# US 12,109,399 B2 · Plunger rod and assembly having modified thread geometry

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- Number: US 12,109,399 B2
- Document ID: US12109399B2
- Status: Granted
- Kind: B2
- Application number: 16/973,830
- Filed: 2019-06-21
- Published: 2021-08-19
- Granted: 2024-10-08
- Earliest claimed: 2018-06-21
- Assignees: West Pharmaceutical Services, Inc.
- Applicants: West Pharmaceutical Services, Inc.
- Inventors: James Thompson; Lauren Shafer Greenberg; Matthew Dylan Sweeney
- Web page: https://patentgrep.com/patent/US12109399B2

## CPC

- A61M 5/31515: {Connection of piston with piston rod}
- A61L 2/18: Liquid substances
- A61L 2103/23: {Containers other than laboratory or medical, e.g. bottles or mail}
- A61M 2005/31516: {reducing dead-space in the syringe barrel after delivery}
- A61M 2205/02: characterised by a particular materials
- 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)}
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

A fluid-dispensing syringe includes a barrel and a plunger assembly disposed within the barrel. The assembly includes a piston with an outer piston surface, an inner piston cavity with an inner piston surface and at least one female thread, and proximal and distal piston ends. The plunger rod includes a rod body having proximal and distal rod ends, with a threaded extension extending distally from the distal rod end. The threaded extension extends distally along a distal length and threadedly engages the at least one female thread along a portion of the distal length. The threaded extension has a ventilation feature configured to create a ventilation space between the threaded extension and the inner piston surface. The proximal piston end and the distal rod end are in spaced relation to form a primary fluid passageway portion from outside of the plunger assembly into the piston cavity.

## Claims

### Claim 1

A plunger assembly comprising:
a piston comprising an inner piston surface, a female thread, an outer surface that faces outwardly relative to a longitudinal axis of the piston, and a proximal-facing piston surface extending radially inwardly from the outer surface, wherein the inner piston surface and the female thread define an inner piston cavity; and
a plunger rod comprising an outer surface that faces outwardly relative to a longitudinal axis of the plunger rod, a distal-facing rod surface extending radially inwardly from the outer surface of the plunger rod, and a threaded extension that extends a length distally from the distal-facing rod surface, wherein:
the threaded extension is configured to threadedly engage with the female thread along at least a portion of the length,
the threaded extension and the inner piston surface define a ventilation space when the plunger rod is fully advanced distally relative to the piston,
the proximal-facing piston surface and the distal-facing rod surface, when the plunger rod is fully advanced distally relative to the piston, are spaced apart and define a fluid passageway therebetween,
the fluid passageway extends from outside of the plunger assembly into the inner piston cavity,
the fluid passageway comprises an inlet that fluidly connects the fluid passageway to outside of the plunger assembly, and
the inlet of the fluid passageway is defined by a space between an edge of the proximal-facing piston surface that intersects with the outer surface of the piston and an edge of the distal-facing rod surface that intersects with the outer surface of the plunger rod.

### Claim 2 (depends on 1)

The plunger assembly according to claim 1, wherein:
the inner piston cavity comprises a proximal cavity end and a distal cavity end,
the female thread is spaced apart from the distal cavity end,
the threaded extension comprises a male thread,
the male thread comprises a proximal male thread end and a distal male thread end,
the male thread is configured such that, when the plunger rod is fully advanced distally, the proximal male thread end is located distally of the female thread, and
the ventilation space is between the threaded extension and the inner piston surface.

### Claim 3 (depends on 1)

The plunger assembly according to claim 1, wherein:
the inner piston cavity comprises a proximal cavity end and a distal cavity end,
the female thread is spaced apart from the distal cavity end,
the threaded extension comprises:
a thread shank comprising a proximal thread shank end and a distal thread shank end; and
a male thread that extends from the thread shank, the male thread comprising a proximal male thread end and a distal male thread end, the proximal male thread end being spaced apart from the proximal thread shank end, and
the ventilation space is between the threaded extension and the inner piston surface.

### Claim 4 (depends on 1)

The plunger assembly according to claim 1, wherein: the outer surface of the plunger rod comprises an outer distal end surface and an outer side surface, and the plunger rod comprises an auxiliary passage that extends from at least one of the outer distal end surface or the outer side surface and that fluidly connects to the ventilation space.

