Safety components for reconstituted, extracted and infused drug solutions

Abstract

A safety component includes: a syringe (S) having a coupling device (S1), a user device (D) having a coupling device (D1), and a safety device (100), the safety device (100) having: a first coupling device (M1) configured to couple with the coupling device (S1) of the syringe (S); and a second coupling device (M2) configured to couple with the coupling device (D1) of the user device (D); the safety device (100) further includes an axial conduit (10) and a first membrane and a second membrane (31, 32) disposed within the axial conduit (10); each membrane (31, 32) is in a closed position and an open position; when the coupling device (S1) of the syringe (S) is coupled with the first coupling device (M1), the first membrane (31) is in an open position; when the coupling device (D1) of the user device (D) is coupled with the second coupling device (M2), the second membrane (32) is in an open position.

Description

Technical Field

[0001] This invention relates to safety components for the reconstitution, extraction, and infusion of pharmaceutical solutions, particularly anti-inflammatory and / or toxic drugs. The field of reference is health safety, particularly the safety of healthy operators and patients during the preparation, administration, or handling of potentially toxic pharmaceutical solutions. Background Technology

[0002] Anti-inflammatory and / or toxic drugs are known to pose potential hazards to human health, patients, and healthy operators (chemists, physicians, and nurses) who handle these drugs daily. Healthy operators and patients face a serious risk of accidental exposure to anti-inflammatory drugs during preparation and administration.

[0003] Generally, anti-inflammatory drugs used intravenously need to be reconstituted (if they are lyophilized, diluted, in a concentrated solution, or removed from the bottle, and if they are already prepared and infused via a coupler to the access point along the infusion line).

[0004] Specifically, the medication is drawn into a syringe and introduced into a bag of saline or a temporary pill for administration to the patient. Typically, the medication is transferred from the bottle to the infusion line via a needle-free syringe connected to a coupling device having a first coupling device for connecting the syringe and a second coupling device for connecting to the preparation line and ultimately to the infusion line.

[0005] However, when using the coupling device, the healthy operator responsible for its operation may be accidentally exposed to chemotherapeutic agents due to potential leaks during the decoupling, transfer, and coupling of the needle-free injector / access component.

[0006] This inconvenience may involve the risk of contamination to healthy operators and patients during preparation and administration.

[0007] The medications to be administered are usually prepared at a location far from the patient and the infusion line; therefore, during transport from the preparation site to the infusion site, some of the liquid / medication may leak from the coupling device, thus exposing the operator or patient to the risk of contamination.

[0008] US2015 / 297839 and US2018 / 200498 disclose an adapter suitable for connection to the tip of a needle-tipped syringe and a patient device. A first membrane is disposed in the adapter and a second membrane is disposed in the patient device. When the adapter is connected to the syringe and the patient device, both membranes are closed and punctured by the needle of the syringe. Clearly, this adapter is not suitable for needle-free syringes.

[0009] US4768568 discloses a protective device suitable for coupling with a vial opening. The protective device has two sealed membranes that are punctured by the needle of a syringe.

[0010] WO2008 / 153560 discloses a medical device for supplying gas, the device comprising a sealed membrane positioned above a filter. A needle tip punctures the membrane to inject gas into a filter positioned below the membrane.

[0011] US2011 / 015566 discloses an adapter for a needle-free injector. This adapter includes a first membrane with an orifice, a second membrane with an orifice, and a cannula disposed between the two membranes. The injector has a head that compresses the first membrane, widening the orifice of the first membrane to allow liquid to pass through, and the head pushes the cannula, which compresses the second membrane, widening the orifice of the second membrane to allow liquid to pass through. It is important to note that the adapter lacks a coupling device for connection to the injector and a patient device. Forward movement of the injector head toward the adapter causes compression of both membranes, puncturing the orifices of both membranes. Therefore, if the injector is accidentally actuated before the adapter is coupled to the patient device, medication may leak during transport of the injector / adapter assembly, potentially damaging the adapter. Summary of the Invention

[0012] The purpose of this invention is to overcome the deficiencies of the prior art and to disclose a reliable, inexpensive and extremely safe assembly for the reconstitution, extraction and infusion of pharmaceutical solutions, while preventing liquid leakage during the coupling or decoupling of the safety device with an upstream syringe and a downstream patient device.

