WO2012082818A2 - Device for removing a needle shield from a syringe and method of using same - Google Patents

Device for removing a needle shield from a syringe and method of using same Download PDF

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Publication number
WO2012082818A2
WO2012082818A2 PCT/US2011/064771 US2011064771W WO2012082818A2 WO 2012082818 A2 WO2012082818 A2 WO 2012082818A2 US 2011064771 W US2011064771 W US 2011064771W WO 2012082818 A2 WO2012082818 A2 WO 2012082818A2
Authority
WO
WIPO (PCT)
Prior art keywords
needle shield
opening
passageway
syringe
plunger
Prior art date
Application number
PCT/US2011/064771
Other languages
French (fr)
Other versions
WO2012082818A3 (en
Inventor
Christopher Evans
Brian Costello
Original Assignee
West Pharmaceutical Services, Inc.
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 West Pharmaceutical Services, Inc. filed Critical West Pharmaceutical Services, Inc.
Publication of WO2012082818A2 publication Critical patent/WO2012082818A2/en
Publication of WO2012082818A3 publication Critical patent/WO2012082818A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3202Devices for protection of the needle before use, e.g. caps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3213Caps placed axially onto the needle, e.g. equipped with finger protection guards

Definitions

  • the present invention is generally directed to a device for removing a needle shield from a syringe and, more particularly, to a needle shield removal system that includes a tool to safely and easily remove a needle shield from a syringe and/or deter or prevent recapping of the needle shield onto the syringe after use.
  • numerous medical procedures employ a device having an exposed sharpened tip attached to a medical instrument.
  • the needle cannula of such devices are commonly covered by a shield during non-use or before use to maintain the cannula in a clean, sometimes sterile, condition and to prevent unintentional needle pricks.
  • needle shields 12 are typically formed of a rubber enclosure having a generally circular lateral cross-section that surrounds the portion of the needle cannula that extends outside or beyond the shoulder of a syringe 14 (see Figs. 13 and 14).
  • An exterior surface of the needle shield 12 may include one or more ribs or projections 12a that extend around the entire outer circumference or perimeter thereof.
  • These types of needle shields are conventionally referred to as a "rubber needle shield.”
  • a generally rigid cover 16 preferably formed of a polymeric material, may enclose the rubber needle shield 12.
  • the rigid cover 16 also has a generally circular lateral cross-section, but is generally larger than the rubber needle shield 12, such that the rubber needle shield 12 can fit within an interior of the rigid cover 16.
  • the rigid cover 16 may include two opposed slots or openings 16a that each extend through a sidewall thereof.
  • the combined rubber needle shield 12 and rigid cover 16 is conventionally referred to as a "rigid needle shield,” generally designated 13 in Fig. 1.
  • the rubber needle shield 12 alone may cover the exposed portion of the needle cannula, or the combined rigid needle shield 13 may enclose the exposed portion of the needle cannula.
  • Both the rubber needle shield 12 and the combined rigid needle shield 13 are often referred to simply as a "needle shield.”
  • a user's body upon abrupt release of the needle shield 12, 13 from the syringe 14, a user's body inherently attempts to compensate for this "breakaway” by slightly “putting on the brakes” or pulling back slightly against the initial force.
  • the "pullback" often results in the hand that directly grasps the needle shield 12, 13 to recoil or "bounce back" toward the uncovered needle cannula in the other hand.
  • users often stab or prick themselves during this process.
  • a device for removing a needle shield from a syringe includes a body having a first end and an opposing second end. A central longitudinal axis extends from the first end to the second end. The first end defines a first opening for receiving at least a portion of the needle shield within the body, The second end defines a second opening. The body defines a passageway between the first and second openings. A pair of opposing projections extend generally perpendicularly to the central longitudinal axis proximate to the second end of the body.
  • a device for removing a needle shield from a syringe includes a body having a first end, an opposing second end, and a central longitudinal axis extending from the first end to the second end.
  • the first end defines a first opening for receiving at least a portion of the needle shield.
  • the second end defines a second opening.
  • the body defines a passageway between the first and second openings.
  • a recess is formed on an interior surface of the body that defines the passageway, the recess being sized and shaped to engage a rib formed on an exterior surface of the needle shield.
  • FIG. 1 is a perspective view of a prior art rigid needle shield for a syringe
  • Fig. 4 is a cross-sectional elevation view of the device shown in Fig. 2 taken along line "4-4" in Fig. 3;
  • FIG. 5 is an enlarged cross-sectional elevation view of a portion of the device shown in Fig. 2 taken from area "5" in Fig. 4;
  • FIG. 6 is another side elevation view of the device shown in Fig. 2;
  • Fig. 7 is a cross-sectional elevation view of the device shown in Fig. 2 taken along line "7-7" in Fig. 6;
  • Fig. 8 is an enlarged cross-sectional elevation view of a portion of the device shown in Fig. 2 taken from area "8" in Fig. 7;
  • Fig. 9 is a top plan view of the device shown in Figs. 3 and 6;
  • Fig. 10 is a bottom plan view of the device shown in Figs. 3 and 6;
  • FIG. 11 is a top perspective view of a modified version of the device shown in Fig. 2, with a plunger and a body of the device shown in a first position;
  • Fig. 12 is a top perspective view of the device shown in Fig. 1 1, with the plunger and the body of the device shown in a second position;
  • FIG. 13 is a perspective view of the device shown in Fig. 2 attached to a conventional syringe;
  • Fig. 14 is a perspective view depicting a user removing a needle shield from a syringe with the device shown in Fig. 2;
  • FIG. 15 is a top perspective view of a device for removing a needle shield from a syringe according to a second preferred embodiment of the present invention.
