Needleless injector and ampule system
A needle-less injector system having an ampule with an elongated hollow body. The elongated hollow body includes a nozzle and an aperture for receiving a plunger. The aperture extends from the second end of the body towards the first end and is in fluid communication with the nozzle. The ampule cooperates with a plunger that has a concave rib that extends about the perimeter of the plunger and towards the first end of the plunger. As the plunger moves through the aperture the concave rib sealingly engages the sidewalls of the aperture.
This is a continuation of U.S. patent application Ser. No. 10/158,853, entitled “Needleless Injector and Ampule System,” filed on May 30, 2002. The present application also relates to U.S. patent application Ser. No. 11/121,439, entitled “Needleless Injector,” filed May 3, 2005.
BACKGROUND OF THE INVENTION1. Field of the Invention
The present invention relates to a system for the subcutaneous delivery of medicaments, and more particularly to a hand held actuator, and a plunger and ampule or vial used to deliver a stream of medication.
2. Description of Related Art
The need for a needle-less injection device that can be used to deliver a fine, high-pressure stream of medication through the skin has been recognized for some time. However, the problems associated with creating this high-pressure stream, particularly with a self-contained, hand-held device, has proven to be a greater challenge than expected. The typical approach at creating these streams has been to use a piston that is driven by a CO2 cartridge, compressed air, or a spring. The piston is then used to drive the medicament from a reservoir through a small nozzle that is used to create the fine stream that is to penetrate the skin. The size and energy of the stream allows the stream to penetrate the skin to a depth where it can then be absorbed by the body.
One important problem is that in order to create such a stream it is difficult to produce a nozzle that provides a tight, uniform stream, and not a spray of the medicament.
Another important problem associated with the design of a needle-less injection system involves the efficient delivery of the dose of medicament held within the reservoir. In other words, it is important that the system does not allow medicament to escape between the piston and the reservoir or cylinder through which the medicament is being delivered. The problem of loss of medicament is typically caused by the escape of medicament under the pressure required to adequately deliver the medicament through the nozzle.
Still another important problem associated with needle-less injection devices, and particularly with hand-held devices of this type, is the provision of sufficient power to create and deliver a stream with sufficient energy so that the stream can penetrate the body to a depth where the medicament can be absorbed.
Yet another problem associated with needle-less devices is maintenance of a required amount of pressure during the delivery of the medicament from the reservoir, through the nozzle.
SUMMARY OF THE INVENTIONOne object of the present invention is to provide a needleless injection device that delivers a fine, high pressure stream of medicament through a surface.
Another object of the present invention is to provide a needleless injection system that delivers the medicament without any loss of quantity thereof.
In accomplishing these and other objects of the present invention, there is provided a needleless injection device including an ampule. The ampule includes an elongated hollow body, the elongated hollow body having a first end and a second end. The first end of the hollow body includes a nozzle, and the second end of the hollow body including an aperture for accepting a plunger. The aperture extends from the second end towards the first end and is in fluid communication with the nozzle. The generally cylindrical plunger, includes a first end and a second end. The plunger also includes a concave rib extending about the perimeter of the plunger and extending towards the first end.
According to one example of the invention, the body of the plunger is centered about an axis and the first end of the plunger includes a generally conical end that is centered about the axis. Additionally, the conical end will extend from the concave portion of the concave rib. Still further, it is contemplated that the plunger will include a second rib, the second rib being between the concave rib and the second end of the plunger.
The plunger is received by the aperture in the ampule, with the concave rib sealingly engaging the sidewalls of the aperture in the body of the ampule. The second rib will also cooperate with the sidewalls of the aperture of the ampule and may provide some sealing function, but will primarily serve to stabilize or align the plunger as it is forced through the ampule.
The ampule connects to an actuator that will provide the power to push the plunger through the ampule and drive the medicament from the ampule through the nozzle. In an illustrated example of the actuator, the actuator includes a casing that holds a spring that is used to drive a rod. The rod in-turn pushes against the plunger, which then pushes the medicament through the ampule.
The release of the spring in the actuator is accomplished by providing a hammer that includes a forward end that is adapted for cooperating with the rod and the trigger mechanism, and an aft end that is adapted for cooperating with the spring. The trigger mechanism is used to retain the spring in a loaded or compressed position, and then release the spring to drive the plunger through the ampule.
