JP-7857294-B2 - Vial adapter

Inventors

• ハンマースホイ， ピーター ルンド
• イグウェビケ， ヘニング ウゾマ
• ペルソン， トミー レナート
• ルビー， トルベン

Assignees

• フェロサン メディカル デバイシーズ エイ／エス

Dates

Publication Date

20260512

Application Date

20211129

Priority Date

20201127

Claims (15)

1. It comprises two chamber sections that extend 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 wherein the first chamber portion and the second chamber portion each have 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 of the circumferentially extending ribs is located 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.

Description

This invention relates to a vial adapter. Bioactive agents are typically stored in medicinal vials, which are vials closed with a puncturable rubber stopper or a vial stopper or cap with a septum. The cap may be removably attached to the vial, or, for example, resealably sealed to the vial. Often, the cap forms a flange extending radially outward from the neck and body of the vial, as shown in Figure 1. Because bioactive agents are expensive and drug waste is undesirable, they are typically stored in vials in a solid and/or dry state, which improves chemical stability and allows for longer storage times. Therefore, pharmaceutical vials typically contain powdered and/or lyophilized drugs or bioactive agents. Prior to administration, such as by injection, the solid bioactive agent can be reconstituted by mixing it with a liquid so that the bioactive agent can be easily withdrawn from the vial, for example, by a syringe. Therefore, liquid transfer between the vial and syringe is necessary for both reconstitution and drug aspiration. To ensure rapid and safe liquid transfer into and from vials, vial adapters can be used. A vial adapter is a liquid transfer device having a puncture member for puncturing or perforating the cap's partition and a fluid transfer port that communicates with the puncture member to allow access to the inside of the vial via the fluid transfer port. The vial adapter is attached to the vial before liquid transfer. 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. Furthermore, the cylindrical chamber may 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]. This disclosure provides a vial adapter that is faster, easier, more fail-safe, and more flexible for fastening the vial adapter to the vial. 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 comprising 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 are provided with 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 is provided with 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. In a preferred embodiment, the first and second chamber portions comprise or are composed of coherent cylindrical chamber walls. In a more preferred embodiment, one or more radially inward ribs are axially extended ribs. In a further preferred embodiment, the axially extended ribs are optionally configured as retainers or wedges for the vial crown and are elastically compressed outward toward the chamber wall. 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. In another or further embodiment, the puncture member of the vial adapter comprises a cylindrical portion and a conical tip portion. The present invention will be described in more detail below with reference to the accompanying drawings. 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. 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. This is a 3D cross-sectional view of a vial adapter according to the present disclosure, which has axially extending ribs. Outline view (A) and cross-sectional view (B) of the vial adapter according to this disclosure, which has axially extending ribs. Outline view (A) and cross-sectional view (B) of a vial adapte