Kit for continuous and coaxial injection of medicaments

Abstract

A kit (10, 100) for subsequently injecting and / or subsequently inserting at least one medical substance and / or at least one element (30) in a fluid or liquid state into a human injection or insertion site, the kit (10, 100) comprising a first syringe element (12, 112) and at least one second syringe element (14, 114), wherein the first syringe element (12, 112) comprises an internally hollow cylindrical body (13, 113), a plunger (15, 115), and a first needle (16, 116), wherein the plunger (15, 115) is adapted for use in... Sliding within the cylindrical body (13, 113), wherein the at least one second syringe element (14, 114) includes a piston (18, 118) and a second needle (19, 119), wherein at least one medical substance is inserted into the cylindrical body (13, 113), wherein the first syringe element (12, 112) is adapted to receive (at least partially receive) the at least one second syringe element (14, 114) in use, or in any case, the second needle (19, 119) is adapted to pass through the plunger (15, 115) in use.

Description

Technical Field

[0001] The present invention relates to a kit for subsequently injecting and / or inserting substances and / or components coaxially into the human body.

[0002] More particularly, the present invention relates to a kit for subsequently injecting and / or inserting a substance and / or component into the human body, such as injecting and / or inserting the same substance or two different substances at the same injection site at consecutive times, or injecting and / or inserting a substance and different components (such as another device) at the same injection site at consecutive times. Background Technology

[0003] In the medical field, it is often useful to insert (e.g., inject) the same or more substances into the same implantation site at consecutive times.

[0004] To do this, for example, it is necessary to inject a first substance into a given site, and then it is necessary to be able to accurately inject a second substance (or, in any case, a second injection) into the same site.

[0005] Obviously, this is a very difficult operation that requires great precision to succeed, especially when the area to be injected is very small.

[0006] An example of this method is related to the treatment of varicose veins or varicose blood vessels, where the method for reducing them involves applying a surfactant substance (or surfactant sclerosing agent, such as, for example, a trade name) to the treatment of varicose veins or varicose blood vessels. or Sodium tetradecyl sulfate or its trade name or The surfactant substance (poly(ethoxylated dodecane)) is injected into the vein to be treated, causing the vein to constrict, and then a viscous substance is injected precisely at the same location on the body using the same needle, which allows blood flow to be sealed by adhering to the inner wall of the target vein.

[0007] This technique is also known as sclerotherapy with a "mousse" or scleromousse (turbulence technique). AIFA (Italian Medicines Agency) issued a document in 2015 regarding... And the announcement released in 2019 regarding The ruling formally confirmed this technology.

[0008] At the same drug concentration, surfactant sclerosing agents allow for increased contact between the sclerosing agent and the venous endothelium.

[0009] In this technique, two disposable plastic syringes and a special connector, still made of disposable plastic, are used to mix (via the connector from one syringe to another) a biocompatible air or gas and a surfactant hardener in a selected dose. Within seconds, through approximately ten steps, a dense foam comprising microbubbles of gas and drug is obtained that can be injected at a prescribed dose. The size of these microbubbles depends on several factors, such as the type of connector, the syringe used, etc., which are associated with specific manufacturing requirements and techniques.

[0010] This is a procedure that requires a highly skilled and attentive surgeon to ensure the success of the operation.

[0011] As mentioned above, this procedure is also needed in other medical fields for inserting two different substances into the human body one after another or at two different times.

[0012] Therefore, there is a need for a device or kit that allows the above actions to be performed in a more convenient and safer manner and that generally satisfies other actions based on the same principles. Summary of the Invention

[0013] The object of this invention is to improve the state of the art in the field of devices for injecting and / or inserting substances and / or components into the human body.

[0014] Within the scope of this technical task, one object of the present invention is to provide a kit for subsequently injecting and / or inserting substances and / or elements, said kit being practical and inexpensive.

[0015] Another object of the present invention is to provide a kit for subsequently injecting and / or inserting substances and / or components, the kit being able to ensure identical injection / insertion sites, while these operations must be performed in successive times relative to each other.

[0016] Another object of the present invention is to provide a kit for subsequent injection and / or subsequent insertion of substances and / or elements, which can be used simply and quickly by medical personnel.

[0017] According to one aspect of the invention, the kit according to claim 1 is provided herein.

[0018] According to one aspect of the invention, the method described herein is provided according to claims 22 and 26.

[0019] The dependent claims relate to preferred and advantageous embodiments of the invention. Attached Figure Description

[0020] Further features and advantages of the invention will become more apparent from the detailed, but non-exclusive, description of a preferred embodiment of a kit according to the invention for subsequently injecting and / or inserting substances and / or elements into the human body, provided by way of non-limiting example in the accompanying drawings, wherein:

[0021] Figure 1 This is a rear perspective view of one type of kit according to the invention, wherein the two parts of the kit are separate from each other;

[0022] Figure 2 yes Figure 1 A landscape view of the kit;

[0023] Figure 3A It is intercepted along the plane of line AA. Figure 2 A partial cross-sectional lateral view of the kit;

[0024] Figure 3B It is intercepted along the plane of line AA. Figure 2 The kit's rear perspective view and partial section view;

[0025] Figure 4 This is a landscape view of the kit according to the aforementioned figures, based on the operating steps;

[0026] Figure 5A It is intercepted along the plane of line AA. Figure 4 A partial cross-sectional lateral view of the kit;

[0027] Figure 5B It is intercepted along the plane of line BB. Figure 4 The kit's rear perspective view and partial section view;

[0028] Figure 6 This is a rear perspective view of the kit according to the invention, wherein two parts of the kit are in an assembled form;

[0029] Figure 7 yes Figure 6 A landscape view of the kit;

[0030] Figure 8A It is intercepted along the plane of line CC. Figure 7 A partial cross-sectional lateral view of the kit;

[0031] Figure 8B It is intercepted along the plane of line CC. Figure 7 The kit's rear perspective view and partial section view;

[0032] Figure 9 yes Figure 8A The kit's magnified detail view and cross-sectional view;

[0033] Figure 10A This is a partial cross-sectional transverse view of one type of kit according to the invention for subsequently injecting and / or inserting substances and / or components;

[0034] Figure 10B It is a plane intercept along line DD. Figure 10A A cross-sectional lateral view of the kit;

[0035] Figure 10C yes Figure 10A A magnified view of the kit's details;

[0036] Figure 11A and Figure 11B yes Figure 10A The other component of the kit is in both assembly and disassembly configurations. Figure 10C Two perspective views of the details;

[0037] Figure 12A This is a partial front perspective cross-section of another type of kit according to the invention for subsequently injecting and / or inserting substances and / or components;

[0038] Figure 12B From Figure 12A A side view of the kit;

[0039] Figure 12C yes Figure 12A Top-down landscape view of the kit;

[0040] Figure 12D yes Figure 12A A magnified perspective view of the kit's details;

[0041] Figure 12E and Figure 12F They are Figure 12A Landscape and perspective views of the components of the kit;

[0042] Figure 13 This is an exploded view of the kit according to the present invention;

[0043] Figure 14 This is an exemplary horizontal view of a kit according to the invention for subsequently inserting at least one substance and at least one element, wherein the second part of the kit is shown in two different modes of operation;

[0044] Figure 15 This is a transverse view of another type of kit for subsequent injection of a substance according to the invention, wherein the two parts of the kit are combined together.

