Enclosed container power supply for a needleless injector

Details Enclosed container power supply for a needleless injector Enclosed container power supply for a needleless injector

1999-02-25

2001-07-10

Nguyen, Anhtuan T. (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C604S068000, C604S212000, C604S216000

Reexamination Certificate

active

06258062

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of Invention
The present invention relates to a power supply that can be used with most needleless injectors or other drug delivery devices for transcutaneous delivery of drugs or other rapid drug delivery. The power supply has a working gas and no active seals that can provide a leak path for the working gas out of an enclosed volume.
2. Description of Prior Art
Needleless injectors are used to inject drugs of various types transcutaneously without using a needle which is the standard modality for drug delivery. Several components that generally form a needleless injector include a power supply, a drug reservoir, and a reset mechanism. The needleless injector is usually activated from a loaded to an unloaded state by some type of trigger mechanism and is held in a loaded state prior to activation by a latch mechanism. Typically the drugs used with most needleless injectors are in a liquid or suspension form although it is possible to inject dry powder or crystalline drug transcutaneously using some needleless injector designs. The drug is usually contained in a reservoir or ampule which can take on many forms. Most ampules have a piston-like mechanism that is associated with them to apply a force onto the contained drug and force the drug out of an orifice at a high velocity and typically through the cutaneous tissue of the patient's arm. Often the piston-like mechanism of the ampule interfaces with a piston or moving surface of a power supply that generates the energy and force needed to force the drug out of the ampule orifice. The orifice found in the ampule of some needleless injectors can be positioned in contact or adjacent to the patient's skin or it can be positioned a small distance away from the skin. Some needleless injectors have a built in ampule that is not removable and can be reused. This type of design may provide a lower overall cost of use but can require cleaning and sterilization by the patient on a regular basis. Other needleless injectors are made with a built in ampule that can be removed either between injections or after several injections for purposes of cleaning or filling the ampule. In this design only the ampule need be disassembled, cleaned, and sterilized on a regular basis. Still other needleless injectors have a place or compartment for a disposable ampule which can be a one-time-use ampule that is provided to the patient in a fully contained state. This design provides the patient with an easy to use, easy to maintain system but may be more costly to provide individually packaged disposable drug doses. Some drugs are not able to withstand individual packaging in a disposable ampule due to material considerations. Other drugs can require such individualized doses for each patient that prepackaging the drug in a separate ampule may be impractical. Some needleless injectors provide for a syringe type of ampule that can be filled by the patient in a manner similarly to a standard syringe. Several problems can arise from this type of ampule system including leakage and lack of control of dose volume. Needleless injectors have advantages over conventional needle injection due to their less invasive nature, the psychological advantage of not inserting a needle through the skin, and other potential advantages including less pain and better sterility control. The present invention is a power supply that can be used with almost all needleless injectors regardless of the type of drug reservoir or ampule they have and regardless of the type of drug reservoir they may interface with.
A needleless injector has a power supply that provides the energy to drive the drug out of the orifice of the ampule. Many different types of power supplies are used with needleless injectors. Mechanical springs including disk springs and coil springs can be compressed to store potential energy that is later released to drive a liquid or dry powder drug transcutaneously into a patients body without the use of a needle. Such springs can be modified to provide spring rates and spring constants that will provide a comfortable and effective delivery of the drug into the patients tissue. Other power supplies include compressed gas cylinders and pistons that compress a gas and store potential energy in the compressed gas; this energy is stored and returned to drive the drug with a high velocity through an orifice into the patient. An additional power supply for needleless injectors include a disposable carbon dioxide liquid-gas cylinder that converts a liquid carbon dioxide into a high pressure carbon dioxide gas that is used to supply the energy to drive the drug through an orifice at high velocity; disposable liquid-gas cylinder power supply systems other than the carbon dioxide power supply could also be used with a needleless injector. The present invention is a power supply that can be used to replace the power supplies of other needleless injector designs including mechanical springs, compressed gas, and disposable liquid-gas systems. Components from other needleless injector patent designs can interface with the power supply of the present invention to provide a more efficient needleless injector device.
The needleless injectors with spring and compressed gas power supplies are generally equipped with or interface with a reset mechanism to restore the power supply to its compressed state such that the needleless injector can be used again for another needleless drug delivery. Some reset mechanisms that are included as a part of the needleless injector include screw thread, hydraulic, lever arm, and the use of compressed gas. Other needleless injectors can be reset using a table top reset unit of a mechanical, electromechanical, or hydraulic nature, or can interface with a hard surface for reset purposes. Some carbon dioxide power supplies can be reset by interfacing with a household item such as a pencil or can be reset with a spring. The power supply of the present invention can interface with a screw thread, hydraulic, lever arm, compressed gas, a table top reset unit, or other reset mechanisms that are presented in most other needleless injector patents. Several other power supply devices include pyrotechnic devices, use of carbonic acid, and special gasses that can convert back and forth between a liquid and a gas in going from a compressed state to an unloaded or fired state.
Lindmayer disclosed in U.S. Pat. No. 4,623,332 a needleless injector that uses disk springs as a power supply to drive a piston forward and deliver liquid medicine from a medicine chamber and out of an orifice. A latch is used to hold the piston in a state of potential energy and a trigger is pressed to release the latch and discharge the medicine. A threaded mechanism is used to reset the coil spring for the next injection. This device is large and heavy due to the requirements placed on the springs to provide a large force in order to generate a high velocity stream out of the orifice. It is desired for the patient to be able to carry a needleless injector unobtrusively with himself such that drug injections can be made throughout the day if necessary. It is therefore desirable to have a more powerful power supply that is smaller and lighter. The power supply of the present invention could be adapted to work with the needleless injector of Lindmayer as well as with other needleless injectors as further discussed.
Several needleless injector devices disclose the use of one or more coil springs in the power supply to generate the energy needed to drive a liquid drug out of an orifice, including U.S. Pat. No. 4,722,728 by Dixon, U.S. Pat. No. 4,850,967 by Cosmai, U.S. Pat. No. 5,569,189 by Parsons, U.S. Pat. No. 3,805,783 by Ismach, U.S. Pat. No. 4,059,107 by Iriguchi, U.S. Pat. No. 4,400,171 by Dettbarn, U.S. Pat. No. 3,782,380 by Van Der Gaast, U.S. Pat. No. 5,501,666 by Spielberg, and U.S. Pat. No. 4,874,367 by Edwards. Problems with most coil springs when used as a power source include the characteristic that compressed springs quickly become wea

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