Accurate, precise microliter dosing syringe

Inventors

Shetty, Gautam N.Castagna, Lou

Assignees

Congruence Medical Solutions LLC

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Publication Number

US-11707577-B2

Patent

Publication Date

2023-07-25

Expiration Date


Abstract

According to some embodiments, a syringe may include a barrel; a delivery conduit; a plunger seal disposed within the barrel; and a plunger rod assembly affixed to an end of the barrel, the plunger rod assembly including a first plunger rod component comprising a first linear gear, a second plunger rod component disposed at least partially in the barrel and engaged with the plunger seal, wherein the second plunger rod component comprises a second linear gear, a first rotational gear having a plurality of gear teeth for engaging the first linear gear, and a second rotational gear having a second plurality of gear teeth for engaging the second linear gear, wherein the first rotational gear is coupled to the second rotational gear such that translation of the first plunger rod component causes translation of the second plunger rod component.

Core Innovation

The invention relates to a plunger rod assembly for a syringe in which a first plunger rod component includes a first linear gear and at least one protrusion, and a second plunger rod component includes a second linear gear. A first rotational gear and a second rotational gear are translationally fixed and each has gear teeth that engage respective ones of the linear gears. The first rotational gear is coupled to the second rotational gear so that translation of the first plunger rod component causes translation of the second plunger rod component.

A rotational component engages the at least one protrusion of the first plunger rod component to translate the first plunger rod component to set the dose, where an axis of rotation extends in a direction of travel of the first plunger rod component. In described embodiments, the translation relationship between the plunger rod components can include a second amount that is less than the first amount, implemented through the coupled gear structure. Directional rotational behavior is controlled using a ratchet component that allows rotation more freely in a first direction than in a second direction.

The invention further describes syringe configurations and dose delivery behavior in which the plunger rod assembly is affixed to an end of a barrel, and includes a plunger seal disposed within the barrel and a delivery conduit. In a dose-setting and delivery sequence, a dosage is set by rotating the rotational component until it disengages from the first plunger rod component, and after disengagement the dosage is delivered by applying a user force directly to an end of the first plunger rod component to advance the plunger seal. The disclosed syringe and package context includes prefilled syringes and blister packaging, together with defined residue and sterility assurance parameters and sub-visible particulate thresholds for drug solutions.

Claims Coverage

The provided set includes three independent claims, each centered on a dose-setting and delivery system using a plunger rod assembly with coupled linear and rotational gears, a rotational component engaging a protrusion, and a rotation axis extending in the direction of travel of a first plunger rod component. Two of the independent claims additionally place the assembly in a syringe and delivery context, and the third recites a method of delivering a dosage using an upward conduit pointing sequence and a disengagement-based transition to user-force delivery. Across the independent claims, the inventive features emphasize the coupled translationally fixed gear arrangement, dose setting via protrusion engagement, and disengagement followed by direct user-force actuation, with additional dependent refinements covering direction control, engagement limits, mounting, and packaging constraints.

Coupled translationally fixed linear and rotational gears translating plunger rod components

A first plunger rod component comprising a first linear gear and at least one protrusion; a second plunger rod component comprising a second linear gear; a first rotational gear that is translationally fixed and comprises a plurality of gear teeth for engaging the first linear gear; a second rotational gear that is translationally fixed and comprises a second plurality of gear teeth for engaging the second linear gear, wherein the first rotational gear is coupled to the second rotational gear such that translation of the first plunger rod component causes translation of the second plunger rod component.

Rotation axis aligned with direction of travel to set dose via protrusion engagement

A rotational component that engages the at least one protrusion of the first plunger rod component to translate the first plunger rod component to set the dose, wherein an axis of rotation of the rotational component extends in a direction of travel of the first plunger rod component.

Syringe with delivery conduit and dose-setting plunger rod assembly

A syringe comprising a barrel, a delivery conduit, a plunger seal disposed within the barrel, and a plunger rod assembly affixed to an end of the barrel, the plunger rod assembly comprising a first plunger rod component comprising a first linear gear and at least one protrusion; a second plunger rod component disposed at least partially in the barrel and engaged with the plunger seal, wherein the second plunger rod component comprises a second linear gear; a first rotational gear that is translationally fixed and comprises a plurality of gear teeth for engaging the first linear gear; a second rotational gear that is translationally fixed and comprises a second plurality of gear teeth for engaging the second linear gear, wherein the first rotational gear is coupled to the second rotational gear such that translation of the first plunger rod component causes translation of the second plunger rod component; and a rotational component that engages the at least one protrusion of the first plunger rod component to translate the first plunger rod component to set the dose, wherein an axis of rotation of the rotational component extends in a direction of travel of the first plunger rod component.

Upward conduit, rotation until disengagement, then user-force delivery after disengagement

A method comprising: while pointing the delivery conduit of the syringe upwards with respect to the barrel, advancing the plunger seal within the barrel by rotating the rotational component; setting a dosage by continuing to rotate the rotational component until the rotational component disengages from the first plunger rod component; and after the rotational component disengages from the first plunger rod component, delivering the dosage by applying a user force directly to an end of the first plunger rod component to advance the plunger seal.

Across the independent claims, the core coverage is directed to a syringe dose-setting architecture in which a rotationally-driven engagement of a protrusion sets dose translation through a coupled gear train that translates a first and second plunger rod component. The rotational component is defined with an axis of rotation extending in the direction of travel of the first plunger rod component, and the method claim further specifies an upward-pointing rotation phase followed by delivery using direct user force after disengagement.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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