Infusion pumps

• US 10,272,196 B2
• Filed: 12/22/2014
• Issued: 04/30/2019
• Est. Priority Date: 09/24/2010
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: PerQFlo, LLC
• Inventors: Smith, Roger E., Causey, James, Gibson, Scott R.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Engel, Matthew A
• Application Number:
  US14/578,996
• Publication Number:
  US 20150133855A1
• Time in Patent Office: 1,590 Days
• CPC Class Codes: A61M 2005/16868 Downstream occlusion sensors
• CPC Class Codes: A61M 2005/16872 Upstream occlusion sensors
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/16854 by monitoring line pressure

Abstract

Ambulatory infusion pumps, pump assemblies, cartridges, baseplates, cannulas, insertion tools, and related components as well as combinations thereof and related methods.

Claims

1. An apparatus, comprising:

a medicament cartridge having a barrel, defining at least a substantial part of a medicament reservoir having a total filled volume, and a plunger in the barrel; and

an infusion pump assembly, including a housing holding the medicament cartridge and a pusher positioned in the housing and relative to the medicament cartridge, configured to push the plunger so as to controllably dispense out of the reservoir a dose of medicament of 0.1% or less of the total filled volume of the reservoir in accordance with a delivery profile and with a single-dose precision of better than plus or minus 20% per dose and configured to obtain the single-dose precision at an end of a time-to-precision period during which the plunger is being pushed in accordance with the delivery profile, the time-to-precision period beginning at an onset of a first pushing of the plunger for a first dose of the medicament since insertion of the medicament cartridge into the housing, and the time-to-precision period ending less than eight hours from the onset of the first pushing of the plunger.

2. The apparatus as claimed in claim 1, wherein the single-dose precision is better than plus or minus 10%.

3. The apparatus as claimed in claim 1, wherein the single-dose precision is better than plus or minus 5%.

4. The apparatus as claimed in claim 1, wherein the time-to-precision period is six hours or less.

5. The apparatus as claimed in claim 1, further comprising:

a drive mechanism in the housing to drive the pusher and thereby to push the plunger.

6. The apparatus as claimed in claim 5, wherein the drive mechanism includes a motor, a lead screw, a gear assembly operatively between the motor and the lead screw, and a drive nut attaching the pusher to the lead screw.

7. The apparatus as claimed in claim 1, wherein the pusher travels along an axis and the housing includes an insertion opening through which the medicament cartridge is inserted in the housing in a direction perpendicular to the axis along which the pusher travels.

8. The apparatus as claimed in claim 7, further comprising:

a rigid chassis mounted in the housing and forming a compartment for the medicament cartridge, the compartment directly communicating with the insertion opening.

9. The apparatus as claimed in claim 1, wherein the reservoir includes a medicament outlet port disposed along or parallel to a longitudinal axis of the pusher.

10. The apparatus as claimed in claim 1, further comprising:

an occlusion sensor including a fluid force deflectable part that is supported by the medicament cartridge and a fixed sensor part that is in the infusion pump assembly housing.

11. The apparatus as claimed in claim 10, wherein the occlusion sensor is configured to detect pressure changes equivalent to six microliters or less.

12. The apparatus as claimed in claim 10, wherein

the fluid force deflectable part comprises a magnet;

and

the fixed sensor part comprises a sensor configured to respond to changes in a magnetic field.

13. The apparatus as claimed in claim 1, further comprising:

a cannula supported in the medicament cartridge, extending out a bottom opening in the housing and having an opening in fluid communication with an outlet port of the reservoir.

14. The apparatus as claimed in claim 1, wherein

the barrel defines an inner diameter;

the plunger is movable over a stroke length; and

the stroke length to inner diameter ratio is about 1.0 or less.

15. The apparatus as claimed in claim 14, wherein the stroke length to inner diameter ratio is between 0.75 and 1.0.

16. The apparatus as claimed in claim 1, wherein the infusion pump assembly is configured to store the delivery profile.

17. The apparatus as claimed in claim 1, wherein the delivery profile includes multiple doses over a multi-hour time period.

18. The apparatus as claimed in claim 1, wherein

the medicament comprises insulin that contains 500 international units of insulin activity per 1.0 cc;

and

the infusion pump assembly is configured to actuate an alarm in response to a missed delivery of 3 international units (6 microliters) of the insulin.

20. The apparatus as claimed in claim 1, wherein the plunger includes a spool-shaped core and a seal around a middle of the core.

21. The apparatus as claimed in claim 20, wherein the plunger includes a fluorinated polymer sleeve shrink-wrapped around at least the seal.

19. An apparatus, comprising:

a medicament cartridge having a barrel, defining at least a substantial part of a medicament reservoir having a total filled volume, and a plunger in the barrel;

an infusion pump assembly, including a housing holding the medicament cartridge and a pusher positioned in the housing and relative to the medicament cartridge, configured to push the plunger so as to controllably dispense out of the reservoir a dose of medicament of 0.1% or less of the total filled volume of the reservoir in accordance with a delivery profile and with a single-dose precision of better than plus or minus 20% per dose and configured to obtain the single-dose precision at an end of a time-to-precision period during which the plunger is being pushed in accordance with the delivery profile, the time-to-precision period beginning at an onset of a first pushing of the plunger for a first dose of the medicament since insertion of the medicament cartridge into the housing, and the time-to-precision period ending less than eight hours from the onset of the first pushing of the plunger;

a detectable structure on the medicament cartridge;

a detector in the infusion pump assembly housing that is configured to detect a presence of the detectable structure when the medicament cartridge has been positioned in the housing; and

a controller that controls a motor that drives the pusher and is configured to determine whether or not the medicament cartridge has been positioned based on signals from the detector.

22. An apparatus, comprising:

a medicament cartridge having a barrel, defining at least a substantial part of a medicament reservoir having a total filled volume, and a plunger in the barrel;

an infusion pump assembly, including a housing holding the medicament cartridge and a pusher positioned in the housing and relative to the medicament cartridge, configured to push the plunger so as to controllably dispense out of the reservoir an amount of medicament of 0.1% or less of the total filled volume of the reservoir in accordance with a delivery profile and with a single-dose precision of better than plus or minus 20% per dose and configured to obtain the single-dose precision at an end of a time-to-precision period during which the plunger is being pushed in accordance with the delivery profile, the time-to-precision period beginning at an onset of a first pushing of the plunger within the medicament cartridge and ending less than eight hours from the onset of the first pushing of the plunger;

a detectable structure on the medicament cartridge;

a detector in the infusion pump assembly housing that is configured to detect a presence of the detectable structure when the medicament cartridge has been positioned in the housing; and

a controller that controls a motor that drives the pusher and is configured to determine whether or not the medicament cartridge has been positioned based on signals from the detector;

wherein the detectable structure comprises a magnet; and

wherein the detector comprises a sensor configured to respond to changes in a magnetic field.