This invention relates to a novel safety disposable syringe needle system which has medical and industrial applications. More particularly, this invention pertains to a syringe which can be filled with fluid, medication or the like and which can effect transient or long term storage of medication or other substances and allow for transfer of them from the interior of the syringe into a medication vial or an intravenous line without requiring attachment to, or use of any additional devices such as detachable needles or access devices or ports. In one embodiment a conventional metal needle, Luer fit or otherwise can be attached to effect percutaneous or other injection.
The syringe tends to eliminate or reduce the likelihood of a needle stick injury. In one embodiment the syringe can be permanently disabled after use by the end user, preventing reuse of the syringe for injection or transfer of fluids. In one embodiment the material (COC) from which the syringe is made, is substantially inert, with respect to the contents allowing storage of medications or the like for prolonged periods of time without significant effects on the composition or activity.
Needle stick injuries among medical personnel such as healthcare workers are of a growing concern both in developed countries and in the developing world. More than 20 diseases can be transmitted through accidental needle stick injuries particularly Hepatitis B, Hepatitis C and Ebola, West Nile fever and others.
The reduction or elimination of needle stick injuries has become an important issue. Prevention of spread of disease is an important factor in a safe work place and assists recruitment and retention of healthcare workers. The “Needle Stick Safety Act” in the US and similar initiatives enacted in Canada and being discussed in Australia and Europe are forcing the adoption of safer technology for syringes and needles having built-in safety features. In developing countries the inappropriate reuse of syringes has been high. Some reports indicate that more than 50% of injections given in Africa in the recent past have been given by reuse of un-sterile and unsafe syringes. Focus has now been turned to both prevention of disease transmission to healthcare workers by prevention of accidental needlestick injuries and to patients through non reuse of syringes.
A syringe with a sharp metal needle is used for injections through the skin. The reconstitution of lyophilized or other powdered medication has traditionally been carried out using sharp metal needles to puncture the stoppers of medication vials to allow addition of diluent and reconstitutions of the drug. The use of a sharp metal needle allows inadvertent accidental needle stick injuries and/or deliberate reuse of syringes or needles for injection.
Traditionally sharp metal needles have also been used for introducing medication into Intravenous infusion lines. Attempts to eliminate needles have been made using completely blunt plastic cannulas and pre-slit septums in intravenous lines. While these have been effective, they have been complicated and expensive requiring additional valves for access to medication valves or complicated additions to the totally blunt cannula which increase expense. They have not received wide spread acceptance.
This invention relates to a safety disposable syringe which additionally can allow for safe storage of fluids or medication within the barrel of the syringe. This enables transfer of the contained fluid into for example medication vials containing lyophilized or other drugs or substances requiring reconstitution with the fluid. The syringe can also be used for transferring the reconstituted medication into an intravenous line using the same syringe. The syringe could also be used for industrial purposes for sampling or adding substances which for example may be toxic to other vessels or containers.
A safety cannula described in U.S. Pat. No. 6,616,632, incorporated herein by reference can access medication vials and intravenous lines without the risk of needle stick injuries. In one embodiment a cannula such as described in this patent or similar could be attached to the syringe using conventional Luer fit or Luer lok connections molded as the front part of the syringe barrel. However attachment of a separate cannula is time consuming and more costly than, as in an aspect of the present invention, a syringe which has an integral safety cannula formed as a single unit with the barrel by for example injection molding.
The current invention allows for access to intravenous lines, medication vials and the like without the need for a separate cannula. In addition because of recently developed plastic resins such as cyclic olefin copolymer(COC) with general impermeability and non-reactivity, storage of dilution fluid or medication, dry or liquid, in the syringe can be achieved. This eliminates the need for a storage vial and for the commonly used sharp metal needle and syringe to access that vial. In one embodiment of the syringe, the syringe can be permanently disabled preventing reuse of the syringe or any part. This can be achieved in a number of ways including a frangible portion on the needle/cannula allowing removal of it from the syringe. In addition, a frangible portion on the plunger enables breakage of the plunger and prevents reuse of the syringe. This can be accomplished for example by fixing one portion of the plunger relative to the barrel and applying a rotational force to the unfixed portion of the plunger to cause breakage of the plunger at a predetermined break point.
