WO2001080931A2 - Dispositif de securite destine a une seringue - Google Patents

Dispositif de securite destine a une seringue Download PDF

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Publication number
WO2001080931A2
WO2001080931A2 PCT/US2001/010808 US0110808W WO0180931A2 WO 2001080931 A2 WO2001080931 A2 WO 2001080931A2 US 0110808 W US0110808 W US 0110808W WO 0180931 A2 WO0180931 A2 WO 0180931A2
Authority
WO
WIPO (PCT)
Prior art keywords
syringe
received
inner member
outer member
shoulder
Prior art date
Application number
PCT/US2001/010808
Other languages
English (en)
Other versions
WO2001080931A3 (fr
Inventor
Dale Carvin Harris
Michael James Malooley
Rodney Hal Monson
Harold Kenneth Yeager
Original Assignee
Eli Lilly And Company
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 Eli Lilly And Company filed Critical Eli Lilly And Company
Priority to AU5522401A priority Critical patent/AU5522401A/xx
Publication of WO2001080931A2 publication Critical patent/WO2001080931A2/fr
Publication of WO2001080931A3 publication Critical patent/WO2001080931A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3271—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position

Definitions

  • the present invention relates to the shielding of a syringe needle to protect against contact with the syringe needle after use.
  • Syringes are commonly used to administer medications and other fluids into a patient, or to aspirate or withdraw a fluid from a patient. Syringes may be marketed in a prefilled condition, wherein a set dosage of medicament is already contained therein, typically in a form ready for use or requiring reconstitution. Alternatively, syringes may be provided empty for aspiration purposes or to be filled from a vial or other source of medicament for injection purposes.
  • the potential for a needle stick is increased under circumstances where use and disposal of the needle may be less than optimal.
  • schizophrenia patients are sometimes brought into an emergency room in an agitated state and may need to be physically restrained.
  • healthcare professionals administer injections of appropriate medications. Under these circumstances there can be an increased risk that the needle will be inadvertently contacted by the person administering the injection or by others in the vicinity.
  • the protective system must be simple to use and reliable in operation, must not be susceptible to premature deployment, and must not interfere with the normal use of the syringe.
  • the present invention generally provides a safety device for a syringe having a needle for injection into a patient.
  • the safety device includes an outer member and an inner member sized to receive the syringe.
  • the outer member is secured to the syringe.
  • the inner member is telescopically received within the outer member and movable between a first, retracted position in which the needle is exposed for use, and a second, extended position in which the needle is covered after use.
  • the outer member and inner member are configured to limit the extension of the inner member with respect to the outer member and to lock the inner member in the extended position.
  • the outer member of the safety device includes a cylindrical body and a shoulder against which a flange of the syringe is received.
  • a separate clip or connector may be used to further secure the syringe to the safety device.
  • the outer member includes a backstop within which a flange of the syringe is received and retained by securement of a cover thereto.
  • one of the inner and outer members includes a projection having a locking surface that fits within a recess on the other of the inner and outer members.
  • the projection fits within the recess of the inner member to lock the inner member when it is in its extended position.
  • the device is easily handled during use, and provides
  • a further object of the present invention is to provide a safety device which is readily coupled with a syringe, and which becomes integral with the syringe once assembled.
  • Another object of the present invention is to provide a safety device which permits adequate visibility of the syringe and its contents.
  • a further object of the present invention is to provide a safety device which is securely locked in the extended, safety position, and which fully covers the syringe needle in the extended position.
  • Figure 1 is a cross-sectional, perspective view of a first embodiment of a safety device combined with a syringe in accordance with the present invention, with the safety device shown in the initial, collapsed position.
  • Figure 2 is a cross-sectional view of the device of Figure 1 shown in the extended position.
  • Figure 3 is an elevational, perspective view of the syringe and safety device of Figure 1.
  • Figure 4 is a side, elevational view of the safety device according to the first embodiment of the invention.
  • Figure 5 is a side, cross-sectional view of the safety device of Figure 4.
