SE537459C2

SE537459C2 - The lancet device

Info

Publication number: SE537459C2
Application number: SE1250202A
Authority: SE
Inventors: Robert Domonkos; Lennart Holm
Original assignee: Vigmed Ab
Priority date: 2012-03-02
Filing date: 2012-03-02
Publication date: 2015-05-05
Also published as: WO2013130008A2; SE1250202A1; WO2013130008A3

Abstract

22 ABSTRACTThe present invention discloses a lancet assembly (100) for protecting a lancet (210) from accidental contact, comprising: a body (221) having an elongated shape With acentral aXis; a lancet shield (110), being pivotable from an open position to a closedposition, in Which closed position the lancet shield (110) is intersecting said central aXis,such that the lancet shield (110) may be pivoted from the open position, in Which theinner space of the lancet shield (110) is separated from the lancet (210), to the closedposition, in Which the inner space of said lancet shield (110) is enclosing the sharp endof the lancet (210); and a hinge structure (120); Wherein the lancet shield (110) ismovably connected to the body (221) by means of the hinge structure (120) for enablingmovement between the open and the closed position; and the lancet shield (110) ishaving a passive state and an active state, the lancet shield (110) being urged towardsthe closed position When in the active state. Methods of manufacturing the lancet assembly (100) are also disclosed. To be published With Fig. 1

Description

LANCET ASSEMBLY TECHNICAL FIELDThe present invention relates to a lancet assembly arranged to shield a lancet from accidental contact.

BACKGROUND The lancet is Widely used in various medical devices for penetrating the skin ofa patient, thereby causing a minor amount of blood to leak out for sampling. Theexisting lancets can be divided into puncture lancets and incision lancets according tothe primary penetrating part of the device. The puncture lancet acts by means ofacupuncture by a short needle or needle like extension. The incision lancet acts bymeans of blade incision by a sharp blade. An unprotected lancet constitutes, after its usefor penetrating the skin, a serious health hazard due to the fact that it may becontarr1inated With infectious agents originating from the patient°s blood, incombination With the lancet°s inherent ability to easily penetrate skin. Hence, themedical personnel Who are handling the used lancet may acquire the correspondingdisease, e. g. HIV or hepatitis, if by accident contacting it With their skin. ln order tocircumvent or alleviate the health hazards associated With such a used lancet, there hasbeen much effort devoted to the development of various kinds of medical devices, inWhich the lancet is enclosed and protected after use.

A maj ority of today' s devices With lancets are either of the unprotected kind,i.e. of a kind in Which the lancet is left exposed after use, or of a type in Which thelancet is only briefly exposed upon the penetration of the skin. The latter type is almostinvariably based on a spring loaded lancet mounted Within a housing. Upon activation,the lancet moves out of the housing With a force and penetrates the skin, and isthereafter immediately and automatically returned and protected by the housing, asdisclosed in e.g. US 4,449,529 and US 2003/0050656.

US 4,449,529 describes an automatic retractable lancet assembly comprising asharp-pointed lancet and a housing. An actuating mechanism releases the lancet foroutWard movement from the housing. Subsequently, the lancet is automaticallyretracted back inside the housing by virtue of a spring element.

US 2003/0050656 describes a single use lancet device comprising a lancet structured to move between a cocked orientation and a piercing orientation. The lancet is remained in the cocked orientation until released by an actuation assembly, structuredto move between an actuated and an un-actuated orientation. Movement into theactuated orientation results in release between a retention member and an engagementhub, whereby the lancet is moved into the piercing orientation.

Disadvantages of automatic spring loaded devices such as the ones described inUS 4,449,529 and US 2003/0050656, or similar automatic spring loaded devices,include a complex construction with several separate parts, which is associated with ahigh cost of production.

Additional related devices, designed to protect medicinal personnel fromundesired contact with sharp objects that may be contan1inated with infectious agentsoriginating from a patient°s blood, include injection needle protectors. Such injectionneedle protectors commonly rely on an elongated shield, which is pivotally movable toenclose and protect the needle.

US 5,242,4l7 describes a syringe with an integral needle guard that pivotsabout a main living hinge on the side of the syringe near the base of the needle. The usermay initiate the rotation of the guard towards the needle. Beyond a certain angle, atension spring pulls the guard into a position surrounding the needle.

A disadvantage of the needle guard of US 5,242,4l7 and similar devices of theprior art, include the risk of accidently pulling the guard out of the position in which itis surrounding the needle. This risk may be n1inimized by the employment of a lockingmechanism that secures the guard in a position surrounding the needle. Such a lockingmechanism may be a flap, equal to or similar to the one described in US 5,242,4l7, thatsnaps around the shaft of the needle. Such a ﬂap may, however, not be applied to theprotection of a lancet since its longitudinal extension is limited, or its shape is in theform of a blade. Other locking mechanisms of needle guards involve locking to the baseof the needle or adjacent parts thereof. However, all locking mechanisms of needleguards of the prior art generally require a manual push of the pivoting lancet guard toovercome the resistance of the locking mechanism. This force needs to be relativelyhigh, which increases the risk of the user not to lock the needle guard in e. g. a stressfulsituation. The needle guard may thus be left unlocked which results in a potential healthhazard. In addition, the needle guard of US 5,242,4l7 and similar devices of the priorart, invariably leaves at least the side of the needle exposed through the slot throughwhich the needle enters when the needle guard is pivoting into the protective position.

