Infusion pump device and method for improved dosing

Patent metadata

Field	Value
Publication number	US-9402951-B2
Application number	US-201314049396-A
Country	US
Kind code	B2
Filing date	Oct 9, 2013
Priority date	Apr 12, 2011
Publication date	Aug 2, 2016
Grant date	Aug 2, 2016

Abstract

An infusion pump device comprising a primary liquid medicament reservoir, a pump with a secondary reservoir to retrieve medicament from the primary reservoir and to subsequently dose the medicament from the secondary reservoir in adjustable volumes (V dose,i ) to a downstream conduit and a control unit to control the operation of the infusion pump device is presented. For metering the volumes (V dose,i ), the control unit causes the infusion pump device to: (a) determine a maximum refill level (V C,max ) for the secondary reservoir, based on external parameters, wherein the maximum refill level does not exceed the maximum capacity of the secondary reservoir; (b) fill the secondary reservoir with medicament from the primary reservoir to the maximum refill level (V C,max ); (c) meter and convey the medicament volumes to the downstream conduit; (d) if the secondary reservoir becomes empty, refill the secondary reservoir as in step (b) and continue with step (c).

First claim

We claim:

1. An infusion pump device comprising a primary reservoir for a liquid medicament, a pump with a secondary reservoir to retrieve the liquid medicament from the primary reservoir and to subsequently dose the liquid medicament from the secondary reservoir in one or more portions of adjustable volume (V dose,i ) to a downstream conduit, and a control unit to control the operation of the infusion pump device, wherein for metering the multitude of portions (V dose,i ) the control unit causes the infusion pump device to carry out the following steps:
filling the secondary reservoir with the liquid medicament from the primary reservoir to a certain adjustable refill level (V refill );
metering and conveying at certain points in time (t i ) the different portions (V dose,i ) of the liquid medicament to the downstream conduit; and
if the secondary reservoir becomes empty, refilling the secondary reservoir and continuing with metering and conveying;
wherein the control unit on a regular basis determines a maximum refill level (V C,max ) for the secondary reservoir or retrieves such a maximum refill level (V C,max ) from another source, wherein the volumes (V dose,i ) of the one more portions of the liquid medicament to be metered and the points in time (t i ) at which they are metered and conveyed are independent from the maximum refill level (V C,max ), and wherein during the metering of the multitude of portions (V dose,i ), the control unit restricts the filling of the secondary reservoir to a refill level (V refill ) that is smaller than or equal to the maximum refill level (V C,max ).

2. The infusion pump device according to claim 1 , wherein if the secondary reservoir becomes empty during the metering of a single portion of the liquid medicament and has to be refilled, the maximum refill level for that particular refilling step is increased to an increased maximum refill level V C,max ′=V C,max +V dose,rem , with V dose,rem being the remaining volume of the single portion that has not yet been completely metered.

3. The infusion pump device according to claim 1 , wherein if the next single portion (V dose,i ) of the liquid medicament to be metered is above a certain threshold, the secondary reservoir is refilled to the maximum refill level (V C,max ) prior to or after administration of the single portion.

4. The infusion pump device according to claim 1 , wherein if the secondary reservoir becomes empty during the metering of the next single portion (V dose,i,next ) of the liquid medicament, prior to metering the next portion the secondary reservoir is refilled with the liquid medicament from the primary reservoir, to an increased maximum refill level V C,max ′=V C,max +V dose,i,next with V dose,i,next being the volume of the single portion that is to be metered next.

5. The infusion pump device according to claim 1 , wherein if the secondary reservoir becomes empty during the metering of a single portion of the liquid medicament and has to be refilled, the refilling of the secondary reservoir is divided in two steps; wherein in a first step the secondary reservoir is filled with the liquid medicament from the primary reservoir to a volume level V dose,rem , with V dose,rem being the remaining volume of the single portion that has not yet been completely metered, and the remaining volume is metered and conveyed, and in a second step the secondary reservoir is filled to the maximum refill level (V C,max ).

