Multiple use needle-less hypodermic injection device for individual users

• US 5,782,802 A
• Filed: 01/30/1997
• Issued: 07/21/1998
• Est. Priority Date: 03/22/1996
• Status: Expired due to Term

• Current Assignee: Bioject Medical Technologies Inc. (Inovio Pharmaceuticals, Inc.)
• Original Assignee: Vitajet Corporation
• Inventors: Landau, Sergio
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US08/792,574
• Time in Patent Office: 537 Days
• Field of Search: 604/68, 604/72, 604/148, 604/218, 604/244, 604/415, 604/241, 604/242
• US Class Current: 604/68
• 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 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: A61M 5/3007 with specially designed jet passages at the injector's distal end

Abstract

A multiple use needle-less hypodermic injection device for individual users comprising of a light weight, pocket sized, spring powered unit, and a multiple use, low cost, easily replaceable thermoplastic injection head. The present invention targets the single-patient-self-injection applications, such as insulin users, when risks of cross contamination between different patients are not present, therefore not requiring the parts containing the medicament dose, or the parts in contact with the delivery of the medicament dose, to be necessarily disposed and replaced after each injection. The low cost plastic injection head is easily refilled by the user without dismounting from the spring powered unit, by means of an adaptor that can be attached to a standard medicament vial, or alternatively, by means of a custom made pre-filled vial which connects directly to said injection head, therefore allowing the low cost thermoplastic injection head to be refilled and used several times without necessarily having to be disposed or removed from the power unit after each injection.

Claims

1. For a needle-less injection device, a disposable injection head assembly comprising in combination:

a nozzle member having an elongate generally cylindrical tubular body formed of transparent polymer, said nozzle member including a stepped through bore having a main cylindrical bore portion leading toward an opening at a rear end thereof, and an outwardly tapering portion connecting between the main cylindrical bore portion and an opening of said through bore on the rear end of the nozzle member, which opening is of a diameter greater than said main cylindrical bore portion, adjacent to said rear end said nozzle member including means for releasably mounting to an injection power unit, and at a forward end thereof said nozzle member including a disc-like end wall closing said main bore portion except for a reduced-diameter portion of said through bore opening forwardly through said disc-like end wall and providing a forwardly-directed injection orifice via which liquid medicament is projected forwardly from said nozzle member, said through bore including a tapering counter bore portion extending between said main bore portion and said reduced-diameter through bore portion at said disc-like end wall;

a piston tip member having a forward face portion configured to be received into said counter bore portion of said through bore in conforming relationship thereto, a sealing member disposed rearwardly of said forward face portion sized to slidably and sealingly be received in said main bore portion, and a rearward extension defining means for removable attachment of said piston tip to a ram; and

a protective cap member defining a blind bore having an opening and receiving said piston tip with said forward face portion within said blind bore and with sealing engagement of said sealing member upon said cap member to provide environmental protection of said forward face portion in said blind bore, said rearward extension of said piston tip extending outwardly of said blind bore, and said protective cap member outwardly including means for allowing secure manual purchase thereon.

2. The disposable injection head assembly of claim 1 for a needle-less injection device, wherein said nozzle member further carries in said stepped through bore at said disc portion, a synthetic gem stone body having a through bore communicating at each end thereof with said stepped through bore of said nozzle member, and said through bore of said gem stone body defining said injection orifice.

3. The disposable injection head assembly of claim 2 for a needle-less injection device, wherein said gem stone body is formed as a disc having a pair of parallel opposite faces, and said through bore thereof extending through said disc between said pair of opposite faces.

4. A multiple use needle-less injection device comprising:

a housing having a front connector assembly including a forwardly disposed opening for receiving a nozzle member of said injection device, said connector assembly further having a pair of diametrically opposed slots extending axially through said opening and leading to a pair of axially spaced apart opposed circumferentially extending constraint surfaces, said forwardly disposed opening also including a pair of diametrically opposed rear slots at a rear of said connector assembly, a nozzle retainer member slidably received at a pair of outwardly extending arm parts thereof in said pair of rear slots, an outer extent of each of said pair of arms extending outwardly of said connector assembly to present a manually-actuated portion by which said nozzle retainer may be manually moved axially, a central portion of said nozzle retainer presenting a pair of protrusions extending axially toward and aligning generally with said opening of said connector assembly, each of said pair of protrusions on one circumferential side thereof defining a sloping ramp surface leading circumferentially to a cusp and to an axially extending abutment surface, and a resilient member urging said nozzle retainer member axially forwardly toward said opening of said connector assembly;

