Motion activated septum puncturing drug delivery device

• US 10,159,785 B2
• Filed: 01/09/2015
• Issued: 12/25/2018
• Est. Priority Date: 03/26/2012
• Status: Active Grant

• Current Assignee: West Pharma. Services IL, Ltd. (West Pharmaceutical Services Incorporated)
• Original Assignee: West Pharma. Services IL, Ltd. (West Pharmaceutical Services Incorporated)
• Inventors: Cabiri, Oz
• Primary Examiner(s): Gilbert, Andrew
• Assistant Examiner(s): Doubrava, John
• Application Number:
  US14/593,041
• Publication Number:
  US 20150119797A1
• Time in Patent Office: 1,446 Days
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• 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 2005/14256 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14533 cam actuated
• CPC Class Codes: A61M 2005/14573 with a replaceable reservoir for quick connection/disconnection with a driving system
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/247 with fixed or steady piercing means, e.g. piercing under movement of ampoule
• CPC Class Codes: A61M 2005/2474 with movable piercing means, e.g. ampoule remains fixed or steady
• CPC Class Codes: A61M 2205/123 with incorporated reservoirs
• 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 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/283 by telescoping of ampoules or carpules with the syringe body
• CPC Class Codes: A61M 5/3146 Priming, e.g. purging, reducing backlash or clearance
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

A method and apparatus are disclosed for delivery of a drug to a recipient. In some embodiments, the delivery apparatus may unseal a drug containing reservoir. In some embodiments, the delivery rate may be controlled and/or adjustable. Optionally the apparatus may be disposable. Optionally, the apparatus may have a low profile and/or be wearable and/or attachable to the recipient. Optionally, discharge of the drug and/or unsealing of the reservoir may be driven by a plunger moving parallel to the base of the apparatus. Optionally, the apparatus may release a hypodermic needle into the recipient. Optionally, release of the hypodermic needle may be in a direction non-parallel and/or orthogonal to the direction of movement of the plunger. Optionally, prior to release, the hypodermic needle may be preserved in an aseptic state by a needle opening septum sealing a needle opening. Optionally, upon release, the hypodermic needle may pierce the needle opening septum.

Claims

1. A wearable drug delivery apparatus for administering a drug to a subject, the drug delivery system comprising:

a housing having a base surface configured to be positioned proximate the subject'"'"'s skin, the base surface defining a base plane;

an actuator positioned within the housing and having a rotatable shaft;

a reservoir positioned within the housing and defining a longitudinal axis thereof, a proximal end thereof and a distal end thereof, the longitudinal axis being substantially parallel to the base plane;

a plunger movably mounted in the reservoir, the plunger being movable along the longitudinal axis;

a reservoir needle connected to the distal end of the reservoir;

a stationary septum mounted in the housing and having a flexible canal connected thereto, the reservoir and the reservoir needle being movable in the housing along the longitudinal axis between a sealed configuration, in which the reservoir needle is embedded in the stationary septum, and a discharge configuration, in which the reservoir needle fully punctures the septum, thereby putting the reservoir in fluid communication with the flexible canal;

an injection needle fluidly connected to the reservoir through the flexible canal when the reservoir needle is in the discharge configuration;

an injection needle septum sealing an injection needle opening in the housing, the infection needle configured to pass through the injection needle septum for positioning in flesh of the subject with a tip of the injection needle positioned beneath a surface of the flesh;

at least one gear operatively connected to the rotatable shaft of the actuator and the plunger such that rotational motion of the at least one gear driven by the rotatable shaft of the actuator results in translational motion of the plunger along the longitudinal axis of the reservoir;

a controller positioned within the housing, the controller configured to drive the actuator by a pulse width modulation to rotate the gears and cause the plunger to translate within the reservoir, the plunger and reservoir configured to cause the drug to flow from the reservoir when the plunger moves toward the distal end, thereby causing the drug to flow through the flexible canal, through the needle and out of the tip of the needle;

a power supply positioned within the housing, the power supply providing power to the controller and the actuator; and

a sensor positioned within the housing, the sensor configured to take measurements of rotations of the rotatable shaft of the actuator and transmit the measurements to the controller, the rotations being directly proportional to translational movement of the plunger, the controller notifying the subject of a malfunction if the rotatable shaft of actuator one of fails to rotate and rotates too slowly upon application of power.

