Drug delivery device with sensor for closed-loop operation

• US 8,409,133 B2
• Filed: 12/18/2008
• Issued: 04/02/2013
• Est. Priority Date: 12/18/2007
• Status: Active Grant

• Current Assignee: InsuLine Medical Ltd.
• Original Assignee: InsuLine Medical Ltd.
• Inventors: Pesach, Benny, Bitton, Gabriel, Nagar, Ron, Weiss, Ram
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US12/809,425
• Publication Number:
  US 20110184342A1
• Time in Patent Office: 1,566 Days
• Field of Search: 604 65- 67
• US Class Current: 604/65
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 2230/50 Temperature
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• 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 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

An apparatus and a system for controlling and/or managing administration of a drug to a body of a patient. The apparatus includes a drug infusion device configured to deliver drug at a predetermined location in the body of the patient, at least one sensor disposed in the drug infusion device and configured to measure a. corresponding property related to the patient and selected from the group consisting of physiological properties, biochemical properties, environmental properties and drug-related properties, a controller disposed in the drug infusion device and configured to receive from the at least one sensor data representative of the measured corresponding property and based on the received data, determine a drug delivery rate. The drug delivery device is configured to deliver the drug to the body of the patient based on the determined drug delivery rate.

Claims

1. An apparatus to control administration of a drug to the body of a patient, the apparatus comprising:

a drug infusion device configured to deliver the drug at a predetermined location on the body of the patient;

at least one sensor disposed in the drug infusion device and configured to measure a property related to the patient, wherein the property is a combination of a physiological property related to the patient, a biochemical property related to the patient, including a drug level in the blood of the patient and/or a rate of change of drug level in the blood of the patient, an environmental property related to the patient, including an ambient temperature, and a drug-related property, including quality of the drug being administered;

a controller disposed in the drug infusion device and configured to receive from the at least one sensor data representative of the measured property and further configured to determine a drug delivery rate based on the received data; and

the drug delivery device is further configured to deliver the drug to the body of the patient based on the determined drug delivery rate.

2. The apparatus of according to claim 1, wherein the controller is further configured to determine, based on the received data, a drug delivery adjustment factor, and wherein the drug delivery device is further configured to adjust a previous drug delivery rate based on the determined adjustment factor;

wherein the drug delivery device is further configured to adjust at least one of a timing, a rate of administration, a temporal delivery profile, and an amount of the drug to be delivered.

3. The apparatus according to claim 1, wherein the at least one sensor is configured to measure at least one of the following

a temperature of the patient at a location proximate to the predetermined location on the body of the patient,

a level of the drug in the body of the patient,

a level of physical activity of the patient,

a blood perfusion at a tissue region proximate to the predetermined location on the body of the patient,

a quality of the drug, and

a blood parameter level of the patient.

4. The apparatus according to claim 3, wherein the controller is configured to determine, based on the measured skin temperature, an adjustment factor configured to adjust the drug delivery rate such that when the measured skin temperature is not within a pre-defined temperature range corresponding to a pre-defined concentration of the drug in the blood of the patient, the drug delivery rate is adjusted such that a measured concentration of the drug in the blood of the patient is configured to be substantially close to the pre-defined concentration of the drug.

5. The apparatus according to claim 3, wherein the controller is further configured to determine the drug delivery rate based on the received data and the measured level of the drug in the body of the patient.

6. The apparatus according to claim 3, wherein the controller is configured to determine an adjustment factor based on the measured level of physical activity.

7. The apparatus according to claim 6, wherein the adjustment factor is configured to decrease the drug delivery rate when the measured level of physical activity is greater than a pre-defined physical activity threshold value;

wherein, when the measured level of physical activity is higher than the pre-defined threshold value, the adjustment factor is configured to adjust the drug delivery rate such that the measured concentration of the drug in the blood of the patient is substantially close to a pre-defined concentration of the drug in the blood of the patient obtain without physical activity by the patient.

8. The apparatus according to claim 1, wherein the drug includes insulin;

and

the drug delivery device further includes an insulin pump and a catheter disposed within the drug delivery device and configured to deliver insulin to the body of the patient;

the catheter is configured to be inserted under the skin of the patient at the predetermined location on the body of the patient.

9. The apparatus according to claim 1, wherein the drug is insulin and the at least one sensor is configured to measure an insulin characteristic.

10. The apparatus according to claim 9, further comprising an alarm means for alerting a user when the insulin characteristic indicates that quality of insulin has deteriorated.

