CA2045691C - Disposable automatic hypodermic needle guard - Google Patents

Disposable automatic hypodermic needle guard Download PDF

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Publication number
CA2045691C
CA2045691C CA002045691A CA2045691A CA2045691C CA 2045691 C CA2045691 C CA 2045691C CA 002045691 A CA002045691 A CA 002045691A CA 2045691 A CA2045691 A CA 2045691A CA 2045691 C CA2045691 C CA 2045691C
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CA
Canada
Prior art keywords
needle
tip
protecting
locking
guard
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.)
Expired - Lifetime
Application number
CA002045691A
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French (fr)
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CA2045691A1 (en
Inventor
Richard C. Sircom
Youssef M. Youssef
Robert S. Solomon
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Smiths Medical ASD Inc
Original Assignee
Medex Inc
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Publication of CA2045691A1 publication Critical patent/CA2045691A1/en
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Publication of CA2045691C publication Critical patent/CA2045691C/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0612Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0618Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3273Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel freely sliding on needle shaft without connection to syringe or needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3213Caps placed axially onto the needle, e.g. equipped with finger protection guards
    • A61M2005/3215Tools enabling the cap placement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • A61M2005/325Means obstructing the needle passage at distal end of a needle protection sleeve

Abstract

A needle tip protecting device is provided for hypodermic needles, catheters and the like. The device is small enough to be stored at the base of the needle prior to and during use. After use it may be slid to cover the needle tip where it automatically self-attaches and becomes non-removable. Various embodiments of mechanisms to achieve this effect are described.