whereby, insertion of a nozzle member having a generally cylindrical body received into said forwardly disposed opening and a pair of radially extending tabs passing along said slots to engage said cusps of said nozzle retainer to move said nozzle retainer axially allowing said tabs to pass axially between said pair of opposed constraint surfaces, relative rotation of said nozzle member causing said tabs to pass circumferentially past said cusp so that said axially extending surfaces of said pair of protrusions engage said pair of tabs and prevent opposite rotation of said nozzle member, and manual axial movement of said nozzle retainer disengaging said axially extending surfaces thereof from said tabs and allowing opposite relative rotation of said nozzle member to align said pair of tabs with said slots and subsequent axial withdrawal of said nozzle member from said opening.

5. A multiple use needle-less hypodermic injection device comprising:

a housing containing a movable ram reciprocable axially along its longitudinal axis, an energy accumulator in said housing and driving said ram forcefully forward, said housing having a connector assembly for receiving an injection nozzle member defining a bore aligned with said movable ram, and a piston tip receivable upon said movable ram for reciprocation within said bore of said nozzle member, said nozzle member having an elongate body formed of transparent polymer material disposed outwardly of said housing, and said bore of said nozzle member extending therethrough along said body to terminate distally generally at an injection orifice, said piston tip in a forward position being disposed adjacent to an end wall of said nozzle member, which end wall carries said injection orifice, and in a second position of maximum spacing from said end wall on said movable ram said piston tip both cooperating with said nozzle body and end wall thereof to define a variable-volume injection chamber for measuring a dose of medicament and defining the most-proximal extent of said injection chamber, said injection chamber being disposed entirely outside of said housing within said nozzle member, whereby said transparent material of said nozzle body allows a user of said injection device to see the entire extent of said injection chamber and medicament therein prior to injection.

6. A nozzle member for a needle-less injection device of the type which confines a quantity of liquid medicament in a chamber cooperatively formed by a piston within a cylinder, and pressurizes this confined liquid medicament by forceful rapid movement of the piston within the cylinder to force the liquid medicament through a fine-dimension injection orifice in the form of a very high speed liquid jet directed toward a recipient thereof and sufficient in velocity and formation to penetrate without confinement of the liquid jet subcutaneously into human skin, said nozzle member comprising:

a nozzle body formed as an elongate cylindrical tubular member having a cylindrical portion forming a cylindrical bore portion for sealing receipt of the piston and cooperating therewith to bound a chamber for receiving the liquid medicament, said nozzle body including an end wall closing one end of said cylindrical bore except for a fine-dimension injection orifice extending therethrough and opening outwardly on said end wall, said end wall including a stepped through bore communicating between said cylindrical bore and ambient outwardly of said end wall, said stepped through bore having a shoulder disposed toward said cylindrical bore portion; and

a disc-like orifice member disposed within said stepped through bore and having a pair of opposite parallel faces one of which is seated on said shoulder and the other of which faces said cylindrical bore, said disc-like orifice member a defining a fine-dimension through bore extending between said pair of opposite parallel faces and defining said fine-dimension injection orifice, said orifice member being formed of synthetic gem stone and said fine-dimension through bore being thermal-formed therein.

7. A multiple use needle-less hypodermic injection device comprising:

a main housing containing a movable ram which may be displaced within a predetermined maximum stroke along its longitudinal axis, said main housing having control means on its outside surface to allow a user to move said movable ram back and forth, or to place said movable ram precisely at any position within said maximum stroke, said main housing also having means to allow a user to energize an energy accumulator contained inside said main housing, said main housing also having means to allow a user to activate or suddenly release energy from said energy accumulator, causing said movable ram to move at high speed from a rear position within said maximum stroke to a fixed forward released position;

an injection head containing a piston tip and a generally cylindrical nozzle, said piston tip having means to be securely attached to and detached from the front end of said movable ram, said nozzle having means to be securely attached to and detached from the front end of said main housing, said piston tip having a single use disposable protective cap which allows a user to securely attached said piston tip onto the front end of said movable ram without having to touch said piston tip and to remove the protective cap, said nozzle having a cylindrical inner bore wherein said piston tip, once attached to said movable ram, may slide back and forth respectively pulled back or impelled forward by said movable ram as it moves along its longitudinal axis, said piston tip having a sealing element which seals tight to said nozzle inner bore as it slides in either axial direction along said inner bore, said nozzle having a counterbore leading from said inner bore to a fine-dimension injection orifice, said nozzle also having means to be connected in fluid flow relation to a vial containing liquid medicament so that the injection orifice and counterbore may be use to aspirate medicament into said nozzle inner bore from the vial.

