present invention, the needle cover structure can move axially relative to the needle part along the axial direction of the needle part.

[0195] In a further embodiment of the present invention, the injection head further comprises a needle sleeve portion sleeved on the needle member and a rotating member operatively connected to the needle member or the needle sleeve portion, the rotating member being configured to adjust the axial position of the needle member and the needle sleeve portion by rotation to adjust the exposed length of the needle member relative to the needle sleeve portion. In some embodiments of the present invention, the axial position of the needle member and the needle sleeve portion is configured to be adjustable between multiple positions so that the exposed length of the needle member can be adjusted between multiple positions, preferably, the exposed length of the needle member can be adjusted between multiple positions such as the needle sleeve portion being retracted, being flush with the needle sleeve portion, being located in the dermis, being located in the epidermis, being located under the skin, being located in the muscle, and being located in the human organ. In some embodiments of the present invention, the axial position of the needle member and the needle sleeve portion is configured to be continuously adjustable so that the exposed length of the needle member can be continuously adjusted.

[0196] In one embodiment of the present invention, the injection head includes a needle sleeve portion sleeved on the needle member and a rotating component operatively connected to the needle member, the rotating component is provided with a screw ring and a first threaded portion, the needle member is provided with a second threaded portion matching the first threaded portion, the rotating component can adjust the axial position of the needle member by rotating the screw ring, for example, in one case, the clockwise rotation of the screw ring can drive the needle member to extend axially toward the distal end, so that the needle member extends out of the needle sleeve portion sleeved on the needle member to form an exposed portion or adjust the length of the exposed portion.

[0197] In another embodiment of the present invention, the injection head includes a needle sleeve portion sleeved on the needle member and a rotating member operatively connected to the needle member, the rotating member is provided with a screwing ring and a first threaded portion, the needle sleeve portion is provided with a second threaded portion matching the first threaded portion, the rotating member can adjust the axial position of the needle sleeve portion by rotating the screwing ring, for example, in one case, the clockwise rotation of the screwing ring can drive the needle sleeve portion to extend axially toward the distal end, so that the needle sleeve portion sleeved on the needle member covers the top end of the needle member to protect the needle member.

[0198] In a further embodiment of the present invention, the injection head includes a needle sleeve portion sleeved on the needle member and a rotating member operatively connected to the needle member, the rotating member is provided with a screwing ring and a first threaded portion, the needle sleeve portion is provided with a second threaded portion matching the first threaded portion, the needle member is provided with a third threaded portion matching the first threaded portion, and the rotating member can adjust the relative axial position of the needle member and the needle sleeve portion sleeved on the needle member by rotating the screwing ring.

[0199] In the embodiment of the utility model, the relative axial position of the needle member and the needle sleeve portion sleeved on the needle member can be infinitely adjusted by the rotating member, so as to realize the infinite adjustment of the retraction, exposure or exposure length of the needle member relative to the needle sleeve portion.

[0200] In some embodiments of the present invention, the injection head 200 includes a connection portion 240 for detachably connecting the injection head 200 to the tube 100;

[0201] In some embodiments of the present invention, Fig.33 and 34 As shown, the connection portion 240 is a threaded connection portion;

[0202] In some embodiments of the present invention, the connection portion 240 is a clamping portion; optionally, the connection portion 240 is an adhesive portion.

[0203] In some embodiments of the present invention, the multi-mode fluid delivery device further comprises a locking member for locking the injection head 200 to the tube, the locking member comprising a connecting portion for detachably connecting the locking member to the tube;

[0204] In some embodiments of the present invention, the connection portion is a threaded connection portion;

[0205] In some embodiments of the present utility model, the connecting portion is a clamping portion;

[0206] In some embodiments of the present invention, the connecting portion is an adhesive portion.

[0207] In some embodiments of the utility model, any of the multi-mode fluid delivery devices 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, wherein the triple vaccine is also called a cat triple vaccine. Thus, the embodiments of the present application also provide corresponding drug-device combination products. In the embodiments of the utility model, the drug-device combination product may include or may be a drug delivery system.

[0208] 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.

[0209] In some embodiments of the present invention, the injection head 200 of the multi-mode fluid delivery device used in combination with the feline triple vaccine is provided with three holes 121 arranged in a circular pattern at equal intervals around the center of the injection head 200, and the three holes 121 are 1.25 mm ± 20% away from the center of the injection head 200.

[0210] In some embodiments of the present invention, the pushing speed of the piston 210 of the multi-mode fluid delivery device used in combination with a feline triple vaccine is configured to be 0.12 m / s±20%.

[0211] In some embodiments of the present invention, the multi-mode fluid delivery device used in combination with a feline triple vaccine is configured so that the outlet jet velocity of the feline triple vaccine when pushed away from the hole 121 in the injection head 200 by the piston 210 is 150.00 m / s±20%.

[0212] In some embodiments of the present invention, the multi-mode fluid delivery device used in combination with a feline triple vaccine is configured so that the diffusion volume of the feline triple vaccine in vivo is more than 1.5 times the undelivered volume of the feline triple vaccine.

[0213] In some embodiments of the present invention, the multimodal fluid delivery device used in combination with a 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, preferably more than 2.0 times, and more preferably more than 4.8 times the average antibody titer of needle injection.

[0214] 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.

[0215] In some embodiments of the present invention, the multimodal fluid delivery device used in combination with a 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, preferably more than 2.0 times, and more preferably more than 3.7 times the average antibody titer of needle injection.

