Patent Application
20060178600
This invention relates to a blood analyzer for determining an analyte such as fructosamine, lactate, cholesterol or in particular glucose on minimal quantities of blood taken from a user immediately prior to analysis, with a housing body, with a blood sampling device having a pricking element, with a test means for accommodating a minimum quantity of blood, with an analyzer device comprising an electronic analyzer and with a display device, together forming a complete system that can be handled as a single unit, whereby the housing body has a pricking position assigned to the working position of the pricking element for being applied to a skin surface of a user and having a charging position designed at another location in the housing body for charging a minimal quantity of blood escaping from the previously pricked skin surface to a test means, whereby a plurality of test means and pricking elements can be inserted into the device and can be brought into a working position for performing several measurement one after the other, whereby in positioning a pricking element in its working position the pricking element can be inserted into the skin surface of a user which is brought to the pricking position and blood escaping from the skin surface, can be charged to a test means by applying the skin surface to the charging position, said test means being in a working position of the test means.
This invention thus relates to complete devices which are also known as “all-in-one” units. The test means may be designed, for example, in the form of a membrane which defines the measurement field and is wetted with the minimal quantity of blood sampled and comprises test reagents with the help of which the analysis is performed. The analysis device may operate optically, for example, preferably by reflectometry, or it may operate electrochemically.
U.S. Pat. No. 5,971,941 A discloses a complete system in the sense described above whereby a cassette with unused test means in the form of strips is inserted into a basic unit and then a particular test strip can be brought into the proper working position by means of a slide. By means of a ram, a pricking element is pushed outward via a deployment device which forms a part of the blood sampling device in order to prick the surface of a user's skin, so that capillary blood can be obtained for analysis. The pricking elements are integrated into a test strip and thus are brought into position together with the test strip. Details of how the analysis is performed cannot be obtained from this publication, however. According to another embodiment described in this publication, a disposable cylindrical attachment or insertion is described, having a pricking element and a tablet-shaped test membrane with continuous opening for the pricking element. This attachment or insert is then inserted into a holding recess of a ram arrangement which forces the pricking element outward for taking the blood sample.
According to one embodiment of German Patent 198 19 407 A1, a plurality of test means in the form of strips with pricking elements integrated into them in a manner not described there can be inserted into an analyzer and brought successively thereafter into a working position. This publication does not contain any clear-cut reference to technical feasibility.
U.S. Pat. No. 4,787,398 A describes a blood sugar meter with a basic unit having a ram arrangement for deflecting a pricking element and an analyzer device and a display device. For each measurement, a replaceable unit must be attached to the basic unit, said replaceable unit comprising a pricking element and a test means in the form of a test strip to be wetted with blood. This replaceable unit is discarded after each use.
A blood analyzer known from European Patent 0 449 525 A1 also comprises an integrated blood sampling device with a pricking element. Before starting operation each time, however, a new pricking element must be manually inserted into the deployment device as part of the blood sampling device and then a test strip must be inserted into the device.
U.S. Pat. No. 4,627,445 A discloses a blood sugar meter with an integrated blood sampling device. Here again however, a new replaceable unit comprising a pricking element and a test means must be mounted on a base plate and then dismantled for each measurement.
U.S. Pat. No. 5,951,492 A is similar. According to this publication, a disposable unit comprises a capillary tube with a test strip provided on the end distal from the body to receive the minimal amount of blood to be taken. The capillary tube is designed with a pricking element on its distal end. Again a new disposable unit of the type described above must be installed before each measurement operation and removed after the measurement.
In addition European Patents 0 877 250 A2, 0 949 506 A2 and 0 811 843 A2 disclose non-generic blood analyzers with which a plurality of test strips may be arranged on a rotating disk as a support for the test means, whereby the test means can be brought successfully into an operating position and can be pushed out of the housing body for wetting them with a minimal quantity of blood.
U.S. Pat. Nos. 6,228,100 B1 and 4,794,926 disclose blood sampling and pricking devices with which a number of pricking elements are arranged on a support that is rotatable with respect to a housing body. According to U.S. Pat. No. 6,228,100 B1, the pricking elements are ejected radially by means of an ejector device and according to U.S. Pat. No. 4,794,926, the pricking elements are oriented in the axial direction and can be activated.
Based on the related art cited above, describing an all-in-one complete device, the object of the present invention is to create a device that can be designed to be compact, i.e., saving space and can be regarded as user friendly. It should be possible to easily insert unused test means and pricking elements into the device and to remove the used one from the device.
This object is achieved according to this invention with a blood analyzer of the type defined in the preamble by the fact that the test means and the pricking elements are arranged on a support that is rotatable with respect to the housing body and they can be inserted with it into the device and by rotating the support the test means and the pricking elements can be brought into different working positions with respect to the body of the housing.
Thus according to this invention both the test means and the pricking means are arranged on a rotatable support and can thus be brought into their respective working positions by a rotating movement. When speaking above of the working positions of the test means and the pricking elements, this is understood to refer to the position or the rotational position of a test means and/or a pricking element with respect to the housing body in which it is used as intended. A pricking element is in the working position of the pricking elements when it can be moved out of this working position to execute a pricking procedure via the pricking position.
A test means is in the working position of the test means when it can be wetted in this working position by a minimal amount of blood. When speaking above of the different working positions of the test means and the pricking elements, this is understood to mean that after pricking the skin surface in the pricking position of the device, a user releases the skin surface, i.e., usually the finger from the pricking position and applies it to the charging position to transfer a minimal amount of blood to a test means. For example, the working position of the pricking elements may be in a 3o'clock position and the working position of the test means may be in a 6 o'clock position. Various working positions of test means and pricking elements, however, can also be achieved in a single rotational position of the support by arranging the pricking elements radially, for example, and orienting the test means axially. The respective pricking position would then be provided radially on the housing body and the charging position would be provided axially on the housing body.
