Adapter for a medical container, medical container comprising said adapter and method of manufacturing said adapter

Abstract

An adapter (1) comprising a proximal portion (2) configured to be fixed to a distal end (102) of a medical container (100), a distal portion (4) configured to receive said connector so as to establish fluid communication between the distal end (102) of the medical container (100) and the connector, said distal portion (4) comprising a window (60) extending through a lateral wall (6) of the adapter. The adapter further comprises an indicator (8) movable between a first position and a second position, in which second position the indicator (8) extends outwardly relative to the first position. The indicator (8) comprises a blocking means configured to block the movement of the indicator (8) from said first position to the second position, and a cam portion (82) configured to be pushed outwardly by the connector when the connector reaches a predetermined position in the adapter (1), thereby unblocking and pushing the indicator (8) to the second position, so as to provide a visual and tactile indication to an end user that the connection between the connector and the adapter (1) is terminated.

Description

Technical Field

[0001] The present invention relates to an adapter for connecting a medical container to a connector, a medical container including the adapter, and a method for manufacturing the adapter. Background Technology

[0002] In this application, the distal end of a component or device should be understood as the end furthest from the user's hand, and the proximal end should be understood as the end closest to the user's hand. Similarly, in this application, "distal direction" should be understood as referring to the injection direction relative to the adapter or medical container of the present invention, while "proximal direction" should be understood as referring to the direction opposite to the injection direction, that is, the direction towards the user's hand holding the medical container during the injection operation.

[0003] Basically, medical containers, such as syringes, are preferably made of glass because of their high chemical inertness, low permeability, and high transparency, which allows for long-term storage and easy inspection.

[0004] Medical containers typically comprise a reservoir for containing a medical product. This container has a distal end in the form of a longitudinal tip that defines an axial channel through which the medical product is dispensed from the container. However, this longitudinal tip alone does not permit parenteral administration and must include a post or adapter that allows the syringe to be connected to a connector (e.g., a needle hub). The connector is typically screwed into the adapter and engages the distal end of the container to establish a fluid path between the reservoir and the connector.

[0005] Properly screwing the connector into the adapter is crucial. When screwing the connector into the adapter, the end user must apply sufficient torque to properly assemble the connector to the distal end of the container. Otherwise, insufficient screwing of the connector into the adapter when transferring fluid between the container and the connector may cause the connector to pop out or leak, with leakage occurring between the connector and the syringe tip. Alternatively, excessive screwing of the connector into the adapter may cause the adapter to rotate or tilt. Summary of the Invention

[0006] Therefore, there is a need for a medical container that provides end users with indications that the connector has been properly screwed into the adapter, thereby increasing end users' confidence in the connection and injection procedures.

[0007] One aspect of the present invention is an adapter for connecting a medical container to a connector, the adapter comprising:

[0008] The proximal portion is configured to be fixed to the distal end of the medical container.

[0009] The distal portion, configured to receive the connector to establish fluid communication between the distal end of the medical container and the connector, includes a window extending through the lateral wall of the adapter.

[0010] An indicator movable between a first position and a second position, wherein in the second position the indicator extends outward relative to the first position, the indicator comprising:

[0011] A blocking device, configured to allow movement of a blocking indicator from a first position to a second position, and

[0012] The cam portion, which protrudes from the window into the inside of the adapter in a first position, is configured to be pushed outward by the connector when the connector reaches a predetermined position in the adapter, thereby releasing the obstruction and pushing the indicator to a second position to provide the end user with a visual indication that the connection between the connector and the adapter has been terminated.

[0013] Therefore, the adapter of the present invention allows the end user to know when the connection from the connector to the adapter should be stopped to avoid underfitting or overfitting, thereby avoiding the risk of leakage or connector ejection during fluid transfer. In fact, the indicator is arranged at a predetermined position on the adapter, corresponding to a leakage limit. Therefore, the indicator is only pushed to the second position when the connector reaches this leakage limit. Furthermore, a blocking device prevents any accidental opening of the indicator before the connector is securely connected to the adapter, thus avoiding misleading the end user into believing that the connection has been terminated. The cam portion pushing the indicator against the blocking device further provides increased turning torque until the blocking device releases the indicator, causing the indicator to move abruptly to the second position. This thus provides an additional tactile indication that the connection has been terminated. Preferably, the indication of connection termination is both visual and tactile.

