WO2013130008A2

WO2013130008A2 - Lancet assembly

Info

Publication number: WO2013130008A2
Application number: PCT/SE2013/050187
Authority: WO
Inventors: Robert Domonkos; Lennart Holm
Original assignee: Vigmed Ab
Priority date: 2012-03-02
Filing date: 2013-03-01
Publication date: 2013-09-06
Also published as: SE537459C2; WO2013130008A3; SE1250202A1

Abstract

The present invention discloses a lancet assembly (100) for protecting a lancet (210) from accidental contact, comprising: a body (221) having an elongated shape with a central axis; a lancet shield (110), being pivotable from an open position to a closed position, 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 the inner space of the lancet shield (110) is separated from the lancet (210), to the closed position, in which the inner space of said lancet shield (110) is enclosing the sharp end of the lancet (210); and a hinge structure (120); wherein the lancet shield (110) is movably connected to the body (221) by means of the hinge structure (120) for enabling movement between the open and the closed position; and the lancet shield (110) is having a passive state and an active state, the lancet shield (110) being urged towards the closed position when in the active state. Methods of manufacturing the lancet assembly (100) are also disclosed.

Description

LANCET ASSEMBLY TECHNICAL FIELD

The 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 of a patient, thereby causing a minor amount of blood to leak out for sampling. The existing lancets can be divided into puncture lancets and incision lancets according to the primary penetrating part of the device. The puncture lancet acts by means of acupuncture by a short needle or needle like extension. The incision lancet acts by means of blade incision by a sharp blade. An unprotected lancet constitutes, after its use for penetrating the skin, a serious health hazard due to the fact that it may be contaminated with infectious agents originating from the patient's blood, in

combination with the lancet's inherent ability to easily penetrate skin. Hence, the medical personnel who are handling the used lancet may acquire the corresponding disease, e.g. HIV or hepatitis, if by accident contacting it with their skin. In order to circumvent or alleviate the health hazards associated with such a used lancet, there has been much effort devoted to the development of various kinds of medical devices, in which the lancet is enclosed and protected after use.

A majority 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 the lancet is only briefly exposed upon the penetration of the skin. The latter type is almost invariably 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 is thereafter immediately and automatically returned and protected by the housing, as disclosed in e.g. US 4,449,529 and US 2003/0050656.

US 4,449,529 describes an automatic retractable lancet assembly comprising a sharp-pointed lancet and a housing. An actuating mechanism releases the lancet for outward movement from the housing. Subsequently, the lancet is automatically retracted 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, structured to move between an actuated and an un-actuated orientation. Movement into the actuated orientation results in release between a retention member and an engagement hub, whereby the lancet is moved into the piercing orientation.

Disadvantages of automatic spring loaded devices such as the ones described in

US 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 a high cost of production.

Additional related devices, designed to protect medicinal personnel from undesired contact with sharp objects that may be contaminated with infectious agents originating from a patient's blood, include injection needle protectors. Such injection needle protectors commonly rely on an elongated shield, which is pivotally movable to enclose and protect the needle.

US 5,242,417 describes a syringe with an integral needle guard that pivots about a main living hinge on the side of the syringe near the base of the needle. The user may initiate the rotation of the guard towards the needle. Beyond a certain angle, a tension spring pulls the guard into a position surrounding the needle.

A disadvantage of the needle guard of US 5,242,417 and similar devices of the prior art, include the risk of accidently pulling the guard out of the position in which it is surrounding the needle. This risk may be minimized by the employment of a locking mechanism that secures the guard in a position surrounding the needle. Such a locking mechanism may be a flap, equal to or similar to the one described in US 5,242,417, that snaps around the shaft of the needle. Such a flap may, however, not be applied to the protection of a lancet since its longitudinal extension is limited, or its shape is in the form of a blade. Other locking mechanisms of needle guards involve locking to the base of the needle or adjacent parts thereof. However, all locking mechanisms of needle guards of the prior art generally require a manual push of the pivoting lancet guard to overcome the resistance of the locking mechanism. This force needs to be relatively high, which increases the risk of the user not to lock the needle guard in e.g. a stressful situation. The needle guard may thus be left unlocked which results in a potential health hazard. In addition, the needle guard of US 5,242,417 and similar devices of the prior art, invariably leaves at least the side of the needle exposed through the slot through which 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 disadvantages mentioned above, to provide an improved lancet assembly which may be produced at a low 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 which may be employed equally well for lancets in the form of a short needle, a needle like extension or a sharp blade.

