CA3111841A1

CA3111841A1 - Safety syringe assembly

Info

Publication number: CA3111841A1
Application number: CA3111841A
Authority: CA
Inventors: Ty L. Prince
Original assignee: Individual
Current assignee: Individual
Priority date: 2018-09-05
Filing date: 2019-09-04
Publication date: 2020-03-12
Also published as: EP3846882A4; EP3846882A1; CA3184653A1; WO2020051178A1

Abstract

The safety syringe assembly is for inserting a needle into a patient and comprises a needle hub assembly and a safety cover. The needle hub assembly includes a needle, needle hub, and hub flex unit. The needle is mounted on the front side of the needle hub while the rear side is for receiving a syringe. The safety cover houses the needle hub assembly in a first position during shipping, a second position during insertion of the needle into the patient, and in a third position after the needle has been inserted into the patient while awaiting disposal. A portion of the safety cover includes magnification enabling a user to view a dosage calibration scale, needle bevel and air bubbles. The hub flex unit assumes a first enlarged position during shipping, is compressed during insertion into the patient, and slides into a third position after usage while awaiting disposal.

Description

SAFETY SYRINGE ASSEMBLY
FIELD OF THE INVENTION
This invention relates generally to medical protective devices and more particularly, to an improved shielding apparatus for use with syringes to achieve needle protection, one handed operation, a product to improve injection efficiency and comfort and consistent bevel orientation.
BACKGROUND OF THE INVENTION
Many medical conditions require treatment that includes medication administered through injections. Injections may be administered on a regular schedule, and patients needing regular injections often inject the medication themselves. Also, accidental stabs from handling syringes and needles are a common problem and can result in transmission of serious diseases.
In addition, conventional syringes may cause problems in inserting a needle at the correct location and minimizing the amount of pain caused.
Beveled needle tips are often used to ease the pain associated with inserting the needle into the skin. The sharp pointed bevel enables a user to accurately target an injection site.
Efforts to properly orientate the bevel of the needle have been made for several decades.
Some representative efforts include:
U.S. Patent Document No. 20170156983 (Tennican) discloses a syringe device for mixing and administering a medicant. The system includes a medicant vial; a syringe assembly comprising a barrel and a piston; a protective material supporting the syringe assembly and medicant vial; and a member within the system, the member separating the piston of the syringe assembly from the medicant vial. Systems are provided that can include a syringe assembly comprising a barrel and a piston having a forward end and an opposing back end, a protective material supporting the syringe assembly, and a needle housing coupled to the protective material.
U.S. Patent No. 9554736 (Gupta; et al.) discloses a device with integrated allergy testing which provides an allergy detection system for use during catheterization. The allergy detection system is incorporated into specialized syringes, connectors for use with standard syringes, or can be an independent test module designed for the sole purpose of allergy detection. The detection system features a test strip, and a structure to couple the system to a connector, syringe or a housing, to form an independent test module. The detection system is used to detect potential allergic reactions.
U.S. Patent No. 4,436,479 (Belloli) discloses a device is described for orienting intravenous needles or other similar articles having relatively long shank portions which terminates in beveled or flat tips. The device has a fixture for supporting the needles at an angle to the horizontal and with the beveled tip resting on a knife edge. A vibrator is coupled to the needle supporting fixture causing the needle to turn to its most stable position on the knife edge where the flat portion engages the knife edge.
There is a need for a safety syringe system that shields needles and protects a user after an injection is administered without requiring a user to carefully replace a small cap on the needle. There is also a need for syringe systems that facilitates orientation of the needle bevel to give accurate injections and reduce patient pain. Proper intradermal allergy testing requires that the needle bevel should always be inserted bevel up and then rotated bevel down, so that a precise amount of allergen is injected into the area every time (This prevents false positives and false negative results because a positive test is defined as an increase in size of 3.0 mm or greater compared to a saline wheal). In addition, injecting with the bevel down prevents backsplash, which occurs when someone injects bevel up and does not insert the needle bevel all the way under the skin.
Although the art has provided improved devices to facilitate the removal and re-engagement of needle guards while lowering the possibility of accidental needle pokes there is still a need for a simple, straight-forward, reliable, easily fabricated device for the removal and replacement of a needle cover which holds the needle cover in a releasable secure position.
An object of the present invention is to minimize the possibility of a misuse of the needle cover and thereby the possibility of an accidental needle poke.