[0216] In some embodiments of the present invention, the multimodal fluid delivery device used in combination with a 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.

[0217] In some embodiments of the present invention, the multimodal fluid delivery device used in combination with a feline trivalent vaccine is configured so that the average antibody titer of the feline trivalent vaccine 60 days after the second dose of a 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 a needle injection of a 100% vaccine dose.

[0218] In some embodiments of the present invention, any of the multi-mode fluid delivery devices 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.

[0219] 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.

[0220] In some embodiments of the present invention, the injection head 200 of the multi-mode fluid delivery device used in combination with the hepatitis B vaccine is provided with three holes 121 arranged in a ring at equal intervals around the center of the injection head 200, and the three holes 121 are 1.25 mm ± 20% away from the center of the injection head 200.

[0221] In some embodiments of the present invention, the pushing speed of the piston 210 of the multi-mode fluid delivery device used in combination with the hepatitis B vaccine is configured to be 0.12 m / s±20%.

[0222] In some embodiments of the present invention, the multi-mode fluid delivery device used in combination with the hepatitis B vaccine is configured so that the outlet jet velocity of the hepatitis B vaccine when it is pushed away from the hole 121 in the injection head 200 by the piston 210 is 150.00 m / s±20%.

[0223] In some embodiments of the present invention, the multi-mode fluid 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.

[0224] In some embodiments of the present invention, the multimodal fluid 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 the average antibody titer of needle injection, preferably more than 1.5 times, and more preferably more than 2.0 times.

[0225] In some embodiments of the present invention, the multimodal fluid 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.

[0226] In some embodiments of the present invention, the multimodal fluid 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.

[0227] In some embodiments of the present invention, the multimodal fluid 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% higher, and more preferably more than 50% higher.

[0228] In some embodiments of the present invention, any of the multi-mode fluid delivery devices in the above embodiments of the present invention can also be used in combination with a pneumonia vaccine for human use. Thus, the present application also provides a corresponding drug-device combination product. In an embodiment of the present invention, the drug-device combination product may include or may be a drug delivery system.

[0229] In some embodiments of the present invention, the injection head 200 of the multi-mode fluid 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 injection head 200, and the three holes 121 are 1.25 mm ± 20% away from the center of the injection head 200.

[0230] In some embodiments of the present invention, the pushing speed of the piston 210 of the multi-mode fluid delivery device used in combination with a pneumonia vaccine for humans is configured to be 0.14 m / s±20%.

[0231] In some embodiments of the present invention, the multi-mode fluid 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 injection head 200 by the piston 210 is 160.00 m / s±20%.

[0232] In some embodiments of the present invention, the multi-mode fluid 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.

[0233] In some embodiments of the present invention, the multimodal fluid 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.

[0234] In some embodiments of the present invention, the multimodal fluid 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 the average antibody titer of needle injection, preferably more than 1.5 times, and more preferably more than 2.0 times.

[0235] In some embodiments of the present invention, a multimodal fluid 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 even more preferably more than 1.5 times the average antibody titer produced by injection of 100% of the vaccine dose.

[0236] In some embodiments of the present invention, any of the multi-mode fluid delivery devices in the above embodiments of the present invention can also be used in combination with GLP-1 polypeptides. Thus, the present application also provides corresponding drug-device combination products. In the embodiments of the present invention, the drug-device combination product can include or can be a drug delivery system.

[0237] In some embodiments of the present invention, the injection head 200 of the multi-mode fluid delivery device used in combination with GLP-1 polypeptides is provided with three holes 121, which are arranged in a ring around the center of the injection head 200 at equal intervals, and the three holes are 1.25 mm ± 20% away from the center.

[0238] In some embodiments of the present invention, the pushing speed of the piston 210 of the multi-mode fluid delivery device used in combination with the GLP-1 polypeptide is 0.16 m / s ± 20%;

[0239] In some embodiments of the present invention, the multi-mode fluid 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 injection head 200 by the piston 210 is 170.00 m / s±20%.

[0240] In some embodiments of the present invention, the multimodal fluid delivery device used in combination with the GLP-1 polypeptide is configured so that the diffusion volume of the GLP-1 polypeptide in vivo is greater than 1.5 times the non-delivery volume of the GLP-1 polypeptide.

[0241] In some embodiments of the present invention, the GLP-1 class polypeptide includes semaglutide, and any of the multi-mode fluid delivery devices in the above embodiments of the present invention can 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.

[0242] In some embodiments of the present invention, the semaglutide (Simeigelutai), also known as semaglutide, is a second-generation glucagon-like peptide-1 (GLP-1) analog, and its molecular formula is C 187 H 291 N 45 O 59 It (molecular weight is 4113.58Da) has excellent hypoglycemic and weight loss effects for diabetic patients, which is significantly better than sitagliptin, insulin glargine U100 or sustained-release exenatide; it is also better than its peer drug liraglutide in weight loss, especially in patients with BMI ≥ 30. Semaglutide can be taken orally or subcutaneously, for example, as an oral dosage form of 7mg / 14mg once a day or a subcutaneous injection of 0.5mg / 1.0mg once a week. Semaglutide not only shows good efficacy in the treatment of diabetes, but also shows significant advantages in weight loss and cardiovascular protection.

[0243] In some embodiments of the present invention, the multimodal fluid delivery device used in combination with semaglutide is configured so that the diffusion volume of the semaglutide in the body is more than 1.5 times the non-delivered volume of the semaglutide.