  • Fig. 16 is a bottom perspective view of the device shown in Fig. 15;
  • Fig. 17 is a side elevation view of the device shown in Fig. 16;
  • Fig. 18 is a cross-sectional elevation view of the device shown in Fig. 15 taken along line "18-18" in Fig. 17;
  • Fig. 19 is a bottom cross-sectional plan view of the device shown in Fig. 15 taken along line "19-19" in Fig. 17;
  • Fig. 20 is a top plan view of the device shown in Fig. 15;
  • Fig. 21 is a cross-sectional elevation view of the device shown in Fig. 15 taken along line "21-21" in Fig. 20;
  • Fig. 22 is a perspective view of a modified version of the device shown in Fig. 2 for use with a safety device;
  • Fig. 22a is an enlarged cross-sectional view of a portion of the device of Fig. 22 taken from area "C";
  • Fig. 23 is a side elevational view of the device shown in Fig. 22 with the safety device attached;
  • FIG. 24 is a side perspective view of another modified version of the device shown in Fig. 2 having a retention ring therein;
  • Fig. 25a is an exploded perspective view of the retention ring of Fig. 24 in a first position for engaging with a rigid needle shield;
  • Fig. 25b is an elevational view of the retention ring of Fig. 24 in a second position engaged with a rigid needle shield.
  • a first preferred embodiment of a device for removing a rigid needle shield 13 from a syringe 14 (Fig. 13) and/or deterring or preventing re-capping of the rigid needle shield 13 onto the syringe 14.
  • the device 10 is preferably sized and shaped to engage and/or receive at least a portion of the rigid needle shield 13 therein.
  • the device 10 preferably includes a body 20 having a first, lower or distal end 22 and an opposing second, upper or proximal end 24.
  • the body 20 preferably has a cylindrical or generally oval shape and is preferably sized and shaped to relatively easily, comfortably and ergonomically fit between two adjacent fingers of a user's hand (see Fig. 14).
  • the body 20 is not limited to a particular size and/or shape, as the outer perimeter of the body 20 may be planar or flat, such as rectangular in shape.
  • Central longitudinal axis 26 (Figs. 2 and 13) extends from at least the first end 22 to the second end 24 of the body 20 and extends through a geometric center of the body 20.
  • the rubber needle shield 12 As the rib 12a passes through the passageway 132 and enters the recess 170, the rubber expands, filling the recess 170 and locking the rubber needle shield 12 in the body 120.
  • the body 120 provides structural rigidity to the rubber needle shield 12 and, therefore, effectively acts similarly to the rigid cover 16 of the rigid needle shield 13.
  • the device 110 of the second preferred embodiment when combined with the rubber needle shield 12 may be considered to be an active rigid needle shield.
  • the device 210 has an expanded body 220 for coupling with a safety device 250.
  • the expanded body 220 has a larger circumference than the body 20, 120 of the device 10, 110 in order to accommodate the safety device 250.
  • the safety device 250 further helps to prevent needle pricks by positioning the needle of the syringe within the body of the safety device 250 during removal of the needle shield 13.
  • the safety device 250 is a WEST B.SAFE safety device, which has a first end 260 and a second end 262. The safety device 250 is inserted into the first end 222 of the device 210.
  • a passageway 264 connects the first end 260 to the second end 262 of the safety device 250.
  • An interior sidewall of the safety device 250 which generally defines the passageway 264, preferably includes a pair of opposing protrusions 252 that extend inwardly into the passageway 264. Specifically, at least a portion of each protrusion 252 extends generally perpendicularly to the central longitudinal axis 226. It is preferred that each protrusion 252 is sized and shaped to fit within a slot 16a in a side wall of a rigid cover 16 of the rigid needle shield 13 (Fig. 2). Thus, when a needle shield 13 is inserted into the safety device 250, the protrusions 252 of the safety device 250 engage with the slots 16a of the needle shield 13 to maintain the needle shield 13 within the safety device 250.
  • the retention ring 350 is co-molded or inserted into the device 310 such that the retention ring 350 contacts with the body 320 at two or more points along the body.
  • the retention ring 350 is shaped such that the spaced-apart legs 42 of the plunger 40 may pass along the passageway 332 through the flat portions of the retention ring 350 that do not make contact with the body 320.
  • a cutout or notches in the inner surface of the body 320 maintain the retention ring 350 in a fixed position and prevent it from being pulled out of the device 310 along with an inserted needle shield (not shown).

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (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

A device for removing a needle shield from a syringe includes body having a first end, an opposing second end, and a central longitudinal axis extending from the first to the second end. The first end defines a first opening for receiving at least a portion of the needle shield. The second end defines at least one second opening. The body defines a passageway between the first opening and the second opening. A plunger is sized and shaped to fit within the passageway, at least a portion of the plunger surrounding at least a portion of the needle shield when the plunger and needle shield are located within the body. When the plunger is inserted into the second opening of the body and the needle shield is inserted into the first opening of the body, opposing forces are applied to the syringe and the body for removing the needle shield from the syringe.

Description

TITLE OF THE INVENTION
[0001] Device for Removing a Needle Shield from a Syringe and Method of Using Same
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of priority pursuant to 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 61/459,507, filed December 14, 2010, the disclosures of which is hereby incorporated by reference in its entirety.
BACKGROUND OF TFIE INVENTION
[0002] The present invention is generally directed to a device for removing a needle shield from a syringe and, more particularly, to a needle shield removal system that includes a tool to safely and easily remove a needle shield from a syringe and/or deter or prevent recapping of the needle shield onto the syringe after use.
