Blood lancet with hygenic tip protection
4 claims: 2 independent, 2 dependent
- 1Lanzette enthaltend eine Lanzettennadel mit einer Spitze und einem der Spitze entgegengesetzten Ende sowie einem ersten Lanzettenkörper oder einem Kopf, der an dem der Spitze entgegengesetzten Ende der Lanzettennadel angeordnet ist und wobei der erste Lanzettenkörper oder der Kopf im Zusammenspiel mit geeigneten Elementen einer Stechhilfe während des Stechvorgangs mit diesem wechselwirken kann sowie einem zweiten Lanzettenkörper, der die Lanzettennadel ausschließlich im Bereich der Spitze vollständig umgibt, wobei der zweite Lanzettenkörper im Bereich der Spitze der Lanzettennadel aus einem elastischen und von der Lanzettennadel mit der Spitze durchstoßbaren Material besteht.
- 2Lanzette gemäß Anspruch 1, dadurch gekennzeichnet, dass die Spitze der Lanzettennadel in den zweiten Lanzettenkörper eingebettet ist.
- 3Lanzette gemäß Anspruch 1, dadurch gekennzeichnet, dass der zweite Lanzettenkörper ein Hohlkörper ist und der Hohlkörper zumindest teilweise aus dem elastischen und von der Lanzettenspitze durchstoßbaren Material besteht.
- 4Stechhilfe mit einem Antriebselement, das mit einem ersten Lanzettenkörper, oder einem Kopf der an einem einer Spitze entgegengesetzten Ende eine Lanzettennadel gemäß einem der Ansprüche 1 - 3 angeordnet ist, zusammenwirkt, so dass die Lanzettennadel in Einstichrichtung bewegt wird und ein Stechvorgang ausgeführt werden kann.
Independent claims4
60 paragraphs, as filed
p0001The invention relates to a lancet comprising a lancet needle with a tip and a lancet body which completely surrounds the lancet needle at least in the region of the tip.
p0002The examination of blood samples in clinical diagnostics enables the early and reliable detection of pathological conditions and also specific and reliable monitoring of physical states. Medical blood diagnostics always requires the collection of a blood sample to be examined individual. While often be obtained in hospitals and to private practitioners by venipuncture several milliliters of blood too examinee for the analysis to allow it to perform a variety of lab tests are sufficient for individual analyzes which are targeted to a parameter nowadays often few microliter blood. Such small amounts of blood do not require venipuncture. It is sufficient here to collect blood through the skin z. B. in the fingertip or earlobe of the examined person to push through a sterile, sharp lancet to win so few microliters of blood for analysis. This method is particularly suitable, if the analysis of the blood sample can be carried out immediately after the blood collection.
p0003Especially in the area of so-called "home monitoring", ie where medical laymen themselves carry out simple analyzes of blood, and there in particular for the regular, several times a day blood collection by diabetics for the control of blood glucose concentration, lancets and associated devices (so-called blood collection devices, blood lancet devices or - as they are to be hereinafter referred to as - lancing devices), offered to allow the least possible discomfort and reproducible blood collection. In addition to lowering with lancing devices the psychological threshold when the sting of his own body, the use of lancets, which are dependent mainly for children who have diabetes and regular blood glucose tests, is of particular importance. Examples of lancets and lancing devices, the commercially available devices (lancing devices) and lancets Glucolet® Bayer AG and Softclix® Roche Diagnostics GmbH are mentioned. Such lancets and devices (lancing devices) are z. B. Object of<patcit id="pcit0001" dnum="WO9848695A"><text>WO-A 98/48695</text></patcit>. <patcit id="pcit0002" dnum="EP0565970A"><text>EP-A 0565970</text></patcit>. <patcit id="pcit0003" dnum="US4442836A"><text>US 4,442,836</text></patcit> or <patcit id="pcit0004" dnum="US5554166A"><text>US 5,554,166</text></patcit>,
p0004The lancets of the prior art usually have a metal lancet needle with a tip which may optionally be sanded. For easier handling of the lancet and optionally for its attachment in a lancing device, a plastic lancet body is in many embodiments of most of the lancet needle injection molded from a rigid, injection-moldable material. The tip of the lancet needle is - surrounded to ensure their sterility by a protective sheath - in unused condition. This is usually made of the same rigid material as the actual lancet body and usually forms a unit therewith. The protective sheath can be separated before using the lancet from the lancet body and removed from the tip of the lancet needle. Between the lancet body and a protective case for this purpose is usually a predetermined breaking point. After using the lancet tip of the lancet needle is present unprotected and thus represents a potential source of injury to the user and possibly other persons.
