LOW DEADSPACE SYRINGE INCLUDING A PIVOTING NEEDLE GUARD
A low deadspace syringe having a pivoting protective needle guard on a fixed needle assembly that is permanently attached to the syringe.
This application is a continuation of U.S. patent application Ser. No. 17/192,481, filed Mar. 4, 2021, now allowed, the entire contents of which are incorporated by reference herein.
FIELD OF THE INVENTIONThis invention relates to a low deadspace syringe having a pivoting protective needle guard on a fixed needle assembly that is permanently attached to the syringe, as shown, for example, in
Low deadspace (LDS) syringes with uni-body fixed needle (FN) integrally molded hubs (
Other traditional molded syringes 400 and needles 401 include Luer 6% taper detachable types as shown by example in
Another type of syringe used today includes a needle guard 61 pivotably attached to an annual ring 62 that is press-fit onto the distal end 63 of a unibody type syringe 60. The annular ring 62 may have the needle guard 61 integrally molded thereto with a living hinge 64 as described in U.S. Pat. No. 7,648,480 (
The above-mentioned patents adapt annular ring technology to uni-body type syringes that have a hub integrally molded at the distal end of the syringe barrel with a needle bonded into the hub prior to attaching the needle guard. An additional shortcoming of this type of design occurs when assembling the needle guard to the completed syringe during manufacturing which may result in the annular ring damaging the sharp needle point when passing over the sharp needle point. In this case, the entire syringe and needle guard would need to be discarded which is costly and adds to the waste cycle negatively impacting the environment.
As mentioned, force fitting the annular ring technology can also result in the needle guard being loosely attached to the syringe which may result in the needle guard spinning while the user is attempting to activate the needle guard. Such movement can lead to a safety issue with potentially dire consequences if the user is accidentally pricked with the used contaminated needle during the shielding process. Balancing of forces with this type of technology is difficult to control when attempting to have the annular ring tight enough to resist rotation when being activating but loose enough to rotate when the user wants to rotate the guard in order to orientate the guard with the bevel point of the needle for some procedures.
Needle pop-off is another serious safety issue that can be caused by interchangeable needles that have not been properly secured (having a connection force between needle hub and syringe tip greater than the activating force) to the syringe barrel tip. Such needles may be inadvertently dislodged when a user attempts to activate a needle guard since the direction of the force to activate the needle guard is in the same direction for removal of the mounted needle from the syringe tip. The current invention is directed to a permanently factory attached hub syringe connection that removes this concern.
SUMMARY OF THE INVENTIONExemplary embodiments of the current invention address at least the above problems and/or disadvantages and provide at least the advantages described below. The current invention relates to a low deadspace syringe having a pivoting protective needle guard on a fixed needle assembly that is permanently attached to the syringe.
In one exemplary embodiment, a low deadspace syringe assembly comprises a syringe barrel having a chamber for retaining fluid and an open distal end having a coupling extending therefrom that is connected to a distal wall opening in the chamber and a needle assembly having a hub, a cannula and a guard rotatably mounted on the hub to rotate from an open position to a locked safety position, wherein the guard covers the distal end of the cannula when in the locked safety position, and the proximal end of the hub having a cork extending therefrom and into the coupling of the syringe barrel to connect a conduit in the hub to the chamber such that the proximal end of the conduit is substantially flush with the distal wall opening in the chamber. With such a configuration deadspace in the syringe is minimized while still providing a pivoting protective needle guard on the fixed needle assembly permanently attached to the syringe barrel.
As used herein, the term “distal,” and derivatives thereof, shall refer to a direction towards a patient, while the term “proximal,” and derivatives thereof, shall refer to a direction away from a patient. Also note that other objects, advantages and salient features of the current invention will become apparent to those skilled in the art from the flowing detailed description of exemplary embodiments of the invention taken in conjunction with the referenced drawings.
