Vial adapter

Abstract

The present invention relates to a vial adapter comprising two chamber portions extending axially from one another, a first chamber portion configured to slidably receive at least a portion of a vial crown and a second chamber portion configured to slidably receive at least a portion of a vial body, the first chamber portion and / or the second chamber portion comprising one or more ribs extending radially inwardly of the chamber wall.

Description

Technical Field

[0001] The present invention relates to a vial adapter.

Background Art

[0002] Bioactive agents are typically stored in pharmaceutical vials, which are vials closed by a vial stopper or cap with a pierceable rubber stopper or septum. The cap may be removably attached to the vial, for example, may be resealably sealed to the vial. In many cases, the cap forms a flange extending radially outward from the neck and body of the vial as shown in FIG. 1.

[0003] Bioactive agents are expensive and wasteful use of drugs is undesirable, so bioactive agents are usually stored in vials in solid and / or dry states, which can improve chemical stability and promote longer storage times. Thus, pharmaceutical vials typically contain powdered drugs and / or lyophilized drugs or bioactive agents.

[0004] Prior to administration, for example, application by injection, the solid bioactive agent can be reconstituted by mixing with a liquid such that the bioactive agent is easily removable from the vial, for example, by a syringe. Thus, liquid transfer between the vial and the syringe is required for both reconstitution and drug aspiration.

[0005] To ensure rapid and safe liquid transfer to and from the vial, a vial adapter can be used. The vial adapter is a liquid transfer device having a piercing member for piercing or puncturing the septum of the cap and a fluid transfer port in fluid communication with the piercing member to provide access to the interior of the vial via the fluid transfer port. The vial adapter is attached to the vial prior to liquid transfer.

[0006] A vial adapter typically further comprises a cylindrical chamber or skirt that concentrically surrounds a puncture member, thereby shielding it. Installation of the vial adapter involves slidably receiving a vial cap within the cylindrical chamber. The cylindrical chamber may further include fastening means for securing the vial adapter to the cap. For example, International Publication No. 99 / 27886 discloses a vial adapter comprising a cylindrical skirt having a radially tapered elastic projection or tab for connection to a vial, and upright ribs for assisting the alignment of the vial during insertion [1]. [Overview of the project]

[0007] This disclosure provides a vial adapter that is faster, easier, more fail-safe, and more flexible for fastening the vial adapter to the vial.

[0008] This is achieved by reducing the angle at which the vial cap can be received within the vial adapter skirt. In particular, this is achieved by a vial adapter having two chamber portions extending axially from each other, wherein the first chamber portion is configured to slidably receive at least a portion of the vial crown, and the second chamber portion is configured to slidably receive at least a portion of the vial body, and the first and / or second chamber portions have one or more ribs extending radially inward from the chamber walls. Preferably, the first chamber portion is configured to slidably receive at least a portion of the vial crown, and the second chamber portion is configured to slidably receive at least a portion of the vial body, and the first chamber portion has one or more ribs extending radially inward from the first chamber wall. Optionally, the second chamber portion is configured to slidably receive a compressive force and expand in response to at least a portion of the vial body.

[0009] In a preferred embodiment, the first and second chamber portions are provided with or constituted from coherent cylindrical chamber walls.

[0010] In a more preferred embodiment, one or more radially inward ribs are axially extended ribs. In a more preferred embodiment, the axially extended ribs are configured as retainers or wedges for the vial crown and are optionally configured to be elastically compressed outward toward the chamber wall.

[0011] In another or further embodiment, one or more radially inward ribs are circumferentially extending ribs, preferably ribs adjacent to slits, such as slits that are partially circumferentially extending and partially axially extending. In a more preferred embodiment, the circumferentially extending ribs are configured as vial crown holders and optionally configured to snap-fit ​​onto the vial crown.

[0012] In another or further embodiment, the puncture member of the vial adapter comprises a cylindrical portion and a conical tip portion. [Brief explanation of the drawing]

[0013] The present invention will be described in more detail below with reference to the accompanying drawings. [Figure 1A] This figure shows an embodiment of a vial adapter, with a pie chart indicating the possible angles at which a vial cap can be received within the vial adapter skirt. [Figure 1B] This figure shows an embodiment of vial adapter (B) according to the present disclosure, and the angles at which a vial cap can be received within the vial adapter skirt are shown by a pie chart. [Figure 2] This is a 3D cross-sectional view of a vial adapter according to this disclosure, which has axially extending ribs. [Figure 3] Outline view (A) and cross-sectional view (B) of the vial adapter according to this disclosure, which has axially extending ribs. [Figure 4] Outline view (A) and cross-sectional view (B) of a vial adapter according to this disclosure, which has axially extending ribs, and the vial adapter is fixed to the vial. [Figure 5] These are outline views of an embodiment of a vial adapter according to the present disclosure, which has circumferentially extending ribs, where (A) and (B) are perspective views and (C) and (D) are corresponding line drawings. [Figure 6] This is an outline view of an embodiment of a vial adapter according to the present disclosure, which has circumferentially extending ribs, the vial adapter being fixed to a vial, (A) and (B) are perspective views, and (C) and (D) are corresponding line drawings. [Figure 7] This is a cross-sectional view of a vial adapter according to the present disclosure, which has circumferentially extending ribs, when the vial adapter is fixed to the vial. A perspective view is shown on the left, and a corresponding line drawing is shown on the right. [Figure 8] This is a perspective view of one embodiment of the vial adapter according to the present disclosure, and is a view from the bottom. [Figure 9] This is a cross-sectional view of one embodiment of the vial adapter according to the present disclosure, and is a view from the bottom. [Figure 10] This is a cross-sectional view of one embodiment of the vial adapter according to the present disclosure, with exemplary dimensions shown. [Figure 11] This is a cross-sectional perspective view of one embodiment of a vial adapter according to the present disclosure, with exemplary dimensions shown. [Figure 12] This is a cross-sectional perspective view of one embodiment of a vial adapter according to the present disclosure, with exemplary dimensions shown. [Figure 13] This is a bottom perspective view of one embodiment of the vial adapter according to this disclosure. [Figure 14] This is a perspective view of one embodiment of the puncture member of a vial adapter according to the present disclosure. [Modes for carrying out the invention]

[0014] The present invention will be described below with the aid of the accompanying drawings. Those skilled in the art will understand that the same features or components of the device are referred to by the same reference numerals in different figures. A list of reference numerals can be found at the end of the detailed description section.