2 Still, another object of the present invention is to provide a user-protective syringe holder that is compatible with syringes of different manufacturers, and which vary somewhat in size.
Accordingly, an object of the present invention is to provide an improved means for orienting intravenous needles, allergy needles or similar articles having elongated shanks with beveled tips.
SUMMARY OF THE INVENTION
The safety syringe assembly of the present invention addresses these needs and these objectives.
The safety syringe assembly is for inserting a needle into a patient.
The safety syringe assembly comprises a needle hub assembly and a safety cover. The needle hub assembly includes a needle, a needle hub, and a hub flex unit. The needle is mounted on the front side of the needle hub. A syringe is attachable to the rear side of the needle hub.
The hub flex unit is mounted upon the needle hub and includes a flex arm and a flat. The flex arm prevents the needle hub assembly from sliding during shipping and the flat prevents the needle hub assembly from rotating within in the syringe cover during shipping.
The safety cover secures the needle hub assembly in a first position during shipping. The safety cover secures the needle hub assembly in a second position during insertion of the needle into the patient. The safety cover secures the needle hub assembly in a third position after the needle has been inserted into the patient while awaiting disposal. A
portion of the safety cover includes magnification enabling a user to view a dosage calibration scale the needle bevel, detect any air bubbles and to draw up the precise amount of fluid.
The hub flex unit assumes a first enlarged position during shipping, is compressed during insertion into the patient, and slides back into a third position after usage while awaiting disposal.

3 Still other objectives of the safety syringe assembly of the present invention will become apparent to those skilled in this art from the following description wherein there is shown and described in the preferred embodiment of this invention, simply by the way of illustration of the best modes contemplated for carrying out the present disclosure. As will be realized, the present disclosure is capable of different embodiments, and its several details are capable of modification in various, obvious aspects all without departing from the invention. Accordingly, the drawings and descriptions will be regarded as illustrative in nature and not as restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
FIGURE 1A depicts a side elevational view of a first preferred embodiment of a safety syringe assembly of the present invention, with a needle hub assembly in a first position for shipping.
FIGURE 1B depicts a side elevational view of the safety syringe assembly of FIGURE 1A, with a needle hub assembly in a second position for insertion of the needle into the skin of the patient.
FIGURE 1C depicts a side elevational view of the safety syringe assembly of FIGURE 1A, with a needle hub assembly in a third position, the safety syringe assembly having been used and awaiting disposal.
FIGURE 2 depicts a side elevational view of the safety cover for use in the safety syringe assembly of FIGURES 1A, 1B, and 1C, the safety cover including two halves joined together by a breakaway cap.
FIGURE 3A depicts a front view and FIGURE 3B depicts a rear view of a first preferred embodiment of the needle hub assembly of FIGURE 1A, 1B, and 1C, including the needle, a needle hub, and a needle flex unit.
FIGURE 4A depicts a cross sectional view through the safety cover and the needle and needle hub. This shows the red stripe, on the left, the needle bevel is up toward the red stripe and the green stripe is on the right. Also depicted is the needle hub indexing flat toward the magnifier. This design insures that the needle is always pointed upward toward the red stripe, is always 90 degrees from the needle hub flat and that the needle, the

