Controlled Dispense Syringe

Patent No. US11744950 (titled "Controlled Dispense Syringe") was filed by Amgen Inc on Feb 12, 2019.

What is this patent about?

’950 is related to the field of prefilled syringes, specifically addressing the problem of inadvertently dispensing therapeutic product along with air (headspace) when removing air from the syringe prior to injection. This is a common issue because prefilled syringes often contain a small amount of air to account for thermal expansion and manufacturing tolerances. Current methods require healthcare providers to carefully expel the air, risking product wastage or injecting air into the patient.

The underlying idea behind ’950 is to mechanically limit the travel of the plunger within the syringe barrel, preventing the expulsion of the air bubble. This is achieved by incorporating a stop feature on the plunger rod that physically prevents the plunger from fully traversing the barrel. The stop is positioned such that when it contacts the end of the syringe barrel, a defined volume of air remains trapped within the syringe.

The claims of ’950 focus on a syringe with a barrel, a stopper, a plunger rod, and an outwardly projecting stop . The key element is the stop's configuration to engage the end surface of the barrel's open proximal end. This engagement halts the plunger's movement during dispensing, ensuring that the headspace remains within the barrel. The claims also cover a method of filling such a syringe and a method of dispensing a predetermined amount of fluid therapeutic product from the syringe.

In practice, the syringe is pre-filled with the therapeutic product and a defined amount of headspace. The plunger rod is then inserted, with the stop positioned to allow the plunger to travel only far enough to dispense the liquid medication, leaving the air bubble behind. The predetermined length between the stop and the plunger's distal end dictates the dispensed volume, ensuring accurate dosing without air injection. This eliminates the need for healthcare providers to manually remove air, reducing the risk of medication waste and improving injection safety.

This design differentiates itself from prior approaches by integrating a physical stop mechanism directly into the plunger rod. Traditional syringes rely on the user's judgment to avoid expelling air, which is prone to error. By contrast, ’950 provides a fixed, mechanical limit that guarantees a consistent and accurate dose delivery, regardless of the user's technique. This is particularly beneficial for self-injection scenarios where patients may lack the training or dexterity to accurately remove air from the syringe.

How does this patent fit in bigger picture?

Technical landscape at the time

In the late 2010s when '691 was filed, prefilled syringes were commonly used for delivering therapeutic products, at a time when precise dosage control and minimizing waste were important considerations. At that time, syringes typically relied on manual operation, and ensuring complete expulsion of the therapeutic product without also expelling air (headspace) often presented a challenge.

Novelty and Inventive Step

The examiner approved the application because the prior art does not teach a syringe with a plunger rod having a stop that prevents the expulsion of headspace, where the length of the headspace left within the barrel during dispensing is substantially equal to the length of the plunger rod between the stop and the proximal end of the barrel before dispensing. The closest prior art, Cottone, does not disclose a relationship between the length of the headspace and the location of the stop on the plunger rod, and modifying Cottone to include this limitation would require altering the way the syringe was designed to function.

Claims

This patent includes 20 claims, with independent claims 1, 10, 17, and 18. Independent claims 1 and 10 are directed to a syringe with a stop on the plunger rod to control headspace. Independent claims 17 and 18 are directed to methods of filling and dispensing, respectively, a syringe with controlled headspace. The dependent claims generally add specific features, components, or steps to the syringe or methods described in the independent claims.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
End surface of the barrel
(Claim 1, Claim 10, Claim 18)
“The plunger rod further includes an outwardly projecting stop that is adjacent the second end. The barrel is configured to contain a fluid therapeutic product. Headspace between the dispensing opening and the stopper and the stop of the plunger rod is configured to engage the end surface of the open proximal end of the barrel to stop movement of the plunger rod during the dispensing operation so that the headspace is left within the barrel.”The surface at the open proximal end of the syringe barrel that the outwardly projecting stop engages to limit the plunger rod's movement.
Fluid therapeutic product
(Claim 1, Claim 10, Claim 17, Claim 18)
“For some drug dispensing devices, a healthcare provider is required to transfer a therapeutic product from a prefilled syringe to a cartridge or device reservoir that is configured for the drug dispensing device. Typically, a prefilled syringe is filled with a predetermined amount of the therapeutic product along with a predetermined amount of air.”A liquid medication or drug intended for therapeutic purposes that is contained within the syringe barrel.
Headspace
(Claim 1, Claim 10, Claim 17, Claim 18)
“A syringe is provided with a plunger assembly that is adapted to have a dispensing stroke sized to dispense a fluid therapeutic product from the syringe without dispensing any air or headspace. More specifically, the syringe includes a plunger rod having a stop feature that stops a dispensing stroke of the plunger rod at a distance corresponding to a level of air or headspace within the syringe.”The volume of air or gas within the barrel of the syringe between the dispensing opening and the stopper.
Outwardly projecting stop
(Claim 1, Claim 10, Claim 17)
“More specifically, the syringe includes a plunger rod having a stop feature that stops a dispensing stroke of the plunger rod at a distance corresponding to a level of air or headspace within the syringe.”A feature coupled to the plunger rod that extends outward and is configured to engage the end surface of the barrel to limit the plunger rod's movement.
Thumb rest
(Claim 18)
“In accordance with one preferred form, the plunger rod can further include a thumb rest portion at the second end. In accordance with a further preferred form, the thumb rest portion can be spaced from the stop.”A portion of the plunger rod that a user engages to push the plunger rod and dispense the fluid therapeutic product.

Litigation Cases New

US Latest litigation cases involving this patent.

Case NumberFiling DateTitle
1:25-cv-01080Feb 7, 2025Amgen Inc. V. Fresenius Kabi Usa, Llc

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US11744950

AMGEN INC
Application Number
US16969691
Filing Date
Feb 12, 2019
Status
Granted
Expiry Date
Nov 21, 2039
External Links
Slate, USPTO, Google Patents