Motion-activated septum puncturing drug delivery device

• US 10,179,204 B2
• Filed: 08/12/2016
• Issued: 01/15/2019
• 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): Price, Nathan R
• Assistant Examiner(s): DOUBRAVA, JOHN A
• Application Number:
  US15/235,931
• Publication Number:
  US 20170035961A1
• Time in Patent Office: 886 Days
• Field of Search: 604121
• 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 method for delivering a drug to a recipient with a delivery apparatus, the delivery apparatus including a surface configured for attaching to the recipient, an actuator, a reservoir containing the drug and being initially sealed by a seal at one end and a piston through another end, a telescoping plunger assembly engaging the piston and configured to be driven by the actuator, a hollow needle positioned stationary with respect to the surface, a sensor operatively connected with the actuator and a processor operatively connected with the sensor and the actuator, the method comprising:

attaching the surface of the delivery apparatus to the recipient;

applying a force with the plunger assembly, via the actuator, to the piston within the reservoir;

puncturing the seal of the reservoir against stationary hollow needle by said force;

discharging the drug from the reservoir by said force subsequent to said puncturing;

detecting a rate of said discharging of the drug via the sensor, and

adjusting said rate of said discharging, via the processor, based on a result of said detecting.

2. The method of claim 1, wherein said applying said force is in a direction substantially parallel to said surface.

3. The method of claim 1, wherein the telescoping plunger assembly further comprises concentrically mounted threaded members configured to convert torque into linear motion, the method further comprising:

generating a torque via the actuator, and

converting said torque into said force via the telescoping plunger assembly.

4. The method of claim 3, wherein said detecting is performed by the sensor measuring a rotation driven by said torque.

5. The method of claim 1, wherein said discharging is at a substantially constant rate for at least 1 minute.

6. The method of claim 1, further comprising:

sensing a puncturing of the seal via the sensor.

7. The method of claim 1, the delivery apparatus further comprising an internal space initially sealed by a septum for long term aseptic storage, an injection needle and a needle insertion mechanism, the method further comprising:

puncturing the septum with the injection needle via the needle insertion mechanism in response to a command of the processor.

8. The method of claim 1, where said actuator includes a motor and the method further comprising:

transforming a rotational motion of said motor into a linear motion via the telescoping plunger assembly, and wherein said discharging is driven by said linear motion.

9. The method of claim 7, wherein the septum seals a needle opening in a housing of the delivery apparatus.

10. The method of claim 7, wherein the injection needle includes a hypodermic needle, the method further comprising:

inserting the injection needle into the recipient via the needle insertion mechanism subsequent to said puncturing and prior to said discharging.

11. A method for delivering a drug to a recipient with a delivery apparatus, the delivery apparatus including a surface configured for attaching to the recipient, an actuator, a reservoir containing the drug and being initially sealed by a seal at one end and a piston through another end, a telescoping plunger assembly engaging the piston and configured to be driven by the actuator, a hollow needle positioned stationary with respect to the surface, a sensor operatively connected with the actuator and a processor operatively connected with the sensor and the actuator, the method comprising:

attaching the surface of the delivery apparatus to the recipient;

applying a force with the plunger assembly, via the actuator, to the piston within the reservoir;

puncturing the seal of the reservoir against the stationary needle by said force;

discharging the drug from the reservoir by said force subsequent to said puncturing; and

detecting a position of the telescoping plunger assembly.

12. The method of claim 11, further including determining with the processor, whether the septum has been punctured based on a result of said detecting.

13. The method of claim 11, further including detecting a rate of said discharging of the drug via the sensor.

14. The method of claim 13, further including adjusting said rate of said discharging, via the processor, based on a result of said detecting.

15. The method of claim 13, wherein said detecting is performed by the sensor measuring a rotation driven by said force.