Drug delivery device

• US 8,597,257 B2
• Filed: 09/09/2011
• Issued: 12/03/2013
• Est. Priority Date: 02/16/2006
• Status: Active Grant

• Current Assignee: PKA Softtouch Corp.
• Original Assignee: PKA Softtouch Corp.
• Inventors: Modi, Pankaj
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US13/229,538
• Publication Number:
  US 20110319834A1
• Time in Patent Office: 816 Days
• Field of Search: 604/19, 604/48, 604/93.01, 604/110, 604/131, 604/132, 604/139, 604141-146, 604156-157, 604/167.01, 604/167.02, 604/181, 604185-189, 604/197, 604/201, 604/232, 604246-249
• US Class Current: 604/214
• CPC Class Codes: A61M 2005/3143 Damping means for syringe components executing relative movements, e.g. retarders or attenuators slowing down or timing syringe mechanisms
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 2205/6081 Colour codes
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/2425 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/282 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/286 upon internal pressure increase, e.g. pierced or burst A61M5/283 takes precedence
• CPC Class Codes: A61M 5/288 by piercing without internal pressure increase A61M5/283 takes precedence
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/31525 Dosing burettes, pipettes B01L3/02
• 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 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

A novel device and method for intradermal delivery of an active agent is provided. The device comprises a housing which contains a reservoir chamber. A flexible reservoir containing the active agent is placed in the chamber. Upon pressure on an actuator the active agents is delivered via a hollow needle to the skin.

Claims

1. A device for administering to an animal a fluid drug comprising:

a housing having a housing open upper end and a housing bottom base defining an inner chamber;

the housing bottom base having an aperture;

the inner chamber adapted to slideably receive therein a reservoir chamber in an initial reservoir chamber position at a first predetermined distance from an interior surface of the housing bottom base, the reservoir chamber being confined to travel along a reservoir chamber travel path relative to the housing;

wherein the reservoir chamber is held at the first predetermined distance by at least one releasable latch which interacts with a latch retainer on the housing open upper end, and wherein the latch includes a notch;

the reservoir chamber defined by a reservoir chamber bottom base and surrounding wall extending from the reservoir bottom base so as provide a reservoir open top;

the reservoir bottom base including a hollow needle having a lower end and an upper non-skin contacting end wherein the needle is mounted in and traverses the reservoir bottom base such that the upper non-skin contacting end is disposed within the interior of the reservoir chamber and just below a flexible filled reservoir body and the lower skin-contacting end can extend beyond the aperture to a second position at a predetermined distance defined by the reservoir chamber travel path of the reservoir chamber bottom base to the housing bottom base position along the reservoir chamber travel path relative the housing;

the flexible filled reservoir body containing therein the fluid drug being located in the reservoir chamber near the reservoir open top and separated from the upper end of the hollow needle in the first predetermined reservoir chamber position; and

an actuator having a plunger operably coupled thereto and terminating in a stopper;

the latch being releasable from the latch retainer when pressure is applied to the actuator;

the plunger adapted to be in slidable communication within the reservoir chamber via the reservoir open top such that, in use, the stopper can communicate with the reservoir body when in a second predetermined reservoir chamber position wherein a force being applied to the actuator causes the lower end of the hollow needle to enter the skin to the second position and further force causes the upper end of the hollow needle to pierce the reservoir body and puts the upper end of the needle into fluid communication with the contents of the reservoir body such that continuous force being applied to the actuator causes the fluid drug to be expelled through the hollow needle;

the plunger including an indent for receiving therein a tab located on the reservoir chamber for maintaining the plunger depressed in the reservoir chamber after the fluid drug is expelled, and engagement of the tab in the indent causing the notch to engage with the latch when the reservoir chamber is returned to the initial position by biasing means whereby the needle is automatically retracted back into the housing in a locked position.

2. The device as defined in claim 1, wherein abutment of the housing bottom base with the reservoir chamber bottom base in the second predetermined reservoir chamber position acts to provide a predetermined length of travel of the hollow needle through the aperture.

3. The device as defined in claim 1, wherein the length of travel of the hollow needle in the second predetermined reservoir chamber position is from about 0.5 mm to about 10 mm extending through the aperture.

