Patent No. US11744950 (titled "Controlled Dispense Syringe") was filed by Amgen Inc on Feb 12, 2019.
’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.
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.
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.
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.
Definitions of key terms used in the patent claims.
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