4 needle bevel, the needle hub are always indexed, with respect to the safety cover, enabling the needle bevel to be toward the red stripe, when viewed through the magnifier or gives the user knowledge of the position of the needle bevel position relative on the safety cover.
FIGURE 4B depicts a cross sectional view through the safety cover, the needle, the needle hub and the syringe of the safety syringe assembly of FIGURE 4A. The end of the syringe attaches to the needle hub, with the raised bump ring on the end of the syringe. This shows how the safety syringe assembly of the present invention are compatible with existing syringe designs.
FIGURE 5 depicts the hub assembly of the safety syringe assemble of FIGURES
1A, 1B, and 1C, highlighting the hub flex unit, the hub flex unit being in a first position during shipping, the hub flex unit being in a second position during insertion of the needle into the skin of the patient, and the hub flex unit being in a third position after the needle has been inserted into the skin of the patient awaiting disposal.
FIGURE 6 depicts a half-section of the needle hub assembly of FIGURE 3A.
FIGURE 7 depicts the needle hub assembly of FIGURES 3A and 3B positioned in one half of the safety cover for use in the safety syringe assembly of FIGURE 2, the safety cover including two halves joined together by the breakaway cap.
FIGURE 8 depicts the needle and needle hub placed into half of the safety cover of FIGURE
2, the needle and needle hub, in the first position with the syringe attached to the needle hub.
FIGURE 9 depicts the safety cover assembly of FIGURES 1A, 1B, and 1C and a syringe in position that enables for filling of the device from the vial of medical fluid. The safety cover magnifies the volume scale to ensure that the proper amount of fluid is drawn.
FIGURE 10 depicts still another preferred embodiment of the safety cover for use with the safety syringe assembly of the present invention with a lock lever to enable unobstructed movement of the needle hub assembly from the second position to the third position along with a Detail "A" of the lock lever.
FIGURE 11 depicts yet still another preferred embodiment of the safety cover for use with the safety syringe assembly of the present invention with a lock lever to enable unobstructed movement of the needle hub assembly from the second position to the third position along with a Detail "B" of the lock lever.
FIGURE 12A depicts a front side view and FIGURE 12B depicts a rear detail view of a second preferred embodiment of the safety cover and needle hub assembly of FIGURE 1A, 1B, and 1C, including the needle, a needle hub, and a needle flex unit. Also depicted is the needle hub indexing flat toward the magnifier. This design ensures that the needle is pointed upward toward the red stripe, is always 90 degrees from the needle hub flat and that the needle, the needle bevel, the needle hub is indexed with respect to the safety cover, enabling the needle bevel to be facing toward the red stripe when viewed through the magnifier or provides the user knowledge of the position of the needle bevel position relative on the safety cover.
DETAILED DESCRIPTION OF THE PRESENT INVENTION
Referring now to the drawings, FIGURES 1A, 1A, and 1C each depict side elevational views of a first preferred embodiment of a safety syringe assembly of the present invention [10].
The safety syringe assembly of the present invention [10] preferably comprises a needle hub assembly [70] and a safety cover [30].
FIGURE 1A depicts the safety cover [30] housing the needle hub assembly [70]
in a first position for shipping. FIGURE 1B depicts the safety cover [30] housing the needle hub assembly [70] in a second position for insertion of the needle [16] into the skin of the patient. FIGURE 1C depicts the safety cover [30] housing the needle hub assembly [70] in a third position, the safety syringe assembly [10] having been used and awaiting disposal.
The needle hub assembly [70] includes a hub flex unit mounted upon a needle hub [76], and the needle hub [76] for retaining the needle [16] securely mounted therewithin. The hub flex unit includes a flex arm [77] and a flat [78]. The flex arm [77]
prevents the needle hub assembly [70] from sliding within the safety cover [30] during shipping.
The flat [78]
prevents the needle hub assembly [70] from rotating within the safety cover [30] during shipping.
The needle hub assembly [70] is preferably color coded at the factory, for either a long injection needle (for example, blue) or a shorter needle for testing (for example, white). This ensures that the proper needle length is used for either injection or testing. The current needles used in the industry color code the cap. The cap is a separate piece which can be switched. If the color-coded caps are switched, a longer injection needle may be used for testing and a shorter testing needle may be used for injections. Using the incorrect needle length can give false allergy test results or not enable the allergy fluid to be injected to the proper depth under the skin.
In addition, the safety cover [30] preferably uses visual indicators or alignment markers [33 and 34], such as colored stripes (for example, a green and a red stripe on the safety cover [30]) to indicate the orientation of the needle bevel [18]. In this example, red shows bevel [18] up for insertion under the skin and the green shows the needle bevel [18]
down for dispensing of the fluid under the skin.
The safety cover [30] is made of clear material enabling light to enter the safety cover [30] providing for a clear view of the needle bevel [18] orientation, the needle length, as well as enabling light into the safety cover [30] for the reading of the syringe volume scale [46], through the lens, during the process of filling the syringe [45] from the vial of allergy fluid.
The safety cover [30] preferably protects either a short needle [16] for testing or a longer needle [16] for injections. The safety cover [30] includes a window [39].