[0244] In some embodiments of the present invention, the multimodal fluid delivery device used in combination with semaglutide is configured so that the weight reduction effect of semaglutide on humans and animals is consistent with that of needle injection, and preferably the weight reduction effect is increased by 2%, further preferably by 5%, and even more preferably by 10% over that of needle injection.

[0245] In some embodiments of the present invention, the multimodal fluid delivery device used in combination with semaglutide is configured so that the body weight loss endpoint of semaglutide in vivo is consistent with that of needle injection, preferably increased by more than 2%, more preferably by more than 5%, and even more preferably by more than 10%.

[0246] In some embodiments of the present invention, the multimodal fluid 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%.

[0247] In some embodiments of the present invention, any multi-mode fluid delivery device in the embodiments of the present invention can also be used in combination with a drug preparation. Thus, the embodiments of the present application also provide corresponding drug-device combination products. In the embodiments of the present invention, the drug-device combination product can include or can be a drug delivery system.

[0248] In some embodiments of the present invention, the pharmaceutical preparation is a rabies vaccine for human use.

[0249] In some embodiments of the present invention, the pharmaceutical preparation is a rabies vaccine for animals.

[0250] In some embodiments of the present invention, the pharmaceutical preparation is a meningitis vaccine for human use.

[0251] In some embodiments of the present invention, the pharmaceutical preparation is a hand, foot and mouth disease vaccine for animals.

[0252] In some embodiments of the present invention, the pharmaceutical preparation is a new coronavirus vaccine for humans.

[0253] In some embodiments of the present invention, the pharmaceutical preparation is a hepatitis A vaccine for human use.

[0254] In some embodiments of the present invention, the pharmaceutical preparation is a vaccine for hemorrhagic fever with renal syndrome for humans.

[0255] In some embodiments of the present invention, the pharmaceutical preparation is a mumps vaccine for human use.

[0256] In some embodiments of the present invention, the pharmaceutical preparation is an HPV vaccine for humans.

[0257] In some embodiments of the present invention, the pharmaceutical preparation is a tumor chemotherapy drug for human use.

[0258] In some embodiments of the present invention, the drug preparation is a tumor nuclear medicine for human use.

[0259] In some embodiments of the present invention, the pharmaceutical preparation is a tumor vaccine for human use, including but not limited to polypeptide vaccines, mRNA vaccines, and DNA vaccines.

[0260] 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.

[0261] 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).

[0262] 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.

[0263] 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).

[0264] 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.

[0265] In some embodiments of the present invention, the drug preparation is pancreatic islets.

[0266] In some embodiments of the present invention, the drug preparation is a botulinum toxin cosmetic drug used for medical cosmetology.

[0267] In some embodiments of the present invention, a needle-free needle tube for a multi-mode fluid delivery device of any of the above embodiments of the present invention is also provided, comprising: a tube 100 for containing fluid, the tube 100 having a first end 110 and a second end 120, wherein the first end 110 is configured to accommodate a piston 210 for pushing the fluid 130, and the second end 120 has a plurality of holes 121 for distributing the fluid 130 in the tube.

[0268] In some embodiments of the present invention, Figure 38 to Figure 39 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 toward the distal end, and a hole 124 is provided on the end surface 123 of the narrowing section 122. The end surface 123 is configured to be circular.

[0269] In some embodiments of the present invention, the total fluid delivery area of ​​the plurality of holes of the needle-free needle tube is 0.009 mm 2 Above, preferably 0.02mm 2 More preferably 0.053 mm 2 , more preferably 0.2800 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 .

[0270] In some embodiments of the present invention, the needle-free needle tube is configured so that the fluid jets passing through the plurality of holes 121 have different in vivo diffusion degrees;

[0271] In other embodiments of the present invention, the diffusivity refers to a comprehensive concept that describes the distribution characteristics of fluid in the body. Specifically, the diffusivity may include but is not limited to the fluid's diffusion volume ratio, diffusion depth, diffusion center, and edge liquid distribution density.

[0272] In some embodiments of the present invention, the apertures of the plurality of holes 121 of the needle-free needle tube are configured such that the fluid jets passing through the plurality of holes 121 have different in vivo diffusion degrees.

[0273] In some embodiments of the present invention, the plurality of holes 121 of the needle-free needle tube include a first hole 121;

[0274] In some embodiments of the present invention, the first hole 121 has a first aperture d1, and the size of the first aperture d1 is configured to allow the fluid jet passing through the first hole 121 to diffuse in at least one of the dermis, epidermis, subcutaneous tissue, muscle, and human organs.

[0275] In some embodiments of the present invention, the plurality of holes 121 of the needle-free needle tube include a first hole 121 and a second hole 121 ′;

[0276] In some embodiments of the present invention, the first hole 121 has a first aperture d1, and the size of the first aperture d1 is configured so that the fluid jet passing through the first hole 121 diffuses in at least one of the dermis, epidermis, subcutaneous tissue, muscle and human organs; the second hole 121' has a second aperture d2, and the size of the second aperture d2 is configured so that the fluid jet passing through the second hole 121' diffuses in at least another one of the dermis, epidermis, subcutaneous tissue, muscle and human organs.

[0277] In some embodiments of the present invention, the plurality of holes 121 of the needle-free needle tube are arranged along a straight line;

[0278] In some embodiments of the present invention, the plurality of holes 121 are arranged in a straight line along the diameter or midline of the second end 120. Preferably, one of the plurality of holes 121 arranged in a straight line along the diameter or midline of the second end 120 is located at the center or center of the second end 120.

