PRE-FILLED SYRINGE HAVING AN ELASTIC AND SLIDING VALVULAR JOINT
20210170107 · 2021-06-10
Inventors
- Jaime Luis SZAPIRO (City of Buenos Aires, AR)
- Germán Andrés SZAPIRO (City of Buenos Aires, AR)
- Sául MORENO BONINO (Moreno, AR)
Cpc classification
A61M5/2448
HUMAN NECESSITIES
A61M5/3202
HUMAN NECESSITIES
A61M5/31513
HUMAN NECESSITIES
A61M2207/00
HUMAN NECESSITIES
A61M5/31511
HUMAN NECESSITIES
A61M5/286
HUMAN NECESSITIES
International classification
A61M5/315
HUMAN NECESSITIES
Abstract
Pre-filled syringes include an elastic and sliding valvular joint acting as a temporary closure to prevent internal chamber(s) from communicating with the outside (or between chambers). The joint includes two discoid cooperative elements: an elastic discoid cap and a sliding receiving discoid seat that has a central passage tube. The cap includes an elastic base from which a compact closing cylinder protrudes. The closing cylinder has a distal area with a plurality of longitudinal grooves. The cap can: (a) half-fit the central tube of the receiving discoid seat, which will allow the communication of fluid through the plurality of grooves, and (b) seal the chamber by completely fitting the central tube of the receiving discoid seat. Accordingly, the half-fit position allows the lyophilization of contents of the syringe.
Claims
1. A pre-filled syringe, comprising: a single internal chamber that stores a product to be injected; an elastic and sliding valvular joint disposed within an interior of the pre-filled syringe, wherein the valvular joint acts as a temporary closure blocking communication between the internal chamber and a communication tube towards an injection needle of the pre-filled syringe; wherein the elastic and sliding valvular joint comprises two discoid cooperative elements arranged inside a main body of the syringe and with a perimeter edge of the valvular joint supported by a cylindrical surface of the main body; wherein a first one of the discoid cooperative elements is an elastic discoid cap, and a second one of the discoid cooperative elements forms a sliding discoid receiving seat on which the elastic discoid cap acts through a central passage tube; wherein the elastic discoid cap of the valvular joint comprises an elastic base, and a compact closing cylinder protrudes from an inner face of the elastic base, the compact closing cylinder having a proximal fit area and a distal area that comprises a plurality of longitudinal grooves; wherein the sliding discoid receiving seat includes the central passage tube facing the compact closing cylinder; wherein the elastic base of the elastic discoid cap has a smaller external diameter than an outer diameter of the sliding receiving discoid seat; and wherein, when the compact closing cylinder is inside the central passage tube of the sliding receiving discoid seat, the elastic base of the elastic discoid cap is fitted inside a circular cavity surrounded by the perimeter edge of the discoid seat, and wherein the valvular joint is configured to adopt two positions: (a) a half-fit position, wherein the external diameter in the proximal fit area of the compact closing cylinder is exposed and a portion of the distal area equivalent to an internal diameter of the central passage tube of the receiving discoid seat is half-fitted, permitting communication of fluid through the plurality of grooves on both sides of the valvular joint, and (b) a completely fit position, wherein the compact closing cylinder completely fits inside the central passage tube of the receiving discoid seat preventing the fluids on both sides of the valvular joint from communicating, and where the external diameter of the proximal fit area of the compact closing cylinder is equivalent to the internal diameter of the central passage tube of the receiving discoid seat, providing an adjusted fit.
2. The pre-filled syringe according to claim 1, wherein the communication of fluids through the plurality of grooves when the valvular joint is in the half-fitted position is configured to allow lyophilization of contents of the syringe with the valvular joint installed inside the syringe.
3. The pre-filled syringe according to claim 1, wherein a compact closing cylinder formed from the elastic base of the elastic discoid cap has a circular section.
4. The pre-filled syringe according to claim 3, wherein a quantity of the grooves in the distal area of the compact closing cylinder is from two to six.
5. The pre-filled syringe according to claim 4, where the quantity of grooves is exactly four.
6. The pre-filled syringe according to claim 3, wherein the external diameter of the proximal fit area is slightly larger than the inner diameter of the central passage tube of the sliding receiving discoid seat, providing an adjusted fit.
