Motion activated septum puncturing drug delivery device

• US 9,463,280 B2
• Filed: 03/26/2012
• Issued: 10/11/2016
• Est. Priority Date: 03/26/2012
• Status: Active Grant

• Current Assignee: West Pharma. Services IL, Ltd. (West Pharmaceutical Services Incorporated)
• Original Assignee: Medimop Medical Projects Ltd. (West Pharmaceutical Services Incorporated)
• Inventors: Cabiri, Oz
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): KOO, BENJAMIN K
• Application Number:
  US13/429,942
• Publication Number:
  US 20130253472A1
• Time in Patent Office: 1,660 Days
• Field of Search: 604/154, 604/155, 604/207, 604/208, 604/224, 604/232
• US Class Current: 1/1
• 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. An apparatus wearable by a recipient having a single motion power train for sequentially unsealing a reservoir and delivering a drug to the recipient, comprising:

a) a seal of the reservoir;

b) a controlled rate power actuator;

c) a piston of the reservoir and a plunger assembly directly engaging the piston and driven by said controlled rate power actuator, and

d) a surface of the apparatus configured for attaching to a skin of the recipient;

e) a needle positioned stationary with respect to said surface and partially inserted into the seal for a predetermined period of time prior to delivering the drug; and

f) a pathway substantially parallel to said surface for movement of the reservoir,

wherein an initial movement of said plunger assembly by said power actuator, after the predetermined period of time, translates the piston to advance the sealed reservoir along said pathway and drives said seal against said stationary hollow needle, to, in turn, fully penetrate said hollow needle through said seal, and subsequent movement of said plunger assembly translates the piston through the unsealed reservoir, to, in turn, discharge the drug from the reservoir.

2. The apparatus of claim 1, where said controlled rate power actuator includes at least one element selected from the group consisting of a direct current motor, a stepper motor, and a linear actuator.

3. The apparatus of claim 1, wherein said plunger is configured for discharging a liquid having a viscosity of at least 10 centipoise.

4. The apparatus of claim 1, wherein said plunger is configured for discharging at a substantially constant rate for at least 1 minute.

5. The apparatus of claim 1, wherein the reservoir is configured for long term storage of the drug inside of the apparatus.

6. The apparatus of claim 1, further comprising:

g) a hypodermic needle, and

h) a needle release, operatively coupled to said plunger, for inserting said hypodermic needle into the recipient.

7. The apparatus of claim 6, wherein a direction of said needle release is non-parallel to a direction of said initial movement of said plunger.

8. The apparatus of claim 6, wherein a direction of said needle release is substantially orthogonal to a direction of said initial movement of said plunger.

9. The apparatus of claim 6, further comprising:

i) a septum located in a needle opening of the surface of the apparatus such that upon release said hypodermic needle punctures said septum before being inserted into the recipient.

10. The apparatus of claim 1, further comprising:

g) a processor for controlling said controlled rate power actuator.

11. The apparatus of claim 10, further comprising:

h) a rotation sensor and wherein said controlling is according to an output of said rotation sensor.

12. The apparatus of claim 10, further comprising:

h) a rotation sensor and wherein said processor senses said driving of one of said hollow needle and said seal toward the other of said hollow needle and said seal, to penetrate said seal, based on an output of said rotation sensor.

13. The apparatus of claim 1, wherein the reservoir includes a cartridge insertable into the apparatus.