Patent Application
20140046270
(a) Field of the Invention
This application relates to a pre-filled, single dose, injection device. More particularly, but not by way of limitation, to
(b) Discussion of Known Art
The need to store a spare key for an automobile has been long recognized.
Therefore, a review of known devices reveals that there remains a need for a simple device that supports a concealed hook for hanging ornaments.
It has been discovered that the problems left unanswered by known art can be solved by providing tool support for holding tools against the turret of a turret lathe, the tool includes:
Prefilled Medical Injection Device
The present invention generally relates to a device or system for delivering a dose of medication, vaccine or other infusate product (hereinafter “medication”). More particularly, a hermetically sealed ampoule prepackaged with medication that incorporates an insertion technology consisting of a specially designed collar integrating a variety of possible connections, including needle free connectors, such as luer-lok and luer slip, as well as staked needle, and needle with an active or passive safety system.
Additionally the device is optimally suited for production through the use of the Blow-Fill-Seal manufacturing technique.
There are pluralities of the hypodermic syringe type injection device. The vast majority of the devices are derivative of French physician Charles Pravaz' well-known design. The design consists of a cylinder body, a piston, and a hypodermic needle. This design works very well for introducing and extracting fluids from patients, and has been adapted recently as a prefilled delivery method made suitable by following specific predetermined safety protocols that add significant cost to the infusion equation.
Prefilled medical injection devices provide health care workers with a more efficient way to administer medications. The ubiquitous hypodermic syringe has seen a multitude of incremental advancements and improvements over the years in order to deal with the myriad of problems hypodermic syringes present in its manufacture, distribution, storage and use. Many of these advancements are unique to the problems relating to the prefilled syringe, which creates many new challenges because of the prefilled format.
For example, prefilled hypodermic syringes face problems relating to chemical interactions with silicone, a common lubricant that allows the plunger to move down the cylinder, as well as adhesives and tungsten. Further, transportation presents additional problems relating to atmospheric changes, creating a potential for pressure increases inside the cylinder body causing the device to extrude medication, wasting medication, while decreases cause the device to suction up outside air, which increases the risk of contamination. Many other problems exist in their use, such as the accidental removal or dislodgement of the plunger, as well as the potential for needlestick injury depending upon the type of needle used. This has been a problem to many health care professionals and has forced them to switch back to the vial syringe method for delivering vaccinations.
Although, there are multitudes of prior arts that incorporate solutions to the above problem the majority of them still carry a major disadvantage. The majority of injection devices require that the device be uncapped and recapped to avoid sticking others with a contaminated needle. The requirement to recap a syringe has created a major risk factor for healthcare workers, accidentally pricking themselves with a soiled needle.
It is therefore an object of the present invention to introduce a device that is prefilled with medication, adjusts to changes in ambient temperature and pressure, while providing a risk reducing mechanism to inject patients. Additionally the invention is designed for a mass production method (Blow-Fill-Seal method) that minimizes the risk of contamination. Blow-Fill-Seal has numerous requirements and limitations and the ampoule and collar (insertion technology) have both been designed to be compatible with Blow-Fill-Seal manufacturing.
The apparatus is to be described in detail and is provided in a manner that establishes a thorough understanding of the present invention. There may be aspects of the present invention that may be practiced without the implementation of some features as they are described. It should be understood that some details have not been described in detail in order to not unnecessarily obscure focus of the invention.
The device is produced using the Blow-Fill-Seal (BFS) manufacturing process. The component of the device is composed primarily of Low Density Polyethylene (LDPE), although it can be made from any of the wide variety of materials 5 available such a HDPE, Polypropylene (PP), PE, and other suitable materials, 8. The device 100 incorporates the needle, 4, and the medication, 5. The manufacturing process creates the device by extruding the LDPE in a tubular shape. The tubular piece of LDPE is referred to as the parison. The parison is extruded into a mould at which point the mould closes and the LDPE is cut at the top. A vacuum is applied to the exterior of the mould and for larger sizes, may be combined with an internal pressure via a mandrel (nozzle) which blows sterile filtered air. This causes the hot parison to take the shape of the mould. At this point the medication, 5, is delivered into the container through the use of an electronic fill system that utilizes the same mandrel used to optionally blow the air. The electronic fill system delivers a precise dose of the drug into the container through the mandrel. When the precise dose has been transferred, the mandrel retracts from the container. Once the mandrel is removed a premade insert 3, with valve, 8, and collar, 2, (and whatever needle or needle free mechanisms) are correctly oriented into position through the use of a vacuum pick up. Once in place the vacuum pick up retracts and a separate seal mould comes in to hermetically seal the top of the device and create the frangible web, 12. To accomplish this needle safety system, 3, with valve, 8, and collar, 2, insert must be compatible with both diameter and the height of the seal mould. Once all components are sealed the moulds open and the container with the attached assembly is removed. The production process integrates the manufacture of the ampoule, along with the filling and finish operations into a single aseptic machine that requires no human interaction and thereby reduces the risk of contamination.
The ampoule, 1, of the invention, in its present embodiment, is a cup shaped receptacle composed of translucent LDPE with a wall thickness of 0.025-0.012″. The external dimension of the ampoule is 0.5″ in diameter (can be larger). The ampoule can hold medication volumes that range from 0.1-5 mL. When being filled the ampoule, 1, must leave about 0.5 ml of headspace with a 0.5 ml dose. This head space is necessary during the fill however creates a problem at time of injection into patient which is overcome at time of use with an aspiration function so that 0.5 ml of nitrogen can be aspirated. The addition of nitrogen provides better stability for the storage of the drug, as nitrogen is an inert gas. Typical overfill must be between 5% and 10% but maybe more with a medication 5 size of 0.1 mL.
The collar, 2, of the invention in its present embodiment, is a cylinder with two concavities positioned bi-laterally. The bilateral concavities serve as a point of contact for the user's fingers when the invention is held. The collar, 2, can be composed of LDPE, High Density Polyethylene (HDPE), or Polypropylene (PP), and with an intended diameter of ˜0.5″ and 0.75″ in length. The collar, 2, has four configurations that determine the overall positioning of internal components. The differences in the configuration are not exclusive to their individual embodiments and the features can be combined to obtain the optimal utility for the device. The collar, 2, configurations that differ are threaded, integrated, and rotating seal activation mechanism, 10, that can be incorporated with either an integrated, 11, or Luer-lok threaded, 7, needle, 4. The threaded Luer-lok collar, 2, 7, has a cavity distal to the ampoule, 1, attachment. The threaded cavity contains a silicone seal, 6, on the bottom that assists in sealing the end face, 9, of the safety needle, 3, assembly. The threaded Luer-lok collar, 2, 7, allows a user to substitute the safety needle, 3, assembly with other attachments that accept a Luer-lok connection, 7. An example of a possible substitution is a needleless heparin-lok, used for heparin flushes. The integrated needle system collar assembly, 2, 4, 11, contains the needle, 4, with safety mechanism attached permanently, 11.
Although the invention has been explained in relation to its preferred embodiment, it is to be understood that many other possible modifications and variations can be made without departing from the spirit and scope of the invention as herein described.
This application claims the benefit of my provisional application having Ser. No. 61/638059, filed Apr. 25, 2012, which is incorporated herein by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 61638059 | Apr 2012 | US |
