INFUSION PUMP SYSTEM WITH DISPOSABLE CARTRIDGE HAVING PRESSURE VENTING AND PRESSURE FEEDBACK

• US 20110152824A1
• Filed: 07/29/2010
• Published: 06/23/2011
• Est. Priority Date: 07/30/2009
• Status: Active Grant

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Tandem Diabetes Care Incorporated
• Inventors: Ulrich, Thomas R., Kinacde, Dan, Nadwoeny, John, Brown, David, Rosinko, Mike, Michaud, Michael, DiPerna, Paul M., Kruse, Geoffrey A.
• Granted Patent: US 9,211,377 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2205/3389 Continuous level detection A61M2205/3393 takes precedence
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• 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 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/31513 Piston constructions to improve sealing or sliding
• CPC Class Codes: F04B 43/113 the actuating fluid being controlled by at least one valve
• CPC Class Codes: F04B 53/143 Sealing provided on the piston
• CPC Class Codes: F16J 15/32 with elastic sealings, e.g. O-rings
• CPC Class Codes: F16J 15/56 Other sealings for reciprocating rods
• CPC Class Codes: G06F 3/0488 using a touch-screen or digitiser, e.g. input of commands through traced gestures
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Embodiments are directed to portable infusion devices, systems, and methods of using the same for dispensing materials. In some cases, the devices, systems and methods may be used for infusing a material such as medicament, e.g., insulin, into a body in need thereof.

Claims

1. An infusion pump system, comprising:

a pump device including a housing, a drive mechanism with a motor, a controller operatively coupled to the drive mechanism and a slot configured to accept a disposable fluid cartridge;

a disposable fluid cartridge which may be operatively coupled to the housing, the cartridge including a delivery mechanism, a collapsible reservoir having an interior volume surrounded by a flexible fluid tight membrane, the interior volume being in fluid communication with a reservoir inlet port, the cartridge also including a substantially rigid shell disposed over the reservoir and forming a second interior volume between an outside surface of the reservoir and an inside surface of the rigid shell with a vent inlet port in communication with the second interior volume;

a pressure sensor disposed between an interior surface of the rigid case and an exterior surface of the collapsible reservoir shell;

a bore within a pump body of the delivery mechanism; and

a spool slidingly disposed in the bore having a collapsible first volume which is configured to communicate with the reservoir inlet port and dispense port of the bore independently of each other.

2. The system of claim 1 wherein at least one seal is always disposed between the reservoir inlet port and dispense port so as to prevent a free flow condition to the dispense port from the reservoir.

3. The system of claim 1 wherein the collapsible first volume is formed between two seals disposed on the spool body an outside surface of the spool body, an inside surface of the bore and an outside surface of the spool body disposed between the two seals with the seals axially displaceable relative to each other to form a collapsible volume between the two seals.

4. The system of claim 1 wherein the pressure sensor is configured to measure small changes in pressure at low pressures.

5. The system of claim 4 wherein the pressure sensor is configured to measure pressures up to about 30 psi.

6. The system of claim 5 wherein the pressure sensor is configured to measure pressures up to about 5 psi.

7. The system of claim 1 wherein the seals of the spool comprise o-rings disposed in angled grooves having overflow grooves below and in communication with the angled grooves.

8. The system of claim 1 wherein the collapsible first volume comprises a section of the spool disposed between the seals of the collapsible first volume that is axially collapsible to allow the seals of the collapsible first volume to axially converge and reduce the volume of the collapsible first volume.

9. An infusion pump for dispensing fluid to a patient, comprising:

a disposable fluid cartridge including;

a delivery mechanism including;

a delivery mechanism body,

a bore disposed in the delivery mechanism body including a distal end, a proximal end disposed towards a drive mechanism of the infusion pump, an interior volume, a reservoir inlet port, a fluid dispense port,

a spool slidingly disposed within the bore including a collapsible first volume which is positionable to overlap the reservoir inlet port independent of an overlap of the fluid dispense port and which is formed between a first seal around the spool, a second seal around the spool, an outer surface of the spool body between the first and second seal and an interior surface of the bore between the first and second seal, the first and second seals being axially moveable relative to each other;

a collapsible fluid reservoir bounded by a flexible membrane and including an interior volume in fluid communication with the reservoir inlet port;

a substantially rigid shell disposed about the collapsible fluid reservoir with an interior volume that contains the collapsible fluid reservoir and a volume disposed between an outer surface of the flexible membrane and an interior surface of the rigid shell;

a drive mechanism operatively coupled to the spool of the delivery mechanism;

a user interface configured to accommodate user data input regarding fluid delivery;

a controller having a processor and memory device operatively coupled to the drive mechanism; and

a power cell operatively coupled to the controller, the GUI and the drive mechanism.

