Infusion system and components thereof
Inventors
DAMIANO, Edward R. • EL-KHATIB, Firas H. • Selagamsetty, Rajendranath • RAMEY, Kirk D.
Assignees
Publication Number
US-12201803-B2
Publication Date
2025-01-21
Expiration Date
2036-07-07
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Abstract
Certain embodiments provide multi-medicament infusion systems for preventing the cross-channeling of medicaments. The system may include one or more of an infusion pump, medicament reservoirs, collars, a multi-channel fluid conduit, and an infusion set. The medicament reservoirs and/or collars may be sized and shaped differently such that the medicament reservoirs can only be inserted into the system selected configurations.
Core Innovation
The invention provides infusion systems and components designed to deliver one or multiple medicaments to a patient while preventing cross-channeling, which is the accidental administration of the wrong medicament through an incorrect channel. The system comprises features such as infusion pumps, medicament reservoirs, collars, multi-channel fluid conduits, and infusion sets with uniquely shaped and sized connectors and reservoirs. These features ensure that each medicament reservoir can only be connected to its intended pathway and delivery channel, thus reducing the risk of accidental misdelivery.
The background identifies the problem of cross-channeling in multi-medicament infusion regimens. Specifically, when multiple drugs are delivered using automated infusion devices, there is a significant risk that a medicament is loaded or infused through the wrong channel, potentially causing serious or fatal outcomes. Proper channeling of drugs, such as insulin and glucagon in diabetes management, is essential to avoid the administration of the incorrect medicament and the adverse consequences that may result.
The core innovation addresses the problem by introducing design features and unique mating connectors for each medicament pathway. Connectors, reservoirs, and couplings are configured with asymmetric and/or differentiated physical characteristics such that only compatible parts can be interconnected. The system employs guide members, engaging fasteners, projection/cavity pairs, and shaped collars to prevent mismatched connections between medicament reservoirs, pumps, and infusion set ports, ensuring that each medicament follows its correct dedicated fluid path.
Claims Coverage
The patent contains one independent claim describing several inventive features related to safety and usability in multi-medicament infusion sets.
Physical separation and independent movement of dual base units
The infusion set includes a first base unit and a second base unit, each with its own port, adhesive portion, and piercing element or function, allowing the two units to be adhered to the patient separately and to move independently to fit body contours during patient movement.
Asymmetric and non-interchangeable connector system with locking
The connector set comprises a first distribution connector and a second distribution connector, each configured to be reversibly coupled only to its designated base unit via physical features (first feature and second feature) that prevent incorrect engagement. Both connectors are asymmetric so they cannot be interchanged. Each connector includes a single retention clip that locks it in place, and the clip is designed for easy one-handed decoupling.
Dedicated fluid path from medicament reservoir to patient
The system establishes a first fluid path from a first medicament reservoir through a first inlet connector, fluid conduit, and distribution connector, ending at the first port of the first base unit and ensuring that the first medicament is only delivered through this dedicated path. Optionally, the second side operates in an analogous manner for a second medicament.
Connector and reservoir pairing to prevent cross-channeling
The first and second inlet connectors and distribution connectors have engagement features that only allow connection to specific pump receptacles or reservoirs. Features on the connectors and reservoirs prevent incorrect engagement, enforcing correct pairing and blocking access to non-matching parts.
The inventive features collectively ensure safe and correct medicament delivery by physically preventing misconnections between medicament reservoirs, connectors, and infusion sites, while supporting ease of use and fitting to patient anatomy.
Stated Advantages
The infusion system mitigates the risk of cross-channeling, thereby preventing the accidental administration of incorrect medicaments.
Design features and unique connectors ensure that only the intended medicament can be delivered through a dedicated fluid path, enhancing safety.
The system allows for independent movement and flexible placement of infusion sites, improving comfort and adaptation to the patient's body.
Retention clips and asymmetric connectors enable single-handed coupling and decoupling, increasing usability even for patients with limited dexterity.
Documented Applications
Use in multi-medicament infusion therapy, such as delivering insulin and glucagon to diabetic patients to regulate blood glucose levels and provide counter-regulatory treatment in emergencies.
Application in automated infusion systems for safe delivery of multiple medicaments in drug regimens requiring precise and separate channeling of distinct pharmaceuticals, hormones, or biologics.
Adaptation for reusable injection pens or syringes with prefilled cartridges for drugs like insulin analogs of different concentrations, ensuring only correct cartridge-pen combinations are possible.
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