Test element magazineField of the invention
The invention discloses a test element magazine which can be used in a system for measuring the concentration of at least one component in a fluid sample. The invention also relates to a test system for measuring the concentration of at least one component in a fluid sample, comprising at least one test element magazine according to the invention. The test element magazine and the test system of the invention can be used in particular in the field of biomedical analysis systems, such as in the field of measuring the concentration of analytes, such as glucose, cholesterol or similar analytes in body fluid samples, such as blood, urine or other body fluids.
Background of the invention
The determination of the concentration of certain components (also called analytes in the following) such as glucose or cholesterol in body fluids such as blood and urine forms a major part of the daily routine of patients suffering from certain diseases such as diabetes. The concentration of the analyte must therefore be determined in a rapid and reliable manner, usually several times a day, in order to take appropriate medical measures.
In order not to unduly restrict the daily routine of the patient, in many cases, mobile analytical test systems are employed, which are easy to transport and handle. Some mobile systems are commercially available and they use different measurement principles. The first measurement principle is to use electrochemical measurements, in which a blood sample obtained from a patient, for example by piercing a portion of the patient's skin with a lancet, is applied to an electrode covered with an enzyme and a mediator. Test elements for these electrochemical measuring concepts are known, for example, from the US patent US 5286362. Other well-known measurement principles are the use of optical measurements, which are based, for example, on the color change of certain chemical substances when they come into contact with the analyte to be detected. Systems for detecting those color reactions and using these color reactions to determine the concentration of an analyte are well known from certain prior art documents, such as from CA 2050677.
Instead of using separate processes for obtaining a fluid sample and analyzing the fluid sample, some well-known concepts and systems are suitable for collecting (sampling) a body fluid and analyzing the body fluid in one step. These concepts are broadly known as "acquisition and measurement" (GAM) concepts. Thus, for example, WO 2005/084546a2 discloses a body fluid sampling device comprising a skin-piercing element having a collection region for receiving body fluid, wherein the device further comprises body fluid receiving means spaced from said collection region. The liquid receiving means may have a test area for carrying out an analytical reaction. Fluid sample from said collection region is automatically or manually delivered to said liquid receiving means to bring said liquid into contact with the test zone.
Likewise, WO 2007/045412a1 describes a test element for use as a disposable article for testing body fluids, comprising a piercing element for piercing a body part, a collecting region arranged on the piercing element for obtaining body fluid through the piercing opening, and at least one optical waveguide for carrying out optical measurements in the collecting region. The collecting region is configured by a collecting aperture of the piercing element, which is elongated in the direction of piercing, and wherein the optical waveguide is fitted into the piercing element so as not to move and is arranged with its distal end in the proximal measuring region of the collecting hole.
However, a major challenge for acquisition and measurement systems and for systems using analytical test elements or "passive" test elements, such as bare lancets, is the clean and hygienic storage of the test elements. It is known from the prior art that certain concepts are known for storing test elements in order to keep the test elements protected from external harmful influences such as moisture and/or contaminants. Thus, WO 03/088834A1 discloses a cartridge containing a plurality of penetrating members. The penetrating member is movable to extend radially outward from the cartridge to penetrate tissue. The cartridge contains a plurality of cavities. Each cavity is defined in part by a deflectable portion. The deflectable portion prevents the penetrating member from exiting the cartridge in the first position, and the deflectable portion is movable to the second position to form an opening that allows the lancet to extend outwardly from the cartridge.
As already indicated in WO 03/088834a1, great efforts have to be made in order to prepare test elements inside the test element magazine, in particular inside the sealed chamber of the test element magazine, for subsequent use. Thus, some well-known ideas are to utilize the operation of separate opening chambers, such as the idea disclosed in WO 03/088834a 1. These concepts avoid contact between the test element and the sealing element of the chamber and thus damage to the test element that may occur during contact between the test element and the sealing element. Thus, when using aluminum foil as a sealing element for the chamber, contact between the sharp cutting edge of the lancet of the test element and the aluminum foil may damage the cutting edge. In addition, if a polymer film or other type of sealing element is used, physical contact between the test element and the sealing element may chemically degrade the performance of the test element, such as the hydrophilic properties of a certain gel and the measuring lancet. Nevertheless, the concept of opening the chamber seal with a separate opening mechanism creates considerable additional mechanical effort and complexity in order to prepare the test element for subsequent use. Therefore, in most cases, additional mechanical elements are required in order to open the sealing element of the chamber in order to prepare the test element for subsequent use.