It is yet another object of the present invention, to provide a lancet assembly which 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 elongated shape with a central axis; a lancet with a sharp end arranged substantially along or parallel to the central axis at an end of the body; a lancet shield, being pivotable from an open position to a closed position, in which closed position the lancet shield is intersecting the central axis, such that the lancet shield may be pivoted from the open position, in which the inner space of the lancet shield is separated from the lancet, to the closed position, in which the inner space of the lancet shield is enclosing the sharp end of the lancet for protecting the lancet from accidental contact; and a hinge structure; wherein the lancet shield is movably connected to the body by means of the hinge structure for enabling movement between the open and the closed position; and the lancet shield is having a passive state and an active state, the lancet shield being urged towards the closed position when in the active state.

According to another aspect of the present invention, the lancet may extend from an end of the body, which end is the end being closest to the lancet shield, wherein the 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 different parts of the same monolithically formed single article.

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

According to yet another aspect of the present invention, the hinge structure has a dead-center position, such that the lancet shield is in the passive state whereby it is being forced by the hinge structure from a first position into the open position if the dead-center position has to be passed to reach the closed position, and in the active state whereby it is being forced by the hinge structure from a second position into the closed position 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 is comprising at least one toggle joint and at least one tension member, the at least one toggle joint and at least one tension member being connected to the lancet shield and to the body .

According to yet another aspect of the present invention, the dead-center position is a position in which the angle between the longitudinal extension of the body and the longitudinal extension of the lancet shield is in the range of 45 to 175°.

According to yet another aspect of the present invention, the dead-center position is a position in which the angle between the longitudinal extension of the body and the longitudinal extension of the lancet shield is in the range of 175 to 190°.

According to yet another aspect of the present invention, the lancet assembly may further comprise a press member, for facilitating a user's control of the spatial orientation of the lancet shield in relation to the body.

According to yet another aspect of the present invention, the lancet assembly may further comprise a shield connective element and a body connective element, for constituting 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 of the lancet shield has a smooth or rounded shape, for minimizing the risk of

unintentional transition from the closed position to the open position.

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, the lancet 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, the lancet shield, the hinge structure and the press member .

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

According to yet another aspect of the present invention, the force needed for the lancet shield to lockingly engage with the body is less that the force by which the lancet shield is being urged towards the closed position when in the active state, for allowing locking of the lancet shield in the closed position by the force by which the lancet 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 the manufacturing of a lancet assembly is provided, comprising the step of molding or injection molding a thermoplastic, 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 is capable will be apparent and elucidated from the following description of non-limiting embodiments of the present invention, reference being made to the accompanying drawings, in which

Fig. 1 A and IB are views from the side (A: non-cross sectional; B: cross- sectional) of a lancet assembly in the open position, with an angle between the longitudinal extension of the body and the longitudinal extension of the lancet shield of about 180°, with a lancet mounted in a groove having an open end facing forwards and a closed end facing in the opposite direction, with a press member which is reachable by a finger of a user, and with a shield connective element in form of a circular extension adapted to mate with the corresponding body connective element in form of a circular grove on the front side of the body, according to one embodiment of the invention;

Fig. 2 A and 2B are views from the forwards facing side of the lancet assembly of Fig. 1 in the open position (A) and in the closed position (B), displaying a triangular shape body and a triangular shaped lancet shield with smooth rounded of edges, according to one embodiment;

