Drug delivery system including holder and drug container

• US 6,382,204 B1
• Filed: 10/14/1999
• Issued: 05/07/2002
• Est. Priority Date: 10/14/1999
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Vedrine, Lionel, Jansen, Hubert
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): Mitchell, Teena
• Application Number:
  US09/417,346
• Time in Patent Office: 936 Days
• Field of Search: 128/200.19, 128/200.11, 128/200.14, 128/200.22, 128/202.17, 128/203.22, 128/203.23, 128/205.15, 604/218, 604/131, 604/134, 604/135, 604/208, 604/188, 604/187, 604/232, 604/73, 604/514, 604/234
• US Class Current: 128/200.19
• CPC Class Codes: A61M 11/06 of the injector type
• CPC Class Codes: A61M 15/0025 with caps
• CPC Class Codes: A61M 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 2005/208 Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
• CPC Class Codes: A61M 2205/073 Syringe, piston type
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 5/31591 Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means
• CPC Class Codes: B05B 11/02 Membranes or pistons acting on the contents inside the container, e.g. follower pistons

Abstract

A drug delivery system for administering preset doses of a substance such as a drug, vaccine or the like is provided. The drug delivery system includes a holder and a pre-filled drug container such as a syringe which is securely retained in the holder. The drug container includes a barrel for containing the substance, a movable stopper situated within the barrel, and a blunt end having an opening through which the substance within the barrel can be expelled. The holder includes a distal portion and a proximal portion, each configured to accommodate the drug container, with the distal portion being able to be assembled to the proximal portion, which acts as a plunger rod during activation of the delivery system. A plurality of slots are provided for controlling the delivery of a substance and extend axially along at least one portion of the holder whereby upon activation of the system, the portions of the holder move towards one another upon the application of a minimum force and the stopper moves a preselected axial distance to expel at least a portion of the substance from the drug container. One application is to a nasal drug container, where approximately equal doses of the substance are desired to be administered to each nostril of the patient.

Claims

1. A system for delivering at least one substance in at least two doses, comprising:

a drug container including a barrel having a rim surrounding an open end and extending to a first end, and a stopper slidably positioned within said barrel;

a holder having a distal portion with a distal end through which said first end of said container extends and an open receiving end for receiving said container and a proximal portion with the distal portion being assembled to said distal portion, with the drug container secured therein; and

a plurality of slots extending axially along at least one of said portions of the holder whereby upon activation of said system, said portions of said holder move towards one another upon the application of a minimum force and said stopper moves a preselected axial distance to expel at least a portion of said substance from said drug container,

at least one detent disposed adjacent said receiving end of said distal portion and dimensioned so that said rim is securely retained in said distal portion by said detent.

2. The system as described in claim 1, wherein said distal portion and said proximal portion of said holder each has a generally tubular interior configured to accommodate said drug container filled with a substance to be delivered and said proximal portion of said holder includes a closed end having a rod extending therefrom for engagement with said stopper of said drug container upon activation.

3. The system as described in claim 1 wherein said preselected axial distance corresponds to about half the distance that said stopper is capable of moving within said barrel to administer about half of the substance held by said drug container.

4. The system as described in claim 1, further comprising a pair of flanges extending radially outwardly from said distal portion of said holder and attached thereto by a plurality of ribs.

5. The system as described in claim 1, wherein said distal portion of said holder includes at least one window to permit visual inspect of the contents of the drug container located within the holder.

6. A system for delivering at least one substance in at least two doses, comprising:

a drug container including a barrel, a first end extending from said barrel, and a stopper slidably positioned within said barrel;

a holder having a distal portion including at least one pair of ribs and a proximal portion having at least one pair of slots with the drug container secured therein;

means for controlling the delivery of a substance contained in the barrel of the drug container whereby upon activation of said system, said portions of said holder move toward one another upon the application of a minimum force and said stopper moves a preselected axial distance to expel at least a portion of said substance from said drug container;

said pair of slots including a first slot and a second slot extending axially along the body of the proximal portion of the holder generally parallel to each other and dimensioned and situated to accommodate said ribs of said distal portion so that one of said ribs is insertable into each slot and able to travel along said slot upon activation of the system.

7. The system as described in claim 6, wherein the first slot is preferably open and is divided into at least two portions, and situated adjacent an open end of the first slot is a bridge extending across at least a portion of the slot, with the bridge being dimensioned so that when a rib comes in contact with the bridge and sufficient force is applied there against, the bridge will fracture to allow passage of the rib along the slot.

8. The system as described in claim 7, wherein a detent is situated adjacent the open end of the first portion of the first slot so that the rib can be clipped between the detent and the bridge prior to activation of the system, and the second portion of the first slot is at least slightly offset from the first portion of the first slot and towards the second slot.

9. The system as described in claim 8, wherein the other rib travels along the second slot to provide structural stability and tracking, with the second slot including biasing means for biasing the rib in the first slot towards the second portion of the slot upon release of the force applied by a user.

