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

• US 20010004681A1
• Filed: 02/05/2001
• Published: 06/21/2001
• Est. Priority Date: 11/18/1998
• Status: Active Grant

• Current Assignee: Bioject Incorporated
• Original Assignee: Bioject Incorporated
• Inventors: Landau, Sergio
• Granted Patent: US 6,689,093 B2
• Time in Patent Office: Days
• US Class Current: 604/70
• 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 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;

a hand piece assembly having a body holding said drug injection cartridge, said hand piece assembly including a source of pressurized gas, and means for selectively applying force from said pressurized gas to said drug injection piston to move said drug injection piston from said second position to a third position substantially ejecting said dose of liquid medication via said injection nozzle;

said hand piece assembly 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, a gas power piston movably received in said bore and having a ram portion extending into said drug injection cartridge to abut with said drug-injection piston, 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 first bore gas-power chamber and separated therefrom by a wall portion carried by said second body portion;

wherein said second body portion in said second bore further carries a cylindrical gas capsule, said cylindrical gas capsule providing said source of pressurized gas and being movably receiving said second bore, said second body portion carrying an end cap having an axially extending recoil abutment member extending toward said gas pressure capsule and effective upon recoil of said gas pressure capsule toward said end cap to limit axial motion of said gas pressure capsule toward said end cap.

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

a pre-filled drug injection cartridge including;

a medication cylinder having an outlet orifice, a plug member sealingly closing the outlet orifice, an injection nozzle, a flow path communicating the outlet orifice to said injection nozzle, 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 sufficiently smaller than said first selected size that said plug member is hydraulically forced from said outlet orifice;

a hand piece assembly having a two-piece body having a first body portion holding said drug injection cartridge, and a second body portion providing an abutment movable relative to said first body portion to move said drug injection piston between said first and second positions;

a source of pressurized gas including a hermetically sealed metallic gas capsule;

trigger means for selectively penetrating said gas capsule and for applying force from said pressurized gas to said drug injection piston to move said drug injection piston from said second position to a third position substantially ejecting said dose of liquid medication via said injection nozzle;

wherein said first body portion defines a first bore, a gas-power piston movably received in said first bore, said gas-power piston having a piston head and a ram portion extending into said drug injection cartridge to abut with said drug-injection piston, said first body portion and said gas-power piston cooperating to define a first variable-volume gas-power chamber in said first bore;

said second body portion sealingly and movably engaging with said first body portion to bound said gas-power chamber, said second body portion defining an elongate second bore in gas flow communication with said gas-power chamber, and said gas capsule being received into said second bore;

wherein said gas capsule is movable axially within said second body portion, and said second body portion carries an end cap axially aligned with axial movement of said gas capsule, said end cap carrying an elongate recoil buffer portion extending toward said end cap and effective upon recoil of said gas pressure capsule toward said end cap to limit axial motion of said gas pressure capsule.

3. 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.

4. The device of

claim 3

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.

5. The device of

claim 4

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.

6. The device of

claim 5

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.

7. The device of

claim 6

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.

8. The device of

claim 7

wherein said cylindrical gas capsule is filled with pressurized nitrogen gas.

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. The device of

claim 4

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 3

wherein said plug member is configured as a ball member.

13. The device of

claim 12

wherein said ball member is formed of polytetrafluoroethylene.

14. The device of

claim 8

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

15. The device of

claim 14

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.

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

a drug-injection piston movable from a first to a second position, said drug-injection piston being cooperable with a drug injection cartridge defining a medication cylinder of selected volume to forcefully reduce the volume of said medication cylinder so that a substantially incompressible liquid medication is displaced as a high velocity injection jet;

said drug injection piston being reciprocally held by a hand piece assembly having a body with means for forcefully moving said drug injection piston selectively from said first to said second position;

said hand piece body including first and second body portions threadably engaged with one another, and one of said first and second body portions includes an axially extending protrusion confronting the other of said first and second body portions, said one of said first and second body portions also including a helical end surface portion extending circumferentially from said protrusion and also confronting the other of said first and second body portions, a trigger member axially movable 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 said key confronting said helical end surface to prevent movement of said trigger member 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, in said second relative position of said first and second body portions said trigger member 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.

