Infusion pump and method for improved filling of a fluidic system

• US 10,525,211 B2
• Filed: 10/09/2013
• Issued: 01/07/2020
• Est. Priority Date: 04/12/2011
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Geipel, Andreas, Dogwiler, Joerg, Haueter, Ulrich, Scheurer, Simon, Zihlmann, Rudolf, Teutsch, David, Kuehni, Florian, Schaltegger, Reto
• Primary Examiner(s): Stigell, Theodore J
• Application Number:
  US14/049,480
• Publication Number:
  US 20140039392A1
• Time in Patent Office: 2,281 Days
• CPC Class Codes: A61M 2005/1402 Priming
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14264 with means for compensating influence from the environment
• CPC Class Codes: A61M 2005/16868 Downstream occlusion sensors
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/3365 Rotational speed
• CPC Class Codes: A61M 2205/3396 Reservoirs being alternately filled and emptied for measuring flow rate or delivered volume
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/16809 by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: A61M 5/365 Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626

Abstract

An infusion pump device and method for filling a fluidic system of the infusion pump with liquid medicament prior to infusion operation is presented. A control unit causes the infusion pump to: (a) bring a pump to an initial state; (b) switch a valve to a first state connecting a secondary reservoir to a first conduit and a primary reservoir; (c) retrieve medicament from the primary reservoir; (d) switch the valve to a second state connecting the secondary reservoir to a second downstream conduit; (e) expel the secondary reservoir contents into the second downstream conduit; (f) switch the valve to the first state; (g) retrieve the primary reservoir medicament; (h) switch the valve to the second state; and (i) expel the secondary reservoir contents into the second downstream conduit by shifting a piston to the initial position.

Claims

1. An infusion pump device comprising a primary reservoir for liquid medicament, a pump with a secondary reservoir to retrieve liquid medicament from the primary reservoir and to subsequently dose the liquid medicament from the secondary reservoir in incremental steps, a first upstream conduit fluidly connecting the primary reservoir with the pump, a second downstream conduit fluidly connected to the pump for transporting the liquid medicament to an infusion site interface, a valve for alternatingly connecting the pump to one of the first upstream conduit and the second downstream conduit, and a control unit to control the operation of the infusion pump device, wherein for filling a fluidic system of the infusion pump device with liquid medicament prior to infusion operation, the control unit causes the infusion pump device to carry out the following steps:

bringing the pump to an initial state where an inner volume of the secondary reservoir is minimal;

switching the valve to a first state, in which the secondary reservoir is connected to the first upstream conduit and the primary reservoir and retrieving a volume of liquid medicament from the primary reservoir, wherein the retrieved liquid volume V_up is at least equal to an inner volume V_B of the first upstream conduit, V_up≥

V_B, wherein prior to retrieving liquid medicament from the primary reservoir, the control unit verifies that the remaining content of the primary reservoir is sufficient for the next step of the filling procedure;

switching the valve to a second state, in which the secondary reservoir is connected to the second downstream conduit, and expelling any air and liquid medicament contents in the secondary reservoir into the second downstream conduit;

switching the valve to the first state and retrieving a second volume of liquid medicament from the primary reservoir, wherein the second retrieved liquid volume V_Down is at least equal to an inner volume (V_D+V_E+V_F) of the second downstream conduit, V_Down≥

(V_D+V_E+V_F);

switching the valve to the second state; and

expelling the contents in the secondary reservoir into the second downstream conduit.

2. The infusion pump device according to claim 1, wherein the retrieved liquid volume V_up is V_Up=V_B*SF_Up, with SF_Up being a factor with 1.0≤

SF_Up≤

2.0; and

/or the retrieved liquid volume V_Down is V_Down=(V_D+V_E+V_F)*SF_Down, with SF_Down being a factor with 1.0≤

SF_Up≤

2.0.

3. The infusion pump device according to claim 2, wherein the factor SF_Up and/or the factor SF_Down is less or equal 1.5.

4. The infusion pump device according to claim 1, wherein prior to retrieving liquid medicament from the primary reservoir, the control unit verifies that the remaining content of the primary reservoir is for all steps of the filling procedure.

