US20040054334A1 - Medical needle assemblies - Google Patents

Medical needle assemblies Download PDF

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Publication number
US20040054334A1
US20040054334A1 US10/609,146 US60914603A US2004054334A1 US 20040054334 A1 US20040054334 A1 US 20040054334A1 US 60914603 A US60914603 A US 60914603A US 2004054334 A1 US2004054334 A1 US 2004054334A1
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US
United States
Prior art keywords
needle
shield
collar
unit dose
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.)
Abandoned
Application number
US10/609,146
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English (en)
Inventor
Alfred Prais
Richard Caizza
Gary Henniger
Espen Karteraas
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.)
Becton Dickinson and Co
Original Assignee
Becton Dickinson and Co
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
Priority claimed from US10/141,114 external-priority patent/US20030125676A1/en
Application filed by Becton Dickinson and Co filed Critical Becton Dickinson and Co
Priority to US10/609,146 priority Critical patent/US20040054334A1/en
Assigned to BECTON, DICKINSON AND COMPANY reassignment BECTON, DICKINSON AND COMPANY ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: HENNIGER, GARY, KARTERAAS, ESPEN D., PRAIS, ALFRED W., CAIZZA, RICHARD J.
Publication of US20040054334A1 publication Critical patent/US20040054334A1/en
Priority to CA2471065A priority patent/CA2471065C/en
Priority to AU2004202713A priority patent/AU2004202713B2/en
Priority to DK04014551T priority patent/DK1491152T3/da
Priority to DE602004014068T priority patent/DE602004014068D1/de
Priority to EP04014551A priority patent/EP1491152B1/en
Priority to AT04014551T priority patent/ATE396653T1/de
Priority to ES04014551T priority patent/ES2305621T3/es
Priority to JP2004185624A priority patent/JP4873840B2/ja
Priority to BR0402520-2A priority patent/BRPI0402520A/pt
Priority to CNB2004100618871A priority patent/CN100467079C/zh
Priority to US11/744,048 priority patent/US7632252B2/en
Abandoned legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/20—Surgical instruments, devices or methods, e.g. tourniquets for vaccinating or cleaning the skin previous to the vaccination
    • A61B17/205—Vaccinating by means of needles or other puncturing devices
    • 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
    • A61M5/3216—Caps placed transversally onto the needle, e.g. pivotally attached to the needle base
    • 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
    • A61M5/344—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub using additional parts, e.g. clamping rings or collets
    • 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
    • A61M5/347—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub rotatable, e.g. bayonet or screw
    • 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
    • A61M5/50—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5086—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile

Definitions

  • the present invention relates to needles for use in medical procedures and, in particular, to safety shielded needles and needle assemblies for use in vaccination procedures.
  • Bifurcated or forked end needles are well-known for providing a simple and effective means for a doctor to administer a vaccine.
  • the bifurcated tip of the bifurcated needle is put into contact with either a dried or liquid substance, which adheres to the bifurcated needle tip.
  • the bifurcated needle tip is then put into contact with the skin of the patient who is being administered the vaccination.
  • the skin is either scratched or pierced with the needle tip so that the vaccination material may be absorbed into the skin of the patient.
  • An alternative method of delivering the vaccination includes placing a drop of the vaccine onto the skin of the patient and contacting the skin of the patient with the bifurcated needle tip through the drop of vaccine.
  • a standard pointed needle tip without a lumen may also be used when the drop of vaccine is applied directly to the skin of the patient.
  • the bifurcated needle is considered a significant medical advancement because it has allowed more people to be vaccinated with less serum. This has been especially important for those living in less developed areas because of the efficient and easy to use design, as well as the ease of replication.
  • Vaccination effectiveness is reduced if the bifurcated needle is reused too many times. Moreover, reuse of such vaccination needles exposes patients to the risk of transmission of infectious diseases through percutaneous contact through the skin. Additionally, medical care workers using traditional vaccination needles are at an increased risk of exposure to infectious diseases due to the design of such needles, which makes them difficult to handle, as well as due to the repeated use of such needles.
  • bifurcated needles used to administer vaccinations are not traditionally sterilized or packaged in a single use container that would enable convenient storage and subsequent use.
  • needles have traditionally been difficult to handle in that they typically do not include a hub attached to the opposite end of a needle from the tip, and do not typically include any sort of shield for protection from the needle prior to and after use.
  • U.S. Pat. No. 3,194,237 to Rubin discloses a vaccination needle having a main shank with a pair of prongs at one end that define a slot of predetermined length, width and depth therebetween to hold an amount of liquid by capillary action.
  • the shank of the needle is of sufficient length so that the non-prong end will function as a handle.
  • U.S. Pat. No. 3,948,261 to Steiner discloses a reusable unit dose container for vaccines contained within a rigid receptacle, with a compressible closure for supporting a bifurcated needle bearing dried vaccine.
  • the closure is adapted to support the needle in the container during a lyophilizing process while liquid vaccine is dried on the needle.
  • the closure has grooves which permit the vaporized liquid from the vaccine to be withdrawn from the receptacle during lyophilizing, and can further seal the container.
  • U.S. Pat. No. 5,188,611 discloses a reusable safety needle arrangement having a collar for engaging a needle and a slotted longitudinal shield which is attached to the collar at a hinge for pivoting over the needle.
  • Such devices incorporating a pivoting shield assembly are typically used with hypodermic syringe needles or double-ended phlebotomy needles.