2. The drug delivery system of claim 1, wherein the power supply is comprised of a battery.

3. The drug delivery system of claim 1, wherein the actuator is comprised of a motor.

4. The drug delivery system of claim 1, wherein the sensor is comprised of a rotation sensor.

5. The drug delivery system of claim 4, further comprising:

a paddle mounted to the rotatable shaft of the actuator, the rotation sensor sensing rotation of the rotatable shaft by detecting rotations of the paddle.

6. The drug delivery system of claim 1, further comprising:

a telescoping assembly positioned between the plunger and the at least one gear for converting rotation of the at least one gear to translational movement of the plunger.

7. The drug delivery system of claim 1, wherein the sensor is comprised of a Hall Effect sensor.

8. The drug delivery system of claim 1, wherein the actuator is comprised of a direct current electric motor.

9. The drug delivery system of claim 1, wherein the controller is configured to determine a volume of the drug discharged from the infection needle based on the measurements of rotations.

10. The drug delivery system of claim 1, wherein the controller is configured to determine a rate of discharge of the drug based on the rate of rotation of the rotatable shaft of the actuator.

11. A wearable drug delivery system for administering a drug to a subject, the drug delivery device comprising:

a housing having a base surface, the base surface defining a base plane;

an actuator positioned within the housing, the actuator including an actuator shaft;

a reservoir positioned within the housing and having a longitudinal axis, the longitudinal axis being substantially parallel to the base plane;

a plunger movably mounted in the reservoir, the plunger being movable along the longitudinal axis of the reservoir;

a reservoir needle connected to an end of the reservoir;

a stationary septum mounted in the housing and having a flexible canal connected thereto, the reservoir and the reservoir needle being movable in the housing along the longitudinal axis between a sealed configuration, in which the reservoir needle is embedded in the stationary septum, and a discharge configuration, in which the reservoir needle fully punctures the septum, thereby putting the reservoir in fluid communication with the flexible canal;

an injection needle fluidly connected to the reservoir through the flexible canal when the reservoir needle is in the discharge configuration;

an injection needle septum sealing an injection needle opening in the housing, the infection needle configured to pass through the injection needle septum for positioning in flesh of the subject with a tip of the injection needle positioned beneath a surface of the flesh in the discharge configuration;

gears operatively connected to the actuator and the plunger, the gears configured such that rotational motion of the gears driven by the actuator is translated into linear motion of the plunger within the reservoir along the longitudinal axis, the gears including an actuator gear mounted to the actuator shaft and a reservoir gear mounted to the reservoir;

a controller positioned within the housing, the controller being in communication with the actuator and operable to control rotation of the actuator;

a power supply positioned within the housing, the power supply providing power to the controller and the actuator; and

a sensor positioned within the housing and being in communication with the controller, the sensor configured to take measurements of rotations of the actuator shaft and transmit the measurements to the controller, the controller configured to control movement of the actuator to cause the plunger to move along the longitudinal axis of the reservoir to discharge the drug into the flesh at a predetermined dosage and rate.

12. The drug delivery system of claim 11, wherein the sensor includes an optical sensor and a paddle mounted to the actuator shaft.

13. The drug delivery system of claim 11, wherein the controller is programmed to deliver an entire content of the drug from the reservoir into the flesh after initial activation at a constant rate of injection.

14. The drug delivery system of claim 11, further comprising:

an injection needle release mounted to the housing, the injection needle being movable within the infection needle release substantially perpendicular to the base plane.

15. The drug delivery system of claim 11, wherein the sensor is comprised of an optical sensor.

16. The drug delivery system of claim 11, wherein the sensor is comprised of a Hall Effect sensor.

17. The drug delivery system of claim 11, wherein the power supply is comprised of a series of batteries mounted in the housing.

18. The drug delivery system of claim 11, wherein the actuator shaft is oriented substantially parallel to the longitudinal axis, the actuator shaft being oriented substantially parallel to the base plane.