Drug delivery device and methodology

• US 20080140007A1
• Filed: 12/11/2006
• Published: 06/12/2008
• Est. Priority Date: 12/11/2006
• Status: Active Grant

• Current Assignee: Kenergy Scientific, Inc.
• Original Assignee: GlynnTech Inc.
• Inventors: Glynn, Kenneth P.
• Granted Patent: US 8,382,713 B2
• Time in Patent Office: Days
• US Class Current: 604/135
• CPC Class Codes: A61M 2005/3104 Caps for syringes without needle
• CPC Class Codes: A61M 2005/3114 Filling or refilling
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2005/3132 having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase
• CPC Class Codes: A61M 2005/31508 provided on the piston-rod
• CPC Class Codes: A61M 5/28 Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• 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

Abstract

Drug delivery devices adapted to receive liquid medication to fill a reservoir, utilize sliding through valves that are closed except when driven by force of liquid medication pushed by a plunger to an open position to feed the medication via needle to a patient or via a connection to an IV port. The devices have multiple seals and automatically close up when pressure on the plunger is released. The methodology is also included.

Claims

1. A drug delivery device, which comprises:

(a.) a main housing having a shaft with a proximal end and a distal end, having a drug holding reservoir within said shaft, and having a drug release conduit located in said shaft toward said distal end, and having an outlet located at said distal end of said shaft;

(b.) a fill port, the fill port being connected to an inlet conduit;

(c.) said inlet conduit connected to said shaft at said holding reservoir;

(d.) a one-way valve located within said inlet conduit between said piercing element and said holding reservoir positioned to permit flow from said drug vial receiving member to said holding reservoir and not the opposite;

(e.) a slide valve having a distal end and a proximal end, and being located in said shaft and adapted for movement within said shaft from a first position to a second position and vice versa, wherein when said slide valve is in said first position, said drug holding reservoir is closed from said drug release conduit, and when said slide valve is in said second position, said drug release conduit is open to permit liquid drug to pass through said slide valve from said drug holding reservoir, said slide valve having a first wall facing toward said holding reservoir and an opposing second wall facing away from said holding reservoir, and said first wall has a liquid inlet channel connecting to said side wall and said second wall has a liquid outlet channel are in proximity to one another and not directly connected to one another;

(f.) a needle functionally connected to said valve outlet at its distal end to said slide valve;

(g.) a plunger being partially and slideably located in said proximal end of said shaft, said plunger having sufficient length to be moved from a first plunger position to a second plunger position, and vice versa;

(h.) a spring located in said shaft at said distal end of said slide valve biasing said slide valve to its first position;

wherein, when the drug fill port is connected to a liquid drug source, and the plunger is moved from the first position to the second position, the liquid drug will be moved from its source into the fill port and through the inlet conduit into the drug holding reservoir, and when said plunger is moved from its second position toward its first position, said first spring will compress and said slide valve will move from its closed, first position to its open, second position in alignment with said drug release conduit, and when said plunger is moved from its second position to its third position, said first spring remains compressed and said second spring will compress and said side arm of said plunger will advance said rod and said piston to move drug through said drug outlet conduit, through said valve and through said needle for injection thereof.

2. The drug delivery device of claim 1 wherein said slide valve includes a valve conduit that connects from said drug release conduit to said needle when said slide valve is in its second position.

3. The drug delivery device of claim 1 wherein said needle is directly connected to said slide valve and travels with said slide valve from its first position to its second position and vice versa.

4. The drug delivery device of claim 3 wherein when said slide valve is in its first position, said needle is fully contained within said shaft, and when said slide valve is in its second position, said needle is partially extended beyond said distal end of said shaft so as to be positioned for injection.

5. The drug delivery device of claim 4 wherein said distal end of said shaft includes a gate that is closed when in its rest position when said needle is fully contained within said shaft and opens when said valve and needle are moved from said first position to said second position and said needle is partially extended.

6. The drug delivery device of claim 1 wherein said device further includes a child resistant mechanism on at least one of said shaft and said plunger, that has a lock position to prohibit movement of said slide valve from said first position to said second position and a go position and said child resistant mechanism must be engaged into said go position from said lock position to permit movement of said plunger to move said slide valve form said first position to said second position.

