US 8,556,867 B2Granted

Drug delivery management systems and methods

AssigneeLifeScan, Inc.

InventorsPeter Krulevitch, Robert Wilk, Ulrich Kraft, Donna Savage, Nick Foley, James Glencross, David Shepherd, Zara Sieh, David Price

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Abstract

Various embodiments of a “smart” drug delivery system are provided which includes an add-on module and a reusable or disposable drug pen in conjunction with a data management unit(s) DMU. Upon attachment to the pen, the add-on module may: determine dosage selected, injection of selected dosage, duration of injection, time of injection, whether the pen has been primed or shaken to thoroughly mix up insulin mixtures, transmit information relating to insulin dosage and injection to a data management unit, provide reminders, error warning or messages on improper usage or reuse of needles, track amount of drug remaining on board the pen or duration of usage of pen with respect to expiry of the drug on board, or provide an audible alarm for locating misplaced pen and module. Methods of using the drug delivery system are also described.

Claims15

Dependent claims

A diabetes management system comprising:

a data management unit including:
a memory;
a processor coupled to the memory;
a display coupled to the processor;
and
a transceiver to receive and transmit data;
and
a drug delivery system including:
a drug delivery pen comprising:
a generally tubular pen housing that extends from a first end to a second end, the housing enclosing at least a portion of a plunger rod coupled to a drug cartridge disposed proximate the first end, the pen housing having a dosage indicator window and a dosage selector coupled to the plunger rod;
an add-on communication unit comprising:
an add-on housing extending along a first longitudinal axis from a first housing end to a second housing end, the add-on housing including an engagement portion that circumscribes at least a portion of the pen housing and capable of being separated from the drug delivery pen, in which the engagement portion comprises first and second extensions, each of the extensions having first and second locating tangs, each locating tang protrudes beyond each of the first and second extensions to fix the add-on housing to the dosage indicator window, and further in which the housing includes:
a memory unit;
a processor coupled to the memory;
an analog-to-digital converter coupled to a dosage sensor attached to the dosage selector of the pen, in which the dosage sensor is disposed in the add-on housing and located on one side of the first longitudinal axis, a power source disposed in the housing, located on another side of the first longitudinal axis and spaced apart from the dosage sensor, the processor being disposed in the add-on housing proximate the first longitudinal axis,
and further in which the dosage sensor comprises a longitudinal member slidable along the longitudinal axis, the longitudinal member connected to a follower portion that extends from the add-on housing proximate the second housing end, and the follower portion being coupled to the dosage selector of the drug delivery pen so as to move longitudinally upon rotation of the dosage selector with respect to the pen housing, the converter being coupled to the processor so as to provide data upon displacement of the dosage selector;
and
a transceiver to transmit and receive data relating to dosage delivery of a drug dosage in the drug cartridge to the data management unit.

15 more elements

A diabetes management system comprising:

a data management unit including:
a memory;
a processor coupled to the memory;
a display coupled to the processor;
and
a transceiver to receive and transmit data;
and
a drug delivery system including:
a drug delivery pen comprising:
a generally tubular pen housing that extends from a first end to a second end, the housing enclosing at least a portion of a plunger rod coupled to a drug cartridge disposed proximate the first end, the pen housing having a dosage indicator window and a dosage selector coupled to the plunger rod;
an add-on communication unit comprising:
an add-on housing extending along a first longitudinal axis from a first housing end to a second housing end, the add-on housing including an engagement portion that circumscribes at least a portion of the pen housing and capable of being separated from the drug delivery pen, in which the add-on housing comprises a generally tubular extension circumscribing a second longitudinal axis to define a hollow bore that extends through a portion of the generally tubular extension of the housing to allow the drug delivery pen to be inserted into the hollow bore in which the housing includes:
a memory unit;
a processor coupled to the memory;
an analog-to-digital converter coupled to a dosage sensor attached to the dosage selector of the pen, in which the dosage sensor is disposed in the add-on housing and located on one side of the first longitudinal axis, a power source disposed in the housing, located on another side of the first longitudinal axis and spaced apart from the dosage sensor, with the processor being disposed in the add-on housing,
and further in which the dosage sensor comprises a longitudinal member slidable along the longitudinal axis, the longitudinal member connected to a follower portion that extends from the add-on housing proximate the second housing end, and the follower portion being coupled to the dosage selector of the drug delivery pen so as to move longitudinally upon rotation of the dosage selector with respect to the pen housing, the converter being coupled to the processor so as to provide data upon displacement of the dosage selector;
and
a transceiver to transmit and receive data relating to dosage delivery of a drug dosage in the drug cartridge to the data management unit.

15 more elements

Dependencies are inferred from the claim text.

Facts

Application: 13/203,697Filed 27 Jan 2010 · us provisional application
Priority: 27 Feb 2009
Published: US 2012/0004637 A15 Jan 2012
Granted: 15 Oct 2013
Term ends: Not estimatedThe source records don’t support an estimate.

Classification34 codes

A61M 5/315
Details: pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ;…
A61M 5/009
Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning…:…
A61M 5/24
Syringes: ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
A61M 5/3129
Details: syringe barrels

Family

Application61/156,386Us provisional application · filed 27 Feb 2009
Application61/156,421Us provisional application · filed 27 Feb 2009
Application61/156,472Us provisional application · filed 27 Feb 2009
Application61/164,250Us provisional application · filed 27 Mar 2009
US 2012/0004637 A1Pre-grant publication · published 5 Jan 2012
US 8,556,867 B2This patent

From the US filing history. Foreign family members aren’t listed.