The use of a rotating support makes it possible to implement a compact design of the housing body. Due to the fact that the used test means and pricking elements are brought out of the working position by rotation of their support, they automatically go in this way to a disposal position without having to provide any additional separate translatory process.
It would also be conceivable and advantageous if the test means were arranged on the same support that is to be handled manually so that the pricking elements and test means can be removed, e.g., from a transfer package as a single unit that can be handled manually and can be inserted with a single operation into the analyzer.
From the standpoint of simplified production of the test means and pricking elements, however, it has also proven advantageous if the support comprises a first support part for the test means and a second support part for the pricking elements which can be assembled to form a unit that can be handled manually, preferably assembling it at the factory so that this easily handled unit can be inserted as a whole into the device and then removed again after use. However, the separate production and provision of test means on a first support part and pricking elements on a second support part should also be included, these parts being insertable individually into the blood analyzer into their rotatable arrangement there although this requires two separate assembly operations by the user.
If various support parts are provided for the test means and the pricking elements, then it proves to be advantageous that these two support parts are coupled together in a rotationally fixed manner so that it is sufficient if a single drive of one support part or the other is provided in the interior of the analyzer. Even if the support parts are assembled to form a single unit that can be handled easily, it would also be conceivable if two separate drive devices were provided in the analyzer, which may prove to be advantageous for some applications.
According to a preferred embodiment of this invention, the support or the support parts or one of the support parts has a central recess within which is provided a drive device for the blood sampling device.
The support or the support parts or one of the support parts is preferably designed in the form of a ring and is arranged so that it can rotate about the ring center in the sense of being rotatable.
The drive for the support or the support parts can be implemented in any known manner, preferably in a compact design. Electric motor drive devices or manually operable mechanical drive devices which may be designed to be controlled by a lever or a slide have proven to be advantageous. Discrete rotational positions of the support or the support parts are preferably provided, and may be implemented either by catch means, stepping means or stop means or through a suitable design of the drive device.
It has proven to be particularly advantageous and compact if the support or the support parts have a central recess which includes a driving means or a part of a driving means for rotating the support or the support part. This driving means is advantageously designed by internal gearing that meshes with another drive wheel.
This invention includes embodiments of the blood analyzer in which the pricking elements are arranged on the support so that when in the working position, they execute a pricking movement in a radial direction with respect to the rotatability of the support as well as embodiments in which the pricking elements execute a pricking motion in the axial direction.
The arrangement of the pricking elements on the support may be implemented in various ways. According to one advantageous embodiment, a particular element is arranged in a sleeve means forming a cylindrical space before execution of a pricking operation and is held by a plunger means that is movable therein. It has proven advantageous if in this case the pricking element forms a syringe part of the plunger means which is designed as an injection molded plastic part.
It is obligatorily necessary for the pricking elements to be surrounded by a sterility barrier on the support before execution of a pricking operation, so the embodiment described above has proven advantageous because in this case the sterility barrier may be formed by the sleeve means and the plunger means which are then closed on all sides. To keep the sleeve means germproof on the side facing away from the plunger means, i.e., to seal it so that it is germ-free and sterile, it has proven advantageous if this end is covered by a sealed film in particular. To achieve a seal between the plunger means and a wall of the cylindrical space that meets requirements, another sealing means is provided there. There may also be a connection between the wall and the plunger means which is overcome in execution of the pricking operation. Furthermore, a sealing compound may also be used there or, for example, ring-shaped bulges and steps, shoulders or recesses which cooperate with these bulges may also be provided in the other parts.
With regard to the manufacturing of the arrangement of the pricking elements on the support described here, it has proven to be advantageous if several sleeve means are joined together in a strip and the ends of the strips are joined together to form a circular shape. In this way, sleeve means can be produced in the form of endless strips, divided into sections and their ends joined to form a circular shape and thus to form a support or a support part. The sleeve means arranged in a strip may also be arranged only along a partial circle, however.
According to another embodiment, the support may have several recesses with a pricking element arranged in each. In this embodiment it has proven advantageous if the pricking elements are arranged in the axial direction based on the rotatability of the support.
It has also proven advantageous if one wall bordering the recess is designed to be deformable so that it can be deflected by a driving device of the blood sampling device together with the pricking element to execute the pricking operation. To increase deformability, zones of weakening may also be provided in the wall bordering the recess. It has also proven advantageous if the recess is designed essentially in the form of a trough or a half-shell.
In this arrangement of the pricking elements on the support, it has also proven to be advantageous if the pricking elements are accommodated in a sterile environment before the execution of a pricking operation. In this case a sterility barrier can be formed advantageously by a film-like covering means that covers the recess. This cover can be removed directly before execution of the pricking operation or it may be designed to be very thin so that it can be pricked by the pricking element.
According to another embodiment of the blood analyzer, the pricking elements have a detachable protective cap means on their free end before the execution of a pricking operation, said cap means preferably forming a sterility barrier and ensuring sterile conditions for the free end of the particular pricking element.
In the execution of the pricking operation, the pricking element can puncture through the protective cap means. However, it would also be regarded as advantageous if the protective cap means could be released by the respective pricking element immediately before the execution of the pricking operation. This may be accomplished in an advantageous manner by slightly retracting the particular pricking element immediately before execution of the pricking operation by the fact that the protective cap means is prevented from moving together with the pricking element by a stop means or the like. It has proven advantageous if the particular protective cap means can be removed from the path of movement of the pricking element after being released from the particular pricking element so that it can be accommodated in a holding space. For example, the force of gravity or a spring means may be used for this purpose.
The arrangement of the test means on the support may also be such that the test means is axially oriented with respect to the rotatability of the support or is radially oriented.