[0279] In some embodiments of the present invention, the plurality of holes 121 arranged along a straight line are arranged at equal intervals;

[0280] In some embodiments of the present invention, the plurality of holes 121 arranged along a straight line are mirror-symmetrical with respect to the diameter or the midline of the second end 120;

[0281] In some embodiments of the present invention, the holes 121 have multiple groups, and each group of holes 121 is arranged along a straight line. Preferably, each group of holes is arranged along a diameter or a center line of the second end 120;

[0282] In some embodiments of the present invention, the plurality of holes 121 are arranged in an array, and the plurality of holes 121 arranged in an array are mirror-symmetrical with respect to the first and second diameters or midlines perpendicular to each other of the second end 120;

[0283] In some embodiments of the present invention, the diameter d of the hole 121 located at the center or center of the second end 120 is different from the diameter d' of the other holes 121' of the plurality of holes 121;

[0284] In some embodiments of the present invention, the aperture of at least one group of holes 121 among the plurality of groups of holes 121 is different from the apertures of the other groups of holes.

[0285] In some embodiments of the present invention, the plurality of holes 121 of the needle-free needle tube are arranged in a ring shape;

[0286] In some embodiments of the present invention, the plurality of holes 121 are arranged in a ring with the center or center of the second end 120 as the center;

[0287] The holes 121 have multiple groups, and each group of holes 121 is arranged in a ring shape. Preferably, the multiple groups of holes 121 are coaxially arranged in a ring shape.

[0288] In some embodiments of the present invention, at least one of the plurality of holes 121 arranged in an annular manner has a different aperture from the other holes 121;

[0289] In some embodiments of the present invention, the aperture of at least one group of holes 121 of the plurality of groups of holes 121 is different from the apertures of the other groups of holes;

[0290] In some embodiments of the present invention, the diameters of the multiple groups of holes 121 coaxially arranged in an annular manner increase or decrease in the radial direction.

[0291] In some embodiments of the present invention, the plurality of holes of the needle-free needle tube include a central hole 121 ″ located at the center or center of the second end 120 and a plurality of peripheral holes 121 located around the central hole;

[0292] In some embodiments of the present invention, the plurality of peripheral holes 121 are arranged in a ring shape, and preferably, the plurality of peripheral holes 121 are arranged in a coaxial ring shape around the central hole 121 ″;

[0293] The peripheral holes 121 have multiple groups, and each group of peripheral holes 121 is arranged in a ring shape. Preferably, the multiple groups of peripheral holes 121 are arranged in a coaxial ring shape around the central hole 121 ″.

[0294] 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 .

[0295] In some embodiments of the present invention, an injection head 200 for a multi-mode fluid delivery device is further provided. The injection head 200 includes one or more needle members 210 and a support portion 220 for supporting the needle members 210 .

[0296] In some embodiments of the present invention, the support portion 220 has a first side 221 and a second side 222 opposite to the first side 221;

[0297] Optionally, the needle member 210 includes a first needle portion 211 located on a first side 221 of the support portion 220;

[0298] Optionally, the needle member 210 includes a fixing pad 230 located on the first side 221 of the support portion 220, and the fixing pad 230 is used to fix the needle member 210;

[0299] Optionally, the needle member 210 includes a second needle portion 212 located on the second side 222 of the support portion 220;

[0300] In some embodiments of the present invention, alternatively, the first needle portion 211 of the needle member 210 does not extend from the first side 221 of the support portion 220 , so that the first side 221 of the support portion 220 forms a needle-free microhole 213 .

[0301] In some embodiments of the present invention, the first needle head 211 of the needle member 210 is flat, and the second needle head 212 of the needle member 210 is sharp.

[0302] In some embodiments of the present invention, the first needle head 211 and the second needle head 212 of the needle member 210 are both sharp.

[0303] In some embodiments of the present invention, the one or more needle members 210 have different adjustable skin insertion depths L;

[0304] In some embodiments of the present invention, at least one of the one or more needle members 210 has an insertion depth that is not substantially inserted but forms a close contact with the human or animal skin.

[0305] In some embodiments of the present invention, at least one of the one or more needle members 210 has an insertion depth that is substantially inserted into the inner layer of human or animal skin.

[0306] In some embodiments of the present invention, at least one of the one or more needle members 210 has an insertion depth that is substantially inserted into the subcutaneous layer of a human or animal.

[0307] In some embodiments of the present invention, at least one of the one or more needle members 210 has an insertion depth that is substantially inserted into the muscle layer of a human body or an animal.

[0308] In some embodiments of the present invention, at least one of the one or more needle members 210 has an insertion depth sufficient to be inserted into an organ in a human or animal body.

[0309] In some embodiments of the present invention, at least one of the one or more needle members has an adjustable insertion depth.

[0310] It can be understood that in the embodiments of the present invention, the dermis, epidermis, subcutaneous layer, muscle or human organ do not correspond to a certain exact and fixed insertion depth value, nor to a certain exact and fixed insertion depth value range. Those skilled in the art can confirm the corresponding insertion depths of the dermis, epidermis, subcutaneous layer, muscle and human organ in the body of the inoculated object based on the inoculated object for needle-free delivery, including but not limited to different types of animals or patients with different physical conditions.