[0013] These objectives are achieved according to the invention having the features of the appended independent claim 1.

[0014] Advantageous embodiments are revealed in the dependent claims.

[0015] The security component according to the invention is defined by claim 1. Attached Figure Description

[0016] For clarity, the components according to the invention will continue to be described with reference to the accompanying drawings, which are for illustrative and not restrictive purposes only, wherein:

[0017] Figure 1 This is a side view of the safety device of the components according to the present invention;

[0018] Figure 2 This is an axial exploded view of the safety device of the component according to the present invention;

[0019] Figure 3 This is an axial view of the safety device, in which the coupling device of the safety device is not coupled;

[0020] Figure 4 It is an axial view of the safety device, in which the coupling device of the safety device is coupled to the corresponding coupling device;

[0021] Figure 5 This is a schematic side view of a needleless injector connected to a safety device.

[0022] Figure 6 It is a schematic side view of a safety device connected to a needleless injector located upstream of the safety device and a patient device located downstream of the safety device, wherein the patient device has a needle.

[0023] Figure 7 This is a schematic side view of a safety device connected to a patient device, where the patient device is connected to a bottle. Detailed Implementation

[0024] refer to Figure 6 A safety assembly for the reconstitution, extraction, and infusion of pharmaceutical liquids is disclosed, generally indicated by reference numeral 200. This safety assembly is particularly suitable for use with anti-inflammatory and / or toxic drugs.

[0025] Safety component 200 includes: safety device 100, syringe S, and user device D. Safety device 100 is adapted to be coupled to syringe S and user device D.

[0026] User device D may have a needle D2 for injecting medication, or user device D may be connected to container Q. Figure 7 (e.g., vials, bottles, or bags) for administering or infusing medication.

[0027] refer to Figure 5 and Figure 6 The syringe S is a needle-free syringe. The syringe S has a head, which includes a coupling device S1 suitable for coupling with the safety device 100.

[0028] refer to Figure 4 The syringe S includes an axial conduit S10 having an opening corresponding to the coupling device S1.

[0029] refer to Figure 6 and Figure 7 User device D includes a coupling device D1 suitable for coupling with safety device 100.

[0030] refer to Figure 4 User device D includes an axial conduit D10 having an opening corresponding to the coupling device D1.

[0031] User device D is adapted for hydraulic connection to container Q for administering or infusing medication. User device D can be a nail, tube, infusion system, etc.

[0032] refer to Figure 2 , Figure 3 and Figure 4 The safety device 100 includes a body 1 having a recessed outer wall to facilitate gripping of the safety device 100.

[0033] Safety device 100 includes:

[0034] - A first coupling device M1, configured to couple with coupling device S1 of syringe S, such that the syringe is secured to a safety device; and

[0035] - A second coupling device M2 is configured to couple with a coupling device D1 of the user device D, such that the user device is fixed to the safety device.

[0036] The first coupling device M1 and the second coupling device M2 of the safety device are located at opposite ends.

[0037] The safety device 100 includes an axial conduit 10 disposed along the body 1, which extends from the first coupling device M1 to the second coupling device M2.

[0038] When the first coupling device M1 of the safety device 100 is coupled with the coupling device S1 of the syringe S, the axial channel 10 of the safety device 100 and the axial channel S10 of the syringe are coaxial.

[0039] When the second coupling device M2 of the safety device 100 is coupled to the coupling device D1 of the user device D, the axial pipe 10 of the safety device 100 and the axial pipe D10 of the user device 10 are coaxial.

[0040] Advantageously, the coupling device S1 of the syringe S includes a Luer-lock male connector, and the coupling device D1 of the user device D includes a Luer-lock female connector; the first coupling device M1 of the safety device 100 includes a Luer-lock female connector; and the second coupling device M2 of the safety device 100 includes a Luer-lock male connector.

[0041] refer to Figure 2 , Figure 3 and Figure 4 The safety device 100 also includes a first membrane 31 and a second membrane 32 disposed within the axial conduit 10. Each membrane 31, 32 can be in a non-compressible closed position, wherein the membrane 31, 32 blocks the axial conduit 10, and in a compressed open position, wherein the membrane 31, 32 does not block the axial conduit 10.