[0003] It is well known to attach a needle assembly to a hypodermic syringe used to inject a substance into the skin of a patient or to withdraw fluids, such as blood, from the patient.
Further, numerous medical procedures employ a device having an exposed sharpened tip attached to a medical instrument. The needle cannula of such devices are commonly covered by a shield during non-use or before use to maintain the cannula in a clean, sometimes sterile, condition and to prevent unintentional needle pricks.
[0004] Referring to Fig. 1, needle shields 12 are typically formed of a rubber enclosure having a generally circular lateral cross-section that surrounds the portion of the needle cannula that extends outside or beyond the shoulder of a syringe 14 (see Figs. 13 and 14). An exterior surface of the needle shield 12 may include one or more ribs or projections 12a that extend around the entire outer circumference or perimeter thereof. These types of needle shields are conventionally referred to as a "rubber needle shield." Further, a generally rigid cover 16, preferably formed of a polymeric material, may enclose the rubber needle shield 12. The rigid cover 16 also has a generally circular lateral cross-section, but is generally larger than the rubber needle shield 12, such that the rubber needle shield 12 can fit within an interior of the rigid cover 16. The rigid cover 16 may include two opposed slots or openings 16a that each extend through a sidewall thereof. The combined rubber needle shield 12 and rigid cover 16 is conventionally referred to as a "rigid needle shield," generally designated 13 in Fig. 1. The rubber needle shield 12 alone may cover the exposed portion of the needle cannula, or the combined rigid needle shield 13 may enclose the exposed portion of the needle cannula. Both the rubber needle shield 12 and the combined rigid needle shield 13 are often referred to simply as a "needle shield." [0005] Removal of a needle shield 12, 13 from a syringe 14, such as by an individual attempting to perform a self-injection of prescribed medicine, is a major contributor to accidental needle prick injuries. Such injuries are due, in part, to the phenomenon of "recoil," which often results when a user tries to carefully overcome a pull force required to remove the needle shield 12, 13 from the syringe 14. Specifically, upon abrupt release of the needle shield 12, 13 from the syringe 14, a user's body inherently attempts to compensate for this "breakaway" by slightly "putting on the brakes" or pulling back slightly against the initial force. Depending on a particular user's reflexes and/or reaction, the "pullback" often results in the hand that directly grasps the needle shield 12, 13 to recoil or "bounce back" toward the uncovered needle cannula in the other hand. As a result, users often stab or prick themselves during this process.
[0006] In addition, rheumatoid arthritis, which is an autoimmune disease characterized by chronic inflammation of the joints leading to progressive cartilage destruction and bone erosion, makes it difficult for certain individuals to remove a needle shield 12, 13 from a syringe 14. While rheumatoid arthritis has been treated for many years with a variety of medicines, some of the drugs are administered through self-injections with a syringe 14. Due to the pain and inflammation in the joints, individuals with rheumatoid arthritis often have difficulty with the self-injection process, especially when attempting to remove a needle shield 12, 13.
[0007] Therefore, it is desirable to provide an accessory or tool that can be joined or attached to a conventional needle shield and/or syringe to provide a mechanical advantage for easier removal of the needle shield from the syringe. It is also desirable to create a device or system that can deter or prevent re-capping of a needle shield onto a syringe after use. The present invention accomplishes these objectives.
BRIEF SUMMARY OF THE INVENTION
[0008] Briefly stated, one aspect of the present invention is directed to a device for removing a needle shield from a syringe includes a body having a first end, an opposing second end, and a central longitudinal axis extending from the first end to the second end. The first end defines a first opening for receiving at least a portion of the needle shield. The second end defines at least one second opening. The body defines a passageway between the first opening and the second opening. A plunger is sized and shaped to fit within the passageway, at least a portion of the plunger surrounding at least a portion of the needle shield when the plunger and needle shield are located within the body. When the plunger is inserted into the second opening of the body and the needle shield is inserted into the first opening of the body, opposing forces are applied to the syringe and the body for removing the needle shield from the syringe.
[0009] In another aspect, a device for removing a needle shield from a syringe includes a body having a first end and an opposing second end. A central longitudinal axis extends from the first end to the second end. The first end defines a first opening for receiving at least a portion of the needle shield within the body, The second end defines a second opening. The body defines a passageway between the first and second openings. A pair of opposing projections extend generally perpendicularly to the central longitudinal axis proximate to the second end of the body. The second opening is located between the projections, wherein an interior sidewall of the body that defines the passageway includes a pair of opposing protrusions that extend inwardly into the passageway generally perpendicularly to the central longitudinal axis. Each protrusion is sized and shaped to fit within a slot in a sidewall of the needle shield. A plunger is sized and shaped to fit within the passageway, at least a portion of the plunger surrounding at least a portion of the needle shield when the plunger and needle shield are located within the body. When the plunger is inserted into the second opening of the body and the needle shield is inserted into the first opening of the body with the protrusions engaged with the slots, opposing forces are applied to the syringe and the body for removing the needle shield from the syringe.
[0010] In yet another aspect, a device for removing a needle shield from a syringe includes a body having a first end, an opposing second end, and a central longitudinal axis extending from the first end to the second end. The first end defines a first opening for receiving at least a portion of the needle shield. The second end defines a second opening. The body defines a passageway between the first and second openings. A recess is formed on an interior surface of the body that defines the passageway, the recess being sized and shaped to engage a rib formed on an exterior surface of the needle shield. A plunger is sized and shaped to fit within the passageway, at least a portion of the plunger surrounding at least a portion of the needle shield when the plunger and needle shield are located within the body. When the plunger is inserted into the second opening and the needle shield is inserted into the first opening with the rib engaged with the recess, opposing forces are applied to the syringe and the body for removing the needle shield from the syringe. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0011] The foregoing summary, as well as the following detailed description of preferred embodiments of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown.