[0015] Chamber for receiving a vial Figure 1 shows an embodiment of a vial adapter 2 for vial 1, the vial adapter comprising a longitudinally extending piercing member 2.1 defining an axial direction and a concentrically surrounding chamber or skirt 2.2 configured to receive the vial cap 1.5 when attaching or mounting the vial adapter to the vial prior to liquid transfer. The chamber or skirt is defined by concentric chamber walls and an upper wall or ceiling transverse to the axial direction and is located near the proximal end of the adapter, on the opposite side of the chamber opening located at the distal end of the adapter.

[0016] Thus, the vial cap, also known as the vial crown, stopper, flange, collar, or finish, is penetrated by the piercing member of the vial adapter upon attachment of the vial adapter. Specifically, the piercing member penetrates the horizontally oriented upper surface of the vial crown which can comprise a septum 1.6 that is more easily pierceable. The piercing member 2.1, also referred to as a piercing element, comprises a hollow spike, for example as part of a cannula, and can function as a fluid transfer port. The term cannula means a tube ending in a spike / angled open end to provide fluid access through the entire cannula.

[0017] It has been found to be particularly advantageous that the chamber portion of the vial adapter 2 is configured to further receive the upper part of the vial. Thus, in addition to receiving the vial crown, the chamber portion is advantageously further configured to receive the vial neck 1.4, the vial shoulder 1.3, and at least a part of the vial body 1.1, as shown in Figure 1B. For example, advantageously, the length of the vial adapter chamber may be configured to receive the entire vial body including the vial bottom 1.2.

[0018] As can be seen from FIG. 1, when the chamber is configured to further receive the upper part of the vial body, the larger the part of the received vial body, the lower the risk of incomplete attachment and misalignment. Correspondingly, the longer the vial adapter chamber in the axial chamber direction or in the direction of the longitudinal puncturing member, the lower the risk of incomplete attachment and misalignment of the vial adapter. The reason for the low risk of incomplete attachment and misalignment is that the angle at which the vial cap may be received within the vial adapter skirt is small. The term "incomplete attachment" means incomplete penetration of the entire longitudinal length of the puncturing member or at least the length of the angled / spiked open end passing through the puncturing member, and the term "misalignment" means deviation from the vertical contact between the puncturing member and the upper surface of the vial crown, for example, deviation from the vertically oriented puncturing member and the horizontal upper surface as shown in FIG. 1.

[0019] For example, the vial adapter shown in FIG. 1A can receive the vial cap at an angle with respect to the vertical line formed by the longitudinal puncturing member of FIG. 1A. This is shown by three parts of a circular graph arranged symmetrically around the vertical puncturing member of FIG. 1A. When the angle of the puncturing member is deviated from the vertical by a first degree (shown by dark dots), the puncturing member may penetrate the cap at a non-vertical angle, and as a result, the vial adapter is misaligned and incompletely attached. When the angle of the puncturing element is deviated from the vertical by a second, larger degree (shown by dotted lines), the inner wall of the vial adapter chamber restricts the angle and partially corrects it, so that the puncturing member can penetrate the cap at a non-vertical angle similar to the misalignment of the first degree. When the angle of the puncturing member is deviated by a third, even larger degree (shown by rig dots), the vial adapter and the vial cannot be attached at all.

[0020] The longer skirt of the vial adapter embodied in Figure 1B facilitates the fact that the vial adapter can only receive the vial cap along the vertical line formed by the longitudinal puncture member in Figure 1B, and therefore angled reception of the vial cap within the vial adapter skirt is impossible. When the angle of the puncture element is slightly deviated from the vertical to a first degree (indicated by dark dots), the inner wall of the vial adapter chamber limits and corrects the angle with respect to the vertical line so that the puncture member penetrates the cap at a vertical angle. When the angle of the puncture member is more significantly deviated from the vertical (indicated by bright dots), the vial adapter and vial cannot be attached at all, as shown by the pie chart symmetrically arranged around the vertical puncture member in Figure 1B.

[0021] To further reduce the risk of misalignment and improper fitting between the vial and vial adapter, and to ensure central puncture of the upper surface of the vial crown, the vial adapter is advantageously formed to fit the vial and configured to receive the vial snugly and slidably. Conventional vials, as shown in Figure 1, have separate crowns and vial bodies, the crowns and bodies having different dimensions, and typically the vial is cylindrical, having a crown with a first cylindrical shape and a vial body with a second, larger cylindrical shape. Thus, the upper surface of the vial crown is typically circular and has circular, concentrically arranged punctureable septa.

[0022] Therefore, advantageously, the vial adapter comprises two chamber portions extending axially from each other, as shown in Figure 1B, wherein the first chamber portion 2.2 is configured to slidably receive and accommodate at least a portion of the vial crown, and the second chamber portion 2.3 is configured to slidably receive and accommodate at least a portion of the vial body. For further improved shape fitting, the first and / or second chamber portions are configured to slidably receive a compressive force and expand in response to vial reception. Advantageously, the second chamber portion is configured to slidably receive a compressive force and expand in response to at least a portion of the vial body.

[0023] More advantageously, the first chamber portion 2.2 is a first cylindrical portion, and the second chamber portion 2.3 is a second cylindrical portion, and the vial adapter comprises two cylindrical portions extending axially from each other in a form fitted to a conventional vial crown and vial body. Thus, the direction of axial extension corresponds to the axial direction defined by the puncture member, i.e., the longitudinal direction of the puncture member and / or the longitudinal direction of the vial. Thus, the first chamber portion is located at the proximal end of the adapter, and the second chamber portion is located at the distal end of the adapter.

[0024] To reduce the angle at which the vial cap may be received within the vial adapter skirt, and thus reduce the risk of misalignment between the vial adapter and the vial, and to ensure central puncture of the upper surface of the vial crown, including the septum, the chamber portion is advantageously configured to slidably receive the larger portion of the vial crown and the larger portion of the vial body.

[0025] In one embodiment of the present disclosure, the second chamber portion is configured to slidably receive at least 20% of the vial body, such as at least 25, 30, 40, 50, 60, 70, 80, 90, or 100% of the vial body. In another or further embodiment, the first chamber portion is configured to slidably receive at least 50% of the vial crown, such as at least 60, 70, 80, 90, or 100% of the vial crown.