  • Figure 6 is a side, cross-sectional view of the safety device of Figure 4 shown in the extended position.
  • Figure 7 is a side, cross-sectional view of the safety device viewed in the direction of the line 7-7 in Figure 4.
  • Figure 8 is a side, cross-sectional view of the safety device as shown in Figure 7 but in the extended position.
  • Figure 9 is a perspective view of a clip useful in securing a syringe to the safety device of Figure 1.
  • Figure 10 is a bottom, plan view of the clip of Figure 9.
  • Figure 11 is a partial, side view of the syringe and safety device coupled together
  • Figure 12 is a side, cross-sectional view of the syringe and safety device assembly of Figure 11.
  • Figure 13 is a perspective view of an alternate embodiment of an outer member useful in accordance with the present invention.
  • Figure 14 is a side, cross-sectional view of the outer member of Figure 13.
  • Figure 15 is a perspective view of an alternate embodiment of an inner member useful in combination with the outer member of Figure 13.
  • Figure 16 is a side, cross-sectional view of the inner member of Figure 15.
  • Figure 17 is a side, cross-sectional view of the alternate embodiment of the safety device with the syringe coupled thereto with a clip, and with the inner member shown in the fully extended position relative to the outer member.
  • Figure 18 is a perspective view of a second alternate embodiment of an inner member useful in the present invention.
  • Figure 19 is a side, cross-sectional view of the inner member of Figure 18 assembled with a complementary outer member.
  • Figure 20 is a side, elevational view of another embodiment of an inner member useful in accordance with the present invention, and particularly including centering
  • Figure 21 is a side, cross-sectional view of the inner member taken in the direction of line 21-21 in Figure 20.
  • Figure 22 is a perspective view of another embodiment of an outer member useful with the present invention in combination with the inner member shown in Figure 20.
  • Figure 23 is a side, elevational view of the outer member taken in the direction of line 23-23 in Figure 22.
  • Figure 24 is a side, cross-sectional view of the outer member of Figure 23.
  • Figure 25 is a side, elevational view of the outer member taken in the direction of line 25-25 in Figure 23.
  • Figure 26 is a side, cross-sectional view of the outer member as shown in Figure
  • Figure 27 is a plan view of the proximal end of the outer member of Figure 22.
  • Figure 28 is a top perspective view of a backstop cover useful with the outer member of Figure 22 to secure a syringe to the safety device.
  • Figure 29 is a bottom, perspective view of the backstop cover of Figure 28.
  • Figure 30 is a side, cross-sectional view of the backstop cover.
  • Figure 31 is a bottom, plan view of the backstop cover.
  • Figure 32 is a perspective view of an assembled safety device in accordance with one embodiment of the present invention, and particularly showing a syringe secured therewith by the backstop and cover.
  • Figure 33 is a side, cross-sectional view of the assembled safety device.
  • the present invention satisfies the continuing need for protection of users and others against accidental needle sticks from a syringe.
  • the safety device is attached to a syringe and becomes integral therewith to assure the presence of the safety device for use when required.
  • the safety device is readily adapted for use with a variety of syringe types, including various types and sizes of needles.
  • the safety device includes many advantages as detailed hereafter with respect to the drawings and description of the preferred embodiments.
  • a combination syringe and safety device 10 in accordance with one embodiment of the present invention.
  • the syringe 11 is received within the telescoping safety device 12 and is attached thereto by a clip shown in subsequent drawings.
  • the safety device comprises an outer member 13 and a telescoping inner member 14.
  • the safety device is extendable from a retracted position shown in Figure 1 to an extended position shown in Figure 2. In the retracted position, the full length of the needle is exposed for use.
  • the safety device includes means for limiting the distal extension of inner member 14 relative to outer member 13.
  • the outer member includes a pair of longitudinal channels 15 located on opposite sides of the interior surface.
  • the inner member includes a pair of opposed tabs 16 sized and positioned to be received within the channels 15.
  • the distal end of each channel defines a shoulder 17.
  • Each of the tabs 16 includes a distal surface 18 shaped to engage the respective shoulder 17.
  • These abutting surfaces are shown as being generally perpendicular to the axis of the safety device, but other configurations providing a sufficient stop for distal travel of the inner member would be equally useful. Therefore, as shown in Figure 2, the distal travel of inner member 14 relative to outer member 13 is limited to the position when the surfaces 18 abut the shoulders 17.