[0012] The application file contains at least one drawing executed in color. Copies of this patent application with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. The color drawings are Figs. 2, 5, 8, 15-19 and 21. In the drawings:
[0013] Fig. 1 is a perspective view of a prior art rigid needle shield for a syringe;
[0014] Fig. 2 is an exploded perspective view of the rigid needle shield of Fig. 1 and a device for removing a needle shield from a syringe according to a first preferred embodiment of the present invention;
[0015] Fig. 3 is a side elevation view of the device shown in Fig. 2;
[0016] Fig. 4 is a cross-sectional elevation view of the device shown in Fig. 2 taken along line "4-4" in Fig. 3;
[0017] Fig. 5 is an enlarged cross-sectional elevation view of a portion of the device shown in Fig. 2 taken from area "5" in Fig. 4;
[0018] Fig. 6 is another side elevation view of the device shown in Fig. 2;
[0019] Fig. 7 is a cross-sectional elevation view of the device shown in Fig. 2 taken along line "7-7" in Fig. 6;
[0020] Fig. 8 is an enlarged cross-sectional elevation view of a portion of the device shown in Fig. 2 taken from area "8" in Fig. 7;
[0021] Fig. 9 is a top plan view of the device shown in Figs. 3 and 6;
[0022] Fig. 10 is a bottom plan view of the device shown in Figs. 3 and 6;
[0023] Fig. 11 is a top perspective view of a modified version of the device shown in Fig. 2, with a plunger and a body of the device shown in a first position;
[0024] Fig. 12 is a top perspective view of the device shown in Fig. 1 1, with the plunger and the body of the device shown in a second position;
[0025] Fig. 13 is a perspective view of the device shown in Fig. 2 attached to a conventional syringe; [0026] Fig. 14 is a perspective view depicting a user removing a needle shield from a syringe with the device shown in Fig. 2;
[0027] Fig. 15 is a top perspective view of a device for removing a needle shield from a syringe according to a second preferred embodiment of the present invention;
[0028] Fig. 16 is a bottom perspective view of the device shown in Fig. 15;
[0029] Fig. 17 is a side elevation view of the device shown in Fig. 16;
[0030] Fig. 18 is a cross-sectional elevation view of the device shown in Fig. 15 taken along line "18-18" in Fig. 17;
[0031] Fig. 19 is a bottom cross-sectional plan view of the device shown in Fig. 15 taken along line "19-19" in Fig. 17;
[0032] Fig. 20 is a top plan view of the device shown in Fig. 15;
[0033] Fig. 21 is a cross-sectional elevation view of the device shown in Fig. 15 taken along line "21-21" in Fig. 20;
[0034] Fig. 22 is a perspective view of a modified version of the device shown in Fig. 2 for use with a safety device;
[0035] Fig. 22a is an enlarged cross-sectional view of a portion of the device of Fig. 22 taken from area "C";
[0036] Fig. 23 is a side elevational view of the device shown in Fig. 22 with the safety device attached;
[0037] Fig. 24 is a side perspective view of another modified version of the device shown in Fig. 2 having a retention ring therein;
[0038] Fig. 25a is an exploded perspective view of the retention ring of Fig. 24 in a first position for engaging with a rigid needle shield; and
[0039] Fig. 25b is an elevational view of the retention ring of Fig. 24 in a second position engaged with a rigid needle shield.
DETAILED DESCRIPTION OF THE INVENTION
[0040] Certain terminology is used in the following description for convenience only and is not limiting. The words "lower" and "upper" designate directions in the drawings to which reference is made. The words "first" and "second" designate an order of operations in the drawings to which reference is made, but do not limit these steps to the exact order described. The words "inwardly" and "outwardly" refer to directions toward and away from, respectively, the geometric center of the device, and designated parts thereof. Additionally, the term "a," "an," and "the," as used in the specification, mean "at least one." The terminology includes the words above specifically mentioned, derivatives thereof, and words of similar import.
[0041] Referring to the drawings in detail, wherein like numerals indicate like elements throughout, there is shown in Figs. 2-14 a first preferred embodiment of a device, generally designated 10, for removing a rigid needle shield 13 from a syringe 14 (Fig. 13) and/or deterring or preventing re-capping of the rigid needle shield 13 onto the syringe 14. The device 10 is preferably sized and shaped to engage and/or receive at least a portion of the rigid needle shield 13 therein. The device 10 provides a user with mechanical advantage for ease of removal of the rigid needle shield 13 from the syringe 14 prior to use of the syringe and/or at least makes it more difficult to reattach the rigid needle shield 13 to the syringe 14 once the two have been separated.
[0042] The device 10 preferably includes a body 20 having a first, lower or distal end 22 and an opposing second, upper or proximal end 24. The body 20 preferably has a cylindrical or generally oval shape and is preferably sized and shaped to relatively easily, comfortably and ergonomically fit between two adjacent fingers of a user's hand (see Fig. 14). However, the body 20 is not limited to a particular size and/or shape, as the outer perimeter of the body 20 may be planar or flat, such as rectangular in shape. Central longitudinal axis 26 (Figs. 2 and 13) extends from at least the first end 22 to the second end 24 of the body 20 and extends through a geometric center of the body 20.