Fig. 3 A and 3B are views from the side (A: non-cross sectional; B: cross- sectional) of the lancet assembly of Fig. 1 in the closed position, with an angle between the longitudinal extension of the body and the longitudinal extension of the lancet shield of about 0°, according to one embodiment;

Fig. 4A and 4B are cross-sectional views from the side of a lancet assembly in the open position, with a lancet not mounted (A) and mounted (B) in a bore having one open end facing forwards and one open end facing in the opposite direction, and with a spherically shaped lancet shield, according to one embodiment; and

Fig. 5 is a cross-sectional view of the lancet assembly of Fig. 4 in the closed position, 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 below with reference to the accompanying drawings in order for those skilled in the art to be able to carry out the invention. The invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The embodiments do not limit the invention, but the invention is only limited by the appended patent claims. Furthermore, the terminology used in the detailed description of the particular embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention.

Embodiments of the present invention will now be described below with reference to Figs.1 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 opening

117 shield connective element

118 body connective element

120 hinge structure

121 toggle joint

122 leg portion

123 toggle joint knee

124 tension member

125 press member lancet

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 for pricking 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 a body 221, a spring loaded lancet shield 110, and means that typically comprise a hinge structure 120 for connecting the lancet shield 110 to the body 221. The body 221 may have an elongated shape, and is preferably adapted such that it can be securely and easily held in one hand during use. The lancet 210 is securely arranged at the front end of the body 221 with its sharp end extending forwards there from. The longitudinal extension of the lancet 210 may be parallel to or intersect with the longitudinal extension of the body 221. Any orientation of the lancet 210, as known to the skilled person, which permits a user to penetrate the skin of a patient when holding the body 221 is, however, possible. The lancet shield 110 is a rigid container or cup shaped structure with one side, which may be spherical or any other suitable shape which is preferably smooth without sharp edges, for constituting a protecting barrier, and another oppositely arranged side, which comprise an opening for allowing entry of at least the sharp end of the lancet 210. The lancet shield 110 is arranged near the front end of the body 221, such as by means of a hinge structure 120, or any other suitable means for connection, 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 closely located to a resilient part, such as a spring or a tension member 124. The lancet shield 110 may, by means of e.g. a hinge structure 120, thus pivot between an open position and a closed position. In the open position, the lancet shield 110 is positioned remote from the front end of the body 221 and the sharp end of the lancet 210, such as being located away from the projection of the front end of the body 221, i.e. not intersecting with the longitudinal extension, i.e. the central axis, of the body 221. The lancet 210 is then separated from the inner space of the lancet shield 110, whereby it may be used to penetrate the skin of a patient. In the closed position, the lancet shield 110 is positioned such that it intersects with the longitudinal extension, i.e. the central axis, of the body 221. The inner space of the lancet shield 110 is thereby enclosing, at least, the sharp end of 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 maximize the enclosure of the sharp end of the lancet 210. Such a contact may be accomplished by the mating interaction between a shield connective element 117 and a body connective element 118. The shield connective element 117 and/or the body connective element 118 may further comprise locking means for enabling the lancet shield 110 to lockingly engage with 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 toggle function. This function is providing the lancet shield 110 and the suitable means for connection, 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 suitable means for connection, e.g. hinge structure 120, towards the closed position. In the passive state, the lancet shield 110 is urged by a force provided by the suitable means for connection, e.g. hinge structure 120, towards an open position. The transition in either direction, between the active and the passive state, corresponds to a "dead-center position", which in turn corresponds to a dead-center angle, which is the angle between the longitudinal extension of the body 221 and the longitudinal extension of the lancet shield 110 at the dead-center position. The user's activation of the safety mechanism of the lancet assembly 100, i.e. transition from passive to active state, may thus be achieved 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 active state from which it will automatically enter the closed position and thereby protect the lancet 210 from accidental contact when not hindered by any foreign object, such as the finger of a user.