Hence, an improved lancet assembly for shielding of a lancet after its employment for e.g. taking a blood sample is desired.

SUMMARY It is an object of the present invention, considering the disadvantagesmentioned above, to provide an improved lancet assembly which may be produced at alow cost and yet securely protects the lancet from accidental contact after use.

It is another object of the present invention, to provide a lancet assembly whichmay be employed equally well for lancets in the form of a short needle, a needle likeextension or a sharp blade.

It is yet another object of the present invention, to provide a lancet assemblywhich may be produced in one piece.

These and other objects, which will appear from the following description,have now been achieved by a lancet assembly comprising a body having an elongatedshape with a central aXis; a lancet with a sharp end arranged substantially along orparallel to the central aXis at an end of the body; a lancet shield, being pivotable from anopen position to a closed position, in which closed position the lancet shield isintersecting the central aXis, such that the lancet shield may be pivoted from the openposition, in which the inner space of the lancet shield is separated from the lancet, tothe closed position, in which the inner space of the lancet shield is enclosing the sharpend of the lancet for protecting the lancet from accidental contact; and a hingestructure; wherein the lancet shield is movably connected to the body by means of thehinge structure for enabling movement between the open and the closed position; andthe lancet shield is having a passive state and an active state, the lancet shield beingurged towards the closed position when in the active state.

According to another aspect of the present invention, the lancet may eXtendfrom an end of the body, which end is the end being closest to the lancet shield, whereinthe lancet is selected from the group consisting of puncture lancets and incision lancets,and wherein the lancet is made of metal or a polymeric material.

According to yet another aspect of the present invention, the lancet is press-fitted, insert-molded or glued to the body, or the lancet and the body constitute differentparts of the same monolithically formed single article.

According to yet another aspect of the present invention, the body comprises agroove or a bore arranged substantially along the central aXis at an end of the body formating with the lancet; the groove having an open end facing the inner space of thelancet shield in the closed position, and a closed end facing away from the inner space of the lancet shield in the closed position, for enabling mounting of the lancet from the front end of the body; and the bore having an open end facing the inner space of thelancet shield in the closed position, and an open end facing away from the inner spaceof the lancet shield in the closed position, for enabling mounting of the lancet fromeither of the front end and the back end of the body.

According to yet another aspect of the present invention, the hinge structurehas a dead-center position, such that the lancet shield is in the passive state whereby itis being forced by the hinge structure from a first position into the open position if thedead-center position has to be passed to reach the closed position, and in the active statewhereby it is being forced by the hinge structure from a second position into the closedposition if the dead-center position has to be passed to reach the open position.

According to yet another aspect of the present invention, the hinge structure iscomprising at least one toggle joint and at least one tension member, the at least onetoggle joint and at least one tension member being connected to the lancet shield andto the body .

According to yet another aspect of the present invention, the dead-centerposition is a position in which the angle between the longitudinal extension of the bodyand the longitudinal extension of the lancet shield is in the range of 45 to l75°.

According to yet another aspect of the present invention, the dead-centerposition is a position in which the angle between the longitudinal extension of the bodyand the longitudinal extension of the lancet shield is in the range of l75 to l90°.

According to yet another aspect of the present invention, the lancet assemblymay further comprise a press member, for facilitating a user°s control of the spatialorientation of the lancet shield in relation to the body.

According to yet another aspect of the present invention, the lancet assemblymay further comprise a shield connective element and a body connective element, forconstituting an interface between the lancet shield and the body in the closed position.

According to yet another aspect of the present invention, the outer surface ofthe lancet shield has a smooth or rounded shape, for minirnizing the risk ofunintentional transition from the closed position to the open position.

According to yet another aspect of the present invention, two parts of the lancetassembly may constitute different parts of the same monolithically formed singlearticle, the parts being independently selected from the list consisting of the body, thelancet shield and the hinge structure .

According to yet another aspect of the present invention, two parts of the lancet assembly may constitute different parts of the same monolithically formed single article, the parts being independently selected from the list consisting of the body, thelancet shield, the hinge structure and the press member .

According to yet another aspect of the present invention, the lancet assemblymay further comprise locking means, the locking means enabling the lancet shield tolockingly engage with the body .

According to yet another aspect of the present invention, the force needed forthe lancet shield to lockingly engage with the body is less that the force by which thelancet shield is being urged towards the closed position when in the active state, forallowing locking of the lancet shield in the closed position by the force by which thelancet shield is being urged towards the closed position when in the active state.

According to yet another aspect of the present invention, a method for themanufacturing of a lancet assembly is provided, comprising the step of molding orinjection molding a therrnoplastic, plastic or polymeric material.