[0014] The first position can advantageously allow the plane tangent to the outer surface of the indicator and the plane tangent to the outer wall of the adapter to be equal to or less than 5°, preferably equal to or less than 2°, and more preferably equal to about 0°.

[0015] The second position can advantageously allow the plane tangent to the outer surface of the indicator and the plane tangent to the outer wall of the adapter to be equal to or greater than 10°, preferably equal to or greater than 20°, and more preferably equal to or greater than 30°.

[0016] The angle difference between the first position and the second position is advantageously equal to or greater than 10°, preferably equal to or greater than 20°, and more preferably equal to or greater than 30°.

[0017] The adapter of the present invention preferably includes an internal thread. Therefore, the connector is screwed onto the adapter. Advantageously, the connector includes at least two wings that are diametrically opposed to each other.

[0018] In one embodiment, the blocking device includes a protrusion configured to abut against the inner surface of the lateral wall of the adapter or against a gripping rib of the adapter.

[0019] The cam portion may include an inclined wall configured to gradually increase the pressure applied to the cam portion by the connector as the connector is screwed into the adapter. This can provide tactile feedback to the end user.

[0020] In one embodiment, the window opens at the root of the thread of the adapter's internal thread.

[0021] The cam portion can extend axially over the main portion of the thread root width. This ensures that the connector's connecting element abuts against the cam portion, regardless of what that connecting element is.

[0022] In one embodiment, the indicator is rotatably attached to the side wall of the adapter.

[0023] Therefore, when the connection is secured, the indicator will open like a flip panel.

[0024] The indicator can have a different color than the rest of the adapter.

[0025] This can enhance the visual cues provided to end users.

[0026] The adapter may have an indicator surface that is hidden from the end user in a first position and visible to the end user in a second position, the indicator surface having a different color than the rest of the adapter. This color difference enhances the visual indication provided to the end user.

[0027] The indicator may have an outer wall that extends axially over the window, preferably along the entire length of the adapter. This long outer wall makes the indicator easily visible to the end user, thereby enhancing visual indication.

[0028] In a first embodiment, the blocking device includes a resilient leg configured to deform and then release when the indicator is pushed from a first position to a second position, thereby emitting a sound. For example, the sound could be a "click".

[0029] In the first embodiment, the blocking device may alternatively or additionally include a protrusion configured to abut against the gripping rib of the adapter.

[0030] In the first embodiment, the indicator is attached to the adapter, preferably clipped onto the adapter.

[0031] Therefore, the indicator and the adapter can be two different parts assembled together. The indicator may include two protrusions or two recesses, and the window includes two recesses or two protrusions, which are configured to receive the two protrusions or recesses to form a pivot connection.

[0032] In the second embodiment, the indicator and adapter are made as a single piece.

[0033] This limits manufacturing costs and the number of manufacturing steps, as this embodiment does not require any assembly steps.

[0034] In this second embodiment, the indicator is connected to the side wall via a resilient arm configured to press the indicator toward the second position.

[0035] As a result, the indicator can be easily moved to the second position. Furthermore, this second position is easier for the user to see because the elastic arm can be configured such that when the indicator reaches the second position, it is substantially orthogonal to the side wall of the adapter.

[0036] In this second embodiment, the blocking device includes a protrusion configured to abut against the inner surface of the lateral wall of the adapter.

[0037] Another aspect of the present invention is a medical container comprising a distal end and the aforementioned adapter, the adapter being mounted on the distal end of the medical container.

[0038] In one embodiment, the medical container includes a cap having a connection portion that engages in an adapter, the connection portion being configured to secure the cap to the adapter without abutting against a cam portion of an indicator.

[0039] Another aspect of the present invention is a method for manufacturing the above-described adapter, the method comprising the following steps:

[0040] - The indicator is formed by injection molding;

[0041] - The adapter is formed by injection molding.

[0042] In one embodiment, the method further includes the step of assembling the indicator and the adapter.

