Monitoring a physiological parameter associated with tissue of a host to confirm delivery of medication

• US 10,441,717 B2
• Filed: 04/15/2014
• Issued: 10/15/2019
• Est. Priority Date: 04/15/2014
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Insulet Corporation
• Inventors: Schmid, Kevin Guido, Dilanni, Steven, Campbell, Robert W., McLaughlin, Ian T., O'Connor, Jason B.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Darb, Hamza A
• Application Number:
  US14/253,271
• Publication Number:
  US 20150290391A1
• Time in Patent Office: 2,009 Days
• Field of Search: 6048901- 891, 604504, 604 66- 67
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• 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 20/17 delivered via infusion or injection

Abstract

A physiological parameter associated with tissue of a host may be monitored in the tissue to confirm subcutaneous delivery of medication to the host. More particularly, such may involve delivering medication subcutaneously to the host with a medical device which includes a sensor used to measure the physiological parameter, particularly within a predetermined time period after delivery of the medication. Such may also or otherwise involve forming a depot in the tissue with the medication, and using the sensor to measure the physiological parameter while the sensor is at least partially within the depot.

Claims

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

providing a medication delivery device which deliver the medication into a tissue of the host, wherein the medication delivery device includes a sensor, and wherein the sensor is used to measure a physiological parameter of the tissue;

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

delivering the medication into the tissue of the host;

forming a depot in the tissue with the medication, the depot formed such that the sensor is at least partially within the depot with the depot disposed between the sensor and the tissue, wherein the depot is disposed between the sensor and the tissue such that the depot reduces the tissue contact with the sensor;

confirming delivery of the medication from the medication delivery device to the host, wherein confirming delivery of the medication comprises using the sensor to measure the physiological parameter of the tissue within a predetermined time period after delivery of the medication and while the sensor is at least partially within the depot with the depot disposed between the sensor and the tissue.

2. The method of claim 1 wherein:

the tissue in contact with the sensor comprises extracellular fluid; and

the depot reduces contact of the extracellular fluid with the sensor.

3. The method of claim 2 wherein:

the depot reduces contact of the extracellular fluid with the sensor by the depot at least partially surrounding the sensor within the depot.

4. The method of claim 1 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.

5. The method of claim 1 wherein:

the predetermined time period is in a range of 0.1 second to 600 seconds.

6. The method of claim 5 wherein:

the predetermined time period is in a range of 0.1 second to 120 seconds.

7. The method of claim 1 wherein:

delivering the medication into the tissue of the host further comprises delivering the medication into subcutaneous tissue of the host.

8. The method of claim 1 wherein:

the sensor comprises a glucose sensor.

9. The method of claim 1 wherein:

the physiological parameter is glucose concentration level.

10. The method of claim 1 wherein:

confirming delivery of the medication from the 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 with the medication delivery device; and

determining that the measured value of the physiological parameter within the predetermined time period after delivery of the medication is less than the predetermined representative value for the physiological parameter provided by the medication delivery device.

11. The method of claim 1 further comprising:

after introducing the 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 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 the value of the physiological parameter measured before delivering the medication into the tissue.

12. The method of claim 1 further comprising:

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

wherein confirming delivery of the medication from the 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 with the medication delivery device; 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 provided by the medication delivery device.

13. The method of claim 12 wherein:

the physiological parameter is interstitial glucose concentration level; and

a predetermined representative value for the numerical difference provided by the medication delivery device is at least 20 mg/dL.

14. The method of claim 1 further comprising:

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

wherein confirming delivery of the medication from the 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 with the medication delivery device; 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 provided by the medication delivery device.

15. The method of claim 14 wherein:

the physiological parameter is interstitial glucose concentration level; and

a predetermined representative value for the percentage change provided by the medication delivery device is at least 15%.

16. The method of claim 1 wherein:

confirming delivery of the medication from the 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 with the medication delivery device; and

after delivery of the medication, determining that the measured value of the physiological parameter while the sensor is within the depot is less than the predetermined representative value for the physiological parameter provided by the medication delivery device.

17. The method of claim 1 further comprising:

after introducing the 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 medication delivery device to the host further comprises;

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

after delivery of 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 the value of the physiological parameter measured before delivering the medication into the tissue.

18. The method of claim 1 further comprising:

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

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

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

after delivery of 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 with the medication delivery device; 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 provided by the medication delivery device.

19. The method of claim 1 further comprising:

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

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

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

after delivery of 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 with the medication delivery device; 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 provided by the medication delivery device.

20. The method of claim 1 wherein:

the medication delivery device includes a cannula.

21. The method of claim 1 further comprising:

forming the depot in the tissue with the medication, the depot formed such that the sensor is completely within the depot with the depot disposed between the sensor and the tissue, wherein the depot disposed between the sensor and the tissue separates the tissue from the sensor such that the depot reduces the tissue contact of the tissue with the sensor.