Needleless hypodermic injection methods and device
First Claim
1. A method of providing a jet injection by pressurizing a fluid injectant within an ampule having a nozzle, comprising the steps of:
- driving a plunger into the ampule with sufficient force to generate a pressure adjacent to the nozzle of from approximately 3900-4300 psi within a rise time of 6 milliseconds;
reducing the pressure substantially linearly with the volume of injectant expelled until the pressure is approximately 1200-2000 psi; and
maintaining the pressure substantially constant until a desired volume of injectant is expelled from the ampule.
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Accused Products
Abstract
A needleless injection device includes an initiator valve controlling flow of compressed gas into a reservoir. A poppet valve connecting to the reservoir has a gas pressure regulation end to regulate flow from the initiator valve into the reservoir. A clamp piston is driven forward by gas pressure from the reservoir and causes jaws to clamp onto a plunger extending into an ampule. The poppet valve opens when reservoir pressure reaches the cracking pressure of the poppet valve. Gas from the reservoir rushes through the poppet valve into a drive chamber and forces a drive piston, containing the clamp piston and jaws, forward causing the plunger to slide into the ampule. A jet of injectant is discharged from the nozzle of the ampule and penetrates through the patient'"'"'s skin. An improved method of needleless injection uses a specific pressure profile, ampule nozzle diameter, patient, injection site, and injectant parameters.
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Citations
29 Claims
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1. A method of providing a jet injection by pressurizing a fluid injectant within an ampule having a nozzle, comprising the steps of:
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driving a plunger into the ampule with sufficient force to generate a pressure adjacent to the nozzle of from approximately 3900-4300 psi within a rise time of 6 milliseconds; reducing the pressure substantially linearly with the volume of injectant expelled until the pressure is approximately 1200-2000 psi; and maintaining the pressure substantially constant until a desired volume of injectant is expelled from the ampule. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 11, 12, 13, 14, 15, 16)
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9. A method of providing a jet injection by pressurizing a fluid injectant within an ampule having a nozzle, comprising the steps of:
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generating an initial pressure proximal to the nozzle of from approximately 3900-4300 psi within 6 milliseconds; reducing the initial pressure generally exponentially over time to a reduced pressure of approximately 1200-2000 psi; and maintaining the reduced pressure until a desired dose of injectant is expelled from the ampule. - View Dependent Claims (10)
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17. A method of needleless injection comprising the steps of:
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pressurizing an injectant within an ampule having a nozzle to a peak pressure of approximately 3900-4300 psi adjacent the nozzle in approximately 1 millisecond; reducing the pressure adjacent the nozzle to approximately 1800 psi, over at least about 25 milliseconds; and maintaining the pressure adjacent the nozzle substantially constant until a desired dosage has been injected. - View Dependent Claims (18, 19, 20)
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21. A method of jet injection comprising the steps of:
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attaching an injectant containing ampule having a nozzle diameter of about 0.004 inches to an injector; placing the nozzle at a standard subcutaneous injection site on a patient, selected from the group consisting of the lateral triceps region, the abdomen, and the thigh; generating an injectant pressure adjacent to the nozzle of approximately 3900-4300 psi within 6 milliseconds, to provide a subcutaneous injection.
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22. Method of jet injection comprising the steps of:
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attaching an injectant containing ampule having a nozzle diameter of about 0.006 inches to an injector; placing the nozzle at the thigh deltoid of patient up to 47 inches tall and weighing up to 50 lbs; and generating an injectant pressure adjacent to the nozzle of approximately 3900-4300 psi within 6 milliseconds. - View Dependent Claims (23, 24)
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25. A method of jet injection comprising the steps of:
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attaching an injectant containing ampule having a nozzle diameter of about 0.008 inches to an injector; placing the nozzle at the thigh or gluteus of a patient; generating an injectant pressure at the nozzle of approximately 3900-4300 psi within 6 milliseconds; - View Dependent Claims (26, 27)
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28. A method of jet injection comprising the steps of:
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attaching an injectant containing ampule having a nozzle diameter of about 0.010 inches to an injector; placing the nozzle at the deltoid of a patient weighing within 20% of lean body weight for the patient'"'"'s height; and generating an injectant pressure adjacent to the nozzle of approximately 3900-4300 psi within 6 milliseconds.
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29. A method of jet injection comprising the steps of:
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attaching an injectant containing ampule having a nozzle diameter of about 0.014 inches to an injector; placing the nozzle at the deltoid of a patient weighing more than 120% of lean body weight for the patient'"'"'s height; and generating an injectant pressure adjacent the nozzle of approximately 3900-4300 psi within 6 milliseconds.
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Specification