Further features of the invention and its embodiments are set forth in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS These and other aspects, features and advantages of which the invention iscapable will be apparent and elucidated from the following description of non-lirnitingembodiments of the present invention, reference being made to the accompanyingdrawings, in which Fig. lA and lB are views from the side (A: non-cross sectional; B: cross-sectional) of a lancet assembly in the open position, with an angle between thelongitudinal extension of the body and the longitudinal extension of the lancet shield ofabout l80°, with a lancet mounted in a groove having an open end facing forwards anda closed end facing in the opposite direction, with a press member which is reachable bya finger of a user, and with a shield connective element in form of a circular extensionadapted to mate with the corresponding body connective element in form of a circulargrove on the front side of the body, according to one embodiment of the invention; Fig. 2A and 2B are views from the forwards facing side of the lancet assemblyof Fig. l in the open position (A) and in the closed position (B), displaying a triangularshape body and a triangular shaped lancet shield with smooth rounded of edges,according to one embodiment; Fig. 3A and 3B are views from the side (A: non-cross sectional; B: cross- sectional) of the lancet assembly of Fig. l in the closed position, with an angle between the longitudinal extension of the body and the longitudinal extension of the lancet shieldof about 0°, according to one embodiment; Fig. 4A and 4B are cross-sectional views from the side of a lancet assembly inthe open position, with a lancet not mounted (A) and mounted (B) in a bore having oneopen end facing forwards and one open end facing in the opposite direction, and with aspherically shaped lancet shield, according to one embodiment; and Fig. 5 is a cross-sectional view of the lancet assembly of Fig. 4 in the closedposition, displaying a lancet of which the sharp end is enclosed in the inner space of the lancet shield, according to one embodiment.

DETAILED DESCRIPTION OF THE EMBODIMENTS Embodiments of the present invention will be described in more detail belowwith reference to the accompanying drawings in order for those skilled in the art to beable to carry out the invention. The invention may, however, be embodied in manydifferent forms and should not be construed as limited to the embodiments set forthherein. Rather, these embodiments are provided so that this disclosure will be thoroughand complete, and will fully convey the scope of the invention to those skilled in the art.The embodiments do not lin1it the invention, but the invention is only limited by theappended patent claims. Furthermore, the terminology used in the detailed descriptionof the particular embodiments illustrated in the accompanying drawings is not intendedto be limiting of the invention.

Embodiments of the present invention will now be described below withreference to Figs.l to 5. Reference to various parts of the drawings are done by numbers according to the table below. number part 100 lancet assembly 110 lancet shield 115 lancet shield opening117 shield connective element118 body connective element120 hinge structure 121 toggle joint 122 leg portion 123 toggle joint knee124 tension member 125 press member 210 lancet221 body The lancet assembly 100 of the invention is designed to protect a lancet 210,arranged in connection thereto, from accidental contact after use, such as after use forpricking the skin of a patient to cause a minor amount of blood to leak out for sampling.It essentially comprises a unique, novel, inventive and advantageous combination of abody 221, a spring loaded lancet shield 110, and means that typically comprise a hingestructure 120 for connecting the lancet shield 110 to the body 221. The body 221 mayhave an elongated shape, and is preferably adapted such that it can be securely andeasily held in one hand during use. The lancet 210 is securely arranged at the front endof the body 221 with its sharp end extending forwards there from. The longitudinalextension of the lancet 210 may be parallel to or intersect with the longitudinalextension of the body 221. Any orientation of the lancet 210, as known to the skilledperson, which pern1its a user to penetrate the skin of a patient when holding the body221 is, however, possible. The lancet shield 110 is a rigid container or cup shapedstructure with one side, which may be spherical or any other suitable shape which ispreferably smooth without sharp edges, for constituting a protecting barrier, and anotheroppositely arranged side, which comprise an opening for allowing entry of at least thesharp end of the lancet 210. The lancet shield 110 is arranged near the front end of thebody 221, such as by means of a hinge structure 120, or any other suitable means forconnection, near the intersection between the front end and the side of the body 221.The suitable means for connection, or hinge structure 120, may comprise or be closelylocated to a resilient part, such as a spring or a tension member 124. The lancet shield110 may, by means of e.g. a hinge structure 120, thus pivot between an open positionand a closed position. In the open position, the lancet shield 110 is positioned remotefrom the front end of the body 221 and the sharp end of the lancet 210, such as beinglocated away from the projection of the front end of the body 221, i.e. not intersectingwith the longitudinal extension, i.e. the central axis, of the body 221. The lancet 210 isthen separated from the inner space of the lancet shield 110, whereby it may be used topenetrate the skin of a patient. In the closed position, the lancet shield 110 is positionedsuch that it intersects with the longitudinal extension, i.e. the central axis, of the body221. The inner space of the lancet shield 110 is thereby enclosing, at least, the sharp endof the lancet 210, to protect it from accidental contact. Preferably, the side of the lancet shield 110, which comprise an opening for allowing entry of at least the sharp end of the lancet 210, is then contacting the front end of the body 221 to maxin1ize the enclosureof the sharp end of the lancet 210. Such a contact may be accomplished by the matinginteraction between a shield connective element 117 and a body connective element118. The shield connective element 117 and/or the body connective element 118 mayfurther comprise locking means for enabling the lancet shield 110 to lockingly engagewith the body 221, in the closed position. Besides allowing the lancet shield to pivot,suitable means for connection, e. g. hinge structure 120, may have a dead-center togglefunction. This function is providing the lancet shield 110 and the suitable means forconnection, e. g. hinge structure 120, with an active state and an optional passive state.In the active state, the lancet shield 110 is urged by a force provided by the suitablemeans for connection, e. g. hinge structure 120, towards the closed position. In thepassive state, the lancet shield 110 is urged by a force provided by the suitable meansfor connection, e. g. hinge structure 120, towards an open position. The transition ineither direction, between the active and the passive state, corresponds to a “dead-centerposition", which in turn corresponds to a dead-center angle, which is the angle betweenthe longitudinal extension of the body 221 and the longitudinal extension of the lancetshield 110 at the dead-center position. The user°s activation of the safety mechanism ofthe lancet assembly 100, i.e. transition from passive to active state, may thus beachieved by movement of lancet shield 110 towards closed position just past the dead-center position. The lancet shield 110 then enters the closed position, or is in an activestate from which it will automatically enter the closed position and thereby protect thelancet 210 from accidental contact when not hindered by any foreign object, such as thefinger of a user.