17. The device of

claim 16

, 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.

18. The device of

claim 17

wherein said first body portion and said second body portion are threadably and adjustably engaged with one another, said second body portion including a wall portion providing an abutment member relatively moving said ram portion in response to relative rotation of said body portions from said first to said second relative position so as to effect an initial determined contraction of the volume of said medication cylinder.

19. The device of

claim 16

wherein said means for forcefully moving said drug injection piston selectively from said first to said second position includes said second body portion defining a second bore receiving a cylindrical pressurized gas capsule, said cylindrical gas capsule providing pressurized gas communication to said gas power chamber for forcefully moving said drug injection piston.

20. The device of

claim 19

wherein said cylindrical gas capsule is filled with pressurized nitrogen.

21. The device of

claim 19

wherein said gas capsule is movable in said second body portion, said gas capsule being able to recoil incident to release of pressurized gas therein, and said second body portion including a recoil buffer member extending axially toward said gas capsule and effective upon recoil of the gas capsule to limit recoil motion of the gas capsule.

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

a hand piece assembly having a body for holding a drug injection cartridge, said hand piece assembly including an energy source for selectively and forcefully ejecting liquid medication from within said drug injection cartridge as a high velocity injection jet;

said hand piece assembly including a first body portion, and a second body portion rotational relative to one another;

one of said first body portion and said second body portion defining a detent finger having a radial projection disposed proximate to a distal end thereof, and the other of said first and second body portions including a radially outer surface across which said distal end sweeps in response to relative rotation of said body portions;

in a first relative position of said body portions, a projection from said detent finger being received into a recess defined on said radially outer surface, and in response to relative rotation of said body portions, said detent finger distal end sweeping across said radially outer surface to drop radially into a second recess on said surface, whereby the dropping of said distal end portion into said second recess provides both a visual and an auditory indication of said body portions being in said second relative position.

23. The device of

claim 22

wherein said second recess is configured as an axially elongate groove on said radially outer surface.

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

a hand piece assembly having a body for holding a drug injection cartridge, said hand piece assembly including an energy source for selectively and forcefully ejecting liquid medication forwardly from within said drug injection cartridge as a high velocity injection jet;

said hand piece assembly including a first body portion, and a second body portion rotational relative to one another;

a forward one of said first body portion and said second body portion defining a radially outer axially extending surface for providing manual purchase upon said device, said surface including surface roughening for improving manual purchase;

a rearward one of said first body portion and said second body portion defining a radially outer surface having a pair of diametrically opposite radially extending plateaus each provided with surface roughening for improving manual purchase, particularly of opposed index and thumb fingers.

25. For use in a single-use needle-less hypodermic injector having a gas capsule for impaling upon a penetrator member to release pressurized gas from within said gas capsule, a hammer assembly for effecting axial driving of said gas capsule onto said penetrator, said hammer assembly comprising:

a ring-like sear carrier member,

a plurality of sear struts integral with said sear carrier member; and

a corresponding plurality of integral frangible hinge sections each connecting a respective one of said plurality of sear struts with said sear carrier member.

26. The hammer assembly of

claim 25

further including a hammer member having an axial surface for impact with said gas capsule, and a respective plurality of sear pockets located axially behind said axial surface a determined dimension.

27. The hammer assembly of

claim 26

wherein each of said plurality of sear struts extends axially toward said hammer member an axial distance which is less than said determined dimension, whereby when said hammer member is forced into engagement at said sear pockets with said plurality of sear struts, said frangible hinge sections are fractured, separating said sear struts from said sear carrier member.