MOTION ACTIVATED SEPTUM PUNCTURING DRUG DELIVERY DEVICE

• US 20130253472A1
• Filed: 03/26/2012
• Published: 09/26/2013
• 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
• Granted Patent: US 9,463,280 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• 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 source;

c) a plunger driven by said controlled rate power source, and

d) a hollow needle;

wherein an initial movement of said plunger drives said hollow needle through said seal and subsequent movement of said plunger discharges the drug from the reservoir.

2. The apparatus of claim 1, where said controlled rate power source 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, further comprising:

e) a surface configured for attaching to a skin of the recipient.

4. The apparatus of claim 3, further comprising:

f) a pathway for movement of the reservoir and wherein said initial movement of said plunger impels the reservoir along said pathway.

5. The apparatus of claim 4, wherein said pathway is substantially parallel to said surface.

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

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

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

9. The apparatus of claim 1, further comprising:

e) a hypodermic needle, and

f) a needle release, for inserting said hypodermic needle into the recipient, said needle release being synchronized to said plunger.

10. The apparatus of claim 9, wherein a direction of said needle release is non-parallel to a direction of said initial movement of said plunger.

11. The apparatus of claim 9, wherein a direction of said needle release is substantially orthogonal to a direction of said initial movement of said plunger.

12. The apparatus of claim 9, further comprising:

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

13. The apparatus of claim 1, further comprising:

e) a processor for controlling said controlled rate power source.

14. The apparatus of claim 13, further comprising:

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

15. The apparatus of claim 13, further comprising:

f) a rotation sensor and wherein said processor senses said driving of said hollow needle through said seal based on an output of said rotation sensor.

16. The apparatus of claim 1, wherein said hollow needle is initially in fluid communication with the reservoir, and wherein said seal is configured for sealing said hollow needle.

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

18. A method for delivering a drug to a recipient with a delivery apparatus, the drug contained in a reservoir initially sealed by a seal for long term aseptic storage, the delivery apparatus including a hollow needle and a plunger, the method comprising:

a) attaching a surface of the delivery apparatus to the recipient;

b) applying a force with the plunger to a contents of the reservoir;

c) puncturing the seal with the hollow needle by said force;

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

e) detecting a rate of said discharging, and

f) adjusting said rate of said discharging based on a result of said detecting.

19. The method of claim 18, wherein said applying said force is in a direction substantially parallel to said surface.

20. The method of claim 18, further comprising:

g) supplying a torque, and

h) converting said torque into said force.

21. The method of claim 20, wherein said detecting is by measuring a rotation driven by said torque.

22. The method of claim 18, wherein said discharging is at a substantially constant rate for at least 1 minute.

23. The method of claim 18, further comprising:

g) releasing a hypodermic needle by the delivery apparatus into the recipient subsequent to said puncturing.

24. The method of claim 18, further comprising:

g) releasing a hypodermic needle by the delivery apparatus into the recipient in a direction non-parallel to said applying of said force.

25. The method of claim 18, further comprising:

g) releasing a hypodermic needle by the delivery apparatus into the recipient in a direction substantially orthogonal to said applying of said force.

26. The method of claim 18, further comprising:

g) sensing by the delivery apparatus of a puncturing of the seal.

27. A method for delivering a drug to a recipient with a delivery apparatus, the delivery apparatus including an internal space initially sealed by a septum for long term aseptic storage, the delivery apparatus including a needle and a processor, the method comprising:

a) attaching a surface of the delivery apparatus to the recipient;

b) puncturing the septum with the needle in response to a command of the processor;

c) discharging the drug subsequent to said puncturing;

e) detecting a rate of said discharging, and

f) adjusting by the processor said rate of said discharging based on a result of said detecting.

28. The method of claim 27, wherein said discharging is driven by an actuator.

29. The method of claim 28, where said puncturing is triggered by said actuator.

30. The method of claim 28. where said actuator includes a motor and the method further comprising:

g) transforming a rotational motion of said motor into a linear motion, and wherein said discharging is driven by said linear motion.

31. The method of claim 27, wherein the septum seals a needle opening in a housing of the delivery apparatus.

32. The method of claim 27, further wherein the needle includes a hypodermic needle, the method further comprising:

g) inserting the needle into the recipient subsequent to said puncturing and prior to said discharging.

33. An apparatus wearable by a recipient for delivering a drug to the recipient having, comprising:

a) an internal space initially aseptic;

b) a septum initially sealing said internal space;

c) a controlled rate power source;

d) a plunger driven by said controlled rate power source, and

e) a needle;

wherein said controlled rate power source triggers puncturing said septum by said needle and subsequently drives movement of said plunger discharging the drug.