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Publication Number

US-12214159-B2

Patent

Publication Date

2025-02-04

Expiration Date


Abstract

Embodiments of devices and methods to maintain preservative concentration in a medication delivered using a medical device are provided. A barrier layer can be used to prevent migration of preservatives. A vent can be used to allow release of preservatives prior to delivery to the patient. An absorbent element can be used to maintain preservative concentration at a desired level. A filter can be used to capture particulates from the medication prior to delivery to a patient.

Core Innovation

An insulin delivery system includes an insulin medication reservoir, an infusion hub, tubing connecting the reservoir to the infusion hub, and a cannula configured to deliver insulin medication to a patient. The system further includes a filter configured to capture particulates from the insulin medication prior to delivery to the patient, and the filter comprises an internal coil within the cannula.

The insulin medication is configured to form aggregate particles out of solution, and the filter is configured to capture and retain such aggregate particles. In one implementation, filter features internal to the cannula are in fluidic contact with the insulin and are configured to affect hydrodynamic flow characteristics within the cannula and create pressure differential regimes that promote capture and retention of aggregate particles formed out of solution.

A related aspect of the delivery system is preservative management, including barrier layers configured to prevent preservative migration and optional vent structures that release preservatives. In addition, the system includes an absorbent element positioned in fluid contact with the insulin medication, configured to absorb and store preservatives from the insulin medication.

Claims Coverage

The independent claims cover an insulin delivery system and related methods for filtering particulates using cannula-integrated internal features, including an internal coil that creates hydrodynamic flow effects and differential pressure regimes to capture and retain aggregates formed out of solution, along with device-level preservative management features referenced in the claim set. Across the independent claims, the core inventive features are the reservoir-to-infusion-hub tubing arrangement, the cannula delivery, and cannula-internal filtration features, including a coil.

Cannula-integrated internal coil particulate filter

A filter configured to capture particulates from the insulin medication prior to delivery to the patient, wherein the filter comprises an internal coil within the cannula.

Hydrodynamic-flow and pressure-differential cannula internal features

A filter comprising features internal to the cannula and in fluidic contact with the insulin configured to affect hydrodynamic flow characteristics of insulin medication flowing within the cannula and to create pressure differential regimes to promote the capture and retention of aggregate particles that have formed out of solution.

Method filtering with an internal cannula coil using differential pressure regimes

Filtering the insulin medication comprises using a coil internal to the cannula, the coil configured to create a region of features affecting hydrodynamic flow characteristics of insulin medication flowing within the cannula and creating differential pressure regimes to promote the capture and retention of aggregate particles that have formed out of solution.

Method using internal cannula flow-path features to create differential pressure regimes

Filtering the insulin medication comprises providing, within a flow path of the insulin medication, features internal to the cannula, thereby affecting hydrodynamic flow characteristics of insulin medication flowing within the cannula and creating differential pressure regimes to promote the capture and retention of aggregate particles that have formed out of solution.

Overall, the independent claims emphasize cannula-integrated internal filtration features, including an internal coil, that modify hydrodynamic flow and create pressure differential regimes to capture and retain aggregate particles formed out of solution, within an insulin delivery system that uses a reservoir, tubing, infusion hub, and a cannula delivering to a patient.

Stated Advantages

Capture and retention of aggregate particles that have formed out of solution prior to delivery of insulin medication to the patient.

Documented Applications

Delivering insulin medication to a patient using an insulin delivery system that includes filtration to capture particulates prior to patient delivery.

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