Apparatus for removing samples from systems having flexible walls and for introducing fluids into the same

• US 8,408,078 B2
• Filed: 03/05/2007
• Issued: 04/02/2013
• Est. Priority Date: 03/29/2006
• Status: Active Grant

• Current Assignee: Sartorius Stedim Biotech GmbH (Sartorius AG)
• Original Assignee: Sartorius Stedim Biotech GmbH (Sartorius AG)
• Inventors: Mennenga, Heyo, Reif, Oscar-Werner, Schmidt, Dieter, Vogt, Reinhard
• Primary Examiner(s): Williams, Hezron E
• Assistant Examiner(s): FAYYAZ, NASHMIYA SAQIB
• Application Number:
  US11/713,978
• Publication Number:
  US 20070227270A1
• Time in Patent Office: 2,220 Days
• Field of Search: 7386381-86385
• US Class Current: 73/863.85
• CPC Class Codes: A61J 1/12 with means for holding samples of contents
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• CPC Class Codes: C12M 33/00 Means for introduction, transport, positioning, extraction, harvesting, peeling or sampling of biological material in or from the apparatus chemical or physical laboratory apparatus in general B01L, devices for taking cell samples A61B10/0045, withdrawing or distributing predetermined quantities of fluid B01L99/00
• CPC Class Codes: C12M 37/04 Seals
• CPC Class Codes: G01N 2001/1056 Disposable (single-use) samplers
• CPC Class Codes: G01N 35/1079 with means for piercing stoppers or septums

Abstract

The invention discloses an apparatus for removing samples or introducing fluids from/into system(s) having flexible walls. A sampler/fluid dispenser (3) is fixed on the outside with a connecting area (4) of its base (5) on a sample removal region/fluid dispensing region (6) of the flexible wall (2) and, in its interior, has a severing element (8). At least the severing element (8) can be pushed forward in the direction of the sample removal region/fluid dispensing region (6) in order to remove the samples and in order to introduce fluids, in such a way that the wall (2) can be perforated within the sample removal region/fluid dispensing region (6). The system (1) comprises containers, bags or tubes for filling, mixing, transporting, storage of media, such as biological liquids, sera, buffers, ultra-pure water and can be used as biological reactors or cell culture vessels in the pharmaceutical and biotechnical industry.

Claims

1. Apparatus for removing samples from a system (1) having at least one flexible wall (2) and for introducing fluids into the system (1), the apparatus comprising:

at least one sampler/fluid dispenser (3) that includes a hard part (14) having opposite front and rear ends;

a severing element (8) having an intermediate region mounted in the hard part (14) and a severing end projecting from the front end of the hard part (14), the intermediate region of the severing element (8) being bent angularly relative to the severing end, a sampling tube (10) being connected to an end of the severing element (8) opposite the severing end and extending angularly from the hard part (14) at a position between the front and rear ends of the hard part (14); and

a substantially tubular base (5) with an open end mounted to the hard part (14) at locations spaced outward from the severing element (8) so that the open end of the substantially tubular base (5) is spaced from the severing element (8), the substantially tubular base (5) further having a closed connecting area (4) remote from the hard part (14) and configured to fix the sampler/fluid dispenser (3) in a fluid tight manner on a sample removal region/fluid dispensing region (6) defined on an outer side of the wall (2) of the system (1), portions of the tubular base (5) between the open end and the closed connecting area (4) being spaced outward from the severing element (8) and being elastic and radially unconfined, the base (5) of the sampler/fluid dispenser (3) being formed as a septum (13), the septum (13) being flexible so that the shape of the septum (13) matches an outer contour of the flexible wall (2) in the sample removal region/fluid dispensing region (6) and so that a pushing of the hard part (14) toward the sample removal region/fluid dispensing region (6) causes the severing element (8) to move through the flexible septum (13) and into an interior of the system (1).

2. Apparatus according to claim 1, wherein system (1) and the sampler/fluid dispenser (3) are internally sterile and the sample removal region/fluid dispensing region (6) and the connecting area (4) are germ free.

3. Apparatus according to claim 1, further comprising a removable protective film covering the connecting area (4).

4. Apparatus according to claim 1, wherein the system (1) comprises at least one bag and/or tube.

5. Apparatus according to claim 1, wherein the fixing to the connecting area (4) is implemented by means of a sterilizing adhesive.

6. Apparatus for sterile transfer of liquid sample, comprising:

a system (1) having at least one flexible wall (2) defining a sterile interior for the system (1), the flexible wall (2) having a sample removal region/fluid dispensing region (6) on an outer surface of the flexible wall (2);

a flexible tubular septum (13) having a closed end defining a connecting area (4) fixedly connected on the outer surface of the sample removal region/fluid dispensing region (6) in substantially face-to-face contact and in a fluid tight manner, the flexible tubular septum (13) further having an open end opposite the closed end, a mounting area adjacent the open end and a flexible tubular part extending from the mounting area to the connecting area (4);

a hard handheld part (14) having opposite front and rear ends, the front end of the hard handheld part (14) being mounted over the mounting area and the open end of the flexible tubular septum (13) so that the tubular part of the flexible tubular septum (13) extends from the hard handheld part (14) to the connecting area (4) and is radially unconfined; and

a severing element (8) having an intermediate portion embedded in the hard handheld part (14) and a leading end projecting from the front end of the hard handheld part (14) toward the connecting area (4) of the flexible tubular septum (13), the intermediate portion of the severing element (8) being bent angularly relative to the leading end, a sampling tube (10) being connected to a rear end of the severing element (8) and extending angularly from the hard handheld part (14) at a position between the front and rear ends of the hard handheld part (14), the severing element (8) being spaced inwardly from the flexible tubular septum (13) at locations on the flexible tubular septum (13) connected to the hard handheld part (14), wherein a pushing of the hard handheld part (14) toward the sample removable region/fluid dispensing region (6) causes the leading end of the severing element (8) to move through the connecting area (4) of the flexible tubular septum (13) and through the sample removal region/fluid dispensing region (6) to which the connecting area (4) is fixedly connected.

7. The apparatus of claim 6, further comprising a sterilizing adhesive connecting the flexible tubular septum (13) to the sample removal region/fluid dispensing region (6) in a fluid tight manner.