SKIN-ATTACHABLE MINIATURE DRUG INJECTION DEVICE WITH REMOTE ACTIVATION CAPABILITY AND DRY DRUG CARRIER WITHIN INJECTION NEEDLE

• US 20150011976A1
• Filed: 01/30/2013
• Published: 01/08/2015
• Est. Priority Date: 01/31/2012
• Status: Active Grant

• Current Assignee: Preci Health SA
• Original Assignee: Preciflex Sa (HYT SA)
• Inventors: Vouillamoz, Lucien, Rosen, Melissa, Walish, Judy L., Bruehwiler, Michel, Yasevac, Daniel
• Granted Patent: US 10,052,435 B2
• Time in Patent Office: Days
• US Class Current: 604/507
• CPC Class Codes: A61B 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 2017/00132 Setting operation time of a device A61B2017/00123 takes precedence
• CPC Class Codes: A61B 2017/00212 using remote controls
• 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 2005/1426 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 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1583 Needle extractors
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2005/2086 having piston damping means, e.g. axially or rotationally acting retarders
• CPC Class Codes: A61M 2005/3022 Worn on the body, e.g. as patches pressure infusion of the skin patch type A61M5/14248
• CPC Class Codes: A61M 2005/3142 Modular constructions, e.g. supplied in separate pieces to be assembled by end-user
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• 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 2205/8218 Gas operated
• CPC Class Codes: A61M 2205/8293 : Solar
• CPC Class Codes: A61M 2209/01 : Remote controllers for specific apparatus
• CPC Class Codes: A61M 2209/088 : on the body
• CPC Class Codes: A61M 2210/12 : Blood circulatory system
• CPC Class Codes: A61M 5/14248 : of the skin patch type
• CPC Class Codes: A61M 5/1454 : spring-actuated, e.g. by a clockwork
• CPC Class Codes: A61M 5/152 : pressurised by contraction of elastic reservoirs containers for dispensing contents by contraction of an elastic bag provided therein, in general B65D83/0061
• CPC Class Codes: A61M 5/155 : pressurised by gas introduced into the reservoir
• CPC Class Codes: A61M 5/172 : electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/2033 : Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/2053 : Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/2066 : comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/31531 : Microsyringes, e.g. having piston bore diameter close or equal to needle shaft diameter
• CPC Class Codes: A61M 5/3202 : Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3234 : Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
• CPC Class Codes: A61M 5/326 : Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
• CPC Class Codes: A61M 5/3273 : freely sliding on needle shaft without connection to syringe or needle
• CPC Class Codes: A61M 5/3291 : Shafts with additional lateral openings
• CPC Class Codes: A61M 5/3293 : characterised by features of the needle hub
• CPC Class Codes: A61M 5/3294 : comprising means for injection of two or more media, e.g. by mixing

Abstract

An active agent or drug injecting device (10) includes a main housing (16) containing a trigger mechanism (24) which can be manually activated via release bar (32) or remotely triggered via wireless receiver (70) activating motor (74), and a second housing (80) containing an injection- and needle-assembly (22). The needle (30) encloses a dry carrier (26) having an active agent (12) disposed thereon. The trigger mechanism triggers the injection assembly to propel the needle into the skin (via spring (54)), to inject the active agent into a living organism (either by letting the active agent diffuse out of the needle or by actively flushing it out), and to subsequently retract the needle back into the housing (80) (via spring (64)).

Claims

1. An active agent injecting device for injecting an active agent into a living organism, the injecting device including:

(a) a main housing;

(b) an energy storage device located inside the main housing, the energy storage device biasing an activation mechanism;

(c) an injection assembly having a needle enclosing a carrier comprising an active agent; and

(d) a trigger mechanism which triggers the injection assembly to release the needle to inject the active agent into the living organism.

2. The device of claim 1, wherein the trigger mechanism is controlled by a sensor.

3. The device of claim 1. wherein the trigger mechanism is controlled by a receiver.

4. The device of claim 3. Wherein the receiver is a wireless receiver.

5. The device of claim 3, wherein the trigger mechanism is controlled as a function of time.

6. The device of claim 1, further including a second housing for housing the trigger mechanism, the second housing releasably connectable to the main housing.

7. The device of claim 1, wherein the active agent is selected from one of a group of active agents consisting of a drugs, vitamins, antivenoms, serums and medications.

12. The device of claim 1, wherein the active agent is an active agent selected from one of a group of active agents consisting of

a. serum albumin,

b. nanoparticies,

c. liposome formulations,

d. PEG conjugation,

e. combinations of (b) and (c),

f. combinations of (c) and (d),

g. combinations of (b) and (d)

h. combinations of (b), (c) and (d),

i. lipoproteins,

j. stabilized nanoparticles, and

k. carbohydrate carriers.

13. A method of using the active agent injector of claim 1, the method including the steps of:

a. preparing the injection area;

b. removing a security seal on the active agent injector;

c. removing a protective layer from an adhesive pad of the active agent injector;

d. adhering the active agent injector to the skin of the user;

e. opening the trigger panel to allow access to the trigger; and

f. activating the trigger, thereby initiating a process of active agent injection.

14. A process of active agent injection using the active agent injector of claim 1, the process including the steps of:

a. initializing an actuation system;

b. priming the active agent injector;

c. inserting the needle subcutaneously in an injection area;

d. releasing the active agent;

e. retracting the needle;

f. after use, removing the active agent injector; and

g. optionally sterilizing the injection area, if this has not already been performed.

15. A process of claim 14, wherein the active agent injection is executed automatically by control electronics in the active agent injector.

16. A method of injecting an active agent in a living organism using the device of claim 1, the method including the steps of:

a. attaching the injection device to the living organism;

b. activating the injection device, thereby causing a stored fluid to be injected through the needle, into the living organism,

c. dissolving into the bloodstream of the living organism using the fluid, active agents in the dry carrier;

d. retracting the needle; and

e. removing the device and optionally disinfecting the injection site.

8. A needle assembly for an active agent injector, the needle assembly having:

a. a needle shaft having slits formed therethrough into an internal channel and a fixation structure to which a dry carrier may be attached;

b. a protective sleeve having a flange formed thereon, the sleeve being in close sliding contact over the needle shaft; and

c. sealing means to seal the needle assembly against contamination.

9. The needle assembly of claim 8, wherein the sealing means is a septum covering an end of the flange.

10. The needle assembly of claim 8, wherein the needle shaft is closed at one end to facilitate gripping.

11. The needle assembly of claim 8, further including an integral flange adapted to be biased by a retraction mechanism for retracting the needle of the needle assembly out of the skin of a living organism.