10. The system as described in claim 9, wherein said biasing means is adapted to include a cut-away portion forming a deflectable arm having an inner wall associated with the second slot so that as the ribs travel along their respective slots, the one rib will deflect the flexible arm to cause the proximal portion of the holder to rotate relative to the distal portion about a central axis so that the rib situated in the first slot can come in contact with a second bridge so that upon sufficient force being applied, the bridge will fracture to allow passage of the rib along the second portion of the first slot.

11. A holder for a drug container, comprising;

a distal portion including at least one pair of ribs and a proximal portion having at least one pair of slots and configured to accommodate a drug container filled with a substance to be delivered, with the distal portion being able to be assembled to the proximal portion for controlling the delivery of the substance, whereby when said portions of said holder are moved towards one another upon the application of a minimum force, at least a portion of the substance can be expelled from said drug container,

said pair of slots including a first slot and a second slot extending axially along the body of the proximal portion of the holder generally parallel to each other and dimensioned and situated to accommodate said ribs so that said ribs of said distal portion are insertable into the slots and able to travel along the slots upon activation of the system.

12. The holder as described in claim 11, wherein a first end of said drug container includes a spray nozzle and said drug container is a syringe, and said distal portion and said proximal portion each has a generally tubular interior configured to accommodate said syringe and said proximal portion of said holder includes a closed end having a rod extending therefrom for engagement with said stopper of said syringe during activation.

13. The holder as described in claim 11, wherein said distal portion further comprises a means for securing said drug container herein with said distal portion having a first end through which a first end of said drug container can extend and a second, open end defining an opening of sufficient size for receiving a barrel of the drug container.

14. The holder as described in claim 11, further comprising a pair of flanges extending radially outwardly from said distal portion and attached there along by a plurality of ribs.

15. The holder as described in claim 11 wherein the first slot is preferably open and is divided into at least two portions, and situated adjacent an open end of the first slot is a bridge extending across at least a portion of the slot, with the bridge being dimensioned so that when a rib comes in contact with the bridge and sufficient force is applied there against, the bridge will fracture to allow passage of the rib along the slot.

16. The holder as described in claim 15, wherein a detent is situated adjacent said open end of the first portion of the first slot so that the rib can be clipped between the detent and the bridge prior to activation of the system, and the second portion of the first slot is at least slightly offset from the first portion of the first slot and towards the second slot.

17. The holder as described in claims 16, wherein one of said ribs travels along the second slot to provide structural stability and tracking, with the second slot including biasing means for biasing the rib in the first slot towards the second portion of the slot upon release of the force applied by a user.

18. The holder as described in claim 11, wherein said distal portion includes at least one window to permit visual inspect of the contents of the drug container when located within the holder.

19. A system for the nasal delivery of a substance, comprising:

a syringe including a barrel, a first end extending from said barrel, said first end including a spray nozzle having an opening for dispensing the substance from said barrel, and at least one stopper slidably positioned within said barrel;

a holder having a distal portion including at least one pair of ribs and a proximal portion having at least one pair of slots, each having a generally tubular interior configuration to accommodate said syringe, with the distal portion being able to be assembled to the proximal portion, which acts as a plunger rod during activation of the system;

means for controlling the delivery of said substance including a plurality of slots extending axially along at least one of said portions of the holder whereby upon activation of said system, said portions of said holder move towards one another upon the application of a minimum force and said stopper moves a preselected axial distance to expel at least a portion of said substance from said syringe, with said preselected axial distance corresponding to about half the distance that said stopper is capable of moving within said barrel to administer about half of said substance contained by said syringe barrel; and

said slots in said proximal portion of said holder including two corresponding sets situated on each side thereof, with each set including a first slot and a second slot extending axially along the body of the proximal portion of the holder generally parallel to each other and dimensioned and situated to accommodate said ribs so that said ribs are insertable into the slots and able to travel along the slots upon activation of the system.

20. The system as described in claim 19, further comprising a pair of flanges extending radially outwardly from said distal portion of said holder and attached there along by a plurality of ribs.

21. The system as described in claim 19 wherein the first slot is preferably open and is divided into at least two portions, and situated adjacent an open end of the first slot is a bridge extending across at least a portion of the slot, with the bridge being dimensioned so that when a rib comes in contact with the bridge and sufficient force is applied there against, the bridge will fracture to allow passage of the rib along the slot.

22. The system as described in claim 21, wherein a detent is situated adjacent said open end of the first portion of the first slot so that the rib can be clipped between the detent and the bridge prior to activation of the system and the second portion of the first slot is at least slightly offset from the first portion of the first slot and towards the second slot.

23. The system as described in claim 22, wherein one of said ribs travels along each of said second slots to provide structural stability and tracking, with each second slot including a cut-away portion forming a deflectable arm for biasing the ribs in the first slots towards the second portions of the slots upon release of the force applied by a user so that as the ribs travel along their respective slots, the ribs traveling along the second slots will deflect the flexible arms to cause the proximal portion of the holder to rotate relative to the distal portion about a central axis so that the ribs situated in the first slots each come in contact with a second bridge so that upon sufficient force being applied, the bridges will each fracture to allow passage of the ribs along the second portions of the first slots.

24. The system as described in claim 19, wherein said distal portion of said holder includes at least one window to permit visual inspect of the contents of the syringe located within the holder.