A simple alternative is to use a seal which is pierced directly by the test element, for example by a lancet of the test element. Proper selection of the sealing element can reduce physical damage to the test element. Thus, if a polymer film barrier is used, puncturing the polymer film barrier with a lancet is less likely to damage the lancet cutting edge. However, this penetration may affect lancet movement in an unpredictable manner. In addition, the polymer film barrier provides a less effective moisture barrier than metal foils such as aluminum foil. Also, physical contact between the test element and the sealing element may degrade some properties of the test element, such as the hydrophilic nature of the test element, which is a key property of the test element in many acquisition and measurement systems.
Summary of the invention
The present invention therefore discloses a test element magazine, and a test system comprising a test element magazine, which at least partly provide a solution for the disadvantages and challenges of the known ideas. The test element magazine and the test system provide solutions which are easy to manufacture in a mass production process. The test element magazine and the test system are designed to be operable while avoiding a separate opening step for opening the chamber seal and, therefore, a relatively simple actuator can be used for engaging and driving the test elements. Thus, the overall cost of the magazine and test system of the present invention can be significantly reduced. In addition, because a separate opening mechanism is not required, the testing system can be designed to have a smaller size than prior art systems, which is particularly advantageous in portable testing systems.
Accordingly, in a first aspect of the invention, a test element magazine is disclosed. The test element magazine may be used in a system for measuring the concentration of at least one component in a fluid sample. Alternatively, the test element magazine may be used for storing lancet or for storing test elements suitable for determining the concentration of a component of a body fluid. Other applications are possible. The component (analyte) may be an analyte such as blood glucose or cholesterol, and the fluid sample may be a bodily fluid sample such as blood, urine, saliva or other bodily fluids. Other types of analyte and/or fluid samples are possible.
The test element magazine comprises at least one test element in at least one chamber, wherein the chambers are individually sealed by a sealing element. The test element includes at least one active portion and at least one support. The active portion is adapted to contact a portion of the patient's skin and/or adapted to contact a fluid sample. Depending on the type of test element, the active moiety may comprise at least one of the following moieties: a piercing part, a sampling part, an analysis test part for determining the concentration of a component of the body fluid. Further examples and embodiments are given below. The support body is adapted to be engaged by an actuator, such as an actuator for effecting a forward/piercing movement of the test element or for effecting a sampling movement. The support body is thus suitable for attachment to an actuator, such as a holder and/or a plunger of a test element. For this purpose, the support body may comprise a planar end surface for absorbing the momentum transferred by the actuator, or the support body may comprise any other means for momentum transfer, such as grooves and/or projections, which can be connected to the actuator. Other embodiments are possible.
The support may be spaced from the active portion, such as by arranging the active portion at a front end of the test element and by arranging the support at a rear/opposite end of the test element. In addition, the materials of the active moiety and the support may differ in their functionality. The support body and the active part can be designed as separate parts of the test element. In addition, the support body can preferably have a maximum width which is perpendicular to the axis of the test element (axis of the piercing movement) and exceeds the maximum width of the active part in order for the support to force the opening of the sealing element, as explained in more detail below. Thus, the test element and/or the support may comprise a shoulder, a bead, a corrugation, a curl, a fold, a flap, a seam or the like or a combination of some elements having the largest width according to the above conditions, other embodiments being possible.
As mentioned above, the test element may comprise a simple lancet intended only for penetration of a skin portion, without any further sampling and/or testing mechanism and/or analytical test portion, such as a simple lancet without any analytical test portion. Alternatively, the test element may comprise the test mechanism and/or the analytical test portion for detecting the components in the fluid sample, without the lancet. However, the test element may preferably be designed to acquire and measure a test element (such as the test elements described in WO 2005/084546A2 or WO 2007/045412A 1) and may therefore comprise a sampling and/or testing mechanism for taking a sample of body fluid and for measuring the concentration of one or more components (also called "analytes" in the following) in the body fluid, as will be explained in more detail below. The sampling mechanism may include a capillary structure within the lancet. The assay mechanism may include a test strip that includes one or more chemicals for detecting the constituent. The trial mechanism may actually be attached to the needle or may be provided in a system separate from the needle. The optical waveguide system may be used for optical detection of the components, as explained in more detail below. Additionally, the test strip may function as a sampling mechanism, which may be attached to a needle, or may be arranged separately. Other embodiments of the test element than the one described above are possible, as will be apparent to the person skilled in the art.
