Two-stage fluid medicament jet injector

• US 5,911,703 A
• Filed: 05/22/1997
• Issued: 06/15/1999
• Est. Priority Date: 05/22/1997
• Status: Expired due to Fees

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Avant Drug Delivery Systems, Inc.
• Inventors: Slate, John B., Burk, Michael W., Gorton, Lanny A.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Hayes, Michael J.
• Application Number:
  US08/861,968
• Time in Patent Office: 754 Days
• Field of Search: 604/68-72, 604/131-136
• 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 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means

Abstract

A jet injector, and a method, for injecting fluid medicament into a patient in a two-stage process. During the first stage fluid is expelled from the injector under relatively high pressure, to create a hole through the skin of the patient. During the second stage, fluid is infused through the hole into the patient at a much lower pressure, and for a much longer period of time. The jet injector includes a syringe unit, and a drive mechanism which is selectively connectable with the syringe unit. Specifically, the drive mechanism includes two springs which are positioned to urge against a push rod as they elongate. When the drive mechanism is engaged with the syringe unit, the push rod is positioned longitudinally co-linear with a plunger in the chamber. When the springs are released, they push the push rod which, in turn, pushes the plunger, causing the fluid to be expelled through an injection tube connected to the chamber. The syringe unit also includes a suction compartment for pulling the skin against a syringe tip at the end of the injection tube. To prepare the injector, the chamber of the syringe unit is filled with a fluid medicament, the drive mechanism is cocked, and the syringe unit is engaged with the drive mechanism. A vacuum source is then connected in fluid communication with the suction compartment. The syringe tip and the opening to the suction compartment are then pressed against the skin, and the injector is activated.

Claims

1. An apparatus for injecting a fluid medicament through a skin area into a patient, which comprises:

a chamber for containing the fluid medicament, said chamber having an aperture;

a drive mechanism for selectively exerting forces on the fluid in said chamber to sequentially expel the fluid through said aperture in two stages, said stages being an impulse stage characterized by a first force on the fluid wherein fluid punctures the skin area of the patient to create a hole through the skin, and a perfusion stage characterized by a second force on the fluid wherein fluid is injected into the patient through the hole, said second force being less than said first force;

an injection tube formed with a lumen and having a first end and a second end, said first end of said injection tube being attached to said chamber to extend said injection tube therefrom with said lumen in fluid communication with said chamber through said aperture;

a skirt attached to said chamber and extending therefrom to surround said injection tube and establish a suction compartment therebetween, said skirt being distanced from said second end of said injection tube to establish an opening into said suction compartment; and

a vacuum source in fluid communication with said suction compartment for creating a subcutaneous pocket in said suction compartment for infusion of said fluid medicament.

2. An apparatus as recited in claim 1 wherein said impulse stage has a duration of less than about 0.005 second, and wherein said perfusion stage has a duration of at least about 2 seconds.

3. An apparatus as recited in claim 1 wherein said apparatus includes a syringe unit comprising said chamber, said injection tube and said skirt, and wherein said syringe unit further comprises a plunger mounted on said chamber for movement into said chamber to expel fluid therefrom.

4. An apparatus as recited in claim 1 wherein said second end of said injection tube is formed with an orifice, the cross sectional area of said orifice being less than the cross sectional area of said lumen, to increase the velocity of the fluid when the fluid is expelled through the orifice.

5. An apparatus as recited in claim 4 wherein said orifice is generally circular with a diameter of about 0.008 inches.

6. An apparatus as recited in claim 4 wherein said second end of said injection tube is formed with a syringe tip around said orifice, said syringe tip being tapered to generally form a point around said orifice, to facilitate creating a seal between the skin area and said orifice.

7. An apparatus as recited in claim 1 wherein said drive mechanism comprises:

a housing;

a push rod slidably disposed on said housing;

an impulse spring disposed on said housing for accelerating said push rod; and

a perfusion spring disposed on said housing for moving said push rod.