Description

VS'O 90/t)85G4 1 ~ ~ ~ ~ PC?/lrA90/00031 TfII~ DLSPt?SABLJr AUTOMATIC HYPODEJdMIC NEFDLIr GUARD
1. FiFla OF THE IhIVFNTION
This invention relates to the sate disposal of hypodermic necdia by a guard device ;vhich protecu the needle tip from exposure after use. More particularly, it relates to a ttp protector which is storable on the noedie and which automatically locks over the and of the needle when slid into position by We steer.
2 BACKGROUND '1~D THE 'ION
Z1 'Ibe dangers of Infection from acddental contact with the pointed end of used hypodetmlc nee4Jes has long been rccogaized and Lt well dosumcntcd. For example, refer to Jogger, Hunt, Bread-Einag,gar and Pearson, the New England Journal of Medicine, August, 1y88. in moat ptoaduets, the greater avoidable risk of accidental needle puncture, or 'needle-stick', occutx during handling of the used needle, when it is generally inserted into a protective sheath for disp~ai. This action usually requires moving the hand which holds the sheath towards the pointed tip of the needle, and any inaccuracy in this operation raises the possibility of a puncture. The risk of this is greatly increased if the operator is working under stress, such as time-pressure or fatigue, or is handicapped by marginal eyesight or ttasteady hands.
22 A number of dcviocs have been developed to deal with the general problem of needle-sticks, and reference may be made to U.S. Patents 4,747,835 (Sandbaus);
4,735,618 (Hagen); 4,735,617 (Nelson, Flume); 4,731,059 (Wanderer, Smgstrcuer);
4,725,?b7 (Vaillaacouri); 4.720,285 (Pickhsrd); 4,623,336 (Pedirano, Kanc);
4,430,082 (Schwabacher, et al), and 4,755,170 (Golden).
2.3 Some of tbese, for example Saadhaus, NelsoNF7ome, and Pedicano/Kane, provide an enlarged conlal entry to the protective :heath, so that the resulting larger target reduces the chance of the operator ttttssiag the catty. This tary be crombined with some non-nunual means of bolding the sheath assembly, fttrtber reducing the risk.
All of these dcvicts require the operator to divert his atteatlon front his immediate task and to exucise some measure of care is piadng the noedle into the sbeathiag devia.
24 Others of these, for example Hagsn sad Vaivancourt, aspire to attafa the acsinble goal of ksepdag the bands wdoUy behtad the sharpened dp oe the needle darlnj the ttsanipnlation of the protective devitx. The Hag=s design stores the tip protetxor uonnd the bane of the needle, but is this mode the btsaal rotadaing memben aro Bolded is as ~ akimbo' oonHgtuaiion, cx<cadiag to either tide of the asedie In a tasanu could iaterfcre with the proper manipulation of the ryringe and needle during iasatiaa sad reaxovaL The Vaillasoourt desigxt ttwuats the tip protector at the distal end of a cylladrial bellows caazi:l with the mmoedle, wbtch tray be collapsed bngitudinalfy to allow atoraje of the tip protector at the acodle bass This is more compact, but requira Bare and attention during the noo4lo sheathing aaton to ensure that the needle b propuly bcat~ ~rlthin the protector. Fathtre to do title could t~sult in tire axdle becoming eap~i again. Both designs appear to aria wtcertaiaty of WO 90/08564 ~ ~ ~ ~ ~ PCTlCA90/00031 . protection in the event of an impact against the tip o! the needle, such as might occur if the laner were dropped. Act both dosigns appear to employ flexed plastic or elastomeric joints or folds for their articulation, operation of the device might enrounter significant stiffness, depending upon the desired mechanical strength of this articuladoa and the Length of time over which the device vaa.s kept in the stored position prior to use.
2.5 Golden provides for a sealing rnver to be placed over a needle tip after being slid down the needle from the base. This tip, made of absorbent material that is not normally stored on the needle prior to use, is not of a dimension that would fit conveniently within a storage arver. The positioning of this cover is either by means of eye judgment, retying on a marker on the needle; or by means of a thickened portion formed near the tip of a specially configured needle. This cnver does not, however, fasten, clamp or lock onto the needle tip In any way. A needle-stick injury could simply occur by the accidental withdrawal of the arver from the tip.
26 Against this background, it is the object of this invention to provide a protective guard for hypodermic nxdles with the following useful functions:
26.1 It provides a protective guard which forms an integral part of the needle assembly and which is dimensionally shorter in length than the needle.
2&.2 The protective guaM may be stored prior to ttse at the base of the needle shah is a tasnner which roquira a minimum of space and is substantially unobtrusive.
263 The protective guard may be retained in its storage position by a retention means which allows the ready release of the protective device when it is to be moved into its protecting position.
26.4 The protective guard may be mavod into its protecting position on the needle tip following needle use in a way which requira no significant training, no manual skills, no visual acuity, or particular level of lighting.
26.5 The protaxivs gonad may be moved into iu protecting position with the hands aharays behind the uocdie tip and with the motion of the hands always diroaod safely away from the needle tip.
2.6.6 'lbe protective guard automatically detetu the needle tip to establish its correct protecting position on the noodle shah with no judgement required of the OpCIiIOr.
26.7 The protective guard automatically locks itself to the needle shah with no additional action required of the operator when It hsi reached the correct a~tia1 protoctiag position.
26.8 ~ According to one further arrangement when the protective guard is Locked is iu protecting poaitloa the sharp tip of the needle is automatically covered by a subsuntisl thiclmess of material to provide a high degree of protecxion against rt;.emergenct of the needle tip from rite protective cover.
26.9 When the protective guard is is its protecting position It preseau a WO ~UU/085~4 ,rj ~j ~ ~ PCT/CA90/00031
3 ' smooth, substantially unobtrusive surface with no protrusions.
2.6.10 When the protecting guard is in its protecting position the used needle may be handled and disposed of with no more than nornnal handling precautions than are customary for potentially contaminated medical materials.
S 2.6.11 When the protecting guard is used in assaxiation with an insenion needle within a catheter, the guard is automatically traruferred from its storage position to the needle tip by the action of withdrawing tits inxrtlon acafle from the catheter.
27 An important area of concern in the disposal of possibly contaminated needles relates to the use of intravenous catheters. In these devices, the needle is usually supplied in a pre-packaged assembly, already inserted inside a flr.~ble, close-fining catheter tube, the latter having a base with coupling meatu to allow the subsequent connection of tubing for intravenous infusion or similar procedures. The needle length is such that iu point extends slightly beyond the distal end of the catheter, thus acting as a piercing mrans to allow insertion of the catheter and needle into a blood vessel in the patient. Thus such needles are known as 'insertion netdles~.
28 Following insertion of the needle and catheter, the needle is withdrawn from inside the catheter and must be disposed of. At this point the operator's attention is taken up with other matters, mainly relating to the attachment of tubing to the cathaer and controlling loss of blood, and this makes him significantly more wlnerable to needle stick accidenu it he must divert his attention to safe disposal of the needle by conventional means.
29 By a simple adaptation, the subject protective guard may be attached to the catheter as part of the pro-packaged assembty, with the needle Iactallcd first through the guard and then inside the catheter. When the operator withdraws the needle from the catheter after insenion Into the patient, the guard remains frictionally attached to the catheter, allowing the needle to slide freely through it in eleher direction, until the point of the nadle is withdrawn inside the body of the guard. At this point the guard loch securely over the tip of the needle, aUaadn; the operator to detach the guard from the catheter by a slight sdditiottal withdrawal fottx. The needle, with the guard in place, may De then disposed of without tnrtber attention from she operator.
2.10 In .this wry, no separate action or tDought Ls required of the operator during the needle withdrawal process, since the guard ~ autotnatlcally applied as thaw noodle point adttt the atheur daring she norms! withdrawal sequence, and therefore no training it rsqtUred in the use of the guard element.
211 These desirable qualities, as w~W as other featurrs and characceristia are provided by the subject invention, using the arrangements, construction, oomponeau, and steps as desWibed and UJuatratod hereafter In this disclosure, and evhich rJCetmplify thLs invention.
3. SU~MA,RY OF T1~E dNYFNI'ION
3.1 Aooording to this invention a segue means of automaueaUy covering the WO 90108564 '~ ~ ~ ~ PCT/CA90/00031
4 pointed end or tip of a hypodermic needle is provided by a nudie tip protecting device in th'e form of a protective guard which is initially stored on the barrel of the needle, remote hour the tip, and which is dis~,placaable to a position enclosing the needle, tip where it automatically locks in this position serving as a protecting means for the needle tip. The protective guard may optionally be stored prior to use at the base of the needle. In this position it may further be contained within the usual protective sheath which arvers a needle prior to use, and may thereby be supplied with the needle in its sealed and sterilized package.
3.2 >3y reason of the fact that the protective guard may be stored oa the needle prior to the natural use of the ncalle, and occupies an insignificant, rompact space, its presents products a minimum interference with the norms! use of the needle. In one application the protective guard may be stored adjacent to or even within the enlarged base of a catheter, in an unobtrusive manner that allows the catheter to be inserted in the normal manner.
3.3 After withdrawal of the needle following sue, the dp of the needle can be immediately covered with the protective guard by a simple manual action of gripping the protective guard with the fingers, sliding it out of its stooge position at the bast of the netdle, and continuing the sliding motion along the needle shah until the guard just over-reaches the end of the needle. There it automatically locks in position with the dp of the needle safety covered inside the protective guard.
3.4 The protective guard achieves thex effects by being provided with an internal energy storage element, such as a spring, that Ls capable of initiating a clamping force through a clamping mechanism. Generally, this clamping fotroe is applied directly to the exterior surface of the nxdie shaft. A latching mechanism serves to suspend initiation of the clamping fotroe prior to withdrawal of the needle tip within the protective guard.
A trigger system releases the latching mechanism oncx the tteedle tip passes within the protecttve gua<td, thereby initiating the clamping force which fs applied to the needle, sad thereby loc>ang the protective guard in piece over the ttetdle tip. These functions ooau satotaatially and eaclox the needle tip with a protecting means which is non-removabty engaged thereto.
33 The damping force need only immobtllu the protective guard against axial or loagitudlarl displaxmeat on the needle. Further, its locling resfstanct nerd not be symmetrical It i: essential to have a high kocldttg resistancx agatnst further removal of the gturd hour the needle. In the otter dlrealon resistaaa to the reemergence of the needle tip from the guard am be substituted or supplemented by arranging for an ocdnding element to accupy the path of the needle sod servo as a containment means.
Once the tip enters the guard the pt~esenct of snsh a blocking element etuures that the needle tip cannot re,~emerge from tlx guard even where the tocldng resistance against displacement of the guard tow>tth the needle base is ov~roome. When such a blocking element is pttsent, it 8s su83dent for the ck:mpkng meshsnum to provide only w0 94/08564 ~ ~ ~ ~ PC'T/CA9~0/00031 a uni-directional or one-way resistance to further removal of the guard from she needle.
3.6 A variety of modus for proving an engagement or locking meaau of locking the protective guard to the needle may be adopted. Some of these locking systems may be rategorizcd as follows:
5 (1) a coa:dal spring system wherein the spring grasps the needle shah in a 'constrictor' fashion;
(2) a 'push nut' style mechanism wherein the edge at the end of a near-petpendicular leaf of metal is pressed into the side of the needle shaft;
(3) a tapered cavity or 'chuck' system wherein a locking element is forced into locking engagement with the nczdle by jamming the locking Clement between the narrowing wall of the tapered cavity and the needle shaft; and (4) a 'canted plan' system whereby locking is effected by canting a plate having a hole therein through which the needle shaft passes in a close, sliding fit.
Other modes of engaging or feting the needle with the guard may be provided as well, including the combination of the above modes with a occluding element, as mentioned is pares 3.5, above.
3.7 Several modes of providing a seating and trigger mesas for detecting the prestnce of the needle dp within the protective guard, and thus activating the trigger-release function may be identified as follows:
(1) a transverse rotatable cylinder is biased to rotate but is restrained from doing so by the prcsenoe of the needle shaft passing transversely through the rylinder;
(2) a 'lever arm' bears against the needle at one end and is biased to rotate and release the loclting mechanism when the needle tip has been drawn past the bearing point; and (3) a 'teasing half' or ding pin' arrangement is provided whereby the withdrawal of the needle tip to within the protective guard allows a sensing element to lessee into the path vacated by the needle and release, the locking system.
Other mode of providing a trigger-release ayttem tray be adoptod as well.
3.g The various modes of locking the protective guard to the needle tray be combined with various latch and trigger mahanlStas.
3.9 Optionally. the protective guard taay be provide! with an outer sheD which is free to rowu easily around its inner body thus isolating the inner body from manuaity-appliod torque which aright read to reduce its grip on the seedk shaft ahee it locks in position on the neoflle tip.
3.10 The protective guard may be slid to the noodle tip by the direct applintion of Snger: to the guar. Alternately, handle mean may bz provided either is the fornt of an arm, or the like, attached to the guard body, or by rue of a simple draw wring that Ls initially stored on the protectfve guard by bciag wrapped around its exterior casing WO 90/08564 ~ ~ ~ ~ PCT/CA90/oU031
6 3.11 Atxording to several embodiments of the im~ention, whoa the latch is released by the passage of the noodle tip inside the end of the protective guard, a component of the trigger mechanism p~itions itself so as to close-ofi the needle opening in the end of the guard. This covers the needle tip with a substantial amount of material, providing a high degree of protection against impact on the end of the needle, such as might be caused by dropping the needle with attached syringe.
1t may also occlude the needle bore thereby reducing the tendency for fluids co drain therefrom.
3.12 The locking action of the protective guard on the needle shah may be accomplishal in ono embodiment by using a simple roil locking spring coaxially surrounding the needle shah in a constricting fashion. The spring may be made of any suitable material, but would typically be made of stainless steel. In its free stag, the inner diameter of this spring is selxted so that it reads to be slightly less than the outer diameter of the needle shaft. Prior to loekdag the protective guard on the end of the netdle, the locking spring is maintained in a partially-unwound state by a spring retention means, such that the inner diameter of the spring is equal to or slightly greater than the outer diameter of the needle shaft, suf8cientiy to allow a close sliding fit and fret re6ative rotational and axial motion of the protector over the audio. This partfalty unwound state is maintained by a torque applied at each end of the spring by two torque-sustxiniag members which are held rotatlonalty coupled by a latch mechanism which serves as a release means when the needko tip enters the protective guard. .
3.13 When this latch mechanism is. releasod, the unwinding torque applied to this spring is released as well, causing the spring to contact and clamp on to the noodle. The relcmmse of the latch mechanism and corresponding release of the torque sustaining members sad spring occurs autotnati~lky. when the tip of the needle is withdrawn inside one end of the prot~cth~e guard by tho operator striding it past the tip of the noodle.
3.14 The fxictionat grip between the Ioddng spring and the needle shall may optionally be augmeat~ by a backup spring, rottoentricalty surrounding the locking spring. This backup spring tray be arranged to apply suppkomentaty torque to the ends of the locking spring ao as to wtnd It ttghta, without slgaificantty restraining rotational friction between the lotting aprfng and the noodle :haft.
3,15 As another alternate emDodimeat of the fmreation, the locking mews cvmprLses a leaf mesas which is preferably in the torte of two or more hardeacd spring stud leaves, taonntod on a snrronadtng narrow. r rim oontxntric with the needle a>ds within a thrust-absorbing housing. 'lrvo loaves arc provided for the convenience of the symmetry they provide, but an arraagetnent with a single feat could also be adopted.
In the case of dual or more hues the radial laws are formed ao that they lie approadmateky is the torn of a :hallow one angled so as to be pointed towards the WO 90/08564 ~ ~ ~ PCT/CA90/00031
7 needle tip and txkaxial with the needle shaft, with the span between the inner ends of the leaves providing a close sliding fit with the outside of the needle shaft.
This allows the latter to move, before the clamping effect is developed, freely between the leaves, in an axially direttion.
3.1b 'This arrangement is recognizably similar to the familiar "push-nut° used to provide axial retention on unthreaded shafts and studs. la such a connector the outer ends of the leaves arc joined in a shallow conic orientation by an exterior frame of material formed integrally with the leaves. The Issues may be of a size and position such that the potential spacing between the inner ends of the leavss, when nearly flattened, is significantly smaller than the diameter of the shaft. This dimensional feature would require that the inner ends of the leaves to be deflected outwards as the nut is pressed onto the shaft, thus deepening the initial conical form of the (caves, On applying reverse axial load on the portions of the leaves next to the shaft, directed towards the base of the conical form, the leave tend to collapse inwards, cutting into the surface of the shaft, and firmly resisting relative axial motion. T. he outward reaction force on the leaves is taken by the surrounding frame of spring material in ~' tension.
3.17 In this embodiment of the present invention, the narrow rim joining the outer ends of the leaves is used solely to hold the leaves in their initial or unlocked position, and the diameter of the rim is such as to provide a slight interference fit in the inner bore of the body of the protective guard, thus retaining it trictionalty in position in the bore.
3.18 Alternately, the radial reactionary, compressive load on the locking !saves may be takes by the bore of the surrounding thrust.absorbing housing or body of the locJdng device, against which the outer cads of the haves press. The narrow rim joining the tocldng leaves, in such case, tmkes no significant Iractlon of this reaction force.
3.19 Locking of the guard to the noodle shaft may be provided by applying an tnxtai force to the inner ends of the leaves through a pressttre sleeve which is biased to stave atdalty along the needle shaft under spring prtssure, in a direction which tends to collapse the leaves radlalty inwardly, fordag them to some in tight frictional intact with the neodle shaft.
3.Z0 If the noodle shaft then attempts to move axially in the same direction a the pressure sleeve, the !caves will tend to collapse fttnber inwards against the noodle slash, baxtue of friction between the two. Provided the tangent of the complement of the angle beea~a the locldng Land the needle axis, as measured in the tmval plane, f; eqtul to or less than the matt of friction between the end of the lava and the attrface of the nudle shaft, sDppaje between the leaves and noodle shag will sot occur, dnaeasing the suds! load will setae a corresponding increase in the fritxlonal grip between the ewo uneil a point it reached where mechanical 6:/0 90/08564 E) ~ ~ PCT/CA90/0043i