7. The pre-filled syringe according to claim 1, wherein the compact closing cylinder formed from the elastic base of the valvular cap includes in the proximal fit area a plurality of external annular flanges that are temporarily supported by the cylindrical surface that defines the central passage of the sliding receiving discoid seat, providing an adjusted fit.
8. The pre-filled syringe according to claim 1, wherein the discoid cooperative elements are arranged as a temporary closure that prevents the main body of the syringe from communicating internally with the communication tube towards the injection needle.
9. The pre-filled syringe according to claim 1, wherein the injection needle is pre-installed in an exit tube of the syringe.
10. The pre-filled syringe according to claim 1, wherein the cooperative discoid elements of the valvular joint comprise an elastomeric material.
11. A pre-filled syringe, comprising: two independent internal chambers containing respectively isolated products to be mixed before an injection; an elastic and sliding valvular joint disposed within an interior of the pre-filled syringe, wherein the valvular joint acts as a temporary closure blocking communication between the two internal chambers; wherein the elastic and sliding valvular joint comprises two discoid cooperative elements arranged inside a main body of the syringe and with a perimeter edge of the valvular joint supported by a cylindrical surface of the main body; wherein a first one of the discoid cooperative elements is an elastic discoid cap, and a second one of the discoid cooperative elements forms a sliding discoid receiving seat on which the elastic discoid cap acts through a central passage tube; wherein the elastic discoid cap of the valvular joint comprises an elastic base, and a compact closing cylinder extends from an inner face of the elastic base, the compact closing cylinder having a proximal fit area and a distal area that comprises a plurality of longitudinal grooves; wherein the sliding discoid receiving seat includes the central passage tube facing the compact closing cylinder; wherein the elastic base of the elastic discoid cap has a smaller external diameter than an outer diameter of the sliding receiving discoid seat; wherein, when the compact closing cylinder is inside the central passage tube of the sliding receiving discoid seat, the elastic base of the elastic discoid cap is fitted inside a circular cavity surrounded by a perimeter edge of the discoid seat, and wherein the valvular joint is configured to adopt two positions: (a) a half-fit position, wherein the external diameter in the proximal fit area of the compact closing cylinder is exposed and a portion of the distal area equivalent to an internal diameter of the central passage tube of the receiving discoid seat is half-fitted, permitting communication of fluid through the plurality of grooves on both sides of the valvular joint, and (b) a completely fit position, wherein the compact closing cylinder completely fits inside the central passage tube of the receiving discoid seat preventing the fluids on both sides of the valvular joint from communicating, and where the external diameter of the proximal fit area of the compact closing cylinder is equivalent to the internal diameter of the central passage tube of the receiving discoid seat, providing an adjusted fit.
12. The pre-filled syringe according to claim 11, further comprising a tip-cap seal configured to close a communication tube of the syringe towards an injection needle end of the communication tube.
13. The pre-filled syringe according to claim 11, wherein the elastic valvular joint delimits the two internal chambers, each one including a different one of the isolated products to be mixed, and at least one of the products is liquid.
14. The pre-filled syringe according to claim 13, wherein the elastic base of the elastic discoid cap of the elastic valvular joint is opposed to a head of a plunger.
15. The pre-filled syringe according to claim 11, wherein the cooperative discoid elements of the valvular joint comprise an elastomeric material.
16. The pre-filled syringe according to claim 11, wherein the communication of fluids through the plurality of grooves when the valvular joint is in the half-fitted position is configured to allow lyophilization of contents of the syringe with the valvular joint installed inside the syringe.
17. The pre-filled syringe according to claim 11, wherein a compact closing cylinder formed from the elastic base of the elastic discoid cap has a circular section.
18. The pre-filled syringe according to claim 17, wherein a quantity of the grooves in the distal area of the compact closing cylinder is from two to six.
