Drug delivery system

• US 7,862,543 B2
• Filed: 07/18/2003
• Issued: 01/04/2011
• Est. Priority Date: 08/05/2002
• Status: Active Grant

• Current Assignee: Avaxzipen Limited
• Original Assignee: Glide Pharmaceutical Technologies Limited
• Inventors: Potter, Charles D. Ogilvy, Potter, David S.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Campbell; Victoria P
• Application Number:
  US10/523,473
• Publication Number:
  US 20060161111A1
• Time in Patent Office: 2,727 Days
• Field of Search: 604/135, 604/136, 604/138, 604/139, 604/189, 604200-206, 604/232, 604/235, 604/218
• US Class Current: 604/138
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61M 2005/005 Magazines with multiple ampoules directly inserted into an injection or infusion device, e.g. revolver-like magazines containing ampoules with or without needles
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• 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 5/3015 for injecting a dose of particles in form of powdered drug, e.g. mounted on a rupturable membrane and accelerated by a gaseous shock wave or supersonic gas flow cell injection devices C12M3/006
• CPC Class Codes: F42B 12/54 by implantation, e.g. hypodermic projectiles

Abstract

A drug delivery system is disclosed which may be a throwaway or reusable device for delivery at least one drug to a patient. Also described is a method for administering a drug using said device and a packaged drug for use with said device. The drug delivery device (10) comprises a housing (12), a means (14) for generating a force capable of pushing a drug (16) from a packaging (18) into a human or animal body, a means (20) for transmitting said force to push the drug (16) from the packaging (18) into the human and animal body, and a means (38, 42b) for triggering the device. Where the device is a single use drug delivery system, a packaged drug (100) forms an integral part of the device. The packaged drug comprises a region (102) allowing it to be slidably mounted to the drug delivery device (10).

Claims

1. A drug delivery device comprising:

(i) a housing including an upper barrel and a lower barrel;

(ii) a means for generating a force capable of pushing a drug from a packaging into a human or animal body;

(iii) said upper barrel being at one end of the device;

(iv) said upper barrel housing the force generating means;

(v) said lower barrel (30) being at a second end of the device remote from said upper barrel which includes a means (20) for transmitting said force to push the drug (16) from the packaging (18) into the human or animal body, a sliding piston (48) and a means (22) for slidably receiving a packaged drug (100) configured such that a packaged drug attached thereto can slide within the device and act against said piston in the device to prime it;

(vi) a means for triggering the device wherein said force generating means and said force transmitting means are configured to push the drug from the packaging into the human or animal body at a velocity of less than 20 m/s;

(vii) said lower barrel being in operative communication with said upper barrel and said packaged drug; and

(viii) wherein the packaged drug is slidably disposed in said lower barrel and comprises a packaging containing a drug, said packaging comprising a two-piece housing having a channel running therethrough in which is disposed a drive pin or other element, a skin piercing means and the drug;

said two-piece housing further comprising i) a region allowing the packaged drug to be slidably mounted to the drug delivery device at a receiving means; and

ii) an end adapted to engage and tension the skin; and

(ix) a resilient means below or otherwise in association with the drive pin or other elements to ensure the drive pin is withdrawn after use.

2. A drug delivery device comprising:

(i) a housing including an upper barrel and a lower barrel;

(ii) a means for generating a force capable of pushing a drug from a packaging into a human or animal body;

(iii) said lower barrel (30) being at an end remote from said upper barrel which includes a means (20) for transmitting said force to push the drug (16) from the packaging (18) into the human or animal body, a sliding piston (48) and a means (22) for slidably receiving a packaged drug (100) configured such that a packaged drug attached thereto can slide within the device and act against said piston in the device to prime it; and

(iv) a means for triggering the device wherein said force generating means and said force transmitting means are configured to push the drug from the packaging into the human or animal body at a velocity of less than 20 m/s;

(v) the means for generating the force capable of pushing the drug is a spring; and

(vi) a spring follower.

3. A drug delivery device as claimed in claim 2 wherein the means for transmitting the force comprises a substantially conical end and the spring follower has a correspondingly shaped recess in the underside thereof.

4. A drug delivery device comprising:

(i) a housing including an upper barrel and a lower barrel;

(ii) a means for generating a force capable of pushing a drug from a packaging into a human or animal body;

(iii) said upper barrel being at one end of the device;

(iv) said upper barrel housing the force generating means;

(v) said lower barrel (30) being at a second end of the device remote from said upper barrel which includes a means (20) for transmitting said force to push the drug (16) from the packaging (18) into the human or animal body, a sliding piston (48) and a means (22) for slidably receiving a packaged drug (100) configured such that a packaged drug attached thereto can slide within the device and act against said piston in the device to prime it;

(vi) a means for triggering the device wherein said force generating means and said force transmitting means are configured to push the drug from the packaging into the human or animal body at a velocity of less than 20 m/s;

(vii) said lower barrel being in operative communication with said upper barrel and said packaged drug;

(viii) wherein the packaged drug is slidably disposed in said lower barrel and comprises a packaging containing a drug, said packaging comprising a two-piece housing having a channel running there through in which is disposed a drive pin or other element, a skin piercing means and the drug;

said two-piece housing further comprising i) a region allowing the packaged drug to be slidably mounted to the drug delivery device at receiving means; and

ii) an end adapted to engage and tension the skin; and

(ix) wherein the packaged drug and striker are slidably mounted in the device such that the device can be primed by pushing the device against the skin.