The test means are preferably oriented axially, which means that the charging position for a skin surface usually of one finger of a user is oriented in the axial direction; if not capillary fluid paths are arranged between the charging position and the test means which is in its working position. With an alignment or orientation of the testing machines with its measurement field generally being planar or extending over an area, it has proven advantageous if the test means are provided on a disk-shaped support part, in particular a ring disk-shaped support part, the plane of which is oriented at a right angle to the axis of rotation of the support and preferably corresponds to a plane of the respective test means.
According to another embodiment of this invention, it has proven advantageous if the charging position on the housing body is covered by a movable covering part when it is not needed and is releasable when an analysis is to be performed.
In another embodiment of this inventive idea, it has proven to be advantageous if by moving the covering part in the direction of release of the charging position, a driving device of the blood sampling device can be activated, i.e., if a triggering pressure or a tension is thereby created or an electric motor driving means is driven. It has proven to be particularly advantageous if the driving device of the blood sampling device can be activated by applying tension to a spring means.
According to a very particularly preferred embodiment of this invention it is proposed that the blood analyzer should have a manually movable adjusting element which is coupled to the driving device for the pricking element and to the rotatable support in such a way that when the adjusting element is moved, the driving device for the pricking element is activated and a rotational movement of the support is induced. This manually movable adjusting element may be, for example, in the form of a wheel, a sliding part or in a preferred manner it may also be formed by the covering part mentioned above. The coupling between the adjusting element and the driving device and/or the support may be designed in such a way that the activation of the driving device and the rotation of the support take place simultaneously. However, it would also be conceivable for these to take place in chronological succession. In particular, the coupling between the adjusting element and the driving device and/or the support could be designed so that the support is rotated during a first phase of movement in a first direction of adjustment and during a second phase of movement, which may be in the opposite direction from the first adjusting direction, for example, the driving device is activated.
To achieve a stepwise further rotation of the support, it has proven advantageous if the adjusting element can be brought during a first phase of movement in a first direction of adjustment into a driving connection with the support and during a second phase of movement it can be brought into a position opposite the direction of adjustment, i.e., in the case of a reverse movement of the adjusting element into its starting position, it can be brought out of a driving connection. In this restoring movement of the adjusting element, it may also prove advantageous if the driving device for the pricking element is thereby resettable into a starting position or resting position.
The coupling between the adjusting element and the support can be implemented in an advantageous manner via a gear drive. For example, a translatory movement or a swiveling movement can be converted to a rotational movement via toothed entraining means and the rotational movement can easily be used to drive the support. However, it would also be conceivable for the coupling between the adjusting element and the support to be implemented in some other way, e.g., by entraining means in the form of catch arrangements or the like.
It has also proven to be advantageous if the drive device for the pricking element comprises a spring that can be put under tension and released suddenly, preferably in the form of a bending spring. To apply tension to this bending spring, the adjusting element may act on a receptacle for the bending spring in particular via a gear drive and can pivot this receptacle in the plane of bending of the bending spring and thereby attention to the driving device for the pricking element, i.e., activate it.
It has proven to be especially advantageous if the bending spring can be brought into a stable position under tension beyond a dead point so that the driving device automatically remains in the activated state. It is then possible to eliminate the use of a releasable catch mechanism.
According to another independent inventive idea, a deployment device for the driving device for the pricking element can also be operated by applying a skin surface to the pricking position. The triggering device may then be designed advantageously as a contact sensor or as a button that can be depressed.
It may prove advantageous if the triggering device is provided in an ergonomically well operable location on the housing body, in particular on the side essentially opposite the pricking position. In another embodiment of this invention, a design in which the triggering device is provided in the pricking position and can be operated by applying the skin surface that is to be pricked. In this regard, an embodiment in which the triggering device has a recess for the passage of the pricking element for execution of the pricking process is preferred.
In another embodiment of this invention it is proposed that a retraction mechanism should be provided which causes retraction of a respective pricking element directly following the pricking operation so that the skin surface of a user is pricked only briefly. Such a retraction mechanism could in the simplest case be implemented by a spring means which exerts a restoring force. Such a spring means could be designed in various ways. For example a pricking element might extend through a spiral or strip-shaped spring means so that in the execution of the pricking operation, this spring means is put under tension. However, it would also be conceivable for such a retraction mechanism to be implemented in the driving device of the blood sampling device, e.g., by a force guide or by a motorized back-and-forth movement of a driving means coupled to the pricking element. For example, if the pricking element is held on a plunger means, a retraction mechanism could also be formed by designing a spring means on the plunger element. However, the retraction mechanism could also be provided by the elastic dimensional stability of a deformable wall area which holds the pricking element directly.
The blood analyzer according to this invention can be manufactured with an essentially circular disk-shaped housing body and/or a circular disk-shaped outside contour. Thus it could be designed in particular in the manner of a watch casing, in particular in the manner of wristwatch housing and in addition could include a time display device. At any rate, it has proven advantageous if the housing body can be worn on the wrist of a user by using a tape mounted in the housing.
In addition, this invention relates to a pricking device for taking a minimal amount of blood from the human or animal body for the purpose of analysis. This pricking device may be designed in the form of an independent instrument or integrated into the blood analyzer described above to form a complete all-in-one instrument. The discussions and descriptions of the pricking device described below and its preferred features are thus regarded as essential to the invention either separately or in combination with the blood analyzer described above and/or in any combination with these features.
This invention thus relates to a pricking device for use in taking a minimal amount of blood from a human or animal body for the purpose of analysis, comprising a housing body and a plurality of pricking elements, wherein the plurality of pricking elements is arranged in or on a support and can be inserted into the housing body together with the support and can be removed from the housing body again after use, whereby a particular pricking element in a working position can be pricked with its pointed end into a skin surface of a user brought into the pricking position on the housing body, and this invention also comprises an ejector device which acts on the pricking element in its working position.
