Device and method for automatic injection and occlusion detection

• US 9,889,254 B2
• Filed: 01/02/2014
• Issued: 02/13/2018
• Est. Priority Date: 07/06/2011
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Haenggi, Roger
• Primary Examiner(s): Landry, II, Gerald
• Application Number:
  US14/146,236
• Publication Number:
  US 20140121632A1
• Time in Patent Office: 1,503 Days
• Field of Search: 604 65- 67, 604131-155, 604505
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile

Abstract

An injection device for injecting automatically a medicament comprises an occlusion detection system with a force measurement unit and two separate occlusion detectors. The occlusion detectors take force measurements at different respective measurement rates and generate occlusion indicating signals based on a set of force measurements taken at the respective measurement rates. The injection device further comprises an alarm generator for generating an occlusion alarm signal in cases where either or both of the occlusion detectors generate an occlusion indicating signal. The two occlusion detectors operating at different measurement rates make it possible to detect occlusions more reliably over a broader range of delivery rates.

Claims

1. An injection device for injecting automatically a medicament, the injection device comprising:

a force measurement unit to measure an injection force;

a first occlusion detector to take force measurements at a first measurement rate and to generate a first occlusion indicating signal based on a set of force measurements taken at the first measurement rate;

a second occlusion detector to take force measurements at a second measurement rate, lower than the first measurement rate, and to generate a second occlusion indicating signal based on a set of force measurements taken at the second measurement rate; and

an alarm generator to generate an occlusion alarm signal in cases where the first occlusion indicating signal is generated by the first occlusion detector or the second occlusion indicating signal is generated by the second occlusion detector.

2. The injection device according to claim 1, wherein the injection device injects the medicament at a variable delivery rate where the first measurement rate corresponds to a defined upper delivery rate limit and the second measurement rate corresponds to a defined lower delivery rate limit which is lower than the defined upper delivery rate limit.

3. The injection device according to claim 1, wherein the first occlusion detector generates the first occlusion indicating signal based on a set of force measurements taken at the first measurement rate during a first measurement period and the second occlusion detector generates the second occlusion indicating signal based on a set of force measurements taken at the second measurement rate during a second measurement period longer than the first measurement period.

4. The injection device according to claim 3, wherein the first occlusion detector generates the first occlusion indicating signal based on a first calculated product of a first vector of weighting factors and the set of force measurements taken at the first measurement rate during a first measurement period and the second occlusion detector generates the second occlusion indicating signal based on a second calculated product of a second vector of weighting factors and the set of force measurements taken at the second measurement rate during a second measurement period longer than the first measurement period.

5. The injection device according to claim 4, wherein the first occlusion detector halves the first measurement rate when the first calculated product is within a first defined threshold range and the second occlusion detector halves the second measurement rate when the second calculated product is within a second defined threshold range.

6. The injection device according to claim 4, wherein the first occlusion detector extends the first measurement period by doubling its duration when the first calculated product is within a first defined threshold range and the second occlusion detector extends the second measurement period by doubling its duration when the second calculated product is within a second defined threshold range.

7. The injection device according to claim 6, wherein the first occlusion detector includes in the extended first measurement period force measurements taken at the first measurement rate before extending the first measurement period and the second occlusion detector includes in the extended second measurement period force measurements taken at the second measurement rate before extending the second measurement period.

8. The injection device according to claim 4, wherein the first occlusion detector generates the first occlusion indicating signal when the first calculated product exceeds a first upper threshold value and the second occlusion detector generates the second occlusion indicating signal when the second calculated product exceeds a second upper threshold value.

9. The injection device according to claim 1, further comprising:

an occlusion detection system to deduct from the force measurements a force offset value and to detect the occlusions based on the force measurements having the force offset value deducted therefrom.

10. A method of detecting an occlusion in an injection device for injecting automatically a medicament, the method comprising:

measuring an injection force;

taking force measurements at a first measurement rate by a first occlusion detector and generating a first occlusion indicating signal based on a set of force measurements taken at the first measurement rate;

taking force measurements at a second measurement rate, lower than the first measurement rate, by a second occlusion detector and generating a second occlusion indicating signal based on a set of force measurements taken at the second measurement rate; and

generating an occlusion alarm signal when where the first occlusion indicating signal is generated by the first occlusion detector or the second occlusion indicating signal is generated by the second occlusion detector.

11. The method according to claim 10, wherein the medicament is injected at a variable delivery rate, the first measurement rate corresponds to a defined upper delivery rate limit and the second measurement rate corresponds to a defined lower delivery rate limit which is lower than the defined upper delivery rate limit.

12. The method according to claim 10, wherein the first occlusion indicating signal is generated by the first occlusion detector based on a set of force measurements taken at the first measurement rate during a first measurement period and the second occlusion indicating signal is generated by the second occlusion detector based on a set of force measurements taken at the second measurement rate during a second measurement period longer than the first measurement period.

13. The method according to claim 12, wherein the first occlusion indicating signal is generated by the first occlusion detector based on a first calculated product of a first vector of weighting factors and the set of force measurements taken at the first measurement rate during a first measurement period and the second occlusion indicating signal is generated by the second occlusion detector based on a second calculated product of a second vector of weighting factors and the set of force measurements taken at the second measurement rate during a second measurement period longer than the first measurement period.

14. The method according to claim 13, wherein the first measurement rate is halved by the first occlusion detector when the first calculated product is within a first defined threshold range and the second measurement rate is halved by the second occlusion detector when the second calculated product is within a second defined threshold range.

15. The method according to claim 13, wherein the first measurement period is extended by the first occlusion detector doubling its duration when the first calculated product is within a first defined threshold range and the second measurement period is extended by the second occlusion detector doubling its duration when the second calculated product is within a second defined threshold range.

16. The method according to claim 15, wherein in the extended first measurement period included by the first occlusion detector are force measurements taken at the first measurement rate before extending the first measurement period and in the extended second measurement period included by the second occlusion detector are force measurements taken at the second measurement rate before extending the second measurement period.

17. The method according to claim 14, wherein the first occlusion indicating signal is generated by the first occlusion detector when the first calculated product exceeds a first upper threshold value and the second occlusion indicating signal is generated by the second occlusion detector when the second calculated product exceeds a second upper threshold value.

18. The method according to claim 10, further comprising:

deducting a force offset value from the force measurements and detecting the occlusions based on the force measurements having the force offset value deducted therefrom.