[0043] In an alternative embodiment, the steps of forming the indicator and forming the adapter are a single step in which the indicator and the adapter are formed together in the same injection mold.

[0044] In the embodiment described, the indicator is injection molded to be in the second position.

[0045] As a result, the normal shape of the indicator is the shape when the indicator is in the second position. Therefore, the first position corresponds to the unstable position: the indicator tends to return to the second position and is only prevented from doing so by the blocking device until the pressure applied to the cam section by the connector overcomes the action of the blocking device, thereby allowing the indicator to freely return to its normal shape, i.e., move to the second position. Attached Figure Description

[0046] The invention and the advantages therefrom will become apparent from the following detailed description given with reference to the accompanying drawings:

[0047] - Figure 1 This is a perspective view of an adapter according to a first embodiment of the present invention, wherein the indicator is in a first position.

[0048] - Figure 2 This is a perspective view of an adapter according to a first embodiment of the present invention, wherein the indicator is in the second position.

[0049] - Figure 3 This is a top view of an adapter according to a first embodiment of the present invention, wherein the indicator is in a first position.

[0050] - Figure 4 This is a perspective view of an adapter according to a second embodiment of the present invention, wherein the indicator is in a first position.

[0051] - Figure 5 This is a perspective view of an adapter according to a second embodiment of the present invention, wherein the indicator is in a first position.

[0052] - Figure 6 This is a perspective view of an adapter according to a second embodiment of the present invention, wherein the indicator is in a second position.

[0053] - Figure 7 This is a top view of an adapter according to a second embodiment of the present invention, wherein the indicator is in a first position.

[0054] - Figure 8 This is a cross-sectional view of a medical container according to an embodiment of the present invention.

[0055] - Figure 9 This is an exploded view of an adapter according to a first embodiment of the present invention.

[0056] - Figure 10 This is an exploded view of an adapter according to a second embodiment of the present invention. Detailed Implementation

[0057] Reference Figure 1 An adapter 1 according to an embodiment of the present invention is shown. (Refer to...) Figure 8The adapter 1 is intended to be mounted on the distal end 102 of the medical container 100, more precisely on the outer surface of the distal end 102. The outer surface may be cylindrical or tapered distally. The adapter 1 allows a connector, such as a needle hub 200, to be connected to the distal end 102.

[0058] Adapter 1 includes a proximal portion 2 and a distal portion 4. The proximal portion 2 may be in the form of a mounting ring configured to be secured to a medical container 100. The distal portion 4 may be in the form of a connecting ring configured to receive a connector to establish reliable fluid communication between the channel of the distal end 102 and the connector. Therefore, the distal portion 4 includes a connecting device, such as an internal thread 40, configured to engage a corresponding connecting device, such as a wing 202 of a needle hub 200, to secure the connector to the distal end 102. Advantageously, the connector (e.g., needle hub 200) received in adapter 1 includes two diametrically opposed wings 202. Figure 8 As shown, the internal thread 40 has a thread crest 40a and a thread root 40b. Alternatively, the connecting device may include a bayonet element, a snap-fit ​​element, or a press-fit element.

[0059] Reference Figure 9 and Figure 10 The adapter 1 has a lateral wall 6, which is provided with a window 60. The window 60 defines a through opening extending from the outer surface of the lateral wall 6 to the inner surface 62. The window 60 can be arranged along the path of the connector's connection device. Figure 9 As shown, window 60 may preferably open at the thread root 40b of the internal thread 40. However, window 60 may open at another location on adapter 1 (e.g., at the thread crest 40a of the internal thread 40). Window 60 may extend parallel to the longitudinal direction of the internal thread 40, i.e., defining an angle with the longitudinal axis A of adapter 1 or with a transverse plane orthogonal to said longitudinal axis A. The lateral wall 6 of adapter 1 may include axial gripping ribs 64. Window 60 may pass through a portion of the lateral wall 6 located between two adjacent gripping ribs 64.