19. The pre-filled syringe according to claim 18, where the quantity of grooves is exactly four.
20. The pre-filled syringe according to claim 17, wherein the external diameter of the proximal fit area is slightly larger than the inner diameter of the central passage tube of the sliding receiving discoid seat, providing an adjusted fit.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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[0066] It is further clarified that in all the figures the same reference numbers correspond to the same or equivalent parts or elements.
DETAILED DESCRIPTION
[0067] Various aspects and examples of an elastic and sliding valvular joint for pre-filled disposable syringes to maintain the contents therein completely isolated and sterile to prevent them from reaching the needle before the moment of the injection, as well as related methods, are described below and illustrated in the associated drawings. Unless otherwise specified, a syringe and/or valvular joint in accordance with the present teachings, and/or its various components, may contain at least one of the structures, components, functionalities, and/or variations described, illustrated, and/or incorporated herein. Furthermore, unless specifically excluded, the process steps, structures, components, functionalities, and/or variations described, illustrated, and/or incorporated herein in connection with the present teachings may be included in other similar devices and methods, including being interchangeable between disclosed embodiments. The following description of various examples is merely illustrative in nature and is in no way intended to limit the disclosure, its application, or uses. Additionally, the advantages provided by the examples and embodiments described below are illustrative in nature and not all examples and embodiments provide the same advantages or the same degree of advantages.
Definitions
[0068] The following definitions apply herein, unless otherwise indicated.
[0069] “Comprising,” “including,” and “having” (and conjugations thereof) are used interchangeably to mean including but not necessarily limited to, and are open-ended terms not intended to exclude additional, unrecited elements or method steps.
[0070] Terms such as “first”, “second”, and “third” are used to distinguish or identify various members of a group, or the like, and are not intended to show serial or numerical limitation.
[0071] “Coupled” means connected, either permanently or releasably, whether directly or indirectly through intervening components.
[0072] “Providing,” in the context of a method, may include receiving, obtaining, purchasing, manufacturing, generating, processing, preprocessing, and/or the like, such that the object or material provided is in a state and configuration for other steps to be carried out.
Description of Illustrative Embodiments
[0073] The pre-filled syringes of the present disclosure comprise a valvular joint that belongs to the group of those syringes that adapt to different body types of conventional syringes, whether single-chamber or double-chamber.
[0074] The constructive and functional design of this valvular joint takes into account (a) the condition of adapting to all types of conventional syringes as well as (b) the non-alteration of automatized processes for getting the products inside the syringe, especially for the cases of double-chamber pre-filled syringes, and also (c) the lack of special and/or complicated tasks demanded to the user when mixing and then injecting.
[0075] As depicted in
[0076] Element (3) is an elastic discoid cap that consists of an elastic discoid base (5) substantially formed in a cylindrical manner.
[0077] This elastic discoid cap (3) stands out especially because a compact closing cylinder (6), which is coaxial with the mentioned elastic discoid base (5), is formed and extends or protrudes from the internal face of elastic discoid base (5). The compact closing cylinder (6) has a proximal fit area (10) and a distal area that comprises a plurality of longitudinal grooves (9).
[0078] Element (4) of valvular joint (1) is a receiving discoid seat that includes a central passage tube (7) facing compact closing cylinder (6) in a way that elastic base (5) of elastic discoid cap (3) fits in a removable manner within the inner perimeter slot located in the opening of central passage tube (7) of sliding receiving discoid seat (4).
[0079] Sliding receiving discoid seat (4) was created in order for elastic discoid cap (3) to produce the closure or opening of valvular joint (1), acting as a cooperative receiving discoid seat. This element is also preferably circular, and it has a central passage tube (7) and a corresponding perimeter ring (8) thicker than the rest of the body of the element.
[0080] Elastic discoid cap (3) and sliding receiving discoid seat (4) of valvular joint (1) are cooperative elements because they act together to perform the valvular closure and opening.
[0081] To this extent, elements (3) and (4) are overlapped and aligned between them inside the syringe; so that the mentioned closing cylinder (6) perfectly fits the interior of central passage tube (7) generating the hermetic closure that prevents the products contained inside syringe (2) previously filled from moving through the tube. The proper fit inside central passage tube (7) is obtained through a bigger diameter of closing compact cylinder (6).