[0311] In some embodiments of the present invention, the plurality of needle members 210 include a first needle member;

[0312] In some embodiments of the present invention, the needle apertures of the one or more needle members 210 may be equal and have a first needle aperture d1, the size of which is configured such that the fluid jets passing through the one or more needle members 210 have different diffusion degrees, preferably, different diffusion depths, so that the fluid jets diffuse in at least one of the dermis, epidermis, subcutaneous tissue, muscles, and human organs.

[0313] In some embodiments of the present invention, the plurality of needle members 210 include a first needle member 210 and a second needle member 210 ′;

[0314] In some embodiments of the present invention, the first needle member 210 has a first skin insertion depth located in one of the dermis, epidermis, subcutaneous layer, muscle and human organs, and the second needle member 210' has a second skin insertion depth located in another of the dermis, epidermis, subcutaneous layer, muscle and human organs;

[0315] In some embodiments of the present invention, the first needle member 210 has a first needle aperture d, and the size of the first needle aperture d is configured so that the fluid jet passing through the first needle member 210 diffuses in at least one of the dermis, epidermis, subcutaneous tissue, muscle and human organs; the second needle member 210' has a second needle aperture d', and the size of the second needle aperture d' is configured so that the fluid jet passing through the second needle member 210' diffuses in at least another one of the dermis, epidermis, subcutaneous tissue, muscle and human organs.

[0316] In other embodiments of the present invention, preferably, the plurality of needle members further include a third needle member 210", and preferably, the third needle member 210" has a third skin insertion depth located in one of the dermis, epidermis, subcutaneous layer, muscle and human organ.

[0317] In some embodiments of the present invention, the plurality of needle members 210 are arranged along a straight line;

[0318] In some embodiments of the present invention, the plurality of needle members 210 are arranged along the diameter or midline of the injection head, preferably, one of the plurality of needle members 210 arranged along the diameter or midline of the injection head 200 is located at the center or center of the injection head 200;

[0319] In some embodiments of the present invention, the plurality of needle members 210 arranged along a straight line are arranged at equal intervals;

[0320] In some embodiments of the present invention, the plurality of needles 210 arranged along a straight line are mirror-symmetrical with respect to the diameter or the midline of the injection head 200;

[0321] In some embodiments of the present invention, the needle members 210 have multiple groups, and each group of needle members 210 is arranged along a straight line. Preferably, each group of needle members 210 is arranged along a diameter or a midline of the injection head;

[0322] The plurality of needle members 210 are arranged in an array. Preferably, the plurality of needle members 210 arranged in an array are mirror-symmetrical with respect to first and second diameters or center lines perpendicular to each other of the end surface of the injection head 200.

[0323] In some embodiments of the present invention, the skin insertion depth L" of the needle member 210" located at the center or center of the injection head 200 is different from the skin insertion depth L of other needle members of the plurality of needle members 210;

[0324] Preferably, the skin insertion depth L' of at least one group of needle members in the plurality of groups of needle members 210 is different from the skin insertion depth L of the other groups of needle members 210;

[0325] Preferably, the needle hole diameter d'' of the needle member 210'' located at the center or centre of the injection head 200 is different from the needle hole diameters d'' of the other needle members 210 of the plurality of needle members 210;

[0326] Preferably, the needle hole diameter d' of at least one group of needle members 210' in the plurality of groups of needle members 210 is different from the needle hole diameters d of the other groups of needle members.

[0327] In some embodiments of the present invention, the plurality of needle members 210 are arranged in a ring shape;

[0328] In some embodiments of the present invention, the plurality of needle members 210 are arranged in a ring with the center or center of the injection head 200 as the center;

[0329] The needle members 210 are provided in a plurality of groups, and each group of needle members 210 is arranged in a ring shape. Preferably, the plurality of groups of needle members 210 are arranged in a coaxial ring shape.

[0330] In some embodiments of the present invention, at least one of the plurality of needle members 210 arranged in an annular manner has a skin insertion depth L′ different from that of the other needle members 210 .

[0331] In some embodiments of the present invention, the skin insertion depth L' of at least one group of needle members 210' of the plurality of groups of needle members 210 is different from the skin insertion depth L of the other groups of needle members.

[0332] In some embodiments of the present invention, the skin insertion depths L of the multiple groups of needle members 210 coaxially arranged in an annular shape decrease or increase radially.

[0333] In some embodiments of the present invention, at least one of the plurality of needle members 210 arranged in an annular manner has a needle hole diameter d′ different from that of the other needle members 210 .

[0334] In some embodiments of the present invention, the needle hole diameter d′ of at least one group of needle members 210 ′ of the multiple groups of needle members 210 is different from the needle hole diameters d of the other groups of needle members 210 .

[0335] In some embodiments of the present invention, the needle apertures d of the plurality of needle members 210 coaxially arranged in an annular manner decrease or increase in the radial direction.

[0336] In some embodiments of the present invention, the plurality of needle members 210 include a central needle member 210 ″ located at the center or center of the injection head 200 and a plurality of peripheral needle members 210 located around the central needle member 210 ″;

[0337] In some embodiments of the present invention, the plurality of peripheral needle members 210 are arranged in a ring shape, and preferably, the plurality of peripheral needle members 210 are arranged in a coaxial ring shape around the central needle member 210 ”;

[0338] The peripheral needle members include multiple groups, and each group of peripheral needle members 210 is arranged in a ring shape. Preferably, the multiple groups of peripheral needle members 210 are arranged in a coaxial ring shape around the central needle member 210 ″.