The test element magazine is designed such that by a forward movement of the test element in the chamber, the support body of the test element exerts a force on the sealing element, thus forcing open the seal of the chamber. The opening force applied to the sealing element is preferably directed in a direction perpendicular to the sealing element, or at least comprises a directional component perpendicular to the sealing element.
The opening force forcing the sealing element open can be applied in different ways. Thus, the test element magazine may be used in a test system comprising an actuator which engages the test element in the chamber and forces a forward movement of the test element, e.g. by pushing the test element. The actuator is adapted to force apart at least a portion of the support body of the test element, thereby enlarging the width of the support body and thereby forcing open the seal of the chamber. Thus, the test element may comprise a hollow rear end portion, wherein the actuator may comprise a plunger which enters said rear end portion and thereby enlarges the rear end portion, thereby forcing open the sealing element of the chamber.
Additionally or alternatively, the chamber may comprise a constricted portion, wherein the chamber is dimensioned such that by forcing the support body of the test element into the constricted portion of the chamber, a force is applied to the sealing element, thereby forcing open the seal of the chamber. Thus, the constriction may be shaped in a way that the clearance in the constriction is narrower than the test element, preferably than the portion of the test element support body which is pushed through that constriction during the action of the test element, such as during a lancing or sampling action.
The constriction of the chamber may comprise one or more of the following constriction elements: a ramp surface, which can be used for the sliding action of the test element; a cam extending into the chamber; a protruding portion that is deep into the chamber; a shoulder extending into the chamber. However, other types of constriction are also possible, such as a conical shape of the chamber, wherein a linear movement of the support body of the test element into the narrower part of the conical chamber provides an opening force which serves to open the sealing of the chamber. The opening force has at least one directional component perpendicular to the axis of the test element in order to be available for opening the chamber seal.
The at least one constriction element is formed at least partially by the magazine body. The magazine body may be formed from a molded plastic component. Thus, the restriction element may be formed during the moulding process of the magazine body.
The sealing element may further comprise at least one cover portion. The cover portion may at least partially cover the chamber. The sealing element may further comprise at least one sealing support, wherein the lid portion is connected to the sealing support by a hinge. Thus, the lid portion may provide an external recess between the test element and a fluid sample, such as a skin portion of a patient, through a "hinged door" opening in the sealing element of the test element magazine, wherein the hinged door opening is opened by contact between the moving test element and the wall of the chamber. The gap between the sealing support and the lid portion may be covered with a foil or film member. The foil or film member may be a frangible member which can be interrupted by a door opening movement of the lid portion of the seal support.
The cover portion may have one or more of the following shapes: a substantially rectangular shape, a multi-layered sheet shape, a pie shape, or any other shape. Preferably, the geometry of the cover portion and the opening covered by the cover portion is designed such that movement of the cover allows the test element to pass through the opening without contact between the test element, e.g. a lancet of the test element, and the opening. The opening covered by the lid portion may be narrower than the width of the test element, so that the perimeter of the door opening confines and guides the test element when the lid portion is in the open position.
As mentioned above, the sealing element may comprise at least one foil or film element, in particular for covering the gap between the sealing support and the lid portion. The foil or film element may comprise at least one of the following materials: aluminum foil, copper foil, polyethylene foil, fluorinated polyethylene foil, metal-coated polymer foil, such as polyethylene coated with aluminum or other metallic or inorganic barrier materials, such as silica and the like, polyethylene terephthalate (PET), and the like. Other polymeric materials and/or metal foil elements are useful, with frangible elements, films or foils preferably being used.
The test element magazine may comprise several types of magazines, such as flat or curved magazines containing one or more test elements. Thus, the test element magazine may comprise one of many possible arrangements of chambers for test elements, wherein the chambers are arranged such that they can be opened separately. Thus, the test element magazine may comprise a linear arrangement of chambers, a zigzag arrangement, a curved arrangement (such as a belt or strip comprising a plurality of chambers), a circular arrangement, a drum-like arrangement or any other type of arrangement. In the following, without limiting the scope of the invention, a mainly circular arrangement is disclosed. However, other types of arrangements may be used.