[0045] Figure 16 This is a horizontal view of another type of kit according to the invention. Detailed Implementation

[0046] Referring to the accompanying drawings, a kit for subsequently injecting and / or inserting substances and / or components into the human body is indicated by reference numeral 10.

[0047] According to this document, unless otherwise stated, the terms “injection” and “insertion”, as well as “substance” and “element”, will be used as synonyms.

[0048] In addition, unless otherwise stated, the term "fluid" is used to refer to liquid substances, gaseous substances, plasmas, etc., or combinations thereof.

[0049] Kit 10, in its first form, includes a first syringe element 12 and at least one second syringe element 14.

[0050] The expressions “subsequent injection” or “subsequent insertion” into a human body site are used to indicate that the first syringe element 12 is adapted to determine, in use, a site for injection and / or insertion into the human body, and that the second syringe element 14 is adapted to inject or insert at least one substance or at least one element into the same injection / insertion site determined by the first syringe element. Therefore, the expression “subsequent” means that it occurs after the injection and / or insertion or aspiration performed by the first syringe element 12, as will be better explained below.

[0051] According to the type shown in the accompanying drawings by way of example only, the first syringe element 12 includes a 5 ml syringe, while the second syringe element 14 includes a 2 ml syringe.

[0052] Naturally, it is also conceivable that the first syringe element 12 and the second syringe element 14 have different capacities. However, the first syringe element 12 has a larger capacity than the second syringe element 14.

[0053] Furthermore, the first syringe element 12 is capable of at least partially accommodating the second syringe element 14 therein.

[0054] In at least one embodiment of the invention, the kit 10 consists only of the first syringe element 12 and the second syringe element 14, obviously in addition to substances (e.g., medical substances and / or components) that can be contained therein and inserted into the human body.

[0055] In fact, the first syringe element 12 and the second syringe element 14 are adapted to contain at least one substance to be inserted into the human body and / or at least one element, such as, for example, a fluid or liquid substance to be injected into the human body, element 30, said element 30 including an optical fiber device, a laser optical fiber device, a radio frequency (RF) device or antenna, a device capable of delivering and / or dispensing steam or other suitable gases (e.g., tubular), a device capable of generating heat and / or radiation (e.g., infrared spectrum or microwaves, etc.).

[0056] In one embodiment of the invention, the substance contained in the first syringe element 12 is, for example, a medical substance, such as a biocompatible surfactant (e.g., a surfactant hardener, for example, a product of a trade name). or Sodium tetradecyl sulfate, or by trade name or (such as oxyethylene dodecane), and the substance contained in the second syringe element 14 is, for example, a medical substance, such as a biocompatible adhesive, such as a cyanoacrylate-based biocompatible adhesive, such as, for example, a cyanoacrylate-based biocompatible adhesive with the trade name Loctite-Attak.

[0057] Maintaining the injection / insertion site is also very important because, in fact, for example with Loctite-Attak, but for other medical substances or adhesives, the injection / insertion site only works by adhesive when the surfaces to be bonded are in contact with each other. Therefore, the injection / insertion site only works after the inner wall of the vein to be treated (if this kit is used as an alternative to the above-mentioned sclerotherapy procedure) has collapsed by the first medical substance or by the surfactant.

[0058] In another form, the substance contained in the first syringe element 12 is the same as the substance contained in the second syringe element 14, but may have different doses and / or different or the same density.

[0059] In another embodiment of the invention, the substance present in the first syringe element 12 and / or the second syringe element 14 may be a biocompatible cementing element.

[0060] In another embodiment of the invention, the first syringe element 12 can be used to aspirate biological fluid present at a given surgical site, while the second syringe element 14 can be used to accurately inject the substance contained therein into the aspiration site.

[0061] In this configuration, the second syringe element 14 may be equipped with a second extra-long needle 19, which is capable of piercing (as better described below and in...) Figure 16(See image) The plunger 15 and / or the capsule or washer 20 of the head 15a of the plunger 15 pass through the liquid that may be aspirated by the first syringe element 12. Thus, a two-component resin, such as a bone cement possibly based on liquid poly(methyl methacrylate) (PMMA), can be inserted into the second syringe element 14 and injected into a vein or injection site, where it hardens after a few minutes, preventing any blood flow.

[0062] Entering into the details of an embodiment of the invention, the first syringe element 12 includes an internally hollow cylindrical body 13, a plunger 15 (or a first piston 15), and a first needle 16. The plunger 15 slides within the cylindrical body 13 along a longitudinal direction precisely defined by the longitudinal axis of the cylindrical body 13 and / or the first syringe element 12.

[0063] In fact, the first syringe element 12 extends along a longitudinal axis (first longitudinal axis), which may also be its axis of symmetry.

[0064] The second syringe element 14 extends along a longitudinal axis (the second longitudinal axis), which may also be its axis of symmetry, and coincides with the longitudinal axis of the first syringe element 12 in use.

[0065] Similarly, the second syringe element 14 includes an internally hollow cylindrical sidewall 17, a piston 18 (or a second piston 18), and a second needle 19.

[0066] The first needle 16 and the second needle 19 are hollow inside and / or respectively include a first inner cavity 16a and a second inner cavity 19a.

[0067] A first connecting element 16b is also present between the first needle 16 and the first end 13a of the cylindrical body 13 to removably connect the first needle 16 of the first syringe element 12 and the cylindrical body 13.

[0068] Similarly, a second connecting element 19b may be present between the second needle 19 and the tip 17a of the cylindrical sidewall 17 to potentially removably connect the second needle 19 of the second syringe element 14 and the cylindrical sidewall 17.

[0069] The first connecting element 16b and / or the second connecting element 19b may include a Luer lock.

[0070] The cylindrical body 13 defines a first end 13a and a second end 13b opposite to the first end 13a, and the first pin 16 may be removably constrained to the first end 13a. The second end 13b is the open end of the cylindrical body 13, through which the cavity 13c inside the cylindrical body 13 can be accessed during use.

[0071] On the other hand, the first end 13a is the end closed by the first needle 16, but it is in fluid communication with the cavity 13c and the inner cavity 16a of the first needle 16.