[0339] In some embodiments of the present invention, the skin insertion depth L" of the central needle member 210" is different from the skin insertion depth L of the plurality of peripheral needle members 210;

[0340] In some embodiments of the present invention, the skin insertion depth L' of at least one group of peripheral needle members 210' of the plurality of groups of peripheral needle members 210 is different from the skin insertion depth L of the other groups of peripheral needle members 210;

[0341] In some embodiments of the present invention, the skin insertion depths of the multiple groups of needle members 210 and the central needle member 210" coaxially arranged in an annular manner decrease or increase radially;

[0342] Preferably, the needle hole diameter d'' of the central needle member 210'' is different from the needle hole diameters d'' of the plurality of peripheral needle members 210;

[0343] In some embodiments of the present invention, the needle hole diameter d' of at least one group of peripheral needle members 210' of the plurality of groups of peripheral needle members 210 is different from the needle hole diameters d of the other peripheral groups of needle members 210;

[0344] In some embodiments of the present invention, the needle apertures of the plurality of groups of needle members 210 and the central needle member 210 ″ coaxially arranged in an annular manner increase or decrease in radial direction.

[0345] In some embodiments of the present invention, the needle member 210 further comprises an interventional soft needle removably connected to the hole.

[0346] In some embodiments of the present invention, a needle kit 400 for a multi-mode fluid delivery device is further provided. The needle kit 400 includes one or more needle sleeves 401 , wherein the needle sleeves 401 are configured to removably surround the first needle portion 211 of the needle member 210 .

[0347] In some embodiments of the present invention, the height of the needle sleeve 401 is greater than or equal to the first needle head 211 of the needle member 210, thereby completely surrounding the first needle head 211;

[0348] In some embodiments of the present invention, the height of the needle sleeve 401 of the needle kit is smaller than the first needle head 211 of the needle member 210 , thereby partially surrounding the first needle head 211 , so that the first needle head 211 extends from the front end of the needle sleeve 401 to form an insertion portion 214 .

[0349] In some embodiments of the present invention, the needle kit 400 includes a first needle kit 410 , and the needle sleeve 401 of the first needle kit 410 is higher than the first needle head 211 of the needle member, thereby completely surrounding the first needle head 211 to protect the first needle head 211 .

[0350] In some embodiments of the present invention, the needle kit 400 is multiple, and preferably, the multiple needle kits 400 include a first needle kit 410 and a second needle kit 420.

[0351] The first needle kit 410 is configured so that the first needle head 211 is partially surrounded, the insertion portion is located in the dermis, the epidermis, the subcutaneous layer, the muscle or the human organ;

[0352] The second needle kit 420 is configured so that it surrounds the first needle head 211 and has another one of the states of being partially surrounded, the insertion portion being located in the dermis, the epidermis, subcutaneously, in the muscle, or in the human organ.

[0353] In some embodiments of the present invention, the needle kits are more than 400, preferably, the plurality of needle kits include a first needle kit 410, a second needle kit 420, a third needle kit 430, a fourth needle kit 440, a fifth needle kit 450 and a sixth needle kit 460;

[0354] The first needle kit 410 is configured so that it completely surrounds the first needle head 211;

[0355] The second needle kit 420 is configured such that the insertion portion 214 thereof surrounding the first needle head 211 is located in the dermis;

[0356] The third needle kit 430 is configured such that the insertion portion 214 surrounding the first needle head 211 is located in the epidermis;

[0357] The fourth needle kit 440 is configured such that the insertion portion 214 surrounding the first needle head 211 is located subcutaneously;

[0358] The fifth needle kit 450 is configured so that its insertion portion 214 surrounding the first needle head 211 is located in the muscle;

[0359] The sixth needle kit 460 is configured such that the insertion portion 214 thereof surrounding the first needle head 211 is located in a human organ.

[0360] In some embodiments of the present invention, the injection head further comprises a needle sleeve portion sleeved on the needle member and a rotating member operatively connected to the needle member or the needle sleeve portion, wherein the rotating member is configured to adjust the axial position of the needle member and the needle sleeve portion by rotation so as to adjust the exposed length of the needle member relative to the needle sleeve portion.

[0361] In some embodiments of the present invention, the axial positions of the needle member and the needle sleeve portion are configured to be adjustable between a plurality of positions so that the exposed length of the needle member can be adjusted between a plurality of positions. Preferably, the exposed length of the needle member can be adjusted between a plurality of positions including the needle sleeve portion being retracted, being flush with the needle sleeve portion, being located in the dermis, being located in the epidermis, being located under the skin, being located in the muscle, and being located in a human organ.

[0362] In some embodiments of the present invention, the axial positions of the needle member and the needle sleeve are configured to be continuously adjustable so that the exposed length of the needle member can be continuously adjusted.

[0363] In some embodiments of the present invention, there is also provided use of the multi-mode fluid delivery device described in any one of the above embodiments of the present invention in the preparation of human clinical medical and animal health care drugs for needle-free injection administration.

[0364] In some embodiments of the present invention, the pharmaceutical preparation is a feline triple vaccine.

[0365] In some embodiments of the present invention, the pharmaceutical preparation is a hepatitis B vaccine.

[0366] In some embodiments of the present invention, the pharmaceutical preparation is a pneumonia vaccine for humans.

[0367] In some embodiments of the present invention, the pharmaceutical preparation is semaglutide.

[0368] In some embodiments of the present invention, the pharmaceutical preparation is a rabies vaccine for human use.

