Substance monitoring and control in human or animal bodies

• US 9,089,305 B2
• Filed: 12/08/2009
• Issued: 07/28/2015
• Est. Priority Date: 12/09/2008
• Status: Expired due to Fees

• Current Assignee: Cambridge Enterprises Limited
• Original Assignee: Cambridge Enterprises Limited
• Inventors: Hovorka, Roman
• Primary Examiner(s): Berdichevsky, Aarti B
• Assistant Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US13/133,335
• Publication Number:
  US 20110257627A1
• Time in Patent Office: 2,058 Days
• Field of Search: 604 65- 67
• US Class Current: 1/1
• 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: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2230/201 Glucose concentration
• 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
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage

Abstract

Diabetes management apparatus comprising a sensor providing measurements of glucose level in a human or animal; an insulin pump for delivering a dose of insulin to said human or animal; and a processor. The processor is adapted to perform the following steps: receive said measurements of glucose level from said sensor; calculate a insulin dose to be delivered by said insulin pump based on said received measurement; assess the validity of the status of the apparatus; and send a command to said insulin pump to deliver said calculated insulin dose, dependent on said assessing step confirming that the status is valid. The insulin pump is configured to deliver a preset dose of insulin unless said processor sends a command to said insulin pump and wherein a said command sent to said insulin pump is valid only for a predetermined time interval so that if no further commands are sent to said insulin pump during said predetermined time interval, said insulin pump reverts to delivering said preset dose of insulin at the end of said predetermined time interval.

Claims

1. A hybrid open and closed loop diabetes management apparatus comprising:

a sensor providing measurements of glucose level in a human or animal when the apparatus is operating in a closed-loop mode for a predetermined time interval;

an insulin pump for delivering both of;

a preset dose of insulin to said human or animal when the apparatus is operating in an open-loop mode, wherein said open-loop mode is a default setting of said apparatus, and

a calculated insulin dose to said human or animal when the apparatus is operating in said closed-loop mode for said predetermined time interval; and

a processor which is adapted to perform the following steps;

receive said measurements of glucose level from said sensor;

calculate said calculated insulin dose to be delivered by said insulin pump in said closed-loop mode based on said received measurement;

assess the validity of the status of the apparatus; and

send a command to said insulin pump to enter said closed-loop mode for said predetermined time interval and deliver said calculated insulin dose during said predetermined time interval, dependent on said assessing step confirming that the status is valid,

wherein said apparatus is configured to operate in said default open-loop mode wherein said insulin pump is configured to deliver said preset dose of insulin unless said processor sends said command to said insulin pump so that said apparatus is configured to operate in said closed-loop mode, and

wherein the command sent to said insulin pump is valid only for said predetermined time interval so that if no further commands are sent to said insulin pump during said predetermined time interval, said insulin pump reverts to said open-loop mode delivering said preset dose of insulin at the end of said predetermined time interval.

2. A hybrid open and closed loop diabetes management apparatus according to claim 1, wherein the preset dose is a pre-programmed continuous infusion rate of insulin and said processor is configured to send a command which alters said continuous infusion rate.

3. A hybrid open and closed loop diabetes management apparatus according to claim 2, wherein the predetermined time interval has a duration of five, ten, fifteen, or eighteen minutes.

4. A hybrid open and closed loop diabetes management apparatus according to claim 1, wherein the predetermined time interval has a duration of five, ten, fifteen, or eighteen minutes.

5. A hybrid open and closed loop diabetes management apparatus according to claim 1, wherein the processor is configured to confirm the validity of the system by assessing whether or not the sensor is providing valid and/or not corrupted glucose measurements.

6. A hybrid open and closed loop diabetes management apparatus according to claim 1, wherein the processor is configured to confirm the validity of the system by assessing whether or not the sensor is communicating correctly with the processor.

7. A hybrid open and closed loop diabetes management apparatus according to claim 1, wherein the processor is configured to confirm the validity of the system by assessing whether or not the insulin pump is correctly delivering insulin.

8. A hybrid open and closed loop diabetes management apparatus according to claim 1, comprising more than one sensor.

9. A hybrid open and closed loop diabetes management apparatus according to claim 8, comprising a plurality of glucose sensors and wherein the processor is configured to confirm the validity of the system by assessing the concordance of the readings from the plurality of glucose sensors.

10. A hybrid open and closed loop diabetes management apparatus according to claim 8, comprising a non-glucose sensor measuring a non-glucose substance and wherein the processor is configured to confirm the validity of the system by assessing the measurements from the non-glucose sensor.

11. A hybrid open and closed loop diabetes management apparatus according to claim 1, wherein the processor is configured to confirm the validity of the system by determining the preferred operational mode for the time of day.

12. A hybrid open and closed loop diabetes management apparatus according claim 1, further comprising a monitor for displaying information to a patient and/or for inputting information from a patient.

13. A hybrid open and closed loop diabetes management apparatus according to claim 12, wherein said processor is integrated in said monitor.

14. A computer-implemented method of controlling a hybrid open and closed loop diabetes management apparatus, the method comprising the steps of:

delivering both of;

a pre-set dose of insulin to a human or animal when the apparatus is operating in an open-loop mode, wherein said open-loop mode is a default setting of said apparatus, and

a calculated insulin dose to said human or animal when the apparatus is operating in a closed-loop mode for a predetermined time interval;

controlling said delivery of insulin in said closed-loop mode by performing the following steps;

calculating said calculated insulin dose to be delivered in said closed-loop mode based on measurements of glucose levels in said human or animal;

performing a status integrity check;

issuing a command to enter said closed-loop mode for said predetermined time interval and deliver said calculated insulin dose during said predetermined time interval, dependent on confirmation that said status integrity check is valid;

wherein the issued command is valid only for said predetermined time interval so that if no further commands are issued during said predetermined time interval, said insulin delivery reverts to said open-loop mode delivering said preset dose of insulin at the end of said predetermined time interval.

15. A carrier carrying computer program code to, when running, implement the method of claim 14.