[0026] To improve the simplicity, robustness, and fail-safe user-friendliness of the vial adapter, it has been found advantageous for the first and / or second chamber portions to have coherent cylindrical chamber walls. Specifically, it has been found advantageous for the second chamber portion, or at least the distal portion of the second chamber portion, to have a coherent cylindrical chamber wall, i.e., without openings and edges such as axially extended slits or deformable surface portions that could form openings or edges within the chamber wall during deformation (which could increase the risk of user injury). Advantageously, the first and / or second chamber portions, as well as the transition zone between the first and second chamber portions, are coherent, forming a coherent and smooth structural surface, and the chamber can only deform to a limited extent, i.e., the chamber wall is not deformed by forming hinged or twisted zones.

[0027] In one embodiment of the present disclosure, the first chamber portion comprises a coherent cylindrical chamber wall. In a further embodiment, the second chamber portion comprises a coherent cylindrical chamber wall. In a further embodiment, the second chamber portion is composed of a coherent cylindrical chamber wall.

[0028] However, in addition to or instead of the above, the first and / or second chamber portions may be provided with one or more slits to facilitate manual insertion and reception of the vial body into the adapter. Figure 1B shows an embodiment in which the vial adapter 2 has four axially extended slits 3.3 arranged around the vial skirt, with two slits visible in the front view (shown by solid lines) and two slits located on the rear (shown by dotted lines).

[0029] To ensure more reliable, uniform, and complete insertion of the vial into the vial adapter, the vial adapter is advantageously provided with one or more spacers 4 positioned in the upper wall of the chamber, as viewed from the bottom, within the chamber, as seen in Figure 8, which shows a perspective view of one embodiment of the vial adapter according to this disclosure. The one or more spacers particularly facilitate the presence of sensory input during complete insertion. For reliable and uniform sensory input during complete insertion, the upper chamber wall is advantageously provided with 2 to 10 spacers, which are preferably arranged rotationally and have 120 degrees of rotational symmetry, as shown in Figure 8, for example. The spacers can have any suitable shape that is flexible and easy to manufacture, such as spherical or hemispherical. Advantageously, the distal end of the spacer 4 has a hemispherical shape, as seen in the cross-sectional view of one embodiment of the vial adapter according to this disclosure in Figure 10.

[0030] In one embodiment of the present disclosure, the first chamber portion has an upper chamber wall comprising one or more spacers, such as 2 to 10 spacers, more preferably 3, 5, or 7 spacers. In a further embodiment, the distal ends of the spacers have a spherical or hemispherical shape.

[0031] To further reduce the risk of misalignment and improper fitting between the vial and the vial adapter, the vial adapter is essentially fitted to the vial in an advantageous manner, such that the vial adapter is configured to receive the vial, i.e., both the vial crown and at least part of the vial body, in a snug, slidable manner. The crown and body of the vial are typically cylindrical, with the crown having a smaller diameter, so it is advantageous that the chamber portion is also cylindrical, and the inner diameter of the first chamber portion is smaller than the inner diameter of the second chamber portion.

[0032] In one embodiment of the present disclosure, the two chamber portions are cylindrical, and the inner diameter of the first chamber portion is smaller than the inner diameter of the second chamber portion. In a further embodiment, the first chamber portion has an inner diameter of 10 to 50 mm, more preferably 15 to 40 mm, most preferably 20 to 30 mm, for example 23 or 25 mm. In a further embodiment, the second chamber portion has an inner diameter of 10 to 50 mm, more preferably 20 to 40 mm, most preferably 25 to 30 mm, for example 27 or 29 mm.

[0033] Ribs extending in the axial direction To further reduce the risk of misalignment between the vial adapter and the vial, and to ensure central puncture of the upper surface of the vial crown, including the septum, it is advantageous for the first chamber portion 2.2 and / or the second chamber portion 2.3 to be equipped with one or more radially inward ribs 3, such as one or more axially extended ribs 3.1, as shown in Figure 2, which illustrates an example of axially extended ribs within the first chamber portion. The ribs extend axially, i.e., parallel to the longitudinal axis of the vial adapter and parallel to the puncture member of the vial adapter.

[0034] In one embodiment of the present disclosure, one or more radially inward ribs extend axially.

[0035] Because the two chamber sections extend axially, it is particularly advantageous that the complete insertion of the vial into the vial adapter, corresponding to the complete penetration of the entire length of the puncture member, can be detected, for example, by sensory input or assembly force. For example, complete insertion can be detected as a change in force, such as a change in assembly force or frictional force. Thus, advantageously, the axially extending rib is configured as a vial crown holder and / or vial body holder, elastically compressing the vial crown and / or vial body and frictionally engaging with the vial crown. Further advantageously, the rib is configured as a wedge, and the frictional force changes during insertion. Thus, the rib is configured as a vial holder that does not depend on a latch mechanism.

[0036] In one embodiment of the present disclosure, the axially extended ribs are configured as vial crown holders and / or vial body holders, such as wedges. In a further embodiment, the axially extended ribs are configured to be elastically compressed outward toward the chamber wall.

[0037] Therefore, advantageously, the axially extending ribs abut against the sides of the vial crown and / or vial body in an elastic compression manner, and the ribs not only guide and stabilize the sliding reception of the vial crown and / or vial body, but also fix or hold the vial crown and / or vial body in a wedge manner. Advantageously, the ribs are configured to be elastically compressed outward toward the chamber wall at least, for example, when the vial crown is received in the adapter, the ribs are elastically compressed toward the chamber wall, exerting a compressive force toward the vial cap. Thus, the abutment portion of the ribs has a vial-holding function, and the ribs constitute a vial holder or vial-holding means. Similarly, the ribs can hold the vial body. Vial-holding means further reduce the risk of misalignment between the vial adapter and the vial.

[0038] To further improve vial insertion and retention, the sides of the axially extended rib facing the vial crown and / or body are advantageously provided with a planar or annular portion for contacting and / or partially engaging with the vial crown and / or body. Thus, the contact interface between the axially extended rib and the vial is advantageously flat and not linear. For example, the side facing the vial crown may be planar and rectangular, as seen in the perspective view of Figure 2. The planar or annular portion of the axially extended rib on the side facing the vial crown and / or body is also seen in the cross-sectional view of Figure 9, which shows one embodiment of the vial adapter according to this disclosure. In the cross-sectional view of Figure 9, the axially extended rib has an isosceles trapezoidal shape with the shorter base side facing the vial. Alternatively, the axially extended rib may be rectangular, triangular trapezoidal, or square in cross-sectional view, as seen in the rib shown in Figure 2. Preferably, the axially extending ribs do not have a triangular shape with a vertex facing the vial when viewed in a cross-sectional view, such that the interface between the axially extending rib and the vial is straight.