[0060] Adapter 1 also includes an indicator 8 configured to indicate to the end user that the connection between the connector and adapter 1 has been completed. Specifically, indicator 8 can be positioned in a first position ( Figure 1 , Figures 3 to 5 , Figure 7 ) and the second position ( Figure 2 , Figure 6 , Figure 10The indicator 8 moves between the first and second positions. In the first position, the indicator 8 rests against or is close to the side wall 6 of the adapter 1. In the second position, the indicator 8 extends outward from the first position. In the first position, the indicator 8 can extend through the window 60. The first position of the indicator 8 relative to the adapter 1 allows the plane tangent to the outer surface of the indicator 8 and the plane tangent to the outer wall of the adapter 1 to be equal to or less than 5°, preferably equal to or less than 2°, more preferably equal to about 0°. The second position of the indicator 8 relative to the adapter 1 allows the angle formed by the plane tangent to the outer surface of the indicator 8 and the plane tangent to the outer wall of the adapter 1 to be equal to or greater than 10°. Preferably, the angle difference between the first and second positions is equal to or greater than 10°, preferably equal to or greater than 20°, more preferably equal to or greater than 30°, so that the end user can easily notice that the connection is complete.

[0061] The adapter 1 includes a blocking device, as will be described in further detail below, which is configured to keep the indicator 8 in a first position as long as the connection between the connector and the adapter 1 has not been completed.

[0062] like Figure 3 and Figure 7 As shown, the indicator 8 also includes a cam portion 82 extending through the window 60 in a first position. The cam portion 82 is configured to be pushed outward by the connector, preferably radially outward, when the connector reaches a predetermined position in the adapter 1, thereby causing the connector to insert into the adapter 1 to overcome the action of the blocking device and push the indicator 8 to a second position. The predetermined position is advantageously defined as the leakage limit of the connector as defined in ISO 80369-7 (2016) (paragraphs 6.1 and 6.2). Leakage can occur whether the connector is under-connected or does not reach the said position. Conversely, if the connector is over-connected, the connector may be damaged or ejected from the adapter. It should be noted that the indicator 8 is configured to be activated only when the connector reaches the leakage limit position (i.e., moves to the second position). The cam portion 82 of the indicator 8, more specifically, is therefore located on the adapter 1 such that the indicator 8 moves to the second position only when the connector reaches the predetermined position.

[0063] like Figure 3 and Figure 7 As shown, in the first position, the cam portion 82 protrudes inward from the inner surface 62 of the side wall 6 of the adapter 1. The cam portion 82 is arranged on the path of the connector, and more specifically, on the path of the connector's connecting device. For example, see reference... Figure 9In the first position, the cam portion 82 is advantageously located in the thread root 40b of the internal thread. It is anticipated that the cam portion 82 can extend axially over the main portion of the thread root 40b width to ensure that when the connector reaches the predetermined position, the wing 202 of the pin seat 200 abuts against the cam portion 82 of the indicator 8. The cam portion 82 may include an inclined wall 820 configured such that the pressure applied to the cam portion 82 by the connector gradually increases as the connector is screwed into the adapter 1. The inclined wall 820 may have a planar or recessed abutment surface. The action of the cam portion 82 and the blocking device produces an increase in turning torque, which is subsequently released, thereby providing the user with further tactile indication of connection termination. The shape of the inclined wall 820 causes the cam portion 82 to be pushed outward by the connector, preferably radially outward, or alternatively in another direction, such as axially outward.

[0064] refer to Figure 3 In a first embodiment, the indicator 8 includes a sound-emitting device, such as a resilient leg 84, configured to emit an audible sound when the indicator 8 moves from a first position to a second position, thereby providing an audible indication to the end user that the connection has been completed. The resilient leg 84 may be configured to deform and then release when the indicator 8 is pushed from the first position to the second position, causing the resilient leg 84 to emit a sound, preferably a click. The resilient leg 84 may extend between the cam portion 82 and the outer wall 80 of the indicator 8. The resilient leg 84 may have a free end 840 configured to abut against the side wall 6 of the adapter 1 in the first position, deform when the connector abuts against the cam portion 82, and return to its normal shape when the indicator 8 moves to the second position. In one embodiment, a blocking device includes the resilient leg 84. The resilient leg 84 may bend inward in its normal shape (i.e., without deformation).