8 ' deformation alters the geometry or material failure occurs.
3.21 According to this alternate embodiment of the invention, in the unlocked state, the pressure sleeve is Pseld away from the locking leaves by a transverse latch shaft, through which the needle shaft passes, preventing iu rotation. On the catiting of the end of the needle from the latch shaft, the latter rotates, releasing the pressure sleeve and allowing it to move azialty and lock the leaves against the needle shaft. The now-rotated transverse latch shaft serves to block passage of the needle tip through the tip protector, preventing tho tIp protector from sliding back down the needle towards the needle bass 3.22 In yet another third embodiment of the invention, the locking leaves as desaibed above are replaced by a plurality of locking elemenu or jaws of hardened material, radially disposed about the needle shaft, and contained within a gradually tapered or narrowing cavity within the body of the guard device which constitutes a conic chuck means. Such jaws may be in the form of bisected conical segments with their bisecting edges presenteQ towards the needle.
3.23 In the unlocked state, these jaws cosy be maintained loosely in the bore but in a generally uniform distribution about the needle axis by compliant lingers engaging each jaw. These fingers may optionally be mnstitutcd by afoul extertsions of the pressure sleeve as described above.
3.24 From its unlocked state, the pressure sleeve may be released by a trigger mochat>iam and urged by an energy storage element, such as a compressed spring, to move axially, forcing the jaws into the conic chuck means and thereby producing a high radial gripping force between the jaws and the needle shaft because of the gcadnal narrowing taper of the cavity walls and the consequent high mechanical force advantage that this creates.
3.25 This atTangemeat is closely analogous to the familiar three-jawed drill chuck, where the axial force required to product the required clamping force is usually developed by some tot7n of screw thread. In this embodiment, the taper of the coatstnmeat cavity ~ much more gradual, chosen masisteat with the vsriotu parts to prodtux a self bddng salon svttich inaeaaa sa axial force is applDed to the needle shaft in the same dtrxtion as the form of the pressure :lei It Iollows that motion of the needle shaft in the opposite direction will ptodatx lessening of the grip of the locidag jai, Dnt th8 may be realstod by selaxing a :prang for the prssatue plate that is of a>~t ttmagth to rafst loosening of the clamping scion.
3.26 la yet another tonrth embodiment of the imentlon, the liking jaws as dcscribod above may be replaced by rolling elomeats in the tot~at of a plurality of substantially cyfindri~l rovers of hardea~ material, uniformly disposed about the axis of the noodle shaft, with the azi: of each rotkr is a plant perpendicular to the nudle shaft ax~s, cad with each roller tnakDag tangential, or aossed-cylinder coarse with rite surface of the aoedie shaft. The rolDen are again contslaod in a gradually tapered V-O 90/08564 ~ ~ ~ PCT/CA90/00031
9 cavity within the body of the guard device, each side of this cavity in this case being a plane surface forming pan of a side surface of a conical polyhedron coaxial with the needle shaft.
3.27 In the unlocked state, these rollers arc retained toosely in the bore by a surrounding containment cage, optionally constituted by an aajal exttnsion of the pressure sleeve as described above.
3.28 From its unlocked state, the pressure sleeve may be released to move axially, bringing the rollers into contact between the wall of the tapered cavity on the outside and the needle shaft on the inside. Subsequent axial motion of the needle shaft in this same direction of motion cxtrses the rollers to roll axially with the needle towards the smaller end of the tapered cavity, increasing the force of contact between the tapered cavity wall and the needle shaft. This resulu in high frictional grip between the rollers and their containment cavity on the outside, and the needle shah on the inside, sutfident to block further motion of the needle in this direction.
Once jammed in this locking position continuing pressure from the pressure sleeve will tend to keep the protective guard in this locked condition.
3.29 In yet another filth embodiment of the invention, the rollers described above are replaced by a plurality of hardened spherical balls, anlfotmly dispossd about the needle shaft axis, with the centers of the bails in a common plane perpendicular to the needle shah axu, and with each ball making contact with the surface of the needle shaft. These balls tray De contained within a gradually tapered conical bore or cavity within the body of the guard device, loosely confined within a cantaining cage which may be an stdal atetuion of the pressure slows as described above.
3.30 in yet another sixth embodiment of the iitveation, the various Locking mechanisms described atbove are replaced by a combined latching and locking plate, reterred to Dsiaw as the lever arm: This leverarm may be tor~med of a flat, hardened strip, bent in the shape of a brosd U with two legs of unequal proportions, lying in the plane of the needle shaft. The loddng plate portion of this lever arm, which is the bnga of the two nneqcul legs of the U, is provided with a hole through its approximate center evhich will allow a net clQSt-tittiug btrt free passage of the needle shah through this leg, with the tad of the shorter leg of the U in contact with that portion of the ne~le shah extettdIng towards its pointed end. troavenientty the hole through the locking plate is oriented to albwv ~ passage at the nctaie shaft when the locMng plate ~s perpendicular thereto. A prec~se prrpendicoLa orient action is not, hasveva, essential, so long as the lacking plate may be canted between the free passage position and a kxldng position 3.31 The 6evcr axnt, which save as con alfgttnteat means far the Docking plate, is containai within the body of the guard device, with the dad of the longer leg of the a held in axial contact with as internal race of the body, by the torte of a heJlal compression spring. The point of conuct between the lever arm and the WO 90/08564 ~ ~ ~ 1'CT/CA90/00031 internal face serves as a pivot point and elearanoe is provided for the sever arm to pivot about this point, Tae spring is contained within a cylindrical cavity is the body on the opposite side of the needle shaft hom the pivot point, the axis of the cavity being close to and parallel wlth the needle a~as, with the free end of the spring extending from the 5 cavity to press axially against the outer end of the longer leg of the lever. This biases the longer leg or locking plate portion of the lever arm to become canted with aspect to the needle shaft. With the needle acteading through the body of the guard device, the lever arm is constrained by the contact of its shorter leg with the side of the needle shaft closer to the tip end to retnaia with iu longer leg held at as angle, vie
10 perpendicularly to the needle axis in the preferred embodiment, that allows free passage of the needle. Optionally, this shorter leg tray be omitted, with the lever arm - contacting the needle direetiy.
3.32 When the guard is slid along the needle so that the end of the latter hat entered the guard body and move4 past the point of contact with the end of the shorter leg of the lever arm, the lever arm it freed to turn about its pivot point under spring pressure so that the hole is the locking plate is no longer coattial with the needle. This muses substantial frictional contact anti locking engagement with the nctdle shelf.
3.33 With the selection of the knoevn appropriau geometry of the lever and needle shaft, aitially relate to the ~effiriGat of friction between them, the frictional grip between the lever and the needle shah may be arranged to ahvays be greater than the applied a~da1 torn on the needle. The lever as thus become self-locking on the needle shaft, without regard to the spring pressure. Thus further motion of the needle is prevented until material failure oaatn. However, pr~ure from the spring serves as a canting means and is preferable as a secure means for etunting that the locking condition is auiataitted.
3.34 By way of further saatrity, the shorter kg of the lever arm which becomes ditplsecd tnto the needle path one the needle Lt no conger in contact with this leg, saves to block the reverse displacement of the needle, this further containing the needle tip within tht protective guard.
3.33 This arrangement is rocognirabty similar to certain retakes of automobile jacks, in wrhidt the weight of the vehicle is aaried upon s forged stool bracket sliding on a vertical cyltndrial steel support cohamn. Frictional grip between ehe bucket and cnlnmn is establt:hed by one or taore r~oaangolar steel plates 5tting closely but freely about the column, bearing axially on their one end against a shoulder is the brackee, and being directed away from perpendicularity with the column axis by a compression spring. The atsangcment permits the bracket to trove in an upward but not downward direction on the column, in the manner of a tatchet. Llhing action is applied by a hand lever pivotod within the bracitet, which traasanits force to the oolutnn through a send claae-fitting plate or plates, bearing on their one end against a shoulder on the WO 9(1!08564 ~ ~ ~ '~ ~ ~ ~ PC'T/CA90/0003t
11 lever, in a manner allowing the lever and associated frietion plates to press downwards against the ~Iumn when she (ever is operated, thus forcing the bracket upwards on the column and raising the vehicle. Lowering the jack is accomplished by detaching the lever handle and using it to slightty trove the first-mentioned plate or plates towards a position more nearly perpendicular to the ass of the column, thus releasing the frictional grip of the bracket with the column.
3.36 Motion of the needle in the opposite direction in ono configuration of this design releases the x1f-locking action, but re-emergence of the needle point from the guard Is blocked Dy the preszatx of the shorter leg of the lever aaoss the path of the needle. An alternate configuration may be provided which effects locking agairut motion in both directions.
3.37 A loosely-fitting rylindrical sleeve surrounding the body of the guard is preferrably added to provide rotational isolation from the means used to move the guard axially on the needle shaft, thereby preventing the forcible removal of the 1S protective guard by accidental or deliberate twisting of the guard relative to the needle.
Such a sleeve may optionally be applied to all embodiments of the protective guard.
3.38 T7tt~s, to summarize for this last embodiment, the Icxking effect is achievtd by canting a locking plate having a hole therein through which the needle slides with a near dose, but loose, sliding 6t. A Locked condition is effcsted automatically by means of a spring and lever arm to cant the locking plate. No ranting force is applied to the locldrtg plate nnil the needle tip is withdrawn into the protective guard. .At that point the lever arm rotates under the influence of the spring, applying s canting force to the lolling plate and thereby locking the protective guard to the nCEdl0.
339 In a further embodiment of the invention s sensing ball mechanism is employed in order to effect engagement of the protective gnsrd to the needle.
A
Locking assembly of the 'ehudt' type is provided within a train body that envelopes the needle by a transverse passage and is slidable t6ereoa. 'Ih~ body is provided with s tapered or narrowing interior avity which lies adjacent to the needle bore, and conveniently tray atarround the netdle shah. A lacking element oottveniently, for the benefit proposes oe syatmetry, in the tone or a pair or aoniatty shaped loddag jaws (although a single jaw element could be adopted) is present within the cavity, rheas locking jags being displaxabk betwxn the bros8er and narrower regions within the interior cavity. A spring means is provided within ehe train body which blears the locking jaws towards the narrowing regions of the cavity whereby the locking jaws may be forced Into jamming engagement between the needle bore and cavity wall.
locking the protaxive guard to the noodle.
3.40 A latch or latdting means teleaseabty retsIas the hocking dement from advancement into the tapered cavity. A nigger means, b>ssd on a unsing element, operates to release the latdting means when the dp of :he needle it withdrawn late the WO i~0/085~64 ~ ~ (~ J ~ ~ ~ 1'CT/CA90/0003i
12 protective guard, allowing the spring means to force the locking jaws into locking engagement with the ncaile.
3.41 In this embodiment this latching or retention means is of the ball-in-socket type: wherein a latching bat! lie partially within a groove or socket generally, or against a stopping surface, formed within the side of the locking jaws. This latching ball also partially rests against a stop surface formed on the interior of the main body of the guard. It is therefore inter-engaged with both elements. The pair of conical jaws are loosely inter-fitted with portions of each over lapping or interleaved with the other. This permits a single latching baU to be use to retain both of the jaws in their latched position.
3.42 The Latching ball is held within the groove in the jaws by a further ball retention element, which may be in the form of a rylindrical sleeve or plunger which is able to slide from a position where it contains the latching ball within the groove on the jaws, to a position where it no longer contaitu the ball whereupon the ball may withdraw from the groove and release the locking jaws. This cylindrical sleeve retention element, therefore, xrves as a releax means for the jaws, thus forming pan of the latching means.
3.43 A trigger means xrves to hold the ball retention clement in its ba1!-retaining position while the needle shah passes entirety through the needle guard.
lJpon activation, this trigger means allows the retention clement to be displaced to a baU-releasing position, once the needle tip is withdrawn w(chin the protective guard 3.44 This trigger meaat is of the xnsing ball type wherein a steel ball xrves as the xasing means for reacting to the prexnce or abxnce of the needle shaft within the guard. This xnsing baU partially rests between a stop surfaee on the hall retention element and a further stop autfsce on the interior of the guard body. By reason of its contact with the stop surtact oti the ball retention element, this second ball prevents the ball retention element Irom moving and thereby releasing the first ball and latching system.
T~ ~~t ~ ~. . also trtained in place by the needle shaft apinst which it rests, and towards which it it biased to move by pressure from ebe ball retention meatu. Th8 prcasare aria from a spring mesas which, comreniently rt>ay be the same spring means that applies presstue against the locitittg element. Thu xcond sensing ball is directed by the inclination of the tltrtha stop anrfatx on the guard body to be dLtplsced into the path of the needles 1t is blocked fmm so moving by the needle, so long as the needle pasxs fully through the guard.
3.46 ' Once the tip of tht needle fs withdrawn into the guard past the xnsing ball, leaving this xmnd or xnsing ball no longer in oonwct with the needle the xnsing ball will move into the path prcvioosly occupied by the ntedle. This displatxment of the xnstag ball then allows the ball retention element to moms sttllideatly to release the leeching ball, and thereby release the Jaws In order tn efte« toc~fng of the guard to WO 90/08564 ~ ~ ~ ~ PCT/CA90/00031
13 rite needle.
3.47 Thus, in this embodiment the latching meam is distinctly removed from the trigger means, and two independent parts, the latching halt and the sensing bail mtut both be displaced from their positions in order for lociang to occur.
3.48 The cocking force of 'the jaws within the chuck is enhanced by any attempt to futthcr remove the guard from the needle. Conversely, it is reduced by an attempt to cattle the needle tip to re-emerge from the guard. Conveniently, the presence of the sensing ball in the needle path can xrve to prevent such a re-emergence.
3.49 Thus, we summarize this last embodiment as providing a tip protective guard for covering the tip of a necdie of comprising:
(1) a main guard body provided with a passage therethrough capable of enveloping a needle inserted therein, said body having a narrowing interior cavity;
(2) a locking element slideable within said cavity capable of grasping and rocking relative movement between said needle and .;aid body in at least one axial direction of said needy (3) - spring means capable of bdasiag said locking element to advance into the narrowing interior of said tapered cavity and lockingly engage said ~0 needle in at least one a:dai direction of said needle;
(4) latching means positioned to releaseably restrain said locking ecement from being advanced Into said cavity, (5) trigger means, posdtionod to release said latching means when the tip of said needle is withdrawn into Bald guard body; and (6) containment means for preventing re-emergence of said needle tip from said body once the needle tip has been vrttbdrawa into said body.
3.50 Farther, in snch needle tip proeeaor said latching means more panicularty comprises a latching ball positioned between a shoulder on said locking elanent and a shoulder on the guard body, said latching ball being releaseably retained is a latching position against said shoulders by a comdally dfsplaoeable retention means positioned to release said latchtag ball upon d~splacemeat of uid raendon means, and afierein said trigger mesas ~mprises a :pond ball ~nstltnting a xasing ball, positioned so as to ratraia told sloeve from dLsplaam~tt, said xasing hall being restrained is a latching position by the presence of the aforesaid aocdle within the gttttrd body sad being poaltlonod such that withdraewval of the end of said nadle to within rite guard body allows rel~se of xid sensing ball by permitting said xnsing ball to move into the path prcviotuly oavpded by the nook.
331 The forcgoLng corutitutes a desaipeioa of four acemptary modes by which the protoctive guard stay be clamped or lockee in place so 1as to mneeal a needle dp. Three mochanlsrns for acing as a latching sad trigger Haas has bren described, 2 ~ ~ 5 ~ 9 ~ 1'CT/CA90/00031
14 wamety a transverse locking shaft or rylinder, the lever arm and the xnsing and latching ball systems, Details of exemplary latching and trigger mechanisms that may be employed are further described in the following sections in mnjunaion with the description of the preferred embodimeutu.
3.52 These and further features of the invention and iu various aspects will be better understood from the description of preferred embodimenu which now follow.
4. DF.SCR1PTION OF PR~FRRF~ EMBODR~~NTS
4.1 SUMMARY OF THE DRAWINGS
Fig. 1 shows a hypodermic needie fitted with the subject guard device, mounted on a syring0. and with the needle removed from iu protective sheath preparatory to use.
Fig. 2 shows the needle following use, with the subject guard device being slid . towards the end of the needle by hand as the first step in the disposal sequence.
Fig. 3 shows the guard devict locked automatically over the end of the needle, and the needle removed from the syringe for disposal.
Fig. 4 shows one embodimene of the guard device employing a rotational ' Docking spring latch, with the device in the unlocked state prior to disposal.
Fig. 5 is a simplified end view of Fig. 4 showing the principal latching cotnponenu, in the unlocked state.
Fig. 6 is a top view of Fig. 5.
Fig, ~ sham the device of Fig. d with the end of the needle drawn inside the device, past the latch, and with the device locked onto the needle.
Flg. 8 is a simplified end view of FIg. 7, showing the prindpal latching components, in the kxkcd state.
Fig. 9 is a top view of Fig. 8.
Fig. l0:howa a second embodiment of the locking spring guard device ~°plaY~B a ~ plunger latch, with the device in the tanlocked state prior to dispoaaL
Fig. 11 fs a csoe;s-sectional end view of Fig. 10, ahaaving the ptindpal latching components in the unlocked sate.
Fig. 12 ahoy the device of Fig. 10 wdth the end of the needle drawn inside the devix, pant the latch, and with the devise locked onto the needle.
Fig. 13 h a ansa xcdousl aced vietv of Fig 12, showing the prindpal Latching components in the lodtod state.
Flg, 14 :baws an embodiment of the guard device fn its protective sheath prior io use, this embodiment indudtng a detachable handle on the guard device.
Fig. 15 slwws the devix of Flg. 14 tetttovod from its proeectfve sheath and mounted on a sninge, ready for tae.
Fig. lti altaws the device of Fib 15 follawiag tae at the needle, with the protaxfve device being tpov~ along the noodle with the detachable handle.