These and other objects, features, aspects and advantages of the present invention will become more apparent from the following detailed description of the preferred embodiment relative to the accompanied drawings, in which:
BRIEF DESCRIPTION OF THE DRAWINGS
Referring to
As shown in
Referring to
It should be appreciated that the ampule 30 will be made from a readily moldable material, such as a pharmaceutical grade polypropylene material that is suitable for injection molding or any other polymer that is suitable for injection molding. An important drawback to the use of polymers as the material for the ampule 30 is that the mechanical properties of these materials allow the materials to deflect under the pressures needed for creating the jet of medicament 34 through the nozzle 38. Additionally, fabrication of the ampule 30 from stiffer materials results in a device that is too brittle or a device that cannot be manufactured through the use of high production rate methods, such as injection molding. Therefore, the machining of the ampules from stainless steel would be a prohibitively expensive approach at manufacturing the device. Furthermore, an opaque material will not allow the user of the device to ascertain whether the plunger 26 has traveled through the desired length of the ampule 30, and delivered the adequate dosage of medicament.
In operation, as illustrated in
Thus, from the accompanying illustrations, it will be understood that the plunger 26 extends about an axis 54 and may also include a first end 56 (
Referring to
Although the present invention has been described in relation to particular embodiments thereof, many other variations and other uses will become apparent to those skilled in the art. It is preferred therefore, that the present invention be limited not by the specific disclosure herein, but only by the appended claims.
Claims
1-15. (canceled)
16. A needleless injector system for holding a fluid and delivering a stream of fluid through an area, the system comprising:
- a plunger extending about an axis and having opposed first and second ends and an external surface, said plunger including at least one concave rib extending about the axis, wherein said at least one concave rib has an outer diameter extending away from and greater than an outer diameter of the external surface; and
- an ampule including an elongated hollow body having a first and second end, the first end of the elongated hollow body including a nozzle, and the second end of the hollow body including an aperture for receiving the plunger, said aperture being in fluid communication with the nozzle, wherein the outer diameter of said at least one concave rib sealing engages the hollow body to expand and seal the aperture in response to a deflection in the hollow body, wherein deflections in the hollow body caused by a pressure force created as the fluid is driven from the hollow body by the plunger is sealed by the at least one concave rib.
17. The system of claim 16, wherein said plunger includes a second rib, the second rib being disposed at the second end of the plunger.
18. The system of claim 16, wherein said first end of said plunger has a conical shape.
19. The system of claim 18, wherein said plunger includes a second rib, the second rib being located at the second end of plunger.
20. The system of claim 16, wherein the ampule is made from a polypropylene material.
21. A needleless injector system for holding a fluid and delivering a stream of fluid through an area, the system comprising:
- a plunger having opposed first and second ends and an external surface, said plunger including at least one concave rib extending from the external surface of the plunger, said at least one concave rib having an outer diameter extending away from and greater than an outer diameter of the external surface; and
- an ampule having an elongated hollow body for receiving the fluid, the hollow body having first and second opposed ends, the first end of the elongated hollow body including a nozzle, the second end of the hollow body being open to receive the plunger, wherein the outer diameter of said at least one concave rib sealingly engages an inner diameter of the hollow body to form a sealing fit therewith to expand and seal the hollow body in response to deflections in the hollow body caused by a pressure force created as the fluid is driven from the hollow body by the plunger.
22. The system of claim 21, wherein said plunger includes a second rib disposed at the second end of the plunger.
23. The system of claim 21, wherein said concave rib is approximately conical in shape.
24. The system of claim 23, wherein said plunger includes a second rib extending from said external surface, said second rib having a generally conical shape and being located at the second end of the plunger.
25. The system of claim 21, wherein the ampule is made of a polypropylene material.
26. The system of claim 21, wherein the plunger is made of a polypropylene material.
27. A method for preventing pressure losses in a needle-less injector system while delivering a stream of fluid, the method comprising the steps of:
- providing a plunger, the plunger having opposed first and second ends and an external surface, said plunger including at least one concave rib having an outer diameter that extends away from and is greater than an outer diameter of the external surface;
- providing an ampule, the ampule having an elongated hollow body, the hollow body having a first end and a second end, the first end of the elongated hollow body including a nozzle, the second end of the hollow body being open to receive the plunger, wherein the outer diameter of said at least one concave rib sealingly engages an inner diameter of the hollow body to form a sealing fit therewith;
- supplying the ampule with fluid and placing the plunger into the hollow body so that the fluid is held between the plunger and the nozzle; and
- compressing the fluid by moving the plunger towards the nozzle, wherein the at least one concave rib expands against the inner diameter of hollow body to seal the hollow body in response to deflections in the hollow body caused by a pressure force created as the fluid is driven from the hollow body by the plunger.
28. The method of claim 27, further comprising the step of forming the plunger form a polypropylene material.
29. The method of claim 27, further comprising the step of forming the ampule from a polypropylene material.
Type: Application
Filed: Jul 21, 2005
Publication Date: Aug 16, 2007
Inventor: Kerry Quinn (Erie, CO)
Application Number: 11/185,736
International Classification: A61M 5/30 (20060101);