[0082] The elastic base (5) of elastic discoid cap (3) has a smaller diameter than the one from elastic discoid cap (3), and when compact closing cylinder (6) is inside central passage tube (7) of receiving discoid seat (4), elastic base (5) of elastic discoid cap (3) is fitted inside a circular cavity surrounded by perimeter ring (8) of receiving discoid seat (4) that forms a thicker cord.
[0083] In this manner, elastic discoid cap (3) of valvular joint (1) can adopt two positions: (a) half-fit, where the external diameter in the proximal area of fit (10) of compact closing cylinder (6) is exposed and the distal area equivalent to the internal diameter of central passage tube (7) of receiving discoid seat (4) is half-fitted, which will allow the communication of fluid through the plurality of grooves (9) on both sides of the valvular joint (1); and (b) completely fit, when compact closing cylinder (6) completely fits inside central passage tube (7) of receiving discoid seat (4) preventing the fluids on both sides of valvular joint (1) from communicating, and where the external diameter of proximal fit area (10) of compact closing cylinder (6) is equivalent to the internal diameter of central passage tube (7) of receiving discoid seat (4) providing an adjusted fit.
[0084] In some examples, the bigger diameter of compact closing cylinder (6) is obtained by a plurality of external annular flanges (11) that are temporary supported by the cylindrical surface that defines central passage tube (7) of sliding receiving discoid seat (4).
[0085] As depicted in
[0086] Indeed, in
[0087] By means of an upper closing cap (16), also known as “tip-cap”, which is in an exit tube (17) of syringe (2), it is possible to guarantee the airtightness and hence, the isolation of the commercial product to be injected.
[0088] Syringe (2) comprises its corresponding needle (18) of injection, which is covered by a protective sheath (19) that usually accompanies the commercial product in its container.
[0089] In
[0090] Furthermore, lower chamber (13) is delimited in its upper part by the same valvular joint (1), by the internal face of the cylindrical wall of the main body of syringe (2) and by a head (20) of a plunger (21), containing the second product (15) duly isolated.
[0091] In the conditions mentioned above, as depicted in
[0092] Once the joint is initially formed,
[0093] For this purpose the user moves head (20) of plunger (21) in the direction (FI) of the injection, generating pressure on the proximate lower chamber (13). This consequently produces the movement of elastic discoid cap (3) fitted in receiving discoid seat (4), being partially disengaged, and hence liberating the communication between both upper and lower chambers (12) and (13). This is possible because when the movement occurs, product (14) flows through grooves (9) of elastic discoid cap (3).
[0094] To facilitate obtaining a solution (22) of the injection, it is preferable that the user vigorously shakes syringe (2). Solution (22) is duly isolated from the outside by closing cap (16).
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[0096] It is emphasized that the elastic discoid plug (3) is kept always half-fitted in central passage tube (7) of receiving discoid seat (4), and the communication between both internal chambers (12) and (13) is kept through grooves (9) during the actions to obtain solution (22) to be injected.
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[0098] The pressure (FI) made from plunger (21) makes compact closing cylinder (6) of elastic discoid cap (3) change to a half-fitted position in central passage tube (7). This is why valvular joint (1) works together during the injection of the content of syringe (2), and in which case it does not affect the flow of fluid. This occurs because the fluid flows perfectly and completely through grooves (9) because elastic discoid cap (3) is half-fitted in tube (7).
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[0101] Indeed, for these cases valvular joint (1) formed by elements (3) and (4) is placed in elastic discoid cap (3) facing plunger (21) of syringe (2) and closing the internal communication of syringe (2) with exit tube (17) of syringe (2), in such a manner that only chamber (23) is delimited by valvular joint (1) as an upper base, and by the cylindrical wall of the main body of syringe (2) and head (20) of plunger (21) as a lower base according to
[0102] In this case, the user also moves plunger (21) in the opposite direction (F) of the injection, producing an internal depression that generates the elastic deformation of elastic discoid cap (3), and hence the movement of compact closing cylinder (6). This opens a communication through its grooves (9) when changing to a half-fitted position in central passage tube (7), according to
[0103] In both cases mentioned above, whether the pre-filled syringe (2) has two chambers (12) and (13) or a single chamber (23), the internal communication of syringe (2) through exit tube (17) is initially and necessarily blocked by an upper tip-cap (16), which is located in exit tube (17) of syringe (2), while needle (18) of the injection is inside protective sheath (19) and separated from syringe (2) inside its corresponding packaging.