[0072] In at least one embodiment of the invention, the first end 13a has a tubular shape (e.g., cylindrical or truncated cone) with a cross-section such as a circle, and the first end 13a is fitted into a special seat for receiving the first connecting element 16b.

[0073] The plunger 15 slides airtightly inside the cylindrical body 13 and / or its cavity 13c.

[0074] The cylindrical sidewall 17 includes a tip 17a and a distal end 17b opposite the tip 17a, to which the second pin 19 may be removably secured. The distal end 17b is an open end of the cylindrical sidewall 17, through which the space 17c inside the cylindrical sidewall 17 can be accessed in use.

[0075] On the other hand, the tip 17a is one end closed by the second needle 19, but is in fluid communication with the space 17c and the inner cavity 19a of the second needle 19.

[0076] In at least one embodiment of the invention, the tip 17a has a tubular shape, such as cylindrical or truncated cone, for example having a circular cross-section, and the tip 17a is fitted into a special seat for receiving the second connecting element 19b.

[0077] Therefore, the first end 13a and the tip 17a each have connecting channels 13a' and 17a', which are respectively connected to the first inner cavity 16a of the first needle 16 and the second inner cavity 19a of the second needle 19, and are connected to the cavity 13c and the space 17c.

[0078] The piston 18 slides, for example, in a gas-sealed manner within the space 17c.

[0079] Contained within the cavity 13c and / or space 17c is at least one substance to be injected into the human body and / or at least one element 30 to be inserted into the human body (described in more detail below).

[0080] At least one substance and / or at least one component are propelled by plunger 15 and / or piston 18, respectively, through the inner cavity 16a of the first needle 16 and / or the inner cavity 19a of the second needle 19.

[0081] Although the piston 18 is generally of a known type in at least one embodiment of the invention, the plunger 15 is unique according to the invention.

[0082] Specifically, the plunger 15 has a head 15a that is adapted to contact the first end 13a of the cylindrical body 13 internally during use when the head 15a is fully inserted into the cavity 13c and / or the cylindrical body 13.

[0083] Head 15a faces the first stitch 16.

[0084] Furthermore, the plunger 15 has a rod portion 15b. The rod portion 15b is hollow and / or includes an internal channel 22. The channel 22 is a passage from the head 15a of the plunger 15 to its end 21.

[0085] The plunger 15 and / or the head 15a of the plunger 15 includes a bladder or washer 20. The bladder or washer 20 is typically made of rubber, and / or has a generally conical shape, or in any case corresponds to the inner region of the cylindrical body 13 at its first end 13a.

[0086] The bladder or gasket 20 is hermetically sealed in such a way that the bladder or gasket 20 allows the plunger 15 to slide inside the cavity 13c of the cylindrical body 13, but at the same time, the bladder or gasket 20 prevents the solution contained in the cavity 13c from flowing out from the side of the bladder or gasket 20.

[0087] When the plunger 15 is fully inserted into the cavity 13c of the cylindrical body 13, the head 15a and / or the bladder or washer 20 contact the first end 13a of the cylindrical body 13 internally, causing the solution inserted into the cavity 13c to flow completely out of the first needle 16. This configuration is, for example, in... Figure 4 , Figure 5A and Figure 5B As can be seen in the text.

[0088] In this configuration, except for the end portion 21, the rod portion 15b is almost entirely contained within the cavity 13c. As can be seen from these figures, the end portion 21 is shaped to allow gripping and / or movement, for example, by two fingers of an operator, and the end portion 21 is, for example, flanged.

[0089] As described above, the rod portion 15b of the plunger 15 has a hollow internal channel 22.

[0090] Such an internal channel 22 is arranged coaxially with the rod 15b, and / or is positioned parallel to and / or coaxially with respect to the longitudinal direction of the first syringe element 12 and / or the sliding direction of the plunger 15.

[0091] Such an internal channel 22 is shaped to allow the second syringe element 14 to be received therein and / or in the recess defined therein. Thus, the internal channel 22 is configured to allow the second syringe element 14 to be inserted therein and subsequently withdrawn.

[0092] In particular, in at least one embodiment of the invention, the internal channel 22 has a configuration corresponding to and / or complementary to that of the second syringe element 14, but slightly larger in size to allow the second syringe element 14 to move and / or be accommodated, possibly removably.

[0093] The size of the internal channel 22 will not excessively exceed the size of the second syringe element 14, because the internal channel 22 must serve as a guide for the insertion and / or reception and / or withdrawal of the second syringe element 14. In fact, in use, for example... Figure 8A As shown, when the second syringe element 14 is accommodated in the first syringe element 12, in order to perform the operation of the kit according to the invention, the second needle 19 is at least partially inserted into the connecting channel 13a' of the first end 13a of the cylindrical channel 13 or into the connecting element 16b. Therefore, it is clear that in order to allow such proper insertion, the second syringe element 14 must be suitably accommodated within the internal channel 22 of the plunger 15 of the first syringe element 12. For example, in Figure 6 and Figure 7 This type of format is also shown in the text.

[0094] In order to penetrate into the connecting channel 13a' and / or into the first connecting element 16b, the second needle 19 pierces the bladder or washer 20 of the rod portion 15b of the plunger 15.

[0095] For example, it can be observed in these figures that the second needle 19 (at least partially), the second connecting element 19b, at least a portion of the cylindrical sidewall 17, and therefore at least a portion of the piston 18 contained within the cylindrical sidewall 17 are housed inside the channel 22.

[0096] In at least one embodiment of the invention, at the connection with the bladder or washer 20, a corresponding end of the head 15a and / or the rod 15b of the plunger 15 may have a gap or hole 23, which allows the second needle 19 to pass through and reach the bladder or washer 20 to pierce the bladder or washer 20 and continue its movement toward the first needle 16.

[0097] This is Figure 9 This can also be seen in the details.

[0098] In any case, the seal of the plunger 15 is guaranteed by the presence of the bladder or gasket 20.

[0099] When the first syringe element 12 and the second syringe element 14 of the kit 10 are assembled in this manner, the piston 18 of the second syringe element 14 can be pressed, allowing the substance contained in the space 17c to flow out through the second needle 19 and then through the first needle 16. Therefore, when injecting the substance (or the first substance) contained in the first syringe element 12, or when the first syringe element 12 aspirates any possible biological fluid, precise injection of the substance (or the second substance) contained in the second syringe element 14 is ensured.

[0100] In the latter case, as described above, the plunger 15 will be positioned at the first end 13a of the cylindrical body 13, away from the first syringe element 12. Therefore, in order to reach the first needle 16, the second needle 19 can have sufficient length (e.g., Figure 16 (It can be observed) or there may be a system, such as an aspiration system, for discharging the liquid aspirated into the human body by the first needle 16, thereby enabling the head 15a of the plunger 15 to approach the first end 13a of the first syringe element 12, and thus allowing the second needle 19 to reach the vicinity of the first needle 16 and perform the injection of the substance contained in the second syringe element 14.