[0065] exist Figure 3 In the first embodiment shown, the blocking device may alternatively or additionally include a protrusion 10 configured to abut against the gripping rib 64. The protrusion 10 may be an axially extending rib or shoulder. The protrusion 10 may have a rounded shape. Figure 3 As shown, the protrusion 10 may be located on the outer wall 80 of the indicator 8, for example, at its edge.

[0066] exist Figures 1 to 3 as well as Figure 9In the first embodiment shown, the indicator 8 may have an outer wall 80 that can close the window 60 in a first position and open the window 60 in a second position. The outer wall 80 may extend parallel to the side wall 6 of the adapter 1 in the first position and may be angled or orthogonal to the side wall 6 in the second position. In the first position, the outer wall 80 may be flush with the outer surface 640 of the side wall 6 or the gripping rib 64, such that the indicator 8 advantageously does not protrude from the side wall 6 of the adapter 1 in the first position. Figure 1 , Figure 2 and Figure 9 As shown, the outer wall 80 of adapter 1 is preferably larger than the window 60, and can extend axially along the main portion of the length of adapter 1, preferably along the entire length of adapter 1, as in Figure 1 and Figure 2 As can be seen in the image. This feature provides better visual indication of whether indicator 8 is in the first or second position.

[0067] exist Figure 7 In the second embodiment shown, the blocking device may include a protrusion 10 configured to abut against the inner surface 62 of the lateral wall 6. The protrusion 10 may be an axial rib. The protrusion 10 may have a rounded shape. Figure 7 As shown, the protrusion 10 may be located on the cam portion 82 of the indicator 8, and more specifically, at the second end 822 of the cam portion 82.

[0068] The indicator 8 is mounted on the adapter 1 in a manner rotatable about a rotation axis, which may be parallel to or orthogonal to the longitudinal axis A of the adapter 1. Preferably, the indicator 8 is mounted on the adapter 1 in a manner rotatable about a rotation axis parallel to the longitudinal axis A of the adapter 1. Therefore, the cam portion 82 is preferably configured to be pushed radially outward by the connector when the connector reaches a predetermined position in the adapter 1. The adapter 1 includes a pivoting connection that rotatably connects the indicator 8 to the side wall 6 of the adapter 1. The indicator 8 thus forms a rotatable flap that closes the window 60 in a first position and opens the window 60 in a second position. Figure 3 or Figure 7 As shown, the axis of rotation may be located at a first end 826 of the cam portion 82, and the cam portion 82 may have a vertex 824 located at a second end 822 opposite to the first end 826. The adapter 1 may include a biasing device configured to bias the indicator 8 toward a second open position, such that when connection is complete, the indicator 8 suddenly pops out to the second position. As a result, the indicator 8 in the second position can be in a stable equilibrium state, while the indicator 8 in the first position can be in an unstable equilibrium state.

[0069] exist Figures 1 to 3 as well as Figure 9 In the first embodiment shown, the indicator 8 and the adapter 1 are two separate parts assembled together. The pivot connection may be formed by two protrusions 12 that engage with two complementary-shaped recesses 14. The protrusions 12 or recesses may be arranged on the indicator 8, while the recesses 14 or corresponding protrusions are arranged in the window 60.

[0070] exist Figures 6 to 7 as well as Figure 10 In the second embodiment shown, the indicator 8 and the adapter 1 are molded as a single piece. The connection may be formed by a resilient arm 86 that connects the indicator 8 to the side wall 6 of the adapter 1, more specifically to the window 60. The resilient arm 86 may form a biasing device that biases the indicator 8 toward a second open position.

[0071] It is anticipated that the indicator 8 will advantageously have a color different from the rest of the adapter 1, and more specifically, a color different from the side wall 6 of the adapter 1. It is also possible that the adapter 1 is provided with an indicating surface that is hidden from the end user when the indicator 8 is in a first position, and becomes visible to the end user when the indicator 8 is in a second position. This indicating surface may have a color different from the rest of the adapter 1, and more specifically, a color different from any surface visible to the end user when the indicator 8 is in the first position. For example, the indicating surface may be the inner surface 80a of the outer wall 80 of the indicator 8, or the edge surface 8a of the indicator 8, or the outer surface 61 of the side wall 6, which is hidden by the indicator 8 in the first position.