p0005To avoid accidental injury on a used lancet needle is users often advisable to insert the tip of the lancet needle after use into the previously removed protective cover. However, the experience that is far from all users follow this recommendation and therefore a large proportion of used lancets are discarded with unprotected tips teaches.<patcit id="pcit0005" dnum="US5304192A"><text>US 5,304,192</text></patcit> and <patcit id="pcit0006" dnum="WO9602189A"><text>WO-A 96/02189</text></patcit> propose as a solution to this problem lancet, in which the tip of the lancet needle can be pushed or pulled after use in the lancet body. Since the lancet body is made in such cases of a non-elastic, substantially rigid or stiff material, the tip of the lancet needle is indeed hidden in the lancet body, but not shielded completely hygienic because the material of the lancet body remains a channel through which the lancet tip with the environment is in contact.
p0006In the systems currently commercially available the provision of the lancet for use in lancing devices usually in bulk form is effected. The user manually removes before each lancing process the lancet from a package, such as a cardboard box or a tube in which a plurality of lancets disorganized, loosely contained poured. Subsequently the lancing device, prepared for example by unscrewing or pulling off a protective cap for receiving the lancet, the lancet holder of the lancing device is exposed. The lancet holder is used on the one hand the inclusion of the lancet. On the other hand, the lancet is performed during the actual lancing process by him. The removed from the pack is manually inserted lancet in the lancet holder of the lancing device and fixed there. Then, the protective sheath surrounding the lancet tip and both these and the user protection, are manually removed from the lancet must. Subsequently the lancing device is sealed with its protective cap. The cap ensures that the lancet from the outside is no longer accessible. They usually have an opening through which the lancet tip can emerge during the actual lancing process. Finally the lancing device is tensioned and is available for the lancing process for the recovery of blood available.
p0007The large number of manual steps of operation for conventional lancet systems (lancet and lancing device) is perceived by users as a disadvantage and is especially problematic with limited perception in the state of hypoglycemia. In addition, the user is not prevented from once to use an inserted lancet several times for lancing and blood gains. This is problematic for a from hygienic reasons, especially if more than one person, the lancet system used, as may be the case for example in medical practices or hospitals. For another, the repeated use of lancets to increasing pain for the user, because since the lancets are designed for single use, they will quickly become dull after repeated use. achieved as methods with the lancing devices and lancets of the prior art is a risk that lancing devices are used with non-matching lancet, ie with lancets, which are not suitable for a special lancing device type and therefore not optimal lancing results (reproducibility, pain poverty, resulting blood volume) be, or that the lancets are improperly inserted into the lancing devices. Furthermore, a user can violate unintentionally misuse of lancets and lancing devices.
p0008Therefore, there is no lack of attempts to eliminate the disadvantages mentioned. Out<patcit id="pcit0007" dnum="US5514152A"><text>US 5,514,152</text></patcit>. <patcit id="pcit0008" dnum="US5152775A"><text>US 5,152,775</text></patcit>. <patcit id="pcit0009" dnum="WO9814125A"><text>WO-A 98/14125</text></patcit>. <patcit id="pcit0010" dnum="US3030959A"><text>US 3,030,959</text></patcit>. <patcit id="pcit0011" dnum="US4794926A"><text>US 4,794,926</text></patcit> and <patcit id="pcit0012" dnum="US5035704A"><text>US 5,035,704</text></patcit> lancing devices are known to stockpile several lancets and can use them for piercing operations consecutively. After the lancing process the lancet can be individually removed from the device. The above-mentioned problems of used lancets are but with the lancet storage nor dissolved in these systems, as with systems which must be individually fitted with lancet manually.
p0009In summary, it should be noted that all of the concepts of the prior art for lancets and lancet systems ie lancing devices or devices that can stockpile the lancet in itself, have the disadvantage that the sterility, that is, the sterility of the unused lancet needle, especially the tip, not is guaranteed until immediately before the lancing process and a safe and hygienic disposal of the lancet once used is entirely up to the user. Especially for systems in which unused lancets should be kept next to used lancets, so particularly in lancet magazines and corresponding lancing devices, dispense the fact a once used lancet eject immediately and keep instead the lancets used up to the use of the entire lancet supply, this represents a significant problem.