It will be appreciated that the cannula, integral with the barrel may have a large variety of configurations, dimensions and surface configurations. The external side walls may be straight, smooth and cylindrical or may be tapered and smooth, both terminating in a cannula tip.
In one embodiment, the barrel and cannula are molded as one single unitary component. This simplifies manufacturing thereby reducing costs. It reduces the work needed to assemble a syringe and eliminates the need to locate, unpackage and attach any additional type of cannula or needle onto the front of the syringe. This also eliminates a step which could allow inadvertent contamination of the fluid path and an ensuing infection.
It has additional benefits such as preventing exposure of a metal needle to the medication. Metal can result in undesired interactions between the fluid within the pre-filled syringe and needle. For example one undesirable effect would be crystallization of the dissolved substance and potential blockage of the needle.
In another embodiment, the plunger can be fixed using a removable clip or similar reversible fixation mechanism in a variety of different axial positions relative to the barrel to allow accurate filling of the syringe to predetermined volumes. This allows for one syringe size to be used for different volumes of solution resulting in simplified packaging.
The axial fixation of the plunger prevents movement of the plunger relative to the barrel during transportation and/or during handling of the syringe during for example penetration of the stopper of a medication vial, or an IV line. The clip or fixation mechanism can be disengaged and removed to allow full plunger movement relative to the barrel when required.
Molding the barrel using an inert plastic material enables the contents(medication) to be exposed to as few as two materials. The possible interactions of the container and contained fluid depends on the nature of the individual materials in which it may come in contact and also the combination of materials. A greater diversity of substances can be stored within the syringe when a small number, for example, two materials are used (no metal cannula or epoxy or other adhesive materials). In one embodiment the material used does not allow for long term storage however the other features of the described syringe may be of value for shorter, transient single use.
In standard syringes the plunger tip is commonly covered by an elastomeric stopper allowing for smooth water-tight axial movement of the plunger. The delivery cannula on the end of the barrel is traditionally closed with a needle cover. In a further embodiment of the proposed syringe, both of these components, the needle cover and stopper may be of the same material. Thus a medication stored in the described syringe is exposed to only the plastic resin from which the barrel is made in addition to the stopper elastomer. Thus many medications currently stored in a glass vial or the like, with an elastomer stopper may be able to be stored in the COC plastic resin syringe.
If it is necessary to reconstitute the medication for any reason immediately prior to giving the drug, this could be accomplished by storing the unreconstituted medication within the barrel of the syringe. The cannula could then be used to draw in diluent from an external source and allow reconstitution in the syringe. Long term compatibility of the reconstituted drug with the syringe barrel material would not be necessary.
If the drug is intended to be given Intravenously, as is often used for medications, the cannula can be used to access an Intravenous port in more than one way. In addition, the syringe may also be used with a standard injection or safety needle, i.e., converted to a standard syringe with a Luer fit attached to a sharp metal needle. To accomplish this, the cannula may have a weakened portion intermediate the cannula tip and the distal end of the barrel. The weakened portion of the cannula may be external to or internal of the cannula. Additionally, the proximal portion of the cannula between the weakened portion and the distal end of the barrel may be shaped and dimensioned to receive a standard Luer fit metal needle. Also, the distal end of the barrel may be shaped and dimensioned to receive a standard Luer Lok™ needle. An externally placed but affixed component to the barrel provides such rotational and threaded function as is present in a Luer Lok. That is, the barrel may be extended beyond the base of the cannula or an external component affixed to provide an internally threaded cylindrical extension, i.e., Luer Lok™. The flanges on a standard Luer fit metal needle may then threadedly engage the internally threaded cylindrical extension to retain the Luer needle about the base of the cannula. Thus, the integrally molded syringe barrel and cannula can be converted for direct injection through an individual's skin using a standard Luer fit steel needle or a safety Luer fit needle by breaking off the distal end of the cannula. Thus the converted syringe would not be reusable once the plunger has been broken by rotation of the plunger relative to the barrel.