[0101] The piston 18 of the second injector element 14 is provided with a rod 24. When the sole purpose of the rod 24 is to pass through the space 17c and eject the substance present in the second injector element 14, the rod 24 may be solid and may be of conventional type.

[0102] Alternatively, the rod 24 may be hollow and contain at least one element 30, which will be better described below.

[0103] The head 18a of the piston 18 has a configuration substantially complementary to the internal configuration of the tip 17a and / or the connecting channel 17a' of the tip 17a of the cylindrical sidewall 17, so as to squeeze all the material contained in the second syringe element 14 and / or the space 17c and cause it to flow out from the second needle 19.

[0104] As shown in the figure, and in at least one embodiment of the invention, the plunger 15 and / or its rod 15b has a generally tubular portion 25a with a circular cross-section, and at the head 15a, an internally hollow conical or truncated conical portion 25b associated with the tubular portion 25a. The base of the conical or truncated conical portion 25b coincides with one of the bases of the generally tubular portion 25a. The internal channel 22 of the rod 15 is formed by the internal space of the generally tubular portion 25a and by the internal space of the conical or truncated conical portion 25b. The internal space of the conical or truncated conical portion 25b is particularly suitable for suitably accommodating the second connecting element 19b of the second syringe element 14.

[0105] On the other hand, at the top region of the conical or truncated conical portion 25b, there is a disc-shaped portion 25c, which serves as a base for supporting and constraining the bladder or washer 20.

[0106] The top region of the conical or truncated conical portion 25b and the disc-shaped portion 25c may include a gap or hole 23 for the second needle 19 to pass through.

[0107] Considering the properties of the material used to make the rod of plunger 15, this gap or hole 23 can be used to facilitate the passage of the second needle 19.

[0108] In fact, the first syringe element 12 is made almost entirely of a deformation-resistant plastic material (except for the first needle 16 and the bladder or washer 20) to perform its substance injection or aspiration function. The first needle 16 and the second needle 19 are made of a metallic material. The bladder or washer 20 is made of a durable but deformable material, thus suited to allow for the sliding of the plunger 15 and the possibility of being punctured by the second needle 19.

[0109] Even the second syringe element 14 is made almost entirely of a deformation-resistant plastic material (except for the second needle 19 and possibly a bladder or gasket) in order to perform its substance injection or aspiration function.

[0110] In at least one embodiment of the invention, apart from the connecting channel 13a', the shape of the bladder or gasket 20 is substantially complementary to the internal shape of the first end 13a of the cylindrical body 13.

[0111] In one embodiment of the invention, such as Figure 10A , Figure 10B , Figure 10C , Figure 11A and Figure 11B As shown, the plunger 15 of the first syringe element 12 has a stop element 26. This stop element 26 is a removal prevention element for the plunger 15, so that the plunger 15 will not be mistakenly removed from the cylindrical body 13 of the first syringe element 12.

[0112] like Figure 11A and Figure 11B As shown in the details, this stop element 26 is essentially annular. It comprises a plurality of flaps 26a, which may be flexible, arranged at the junction between the bladder or washer 20 and the head 15a of the plunger 15. These flaps 26a are arranged annularly around the head 15a. Each flap 26a extends from the head 15a of the plunger 15 toward the outside of the plunger 15 and faces the end 21 of the plunger 15.

[0113] Multiple flaps 26a separate each flap from its adjacent flap in this stop element 26. In this way, a space or gap 26b is created between one flap and another, and this allows the flaps 26a to bend and / or move and / or change position if the plunger 15 moves toward the first end 13a or the second end 13b of the cylindrical body 13.

[0114] Specifically, if the plunger 15 is pressed against the first end 13a of the cylindrical body 13, the vane 26a will be pressed against the rod portion 15b, allowing the plunger 15 to slide in such a direction; therefore, on the other hand, when the plunger 15 is pulled towards the second end 13b of the cylindrical body 13, the vane 26a will be pushed against the inner wall of the cylindrical body 13, thereby performing the stopping and / or anti-removal function performed by the stop element 26.

[0115] Furthermore, the fact that the stop element 26 is shaped in this way allows it to be adapted to the variable inner diameter of the cylindrical body 13 and / or the first syringe element 12. Naturally, the diameter of the stop element 26 can vary depending on the inner diameter and / or capacity of the cylindrical body 13 of the first syringe element 12.

[0116] The larger diameter of the stop element 26 (determined by the free end of the vane 26a) is slightly larger than the diameter of the head 15a of the bladder or washer 20 and / or plunger 15. In any case, assuming the vane 26a is flexible, the larger diameter of the stop element 26 is variable.

[0117] The flexibility of the stop element 26 can be given by the presence of the space or gap 26b between one winglet and another, or by the flexibility of the material used to manufacture the winglet 26a, or by a combination thereof.

[0118] from Figure 11A and Figure 11B As can be seen, the plurality of blades 26a are substantially cuboid in shape, possibly having beveled edges or their free ends being substantially round or curved, but other shapes may also be provided. The plurality of blades 26a are arranged substantially along the circumference of the bladder or washer 20, for example forming a ring of blades 26a. In this way, the plurality of blades 26a substantially protrude from the bladder or washer 20 and / or from the head 15a of the plunger 15.

[0119] Furthermore, there is an annular hollow region 26c disposed between the plurality of vanes 26a and the head 15a of the plunger 15. This annular hollow region 26c allows the vanes 26a to move toward the head 15a of the plunger 15, thereby enabling the anti-removal function of the stop element 26.

[0120] Figure 12A , Figure 12B , Figure 12C and Figure 12DDifferent types of stop element 126 are shown.

[0121] The stop element 126 has the same function as the stop element 26, but is shaped to form a ring nut 126a.

[0122] The ring nut 126a is approximately ring-shaped and has a circular cross-section (in Figure 12E and Figure 12F (See image). The annular nut 126a is accommodated between the bladder or washer 20 and the head 15a of the plunger 15, and / or the annular nut 126a is fitted at the tip region of the conical or truncated conical portion 25b of the rod portion 15b of the plunger 15.

[0123] The annular nut 126a of the stop element 126 has a cutout 126b, which is, for example, transverse and / or oblique, such as... Figure 12F As shown.

[0124] In this way, the ring nut 126a has an open-loop configuration, and / or the ring nut 126a can adapt to the variable inner diameter of the cylindrical body 13 of the first syringe element 12.

[0125] Naturally, the diameter of the annular nut 126a can vary depending on the different capacity and / or different inner diameter of the first syringe element 12.