  • shieldable syringes or needle assemblies are well known in the art for needles used to inject fluids and medicine into the circulatory system of the patient (i.e., venipuncture) such shielding has not previously been used in connection with vaccination needles such as bifurcated needles.
  • a need exists for a shieldable needle assembly for use with a unit dose vaccination needle that is easily manufactured, that is simple to use, that is easily sterilized and maintained in a sterile condition until used, that can be safely disposed of, and that does not interfere with normal practices of bifurcated needle use.
  • the present invention is directed to a shieldable unit dose needle assembly for administering a unit dose of a vaccine to a patient.
  • the shieldable assembly includes a needle holding member having a proximal end and a distal end, with the distal end including a male tapering surface.
  • the shieldable assembly also includes a unit dose needle having a handle end and a prong end configured to hold a unit dose of a vaccine.
  • the shieldable assembly further includes a collar having a proximal end and a distal end including a needle end, with the unit dose needle extending from the needle end of the collar.
  • the collar surface includes a proximal end having a female tapering surface in engagement with the male tapering surface at the distal end of the needle holding member.
  • the collar provides for pivotal movement of the shield between a retracted position and a shielded position.
  • the shieldable assembly further includes a shield in pivotal engagement with respect to the unit dose needle, and is pivotally movable between the retracted position pivotally spaced from the prong end of the unit dose needle and the shielded position encompassing or enveloping the prong end of the unit dose needle.
  • the unit dose needle desirably is in the form of a bifurcated needle, with the prong end including at least two pointed prongs which are capable of penetrating or abrading the skin of a patient, and which are separated by a U-shaped or V-shaped channel capable of holding the unit dose of vaccine.
  • the distal end of the needle holding member includes an annular collar having internal threads adjacent the male tapering surface, and the proximal end of the collar includes a structure for threaded engagement with the internal threads of the annular collar when the female tapering surface is in engagement with the male tapering surface.
  • the shieldable assembly further includes a projection member coupled to the collar end and a top surface including an outwardly and a distally extending tab.
  • the shield includes a first ramp that is able to contact the projection member when the shield is rotated to the retracted position.
  • the projection member desirably is flexibly mounted to the collar.
  • the shieldable assembly further includes a means for preventing pivotal movement of the shield between the shielded position and the retracted position after the shield has been pivoted to the shielded position.
  • the shield may be pivotally connected to the collar through a hinged connection established by a hanger bar located on the shield and a hook arm located on the collar, or through a living hinge extending between the shield and the collar.
  • a unit dose needle assembly and a needle holding assembly form a shieldable assembly for administering a unit dose of a vaccine.
  • the unit dose needle assembly includes a collar having a female tapering surface at a proximal end thereof and a solid elongated unit dose needle extending from a distal end thereof.
  • the unit dose needle has a length capable of retrieving a unit dose of a vaccine from a separate container and having a patient end containing and administering the unit dose of a vaccine.
  • the needle holding assembly has an elongated body with a proximal end and a distal end. The distal end includes a male tapering surface in engagement with the female tapering surface of the collar of the unit dose needle assembly.
  • the distal end also includes an annular collar having internal threads in threaded engagement with corresponding structure on the proximal end of the collar.
  • the needle holding assembly further includes a shield in pivotal engagement with respect to the unit dose needle assembly and is pivotally movable between a retracted position pivotally spaced from the patient end of the unit dose needle and a shielded position encompassing the patient end of the unit dose needle.
  • FIG. 1 is a perspective view of the shieldable unit dose needle assembly of the present invention including related packaging features
  • FIG. 2 is a perspective view of the unassembled pieces of FIG. 1;
  • FIG. 3 is a bottom view of the shield as shown in FIG. 2;
  • FIG. 4 is a cross-sectional view of the collar as shown in FIG. 2 taken along lines 4 - 4 thereof;
  • FIG. 5 is a cross-sectional view of the needle hub as shown in FIG. 2 taken along lines 5 - 5 thereof;
  • FIG. 6 is a cross-sectional view of the shield as shown in FIG. 2 taken along lines 6 - 6 thereof;
  • FIG. 7 is a cross-sectional side view of the shieldable assembly of FIG. 1;
  • FIG. 8 is a perspective view of the shieldable assembly of FIG. 1 with the needle packaging cover sleeve removed and the shield in a retracted position;
  • FIG. 9 is a cross-sectional side view of the shieldable assembly of FIG. 1 shown with the needle packaging cover sleeve removed and the shield in a retracted position;
  • FIG. 10 is a cross-sectional side view of the shieldable assembly of FIG. 1 with the needle packaging cover sleeve removed and the shield in a fully shielded position;
  • FIG. 11 is a cross-sectional view of a unit dose needle assembly for use with a shieldable assembly in accordance with an alternate embodiment of the present invention
  • FIG. 12 is a cross-sectional view of a collar for engagement with the unit dose needle assembly of FIG. 11;
  • FIG. 13 is a cross-sectional side view of a shieldable assembly including the unit dose needle assembly of FIG. 11;
  • FIG. 14 is a cross-sectional view of an alternate unit dose needle assembly for use in a shieldable assembly in accordance with a further embodiment of the present invention.
  • FIG. 15 is a cross-sectional view of a collar for engagement with the unit dose needle assembly of FIG. 14;
  • FIG. 16 is a cross-sectional side view of a shieldable assembly including the unit dose needle assembly of FIG. 14;
  • FIG. 17 is a cross-sectional view of a further alternate unit dose needle assembly for use in a shieldable assembly in accordance with a further embodiment of the present invention.