[0104] In the market there are pre-filled syringes (2), which are commercialized with needle (18) being previously installed in their exit tube (17). The syringes (2) may have two chambers (12) and (13) or one single chamber (23) to contain two separate products that are mixed to obtain either one solution (22) to be injected, or one injectable solution (24), respectively. In the case of double-chamber syringes, the exit of the liquid to be injected towards the previously installed needle is through the valvular closing cap. This is described in Argentine patent AR 250777 V1, entitled “VALVULAR SAFETY CAP APPLICABLE TO DISPOSABLE PRE-FILLED SYRINGES.”
[0105] In some embodiments, valvular joint (1) can be used in a pre-filled syringe (2) of the present disclosure in a form different to what has been described herein. That is to say, cap (3) of valvular joint (1) is facing head (20) of the plunger of syringe (2), making the necessary adjustments for the correct functioning.
Illustrative Combinations and Additional Examples
[0106] This section describes additional aspects and features of syringes of the present disclosure, presented without limitation as a series of paragraphs, some or all of which may be alphanumerically designated for clarity and efficiency. Each of these paragraphs can be combined with one or more other paragraphs, and/or with disclosure from elsewhere in this application, in any suitable manner. Some of the paragraphs below expressly refer to and further limit other paragraphs, providing without limitation examples of some of the suitable combinations.
[0107] A0. A pre-filled syringe (2) with a single internal chamber (23) that stores the product to be injected, or with two independent internal chambers (12 and 13) that contain respectively isolated products (14 & 15), which have to be mixed before the injection, that comprise an elastic and sliding valvular joint (1) suitable to act in the interior of the pre-filled syringe (2), where the valvular joint (1) acts as a temporary closure blocking the communication between the internal chamber (23) and the communication tube (17) towards the injection needle (18), or between the two internal chambers (12 and 13). The joint (1) comprises two discoid cooperative elements (3 and 4) arranged inside the main body of the syringe (2) and with its perimeter edge supported by its cylindrical surface. While one of the elements is an elastic discoid cap (3), the other forms a sliding discoid receiving seat (4) on which the cap (3) acts through a central passage tube (7), where the perimeter edges of the sliding discoid receiving seat (4) forms a cord, which is thicker and less elastic that the rest of the body of the discoid seat (4). The pre-filled syringe (2) is characterized because the elastic discoid cap (3) of the valvular joint (1) comprises an elastic base (5) and from its inner face a compact closing cylinder (6) is formed with a distal area that comprises a plurality of longitudinal grooves (9) and a proximal fit area (10), while the sliding discoid receiving seat (4) includes a central passage tube (7) facing the compact closing cylinder (6) in such a way that the elastic base (5) of the discoid cap (3) fits in a removable manner within the inner perimeter slot located in the opening of the central passage tube (7) of the sliding receiving discoid seat (4), where the elastic base (5) of the elastic discoid cap (3) has a smaller diameter than the one from the sliding receiving discoid seat (4). And when the compact closing cylinder (6) is inside the central passage tube (7) of the sliding receiving discoid seat (4), the elastic base (5) of the elastic discoid cap (3) is fitted inside a circular cavity surrounded by the perimeter edge (8) of the discoid seat (4) that forms the thicker cord, and which can adopt two positions: (a) half-fit, where the external diameter in the proximal area of fit (10) of the compact closing cylinder (6) is exposed and the distal area equivalent to the internal diameter of the central passage tube (7) of the receiving discoid seat (4) is half-fitted. This allows the communication of fluid through the plurality of grooves (9) on both sides of the valvular joint (1), and (b) completely fit when the compact closing cylinder (6) completely fits inside the central passage tube (7) of the receiving discoid seat (4) preventing the fluids on both sides of the valvular joint (1) from communicating, and where the external diameter of the proximal fit area (10) of the compact closing cylinder (6) is equivalent to the internal diameter of the central passage tube (7) of the receiving discoid seat (4) providing an adjusted fit. The cooperative discoid elements (3 and 4) of the valvular joint (1) are manufactured with an elastomeric material either by injection or compression.