Preferably, the test element magazine comprises a disk magazine, preferably a disk magazine having a circular shape. The disk magazine may comprise a plurality of test elements which are arranged radially in individual chambers, with the active parts of the test elements facing outwards. The disk magazine comprises an intermediate volume of disks which is empty as if the disks were freely rotating around the rotating mechanism.
The test element magazine may further comprise a disk, wherein the sealing element at least partially covers the disk. The tray may comprise one or more moulded plastics elements. Thus, the chamber for the sealing element may be formed at least partly during a simple moulding process.
The test elements may comprise one or more test elements for analyzing a fluid sample, such as electrochemical and/or optical test elements as are well known in the art described above. Thus, the test element may comprise a substance which changes at least one chemical or physical property as a function of the concentration of the component in the liquid when the liquid is brought into contact with the substance. The at least one chemical or physical property includes an optical property and/or a physical property.
In addition or alternatively to the chemical substance, the test element, in particular the active part of the test element, may comprise a lancet. The lancet may comprise a needle and/or any other mechanism for puncturing or cutting a skin portion of a living being, such as a human or animal patient.
In a preferred embodiment of the invention, the test element may be designed for acquisition and measurement purposes, as described above. Thus, a lancet and a chemical substance may be provided, and the lancet may comprise a capillary element for taking a liquid sample. To this end, the lancet may further comprise a hydrophilic surface, preferably the inner surface of the capillary element.
In another embodiment of the invention, the support body of the test element may comprise a sealing portion. The sealing portion may form a sealing portion of the chamber. Thus, the test element may comprise a sterile portion and an engagement portion, the sterile portion being located inside the chamber and the engagement portion being located outside the chamber. This portion between the engaging portion and the sterile portion of the test element may provide a tight sealing contact with the chamber wall, thus providing protection of the sterile portion against detrimental effects.
In another aspect of the present invention, a test system for measuring the concentration of at least one component (analyte) in a fluid sample is provided. The test system may comprise a test element magazine as described in one or more of the embodiments above. In addition, the test system may comprise at least one actuator comprising an engagement portion for engaging the test elements in the test element magazine.
The actuator may be adapted to force the support body of the test element into the constricted portion of the chamber, thereby forcing open the seal of the chamber. The actuator may also be adapted to force the test element to perform a lancing action and/or a sample collection action.
The engagement portion may include an optical port for optically contacting the test element. Thus, a light transmitting mechanism may be provided to cause light from the measuring instrument to illuminate the chemical substance while undergoing a change in one or more chemical or physical properties as a result of contact with the analyte, and to return light to the measuring instrument to measure the color change.
Additionally or alternatively, the engagement portion may include an electrical port for electrically contacting the test element. Thus, the test system may comprise a mechanism for electrochemically determining the concentration of an analyte in a body fluid.
Drawings
For a more complete understanding of the present invention, reference is now made to the following descriptions taken in conjunction with the accompanying drawing, in which:
fig. 1 schematically shows a perspective view of a first embodiment of a test element magazine;
fig. 2 shows a cross-sectional view of a second embodiment of a test element magazine;
fig. 3 shows a top view of a portion of the test element magazine of fig. 2;
fig. 4 shows a cross-sectional view of a third embodiment of a test element magazine;
fig. 5 shows a fourth embodiment of a test element magazine;
FIG. 6 shows an embodiment of a test element; and
fig. 7 shows a schematic representation of an embodiment of the test element.
Detailed Description
In fig. 1, a perspective view of a first embodiment of a test element magazine 110 is schematically shown. The test element magazine in this embodiment is a circular shaped disk magazine with a circular shaped central opening 112. The central opening 112 may be used to partially accommodate a rotation mechanism for angularly positioning the test element magazine and/or may be used to accommodate at least a portion of an actuator for engaging a test element of the test element magazine 110.
The test element magazine 110 comprises a number of individually sealed chambers 114, each chamber 114 comprising a test element (not shown in fig. 1).
The test element magazine 110 comprises a magazine body 116, which magazine body 116 may be formed from a moulded rigid plastic element.