8. An apparatus as recited in claim 7 wherein said impulse spring and said perfusion spring are mounted coaxially.

9. An apparatus as recited in claim 3 wherein said drive mechanism comprises:

a housing;

a push rod slidably disposed on said housing;

an impulse spring disposed on said housing for accelerating said push rod; and

a perfusion spring disposed on said housing for moving said push rod,

and wherein said syringe unit is engageable with said drive mechanism to position said push rod longitudinally co-linear with said plunger, for said push rod to push said plunger to cause the fluid to be expelled from said aperture of said chamber.

10. An apparatus as recited in claim 9 wherein said impulse stage has a beginning and wherein said push rod collides with said plunger at said beginning of said impulse stage, and wherein said push rod urges against said plunger during said perfusion stage.

11. An apparatus as recited in claim 7 further comprising:

a latch mounted on said housing for holding said push rod with said impulse spring in a compressed configuration and with said perfusion spring in a compressed configuration; and

a trigger mounted on said housing for releasing said push rod from said latch to allow said push rod to be moved by said impulse spring and said perfusion spring.

12. An apparatus for injecting a fluid medicament through a skin area into a patient, which comprises:

a chamber for containing the fluid, said chamber having an aperture;

a plunger mounted on said chamber for movement into said chamber to expel the fluid through said aperture;

actuator means for exerting forces on said plunger to expel the fluid from said chamber through said aperture and to sequentially puncture the skin area of the patient to create a hole therethrough and to cause the fluid to infuse into the patient through the hole;

a suction compartment attached to said chamber, said suction compartment having an opening surrounding said aperture, said suction compartment having a suction port; and

a vacuum source attachable in fluid communication with said suction port for establishing a partial vacuum in said suction compartment, to pull the skin area against said aperture and into said suction compartment to create a subcutaneous pocket for infusion of said fluid medicament.

13. An apparatus as recited in claim 12 wherein said actuator means is a drive mechanism comprising:

a housing;

a push rod slidably disposed on said housing;

an impulse spring disposed on said housing for accelerating said push rod, said accelerated push rod colliding with said plunger and pushing said plunger with a first force to expel the fluid from said chamber through said aperture to create said hole through the skin area; and

a perfusion spring disposed on said housing for pushing said plunger with a second force, said second force causing the fluid to be expelled from said chamber through said aperture to infuse into the patient through said hole in the skin area.

14. An apparatus as recited in claim 13 wherein said first force is greater than said second force, and wherein the duration of said first force is less than about 0.005 second, and wherein the duration of said second force is at least about 2 seconds.

15. A method for injecting a fluid medicament through a skin area into a patient, which comprises the steps of:

providing a syringe unit, said syringe unit being formed with a chamber having an aperture, said chamber for containing the fluid and wherein said syringe unit further comprises a suction compartment having an opening surrounding said aperture, and wherein said suction compartment is formed with a suction port;

providing a drive mechanism for selectively exerting forces on the fluid in said chamber to sequentially expel the fluid through said aperture in two stages, said stages being an impulse stage characterized by a first force wherein the fluid punctures the skin area of the patient to create a hole through the skin area, and a perfusion stage characterized by a second force wherein the fluid is injected into the patient through said hole, said second force being less than said first force;

cocking said drive mechanism;

placing the fluid in said chamber;

engaging said syringe unit with said drive mechanism;

positioning said aperture against the skin area of the patient;

connecting a vacuum source in fluid communication with said port in said suction compartment, for creating a partial vacuum in said suction compartment when said opening of said suction compartment is placed against the skin area of the patient to pull the skin area against said aperture and to create a subcutaneous pocket for infusion of said fluid; and

activating said drive mechanism to cause the fluid to be expelled through said aperture in said two stages.

16. A method as recited in claim 15 in which said impulse stage has a duration of less than about 0.005 second, and said perfusion stage has a duration of at least about 2 seconds.