A user may typically use a lancet assembly 100, comprising a mounted or integrated lancet 210, in accordance with a three step procedure, as exemplified for the following medical application: (i) the lancet shield 110 is in open position and passive state when the user pricks or penetrates the skin of a patient with the lancet 210, (ii) the user activates the safety function by manually moving the lancet shield 110 passed the dead-center position, for example with a finger of the hand which is holding the body 221, whereby the lancet shield 110 is set in an active state, (iii) the lancet shield 110 automatically enters the closed position to protect the lancet 210 from accidental contact.

According to one embodiment, the lancet assembly may be provided with a press 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 the lancet shield 110 in relation to the body 221, by transferring any movement applied by the user thereon to the lancet shield 110. Preferably, the press member is arranged such that it may easily be controlled by e.g. a finger of the same hand which is holding the body 221 during use. Hence, by employment of a press member 125, a user may easily activate the safety function by moving the lancet shield 110 passed the dead-center position, whereby the lancet shield 1 10 automatically enters the closed position. In embodiments where the lancet assembly 100 is in a default active state, i.e. in an active state during pricking or penetration of skin with the lancet 210, the press member 125 may be actively hold by the user during the penetration to prevent transition to a closed position. By releasing the press member 125, the lancet shield 110 will then

automatically enter the closed position and protect the lancet 210. This is a highly advantageous from a safety perspective since the activation of the safety mechanism thereby is achieved by a "passive action" (release of the press member 125) in contrast to the corresponding "active action" (movement past the dead-center position), which is necessary for activation of the safety mechanism in the passive state. The surface of the press member 125 may, partly or fully, be roughed or provided with ribs or the like which may increase the friction between the surface and the top of a finger.

According to one embodiment, the lancet assembly 100 may comprise a shield connective element 117 and/or a body connective element 118, for forming an interface between the lancet shield 110 and the body 221 in the closed position. The shield connective element 117 and/or the body connective element 118 may be adapted such that they, together or alone, provide an interface without any opening, or with a minimal opening, between the lancet shield 110 and the body 221, in the closed position. The possibility 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. The shield connective element 117 may, for example, be a protrusion or extension that extends from the side of the lancet shield 110, which side comprise an opening for allowing entry of at least the sharp end of the lancet 210, or a recess or groove at that side. The body connective element 118 may, for example, be a protrusion or extension that extends from the front end of the body 221, or a recess or groove at that side. When the shield connective element 117 is, for example, a protrusion or extension, it may mate with the body connective element 118, in form of a corresponding recess or groove. 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 117 and the body connective element 118 preferably provides an interface without any opening, or with a minimal opening only, between the lancet shield 110 and the body 221. The shield connective element 117 and/or the body connective element 118 may comprise or be constituted by other types of well known connective elements, including, for example two planar surfaces with a sufficiently large contact area, a soft material such as a polymeric foam, or any other suitable material that forms a large contact area with an opposing body by readily accommodating irregularities in the latter, adhesive tape or an adhesive film. Advantages of mating of the shield connective element 117 and the body connective element 118 in the form of recess/protrusion- mating, include a minimized risk for unintentional opening of the lancet shield 110, when being in the closed position, due to the extra force needed to disconnect the mated recess/protrusion, as compared to the case without any such shield connective elements 117 and the body connective elements 118. Employment of any type of adhesive material as connective element, or part of the connective elements, leads to the same advantage.

According to one embodiment, the lancet 210 may be selected from the group consisting of puncture lancets and incision lancets. The lancet may be made of a metal or suitable alloy, such as metals or alloys commonly used for lancets, needles or other sharp medical instruments. The lancet may also be made of a suitable polymeric, plastic or ceramic material, such as a suitable polymeric, plastic or ceramic material commonly used 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 of the body 221.

