Single-use needle-less hypodermic jet injection apparatus and method

• US 6,689,093 B2
• Filed: 02/05/2001
• Issued: 02/10/2004
• Est. Priority Date: 11/18/1998
• Status: Expired due to Fees

• Current Assignee: Bioject Incorporated
• Original Assignee: Bioject Incorporated
• Inventors: Landau, Sergio
• Primary Examiner(s): Hayes, Michael J.
• Application Number:
  US09/778,970
• Publication Number:
  US 20010004681A1
• Time in Patent Office: 1,100 Days
• Field of Search: 604/68-72, 604/140, 604/141, 604/143, 604/148, 604/232, 604/131
• US Class Current: 604/69
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2005/2462 by displacing occluding plugs
• CPC Class Codes: A61M 2005/287 by displacing occluding plugs
• CPC Class Codes: A61M 2005/3104 Caps for syringes without needle
• 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 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/2459 upon internal pressure increase, e.g. pierced or burst A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/286 upon internal pressure increase, e.g. pierced or burst A61M5/283 takes precedence
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• 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 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means

Abstract

A gas-powered, single-use, needle-less hypodermic jet injection device (10, 210, 410) includes a hand-held injector (12, 212, 412), and a drug injection cartridge (14, 114, 414) which provides a volume of liquid medication to be injected, an injection orifice, and an injection piston. Forceful movement of the injection piston causes an injection jet of medication to be expelled from the injection orifice. The injection device also includes a hermetically sealed gas pressure cartridge (82, 182, 482) which remains sealed until the moment of injection and powers the jet injection after opening of this cartridge.

Claims

1. A needle-less hypodermic jet injection device comprising:

a pre-filled drug injection cartridge including;

a medication cylinder having an outlet orifice,

an injection nozzle,

a flow path communicating the outlet orifice to said injection nozzle,

a plug member in a first position sealingly disposed in said flow path,

a drug-injection piston in a first position cooperating with said medication cylinder to define a variable-volume chamber of first selected size,

a dose of substantially incompressible liquid medication substantially filling said variable-volume chamber at said first size with substantially no ullage volume,

said drug-injection piston having a second position cooperating with said medication cylinder to define a variable-volume chamber of second selected size smaller than said first selected size, so that said incompressible liquid medication displaces said plug member from said first position of sealing disposition in said flow path to a second position of capture in said flow path, said medication cylinder and said plug member in said second position thereof cooperatively defining an open flow path between said variable-volume chamber and said injection nozzle;

a hand piece assembly having a body holding said drug injection cartridge, said hand piece assembly including means for forcefully moving said drug injection piston from said second position to a third position so as to reduce the volume of said variable-volume chamber substantially ejecting said dose of liquid medication via said injection nozzle;

said hand piece assembly further including a first body portion holding said drug injection cartridge, and an abutment member selectively movable into engagement with said drug injection piston to move said drug injection piston from said first position to said second position.

2. The device of claim 1 wherein said hand piece assembly further includes a first bore within said first body portion, said drug injection piston including a gas power piston movably received in said bore and having a ram portion extending into said drug injection cartridge to abut with a sealing member movably received therein, said body and gas-power piston cooperating to define a first variable-volume gas-power chamber in said first bore;

said hand piece assembly further including a second body portion adjustably engaging with said first body portion, said second body portion defining an elongate second bore in gas flow communication with said gas-power chamber and separated therefrom by a wall portion carried by said second body portion.

3. The device of claim 2 wherein said first body portion and said second body portion are threadably and adjustably engaged with one another, said wall portion of said second body portion defining said abutment member.

4. The device of claim 3 wherein said second body portion in said second bore further carries a cylindrical pressurized gas capsule, said cylindrical gas capsule providing said means for forcefully moving said drug injection piston.

5. A needle-less hypodermic jet injection device comprising:

a pre-filled drug injection cartridge including;

a medication cylinder having an outlet orifice,

an injection nozzle,

a flow path communicating the outlet orifice to said injection nozzle,

a plug member in a first position sealingly disposed in said flow path,

a drug-injection piston in a first position cooperating with said medication cylinder to define a variable-volume chamber of first selected size,

a dose of substantially incompressible liquid medication substantially filling said variable-volume chamber at said first size with substantially no ullage volume,

said drug-injection piston having a second position cooperating with said medication cylinder to define a variable-volume chamber of second selected size smaller than said first selected size, so that said incompressible liquid medication displaces said plug member from said first position of sealing disposition in said flow path to a second position of capture in said flow path, said medication cylinder and said plug member in said second position thereof cooperatively defining an open flow path between said variable-volume chamber and said injection nozzle;

a hand piece assembly having a body holding said drug injection cartridge, said hand piece assembly including means for forcefully moving said drug injection piston from said second position to a third position so as to reduce the volume of said variable-volume chamber substantially ejecting said dose of liquid medication via said injection nozzle;

said hand piece assembly further including a first body portion holding said drug injection cartridge, and an abutment member selectively movable into engagement with said drug injection piston to move said drug injection piston from said first position to said second position;