Such a pricking device is known from German Patent 10057832 C1.
Other pricking devices having a plurality of pricking elements are also known from U.S. patent 2002/0087056 A1 or WO 02/36010 A1.
European Patent 0 589 186 B1 describes, for example, providing the ground tip of a pricking element with a safety cap means which is manually twisted off before executing the pricking process.
According to WO 01/66010 A1, a plurality of pricking elements may be accommodated in independent compartments of a magazine, a respective opening in the compartment being sealed by an elastic material which can be punctured in the pricking operation.
Based on a pricking device according to German Patent 100 57 832 C1 mentioned above, the object of the present invention is to improve upon the handling of the pricking element inside the housing body and to ensure effective protection of the free ends of the pricking elements without thereby making the execution of the ejection process too complicated or being associated with any great demand for space.
This object is achieved according to this invention starting from a pricking device of the type defined in the preamble such that a particular pricking element is accommodated in a holding body in at least some areas and an end section of the pricking element which forms the pointed insertable end is surrounded by a detachable safety cap means; the longitudinal dimension of the respective element with the holding body and the safety cap means amounts to ≦15 mm in the pricking direction and the safety cap means can preferably be brought out of the path of movement of the pricking element by means of an internal displacement element before execution of the pricking process, preferably across the pricking direction.
As indicated above, the pricking device may be integrated into a blood analyzer so that the following is also regarded as inventive: a blood analyzer for determining an analyte such as fructosamine, lactate, cholesterol or especially glucose on minimal amounts of blood taken from a user immediately prior to that, comprising a housing body, a blood sampling or pricking device having a pricking element and an ejector device for the pricking element, comprising a test means for receiving a minimal amount of blood, with an analyzer device comprising an electronic analyzer and with a display device forming a complete system that can be handled as a single instrument, whereby the housing body has a pricking position associated with the working position of the pricking element for bringing a skin surface of a user in contact with the pricking element and a charging position which is provided in particular on another location on the housing for charging a minimal amount of blood that is escaping from the previously pricked skin surface onto a test means, whereby a plurality of test means and pricking elements can be inserted into the device accordingly, the test means and pricking elements being suitable for performing several measurements in succession in a working position, whereby when a pricking element is positioned in its working position, the pricking element can be used to prick the skin surface of a user, said skin surface having been brought in contact with the pricking position, so that blood escaping from the skin surface can be charged to a test means by applying the skin surface to the charging position, which is in a working position of the test means, whereby the blood analyzer is further designed so that a respective pricking element is accommodated in at least some areas in a holding body and the end section of the pricking element forming the pointed insertable end is surrounded by a detachable safety cap means; the length dimension of the respective pricking element with the holding body and the safety cap amounts to ≦15 mm in the pricking direction, and the safety cap means can be brought out of the path of movement of the pricking element by means of a displacement element inside the device before execution of the pricking operation, preferably across the pricking direction.
Due to the fact that a respective element is accommodated in a holding body which may be in particular a plastic injection molded part which is integrally molded onto the pricking element, an extensive miniaturization of the pricking element to a maximum dimension of 15 mm, in a preferred embodiment max. 14 mm and in particular max. 13 mm can be achieved, whereby the length dimension also includes the holding body and the safety cap means. The safety cap means inside the pricking device is removable from the path of movement of the pricking element immediately before the execution of the pricking operation. For example, the respective safety cap means could first be pulled away from the pricking element in the pricking direction so that it exposes the free end of the pricking element so that it can be brought to the side preferably across the pricking direction and can be brought to the side automatically by means of a displacement element to then be able to execute the pricking operation. It would also be conceivable for the respective safety cap means to remain initially in its position and for the pricking element to be retracted slightly in the direction opposite the direction of pricking so that the free end of the pricking element is released from the safety cap means.
Although the safety cap means could be brought onto the free pointed end of the pricking element independently of the production of the holding body, in the mean time it has proven advantageous from the standpoint of manufacturing technology, especially in view of the desired miniaturization, if the safety cap means is also integrally molded on the pricking element, preferably in the same operation together with the holding body. In such a case, the safety cap means can show a transition to the holding body in one piece by way of a section which forms a weakened area or an intended breaking area. This simplifies handling of the pricking elements directly following their manufacture.
Although the section forming the weakened area or the intended breaking area could be detachable by twisting off the safety cap means, but following the discussion above, it has proven more advantageous if the section forming the weakened area or intended breaking area can be broken in response to tensile stress in the longitudinal direction of the respective pricking element, i.e., in the pricking direction.
To release the safety cap means, it could be removed by essentially any type of displacement means, e.g., in the form of a ram or sleeve, by first pulling it off the pricking element in the pricking direction or, as already mentioned, the pricking element could be moved backward in the direction opposite the pricking direction and thereby removed from the safety cap means. According to an especially preferred embodiment of this invention, the safety cap means is releasable from the pricking element in applying tension to the ejector device. Thus a movement to release the safety cap means is associated with applying tension to the ejector device. In particular, the pricking element is then retracted in the direction opposite the direction of pricking.
According to another inventive idea, the holding body for the pricking element not only has a holding function for the pricking element but also has a guidance function in the execution of the ejection process. The outside shape of the holding body is complementary to that of the guide means, e.g., in the form of guide walls for slidingly displaceable arrangement of the pricking element.
In another embodiment of the holding body, it has at least one position securing means, in particular in the form of a protruding web. Such a protruding web may keep the holding body and thus the pricking element in a position in the plane, for example, i.e., it may prevent rotation about the longitudinal axis of the pricking element, in particular during the ejection process, or the pricking element may slide out of the support when replacing a pricking element support.
However, a particular holding body may also have a web that is elastically spreadable in the pricking procedure and can thus exert a retraction force on the pricking element, so that the holding body together with the pricking element is retracted again behind a contact face on the housing body.