The magazine 116 is covered by a sealing element 118, in this embodiment the sealing element 118 comprises a dome-shaped molded sealing support 120, said sealing support 118 acting as a framework for the sealing element 118 and substantially covering the magazine 116.
The sealing member 118 additionally includes a number of cover portions 122, with each cover portion 122 covering one of the chambers 114. Without limiting the scope of the invention, only three of the cover portions 122 and only a portion of the chamber 114 are shown in FIG. 1.
Cover portion 122 may also be formed from a rigid plastic molded component and may be formed as an integral part with seal carrier 120. The lid portion 122 is connected to the sealing support 120 by a hinge 124, which hinge 124 can be used to open the lid portion 122, i.e. to deflect from the openings 126 covered by the lid portion, thus emptying these openings 126 for access to the test elements comprised in the respective chambers 114. The hinge 124 may simply comprise a connecting line between the lid portion 122 and the seal carrier 120, or the hinge 124 may comprise a thin flexible segment in the molded plastic part forming the seal carrier 220 and the lid portion 122, as will be shown below.
In opening 126, gap 128 is formed between cover portion 122 and seal support 120. To close these gaps 128 and protect the interior of the chamber 114 from moisture and/or contamination that may enter through the gaps 128, the sealing element 118 may further include a membrane element 130, the membrane element 130 at least partially covering the dome of the seal support 120. The membrane element 130 may also have a dome-like shape and may be formed from a metal foil, such as aluminum foil, and preferably completely covers the gap 128. Only a portion of the thin-film element 130 is shown in fig. 1. The membrane element 130 preferably comprises or even consists of a frangible membrane element that can be broken along the line of the gap 28 once the lid portion 122 of the chamber 114 is opened by pivoting the lid portion 122 about the respective hinge 124. The film member 130 may be glued to the seal carrier 120 and the seal carrier 120 may be glued to the magazine 116. Other joining techniques such as welding, crimping, molding or the like may be used.
In fig. 2 and 3, a second embodiment of a test element magazine 110 is shown. Therein, fig. 2 shows a cross-sectional side view of the chamber 114 of the test element magazine, while the chamber 114 contains the test element 132. In addition, like in the exemplary embodiment shown in fig. 1, the test element magazine 110 has a substantially circular shape and comprises a plurality of radial chambers 114, which chambers 114 contain test elements 132, said test elements 132 having radially outwardly directed lancets 134. Test element 132 further includes a support body 136, wherein support body 136 exhibits a larger cross-section than lancet 134. Thus, support body 136 may be formed of a molded plastic material that secures lancet 134.
As can be seen in fig. 2, similar to the embodiment in fig. 1, the test element magazine 110 comprises a molded magazine body 116, which magazine body 116 is disk-shaped in this exemplary embodiment with a central axial flange 138 and a central circular opening 112, in this embodiment the opening 112 being formed as a blind hole instead of a through hole. Other embodiments of the central opening 112 are possible.
As in fig. 1, the magazine body 16 in the embodiment of fig. 2 is covered by a sealing member 118, which sealing member 118 comprises a sealing support 120 (only partially visible in fig. 2) and a number of lid portions 122. The cover portion 122 and seal carrier 120 may be formed of a molded rigid plastic material, preferably as an integral component, similar to the embodiment of fig. 1. Cover portion 122 and seal support 120 are connected by a hinge 124, which hinge 124 is formed by a thin section of the molded plastic part forming seal support 120 and cover portion 124. Generally, the seal support 120 and the lid portion 122 form a domed portion that substantially covers the magazine 116 and may be attached to the magazine 116 by gluing or other attachment techniques, as described above.
In addition, the sealing member 118 includes a frangible membrane member 130, which membrane member 130 may also comprise aluminum foil, copper foil, polymer foil, or other frangible element, and the membrane member 130 covers the sealing support 120 and the lid portion 122, thereby sealing the gap 128 around the lid portion 122.