6. The infusion pump device according to claim 1 , wherein the control unit or a separate system on a regular basis recalculates the maximum refill level (V C,max ) as a function of the average volume of the liquid medicament that has been metered within a certain time period in the past, and if the recalculation has been carried out by a separate system subsequently provides the recalculated maximum refill level (V C,max ) to the control unit.

7. The infusion pump device according to claim 6 , wherein the maximum refill level (V C,max ) is recalculated based on the average volume of the liquid medicament that has been metered within a period that includes at least the last 24 hours.

8. The infusion pump device according to claim 1 , further comprising,
one or more sensor units to detect changes in environmental temperature and/or environmental pressure.

9. The infusion pump device according to claim 1 , wherein the control unit, or a separate system, on a regular basis recalculates the maximum refill level (V C,max ) as a function of the changes in environmental temperature and/or environmental pressure within a certain time period in the past, and if the recalculation has been carried out by a separate system subsequently provides the recalculated maximum refill level (V C,max ) to the control unit by storing it in a memory unit.

10. A method for operating an infusion pump device comprising a primary reservoir for a liquid medicament, and a pump with a secondary reservoir which retrieves the liquid medicament from the primary reservoir and subsequently conveys the liquid medicament from the secondary reservoir in one or more portions of adjustable volume (V dose,i ) to a downstream conduit, wherein for metering the multitude of portions (V dose,i ), the method comprises:
filling the secondary reservoir with the liquid medicament from the primary reservoir to a certain adjustable refill level (V refill );
metering and conveying at certain points in time (t i ) the different portions (V dose,i ) of the liquid medicament to the downstream conduit; and
if the secondary reservoir becomes empty, refilling the secondary reservoir and continuing with metering and conveying, wherein on a regular basis a maximum refill level (V C,max ) for the secondary reservoir ( 14 ) is determined, or is retrieved from another source, wherein the volumes (V dose,i ) of the one more portions of the liquid medicament to be metered and the points in time (t i ) at which they are metered and conveyed are independent from the maximum refill level (V C,max ), and wherein during the metering of the multitude of portions (V dose,i ) the filling of the secondary reservoir is restricted to a refill level (V refill ) that is smaller than or equal to the maximum refill level (V C,max ).

11. The method according to claim 10 , wherein if the secondary reservoir becomes empty during the metering of a single portion of the liquid medicament and has to be refilled, the maximum refill level for that particular refilling step is increased to an increased maximum refill level V C,max ′V=V C,max V dose,rem with V dose,rem being the remaining volume of the single portion that has not yet been completely metered.

12. The method according to claim 10 , wherein if the next single portion (V dose,i ) of the liquid medicament to be metered is above a certain threshold, the secondary reservoir is refilled to the maximum refill level prior or after administration of the single portion.

13. The method according to claim 10 , wherein if the secondary reservoir becomes empty during the metering of the next single portion (V dose,i,next ) of the liquid medicament, prior to metering the next portion the secondary reservoir is refilled with the liquid medicament from the primary reservoir, to an increased maximum refill level V C,max ′=V C,max +V dose,i,next with V dose,i,next being the volume of the single portion that is to be metered next.

14. The method according to claim 10 , wherein if the secondary reservoir becomes empty during the metering of a single portion of the liquid medicament and has to be refilled, the refilling of the secondary reservoir is divided in two steps; wherein

Assignees

• Roche Diagnostics Int Ag

Inventors

• Geipel Andreas
• Dogwiler Joerg
• Haueter Ulrich
• Scheurer Simon
• Zihlmann Rudolf
• Teutsch David
• Kuehni Florian
• Schaltegger Reto

Classifications

• A61M2005/1402

  Priming · CPC title

• A61M2205/3306

  Optical measuring means · CPC title

• A61M2005/14208

  with a programmable infusion control system, characterised by the infusion program · CPC title

• A61M5/142

  Pressure infusion, e.g. using pumps · CPC title

• A61M5/31511

  Piston or piston-rod constructions, e.g. connection of piston with piston-rod (A61M5/5066 takes precedence) · CPC title