Convertible plungers and methods for assembling the same in a medical barrel

Patent metadata

Field	Value
Publication number	US-2018200450-A1
Application number	US-201615744496-A
Country	US
Kind code	A1
Filing date	Jul 13, 2016
Priority date	Jul 14, 2015
Publication date	Jul 19, 2018
Grant date	—

Abstract

Disclosed are plunger assemblies including various convertible plungers and methods of making the same. Each plunger assembly is configured for disposition within a barrel of a medical container, e.g., a syringe, and displaced within the barrel from an engagement position to a release position. The engagement position is configured to provide a compression seal between a storage sealing section of the plunger and an inner wall of the syringe barrel. In the release position, the compression seal is reduced or eliminated. Also disclosed are methods for making convertible plungers and as assembling them into syringes, e.g., pre-filled syringes.

First claim

What is claimed is:

1 . A convertible plunger comprising:
a. an internal portion and a generally cylindrical exterior surface that surrounds at least part of the internal portion; b. the generally cylindrical exterior surface comprising a compressible and resilient storage sealing section that is maintained in an expanded state by outward radial pressure provided by the internal portion; c. the internal portion being comparatively more rigid than the storage sealing section; d. the expanded state being reducible to a constricted state by an operation that is applied to the internal portion of the plunger to reduce or eliminate the outward radial pressure; e. the storage sealing section in the constricted state:
i. having a reduced maximum diameter or cross-sectional width than the storage sealing section in the expanded state; and/or
ii. being less resistant to inward radial compression compared to the storage sealing section in the expanded state;
f. wherein the storage sealing section is configured to be set in the expanded state through application of a setting force onto the convertible plunger in a distal direction when the convertible plunger is disposed in a medical barrel; g. the operation being application of an actuation force onto the convertible plunger in the distal direction when the convertible plunger is disposed in the medical barrel; h. the convertible plunger further including a liquid sealing section on a distal end of the convertible plunger, the liquid sealing section having a generally cylindrical exterior surface configured to provide a seal against an inner wall of the medical barrel when the convertible plunger is disposed therein, the liquid sealing section having a film or a cap covering a product-facing surface and a sidewall of the liquid sealing section.

2 . A pre-filled syringe comprising:
a. a medical barrel having an inner wall and an injectable drug product disposed in a product containing area of the medical barrel, the medical barrel having a distal dispensing end for dispensing the injectable drug product and an open proximal end configured for receipt of a convertible plunger; and b. a convertible plunger according to claim 1 disposed within the medical barrel.

3 . (canceled)

4 . A convertible plunger comprising:
a. an internal portion and a generally cylindrical exterior surface that surrounds at least part of the internal portion; b. the generally cylindrical exterior surface comprising a compressible and resilient storage sealing section that is maintained in an expanded state by outward radial pressure provided by the internal portion; c. the internal portion being comparatively more rigid than the storage sealing section; d. the expanded state being reducible to a constricted state by an operation that is applied to the internal portion of the plunger to reduce or eliminate the outward radial pressure; e. the storage sealing section in the constricted state:
i. having a reduced maximum diameter or cross-sectional width than the storage sealing section in the expanded state; and/or
ii. being less resistant to inward radial compression compared to the storage sealing section in the expanded state;
f. a plunger head provided at a distal end of the convertible plunger, the plunger head comprising a liquid sealing section configured to provide a liquid tight seal and a CCI seal against an inner wall of a medical barrel, wherein the plunger head comprises a first component; g. the storage sealing section being mounted to and axially movable about a second component or integral with the second component; h. wherein the first component and second component are separate components that are assembled to form the convertible plunger.

5 . A pre-filled syringe comprising:
a. a medical barrel having an inner wall and an injectable drug product disposed in a product containing area of the medical barrel, the medical barrel having a distal dispensing end for dispensing the injectable drug product and an open proximal end configured for receipt of a convertible plunger; and b. a convertible plunger according to claim 4 disposed within the medical barrel.

6 .- 9 . (canceled)

10 . The syringe of claim 2 , wherein flowable lubricant is absent from the product containing area.

11 . The syringe of claim 2 , wherein the barrel is made from an injection moldable thermoplastic resin and has an organo-siloxane coating or layer on the interior wall thereof.

12 .- 13 . (canceled)

14 . The syringe of claim 2 , wherein the storage sealing section in the expanded state forms a CCI and gas-tight seal over a product shelf-life of 24 months.

15 . The syringe of claim 2 , wherein the plunger provides a break loose force and glide force below 10 N and wherein the plunger provides a differential between break loose force and glide force of below 1.0 N, entirely without the presence of a flowable lubricant between the barrel and the plunger's barrel-contacting surfaces.

16 .- 18 . (canceled)

19 . The syringe of claim 2 , wherein the storage sealing section includes at least two annular ribs separated by an annular valley therebetween.

20 .- 22 . (canceled)

23 . The syringe of claim 2 , wherein the syringe is a component of an auto injector.

24 .- 25 . (canceled)

26 . The syringe of claim 2 , wherein the storage sealing section is on an outer storage ring disposed about the convertible plunger, the convertible plunger being configured to axially translate distally relative to the storage ring when transitioning from storage mode to dispensing mode.

27 . The syringe of claim 2 ,
a. the injectable drug product comprising a polypeptide composition or protein composition that is susceptible to one or more of the following negative effects from interaction with particles generated from a flowable lubricant:
i. denaturing of proteins in the composition;
ii. agglomeration of proteins in the composition;
iii. degradation of proteins in the composition;
iv. triggering an undesired immune response in a patient; and
v. degrading efficacy of the drug product;
b. wherein flowable lubricant-generated particles are absent from the drug product such that the drug product is not subject to the one or more of the negative effects from flowable lubricant-generated particles.

28 .- 30 . (canceled)

31 . A convertible plunger comprising:
a. a first subassembly comprising a connector body having a distal end and a proximal end, the first subassembly further comprising a plunger head, which is a separate component that is assembled to the distal end of the connector body, the plunger head having a liquid sealing section configured to contact and provide a seal against an interior wall of a medical barrel when disposed therein; b. a second subassembly comprising an elongate ring carrier having a distal end and a proximal end, the distal end of the ring carrier being secured to the proximal end of first subassembly, the proximal end of the ring carrier configured to be secured to a plunger rod, the ring carrier comprising, from its proximal end, an annular dispensing platform and an annular storage platform distal to the dispensing platform, the annular storage platform having a larger maximum diameter or cross-sectional width than the dispensing platform, the second subassembly further comprising a compressible and resilient storage ring disposed about the ring carrier and configured to displace axially thereon; c. wherein the storage platform is comparativ

Assignees

• Sio2 Medical Products Inc

Inventors

• Lilly Brian Russell
• Kelly Kenneth Wade
• Rogers Joseph W
• Giraud Jean-Pierre
• Rabinne Bruce
• Hunt Benjamin
• Freeman Zachary Dean

Classifications

• A61M2005/3121

  via the proximal end of a syringe, i.e. syringe end opposite to needle cannula mounting end · CPC title

• A61M5/31513 Primary

  Piston constructions to improve sealing or sliding · CPC title

• A61M2205/0216

  Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking · CPC title

• A61M2005/3101

  Leak prevention means for proximal end of syringes, i.e. syringe end opposite to needle mounting end · CPC title