w0 90/0856 ~ ~ ~ PCT/CA9~0/04031 i5 Fig. 17 shows the device of Fg. 15 with the protective device locked on the end of the needle and the detachable handle pulled free for disposal.
Flg. 18 is a partial CfO~S-SCCtIpn Of the device in the alternate embodiment employing locking leaves, shown in iu unlocked state.
FIg. 19 is a partial aoss-section of Fg. 18 showing the latch shaft in iu unlocked position.
Fig. 20 is a cross-section of the device of Fig. 18 in iu unlocked state, rotated ninety degrees from Fig. 18.
Fig. 21 is a cross-section of Fig. 20 showing the locking leaves in their unlocked position, viewed from within.
Fig. 22 is a aoss-section of the device of Fig. 18 in iu locked state.
Fig. 23 is a cross-section of Fig. 22 showing the latch in its locked position.
Fig. 24 is an exploded perspective view of the device of Fig. 22.
Fig. 25 is a partial cross-section of the device in the embodiment incorporating 1S jaws within a chuck, shown in iu unlocked state.
Fig. 26 is a cross-section of Fig. 25 showing an end view of the locking jaws, viewed from within.
Fig. 27 is a partial cross-section showing the device of Fig. 25 in iu locked state.
Fig. 28 is a perspective view of the device of Fig. 25 showing the locking jaws and their means of retention Fig. 29 is a partial cross section of the device in the embodiment incorporating locking roUets within a tapered cavity, shown is iu locked state.
Fig. 30 is a cross sectional end view of Fig. 29.
Fig. 31 is a partial perspective view of the locking sleeve portion of Fig.
29, showing the placement of the locking ropers within their containment means.
Fig. 32 is a partial cross-section of the device in the embodiment incorporating locking balls within a conical bore, shown in iu locked state.
Fig. 33 is a cross-sectional end view of Fig. 32 Fig. 34 is a partial perspective view of the locking sleeve portion of Fig.
32, sboaving the placement of the locling balls within their ~atainment means.
Fig. 35 is a longitudinal cross.soaion of a vented-plate locfdag device showing the telatianship of the parts to the aaiocked state.
Fig. 36 is a cross-sectional view showing the locking lever contained within its cavity in the body of the devict.
Fig. 37 is ass-sectional view showing the needle and spring contained within the mid-portion of the body of the device.
Fig. 38 is a cr~.c-sectional view shaving the latch portion of ehe lever in contact with the needle shaft in the unlocked state.
Fig. 39 is a longitudinal cross-section of the device showing the relationship of the parts in the locked state.
Fig. 40 shows the guard device of Fig. 39 fitted to an intravenous catheter assembly, prior to insertion into a patient.
Fig. 41 shows the catheter inserted into a patient with the guard in place on the catheter and the needle being withdrawn.
Fig. 42 shows the needle fully withdrawn from the catheter with the guard locked over the point of the needle.
Fig. 43 shows a catheter with needle protector based on a double trigger mechanism utilizing a ball-latch and sensing ball system, in cocked condition.
Fig. 44 shows the device of Fig. 43 in transition to grasping the needle.
Fig. 45 shows the device of Fig. 43 with the needle grasped by the guard element.
Fig. 46 is a side view of the jaw element of Fig. 43.
Fig. 47 is an end view of the jaw element of Fig. 46.
Fig. 48 is a further side view of the jaw element of Fig. 43.
Fig. 49 is an end view cross-section through Fig. 48.
Fig. 50 is a side view cross-section through Fig. 47.
Fig. 51 is an end view cross-section of the jaw element of Fig. 43 as it embraces a needle.
Fig. 52 is an alternate version of the embodiment of Fig. 35, in an unlocked state.
Fig. 53 shows the embodiment of Fig. 52 in a locked state.
4.2 DETAILED DESCRIPTION OF EMBODIMENTS
4.2.1 Referring to Fig. 1, the hypodermic needle 1 is attached to the syringe 2 by a needle connector or base element 3 of conventional design as regards its attachment to the syringe. The needle is optionally provided with a guard retainer 4 in the form of a hollow cylinder coaxial with the needle, with one end attached to the needle connector element 3, and with its other end directed towards the opposite or :i'O 90/08564 pCT/CA90/00031 tip-end of the needle. 'Ibis cylinder 4 attaches frlttionally to the outer drcurriference of the guard device 5, hereinafter refertod to as the 'guard' or 'protective guard°. The guard may be removed axially from the guard housing 4 with normal finger effort, and thereafter may be slid a~oally with slight or no frictional resistance along the length of the needle. Alternately, the retainer 4 may be detached from the base 3 and used as a gripping mans to slide the guard along the needle. While the retainer 4 provides convenience In coupling and handling the parts of the needle assembly, It is purely optional. If omitted, the guard 5 tnay be provided with a tight sliding fit on the needle 1 that will allow it to be stored on the needle 1 near the bax 3.
4.22 Prior to ux, the needle 1, guard retainer 4, and guard S may be stored in a protective sheath 6 of conventional design. The sheath 6 may be frictionaily retatned arially on the retainer 4 by itnvardly-directed detcnt projeztioru on the inner bore of the sheath entry opening, following well-established practice. Such cstabtished practice allows the needle to be retained within and gripped by the protective sheath while fitting the needle to the syringe or other device,. The fiittional ~upling between the sheath 6 and retainer 4 is xlected to release more eastty than the ~upling between the retainer 4 and noodle bax 3. This allows for removal of the sheath 6 without disturbing the retainer 4 or guard 5. The sheath 6 tray opUonally be provided with an inner sboalder 7 which will axially bias the guard 5 towards iu stored position inside the rotainer 4.
423 Referring to Flg.2, all motion: of the guard 5 during the disposal process are axial and directed away from the point of the needle 1, with the hands held away safely to the tear of the latter. Provided the guard 5 is not slid beyond the point of tbc noodle 1, it may be ali~d fa either direction along the noodle, and may be retitraed to its storrd position In the retainer 4 if desirsd. While Irictionally stored in and when releasod from its retainer 4 the grand 5 is is iu unloclred state.
4Z~ ~ ~~ is ~t& 3. ~bea the gnarl 5 reaches the end of the needle 1, and when the point of the needle it entirety eacJosod within the guard, an armed locitiag mochaaitm wlthtn gttard S is release to Srmly gdp the guard to the needle 1.
Ono advantage of the eaxmplary triggsr mechanLsm deacn'bed ncatt is thst the opening in the outer end of the guard is closed-off to completely cover the point of the needle against accidental protrusion, even in the event of failure of the locking mechanism to hold the guard in place against impact, such as may be caused by dropping the needle and attached syringe. The guard 5 is now in what is referred to herein as its locked state.
4.2.5 Referring to Fig. 4, the body of the guard in this first embodiment is composed of three principal cylindrical parts; inner core 8, outer core 9, and shell 10. With other components omitted, the inner and outer cores are free to rotate with respect to one another about their common longitudinal axis.
4.2.6 At the larger open end of the outer core 9, where it forms a meeting face 11 with the inner core 8, radial support of the two mating parts with respect to one another is provided by the common diameter 12. Similarly, at the opposite end of the assembly, relative radial support is provided by common diameter 13.
4.2.7 Axial positioning of the inner core 8 and the outer core 9 is maintained in the one direction by mating face 11, and in the opposite direction by the shell 10, which is fitted with inwardly directed flanges 14 at each end, each of which bears against the axial face of a circular coaxial rabbet 15 in the end face of inner core 8 and outer core 9.
4.2.8 The shell 10 is so dimensioned as to allow it to be pressed over the inner and outer cores during assembly, and to snap into position as shown, forming a loose fit with the inner and outer core to allow free rotation of all three components relative to one another.
4.2.9 The inner core 8 and the outer core 9 each have a central axial bore 90, 91 respectively, sized to allow free passage of the shaft of the needle 1 with a close sliding fit. Surrounding the needle shaft 1 is a close-wound locking spring 16, whose unrestrained or free inner diameter is significantly less than the outer diameter of the needle 1. The locking spring 16 is accommodated within the inner core 8 by axial bore 17 and within the outer core 9 by axial bore 18.
4.2.10 Each end of the spring 16 is turned outwards at ninety degrees to form a radial extension 19 and 20.
Extension 19 fits into an axial groove 21 in inner core 8 _._ T ._ ~O 90/08564 ~ ~ ~ PCT/CA90/00031 atending the foil length of bore 17, and eztcasion 20 fits into a~dal groove 22 in outer core'9 extending the full length of bore 18. By this arrangement, the inner core 8 and the outer core 9 may be rotated with respect to one another to apply torque to the spring 15 about its longitudinal axis. Such torque tray be applied with two tools such as spanner wrenches, fitted to the outer face of the inner core 8 at spanner holes 23, and to the outer face of the outer core 9 at spanner holes 24.
4.211 In the embodiment shrnm in this diselosure, the locking spring 16 is wound with a right-hand spiral, similar to a right hand screw thread. Turning each spanner wrench in a clockwise direction with respect to the other, as viewed from the outside end of the guard 5, will cause torque to be applied to the spring 16 in such a direction as to catue it to unwind and thereby incrcau its diameter. The extent of this increase in diameter is timited by the diameter of bore 17 in the inner core 8 and by bore 18 in the outer corn 9. Bores 17 and 18 are of equal diameter, thus forming a substantially continuous cylindrical surface coaxyal with the needle shaft 1.
4.2.12 Bores 17 and 18 are of such a diameter that when the spring 16 has been rotationally expanded to ~mpletely all these bores, the inner diameter of the spring 16 has increased to be sufficiently larger than the outer diameter of the needle shah 1, to allow the needle 1 to move freely both axially and rotationally through the center of the guard 5. On releasing Ne torque appliod with the spanner wrenchu, the locking spring 16 rewinds itself tightly around the nxdle shaft, producing a substantial friaiottal grip between the spring 16 and t)se needle 1 in an tvdal direction.
4.2.13 The rewinding effort of the locking spring 16 tray be augmented by backup sprung 25, wdich It loosely soootnmodated in the annular space 26 between bores 12 ttnd 13. Ono end of spring 25 Is turned outwards at ninety degrees to form a radW extension 27, which tiu into longitudinal groove 28 sntending part way along the outer arall of bore diameter 12. T6e opposite end of spring 25 is turned inwards at ninety degrees to form radial extcmion 29. ducteQ utwards w lit Into groove 30 8 Y bong the length of journal diameter 13.
4.2.14 Daring assembly of the guard 5, tDe inner soro 8 and the outer core 9 are separated axially by an amount sutl9dent to disengage extension 20 of locking spring N'O 90/0856A ~ ~ ~ ~ ~ ~ ~ Ptr1'/CA90/00031 ' 16 from gtnove 22 of the outer core 9, while retaining engagement of extension 19 in groove 21 of inner core 8. Because of the greater length of groove 28, extension 27 of backup spring 25 remains engaged with the outer core 9, and extension 29 remains engaged with groove 30 of the inner rnte 8. This allows clockwise torque to be applied 5 to the backup spring 2S using the spanner wrenchts, without applying torque to locking spring 16. When grooves 21 and 22 are in alignment, and while this torque is maintained, the Inner core 8 and the outer core 9 are moved together axially, re-engaging extension 20 of locking spring 16 in groove 22. On releasing the applied wrench torque, the torque applied to the backup spring 25 is transmitted to locking 10 spring 16, increasing its tightness of wrap around the shaft of the needle 1, and greatly adding to the frictional grip between locking spring and needle shaft.
4.2.15 With the shell 10 in place as shown in Fig. 4, no significant torque can be appld~ to either the inner core 8 or the outer core 9 by normal handling of the outer surtax of the sleeve 10. This prevents the grip of the locking spring 16 from
15 being degraded by applying an inadvertent cloekcwise torque to either the inner or outer core. Such a torque, if applied, would tend to umvirtd the locking spring and reducts its frictional grip.
4.2.16 The outer surface of shell 10 may be provided with a number of ribs, rings, grooves, knurls, or similar provisions to inaease the grip in the axial direction 20 Detavoen the operator's fingers; or. pattachment means for a separate manipulative implettxnt to be oonnectod to the anrbcx of shell 10, as further described beloetr.
4.2.17 To allow axial motion of the 8nard 5 along the tacalle 1, it is neoessaty to fold the lorling spring 16 in its expanded or partially unwound state, as described above. Tbb roquires holding the inner core 8 and the outer core 9 In their rotational reJatkonship after clocka~e torque has boea appllod to one with respect to the other.
4218 In the embodtment shown In Fig. 4, this holdint anion is provide by a cylindrical member do the form of rotational latc8 31. p~~ ~lY ~ ~e ~Y of the inner core 8 with its axis ci~e to and parallel with the meeting plane 11, which forms tits end face of the outer core 9.