5. The infusion pump device according to claim 4, wherein if the control unit finds the remaining content of the primary reservoir to be not sufficient, the control unit requests a user to replace or refill the primary reservoir.

6. The infusion pump device according to claim 1, wherein during the filling, the control unit monitors the pressure in the second downstream conduit.

7. The infusion pump device according to claim 1, further comprising, a detector that is able to detect the presence of air bubbles in the second downstream conduit.

8. The infusion pump device according to claim 1, wherein the pump is a cylinder pump with a cylinder as the secondary reservoir and a piston slidably arranged within the cylinder.

9. The infusion pump device according to claim 1, wherein during the filling, the control unit monitors the accumulated amount of air in the second downstream conduit.

10. The infusion pump device according to claim 9, wherein the control unit repeats the filling when the accumulated amount of air exceeds a certain threshold value.

21. The method according to claim 11, wherein the method is carried out with an infusion pump device according to claim 1.

11. A method for priming an infusion pump device comprising a primary reservoir for liquid medicament, a pump with a secondary reservoir that retrieves liquid medicament from the primary reservoir and subsequently doses the liquid medicament from the secondary reservoir in incremental steps, a first upstream conduit fluidly connecting the primary reservoir with the pump, a second downstream conduit fluidly connected to the pump for transporting the liquid medicament to an infusion site interface, a valve for alternatingly connecting the pump to one of the first upstream conduit and the second downstream conduit, and a control unit to control the operation of the infusion pump device, wherein for filling a fluidic system of the infusion pump device with liquid medicament prior to infusion operation the method comprises:

bringing the pump to an initial state where an inner volume of the secondary reservoir is minimal;

switching the valve to a first state, in which the secondary reservoir is connected to the first upstream conduit and the primary reservoir and retrieving a volume of liquid medicament from the primary reservoir, wherein the retrieved liquid volume V_up is at least equal to an inner volume V_B of the first upstream conduit, V_up≥

V_B, wherein prior to retrieving liquid medicament from the primary reservoir, the control unit verifies that the remaining content of the primary reservoir is sufficient for the next step of the filling procedure;

switching the valve to a second state, in which the secondary reservoir is connected to the second downstream conduit, and expelling any air and liquid medicament contents in the secondary reservoir into the second downstream conduit;

switching the valve to the first state, and retrieving a second volume of liquid medicament from the primary reservoir, wherein the second retrieved liquid volume V_Down is at least equal to an inner volume (V_D+V_E+V_F) of the second downstream conduit, V_Down≥

(V_D+V_E±

V_F);

switching the valve to the second state; and

expelling the contents in the secondary reservoir into the second downstream conduit.

12. The method according to claim 11, wherein the retrieved liquid volume V_up is V_Up=V_B*SF_Up, with SF_Up being a factor with 1.0≤

SF_Up≤

2.0 and/or the retrieved liquid volume V_Down in is V_Down=(V_D+V_E+V_F)*SF_Down, with SF_Down being a factor with 1.0≤

SF_Up≤

2.0.

13. The method according to claim 12, wherein the factor SF_Up, and/or the factor SF_Down is less or equal 1.5.

14. The method according to claim 11, wherein prior to retrieving liquid medicament from the primary reservoir, the control unit verifies it is verified that the remaining content of the primary reservoir is sufficient for all of the filling procedure.

15. The method according to claim 14, wherein if the remaining content of the primary reservoir is found to be not sufficient, the primary reservoir is replaced or refilled before the filling procedure is carried out.

16. The method according to claim 11, wherein during the filling procedure, the pressure in the second downstream conduit is monitored.

17. The method according to claim 11, wherein during the filling procedure, the presence of air bubbles in the second downstream conduit is detected.

18. The method according to claim 11, wherein the pump is a cylinder pump with a cylinder as the secondary reservoir and a piston slidably arranged within the cylinder.

19. The method according to claim 11, wherein during the filling procedure, accumulated amount of air in the second downstream conduit is monitored.

20. The method according to claim 19, wherein the filling procedure is repeated when the accumulated amount of air exceeds a certain threshold value.