Automatically Operating Injection Device and Method for Determining An Injection Occlusion

• US 20100245104A1
• Filed: 04/21/2010
• Published: 09/30/2010
• Est. Priority Date: 10/22/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics International AG (Roche Holding AG)
• Inventors: Kuehni, Florian, Prod'hom, Gilles, Bruegger, Martin, Oberli, Markus
• Granted Patent: US 8,618,948 B2
• Time in Patent Office: Days
• US Class Current: 340/665
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066

Abstract

An automatically operating injection device with an occlusion alarm unit and a method for determining an injection occlusion are disclosed. The method includes generating a plurality of evaluation forces based on a series of force measurements and based on an evaluation time period; determining whether an occlusion exists based on either an evaluation of the plurality of evaluation forces or whether one or more of the series of force measurements exceeds a force threshold; and providing an injection occlusion alarm if an occlusion is determined to exist.

Claims

1. An injection device for automatically injecting a medicament into a human, the injection device comprising an injection unit, a measurement unit, a first memory, a second memory, a switching unit, an evaluation unit, and an occlusion alarm unit, wherein:

the injection unit is coupleable to the human to deliver automatically a plurality of injections of the medicament into the human, wherein the plurality of injections are each delivered according to an injection time period;

the measurement unit is mechanically coupled to the injection unit and measures an injection force, at the injection time period, for each of the plurality of injections;

the first memory is electrically coupled to the measurement unit and stores a value of the injection force for each of the plurality of injections measured by the measurement unit, thereby forming a series of force measurements;

the switching unit is electrically coupled to the first memory and the second memory such that the switching unit reads the series of force measurements from the first memory, generates a plurality of evaluation forces based on an evaluation time period, and writes the plurality of evaluation forces to the second memory;

the evaluation unit is electrically coupled to the second memory and determines whether to provide an occlusion alarm signal either based on an evaluation of the plurality of evaluation forces or if one or more of the series of force measurements exceeds a force threshold; and

the occlusion alarm unit which receives the occlusion alarm signal such that the occlusion alarm unit provides an injection occlusion alarm based on the occlusion alarm signal.

2. The injection device of claim 1, wherein the evaluation of the evaluation unit, in which to provide the occlusion alarm signal, includes at least one of a determination that a force gradient for the plurality of evaluation forces exceeds an upper gradient threshold and a determination that a median force gradient for the plurality of evaluation forces exceeds a gradient median threshold.

3. The injection device of claim 2, further comprising a first comparator unit electrically coupled to the evaluation unit, and wherein the evaluation unit determines the force gradient for the plurality of evaluation forces, and the first comparator unit generates the occlusion alarm signal based on whether the force gradient exceeds the upper gradient threshold, wherein the upper gradient threshold is based on the evaluation time period.

4. The injection device of claim 2, further comprising a median calculation unit and a second comparator unit, wherein:

the occlusion alarm signal is a first occlusion alarm signal;

the median calculation unit is electrically coupled to the second memory and calculates the median force gradient for the plurality of evaluation forces;

the second comparator unit is electrically coupled to the median calculation unit and generates a second occlusion alarm signal based on whether the median force gradient exceeds the gradient median threshold; and

the occlusion alarm unit is electrically coupled to the second occlusion alarm signal such that the occlusion alarm unit provides the injection occlusion alarm based on a logical “

AND”

of the first occlusion alarm signal and the second occlusion alarm signal.

5. The injection device of claim 4, further comprising a third comparator unit, wherein:

the third comparator unit is electrically coupled to the first memory and generates a third occlusion alarm signal based on whether one or more of the series of force measurements exceeds the force threshold; and

the occlusion alarm unit is electrically coupled to the third occlusion alarm signal such that the occlusion alarm unit provides the injection occlusion alarm based on a logical “

OR”

of the third occlusion alarm signal and a result of a logical “

AND”

of the first occlusion alarm signal and the second occlusion alarm signal.

6. The injection device of claim 1, wherein the evaluation time period is a multiple of the injection time period.

7. The injection device of claim 1, wherein the evaluation time period is 0.5, 1, 2, 4, or 8 hours.

8. The injection device of claim 3, wherein the evaluation unit calculates the force gradient of the plurality of evaluation forces by using a finite-impulse-response (FIR) filter having at least 11 coefficients.

9. The injection device of claim 3, wherein the evaluation time period is based on a previous comparison by the first comparator unit, wherein the previous comparison was less than the upper gradient threshold and greater than a lower gradient threshold, wherein the lower gradient threshold is based on the evaluation time period.

10. The injection device of claim 9, wherein the upper gradient threshold and the lower gradient threshold are determined statistically from experiments and are based on an observation time period, wherein:

the force gradient above the upper gradient threshold indicates an injection occlusion;

the force gradient below the lower gradient threshold indicates no injection occlusion; and

the force gradient between the lower gradient threshold and the upper gradient threshold is indeterminate of an injection occlusion.

11. A method for detecting an injection occlusion in an injection device for automatically injecting a medicament into a human, the method comprising:

measuring an injection force, at an injection time period, for each of a plurality of injections automatically delivered by the injection device into the human, thereby forming a series of force measurements, wherein the plurality of injections are each delivered according to the injection time period;

generating a plurality of evaluation forces based on the series of force measurements and based on an evaluation time period;

determining whether an occlusion exists based on either an evaluation of the plurality of evaluation forces or whether one or more of the series of force measurements exceeds a force threshold; and

providing an injection occlusion alarm if an occlusion is determined to exist.

12. The method of claim 11, wherein determining whether an occlusion exists based on the evaluation of the plurality of evaluation forces comprises determining whether a force gradient for the plurality of evaluation forces exceeds an upper gradient threshold and determining whether a median force gradient for the plurality of evaluation forces exceeds a gradient median threshold.

13. The method of claim 12, wherein the upper gradient threshold is based on the evaluation time period.

14. The method of claim 12, wherein the median force gradient is based on the plurality of evaluation forces.

15. The method of claim 11, wherein the evaluation time period is a multiple of the injection time period.

16. The method of claim 11, wherein the evaluation time period is 0.5, 1, 2, 4, or 8 hours.

17. The method of claim 13, wherein determining whether the force gradient for the plurality of evaluation forces exceeds the upper gradient threshold comprises determining the force gradient by using a finite-impulse-response (FIR) filter having at least 11 coefficients.

18. The method of claim 13, wherein the evaluation time period is based on a previous determination that the force gradient for the plurality of evaluation forces was less than the upper gradient threshold and greater than a lower gradient threshold, wherein the lower gradient threshold is based on the evaluation time period.

19. The method of claim 18, wherein the upper gradient threshold and the lower gradient threshold are determined statistically from experiments and are based on an observation time period, wherein:

the force gradient above the upper gradient threshold indicates an injection occlusion;

the force gradient below the lower gradient threshold indicates no injection occlusion; and

the force gradient between the lower gradient threshold and the upper gradient threshold is indeterminate of an injection occlusion.

20. A computer-readable medium having computer-executable instructions for performing a method for detecting an injection occlusion in an injection device for automatically injecting a medicament into a human, the method comprising:

measuring an injection force, at an injection time period, for each of a plurality of injections automatically delivered by the injection device into the human, thereby forming a series of force measurements, wherein the plurality of injections are each delivered according to the injection time period;

generating a plurality of evaluation forces based on the series of force measurements and based on an evaluation time period;

determining whether an occlusion exists based on either an evaluation of the plurality of evaluation forces or whether one or more of the series of force measurements exceeds a force threshold; and

providing an injection occlusion alarm if an occlusion is determined to exist.