'~~~4~~~1 4.2.19 The body of latch 31 is substantially cylindrical in form, with a semi.
cylindrical extension 32 protruding beyond the diameter 12 of the inner core 8. 'Ibis extension 32 forms a plane surface 3?,a lying along the plane of the axis of latch 31, and is shown more clearly in simplified end view Fig. 5 and simplified top view Fig. 6.
This plane surface 32a ~ctends into a notch 33 in the end fxe of outer core 9.
One side of this notch 33 is in a plane radial to the cylindri~l aril of the inner core 9, parallel to plane surface 32a of latch 31; and the other side s in the fornt of a spiral ramp, shaped to provide clearance with the cylindrical surfacs of the protrusion of latch 31.
4.2.20 The point of closest engagement of latch 31 with notch 3, shown as 34, lies on the diametral plane of latch 31, but at a distance 35 from its axis.
The direction of the combined torques of the locking spring 10 and the backup spring ZS
paexses the plane face of notch 33 against the plane face 32a of latch 31, and this tends to rotate latch 31 in a cloekwise direction at viewed in Fig. !.
4.221 The needle shaft 1 passes through a hole 36 in latch 31 which is transverse to the rotational axis of the latch, thus preventing its rotation about this axis.
The engagement of Latch 31 with the notch 33 in the end face of outer core 9 prevents the rotation of the outer con 9 with aspect to the inner core 8. This is because the latch 31 is transversely placed in the body of inner core 8, and is prevented by the presencx of needle 1 from totaling about its own axis and otat of engagement with notch 33.
4.2.22 a the needle shaft 1 is withdrawn through the body of guard 5 and the tip of the needle disengages the latch 31 ax shaam in Fig. 7, then the latch rotates as a result of the torque applied to the place lace 32a. This diseagagca the latch from notch 33, cad allows the rotation of the outer core 9 under the combined torque of the locldag spring 16 and backup spring 25. This action fs sbo~m in simplified form in end view Fig. 8 and top vitro Fig. 9.
4.2.23 The ditt>casdotts of the loc3dng xpriag 16 are chorea with reapcct to the:
outside diameter of axdle shaft 1 so that the outer care 9 rotates apprwdmately one halt turn about its axis, as locking spring 16 rewinds from iu expanded diameter within 2~~ ~~i~~.
bore 12 to to fully-locked state, wrapped tightly about the needle shaft 1.
This is thrnvn in Ftg. 8, where notch 33 is diametrically opposite to iu position shown in Fig.
5.
q,~2q With the latch 31 rotated to the position shown in Fig. 7 and Fig. 9.
the tip of ncalle i is prevented from re-emerging from the guard 5 in the event of failure at the locking spring 16 to withstand an anernally applied force against guard 5 directed tawards the base of the needle 1.
4.2.25 Fig. 10 shows a second embodiment of this first deviee, in which the rotational latch 31 of Fig. 4 is replacrd by a rylindrical plunger latch 36, placed transversely in the body of inner core 8 which serves as a "setuing pin'. As shown in cross section Fig. 11, the outer end 36a of ehe latch 3b is of appro~dmately spherical form, and is in contact with the cam surface 37 formed as an outward exeeruion of bore 12 of the outer core 9. The remaining componenu of the embodiment ate substantially the same as described for Fig. 4.
4.2.26 The combined forgoes of locking spring 16 aad backup spring 25 tend to rotate outer core 9 in a cJockvvESe direction with rcspat to the inner core 8, as viewed in Fi& 11. This develop s force against the spherical outer end of plunger 36 with a component a~da1 to plunger 36 tending to move the plunger inwards.
Inwards motion of plunger 36 ix blocked by the presence of needle shaft 1, thus preventing Zp rotation of outer gore 9 retative~ to itsna core 8.
4.2.27 In Fig, 12 the needle has been withdrawn into the body of Ute guard 5 tmdl itt tip hat dlsenga=od the inner end of locJdng plunger 36. This allows the plnnaea 36 to move rsdtalty inwards and thus permit the onur core 9 to rotate ~p~e ,with respect to the inner core 8 as shown in Fig. 13. 'Ibis allows the locking xptinj 16 to 8irmly grip the noodle shaft 1 and a~nre the gnarl 5 to the end of the needle, at dearn'bed above.
d,~g In the locked state as shown in Fig. 12, the position of the plunger 36 blacks the tip of the noodltv 3 from ae-emerging from ?be gnarl 5. in the same manner ax desadbed t~r the prcviotu embodImGat.
3p q,~g In irutanoes where it ix desirable to inause the separacton between the operator's fingers and a possibly contaminated needle, a further embodiment provides a detachable handle to allow the operator to slide the guard device along the needle from a safe distance. Fig. 14 shows this embodiment, where detachable handle 38 is frictionally attached to guard 5, and the assembly of needle 1, guard 5, and handle 38 are encased in protective sheath 39, ready for use. The entry of protective sheath 39 is provided with a key-hole shaped cross-section to accommodate handle 38, and the other retaining features described above would also be included in the entry of the sheath.
4.2.30 In Fig. 15, syringe 2 has been fitted to the needle connector or base 3, the circular clip 40 of handle 38 has been snapped over the body of syringe 2 for retention, and the needle and guard assembly have been removed from the protective sheath ready for use.
Handle 38 is frictionally attached to guard 5 by circular clip 41.
4.2.31 Fig. 16 shows guard device 5 being slid along needle shaft 1 following use, using handle 38. When guard 5 locks on the end of needle 1, handle 38 may be detached for disposal by pulling or twisting, as shown in Fig. 17.
4.2.32 An alternate embodiment of the invention may be constructed which relies on a locking system of the "push nut" type. The general assembly of the components for this embodiment may be seen in exploded view Fig. 24 wherein a pair of locking leaf elements 51 are mounted on a rim 52 within a body 43, coaxially with the needle 1.
4.2.33 Referring to Fig. 18, latch shaft 42 is mounted transversely in the body 43. A portion of the left side of latch 42 is relieved to form a flat surface 44 in the axial plane on either side of an unrelieved center portion 45, through which the needle shaft passes at right angles to the latch axis, thus preventing its rotation in the body 43.
4.2.34 Sliding axially in the bore 46 of body 43 is pressure sleeve 47, in the form of a hollow cylinder, largely closed at the right end.
A portion of its left half is cut away to form bifurcated arms 48 which engage the plane surfaces 44 of latch 42, thus preventing motion of the pressure sleeve to the right when latch 42 is in the position shown.
3 5 4.2.35 Referring to Fig. 20, pressure sleeve 47 is pressed to the right by ~0 9'0~0>;~ ~ ~D 4 5 ~ ~ ~. P~»~9o~0~131 compraslon spring 49, whose leftwards teaetion is taken by spring plunger 50, sliding freely within sleeve 47, and which presses against larch 42. The latter 42 holds plunger 47 away from the ends of locking Jwrx 51, which are retained in bore 46 by retaining rim 52, Integral with leaves 51. The rim 52 is deflected out of its free form to produce a slight interference fit in bore 46, thereby allowing it to be retained at the bottom of the bore.
4.2.36 The locking leaf assembly is shown in Fg. 21, two leaves being shown in this example. Optionally one leaf or more than two leaves could be employed with equivalent results. In Fig. 20 spring pressure to the right on sleeve 47 is transmitted to the plant surfatxs 4.4 of latch 42 by arms 48, the ends of which are radially separated from the axis of latch 42 by distance 53. This fornu a small turning moment tending to cause rotation of the tatch in a dockwist direction as viewed in Fig. 18, this rotation being prevented by the needle shaft passing through the axis of the latch.
4.237 In Fig. 22, needle 1 has been withdrawn until lts tip is inside body 43 i5 and fr~ of latch 42, allowing the latter to rotate until its plane surfacGS
44 are parallel with the axis of pressure slave 47. This allorovs the latter to slide to the right past the latch and apply spr(ng pressure to the ends of locking leaves 51, pressing them against the needle shaft 1. This loch the latter in position, prevtntIng further motion to the right, relative to the body. The continued engagement of the arms 48 of sleeve 47 with the cut-away portions of latch 42 prevents the latter from falling out of body 43, and from rotating significantly about its own arils.
d.238 The noodle is now prevented from wiehdrtraring from body 43 to the t~ltt, end's latch 42 is now turned and DocJcsd in position with its needle held 54 st tithe angles to the tteodle axis" the tsted9e point cannot re-entsrge from the left cad of the body, even though the otte.way ticking action of S1 retry permit motion in this direction 4.239 A thud aJterrwte embodiment it :bows la Fig. 25 wherein tht general loc~ng means oomptises throe: locking jaws SS contained tn a gently taperod conical cavity tn the form of a bore 56 is the chuck body 43. In this esample, these jaws are formed from sheet material into an approadmatety Gshapcd cross-section and then 4°JO 90/08564 a ' hardened although alternate forms may be used. These are arranged uniformly about the needle shaft as shown in Fig. 2b, .and are retained loosely in this position by fingers 57 extending axially from the end of pressure sleeve 47, and fitting inside the jaws S5.
Tltis is shown in Fig. 28, one jaw being omitted for clarity.
S 4.2.40 Fingers 57 extend from a reduced portion or spigot 38 of pressure sleeve 47, to allow entry of the latter into bore Sb during loddng, This spigot is provided with axial sloe 59 as shown in Fig. 28 to allow its outer end to collapse slightly in diameter as it is forced into the tapered bore 56. Further elasticity is imparted to this spigot bore 60, shown in Fig. 25, by a reduction in its wall thickness in the vicinity of its junction with the main body of the pressure sleeve 47. A
greater wall thickness is retained at its outer end where it presses against the locking jaws 55.
4.2.41 In the locked state, pressure sleeve 47 is releasa8 by latch 42 as in Fig.
24 and its spigot drives jaws 55 into the narrowing annular spaee 56 between the needle shah 1 and the teperul bore 56, forcing the jaws SS against the needle shaft 1. Contact between the two is made along the narrow rectangular edges of the C-shaped jaws 55.
By 6ntly serrating these edges in the blanking stage of forming the jaws, the coctfacient of friction between Jaw and needle shaft may be substantizlly increased.
4.242 By providing a suitable leagth'of tapered bore 56, this clamping means can accottunodate a range of needle diameters.
4243 A fourth alternate embodiment it s6awn in Fig, 29, wherein the general locking means comprises a plurality of locking rollers 61 of lsardened material, two Dei~ag shown in this example. These are loosely ~ntained in an axially tapering cavity 62 of substantially recungular cross-suction in the body 43 of the guard device. Each iocHng roper 61 is foosety retalnod within a snbatantislly rectangular cavity 63 in a rectangular atettsion 64 of pressure sletve 47. With the axis of each locking roller 61 in a ootamon plane papendlcular to the axis of the noodle shaft 1, aced with each eolier bl unifortnty disposed about Ute axis of neodk shah 1, as shown in Fig. 30.
4.2.44 In the unlocked sate, the ptrsstue sleeve 47 is held by the latch 42 against the pressure of the spring 49 as desaibod shave, such that the Locking rollers 61 are held loosely by extension 64 in the larger portion of the tapered cavity 62, 94-07-03 16:26 ID= P03/19 ~6 making no significant contact with the walls 65 of the cavity 62 or with the needle shaft 1. In this state, the needle shaft 1 is free to move both axially and rotationally within its bore 92 iri the guard device.
4.2.45 In the locked state, as shown in Fig. 29, the latch 42 releases the pressure sleeve 47 by the same action as in Fig. 24 to move under pressure of spring 49 towards the narrowing end of cavity 62 as described above, so that extension 64 carries the locking rollers 61 into contact with the wall 65 of the tapering Cavity 62 oa the outside and the needle shaft y on the inszde. Motion of the needle shaft 1 relative to the body 43 :in the same direction as the spring directed motion of pressure sleeve 47 wild. cause the locking rollers 61 to roll further into the gradually narrowing end of cavity 62, exerting a high xadial pressure against the wall 65 and the surface of the needle shaft 1. This prevents further m4tion of the needle by frictional grip betweaz~ the rollers 61, the cavity walls 65, and the needle ~chaft 1.
4.2.46 By providing a suitable length of tapered cavity 62, this clrimpirlg means can accommodate a range of needle diameters from any 24 arbitrary maximum vt~lue down to zero, 4.2.47 A fifth alternate embodiment is shown in Fig. 32, wherein the general locking means comprises a plurality of locking balls 66 of hardened material, three being shown in this example, as more clearly seen in Fig. 33. The balls 66 are loosely contained is an axially taperi~xg bore 67 of circular cross-section in the body 43 of the guard device. Each locking ball 66 is loosely retained within a cage optionally composed of a substantially cylindrical cavity 68, the axis of each said cavity being perpendicular to the needle axis in a cylindrical extension 69 of pressure sleeve 47. The center of each locking bail 66 lies in a common plain perpendicular to the axis of the treadle shaft l, and the balls u6 are disposed uniformly about the needle shaft l, as shown in Fig. 33. In all other respects, the action of the locking balls 66 in the locked state is similar to that of the locking rollers 61 as described above.
4.2.48 By providing a suitable length of tapered bore 6'7, this clamping means can accommodate a range of needle diameters from any arbitrary maximum value down to a minimum diameter determined by the point at which the lockaz~g balls Come into contact with one another.
When three balls axe used, this minimum needle diameter is 04-07-03 16:26 ID= P04~19 theoretically approximately 0.155 of the diameter of the locking balls.