As can be seen in fig. 2, the test elements 132 are arranged in a radial manner within the chamber 114. Each test element 132 projects with a rear portion of supporting body 136 partially into central opening 112. The magazine body 116 and the sealing support 120 each comprise a conical plug 140, which conical plug 140 projects into the chamber 114, wherein the conical plug 140 is designed to firmly fix the supporting body 136 of the test element 132, thereby sealing the chamber 114 from the surroundings, in particular from the central opening 114. Thus, each test element 132 is in fact subdivided into a sterile portion 142, a sealing portion 144, and an engaging portion 146, the sterile portion 142 being arranged inside the sealed chamber 114, the sealing portion 144 cooperating with the conical plug 140 to seal the chamber 114, and the engaging portion 146 being located outside the chamber 114 while projecting into the central opening 112.
The engagement portion 146 may include an optical port and/or an electrical port for optically and/or electrically contacting the test element 132. Thus, the optical and/or electrical port 148 may include one or more optical fibers that may be optically contacted (see below), and/or one or more electrical contacts, to electrically contact the test element 132. Further details are given below. In addition, the engagement portion 146 may be used to mechanically engage the test element 132, for example, for protruding the test element 132 in order to perform a lancing action and/or for retracting the test element 132 after performing a lancing action, for example, for collecting a bodily fluid sample. To this end, as explained in more detail below, the actuator can engage the engagement portion 146 of the test element 132 in the measuring position through the central opening 112 of the test element magazine 110.
In particular, where the test elements 132 are formed as acquisition and measurement test elements, these test elements 132 may include an active portion, which is preferably part of the sterile portion 142. In the embodiment shown in fig. 2 and 3, the active portion may include a lancet 134 of the test element 132. In many cases, it is important for these active portions, such as lancets, not to touch any portion of the magazine 116 and/or the sealing element 118. Any contact may degrade the active portion, for example due to degradation of the hydrophilic properties of the lancet 134, which in turn may degrade the sampling motility or even impede the sampling action.
To this end, in accordance with the present invention, chamber 114 includes a constricted portion 150. These constrictions 150 are dimensioned in a manner such that when the supporting body 136 of the test element 132 is pushed into these constrictions 150, an opening force is exerted on the sealing element 118, thus opening the chamber 114 without the active part of the test element 132 touching the magazine 116 and/or the sealing element 118.
In the embodiment of the invention shown in fig. 2 and 3, the constricted portion 150 of the chamber 114 includes a door opening cam 152. In this embodiment, the door opening cams 152 are part of the lid portion 122 of the sealing member 118 and extend into the interior of the chamber 114. By pushing the test element 132 radially outward in fig. 2 (i.e., applying a force from right to left in fig. 2), the enlarged supporting body 136 of the test element 132 is compressed into the constricted portion 150, contacts the door opening cam 152, and thus opens the cover portion 122 by rotating the cover portion 122 about the hinge 124, thereby interrupting opening of the frangible membrane element 130 and the opening chamber 114 without the lancet 134 touching the cover portion 122 or any other portion of the sealing element 118. Thus, in one movement, the test element 132 may be utilized to open the chamber 114 and perform a lancing action. No separate mechanism is required to open the chamber 114. The initial outward radial lancet action causes the support body 136 of the test element 132 to contact and lift the cam surface of the door opening cam 152 inside the cover portion 122.
In the embodiment of fig. 1, the lid portion 122 of the sealing member 118 is more or less shaped like a pie. Nevertheless, the opening 126 covered by the cover portion 122 is preferably narrow except where the test element is present, so that the test element is contained and guided by the sealing element on each side of the opening. Thus, in the embodiment shown in fig. 2 and 3 (and particularly with respect to the top view of fig. 3), the lid portion 122 is bottle-shaped with a narrow guide portion 154 and a wider opening portion 156. After opening the cover part 122 by the above-described mechanism, the test element 132, in particular the supporting body 136 of the test element 132, can still be in contact with the sealing part 118 in the region of the guide part 154, which allows for a radial piercing action of the test element 132 in a well-defined direction, which is guided by the guide part 154. On the other hand, the opening portion 156 is wide enough to prevent the lancet 134 from reaching the sealing element 118.
In fig. 4, a second embodiment of a test element magazine 110 is shown in a sectional side view similar to the view in fig. 2. In addition, in this embodiment, the test element 132 with the support body 136 is included in the sealed chamber 114, for example facing radially outward in the disk-shaped test element magazine 110. In addition, the test element magazine 110 comprises a magazine body 116 and a sealing element 118. Each sealing element further includes a sealing support 120 and a number of cover portions 112, the cover portions 122 being shaped in a similar manner to the embodiment shown in fig. 1 and 3. Other shapes are possible.