A user may typically use a lancet assembly 100, comprising a mounted orintegrated lancet 210, in accordance with a three step procedure, as exemplified for thefollowing medical application: (i) the lancet shield 110 is in open position and passivestate when the user pricks or penetrates the skin of a patient with the lancet 210, (ii) theuser activates the safety function by manually moving the lancet shield 110 passed thedead-center position, for example with a finger of the hand which is holding the body221, whereby the lancet shield 110 is set in an active state, (iii) the lancet shield 110automatically enters the closed position to protect the lancet 210 from accidentalcontact.

According to one embodiment, the lancet assembly may be provided with apress member 125. Such a press member 125 may be an extension of the needle shield 110 or a suitable part of the hinge structure 120, such as the tension member 124. Such a press member 125 may facilitating a user°s control of the spatial orientation of thelancet shield 110 in relation to the body 221, by transferring any movement applied bythe user thereon to the lancet shield 110. Preferably, the press member is arranged suchthat it may easily be controlled by e. g. a finger of the same hand which is holding thebody 221 during use. Hence, by employment of a press member 125, a user may easilyactivate the safety function by moving the lancet shield 110 passed the dead-centerposition, whereby the lancet shield 110 automatically enters the closed position. lnembodiments where the lancet assembly 100 is in a default active state, i.e. in an activestate during pricking or penetration of skin with the lancet 210, the press member 125may be actively hold by the user during the penetration to prevent transition to a closedposition. By releasing the press member 125, the lancet shield 110 will thenautomatically enter the closed position and protect the lancet 210. This is a highlyadvantageous from a safety perspective since the activation of the safety mechanismthereby is achieved by a “passive action” (release of the press member 125) in contrastto the corresponding “active action” (movement past the dead-center position), which isnecessary for activation of the safety mechanism in the passive state. The surface of thepress member 125 may, partly or fully, be roughed or provided with ribs or the likewhich may increase the friction between the surface and the top of a finger.

According to one embodiment, the lancet assembly 100 may comprise a shieldconnective element 117 and/or a body connective element 118, for forrr1ing an interfacebetween the lancet shield 110 and the body 221 in the closed position. The shieldconnective element 117 and/or the body connective element 118 may be adapted suchthat they, together or alone, provide an interface without any opening, or with a minimalopening, between the lancet shield 110 and the body 221, in the closed position. Thepossibility of entrance of any foreign object into the inner space of the lancet shield 110,or exit of anything contained therein, such as blood residues, is thereby minimized. Theshield connective element 117 may, for example, be a protrusion or extension thatextends from the side of the lancet shield 110, which side comprise an opening forallowing entry of at least the sharp end of the lancet 210, or a recess or groove at thatside. The body connective element 118 may, for example, be a protrusion or extensionthat extends from the front end of the body 221, or a recess or groove at that side. Whenthe shield connective element 117 is, for example, a protrusion or extension, it maymate with the body connective element 118, in form of a corresponding recess orgroove. When the shield connective element 117 is, for example, a recess or groove, it may mate with the body connective element 118, in form of a corresponding protrusion or extension. Mating, in the closed position, between the shield connective element 117and the body connective element 118 preferably provides an interface without anyopening, or with a rr1inimal opening only, between the lancet shield 110 and the body221. The shield connective element 117 and/or the body connective element 118 maycomprise or be constituted by other types of well known connective elements,including, for example two planar surfaces with a sufficiently large contact area, a softmaterial such as a polymeric foam, or any other suitable material that forms a largecontact area with an opposing body by readily accommodating irregularities in thelatter, adhesive tape or an adhesive film. Advantages of mating of the shield connectiveelement 117 and the body connective element 118 in the form of recess/protrusion-mating, include a rninimized risk for unintentional opening of the lancet shield 110,when being in the closed position, due to the extra force needed to disconnect the matedrecess/protrusion, as compared to the case without any such shield connective elements117 and the body connective elements 118. Employment of any type of adhesivematerial as connective element, or part of the connective elements, leads to the sameadvantage.

According to one embodiment, the lancet 210 may be selected from the groupconsisting of puncture lancets and incision lancets. The lancet may be made of a metalor suitable alloy, such as metals or alloys commonly used for lancets, needles or othersharp medical instruments. The lancet may also be made of a suitable polymeric, plasticor ceramic material, such as a suitable polymeric, plastic or ceramic material commonlyused in medical art for penetrating or cutting skin or tissue.