wherein said hand piece assembly further includes a first bore within said first body portion, said drug injection piston including a gas power piston movably received in said bore and having a ram portion extending into said drug injection cartridge to abut with a sealing member movably received therein, said body and gas-power piston cooperating to define a first variable-volume gas-power chamber in said first bore;

said hand piece assembly further including a second body portion adjustably engaging with said first body portion, said second body portion defining an elongate second bore in gas flow communication with said gas-power chamber and separated therefrom by a wall portion carried by said second body portion;

wherein said first body portion and said second body portion are threadably and adjustably engaged with one another, said wall portion of said second body portion defining said abutment member;

wherein said second body portion in said second bore further carries a cylindrical pressurized gas capsule, said cylindrical gas capsule providing said means for forcefully moving said drug injection piston;

wherein said pressurized gas capsule is axially movable in said second body portion, said second body portion carrying an end cap in axial alignment with said gas capsule, and said end cap including an elongate recoil buffer extending toward said gas capsule and effective upon recoil of said gas capsule incident to relief of pressurized gas therein to limit recoil motion of said gas capsule toward said end cap.

6. The device of claim 5 wherein said cylindrical gas capsule is filled with pressurized nitrogen gas.

7. The device of claim 6 wherein said handpiece assembly further includes a yieldable resistance means for yieldably resisting axial movement of said trigger sleeve toward said first body portion.

8. The device of claim 7 wherein said yieldable resistance means is configured to require an axial force applied to said trigger sleeve of from about three pounds to about 4 pounds in order to move said trigger sleeve forwardly.

9. The device of claim 5 wherein said second body portion of said hand piece assembly carries an axially movable tubular trigger sleeve, said trigger sleeve being selectively movable toward said first body portion to release pressurized gas from said gas capsule into communication with said gas power piston.

10. A needle-less hypodermic jet injection device comprising:

a pre-filled drug injection cartridge including;

a medication cylinder having an outlet orifice,

an injection nozzle,

a flow path communicating the outlet orifice to said injection nozzle,

a plug member in a first position sealingly disposed in said flow path,

a drug-injection piston in a first position cooperating with said medication cylinder to define a variable-volume chamber of first selected size,

a dose of substantially incompressible liquid medication substantially filling said variable-volume chamber at said first size with substantially no ullage volume,

said drug-injection piston having a second position cooperating with said medication cylinder to define a variable-volume chamber of second selected size smaller than said first selected size, so that said incompressible liquid medication displaces said plug member from said first position of sealing disposition in said flow path to a second position of capture in said flow path, said medication cylinder and said plug member in said second position thereof cooperatively defining an open flow path between said variable-volume chamber and said injection nozzle;

a hand piece assembly having a body holding said drug injection cartridge, said hand piece assembly including means for forcefully moving said drug injection piston from said second position to a third position so as to reduce the volume of said variable-volume chamber substantially ejecting said dose of liquid medication via said injection nozzle;

said hand piece assembly further including a first body portion holding said drug injection cartridge, and an abutment member selectively movable into engagement with said drug injection piston to move said drug injection piston from said first position to said second position;

wherein said hand piece assembly further includes a first bore within said first body portion, said drug injection piston including a gas power piston movably received in said bore and having a ram portion extending into said drug injection cartridge to abut with a sealing member movably received therein, said body and gas-power piston cooperating to define a first variable-volume gas-power chamber in said first bore;

said hand piece assembly further including a second body portion adjustably engaging with said first body portion, said second body portion defining an elongate second bore in gas flow communication with said gas-power chamber and separated therefrom by a wall portion carried by said second body portion;

wherein said first and second body portions are threadably engaged with one another, and one of said first and second body portions includes an axially extending protrusion, said one of said first and second body portions also including a helical end surface portion confronting the other of said first and second body portions, a trigger sleeve axially movably captured on said handpiece body, and one of said first and second body portions and said trigger sleeve defining a radially and axially extending key portion while the other of said first and second body portions and said trigger sleeve defines a radially and axially extending keyway, in a first relative position of said first and second body portions in which said drug injection piston is in said first position said key confronting said helical end surface to prevent movement of said trigger sleeve and also engaging said protrusion to allow only unidirectional relative rotation of said first and second body portions, said body portions being relatively rotatable on said threaded engagement with said key tracking said helical surface to align with and be receivable into said keyway in a second relative position of said first and second body portions and to simultaneously move said drug injection piston from said first to said second position by axial relative movement of said abutment member, in said second position of said first and second body portions said trigger sleeve being movable to receive said key into said keyway and to effect said means for forcefully moving said drug injection piston to effect ejection of said medication as a high velocity jet.

11. The device of claim 10 further including said helical end surface leading helically and circumferentially to a circumferentially disposed step on the other of said first and second body portions, whereby in said second relative position of said first and second body portions said key engages said step to align said key with said keyway and prevent further relative rotation of said first and second body portions.

12. The device of claim 10 wherein said plug member is configured as a ball member.

13. The device of claim 12 wherein said ball member is formed of polytetrafluoroethylene.