[0039] In one embodiment of the present disclosure, the axially extending rib comprises a planar or annular portion, as shown in the cross-sectional view, for engaging with the vial crown or vial body. In a further embodiment, the axially extending rib has a cross-sectional shape selected from the group consisting of isosceles trapezoidal, trilateral trapezoidal, rectangular, or square.

[0040] To further improve vial insertion and retention, it is advantageous for the axially extending ribs to be positioned along the lengths of both the first and second chamber portions, corresponding to the total length of the two extending chambers, as shown in Figures 11-13.

[0041] The intensity of sensory input upon full insertion depends on the number, size, shape, and configuration of the axially extending ribs.

[0042] Advantageously, the adapter comprises two or more axially extending ribs arranged rotationally symmetrically around the chamber wall, for example, by being equally spaced along the circumferential direction of the cylindrical chamber portion. For example, the first cylindrical portion may comprise four axially extending ribs spaced at 90-degree intervals, such that the ribs are arranged rotationally symmetrically around a rotation axis consisting of four parts, as seen from the axial direction in Figure 2.

[0043] In one embodiment of the present disclosure, the adapter comprises two or more axially extended ribs, preferably four axially extended ribs, such as three, four, five, six, seven, eight, nine, or ten axially extended ribs. In a further embodiment, the axially extended ribs are arranged rotationally symmetrically within a cylindrical portion, such as a first cylindrical portion. In a further embodiment, the axially extended ribs are arranged at equal intervals along the circumferential direction of the cylindrical portion, such as a first cylindrical portion.

[0044] The axially extending ribs may extend inward from the chamber wall, that is, they may project from the inner chamber wall toward the chamber's central axis or puncture member at different angles. For example, as shown in Figure 2, the ribs may extend radially inward in a direction similar to the spokes of a radial motorcycle, where the spokes extend from the circular periphery toward the central hub. Thus, the ribs project perpendicularly from the inner chamber wall, as seen from the axial direction in Figure 2.

[0045] Similar to spokes on a bicycle, which can be mounted radially or tangentially to the hub, the rib extends favorably inward along with its tangential components. Thus, the inward extension of the rib may comprise radial and tangential components. The inward extension of the rib may be defined by a radial angle, which is defined as the angle with respect to the tangency of the chamber wall. Thus, the rib shown in Figure 2 has a radial angle of 90 degrees, similar to radial spokes on a bicycle.

[0046] To ensure a more flexible and slidable reception of the vial crown and / or vial body within the chamber, and to improve sensory input during full insertion, the ribs are advantageously extended inward at a radial angle of less than 90 degrees, and even more advantageously, all ribs are extended inward at the same radial angle. Furthermore, as shown in Figure 2, the ribs may extend linearly inward, as seen in the axial cross-sectional view, or they may have an inwardly curved shape, and the ribs are arranged similarly to the impeller blades when viewed from the axial direction.

[0047] In one embodiment of the present disclosure, the axially extending rib extends inward at a radial angle of 90 degrees. In another embodiment, the axially extending rib extends inward at a radial angle of less than 90 degrees, preferably less than 80, 70, 60, 50, 40, or 30 degrees. In yet another embodiment, the axially extending rib extends inward at the same radial angle.

[0048] Figures 3 and 4 show embodiments of the vial adapter according to this disclosure without a vial attached. Figure 4B shows a cross-sectional view of an embodiment in which the upper part of the axially extended rib abuts against or is compressed against the side of the crown. The term “upper part of the rib” means the longitudinal portion of the rib proximal to the upper wall or ceiling of the chamber and distal to the chamber opening.

[0049] To ensure a more flexible and slidable reception of the vial crown and / or vial body within the chamber, to ensure complete insertion, and to reduce the risk of improper fitting of the adapter and vial crown and / or vial body, the dimensions of the ribs are advantageously varied along the axial direction. For example, as shown in Figures 2–4, the ribs extend inward from the chamber wall with a smaller lower axial portion of the rib proximal to the chamber opening, and with a larger upper axial portion of the rib proximal to the chamber top or ceiling. For example, the inward extension of the rib may vary linearly along a portion of the axial direction, as shown in Figures 2–4.

[0050] The change in the inward extension of the rib facilitates easier sliding reception of the vial crown within the chamber and, furthermore, can result in a physically perceptible change in the force or assembly force required to insert or receive the vial when fully inserted, as well as the spring force. Thus, the risk of incomplete installation can be further reduced as the user performing the installation can easily notice a complete installation. This is particularly advantageous for vial caps with deviations in vial dimensions, as incomplete installations can be monitored for caps with different tolerances.

[0051] In one embodiment of the present disclosure, the inner extension of an axially extending rib varies along the axial extension. In a further embodiment, the inner extension of the rib decreases toward the distal end. In a further embodiment, the inner extension of the rib varies linearly along at least a portion of the axial extension.

[0052] To improve vial retention and sensory input when fully inserted, and at the same time reduce the risk of incomplete installation and ensure flexible and slidable reception of the vial crown within the chamber, it is advantageous for the ribs to have curved portions when viewed axially. For example, the ribs are advantageously shaped as impeller blades when viewed axially.

[0053] In one embodiment of the present disclosure, the axially extending rib has a curved portion when viewed from the axial direction. In a further embodiment, the axially extending rib is formed as an impeller blade when viewed from the axial direction.

[0054] Ribs extending in the circumferential direction To reduce the risk of misalignment between the vial adapter and the vial and to improve sensory input during complete vial insertion, the first chamber portion 2.2 and / or the second chamber portion 2.3 may additionally or alternatively include one or more radially inward ribs 3, such as one or more circumferentially extending ribs 3.2, as shown in Figure 5, which shows an embodiment of the adapter separated from the vial, and Figure 6, which shows an embodiment of the adapter attached to the vial. For example, the circumferentially extending ribs extend along a portion of the inner circumference of the first chamber wall, as indicated by the dotted arrows in Figures 5 and 6. Figure 7 shows a cross-sectional view of one embodiment of the vial adapter when a vial is inserted, where (A) shows the vial crown in the second chamber portion, (B) shows the vial crown entering the first chamber portion, and (C) shows complete insertion.

[0055] In one embodiment of the present disclosure, one or more radially inward ribs are circumferentially extended ribs that extend along at least a portion of the circumference of a chamber wall, such as a first chamber wall and / or a second chamber wall.