According to one embodiment, the lancet 210 may be integrated with the body 221. The lancet 210 and the body 221, and optionally any other part of the lancet assembly 100, may for example be of the same material and monolithically formed as a single article when produced, such as produced by molding. Suitable materials for an integrated lancet 210 and body 221 allow production of a sharp point or edge that may penetrate skin and is well known to the skilled person. Advantages of an integrated lancet 210 and body 221 include a reduced cost of production as compared to the case when 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 example, spherical or elliptic shapes, triangular or cubic shapes with cut of corners and edges, 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 unintentional transition from the closed position to the open position, where the sharp end of the lancet 210 is exposed, by a contact between the user or a foreign object and the outer exposed surface of the lancet shield 110.

According to one embodiment, the in the closed position outer exposed surface of the lancet shield 110, may be provide with one or several elements that facilitates the movement on skin. It may, for example, be curved such that there are no edges, or at least no or a minimum of sharp edges, that contact the skin upon touching it. This surface may preferably be adapted such that the friction between the same and skin is low. 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 to the open position, where the sharp end of the lancet 210 is exposed, by a contact between the user or a foreign object and the outer exposed surface of the lancet shield 110.

According to one embodiment, the lancet shield 110 may be provided with additional elements for improvement of e.g. the safety, appearance or handling of the lancet assembly 100. Such elements include, for example, integrated ribs for

improvement of the capability to resist external forces and coloration for indication of e.g. size of the lancet 210.

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

The body 221 may comprise means for securely fitting to and mating with a lancet 210. Such means may be constituted by a groove or bore extending through a part of the front end of the body 221. The inner surface of the groove or bore may have essentially the same shape as the outer surface of the lancet 210 at a section thereof onto which 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. When fitted to the body 221, by e.g. press fitting, the lancet 210 is thereby securely fitted thereon and may not be moved relative the body 221. The optimal difference in spatial extension of the groove or bore and the lancet 210, for e.g. secure press fitting, is well known to the one skilled in the art.

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

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

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

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

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

Such a bore may have an open end facing the inner space of the lancet shield

110 in the closed position, and an open end facing away from the inner space of the lancet shield 110 in the closed position. Mounting of the lancet 210 from either of the front 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 110 with a force to one of either of two oppositely-disposed positions, the open position or the closed position. In the closed position, the lancet 210 is protected by the lancet shield 110. In the open position, the lancet 210 is exposed and may be used to penetrate the skin of a patient. When a greater opposite external force is applied, such as the force applied 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 lancet shield 110 into the closed position, just after it has passed the dead-center position.

Above described dead-center toggle function of the hinge structure 120 may be achieved 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 one or several tension members 124. A dead-center toggle function of the hinge structure 120 may thus be achieved. The one or several toggle joints 121 may be connected to spatially closely related portions of the lancet shield 110 and the body 221. Each toggle joint 121 may preferably consist of two relatively rigid leg portions 122 that are attached 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 moved relative each other to allow movement of the lancet shield 110 between closed and open position. The one or several tension members 124 may be able to resiliently stretch or expand to a limited amount. When stretched or expanded, a tension member 124 is elongated and strives to retain its original shorter length. Hence, a stretched or expanded tension member 124 will impose a force in the direction opposite the direction of the stretching or expansion. The point of attachment of a tension member 124 at the lancet shield 110 is preferable above the point of attachment of the corresponding toggle joint 121. The point of attachment of a tension member 124 at the body 221 is preferable below the point of attachment of the corresponding toggle joint 121. A tension member 124 may preferably be mounted close to the corresponding toggle joint 121, but preferably not so close that it may touch any part of the latter, whereby the intended function of the hinge structure 120 may otherwise be compromised. The dead-center position of the hinge structure 120 corresponds to a specific angle, the dead-center angle, between the longitudinal extension of the body 221 and the longitudinal extension of the lancet shield 110. In the closed position, the angle between the longitudinal extension of the body 221 and the longitudinal extension of the lancet shield 110 is about 0°, as illustrated in e.g. Fig. 5. In the open position, the angle between the longitudinal extension of the body 221 and the longitudinal extension of the lancet shield 110 may be about 180° or more, as illustrated in e.g. Fig. 4A and 4B. If the angle between the longitudinal extension of the body 221 and the longitudinal extension of the lancet shield 110 is less than the dead-center angle, the lancet shield 110 strives toward the closed position. If 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 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 may easily configure the hinge structure 120 to achieve a desired dead-center angle. For example, longer leg portions 122 will result in an increase of the dead-center angle and moving the point of attachment of a tension member 124 further above the point of attachment 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 least one, such as one, hinge and at least one, such as one, spring.

