Fluid reservoir seating procedure for a fluid infusion device

• US 10,071,200 B2
• Filed: 09/15/2016
• Issued: 09/11/2018
• Est. Priority Date: 12/22/2010
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Alderete, Jr., Juan M., Monirabbasi, Salman
• Primary Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US15/267,072
• Publication Number:
  US 20170056589A1
• Time in Patent Office: 726 Days
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• 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 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• 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
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile

Abstract

A fluid infusion device including a housing that receives a sealed fluid reservoir is presented here. The fluid infusion device includes a drive motor assembly, an actuation mechanism, a force sensor, and at least one processor in the housing. The processor detects insertion of the fluid reservoir and incrementally rewinds the drive motor assembly to achieve an equilibrium state. The processor advances the drive motor assembly and obtains at least one measure of force using the force sensor until the at least one measure of force indicates that the fluid reservoir has reached an initial seated state. The processor performs a stabilizing cycle with the drive motor assembly. The processor advances the drive motor assembly and obtains at least one subsequent measure of force using the force sensor until the at least one subsequent measure of force indicates that the fluid reservoir has reached a subsequent sealed state.

Claims

1. A fluid infusion device comprising:

a housing that receives a sealed fluid reservoir, the fluid reservoir comprising a plunger and a shaft coupled to the plunger;

a drive motor assembly in the housing;

an actuation mechanism in the housing, wherein the actuation mechanism is operatively coupled to the drive motor assembly;

a force sensor in the housing and operatively coupled to the actuation mechanism to obtain measures of force associated with interaction of the shaft with the actuation mechanism; and

at least one processor in the housing and operatively coupled to the drive motor assembly and the force sensor, wherein the at least one processor;

detects insertion of the fluid reservoir into the housing;

thereafter, incrementally rewinds the drive motor assembly to achieve an equilibrium state for the fluid reservoir;

thereafter, advances the drive motor assembly and obtains at least one measure of force using the force sensor until the at least one measure of force indicates that the fluid reservoir has reached an initial seated state;

thereafter, performs a stabilizing cycle with the drive motor assembly to stabilize the fluid reservoir; and

thereafter, advances the drive motor assembly and obtains at least one subsequent measure of force using the force sensor until the at least one subsequent measure of force indicates that the fluid reservoir has reached a subsequent sealed state.

2. The fluid infusion device of claim 1, wherein, after detecting insertion of the sealed fluid reservoir into the housing, the at least one processor:

obtains at least one initial measure of force that indicates that the fluid reservoir is in need of depressurization; and

performs a depressurizing operation by rewinding the drive motor assembly.

3. The fluid infusion device of claim 2, wherein performing the stabilizing cycle comprises:

advancing the drive motor assembly by a first amount; and

thereafter, rewinding the drive motor assembly by a second amount.

4. The fluid infusion device of claim 2, wherein, the at least one processor obtains the at least one initial measure of force and compares the at least one initial measure of force to a first threshold force value to determine that the fluid reservoir is in need of depressurization.

5. The fluid infusion device of claim 2, wherein the at least one processor obtains a current measure of force after the rewinding of the drive motor assembly, and the at least one processor determines the fluid reservoir is depressurized based on a comparison between the current measure of force and a first threshold force value.

6. The fluid infusion device of claim 2, wherein the at least one processor generates an alarm based on the rewinding of the drive motor assembly exceeding a predetermined maximum amount.

7. The fluid infusion device of claim 1, wherein, in order to achieve the equilibrium state for the fluid reservoir, the at least one processor:

obtains an initial comparative measure of force using the force sensor, and the initial comparative measure of force is associated with interaction of the shaft with the actuation mechanism;

thereafter, rewinds the drive motor assembly by a predetermined amount;

thereafter, obtains a subsequent comparative measure of force using the force sensor, the subsequent comparative measure of force associated with interaction of the shaft with the actuation mechanism;

calculates a difference between the initial comparative measure of force and the subsequent comparative measure of force;

compares the difference to an equilibrium threshold value; and

determines that the equilibrium state is achieved based on the comparison.

8. The fluid infusion device of claim 7, wherein the at least one processor determines that the equilibrium state is achieved based on the difference being less than the equilibrium threshold value.

9. The fluid infusion device of claim 1, wherein the at least one processor advances the drive motor assembly and obtains the at least one measure of force using the force sensor, and the at least one processor determines that the fluid reservoir has reached the initial seated state based on at least one of a first condition and a second condition being satisfied, the first condition different than the second condition.