7. The drug delivery device of claim 1 wherein said needle is physically separate from said slide valve and is stationary relative to said shaft.

8. The drug delivery device of claim 1 wherein said device includes a catch mechanism to prevent removal of said plunger from said shaft once it is positioned therein.

9. The drug delivery device of claim 1 wherein said main housing includes a keyway for slide valve to position siad slide valve channels in bias with said drug release conduit of said main housing.

10. The drug delivery device of claim 1 wherein said main housing is comprised of at least two assembled sections.

12. The drug delivery device of claim 1 wherein said slide valve includes a valve conduit that connects from said drug release conduit to said needle when said slide valve is in its second position.

13. The drug delivery device of claim 1 wherein said needle is directly connected to said slide valve and travels with said slide valve from its first position to its second position and vice versa.

14. The drug delivery device of claim 3 wherein when said slide valve is in its first position, said needle is fully contained within said shaft, and when said slide valve is in its second position, said needle is partially extended beyond said distal end of said shaft so as to be positioned for injection.

15. The drug delivery device of claim 4 wherein said distal end of said shaft includes a gate that is closed when in its rest position when said needle is fully contained within said shaft and opens when said valve and needle are moved from said first position to said second position and said needle is partially extended.

16. The drug delivery device of claim 1 wherein said device further includes a child resistant mechanism on at least one of said shaft and said plunger, that has a lock position to prohibit movement of said slide valve from said first position to said second position and a go position and said child resistant mechanism must be engaged into said go position from said lock position to permit movement of said plunger to move said slide valve form said first position to said second position.

17. The drug delivery device of claim 1 wherein said needle is physically separate from said slide valve and is stationary relative to said shaft.

18. The drug delivery device of claim 1 wherein said device includes a catch mechanism to prevent removal of said plunger from said shaft once it is positioned therein.

19. The drug delivery device of claim 1 wherein said main housing includes a keyway for slide valve to position siad slide valve channels in bias with said drug release conduit of said main housing.

20. The drug delivery device of claim 1 wherein said main housing is comprised of at least two assembled sections.

24. The drug delivery methodology of claim 13 wherein when said slide valve is in its first position, said needle is fully contained within said shaft, and when said step C. is effectuated, said slide valve is moved to its second position and said needle is partially extended beyond said distal end of said shaft so as to be positioned for injection.

25. The drug delivery methodology of claim 14 wherein said distal end of said shaft includes a gate that is closed when in its rest position when said needle is fully contained within said shaft and opens when step C. is effectuated, said valve and needle are moved from said first position to said second position and said needle is partially extended.

11. A drug delivery device, which comprises:

(a.) a main housing having a shaft with a proximal end and a distal end, having a drug holding reservoir within said shaft, and having a drug release conduit located in said shaft toward said distal end, and having an outlet located at said distal end of said shaft;

(b.) a fill port with an optional one way valve, the fill port being connected to an inlet conduit;

(c.) said inlet conduit connected to said shaft at said holding reservoir;

(d.) a one-way valve located within said inlet conduit between said piercing element and said holding reservoir positioned to permit flow from said drug vial receiving member to said holding reservoir and not the opposite;

(e.) a slide valve having a distal end and a proximal end, and being located in said shaft and adapted for movement within said shaft from a first position to a second position and vice versa, wherein when said slide valve is in said first position, said drug holding reservoir is closed from said drug release conduit, and when said slide valve is in said second position, said drug release conduit is open to permit liquid drug to pass through said slide valve from said drug holding reservoir, said slide valve having a first wall facing toward said holding reservoir and an opposing second wall facing away from said holding reservoir, and said first wall has a liquid inlet channel connecting to said side wall and said second wall has a liquid outlet channel are in proximity to one another and not directly connected to one another;

(f.) a needle functionally connected to said valve outlet at its distal end to said slide valve;

(g.) a plunger being partially and slideably located in said proximal end of said shaft, said plunger having sufficient length to be moved from a first plunger position to a second plunger position, and vice versa;

