Methodology for drug delivery device with sliding valve

• US 8,100,853 B2
• Filed: 12/28/2009
• Issued: 01/24/2012
• Est. Priority Date: 11/15/2006
• Status: Expired due to Fees

• Current Assignee: GlynnTech Inc.
• Original Assignee: Glynn Tech Incorporated
• Inventors: Glynn, Kenneth P.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): HOLLOWAY, IAN KNOBEL
• Application Number:
  US12/655,230
• Publication Number:
  US 20100137833A1
• Time in Patent Office: 757 Days
• Field of Search: 604/191, 604/70, 604/68
• US Class Current: 604/68
• CPC Class Codes: A61M 2005/3118 via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
• 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 5/204 connected to external reservoirs for multiple refilling
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• 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
• CPC Class Codes: A61M 5/502 for blocking the piston

Abstract

Drug delivery devices adapted to receive liquid medication vials 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 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 holding reservoir, said manual drug delivery device including the following structure;

i.)a main housing having a linear shaft with a proximal end, a distal end and a side wall, and having a drug holding reservoir within said shaft toward said proximal end, and having a drug release conduit located on said shaft side wall toward said distal end, and having a shaft outlet located at said distal end of said shaft;

ii.) a drug vial receiving member adapted to receive, hold, and pierce a drug vial, said member having a hollow vial piercing element connected to an inlet conduit;

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

iv.) a one-way valve located within said inlet conduit between said vial piercing element and said holding reservoir positioned to permit flow to said holding reservoir and not the opposite;

v.) a slide valve having a proximal end, said proximal end being a first wall, and having a distal end, said distal end being a second wall, said side valve having a side wall connecting said distal end and said proximal end, said slide valve first wall facing toward said holding reservoir and said slide valve second wall facing away from said holding reservoir, said first wall having a liquid inlet channel connected to said side wall, and said second wall having a liquid outlet channel connected to said side wall, said liquid inlet channel and said liquid outlet channel being in proximity to one another and not directly connected to one another, and having a seal located on said side wall between said liquid inlet channel and said liquid outlet channel, said slide valve 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 slide valve is away from said drug release conduit and said drug holding reservoir is closed from said drug release conduit, and when said slide valve is in said second position, said slide valve is located at said drug release conduit and said drug release conduit is open to permit liquid drug to pass from said drug holding reservoir through said slide valve via, in sequence, said liquid inlet channel, said drug release conduit, and said liquid outlet channel, to a needle;

vi.) a needle functionally connected at its distal end to said slide valve;

vii.) a plunger being partially and slidably located in said proximal end of said shaft, said plunger having a rod and a piston, said plunger having sufficient length to be moved from a first plunger position to a second plunger position to a third plunger position, and vice versa;

;

viii.) 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 vial receiving member is loaded with a piercable drug vial containing liquid drug, and the plunger is pulled back from the first position to the second position, the liquid drug will be moved from the vial through the hollow vial piercing element and through inlet conduit into the drug holding reservoir, and when said plunger is pushed forward from its second position toward its first position, said 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 said needle will move to a functional position through said shaft outlet, and when said plunger is moved from its second position to its third position, said spring remains compressed and the force of the plunger will advance the liquid drug through said liquid inlet channel, through said drug outlet conduit, through said liquid outlet channel and through said needle for injection thereof;

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; and

D.) moving said plunger from its second position to its third position, while said first spring remains compressed, 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.

2. The drug delivery methodology of claim 1 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.

3. The drug delivery methodology 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 when said step C. is effectuated.

4. The drug delivery methodology of claim 3 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.

5. The drug delivery methodology of claims 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 step C. is effectuated, 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 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 from said first position to said second position.

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

8. The drug delivery methodology 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 methodology of claim 1 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.

10. The drug delivery methodology of claim 1 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.