Considerations relating to the retention of the locking balls place a pract~.ca.l limit of approximately 0.3 of the ball diameter. The minimum diameter of needle which can be gripped becomes progressively larger ax more than three balls of a given size are used.
4.2.49 Thus three alternate embodiments have been described which rely on a narrowing cavity to achieve the locking effect. The laxch and trigger mechanism described for each case has been of the transverse rotating cylinder Glass. An alternate latch and trigger system could be substituted, relying, for example, on the next described sensing pin or lever arm types of systems.
4.2.50 A sixth embodiment is shown in Fig. 35, wherein the general locking means Comprises a pivpting lever arm or lever 101 of stiff mateYial, formed in the general shape of a broad U of unequal proportions, with the longer vertical leg 102, referred to as the locki~sg plate 102, pxovided with a hole 103 of xlightly larger diameter than that of the needle shaft 1 sufficient to allow the lacking plate 102 to Cant" on t:he needle 1 as shown in figure 39. This hale 103 is also shown in cross-xectional view Fig. 36.
4.2.51 A helical compression xpring 104, also shown in simplified cross-sectional view Fig. 37, is contained in a largely compressed state in longitudinal cavity 105 within the guard body 106, with its free end 125 pressing against the locking plate 102 of lever 101, and ~urgi~ig~the levex 101 axially against: trie sloping Internal zace .gym m body 106, making contact at pivot point 10$. The turning moment of the spring force tends to rotate lever 101 in a counter-clockwise direction about pivot point 108, but the shorter vertical leg 109 of lever 101, referred to as the latching or locking leg, prevents rotation by making contact with the needle Shaft 1 at point 1,10. This is shown also in simplific!d cross-sectional view dig. 38.
4.2.52 By appropriate choice of the slope of face 107 in relation to the geometry of lever 101, a. component of reaction force will be developed to act as pivot point 108 in a downward di~xection against levCr 101, equal and opposite to the upward reaction force against rhA lPUi.r ar. nn,nr. 110. Thifi balancirsa of vertical forces against WO 90/08364 ~ ~ ~ PCT/CA90/00031 lever 101 substantially removes any radial force between nxdle shaft 1 and the walls of hole 103 in lever 101, thereby reducing a~aa1 frictional drag between the needle and lever when moving the guard device a~ally along the needle shaft.
4.2.53 In Fig. 39 the needle shaft is shovm withdrawn into the guard and past the point o! contact with the xnsiag end of locking Icg 109 of lever or pivot arm 101.
'ntis allows lever 101 to rotate in a counter-clockwise direction about pivot point 108 under the urging of spring 104, which rotates the locking plate 102 until funher rotation is prevented by the axial mt5alignment of hole 703 and needle shaft 1.
4.2.Sb By utili~lng well-known relationships between the thickness 111 of latch 101, as shown in Fg. 35, the distance 112 between the pivot point 108 and the centre of the needle shaft 1, the diameter of hole 103, the diameter of needle shaft 1, and the coefficient of friction between Latch 101 and needle shaft 1, a critical geometry is established, whereby the a~oal frictional grip between levtr 101 and needle shaft 1 is always greatei rhea the exteraalty-applied axial force on the netdte in the direction 'A' relative to the guard deyi~. 'Ibtu funkier motion of the needle shaft in this direction is prevented by the locking of piste 102 on needle shaft 101, lts a~dal motion with respect to the guard body 106 being blocked by sloping tea 107. With increasing applied aydal force in direction 'A', this locking action will persist until material deformation occurs, distorting the geometry beyond the critical ~nfiguration.
4.2.55 Thfs IocJdng action is telustd it the relative needle motion is rtveesed to direction B', by attempting to sUde the gttasd device bark onto the axdle.
I~inwevet, nosh motion is blotted by the presence of btchlng kg 109 in the return path of the noodle, preventing re-Gxposure of the noedlt point by a substantial obstruetioa of hardened material Alternately, as sbovra in Fignra 32 and 53, a complementary pivot polat 136 mry be provided oa the guard body 706 adjmoeat and on the outward side of the spring 104. Thfs pressure polar 136 Fs loestod so as to apply a canting force to a modified locking plate 132 through a sontacdag flange 133 at the end of the loctang plate 132 when the needle is moved to direction for rt-emargtact of the tip, as shown in Fig. 53 thus leaking the guard body 106 agatast reatoval in thh direction as well.
On initial displaxment towards r~emergeace, the ttadle, wU1 carry the lever arm 130, forward until the contacting flange 133 rests against the complementary pivot point 136, identified in this position as 133A. Any further attempt at displacement will apply the same canting force to the locking plate 132. As a further modification over the embodiment of Figure 35, the guard body 131 of Figure 52 is lengthened to provide clearance space 135 for the additional displacement of lever arm 130.
Additionally, the surface 134 on the interior body portion 131 is inclined to provide freedom for the locking plate 132 to become canted.
4.2.56 To prevent the guard device from being removed forcibly from the needle by its repeated rotation about the needle shaft, the body 106 is preferably surrounded by loosely-fitting sleeve 113, which provides rotational isolation of the body 106 from the external operating means. Sleeve 113 is retained axially on body 106 by snap lips 114, fitting into a circular rabbet 115 in one end of the body.
Referring to Fig. 39, the inner face 116 of sleeve 113 is relieved over most of its surface to make axial contact with body 106 only over a small diameter 117. This reduces the frictional torque transmitted between sleeve 113 and body 106 by combined axial and rotational force applied to the guard device by the external operating means, thus enhancing its rotational isolation.
4.2.57 Fig. 40 shows the protective guard device 5 fitted to a needle 1 and attached to a catheter 118 as part of an intravenous catheter assembly. The embodiment of Fig. 35 is shown here as an example but any other embodiment could be similarly employed. The outer shell 113 of the guard extends over and is frictionally retained on the tubing attachment chuck 119 or base of the catheter 118. The needle 1 extends through the guard 5 and the catheter 118 to emerge slightly beyond the distal end 120 of the catheter. The needle may be moved freely within the catheter 118 in any direction, either axially or rotationally, impeded only by the slight drag of the latch 109 of guard 5 and the constriction of the reduced end 120 of the catheter tube 118.
4.2.58 The inner diameter 121 of the extended portion of shell 113 is such as to provide a frictional axial retention force between shell 113 and catheter chuck 119 significantly greater than the maximum axial drag of needle 1 within guard 5, and comparable to the initial axial retention familiarly encountered between the needle and catheter in a conventional intravenous catheter assembly. This retains guard 5 on , catheter chuck 119 during needle withdrawal, as shown in Fig. 41. Here the operator has inserted needle 1 and catheter 118 into a blood vessel in the patient 122, and is withdrawing needle 1 from catheter 118 through guard 5, holding catheter 118 in place with one hand 123 and 5 holding needle 1 with the other hand 124. The guard 5 remains frictionally retained on chuck 119 of the catheter.
4.2.59 when the needle point passes the latching leg 109 and the guard 5 locks automatically onto needle shaft 1, the operator exerts a slightly increased withdrawal force on the needle, sufficient to 10 release guard 5 from catheter chuck 119, as shown in Fig. 42. The operator can now dispose of the protected needle without further action, while attending to the catheter tube attachment.
4.2.60 A seventh embodiment is shown in Figures 43 to 51. This version relies on a ball-latching mechanism to main the guard in a 15 cocked condition, and a sensing-ball arrangement to serve as the trigger. This embodiment is shown in a form adapted to be installed on a catheter assembly. It could equally be applied to a straight needle, as used on a syringe.
4.2.61 Prior to use, the needle guard assembly Figs. 43-51, 20 inclusive, is housed largely within the base of the catheter 209. The guard base 201 provides radial support for the base 210 of the needle 1 but does not frictionally retain it axially. The guard shell 202, which is retained on guard base 201 by snap-fit shoulders 212, has an outer surface tapered to fit the correspondingly tapered bore 213 of 25 the catheter base 209, with moderate axial frictional retention therein.
4.2.62 During insertion of the catheter, the necessary axial thrust is transferred from the face 214 of the needle base 210 to the guard base 201 and thence through face 215 of the latter to catheter base 30 209, without affecting the respective radial fits described in para 2.4.61 above.
4.2.63 During withdrawal of the needle from the catheter, the needle base 210 readily releases from the guard base 201, while the latter is axially retained within the catheter base 209 by the greater frictional grip between the two, per para 2.4.61 above.
4.2.64 With the needle 211 passing wholly through the needle guard assembly as in Fig. 43 plunger 203 is urged towards the pointed end of the needle 211 by compression spring 204, but is prevented from moving axially by the three-point confinement of sensing ball 205, which makes contact with plunger 203 against the latter's perpendicular end face at point 216, against the sloping internal end face 227 of guard shell 202 at point 217, and against the needle shaft 211 at point 218. The sensing ball 205 is free to move orbitally about the needle axis in the annular space 219 surrounding the needle.
4.2.65 The reactionary force at the opposite end of spring 204 acts against the perpendicular end face of the pair of locking jaws 206 and 207, but motion of these latter parts is prevented by the confinement of latching ball 208. This makes contact with jaw 207 on the curved side of its groove 220 at point 221, with the perpendicular end face of guard base 201 at point 222, and with the cylindrical inner surface of plunger 203 at point 223. Axial motion of locking jaw 206 is prevented by its being axially locked to jaw 207 as will be described below. Latching ball 208 is free to move orbitally about the needle axis in the annular space 224 surrounding locking jaws 206 and 207.
4.2.66 With jaws 206 and 207 held axially as shown in Fig. 43, their tapered outer surfaces are confined within the correspondingly tapered inner bore 225 of guard base 201 to an extent sufficient to radially support the needle shaft 211 on the cylindrical inner surfaces 226 of the locking jaws, yet without developing sufficient frictional contact to significantly impede the axial movement of the needle shaft through the jaws.
4.2.67 Similarly, the pressure of plunger 203 against sensing ball 205 is redirected by contact point 217 to produce a reduced force at contact point 218, such that the frictional force between the polished surfaces of sensing ball 205 and needle shaft 211 negligibly impedes the axial movement of the needle shaft 211 within the needle guard.
4.2.68 As the point of the needle enters the needle guard during withdrawal, sensing ball 205 passes over the end of the needle, following the inclined inner end face 227 of body shell 202, under the axially-directed urging of plunger 203, driven by spring 204. The greatest extent of this motion before the sensing ball 205 becomes free of the needle occurs with the bevel 228 of needle 211 rotationally oriented to be tangent with the surface of ball 205 as shown in Fig.
44, and with the point of tangency 229 being on the end of a line i passing through the centre of the sensing ball 205 to an opposite point of contact 230 between the sensing ball 205 and the corner of ball socket 231 in the end of guard shell 202.
4.2.69 It will be seen that the configuration in Fig. 44 is a critical one, in that reversal of the needle withdrawal motion will not cause the ball to likewise reverse its motion towards the configuration of Fig. 43, because the force exerted on the ball by the tangential face 228 of the needle acts on a line through the centre of the ball, and therefore cannot move it in any direction. It will be seen further that when the configuration of Fig. 44 is reached, the spring-driven plunger 203 will force sensing ball 205 free of the needle 211, and drive it into ball cavity 231, as shown in Fig. 45.
4.2.70 With the configuration of Fig. 44, the geometry of the containment of latching ball 208 is the same as in Fig. 43, so that the locking jaws 206 and 207 cause no significant resistance to the axial motion of the needle 211, yet continue to provide radial support to it.
Thus the withdrawal motion of the needle 211 can continue beyond the critical configuration of Fig. 44, ensuring that sensing ball 205 is released into its cavity 231 to block the re-emergence of the needle point, before the locking jaws 206 and 207 are activated.
4.2.71 When the plunger 203 moves to the position of Fig. 4S, it releases latching ball 208 from the confinement of Figs. 43 and 44, allowing locking jaws 206 and 207 to be driven by spring 204 into the confinement of tapered bore 225 in guard base 201. This causes the jaws 206 and 207 to grip the needle shaft 211. The angle of taper of bore 225 is critically selected with respect to the coefficients of friction between the jaws 206 and 207 and needle shaft 211 and between the jaws and bore 225, such that the axial component of frictional grip between the jaws and the needle shaft is always greater than the externally-applied axial force on the needle, which develops this gripping force. Thus the needle cannot be withdrawn from the needle guard, as the gripping force of the jaws on the needle increases with withdrawal force until material failure occurs. Re-emergence of the needle is resisted to a much lesser degree by the locking jaws 206 and 207, but such re-emergence is blocked by the sensing ball 205 which now blocks the exit path of the needle 211 from the guard.

