Durable needle-less jet injector apparatus and method

• US 6,648,850 B2
• Filed: 06/08/2001
• Issued: 11/18/2003
• Est. Priority Date: 06/08/2001
• Status: Expired due to Fees

• Current Assignee: Bioject Incorporated
• Original Assignee: Bioject Incorporated
• Inventors: Landau, Sergio
• Primary Examiner(s): Huson, Gregory L.
• Assistant Examiner(s): WIEKER, AMANDA FLYNN
• Application Number:
  US09/877,911
• Publication Number:
  US 20020188249A1
• Time in Patent Office: 893 Days
• Field of Search: 604/68-72, 604/136, 604/140-145, 604/181-187, 604/207-211, 604/246
• 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 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• 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 5/31553 without axial movement of dose setting member
• CPC Class Codes: A61M 5/31556 Accuracy improving means

Abstract

A gas-powered, durable, needle-less hypodermic jet injection device (10, 110) includes a hand-held injector (12, 112) 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 (28) which is opened in preparation to effecting a jet injection, and which powers the jet injection, but from which pressurized gas is not allowed to flow in volume until a user of the device shifts a valving spool (24).

Claims

1. A jet injection device comprising:

a device body having a forward end;

an injection cylinder carried at the forward end of said device body and having a cylinder bore in which an injection piston is movable to cooperatively define a variable-volume chamber for holding a dose of liquid medication;

a fine-dimension injection orifice in liquid flow communication with said variable-volume chamber to receive liquid medication and discharge this medication as a high velocity forceful jet for jet injection of medication upon forceful movement of said injection piston in said cylinder;

a power source in said device body for forcefully moving said piston in said cylinder in response to communication of gas pressure to a gas pressure piston, a source of gas pressure; and

a trigger assembly for effecting communication of pressurized gas from said source to said gas pressure piston, said trigger assembly including a stem member with a pair of apertures spaced axially apart, and a pair of axially spaced apart seal elements movable along said stem from a first position in which said seal elements bracket only a single one of said axially spaced apart apertures,

said trigger assembly being manually movable axially to a second position in which said pair of seal elements bracket both of said pair of axially spaced apertures to communicate pressurized gas from one of said pair of apertures to the other of said pair of apertures and to said gas pressure piston.

2. The jet injection device of claim 1 wherein said trigger assembly further includes a trigger sleeve movable axially along said stem.

3. The jet injection device of claim 2 wherein said trigger sleeve carries said pair of seal elements in axially spaced apart relation, said trigger sleeve further cooperating with said stem member and with said pair of seal members to define an axially and radially extending annular chamber about said stem and between said pair of seal members.

4. The jet injection device of claim 3 wherein said stem member further defines a pair of axially extending bores aligned with one another and extending from opposite ends of said stem member toward but short of one another to not communicate internally of said stem member with one another, and wherein said pair of apertures comprises at least one cross bore extending outwardly from each of said pair of axially extending bores to open outwardly on an outer surface of said stem member.

5. The jet injection device of claim 3 wherein said source of pressurized gas includes a gas pressure cartridge with a penetrable diaphragm portion, and said jet injection device includes a penetrator member, and means for impaling said gas pressure cartridge at said diaphragm portion thereof upon said penetrator member to release pressurized gas from within said gas pressure cartridge, and to communicate this pressurized gas to said annular chamber.

6. The jet injection device of claim 1 wherein said gas pressure piston abuts against a movable ram member, said ram member including an elongate gear rack section formed along a side thereof, and a thumb wheel rotationally carried by said injector body and including a pinion gear drivingly engaged with said ram member gear rack section, whereby a user of said injection device may retract said injection piston to draw liquid medication into said injection cylinder by manual rotation of said thumb wheel preparatory to effecting a jet injection with said device.

7. The jet injection device of claim 6 wherein said ram carries a measurement indicating means for indicating to a user of said device the volume of liquid medication within said injection cylinder.

8. The jet injection device of claim 7 wherein said measurement indicating means includes said ram member carrying a pointer moving axially of said device in response to movement of said ram member, and a measurement scale carried on said device body and along which said pointer moves.

9. The jet injection device of claim 7 wherein said measurement indicating means includes said ram member carrying a binary scale moving along with said ram member, and means for responding to axial movement of said binary scale to indicate the volume of liquid medication in said injection cylinder, and to indicate digitally to a user of said device said volume of liquid medication.

10. The jet injection device of claim 7 wherein said measurement indicating means includes electronic means for responding to axial movement of said ram member, and for indicating digitally to a user of said device said volume of liquid medication in said injection cylinder.

