Automatically operating injection device and method for determining an injection occlusion

• US 8,618,948 B2
• Filed: 04/21/2010
• Issued: 12/31/2013
• 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: Oberli, Markus, Kuehni, Florian, Bruegger, Martin, Prod'hom, Gilles
• Primary Examiner(s): Lu, Shirley
• Application Number:
  US12/764,587
• Publication Number:
  US 20100245104A1
• Time in Patent Office: 1,350 Days
• Field of Search: 340/665, 604/131, 604/151, 604/6, 604/65, 604/67
• 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, a comparator 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 second memory also stores gradient values of force increase values predetermined statically by experiment as a function over increasing observation periods and which form first, second and third gradient value parts, where the first gradient value part defines a first area in which an occlusion is present, where the second gradient value part defines a second area in which no occlusion is present, and the third gradient value part defines a third area which lies between the first and second areas and in which it is not possible to conclude unambiguously that there is an occlusion;

the evaluation unit is electrically coupled to the second memory and determines whether to provide an occlusion alarm signal based on an evaluation of the plurality of evaluation forces from the comparator unit which concludes that there is an occlusion;

the comparator unit, which is electrically coupled to and interacts with the evaluation unit, is configured to compare the plurality of evaluation forces with the stored gradient values of force increase values predetermined statically by experiment to conclude one of;

that there is an occlusion if the evaluation forces are in the first area defined by the first gradient value part,

that there is no occlusion if the evaluation forces are in the second area defined by the second gradient value part, and

that there is no determinable occlusion if the evaluation forces are in the third area defined by the third gradient value part; 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, further 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, wherein the evaluation unit determines the force gradient for the plurality of evaluation forces, and the 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 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.

20. The injection device of claim 1, further comprising a downsampler connected to the switching unit and configured to modify automatically a time interval between the force values to be stored as a function of an evaluation result from the evaluation unit.

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 with an measurement unit of the injection device mechanically coupled to an injection unit of the injection device which injects the medicament into the human, at an injection time period, for each of a plurality of injections automatically delivered by the injection unit 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 via a switching unit of the injection device;

determining whether an occlusion exists based on an evaluation of the plurality of evaluation forces being compared by a comparator unit of the injection device to gradient values of force increase values stored as a function over increasing observation periods on the injection device and predetermined statically by experiment in which the gradient values form first, second and third gradient value parts, where the first gradient value part defines a first area in which an occlusion is present, where the second gradient value part defines a second area in which no occlusion is present, and the third gradient value part defines a third area which lies between the first and second areas and in which it is not possible to conclude unambiguously that there is an occlusion, and wherein the comparator unit determines one of;

that there is an occlusion if the evaluation forces are in the first area defined by the first gradient value part,

that there is no occlusion if the evaluation forces are in the second area defined by the second gradient value part, and

that there is no determinable occlusion if the evaluation forces are in the third area defined by the third gradient value part; and

providing an injection occlusion alarm if an occlusion is determined by the comparator unit to exist.

12. The method of claim 11, further 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.