  • opposed tabs 16 received within channels 15 provides an exemplary means for controlling extension of the inner member, but various alternate approaches may be employed. For example, these members may be reversed such that the tabs are located on the outer member and the channels are located on the inner member.
  • the number of such mechanisms is also not critical, as one or more such systems could be employed.
  • the use of two opposed and identical mechanisms provides advantages such as symmetry to facilitate assembly, enhanced locking strength due to the duplication of the abutting surfaces, and greater stability for the safety device as the inner member is extended.
  • Other approaches to controlling the extension of one member relative another are also known in the art and are contemplated herein.
  • the safety device further includes means for locking the inner member in the extended position once it has been fully deployed.
  • the inner member 14 includes at least one locking tab 19 which is initially received within an aperture 20 in the outer member.
  • the tab 19 includes an angled distal surface 21 which is positioned adjacent a complementary, angled surface 22 of the outer member. The presence of these adjacent, angled surfaces enables the inner member 14 to be telescoped distally relative to the outer member as the tab 19 is forced inwardly along the angled surface 22. Sufficient clearance is provided between the interior of the inner member 14 and the exterior of the syringe 11 to permit the inner member to flex as the tab 19 is moved inwardly.
  • the requirement for the inner member to flex in this manner provides a resistance against the extension of the inner member relative the outer member, and initially retains the inner member in the retracted position. Accordingly, the amount of resistance can be predetermined by selection of the size of the tab 19, the angle and/or shape of the surfaces 21 and 22, the type and thickness of the materials, and other design parameters. This permits the safety device to be designed with a desired amount of effort being required to extend the inner member, thereby preventing premature deployment.
  • the proximal side of the tab 19 includes a locking surface 23 which engages a complementary shoulder 24 defined on the proximal side of a channel 25 defined by the outer member 15.
  • the tab and receiving channel may be reversed such that the tab is carried by the outer member and the receiving channel is defined by the inner member.
  • the safety device preferably includes a pair of locking tabs and complementary channels positioned on opposite sides, thereby providing such advantages as symmetry for purposes of assembly, increased locking due to the presence of two systems, and greater stability for the safety device as the inner member is deployed.
  • Other approaches to locking the extension of one member relative to another are also known in the art and are contemplated herein.
  • the inner member may be rotated from its assembled position relative to the outer member to avoid engagement between the tabs 19 and shoulders 24. In this position, the inner member is slid into the outer member to a point at least beyond the position at which the tabs 19 could be received within the channels 25. The inner member is then rotated relative to the outer member to move the tabs 16 into the respective channels 15. Full insertion of the inner member into the outer member will cause the tabs 19 to be received within the apertures 20, thereby completing assembly of the safety device.
  • the tabs 16 are provided with angled, proximal surfaces 27 which facilitate insertion of the inner member into the outer member.
  • the distal end 28 of the outer member 13 may be provided with an inwardly tapered edge 29 which cooperates with the angled surface 27 to facilitate assembly of the two members.
  • the syringe 11 is secured to the outer member 13 in any manner suitable to assure proper operation of the safety device.
  • the syringe could be glued or otherwise directly connected with the outer member.
  • coupling means may be employed to hold the syringe and the safety device together without such direct connection.
  • the syringe is coupled with the safety device by a clip 30.
  • the clip 30 provides for securement of the syringe to the safety device, and also provides other advantages, as hereafter described.
  • Clip 30 includes a proximal member 31 and a distal member 32 connected by a wall 33.
  • the distal member 32 defines a central aperture 34 sized to receive the outer member 13, and an angled lead opening 35 to permit passage of the outer member therethrough into the central aperture.