[0126] Similarly, as shown by the flap 26a of the stop element 26, the annular nut 126a allows the plunger 15 to slide toward the first end 13b of the cylindrical body 13, while the stop element 126 prevents the piston 15 from being removed from the cylindrical body 13 due to the annular nut 126a as the plunger 15 moves away from the first end 13c. In fact, the notch 126b determines that the total diameter of the annular nut 126a changes as the plunger 15 moves (this diameter decreases during the plunger 15's advance and increases during the piston removal, effectively preventing the plunger 15 from exiting the cylindrical body 13).

[0127] In at least one embodiment of the invention, the stop elements 26, 126 are positioned distally relative to the bladder or washer 20, i.e., arranged between the bladder or washer 20 and the rod portion 15b of the plunger 15.

[0128] Therefore, as can be seen from the above description, in order to perform the desired function, the second syringe element 14 is coaxial with the first syringe element 12, and / or with the internal channel 22 of the rod 15b of the plunger 15 of the first syringe element 12. Similarly, the second needle 19 is coaxially generated at the insertion direction of the first needle 16, thereby allowing the injection of the substance contained in the second syringe element 14 precisely at the injection point of the first needle 16 of the first syringe element 12.

[0129] Therefore, the presence of the coaxiality and / or at least the hollow internal channel 22 of the rod portion 15b of the plunger 15 ensures the alignment of the second needle 19.

[0130] When the plunger 15 is at least partially housed in the cylindrical body 13 (first chamber), an inner chamber is formed in the cavity 13c between the cylindrical body 13 and the plunger 15, and / or when the plunger 18 is at least partially housed in the cylindrical sidewall 17 (second chamber), an inner chamber is formed in the space 17c between the cylindrical sidewall 17 and the plunger 18. In at least one embodiment of the invention, at least one substance present in the inner chamber is inserted into the corresponding first syringe element 12 and / or second syringe element 14 before use.

[0131] For example, surfactants must, in fact, form a foam before injection. Similarly, cyan acrylic glue (Loctite-Attak) or other adhesives polymerize rapidly upon contact with moisture, and therefore must be loaded into the second syringe element 14 just before use.

[0132] To allow operation of the kit according to the invention, in at least one embodiment (not shown), the first syringe element 12 may include a puncturable membrane disposed at a first end 13a of the cylindrical body 13. This puncturable membrane is adapted to be punctured by a second needle 19 of the second syringe element 14, allowing a second medical substance to be injected into the injection site of the first needle 16.

[0133] Furthermore, this puncture-resistant membrane is adapted to allow fluid (e.g., a first medical substance, if present) to flow only in the extrusion or injection direction, and not in the opposite suction direction, in order to prevent leakage of the second medical substance at a site other than the injection site during the injection step.

[0134] In at least one embodiment of the invention, there is at least one cap for covering and protecting the first needle 16 and / or the second needle 19.

[0135] like Figure 14 As shown, another form of the kit is such that the first syringe element 12 (shaped essentially as described above) contains the substance to be injected into the human body, while the second syringe element 14 includes at least one element 30. In this case, the rod 24 of the piston 18 is hollow, allowing the element 30 (in the form of the device listed above) to be inserted into and accommodated therein. For example, Figure 14A second component 14 is shown (shown in the upper part and right side of the figure), which includes an element 30 in the form of an optical fiber and / or laser suitable for, for example, heating and / or transferring heat to an injection point on the human body. Also visible is another second component 14 (shown in the middle and right side of the figure) including an element 30 in the form of a tube for transferring steam and / or heat, or a second component 14 including an element 30 in the form of a radio frequency device or antenna (shown in the lower part and right side of the figure).

[0136] At least one element 30 has an extended shape and a very small (relative to its length) thickness or cross section so that it can pass through the second needle 19 and / or the first needle 16.

[0137] For example, this type of kit is useful when it is necessary to transfer heat and / or moisture in the form of steam to the injection site of a first substance (such as glue or adhesive), or when it is necessary to dispense a different sealant than the first dispensing substance at such a point.

[0138] In this way, the second syringe element 14 serves as a carrier for at least one element 30.

[0139] At least one element 30, such as, for example Figure 14 The laser fiber or steam pipe shown utilizes the coaxiality of the system to accurately transfer, for example, heat (laser or steam) to the desired point.

[0140] like Figure 14 As shown, at least one element 30 is at least partially inserted into and / or accommodated inside the rod portion 24 of the piston 18, passing through the second needle 19 to reach the vicinity of the first needle 16 of the first syringe element 12 (when the second syringe element 14 is accommodated inside the first syringe element 12), and at least one element 30 can only be partially inserted into and / or accommodated in the first needle 16.

[0141] To achieve this, as described above, the second needle 19 pierces the plunger 15 and / or bladder or washer 20 of the first syringe element 12 to allow at least one element 30 to reach the vicinity of the first needle 16. Alternatively or additionally, the second needle 19 passes through a gap or hole 23 present in the plunger 15. Only after the second needle 19 has passed through the plunger 15 is at least one element 30 (in the form of a fiber or tube) pushed toward the first end 13a of the cylindrical body 13, passing through the second needle 19 and at least partially through the first needle 16. Once close to the injection site, at least one element 30 can perform its function, such as, for example, transmitting heat, which, in at least one application, may have thrombotic properties relative to the vein wall to be treated.

[0142] In order to reach and pass through the second needle 19, at least one element 30 can pierce the head 18a of the piston 18 of the second syringe element 14 in turn (e.g., by a piercing element disposed at the inner end of at least one element 30), or pass through a hole or channel specifically provided at the head 18a of the piston 18 (which may be initially properly positioned and can be closed by a ruptureable membrane pierced by at least one element 30).

[0143] In use, the present invention also provides a method for using kit 10 and / or for injecting and / or inserting at least one substance and / or at least one element, the method comprising the steps of: providing a first syringe element 12 and at least one second syringe element 14, providing at least one substance, and inserting or loading the at least one substance into the first syringe element 12 and / or at least one second syringe element 14.

[0144] The next step is to position the first syringe element 12 at an injection site on the human body (such as, for example, varicose veins to be treated), inject at least one substance (or a first substance) at the injection site using the first syringe element 12, or aspirate fluid, such as a biological fluid, from the injection site using the first syringe element 12.

[0145] The next step is to position the plunger 15 at the end of the stroke position at the first end 13a of the cylindrical body 13 of the first injector element 12 (potentially injecting the substance contained therein into the injection site) and to insert the second injector element 14 into the hollow internal channel 22 of the rod portion 15b of the plunger 15 of the first injector element 12. Such insertion is performed along a direction coaxial with the internal channel 22 of the cylindrical body 13 and / or the first injector element 12 and / or the rod portion 15b of the plunger 15.