[0369] In some embodiments of the present invention, the pharmaceutical preparation is a rabies vaccine for animals.

[0370] In some embodiments of the present invention, the pharmaceutical preparation is a meningitis vaccine for human use.

[0371] In some embodiments of the present invention, the pharmaceutical preparation is a hand, foot and mouth disease vaccine for animals.

[0372] In some embodiments of the present invention, the pharmaceutical preparation is a new coronavirus vaccine for humans.

[0373] In some embodiments of the present invention, the pharmaceutical preparation is a hepatitis A vaccine for human use.

[0374] In some embodiments of the present invention, the pharmaceutical preparation is a vaccine for hemorrhagic fever with renal syndrome for humans.

[0375] In some embodiments of the present invention, the pharmaceutical preparation is a mumps vaccine for human use.

[0376] In some embodiments of the present invention, the pharmaceutical preparation is an HPV vaccine for humans.

[0377] In some embodiments of the present invention, the pharmaceutical preparation is a tumor chemotherapy drug for human use.

[0378] In some embodiments of the present invention, the drug preparation is a tumor nuclear medicine for human use.

[0379] In some embodiments of the present invention, the pharmaceutical preparation is a tumor vaccine for human use, including but not limited to polypeptide vaccines, mRNA vaccines, and DNA vaccines.

[0380] In some embodiments of the present invention, the pharmaceutical preparation is a swine diarrhea bivalent vaccine.

[0381] In some embodiments of the present invention, the pharmaceutical preparation is an inactivated blue ear vaccine.

[0382] In some embodiments of the present invention, the pharmaceutical preparation is a foot-and-mouth disease vaccine.

[0383] In some embodiments of the present invention, the pharmaceutical preparation is a bovine bivalent vaccine.

[0384] In some embodiments of the present invention, the pharmaceutical preparation is a Pasteurella vaccine.

[0385] In some embodiments of the present invention, the drug preparation is insulin.

[0386] In some embodiments of the present invention, the drug preparation is a botulinum toxin cosmetic drug used for medical cosmetology.

[0387] In some embodiments of the present invention, a multi-modal drug preparation delivery method is also provided, characterized in that:

[0388] Determining a drug preparation delivery mode according to the acquired preset information, wherein the delivery mode includes a first delivery mode and a second delivery mode;

[0389] When the first delivery mode is determined, the drug preparation is delivered needle-free through a tube with a hole, and a first delivery parameter of the needle-free delivery is determined according to the preset information, wherein the first delivery parameter includes a piston speed of the tube, an aperture of the hole, and a jet velocity of the hole;

[0390] When the second delivery mode is determined, an injection member with one or more needle members is connected to a tube to deliver the drug preparation through the injection head with a needle, and second delivery parameters of the needle delivery are determined according to the preset information, wherein the second delivery parameters include the insertion depth, aperture, jet speed of the needle member and the piston speed of the tube;

[0391] In the selected delivery mode, the drug formulation is delivered according to determined delivery parameters.

[0392] In some embodiments of the present invention, the preset information includes at least one of inoculum information, inoculation position information and drug preparation information, wherein the inoculation position information includes at least one of inoculation site information, delivery depth information and delivery diffusion information.

[0393] In some embodiments of the present invention, the diffusion information includes at least one of diffusion volume ratio, diffusion breadth, diffusion depth, diffusion center and diffusion edge distribution density.

[0394] In some embodiments of the present invention, the number of holes is multiple, and the first delivery parameter of the needle-free delivery is determined according to the preset information, including:

[0395] The number and arrangement of the plurality of holes on the second end of the tube are determined according to the preset information.

[0396] In some embodiments of the present invention, the step of connecting an injection head with one or more needle members to a tube to deliver the drug preparation through the injection member with a needle comprises:

[0397] One or more needle members of the injection member are removably docked with corresponding self-closing resilient portions or holes in the second end of the tube.

[0398] In some embodiments of the present invention, the second delivery parameter of the needle delivery is determined according to the preset information, including:

[0399] The height, quantity and arrangement of the multiple needle parts on the head are determined according to the preset information.

[0400] In some embodiments of the present invention, the method further comprises installing a plurality of needle kits on the plurality of needle members according to the preset information to adjust the exposed length of the needle members to control the insertion depth of the plurality of needle members.

[0401] The multi-mode fluid 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 multi-mode fluid delivery device of the utility model, the components of the multi-mode fluid delivery device and the related drug-machine combination device, and by controlling the flow rate, delivery depth and dispersion of the drug and vaccine jets:

[0402] (1) The multi-mode fluid delivery device of the embodiment of the utility model is not limited to a single delivery mode, but combines three modes of needle-free injection, microneedle injection and needle injection, comprehensively providing a wider range of applications and being able to meet the delivery needs of different types of drugs and vaccines.

[0403] (2) The multi-mode fluid delivery device of the embodiment of the utility model can achieve a significant increase in the delivery volume, including a significant increase in the delivery volume without breaking the skin, and can be widely used in the delivery of drugs and vaccines for human and veterinary use.

[0404] (3) The multi-mode fluid delivery device of the embodiment of the utility model significantly improves the diffusion volume of the delivered substances, especially drugs and vaccines, in the body through multi-porous needle-free delivery, 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.

[0405] (4) The multi-mode fluid delivery device of the embodiment of the utility model achieves precise delivery of drugs and vaccines at different depths in the body according to the characteristics of different drugs and vaccines by precisely controlling the jet velocity of drugs and vaccines and optimizing the size and distribution of the pinholes and needles. In particular, it achieves precise delivery of the delivery substance to at least one or more target locations within the skin, subcutaneous tissue, muscle or human organs at the same time.