  • the lead opening reduces to a distance slightly less than the outside diameter of the outer member 13. Therefore, when the clip 30 is pushed over the outer member, it flexes outwardly in order for the outer member to be moved into the central aperture 34, thereby providing a means of attachment of the clip to the outer member.
  • the proximal member 31 similarly includes a central aperture 36 and a lead opening 37.
  • the syringe 11 includes a plunger 38 which is received through the lead opening and into the central aperture 36 when the clip is attached to the safety device.
  • the central aperture is sized to be sufficiently large to receive the plunger 38, but may also be sized sufficiently small as to prevent withdrawal of the stopper 39 received within the body 40 of the syringe.
  • the clip 30 thereby makes the syringe safer to use in that the stopper 39 is not removable and the contents of the syringe therefore cannot be exposed.
  • the outer member 13 includes a radially-extending flange 41 and an axially-extending flange 42.
  • the distal member 32 of the clip is received underneath the flange 41, and the proximal member 31 of the clip is received over the flange 42.
  • flange 42 is displaced outwardly of the main body of the outer member, thereby defining a central recess 43 and a surrounding circumferential shoulder 44.
  • Syringe 11 includes a flange 45 which extends outwardly at the proximal end of the syringe. Flange 45 is received within recess 43 and overlaps with shoulder 44. The proximal member 31 of the clip therefore sandwiches the flange 45 against the shoulder 44, thereby providing securement of the syringe with the safety
  • the syringe 11 is simply inserted into the safety device with the flange 45 resting against the shoulder 44.
  • the clip 30 is slid over the outer member 13 with the syringe plunger being received within central aperture 36 and the flange 41 being received between the proximal and distal members of the clip. The clip is thereby firmly attached to the safety device, and the syringe is held securely with the safety device.
  • Suitable variations in the design of the clip are contemplated herein.
  • the basic function of the clip is to couple the syringe with the safety device in a secure manner, and alternative designs which accomplish this function are equally useful with the present invention.
  • syringe needle 46 is shielded by a cover 47 in its assembled state prior to use.
  • the safety device is sized such that the cover 47 can remain in place during assembly of the syringe with the safety device.
  • the cover should remain in place as long as possible, but can be readily removed when required, without disassembly of the syringe from the safety device.
  • the syringe may be coupled with the safety device without limiting other operations that may be required for the syringe prior to use.
  • certain medications may be prefilled in the syringe as a dry powder, and will therefore need to be reconstituted prior to use.
  • This operation can be accomplished with the syringe and safety device assembled together, without deployment of the safety device.
  • One advantage of the inventive design is that the outer member 13 can be grasped during such operations, thereby protecting against undesired deployment of the inner member.
  • the outer member 13 may be readily held while the needle cover 47 is removed and the syringe plunger 38 is then pulled outwardly to draw diluent into the syringe in order to reconstitute a powder medication.
  • the assembled syringe and safety device provide a solution to the combined need
  • the combined unit Prior to administration of a medicament to a patient, the combined unit has the safety device in the retracted position as shown in Figure 3.
  • the needle 46 is exposed and is inserted into the patient in the required fashion, for example intramuscularly or subcutaneously.
  • the device may be held in any of a variety of fashions by grasping the outer member appropriately. Such techniques are well known in the art, and are equally useful with the present invention.
  • the plunger is manipulated to administer the medication through the needle in conventional manner.
  • the members of the safety device are preferably made to be sufficiently transparent or translucent to permit the fluid within the syringe body to be visualized.
  • the syringe or its contents are viewed through the safety device to monitor the administration of the medication or to check labeling or other information present on the syringe body.
  • the inner and outer members are therefore preferably made of materials suitable to permit adequate visualization of the syringe and its contents for these and other purposes.
  • the inner member is extended to shield the syringe needle.
  • the inner member 14 includes a ring-shaped flange 48 that extends radially and axially outward of the outer member 13.
  • the user of the device simply presses against the flange 48 of the inner member 14 as the outer member 13 is withdrawn from the patient.