For the execution of the pricking procedure, it would be conceivable for the pricking device to have an ejector element which is under spring tension and strikes one end of the holding body and/or the respective pricking element in the pricking direction and moves it suddenly in the pricking direction. On the other hand, it has proven advantageous if the respective holding body has engagement means that cooperate with the pricking device. By means of these engagement means, a particular holding body can be coupled to the pricking device and in particular can be moved into an activated position with the tension applied to the pricking device. In this way, as mentioned above, the safety cap means can be released from the pricking element to release the safety cap means in this way, it is necessary for the safety cap means to strike against a stop means or to be otherwise held back. In an advantageous manner, the respective safety cap means is held in a form-fitting manner with respect to the support in the longitudinal direction of the pricking element so that it does not participate in this regard in a movement of the holding body together with the pricking element but instead is released from the holding body and the pricking element.
It has also proven advantageous if the safety cap means is movable across the path of movement of the pricking element in a force-guided manner. This may be accomplished expediently by a complementary design of the support or components on the support and the safety cap means. It is pointed out explicitly that a concrete design of the safety cap means is not necessary for this purpose but instead there must always be a complementary design of the outside contour of the safety cap means and suitable receptacles, preferably in or on the support, so that immediately after the safety cap means is released from the pricking element and/or from the holding body of the pricking element, the safety cap means can be moved along this forced guidance out of the path of movement of the pricking element by means of the displacement element inside the device.
To move the safety cap means reliably and rapidly, in particular out of the path of movement, it is preferably under an initial tension, in particular across the path of movement of the pricking element. The displacement element is advantageously directly or indirectly under a prestress against the safety cap means. To avoid a relative movement between the safety cap means and the displacement element, it has proven advantageous that a displacement element is permanently assigned to each safety cap means, i.e., even outside of the respective working physician.
It should also be pointed out that for the design of the displacement element, no obligatory requirements need be made except that after displacement of the released safety cap means the path of movement for the pricking element must be released again. In particular in this regard, it has proven to be advantageous if the displacement element has a U-shaped strap in particular which moves the safety cap means out of the path of movement of the pricking element. Due to the strap-like design, the displacement element may continue to apply a load against the safety cap means even after the displacement operation so that the pricking element can move between the legs of the strap.
It has proven to be especially advantageous that the support has disposal positions for a respective safety cap means such that the particular safety cap means can be accommodated in a manner in which it cannot be lost after being separated from the pricking element. It has proven to be especially advantageous that receptacle positions defined in this way, in particular receptacle cavities, are provided on the support and that the safety cap means can be removed from the housing body together with the support.
According to another inventive idea, the particular safety cap means is accommodated in a clamped position in its disposal position so that it is accommodated there without causing any interfering noises. For example, it may be held under pretension of load against a wall of the support. It has proven to be particularly advantageous if the displacement element can be used for this purpose. To this end, it is advantageously designed such that it is in surface contact with the safety cap means, at least in the disposal position.
With regard to a compact design of the device, it has proven advantageous that the safety cap means is under pretension on the free end of the pricking element in its starting position, and in its disposal position, it is under pretension by the same means in particular and preferably by the displacement element.
The displacement element is preferably mounted on the support so that it can be inserted with the support into the housing body.
In a preferred embodiment of this inventive idea, the displacement element is provided on the support in such a way that it holds the pricking element with their holding bodies and the safety cap means reliably so that they cannot be lost but at the lost time so that they are slidingly displaceable on the support. In such a case it has proven advantageous if the displacement element is designed as a spring element which is in contact with the safety cap means under a load. With a rotatable design of the support for the pricking elements, the displacement element may be designed as a spring ring having spring tongues protruding radially.
Preferred embodiments of the ejector device are explained below. The ejector device may be a plunger means that can be put under tension or a ram means as an ejector element for executing the pricking operation. Although it is conceivable for the ejector element to strike the free end of the holding body or the pricking element to accelerate it suddenly, it has proven advantageous if an ejector element of the ejector device is already connected to the holding body even before the execution of the ejection process. For this reason, the ejector element has a coupling area which can be coupled to the holding body for the pricking element so that the ejector element and the pricking element are in entraining connection even before the execution of the ejection process, i.e., the ejector element together with the holding body can execute a tension movement.
The form-fitting connection between the ejector element and the holding body and/or the pricking element can be achieved through any desired clamping means, catch straps or similar detachable connections. However, in another embodiment of this invention, the coupling area of the ejector element and the holding body can be coupled in such a way that the two can be moved in relation to one another across the pricking direction into a form-fitting entrainment connection. In such a case it is not necessary to use any flexible claws, catch means or clamping means. In particular in the case of a concentric rotatable arrangement with radially aligned pricking elements, the holding body and the coupling area of the ejector element can be rotated into the entrainment connection in the peripheral direction of the rotatable arrangement.
To apply tension to the ejector element of the ejector device against a tension force, the ejector element has a tension cam which protrudes across the pricking direction. Again, any design of the ejector device would be conceivable for applying tension to the ejector element, but the tension cam described has proven to be advantageous inasmuch as it allows a displacement of the tension mechanism for the ejector element into a parallel plane. The tension cam may then be guided in an advantageous manner along a curved path of an adjustable or operable tension means. During this movement of the tension cam along the curved path, the ejector element which is force guided in a linear path is brought into an activated state in which it is under tension. The above mentioned curved path may advantageously be a cam path or a cam guidance path of essentially any desired implementation.
It has also proven advantageous that after executing the movement in the tension direction, the tension means can be moved back under the control of a spring force. This may be, for example, a lever which is disk-shaped in particular and is mounted so that it can be pivoted or rotated, applying tension to a recoil spring with its movement in the tension direction. For example the tension means may include a lever which protrudes above the housing of the pricking device and can be deflected manually in the tension direction and returns automatically to the starting position when released again.
