Confirmation of delivery of medication to a host

• US 10,448,885 B2
• Filed: 06/13/2016
• Issued: 10/22/2019
• Est. Priority Date: 06/12/2015
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Insulet Corporation
• Inventors: Schmid, Kevin G.
• Primary Examiner(s): Vu, Quynh-Nhu H.
• Application Number:
  US15/180,724
• Publication Number:
  US 20160361013A1
• Time in Patent Office: 1,226 Days
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/702 automatically during use
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients

Abstract

A method of treating a host with a medication, comprising assigning a unique identifier to a host treatment apparatus; assigning a unique identifier to the host; storing the unique host identifier and the unique host treatment apparatus identifier on at least one remote server of a network and associating the unique host identifier and the unique host treatment apparatus identifier on the at least one remote server such that the unique host identifier and the unique host treatment apparatus identifier are exclusively associated to each other; activating the host treatment apparatus; coupling the host medication delivery device to the host; operating the host medication delivery device to deliver the medication contained in the host medication delivery device to the host; and operating the host treatment apparatus such that the host treatment apparatus communicates wirelessly to the at least one remote server an operational status of the host medication delivery device.

Claims

1. A method of treating a host with a medication, the method comprising:

assigning a unique host treatment apparatus identifier to a host treatment apparatus comprising a host medication delivery device which delivers medication into tissue of the host subcutaneously, wherein the unique host treatment apparatus identifier distinguishes the host treatment apparatus from a plurality of other host treatment apparatuses, and wherein the host medication delivery device includes a sensor, wherein the sensor is used to measure a physiological parameter associated with the tissue and disposed within the host medication delivery device;

assigning a unique host identifier to the host to be treated by the host treatment apparatus, wherein the unique host identifier distinguishes the host from a plurality of other hosts;

storing the unique host identifier and the unique host treatment apparatus identifier on at least one remote server of a network, and associating the unique host identifier and the unique host treatment apparatus identifier on the at least one remote server of the network such that the unique host treatment apparatus identifier is exclusively associated with the unique host identifier to the exclusion of the other hosts;

filling the host medication delivery device with medication;

activating the host treatment apparatus;

coupling the host medication delivery device to the host such that the host medication delivery device is arranged to deliver the medication contained in the host medication delivery device to the host subcutaneously;

introducing the host medication delivery device including the sensor into the tissue;

operating the host medication delivery device to deliver the medication contained in the host medication delivery device into the tissue of the host subcutaneously; and

confirming delivery of the medication from the host medication delivery device to the host, wherein confirming delivery of the medication comprises using the sensor to measure the physiological parameter within a predetermined time period after delivery of the medication;

operating the host treatment apparatus such that the host treatment apparatus communicates wirelessly to the at least one remote server of the network to report confirmation of the delivery of the medication from the host medication delivery device to the host to the at least one remote server of the network;

wherein the at least one remote server of the network receives a wireless communication from the host treatment apparatus as to the delivery of the medication from the host medication delivery device to the host while the host medication delivery device is coupled to the host; and

in response to the wireless communication from the host treatment apparatus as to the delivery of the medication from the host medication delivery device to the host, the at least one remote server of the network reports the delivery of the medication from the host medication delivery device to the host to at least one client user of the network while the host medication delivery device is coupled to the host.

2. The method of claim 1 wherein:

the step(s) of storing the unique host identifier and the unique host treatment apparatus identifier on at least one remote server of a network, and associating the unique host identifier and the unique host treatment apparatus identifier on the at least one remote server of the network such that the unique host treatment apparatus identifier is exclusively associated with the unique host identifier further comprises

associating the unique host identifier and the unique host treatment apparatus identifier in a computer software program which resides on the at least one remote server of the network; and

the step of operating the host treatment apparatus such that the host treatment apparatus communicates wirelessly to the at least one remote server of the network a delivery of the medication from the host medication delivery device to the host further comprises

operating the host treatment apparatus such that the host treatment apparatus communicates wirelessly to the computer software program residing on the at least one remote server of the network a delivery of the medication from the host medication delivery device to the host.

3. The method of claim 1 wherein:

the unique host treatment apparatus identifier is a unique identifier of the host medication delivery device.

4. The method of claim 1 wherein:

the host treatment apparatus further comprises a host remote control device, wherein the host medication delivery device and the host remote control device are configured to communicate wirelessly to each other.

5. The method of claim 1 further comprising:

introducing the host medication delivery device including the sensor into the tissue such that the tissue is in contact with the sensor; and

forming a depot in the tissue with the medication, wherein the depot reduces the tissue contact with the sensor by displacing the tissue from the sensor.

6. The method of claim 5 wherein:

the predetermined time period is less than a time required for the depot to be completely absorbed into the tissue and the tissue reestablishes contact with the sensor where the depot was located.

7. The method of claim 1 wherein:

confirming delivery of the medication from the host medication delivery device to the host further comprises

determining a value of the physiological parameter measured within the predetermined time period after delivery of the medication;

providing a predetermined representative value for the physiological parameter, wherein the predetermined representative value of the physiological parameter is stored with at least one of the host treatment apparatus and the at least one remote server of the network; and

determining that the measured value of the physiological parameter within the predetermined time period after delivery of the medication is less than or greater than the predetermined representative value for the physiological parameter stored with at least one of the host treatment apparatus and the at least one remote server of the network.

8. The method of claim 1 further comprising:

after introducing the host medication delivery device including the sensor into the tissue, using the sensor to measure the physiological parameter before delivering the medication into the tissue; and

wherein confirming delivery of the medication from the host medication delivery device to the host further comprises

determining a value of the physiological parameter measured before delivering the medication;

determining a value of the physiological parameter measured within the predetermined time period after delivery of the medication; and

determining that the value of the physiological parameter measured within the predetermined time after delivery of the medication is less than or greater than the value of the physiological parameter measured before delivering the medication into the tissue.