[0406] (5) The multi-mode fluid 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 the control of the diffusion volume ratio, diffusion breadth and diffusion center at the specified position, and achieving specific diffusion effects according to different delivery requirements. On the basis of the above-mentioned problems solved and / or effects achieved, the utility model is also used in combination with cat triple vaccine, hepatitis B vaccine, human pneumonia vaccine, GLP-1 peptide, especially semaglutide, to achieve further technical effects as recorded in the embodiments of the utility model.

[0407] The utility model proposes a specific example such as Fig.40 and Fig.41 As shown, one structural configuration of the multi-mode fluid delivery device is shown, specifically, the second end further 120 has a transition section 122 that narrows axially from the tube 100 to the distal end, the end face 123 of the transition section 122 is constructed as a circle with a diameter of 2.5 mm and is provided with three holes 121, the three holes 121 are arranged in a ring shape at equal intervals around the center of the end face 123, and the adjacent connecting lines of the three holes and the center (center) of the end face 123 form an angle of 120°, wherein the apertures of the three holes 121 are uniformly set to d and the distances from the center of the end face 123 are uniformly set to l.

[0408] 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 multi-mode fluid 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 having a self-sealing elastic portion disposed therein; an injection head detachably connected to the tube, the injection head comprising one or more needle members for injection, the one or more needle members for injection being configured to removably dock with the self-closing elastic portion in the second end; and A motorized power mechanism includes a piston disposed in the first end of the tube and capable of pushing the fluid or is operatively connected to the piston to apply a delivery pressure to the piston pushing the fluid.

2. The multi-mode fluid delivery device according to claim 1, characterized in that The second end is provided with a hole for distributing the fluid in the tube, and the self-closing elastic portion is arranged in the hole.

3. The multi-mode fluid delivery device according to claim 1 or 2, characterized in that: The motorized power mechanism is any one of compressed gas drive, spring drive, electromagnetic drive or a combination of the above drive modes.

4. The multi-mode fluid delivery device according to claim 1 or 2, characterized in that: At least one of the one or more needle members for injection has a hole diameter in the range of 0.06 mm to 1.50 mm; The self-sealing elastic portion has a diameter in the range of 0.06 mm to 1.50 mm.

5. The multi-mode fluid delivery device according to claim 1 or 2, characterized in that: The total fluid delivery area of ​​the plurality of needles for injection is 0.009 mm 2 The single hole area of ​​the needle member for injection is 0.0028 to 0.035 mm 2 .

6. The multi-mode fluid delivery device according to claim 1 or 2, characterized in that: The plurality of needle members for injection are arranged in a straight line or in a circle.

7. The multi-mode fluid delivery device according to claim 1 or 2, characterized in that: The plurality of needle members for injection include a central needle member located at the center of the injection head and a plurality of peripheral needle members located around the central needle member.

8. The multi-mode fluid delivery device according to claim 1 or 2, characterized in that: The injection head includes a support portion for supporting the needle member for injection and a first needle portion located at a side of the support portion facing away from the tube.

9. The multi-mode fluid delivery device according to claim 2, characterized in that: The needle member for injection includes an interventional soft needle removably connected to the hole of the tube.

10. The multi-mode fluid delivery device according to claim 2, wherein: The holes for distributing the fluid in the tube have a diameter in the range of 0.06 mm to 1.50 mm.

11. The multi-mode fluid delivery device according to claim 2, characterized in that: The total fluid delivery area of ​​the plurality of holes for distributing the fluid in the tube is 0.009 mm 2 The single hole area of ​​the hole for distributing the fluid in the pipe is 0.0028 to 0.035 mm 2 .

12. The multi-mode fluid delivery device according to claim 8, characterized in that: The multi-mode fluid delivery device further includes a needle kit including a needle sleeve for removably surrounding a first needle portion of the needle member for injection and for adjusting an exposed length of the needle member.

13. The multi-mode fluid delivery device according to claim 12, characterized in that: The height of the needle sleeve of the needle kit is less than or equal to the first needle head of the needle member for injection, thereby partially surrounding the first needle head, so that the first needle head extends from the front end of the needle sleeve to form an insertion portion.

14. The multi-mode fluid delivery device according to claim 13, wherein: The needle kit includes a first needle kit, wherein the height of the needle sleeve of the first needle kit is greater than the first needle portion of the needle member for injection, thereby completely surrounding the first needle portion to protect the first needle portion.

15. The multi-mode fluid delivery device according to claim 1 or 2, characterized in that: The injection head further comprises a needle sleeve portion sleeved on the needle member for injection and a rotating member operatively connected to the needle member for injection or the needle sleeve portion, wherein the rotating member is configured to adjust the axial positions of the needle member for injection and the needle sleeve portion by rotation so as to adjust the exposed length of the needle member for injection relative to the needle sleeve portion.

16. A tube for a multi-mode fluid delivery device according to any one of claims 1 to 15, characterized in that: The tube has a first end and a second end, wherein the first end is configured to accommodate a piston for pushing the fluid in the tube, and the second end is provided with a self-closing elastic portion.

17. The tube of the multi-mode fluid delivery device of claim 16, wherein: The second end is provided with a plurality of holes for distributing the fluid in the tube, and the self-closing elastic portion is disposed in the plurality of holes.

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