[0043] As shown in Figs. 2, 5 and 8, the first end 22 of the body 20 preferably defines a first opening 28 for receiving at least a portion of the rigid needle shield 13 of the syringe 14 within the body 20. As shown in Figs. 2, 3, 11 and 12, the second end 24 of the body 20 preferably defines a second opening 30. The first opening 28 and second opening 30 preferably have a substantially similar or identical diameter and/or cross-sectional area. Thus, the body 20 defines a passageway 32 that extends through the body 20 from the first opening 28 to the second opening 30 such that an apparatus of proper size and/or shape may be passed through the entire interior of the body 20. In the present embodiment, the exterior surface of the body 20 has substantially the same shape as an interior sidewall 36 (see Figs. 5 and 8) or surface (i.e., the passageway 32 of the body 20), but the body 20 is not limited to this configuration.
[0044] Referring to Figs. 2, 3, 7 and 9-14, the body 20 may include a pair of opposing projections 34 that extend outwardly therefrom and preferably at least generally perpendicularly to the central longitudinal axis 26. The opposing projections 34 are preferably located at or near the second end 24 of the body 20 and are generally located on opposing sides of the second opening 30. However, the opposing projections may be placed at other points on the body 20 without departing from the scope of this invention. As shown in Fig. 14, each of the projections 34 is sized and ergonomically shaped to receive at least one finger, preferably an index finger, of a user's hand H therein. More specifically, at least a portion of a bottom or distal surface of each projection 34 (facing the first end 22) is at least generally arcuate to accommodate at least a portion of a finger therein.
[0045] Referring to Figs. 2 and 5, the interior sidewall 36 of the body 20, which generally defines the passageway 32, preferably includes a pair of opposing protrusions 38 that extend inwardly into the passageway 32. Specifically, at least a portion of each protrusion 38 extends generally perpendicularly to the central longitudinal axis 26. It is preferred that each protrusion 38 is sized and shaped to fit within a slot 16a in a side wall of a rigid cover 16 of the rigid needle shield 13.
[0046] Referring to Figs. 2, 5, 8, 11, 12 and 14, the device 10 preferably includes a plunger 40 that is sized and shaped to fit within the passageway 32 of the body 20. The plunger 40 is preferably movable relative to the body 20. The plunger 40 preferably includes a pair of spaced- apart legs 42 that extend from and are fixedly, integrally and unitarily connected to a push button 44. Specifically, a first or distal end 42a of the legs 42 extend away from the push button 44, and a second or proximal end 42b of the legs 42 are fixedly, integrally and unitarily formed with the push button 44. The push button 44 is preferably sized and ergonomically shaped to receive at least one finger, preferably a thumb, of a user's hand therein.
[0047] When the plunger 40 is inserted into the passageway 32 of the body 20, each leg 42 preferably extends generally parallel to the central longitudinal axis 26 and the push button 44 generally extends perpendicularly to the central longitudinal axis 26. Further, when the plunger 40 is properly positioned within the passageway 32, each leg 42 is preferably radially spaced- apart from each protrusion 38, such that the protrusions 38 do not limit the longitudinal motion of the plunger 40, but the protrusions 38 do limit the lateral or radial motion of the plunger 40 within the body 20.
[0048] Referring to Figs. 2, 13 and 14, in one optional scenario, when a user desires to remove the rigid needle shield 13 from the syringe 14, the user may initially insert the distal or closed end of the rigid needle shield 13 into the first opening 28 at the first end 22 of the body 20. The user slides the combined body 20 and plunger 40 over the rigid needle shield 13 until most of the rigid needle shield 13 is located within the passageway 32 and the protrusions 38 engage the slots 16a proximate the proximal open end of the rigid needle shield 13 to lock the rigid needle shield 13 in place within the passageway 32. In this scenario, the device 10 is effectively a re-useable accessory used as an assisting tool in the process of needle shield 13 removal. In another optional scenario, the device 10 is preferably pre-attached to the rigid needle shield 13, such as during manufacture and/or prior to shipment to an end user. In other words, a manufacturer or distributor, for example, may pre-insert the rigid needle shield 13 of the syringe 14 into the first opening 28 at the first end 22 of the body 20, so that the end user is not required to perform such a step. In this scenario, the device 10 may be designed to be disposable after one or more uses, but the present invention is not limited in this manner.
[0049] Once the device 10 is properly attached to the rigid needle shield 13 and the user desires to remove the rigid needle shield 13 from the syringe 14, one of the user's hands (i.e., first hand) preferably either pushes the push button 44 along the central longitudinal axis 26 toward the syringe 14 (i.e., with the user's thumb) or holds the push button 44 in place (i.e., at generally one point along the central longitudinal axis 26), and also pulls the projections 34 of the body 20 away from the syringe 14 along the central longitudinal axis 26 (i.e., with each index finger of the same hand). At the same time, the user's other hand (i.e., second hand) preferably grasps the syringe 14 and either pulls the syringe 14 away from the combined body 20 and plunger 40 or holds the syringe 44 in place. In other words, the device 10 has at least a first position or configuration (Fig. 11) wherein the device 10 generally surrounds the entire rigid needle shield 13 properly attached to the syringe 14, and a second position or configuration (Fig. 12) wherein the device 10 separates the rigid needle shield 13 from the syringe 14.