  • This operation readily and automatically extends the inner member relative to the outer member, moving the safety device into the safety position shown in Figure 2.
  • the extension of the inner member is limited by the tabs 16, and retraction of the inner member is prevented by locking tabs 19.
  • the inner member thereby extends axially to a position that fully covers the needle and protects the user and others from accidental contact with the tip of the needle.
  • the amount of force required to extend the inner member in this fashion is predetermined. This can be accomplished, for example, by selectively configuring the tabs 19, and particularly the complementary surfaces 21 of tabs 19 and surfaces 22 of outer member 13. It will be apparent that other modifications could also be made to control the force required, both for this embodiment and in alternate embodiments described hereafter.
  • the predetermined force required for extension is preferably selected to match the amount of force which a health care professional could be expected to apply under the circumstances of use. For example, some studies suggest that a force of between about 0.5 and about 4.0 pounds, preferably about 1.0 pounds of force is suitable. However, the design of the present invention guards against premature deployment since the user has the full length of the outer member to hold while performing such operations as reconstituting a medicament or aspirating fluid into the syringe, without the risk of
  • the clip 30 may also function as a means for holding the syringe during use.
  • the perimeter of the clip may be sized to provide for contact surfaces for the user of the syringe, typically by the fingers.
  • the contact of the distal member 32 with the underside of the flange 41 provides a bearing surface to permit pressure to be applied against the clip during use.
  • the outer member 49 defines longitudinal slots 50 that receive tabs 51 of inner member 52 to provide an end stop for outward extension of the inner member relative to the outer member.
  • the surfaces of the tabs 51 are configured as in the previous embodiment to facilitate assembly of the two components and to assure a definitive end stop to extension of the safety device once assembled.
  • Inner member 52 further includes an integral pair of opposed arms 53 carrying projections 54.
  • the outer member includes co ⁇ esponding apertures 55 to receive the projections 54 in the retracted position.
  • the arms 53 are preferably formed integrally with the cylindrical body of the inner member, and may be canted outwardly to assure that the projections 54 seat firmly within the receiving apertures 55 in the outer member.
  • the size and shape of the arms 53 and projections 54 are readily modified to provide the desired resistance to sliding movement of the inner member, thereby determining the force required to deploy the inner member to the safety
  • the syringe is again depicted as coupled with the safety device by means of a clip 57.
  • This clip functions essentially the same as for the previous embodiment, with the following differences.
  • the outer member 49 includes only an axially-extending flange 58.
  • the clip 57 is received over the flange 58 and sandwiches the flange 59 of syringe 60 against an annular shoulder 61 formed by the outer member.
  • the clip further includes a partial, circular lip 62 that extends distally. The lip 62 is sized and positioned to bear against the interior of the syringe to firmly center and hold the syringe in place within the outer member 49.
  • FIG. 18 A related embodiment is depicted in Figures 18 and 19.
  • This embodiment is similar to the previous embodiments, except that the outer member 63 includes inwardly- extending end stops 64. These end stops are received within co ⁇ esponding slots 65 defined by the inner member 66.
  • This embodiment therefore exemplifies a reversal of parts with regard to the portions providing the end stop for extension of the inner member.
  • other variations including reversals of parts, can be employed for other aspects of the safety device.
  • FIG. 20-33 Another embodiment is shown in Figures 20-33.
  • an inner member 67 which includes additional features to assist in centering and stabilizing the syringe body within the member.
  • the inner member 67 includes slightly modified arms 68 including outwardly-extending projections 69 operating in the same manner as previously described with respect to the embodiment of Figure 15. These arms terminate a short distance from the proximal end 70 of the inner member, thereby providing proximal gaps 71 adjacent to the arms.
  • the proximal end of the inner member also defines a pair of opposed recesses 72 aligned with the end stops 73. These proximal gaps 71 and recesses 72 cooperate with alignment features of the outer member, as hereafter described.
