Multi-cartridge fluid delivery device

Inventors

Gonnelli, Robert R. • Levesque, Steven F. • Nardi, Ronald V.

Assignees

Mannkind Corp • Biovalve Technologies Inc

Abstract

A fluid delivery device for administering a first medicament and a second medicament includes a first fluid reservoir configured to contain the first medicament and a second fluid reservoir configured to contain the second medicament. The fluid delivery device may include one or more basal drive mechanisms to provide a basal delivery of one or more of the first and second medicaments. The fluid delivery device may further include one or more bolus drive mechanisms to provide a bolus delivery of one or more of the first and second medicaments.

Core Innovation

The invention concerns a dual/multi-cartridge fluid delivery device with separate first and second medicaments, where the device delivers basal delivery and bolus delivery. The device includes a first basal delivery of the first medicament and a second basal delivery of the second medicament, and also delivers a first bolus delivery of the first medicament and a second bolus delivery of the second medicament. Basal delivery is a sustained delivery of medicament, while bolus delivery is a predetermined amount delivered over a shorter amount of time than the basal delivery.

The device architecture supports basal and bolus actuation using a basal drive mechanism and a bolus drive mechanism. The basal drive mechanism includes drive components such as coil spring, basal drive piston, hydraulic fluid reservoir, pump chamber, and flow restrictors, and may use reservoir and actuation structures such as flexible or balloon-type basal reservoirs, hinged plates, and flexible barrier members. The bolus drive mechanism uses a ratchet and bolus piston to deliver predetermined bolus amounts for the first and second medicaments.

Multiple device architecture variants are described for reducing mixing and enabling delivery with different needle arrangements. Separate versus shared needle arrangements include spatial separation and depth-differential needles to reduce mixing, and an optional Y-shaped needle enabling mixing when compatible. Additional variants include separate vs single vs multiple basal drive mechanisms, with piston and piston-size variations used to change bolus ratio between medicaments, and optional single-needle delivery configurations. Documented example medicament pairings include insulin and an insulin analog, together with a second medicament, including broader medicament pairings such as incretin (GLP-1) and other listed therapeutic classes.

Claims Coverage

The independent claims are directed to a method of administering first and second medicaments with distinct basal and bolus deliveries, and to a corresponding fluid delivery device. Across the independent claims, the inventive features center on separate basal and bolus delivery for first and second medicaments using corresponding drive mechanisms, together with the temporal distinction that basal delivery is sustained and bolus delivery is a predetermined amount delivered over a shorter time.

The independent claims cover both a method and a fluid delivery device that administer two medicaments using separate basal and bolus deliveries. The claims require basal delivery as sustained and bolus delivery as a predetermined amount over a shorter time, with basal and bolus deliveries performed using corresponding basal and bolus drive mechanisms, including a bolus drive mechanism that includes a ratchet and a bolus piston coupled to the ratchet.

Stated Advantages

Documented Applications