Dead end container and container assembly with dead end container

Patent metadata

Field	Value
Publication number	US-2021060256-A1
Application number	US-202017011676-A
Country	US
Kind code	A1
Filing date	Sep 3, 2020
Priority date	Sep 4, 2019
Publication date	Mar 4, 2021
Grant date	—

Abstract

A container for accommodating pharmaceutical compositions, which is installable in a medical device, is provided. The container includes a hollow cylindrical body having an open end and a dead end opposite to the open end. The dead end is closed by a bottom portion. The hollow cylindrical body and the bottom portion are formed integrally and of the same material. The bottom portion transitions into the hollow cylindrical body via a curved heel that is defined by an outer radius r o , an inner radius r i and a thickness d h in a center portion of the curved heel, wherein the following condition is fulfilled: r i +d h −r o >0 mm.

First claim

What is claimed is:

1 . A container for accommodating pharmaceutical compositions, the container comprising:
a hollow cylindrical body having an open end and a dead end opposite to the open end, the open end being configured to receive a plunger that is slidable relative to the hollow cylindrical body from the open end towards the dead end; a bottom portion closing the dead end, the hollow cylindrical body and the bottom portion being formed integrally and of a common material, the common material comprises glass or polymer a curved heel between the bottom portion and the hollow cylindrical body, wherein the curved heel is defined by an outer radius (r o ) in mm, an inner radius (r i ) in mm, and a thickness (d h ) in mm in a center portion of the curved heel, and wherein the curved heel fulfills: r i +d h −r o >0 mm.

2 . The container of claim 1 , wherein the hollow cylindrical body has a length (L) in mm, an outer diameter (D O ) in mm, an inner diameter (D I ) in mm, a difference (D) between the outer diameter (D O ) and the inner diameter (D I ) in mm,
wherein the common material has a tensile strength (Ts) in MPa, and wherein 1.00 MPa≤A≤12.00 MPa, where A=D×Ts±L.

3 . The container of claim 1 , wherein the hollow cylindrical body has a length (L) in mm, an outer diameter (D o ) in mm, an inner diameter (D I ) in mm, a difference (D) between the outer diameter (D O ) and the inner diameter (D I ) in mm,
wherein the common material has a Young's modulus (E) in GPa, and wherein 0.10 GPa.≤B≤10.00 GPa, where B=D×E±L.

4 . The container of claim 1 , further comprising a pressure compliance of at least 0.64 N/mm 2 ×(inner diameter) 2 .

5 . The container of claim 1 , wherein the hollow cylindrical body has a wall thickness (d w ) in mm, a length (L) between 35 mm and 120 mm, an outer diameter (D o ) between 8.65 mm and 30 mm, an inner diameter (D I ) between 4.65 mm and 27 mm, and a ratio of the length (L) to the outer diameter (D O ) of between 3:1 and 15:1.

6 . The container of claim 1 , wherein the hollow cylindrical body has an outer diameter (D O ) in mm, an inner diameter (D I ) in mm, and a length (L) in mm, wherein the outer diameter (D O ) and/or the inner diameter (D I ) varies not more than 5% over the length (L).

7 . The container of claim 1 , further comprising a burst pressure of at least 110% compared to an identical container with a curved heel that does not fulfill r i +d h −r o >0 mm.

8 . The container of claim 1 , further comprising a vertical load strength of at least 110% compared to an identical container with a curved heel that does not fulfill r i +d h −r o >0 mm.

9 . The container of claim 1 , wherein the hollow cylindrical body has a wall thickness (d w ) in mm, and wherein one or more of the following conditions is/are fulfilled:
d h 3 ±(r o ×d w )>0.8 mm, [100×(d h 3 ×r i )±(d w ×D O 2 )]+(4.4 mm 2 ±D O )>0.55 mm, and r i >0.7 mm.

10 . The container of claim 1 , wherein the bottom portion is a circular bottom having a minimum thickness (d b,min ), and wherein d h ±d b,min <3.0.

11 . The container of claim 1 , wherein the common material is selected from a group consisting of borosilicate glass, alumino-silicate glass, soda lime glass, and a fused silica.

12 . The container of claim 1 , wherein the common material is cycloolefin copolymer or cycloolefin polymer.

13 . The container of claim 1 , further comprising an inner surface having an average Zn-leachability of 0.00085 μg/cm 2 or less.

14 . The container of claim 1 , further comprising an inner surface having an average Zn-leachability of 0.00055 μg/mm 2 or less.

15 . A container assembly for accommodating pharmaceutical compositions, the container assembly comprising:
a plunger configured to be pierceable by a cannula; a hollow cylindrical body having an open end and a dead end opposite to the open end, the open end receiving the plunger at the open end so as to sealingly close the open end, the plunger being slidable relative to the hollow cylindrical body from the open end towards the dead end; a bottom portion closing the dead end, the hollow cylindrical body and the bottom portion being formed integrally and of a common material, the common material comprises glass or polymer a curved heel between the bottom portion and the hollow cylindrical body, wherein the curved heel is defined by an outer radius (r o ) in mm, an inner radius (r i ) in mm, and a thickness (d h ) in mm in a center portion of the curved heel, and wherein the curved heel fulfills: r i +d h −r o >0 mm.

16 . The container assembly of claim 15 , further comprising a burst pressure of at least 110% compared to an identical container with a curved heel that does not fulfill r i +d h −r o >0 mm.

17 . The container of claim 15 , further comprising a vertical load strength of at least 110% compared to an identical container with a curved heel that does not fulfill r i +d h −r o >0 mm.

18 . The container assembly of claim 15 , wherein the hollow cylindrical body has a length (L) in mm, an outer diameter (D O ) in mm, an inner diameter (D I ) in mm, a difference (D) between the outer diameter (D O ) and the inner diameter (D I ) in mm,
wherein the common material has a tensile strength (Ts) in MPa and a Young's modulus (E) in GPa, wherein 1.00 MPa≤A≤12.00 MPa, where A=D×Ts±L, and/or wherein 0.10 GPa.≤B≤10.00 GPa, where B=D×E±L.

19 . The container assembly of claim 15 , further comprising a pharmaceutical composition in the hollow cylindrical body.

20 . A medical device for expelling or injecting pharmaceutical compositions, comprising:
the container assembly of claim 19 ; a cannula for expelling the pharmaceutical composition from the container assembly through the cannula, wherein the cannula is arranged so as to pierce the plunger upon actuation, and an actuation mechanism configured to move the container and the plunger relative to each other in a substantially axial direction to apply pressure to the pharmaceutical composition accommodated in the container for expelling the pharmaceutical composition through the cannula.

Assignees

• Schott Schweiz Ag

Inventors

• Kloke Arne
• Busimi Anil-Kumar
• Bauert Dominique

Classifications

• A61M5/3129 Primary

  Syringe barrels (A61M5/3205 and A61M5/50 take precedence) · CPC title

• A61M5/31511

  Piston or piston-rod constructions, e.g. connection of piston with piston-rod (A61M5/5066 takes precedence) · CPC title

• A61M2005/3131

  specially adapted for improving sealing or sliding · CPC title

• B01L3/5082 Primary

  Test tubes per se · CPC title

• A61J7/0053

  Syringes, pipettes or oral dispensers · CPC title