[0042] When the coupling device S1 of the syringe S is coupled to the first coupling device M1 of the safety device 100, the first membrane 31 is normally closed and can be compressed to the open position.

[0043] When the coupling device D1 of the user device D is coupled to the second coupling device M2 of the safety device 100, the second membrane M2 is normally closed and can be compressed to the open position.

[0044] Security component 200 includes:

[0045] - A first compression device SS, associated with a coupling device S1 of the syringe, compresses the first diaphragm 31 to the compression open position when the coupling device S1 of the syringe is coupled to the first coupling device M1 of the safety device 100; and

[0046] - The second compression device 2, which is associated with the coupling device D1 of the user device, compresses the second membrane 32 to the compression open position when the coupling device D1 of the user device is coupled to the second coupling device M2 of the safety device 100.

[0047] The second compression device 2 compresses the second membrane 32 to deform it in the open position. The second compression device 2 includes a sleeve 25, which is mounted to slide axially within the axial conduit 10 of the safety device 100.

[0048] When the coupling device D1 of user device D is coupled to the second coupling device M2 of safety device 100, the sleeve 25 can be in the non-operating position where the second membrane 32 is not compressed. Figure 3 Slide to the operating position where the second membrane 32 is compressed. Figure 4 ).

[0049] The sleeve 25 includes a tip 21 that, when the sleeve 25 is in its operating position, pushes the second membrane 32 to its open position. The sleeve 25 includes a through-axial conduit 20 and a hole 20a provided in the tip 21.

[0050] refer to Figure 3 When the coupling device D1 of the user device D has not yet been coupled with the second coupling device M2 of the safety device 100, the tip 21 of the sleeve rests on the second membrane 32 without compression, and the end portion 22 of the sleeve protrudes outward from the axial pipe 10 of the body of the safety device, corresponding to the second coupling device M2 of the safety device 100.

[0051] refer to Figure 4When the coupling device D1 of the user device D is coupled to the second coupling device M2 of the safety device 100, the end portion 22 of the sleeve 25 is coupled through interference inside the axial conduit D10 of the user device D. In this way, the user device pushes the sleeve 25 toward its operating position toward the second membrane 32 while compressing it.

[0052] refer to Figure 4 The first compression device SS includes the tip of the coupling device S1 of the syringe S, which is adapted to push the first membrane 31 to its open position when the coupling device S1 of the syringe S is coupled to the first coupling device M1 of the safety device 100.

[0053] refer to Figure 3 and Figure 4 Each membrane 31, 32 includes a central aperture F1, F2, the size of which is appropriately determined to prevent liquid passage when the membranes 31, 32 are in the closed position, and thus the axial conduit 10 of the safety device is blocked. Conversely, when the membranes 31, 32 are in the open position, the central aperture F1, F2 enlarge, creating a through-hole that allows liquid to pass through, such as... Figure 4 As shown.

[0054] refer to Figure 2 , Figure 3 and Figure 4 The safety device 100 is provided with a seat 1a along the axial pipe 10, which is adapted to receive two membranes 31 and 32.

[0055] The two membranes 31 and 32 are identical and opposite to each other. More precisely, the two membranes 31 and 32 are semi-integral, arranged in contact with each other, and have conduits 310 and 320 in a coaxial position communicating with holes F1 and F2. The conduits 310 and 320 of each membrane 31 and 32 terminate on one side with the conduit 320 and 310 of the other membrane 32 and 31, and on the other side with the holes F1 and F2 of the membrane 31 and 32.

[0056] The safety device 100 also includes a cover 4, which includes a first portion 41 inserted into the axial conduit 10 of the safety device 100 and a second portion 42 including the first coupling device M1 of the safety device 100.

[0057] The seat 1a that accommodates the two membranes 31 and 32 is defined by the first part 41 of the cover 4 and a part of the axial conduit 10 of the safety device 100.

[0058] Preferably, the second membrane 32 continuously pushes the sleeve 25 to its non-operating position. More precisely, the second membrane 32 includes an elastic element that tends to bring the second membrane 32 to its closed position, thereby pushing the sleeve 25 to its non-operating position. Thus, the second membrane 32 serves as a pushing device for the sleeve 25. Alternatively, the safety device 100 may include a pushing device to push the sleeve 25 to its non-operating position. For illustrative purposes, the pushing device may be a helical spring disposed around the sleeve 25 to push the sleeve to its non-operating position.