  • FIG. 18 is a cross-sectional view of a collar for engagement with the unit dose needle assembly of FIG. 17;
  • FIG. 19 is a cross-sectional side view of a shieldable assembly including the unit dose needle assembly of FIG. 17;
  • FIG. 20 is a side-sectional view of a shieldable assembly in a further embodiment of the present invention, showing the unit dose needle separated from the shield assembly;
  • FIG. 21 is a cross-sectional view taken along line 21 - 21 of FIG. 20;
  • FIG. 22 is a side view of a shieldable assembly in yet a further embodiment of the present invention, showing the rigid packaging cover separated from the needle;
  • FIG. 23 is a perspective view of a shieldable needle assembly in an alternate embodiment of the present invention with a unit dose needle assembly and a needle holding assembly;
  • FIG. 24 is an exploded view of the unassembled pieces shown in FIG. 23;
  • FIG. 25 is an exploded perspective view of the unit dose needle assembly as shown in FIG. 23;
  • FIG. 26 is a side cross-sectional view of the shieldable needle assembly as shown in FIG. 25;
  • FIG. 27 is a side cross-sectional view of the shieldable needle assembly as shown in FIG. 23 including the needle holding assembly;
  • FIG. 28 is an enlarged cross-sectional view of a proximal end of the needle holding member in FIG. 23;
  • FIG. 29 is a side cross-sectional view of the shieldable needle assembly of FIG. 23 with the shield in a retracted position;
  • FIG. 30 is a side perspective view of the shieldable needle assembly of FIG. 23 with the needle packaging cover sleeve removed and the shield in a shielding position;
  • FIG. 31 is a bottom perspective view of the shieldable needle assembly of FIG. 23 shown with the needle packaging cover sleeve removed and the shield in a shielding position.
  • FIGS. 1 and 2 illustrate a shieldable unit dose needle assembly 10 in accordance with the present invention, and the related packaging features.
  • the shieldable needle assembly 10 includes a unit dose needle such as a bifurcated needle 12 and a hub 22 , which together form a single use, unit dose needle assembly 60 .
  • the shieldable needle assembly 10 further includes a safety shield assembly including a collar 90 , a housing in the form of a pivotable shield 140 , and a handle 70 .
  • the needle assembly 10 of the present invention is intended for use for the administration of vaccines applied to or through the skin of the patient, and is intended as a single use vaccination needle assembly including features to maintain sterility of the needle during packaging, and to provide safety shielding for the medical practitioner after use, as will be described in more detail herein.
  • the needle assembly 10 includes a unit dose needle assembly 60 , as shown in FIGS. 2 and 5.
  • the unit dose needle assembly 60 generally includes a unit dose needle for administering a unit dose of a vaccine, such as a bifurcated needle 12 , which is supported by a hub 22 .
  • needle assembly 10 is described herein in terms of a preferred embodiment including a bifurcated needle 12 as the unit dose needle, needle assembly 10 may include any unit dose needle capable of administering a unit dose of a vaccine, such as in a lyophilized dry form or liquid form, as is well-known in the art.
  • the bifurcated needle 12 includes a handle end at proximal end 14 , and an opposed prong end at distal end 16 .
  • Bifurcated needle 12 is provided with two sharp prongs 18 positioned at a distal end 16 of the needle.
  • the prongs 18 are separated by a U-shaped channel 20 configured to hold a unit dose of vaccine.
  • the prongs 18 are intended to penetrate or abrade the skin of the patient to administer the vaccine disposed in the U-shaped channel 20 .
  • Bifurcated needle 12 may be constructed of any material known in the art, such as metal or plastic, and is desirably constructed of a medical grade surgical steel.
  • Needle assembly 10 may further include a hub 22 fixedly attached to the proximal end 14 of bifurcated needle 12 , such as through an adhesive joint 24 .
  • Adhesive joint 24 may be provided through any adhesive capable of fixedly attaching or adhering bifurcated needle 12 to hub 22 , such as an oven or U.V. cured epoxy or equivalent adhesive.
  • Hub 22 includes a hub housing 26 including a proximal end 28 and a distal end 30 .
  • distal end 30 of hub 22 includes an internal bore having an internal diameter of approximately the same size as or a slightly larger size than the outer diameter of the proximal end 14 of bifurcated needle 12 , for accommodating and fixedly adhering bifurcated needle 12 within such an internal bore of hub 22 .
  • unit dose needle assembly 60 including bifurcated needle 12 and hub 22 are interengaged with a safety shield assembly, thus providing a shieldable feature for bifurcated needle 12 after use.
  • this shieldable feature is achieved through a shield assembly including collar 90 , shield 140 , and handle 70 .
  • Collar 90 acts as a fitting for mating shield 140 and handle 70 with bifurcated needle 12 through hub 22 .
  • collar 90 may include two sections, a forward annular skirt 92 at a distal end thereof, and a rearward annular skirt 94 at a proximal end thereof.
  • the forward annular skirt 92 is cylindrical, including an inner sidewall 96 and an outer sidewall 98 , and mates with the rearward annular skirt 94 at a shoulder 100 .
  • Rearward annular skirt 94 is cylindrical, including an inner sidewall 102 and an outer sidewall 104 , and extends from shoulder 100 opposite of forward annular skirt 92 .