The safety syringe assembly of the present invention [10] enables one-handed operation by the medical technician or user.
The safety cover [30] and needle hub assembly [70] of the present invention are both indexed to the needle bevel [18] ensuring that during either testing or injection, the needle bevel [18] is up for insertion and down for dispensing. The current needle used in the allergy industry is not indexed to the needle bevel [18]. This enables the needle bevel [18] to be inserted in any orientation and dispensed in any orientation. This current product is deficient in that it does not enable the proper circular bubble to be created under the skin for testing (enabling false positives or no positive at all) and can cause the fluid to be sprayed back onto the medical technician or user during injection.
The safety cover [30] has now moved past the original position with the needle hub pads locked into recesses into this safe (disposal) pocket of the safety cover [30]. Once in this position, the needle [16], needle hub [76], safety cover [30] and syringe [45]
can be disposed of together or the needle [16], needle hub [76] and safety cover [30]
can be removed from the syringe [45] and disposed of separately.
FIGURE 2 depicts a side elevational view of the safety cover [30] for use in the safety syringe assembly [10] of FIGURES 1A, 1B, and 1C, the safety cover [30]
including two halves joined together by a breakaway cap [40]. The breakaway cap [40] is attached to both halves of the safety cover [30], holding them together and in position, relative to each other, until needle hub assembly [70] can be placed into the safety cover [30]
and the breakaway cap [40] glued closed. Preferably, the two halves of the safety cover [30] are glued together. The adhesive is applied as recommended by the manufacturer taking care to avoid the hub assembly and the windows [39].
Also depicted are the two openings for the needle hub pads assemblies, an initial position, as well as the locking recesses used to lock the needle hub assembly [70] into a disposal position.
The assembly is closed, clamped and cured per manufacturer instructions.
Packaging and sterilization protocols are then followed.
FIGURE 3A depicts a front view and FIGURE 3B depicts a rear view of a first preferred embodiment of the needle hub assembly [70] of FIGURE 1A, 1B, and 1C, including the needle [16], a needle hub [76], and a needle [16] flex unit. The needle hub [76] includes locking pads and 4 spring members, two spring members for each pad, that are used to hold the needle [16] and needle hub [76] in their initial position or are used to lock the needle [16] and needle hub [76] in their locked position for disposal.
FIGURE 4A depicts a cross sectional view through the safety cover [30] and the needle [16]
and needle hub [76]. This shows the red stripe, on the left, the needle bevel [18] up toward the red stripe and the green stripe on the right. Also depicted is the needle hub [76] indexing flat [78] toward the magnifier. This design insures that the needle [16] is always pointed upward toward the red stripe, is always 90 degrees from the needle hub flat [78] and that the needle [16], the needle bevel [18], the needle hub [76]
are always indexed, with respect to the safety cover [30], enabling the needle bevel [18]
to be toward the red stripe, when viewed through the magnifier or gives the user knowledge of the position of the needle bevel position relative on the safety cover [30]. This shows the red stripe, on the left, the needle bevel [18] up toward the red stripe and the green stripe on the right. It also shows the needle hub indexing flat [78] toward the magnifier. This design ensures that the needle [16] is always pointed up toward the red stripe, is always 90 degrees from the needle hub flat [78] and that the needle [16], the needle bevel [18], the needle hub [76] are always indexed, with respect to the safety cover [30], enabling for the needle bevel [18] to be toward the red stripe, when viewed through the magnifier or provides the medical professional knowledge of the position of the needle bevel [18]
relative to the red stripe on the safety cover [30].
FIGURE 4B depicts a cross sectional view through the safety cover [30], the needle [16], the needle hub [76] and the syringe [45] of the safety syringe assembly [10]
of FIGURE 4A.
The end of the syringe [45] attaches to the needle hub [76], with the raised bump ring on the end of the syringe [45]. This shows how the safety syringe assembly of the present invention [10] are compatible with existing syringe designs. FIGURE 4B shows how the end of the syringe [45] attaches to the needle hub assembly [70], with the raised bump ring on the end of the syringe [45]. This design enables the safety syringe assembly [10] of the present invention to be compatible with an existing syringe design. This syringe design is made in the millions each year. Slight modifications to the needle hub [76]
can be made enabling the safety syringe assembly [10] to be used with other standard medical syringes.
FIGURE 5 depicts the hub assembly of the safety syringe assemble of FIGURES
1A, 1B, and 1C, highlighting the hub flex unit, the hub flex unit being in a first position during shipping, the hub flex unit being in a second position during insertion of the needle [16] into the skin of the patient, and the hub flex unit being in a third position after the needle [16]
has been inserted into the skin of the patient awaiting disposal.
The safety syringe assembly of the present invention [10] enables the medical technician or user to push one or two buttons on the needle hub [76], releasing the needle [16] and hub from an initial safety position. After the release, the syringe [45], protected needle [16] and safety cover [30] can be placed on the top of the vial of allergy fluid and be safely inserted into the vial for the extraction of the fluid into the syringe [45].
This protects the medical technician or user from the potential stick hazard of an exposed needle [16]
during the process of extracting fluid from the vial.