[0056] Because the two chamber sections extend axially, it is particularly advantageous that the complete insertion of the vial into the vial adapter, corresponding to the complete penetration of the entire length of the puncture member, can be detected, for example, by sensory input or assembly force. For example, complete insertion can be detected as a change in force, such as friction, spring force, or a released force such as a snap fit. Therefore, advantageously, the circumferentially extending ribs are configured as vial crown holders, for example by being elastically flexible, and configured to engage with the vial crown in a snap fit. Additionally or alternatively, the circumferentially extending ribs may be configured as vial body holders.

[0057] In one embodiment of the present disclosure, at least one circumferentially extended rib is configured as a vial crown holder and / or vial body holder. In a further embodiment, at least one circumferentially extended rib is configured to snap-fit ​​onto the vial crown. In a further embodiment, at least one circumferentially extended rib is flexible.

[0058] The risk of misalignment and the intensity of sensory input upon full insertion depend on the number, size, shape, and configuration of the circumferentially extending ribs. For example, the adapter may advantageously have two circumferentially extending ribs positioned on either side of the first chamber portion, as shown in Figure 7.

[0059] Advantageously, in one embodiment of the present disclosure, the adapter comprises one or more circumferentially extended ribs, such as two, three, or four circumferentially extended ribs. In a further embodiment, at least one circumferentially extended rib extends to less than 50% of the circumference of the first chamber wall and / or the second chamber wall, for example, 40%, 30%, 25%, 20%, 15%, 10%, or 5%. In a further embodiment, the length of the circumferentially extended rib is less than 2 cm, such as less than 1.5 cm or less than 1 cm.

[0060] To ensure a more flexible and slidable reception of the vial crown and vial body within the chamber and to improve sensory input during full insertion, the circumferentially extending ribs are advantageously extended inward at an angle such as 90 degrees or a different angle of inclination. Preferably, the inclination is toward the first chamber portion or proximal end, thereby facilitating slidable insertion, and the ribs do not function as a return. Further advantageously, the ribs have a rectangular or triangular shape, as seen in the cross-sectional view of Figure 7. The circumferentially extending ribs can have any triangular shape as seen in the cross-sectional view, such as equilateral triangles, isosceles triangles, and scalene triangles. In a preferred embodiment, the ribs have a scalene triangular shape, i.e., an asymmetrical triangular shape where all sides are of different lengths and the shorter leg of the triangle faces the upper chamber wall, as seen, for example, in Figure 10. This can further improve the slidable reception of the vial within the chamber and the sensory input during full insertion.

[0061] In one embodiment of the present disclosure, at least one circumferentially extending rib extends inward at an angle of 90 degrees. In another embodiment, at least one circumferentially extending rib extends inward at an angle inclined toward the chamber portion. In a further embodiment, at least one circumferentially extending rib has a rectangular or triangular shape as seen in the cross-sectional view.

[0062] In another further embodiment of the present disclosure, the circumferentially extending ribs have a triangular shape selected from the group of equilateral triangles, isosceles triangles, and scalene triangles, preferably scalene triangles, with the shorter legs of the triangles facing the upper chamber wall.

[0063] The adapter is preferably configured to snap-fit ​​onto the vial opening. As a result, the circumferentially extended ribs may be positioned within the first chamber portion at different distances from the distal end. For example, the circumferentially extended ribs may be positioned at the distal end of the first chamber portion, as shown in Figure 5A, or away from the distal end, as shown in Figure 5B. Advantageously, the circumferentially extended ribs are located near the distal end of the first chamber, i.e., near the transition between the first and second chamber portions, as seen, for example, in Figure 10.

[0064] In one embodiment of the present disclosure, at least one circumferentially extending rib is located at the distal end of the first chamber portion. In another embodiment, at least one circumferentially extending rib is located at a distance of less than 50%, 40%, or 30% of the length of the first chamber from the distal end of the first chamber portion.

[0065] To further improve insertion, particularly sensory input during full insertion, and snap-fit ​​attachment, circumferentially positioned ribs are advantageously located adjacent to circumferentially positioned slits and one or more partially axially positioned slits. For example, the horizontal circumferentially positioned ribs shown in Figures 5-6 may be positioned adjacent to a horizontally positioned slit connected to two vertically positioned slits, as seen in Figures 5-6.

[0066] In one embodiment of the present disclosure, at least one circumferentially extending rib is adjacent to at least one circumferentially extending slit. In a further embodiment, at least one circumferentially extending slit is connected to at least one partially axially extending slit. In a further embodiment, at least one circumferentially extending slit is connected to two or more axially extending slits. In a further embodiment, two or more axially extending slits extend toward the proximal end and / or distal end.

[0067] The dimensions of the slit can be optimized to further improve sensory input during full insertion and user convenience at the snap-fit ​​mounting section.

[0068] In one embodiment of the present disclosure, the length of the circumferentially extending slit is the same as or less than the length of the axially extending slit, for example, by at least 70%, 60%, 50%, 40%, or 30%. In a further embodiment, the circumferentially extending slit is located within a first chamber portion, and the axially extending slit is located within the first chamber portion and / or a second chamber portion.

[0069] To facilitate handling and storage, the vial adapter may be provided with additional circumferentially extended ribs extending radially outward from the chamber wall. Preferably, the additional circumferentially extended ribs are located at the distal end of the second chamber, for example, as shown in Figures 10-12, thereby forming a support base for the storage configuration.

[0070] Puncture member The vial adapter implicitly includes a puncture member 2.1 for puncturing the cap septum and facilitating the transfer of liquid between the inside of the vial and the adapter port. Thus, the puncture member may have a hollow, elongated structure, such as a hollow cylindrical shape, as seen in Figures 2-3. Surprisingly, it has been found to be advantageous for the tip 2.12 of the puncture member to have a conical shape similar to a sharpened pencil, as seen in Figures 13-14, which show a perspective view from the bottom of an embodiment of the vial adapter according to this disclosure. Thus, the tip of the puncture member has a smooth surface and does not have facets like a pyramidal tip. This shape facilitates the elastic septum to be perforated in a resealable manner, because the septum membrane is not cut or cut open by facets as it would be with a pyramidal tip, but instead opens by the compressive force generated by contact with the smooth cone surface.

[0071] In one embodiment of the present disclosure, the puncture member comprises a cylindrical portion and a conical tip portion.