  • the inner diameter of forward annular skirt 92 is larger than the inner diameter of rearward annular skirt 94 .
  • the inner diameters for collar 90 can be formed as a constant inner diameter.
  • a hook member 114 Extending on outer sidewall 98 of forward skirt section 92 is a hook member 114 , and located opposite or downwardly of hook member 114 on outer sidewall 98 are latches in the form of locking dents or protrusions 118 .
  • Collar 90 further includes handle 70 extending from the proximal end thereof adjacent rearward annular skirt 94 .
  • Handle 70 may be integrally formed with collar 90 , or may be a distinct and separate piece as shown in FIG. 2, which is force fitted and affixed onto outer sidewall 104 of rearward annular skirt 94 of collar 90 , such as with an adhesive, solvent welding, ultrasonic welding, snap fit, or other equivalent method.
  • Handle 70 may be of a solid construction, or may be hollow with an internal cavity. In such an embodiment, bifurcated needle 12 may extend entirely through hub 22 and into the hollow internal cavity of handle 70 , which may facilitate manufacturing and assembling of the needle assembly 10 .
  • Handle 70 provides a medical practitioner with a surface area for grasping and using needle assembly 10 during administration of a vaccine, as will be discussed in more detail herein. Accordingly, handle 70 includes a surface area capable of accommodating a practitioner's fingers for use, and is therefore desirably somewhat elongated in structure. The length of the handle 70 is optimized to provide beneficial ergonomic conditions for administering the vaccination or performing other medical procedures utilizing the bifurcated needle 12 . Additionally, handle 70 desirably includes a specific profile for accommodating a user's fingers, such as arcuate surfaces 72 extending along opposing sides of handle 70 .
  • handle 70 may include structure for effectively grasping needle assembly 10 , such as ribs 74 extending along opposing sides of handle 70 .
  • handle 70 includes such ribs 74 along the arcuate surfaces 72 , as shown in FIG. 1.
  • shield 140 comprises a rearward end 144 and a forward end 146 .
  • Forward end 146 of shield 140 includes a slot or longitudinal opening 160 formed by sidewalls 162 that extend downwardly from top section 163 and run substantially opposite of one another in parallel along the length of slot 160 toward forward end sidewall 164 .
  • Means for trapping and retaining a needle in slot 160 may be provided in the form of an arm 167 that is located at one of sidewalls 162 to secure the used needle.
  • Arm 167 is deflectable by needle 12 when the needle 12 enters slot 160 . Once needle 12 passes the end of arm 167 , arm 167 moves back to its original position, whereby needle 12 is permanently trapped in slot 160 by arm 167 .
  • Collar engaging area 166 At rearward end 144 of shield 140 is a collar engaging area 166 that is a continuation of slot 160 .
  • Collar engaging area 166 includes a rearward end 168 , a forward end 170 , a top finger guide area 172 , parallel sidewalls 174 that extend downwardly and inwardly from top finger guide area 172 and into sidewalls 162 , an underside area 176 for surrounding collar 90 , and extending arms 180 to hold hanger bar 182 .
  • Parallel sidewalls 174 include an inner surface 175 where detents such as barb dents 194 are located.
  • Top finger guide area 172 comprises a first ramp 184 that extends slightly on an upward slope from the rearward end of collar 90 engaging area to a shoulder 186 . From shoulder 186 extends a second ramp 188 which slopes downwardly toward top section 163 . Most preferably, first ramp 184 comprises touch bumps 190 . Touch bumps 190 provide a tactile and visual guide to alert the user that the user's finger has contacted shield 90 and that the shield is in a defined or controlled position. Touch bumps 190 may be any configuration so long as they extend and are distinct from top finger guide area 172 . Touch bumps 190 may also be of a distinguishing color as compared to top finger guide area 172 or shield 140 .
  • Second ramp 188 has interior surface 192 for urging needle 12 toward the center of slot 160 as shield 140 is being rotated into the closed position.
  • the exterior surfaces are slightly inclined and extend radially from second ramp 188 .
  • the interior surfaces are especially helpful if the longitudinal axis of needle 12 is misaligned with respect to the longitudinal axis of hub 22 .
  • Extending arms 180 are located at rearward end 168 and at the beginning of top finger area 172 and hold hanger bar 182 .
  • Hanger bar 182 is provided for pivotal engagement with hook member 114 of collar 90 .
  • the cooperating surfaces of hanger bar 182 and hook member 114 are designed so as to permit rotational or pivotal movement of shield 140 with respect to collar 90 .
  • Such engagement between hanger bar 182 and hook member 114 provides for pivotal movement of shield 140 between a retracted position as shown in FIG. 9, with shield 140 pivotally spaced from bifurcated needle 12 , and a shielded position as shown in FIG. 10, with shield 140 encompassing bifurcated needle 12 .
  • barb dents 194 Located downwardly from extending arm 180 and hanger bar 182 and on inner surface 175 of parallel sidewalls 174 are barb dents 194 . Barb dents 194 cooperate with locking dents 118 on collar 90 to secure shield 140 in its final locked or shielded position.
  • the safety shield assembly and the unit dose needle assembly are assembled together, whereby bifurcated needle 12 is connected to hub 22 and sealed with adhesive at adhesive joint 24 .
  • Hub 22 is then joined with collar 90 in either a fixed or non-fixed manner.
  • Hub 22 can be fixedly joined with collar 90 by such techniques such as ultra-sonic welding techniques or any other bonding techniques, or mechanical fit, whereby rearward annular skirt 94 of collar 90 may be mated with hub 22 .