FIGURE 6 depicts a half-section of the needle hub assembly [70] of FIGURE 3A.
The hub well, into which the cannula is inserted, has two functions. The hub well [86]
helps to align the adhesive-dispensing tip with the cannula-to-hub bond joint and the hub well [86]
helps to promote adhesive flow into the bond line.
FIGURE 7 depicts the needle hub assembly of FIGURES 3A and 3B positioned in one half of the safety cover [30] for use in the safety syringe assembly [10] of FIGURE 2, the safety cover [30] including two halves joined together by the breakaway cap [40].
The needle [16] and needle hub [76] are inserted into a half [36] of the safety cover without the magnifier. It also shows the needle [16] and needle hub [76] in their initial position. After the needle [16] and needle hub [76] are placed into this position, an adhesive can be placed on the edge of half of the safety cover [30] and the safety cover [30] is closed, creating the safety cover [30], needle [16] and needle hub assembly [70].
This safety syringe assembly [10] is now ready to have the syringe [45]
inserted.
FIGURE 8 depicts the needle [16] and needle hub [76] placed into half of the safety cover [30] of FIGURE 2, the needle [16] and needle hub [76], in the first position with the syringe [45] attached to the needle hub [76].
The needle [16] and needle hub [76] are shown into half of the safety cover, the needle [16] and needle hub [76], in their initial position, with the syringe [45]
attached to the needle hub [76]. The syringe volume scale [46] does not have to be placed in this position because it can be rotated, later, on the needle hub [76], to enable the scale [46] to be visible through the magnifier.
To initiate operation, the syringe [45] is pushed firmly into the needle hub [76] taking care not to depress the flex arms [77].
FIGURE 9 depicts the safety cover [30] assembly of FIGURES 1A, 1B, and 1C and a syringe [45] in position that enables for filling of the device from the vial of medical fluid. The safety cover [30] magnifies the volume scale [46] to ensure that the proper amount of fluid is drawn.
The safety cover [30] includes magnification to magnify the volume scale [46]
on the syringe [45], for both a long and short needle, and magnifies a large portion of the volume scale [46]. Magnifying is particularly important when injecting low doses (0.01 to 0.30 ml) and permitting the practitioner, nurse, or user to detect air bubbles that can significantly alter the amount of allergen drawn into the syringe [45] and can also increase the risk of blood clots developing in the patient after injection. In addition, magnification can significantly affect the reproducibility of the skin test wheal (bleb) when comparing the saline negative control injection to the actual allergy injection. Proper intradermal allergy testing requires inserting the needle [16] under skin bevel [18] up and rotating the needle [16] 180 degrees and injecting the allergen bevel [18] down to prevent splash-back on the practitioner, nurse, or user if the needle bevel [18] is not fully inserted and to have all of the allergy tests injected needle bevel [18] down so every test is done the same way by all practitioners.
For scale alignment, when the thumb stop [49] and the plunger [88] are aligned, the scale [46] appears in the magnifying window and the needle bevel [18] faces upward.
The safety cover magnifier magnifies the volume scale [46] to ensure that the proper amount of fluid is drawn into the syringe [45]. With the needles and syringes, used today, it is difficult to read the small graduations, on the syringe volume scale [46]. Without drawing in the proper amount of allergy fluid, false positives or false negatives are possible, during testing. Without the proper volume of allergy fluid being drawn into the syringe [45], allergy injections could be less affective.
FIGURE 10 depicts another preferred embodiment of the safety cover [30] for use with the safety syringe assembly [110] of the present invention with a lock lever [112]
to enable unobstructed movement of the needle hub assembly [170] from the second position to the third position along with a Detail "A" of the lock lever [112]. The lock lever ensures that the flex arm [77] of the needle hub assembly [70] will not become reengaged with the window [39] of the safety cover [30].
FIGURE 11 depicts yet another preferred embodiment of the safety cover [30]
for use with the safety syringe assembly [10] of the present invention with a lock lever [212] to enable unobstructed movement of the needle hub assembly [70] from the second position to the third position along with a Detail "B" of the lock lever [212]. The lock lever ensures that the flex arm [77] of the needle hub assembly [70] will not become reengaged with the window [39] of the safety cover [30].
FIGURE 12A depicts a front view and FIGURE 12B depicts a rear view of a second preferred embodiment of the needle hub assembly [70] of FIGURE 1A, 1B, and 1C, including the needle [16], a needle hub [76], and a needle flex unit. The needle hub assembly [70]
includes locking pads and four spring members, two spring members for each pad, that are used to hold the needle [16] and needle hub [76] in their initial position or are used to lock the needle [16] and needle hub [76] in their locked position for disposal.
To perform a visual check, the needle [16] should be clearly visible in the magnifier [44]
of the safety cover with the needle bevel [18] facing toward the red stripe.
To initiate filling, the one or more flex arms [77] are pressed, and the safety cover [30]
slides back on the syringe [45] to expose the needle [16]. Then fill the safety syringe assembly of the present invention [10] to the desired level, as the cap is unlocked into this position, as the syringe [45] is held and the plunger [88] is pulled to fill.
To dispose after dispensing, pull the plunger [88] back so that the needle hub assembly [70] is in the shipping position and depress the arms [77] again, continuing pulling until the needle hub assembly [70] snaps into the dispose pockets [32] and the syringe [45] pops off.
The release points on the needle hub [76] are tapered such that after injection, the safety cover [30] can be moved into a locked position that insures that the needle [16] with allergy fluid, potential blood and bodily fluid will not expose the medical technician or user to any bio-hazards because the safety cover [30] will completely cover the needle [16].
The safety cover [30], with the needle [16] and needle hub [76] in the locked position lock the safety cover [30], needle [16] and needle hub [76] together such that this bio-hazard can be properly disposed of, in a sharps container and the syringe [45] can be separated from the safety cover [30], needle [16] and needle hub [76] for recycling by placing the syringe [45] in a separate container.
For shipping, the hub with flex arms [77] are positioned in shipping windows with the needle [16] pointing toward sharps guard and needle bevel [18] toward red stripe.