### Claim 5 (depends on 1)

The plunger assembly of claim 1, wherein:
the proximal-facing piston surface is outside of the inner piston cavity,
the inner piston cavity comprises an opening at an interface with the proximal-facing piston surface, and
the interface is a proximal-terminal end of the inner piston cavity.

### Claim 6 (depends on 1)

The plunger assembly according to claim 1, wherein:
the inner piston cavity comprises a proximal cavity end and a distal cavity end,
the female thread comprises a plurality of female threads, the plurality of female threads have a female-thread major diameter and a female-thread minor diameter;
the threaded extension comprises:
a thread shank comprising a proximal thread shank end and distal thread shank end, the thread shank having a variable diameter, and
a plurality of male threads that extend from the thread shank, the plurality of male threads have a constant male thread major diameter; and
the ventilation space is between the thread shank and the female-thread minor diameter.

### Claim 7 (depends on 6)

The plunger assembly according to claim 6, wherein the ventilation space comprises a plurality of spaces between the thread shank and the female-thread minor diameter.

### Claim 8 (depends on 7)

The plunger assembly according to claim 7, wherein: the outer surface of the plunger rod comprises an outer distal end surface and an outer side surface, and the plunger rod comprises an auxiliary passage that extends from at least one of the outer distal end surface or the outer side surface and that fluidly connects to the ventilation space.

### Claim 9 (depends on 1)

The plunger assembly according to claim 1, wherein:
the threaded extension comprises a thread shank and a discontinuous male thread comprising a plurality of protrusions that extend from the thread shank; and
the ventilation space is between the plurality of protrusions.

### Claim 10 (depends on 9)

The plunger assembly according to claim 9, wherein the plurality of protrusions comprises at least one of a hemispherical body or a rod-shaped body with a hemispherical radially outward portion.

### Claim 11 (depends on 9)

The plunger assembly according to claim 9, wherein the thread shank has a variable male thread shank diameter.

### Claim 12 (depends on 9)

The plunger assembly of claim 9, wherein: the outer surface of the plunger rod comprises an outer distal end surface and an outer side surface, and the plunger rod comprises an auxiliary passage that extends from at least one of the outer distal end surface or the outer side surface and that fluidly connects to the ventilation space.

### Claim 13 (depends on 1)

The plunger assembly according to claim 1, wherein:
the inner piston cavity comprises a proximal cavity end and a distal cavity end;
the female thread comprises a plurality of female threads, the plurality of female threads having a female-thread major diameter and a female-thread minor diameter;
the threaded extension comprises:
a thread shank with a thread shank axis; and
a plurality of male threads that extend from the thread shank, the plurality of male threads having a truncated portion; and
the ventilation space is between the truncated portion and the plurality of female threads.

### Claim 14 (depends on 13)

The plunger assembly according to claim 13, wherein:
the truncated portion comprises a planar cut portion of the plurality of male threads; and
the ventilation space is between the planar cut portion and the plurality of female threads.

### Claim 15 (depends on 13)

The plunger assembly according to claim 13, wherein: the outer surface of the plunger rod comprises an outer distal end surface and an outer side surface, and the plunger rod comprises an auxiliary passage that extends from the outer side surface to the truncated portion.

### Claim 16 (depends on 13)

The plunger assembly according to claim 13, wherein: the outer surface of the plunger rod comprises an outer distal end surface and an outer side surface, and the plunger rod comprises an auxiliary passage that extends from at least one of the outer distal end surface or the outer side surface to the truncated portion to connect to the ventilation space.

### Claim 17 (depends on 16)

The plunger assembly according to claim 16, wherein the auxiliary passage extends from the outer side surface to the truncated portion.

### Claim 18 (depends on 1)

A fluid-dispensing syringe comprising:
a syringe barrel; and
the plunger assembly of claim 1, wherein the piston is within the syringe barrel.

### Claim 19 (depends on 1)

A method of sterilizing the plunger assembly of claim 1, the method comprising introducing a sterilizing fluid into an external environment surrounding the plunger assembly, thereby causing the sterilizing fluid to flow into the inner piston cavity and sterilize the inner piston cavity.

### Claim 20 (depends on 1)

A method of sterilizing a fluid-dispensing syringe comprising the plunger assembly of claim 1 and a syringe barrel with the piston within the syringe barrel, the method comprising introducing a sterilizing fluid into the syringe barrel, thereby causing the sterilizing fluid to flow into the inner piston cavity and sterilize the inner piston cavity.