. . d~

4.2.72 The self-locking action of the jaws in the direction of withdrawal of the needle from the guard is independent of the axial force on the jaws of spring 204, and the latter acts only as the initiator of the locking action, by moving the jaws into the confinement of tapered bore 225. Once in this position application of further withdrawal force on the needle 211 enhances the locking effect of the jaws 206 and 207 as they are drawn deeper into the narrowing cavity of the tapered bore 225.
4.2.73 The rotational component of the coefficient of friction between locking jaws 206 and 207 and bore 225 is significantly less than the rotational component of the coefficient of friction between the locking jaws and needle shaft 211. This maintains the rotational grip between the locking jaws and the needle shaft if the latter is rotated with respect to the needle guard, with relative rotation occurring between the locking jaws and bore 225.
4.2.74 The locking jaws 206 and 207 are shown in enlarged views Figs. 46 to 50. The two jaws are identical, each having a substantially rectangular lug 234 extending from its diametral plane on one side of its central axis, which engages a corresponding substantially rectangular recess 235 in the opposite jaw when the two are placed together on a common diametral plane. The resulting engagement of each lug and recess prevents relative axial motion of the two jaws. This allows the use of a single latching ball 208, as described above, holding the two jaws as an axially-coupled pair in the unlocked position.
4.2.75 The tapered outer surface 232, Fig. 46, is polished to reduce the coefficient of friction between the jaw and the bore 225 of the guard body 201.
4.2.76 The internal bore 226, Fig. 49, is provided with a relatively coarse surface finish, and is furthermore of a slightly smaller diameter than that of the needle shaft 211. This produces contact with needle shaft 211 along axial lines of concentrated pressure 233, as shown in Fig. 51. This causes the exclusion of any bodily fluids which may be on the surface of the needle, and provides a high frictional grip both axially and WO 90/0856A ~ ~ ~ ~ ~) ~ ~ PCT/CA90/00031 rotationally.
4.2.77 'Ibis last embodiment demonstrates the use of a narrowing-cavity or chuck-action clamping system, in combination with a sensing ball trigger mechanism. A
second latching ball is also empioyai to maintain the guard in its cocked condition.
The major components In this embodiment may be readily manufactured by injection molding without onerous tolerance requirements, and this design has the capacity of having one siu tit a range of needle diameters.
4.2.78 All of the principal parts of the device may be made of any suitable material, such as of injection moulded plastic, eg. Nylon, or of corrosion-resistant metal such as stainless steal, according to such considerations as convenience of manufacture, cost and other factors relevant to medical devicrs.
4.2.79 Throughout the foregoing disclosure a hollow hypodermic needle has been depicted. The needle need not, however, be hollow. The protective guard contemplataf by this Invention is equally applicable to solid needlts, such as might be used for smallpox inoculations.
4.2.80 The foregoing has constituted a detailed description of specific exemplary embodiments of the invention. The invention in iu most general and more specific aspects is more particularly described and claimed in the claims which now touaw.

Claims

1. A needle tip protecting device for covering the tip of a needle (1) comprising ,protecting means (5) having engagement means (102) for automatically, non-removably, directly engaging the outer surface of the needle (1) with said protecting means (5) when said protecting means (5) is moved from a position on said needle (1), spaced from said tip, to a position where said protecting means (5) encloses said tip, said engagement means (102) comprising:

(a) locking means (51) adapted to lockingly engage with the surface of said needle (1) and thereby restrain axial displacement of said protecting means (5) with respect to said needle (1) in the direction proceeding toward the tip of said needle (1), when said protecting means (5) encloses said tip; and (b) means (109) to prevent re-emergence of said tip from said protecting means upon attempted movement of said protecting means (5) in the opposing axial direction.

2. A needle tip protecting device as claimed in claim 1, wherein said engagement means (102) is characterized by a clamping means (206, 207) which applies a clamping force to the outer surface of said needle (1).

3. A needle tip protecting device as in claim 1 or 2 wherein said means (109) to prevent re-emergence of said tip is a barrier that is placed in the path of the needle (1).

4. A needle tip protecting device as in any one of claims 1, 2 or 3 wherein said engagement means is characterized by:

(i) a spring (16) adapted to applying an engaging force to said needle (1) when said spring (16) is permitted to contract in a constricting fashion;

(ii) a retention means (31) positioned to hold said spring (16) in a partially expanded condition to permit said protecting means (9) to be slid along said needle (1) prior to enveloping the tip of said needle (1); and (iii) release means (31) positioned to release said spring and permit it to lockingly engage said needle (1) when said protecting means (9) encloses said tip.