[0146] This insertion is performed such that the second needle 19 of the second syringe element 14 is at least partially inserted into the first end 13a of the cylindrical body 13 and / or the first connecting element 16b of the first needle 16.

[0147] At this time, at least one substance (or a second substance) loaded into the second syringe element 14 can be loaded through the first needle 16 of the first syringe element 12.

[0148] If the first syringe element 12 aspirates liquid or fluid present at the injection site, a second syringe element 14 is first inserted to aspirate the aspirated liquid or fluid present inside the cylindrical body 13 of the first syringe element 12. Once this step is completed, another second syringe element 14 is inserted, thereby continuing to inject at least one substance loaded into the second syringe element 14 into the injection site.

[0149] Then, the piston 18 of the second syringe element 14 is transported and / or pushed in the direction of the second needle 19.

[0150] Alternatively, if the biological fluid is aspirated from a human body part, the method involves aspirating the fluid via the first syringe element 12, at least partially removing the plunger 15 from the cylindrical body, thereby creating a vacuum within the cavity 13c for aspirating the biological fluid in use. Then, a second syringe element 14 with a second needle 19 is provided (e.g., ...). Figure 16 As shown), the second needle 19 is sized to reach the vicinity of the first needle 16 (although the plunger 15 is in a position removed relative to the first end 13a of the cylindrical body 13) so that the substance contained in the second syringe element 14 can be injected into the aspiration site performed by the first needle 16. Alternatively, the following steps can be provided: connecting a system (e.g., an aspiration system) to the first syringe element 12 to remove the liquid aspirated by the first needle 16 from the first syringe element 12, thereby enabling the head 15a of the plunger 15 to approach the first end 13a of the first syringe element 12, and thus allowing the second needle 19 to reach the vicinity of the first needle 16 and perform the injection of the substance contained in the second syringe element 14.

[0151] Naturally, in order to operate the kit of the present invention, the length of the cylindrical body 13 of the first syringe element 12 is equal to or less than the length of the second syringe element 14, such that when the plunger 15 is fully inside the cylindrical body 13 and when the second syringe element 14 is located in the plunger 15, the operator can actuate the piston 18 from the outside (e.g., Figure 6 A and Figure 6 (as shown in B).

[0152] During the step of inserting the second syringe element 14, the second needle 19 pierces the plunger 15 (and / or a portion thereof and / or its head 15a and / or a puncturable membrane) and / or the bladder or washer 20, and / or the second needle 19 passes through the gap or hole 23 of the plunger 15.

[0153] refer to Figure 15 According to another type, a kit for subsequently injecting a substance into the human body is indicated by reference numeral 100. Components corresponding to the previous type are indicated by the same reference numerals plus 100.

[0154] Compared to the previous model, Kit 100 requires assembling the components together to provide a compact and quick-to-use solution. Furthermore, it remains an easy-to-operate model that can be used by non-professionals.

[0155] Kit 100 includes a first syringe element 112. In contrast to the previous type, the first syringe element 112 stably and permanently (e.g., in a constrained manner) accommodates a second syringe element 14 therein. Therefore, kit 100 can be said to also include the second syringe element 114. As described above, the second syringe element 114 is stably and permanently constrained to the first syringe element 112.

[0156] The first syringe element 112 contains at least two substances, such as a first medical substance and a second medical substance, the first medical substance being, for example, a biocompatible surfactant, and the second medical substance being, for example, a biocompatible adhesive of the type described above, or the same medical substance, but present in two different doses or densities.

[0157] Specifically, as indicated in the first type, the first syringe element 112 includes an internally hollow cylindrical body 113, a plunger 115 (or a first piston 115), and a first needle 116.

[0158] The plunger 115 slides airtightly inside the cylindrical body 113 along the longitudinal direction specifically defined by the cylindrical body 113.

[0159] Specifically, the plunger 115 has a head 115a, which, in use, is adapted to contact the first end 113a of the cylindrical body 113 internally when the head 115a is fully inserted into the cavity 113c and / or the cylindrical body 113.

[0160] The head 115a faces the first stitch 116 or the second stitch 119.

[0161] The second syringe element 114 includes a piston 118 (or a second piston 118) and a second needle 119.

[0162] The second syringe element 114 shares a cylindrical body 113 with the first syringe element 112. Therefore, unlike the first syringe element 112, the second syringe element 114 does not include its own walls, but is essentially composed of a piston 118 and a second needle 119. A rod portion 115b is present for actuating the plunger 115 and the piston 118; this rod portion 115b can be said to belong to both the first syringe element 112 and the second syringe element 114.

[0163] Therefore, kit 100 essentially includes a first cylindrical body 113, a plunger 115, a first needle 116, a piston 118, a second needle 119, and a rod 115b, obviously in addition to at least one medical substance contained therein (in addition to the sealing and connecting elements described below).

[0164] Inside the first syringe element 112 (and / or cylindrical body 113), the presence of the plunger 115 and piston 118 defines two spaces or chambers (in detail, such as the first cavity 113c and the space 117c) in which two medical substances can be contained.

[0165] In detail, the first cavity 113c is arranged between the plunger 115 and the first end 113a of the cylindrical body 113, while the space 117c is arranged between the plunger 115 and the piston 118.

[0166] Specifically, the first medical substance is present in the first cavity 113c, while the second medical substance is present in the space 117c.

[0167] Therefore, the piston 118 has a head 118a that contacts the second medical substance and a base surface 118b that is externally opposite the head 118a during use. During use, a rod 115b is connected to the base surface 118b, and when both the first and second medical substances are present, the rod 115b is adapted to be actuated to allow dispensing of at least one or both medical substances.

[0168] The first needle 116 and the second needle 119 are hollow inside and / or respectively include a first inner cavity and a second inner cavity, the first inner cavity and the second inner cavity may be fluidly connected and / or may be coaxial.

[0169] Thus, a first connecting element may exist between the first pin 116 and the first end 113a of the cylindrical body 113, and / or a second connecting element may exist between the second pin 119 and the first end 113a of the cylindrical body 113, so as to removably connect the first pin 116 and / or the second pin 119 to the cylindrical body 113.

[0170] More specifically, the first needle 116 is externally connected to the first end 113a of the cylindrical body 113, while the second needle 119 is internally connected to the first end 113a. Therefore, the first needle 116 and the second needle 119 have opposite orientations.

[0171] Similar to the first embodiment of the present invention, the cylindrical body 113 has a second end 113b opposite to the first end 113a, and the second end constitutes the open end of the cylindrical body 113.

[0172] The plunger 115 slides inside the cavity 113c, while the piston 118 slides inside the space 117c. However, in the first operating step, it also slides inside the first cavity 113c.