10. The pump of claim 9 wherein the first and second seals comprise o-rings disposed in angled grooves having overflow grooves below.

11. The system of claim 9 wherein the collapsible first volume comprises a volume bounded by at least one seal that is axially displaceable relative to a section of the spool body and which forms a substantially fluid tight seal between an outside surface of the seal and an inside surface of the bore and a fluid tight seal between an outside surface of a slide portion of the spool and an aperture of the seal.

12. The system of claim 9 wherein at least one seal is always disposed between the reservoir inlet port and dispense port so as to prevent a free flow condition to the dispense port from the reservoir.

13. A method dispensing from an infusion pump system, comprising:

providing an infusion pump system including;

a disposable fluid reservoir cartridge including;

a delivery mechanism including;

a delivery mechanism body,

a bore disposed in the delivery mechanism body including a distal end, a proximal end disposed towards a drive mechanism of the infusion pump, an interior volume, a reservoir inlet port, a fluid dispense port, a vent inlet port and a vent outlet port;

a spool slidingly disposed within the bore including a collapsible first volume which is positionable to overlap the reservoir inlet port independent of an overlap of the fluid dispense port and which is formed between a first seal around the spool, a second seal around the spool, an outer surface of the spool body between the first and second seal and an interior surface of the bore between the first and second seal, the first and second seals being axially moveable relative to each other;

a collapsible fluid reservoir bounded by a flexible membrane and including an interior volume in fluid communication with the reservoir inlet port, a substantially rigid shell disposed about the collapsible fluid reservoir with an interior volume that contains the collapsible fluid reservoir and a volume disposed between an outer surface of the flexible membrane and an interior surface of the rigid shell; and

a drive mechanism operatively coupled to the spool of the delivery mechanism;

initiating a dispense cycle by driving the spool with the drive mechanism to a position with the collapsible first volume in communication with the reservoir inlet port;

driving the spool so as to separate the first and second seals of the collapsible first volume and draw fluid into the first volume through the reservoir inlet port from the reservoir thereby decreasing the pressure in the volume between the reservoir and interior surface of the rigid shell;

driving the spool with the drive mechanism to a position with the collapsible first volume in communication with the fluid dispense port; and

driving the spool so as to at least partially collapse the collapsible first volume and dispense fluid from the collapsible first volume through the fluid dispense port.

14. The method of claim 13 wherein at least one seal is always disposed between the reservoir inlet port and dispense port so as to prevent a free flow condition to the dispense port from the reservoir.

15. A delivery mechanism for an infusion pump comprising:

a bore disposed in a delivery mechanism body;

a spool disposed in the bore which is axially displaceable within the bore; and

a collapsible volume bounded by an outside surface of the spool, an inside surface of the bore, a first seal between the spool and the bore that is axially fixed relative to the spool but displaceable relative to an inside surface of the bore and a second seal between the spool and inside surface of the bore which is configured to slide over a slide portion of the spool disposed in an aperture of the second seal, which forms a substantially fluid tight but displaceable seal between an outside surface of the second seal and the inside surface of the bore and which forms a fluid tight but displaceable seal between an outside surface of the slide portion and the second seal.

16. The mechanism of claim 15 wherein the friction between inside surface of bore and second seal is greater than friction between outside surface of slide portion of spool and aperture of second seal.

17. The mechanism of claim 15 wherein the second seal comprises an o-ring.

18. The mechanism of claim 15 wherein the spool comprises an elongate cylindrical member having a transverse dimension of about 0.5 mm to about 10 mm.

19. The mechanism of claim 15 wherein at least one seal is always disposed between the reservoir inlet port and dispense port so as to prevent a free flow condition to the dispense port from the reservoir.