  • Hub 22 may be contained or force fitted within inner sidewall 102 of rearward annular skirt 94 of collar 90 .
  • Collar 90 is aligned with distal end 16 of bifurcated needle 12 .
  • a packaging needle cover 50 which may be in the form of a semi-rigid sleeve is force fitted into inner sidewall 96 of forward annular skirt 92 of collar 90 to cover bifurcated needle 12 .
  • needle cover 50 and collar 90 may include interengaging structure for mating therebetween, such as corresponding threaded surfaces for threaded engagement therebetween or slight interference or friction fits therebetween.
  • shield 140 is connected to collar 90 whereby hanger bar 182 is force fitted into hook member 114 with slot 160 facing needle cover 50 .
  • shield 140 is connected to collar 90 by a force fit or interface fit between hanger bar 182 and hook member 114 .
  • shield 140 is always oriented in a stable position and will not move unless movement of the shield 140 is positively initiated by the user. Shield 140 can then be moved toward needle cover 50 for a low profile packaged product.
  • a label 196 may be applied to the finally assembled parts. The label 196 may be used to provide tamper evidence, thereby prevent tampering of the parts, so that they are not reused.
  • Needle cover 50 provides a hermetically sealed barrier enclosing bifurcated needle 12 in a sterile environment therein.
  • FIGS. 11 - 31 depict further embodiments of the present invention that include many components which are substantially identical to the components of FIGS. 1 - 10 . Accordingly, similar components performing similar functions will be numbered identically to those components of FIGS. 1 - 10 , except that a suffix “a” will be used to identify those similar components in FIGS. 11 - 13 , a suffix “b” will be used to identify those similar components in FIGS. 14 - 16 , a suffix “c” will be used to identify those similar components in FIGS. 17 - 19 , a suffix “d” will be used to identify those similar components in FIGS. 20 - 21 , a suffix “e” will be used to identify those similar components in FIG. 22, and a suffix “f” will be used to identify those similar components in FIGS. 23 - 31 .
  • a suffix “a” will be used to identify those similar components in FIGS. 11 - 13
  • a suffix “b” will be used to identify those similar components in FIG
  • FIG. 11 depicts an alternate embodiment of a unit dose needle assembly 60 a for use with a shieldable needle assembly in accordance with the present invention.
  • hub 22 a includes a hub housing 26 a including a proximal end 28 a and a distal end 30 a separated by flange 32 a .
  • Bifurcated needle 12 a extends from distal end 30 a of hub 22 a , and is affixed thereto through adhesive joint 24 a .
  • Proximal end 28 a of hub 22 a further includes external threads 34 a for providing interengagement with collar 90 a.
  • collar 90 a desirably includes internal threads 108 a extending within forward annular skirt 92 a .
  • Internal threads 108 a of collar 90 a and external threads 34 a of hub 22 a provide interengaging threaded structure between collar 90 a and unit dose needle assembly 60 a , thereby providing a means for attaching unit dose needle assembly 60 a to collar 90 a to provide a shielding feature.
  • unit dose needle assembly 60 a can be provided as a separate structure which can be attached to a separate shielding structure in the form of a shield assembly including collar 90 a , shield 140 a and handle 70 a by threading external threads 34 a with internal threads 108 a of collar 90 a , thereby providing a shieldable needle assembly 10 a as shown for use in FIG. 13.
  • FIG. 14 depicts a further embodiment of a unit dose needle assembly 60 b for use with a shieldable needle assembly 10 b in accordance with the present invention.
  • hub 22 b includes a hub housing 26 b including a proximal end 28 b and a distal end 30 b , with bifurcated needle 12 b extending from and affixed to distal end 30 b through adhesive joint 24 b .
  • the external surface of hub housing 26 b may define an outer tapered surface 36 b extending therealong.
  • Proximal end 28 b of hub 22 b further includes a full or partial hub rim 38 b extending fully or partially circumferentially about the proximal end thereof, with an internal luer taper 40 b extending internally within a portion of hub housing 26 b .
  • Internal luer taper 40 b may further include internal threads 42 b for providing threaded interengagement with collar 90 b.
  • collar 90 b includes a nub 10 b having external threads 112 b extending thereabout for threaded engagement with internal threads 42 b of hub 22 b , providing interengaging threaded structure therebetween in a similar manner as with the assembly described in FIGS. 11 - 13 .
  • Handle 70 b is affixed to outer sidewall 104 b , thereby providing a separate shielding structure in the form of a shield assembly including collar 90 b , shield 140 b and handle 70 b for attachment with unit dose needle assembly 60 b .
  • needle cover 50 b desirably mates with outer tapered surface 36 b of hub 22 b , within forward annular skirt 92 b of collar 90 b.
  • FIGS. 17 - 19 depict yet a further embodiment of a unit dose needle assembly 60 c for use with a shieldable needle assembly 10 c in accordance with the present invention.
  • hub 22 c includes a hub housing 26 c including a proximal end 28 c and a distal end 30 c , with bifurcated needle 12 c extending from and affixed to distal end 30 c through adhesive joint 24 c .
  • the external surface of hub housing 26 c defines an outer tapered surface 36 c extending therealong.
  • Proximal end 28 c of hub 22 c further includes luer lugs or a hub rim 38 c extending fully or partially circumferentially about the proximal end thereof, with an internal luer taper 40 c extending internally within a portion of hub housing 26 c.