[0072] The puncture member further comprises one or more openings 2.11 for transferring liquid at the contacts of the vial adapter. For efficient liquid transfer and to reduce pressure drop across the vial adapter, the puncture element advantageously comprises multiple openings, preferably 2 to 8 openings. For example, the puncture element comprises three openings 2.11, as seen in Figure 8 (perspective view from the bottom) and Figures 13-14 (perspective views).

[0073] In one embodiment of the present disclosure, the puncture member comprises a plurality of openings, more preferably 2 to 8 openings, for example 3, 4, or 5 openings.

[0074] To enable both efficient fluid transfer and puncture strength, the opening 2.11 is advantageously positioned rotationally symmetrically around the puncture element with, for example, 120 degrees of rotational symmetry, as seen in Figures 8, 13-14, and it is even more preferable that the opening is positioned proximal to the distal tip 2.12 of the puncture element. Even more advantageously, the opening is a straight slit positioned along at least a portion of the cylindrical portion and at least a portion of the conical portion of the puncture element, as is most clearly seen in Figure 14.

[0075] In one embodiment of the present disclosure, the opening is formed as a straight slit positioned along at least a portion of the cylindrical and conical portions of the puncture member.

[0076] Even more surprisingly, the combined relative positions of the distal tip 2.12 of the puncture element, the circumferentially extending slit 3.3, and / or the circumferentially extending rib 3.2 within the chamber skirt were found to affect the performance of the vial adapter, particularly the sensory input during full insertion, fluid transfer efficiency, and puncture strength. Figure 10 shows a cross-sectional view of one embodiment of the vial adapter according to the present disclosure, and Figures 11-12 show cross-sectional perspective views of one embodiment of the vial adapter according to the present disclosure, with preferred exemplary dimensions shown.

[0077] In one embodiment of the present disclosure, the distal tip of the puncture member is located between 25 and 50 percent of the chamber length from the upper wall, more preferably between 30 and 45 percent, for example, 35, 37, 40, or 44 percent.

[0078] In one embodiment of the present disclosure, the circumferentially extending slit is positioned at essentially the same distance from the upper wall to the distal tip of the puncture member with respect to the chamber length.

[0079] In one embodiment of the present disclosure, the circumferentially extending ribs are located 15-30%, more preferably 20-30%, and for example, at least 23%, from the top wall relative to the chamber length.

[0080] liquid transfer The vial adapters of this disclosure are advantageously applicable to medicinal vials or cartridges. Medicinal vials contain bioactive agents, where “bioactive agent” is defined as any agent, drug, compound, composition or mixture that provides several pharmacological, often beneficial effects that can be demonstrated in vivo or in vitro. Thus, an active substance is considered bioactive if it has an interaction or effect with cells and tissues in the body of a human or animal. As used herein, this term further includes any physiologically or pharmacologically active substance that produces a local or systemic effect in an individual. Bioactive agents may be proteins, such as enzymes. Further examples of bioactive agents include, but are not limited to, agents containing or composed of oligosaccharides, polysaccharides, optionally glycosylated peptides, optionally glycosylated polypeptides, oligonucleotides, polynucleotides, lipids, fatty acids, fatty acid esters and secondary metabolites. These may be used prophylactically or therapeutically in connection with the treatment of an individual, such as a human or any other animal. As used herein, the term “bioactive agent” does not encompass cells, such as eukaryotic or prokaryotic cells.

[0081] Bioactive agents such as thrombin are typically expensive and are stored in a solid and / or dry state to ensure chemical stability, longer storage time, and therefore less material waste. Advantageously, bioactive agents can be stored as lyophilized agents, such as lyophilized thrombin. Lyophilization, also known as freeze-drying, involves dehydrating the bioactive agent so that it is maintained and stored in a dry solid state. Thus, lyophilization provides an efficient storage form. However, for lyophilized bioactive agents to be used for injection, they need to be reconstituted by mixing the lyophilized agent with a liquid.

[0082] It is known in the art that the shelf life of injectable substances such as thrombin increases when the substance is stored in powder form. Freeze-drying is one method for producing powdered substances from liquid materials. This involves rapidly freezing the material at a very low temperature, followed by rapid dehydration by sublimation in a high vacuum.

[0083] The resulting lyophilized material is typically stored in a glass vial or cartridge sealed with a cap such as a rubber stopper or septum. The powder or solid material needs to be reconstituted before administration. This is achieved by mixing the powder with an appropriate diluent or liquid.

[0084] In one embodiment of the present disclosure, the bioactive agent is a dried or freeze-dried substance. In a further embodiment, the bioactive agent comprises thrombin. In a further embodiment, the bioactive agent comprises or comprises freeze-dried thrombin.

[0085] In one embodiment of this disclosure, the thrombin is recombinant thrombin. In one embodiment of this disclosure, the thrombin is human thrombin.

[0086] The bioactive agent is advantageously reconstituted by a liquid that can dissolve the agent or keep it in an essentially stable suspension. Even more advantageously, the liquid is of a type that acts as a diluent, allowing for easy adjustment of the concentration of the bioactive agent. For example, thrombin can be readily dissolved and / or suspended in water, sterile water, saline, sterile saline, or a mixture of water and glycerol.

[0087] In one embodiment of the present disclosure, the liquid is a diluent. In further embodiments, the liquid is an aqueous medium selected from the group consisting of water, glycerol, sterile water, physiological saline, sterile saline solution, calcium chloride solution, buffered aqueous solution, and combinations thereof.

[0088] The reconstitution of dried preparations of bioactive agents such as thrombin traditionally involves using a needle-equipped syringe to withdraw the diluent from one separate vial and inject it into another separate vial containing the dried thrombin, then shaking or swirling the latter vial to thoroughly mix the two components. Next, using a needle-equipped syringe, the desired amount of the reconstituted bioactive agent is withdrawn from this vial. Because two separate containers are used, the person reconstituting the bioactive agent must be reliable and accurate in mixing the correct amount to produce the appropriate concentration of the mixture. Furthermore, the person reconstituting the bioactive agent must be quick, as time can be critical during medical procedures, for example, in the operating room (OR), where an incorrect concentration of bioactive agent can lead to increased blood loss and longer operating times for surgical procedures.

[0089] To ensure the rapid, easy, and fail-safe transfer of diluents and mixtures into and / or from vials, the vial adapter according to this disclosure is advantageously used for one or more vials. Furthermore, the absence of a snap fit on the vial cap provides a more flexible fastening of the vial adapter to the vial, thereby facilitating quicker attachment and removal.