10. The fluid infusion device of claim 9, wherein the at least one processor repeats the advancing of the drive motor assembly and the obtaining of the at least one measure of force, and the first condition is a number (N) of consecutive respective measures of force that exceeds a seating threshold force value, wherein N is an integer greater than one.

11. The fluid infusion device of claim 9, wherein the at least one processor repeats the advancing of the drive motor assembly and the obtaining of the at least one measure of force, and the second condition is a comparison of a difference between an initial one of the at least one measure of force and a subsequent one of the at least one measure of force and a seating threshold force value.

12. The fluid infusion device of claim 3, wherein advancing the drive motor assembly by the first amount further comprises after advancing the drive motor assembly by the first amount, the at least one processor:

obtains a measure of force using the force sensor;

determines a number of consecutive measures of force exceeds a ramp up threshold force value; and

based on the determination, thereafter, rewinds the drive motor assembly by the second amount.

13. The fluid infusion device of claim 3, wherein rewinding the drive motor assembly by the second amount further comprises after rewinding the drive motor assembly by the second amount, the at least one processor:

obtains a measure of force using the force sensor;

determines a number of consecutive measures of force are below a ramp down threshold force value; and

based on the determination, determines that the fluid reservoir is stabilized.

14. The fluid infusion device of claim 1, wherein the at least one processor determines that the at least one subsequent measure of force indicates that the fluid reservoir has reached the subsequent sealed state based on a plurality of the subsequent measures of force exceeding a second seating threshold force value.

15. The fluid infusion device of claim 1, further comprising a base plate coupled to the housing of the fluid infusion device that establishes a fluid flow path from the fluid reservoir to a fluid delivery path in the base plate.

16. A fluid infusion device comprising:

a housing that receives a sealed fluid reservoir, the fluid reservoir comprising a plunger and a shaft coupled to the plunger;

a drive motor assembly in the housing;

an actuation mechanism in the housing, wherein the actuation mechanism is operatively coupled to the drive motor assembly;

a force sensor in the housing and operatively coupled to the actuation mechanism to obtain measures of force associated with interaction of the shaft with the actuation mechanism; and

at least one processor in the housing and operatively coupled to the drive motor assembly and the force sensor, wherein the at least one processor;

detects insertion of the fluid reservoir into the housing;

obtains a first measure of force using the force sensor, the first measure of force associated with interaction of the plunger shaft with the actuation mechanism;

determines that the first measure of force is greater than a first threshold force value;

based on the determination, depressurizes the fluid reservoir by rewinding the drive motor assembly by a first rewind amount;

thereafter, incrementally rewinds the drive motor assembly by a second rewind amount to achieve an equilibrium state for the fluid reservoir;

thereafter, advances the drive motor assembly by a first forward amount to obtain an initial seated state for the fluid reservoir;

thereafter, advances the drive motor assembly by a second forward amount;

thereafter, rewinds the drive motor assembly by a third rewind amount to stabilize the fluid reservoir; and

thereafter, advances the drive motor assembly by a third forward amount and obtains at least one subsequent measure of force using the force sensor until the at least one subsequent measure of force indicates that the fluid reservoir has reached a subsequent sealed state.

17. The fluid infusion device of claim 16, wherein the at least one processor obtains a current measure of force after the rewinding of the drive motor assembly by the first rewind amount, and the at least one processor determines the fluid reservoir is depressurized based on a comparison between the current measure of force and a first threshold force value.

18. The fluid infusion device of claim 16, wherein advancing the drive motor assembly by the second forward amount further comprises after advancing the drive motor assembly by the second forward amount, the at least one processor:

obtains a measure of force using the force sensor;

determines a number of consecutive measures of force exceeds a ramp up threshold force value; and

based on the determination, thereafter, rewinds the drive motor assembly by the third rewind amount.

19. The fluid infusion device of claim 16, wherein rewinding the drive motor assembly by the third rewind amount further comprises after rewinding the drive motor assembly by the third rewind amount, the at least one processor:

obtains a measure of force using the force sensor;

determines a number of consecutive measures of force are below a ramp down threshold force value; and

based on the determination, determines that the fluid reservoir is stabilized.

20. The fluid infusion device of claim 16, wherein the at least one processor determines that the at least one subsequent measure of force indicates that the fluid reservoir has reached the subsequent sealed state based on a plurality of the subsequent measures of force exceeding a seating threshold force value.