# US 11,439,755 B2 · Medication container having an end plug, use of a plug-securing part to secure an end plug in a medication container and plug-securing part

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- Number: US 11,439,755 B2
- Document ID: US11439755B2
- Status: Granted
- Kind: B2
- Application number: 16/613,260
- Filed: 2018-04-27
- Published: 2021-06-03
- Granted: 2022-09-13
- Earliest claimed: 2017-05-16
- Assignees: Vetter Pharma-Fertigung GmbH & Co. KG
- Applicants: Vetter Pharma-Fertigung GmbH & Co. KG
- Inventors: Joachim Glocker
- Web page: https://patentgrep.com/patent/US11439755B2

## CPC

- A61M 5/19: having more than one chamber
- A61J 1/062: {Carpules}
- A61J 1/1406: {Septums, pierceable membranes}
- A61J 1/16: Holders for containers
- A61M 5/002: {Packages specially adapted therefor, e.g. packages for syringes or needles or kits for diabetics}
- A61M 5/2448: {comprising means for injection of two or more media, e.g. by mixing}
- A61M 5/2466: {by piercing without internal pressure increase (A61M5/2429 takes precedence)}
- A61M 2005/2462: {by displacing occluding plugs}
- A61M 2005/3104: {Caps for syringes without needle}
- A61M 2005/3106: {Plugs for syringes without needle}
- A61M 2005/3121: {via the proximal end of a syringe, i.e. syringe end opposite to needle cannula mounting end}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE

## Abstract

A medicament container for a syringe or carpule has a base body surrounding an interior at least in sections. The base body has a central axis and a proximal opening. An end plug is arranged in the interior such that the end plug in the interior is displaceable along the central axis and separates a first proximal region of the interior from a second distal region of the interior. A plug securing part is at least partially insertable into the second region through the proximal opening. When inserted into the interior, the plug securing part is arranged closer to the proximal opening than the end plug and is fixedly held in the interior by the positive and/or non-positive connection at least in a holding area.

## Claims

### Claim 1

A medicament container, the medicament container comprising:
a base body that at least partially surrounds an interior, the base body having a central axis and a proximal opening, wherein the medicament container forms a dual chamber system; and
an end plug arranged in the interior and displaceable along the central axis, the end plug separates a first region of the interior from a second region of the interior, the first region being a distal region of the interior with respect to the end plug, the second region being proximal region of the interior with respect to the end plug, the medicament container including a plug securing part insertable at least partially into the second region of the interior through the proximal opening, the plug securing part, when inserted into the interior, being closer to the proximal opening than the end plug, and held, at least in a holding area, in a fixed position in the interior by a connection selected from a positive connection, a non-positive connection and a combination thereof, wherein the plug securing part has at least one elastic holding element with an elasticity that acts on the central axis at least radially, wherein the elastic holding element is configured to hold the plug securing part, when inserted into the interior, onto the base body.

### Claim 2 (depends on 1)

The medicament container according to claim 1, wherein the plug securing part is arranged in such a fixed position and/or relative to the end plug that a displacement of the end plug is limited in a proximal direction by the plug securing part.

### Claim 3 (depends on 1)

The medicament container according to claim 1, wherein the plug securing part interacts with an inner wall of the base body in a positive manner and/or non-positive manner.

### Claim 4 (depends on 1)

The medicament container according to claim 1, wherein, the elastic holding element is configured to hold plug onto an inner wall of the base body.

### Claim 5 (depends on 1)

The medicament container according to claim 1, wherein the elastic holding element is selected from a group consisting of:
a) a spring;
b) a vulcanized elastomer;
c) a material weakening zone; and
d) combinations thereof.

### Claim 6 (depends on 1)

The medicament container according to claim 1, wherein the elastic holding element includes a recess into material adjoining an outside perpendicular to the central axis is elastically deformable.

### Claim 7 (depends on 1)

The medicament container according to claim 1, wherein the plug securing part comprises, at least in a distal region of the plug securing part one of a round, cross-shaped and i-shaped cross-section.

### Claim 8 (depends on 1)

The medicament container according to claim 1, wherein the plug securing part has a stop structure, wherein the plug securing part comprises, in a region of the stop structure, at least a radial extension in an inserted state perpendicular to a central axis which is at least greater than a minimum but preferably greater than a maximum radial extension of the proximal opening of the base body so that an insertion depth of the plug securing part into the medicament container is limited by abutment of the stop structure against the medicament container.

### Claim 9 (depends on 1)

The medicament container according to claim 1, wherein a grip section is formed at a proximal end of the plug securing part, when inserted, which comprises at least one of:
a) an undercut structure;
b) material that is easy to grasp; and
c) a rough surface structure.

### Claim 10 (depends on 1)

The medicament container according to claim 1, wherein the medicament container has a safety indicator, which, in an inserted state of the plug securing part, is arranged in one area in which the plug securing part adjoins the base body, on the base body and on the plug securing part in such a way that the safety indicator is altered by a displacement of the plug securing part.