  • the inner member 67 also includes a pair of arms 74, preferably formed integrally with the cylindrical body 75 of the inner member. Each of the arms 74 carries a pair of inwardly-extending projections 76 ( Figure 21). These projections 76 are urged by the angled arms 74 against the body of a syringe received within the inner member 67, thereby centering and stabilizing the distal portion of the syringe within the member 67.
  • the outer member 77 includes a cylindrical body 78 and a backstop portion 79.
  • the body 78 defines a pair of longitudinal slots 80 which receive the end stops 73 of the inner member to limit the extension of the inner member as previously described.
  • the outer member also defines a pair of interior recesses 81 providing shoulders 82 against which are received the projections 69 of arms 68 when the inner cylinder is extended, thereby locking the inner cylinder in the fully extended position once deployed.
  • This alternate embodiment is further distinguished by the inclusion of the backstop portion 79 with the outer member 77, preferably as an integral part therewith.
  • the backstop portion cooperates with a backstop cover, described hereafter, to provide secure coupling of the syringe with the safety device.
  • This embodiment therefore demonstrates a variation of the previous embodiments in terms of the coupling of the syringe with the safety device, and it will be appreciated that other such variations may be employed.
  • the backstop portion 79 and the outer member 77 include several features to assist in the centering of the syringe within the proximal part of the safety device.
  • the outer member includes a plurality of ribs 85 along the entry to the interior of the cylindrical body 78 which extend within the gaps 71 and recesses 72 of the inner member when the safety device is in the collapsed position. These ribs are positioned to receive the syringe body and to center it therebetween.
  • the backstop 79 similarly includes a plurality of ribs 86 which are positioned to receive the flange of the syringe therebetween.
  • the ribs 85 may be positioned anywhere around the periphery of the cylindrical body 78 to sufficiently support and align a syringe received therein.
  • the outer member includes six such ribs.
  • a rib is aligned with each of the slots 80.
  • a pair of ribs is positioned adjacent the position for each of the arms 68 of the inner member. These pairs of ribs are spaced apart a sufficient distance to permit the arms 68 to extend therebetween when the safety device is in the fully collapsed position.
  • the backstop portion 79 is further provided to couple the syringe with the safety device by sandwiching the syringe flange axially therein.
  • Backstop 79 includes a base 87 that is secured to the body 78 and extends outwardly therefrom, forming a surface 88 which can assist in the use of the syringe, particularly in moving the plunger down into the syringe, as previously described.
  • An upstanding perimeter wall 89 defines a circumferential groove 90 used to attach a cover to the backstop.
  • a tab 91 extends beyond the wall 89 to complement the backstop cover as described hereafter.
  • the backstop cover 92 is shown in detail in Figures 28-31.
  • Cover 92 includes a top 93 and a perimeter wall 94 extending downwardly therefrom.
  • the wall 94 includes an inwardly-facing bead 95 that is sized and positioned to be received within the groove 90 of the backstop when the cover is attached thereto.
  • a pair of walls 96 also extend from the top 93 and engage the interior surfaces 97 of the upstanding wall 89 of the backstop to further secure the cover to the backstop.
  • a pair of crush ribs 98 extend from the top 93 and are sized and positioned to deform against the proximal side of the syringe flange to securely hold the syringe within the safety device.
  • the cover 92 further defines a center hole 99 and a lead opening 100 extending thereto.
  • the hole 99 is sized to receive the syringe plunger.
  • the lead opening allows the cover to be moved over the plunger as the cover is attached to the backstop. Therefore, the cover can be attached to the backstop even when the plunger is already received within the syringe body placed within the safety device.
  • the upstanding tab 91 is received within the lead opening 100 upon assembly of the cover to the backstop, thereby filling a portion of the opening 100.
  • This alternate embodiment of the present invention is assembled and used generally in the same fashion as described with respect to previous embodiments.
  • the inner member 67 is inserted into the outer member 77 to the fully collapsed position.
  • the arms 68 are aligned with the recesses 81 and pressed inwardly until the projections 69 have cleared past the shoulders 82.
  • the inner member is then fully inserted into the outer member.
  • a syringe 101 (Figure 33) is placed into the inner member and the flange 102 is received against the proximal edges of the ribs 85 and the proximal surface of the base 87.
