Positive displacement pump

• US 10,398,831 B2
• Filed: 08/14/2015
• Issued: 09/03/2019
• Est. Priority Date: 05/11/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Neta, Avraham, Shalev, Yossi
• Primary Examiner(s): Bouchelle, Laura A
• Application Number:
  US14/826,804
• Publication Number:
  US 20150352276A1
• Time in Patent Office: 1,481 Days
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2210/04 Skin
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: F04B 43/1269 the rotary axes of the rollers lying in a plane perpendicular to the rotary axis of the driving motor

Abstract

Systems, methods and apparatuses for delivering therapeutic fluid to the body of a patient are disclosed. The apparatus includes a dispensing unit having a driving mechanism, a pumping mechanism, a reservoir containing therapeutic fluid, and an outlet port. The driving mechanism causes the pumping mechanism to positively displace therapeutic fluid within the reservoir for delivery of therapeutic fluid to the body of the patient via the outlet port.

Claims

1. An apparatus for delivering a therapeutic fluid into a body of a patient, comprising:

a dispensing unit with;

a reusable part;

a disposable part comprising a housing with an outlet port, a reservoir for the therapeutic fluid and a connecting lumen that is part of and extends from the outlet port and which is in fluid communication directly with the reservoir;

a plunger having a plunger head and a plunger rod for displacing the therapeutic fluid from the reservoir to the outlet port;

a driving mechanism; and

an electronic component including at least a controller for controlling at least the operation of the driving mechanism, and

a cradle with upper and bottom sides, wherein the bottom side is adherable to skin of the patient, and the dispensing unit is connectable to and disconnectable from the upper side of the cradle, wherein the cradle further comprises a tubular protrusion emerging upwardly from the upper side which defines a well therein, the outlet port being configured as a recess in the housing of the disposal part which is sized to accommodate the tubular protrusion of the cradle, and the connecting lumen is configured to pierce a septum provided in the well upon accommodation of the tubular protrusion of the cradle in the outlet port which simultaneously fluidically connects, via the connecting lumen, the reservoir to a cannula extending from the bottom side of the cradle.

2. The apparatus of claim 1 wherein the reservoir has a substantially flat cross-sectional profile with a shape selected from the group consisting of an oval, an ellipse, and a rectangle.

3. The apparatus of claim 1, wherein the disposable part comprises a cross-section of less than fifteen millimeters.

4. The apparatus of claim 1 wherein the reservoir is a part of a syringe fitted with the plunger, and the plunger comprises a displaceable piston plunger.

5. The apparatus of claim 1 wherein the outlet port is configured and dimensioned to fit to a drug glass bottle cork.

6. The apparatus of claim 1 wherein the outlet port is provided with a short connecting element having a sharp hollow tip for fluid communication between the reservoir and a bottle, which enables drug drawing from the bottle upon backward movement of the plunger while the bottle is positioned upside down.

7. The apparatus of claim 1 wherein the fluid is drawn from a container by pulling on a shaft of the plunger that creates a suction effect thereby drawing the fluid from the container.

8. The apparatus of claim 1 wherein the reservoir has either an elliptical or an oval cross-sectional configuration such that the reservoir has a profile comprising a thickness of about ten millimeters.

9. The apparatus of claim 1 wherein the reservoir contains a maximum of two cubic centimeters of fluid.

10. The apparatus of claim 1 wherein the housing is made at least partially from a transparent material to allow the patient to continuously monitor a level and/or a content of fluid in the reservoir.

11. The apparatus of claim 1 wherein the outlet port of the disposable part allows direct filling of the reservoir with the therapeutic fluid from a therapeutic fluid container connectable directly to the disposable part via the outlet port.

12. The apparatus of claim 1 further comprising a detachable auxiliary rod coupleable to the plunger head when the plunger rod is disconnected from the plunger head, for enabling the pulling of the plunger head outwardly within the reservoir.

13. The apparatus of claim 1, wherein the cradle further comprises anchoring latches disposed around a perimeter of the cradle to secure releasably the dispensing unit to the cradle.

14. The apparatus of claim 13, wherein the anchoring latches create a snap-fit locking arrangement between the latches and the dispensing unit.

15. The apparatus of claim 1 wherein a therapeutic fluid container is connectable directly to the disposable part via the outlet port to fluidically connect the reservoir to the container and wherein the plunger rod is configured to disconnect from the plunger head and be replaceable by a detachable auxiliary rod, the auxiliary rod being configured to couple directly to the plunger head for enabling the pulling of the plunger head outwardly within the reservoir to fill the reservoir with the therapeutic fluid from the container via the connecting lumen.

16. A method for delivering a therapeutic fluid into a body of a patient, comprising:

providing an apparatus comprising;

a dispensing unit which has;

a reusable part;

a disposable part comprising a housing with an outlet port, a reservoir for the therapeutic fluid and a connecting lumen that is part of and extends from the outlet port and which is in fluid communication directly with the reservoir;

a plunger having a plunger head and a plunger rod for displacing the therapeutic fluid from the reservoir to the outlet port;

a driving mechanism; and

an electronic component including at least a controller for controlling at least the operation of the driving mechanism; and

a cradle with upper and bottom sides, wherein the bottom side is adherable to skin of the patient, and the dispensing unit is connectable to and disconnectable from the upper side of the cradle, wherein the cradle further comprises a tubular protrusion emerging upwardly from the upper side which defines a well therein, the outlet port being configured as a recess in the housing of the disposal part which is sized to accommodate the tubular protrusion of the cradle, and the connecting lumen is configured to pierce a septum provided in the well upon accommodation of the tubular protrusion of the cradle in the outlet port which simultaneously fluidically connects, via the connecting lumen, the reservoir to a cannula extending from the bottom side of the cradle;

piercing a septum of a container with a connecting element of the reservoir; and

pulling on a shaft of the plunger, creating a suction effect thereby drawing the therapeutic fluid from the container.

17. The method of claim 16 further comprising disconnecting the plunger rod from the plunger head and coupling an auxiliary rod to the plunger head, followed by pulling of the plunger head outwardly within the reservoir.

18. The method of claim 16 further comprising connecting the reusable part to the disposable part, and then connecting the dispending unit to the cradle.

19. The method of claim 17 wherein pulling of the plunger head outwardly within the reservoir via the auxiliary rod fills the reservoir with the therapeutic fluid from the container via the connecting lumen.