Infusion pump system with disposable cartridge having pressure venting and pressure feedback

• US 8,287,495 B2
• Filed: 10/10/2011
• Issued: 10/16/2012
• Est. Priority Date: 07/30/2009
• Status: Active Grant

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Tandem Diabetes Care Incorporated
• Inventors: Michaud, Michael, Kruse, Geoffrey A.
• Primary Examiner(s): Mehta, Bhisma
• Application Number:
  US13/270,160
• Publication Number:
  US 20120029433A1
• Time in Patent Office: 372 Days
• Field of Search: 604/122, 604/123, 604/132, 604/151, 604/152, 604/153, 604/154
• US Class Current: 604/151
• 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. A portable infusion pump system, comprising:

(a) a pump device configured to accept a disposable fluid cartridge, including;

(i) a housing,

(ii) a drive mechanism with a motor, and

(iii) a controller operatively coupled to the drive mechanism; and

(b) a disposable fluid cartridge which may be operatively coupled to the housing of the pump device, including;

(i) 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,

(ii) a substantially rigid shell disposed over the collapsible reservoir, forming a second interior volume between an outside surface of the collapsible reservoir and an inside surface of the substantially rigid shell with a vent inlet port in communication with the second interior volume, and

(iii) a delivery mechanism including a bore within a pump body of the delivery mechanism, a spool slidingly disposed in the bore forming a collapsible first volume which is configured to communicate with the reservoir inlet port and dispense port of the bore independent of the reservoir inlet port, and a vent second volume isolated from the collapsible first volume, the vent second volume configured to be moveable between a position that allows the vent inlet port to communicate with a vent outlet port and a position where the vent inlet port and vent outlet port are isolated from each other.

2. The system of claim 1 further comprising a pressure sensor disposed in fluid communication with the second interior volume between an interior surface of the rigid shell and an exterior surface of the collapsible reservoir.

3. The system of claim 2 wherein the pressure sensor is configured to measure small changes in gauge pressure at low pressures.

4. The system of claim 3 wherein the pressure sensor is configured to measure pressures up to about 30 psi gauge.

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

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

7. The system of claim 1 wherein the vent second volume is formed by two seals disposed on the spool body, an outside surface of the spool body and an inside surface of the bore, an axial separation between the seals forming the vent second volume being greater than an axial separation between the vent inlet port and vent outlet port.

8. The system of claim 1 wherein the collapsible first volume comprises a first seal disposed on a distal section of the spool and a second seal disposed on a main section of the spool, the distal section of the spool being axially displaceable relative to the main section of the spool.

9. The system of claim 8 wherein the collapsible first volume comprises a volume bounded by at least one seal that:

(i) is axially displaceable relative to a slide portion of the spool,

(ii) forms a first fluid tight seal between an outside surface of the seal and an inside surface of the bore, and

(iii) forms a second fluid tight seal between an outside surface of the slide portion of the spool and an aperture of the seal.

10. A portable infusion pump system for dispensing fluid to a patient, comprising:

(A) a disposable fluid cartridge including;

(1) a delivery mechanism including;

(a) a delivery mechanism body,

(b) a bore disposed in the delivery mechanism body, the bore including an interior volume, a reservoir inlet port, a fluid dispense port, a vent inlet port and a vent outlet port,

(c) a spool slidingly disposed within the bore,

(d) 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 seal and second seal and an interior surface of the bore between the first seal and second seal and wherein the first and second seals are axially displaceable relative to each other, and

(e) a vent second volume which is positionable to simultaneously overlap the vent inlet port and vent outlet port 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;

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

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

(B) a drive mechanism operatively coupled to the spool of the delivery mechanism;

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

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

(E) a power cell operatively coupled to the controller, the user interface and the drive mechanism.

11. The system of claim 10 wherein the collapsible first volume comprises a volume bounded by at least one seal that:

(i) is axially displaceable relative to a slide portion of the spool,

(ii) forms a first fluid tight seal between an outside surface of the seal and an inside surface of the bore, and

(iii) forms a second fluid tight seal between an outside surface of the slide portion of the spool and an aperture of the seal.

12. The system of claim 10 further comprising at least one pressure sensor disposed in communication with the volume between an outside surface of the flexible membrane of the collapsible reservoir and an inside surface of the substantially rigid shell.

13. The system of claim 10 wherein the user interface comprises a graphic user interface operatively coupled to the controller.

14. The system of claim 13 wherein the graphic user interface comprises a touch screen interface.

15. The system of claim 10 wherein the power cell comprises a battery.

16. The system of claim 10 wherein at least one seal is always disposed between the reservoir inlet port and fluid dispense port so as to prevent a free flow condition to the fluid dispense port from the collapsible reservoir.

17. A portable infusion pump system, comprising:

a disposable fluid cartridge including;

(1) a delivery mechanism including;

(a) a delivery mechanism body,

(b) a bore disposed in the delivery mechanism body, the bore including an interior volume, a reservoir inlet port, a fluid dispense port, a vent inlet port and a vent outlet port,

(c) a spool slidingly disposed within the bore,

(d) 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 seal and second seal and an interior surface of the bore between the first seal and second seal, and wherein the first and second seals are axially displaceable relative to each other, and

(e) a vent second volume which is positionable to simultaneously overlap the vent inlet port and vent outlet port 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;

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

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

18. The system of claim 17 further comprising a drive mechanism operatively coupled to the spool of the delivery mechanism.

19. The system of claim 18 further comprising a user interface configured to accommodate user data input regarding fluid delivery.

20. The system of claim 19 further comprising a controller having a processor and memory device operatively coupled to the drive mechanism.

21. The system of claim 20 further comprising a power cell operatively coupled to the controller, the user interface and the drive mechanism.

22. The system of claim 17 wherein at least one seal is always disposed between the reservoir inlet port and fluid dispense port so as to prevent a free flow condition to the fluid dispense port from the collapsible reservoir.