  • the distal portion of the syringe body 103 is centered in position by the arms 74 and projections 76 which bear against the body.
  • the proximal portion of the syringe body is centered by the ribs 85 and
  • the cover 92 is then attached to the backstop 79. Specifically, the backstop is moved over the plunger 104 by passing the plunger through the lead opening 100 and into the center hole 99. The cover is then moved axially onto the backstop and snapped into position as the bead 95 of the cover is received within the co ⁇ esponding groove 90 of the backstop. The tab 91 is received within the lead opening to complete the perimeter su ⁇ ounding the plunger. Also in this process, the crush ribs 98 are pressed against the syringe flange 102 and deform against the flange to securely hold the syringe in position.
  • the cap 105 is removed to expose the needle 106.
  • the plunger 104 is manipulated as needed, for example, to reconstitute a dry medicament, to aspirate fluid into the syringe body, or to administer the medicament to a patient.
  • the user is able to grasp the body of the outer member 77 and/or bear against the backstop 79 during these actions.
  • the center hole 99 is preferably sized to prevent the syringe stopper 107 from being pulled past the cover 92 during any of these processes, thus preserving sterility.
  • the inner member 67 is deployed.
  • the user simply presses against the ring 108 extending radially outwardly beyond the outer member at the same time that the outer member is pulled toward the user.
  • This action preferably and easily occurs by the user pressing the ring 108 against the patient as the outer member is pulled away from the patient.
  • the needle 106 is drawn out of the patient and into the inner member 67.
  • the device therefore provides the advantage that the needle is never exposed after it has been inserted into the patient.
  • the inner member is already deployed into the fully-extended, safety position with the needle fully covered by the inner member.
  • the inner member can also be extended in the same fashion after the assembly is removed from the patient.
  • the described safety device of the present invention ensures that a syringe needle is protected against accidental contact with the user or others.
  • the device uses an inner member which is manually extended to the safety position by telescoping outwardly with respect to an outer member held by the user of the device.
  • the components of the safety device may be fabricated from a variety of suitable materials. Sturdy plastic materials are preferred for their low cost and ease of fabrication.
  • the materials should be sufficiently transparent or translucent, at least at relevant portions, to permit viewing of the syringe and its contents. This will enable the user to check the labeling of the syringe, and to confirm matters concerning materials drawn into or dispensed from the syringe body.
  • the materials should also be selected to provide required strength and durability of the assembly in the collapsed and deployed conditions.
  • the components should be sufficiently strong as to endure the anticipated handling of the device during normal use, and foreseeable mishandling of the device such as by dropping.
  • the components have also been shown in particular shapes and configurations, but these are not required.
  • the inner and outer members have been shown as having cylindrical bodies because they are readily formed and assembled and are convenient for use. Other shapes for these components could also be used.
  • the safety device advantageously provides visual, audible and tactile feedback with regard to its assembly and use.
  • the insertion of the inner member into the outer member provides a definite indication of the full insertion point as the projections 69 are received within the recesses 109 ( Figure 26) between the ribs 85.
  • the cover 92 snaps onto the backstop 79 as an indication of its proper placement.
  • the arms 68 and projections 69 drop into the recesses 81 as a similar confirmation that the inner member has been moved to and locked in the fully extended position.
  • the ring 108 is sized and positioned to minimize the possibility of accidental deployment of the inner member, while being easily used when appropriate.
  • the ring may be colored or textured in a way to bring attention to it. This will help to alert the user to the fact that the ring is used for deployment of the inner member, and that it should be pushed against only when it is time to deploy the inner member.
  • the safety device is readily adapted to be used with a variety of syringes.
  • the invention has been shown and described as used with a syringe having a fixed needle and standard needle cap.
  • the safety device is designed to accommodate a variety of syringe and needle designs, including removable needles and needles of varying lengths.
  • the safety device is attached to a given syringe, and the entire assembly is discarded after use.