p0010The object of the invention is to eliminate the disadvantages of the prior art. In particular, it is the object of the present invention to provide lancets in which at least the lancet needle tip in the unused state to sterile immediately before use, that is sterile, is kept and can be hygienically stored in the used state. Ideally, this task should be solved without the user having to take separate measures for the hygienic storage. In addition, the user should be protected from accidental injury by the lancet, in particular the used lancet.
p0011The object is solved by the subject matter of the invention, as characterized in the claims.
p0012A lancet contains a lancet needle with a tip and a lancet body which completely surrounds the lancet needle at least in the region of the tip, which is in the lancet, the lancet body at least in the region of the tip of the lancet needle of an elastic material, in which the tip of the lancet needle is embedded ,
p0013The lancets are designed for single use and should therefore be referred to as disposable blood lancets or disposable blood lancets. The lancet of the invention comprises a needle (lancet needle) with a tip. The needle is usually several millimeters (mm) to a few centimeters (cm) long and has an elongated shape. Typically, needles a cylindrical shape since this needle shape is particularly easy to manufacture; However, needle shapes with a different shape are possible. The tip portion of the needle includes the needle tip which is inserted in the intended use of the lancet into the tissue. The tip of the lancet needle is therefore the part of the lancet which comes into contact with skin of stabbing the individual, this violated if necessary and so the outflow of body fluid, in particular blood or interstitial fluid, causes.
p0014The tip of the lancet needle can for example be rotationally symmetrical as is generally the case for sewing needles. However, it has proven advantageous when installing one or more cuts at the needle tip. The case arising, inclined to the longitudinal axis of the needle, tapered in a tip edge during lancing serve as a sharp edge and make the puncturing process less painful than is the case with rotationally symmetrical needles.
p0015The lancet needle of the lancet according to the invention is made of a material which is sufficiently hard to withstand mechanical stress during the injection process, the processing steps or any other occurring loads without deformation. Furthermore, the material must be such that no particles break during the injection process, or pulling away. Finally the needle material must also be workable in that the needle tip sufficiently pointed and the edges of the needle tip can be ground optionally sufficiently sharp. Highly suitable materials for the lancet needle are above all metals and of these in particular stainless steels. However, also the needles of ceramics or plastics conceivable. Stainless steel needles are particularly preferred.
p0016According to the invention, the tip of the lancet needle of the lancet according to the invention of a plastic body which is to be referred to as the lancet body, surrounded. It is essential that the lancet body consisting of an elastic material in the region of the tip of the lancet needle. The tip of the lancet needle is completely surrounded on all sides by this elastic material, that is, in this embedded, and so cut off from the surrounding area. The elastic material of the lancet body, which can form the lancet body completely or only partially, in different embodiments, is characterized in that it is soft, deformable and pierced by the lancet needle with its tip without damaging the tip. During the lancing process the lancet needle is moved along its longitudinal axis relative to the lancet body and exits with its tip of the lancet body to so prick for blood collection in the skin to be examined individual can. An important feature is also that the elastic material optionally again closes upon retraction of the lancet needle in the lancet body tightly around the tip of the lancet needle. After the lancing process the lancet needle can be placed in a preferred embodiment, in a reversal of the movement during the lancing process in its initial position relative to the lancet body, in which the tip is again completely enclosed on all sides by the elastic material of the lancet body.
p0017The elastic material of the lancet body which completely surrounds the tip of the lancet needle ensures the sterility of the lancet needle tip prior to use, preferably until immediately before their use, and where applicable, for a hygienic enclosure of the lancet needle tip after their use. The elastic material is, therefore, germ-tight manner for the ingress or escape of pathogens, depending upon whether the lancet needle is unused or used. In addition the elastic material represents a mechanical protection for the lancet needle tip and thus also prevents accidental injury on the lancet needle tip.
p0018As the elastic material of the lancet body of the present invention, rubber, caoutchouc, silicone, elastomers and in particular thermoplastic elastomers have been found suitable. These include the essential for the present invention characteristics: they are soft, deformable, can be pierced by the lancet needle without damaging the tip and close tightly around the used lancet needle tip. Furthermore, they can be used for injection molding processes that allow mass production of lancets in large numbers.
p0019Thermoplastic elastomers, which are also called elastoplasts or thermal Laste or thermoplastic rubbers, ideally have a combination of properties of elastomers and the processing properties of thermoplastics. Thermoplastic elastomers are for example styrene oligoblock copolymers (so-called TPE-S), thermoplastic polyolefins (TPE-O), thermoplastic polyurethanes (TPE-U), thermoplastic copolyesters (TPE-E) and thermoplastic copolyamides (TPE-A). In particular, for example, have thermoplastic elastomers based on styrene-ethylene-butylene-styrene polymers (SEBS polymers, eg. B. Evoprene® of Evode Plastics or thermal load of K Gummiwerk Kraiburg GmbH) proved to be suitable.