[0090] The liquid mixture may be further transferred from a second vial, advantageously assisted by an attached vial adapter. For example, if the bioactive agent is of the type that acts as a coagulant, such as thrombin, the bioactive agent is further mixed into the fluid paste to act as a hemostatic matrix. To ensure that the paste acts as an efficient hemostatic matrix, the liquid mixture is transferred to the paste to ensure a sufficiently uniform mixing of the bioactive agent within the paste.

[0091] Thrombin is added to the paste of this disclosure in an amount sufficient to ensure effective hemostasis of the paste. In one embodiment, thrombin is present in concentrations ranging from about 100 IU / ml paste to about 500 IU / ml paste, for example, about 150 IU / ml paste to about 450 IU / ml paste, for example, about 200 IU / ml paste to about 400 IU / ml paste, for example, about 250 IU / ml paste to about 350 IU / ml paste.

[0092] In one embodiment, thrombin is present in the paste at a concentration ranging from about 50 IU / g paste to about 5000 IU / g paste, preferably about 100 IU / g paste to about 1000 IU / g paste, for example, in the range of about 200 IU / g paste to about 800 IU / g paste.

[0093] Advantageously, the components are pre-loaded into syringes, vials, and containers in predetermined amounts and ratios. Thus, the step of measuring the exact amount of components is avoided, and a predetermined amount of liquid mixture or paste is produced quickly, easily, and conveniently. However, complete liquid transfer is required to ensure the exact amount of mixture, which is facilitated by the simple and fail-safe vial adapter provided by this disclosure.

[0094] item This disclosure can be further described by referring to the following items. 1. A vial adapter comprising two axially extending chamber portions, the first chamber portion configured to slidably receive at least a portion of the vial crown, and the second chamber portion configured to slidably receive at least a portion of the vial body, wherein the first chamber portion and / or the second chamber portion each have one or more ribs extending radially inward from the chamber walls. 2. The vial adapter described in item 1, wherein the first chamber portion comprises a coherent cylindrical chamber wall. 3. The vial adapter according to item 1 or 2, wherein the second chamber portion comprises a coherent cylindrical chamber wall. 4. The vial adapter described in item 3, wherein the second chamber portion consists of a coherent cylindrical chamber wall. 5. The vial adapter according to any one of items 1 to 4, wherein the first chamber portion is configured to slidably receive at least 50% of the vial crown, such as at least 60, 70, 80, 90, or 100% of the vial crown. 6. The vial adapter according to any one of items 1 to 5, wherein the first chamber portion has an upper chamber wall comprising one or more spacers, such as 2 to 10 spacers, more preferably 3, 5, or 7 spacers. 7. The vial adapter according to item 6, wherein the distal end of the spacer has a spherical or hemispherical shape. 8. A vial adapter as described in any one of items 1 to 7, wherein the two chamber sections are cylindrical, and the inner diameter of the first chamber section is smaller than the inner diameter of the second chamber section. 9. The vial adapter according to any one of items 1 to 8, wherein the first chamber portion has an inner diameter of 10 to 50 mm, more preferably 15 to 40 mm, most preferably 20 to 30 mm, for example 23 or 25 mm. 10. The vial adapter according to any one of items 1 to 9, wherein the second chamber portion has an inner diameter of 10 to 50 mm, more preferably 20 to 40 mm, most preferably 25 to 30 mm, for example 27 or 29 mm. 11. The vial adapter according to any one of items 1 to 10, wherein the second chamber portion is configured to slidably receive at least 20% of the vial body, such as at least 25, 30, 40, 50, 60, 70, 80, 90, or 100% of the vial body. 12. A vial adapter as described in any one of items 1 to 11, having one or more radially inward ribs extending axially. 13. The vial adapter according to item 12, wherein axially extending ribs constitute a vial crown holder and / or vial body holder, for example, a wedge. 14. A vial adapter according to item 12 or 13, wherein the axially extending ribs have planar or annular portions, as seen in the cross-sectional view, for engaging with the vial crown and / or vial body. 15. The vial adapter according to item 14, wherein the axially extending ribs have a cross-sectional shape selected from the group of isosceles trapezoid, trilateral trapezoid, rectangle, or square. 16. A vial adapter according to any one of items 12 to 15, wherein axially extending ribs are configured to be elastically compressed outward toward the chamber wall. A vial adapter according to any one of items 12 to 16, comprising two or more axially extended ribs, preferably four axially extended ribs, such as 17.3, 4, 5, 6, 7, 8, 9, or 10 axially extended ribs. 18. A vial adapter according to any one of items 12 to 17, wherein axially extending ribs are arranged rotationally symmetrically within the cylindrical portion. 19. A vial adapter according to any one of items 12 to 18, wherein axially extending ribs are arranged at equal intervals along the circumference of the cylindrical portion. 20. A vial adapter as described in any one of items 12-19, wherein the axially extending rib extends inward at a radial angle of 90 degrees. 21. A vial adapter according to any one of items 12 to 19, wherein the axially extending ribs extend inward at a radial angle of less than 90 degrees, preferably at an angle of less than 80, 70, 60, 50, 40, or 30 degrees. 22. A vial adapter as described in item 21, wherein the axially extending ribs extend inward at the same radial angle. 23. A vial adapter as described in any one of items 12 to 22, wherein the inner extension of the axially extending rib varies along the axial extension. 24. The vial adapter described in item 23, wherein the inner extension of the axially extending rib is smaller toward the distal end. 25. A vial adapter according to any one of items 23 to 24, wherein the inner extension of the axially extending rib changes linearly along at least a portion of the axial extension. 26. A vial adapter according to any one of items 12 to 25, wherein the axially extending rib has a curved portion when viewed from the axial direction. 27. The vial adapter described in item 26, wherein axially extending ribs are formed as impeller blades when viewed from the axial direction. 28. A vial adapter according to any one of items 1 to 27, wherein one or more radially inward ribs are circumferentially extended ribs that extend along at least a portion of the circumference of the chamber wall. 29. The vial adapter according to item 28, wherein at least one circumferentially extending rib constitutes a vial crown holder and / or vial body holder. 30. A vial adapter according to item 28 or 29, wherein at least one circumferentially extending rib is configured to snap-fit ​​onto the vial crown. 31. A vial adapter according to any one of items 28 to 30, wherein at least one circumferentially extending rib is flexible. 32. A vial adapter as described in any one of items 28 to 31, comprising one or more circumferentially extending ribs, such as two, three, or four circumferentially extending ribs. 33. A vial adapter according to any one of items 28 to 32, wherein at least one circumferentially extending rib extends less than 50% of the circumference of the first chamber wall and / or the second chamber wall, e.g., 40%, 30%, 25%, 20%, 15%, 10%, or 5%. 34. A vial adapter as described in any one of items 28-33, wherein the length of the circumferentially extending rib is less than 2 cm, for example, less than 1.5 cm or less than 1 cm. 35. A vial adapter as described in any one of items 28-34, wherein at least one circumferentially extending rib extends inward at a 90-degree angle. 36. A vial adapter according to any one of items 28-34, wherein at least one circumferentially extending rib extends inward at an angle inclined toward the chamber portion. 37. A vial adapter according to any one of items 28 to 36, wherein at least one circumferentially extending rib has a rectangular or triangular shape as seen in the cross-sectional view. 38. The vial adapter according to item 37, wherein the circumferentially extending ribs have a triangular shape selected from the group of equilateral triangles, isosceles triangles, and scalene triangles, preferably scalene triangles, with the shorter legs of the triangles facing the upper chamber wall. 39. A vial adapter according to any one of items 28 to 38, wherein at least one circumferentially extending rib is located at the distal end of the first chamber portion. 40. A vial adapter according to any one of items 28 to 39, wherein at least one circumferentially extending rib is positioned at a distance of less than 50%, 40%, or 30% of the length of the first chamber from the distal end of the first chamber portion. 41. A vial adapter according to any one of items 28 to 40, wherein at least one circumferentially extending rib is adjacent to at least one circumferentially extending slit. 42. The vial adapter according to item 41, wherein at least one circumferentially extending slit is connected to at least one partially axially extending slit. 43. The vial adapter described in item 42, wherein at least one circumferentially extending slit is connected to two or more axially extending slits. 44. A vial adapter as described in item 43, wherein two or more axially extending slits extend toward the proximal and / or distal ends. 45. A vial adapter as described in any one of items 42-44, wherein the length of the circumferential slit is equal to or less than the length of the axial slit, for example, by at least 70%, 60%, 50%, 40%, or 30%. 46. ​​A vial adapter according to any one of items 42 to 45, wherein a circumferentially extending slit is located within a first chamber portion, and an axially extending slit is located within the first chamber portion and / or a second chamber portion. 47. A vial adapter according to any one of items 1 to 46, wherein the puncture member comprises a cylindrical portion and a conical tip portion. 48. The vial adapter according to any one of items 1 to 47, wherein the puncture member comprises a plurality of openings, more preferably 2 to 8 openings, for example 3, 4, or 5 openings. 49. The vial adapter according to item 48, wherein the opening is formed as a straight slit positioned along at least a portion of the cylindrical and conical portions of the puncture member. 50. The vial adapter according to any one of items 47 to 49, wherein the distal tip of the puncture member is located between 25 and 50 percent of the chamber length from the upper wall, more preferably between 30 and 45 percent, for example, 35, 37, 40, or 44 percent. 51. A vial adapter according to any one of items 47-50, wherein a circumferentially extending slit is positioned at essentially the same distance from the upper wall to the distal tip of the puncture member relative to the length of the chamber. 52. A vial adapter according to any one of items 28 to 51, wherein the circumferentially extending ribs are located 15 to 30%, more preferably 20 to 30%, for example, at least 23%, from the upper wall relative to the length of the chamber.