9. The method of claim 1 further comprising:

after introducing the host medication delivery device including the sensor into the tissue, using the sensor to measure the physiological parameter before delivering the medication into the tissue; and

wherein confirming delivery of the medication from the host medication delivery device to the host further comprises

determining a value of the physiological parameter measured before delivering the medication;

determining a value of the physiological parameter measured within the predetermined time period after delivery of the medication;

determining a numerical difference between the value of the physiological parameter measured before delivering the medication into the tissue, and the value of the physiological parameter measured within the predetermined time after delivering the medication into the tissue;

providing a predetermined representative value for the numerical difference of the physiological parameter, wherein the predetermined representative value for the numerical difference of the physiological parameter is stored with at least one of the host treatment apparatus and the at least one remote server of the network; and

determining the numerical difference between the two measured values of the physiological parameter is greater than the predetermined representative value for the numerical difference of the physiological parameter stored with at least one of the host treatment apparatus and the at least one remote server of the network.

10. The method of claim 1 further comprising:

after introducing the host medication delivery device including the sensor into the tissue, using the sensor to measure the physiological parameter before delivering the medication into the tissue; and

wherein confirming delivery of the medication from the host medication delivery device to the host further comprises

determining a value of the physiological parameter measured before delivering the medication;

determining a value of the physiological parameter measured within the predetermined time period after delivery of the medication;

determining a percentage change between the value of the physiological parameter measured before delivering the medication into the tissue, and the value of the physiological parameter measured within the predetermined time after delivering the medication into the tissue;

providing a predetermined representative value for the percentage change of the physiological parameter, wherein the predetermined representative value for the percentage change of the physiological parameter is stored with at least one of the host treatment apparatus and the at least one remote server of the network; and

determining the percentage change between the two measured values of the physiological parameter is greater than the predetermined representative value for the percentage change of the physiological parameter stored with at least one of the host treatment apparatus and the at least one remote server of the network.

11. The method of claim 1 wherein:

wherein introducing the host medication delivery device including the sensor into the tissue further comprises

introducing the host medication delivery device including the sensor into the tissue such that the tissue is in contact with the sensor;

forming a depot in the tissue with the medication, wherein the sensor is at least partially within the depot and the depot reduces the tissue contact with the sensor by displacing the tissue from the sensor; and

wherein confirming delivery of the medication from the host medication delivery device to the host, wherein confirming delivery of the medication comprises using the sensor to measure the physiological parameter within a predetermined time period after delivery of the medication further comprises

confirming delivery of the medication from the host medication delivery device to the host, wherein confirming delivery of the medication comprises using the sensor to measure the physiological parameter within a predetermined time period after delivery of the medication while the sensor is within the depot.

12. The method of claim 11 wherein:

confirming delivery of the medication from the host medication delivery device to the host further comprises

determining a value of the physiological parameter while the sensor is within the depot;

providing a predetermined representative value for the physiological parameter, wherein the predetermined representative value of the physiological parameter is stored with at least one of the host treatment apparatus and the at least one remote server of the network; and

determining that the measured value of the physiological parameter while the sensor is within the depot is less than or greater than the predetermined representative value for the physiological parameter stored with at least one of the host treatment apparatus and the at least one remote server of the network.

13. The method of claim 11 further comprising:

after introducing the host medication delivery device including the sensor into the tissue, using the sensor to measure the physiological parameter before delivering the medication into the tissue; and

wherein confirming delivery of the medication from the host medication delivery device to the host further comprises

determining a value of the physiological parameter measured before delivering the medication;

determining a value of the physiological parameter measured while the sensor is within the depot; and

determining that the value of the physiological parameter measured while the sensor is within the depot is less than or greater than the value of the physiological parameter measured before delivering the medication into the tissue.

14. The method of claim 11 further comprising:

after introducing the host medication delivery device including the sensor into the tissue, using the sensor to measure the physiological parameter before delivering the medication into the tissue; and

wherein confirming delivery of the medication from the host medication delivery device to the host further comprises

determining a value of the physiological parameter measured before delivering the medication;

determining a value of the physiological parameter measured while the sensor is within the depot;

determining a numerical difference between the value of the physiological parameter measured before delivering the medication into the tissue, and the value of the physiological parameter measured while the sensor is within the depot;

providing a predetermined representative value for the numerical difference of the physiological parameter, wherein the predetermined representative value for the numerical difference of the physiological parameter is stored with at least one of the host treatment apparatus and the at least one remote server of the network; and

determining the numerical difference between the two measured values of the physiological parameter is greater than a predetermined representative value for the numerical difference of the physiological parameter stored with at least one of the host treatment apparatus and the at least one remote server of the network.

15. The method of claim 11 further comprising:

after introducing the host medication delivery device including the sensor into the tissue, using the sensor to measure the physiological parameter before delivering the medication into the tissue; and

wherein confirming delivery of the medication from the host medication delivery device to the host further comprises

determining a value of the physiological parameter measured before delivering the medication;

determining a value of the physiological parameter measured while the sensor is within the depot;

determining a percentage change between the value of the physiological parameter measured before delivering the medication into the tissue, and the value of the physiological parameter measured while the sensor is within the depot;

providing a predetermined representative value for the percentage change of the physiological parameter, wherein the predetermined representative value for the percentage change of the physiological parameter is stored with at least one of the host treatment apparatus and the at least one remote server of the network; and

determining the percentage change between the two measured values of the physiological parameter is greater than a predetermined representative value for the percentage change of the physiological parameter stored with at least one of the host treatment apparatus and the at least one remote server of the network.