According to one embodiment, the hinge structure 120 may comprise at least one toggle joint 121 and at least one tension member 124. Each toggle joint 121 and each tension member 124 may be connected to the lancet shield 110 and to the body 221.

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

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

According to one embodiment, the hinge structure 120 may comprise one tension member 124 which is V-shaped and extending outwards so that it can be easily pressed on by a user. The distal end, i.e. the point of the V of the V-shaped tension member 124, may be shaped as or comprise a press member 125. The user may then advantageously activate the safety mechanism by pressing on the tension member 124 or the press member 125 thereof with, for example, a finger of the same hand which is holding the body 221. The press member 125 is preferably configured, as known in the art, 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. It may be equipped with groves or elevations. Such groves or elevations minimize the risk of the finger slipping of the press member 125 when the user is pushing it.

According to one embodiment, the dead-center position may be 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 to 175°.

According to one embodiment, the dead-center position may be 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 to 190°. Such a dead-center angle advantageously makes the transition to the closed position automatic if the lancet assembly 100 is adapted such that the lancet shield 110 can only be opened to an angle which is less than such a dead-center angle. Such a restricted opening can be achieved by e.g. a design in which the press member 125 hinders further opening by being mechanically restricted by a contact with the body 221.

The lancet assembly 100 may comprise a suitable locking mechanism, which locks the lancet shield 110 in the closed position so that it may not, or only with great difficulty, be returned to the open position. The force applied by the hinge structure 120 may, in collaboration with the locking mechanism of the lancet assembly 100, thus lock the lancet shield 110 in the closed position without the need of any applied external force. In embodiments where the lancet assembly 100 is provided with a locking mechanism, the hinge structure 120 is preferably arranged such that it forces the lancet shield 110 into the closed position with a force greater than the force needed for the locking mechanism of the lancet assembly 100 to lock the lancet shield 110 in the closed position. The locking mechanism of the lancet assembly 100 may comprise one or several locking elements, i.e. locking means, such as e.g. resilient hooks extending from either the lancet shield 110 or the body 221, that lockingly engages with corresponding recesses of the body 221 or the lancet shield 110, respectively, in the closed position, or any other suitable locking element known in the art. The lancet shield 110 may thus not be returned to the open position, which is beneficial for the safety of the lancet assembly 100.

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

According to one embodiment, the locking mechanism may comprise one or several, such as one or two, locking elements extending from or forming a part of the lancet shield 110. A locking element may be a hooked formed extension of the lancet shield 110. It may be resiliently bended out of its resting state upon initial contact with the body 221 in the movement towards the closed position. Upon entering the closed position, a part of the locking element, such as a distal hook-shaped end, may snap into a corresponding recess of the body 221, or around an edge of the body 221, and thereby lock the lancet shield 110 in the closed position. According to one embodiment, the force needed for the lancet shield 110 to lockingly engage with the body 221 may be less that the force by which the lancet shield 110 is being urged towards the closed position when in the active state. The lancet shield may thus be securely locked in the closed position by the force by which the 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 suitable material such as, for example, a thermoplastic, plastic or polymeric material. 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 as polypropylene (PP) may be selected. These materials all allow for manufacturing of the lancet assembly 100 as a

monolithically formed single article, which is highly beneficial with regard to keeping manufacturing costs down. Preferably, the thermoplastic, plastic or polymeric material has a suitable combination, for its intended purpose, of tenacity, rigidity, fatigue resistance, elasticity, and creep deformation resistance. The manufacturing of lancet assembly 100 of the invention, may comprise one or several steps selected from the group of steps consisting of: provision of a thermoplastic, plastic or polymeric material as starting material for lancet assembly 100; molding or injection molding a

thermoplastic, plastic or polymeric material into one monolithically formed lancet assembly 100, which may or may not comprise the lancet 221; and mounting lancet 210 on body 221 by, for example, press-fitting or gluing.