  • collar 90 c includes a tapered nub 110 c , having a profile for mating with the internal surface of internal luer taper 40 c of hub 22 c .
  • collar 90 c preferably includes internal threads 108 c extending within forward annular skirt 92 c . Internal threads 108 c of collar 90 c mate with hub rim 38 c of hub 22 c , thereby providing interengaging threaded structure between collar 90 c and unit dose needle assembly 60 c , for attaching unit dose needle assembly 60 c to collar 90 c to provide a shielding feature.
  • Handle 70 c is affixed to outer sidewall 104 c .
  • needle cover 50 c desirably mates with outer tapered surface 36 c of hub 22 c , within forward annular skirt 92 c of collar 90 c .
  • needle cover 50 c may include an annular rim extending circumferentially about the end thereof, for threaded engagement with internal threads 108 c of collar 90 c after hub 22 c has been mated therewith.
  • FIGS. 20 and 21 depict a unit dose needle assembly 60 d in combination with a shield assembly including a living hinge 132 d extending between collar 90 d and shield 140 d .
  • Living hinge 132 d permits shield 140 d to pivot between the retracted position and the shielded position, as discussed with respect to the above embodiments.
  • Living hinge 132 d , collar 90 d , shield 140 d , and handle 70 d can be integrally molded and formed as a single shielding structure to form a shield assembly.
  • Unit dose needle assembly 60 d can then be attached to such a shield assembly, thereby forming needle assembly 10 d .
  • Shield 140 d may further include arm 167 d , which acts as a locking mechanism with bifurcated needle 12 d in a similar manner as described above. Additionally, in an embodiment where living hinge 132 d , collar 90 d , shield 140 d , and handle 70 d are integrally molded, bifurcated needle 12 d can be assembled through bonding means to a bore (not shown) in the collar to provide an easier to manufacture assembly. Additionally, it is contemplated that bifurcated needle 12 d can be integrally molded as an extension from the collar when made from similar moldable materials.
  • a unit dose needle assembly 60 e is shown in combination with a shield assembly including a living hinge 132 e , with a locking mechanism in the form of an elongated door 136 e on shield 140 e .
  • Elongated door 136 e acts as a locking mechanism with bifurcated needle 12 e in a similar manner as described above with respect to arm 167 acting as a means for trapping bifurcated needle 12 .
  • elongated door 136 e extends over substantially the entire length of the longitudinal slot of shield 140 e .
  • Elongated door 136 e is biased to close the longitudinal slot after shield 140 e has been pivoted about living hinge 132 e and bifurcated needle 12 e is encompassed in shield 140 e .
  • elongated door 136 e is in the form of a trap door extending from a first sidewall of shield 140 e to a second sidewall of shield 140 e , with the trap door abutting a stop on the second sidewall.
  • a pair of elongated doors may be alternatively provided, each extending from a sidewall of the housing of shield 140 e , and with the doors overlapping to close the housing.
  • the elongate door member is attached to the shield 140 e by a resilient living hinge.
  • FIGS. 23 - 31 depict an alternate embodiment of a shieldable needle assembly 10 f in accordance with the present invention.
  • the shieldable needle assembly 10 f includes a unit dose needle assembly 60 f connected to a needle holding assembly 200 .
  • needle holding assembly 200 includes needle holding member 202 which is defined by a generally cylindrical body 204 extending between proximal end 206 and distal end 208 .
  • the cylindrical body 204 may be a hollow member, such as a conventional syringe barrel, or may be a solid member.
  • Proximal end 206 of the body 204 of needle holding member 202 desirably includes structure for grasping needle holding member 202 , such as a circumferential flange or a pair of flange tabs 210 .
  • the overall dimensions of needle holding member 202 such as the length and circumference are configured so as to provide an appropriate handle portion for effectively grasping the shieldable needle assembly 10 f .
  • needle holding assembly is a standard 3 cc syringe as is known in the art, but without any internal plunger mechanism as would be conventionally used with a syringe for delivering fluids.
  • the needle holding member 202 includes a tapered tip 212 projecting distally therefrom at distal end 208 .
  • Tapered tip 212 includes a male tapering surface such as a male luer taper 214 . It is noted, however, that tapered tip 212 need not have any opening therethrough, and may be a solid member, which may provide additional structural integrity to the tapered tip 212 .
  • Needle holding member 202 may also include a luer collar 216 at distal end 208 , which is generally adjacent tapered tip 212 and generally surrounds tapered tip 212 . Luer collar 216 may include a plurality of internal threads 218 for threadably receiving a hub of the unit dose needle assembly 60 f , as explained further herein.
  • the unit dose needle assembly 60 f is preferably supported by the needle holding assembly 200 at the distal end 208 of needle holding member 202 via collar 90 f .
  • Collar 90 f includes a forward annular skirt 92 f at its distal end and a rearward annular skirt 94 f at its proximal end.
  • the forward annular skirt 92 f may mate with a hub 22 f .
  • Preferably forward annular skirt 92 f includes hub 22 f integral within inner sidewall 96 f as shown in FIG. 24.
  • forward annular skirt 92 f of collar 90 f includes an internal bore 220 but having an internal diameter of approximately the same size as or a slightly larger size than the outer diameter of the proximal end 14 f of the bifurcated needle 12 f for accommodating the bifurcated needle 12 f within internal bore 220 .