In an embodiment of this invention which is especially important, the tension means for applying tension to or activating the ejector device is also an adjusting means to bring a particular pricking element into a working position and to bring a used pricking element into a disposal position. Thus in particular the support with the pricking elements may be advanced by one step, in particular by rotating it further. Instead of advancing the support, it would also be conceivable to advance the ejector device in relation to the support. According to the inventive idea explained above, one adjusting movement causes the ejector device to be activated and a new, as yet unused pricking element to be brought into the working position and/or the ejector device to be brought into the working position.
The tension means, i.e., the tension mechanism may be designed and arranged in such a way that in a first phase of the movement, it is in a driving connection with the support for the pricking elements and in a second phase of the movement it is in a driving connection with the ejector element. In such a case the driving connection between the tension means and the support may be released at the end of the first movement phase by having the tension means or an arm of the tension means slide up against a ramp means. In this way it is possible to achieve the effect that despite operation by the same tension means, a new pricking element is brought into the working position first in the first phase by restoring the support and in particular is coupled to the ejector element and then in the second phase of the movement, the ejector element is moved in the tension direction, in particular together with the pricking element coupled to it.
It has already been pointed out that the prinking device may contain additional components and in particular together with a plurality of test means, an analyzer device and a display device, it may form a blood analyzer which can be handled as a single device, also known as an all-in-one device.
In such a case it has proven advantageous that the test means can also be brought one after the other into a working position in which the required minimal amount of blood can be applied to the particular test means from a previously pricked skin surface of a user. The test means may be for example membranes with test reagents contained in them with the help of which the analysis is performed optically or electrochemically or electrophysically in a known way which therefore need not be described in greater detail here. For example, in this way an analyte such as fructosamine, lactate, cholesterol or in particular glucose can be qualitatively and preferably also quantitatively determined in the minimal amount of blood just sampled.
According to a preferred embodiment of this invention, the pricking elements and/or the test means are arranged concentrically with a point of rotation so that their respective working positions are rotatable. Therefore, a first support for the pricking elements and a separate second support for the test means are advantageously provided. However, these supports may also be combined to form one unit so that they can be inserted into the device and removed from the device as one easy-to-manage unit.
With respect to extensive miniaturization of the device, it has proven to be especially advantageous if the pricking elements have a recessed circular segment with a radial arrangement on the support so that the support can be inserted into the housing body in such a way that the ejector device extends into this circular segment. Therefore due to the fact that no pricking element is provided in pie-shaped circular segment which may encompass in particular 100 to 200 in the circumferential direction, the ejector device may extend into the circular segment in the radial direction in this area. Therefore the insertion of the support with the pricking elements and optionally also with the test means into the housing body is not prevented by the ejector device. This also proves to be advantageous when-as described above-a particular pricking element and/or a holding body for a particular pricking element and an ejector element of the ejector device are rotated in relation to one another into a coupling connection.
Additional details, features and advantages of this invention are derived from the patent claims and the attached drawings and the following description of a preferred embodiment of this invention. It should be pointed out that each feature claimed in the patent claims is considered essential to this invention, regardless of how the features are combined and regardless of their reference back to the claims, so that patent protection is also claimed for specific embodiments of the blood analyzer or the pricking elements, the support(s), the ejector device, the driving mechanism and adjusting mechanism for the pricking elements, regardless of the design of other components, in particular regardless of the design currently claimed for the blood analyzer according to claim 1.
In the drawings:
a through c show the production process for a pricking element;
The housing body 4 of the blood analyzer 2 according to this invention is designed in a circular disk shape in the manner of the casing of a wristwatch. It also includes opposing fastening means 16 in the form of two aligned openings 18 to receive a strap of an essentially conventional wristwatch band.
A pricking position 22 is formed on a wall 20 of the housing body 4 which is in the shape of a cylindrical section for coming in contact with a skin surface, in particular of a user's finger. The pricking position 22 is formed by a sliding part 24 which is movable in the circumferential direction with respect to the wall 20 and has a through-opening 26 in the form of an elongated hole extending in the circumferential direction such that a pricking element 8 can be pushed through the opening so that the skin surface of the user can be pricked to obtain a minimal amount of blood. By adjusting the sliding part 22 [sic; 24 above] in the circumferential direction, the depth of penetration of the pricking element 8 can be adjusted. The pricking element 8 in
As shown by
The segment 28 is held displaceably along a convexly curved side 36 facing inward by means of a sliding guide rail 38 with an engagement place on the remaining housing body 4. When the blood analyzer is not in use, this segment can cover the charging position 30 so that its other convexly curved side 42 which is provided with a grooved gripping surface 40 forms a part of the cylindrical outside 20 of the housing body 4.
When a blood analysis is to be performed, the user slides the segment 28 into the position illustrated in
The support 50 as a fist support part 52 in the form of an essentially planar ring disk 54 for the test means 10 and a second support part 56 in the form of a strip 58 which is curved into a circular shape and has pricking elements 8 held on it, arranged in radial direction.
The second support part 56 is placed on another ring disk-shaped support part 60 the plane of which extends parallel to the first support part 52. The second support part 56 and this additional support part 60 are coupled together in a rotationally fixed manner by recesses 62 on a part and intermeshing projections 64 on the other part. The recesses 62 and the projections 64 may also cooperate in a frictionally engaged manner so that the second support part 56 is permanently joined to the additional support part 60. The first support part 52 can be clipped in a similar manner onto the second support part 56 by the fact that form-fitting and/or preferably clamping recesses 62 and projections 66 between these two parts work together cooperatively.