5. A needle tip protecting device as in any one of claims 1, 2 or 3 wherein said device comprises a body (43) and said engagement means is characterized by:

(i) a locking element in the form of leaf means (51) mounted in said body (43);

(ii) an energy storage means (49); and (iii) latch means (42) for releaseably containing said energy storage means (49), whereby, upon entry of the needle tip within said protecting means (50), said leaf means (51) is thereupon, by the release of said latch means (42), thrust by said energy storage means (49) into jamming engagement with said needle (1).

6. A needle tip protecting device as in claim 5 wherein said leaf means (42) is characterized by a pair of leaf elements (42) that are conically deployed about said needle (1) in a symmetrical fashion.

7. A needle tip protecting device as in any one of claims 1, 2 or 3 wherein said engagement means (102) is characterized by:

(i) a body (43), having a narrowing cavity (56) therein; and (ii) jaw means (55), contained within said cavity, said jaw means (55) being biased to move into the narrowing portion of said cavity (56) and lockingly engage said needle (1) when said protecting means (43) is positioned so as to envelop the tip of said needle (1).

8. A needle tip protecting device as in claim 7 wherein said jaw means (55) is characterized in that it is a rolling element (61).

9. A needle tip protecting device as in claim 8 wherein said jaw means (55) is characterized in that it is cylindrical (61).
.
10. A needle tip protecting device as in claim 8 wherein said jaw means (55) is characterized in that it is spherical (66).

11. A needle tip protecting device as in claim 7 wherein said jaw means (206,207) is characterized in that it is comprised of at least a pair of bisected conical segments (206,207) that respectively contact said needle (1) along their bisecting edges (233).

12. A needle tip protecting device as in any one of claims 1, 2 or 3 wherein said engagement means is characterized by:

(i) a body (106) having an interior cavity;

(ii) a locking plate (102) positioned within said cavity, said locking plate (102) having an opening (103) therethrough, said opening (103) being penetrated by said needle (1);

(iii) alignment means (101) to maintain said opening (102) and said needle (1) in sliding alignment while the needle tip is outside of said protecting means (5); and (iv) canting means (104) to cant said locking plate (102) into locking engagement with said needle (1) when said tip enters within said protecting means (5).

13. A needle tip protecting device as in claim 12 wherein said canting means (104) is characterized by energy storage means (104) comprising a spring means (104) with a first end thereof in contact with said body (106) and with the second end thereof coupled to said locking plate (102), the stored energy of said spring (104) being thereby directed to bias said locking plate (102) to be canted on said needle shaft.

14. A needle tip protecting device as in any one of claims 12 or 13 characterized in that said alignment means comprises:

(i) a lever arm (101), with first and second ends, contained within said body (106) and having the first end of said lever arm (101) attached to a first end of said locking plate (102), and the second end of said lever arm (101) in contact with said needle (1), said lever arm (101) being aligned so as to prevent canting of said locking plate (102) while said needle tip is exterior to said needle protecting means (106);
and said canting means comprises:
(ii) spring means (104) positioned to bias said looking plate (102) to be canted into locking engagement with said needle (1) when said lever arm (101) ceases to be in contact with said needle.

15. A needle tip protecting device as in any one of claims 1, 2 or 3 characterized in that said device further comprises:
(a) a body (202) serving as said protective means, said body (202) being provided with a passage therethrough capable of enveloping a needle (211) inserted therein, said body having a narrowing interior cavity (225);
(b) said locking means being in the form of locking jaw means (206) within said cavity (225) capable of engaging and locking relative movement between said needle (211) and said body (202) in at least one axial direction of said needle (211);
(c) spring means (204) within said body (202) positioned to bias said locking jaw means (206) to advance into the narrowing interior of said cavity (225) and lockingly engage said needle (211) in at least one axial direction of said needle (211);
(d) latch means (208) positioned to releaseably restrain said locking jaw means (206) from being advanced into said cavity (225); and (e) trigger means (205), positioned to release said latching means (208) when the tip of said needle (211) is withdrawn into said body (202).

15. A needle tip protecting device as in claim 15 characterised in that:
(a) a coaxially displaceable retention means (203) is mounted an said needle (211);
(b) said latch means comprises a latching ball (208) positioned between a shoulder (220) on said locking jaw means (206) and a shoulder (222) an said guard body (202), said latching ball (208) being releaseably retained in a latching position against each of said shoulders by said coaxially displaceable retention means (203) positioned to release said latching ball (208) upon displacement of said retention means (203); and (c) said trigger means comprises a second ball constituting a sensing ball (205), positioned so as to restrain said retention means (203) from displacement, while said needle (211) passes entirely through said body (202), and being positioned and biased to move into the path previously occupied by said needle (211) upon withdrawal of the tip of said needle (211) to within said body (202) and thereby permit displacement of said retention means (203), release of said latching ball (208), and engagement of said locking means with said needle (211).

17. A needle tip protecting device as in any one of claims 1, 2 or 3 characterized in that said device comprises:
(a) a body (202) serving as said protecting means, said body (202) having a tapered interior cavity (225) with a tapering interior surface;

(b) said locking jaw means being in the form of a jaw element (206) positioned adjacent said needle (211);
(c) spring means (204) positioned to bias said jaw element (206) to move into jamming engagement between said needle (211) and the tapering surface of said interior cavity;
(d) a retention member (203) within said body (242), said retention member (203) being biased to be displaced towards the tip of said needle (211);
(e) latch means (20B) in the form of a latching element (208) releaseably held in a mutually engaging position between said jaw element (206) and said body (202) by said retention (203) member;
retention member (203) and the inner end of said body (202) most proximate to the needle tip, said sensing element (205) being initially in contact with said needle (211) and being biased to move into axial alignment with said needle (211) under the urging of pressure from said retention member (203), whereby, upon withdrawal of said needle (211) past the point of contact with said sensing element (205), said sensing element (205) will move into coaxial alignment with said needle (211) and said retention member (203) will advance in the direction of the tip of the needle (211) and release said latching element (208), thus permitting said jaw element (206) to effect engagement with said needle (211).

18. A needle tip protecting device as in any one of claims 1, 2 or 3 comprising:
(a) a body (202) serving as said protecting means, said body (202) having a needle entry opening therethrough, which body (202) is adapted to substantially surround the shaft of a needle (211) and slide axially thereon;
(b) said locking means (206) being associated with said body for fixing said body (202) in a needle-protecting position over the tip of said needle (211) and comprising means for applying an engaging force (206) to said needle (211) that will restrain relative movement between said body (202) and said needle shaft (211) in at least the axial direction for removal of the body (202) from said needle shaft (211);
(c) energy storage means (204) within said protecting device for actuating said locking means (245):
(d) retention means (208) for releaseably suspending the actuation of said locking means (205) by said energy storage means (204); and (e) trigger means (205) for sensing the presence or absence of the tip of said needle (211) within said protecting means (208) and releasing said retention means (209) where the tip of said needle (211) is withdrawn into said body (202) thereby allowing said energy storage (204) means to actuate said locking means (206).

19. A needle tip protecting device as in any one of claims 1, 2 or 3 characterized in that said device comprises a sensing means (109) for detecting the presence and absence of the needle tip within the protecting means (106) and for activating engagement of said protecting means (106) with said needle (1) when said tip is drawn within said protecting means (106).

20. A needle tip protecting device as in claim 19 wherein said sensing means (42) comprises a cylindrical member (42) mounted in said device with its axis transverse to the axis of said needle (1), said cylindrical member (42) being pierced by said needle (1) and being biased to rotate about its axis but restrained from such rotation by the presence of said needle (1) therethrough.

21. A needle tip protecting device as in claim 19 wherein said sensing means comprises a pivoting arm (101) with a free sensing end (110), said arm (201) being biased to rotate about a pivot point (108) in a direction that tends to bring said sensing end (110) into the path of said needle (1) through said device, said arm (101) being restrained from rotation by the presence of said needle (1) in contact with said sensing end (110).

22. A needle tip protecting device as in claim 19 wherein said sensing means comprises a sensing element (109) that is located adjacent to said needle (1) when the needle (1) passes entirely through said protective means (106), and is biased to move into the path of said needle (1) through said device when the needle tip is withdrawn into the protecting means (106), thereby effecting engagement of said protecting means (106) with said needle.

23. A catheter assembly comprising a catheter (118) with a base (119) in combination with an insertion needle (1) as said needle and a needle tip protecting device as in any of the preceding claims characterized in that said needle tip protecting device:
(a) is coupled to and detachably retained with said base (119) of said catheter (118), with said insertion needle (1) passing therethrough;
(b) remains coupled to said catheter base (119) during withdrawal of said needle (1) from said catheter (118), until the tip of said needle (1) enters said needle protecting device (5) and is non-removeably engaged therein; and (c) thereafter may be detached from said catheter base (119) by further axial withdrawal of said insertion needle (1).

24. A needle assembly comprising a needle (1) having a base end and a pointed end wherein a needle tip protective device (5) as in any one of the preceding claims is mounted on said needle (1) in a stored position.

25. A needle tip protecting device as in any one of the preceding claims characterized by an outer, substantially cylindrical shell (113), rotationally isolated from said protecting means (106) so as to prevent said protecting means (106) from being disengaged from said needle (1) by the application of an external rotational force, after engagement with said needle (1) has been effected.

25. A needle tip protecting device as in any one of the preceding claims characterized by a handle (38) means connected to said protecting means (5) for remotely moving said protecting means (5) along said needle (1) without direct manual contact with said protective means (5).

26. A needle tip protecting device as in claim 18 characterized in that said locking means and energy storage means are provided by:
(a) a cylindrical coil spring (16) having two end coupling elements (19,20) and whose inner diameter in its free state is sufficiently less than the outer diameter of the needle shaft (1) such as to generate a substantial frictional coupling with the needle (1) when said spring (26) is disposed an said needle shaft (1);
and said retention means is provided by:
(b) a torque sustaining means (31) positioned to apply torque about the axis of said coil spring (16) to each end coupling element (19,20) of said coil spring in relative directions such as to partially unwind and increase the diameter of said coil spring (16) thereby placing said spring (16) in a preloaded, unlocked state before being released by said trigger means.
CA002045691A 1989-02-01 1990-02-01 Disposable automatic hypodermic needle guard Expired - Lifetime CA2045691C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US30930589A 1989-02-01 1989-02-01
US309,305 1989-02-01
PCT/CA1990/000031 WO1990008564A1 (en) 1989-02-01 1990-02-01 Disposable automatic hypodermic needle guard

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Publication Number Publication Date
CA2045691A1 CA2045691A1 (en) 1990-08-02
CA2045691C true CA2045691C (en) 2005-09-27

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US (3) US5322517A (en)
EP (1) EP0456694B1 (en)
JP (1) JP2935562B2 (en)
AT (1) ATE129163T1 (en)
AU (1) AU649218B2 (en)
CA (1) CA2045691C (en)
DE (1) DE69023124T2 (en)
ES (1) ES2081973T3 (en)
WO (1) WO1990008564A1 (en)

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JPH04504512A (en) 1992-08-13
CA2045691A1 (en) 1990-08-02
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ATE129163T1 (en) 1995-11-15
EP0456694B1 (en) 1995-10-18
WO1990008564A1 (en) 1990-08-09
ES2081973T3 (en) 1996-03-16
US5611781A (en) 1997-03-18
EP0456694A1 (en) 1991-11-21
US5328482A (en) 1994-07-12
DE69023124T2 (en) 1996-11-14
JP2935562B2 (en) 1999-08-16
AU5029190A (en) 1990-08-24
US5322517A (en) 1994-06-21

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