According to one embodiment, the lancet 210 may be press-fitted, insert-molded or glued to the body 221, such as in a groove, hole or bore at the front end ofthe body 221.

According to one embodiment, the lancet 210 may be integrated with the body221. The lancet 210 and the body 221, and optionally any other part of the lancetassembly 100, may for example be of the same material and monolithically formed as asingle article when produced, such as produced by molding. Suitable materials for anintegrated lancet 210 and body 221 allow production of a sharp point or edge that maypenetrate skin and is well known to the skilled person. Advantages of an integratedlancet 210 and body 221 include a reduced cost of production as compared to the casewhen these parts have to be mounted together after individual production.

According to one embodiment, the outer surface of the lancet shield 110 may have a smooth or rounded shape. Suitable smooth or rounded shapes include, for ll example, spherical or elliptic shapes, triangular or cubic shapes With cut of corners andedges, or any other well known suitable shape Which is hard to get a grip on.Advantages of such smooth or rounded shapes include a reduced risk of unintentionaltransition from the closed position to the open position, where the sharp end of thelancet 210 is exposed, by a contact between the user or a foreign object and the outerexposed surface of the lancet shield 110.

According to one embodiment, the in the closed position outer exposed surfaceof the lancet shield 110, may be provide with one or several elements that facilitates themovement on skin. lt may, for example, be curved such that there are no edges, or atleast no or a minimum of sharp edges, that contact the skin upon touching it. Thissurface may preferably be adapted such that the friction between the same and skin islow. It may, for example, be well polished or made of a low-friction material.Advantages include a reduced risk of unintentional transition from the closed position tothe open position, where the sharp end of the lancet 210 is exposed, by a contactbetween the user or a foreign object and the outer exposed surface of the lancet shield1 10.

According to one embodiment, the lancet shield 110 may be provided withadditional elements for improvement of e. g. the safety, appearance or handling of thelancet assembly 100. Such elements include, for example, integrated ribs forimprovement of the capability to resist external forces and coloration for indication ofe.g. size of the lancet 210.

According to one embodiment, the lancet shield 110 may be provided with anabsorbing pad located in the inner space thereof for the absorption of blood residues onthe lancet 210 or the front end of the body 221. Such blood residues may contarr1inatethe lancet assembly 100 after use. Suitable materials for such an absorbing pad include,for example, cotton, cellulose or cherr1ically modified cellulose, or any other knownmaterial suitable for absorbing blood or any other similar biological ﬂuid. Advantagesof an absorbing pad include a minimized risk for such blood residues to leak out from adisposed lancet assembly 100.

The body 221 may comprise means for securely fitting to and mating with alancet 210. Such means may be constituted by a groove or bore extending through a partof the front end of the body 221. The inner surface of the groove or bore may haveessentially the same shape as the outer surface of the lancet 210 at a section thereof ontowhich the lancet 210 is fitted. The spatial extension, such as the diameter, of the groove or bore may be slightly less than the corresponding spatial extension of the lancet 210. 12 When fitted to the body 221, by e. g. press fitting, the lancet 210 is thereby securelyfitted thereon and may not be moved relative the body 221. The optimal difference inspatial extension of the groove or bore and the lancet 210, for e. g. secure press fitting, iswell known to the one skilled in the art.

According to one embodiment, the lancet 210 may be securely fitted to thebody 221 by press-fitting. The lancet 210 is thereby securely fitted in, for example, agroove or bore of the body 221. Advantages of a press-fitted lancet 210 include thelower cost of production in comparison to other means of connection.

According to one embodiment, the lancet 210 may be securely fitted to thebody 221 by gluing.

According to one embodiment, the lancet 210 may be securely fitted to thebody 221 by welding.

According to one embodiment, the lancet 210 may be integrated with the body221. The lancet 210 and the body 221 are thus parts of the same monolithically formedarticle.

According to one embodiment, the body 221 may comprise a groove or a borearranged substantially along or near the central axis of the body at an end of the body221, for mating with the lancet 210. Such a groove may have an open end facing theinner space of the lancet shield 110 in the closed position, and a closed end facing awayfrom the inner space of the lancet shield 110 in the closed position. Mounting of thelancet 210 from the front end of the body 221 is thereby enabled. Advantageously, theclosed end n1inimizes the risk of accidently pushing the lancet 210 further into the body221, such as in production of the lancet assembly 100, whereby the sharp end of thelancet 210 might otherwise be inaccessible for use.

Such a bore may have an open end facing the inner space of the lancet shield110 in the closed position, and an open end facing away from the inner space of thelancet shield 110 in the closed position. Mounting of the lancet 210 from either of thefront end and the back end of the body 221 is thereby enabled.

The hinge structure 120 may be so arranged that it forces the lancet shield 110with a force to one of either of two oppositely-disposed positions, the open position orthe closed position. In the closed position, the lancet 210 is protected by the lancetshield 110. In the open position, the lancet 210 is exposed and may be used to penetratethe skin of a patient. When a greater opposite external force is applied, such as the forceapplied by a user, to the lancet shield 110 or any extension thereof, in a direction from the open position and past the dead-center position, the hinge structure 120 snaps the 13 lancet shield 110 into the closed position, just after it has passed the dead-centerposition.