(h.) a spring located in said shaft at said distal end of said slide valve biasing said slide valve to its first position;

wherein, when the drug fill port is connected to a liquid drug source, and the plunger is moved from the first position to the second position, the liquid drug will be moved from its source into the fill port, and through the optional one-way valve, if there is one, and through the inlet conduit into the drug holding reservoir, and when said plunger is moved from its second position toward its first position, said first spring will compress and said slide valve will move from its closed, first position to its open, second position in alignment with said drug release conduit, and when said plunger is moved from its second position to its third position, said first spring remains compressed and said second spring will compress and said side arm of said plunger will advance said rod and said piston to move drug through said drug outlet conduit, through said valve and through said needle for injection thereof.

22. The drug delivery methodology of claim 11 wherein said slide valve includes a valve conduit that connects from said drug outlet conduit to said needle when said slide valve is in its second position so as to permit said drug to flow therethrough.

23. The drug delivery methodology of claim 11 wherein said needle is directly connected to said side valve and travels with said slide valve from its first position to its second position and vice versa when said step C. is effectuated.

26. The drug delivery methodology of claim 11 wherein said device further includes a child resistant mechanism that has a lock position to prohibit movement of said slide valve from said first position to said second position and a go position and said methodology includes the step of engaging said child resistant mechanism by moving it into said go position from said lock position to permit movement of said slide valve form said first position to said second position.

27. The drug delivery methodology of claim 11 wherein said needle is physically separate from said slide valve and is stationary relative to said shaft.

28. The drug delivery methodology of claim 11 wherein said device includes a catch mechanism to prevent removal of said plunger from said shaft once it is positioned therein.

29. The drug delivery methodology of claim 11 wherein said main housing includes a runway for said side arm and said arm includes a catch that fits into said runway such that when said plunger is partially positioned within said shaft, said catch inhibits removal of said plunger from said shaft.

30. The drug delivery methodology of claim 11 which further includes the step of releasing said plunger so that the first spring and second spring are uncompressed and said slide valve returns to its first position.

21. A methodology for drug delivery utilizing a manual drug delivery device, which comprises the steps of:

A.) loading a drug holding reservoir of a manual drug delivery device with a predetermined amount of a liquid drug and sealing said liquid drug in said drug holding reservoir, said manual drug delivery device including the following structure;

(i) a main housing having a shaft with a proximal end and a distal end, and having said drug holding reservoir separate from said shaft, and having a drug outlet conduit connected from said drug holding reservoir to said shaft;

(ii) fill means on said main housing for loading a drug into said drug holding reservoir, said fill means including opening and closing means and a one way valve to permit liquid to enter said device and to not exit said device through said fill port;

(iii) a piston with a drive rod, said piston being slideably located within said reservoir;

(iv) a slide valve having a distal end and a proximal end, and being located in said shaft and adapted for movement within said shaft from a first position to a second position and vice versa, wherein when said slide valve is in said first position, said drug outlet conduit is closed from said shaft, and when said slide valve is in said second position, said drug outlet conduit is open to permit liquid drug to pass through said slide valve;

(v) a needle functionally connected at its distal end to said slide valve;

(vi) a plunger having a side arm, said plunger being partially and slideably located in said proximal end of said shaft, said side arm being in alignment with said rod, said plunger having sufficient length to be moved from a first plunger position, being a rest position, to a second plunger position, being a slide valve open position, and from said second position to a third position, being an injection position;

(vii) a first spring located in said shaft at said distal end of said slide valve, and a second spring located in said shaft at said proximal end of said slide valve between said plunger and said slide valve, said first spring being weaker than said second spring so as to yield and compress fully before said second spring compresses;

B.) positioning said device adjacent a drug injection receiver;

C.) moving said plunger into said shaft from said first position to said second position, so as to compress said first spring and so as to move said slide valve from its closed, first position to its open, second position in alignment with said drug outlet conduit;

D.) moving said plunger from its second position to its third position, while said first spring remains compressed, and so as to compress said second spring and advance said side arm of said plunger to act upon said rod and said piston to move said drug through said drug outlet conduit, through said valve and through said needle to inject said drug into said injection receiver.