Device and method for drug delivery
Inventors
Pesach, Benny • Bitton, Gabriel • Nagar, Ron • Weiss, Ram
Assignees
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Publication Number
US-9731084-B2
Publication Date
2017-08-15
Expiration Date
Abstract
A therapeutic treatment device, system and method for improving administration of a temperature sensitive drug into a tissue on the body of a patient at a drug injection site are disclosed. The device includes a treatment element with a controllable heating element in temperature communicative contact with the tissue adjacent to the drug injection site. The controllable heating element is configured to heat the tissue adjacent to the drug injection site to a controllable temperature but does not heat the injected drug above a predetermined limiting temperature, above which degradation of the injected drug may occur.
Core Innovation
The invention relates to a treatment device for effecting the adsorption of a drug in tissue. The device comprises a processor and a treatment element having a disposable part and a reusable part, and the treatment element further comprises at least one identification element configured to determine prior use of the disposable part and an injection area for administering a plurality of injections of a drug into an injection site of a tissue.
The treatment element is used to apply treatment to tissue at or adjacent the injection site during at least one of before, during and after injection of the drug for a predetermined period of time. The treatment is configured to improve the pharmacokinetic and/or pharmacodynamic properties of the injected drug, including applying heat to tissue adjacent the injection site using a controllable heating element under processor control.
The disclosure includes a temperature limit intended to prevent the injected drug from exceeding a predetermined limiting temperature associated with drug degradation, and describes mechanisms that include vasodilatation and capillary pore widening. It further describes sensor-based injection timing detection and feedback, including temperature sensing and detection of injection into tissue, as well as optional impedance measurement to provide signals indicative of the volume of the drug stored in tissue at a location, with the processor adjusting treatment based on those signals.
Example device configurations described include a heating pad with a heating element, power source, and temperature sensor feedback, with a range of heating-pad geometries.
Claims Coverage
Independent claim clm-00001 covers a treatment device with a processor-controlled treatment element that includes disposable/reusable parts plus identification elements for determining prior use, and an injection area for multiple injections, where treatment is applied before/during/after injection for a predetermined period to improve pharmacokinetic and/or pharmacodynamic properties. Dependent claims further refine the core with temperature limiting to prevent drug degradation, sensor-based activation based on injection detection, optional volume-related monitoring using impedance, and identification/timing detection sensor modalities such as skin folding, pressure, and proximity.
Processor-controlled treatment for adsorption and PK/PD improvement
A treatment device comprising a processor and a treatment element having a disposable part and a reusable part, with at least one identification element configured to determine prior use of the disposable part, and an injection area for administering a plurality of injections of a drug into an injection site of a tissue; the treatment element is controlled by the processor and configured to apply a treatment to the tissue at or adjacent the injection site during at least one of before, during and after injection of the drug for a predetermined period of time; the treatment is configured to improve the pharmacokinetic and/or pharmacodynamic properties of the injected drug.
Temperature limiting treatment to prevent drug degradation
The device includes a processor-controlled heating element configured to heat tissue to a predetermined temperature less than a predetermined limiting temperature above which the drug degrades.
Injection detection sensor for activating the treatment
The device includes a detection sensor configured to detect injection of the drug into tissue, provide one or more signals to the processor, and activate the treatment element based on the one or more signals.
Volume-indicative measurement with processor-adjusted treatment
The device includes a measurement mechanism providing signals indicative of the volume of the drug stored in tissue at a location, and the processor adjusts treatment application based on the signals.
Impedance-based measurement for drug stored volume
The measurement mechanism comprises an impedance sensor configured to measure impedance of the tissue at the location.
Identification sensors for determining prior use and/or injection timing
The identification mechanism comprises at least one of a skin sensor sensing folding of skin, a pressure sensor on the treatment element, a pressure sensor on a marker for finger placement during injection, and a proximity sensor sensing proximity of a device for injecting the drug into the tissue.
Across the independent claim and refinements described, the inventive coverage centers on a processor-controlled treatment element integrated with disposable/reusable structure and identification elements for prior-use determination, applied at or adjacent an injection site before/during/after injections for a predetermined period to improve pharmacokinetic and/or pharmacodynamic properties, with dependent features further narrowing the treatment control by temperature limiting and enabling sensor-based injection detection and feedback, including impedance-based volume-related adjustment and multiple sensing modalities for skin/pressure/proximity identification.
Stated Advantages
Improves the pharmacokinetic and/or pharmacodynamic properties of the injected drug.
Prevents the injected drug from exceeding a predetermined limiting temperature associated with drug degradation (via temperature constraint).
Reduces variability and improves timing of drug action as described in the disclosure (e.g., improved timing of insulin action and reduced absorption variability).
Enables treatment activation based on detection of injection into tissue.
Enables processor adjustment of treatment application based on signals indicative of drug volume stored in tissue, including impedance measurement of tissue impedance.
Documented Applications
Administering a plurality of injections of a drug into an injection site of tissue using an injection area on a treatment device that applies treatment before, during, and/or after injection to improve drug pharmacokinetic and/or pharmacodynamic properties.
Use with temperature-sensitive drugs such as insulin to improve insulin pharmacokinetics/pharmacodynamics by heating tissue adjacent the injection site while limiting temperature to prevent drug degradation.
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