5. A drug delivery device comprising:

(i) a housing including an upper barrel and a lower barrel;

(ii) a means for generating a force capable of pushing a drug from a packaging into a human or animal body;

(iii) said upper barrel being at one end of the device;

(iv) said upper barrel housing the force generating means;

(v) said lower barrel (30) being at a second end remote from said upper barrel which includes a means (20) for transmitting said force to push the drug (16) from the packaging (18) into the human or animal body, a sliding piston (48) and a means (22) for slidably receiving a packaged drug (100) configured such that a packaged drug attached thereto can slide within the device and act against said piston in the device to prime it;

(vi) a means for triggering the device wherein said force generating means and said force transmitting means are configured to push the drug from the packaging into the human or animal body at a velocity of less than 20 m/s;

(vii) said lower barrel being in operative communication with said upper barrel and said packaged drug; and

(viii) wherein the packaged drug is slidably disposed in said lower barrel and comprises a packaging containing a drug, said packaging comprising a two-piece housing having a channel running there through in which is disposed a drive pin or other element, a skin piercing means and the drug;

said two-piece housing further comprising i) a region allowing the packaged drug to be slidably mounted to the drug delivery device at receiving means; and

ii) an end adapted to engage and tension the skin; and

(ix) wherein the means for transmitting the force is a striker;

(x) wherein a region of the striker is shaped to fit a correspondingly shaped surface in a wall separating said upper and lower barrels defined by the housing such that the striker is aligned to strike the drive pin or other element in the packaged drug on actuation

(xi) wherein the striker comprises a substantially frustoconical shoulder region which engages a substantially frustoconical surface in the wall separating said upper and lower barrels defined by said housing; and

(xii) wherein the sliding piston has an aperture therein and the device comprises a slewing spring and the striker, all housed in said lower barrel, the device being triggered by the sliding of the piston up said lower barrel until the shoulder region of the striker engages the shaped surface and aligns the striker with the aperture in the sliding piston such that the striker moves down the aperture under the action of the force generating means.

6. A drug delivery device as claimed in claim 5 wherein the device is primed and actuated by a single action.

7. A device as claimed in claim 6 wherein pushing the packaged drug up the lower barrel with sufficient force causes the device to be primed and actuated.

8. A device as claimed in claim 6 wherein the action of pushing the packaged drug up the lower barrel with sufficient force causes the sliding piston to move up the lower barrel thereby causing the striker to be pushed up the lower barrel out of a first position in which it is not axially aligned with the aperture in the sliding piston which operatively communicates with the packaged drug and at the same time acts on a spring follower in the upper barrel causing the spring to be compressed and the device primed such that when the required delivery force is generated the striker is axially aligned with the aperture of the sliding piston and is thus actuated such that the spring acts through the spring follower and striker upon the drive pin or a like element in the packaged drug to deliver the drug into the human or animal body.

9. A packaged drug, for use with a drug delivery device, comprising a packaging containing a drug, said packaging comprising a housing having a channel running there through an in which is disposed a drive pin or other element, a skin piercing means, and the drug, said housing further comprising i) a region allowing the packaged drug to be slidably mounted to the drug delivery device;

and ii) an end adapted to engage and tension the skin; and

further comprising a resilient means below the drive pin head to ensure the drive pin is withdrawn after use.

10. A packaged drug, for use with a drug delivery device, comprising a packaging containing a drug, said packaging comprising a housing having a channel running there through an in which is disposed a drive pin or other element, a skin piercing means, and the drug, said housing further comprising i) a region allowing the packaged drug to be slidably mounted to the drug delivery device;

and ii) an end adapted to engage and tension the skin; and

further comprising a receptacle having a breakable base and being sealed by the drive pin or other element which drive pin or other element comprises an elongate body and a plurality of flexible arms.

11. A packaged drug as claimed in claim 10 in which the arms of said element, in use, ride over one or more ramped surfaces provided on the housing such that they are displaced and/or break away from the elongate body so the elongate body of the drive pin can travel down the receptacle, causing the drug to be expelled from the base of the receptacle which breaks under the pressure exerted thereon.

12. A packaged drug as claimed in claim 10 further comprising a pioneer projectile below the base of the receptacle.

13. A packaged drug, for use with a drug delivery device, comprising a packaging containing a drug, said packaging comprising a housing having a channel running there through an in which is disposed a drive pin or other element, a skin piercing means, and the drug, said housing further comprising i) a region allowing the packaged drug to be slidably mounted to the drug delivery device;

and ii) an end adapted to engage and tension the skin; and

wherein a placebo is disposed behind the drug.