[0059] refer to Figure 3 and Figure 4 The safety device 100 includes a stop device B adapted to stop the sleeve 25 in its non-operating position to prevent the sleeve from completely exiting the axial conduit 10 of the safety device 100. The stop device B includes: a stop tooth B1, preferably formed as a radially outwardly projecting annular collar disposed in the longitudinal conduit 10; and a plurality of radial tabs B2 disposed around the sleeve and projecting radially outward. When the sleeve 25 is in the non-operating position, the radial tabs B2 are adapted to be stopped abutted against the stop tooth B1.

[0060] The following is a description of the use and operation of safety device 100.

[0061] First, a needleless injector S with a coupling device S1 is provided, which is connected to a safety device 100 via a first coupling device M1, such as... Figure 5 As shown. Thus, the first compression device SS of the coupling device S1 of the syringe S pushes the first membrane 31 to its open position, thereby releasing the channel through the first membrane 31.

[0062] Subsequently, the second coupling device M2 of the safety device 100 is connected to the coupling device D1 of the user device D. Figure 6 The user device D is located downstream of the safety device 100 and connected to the bottle, vial, or bag. Thus, the sleeve 25 is in the operating position, and the second membrane 32 is pushed to its open position by the sleeve 25, thereby releasing its passage. In this case, both membranes 31 and 32 are in the open position. Figure 4 Therefore, by pulling back the plunger ST of the syringe S, the liquid contained in the bottle, vial, or bag connected to the user device D can be extracted.

[0063] After the liquid is extracted from the syringe S, the safety device 100 is disconnected from the user device D, so the sleeve 25 is in the non-operating position and the second membrane 32 is in the closed position to prevent liquid from leaking from the conduit 10 of the safety device 100.

[0064] In this way, the interconnected syringe S and safety device 100 can be safely transported from the extraction / preparation point to the administration / infusion point.

[0065] After the syringe S and safety device 100 are delivered to the administration / infusion point, the second coupling device M2 of the safety device 100 is coupled to the coupling device D1 of another user device D, which is connected to the container Q. Figure 7 The container Q is connected to the drug solution to be administered / infused.

[0066] The coupling of the second coupling device M2 of the safety device 100 with the coupling device D1 of the user device D positions the sleeve 25 in the operating position, thereby positioning the second membrane 32 in the open position. Thus, the syringe and the user device D are hydraulically connected via the safety device, and when the plunger ST of the syringe is pushed, the liquid in the syringe S flows through the axial conduit 10 of the safety device, then through the axial conduit D10 of the user device D, and finally into the container Q connected to the user device D.

[0067] After emptying the syringe S, the syringe S can be separated from the safety device 100 by disconnecting the coupling device S1 of the syringe S from the first coupling device M1 of the safety device 100 (see [link]). Figure 7 ).

[0068] In this case, the first membrane 31 is set in the closed position, closing the passage and preventing liquid from leaking from the axial conduit 10 of the safety device 100.

[0069] The advantages of the present invention will become apparent after the foregoing description.

[0070] In particular, the safety device 100 provides dual safety in both directions of liquid flow. In fact, the safety device 100 allows liquid to pass through the axial conduit 10 during extraction and administration, only when the syringe S and the user device D are coupled to the safety device 100.

[0071] When the safety device 100 is not connected to an upstream or downstream component, that is, when the coupling devices M1 and M2 of the safety device 100 are not connected to the coupling devices S1 and D1 of another component, liquid leakage is prevented because one of the two diaphragms 31 and 32, which act as safety valves, is closed.

[0072] Therefore, when the coupling devices M1 and M2 are decoupled, the liquid (chemotherapeutic drugs or toxic liquid) will not leak from the axial pipe 10, because in this case a tight compartment is also established by closing one of the two membranes 31 and 32.

[0073] In summary, safety device 100 allows for the safe transport of syringes and infusion systems, preventing the leakage of harmful drugs that may be dispersed in the environment or come into direct contact with patients or operators from the syringes or infusion systems, which could have serious health consequences.

