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

Patent metadata

Field	Value
Publication number	US-11896807-B2
Application number	US-202117248972-A
Country	US
Kind code	B2
Filing date	Feb 16, 2021
Priority date	May 31, 2016
Publication date	Feb 13, 2024
Grant date	Feb 13, 2024

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 assembling them into syringes, e.g., pre-filled syringes.

First claim

What is claimed is:

1. A convertible plunger comprising:
a. a first subassembly comprising a connector body having a distal end and a proximal end, the proximal end of the connector body comprising a recess or axial channel, 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 being configured to be secured to a plunger rod, the ring carrier comprising 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 ring carrier further comprising an annular insertion platform distal to the annular storage platform, the annular insertion platform having a smaller maximum diameter or cross-sectional width than the storage platform, the insertion platform being disposed in the recess or axial channel so as to fixedly secure the first subassembly to the second subassembly, 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 more rigid than the storage ring.

2. The convertible plunger of claim 1 , comprising a fluoropolymer film wrapped about the liquid sealing section.

3. The convertible plunger of claim 1 , wherein the storage ring includes at least two annular ribs separated by an annular valley therebetween.

4. The convertible plunger of claim 1 , wherein the storage ring in an uncompressed state comprises a rib on an inside surface of the storage ring and an opposing rib on the outer surface of the storage sealing section.

5. The convertible plunger of claim 1 , the storage ring comprising an outer surface facing generally radially outward away from the ring carrier, wherein when the storage ring is in an uncompressed state, the outer surface comprises a proximal end, a distal end and a radial plane of symmetry between the proximal and distal ends that is equidistant from the proximal and distal ends, wherein the outer surface is symmetrical on either side of the radial plane of symmetry.

6. The convertible plunger of claim 1 , the storage ring comprising an inner surface facing inward toward the ring carrier, the inner surface having a width that runs from a proximal end of the storage ring to a distal end of the storage ring, wherein, when the storage ring is uncompressed, the inner surface is symmetrical across the width of the inner surface of the storage ring.

7. The convertible plunger of claim 6 , wherein the storage ring includes at least two annular ribs separated by an annular valley therebetween.

8. 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 disposed within the medical barrel, the convertible plunger comprising:
(I) 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;
(II) 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 being configured to be secured to a plunger rod, the ring carrier comprising 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;
(III) wherein the storage platform is more rigid than the storage ring;

wherein the storage sealing section, when the storage ring is disposed about the storage platform, is maintained in an expanded state by outward radial pressure provided by the storage platform to create compression between the storage sealing section and the inner wall of the barrel, thereby rendering the convertible plunger in storage mode, the expanded state being reducible to a constricted state upon transitioning the storage ring to being disposed about the dispensing platform whereupon the compression between the storage sealing section and the inner wall of the barrel is reduced or eliminated, thereby rendering the convertible plunger in dispensing mode.

9. The pre-filled syringe of claim 8 , wherein the entire storage ring is disposed about the storage platform when the plunger is in storage mode.

10. The pre-filled syringe of claim 9 , wherein the entire storage ring is disposed about the dispensing platform when the plunger is in dispensing mode.

11. The pre-filled syringe of claim 8 , 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.

12. The pre-filled syringe of claim 11 , wherein the convertible plunger in storage mode is configured to transition to dispensing mode upon providing an actuation force onto the convertible plunger in a distal direction.

13. The pre-filled syringe of claim 8 , the proximal end of the connector body comprising a recess or axial channel, the ring carrier further comprising an annular insertion platform distal to the annular storage platform, the annular insertion platform having a smaller maximum diameter or cross-sectional width than the storage platform, wherein the insertion platform is configured to be disposed in the recess or axial channel so as to fixedly secure the first subassembly to the second subassembly.

14. A method for assembling the convertible plunger into the pre-filled syringe of claim 13 , the method comprising the following steps:
i. loading the first subassembly into the medical barrel through the open proximal end thereof;
ii. positioning the storage ring about the insertion platform so as to place the storage ring in a load position and axially aligning the second subassembly with the first subassembly;
iii. after step (ii) and while the storage ring is in the load position, disposing the second subassembly into the open proximal end of the medical barrel at least to a depth in which the storage ring is disposed within the medical barrel; and
iv. securing the first subassembly to the second subassembly by disposing the insertion platform in the recess or axial channel, thereby assembling the convertible plunger;
wherein step (iv) causes the storage ring to move from the load position to the expanded state, thereby placing the plunger in storage mode.

15. The method of claim 14 , wherein the storage sealing secti

Assignees

• Sio2 Medical Products Inc
• Sio2 Mat Products Inc

Inventors

• Lilly Brian Russell
• Kelly Kenneth Wade
• Rogers Joseph W
• Giraud Jean-Pierre
• Rabinne Bruce
• Pichot Herve
• Hunt Benjamin
• Freeman Zachary Dean
• Roe Dalton
• Abrams Robert S

Classifications

• A61M5/31513 Primary

  Piston constructions to improve sealing or sliding · CPC title

• A61F9/0008

  Introducing ophthalmic products into the ocular cavity or retaining products therein (putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00) · CPC title

• A61M2005/3101

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

• A61M2005/3121

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

• A61M2207/00

  Methods of manufacture, assembly or production · CPC title