  • Collar 90 f including the unit dose needle assembly 90 f within its forward annular skirt 92 f , connects or joins needle holding assembly 200 through the rearward annular skirt 94 f of the collar 90 f .
  • Rearward annular skirt 94 f desirably includes an internal luer taper 222 which extends internally within a portion of rearward annular skirt 94 f of collar 90 f .
  • Internal luer taper 222 is a female tapering surface which extends internally within at least a portion of rearward annular skirt 94 f , for engagement with the male luer taper 214 of needle holding member 202 .
  • unit dose needle assembly 60 f can be attached to needle holding assembly 200 , which can provide shieldable needle assembly 60 f with an appropriate handle portion for the assembly, thereby facilitating ease of use of the assembly.
  • Collar 90 f further includes a resilient projection 250 .
  • the projection 250 extends from collar 90 f and comprises a hinged or cantilevered area represented by a hinge 252 that is integral with the collar 90 f and a tab 254 that extends generally in the direction of the hook member 114 f .
  • Hinge 252 can be a living hinge or a portion configured to facilitate bending.
  • the tab 254 in this embodiment is in opposing relation to the opening to a channel 256 when the projection 250 is unflexed, as shown in FIGS. 26 - 27 .
  • the projection 250 is configured such that the tab 254 preferably contacts the shoulder 100 f of the collar 90 f when projection 250 is urged towards the longitudinal axis of the collar 90 f.
  • a shield 140 f as described above is pivotally attached to the collar 90 f .
  • the shield 140 f is shown rotated back towards the needle holding assembly 200 .
  • the first ramp 184 f of the shield 140 f engages the tab 254 and displaces projection 250 since it is not a rigid structure.
  • This flexibility is an important feature of the present embodiment since it reduces the possibility of dislodging the hanger bar 182 f from the channel 256 if the shield 140 f is urged against projection 250 .
  • a projection such as a ridge also helps prevent displacement or dislodging of the hinge pin from the channel during normal use. As the tab 250 tends to assume its resting position shown in FIG.
  • Resilient projection 250 further provides guidance to the user's finger to guide it radially distally outwardly into a smooth transition onto the shield 140 f . Also, it is intended that that user should not apply excessive force to the shield 140 f . Excessive and unnecessary force applied to the shield 140 f will force the shield 140 f against the projection 250 which, if not resilient, could act as a fulcrum to magnify forces on hanger bar 182 f which could easily break it or dislodge it from channel 256 . However, because projection 250 is resilient, it pivots inwardly to reduce forces being applied to hanger bar 250 . When the excessive and unnecessary force is discontinued, the resilient projection pivots outwardly moving the shield 140 f with it to the desired needle shield position for shielding the bifurcated needle 12 f after use.
  • shieldable needle assembly 10 is provided as shown in FIG. 1 for use in administering a vaccine to a patient.
  • unit dose needle assembly 60 a , 60 b , 60 c , 60 d , 60 e , or 60 f may be provided for attachment to a shield assembly including collar 90 a , 90 b 90 c , 90 d , 90 e , or 90 f shield 140 a , 140 b , 140 c , 140 d , 140 e or 140 f and handle 70 a , 70 b , 70 c , 70 d , or 70 e , or needle holding assembly 200 respectively, by threadably engaging the corresponding threaded surfaces of the respective hub and collar.
  • needle assembly 10 The user then grasps needle assembly 10 with handle 70 between finger and thumb at arcuate surfaces 72 .
  • the user can grasp needing holding assembly 200 between finger and thumb or may grasp it with the entire palm, providing an effective grasping surface due to its size, Shield 140 is then rotated back by the user toward the handle 70 or needle holder 200 .
  • needle cover 50 is removed from the bifurcated needle 12 .
  • Needle assembly 10 can then be used for administration of a vaccine through the skin of a patient, using handle 70 as a handle for holding the assembly during use.
  • a unit dose of a vaccine contained within U-shaped channel 20 may be administered percutaneously to the patient by way of bifurcated needle 12 .
  • the unit dose of the vaccine may be contained within U-shaped channel 20 during packaging and prior to removal of needle cover 50 , or the unit dose of the vaccine may be placed within U-shaped channel 20 after removal of needle cover 50 immediately prior to administration such as by accessing a vial containing multiple doses in liquid form where submersion of the U-shaped channel 20 into the vaccine retains the vaccine during removal of the bifurcated needle 12 from the vial.
  • the pointed prongs of bifurcated needle 12 penetrate the stratum corneum layer of the skin and deliver the vaccine contained within U-shaped channel 20 to the deep epidermis.
  • the user After administration of the vaccine is complete, the user easily pivotally rotates shield 140 from the open or retracted position toward bifurcated needle 12 to an intermediate position and then the user pushes on shield 140 at the top finger guide area 172 to move shield 140 into a final, non-retractable shielded position whereby needle 12 is trapped in longitudinal opening 160 .
  • shield 140 may include a latch or locking dent and the collar may include a detent or a barb dent for providing means for locking the shield in the shielded position.
  • a needle locking mechanism such as a hook or arm 167
  • the needle snaps past arm 167 and is trapped when bifurcated needle 12 is contained within shield 140 as shield 140 is pivoted into the closed or shielded position.
  • a gel material may be located in the shield near arm 167 so that when bifurcated needle 12 snaps past arm 167 , it will come to rest within the gel material.
  • the means for locking is preferably irreversible, in that once the shield is pivoting to the shielding position and locked in place, it cannot be pivoted away to expose the needle without excessive force or displacement by the user.