[0050] During the removal process, the distal ends 42a of the plunger legs 42 engage and/or push against a shoulder (not shown) of the syringe 14, while the body 20 pulls the rigid needle shield 13 away from the syringe 14. Thus, the combination of the above-described forces allows the user to relatively easily, quickly and safely remove the rigid needle shield 13 from the syringe 14. In addition, the device 10 generally prevents the user from reattaching the rigid needle shield 13 to the syringe 14 because the rigid needle shield 13 is generally locked or fixedly held within the body 20 of the device. While in this case, the device 10 and the secured rigid needle shield 13, is designed to be disposable or thrown-out after removing the rigid needle shield 13 from the syringe 14, in other embodiments the device 10 may also be separated from the rigid needle shield 13 and reusable. [0051] Referring to Figs. 15-21 , a second preferred embodiment of the device 110 is shown, wherein like referenced numerals are utilized to indicate like elements throughout the several views. The reference numerals of the second preferred embodiment are distinguishable from those of the first preferred embodiment by a factor of one hundred (100), but otherwise indicate the same elements as in the first preferred embodiment, except as otherwise specified. The device 110 of the second preferred embodiment is substantially similar to that of the first preferred embodiment. For example, the device 1 10 includes a body 120 having a first end 122 with a first opening 128, a second end 124 with at least one second opening 130, and a central longitudinal axis 126 (Fig. 21) extending through a passageway 132 thereof. Projections 134 preferably extend outwardly from the body 120. A plunger 140 having a push button 144 and spaced-apart legs 142, each having a distal end 142a and a proximal end 142b, is preferably movably inserted into the passageway 132. In the second preferred embodiment, two spaced- apart second openings 130 (see Fig. 15) each receive at least a portion of one of the legs 142 therein. Additional similarities between the first and second preferred embodiments are omitted herein for the sake of brevity and convenience and are not limiting.
[0052] A primary difference between the first and second preferred embodiments is that the second preferred embodiment is designed to remove a rubber needle shield 12 (i.e., a needle shield without a rigid cover 16) from a syringe 14 and/or prevent a rubber needle shield 12 from being re-attached to the syringe 14. Specifically, an interior sidewall 136 or surface of the body 120 that defines the passageway 132 preferably includes a recess 170 (Figs. 18 and 21) therein. The recess 170 preferably extends around the entire periphery or circumference of the passageway 132 and is sized and shaped to engage one or more of the ribs 12a formed on an exterior surface of the rubber needle shield 12. The recess 170 is preferably formed as a cut-out in the wall of the passageway 132, such that a portion of the passageway 132 proximate the first end 122 is asymmetric along the central longitudinal axis 126 with a portion of the passageway 132 proximate the second end 124. In use, a rubber needle shield 12 is inserted into the passageway 132 until the rib 12a contacts the recess 170. The rib 12a has a wider circumference than the passageway 132 such that when the rib 12a enters the passageway, the rib 12a contracts. As the rib 12a passes through the passageway 132 and enters the recess 170, the rubber expands, filling the recess 170 and locking the rubber needle shield 12 in the body 120. The body 120 provides structural rigidity to the rubber needle shield 12 and, therefore, effectively acts similarly to the rigid cover 16 of the rigid needle shield 13. Thus, the device 110 of the second preferred embodiment when combined with the rubber needle shield 12 may be considered to be an active rigid needle shield.
[0053] Referring to Figs. 18 and 21, a length of the passageway 132, as measured along the central longitudinal axis 126, is at least slightly longer than a length of the rubber needle shield 12, as measured along the central longitudinal axis 126, such that a space or gap 172 is formed within the body 120 proximate the second end 124 when the rubber needle shield 12 is fully and properly located therein with the ribs 12a locked into the recess 170. The space 172 assures that the rubber needle shield 12 can be properly inserted within the passageway 132, as omitting this feature has been found to create undesirable wedging of the rubber needle shield 12 within the passageway 132.
[0054] The removal process using the device 110 is similar to the removal process described above with respect to the device 10 of the first embodiment. When a syringe 14 having a rubber needle shield 12 is inserted into the first opening 128 of the body 120, the ribs 12a of the needle shield 12 engage with the recess 170 of the device 110 to lock the needle shield 12 in place within the passageway 132. The rubber of the ribs 12a contracts and then expands when passing into the recess 170, thereby holding the needle shield 12 in place. The user then presses the plunger 140 along the central longitudinal axis 126 into the device 110, while holding the syringe 14 with the other hand. Alternatively, the user may pull the device 1 10 towards the plunger 140 using the projections 134. Due to the motion, the distal end 142a of the spaced-apart legs 140 contact a shoulder (not shown) of the syringe 14 to remove the needle shield 12 from the syringe 14. As a result, the needle shield 12 is maintained in the device 110, while the syringe 14 is pushed away from the needle shield 12.
[0055] Referring now to Figs. 22 and 23, a third preferred embodiment of the device 210 is shown for use with a safety device 250. The reference numerals of the third preferred embodiment are distinguishable from those of the first preferred embodiment by a factor of two hundred (200), but otherwise indicate the same elements as in the first preferred embodiment, except as otherwise specified. Similarities between the first, second and third preferred embodiments are omitted herein for the sake of brevity and convenience and are not limiting.
[0056] The device 210 has an expanded body 220 for coupling with a safety device 250. The expanded body 220 has a larger circumference than the body 20, 120 of the device 10, 110 in order to accommodate the safety device 250. The safety device 250 further helps to prevent needle pricks by positioning the needle of the syringe within the body of the safety device 250 during removal of the needle shield 13. In one embodiment the safety device 250 is a WEST B.SAFE safety device, which has a first end 260 and a second end 262. The safety device 250 is inserted into the first end 222 of the device 210. A passageway 264 connects the first end 260 to the second end 262 of the safety device 250. The safety device 250 is configured to be coupled with the device 210, for example, by a compression fit, snap connectors or the like. When the safety device 250 is coupled with the device 210, a central longitudinal axis 226 extends from at least the first end 264 of the safety device 250 to the second end 224 of the body 220 and extends through a geometric center of the safety device 250 and the body 220.