The test means 10 are arranged in concentric recesses 68 provided on the first support part which are punched recesses or punched holes. They are arranged in such a way that they are accessible in the axial direction, i.e., in the direction of an axis of rotation 70 of the support 50. In the case of each test means 10, contacts 69 are indicated on the top side of the first support part 52, such that an electrode array (not shown) of the test means can be contacted and can be connected to the electronic analyzer. Thus in the present case, electrochemical test means are used; such means are adequately well known and therefore need not be described in greater detail here.
The radially arranged pricking elements 8 on the second support part 56 each pass through a spring element 74 which can be put under tension in the radial direction. The pricking elements 8 have a thickened head 76 on the inside radially which cannot move due to the spring 74. In ejection of the spring element 74 in the radial direction, the spring element 74 is therefore put under tension, therefore causing a radial retraction of the spring element 74 essentially into the position shown in
The three support parts 52, 56 and 60 are designed in the form of a ring and have a central recess 80 in which the ejector mechanism 44 is accommodated, as shown in
In the sectional view according to
Additional embodiments of the design of the blood sampling device are explained below. In a perspective view,
The sleeve means 100 have a cover 112 in the form of a film section on the outside radially such that the pricking element can either puncture through the film section or the film is partially or entirely removed immediately before executing the operation.
As shown by the detailed diagram in
A spring ring 148 is preferably undetachably connected to the support 142 from above by essentially any known joining means such that the holding rams 144 are movable in the radial direction but are held so they cannot be lost. A web 150 of the spring ring 148 arranged above a respective safety cap means 147 exerts a slight pressure in the axial direction on the safety cap means 147. The ejector mechanism of the blood sampling device is designed in the present case so that immediately before execution of a pushing, i.e. pricking operation, the holding ram 144 which is in the working position is pulled slightly toward the inside radially. In doing so, the safety cap means 147 is initially held in its position by stop means so that the respective pricking element 140 is released from the safety cap means 147. The safety cap means is then moved into a recess 152 in the support part 144 under the action of the resilient web 150 so that the safety cap means is brought out of the path of movement of the pricking element 140. This process of retracting the holding ram 144, releasing the safety cap means 147 and bringing the safety cap means out of the path of movement of the pricking element is depicted in
It includes a support part with holding rams 172 that are arranged so they can move radially and have pricking elements each of which is covered by a safety cap means 174, the arrangement here largely corresponding to that according to
The ejector element 184 also has on its circumference a holding means 194, e.g., in the form of a ring groove by means of which the ejector element 184 can be held in the receptacle 182 when tension is applied to the spring 188. This can be accomplished by a catch mechanism, which is formed in the present example by a clamping spring 196 and cooperates with the holding means. The ejector element 184 has an engagement means 198 on its outer end radially to retract the holding ram 172 in order to release the safety cap means 174. The engagement means engages behind: an engageable section 200 of the holding ram 172. This engageable section may be formed by a thickened end 201 which is therefore also designed to accommodate a pushing force and is on the holding ram 172.
A control lever 202 which is designed to cover an area and can rotate about the axis of rotation 70 of the support part 170 is provided on the outside of the support part 178. The control lever 202 comprises a cam control surface 204 which cooperates with a cam means 206 of the ejector element 184 which extends in the axial direction through a recess 208 in the bottom of the support part 178. When the control lever 202 in
In addition, the control lever 202 has an entraining means 210 in the form of a catch lever 212 which is elastic in the axial direction and by means of which the support part 170 and thus the arrangement of the pricking elements can be rotated in the circumferential direction. To this end, the catch lever 212 engages through a recess 214 which extends in the peripheral direction in the bottom of the support part 178 and grips the support part 170. Therefore the support part advantageously has a crown catch arrangement 216 which is merely indicated in
When the control lever 202 is rotated starting from the position illustrated in
To ensure that a particular pricking element is positioned exactly in the working position of the pricking elements and its not transported further inadvertently, a transport interruption device 220 is provided exactly in this rotational position. This transport interruption device 220 is designed for example and in an advantageous manner so that it causes an axial deflection of the catch lever 212 so that its entrainment means 210 can no longer cooperate with the crown catch arrangement 216. Therefore, the catch lever 212 includes a radial projection 222 which slides toward an outside of the support part 178. This outside of the support part 178 has a slope 224 at an appropriate location which raise the catch lever in the axial direction in the sense described above when the control lever 202 reaches this slope 224 in its rotation. When the control lever 202 is rotated back, the entrainment means 210 of the catch lever 212 slides over the oblique flanks of the crown catch arrangement without causing the support part 170 to rotate back however. To reliable prevent the support part 170 from turning backwards, a reverse rotation prevention device 226 is divided, this device being implemented in an advantageous manner through a suitably oriented crown catch gearing 228 on the inside of the support part 178, as illustrated for example in
When the control lever is turned further according to
Finally,
At the next moment, the restoring spring 192 causes a retracting movement of the ejector element 184 into the starting position shown in
The driving device for a pricking element which is in the working position shall be referred to on the whole with reference number 250 and comprises an ejector mechanism 44 with a ram 48 which acts on the respective pricking element. The driving device 250, however, also includes a tension mechanism which is formed in the present case by the first gear wheel 246 and a bending spring 252, and has a triggering device 254 comprising a lever arrangement 256.
The bending spring 252 is attached at one end on a bending spring receptacle 258 on the second gear wheel 246 and at the other hand on a bending spring receptacle 260 on a component 262 which can be swiveled with respect to the housing body 4. This swivelable component 262 is part of the lever arrangement 256 which connects this component 262 to a pushbutton 264 in the pricking position 22 on the housing body 4.