p0020During the lancing process the lancet needle is moved relative to the lancet body. The latter is preferably fixed from the lancing device or the lancing device in position. The lancet needle can be especially formed for the purpose of their drive, for example, have a needle head at the top end opposite, or in addition to the lancet body which encloses the tip, have a further lancet body which can be moved by a drive element of the lancing device. The shape of the needle or the additional lancet body can interact appropriately with a corresponding drive device in the lancing device (lancing device).
p0021To achieve the advantage that the lancet needle tip is enclosed before use hygienically from the elastic material of the lancet body, and is also surrounded by their use hygienically from the elastic material, it is of course necessary, the lancet needle after use, ie largely in after the lancing process, their bring to original relative position with respect to the lancet body containing the elastic material. This can be achieved by appropriate interaction with a correspondingly adapted lancing device. It is only important that the lancet needle tip is enclosed by the elastic material of the lancet body after use again and so accidental injury is prevented at the needle tip.
p0022To increase the stability of the elastic material it is possible to combine it with a stiff material, for example a rigid plastics material. The elastic material may be, for example, on its outside, which does not come with the tip of the lancet needle into contact with a layer of rigid material, for example, a rigid plastic, stabilized. It is also possible to manufacture the lancet body only in the region of the lancet needle tip of an elastic material, however, to manufacture the lancet body from conventional, rigid plastics in the rest. In this case, the elastic material and the rigid material may be glued together or be joined together by an injection molding process, for example a two-component injection molding process. The stiff material of the lancet body ensures a mechanical stabilization of the elastic material during the lancing process and facilitates the fixing of the elastic part of the lancet body during the lancing process by the lancing device.
p0023Another object of the invention is a lancet containing a lancet needle with a tip and a hollow body which surrounds at least the tip of the lancet needle, wherein in case of the lancet according to the invention the lancet needle in the region of its tip in the hollow body is movable and the hollow body at least partially elastic from a material which can be pierced by the tip of the lancet needle during the lancing process and optionally closes after the retraction of the tip of the lancet needle in the hollow body.
p0024While the lancet described above according to the first aspect of the invention the lancet needle for the purpose of sterility prior to use and hygienic seclusion after use in the field of their tip sides completely thus surrounded and without remaining cavity at the tip of an elastic material embedding the lancet needle tip in itself, is the tip of the lancet needle is surrounded in the described now second object of the invention of a fully enclosed hollow body. Advantageously, this hollow body in the areas that do not come into contact with the tip of the lancet needle, made of a rigid, preferably injection-moldable material. is essential to the invention that the hollow body, is in the area where he is pierced during the lancing process the lancet needle tip of an elastic material.
p0025During the lancing process the lancet needle is moved relative to the hollow body which represents the lancet body moves. Support and drive the lancet needle and fixation of the lancet body can, as described above, can be realized by suitable constructional measures in the lancing device.
p0026The elastic material that makes up part of the hollow lancet body is pierced during the lancing process the lancet needle tip and closes optionally after retracting the lancet needle tip into the hollow body again and so seals the hollow body. The lancet needle tip is thus sterile sealed in the hollow body until immediately before use and is hygienically enclosed after use in it.
p0027The lancet of this subject invention comprises, like the lancet of the alternative inventive subject matter described above in addition to the lancet body which encloses the tip of the lancet needle, a further lancet body which with suitable elements of a lancing device during the lancing process interacts in interaction with these. Similarly, the lancet needle can be specially shaped, for example, have a head at the top of the opposite end.
p0028For the properties of the elastic material and the connection of the elastic material with the rigid material of the lancet body applies to the above with respect to the first object of the invention is said.
p0029The lancet of a set of lancets can be of the type that the lancet needle tip is around the top sides fully enclosed or encapsulated by an elastic material without whereabouts of a cavity, or of the type that the lancet needle tip is enclosed by a hollow body. The individual lancets, which in turn each consist of at least a lancet needle and a lancet body are interconnected in the set of lancets. Advantageously, the connection is via the lancet body. identical lancets are preferably connected to each other.