  • the shieldable needle assembly of the present invention provides for a single use unit dose application of a vaccine.
  • the needle assembly can be packaged as a sterile assembly for single use.
  • the needle assembly can be packaged in an appropriate box and shelf carton as required for storage and shipment.
  • the unit dose needle assembly and the shield assembly can be packaged separately in sterile packaging, and assembled just prior to use by the medical practitioner.
  • the shield, collar, handle and hub of the safety shield assembly of the present invention are comprised of moldable parts which can be mass produced from a variety of materials such as one or more moldable plastics including, for example, polyethylenes, polypropylenes, polyamides, polyesters, fluorinated polyethylenes, polyvinyl chloride, polystyrene, and the like. Materials will be selected which will provide the proper covering and support for the structure of the invention in its use, but which will also provide a degree of resiliency for the purpose of providing the cooperative movement relative to the shield and the collar of the assembly.
  • the shield, collar, handle and hub are constructed of rigid polymeric materials, thereby providing a “hard pack” configuration to the needle assembly.
  • This “hardpack” configuration provides the benefits of a sterile barrier without requiring additional packaging.
  • the inventive assembly also provides the benefit of an individual sterile package, which has in the past typically required paper packaging in a pouch or blister-type package. Further, bifurcated needles have traditionally been multiple use products which are re-sterilized in between uses.
  • the hardpack configuration provides the benefit of a single use application and a sterile package in combination.

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US10/609,146 2001-12-28 2003-06-27 Medical needle assemblies Abandoned US20040054334A1 (en)

Priority Applications (12)

Application Number Priority Date Filing Date Title
US10/609,146 US20040054334A1 (en) 2001-12-28 2003-06-27 Medical needle assemblies
CA2471065A CA2471065C (en) 2003-06-27 2004-06-15 Medical needle assemblies
AU2004202713A AU2004202713B2 (en) 2003-06-27 2004-06-21 Medical needle assemblies
ES04014551T ES2305621T3 (es) 2003-06-27 2004-06-22 Conjuntos de aguja medica con protector de aguja giratorio.
AT04014551T ATE396653T1 (de) 2003-06-27 2004-06-22 Nadelvorrichtung mit pivotierbarem nadelschutz
EP04014551A EP1491152B1 (en) 2003-06-27 2004-06-22 Medical needle assemblies with pivotable needle shield
DE602004014068T DE602004014068D1 (de) 2003-06-27 2004-06-22 Nadelvorrichtung mit pivotierbarem Nadelschutz
DK04014551T DK1491152T3 (da) 2003-06-27 2004-06-22 Medicinsk nålesamling med drejelig nåleskærm
JP2004185624A JP4873840B2 (ja) 2003-06-27 2004-06-23 医療用針アセンブリ
BR0402520-2A BRPI0402520A (pt) 2003-06-27 2004-06-24 Conjuntos de agulha médica
CNB2004100618871A CN100467079C (zh) 2003-06-27 2004-06-25 医用针组件
US11/744,048 US7632252B2 (en) 2002-05-09 2007-05-03 Medical needle assemblies

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US34412601P 2001-12-28 2001-12-28
US10/141,114 US20030125676A1 (en) 2001-12-28 2002-05-09 Medical needle assemblies
US10/609,146 US20040054334A1 (en) 2001-12-28 2003-06-27 Medical needle assemblies

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EP (1) EP1491152B1 (es)
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AT (1) ATE396653T1 (es)
AU (1) AU2004202713B2 (es)
BR (1) BRPI0402520A (es)
CA (1) CA2471065C (es)
DE (1) DE602004014068D1 (es)
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EP2094335A1 (en) * 2006-12-21 2009-09-02 Melsungen AG, B., Braun Hinged cap for needle device
EP2094335A4 (en) * 2006-12-21 2012-12-12 Braun Melsungen Ag HINGE CAP FOR A NEEDLE DEVICE
WO2008076459A1 (en) 2006-12-21 2008-06-26 Melsungen Ag, B., Braun Hinged cap for needle device
US20090018510A1 (en) * 2007-07-12 2009-01-15 Graham John Madin Needlestick prevention device
US8226604B2 (en) 2007-07-12 2012-07-24 Star Syringe Limited Needlestick prevention device
US8622960B2 (en) 2007-07-12 2014-01-07 Star Syringe Limited Needlestick prevention device
US10639430B2 (en) 2010-11-22 2020-05-05 B. Braun Melsungen Ag Hinged shield assemblies and related methods
US20140364804A1 (en) * 2013-06-06 2014-12-11 Randall Stillson Tamper evident lock iv needle cap
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JP4873840B2 (ja) 2012-02-08
EP1491152B1 (en) 2008-05-28
AU2004202713A1 (en) 2005-01-20
CA2471065C (en) 2011-08-16
BRPI0402520A (pt) 2005-03-29
US7632252B2 (en) 2009-12-15
ES2305621T3 (es) 2008-11-01
EP1491152A1 (en) 2004-12-29
CN1575822A (zh) 2005-02-09
US20070260191A1 (en) 2007-11-08
CA2471065A1 (en) 2004-12-27
DE602004014068D1 (de) 2008-07-10
JP2005013734A (ja) 2005-01-20
CN100467079C (zh) 2009-03-11
ATE396653T1 (de) 2008-06-15
AU2004202713B2 (en) 2009-11-19
DK1491152T3 (da) 2008-09-15

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