Above described dead-center toggle function of the hinge structure 120 may beachieved by various assemblies, such as for example spring loaded hinges or other“snap” mechanisms, well known in the art.

The hinge structure 120 may comprise one or several toggle joints 121 and oneor several tension members 124. A dead-center toggle function of the hinge structure120 may thus be achieved. The one or several toggle joints 121 may be connected tospatially closely related portions of the lancet shield 110 and the body 221. Each togglejoint 121 may preferably consist of two relatively rigid leg portions 122 that areattached together at their ends in their longitudinal direction at a toggle joint knee 123.The toggle joint knee 123 may be flexible such that the leg portions 122 may be movedrelative each other to allow movement of the lancet shield 110 between closed and openposition. The one or several tension members 124 may be able to resiliently stretch orexpand to a lirr1ited amount. When stretched or expanded, a tension member 124 iselongated and strives to retain its original shorter length. Hence, a stretched or expandedtension member 124 will impose a force in the direction opposite the direction of thestretching or expansion. The point of attachment of a tension member 124 at the lancetshield 110 is preferable above the point of attachment of the corresponding toggle joint121. The point of attachment of a tension member 124 at the body 221 is preferablebelow the point of attachment of the corresponding toggle joint 121. A tension member124 may preferably be mounted close to the corresponding toggle joint 121, butpreferably not so close that it may touch any part of the latter, whereby the intendedfunction of the hinge structure 120 may otherwise be comprorr1ised. The dead-centerposition of the hinge structure 120 corresponds to a specific angle, the dead-centerangle, between the longitudinal extension of the body 221 and the longitudinalextension of the lancet shield 110. ln the closed position, the angle between thelongitudinal extension of the body 221 and the longitudinal extension of the lancetshield 110 is about 0°, as illustrated in e. g. Fig. 5. In the open position, the anglebetween the longitudinal extension of the body 221 and the longitudinal extension of thelancet shield 110 may be about 180° or more, as illustrated in e. g. Fig. 4A and 4B. lf theangle between the longitudinal extension of the body 221 and the longitudinal extensionof the lancet shield 110 is less than the dead-center angle, the lancet shield 110 strivestoward the closed position. lf this angle is greater than the dead-center angle, the lancet shield 110 strives toward the open position. The dead-center angle may be in the range 14 of 45 to 200°, such as 45 to 175° or 80 to 170° or 80 to 120° or 90 to 110°, or about 90°,such as 85 to 95°, or about 180°, such as 175 to 190 °. The one skilled in the art mayeasily configure the hinge structure 120 to achieve a desired dead-center angle. Forexample, longer leg portions 122 will result in an increase of the dead-center angle andmoving the point of attachment of a tension member 124 further above the point ofattachment of the corresponding toggle joint 121 will result in a decrease of the dead-center angle.

According to one embodiment, the hinge structure 120 may comprise at leastone, such as one, hinge and at least one, such as one, spring.

According to one embodiment, the hinge structure 120 may comprise at leastone toggle joint 121 and at least one tension member 124. Each toggle joint 121 andeach tension member 124 may be connected to the lancet shield 110 and to the body221.

According to one embodiment, the hinge structure 120 may comprise onetoggle joint 121 and one tension member 124, which may be placed in close proxirnity.

According to one embodiment, the hinge structure 120 may comprise twotoggle joints 121 and one tension member 124, which may be placed in close proxirnity.The tension member 124 may be placed between the two toggle joints 121.

According to one embodiment, the hinge structure 120 may comprise onetension member 124 which is V-shaped and extending outwards so that it can be easilypressed on by a user. The distal end, i.e. the point of the V of the V-shaped tensionmember 124, may be shaped as or comprise a press member 125. The user may thenadvantageously activate the safety mechanism by pressing on the tension member 124or the press member 125 thereof with, for example, a finger of the same hand which isholding the body 221. The press member 125 is preferably configured, as known in theart, to be easily reached be the user and to be pressed on with a finger. Its outer surface,which the user presses on, may be planar or slightly convex or concave. lt may beequipped with groves or elevations. Such groves or elevations n1inin1ize the risk of thefinger slipping of the press member 125 when the user is pushing it.

According to one embodiment, the dead-center position may be a position inwhich the angle between the longitudinal extension of the body 221 and the longitudinalextension of the lancet shield 110 is in the range of 45 to 175°.

According to one embodiment, the dead-center position may be a position inwhich the angle between the longitudinal extension of the body 221 and the longitudinal extension of the lancet shield 110 is in the range of 175 to 190°. Such a dead-center angle advantageously makes the transition to the closed position automatic if the lancetassembly 100 is adapted such that the lancet shield 110 can only be opened to an anglewhich is less than such a dead-center angle. Such a restricted opening can be achievedby e. g. a design in which the press member 125 hinders further opening by beingmechanically restricted by a contact with the body 221.