11. A method of providing a jet injection device, said method comprising steps of:

providing a device body having a forward end;

providing an injection cylinder, and carrying said injection cylinder at a forward end of said device body, providing said injection cylinder with a cylinder bore in which an injection piston is movable to cooperatively define a variable-volume chamber for holding a dose of liquid medication;

providing a fine-dimension injection orifice in liquid flow communication with said variable-volume chamber to receive liquid medication, and discharging the liquid medication as a high velocity forceful jet for jet injection of medication upon forceful movement of said injection piston in said cylinder;

providing a power source in said device body for forcefully moving said piston in said cylinder in response to communication of gas pressure to a gas pressure piston,

providing a source of gas pressure; and

providing a trigger assembly for effecting communication of pressurized gas from said source to said gas pressure piston, configuring said trigger assembly to include a stem member with a pair of apertures spaced axially apart, and providing a pair of axially spaced apart seal elements movable along said stem from a first position in which said seal elements bracket only a single one of said axially spaced apart apertures,

providing for said trigger assembly to be manually movable axially to a second position in which said pair of seal elements bracket both of said pair of axially spaced apertures to communicate pressurized gas from one of said pair of apertures to the other of said pair of apertures and to said gas pressure piston.

12. The method of claim 11 further including the step of providing said trigger assembly to further include a trigger sleeve movable axially along said stem.

13. The method of claim 12 further including the step of configuring said trigger sleeve to carry said pair of seal members in axially spaced apart relation, and utilizing said trigger sleeve to cooperate with said stem member and with said pair of seal elements to define an axially and radially extending annular chamber about said stem and between said pair of seal elements.

14. The method of claim 13 further including utilizing said stem member to define a pair of axially extending bores aligned with one another and extending from opposite ends of said stem member toward but short of one another to not communicate internally of said stem member with one another, and wherein said pair of apertures comprises at least one cross bore extending outwardly from each of said pair of axially extending bores to open outwardly on an outer surface of said stem member.

15. The method of claim 13 further including the step of including in said source of pressurized gas a gas pressure cartridge, and providing said gas pressure cartridge with a penetrable diaphragm portion, and providing said jet injection device with a penetrator member, providing said jet injection device further with means for impaling said gas pressure cartridge at said diaphragm portion thereof upon said penetrator member, and utilizing said impaling of said gas pressure cartridge to release pressurized gas from within said gas pressure cartridge and to communicate this pressurized gas to said annular chamber.

16. The method of claim 11 further including the steps of abutting said gas pressure piston against a movable ram member, and including on said ram member an elongate gear rack section formed along a side thereof, providing a thumb wheel rotationally carried by said injector body, and including with said thumb wheel a pinion gear drivingly engaged with said ram member gear rack section, and utilizing manual rotation of said thumb wheel to retract said injection piston to draw liquid medication into said injection cylinder preparatory to effecting a jet injection with said device.

17. The method of claim 16 further including the steps of carrying on said ram a measurement indicating means for indicating to a user of said device the volume of liquid medication within said injection cylinder.

18. The method of claim 17 further including the steps of carrying on said ram member a pointer moving axially of said device in response to movement of said ram member, and carrying on said device body a measurement scale along which said pointer moves.

19. The method of claim 17 wherein said measurement indicating means includes carrying on said ram member a binary scale moving along with said ram member, and also including means for responding to axial movement of said binary scale to indicate the volume of liquid medication in said injection cylinder so as to indicate digitally to a user of said device said volume of liquid medication.

20. A method of operating a jet injection device, said method comprising steps of:

providing a device body having a forward end;

providing an injection cylinder, and carrying said injection cylinder at a forward end of said device body, providing said injection cylinder with a cylinder bore in which an injection piston is movable to cooperatively define a variable-volume chamber for holding a dose of liquid medication;

providing a fine-dimension injection orifice in liquid flow communication with said variable-volume chamber to receive liquid medication, and discharging the liquid medication as a high velocity forceful jet for jet injection of medication upon forceful movement of said injection piston in said cylinder;

providing a power source in said device body for forcefully moving said piston in said cylinder in response to communication of gas pressure to a gas pressure piston,

providing a source of gas pressure; and

providing a stem member with a pair of axially extending bores extending from opposite ends of said stem member toward but short of one another, and a pair of apertures spaced axially apart and communicating respectively with one of said pair of bores,

providing an axially spaced apart pair of seal elements slidably movable along said stem member between a first position in which said pair of seal elements bracket only a single one of said pair of apertures, and a second position in which said pair of seal elements bracket both of said pair of apertures;

utilizing said pair of seal elements and a trigger sleeve carrying this pair of seal elements for axial movement along said stem member between said first and said second positions to cooperatively define an axially and radially extending annular chamber about said stem member at said apertures; and

moving said trigger sleeve from a first of said first and second positions to a second of said positions to communicate pressurized gas from said source along one of said axially extending bores, radially outwardly from said one axially extending bore to said annular chamber via one of said pair of apertures, along said annular chamber between said pair of seal elements, radially inwardly via the other of said pair of apertures from said annular chamber to the other of said axially extending bores, and along said other axially extending bore to said gas pressure piston.