Following use, the syringe can be permanently disabled by breaking the plunger. The syringe cannot then be reused.
In a preferred embodiment of the present invention there is provided a syringe comprising: a syringe barrel having proximal and distal ends; a plunger in part disposed in said barrel and having a bung or stopper adjacent an end of the plunger within the barrel, said plunger being movable toward and away from the distal end of the barrel; the distal end of the barrel terminating in an elongated end cannula having a central opening in communication with the interior of the barrel between the distal end of the barrel and plunger bung for receiving fluid into or expelling fluid from the barrel; the barrel and cannula being molded from and formed of a single unitary plastic material.
In a further preferred embodiment hereof, there is provided a syringe comprising: a syringe barrel having proximal and distal ends; a plunger in part disposed in said barrel and having a bung or stopper adjacent an end of the plunger within the barrel, said plunger being movable toward and away from the distal end of the barrel; the distal end of the barrel terminating in an elongated end cannula having a central opening in communication with the interior of the barrel between the distal end of the barrel and plunger bung for receiving fluid into or expelling fluid from the barrel; the plunger having an end portion adjacent the bung and separable from remaining portions of the plunger, said plunger end portion and the barrel having cooperating surfaces enabling separation of the plunger end portion and the remaining portions of the plunger in response to relative rotation of the plunger and the barrel.
In a further preferred embodiment hereof, there is provided a syringe comprising: a syringe barrel having proximal and distal ends; a plunger in part disposed in said barrel and having a bung adjacent an end of the plunger within the barrel, said plunger being movable toward and away from the distal end of the barrel; the distal end of the barrel terminating in an elongated end cannula having a central opening in communication with the interior of the barrel between the distal end of the barrel and plunger bung for receiving fluid into or expelling fluid from the barrel; and an annular collar about the cannula, said collar having features such as an annular groove about an external surface thereof sized to receive the tip of a medication vial enabling the collar to seal between the cannula and the vial lip.
In a further preferred embodiment hereof, there is provided a syringe comprising: a syringe barrel having proximal and distal ends; a plunger in part disposed in said barrel and having a bung adjacent an end of the plunger within the barrel, said plunger being movable toward and away from the distal end of the barrel; the distal end of the barrel terminating in an elongated end cannula having a central opening in communication with the interior of the barrel between the distal end of the barrel and plunger bung for receiving fluid into or expelling fluid from the barrel; and a clip engageable with the plunger and the barrel at each of a plurality of selected axial locations of the plunger relative to the barrel thereby to fix the axial location of the plunger relative to the barrel at a selected location therealong.
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As illustrated, the barrel 12 and the cannula 16 are molded as a single unitary piece thereby eliminating differences in materials between the barrel and cannula as well as any adhesive typically required to connect a metal needle to the barrel. The plastic parts of the syringe including the integral barrel and cannula are formed of a plastic material and preferably a Cyclic Olefin Copolymer (COC) which acts as a barrier to water or other molecules thereby allowing the syringe to be prefilled with water or other solutions or dry and/or powdered medication. The syringe 10 of course operates in the usual manner whereby axial withdrawal of the plunger relative to the syringe barrel may draw fluid into the syringe and axial displacement of the plunger toward the distal end of the barrel expels fluid from the syringe.
The shape of the integral cannula 16 may be the same as disclosed in U.S. Pat. No. 6,616,632 incorporated herein by reference and it will be appreciated that the attributes thereof are applicable to the present invention. Also, the cannula outer surface may have formations which provide respective different resistances to movement of the cannula through a membrane. The formations may be of the type described and illustrated with respect to
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While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.
This application relates to prior provisional applications Ser. Nos. 60/610,194 filed Sep. 16, 2004; 60/625,724 filed Nov. 8, 2004; 60/635,178 filed Dec. 13, 2004; and 60/640,177 filed Dec. 30, 2004.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/CA05/01411 | 9/15/2005 | WO | 3/9/2007 |
Number | Date | Country | |
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60610194 | Sep 2004 | US | |
60625724 | Nov 2004 | US | |
60635178 | Dec 2004 | US | |
60640177 | Dec 2004 | US |