The lancet assembly 100 may comprise a suitable locking mechanism, whichlocks the lancet shield 110 in the closed position so that it may not, or only with greatdifficulty, be returned to the open position. The force applied by the hinge structure 120may, in collaboration with the locking mechanism of the lancet assembly 100, thus lockthe lancet shield 110 in the closed position without the need of any applied externalforce. In embodiments where the lancet assembly 100 is provided with a lockingmechanism, the hinge structure 120 is preferably arranged such that it forces the lancetshield 110 into the closed position with a force greater than the force needed for thelocking mechanism of the lancet assembly 100 to lock the lancet shield 110 in theclosed position. The locking mechanism of the lancet assembly 100 may comprise oneor several locking elements, i.e. locking means, such as e.g. resilient hooks extendingfrom either the lancet shield 110 or the body 221, that lockingly engages withcorresponding recesses of the body 221 or the lancet shield 110, respectively, in theclosed position, or any other suitable locking element known in the art. The lancetshield 110 may thus not be retumed to the open position, which is beneficial for thesafety of the lancet assembly 100.

The force, kinetic energy or momentum provided by the hinge structure 120 asit moves the lancet shield 110 into the closed position may be sufficient to activate thelocking mechanism. The locking mechanism may be, for example, a part of or anextension of the lancet shield 110. It may also be a recess in the lancet shield 110 that acorresponding protrusion connected to e.g. the mounting base 140 mates with in theclosed position.

According to one embodiment, the locking mechanism may comprise one orseveral, such as one or two, locking elements extending from or forming a part of thelancet shield 110. A locking element may be a hooked formed extension of the lancetshield 110. It may be resiliently bended out of its resting state upon initial contact withthe body 221 in the movement towards the closed position. Upon entering the closedposition, a part of the locking element, such as a distal hook-shaped end, may snap intoa corresponding recess of the body 221, or around an edge of the body 221, and therebylock the lancet shield 110 in the closed position. 16 According to one embodiment, the force needed for the lancet shield 110 tolockingly engage with the body 221 may be less that the force by which the lancetshield 110 is being urged towards the closed position when in the active state. Thelancet shield may thus be securely locked in the closed position by the force by whichthe lancet shield 110 is being urged towards the closed position when in the active state.

The lancet assembly 100, or separate parts thereof, may be made of a suitablematerial such as, for example, a thermoplastic, plastic or polymeric material. Suitablematerials for accomplishment of inherent resiliency in e. g. hinge structure 120 orlocking elements are well known in the art. Examples of such suitable materials include,but is not limited to, polypropylene (PP), high-density polyethylene (HDPE), polyamide(PA) and acrylnitrile-butadiene-styrene copolymer (ABS). Preferably, a material such aspolypropylene (PP) may be selected. These materials all allow for manufacturing of thelancet assembly 100 as a monolithically formed single article, which is highly beneficialwith regard to keeping manufacturing costs down. Preferably, the thermoplastic, plasticor polymeric material has a suitable combination, for its intended purpose, of tenacity,rigidity, fatigue resistance, elasticity, and creep deformation resistance. The selection ofa suitable therrnoplastic, plastic or polymeric material may easily be made by the oneskilled in the art. The one skilled in the art may also perform standard experiments inorder to screen a range of therrnoplastic, plastic or polymeric materials, whereby asuitable material may be selected on the basis of the results of such experiments. Themanufacturing of lancet assembly 100 of the invention, may comprise one or severalsteps selected from the group of steps consisting of: provision of a thermoplastic, plasticor polymeric material as starting material for lancet assembly 100; molding or injectionmolding a therrnoplastic, plastic or polymeric material into one monolithically formedlancet assembly 100, which may or may not comprise the lancet 221; and mountinglancet 210 on body 221 by, for example, press-fitting or gluing.

According to one embodiment, the lancet assembly 100 may be made of atherrnoplastic, plastic or polymeric material, as known in the art. An advantage of theuse of a therrnoplastic, plastic or polymeric material for the construction of the lancetassembly 100, in comparison to e.g. metal, is the greater freedom of variation of variousdetails of the same. For example, a plastic lancet assembly 100 may be moreconveniently molded than the corresponding metallic article. Another advantageincludes the possibility to colour-code a plastic lancet assembly 100. Yet anotheradvantage of a plastic or polymeric lancet assembly 100, is the higher chemical inertness and/or resistance, in comparison to e.g. metal, towards e. g. corrosion. Yet 17 another advantage of lancet assembly 100 of the invention, like a plastic or polymericlancet assembly 100, is that it may be molded and produced in one functional piece, i.e.it does not have to be assembled by the combination of more than one separate articlelike other corresponding devices of the prior art. Hence, a reduction in the cost ofproduction is resulting.

According to one embodiment, at least two parts of the lancet assembly 100may constitute different parts of the same monolithically formed single article. Suchparts may be independently selected from the list consisting of the body 221, the lancetshield 110, the press member 125, and the hinge structure 120. Preferably, the body221, the lancet shield 110, the press member 125, and the hinge structure 120 are alldifferent parts of the same monolithically formed single article, such as a single articleproduced by molding.

According to one embodiment, the lancet assembly 100 may be manufacturedby a method comprising a step of molding or injection molding a thermoplastic, plasticor polymeric material.

In the claims, the term “comprises/comprising” does not eXclude the presence of other elements or steps. Furthermore, although individually listed, a plurality of means, elements or method steps may be implemented by e. g. a single unit or processor.