21. The method of claim 20 further including the step of including in said source of pressurized gas a gas pressure cartridge, and providing said gas pressure cartridge with a penetrable diaphragm portion, and providing said jet injection device with a penetrator member, providing said jet injection device further with means for impaling said gas pressure cartridge at said diaphragm portion thereof upon said penetrator member, and utilizing said impaling of said gas pressure cartridge to release pressurized gas from within said gas pressure cartridge and to communicate this pressurized gas to said annular chamber.

22. The method of claim 20 further including the steps of abutting said gas pressure piston against a movable ram member, and including on said ram member an elongate gear rack section formed along a side thereof, providing a thumb wheel rotationally carried by said injector body, and including with said thumb wheel a pinion gear drivingly engaged with said ram member gear rack section, and utilizing manual rotation of said thumb wheel to retract said injection piston to draw liquid medication into said injection cylinder preparatory to effecting a jet injection with said device.

23. The method of claim 22 further including the steps of carrying on said ram a measurement indicating means for indicating to a user of said device the volume of liquid medication within said injection cylinder.

24. The method of claim 23 further including the steps of carrying on said ram member a pointer moving axially of said device in response to movement of said ram member, and carrying on said device body a measurement scale along which said pointer moves.

25. The method of claim 23 wherein said measurement indicating means includes carrying on said ram member a binary scale moving along with said ram member, and also including means for responding to axial movement of said binary scale to indicate the volume of liquid medication in said injection cylinder so as to indicate digitally to a user of said device said volume of liquid medication.

26. A durable, refillable, needle-less let injection device comprising:

a re-fillable drug injection cartridge including;

a medication cylinder, an injection nozzle communication with said medication limier a drug-injection piston in a first position cooperating with said medication cylinder to define a variable-volume chamber of first selected size for receiving 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 recess thereon facing an open end of said medication cylinder, and said drug injection piston including means for removably retaining engagement thereof onto an injection ram, said drug injection cartridge at a forward end thereof including means for releasable coupling in sealing relation with a medication vial, and said drug injection cartridge at an aft end thereof including latching means for releasable engaging with a body of said device;

a hand piece body of said device, said body having a generally cylindrical elongate shape with an axially disposed opening at one end for receiving said drug injection cartridge, and a latching member movable between a first position in which said latching means of said medication cylinder is engaged to removably retain said medication cylinder at said body recess;

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

penetrating means for penetrating said sealed gas capsule to release pressurized gas therefrom, and

trigger means for selectively controlling flow of said pressurized gas from said gas capsule to a gas pressure piston and for controlling a application of force from said pressurized gas to said gas pressure piston and drug injection piston to move said drug injection piston from said first position to a second position in which said variable volume chamber is substantially reduced in volume, and said liquid medication is forcefully expelled from said chamber via said injection orifice to form a high-velocity injection jet, wherein said trigger means includes a trigger sleeve, a stem, and a pair of sealing members movable axially along said stem in response to axial movement of said trigger sleeve.

27. The jet injection device of claim 26 wherein said trigger sleeve carries said pair of seal members in axially spaced apart relation, said trigger sleeve further cooperating with said stem member and with said pair of seal members to define an axially and radially extending annular chamber about said stem and between said pair of seal members.

28. The jet injection device of claim 26 wherein said stem member further defines a pair of axially extending bores aligned with one another and extending from opposite ends of said stem member toward but short of one another to not communicate internally of said stem member with one another, said stem member also defining at least one cross bore extending outwardly from each of said pair of axially extending bores to open outwardly on an outer surface of said stem member.

29. The jet injection device of claim 28 wherein said gas pressure piston abuts against a movable ram member, said ram member including an elongate gear rack section formed along a side thereof, and a thumb wheel rotationally carried by said body and including a pinion gear drivingly engaged with said ram member gear rack section, whereby a user of said injection device may retract said injection piston to draw liquid medication into said injection cylinder by manual rotation of said thumb wheel preparatory to effecting a jet injection with said device.

30. The jet injection device of claim 29 wherein said ram carries a measurement indicating means for indicating to a user of said device the volume of liquid medication within said injection cylinder.

31. The jet injection device of claim 30 wherein said measurement indicating means includes said ram member carrying a pointer moving axially of said device in response to movement of said ram member, and a measurement scale carried on said device body and along which said pointer moves.

32. The jet injection device of claim 30 wherein said measurement indicating means includes said ram member carrying a binary scale moving along with said ram member, and means for responding to axial movement of said binary scale to indicate the volume of liquid medication in said injection cylinder, and to indicate digitally to a user of said device said volume of liquid medication.