4. The device as defined in claim 1, wherein the length of travel of the hollow needle in the second predetermined reservoir chamber position is from about 1.5 mm to about 8 mm extending through the aperture.

5. The device as defined in claim 1, wherein the length of travel of the hollow needle in the second predetermined reservoir chamber position is from about 3 mm to about 8 mm extending through the aperture.

6. The device as defined in claim 1, wherein the biasing means is located within the inner chamber between the housing bottom base and the reservoir bottom base so as to bias the reservoir chamber in the first predetermined reservoir chamber position.

7. The device as defined in claim 6, wherein the biasing means is a spring.

8. The device as defined in claim 6 wherein the biasing means comprises an air bladder.

9. The device as defined in claim 1, further comprising a septum covering the aperture which is piercable by the hollow needle extending through the aperture in the second predetermined reservoir chamber position.

10. A device for administering to an animal a fluid drug comprising:

a housing having a housing open upper end and a housing bottom base defining an interior chamber;

the housing bottom base having an aperture therein;

the interior chamber adapted to slideably receive therein a reservoir chamber in an initial reservoir chamber position at a first predetermined distance from the interior surface of the base of the housing, the reservoir chamber being confined to travel along a reservoir chamber travel path relative the housing;

the reservoir chamber defined by a reservoir chamber bottom base and surrounding reservoir chamber wall extending from the reservoir bottom base so as provide a reservoir open top;

the reservoir bottom base including a single hollow needle having a lower end and an upper non-skin contacting end wherein the needle is mounted in and transverses the reservoir bottom base such that the upper non-skin contacting end is disposed within the interior of the reservoir chamber and just below the reservoir and the lower skin-contacting end can extend beyond the aperture to a second position at a predetermined distance defined by the reservoir chamber travel path of the reservoir chamber bottom base to the housing base relative the housing;

a flexible filled reservoir body containing therein the fluid drug being located in the reservoir chamber near the reservoir open top and separated from the upper end of the hollow needle in the first predetermined reservoir chamber position; and

an actuator having a plunger operably coupled thereto and terminating in a stopper, the stopper having formed therein a frustoconical depression;

the frustoconical depression having a depth corresponding to the length of the upper non-skin contacting end of the needle disposed within the interior of the reservoir chamber;

the plunger adapted to be in slidable communication within the reservoir chamber via the reservoir open top such that, in use, the stopper can communicate with the flexible filled reservoir body with a portion of the flexible filled reservoir body being received in the depression when in a second predetermined reservoir chamber position, wherein a force being applied to the actuator causes the lower end of the hollow needle to enter the skin to the second position and further force causes the upper end of the hollow needle to pierce the reservoir body and puts the upper end of the needle into fluid communication with the contents of the flexible filled reservoir body such that continuous force being applied to the actuator causes the stopper to compress the flexible filled reservoir body and the fluid drug through the hollow needle and wherein the upper non-skin contacting end of the needle is located within a portion of the flexible filled reservoir body received in the depression once substantially all of the fluid drug is expelled;

the reservoir chamber is held at said first predetermined distance by at least one releasable latch;

said at least one releasable latch engagable with a latch retainer located on said housing upper end;

said at least one releasable latch including a notch;

said at least one releasable latch being released from said latch retainer when sufficient pressure is applied to said actuator;

said plunger including an indent for receiving therein a tab located on the reservoir chamber for maintaining said plunger depressed in said reservoir chamber after the fluid drug is expelled and engaging the tab in the indent causes the notch to engage with said at least one releasable latch when the reservoir chamber is returned to the said initial position by biasing means thereby retracting and locking said lower skin-contacting end of said needle within said housing.

11. The device as defined in claim 10, wherein abutment of the housing bottom base with the reservoir chamber bottom base in the second predetermined reservoir chamber position acts to provide a predetermined length of travel of the hollow needle through the aperture.

12. The device as defined in claim 10, wherein the biasing means is located within the inner chamber between the housing bottom base and the reservoir bottom base so as to bias the reservoir chamber in the initial reservoir chamber position.

13. The device as defined in claim 12, wherein the biasing means is a spring.