p0030The lancet may be joined together or to a carrier strip, for example of paper or plastic in the set of lancets either thin webs or bridges to be secured. Preferably, the compound of the lancet is done such that the individual lancet needles of the individual lancets of the set of lancets are enclosed in a continuous piece of elastic material. The elastic material may have in this case, the form of an elastic band. The elastic band as a connection form of several, preferably a plurality of identical lancet is preferably for the lancet according to the first aspect of the invention, that is the lancet, wherein the lancet needle tip is completely embedded in the elastic material, is suitable. However, it is also possible, an elastic band material as a connecting material for the lancet according to the second aspect of the invention, that is, the lancet with a hollow body to the lancet needle tip to use.
p0031In addition, the subject matter of the invention can be used in a lancet magazine with chambers for storing lancets. The magazine contains at least two lancets which each contain a lancet needle with a tip and which are each accommodated in individual, independent chambers of the lancet magazine. In this case, each chamber at least one opening for the exit of the tip of the lancet needle. The lancet magazine is characterized in that said opening of the chamber is closed by an elastic material. The elastic material is pierced by the tip of the lancet needle during the lancing process and closes optionally after the retraction of the tip of the lancet needle into the chamber again.
p0032Like the set of lancets, the lancet magazine of the common storage of unused lancets (coffering) and optionally also the storage once the used lancet is used (Wiederkassettierung). Unlike the set of lancets, the individual lancets in the case of the lancet magazine are not directly connected to each other but are located in individual chambers of the magazine. In this they are independently. In the magazine, the chambers are arranged regularly geometrically substantially, adjacent chambers include at least one, preferably two joint Wa (e) nd (e).
p0033The individual chambers of the magazine have at least one outlet opening for the tip of the lancet needle. This outlet opening is closed by an elastic material having the above mentioned characteristics, which were discussed in connection with the first aspect of the invention. During the lancing process the tip of the lancet needle can penetrate through the elastic material. The elastic material closes again if necessary during the retraction of the lancet needle tip into the chamber of the lancet magazine. The chamber is then resealed.
p0034the chamber of the lancet magazine can be sealed by suitable constructional measures that the lancet needle is sterile before use in the field of their tip and optionally hygienically shielded from the environment after use. For example, the lancet having a lancet body, which interacts with corresponding by suitable shaping of the inner wall of the chamber of the lancet magazine, so as to enable a sealing.
p0035The arrangement of the individual chambers in the lancet magazine can be arbitrary. For example, can be arranged side by side to give a substantially cuboid or bar-shaped magazine a plurality of lancet chambers. However, it is also conceivable that the chambers are arranged symmetrically about a central axis, so that a lancet magazine in the form of a drum (similar to the drum of a drum turret) results. However, Any other arrangements are also conceivable and possible.
p0036Finally, a subject is the use of an elastic material as a component of a lancet or of a lancet magazine, wherein the elastic material is used to maintain the sterility of at least the tip of a lancet needle in the unused state. In a preferred embodiment the elestische material can also be used to achieve a hygienic shielding at least the tip of a lancet needle in the used state.
p0037The use of an elastic material for shielding the tip of the lancet needle makes it possible to ensure the sterility of an unused lancet needle tip and optionally shield the used lancet needle tip hygienic.
p0038The sterility of the lancet needle tip in the unused state is required through appropriate measures, such as gamma irradiation. Once sterilized the lancet needle tips remain through the appropriate lancet body or an appropriate lancet magazine which include, among others, an elastic material obtained. Unlike in the prior art, where so far no elastic materials are described for shielding the lancet needle tips, but the use of the elastic material according to the present invention also enables the hygienic shielding the lancet needle tip used. The use of the elastic material is a possibly momentarily existing channel through which the lancet needle can pass for the purpose of piercing, after retraction of the lancet needle, ie after completion of the lancing process, resealed. Possibly adhering after the lancing process of the lancet needle tip contamination, in particular germs and infectious material can not reach the outside world thus. This is particularly advantageous for disposable lancets, which are disposed separately according to their use. From quite outstanding importance but this property is for lancets and lancet magazines sentences, are where stored next unused and used lancets, and which can then be disposed of as a whole.