The syringe [45] can be rotated to any position, but the needle bevel [18]
will maintain its position.
The safety syringe assembly [10] is snapped off and disposed of in recycling.
The needle hub assembly [70] is locked into the dispose pocket [32] and cannot be dislodged easily.
The needle [16] is contained and is disposed of in the sharps container while the syringe [45] is recycled.
Throughout this application, various Patents and Applications are referenced by number and inventor. The disclosures of these documents in their entireties are hereby incorporated by reference into this specification in order to more fully describe the state of the art to which this invention pertains.
It is evident that many alternatives, modifications, and variations of the safety syringe assembly of the present invention will be apparent to those skilled in the art in lieu of the disclosure herein. It is intended that the metes and bounds of the present invention be determined by the appended claims rather than by the language of the above specification, and that all such alternatives, modifications, and variations which form a conjointly cooperative equivalent are intended to be included within the spirit and scope of these claims.

PARTS LIST
- Safety Syringe Assembly - 1st Embodiment 16 - Needle 18 - Needle Bevel 30 - Safety Cover 32 - Dispose Pocket 33 and 34 - Up and Down Alignment Markers 36 and 38 - Safety Cover First and Second Portions 39 - Safety Cover Window 40 - Breakaway Cap 44 - Magnifier 45 - Syringe 46 - Syringe Calibration Scale 49 - Thumb Stop 70 - Needle Hub Assembly 74 - Hub Flex Unit 76 - Needle Hub 77 and 78 - Hub Flex Arm and Hub Flat 82 - Alignment Pins 84 - Alignment Holes 86 - Hub Well 88 - Plunger 110 - Safety Syringe Assembly - 2nd Embodiment 112- Lock Lever 170 - Needle Hub Assembly 212 - Lock Lever