20. An infusion pump for dispensing fluid to a patient, comprising:

a disposable fluid cartridge including;

a delivery mechanism including;

a delivery mechanism body,

a bore disposed in the delivery mechanism body including a distal end, a proximal end disposed towards a drive mechanism of the infusion pump, an interior volume, a reservoir inlet port, a fluid dispense port, a vent inlet port and a vent outlet port;

a spool slidingly disposed within the bore including;

a collapsible first volume bounded by an outside surface of the spool, an inside surface of the bore, a first seal between the spool and the bore that is axially fixed relative to the spool but displaceable relative to an inside surface of the bore and a second seal between the spool and inside surface of the bore which is configured to slide over a slide portion of the spool disposed in an aperture of the second seal, which forms a substantially fluid tight but displaceable seal between an outside surface of the second seal and the inside surface of the bore and which forms a fluid tight but displaceable seal between an outside surface of the slide portion and the second seal, and

a vent second volume which is positionable to overlap the vent inlet port and vent outlet port simultaneously and which is formed by a third seal around the spool, a fourth seal around the spool, an outside surface of the spool between the third and fourth seal and an inside surface of the bore between the third and fourth seal;

a collapsible fluid reservoir bounded by a flexible membrane and including an interior volume in fluid communication with the reservoir inlet port,

a substantially rigid shell disposed about the collapsible fluid reservoir with an interior volume that contains the collapsible fluid reservoir and a vented volume disposed between an outer surface of the flexible membrane and an interior surface of the rigid shell, the vent inlet port being in fluid communication with the vented volume.

21. The infusion pump of claim 20 further comprising a drive mechanism operatively coupled to the spool of the delivery mechanism.

22. The infusion pump of claim 21 further comprising a user interface configured to accommodate user data input regarding fluid delivery.

23. The infusion pump of claim 22 further comprising a controller having a processor and memory device operatively coupled to the drive mechanism.

24. The infusion pump of claim 23 further comprising a power cell operatively coupled to the controller, the GUI and the drive mechanism.

25. The infusion pump of claim 20 wherein at least one seal is always disposed between the reservoir inlet port and dispense port so as to prevent a free flow condition to the dispense port from the reservoir.

26. An infusion pump system comprising,

a housing;

a disposable cartridge including a collapsible reservoir surrounded by a flexible material and a substantially rigid container sealed around the flexible material of the collapsible reservoir, the cartridge releasably secured to the housing;

a disposable delivery mechanism disposed within the disposable cartridge and having an reservoir inlet port in fluid communication with an interior volume of the reservoir;

a drive mechanism including a motor disposed in the housing and detachably coupled to a spool member of the delivery mechanism, the drive mechanism being operatively coupled to the spool member;

at least one pressure sensor disposed in a volume disposed between the outside surface of the flexible material of the reservoir and an inside surface of the substantially rigid container/case;

a graphic user interface operatively coupled to a controller;

a power storage cell;

a vent inlet port disposed on the delivery mechanism in fluid communication with the volume disposed between the outside surface of the flexible material of the reservoir and an inside surface of the substantially rigid container/case; and

a controller including at least one processor and a memory device, the controller operatively coupled to the drive mechanism, GUI, and at least one pressure sensor and configured to generate a signal to the drive mechanism to displace the spool of the delivery mechanism.

27. The system of claim 26 wherein the controller includes a first low power processor and a second processor.

28. The system of claim 26 wherein the energy storage cell comprises a battery.

29. The system of claim 26 wherein the GUI comprises a touch screen interface.

30. The system of claim 26 wherein the system further comprises a second pump device with a second controller having a processor and memory device coupled thereto, the second pump being configured to operatively couple to the disposable cartridge and including a compact configuration with only basic pumping features with no GUI.

31. The system of claim 30 wherein the first pump device is configured to communicate with the second pump device and the GUI of the first pump may be used to communicate with the second controller.

32. The system of claim 26 wherein at least one seal is always disposed between the reservoir inlet port and dispense port so as to prevent a free flow condition to the dispense port from the reservoir.

33. An infusion pump system comprising,

a housing;

a disposable cartridge including a collapsible reservoir surrounded by a flexible material and a substantially rigid shell sealed around the flexible material of the collapsible reservoir, the cartridge releasably secured to the housing;

a disposable delivery mechanism disposed within the disposable cartridge and having a reservoir inlet port in fluid communication with an interior volume of the reservoir;

a drive mechanism including a motor disposed in the housing and detachably coupled to a spool member of the delivery mechanism, the drive mechanism being operatively and detachably coupled to the spool member of the delivery mechanism;

at least one pressure sensor disposed in a volume disposed between the outside surface of the flexible material of the reservoir and an inside surface of the substantially rigid container/case;

a graphic user interface operatively coupled to a controller;

a power storage cell; and

a controller including at least one processor and a memory device, the controller operatively coupled to the drive mechanism, GUI, and at least one pressure sensor and configured to generate a signal to the drive mechanism to displace the spool of the delivery mechanism.

34. The system of claim 33 wherein at least one seal is always disposed between the reservoir inlet port and dispense port so as to prevent a free flow condition to the dispense port from the reservoir.