[0108] A1. The pre-filled syringe (2) according to A0, wherein the communication of fluids through a plurality of grooves (9) when the valvular joint (1) is in a half-fitted position (a) allows the lyophilization of the content of the syringe with the valvular joint (1) installed inside the syringe (2).
[0109] A2. The pre-filled syringe (2) according to A0 or A1, wherein a compact closing cylinder (6) formed from the elastic base (5) of the elastic discoid cap (3) has a circular section, where the quantity of grooves (9) of the plurality of grooves from the distal zone of the compact closing cylinder (6) is from two to six, preferably four.
[0110] A3. The pre-filled syringe (2) according to any one of paragraphs A0 through A2, wherein a compact closing cylinder (6) formed from the elastic base (5) of the elastic discoid cap (3) has a circular section, where the external diameter of the proximal fit area (10) is slightly bigger than the diameter of the central passage tube (7) of the sliding receiving discoid seat (4) providing an adjusted fit.
[0111] A4. The pre-filled syringe (2) according to any one of paragraphs A0 through A3, wherein alternatively the compact closing cylinder (6) that is formed from the elastic base (5) of the valvular cap (3), includes in a proximal fit area (10) a plurality of external annular flanges (11) that are temporary supported by the cylindrical surface that defines the central passage (7) of the sliding receiving discoid seat (4) providing an adjusted fit.
[0112] A5. The pre-filled syringe (2) according to any one of paragraphs A0 through A4, wherein the discoid cooperative elements (3 and 4) are combined with a tip-cap (16) seal that closes the communication tube towards the injection needle (18), which is not pre-installed in its position. This is a temporary closure resource for pre-filled syringes (2) of double internal coaxial chambers (12 and 13), where the discoid cooperative elements (3 and 4) are arranged in a way that they act as a separating partition between both chambers (12 and 13).
[0113] A6. The pre-filled syringe (2) according to any of A0 and A2 to A4, wherein the discoid cooperative elements (3 and 4) are arranged as a temporary closure that prevents the main body of the syringe (2) from communicating internally with the communication tube towards the injection needle (18). This could be a temporary closure resource for single pre-filled chamber syringes (2).
[0114] A7. A pre-filled syringe (2) according to any one of paragraphs A0 through A4, wherein the elastic valvular joint (1) delimits two chambers (12 and 13), each one including a different product (14 and 15), and, at least one of these products is liquid. And upon mixing both products (14 and 15), a solution (22) is obtained to be injected. The elastic base (5) of the elastic discoid cap (3) of the elastic valvular joint (1) is opposed to the head (20) of the plunger (21).
[0115] A8. A pre-filled syringe (2) according to A7, wherein the elastic valvular joint (1) delimits a chamber (23) that contains a solution (22) to be injected, where the elastic base (5) of the elastic discoid cap (3) of the elastic valvular joint (1) faces the head (20) of the plunger (21).
[0116] A9. The pre-filled syringe (2) according to any one of paragraphs A0 through A8, wherein the injection needle (18) is pre-installed in the exit tube (17) of the syringe (2).
CONCLUSION
[0117] The disclosure set forth above may encompass multiple distinct examples with independent utility. Although each of these has been disclosed in its preferred form(s), the specific embodiments thereof as disclosed and illustrated herein are not to be considered in a limiting sense, because numerous variations are possible. To the extent that section headings are used within this disclosure, such headings are for organizational purposes only. The subject matter of the disclosure includes all novel and nonobvious combinations and subcombinations of the various elements, features, functions, and/or properties disclosed herein. The following claims particularly point out certain combinations and subcombinations regarded as novel and nonobvious. Other combinations and subcombinations of features, functions, elements, and/or properties may be claimed in applications claiming priority from this or a related application. Such claims, whether broader, narrower, equal, or different in scope to the original claims, also are regarded as included within the subject matter of the present disclosure.