Implantable solid-liquid drug delivery apparatus, formulations, and methods of use

Inventors

Imran, Mir

Assignees

Incube Laboratories LLC

Abstract

Embodiments provide apparatus and methods for delivering liquid form medication within the body wherein the medication is stored in solid form and then mixed with a liquid in an apparatus implanted within the body. One embodiment provides an implantable apparatus for in vivo delivery of medication comprising a housing including a reservoir, a store of solid form medication (SSM) and a pump. An SSM element is added to the reservoir along with fluid to form a medication solution comprising at least one drug. The medication solution is then delivered to a delivery site using a pumping means to pump solution from the reservoir through a delivery member such as catheter to a delivery site. Embodiments of the invention are particularly useful for delivering medication to a patient to treat a medical condition over an extended period of time without requiring the patient to take external medication.

Core Innovation

An implantable solid-to-liquid drug delivery apparatus and method are provided in which a housing implanted in a patient includes a mixing chamber carrying a plurality of solid medication doses in an internal volume and a catheter implanted in the patient between the mixing chamber and a delivery site. A liquid is delivered transcutaneously to the mixing chamber so that at least one solid medication dose dissolves or becomes suspended in the liquid to form the liquid medication. The liquid medication is then delivered to the delivery site via the implanted catheter for extended treatment without external dosing.

Solid medication doses are caused to enter the mixing chamber by being advanced from an internal space of the housing through a split membrane in a side of the mixing chamber, and the solid medication dose is carried in a carousel that is configured to be incremented. The disclosed apparatus includes mixing and delivery components arranged to support repeated dose formation in the mixing chamber, including controllable valves and a pump/catheter system for delivering the resulting drug solution to the delivery site. Optional mixing elements are also described to aid in forming the liquid medication.

The system further supports monitoring and control of the delivery process using a controller/microprocessor and sensors, including sensors for detecting fluid addition and for detecting mixing completion or concentration, including optical density and Beer's law, as well as fluid/pressure thresholds. The document also describes patient-condition-triggered titration using the controller/microprocessor and wireless initiation, along with optional configurations such as intermediate reservoirs/chambers, alternative residual-pressure transfer instead of pumping, multiple delivery sites/catheters, and catheter features including biocompatible polymers, atraumatic tip, and coatings.

Claims Coverage

The partial content provides one independent claim (clm-00001). It includes an implanted mixing-chamber and catheter system and a dose-forming mechanism using a carousel and a split membrane, combined with transcutaneous liquid delivery and delivery via the catheter; additional refinements across dependent claims add specific delivery mechanics, sensing, monitoring parameters, and implantation duration.

Across the independent claim and dependent refinements, the core coverage centers on an implanted housing with a mixing chamber and an implanted catheter, transcutaneous liquid delivery into the mixing chamber, and a carousel/split-membrane mechanism that advances solid medication doses into the mixing chamber to dissolve or suspend and thereby form liquid medication for catheter delivery.

Stated Advantages

Documented Applications