The invention will be more fully understood from the following detailed description, in conjunction with the following figures, where:
Referring to
The needle hub 102 is permanently mounted to the syringe barrel 103 in the manufacturing process. As shown in
As shown in
As shown in
A preferred embodiment of needle guard 101 includes user controlled manual locks activated soon after an injection and before disposal. The user activates the needle guard 101 causing rotation of needle guard 101 over the needle cannula 911 with a force typically by a finger or hard surface. In the preferred embodiment the needle guard 101 includes a one-way secured lock. As shown in
The preferred embodiment also includes at least one needle hook lock 1501. The needle hook lock 1501 is housed within the needle and hub channel 1303 and may be attached to one side wall 1301 or may extend from a supporting post 1502 mounted on a wall connected to the side walls.
In the preferred embodiment (hub & needle lock configuration) dual locks engage nearly simultaneously when needle guard 101 is rotated into the desired locked position, as shown in
As shown in
Syringes normally come in standard volume capacities of 1, 2, 3, 5 and 10 mL for skin injections. For each size the length of the barrel is optimized based on the volume capacity and graduation of unit markings so that a user can accurately set the plunger to a dosage mark. Vaccine immunization typically requires a fraction of the smallest lml version of syringe. The optimal syringe assembly of the current invention shown in
Also note that the invention is suitable to self-contained syringes that do not require flexible packaging and instead use plastic caps to maintain sterility; re-use prevention (RUP) syringes with frangible plunger features that prevent re-use after an injection has been completed (as shown and described in EP0925083B1) and fixed dose auto-disable (AD) syringes with plunger locking element features that prevent re-use during and/or after movement of the plunger in the injection phase (as shown and described in U.S. Pat. No. 9,205,205).
The current invention also offers a low deadspace syringe with a protective guard design for either a healthcare provider or patient that can be easily and safety activated without the fear of the guard spinning or popping off during activation of the needle guard is beneficial and has been previously disclosed. Preventing unintended rotational movement of the needle guard during activation will remove the risk of a potential needle stick injury from occurring. The mounting of the needle guard to the needle hub adapter without allowing a means for rotation solves this potential issue. Having the needle hub permanently fixed to the barrel and the guard mounted directly to the hub also eliminates the hazard of a needle popping off the syringe distal tip if it had not been securely fastened by the user which can occur with Luer slip detachable type needles and syringes. Another benefit of the current invention is the low profile of the needle guard which allows for unobstructed visual viewing of the injection site and needle point position prior to injecting the patient. The low profile aids in reducing the likelihood the needle guard will snag onto loose clothing or bedding and get damaged or cause a needlestick injury. Another beneficial design feature is the distal end of needle guard (proximal to user before activation) having a slanted inverse ramp or curvature area 1202, as shown in
The manufacturability of the current invention two pieces syringe barrel is also an improvement when compared to the one piece uni-body syringe barrel since the metal core-pin that creates the fluid chamber of the molded barrel is held in place by a support pin at the distal end that is much greater in diameter and stiffness within the mold which minimizes core shift (bending), the major contributing factor that causes syringe barrel bow in the molding process which is undesirable. “Bow” (banana shape) occurs when the proximal and distal ends of the barrel are out of alignment with the horizontal axis of the barrel cylinder, causing alignment issue in the assembly process. Alternatively, reducing the overall length of the barrel will also be beneficial towards molding the optimal straight concentric barrel.
Orienting needle bevel 915 relative to needle guard 101 is desirable in some injection practices like intradermal injections and this is easily achieved by the current invention during the manufacturing process when mounting the needle 911 in needle hub 102, thereby eliminating the user needing to rotate the needle guard during use.
The current invention also allows for color coding needle hub 102 by pigmenting the raw material to quickly and easily identifying the gauge of the needle cannula 911 is most desirable; having needle hub 102 molded separately from syringe barrel 103 as describe in this invention allows this improvement over integrally molded needle hub syringes. Integrally molded hub syringes cannot offer coloring options since the barrel is required to be made of a clear material so that the fluid content can easily be viewed.