[0057] An interior sidewall of the safety device 250, which generally defines the passageway 264, preferably includes a pair of opposing protrusions 252 that extend inwardly into the passageway 264. Specifically, at least a portion of each protrusion 252 extends generally perpendicularly to the central longitudinal axis 226. It is preferred that each protrusion 252 is sized and shaped to fit within a slot 16a in a side wall of a rigid cover 16 of the rigid needle shield 13 (Fig. 2). Thus, when a needle shield 13 is inserted into the safety device 250, the protrusions 252 of the safety device 250 engage with the slots 16a of the needle shield 13 to maintain the needle shield 13 within the safety device 250. The device 210 has an optional pair of opposing protrusions 270 proximal to the second end 222. The protrusions 270 engage with the top portion of the needle shield 13, as shown in Fig. 22a. Specifically, at least a portion of each protrusion 270 extends generally perpendicularly to the central longitudinal axis 226. The protrusions 270 capture the top of the needle shield 13, preferably by engaging with ribs or openings (not shown) in the needle shield 13 to further prevent the needle shield 13 from accidentally becoming disengaged from the device 210. Once the syringe 14 with a needle shield 13 has been inserted into the device 10 with coupled safety device 250, the removal operation is identical to that of the first embodiment and will not be described herein for brevity.
[0058] While each of the preferred embodiments have been described as having a pair of opposing protrusions 38, 138, 270, other retention members may be implemented. Referring to Fig. 24, a device 310 according to a fourth preferred embodiment is shown with a retention ring 350 in the body 320. The reference numerals of the fourth preferred embodiment are distinguishable from those of the first preferred embodiment by a factor of three hundred (300), but otherwise indicate the same elements as in the first preferred embodiment, except as otherwise specified. The device 310 is identical to the device 10, except that the pair of opposing protrusions 38 of the device 10 have been replaced with the retention ring 350. The plunger 40 of the first embodiment is used with the device 310, as described below, but is not shown for brevity. Using the retention ring 350 instead of the protrusions allows the device 310 to be compatible with a wide range of rubber and rigid needle shields that do not have ribs or openings, as described above. For example, the device 310 may be used with a rigid needle shield that does not have slots that may be frictionally engaged with by the opposing protrusions 38 of the device 10.
[0059] The retention ring 350 is co-molded or inserted into the device 310 such that the retention ring 350 contacts with the body 320 at two or more points along the body. The retention ring 350 is shaped such that the spaced-apart legs 42 of the plunger 40 may pass along the passageway 332 through the flat portions of the retention ring 350 that do not make contact with the body 320. When the retention ring 350 is inserted into the device 310, preferably a cutout or notches in the inner surface of the body 320 maintain the retention ring 350 in a fixed position and prevent it from being pulled out of the device 310 along with an inserted needle shield (not shown). The retention ring 350 includes a plurality of inner flexing members 352 and an opening 354 for accepting and gripping a rigid or rubber needle shield 12, 13. Referring to Figs. 25 A, the retention ring 350 is shown with the flexing members 352 in an unflexed state for being coupled with a needle shield 13. In Fig. 25B, the needle shield 13 is inserted into the retention ring 350 through the opening 354, thereby flexing the flexing members 352 in the direction of insertion. As a result of the insertion, the flexing members 352 grab (or dig into) the needle shield 13 and prevent the needle shield 13 from being pulled back out of the retention ring 350.
[0060] In yet other embodiments, the projections 34, 134, 270 may be replaced by various combinations of retention members (not shown), such as spikes, blades, and the like. One or more such retention members may be implemented on opposing sides of the device 10, 110, 210. Alternatively, such retention members may be implemented uniformly around the circumference of the device 10, 1 10, 210. The retention members may be co-molded or inserted into the device 10, 1 10, 210. The retention members are angled to permit the needle shield 13 to be inserted into the device 10, 110, 210, but prevent manual removal of the needle shield 13 from the device 10, 110, 210 by digging into its surface.
[0061] Those skilled in the art will appreciate that changes could be made to the
embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.

Claims

CLAIMS We claim:
1. A device (10, 110, 210, 310) for removing a needle shield (12, 13) from a syringe (14), the device characterized by:
a body (20, 120, 220, 320) having a first end (22, 122, 222, 322), an opposing second end
(24, 124, 224, 324), and a central longitudinal axis (26, 126, 226, 326) extending from the first end (22, 122, 222, 322) to the second end (24, 124, 224, 324), the first end (22, 122, 222, 322) defining a first opening (28, 128, 228, 328) for receiving at least a portion of the needle shield (12, 13), the second end (24, 124, 224, 324) defining at least one second opening (30, 130, 230, 330), the body (20, 120, 220, 320) defining a passageway (32, 132, 232, 332) between the first opening (28, 128, 228, 328) and the second opening (30, 130, 230, 330); and
a plunger (40, 140, 240) sized and shaped to fit within the passageway (32, 132, 232, 332), at least a portion of the plunger (40, 140, 240) surrounding at least a portion of the needle shield (12, 13) when the plunger (40, 140, 240) and needle shield (12, 13) are located within the body (20, 120, 220, 320),
wherein, when the plunger (40, 140, 240) is inserted into the second opening (30, 130, 230, 330) of the body (20, 120, 220, 320) and the needle shield (12, 13) is inserted into the first opening (28, 128, 228, 328) of the body (20, 120, 220, 320), opposing forces are applied to the syringe (14) and the body (20, 120, 220, 320) for removing the needle shield (12, 13) from the syringe (14).
2. The device (200) according to claim 1, further comprising a safety device (250) inserted in the first opening (228) at the first end (222).