Additionally, as in fig. 2 and 3, the chamber 114 includes a constricted portion 150. In contrast to the embodiment shown in fig. 2 and 3, the constriction 150 includes a plurality of ramp-shaped projections 158, the projections 158 being part of the lid portion 122 and/or the magazine body 116. These ramp-shaped protrusions 158 extend into the interior of the chamber 114 and are arranged adjacent to the portion of the test element 132 in which the lancing blood 134 meets the support body 136. Once the test element 132 is forced towards the left in fig. 4 (performing a radially outward piercing action), the test element 132 may be driven by an actuator which engages the support body 136 of the test element 132 at the rear end of fig. 4, the test element 132 being raised at its front end, thereby pushing open the cover portion 122 and thus emptying the opening 126.
In fig. 4, the membrane element 130 is not shown, but in an alternative embodiment, an additional membrane element 130 may be provided for sealing the gap between the lid portion 122 and the seal support 120. The top view of the lid portion 122 is preferably similar to the top view of the embodiment shown in FIG. 3, although other embodiments may be used. The embodiment of fig. 4 clearly shows that the design of the constriction 150 can be varied, as clearly noted by those skilled in the art, and still be used to open the lid portion 122 without the active portion of the test element 132, e.g., the lancet 134, touching any portion of the sealing element 118 and/or the magazine 116.
In fig. 5, a fourth embodiment of a test element magazine 110 is shown in a view similar to that shown in fig. 4.
In the embodiment shown in fig. 5, which is more or less similar to the embodiment in fig. 4, the constriction 150 comprises a ramp 160, said ramp 160 guiding the test element 132 at an acute angle towards the lid portion 122 of the sealing element 118. The width of supporting body 136 of test element 132 and the arrangement of ramp 160 are designed such that the shoulder of supporting body 136 hits cover portion 122 before lancet 134 touches cover portion 122. Thus, the cover portion 122 is pushed open by lifting the cover portion 122 about the hinge 124, while the lancet 134 does not touch the cover portion 122 or any other portion of the magazine 116 and/or sealing element 118.
In addition, similar to the embodiment shown in fig. 2, in the embodiment shown in fig. 5, the sealing support 120 of the sealing element 118 comprises a conical plug 140, which conical plug 140 engages the rear end of the supporting body 136 of the test element 134, thus sealing the chamber 114 against the central opening 112 of the disk-shaped test element magazine 110. Additionally, as schematically shown in fig. 5, the central opening 112 may be used by the actuator 162 to engage the test element 132 at its rear end, thereby mechanically forcing the test element 132 to perform a lancing action. In addition, the actuator 162 may be used to optically and/or electrically contact the test element 132.
In fig. 6, an exemplary embodiment of a test element 132 is shown in a side sectional view. Test element 132 includes an active portion formed by lancet 134 and chemical 164. As described above, the chemical substance 164 may be shaped like a rectangular or circular element, for example with a thin film of material, at the transition between the lancet 134 and the support body 136 of the test element, said chemical substance 164 may comprise one or more substances which change chemical and/or physical properties when brought into contact with a specific analyte. Thus, the chemical 164 may include one or more enzymes, such as gluconolactone, for detecting glucose in a bodily fluid sample, such as a blood sample.
For sampling, the lancet 134 includes a capillary element 166 forming a slit, the capillary element 166 extending from the sharp edge of the lancet 134 towards the chemical 164. Thus, after perforating a skin portion of a living body, such as a human or animal patient, a blood sample may be drawn by capillary force, via the capillary element 166, to the chemical 164. The capillary element 166 may include a hydrophilic surface to facilitate sampling of aqueous body fluids.
This supporting body 136 of the test element 132 can be used to mechanically fasten it to the lancet 134. In addition, support body 136 may be used to mechanically engage test element 132 via engagement portion 168 of actuator 162. This is schematically illustrated in fig. 6.