Claims

WO 2020/051178 PCT/US2019/049441

1 . A safety syringe assembly in administering a needle into skin of a patient, said safety syringe assembly comprising:
a needle hub assembly including a hub flex unit mounted upon a needle hub, and said needle hub for retaining said needle securely mounted therewithin, said hub flex unit including a flex arm and a flat; and a safety cover, said safety cover including a window;
whereby said flex arm prevents said needle hub assembly from sliding within said safety cover during shipping, and said flat prevents said needle hub assembly from rotating within said safety cover during shipping; and whereby said safety cover houses said needle hub assembly in a first position, said safety cover houses said needle hub assembly in a second position, and said safety cover houses said needle hub assembly in a third position, said first position of said safety cover being for shipping, said second position of said safety cover being for insertion of said needle into said skin of said patient, and said third position of said safety cover being for disposal of said needle hub assembly after said needle has been inserted into said skin of said patient awaiting disposal.

2. The safety syringe assembly of Claim 1, wherein said safety syringe assembly enables operation with one hand.

3. The safety cover syringe assembly of Claim 1, wherein said needle and said needle hub may be separated from said syringe assembly, enabling said safety cover, said needle and said needle hub to be disposed in a sharps container, said syringe to be disposed in a separate container from said safety cover for recycling.

4. The safety syringe assembly of Claim 1, wherein in said third position relative to said safety cover said needle hub assembly is locked into a position surrounded within said safety cover to protect personnel from contaminated body fluid.

5. The safety syringe assembly of Claim 1, wherein a portion of said safety cover is made of a clear material enabling light to pass therethrough, said portion including magnification enabling a user to view a dosage calibration scale, the needle bevel and air bubbles.

6. The safety syringe assembly of Claim 1, wherein when a thumb stop and a plunger of said safety cover are in alignment, said dosage calibration scale is within said magnification, said needle bevel being visible.