[0074] Although the coupling devices M1, M2, S1, and D1 shown in the accompanying drawings include double-locking connectors, the coupling devices may also include magnetic coupling devices, bayonet coupling devices, etc.

Claims

1. A safety component (200) for reconstituted, extracted, or infused drug solutions, comprising: - A needle-free injector (S), comprising an axial conduit (S10) communicating with an opening, and a coupling device (S1) corresponding to said opening, and - Safety device (100), comprising: - A first coupling device (M1), configured to couple with the coupling device (S1) of the syringe (S), thereby securing the safety device to the syringe. -Axial conduit (10), and - A first membrane and a second membrane (31, 32) are disposed within the axial conduit (10); each membrane (31, 32) is provided with a through hole (F1, F2) and is in a non-compressible closed position, wherein the hole of the membrane is closed and obstructs the passage of liquid in the axial conduit, and in a compressible open position, wherein the hole of the membrane is open and does not obstruct the passage of liquid in the axial conduit (10); each membrane (31, 32) has a channel (310, 320) communicating with the through hole (F1, F2); The security component (200) also includes: - A first compression device (SS), associated with the coupling device (S1) of the syringe, which, when the coupling device (S1) of the syringe is coupled to the first coupling device (M1) of the safety device (100), compresses the first membrane (31) to the compression open position; and - A second compression device (2) comprising a sleeve (25) slidably mounted in the axial conduit (10) of the safety device (100) to compress the second membrane (32) to the compression open position; the sleeve (25) comprising an end portion (22) and a tip (21); Its features are, The safety component (200) also includes a user device (D) comprising an axial conduit (D10) communicating with an opening and a coupling device (D1) corresponding to the opening, the user device (D) having a needle (D2) for injecting medication into a user, or the user device (D) being connected to a container (Q) for administering / infusing medication. The safety device (100) includes a second coupling device (M2) configured to couple with the coupling device (D1) of the user device (D), thereby securing the safety device to the user device; When the coupling device (D1) of the user device (D) is coupled to the second coupling device (M2) of the safety device (100), the end portion (22) of the sleeve (25) is coupled into the axial conduit (D10) of the user device (D) by intervention, and the tip (21) of the sleeve (25) is adapted to push the second membrane (32) to its compressed open position, thereby enlarging the through hole (F2) of the second membrane (32).

2. The security component (200) according to claim 1, wherein, The coupling device (S1) of the syringe (S) includes a male Luer lock connector; the coupling device (D1) of the user device (D) includes a female Luer lock connector; the first coupling device (M1) of the safety device (100) includes a female Luer lock accessory; and the second coupling device (M2) of the safety device (100) includes a male Luer lock connector.

3. The security component (200) according to claim 1, wherein, The first compression device (SS) includes the tip of the coupling device (S1) of the syringe (S), which is adapted to push the first membrane (31) to the open position when the coupling device (S1) of the syringe (S) is coupled to the second coupling device (S2) of the safety device (100).

4. The security component (200) according to claim 1, wherein, The membranes (31, 32) are shaped as halves and are positioned in relative positions that are in contact with each other.

5. The security component (200) according to claim 1, wherein, The safety device (100) is provided with a seat (1a) for the two membranes (31, 32) along the axial pipe (10).

6. The security component (200) according to claim 5, wherein, The safety device (100) includes a cover (4) having: a first portion (41) inserted into an axial conduit (10) of the safety device (100); and a second portion (42) including the first coupling device (M1) of the safety device (100).

7. The security component (200) according to claim 6, wherein, The seat (1a) that houses the two membranes (31, 32) is defined by the first part (41) of the cover (4) and a part of the axial conduit (10) of the safety device (200).

8. The security component (200) according to claim 1, wherein, The second membrane (32) pushes the sleeve (25) to its non-operating position.

9. The security component (200) according to claim 1, wherein, The safety device (100) includes a stop device (B) adapted to stop the sleeve (25) in its non-operating position; the stop device (B) includes at least one stop tooth (B1) disposed in the axial conduit (10) and a radial protrusion (B2) disposed in the sleeve (25); when the sleeve (2) is in the non-operating position, the radial protrusion (B2) is adapted to be stopped against the stop tooth (B1).

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