Additionally, although individual features may be included in different claims, thesemay possibly advantageously be combined, and the inclusion in different claims doesnot imply that a combination of features is not feasible and/or advantageous. In LL 77 LL addition, singular references do not eXclude a plurality. The terms a , an", “first”,“second” etc do not preclude a plurality. Reference signs in the claims are providedmerely as a clarifying example and shall not be construed as limiting the scope of the claims in any Way.

Claims

1. A lancet assembly (100) comprising: a body (221) having an elongated shape With a central aXis; a lancet (210) With a sharp end arranged substantially along or parallel to said centralaxis at an end of said body (221); a lancet shield (110), being pivotable from an open position to a closed position, inWhich closed position said lancet shield (110) is intersecting said central aXis, such thatsaid lancet shield (110) may be pivoted from said open position, in Which the innerspace of said lancet shield (110) is separated from said lancet (210), to said closedposition, in Which said inner space of said lancet shield (110) is enclosing the sharp endof said lancet (210) for protecting said lancet (210) from accidental contact; and a hinge structure (120), Wherein said lancet shield (110) is movably connected to saidbody (221) by means of said hinge structure (120) for enabling movement between saidopen and said closed position; and said lancet shield (110) is having a passive state and an active state, said lancet shield (110) being urged towards said closed position When in said active state.

2. The lancet assembly (100) according to claim 1, Wherein said lancet (210) is eXtending from an end of said body (221), Which end is the endbeing closest to said lancet shield (110); said lancet (210) is selected from the group consisting of puncture lancets and incisionlancets; and said lancet (210) is made of metal or a polymeric material.

3. The lancet assembly according to claim 1 or 2, Wherein said lancet (210) is press-fitted, insert-molded or glued to said body (221), or Wherein said lancet (210) and said body (221) constitute different parts of the same monolithically formed single article. 19

4. The lancet assembly (100) according to any one of the preceding claims, wherein saidbody (221) comprises a groove or a bore arranged substantially along said central aXis atan end of said body (221) for mating with said lancet (210); said groove having an open end facing said inner space of said lancet shield (110) insaid closed position, and a closed end facing away from said inner space of said lancetshield (110) in said closed position, for enabling mounting of said lancet (210) from thefront end of said body (221); and said bore having an open end facing said inner space of said lancet shield (110) in saidclosed position, and an open end facing away from said inner space of said lancet shield(110) in said closed position, for enabling mounting of said lancet (210) from either of the front end and the back end of said body (221).

5. The lancet assembly (100) according to any one of the preceding claims, wherein saidhinge structure (120) has a dead-center position, such that said lancet shield (110) is insaid passive state whereby it is being forced by said hinge structure (120) from a firstposition into said open position if said dead-center position has to be passed to reachsaid closed position, and in said active state whereby it is being forced by said hingestructure (120) from a second position into said closed position if said dead-center position has to be passed to reach said open position.

6. The lancet assembly (100) according to any one of the preceding claims, wherein saidhinge structure (120) is comprising at least one toggle joint (121) and at least onetension member (124), said at least one toggle joint (121) and at least one tension member (124) being connected to said lancet shield (110) and to said body (221).

7. The lancet assembly (100) according to claim 5 or 6, wherein said dead-centerposition is a position in which the angle between the longitudinal extension of the body(221) and the longitudinal extension of the lancet shield (110) is in the range of 45 to175°.

8. The lancet assembly (100) according to claim 5 or 6, wherein said dead-centerposition is a position in which the angle between the longitudinal extension of the body(221) and the longitudinal extension of the lancet shield (110) is in the range of 175 to190°.

9. The lancet assembly (100) according to any one of the preceding claims, furthercomprising a press member (125), for facilitating a user°s control of the spatial orientation of said lancet shield (110) in relation to said body (221).

10. The lancet assembly (100) according to any one of the preceding claims, furthercomprising a shield connective element (117) and a body connective element (118), forconstituting an interface between said lancet shield (110) and said body (221) in the closed position.

11. The lancet assembly (100) according to any one of the preceding claims, whereinthe outer surface of said lancet shield (110) has a smooth or rounded shape, forn1inimizing the risk of unintentional transition from said closed position to said open position.

12. The lancet assembly (100) according to any one of the preceding claims , wherein atleast two parts constitute different parts of the same monolithically formed singlearticle, said parts being independently selected from the list consisting of said body (221), said lancet shield (110) and said hinge structure (120).

13. The lancet assembly (100) according to claim 9, wherein at least two parts constitutedifferent parts of the same monolithically formed single article, said parts beingindependently selected from the list consisting of said body (221), said lancet shield(110), said hinge structure (120) and said press member (125).

14. The lancet assembly (100) according to any one of the preceding claims, further 21 comprising locking means, said locking means enabling said lancet shield (110) to lockingly engage with said body (221).

15. The lancet assembly (100) according to claim 14, wherein the force needed for saidlancet shield (110) to lockingly engage with said body (221) is less that the force bywhich said lancet shield (110) is being urged towards said closed position when in saidactive state, for allowing locking of said lancet shield (110) in said closed position bythe force by which said lancet shield (110) is being urged towards said closed position when in said active state.

16. A method for the manufacturing of a lancet assembly (100) according to any one ofthe preceding claims, comprising the step of molding or injection molding a therrnoplastic, plastic or polymeric material.