Device for subcutaneous delivery of fluid medicament
Inventors
Shor, Eran • Mor, Tsabar • David, Tamir Ben • Lilach, Nir • Grossfeld, Rami • Alfandari, Shai • Nadler, Ram • GOLOM, DMITRY • Shaki, Daniel • Tikochinsky, Yoav • Ozsumer, Serdar
Assignees
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Publication Number
US-11779697-B2
Publication Date
2023-10-10
Expiration Date
Abstract
An improved device delivers a fluid medicament to the subcutaneous tissue of a user. The device is better suited for patients with Parkinson's Disease and other central nervous system disorders, than conventional infusion devices. The device can include a reusable part including a drive component (e.g., motor) and control electronics and a disposable part including a medicament reservoir. Medicament can be evacuated from the medicament reservoir by a plunger assembly that includes a plunger attached to a lead screw that is rotated by a nut, all within the disposable part. The device can be fluidically coupled with the tissue via a flexible cannula. Various embodiments relate to an improved cannula insertion mechanism that delivers the cannula under a force applied by a spring. Various embodiments relate to improved filling of the device, for example, using a vial adapter and an automated filling station.
Core Innovation
The invention provides a method for treating Parkinson's disease by subcutaneously administering a liquid medicament comprising levodopa and carbidopa to a patient in need thereof. The subcutaneous administration is performed using a subcutaneous delivery device that includes a reusable part and a disposable part engageable with the reusable part. The reusable part comprises a drive component and a control unit for controlling the drive component, and the disposable part comprises a reservoir containing the liquid medicament.
The disposable part includes a reservoir having a bushing fixedly mounted in the reservoir, a plunger head moveable by a lead screw in the reservoir, and a nut concentrically secured by and rotatable in the bushing, wherein the nut is threadedly engaged with a thread of the lead screw. The reusable part is detachably coupled to the disposable part such that the nut is coupled with the drive component. Rotating the nut in the bushing linearly displaces the lead screw, thereby administering the liquid medicament from the reservoir to the subcutaneous tissue of the patient.
Fluidically coupling the reservoir to the subcutaneous tissue can be achieved by adhering an exterior surface of the disposable part to a patient's skin surface, including with micro dermal anchors attached to an exterior surface. Alternatively, fluidically coupling is performed by inserting a cannula fluidically coupled with the reservoir into the patient's subcutaneous tissue.
Claims Coverage
The provided material identifies one independent claim focused on a Parkinson’s treatment method using a reusable/disposable subcutaneous delivery device architecture with lead-screw nut-driven linear displacement. Dependent claims further narrow the fluidic coupling approach and, in at least one case, add a battery to power the reusable part.
Parkinson’s treatment by subcutaneous levodopa/carbidopa administration using reusable and disposable delivery parts
A method for treating Parkinson's disease comprising subcutaneously administering to the patient a liquid medicament comprising levodopa and carbidopa using a device having a reusable part with a drive component and a control unit and a disposable part engageable with the reusable part, the disposable part comprising a reservoir that contains the liquid medicament.
Lead-screw driven plunger head with bushing-mounted nut rotatably secured in the reservoir
In the disposable part, a reservoir comprises a bushing fixedly mounted in the reservoir; a plunger head moveable by a lead screw in the reservoir; and a nut concentrically secured by and rotatable in the bushing, threadedly engaged with a thread of the lead screw, such that rotating the nut in the bushing linearly displaces the lead screw.
Detachably coupling nut to reusable drive component for dispensing
Engaging the reusable part with the disposable part detachably couples the nut with the drive component so that, by rotating the nut, the lead screw is linearly displaced to administer the liquid medicament from the reservoir to the subcutaneous tissue.
Fluidic coupling to subcutaneous tissue via skin adhesion or cannula insertion
Fluidically coupling the reservoir to the subcutaneous tissue of the patient is narrowed to either adhering an exterior surface of the disposable part to a patient's skin surface, including with micro dermal anchors, or inserting a cannula fluidically coupled with the reservoir into the patient’s subcutaneous tissue.
Battery-powered reusable part
Providing a battery as part of at least one of the reusable and disposable parts and powering the reusable part with that battery.
The claim coverage centers on subcutaneous administration of a levodopa/carbidopa liquid medicament for Parkinson’s disease using a reusable drive/control portion and a disposable reservoir portion, where nut rotation in a bushing-driven lead screw system displaces a plunger head to dispense into subcutaneous tissue. The dependent refinements emphasize specific mechanisms for fluidic coupling, including skin adhesion with micro dermal anchors or cannula insertion, and battery power for the reusable part.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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