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WO2020051178A1 - Ensemble seringue de sécurité - Google Patents

Ensemble seringue de sécurité Download PDF

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Publication number
WO2020051178A1
WO2020051178A1 PCT/US2019/049441 US2019049441W WO2020051178A1 WO 2020051178 A1 WO2020051178 A1 WO 2020051178A1 US 2019049441 W US2019049441 W US 2019049441W WO 2020051178 A1 WO2020051178 A1 WO 2020051178A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
safety cover
needle hub
hub
assembly
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2019/049441
Other languages
English (en)
Inventor
Ty L. PRINCE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to EP19857259.6A priority Critical patent/EP3846882A4/fr
Priority to CA3111841A priority patent/CA3111841A1/fr
Publication of WO2020051178A1 publication Critical patent/WO2020051178A1/fr
Anticipated expiration legal-status Critical
Priority to AU2021201821A priority patent/AU2021201821B2/en
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3293—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle hub
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/1782—Devices aiding filling of syringes in situ
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3125—Details specific display means, e.g. to indicate dose setting
    • A61M2005/3126—Specific display means related to dosing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M5/3137—Specially designed finger grip means, e.g. for easy manipulation of the syringe rod
    • A61M2005/3139—Finger grips not integrally formed with the syringe barrel, e.g. using adapter with finger grips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3246—Constructional features thereof, e.g. to improve manipulation or functioning being squeezably deformable for locking or unlocking purposes, e.g. with elliptical cross-section
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3253—Constructional features thereof, e.g. to improve manipulation or functioning disconnecting the needle hub from the syringe barrel during removal of the sleeve from the syringe barrel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A61M2205/585—Means for facilitating use, e.g. by people with impaired vision by visual feedback having magnification means, e.g. magnifying glasses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/586—Ergonomic details therefor, e.g. specific ergonomics for left or right-handed users
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub

Definitions

  • 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.
  • 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.
  • 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.
  • U.S. Patent Document No. 20170156983 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 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 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.
  • 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.
  • 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).
  • 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.
  • 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. 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.
  • 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.
  • 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.
  • 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 1 B 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 1 C 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, 1 B, and 1 C, 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, 1 B, and 1 C, 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 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, 1 B, and 1 C, 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, 1 B, and 1 C 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 1 1 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 1 A, 1 B, and 1 C, 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.
  • FIGURES 1A, 1A, and 1 C 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 1 B 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 1 C 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 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.
  • 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].
  • 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].
  • 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, 1 B, and 1 C, 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.
  • 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].
  • 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, 1 B, and 1 C, 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 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].
  • 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, 1 B, and 1 C, 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.
  • 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, 1 B, and 1 C 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.
  • 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.
  • the safety cover magnifier magnifies the volume scale [46] to ensure that the proper amount of fluid is drawn into the syringe [45].
  • 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, 1 B, and 1 C, 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.
  • 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.
  • 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.
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Environmental & Geological Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un ensemble seringue de sécurité qui est destiné à insérer une aiguille dans un patient et qui comprend un ensemble raccord d'aiguille et un couvercle de sécurité. L'ensemble raccord d'aiguille comprend une aiguille, un raccord d'aiguille et une unité de flexion de raccord. L'aiguille est montée sur le côté avant du raccord d'aiguille tandis que le côté arrière est destiné à recevoir une seringue. Le couvercle de sécurité reçoit l'ensemble raccord d'aiguille dans une première position pendant le transport, une deuxième position pendant l'insertion de l'aiguille dans le patient, et une troisième position une fois que l'aiguille a été insérée dans le patient tout en attendant la mise au rebut. Une partie du couvercle de sécurité comprend un agrandissement permettant à un utilisateur de visualiser une échelle d'étalonnage de dosage, un biseau de l'aiguille et des bulles d'air. L'unité de flexion de raccord adopte une première position agrandie pendant le transport, est comprimée pendant l'insertion dans le patient, et coulisse dans une troisième position après utilisation tout en attendant la mise au rebut.
PCT/US2019/049441 2018-09-05 2019-09-04 Ensemble seringue de sécurité Ceased WO2020051178A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP19857259.6A EP3846882A4 (fr) 2018-09-05 2019-09-04 Ensemble seringue de sécurité
CA3111841A CA3111841A1 (fr) 2018-09-05 2019-09-04 Ensemble seringue de securite
AU2021201821A AU2021201821B2 (en) 2018-09-05 2021-03-23 Processes for utilizing safety syringe assemblies

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862727136P 2018-09-05 2018-09-05
US62/727,136 2018-09-05

Related Child Applications (1)

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AU2021201821A Division AU2021201821B2 (en) 2018-09-05 2021-03-23 Processes for utilizing safety syringe assemblies

Publications (1)

Publication Number Publication Date
WO2020051178A1 true WO2020051178A1 (fr) 2020-03-12

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EP (1) EP3846882A4 (fr)
CA (2) CA3111841A1 (fr)
WO (1) WO2020051178A1 (fr)

Citations (4)

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Publication number Priority date Publication date Assignee Title
US6322540B1 (en) * 2000-03-10 2001-11-27 International Technology Group Safe needle device for syringe
US20050101918A1 (en) * 2003-11-12 2005-05-12 Chang-Tzu Chen Protective injection needle
US9078978B2 (en) * 2011-12-28 2015-07-14 Stat Medical Devices, Inc. Needle assembly with safety system for a syringe or fluid sampling device and method of making and using the same
US20170106149A1 (en) * 2014-03-24 2017-04-20 Medimmune, Llc Single-Use, Self Destructing Shield for Syringe Needle

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Publication number Priority date Publication date Assignee Title
US6017329A (en) * 1989-03-02 2000-01-25 Hake; Lawrence W. Hypodermic needle guard and method to prevent needle stick injuries
US5713873A (en) * 1993-10-18 1998-02-03 Marlene J. Mash Hypodermic needle assembly
US6190361B1 (en) * 2000-04-18 2001-02-20 Gettig Technologies, Inc. Selectively lockable needle guard
US20090187153A1 (en) * 2008-01-14 2009-07-23 West Richard L Winged needle assembly and frangible cover

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Publication number Priority date Publication date Assignee Title
US6322540B1 (en) * 2000-03-10 2001-11-27 International Technology Group Safe needle device for syringe
US20050101918A1 (en) * 2003-11-12 2005-05-12 Chang-Tzu Chen Protective injection needle
US9078978B2 (en) * 2011-12-28 2015-07-14 Stat Medical Devices, Inc. Needle assembly with safety system for a syringe or fluid sampling device and method of making and using the same
US20170106149A1 (en) * 2014-03-24 2017-04-20 Medimmune, Llc Single-Use, Self Destructing Shield for Syringe Needle

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP3846882A4 *

Also Published As

Publication number Publication date
EP3846882A1 (fr) 2021-07-14
CA3184653A1 (fr) 2020-03-12
CA3111841A1 (fr) 2020-03-12
EP3846882A4 (fr) 2022-09-14

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