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

Abstract

Un dispositif de sécurité pour une seringue comprend des éléments internes et externes télescopiques. Les éléments comprennent des parties saillantes et des évidements complémentaires qui limitent l'extension totale de l'élément interne et qui bloquent l'élément interne en place lorsqu'il est complètement étiré. L'élément interne comprend une bague située à l'extrémité distale qui s'étend radialement à l'extérieur de l'élément externe et qui est poussée pour déployer l'élément interne. L'élément interne est fixé au bord proximal d'une seringue logée dans le dispositif de sécurité. Une pince ou une protection est attachée à l'élément externe et fixe l'élément externe sur le bord de la seringue.
PCT/US2001/010808 2000-04-21 2001-04-17 Dispositif de securite destine a une seringue WO2001080931A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU5522401A AU5522401A (en) 2000-04-21 2001-04-17 Safety device for a syringe

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US26629600P 2000-04-21 2000-04-21
US60/266,296 2000-04-21

Publications (2)

Publication Number Publication Date
WO2001080931A2 true WO2001080931A2 (fr) 2001-11-01
WO2001080931A3 WO2001080931A3 (fr) 2002-07-04

Family

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Family Applications (1)

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PCT/US2001/010808 WO2001080931A2 (fr) 2000-04-21 2001-04-17 Dispositif de securite destine a une seringue

Country Status (2)

Country Link
AU (1) AU5522401A (fr)
WO (1) WO2001080931A2 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002070058A1 (fr) * 2001-03-07 2002-09-12 Safe Ject Ab Seringue hypodermique pouvant etre jetee en toute securite et comprenant des boitiers interne et externe et une aiguille retractable
EP1340514A1 (fr) * 2002-01-31 2003-09-03 Safety Syringes, Inc. Dispositif autoprotecteur jetable pour seringue
WO2004058338A1 (fr) * 2002-12-31 2004-07-15 Teva Medical Ltd. Dispositif de protection d'aiguille
US8372044B2 (en) 2005-05-20 2013-02-12 Safety Syringes, Inc. Syringe with needle guard injection device
US9943646B2 (en) 2014-08-21 2018-04-17 Owen Mumford Ltd. Safety syringe

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2700959A1 (fr) * 1993-02-02 1994-08-05 Creange Alain Seringue à protection d'aiguille incorporée.
US5417660A (en) * 1992-02-03 1995-05-23 T. A. Kershenstine Self-locking syringe holder for use with a hypodermic syringe
WO1996029107A1 (fr) * 1995-03-17 1996-09-26 Radiometer Medical A/S Moyen de protection
US5891092A (en) * 1997-10-02 1999-04-06 Visionary Medical Products Corporation Disposable safety syringe and method of making the same
US5921964A (en) * 1993-02-08 1999-07-13 Martin; Robin Safety blood collecting device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5417660A (en) * 1992-02-03 1995-05-23 T. A. Kershenstine Self-locking syringe holder for use with a hypodermic syringe
FR2700959A1 (fr) * 1993-02-02 1994-08-05 Creange Alain Seringue à protection d'aiguille incorporée.
US5921964A (en) * 1993-02-08 1999-07-13 Martin; Robin Safety blood collecting device
WO1996029107A1 (fr) * 1995-03-17 1996-09-26 Radiometer Medical A/S Moyen de protection
US5891092A (en) * 1997-10-02 1999-04-06 Visionary Medical Products Corporation Disposable safety syringe and method of making the same

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002070058A1 (fr) * 2001-03-07 2002-09-12 Safe Ject Ab Seringue hypodermique pouvant etre jetee en toute securite et comprenant des boitiers interne et externe et une aiguille retractable
US6562003B2 (en) 2001-03-07 2003-05-13 JK Medicinkonsult Förvaltning AB Safely disposable hypodermic syringe
EP1340514A1 (fr) * 2002-01-31 2003-09-03 Safety Syringes, Inc. Dispositif autoprotecteur jetable pour seringue
US6872194B2 (en) 2002-01-31 2005-03-29 Safety Syringes, Inc. Disposable self-shielding syringe guard
WO2004058338A1 (fr) * 2002-12-31 2004-07-15 Teva Medical Ltd. Dispositif de protection d'aiguille
US8372044B2 (en) 2005-05-20 2013-02-12 Safety Syringes, Inc. Syringe with needle guard injection device
US9943646B2 (en) 2014-08-21 2018-04-17 Owen Mumford Ltd. Safety syringe
US10661011B2 (en) 2014-08-21 2020-05-26 Owen Mumford Limited Safety syringe
US11291770B2 (en) 2014-08-21 2022-04-05 Owen Mumford Limited Safety syringe

Also Published As

Publication number Publication date
AU5522401A (en) 2001-11-07
WO2001080931A3 (fr) 2002-07-04

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