8. The multiple use needle-less injection device of claim 7 wherein said energy accumulator includes a compression spring.

9. The multiple use needle-less injection device of claim 7 wherein said means for securing said piston tip from said movable ram includes said piston tip defining a bore with a rear opening and plural longitudinal slots located at the rear end of said piston tip, said slots allowing the rear opening of said piston tip to flex outwardly to allow the piston tip to be pushed over a conical tip defined on a forward end of said movable ram.

10. The multiple use needle-less injection device of claim 7 wherein said means secure said nozzle to said main housing includes a nozzle retainer movable within said main housing, said nozzle retainer having a pair of opposed projections extending from the outer surface of said main housing and that may be manually engaged and axially moved by a user.

11. The multiple use needle-less injection device of claim 7 wherein said nozzle includes means for locking within said main housing in response to axially applied forward urging thereof, and said nozzle retainer when securing said nozzle to said main housing applies constant forwardly directed axial force against said nozzle maintaining said nozzle locked inside said main housing.

12. The multiple use needle-less injection device of claim 11 further including a coil compression spring pushing forwardly said nozzle retainer.

13. The multiple use needle-less injection device of claim 7 further including means to removably attach said nozzle to a medicament vial, said means for removably attaching to said vial including:

said nozzle having plural protruding tabs at a forward end thereof; and

a vial head including plural tabs protruding toward said nozzle, and plural side openings on the circumference of the vial head, said side openings including two or more flexible arms circumscribing and locking on said protruding tabs of said nozzle as said medicament vial head is engaged and twisted over the said nozzle.

14. A multiple use needle-less hypodermic injection device for injecting liquid medicament subcutaneously of human skin in a high velocity unconstrained liquid jet;

said injection device comprising;

a housing containing a movable ram reciprocable axially along its longitudinal axis, an energy accumulator in said housing and when released driving said ram forcefully forward, said housing having a discharge mechanism both for storing energy in said energy accumulator in response to manual manipulation of said housing when cocked, and for releasing said accumulator mechanism to effect a medicament injection when triggered;

said discharge mechanism including an axially movable discharge shaft forward axial movement of which effects release of said accumulator mechanism, said discharge shaft having a crowned end surface, a trigger mechanism in juxtaposition with said end surface of said discharge shaft and including a first ball member axially spaced from and aligned with said crowned surface, a second ball member carried in a laterally movable member having a portion extending outwardly of said housing to define a trigger push button, said second ball member having a diameter larger than a certain axial spacing between said crowned surface and said first ball member when said discharge mechanism is cocked, and lateral manual movement of said push button to trigger said discharge mechanism forcing said second ball member in rolling contact between said crowned surface and said first ball member to move said discharge shaft axially and trigger said discharge mechanism.

15. A disposable medicament vial especially configured for tamper resistance and for sealing interface with a needle-less injection device, said vial comprising:

an ampule having a body defining a chamber therein and an opening from said chamber with an outwardly extending rim circumscribing said opening;

a polymer stopper received into said opening and closing said chamber, said stopper having an outwardly extending flange portion overlying said rim of said ampule and a penetrable septum portion centrally located thereof;

a molded polymer head received on said stopper, said head including a base portion with an outwardly extending rim seated upon said flange portion of said stopper and in axial congruent juxtaposition to said rim of said ampule, said base portion carrying a medicament inlet needle penetrating said penetrable septum of said stopper and opening at a beveled end thereof into said chamber;

said base portion outwardly carrying an elastomeric disc having a center hole with which an opposite end of said inlet needle communicates;

said base portion outwardly including means for securing to a nozzle of a needle-less injection device so as to communicate an injection orifice of the device with the center hole of the elastomeric disc to aspirate medicament from said ampule into the injection device via said inlet needle;

said head further including a tamper resistant frangible plastic cap received over said means for securing said base portion to an injection device and obstructing access to said elastomeric disc, said cap also having a respective outwardly extending rim circumscribing said base portion and in axial congruent juxtaposition to both said rim of said base portion and said rim of said ampule, said cap having frangible means for separating a distal portion of said cap from said rim thereof, and

a malleable metal band circumscribing both said ampule, said stopper, said base portion, and said cap at each said rim, said band being crimped into permanent engagement with each rim of said ampule and of said cap, capturing said rim of said base portion and said flange of said stopper therebetween.