Three-position plungers, film coated plungers and related syringe assemblies

Patent metadata

Field	Value
Publication number	US-2017296756-A1
Application number	US-201515510777-A
Country	US
Kind code	A1
Filing date	Oct 14, 2014
Priority date	Sep 10, 2014
Publication date	Oct 19, 2017
Grant date	—

Abstract

A three-position plunger is provided including a sleeve having an opening at a distal end, a pre-load cavity proximal to and in communication with the opening, a first cavity proximal to and in communication with the pre-load cavity, a second cavity proximal to and in communication with the pre-load cavity, and at least one rib. The rib(s) is generally aligned with the first cavity. The plunger further includes an insert configured to be displaced from the pre-load cavity to the first cavity and from the first cavity to the second cavity. The insert is configured to provide support for the compression of the rib(s) when the insert is positioned in the first cavity.

First claim

What is claimed is:

1 . A three-position plunger comprising: a sleeve having an opening at a distal end thereof, a pre-load cavity proximal to and in communication with the opening, a first cavity proximal to and in communication with the pre-load cavity, a second cavity proximal to and in communication with the pre-load cavity, and at least one rib, the at least one rib being generally aligned with the first cavity; and an insert configured to be displaced from the pre-load cavity to the first cavity and from the first cavity to the second cavity, the insert being configured to provide support for the compression of the at least one rib when the insert is positioned in the first cavity.

2 . The three-position plunger of claim 1 , further including a connector body operably connected to the sleeve, wherein a portion of the connector body is positioned within the sleeve and is configured to provide support for compression of the sleeve against an inner surface of a sidewall of a barrel.

3 . The three-position plunger of claim 2 , further including a plunger rod having a shaft configured to displace the insert from the first cavity to the second cavity when the shaft is displaced from a first position to a second position, wherein the plunger rod is operably connected to the connector body.

4 . The three-position plunger of claim 1 , further including a film coating or molded cap on at least a portion of the sleeve, wherein the film coating or molded cap has a lubricity that is greater than a lubricity of a material of a sidewall of the plunger.

5 . A syringe comprising a three-position plunger of claim 1 disposed therein, the syringe being made form an injection moldable thermoplastic material, the syringe comprising an organo-siloxane coating or layer, as a plunger-contacting surface, substantially without presence of a flowable lubricant.

6 . The syringe of claim 5 , wherein the organo-siloxane coating or layer is a pH protective coating, as a top layer of a trilayer coating set.

7 . The syringe of claim 5 , wherein the syringe is a prefilled syringe comprising a drug product contained within a product containing area.

8 . A prefilled syringe comprising a barrel having an inner wall and a drug product contained within a product containing area, the prefilled syringe further comprising a convertible plunger having an internal portion and a generally cylindrical exterior surface, wherein at least a portion of the exterior surface is maintained in an initial expanded state by a property of the internal portion, the expanded state providing a compressive force against the inner wall, the plunger being reducible to a constricted state wherein the compressive force against the inner wall is reduced or removed by an operation that is applied to the internal portion of the plunger to alter the property, the syringe being made from an injection moldable thermoplastic material, wherein the convertible plunger provides a break loose force and glide force below 10 N, substantially without the presence of a flowable lubricant between the exterior surface of the convertible plunger and the inner wall of the barrel.

9 . The prefilled syringe of claim 8 , wherein the break loose force is less than 2N higher than the glide force.

10 . The prefilled syringe of claim 8 , comprising an organo-siloxane coating or layer, as a plunger-contacting surface.

11 . The prefilled syringe of claim 8 , wherein the organo-siloxane coating or layer is a pH protective coating, as a top layer of a trilayer coating set.

12 . The prefilled syringe of claim 8 , wherein the property is mechanically produced outward radial pressure provided by a solid compression material, wherein the operation comprises axially displacing the solid compression material within the internal portion of the plunger.

13 . The prefilled syringe of claim 12 , wherein the operation comprises axially displacing the solid compression material from a first cavity to a second cavity within the internal portion of the plunger.

14 . The prefilled syringe of claim 8 , wherein the convertible plunger provides a break loose force and glide force below 7 N and wherein the break loose force is less than 1.5 N higher than the glide force.

15 . The prefilled syringe of claim 8 , wherein the initial expanded state provides container closure integrity for the drug product over a desired shelf-life, as demonstrated by a vacuum decay leak detection method.

16 . The prefilled syringe of claim 15 , wherein the initial expanded state provides sterility and a gas barrier for the drug product over a desired shelf-life.

17 . The prefilled syringe of claim 8 , wherein the syringe barrel is made from an injection moldable thermoplastic material.

18 . The prefilled syringe of claim 8 , wherein the syringe barrel is made from glass.

19 . The prefilled syringe of claim 8 , wherein the convertible plunger is comprised of a sleeve, the sleeve including a film coating or molded cap on at least a portion of the sleeve, wherein the film coating or molded cap has a lubricity that is greater than a lubricity of a material of a sidewall of the plunger.

20 . A method of assembling a syringe having a convertible plunger, the method comprising the steps of:
a. providing a syringe barrel, the syringe barrel having a plunger-insertion opening; b. providing a three-position plunger comprising: a sleeve having an opening at a distal end thereof, a pre-load cavity proximal to and in communication with the opening, a first cavity proximal to and in communication with the pre-load cavity, a second cavity proximal to and in communication with the pre-load cavity, and at least one rib, the at least one rib being generally aligned with the first cavity; and an insert configured to be displaced from the pre-load cavity to the first cavity and from the first cavity to the second cavity, the insert being configured to provide support for the compression of the at least one rib when the insert is positioned in the first cavity; and c. inserting the three-position plunger into the plunger-insertion opening of the syringe barrel while the insert is disposed in the pre-load cavity and advancing the insert into the first cavity once the sleeve has been fully inserted into the barrel.

Assignees

• Sio2 Medical Products Inc

Inventors

• Giraud Jean-Pierre
• Sol Bernard
• Pangborn Robert J
• Abrams Robert S
• Rogers Joseph W
• Sagona Peter J
• Mims Michael J

Classifications

• A61L31/14

  Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials} · CPC title

• A61L31/10

  Macromolecular materials · CPC title

• A61M2205/0238

  the material being a coating or protective layer · CPC title

• A61M2207/00

  Methods of manufacture, assembly or production · CPC title

• A61L2400/10

  Materials for lubricating medical devices · CPC title