[0072] Adapter 1 can be made of plastic material, more precisely, of any rigid polymer suitable for medical use, such as high-density polyethylene (PE), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyoxymethylene (POM), polystyrene (PS), polybutylene terephthalate (PBT), polyamide (PA), and combinations thereof. Preferably, adapter 1 is made of polycarbonate (PC). Indicator 8 can be made of the same material as the rest of adapter 1, or of a different material, such as high-density polyethylene (PE), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyoxymethylene (POM), polystyrene (PS), polybutylene terephthalate (PBT), polyamide (PA), and combinations thereof. Figures 1 to 3 as well as Figure 9 In the first embodiment shown, the indicator may preferably be made of polycarbonate (PC). Figures 4 to 7 as well as Figure 10In the second embodiment shown, the indicator may preferably be made of polypropylene (PP) or polyoxymethylene (POM).

[0073] Reference Figures 8 to 10 The present invention also relates to a medical container 100, which includes a distal end 102 and an adapter 1 having the above-described features, the adapter 1 being mounted on the distal end 102 of the medical container 100. The medical container 100 may be a syringe, such as a pre-fillable or pre-filled syringe, and includes a tubular cylinder 104 defining a reservoir for a medical product. The tubular cylinder 104 has a distal end 102 that protrudes from a distal shoulder 106. The distal end 102 may be cylindrical or distally tapered. The distal end 102 includes an internal channel 108 communicating with the reservoir. The tubular cylinder 104 and the distal end 102 are preferably made of glass. The medical container 100 may be provided with a piston and plunger rod (not shown) for discharging medication from the reservoir and through the channel. The adapter 1 may be secured to the distal end 102 by adhesive, screwing, friction, or snap-fit.

[0074] Reference Figure 8 The medical container 100 may include a cap 110 having external threads 112 configured to engage the internal threads 40 of an adapter 1, thereby securing the cap to the adapter 1. The cap 110 is configured to be secured to the adapter 1, but its external threads 112 do not abut against the cam portion 82 of the indicator 8. Therefore, the cap 110 may include a connecting portion 114 whose length is less than the distance between the distal end of the adapter 1 and the cam portion 82 of the indicator 8. Furthermore, the cap 110 may include a proximal abutment surface 116 configured to abut against the distal end of the adapter 1, preventing the cap 110 from being further inserted into the adapter 1, thereby preventing the cap 110 from applying any pressure to the cam portion 82. The cap 110 may include an inner cap 118, which may be made of a softer material than the cap to seal the distal end 102.

[0075] The following reference Figures 1 to 2 or Figures 4 to 6 Describe the use of adapter 1.

[0076] The user inserts the connector into the distal end of the adapter 1 and engages the wing 202 of the needle holder 200 with the internal thread 40 of the adapter 1. The user begins to screw the needle holder 200 into the adapter 1. Once the needle holder 200 reaches the predetermined position, the wing 202 of the needle holder 200 begins to abut against the cam portion 82 of the indicator 8, applying radial pressure to the cam portion 82. However, due to the blocking device, the indicator 8 remains in the first position and does not open unless the radial force applied by the needle holder 200 to the cam portion 82 is sufficiently high. The user continues to screw the needle holder 200 into the adapter 1. Therefore, the radial force applied by the needle holder 200 increases until it overcomes the blocking device. The indicator 8 then moves toward the second position, allowing the end user to see that the needle holder 200 has reached the predetermined position. Thus, the connection is complete. Figure 2 and Figure 6 In this position, the connection between the needle hub 200 and the adapter 1 is secure enough to allow the user to perform injection procedures without the risk of leakage. This position also prevents any over-tightening that would cause the user to apply excessive torque, thus causing the adapter 1 to rotate relative to the distal end 102, and / or causing the needle hub 200 and / or the adapter 1 to break.

[0077] The present invention also relates to a method for manufacturing the adapter 1 described above, the method comprising the following steps:

[0078] - The indicator 8 is formed by injection molding;

[0079] - Adapter 1 is formed by injection molding.