### Claim 11 (depends on 10)

The medicament container according to claim 10, wherein the safety indicator is selected from a label and a shrinkable sleeve.

### Claim 12 (depends on 10)

The medicament container according to claim 10, wherein the safety indicator is damaged or at least partially removed by a displacement of the plug securing part.

### Claim 13 (depends on 1)

The medicament container according to claim 1, wherein the plug securing part comprises polypropylene, polystyrene and/or at least one resin.

### Claim 14 (depends on 1)

The medicament container according to claim 1, wherein the plug securing part has an RFID chip.

### Claim 15 (depends on 1)

The medicament container according to claim 1, wherein the plug securing part is shaped such that, when inserted, it does not cover any outer peripheral surface of the medicament container.

### Claim 16 (depends on 1)

A method of using the plug securing part for securing the end plug in the medicament container according to claim 1, wherein the plug securing the part is inserted into the second region through the proximal opening so that it is positioned closer to the proximal opening than the end plug, wherein the plug securing part is held at least in a holding area of the second region of the medicament container by a positive connection and/or non-positive connection.

### Claim 17 (depends on 16)

The method according to claim 16, wherein the displacement of the end plug is limited by the plug securing part such that a sterility of the first region of the interior is ensured.

### Claim 18

A medicament container, the medicament container comprising:
a base body that at least partially surrounds an interior, the base body having a central axis and a proximal opening, wherein the medicament container forms a dual chamber system; and
an end plug arranged in the interior and displaceable along the central axis, the end plug separates a first region of the interior from a second region of the interior, the first region being a distal region of the interior with respect to the end plug, the second region being a proximal region of the interior with respect to the end plug, the medicament container including a plug securing part insertable at least partially into the second region of the interior through the proximal opening, the plug securing part, when inserted into the interior, being closer to the proximal opening than the end plug, and held, at least in a holding area, in a fixed position in the interior by a connection selected from a positive connection, a non-positive connection and a combination thereof,
wherein the medicament container has a safety indicator, which, in an inserted state of the plug securing part, is arranged in one area in which the plug securing part adjoins the base body, on the base body and on the plug securing part in such a way that the safety indicator is altered by a displacement of the plug securing part.

### Claim 19

A medicament container, the medicament container comprising:
a base body that at least partially surrounds an interior, the base body having a central axis and a proximal opening, wherein the medicament container forms a dual chamber system; and
an end plug arranged in the interior and displaceable along the central axis, the end plug separates a first region of the interior from a second region of the interior, the first region being a distal region of the interior with respect to the end plug, the second region being a proximal region of the interior with respect to the end plug, the medicament container including a plug securing part insertable at least partially into the second region of the interior through the proximal opening, the plug securing part, when inserted into the interior, being closer to the proximal opening than the end plug, and held, at least in a holding area, in a fixed position in the interior by a connection selected from a positive connection, a non-positive connection and a combination thereof,
wherein the plug securing part has a stop structure, wherein the plug securing part comprises, in a region of the stop structure, at least a radial extension in an inserted state perpendicular to a central axis which is at least greater than a minimum but preferably greater than a maximum radial extension of the proximal opening of the base body so that an insertion depth of the plug securing part into the medicament container is limited by abutment of the stop structure against the medicament container, and
wherein the stop structure is arranged at an axial distance from a distal end of the plug securing part that is less than or equal to an axial distance between a proximal end of the end plug and the proximal opening of the base body such that the end plug cannot be displaced by the plug securing part.

### Claim 20

A method of using a plug securing part for securing an end plug in a medicament container, the method comprising:
providing the medicament container, the medicament container including a base body that at least partially surrounds an interior, the base body having a central axis and a proximal opening, wherein the medicament container forms a dual chamber system;
arranging the end plug in the interior such that the end plug is displaceable along the central axis and, the end plug separates a first region of the interior from a second region of the interior, the first region being a distal region of the interior with respect to the end plug, the second region being a proximal region of the interior with respect to the end plug;
inserting the plug securing part at least partially into the second region of the interior through the proximal opening, the plug securing part, when inserted into the interior, being closer to the proximal opening than the end plug, and held, at least in a holding area, in a fixed position in the interior by a connection selected from a positive connection, a non-positive connection and a combination thereof, wherein the plug securing part is inserted into the second region through the proximal opening so that it is positioned closer to the proximal opening than the end plug, wherein the plug securing part is held at least in a holding area of the second region of the medicament container by the positive connection and/or the non-positive connection;
holding the plug securing part onto the base body when inserted into the interior by at least one elastic holding element of the plug securing part, the at least one elastic holding element having an elasticity acting on the central axis at least radially, and
subjecting the medicament container to a pressure gradient by a change in altitude and retaining the plug within the medicament container with the plug securing part.
