Products, systems and methods are disclosed for lowering the concentrations of at least one of preservatives and fibrils in a liquid insulin composition. One method comprises replacing at least a portion of at least one of phenol and m-cresol with at least one of cyclodextrins, cyclodextrin polymers, cyclodextrin beads, and an ion exchange resin.

A method and apparatus for injecting supportive and therapeutic agents into bone marrow. During conventional chemotherapy for leukemia, lymphoma, multiple myeloma and other bone related diseases, chemotherapeutic agents are typically injected intravenously. Intravenous injection, however, as a method of chemotherapy, has a number of potential disadvantages. By injecting therapeutic agents directly into the bone marrow using the present method and apparatus, these disadvantages can be avoided. A stronger needle with a shorter and sharper tip, when compared to a conventional intravenous or sternal puncture needle, designed to optimally administer therapeutic agents into bone marrow without causing injury is disclosed. The method includes injecting therapeutic agents into large reservoirs of bone marrow in accessible areas such as ilium and sternum is most likely to have a significant effect in treating bone marrow diseases. The needle may have side holes for wider and more even distribution of therapeutic agents throughout the marrow.

The present invention provide a puncture instrument capable of administering (supplying) a drug solution. The puncture instrument includes a puncture tip section (2); a first tubular body (3) connected to the puncture tip section (2) at the distal end; and an outer tubular body (5) at least partially covering the first tubular body (3). The first tubular body (3) is formed to be rotatable around an axis along the longitudinal direction. The first tubular body (3) has an outer diameter smaller than an inner diameter of the outer tubular body (5). A drug solution supply path (5a) is provided on the outside of the first tubular body (3).

The invention relates to a polymer needle comprising a body portion with a cylindrical cross-section and a tip portion in extension to the body portion. The tip portion of the needle forms at least two converging surfaces defining an edge. The needle forms a plurality of conduits arranged about a central solid core. The conduits and the core extend from the body portion into the tip portion such that each conduit terminates in one of the tip surfaces and the solid core forms the tip. The invention further relates to an apparatus for cleaving a polymer fibre at elevated temperatures. The polymer needle is prepared by this cleaving apparatus. The cleaving apparatus comprises a holding means for holding the fibre, a guide for guiding the movement of a cleaving knife, and a cleaving knife forming a cutting face of V-shape.

A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters.

A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters.

A diagnostic Electrochemical Impedance Spectroscopy (EIS) procedure is applied to measure values of impedance-related parameters for one or more sensing electrodes. The parameters may include real impedance, imaginary impedance, impedance magnitude, and/or phase angle. The measured values of the impedance-related parameters are then used in performing sensor diagnostics, calculating a highly-reliable fused sensor glucose value based on signals from a plurality of redundant sensing electrodes, calibrating sensors, detecting interferents within close proximity of one or more sensing electrodes, and testing surface area characteristics of electroplated electrodes. Advantageously, impedance-related parameters can be defined that are substantially glucose-independent over specific ranges of frequencies. An Application Specific Integrated Circuit (ASIC) enables implementation of the EIS-based diagnostics, fusion algorithms, and other processes based on measurement of EIS-based parameters.

A system and method for controlling and monitoring a diabetes-management system through the use of a model that predicts or estimates future dynamic states of glucose and insulin from variables such as insulin delivery or exogenous glucose appearance as well as inherent physiological parameters. The model predictive estimator can be used as an insulin bolus advisor to give an apriori estimate of postprandial glucose for a given insulin delivery profile administered with a known meal to optimize insulin delivery; as a supervisor to monitor the operation of the diabetes-management system; and as a model predictive controller to optimize the automated delivery of insulin into a user's body to achieve a desired blood glucose profile or concentration. Open loop, closed-loop, and semi-closed loop embodiments of the invention utilize a mathematical metabolic model that includes a Minimal Model, a Pump Delivery to Plasma Insulin Model, and a Meal Appearance Rate Model.

An apparatus provides targeted placement of openings for infusing fluids into a body. The apparatus provides a driving force to a penetrating medical device, such as a needle, when the apparatus tip encounters material of high resistance. When the apparatus tip encounters a low resistance material, no further driving force is applied to the apparatus due to contraction of an element made of interlaced flexible elements. A multi-opening needle is provided in some embodiments wherein placement of one of the openings in a target region with a relatively lower external pressure allows pressurized fluid to exit the needle while openings remaining in higher pressure, non-target regions do not release substantial amounts of the fluid.

Disclosed are examples for a system for drug delivery and components thereof. The system may include an on-body pump device and a secondary unit. The on-body pump device may include a reservoir and a fluid pathway. The reservoir may be configured to hold a liquid drug. The secondary unit may be removably coupled to the on-body pump device. The secondary unit may be configured to receive a prefilled cartridge containing a liquid drug, expel the liquid drug from the prefilled cartridge, and deliver the liquid drug to the reservoir of the on-body pump device via the fluid pathway. Examples of variations to the secondary unit are also disclosed.