In the outward movement of the covering part 28, the second gear wheel 246 does not rotate just the support part 60 further, but instead swivels the bending spring receptacle 258 and thereby puts the bending spring 252 in a taut state. By operating the pushbutton 264, the other bending spring receptacle 260 is also pivoted by the lever arrangement 56 so that the bending spring 252 is suddenly relaxed from its stable taut state in which it is under tension beyond a dead point, thereby causing the ram 48 to be pushed radially outward and this in turn causes the respective element to execute the pricking operation also by pushing it radially outward. This movement sequence is illustrated in
When minimal amounts of blood for applying to a test means of the blood analyzer were mentioned above, this was understood to refer to quantities of blood of <20 μL, in particular <10 μL and preferably <5 μL.
Above the pricking elements 8′, a ring disk 18′ made of spring steel can be seen in
Above the ring disk 18′ there is a second support 20′, illustrated with the contact 22′ which is indicated schematically for the test means 24′ provided in the area of the contact 22′ for performing the blood analysis, i.e., for determining the presence and concentration of an analyte, e.g., blood sugar, lactate, cholesterol or fructosamine. It would be conceivable for these membrane-like test means 24′ which are not shown in detail but are in particular like a membrane to be acted upon by the required minimum amount of blood through a charging opening in the cover part 4′ of the pricking device. However, it would also be conceivable for an analytical test strip (not shown) to be output through a slot-shaped opening 28′ and to be wetted with a minimal amount of blood. Then an analysis can be performed by amperometer or potentiometry via the contact 22′ and an analyzer device (not shown). Inclusion of separate analysis test strips would also be conceivable; these test strips could then be inserted through the slotted opening 28′ to the contact 22′ on the support 20′ which is thus not included in the interior of the housing body 6′ on the support 20′. In a preferred embodiment, however, the second support 20′ carries a number of test means 24′ corresponding to the number of pricking elements 8′.
A display device having a display screen can be mounted on the visible side of the covering part 4′ which faces upward in
In the middle of the dome-shaped elevation 36′, the ejector device labeled with reference number 10′ on the whole is accommodated. It includes an ejector element 50′ which is to be described in greater detail below, an ejector spring 52′ and a restoring spring 54′, a triggering means 56′ and a cover 58′. The ejector device 10′ can be activated by swiveling the operating lever 40′ and thus the disk-shaped component 42′ by applying tension to the ejector element 50′ against the pressure of the ejector spring 52′. By operating the triggering means 56′, the ejector element 50′ is ejected in the radial direction and executes a pricking operation together with a pricking element 8′, whereupon the pricking element 8′ is briefly pushed forward over the contact position 60′ shown in
The components mentioned briefly above will now be described in greater detail below in terms of design and function on the basis of individual diagrams:
A web 74′ which has a rounded free end 76′ and is formed in one piece with the holding body 62′ and stands away from it can also be discerned forming an oblique angle of approximately 400 to the longitudinal direction of the pricking 8′. The web 74 is designed to be spreadable in the direction of the double arrow 78′ or elastically deformable with respect to the cube-shaped holding body 62′ for the element 8′. On the one hand it ensures a stabilization in the contact plane for the holding body 62′ and prevent tilting about the longitudinal direction, for example. After executing a pushing operating, however, it may also initiate a retraction torque into the holding body and thus into the pricking element 8′, thereby retracting the latter again. It also secures the pricking element 8′ to prevent it from sliding out of the guide recesses 16′ in the support 14′.
The safety cap means 64′ has an H-shaped design when seen from above. It has guide recesses 80′ on both sides with which it is held on the support 14′ so that it cannot be displaced in the longitudinal direction of the pricking element 8′, i.e., in the radial direction, but on the other hand, it can slide laterally, namely normal to the longitudinal direction of the pricking elements 8′ with respect to the support.
a, b and c illustrate the dimensioning of the pricking element which is largely miniaturized with the holding body and the safety cap means. In its longitudinal direction it includes a length of only 12.5 mm, including the holding body 62′ and the safety cap means 64′.
In addition, strip-shaped guide bars 104′ oriented in the axial direction and engaging in the guide recesses 80′ of the respective safety cap means 64′ can also be seen in
Putting the ejector device 10′ under tension will now be described. As shown in
A web 134′ on the disk-shaped component 42′ extending in the circumferential direction can be seen in
Thus, on the whole this invention makes available a pricking device with miniaturized pricking elements, thereby making it possible to design the pricking device in the manner and size of wristwatch to be worn on a user's wrist. The pricking device may also be integrated into a blood analyzer or it may have the components of a blood analyzer of the type described above. The pricking device includes a plurality of pricking elements, in particular between five and twelve, which are inserted as a cassette on the support 14′ into the housing body 6′. To do so a user flips open the cover part 4′ and places a support cassette in the interior, paying attention to certain orientation marks. The cover part 4′ is then closed and a first pricking element 8′ is brought into the working position via the operating lever 40′. In doing so, the pricking element 8′ and/or its housing body 62′ is brought into an entrainment coupling with the pushing element 50′ and is pulled radially inward following that. In this process, the safety cap means 64′ on the free end 65′ if the pricking element 8′ is separated and is brought into a disposal position 103′ on the support 14′ across the pricking direction 12′. When the pricking device 10′ activated in this way is released, the pushing element 50′ together with the molding body 62′ and the pricking element 8′ is accelerated suddenly in the radial direction by the release of the pushing spring 52′ and is thus brought again into the starting position by means of the recoil spring 54′. By operating the operating lever 40′ again, the support 14′ is again rotated beyond the shoulder 140′, i.e., the used pricking element is rotated out of the working position and a pricking element that has not yet been used is brought into the working position, etc. When all the pricking elements have been used, the support 14′ cannot be moved further because of a stop, and the user is notified in this way that a new cassette with new pricking elements must be inserted.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10208575.7 | Feb 2002 | DE | national |
| 60411834 | Sep 2002 | US | national |
| 10245721.2 | Sep 2002 | DE | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/EP03/01700 | 2/20/2003 | WO | 5/31/2005 |