11. The apparatus according to claim 9, wherein the drug is insulin and the at least one sensor is configured to detect information from an insulin packaging.

12. The apparatus according to claim 11, wherein the information is selected from a group consisting of:

a concentration of the insulin, an expiration date of insulin, and an authentication marker of the insulin;

wherein the alarm means is configured to generate an alert if the expiration date of insulin has passed.

13. The apparatus according to claim 1, wherein the controller is configured to determine an adjustment factor configured to adjust the drug delivery rate based on a time selected from a group consisting of:

time passed from the bolus drug delivery and the time of day.

14. A method for controlling administration of a drug to the body of a patient using a drug delivery device having at least one sensor and a controller, the method comprising the steps of:

measuring a property related to the patient, wherein the property is a combination of a physiological property related to the patient, a biochemical property related to the patient, including a drug level in the blood of the patient and/or a rate of change of drug level in the blood of the patient, an environmental property related to the patient, including an ambient temperature, and a drug-related property, including quality of the drug being administered;

receiving data representative of the measured property;

based on the received data, determining a drug delivery rate; and

using the determined drug delivery rate, delivering the drug to the body of the patient at a predetermined location on the body of the patient.

15. The method according to claim 14, further comprising

determining an adjustment factor based on the received data;

and

adjusting the drug delivery rate based on the determined adjustment factor;

wherein said adjusting further comprises

adjusting at least one of a timing, a rate of administration, a temporal drug delivery profile, and an amount of the drug to be delivered.

16. The method according to claim 14, further comprising

measuring a skin temperature of the patient at an area proximate to the predetermined location on the body of the patient;

and,

determining an adjustment factor based on the measured skin temperature;

wherein the adjustment factor is configured to adjust the drug delivery rate such that when the measured skin temperature is not within a pre-defined temperature range corresponding to a pre-defined concentration of the drug in the blood of the patient, the drug delivery rate is adjusted such that a measured concentration of the drug in the blood of the patient is configured to be substantially close to the pre-defined concentration of the drug.

17. The method according to claim 14, further comprising:

measuring a level of the drug in the body of the patient;

determining the drug delivery rate based on the received data and the measured level of the drug in the body of the patient.

18. The method according to claim 14, further comprising

measuring a level of physical activity of the patient;

and,

determining an adjustment factor based on the measured level of physical activity.

19. The method according to claim 18, wherein the adjustment factor is configured to decrease the drug delivery rate when the measured level of physical activity is greater than a pre-defined physical activity threshold value;

wherein, when the measured level of physical activity is higher than the pre-defined threshold value, the adjustment factor is configured to adjust the drug delivery rate such that the measured concentration of the drug in the blood of the patient is substantially close to a pre-defined concentration of the drug in the blood of the patient obtain without physical activity by the patient.

20. The method according to claim 14, wherein the measuring step is selected from a group consisting of:

measuring blood perfusion at a tissue region substantially proximate to the predetermined location on the body of the patient,

measuring a quality of the drug; and

measuring a blood parameter level of the patient.

21. The method according to claim 14, wherein the drug includes insulin, and wherein the delivering step further comprises delivering the drug to the body of the patient using an insulin pump and a catheter disposed within the drug delivery device and configured to deliver insulin to the body of the patient;

the catheter is configured to be inserted under the skin of the patient at the predetermined location on the body of the patient.

22. The method according to claim 14, wherein the determining further comprises determining an adjustment factor configured to adjust the drug delivery rate based on a time selected from a group consisting of:

time passed from the bolus drug delivery and the time of day.

23. A system for managing or controlling administration of a drug to the body of a patient, comprising:

a drug infusion device for administering the drug to a subject at a predetermined location on the subject;

a sensor for detecting at least one parameter related to the subject, wherein the parameter is a combination of a physiological parameter related to the patient, a biochemical parameter related to the patient, including a drug level in the blood of the patient and/or a rate of change of drug level in the blood of the patient, an environmental parameter related to the patient, including an ambient temperature, and a parameter related to the drug itself, including quality of the drug being administered; and

a controller for controlling the device for administering the drug to the subject in accordance with the at least one parameter.

24. The system according to claim 23, wherein the drug is insulin.

25. The system according to claim 24, wherein the device for administering the drug comprises an insulin pump and a catheter.

26. The system according to claim 23, wherein the controller is further configured to determine an adjustment factor configured to adjust the drug delivery rate based on a time selected from a group consisting of:

time passed from the bolus drug delivery and the time of day.