p0039The invention has the following advantages:<ul><li>The tip of the lancet needle is in all embodiments of the unused state germ-proof shield, ie, germs can not penetrate to the lancet needle tip until immediately before using the lancet. After suitable sterilization the lancet tips remain sterile for a long time.</li><li>The tip of the lancet needle can be hygienically screened in all embodiments in the used state. Inadvertent contamination of the environment (user, objects, other lancets) is largely excluded.</li><li>The user of the lancet according to the invention is protected on a used lancet needle from accidental injury. The same goes for persons other than the actual user.</li><li>The lancets and lancing charges of the invention are inexpensive to produce in large numbers with conventional injection molding process.</li><li>The lancets and lancing charges of the invention are largely miniaturized and are therefore suitable for use in compact, automated systems.</li></ul>
p0040The invention is by the following <figref idrefs="f0001 f0002">Figures 1-6</figref> explained in more detail.
p0041The numbers in the figures denote:<dl id="dl0001" compact="compact"><dt>1</dt><dd>Lancet needle</dd><dt>2</dt><dd>Tip of the lancet needle</dd><dt>3</dt><dd>Lancet body made of elastic material</dd><dt>3 '</dt><dd>Edge of the lancet body 3</dd><dt>4</dt><dd>stabilizing layer</dd><dt>5</dt><dd>Lancet body made of rigid material</dd><dt>5 '</dt><dd>Protrusion of the lancet body</dd><dt>6</dt><dd>Closure of elastic material</dd><dt>7</dt><dd>Lancet body</dd><dt>8th</dt><dd>chamber wall</dd><dt>9</dt><dd>Lancet body</dd><dt>10</dt><dd>lancet</dd><dt>11</dt><dd>Set of lancets</dd><dt>12</dt><dd>Lancet (10) into chamber</dd></dl>
p0042In <figref idrefs="f0001">figure 1</figref> is displayed by a preferred embodiment of a lancet schematically a longitudinal section.
p0043In <figref idrefs="f0001">figure 2</figref> is represented by an alternate, also preferred embodiment of a lancet schematically a longitudinal section.
p0044In <figref idrefs="f0001">figure 3</figref> is shown by another alternative, a preferred embodiment of the lancet according to the invention, schematically, a longitudinal section.
p0045<figref idrefs="f0001">figure 4</figref> shows a schematic view of a preferred embodiment of a set of lancets.
p0046In <figref idrefs="f0002">figure 5</figref> is imaged by a chamber of a preferred lancet magazine including a lancet therein a schematic longitudinal section.
p0047<figref idrefs="f0002">figure 6</figref> shows another preferred embodiment of a lancet in a schematic sectional illustration.
p0048In the <figref idrefs="f0001">figure 1</figref> illustrated preferred embodiment of the lancet (10) contains a lancet needle (1) which is surrounded by a lancet body (3), which is made of an elastic material in the region of its tip (2). The tip (2) of the lancet needle (1) is completely surrounded by the elastic material of the lancet body (3). Outside the region of the tip (2) of the lancet needle (1), the lancet body (3) has a recess, which causes the lancet body (3) at least on one side of an edge (3 ') has, with the corresponding gripping or holding devices can interact in a lancing device to hold the lancet body (3). Sticking of the lancet body (3) is necessary because during the lancing process the lancet needle (1) relative to the lancet body (3) must be moved and can pass through it in the region of the tip (2) of the lancet needle (1) must.<figref idrefs="f0001">figure 1</figref> A shows the lancet (10) at the end of forward movement of the lancing process.
p0049The recess in the lancet body (3) also serves to reduce the frictional forces between the lancet needle (1) and the lancet body (3) during the puncturing movement.
p0050The cross section of the lancet needle (1) and the lancet body (3) perpendicular to the longitudinal axis of the needle preferably has a round shape. However, it is also possible that the cross section has any other shape, for example square or rectangular. It is also not necessary that the lancet needle (1) and the lancet body (3) in cross section have the same shape. For example, the lancet needle (1) may have a substantially circular cross section and the lancet body (3) have a rectangular cross-section.
p0051In <figref idrefs="f0001">figure 2</figref> is shown schematically in longitudinal section a further likewise preferred embodiment of a lancet (10). The lancet (10) consists essentially of the same elements as those in<figref idrefs="f0001">figure 1</figref> Illustrated lancet (10). Notwithstanding the in<figref idrefs="f0001">figure 1</figref> Lancet (10) is shown on one side of the lancet body (3) made of elastic material, applying a stabilizing layer (4). This stabilization layer (4) may be adhered to the lancet body (3). However, it is preferable that the stabilization layer (4) is joined together with the lancet body (3) in an injection molding process with the lancet needle (1).
p0052The stabilization layer (4) serves to prevent deformation of the elastic lancet body (3) during the lancing process. In particular an elongation of the elastic lancet body (3) is to be prevented.