According to one embodiment, the lancet assembly 100 may be made of a thermoplastic, plastic or polymeric material. An advantage of the use of a

thermoplastic, plastic or polymeric material for the construction of the lancet assembly 100, in comparison to e.g. metal, is the greater freedom of variation of various details of the same. For example, a plastic lancet assembly 100 may be more conveniently molded than the corresponding metallic article. Another advantage includes the possibility to colour-code a plastic lancet assembly 100. Yet another advantage 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 another advantage of lancet assembly 100 of the invention, like a plastic or polymeric lancet 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 article like other

corresponding devices of the prior art. Hence, a reduction in the cost of production is resulting. According to one embodiment, at least two parts of the lancet assembly 100 may constitute different parts of the same monolithically formed single article. Such parts may be independently selected from the list consisting of the body 221, the lancet shield 110, the press member 125, and the hinge structure 120. Preferably, the body 221, the lancet shield 110, the press member 125, and the hinge structure 120 are all different parts of the same monolithically formed single article, such as a single article produced by molding.

According to one embodiment, the lancet assembly 100 may be manufactured by a method comprising a step of molding or injection molding a thermoplastic, plastic or 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, these may possibly advantageously be combined, and the inclusion in different claims does not imply that a combination of features is not feasible and/or advantageous. In 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 provided merely 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 central axis at an end of said body (221);

a lancet shield (110), being pivotable from an open position to a closed position, in which closed position said lancet shield (110) is intersecting said central axis, such that said lancet shield (110) may be pivoted from said open position, in which the inner space of said lancet shield (110) is separated from said lancet (210), to said closed position, in which said inner space of said lancet shield (110) is enclosing the sharp end of 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 said body (221) by means of said hinge structure (120) for enabling movement between said open 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 end being closest to said lancet shield (110);

said lancet (210) is selected from the group consisting of puncture lancets and incision lancets; 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.

4. The lancet assembly (100) according to any one of the preceding claims, wherein said body (221) comprises a groove or a bore arranged substantially along said central axis at an 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) in said closed position, and a closed end facing away from said inner space of said lancet shield (110) in said closed position, for enabling mounting of said lancet (210) from the front end of said body (221); and

said bore having an open end facing said inner space of said lancet shield (110) in said closed 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 said hinge structure (120) has a dead-center position, such that said lancet shield (110) is in said passive state whereby it is being forced by said hinge structure (120) from a first position into said open position if said dead-center position has to be passed to reach said closed position, and in said active state whereby it is being forced by said hinge structure (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 said hinge structure (120) is comprising at least one toggle joint (121) and at least one tension 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-center position 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 to 175°.

8. The lancet assembly (100) according to claim 5 or 6, wherein said dead-center position 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 to 190°.

9. The lancet assembly (100) according to any one of the preceding claims, further comprising 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, further comprising a shield connective element (117) and a body connective element (118), for constituting 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, wherein the outer surface of said lancet shield (110) has a smooth or rounded shape, for minimizing 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 at least two parts constitute different parts of the same monolithically formed single article, 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 constitute different parts of the same monolithically formed single article, said parts being independently 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 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 said lancet shield (110) to lockingly engage with said body (221) is less that the force by which said lancet shield (110) is being urged towards said closed position when in said active state, for allowing locking of said lancet shield (110) in said closed position by the 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 of the preceding claims, comprising the step of molding or injection molding a thermoplastic, plastic or polymeric material.