[0080] Reference Figures 1 to 3 as well as Figure 9 The method for the adapter 1 according to the first embodiment may further include the step of assembling the indicator 8 and the side wall 6 of the adapter 1. For example, the indicator 8 is clipped into the side wall 6 of the adapter 1. More specifically, the protrusion of the indicator 8 is located in the recess of the window 60. Thus, the indicator 8 is mounted on the adapter 1 in a single, simple step in a rotatable manner.

[0081] Reference Figures 4 to 7 as well as Figure 10The adapter 1 shown according to the second embodiment involves forming the indicator 8 and the adapter 1 in a single step, forming the indicator 8 and the rest of the adapter 1 in the same injection mold. Therefore, the adapter 1 and the indicator 8 can be made of the same material, or they can be co-injected to be made of two different materials. In this case, the material of the indicator 8 can be less rigid than the material forming the rest of the adapter 1. Preferably, the indicator 8 and the adapter 1 are injection molded together, with the indicator 8 in a second position such that the normal shape of the indicator 8 is a second open position. In this second position, the elastic arm 86 does not deform. Another step included in the method is to move the indicator 8 to a first position until the blocking device is activated, thereby overcoming the spring action of the deformed elastic arm 86 and holding the indicator 8 in the first position.

Claims

1. An adapter (1) for connecting a medical container (100) to a connector, the adapter (1) comprising: The proximal portion (2) is configured to be fixed to the distal end (102) of the medical container (100). The distal portion (4), configured to receive the connector to establish fluid communication between the distal end (102) of the medical container (100) and the connector, includes a window (60) extending through a lateral wall (6) of the adapter. An indicator (8) movable between a first position and a second position, wherein in the second position the indicator (8) extends outward relative to the first position, the indicator (8) comprising: A blocking device, configured to block movement of the indicator (8) from the first position to the second position, and A cam portion (82) protrudes from the window (60) into the inside of the adapter (1) in the first position. The cam portion (82) is configured to be pushed outward by the connector when the connector reaches a predetermined position in the adapter (1), thereby removing the obstruction and pushing the indicator (8) to a second position to provide the end user with a visual indication that the connection between the connector and the adapter (1) has been terminated. The blocking device includes a protrusion (10) configured to abut against the inner surface of the side wall (6) of the adapter or against the gripping rib (64) of the adapter (1); or the blocking device includes an elastic leg (84) configured to abut against the side wall (6) of the adapter (1) in a first position and configured to deform and subsequently release when the indicator (8) is pushed from the first position to the second position, thereby emitting a sound.

2. The adapter (1) according to claim 1, wherein, The window (60) opens at the thread root (40b) of the internal thread (40) of the adapter (1).

3. The adapter (1) according to claim 1, wherein, The indicator (8) is rotatably connected to the side wall (6) of the adapter (1).

4. The adapter (1) according to any one of claims 1-3, wherein, The indicator (8) is clipped onto the adapter (1).

5. The adapter (1) according to any one of claims 1-3, wherein, The indicator (8) and the adapter (1) are made from a single piece.

6. The adapter (1) according to any one of claims 1-3, wherein, The indicator (8) is connected to the side wall (6) via an elastic arm (86) configured to press the indicator (8) toward the second position.

7. A medical container (100) comprising a distal end (102) and an adapter (1) according to any one of claims 1-6, the adapter (1) being mounted on the distal end (102) of the medical container (100).

8. The medical container (100) according to claim 7, wherein, The medical container (100) includes a cap having a connection portion that engages in the adapter (1) and is configured to secure the cap to the adapter (1) without abutting against the cam portion (82) of the indicator (8).

9. A method for manufacturing an adapter (1) according to any one of claims 1-6, the method comprising the following steps: - The indicator (8) is formed by injection molding; - The adapter (1) is formed by injection molding.

10. The method according to claim 9, wherein, The method also includes the step of assembling the indicator (8) and the adapter (1).

11. The method according to claim 9, wherein the steps of forming the indicator (8) and forming the adapter (1) are a single step of forming the indicator (8) and the adapter (1) together in the same injection mold.

12. The method according to claim 11, wherein, The indicator (8) is injection molded so that it is in the second position.

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