p0053In <figref idrefs="f0001">figure 3</figref> is shown in a schematic longitudinal section of an embodiment of the lancet (10) according to the invention. The lancet body (3, 5) of the lancet (10) is in this preferred case, of two different components. The tip (2) of the lancet needle (1) is enclosed by a lancet body (3) made of an elastic material. Away from the tip portion (2) of the lancet needle (1) the lancet needle (1) with a lancet body (5) of a rigid material is connected. The lancet body (5) of rigid material in turn is connected with the lancet body (3) made of elastic material. To (3) to increase the connection surface between the elastic lancet body material and rigid lancet body material (5), the rigid lancet body material (5) may have protrusions 5 '. The connection between the rigid and elastic material (3, 5) of the lancet body can again be effected by gluing or two-component injection molding.
p0054While in the case of the embodiments according to <figref idrefs="f0001">Figures 1 and 2</figref> takes place a hold of the lancet body (3) during the lancing process by directly acting on the elastic material of the lancet body (3), in the case of the embodiment according to <figref idrefs="f0001">figure 3</figref> the lancet body (5), which consists of a rigid material, held during the lancing process. The lancet needle (1) is moved along its longitudinal axis. You penetrates the surface of the elastic lancet body (3). After the lancing process the lancet needle (1) is returned accordingly, can put so that the elastic lancet body (3) back to the top (2) of the lancet needle (1). The lancet body (3, 5) is fixed during the lancing process in place.
p0055In <figref idrefs="f0001">figure 4</figref> is mapped to a set of lancets (11) is a schematic plan. A plurality of lancet needles (1) with a tip (2) are embedded in this embodiment, the set of lancets (11) in a single band-like lancet body (3) made of elastic material. The set of lancets (11) is suitable for use in an automated system in which a plurality of lancets stored and can be used for puncturing operations individually.
p0056A longitudinal section through the longitudinal axis of an individual lancet of the set of lancets (11) correspond substantially to the representation of the lancet (10) in <figref idrefs="f0001">1 or 2</figref>, The set of lancets (11) - analogous to the lancet from<figref idrefs="f0001">figure 2</figref> - A stabilization layer (4) (in <figref idrefs="f0001">figure 4</figref> not shown). This stabilizes the set of lancets (11) as a whole and the individual, it contains lancets not only during the lancing process, but also gives it a mechanical strength, for example, for the automated handling of the set of lancets (11) in a mechanical system for the storage and use the lancet may be advantageous.
p0057Since the lancet body (3) of the set of lancets (11) consists of an elastic material, it is possible, the entire set of lancets (11) to be packed compactly, for example, by spirally rolling up around the longitudinal axis of the first lancet needle (2) in the set of lancets (11).
p0058In <figref idrefs="f0002">figure 5</figref> is a schematic longitudinal section through a chamber of the lancet magazine is included in a lancet (10) shown. In lancet magazine the individual chambers can be arranged as desired. For example, the chambers can be arranged side by side or one behind the other and thus form an essentially cuboid magazine or around a central axis to be arranged radially and thus substantially form a cylindrical or drum-shaped magazine. The lancet (10) is enclosed in the chamber from the chamber walls (8). In the embodiment shown, the<figref idrefs="f0002">figure 5</figref> have the lancet body (7) which surrounds the lancet needle (1), and the chamber wall (8) on one another matched complementary shape so that the area of the tip (2) of the lancet needle (1) is a closed cavity. In addition to the chamber wall (8) and the lancet body, the cavity is closed by a closure (6) of elastic material. The shutter (6) can be penetrated during the lancing process by the tip (2) of the lancet (10) and closes after the retraction of the lancet (10) into the chamber of the magazine, similar to the septum of a glass ampoule, for example, for storing vaccines be used. The shutter (6) of elastic material thus ensures a hygienic storage and disposal of an already used lancet (10).
p0059An analog "Septumfunktion" meets the shutter (6) of the lancet body (9) in the lancet (10) according to <figref idrefs="f0002">figure 6</figref>, This lancet (10) consists of a lancet needle (1) with a tip (2), which is located in a closed cavity of the lancet body (9), which is made from a rigid material, and the closure (6) from elastic material is formed. During the lancing process the lancet needle (1) slides with its tip (2) advancing along its longitudinal axis, while the lancet body (9) is held stationary by suitable means in a lancing device. The tip (2) penetrates the lancet needle (1) the closure (6) made of elastic material.<figref idrefs="f0002">figure 6</figref> A shows the lancet (10) at the end of forward movement of the lancing process.
p0060The elastic material properties of the closure (6) ensures that after retracting the lancet needle (1) after the lancing process and in particular after the retraction of the tip (2) of the lancet needle (1) into the cavity of the lancet body (9), similar to the cavity again is closed.