[0173] The first end 113a has a connection channel therein that connects to the first cavity of the first needle 116, the second cavity of the second needle 119, and the cavity 113c.

[0174] In this further embodiment, the rod 115b can be hollow or solid.

[0175] In use, the operator applies a thrust to the lever 115b.

[0176] Therefore, the rod 115b is pushed toward the first needle 116, which effectively determines the outflow of at least one first medical substance contained in the cavity 113c.

[0177] Because space 117c is actually closed and filled with at least one second medical substance, space 117c is incompressible. When rod 115b is actuated, rod 115b pushes piston 118 and space 117c, thereby pushing plunger 115 toward first end 113a of first syringe element 112. Therefore, piston 118 and plunger 115 slide as a whole until plunger 115 reaches the vicinity of first end 113a of cylindrical body 113.

[0178] This is the first step in using kit 100.

[0179] Once the first medical substance has been completely or substantially completely dispensed, the plunger 115 is located inside the first end 113a of the first syringe element 112. In this way, the second needle 119, disposed inside the first end 113a, can pierce the plunger 115.

[0180] Therefore, in practice, while the tip of the first needle 116 is outside the first syringe element 112, the second needle 119 has a tip facing the interior of the cylindrical body 113 in order to dispense at least one medical substance at a target site on the human body. In particular, the tip faces the plunger 115.

[0181] Therefore, the length of the second needle 119 is greater than the thickness of the plunger 115 so that it can pierce the plunger 115 and penetrate into the space 117c.

[0182] When the plunger 115 approaches the second needle 119, the second needle 119 begins to pierce the plunger 115.

[0183] After piercing the plunger 115, assuming that the space 117c is no longer a closed space, the push rod 115b is still used to allow the piston 118 to move toward the plunger 115, and to dispense the second medical substance contained in the space 117c. Thus, in this second operational step, the second medical substance is precisely dispensed into the injection site of the first medical substance, as shown in the present invention.

[0184] The second medical substance is dispensed via the second needle 119 using the first needle 116.

[0185] In this case, except for the end portion 121, the rod portion 115b is almost completely contained within the cavity 113c.

[0186] The plunger 115 and / or the head 115a of the plunger 115 may include a bladder or gasket, as shown in the first embodiment of the invention of kit 10.

[0187] This bladder or gasket is hermetically sealed in the sense that it allows the plunger 115 to slide within the cavity 113c of the cylindrical body 113, but at the same time, it prevents the medical solution contained in the cavity 113c from leaking out from the side of the bladder or gasket. In this case, the second needle 119 punctures the bladder or gasket of the plunger 115.

[0188] In this type, the kit is filled with at least one substance at the factory, rather than by a doctor.

[0189] A similar bladder or gasket can also be provided for piston 118.

[0190] It is obvious that the present invention is suitable for operation due to the presence of the second needles 19 and 119, which are suitable for passing through the plungers 15 and 115 during use.

[0191] In one embodiment of the invention, plunger 115 may include a stop element, as described in kit 10 of the invention.

[0192] Therefore, it has been observed that by providing an easy-to-use and practical kit, the present invention can be adapted to specific surgical requirements, allowing for precise implantation even for injections following the first injection at the same injection site.

[0193] Without departing from the scope of protection outlined in the appended claims, the features described for the embodiments or variations may also exist in other embodiments or variations.

[0194] Without departing from the scope of the appended claims, the kits 10 and 100 according to the invention are readily subject to various modifications and variations.

Claims

1. A kit for injecting and / or inserting at least one substance in a fluid or liquid state into an injection site or insertion site of the human body, comprising a first syringe element and at least one second syringe element, wherein, The first syringe element includes a hollow cylindrical body, a plunger, and a first needle, wherein the plunger is adapted to slide within the cylindrical body during use, and the at least one second syringe element includes a piston and a second needle, wherein at least one substance and / or the at least one element is inserted into the cylindrical body and / or the second syringe element, characterized in that the second needle is adapted to pass through the plunger during use. The plunger includes a head and a rod, the head facing the first needle in use, the rod being hollow and / or including an internal channel therein, and / or the kit including the rod. Wherein, the first syringe element is adapted to at least partially accommodate the at least one second syringe element therein during use, and / or wherein the rod portion and / or the internal channel of the rod portion is adapted to at least partially accommodate the at least one second syringe element therein during use.

2. The kit according to claim 1, wherein, The internal channel is coaxial with the rod and / or with the first syringe element, and / or the internal channel has a configuration corresponding to and / or complementary to the configuration of the second syringe element, but slightly larger, to allow for removable reception of the second syringe element.

3. The kit according to claim 1, wherein, The plunger and / or the rod portion includes a generally tubular portion and a conical or truncated conical portion at the head, wherein the internal channel of the rod portion comprises both the generally tubular portion and the conical or truncated conical portion.

4. The kit according to claim 3, wherein, The plunger and / or the head of the plunger includes a bladder or washer, and a disc-shaped portion is present in the tip region of the conical or truncated conical portion facing the first needle, the disc-shaped portion serving as a base for supporting and constraining the bladder or washer.

5. The kit according to any one of claims 1-3, wherein, The first needle and the second needle are hollow inside, and / or each includes a first inner cavity and a second inner cavity, and the at least one substance can flow through the first inner cavity and the second inner cavity during use.

6. The kit according to any one of claims 1-3, wherein, The cylindrical body includes a first end to which the first needle is removably constrained, a cavity inside the cylindrical body, and a second end opposite to the first end, wherein the second end is open and for entering the cavity.

7. The kit according to any one of claims 1-3, wherein, The second syringe element includes an internally hollow cylindrical sidewall, the cylindrical sidewall including a tip, an internal space, and a distal end opposite the tip, the second needle being removably constrained to the tip, the internal space of the cylindrical sidewall for receiving the at least one substance, wherein the distal end is open and for access to the internal space, wherein the piston is adapted to slide within the cylindrical sidewall in use, and / or wherein the piston is adapted to slide within the cavity of the first syringe element in use.

8. The kit according to claim 4, wherein, The bladder or gasket is made of rubber and / or has a substantially conical construction or an internal region corresponding to the first end of the cylindrical body, and / or wherein the bladder or gasket is adapted to be pierced by the second needle in use.

9. The kit according to claim 8, wherein, At the bladder or washer, the head and / or the plunger and / or the disc-shaped portion and / or the conical or truncated conical portion have an opening or hole for the second needle to pass through in use.

10. The kit of claim 7, comprising a first connecting element and / or a second connecting element, the first connecting element removably connecting the first pin to the cylindrical body between the first pin and the cylindrical body, the second connecting element removably connecting the second pin to the cylindrical body or the cylindrical sidewall between the second pin and the cylindrical body or the cylindrical sidewall, and / or, wherein, The plunger includes an opening or hole at the head of the plunger, wherein the first connecting element is adapted to at least partially receive the second needle during use.