3. The device (200) according to claim 2, wherein the safety device (250) includes a pair of opposing projections (252) configured for engaging with slots (16a) in a sidewall of the rigid cover (16) of the needle shield (13).
4. The device (1 10) according to claim 1, wherein the needle shield is a rubber needle shield (12).
5. The device (110) according to claim 4, wherein the body 120 includes a recess (170) for engaging with a rib (12a) of the needle shield (12).
6. The device (200) according to claim 1, wherein an interior sidewall (236) of the body (220) that defines the passageway (232) includes a pair of opposing protrusions (270) proximate to the second end (224) that extend inwardly into the passageway (232) generally perpendicularly to the central longitudinal axis (26), each protrusion (270) being sized and shaped to grip a sidewall of the needle shield (12, 13).
7. The device (10) according to claim 1, wherein an interior sidewall (36) of the body (20) that defines the passageway (32) includes a pair of opposing protrusions (38) that extend inwardly into the passageway (32) generally perpendicularly to the central longitudinal axis (26), each protrusion (38) being sized and shaped to fit within a slot (16a) in a sidewall of the needle shield (13) when the needle shield (13) is inserted into the passageway (32).
8. The device (10, 210, 310) according to claim 1, wherein the needle shield is a rigid needle shield (13).
9. The device (310) according to claim 1, wherein a retaining ring (350) having a plurality of flexing members (352) and an opening (354) is inserted or co-molded into the passageway (332) of the body (320).
10. A device (10) for removing a needle shield (13) from a syringe (14), the device (10) characterized by:
a body (20) having a first end (22) and an opposing second end (24), a central longitudinal axis (26) extending from the first end (22) to the second end (24), the first end (22) defining a first opening (28) for receiving at least a portion of the needle shield (13) within the body (20), the second end (24) defining a second opening (30), the body (20) defining a passageway (32) between the first and second openings (28, 30), a pair of opposing projections (34) extending generally perpendicularly to the central longitudinal axis (26) proximate to the second end (24) of the body (20), the second opening (30) being located between the projections (34), wherein an interior sidewall (36) of the body (20) that defines the passageway (32) includes a pair of opposing protrusions (38) that extend inwardly into the passageway (32) generally perpendicularly to the central longitudinal axis (26), each protrusion (38) being sized and shaped to fit within a slot (16a) in a sidewall of the needle shield (13); and a plunger (40) sized and shaped to fit within the passageway (32), at least a portion of the plunger (40) surrounding at least a portion of the needle shield (13) when the plunger (40) and needle shield (13) are located within the body (20),
wherein, when the plunger (40) is inserted into the second opening (30) of the body (20) and the needle shield (13) is inserted into the first opening (28) of the body (20) with the protrusions (38) engaged with the slots (16a), opposing forces are applied to the syringe (14) and the body (20) for removing the needle shield (13) from the syringe (14).
11. The device (10) according to claim 10 wherein the pair of opposing projections (34) are sized and shaped to receive at least one finger of a hand therein.
12. The device (10) according to claim 10 wherein the plunger 40 comprises a pair of spaced-apart legs (42) that extend from and are integrally and unitarily connected to a push button (44).
13. A device (110) for removing a needle shield (12) from a syringe (14), the device (1 10) characterized by:
a body (120) having a first end (122), an opposing second end (124), and a central longitudinal axis (126) extending from the first end (122) to the second end (124), the first end (122) defining a first opening (128) for receiving at least a portion of the needle shield (12), the second end (124) defining a second opening (130), the body (120) defining a passageway (132) between the first and second openings (128, 130), a recess (170) formed on an interior surface of the body (120) that defines the passageway (132), the recess (170) being sized and shaped to engage a rib (12a) formed on an exterior surface of the needle shield (12); and
a plunger (140) sized and shaped to fit within the passageway (132), at least a portion of the plunger (140) surrounding at least a portion of the needle shield (12) when the plunger (140) and needle shield (12) are located within the body (120),
wherein, when the plunger (140) is inserted into the second opening (130) and the needle shield (12) is inserted into the first opening (128) with the rib (12a) engaged with the recess (170), opposing forces are applied to the syringe (14) and the body (120) for removing the needle shield (12) from the syringe (14).
14. The device (1 10) according to claim 13, further including a pair of opposing projections (134) sized and shaped to receive at least one finger of a hand therein.
15. The device (1 10) according to claim 13 wherein the plunger ( 140) comprises a pair of spaced-apart legs (142) that extend from and are integrally and unitarily connected to a push button 144.
PCT/US2011/064771 2010-12-14 2011-12-14 Device for removing a needle shield from a syringe and method of using same WO2012082818A2 (en)

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CN113727748A (en) * 2019-04-26 2021-11-30 贝克顿迪金森法国公司 Needle cap with undercut
US11273265B2 (en) 2016-07-28 2022-03-15 Ypsomed Ag External cap having needle protection cap remover element and method for assembling an injection device

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ES2605734T3 (en) * 2001-12-13 2017-03-16 Becton, Dickinson And Company Needle closure system extractor
GB0403335D0 (en) * 2004-02-14 2004-03-17 Liversidge Barry P Medical injector handling device
IL161660A0 (en) * 2004-04-29 2004-09-27 Medimop Medical Projects Ltd Liquid drug delivery device
GB0800103D0 (en) * 2008-01-04 2008-02-13 Owen Mumford Ltd Sheath removver device

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11273265B2 (en) 2016-07-28 2022-03-15 Ypsomed Ag External cap having needle protection cap remover element and method for assembling an injection device
CN113727748A (en) * 2019-04-26 2021-11-30 贝克顿迪金森法国公司 Needle cap with undercut

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