2 sheets
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Every citation, both ways
| Document | Relation | Office |
|---|---|---|
| EP0931507A | Cites | European Patent Office (EPO) |
| DE4320463A1 | Cites | Germany |
| US4889117A | Cites | United States of America |
| US5122123A | Cites | United States of America |
| US5636640A | Cites | United States of America |
63 members in 26 offices
Priority claims3
| Document | Office | Kind | Date |
|---|---|---|---|
| 10010694 | Germany | – | |
| 10010694 | Germany | A | |
| 01909796 | European Patent Office (EPO) | A |
Members63
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| DE10010694A1 | Germany | A1 | |
| CA2401837A1 | Canada | A1 | |
| WO0166010A1 | World Intellectual Property Organization (WIPO) | A1 | |
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| NO20024186D0 | Norway | D0 | |
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| KR20020086603A | Republic of Korea | A | |
| EP1263320A1 | European Patent Office (EPO) | A1 | |
| BR0108963A | Brazil | A | |
| SK12382002A3 | Slovakia | A3 | |
| IL151481A0 | Israel | A0 | |
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| HU0300217A2 | Hungary | A2 | |
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| CZ20022901A3 | Czechia | A3 | |
| US2003153939A1 | United States of America | A1 | |
| JP2003527897A | Japan | A | |
| HK1052852A | Hong Kong, China | A | |
| HK1052852A1 | Hong Kong, China | A1 | |
| ZA200207090B | South Africa | B | |
| RU2002126538A | Russian Federation | A | |
| AU2001237415B2 | Australia | B2 | |
| RU2231985C2 | Russian Federation | C2 | |
| PL360249A1 | Poland | A1 | |
| NZ521015A | New Zealand | A | |
| EP1514515A2 | European Patent Office (EPO) | A2 | |
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| JP3703765B2 | Japan | B2 | |
| JP2005270679A | Japan | A | |
| CN1748644A | China | A | |
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| KR100615868B1 | Republic of Korea | B1 | |
| KR100685695B1 | Republic of Korea | B1 | |
| PL194815B1 | Poland | B1 | |
| EP1832232A1 | European Patent Office (EPO) | A1 | |
| EP1263320B1 | European Patent Office (EPO) | B1 | |
| AT378006T | Austria | T | |
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| DE50113265D1 | Germany | D1 | |
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| DK1263320T3 | Denmark | T3 | |
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| US2009043325A1 | United States of America | A1 | |
| HU226544B1 | Hungary | B1 | |
| SK286932B6 | Slovakia | B6 | |
| CZ301180B6 | Czechia | B6 | |
| CA2401837C | Canada | C | |
| BR0108963B1 | Brazil | B1 | |
| EP1514515B1This record | European Patent Office (EPO) | B1 | |
| AT549973T | Austria | T | |
| ATE549973T1 | Austria | T1 | |
| ES2382708T3 | Spain | T3 | |
| CY1107190T1 | Cyprus | T1 | |
| BR0117208B1 | Brazil | B1 | |
| NO337221B1 | Norway | B1 | |
| US9901296B2 | United States of America | B2 | |
| US2018160957A1 | United States of America | A1 | |
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Numbers
- Publication
- 1514515
- Application
- 40269367
Titles3
- German
- Blutlanzette mit hygienischem Spitzenschutz
- English
- Blood lancet with hygenic tip protection
- French
- Lancette a protection de pointe hygenic
Classification
- CPC, 12
- A61B5/15165
- A61B5/151
- A61B5/150022
- A61B5/150412
- A61B5/150503
- A61B5/150572
- A61B5/150633
- A61B5/15142
- A61B5/15151
- A61B5/15171
- A61B5/15176
- A61B5/15186
- IPC, 7
- A61B5 151
- A61B5 15
- A61B5 155
- A61B17 20
- A61B17 34
- A61M5 158
- A61M5 32
Designated states20
- Contracting states, 20
- Austria
- Belgium
- Switzerland
- Cyprus
- Germany
- Denmark
- Spain
- Finland
- France
- United Kingdom
- Greece
- Ireland
- Italy
- Liechtenstein
- Luxembourg
- Monaco
- Netherlands (Kingdom of the)
- Portugal
- Sweden
- Türkiye