7. The safety syringe assembly of Claim 1, wherein for said first position of said safety cover is between said second position and said third position.

8. The safety syringe assembly of Claim 1, wherein said hub flex unit being in a first position during shipping, said hub flex unit being in a second position during insertion of said needle into said skin of said patient, and said hub flex unit being in a third position after said needle has been inserted into said skin of said patient awaiting disposal.

9. The safety syringe assembly of Claim 1, wherein said user pushes a finger into said window to depress said flex arm to initiate movement of said needle hub assembly from said first position into said second position.

10. A safety cover for use in administering a needle into skin of a patient, said safety syringe assembly comprising:
a safety cover, said safety cover including a thumb stop, and a window; and a needle hub assembly including a needle hub for retaining a needle mounted thereon, said needle hub including a flex arm and a flat, said flex arm preventing said needle hub from sliding within said safety cover, said flat preventing said needle hub from rotating within in said safety cover during shipping;
whereby said safety cover is compatible with a needle hub assembly, said needle hub assembly including a needle hub, said needle hub having a needle mounted on a front side thereof, said rear side of said needle hub being compatible for receiving a syringe, said needle hub assembly including a hub flex unit, said hub flex unit including a flex arm, said flex arm preventing said needle hub from sliding within a syringe assembly cover during shipping; and whereby said safety cover houses said needle hub assembly in a first position, in a second position, and in a third position, said first position being for shipping, said second position being for inserting said needle into skin of a patient, and said third position being for disposal of said needle hub assembly after said needle has been inserted into said skin of said patient.

11. The safety cover of Claim 10, wherein an unassembled safety cover includes a first portion and a second portion joined together by a breakaway cap.

12. The safety cover of Claim 10, wherein said safety cover includes at least one visual indicator of an orientation of a needle bevel, enabling said needle bevel to be inserted under said skin of said patient with needle bevel up, said safety cover, needle, needle hub and syringe to be rotated such that said needle bevel is down after insertion into said patient.

13. The safety cover of Claim 10, wherein a breakaway cap is attached to a first and second portion of said safety cover, holding said first and second portion together and in position relative to each other, prior to inserting said needle hub assembly into said safety cover.

14. The safety cover of Claim 10, wherein a portion of said safety cover is made of a clear material enabling light to pass therethrough and includes magnification enabling a user to view a dosage calibration scale, a needle bevel and air bubbles.

15. A needle hub assembly for use in a safety syringe assembly for administering a needle into skin of a patient, said needle hub assembly comprising:
a needle;
a needle hub, said needle hub having said needle mounted on a front side thereof, said rear side of said needle hub being compatible for receiving a syringe; and a hub flex unit mounted upon said needle hub, said hub flex unit including a flex arm and a flat, said flex arm preventing said needle hub assembly from sliding within a safety cover, said flat preventing said needle hub assembly from rotating within in said safety cover during shipping;
whereby said flex arm extends through a window of said safety cover; and whereby a user of said needle hub assembly releases said needle hub assembly from a storage position within said safety cover by pressing said flex arm.

16. The needle hub assembly of Claim 15, wherein said flex arm can be rotated into any position but said needle bevel maintains an initial position.

17. The needle hub assembly of Claim 15, wherein said needle hub includes a hub well for storing adhesive.

18. The needle hub assembly of Claim 15, wherein said hub flex unit is in a first position during shipping, said hub flex unit is in a second position during insertion of said needle into said skin of said patient, and said hub flex unit is in a third position after said needle has been inserted into said skin of said patient awaiting disposal.

19. The needle hub assembly of Claim 15, wherein said hub flex unit assumes a first position during shipping, and is compressed after usage while awaiting disposal.

20. The needle hub assembly of Claim 16, wherein visual indicators on said safety cover indicate needle bevel position enable a needle bevel to be inserted under said skin of said patient with said needle bevel up, said safety cover, said needle, said needle hub and said syringe to be rotated such that said needle bevel is down after insertion into said patient.