11. The kit according to any one of claims 1-3, wherein, The at least one substance is a medical substance, which is a biocompatible surfactant, a biocompatible adhesive, and / or a biocompatible bonding element. The biocompatible surfactant is a surfactant-curing drug, such as sodium tetradecyl sulfate traded under the names Fibro-Vein® or Trombovar®, or oxidized polyethoxylated dodecane traded under the names Atossisclerol® or Sotradecol®. The biocompatible adhesive is a cyanoacrylate-based biocompatible adhesive, such as a cyanoacrylate-based biocompatible adhesive traded under the name Loctite-Attak®.

12. The kit of claim 4, comprising a generally annular stop element adapted to at least partially prevent the plunger from being withdrawn from the cylindrical body during use, wherein, The stop element is placed at the head of the bladder or washer and / or the plunger.

13. The kit according to claim 12, wherein, The stop element includes a plurality of flaps, which may be flexible and arranged in a ring around the head if desired, and / or wherein each flap is outwardly away from the head relative to the plunger, and / or at the end facing the plunger and / or the second end of the cylindrical body in use, and / or wherein each flap is separated from each adjacent flap by a space or gap between the flaps, such that if the plunger moves toward the first end of the cylindrical body or toward the second end of the cylindrical body, each of the plurality of flaps flexes and / or moves and / or changes position.

14. The kit according to claim 13, wherein, The plurality of blades have free ends, and the stop element has a larger diameter at the free ends, the larger diameter being slightly larger than the diameter of the head of the bladder or washer and / or the plunger, and / or wherein an annular hollow region exists between the plurality of blades and the head of the plunger to allow the plurality of blades to bend and / or move toward the head.

15. The kit according to claim 12, wherein, The stop element has a generally annular ring nut including a cylindrical section, and / or an annular nut including a slit, the slit being transverse and / or inclined, such that the annular nut can adapt to the variable inner diameter of the cylindrical body of the first syringe element.

16. The kit according to claim 7, wherein, When the plunger is at least partially housed within the cylindrical body of the first syringe element, the at least one substance is housed in a first internal chamber formed in the cavity between the cylindrical body and the plunger, and / or, when the piston is at least partially housed within the cylindrical sidewall of the second syringe element, the at least one substance is housed in a second internal chamber formed in the space between the cylindrical sidewall and the piston, and / or, when both the plunger and the piston are housed within the cylindrical body of the first syringe element, the at least one substance is housed in a second internal chamber formed between the plunger and the piston.

17. The kit according to any one of claims 1-3, wherein, The second syringe element includes at least one element in the form of an optical fiber device, a laser optical fiber device, a device capable of transmitting and / or conveying steam or other suitable gas, a radio frequency device or antenna with a tubular structure, or a device capable of generating heat and / or radiating infrared or microwave radiation, wherein the at least one element has an elongated structure and is capable of being housed inside the piston, the second needle reaching the vicinity of the first needle or at least partially housed in the first needle, and / or wherein the at least one element includes a perforating element placed inside it to perforate the piston, and / or wherein the at least one element is capable of being housed in the hollow rod portion of the piston and housed or pushed into a channel present in the head of the piston.

18. The kit according to claim 6, wherein, The first syringe element includes a puncturable membrane located at the first end of the cylindrical body, wherein the puncturable membrane is adapted to be punctured by the second needle of the second syringe element, such that the second needle approaches the first needle.

19. The kit according to any one of claims 1-3, wherein, The first needle faces the outside of the first syringe element and / or toward the injection site during use, while the second needle faces the cavity of the cylindrical body during use, wherein the first needle and the second needle are coaxial.

20. A method of assembling a kit according to any one of claims 1 to 19 for injecting and / or inserting at least one substance and / or at least one element into an injection site or insertion site of the human body, comprising the following steps: A first syringe element is provided, comprising an internally hollow cylindrical body, a plunger, and a first needle, wherein the plunger is adapted to slide within the cylindrical body during use. At least one second syringe element is provided, the at least one second syringe element comprising an internally hollow cylindrical sidewall, a piston, and a second needle, wherein the piston is adapted to slide inward into the cylindrical sidewall during use. Provide at least one substance and / or at least one element, Insert or load the at least one substance and / or the at least one element into the cylindrical body and / or the cylindrical sidewall. The plunger is placed at the first end of the cylindrical body at the end of the stroke. The invention is characterized in that at least one second syringe element is at least partially inserted into the interior of the first syringe element and / or the hollow internal channel of the plunger and / or the rod portion of the plunger, such that the at least one second syringe element is at least partially accommodated within the interior of the first syringe element.

21. The method according to claim 20, wherein, The step of inserting at least one second syringe element at least partially into the interior of the first syringe element is performed along a direction coaxial with the internal channel of the cylindrical body and / or the first syringe element and / or the plunger.

22. The method of claim 20 or 21, comprising the step of perforating the first syringe element at least partially inside the first syringe element via a second bladder or washer for the plunger and / or the head of the plunger and / or a puncturable membrane of the first syringe element located at the first end of the cylindrical body during the step of inserting the at least one second syringe element into the first syringe element, and / or comprising the step of passing the second needle through an opening or hole present at the head of the plunger.

23. The method according to claim 20 or 21, wherein, The step of inserting or loading the at least one substance into the cylindrical body and / or the cylindrical sidewalls is performed immediately before use.

24. A method of assembling a kit for injecting at least one substance in a fluid or liquid state into an injection site of the human body according to any one of claims 1 to 19, comprising the steps of: A first syringe element is provided, comprising an internally hollow cylindrical body, a plunger, and a first needle, wherein the plunger is adapted to slide within the cylindrical body during use. At least one second syringe element is provided, the at least one second syringe element comprising a piston and a second needle, wherein the piston is adapted to slide within the cylindrical body during use. Provide a first substance and at least one second substance, The first substance is inserted or loaded between the plunger and the first end of the cylindrical body, or inserted or loaded into the cavity, and the at least one second substance is inserted or loaded between the plunger and the piston, or inserted or loaded into the space. The plunger is positioned at the first end of the cylindrical body at the end of the stroke. The characteristic feature is that, during the step of positioning the plunger at the end of the stroke, the second needle punctures the plunger.

25. The method of claim 24, further comprising the step of actuating the plunger and the piston via a rod, and / or, wherein, The step of positioning the plunger at the end of the stroke occurs by the rod acting on the piston.

26. The method according to claim 24 or 25, wherein, The plunger slides inside the cavity, while the piston slides inside the space and at least partially inside the cavity, and / or, wherein the piston and the plunger slide as a single body until the plunger approaches the first end of the cylindrical body.

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