[0095] References [1] International Publication No. 99 / 27886 [Explanation of Symbols]

[0096] 1 vial 1.1 Vial Body 1.2 Bottom of the vial 1.3 Vial shoulder 1.4 Vial neck 1.5 Vial crown or vial cap 1.6 Cap bulkhead 2 vial adapters 2.1 Puncture Member 2.11 Puncture Member Opening 2.12 Tip of the puncture member 2.2 First Chamber Section 2.3 Second Chamber Section 3. Radial inner ribs 3.1 Ribs extending in the axial direction 3.2 Ribs extending in the circumferential direction 3.3 Slit 4 Spacers

Claims

1. comprising two chamber portions extending axially from each other, The first chamber portion is configured to slidably receive at least a portion of the vial crown, The second chamber portion is configured to slidably receive at least a portion of the vial body, The distal tip of the puncture member is located between 25 and 50 percent of the chamber length from the upper wall. A vial adapter in which the first chamber portion and the second chamber portion are each provided with one or more axially extending ribs extending radially inward from the chamber wall.

2. The vial adapter according to claim 1, wherein the second chamber portion comprises or is composed of a cylindrical chamber wall.

3. The vial adapter according to claim 1 or 2, wherein the axially extending ribs are configured as vial crown holders and / or vial body holders.

4. The vial adapter according to any one of claims 1 to 3, wherein the axially extending ribs are configured to be elastically compressed outward toward the chamber wall when a vial is inserted into the vial adapter.

5. The vial adapter according to any one of claims 1 to 4, wherein the axially extending rib comprises a planar or annular portion for engaging with the vial crown and / or the vial body.

6. The vial adapter according to claim 5, wherein the axially extending rib has a cross-sectional shape selected from the group consisting of isosceles trapezoid, trilateral trapezoid, rectangle, or square.

7. The vial adapter according to any one of claims 1 to 6, wherein the axially extending rib extends inward at a radial angle of less than 90 degrees.

8. The vial adapter according to any one of claims 1 to 7, wherein the one or more radially inner ribs are circumferentially extending ribs that extend along at least a portion of the circumference of the chamber wall.

9. The vial adapter according to claim 8, wherein at least one of the circumferentially extending ribs is configured to snap-fit ​​onto the vial crown.

10. The vial adapter according to claim 8 or 9, wherein at least one circumferentially extending rib is positioned at the distal end of the first chamber portion.

11. The vial adapter according to any one of claims 8 to 10, wherein at least one of the circumferentially extending ribs is adjacent to at least one circumferentially extending slit.

12. The vial adapter according to claim 11, wherein at least one circumferentially extending slit is connected to at least one partially axially extending slit.

13. The vial adapter according to claim 12, wherein the at least one circumferentially extending slit is connected to two or more axially extending slits.

14. The vial adapter according to any one of claims 1 to 13, wherein the puncture member comprises a cylindrical portion and a conical tip portion.

15. The vial adapter according to any one of claims 1 to 14, wherein the distal tip of the puncture member is located between 30 and 45% of the chamber length from the upper wall.

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