In the embodiment of fig. 5, the actuator 162, for illustrative purposes only, is shown as a simple plunger. However, in the embodiment of FIG. 6, and in other embodiments as well, actuator 162 may include a multi-tipped engaging portion 168, with tip portion 168 being useful for several types of engagement between actuator 162 and trial element 132. Thus, in particular for the purpose of achieving a measuring effect, but also for the test element simply comprising the lancet 134, in the absence of any chemical substance 164, not only a forward puncturing action but also a retraction movement after puncturing a skin portion of the patient may be desired. To this end, the engagement portion 168 of the actuator 162 can include a gripper that engages the rear engagement portion 146 of the test element 132. Additionally or alternatively, as shown in the embodiment of FIG. 6, the actuator 162 and the engagement portion 168 of the actuator 162 may comprise a tapered plunger including a protrusion 170, the protrusion 170 engaging a gripping portion 172 of the engagement portion 146 of the trial 132. Thus, after the forward end of the plunger of the actuator 162 is pushed into the gripping portion 172 of the engagement portion 146 of the trial 132, forward and rearward movement of the trial 132 can be accomplished by a suitable forward or retracting action of the actuator 162.
In addition, as also shown in the embodiment shown in FIG. 6, other types of bonding may be used in addition to mechanical bonding. Thus, in the embodiment of FIG. 6, the engagement portion 168 of the actuator 162 includes an optical port 174, the optical port 174 being coupled to a plurality of optical fibers 176 within the actuator 162. The optical port 174 can optically contact the optical port 148 inside the support body 136 of the test element 132. This optical port 148 of test element 132 may be connected to chemical 164 via a plurality of optical fibers 178 inside support 136. Thus, for example, one optical fiber 178 (e.g., a central fiber) may be provided for directing excitation light from the light source through the actuator 162 to the chemical 164, and two or more optical fibers 178 may be provided for directing light emitted from the chemical 164 to the light detector. Thus, optical measurements may be performed to detect a color change of the chemical and/or to detect a change in the fluorescence properties of the chemical 164 to determine the concentration of the analyte within the bodily fluid sample. Other optical detection methods are well known and may be used alternatively or additionally.
Other types of interconnects may be used in addition to mechanical and optical interconnects. The actuator 162 and the interconnecting portions 168, 146 of the test element 132 may be adapted for electrical interconnection of the test element 132. Thus, for example, electrochemical measurements may be performed, such as electrochemical measurements that utilize the chemical species 164 to change their electrochemical properties upon contact with the analyte.
In fig. 7, an embodiment of an assay system 180 for measuring the concentration of at least one component (analyte) in a fluid sample is shown in a simplified schematic cross-sectional side view. The test system 180 comprises a test element magazine 110, such as the test element magazine 110 described in the embodiments shown above. In addition, the testing system 180 includes a rotation mechanism 182, which rotation mechanism 182 may be used to mechanically hold the test element magazine 110 and to position a particular test element chamber 114 in front of a puncture opening 184 in a housing 186 of the testing system 180. The housing 186 may also include mechanical support elements for supporting some or all of the components of the testing system 180.
The testing system 180 further comprises an actuator 162, which actuator 162 is adapted to engage one of the test elements 132 (only schematically shown in fig. 7) in the measuring position inside the test element magazine 110.
The testing system 180 may also include a measurement system 188. The measurement system 188 may be provided with an optical excitation source and one or more optical detectors, both of which are connected to the engagement portion 168 of the actuator 162 via optical fibers 176 for optically contacting the test element 132 and performing the above-described measurements. The measurement system 188 may additionally include electronic components for performing the above-described measurements, and may additionally include one or more computer components, such as a microprocessor, and input/output mechanisms, storage mechanisms (e.g., volatile and/or non-volatile data storage), or other components. The measurement system 188 may additionally be adapted to control the actuator 162 to control the entire sampling process.
List of reference numerals
Description of the reference symbols
110 test element magazine
112 central opening
114 chamber
116 magazine body
118 sealing element
120 seal carrier
122 cover part
124 hinge joint
126 opening
128 gap
130 thin film element
132 test element
134 lancet
136 support body
138 axial flange
140 conical plug
142 sterile part
144 sealing part
146 engaging part
148 optical/electrical port
150 constriction
152 door opening cam
154 guide portion
156 opening part
158 projection
160 bevel
162 actuator
164 chemical substance
166 capillary element
168 engagement portion
170 protrusion
172 clamping part
174 optical part
176 optical fiber
178 optical fiber
180 test system
182 rotating mechanism
184 puncture the opening
186 casing
188 measuring system