Reading the syringe barrel graduation is also important to the medication preparation of the syringe by a healthcare worker. When manufacturing the current invention syringe barrel 103 and needle hub 102 with the needle guard 101, needle guard 101 may be positioned to best view the graduation. Another benefit to having the manufacturer position needle hub 102 and needle guard 101 is to align needle guard 101 with the finger flanges 107 of syringe 103 to minimize syringe packaging.
As will be recognized by those skilled in the art, the subject invention is not limited to these arrangements.
Claims
1. A safety syringe assembly comprising:
- a syringe barrel having an open proximal end, an open distal end, and a chamber therebetween for retaining fluid, said open distal end having a coupling extending therefrom and connected to a distal wall opening in said chamber; and
- a needle assembly comprising: a hub having a proximal end, a distal end, and a conduit therethrough, said proximal end of said hub having a cork extending therefrom and into said coupling of said open distal end of said syringe barrel to connect said conduit to said chamber such that said proximal end of said conduit is substantially inserted into said open distal end of said syringe barrel; a cannula having a proximal end, a distal end, and a lumen therethrough, said proximal end of said cannula mounted within said conduit of said hub; and a guard rotatably mounted on said hub to rotate from an open position to a locked safety position, wherein said guard covers said distal end of said cannula when in said locked safety position.
2. A safety syringe assembly of claim 1, wherein said guard is rotatably mounted on said hub using a hinge.
3. A safety syringe assembly of claim 2, wherein said hinge is a pivot hinge having a pivot shaft on said guard that is received in a pivot mount clasp on said hub.
4. A safety syringe assembly of claim 3, wherein said guard can be user dependently parked between said open position and said locked safety position.
5. A safety syringe assembly of claim 2, wherein said hinge is a living hinge connecting said guard to said hub.
6. A safety syringe assembly of claim 1, wherein said guard has a tapered distal end to provide a gap between said guard and said syringe barrel when said guard is in said open position to facilitate activation by a user.
7. A safety syringe assembly of claim 1, further comprising a plunger rod having a distal end and a proximal end, said plunger rod being slidably mounted within said chamber of said syringe barrel.
8. A safety syringe assembly of claim 7, wherein dead-space between said distal end of said cannula and said distal end of said plunger rod is no more than 10 μL when said distal end of said plunger rod abuts said distal wall opening of said chamber.
9. A safety syringe assembly of claim 7, wherein said distal end of said plunger rod includes a stopper and wherein dead-space between said distal end of said cannula and said stopper is no more than 10 μL when said stopper of said plunger rod abuts said distal wall opening of said chamber.
10. A safety syringe assembly of claim 1, wherein said guard locks to said hub when in said locked safety position.
11. A safety syringe assembly of claim 1, wherein said guard traps said cannula within said guard when in said locked safety position.
12. A safety syringe assembly of claim 1, wherein said guard locks to said hub and traps said cannula within said guard when in said locked safety position.
13. A safety syringe assembly of claim 1, wherein said guard provides an audible click when entering said locked safety position.
14. A safety syringe assembly of claim 1, wherein said guard provides tactile feedback when entering said locked safety position.
15. A safety syringe assembly of claim 1, wherein said hub is permanently fixed to said syringe barrel.
16. A safety syringe assembly of claim 1, wherein said hub is attached to said syringe barrel using a snap-fit.
17. A safety syringe assembly of claim 1, wherein said syringe assembly includes a re-use prevention frangible plunger feature to prevent re-use after the injection has been completed.
18. A safety syringe assembly of claim 1, wherein said syringe assembly includes an auto-disable plunger locking element feature to prevent re-use after the injection has been completed.
19. A safety syringe assembly of claim 1, wherein said syringe barrel includes gradations on an exterior surface and said hub is attached to said syringe barrel such that said guard does not cover said gradations when in said open position.
20. A safety syringe assembly of claim 1, wherein said distal end of said cannula includes a bevel and said guard is mounted on said hub such that said bevel is properly aligned with said guard to ensure that said guard does not interfere with injection technique when performing an injection with said safety syringe assembly.
Type: Application
Filed: Dec 2, 2021
Publication Date: Sep 8, 2022
Inventor: Richard Caizza (Union City, NJ)
Application Number: 17/540,805