Blood lancet with hygenic tip protection
Abstract
Lancet body (3) comprises elastic material into which the needle (1) tip (2) is embedded. Preferred features: In a development, the needle is movable within a hollow elastic body surrounding its tip region. The elastic body is penetrated when the needle is put to use, The tip is re-enclosed in the body, on withdrawal. The elastic material is a thermoplastic elastomer. It is stabled by a rigid material. In a set of such lancets, two are connected together by the elastic material. A lancet magazine is also claimed. This has independent chambers each with opening(s) for needle tip exit. The openings are closed by elastic material, which is penetrated by tip exit during use. each tip is sealed back into its chamber, on retraction.

Term
Term ended
Projected expiry passed 28 February 2021, 5.6 years ago.
- Priority
- Filed
- Published
- Projected expiry
- Today
8 claims: 8 independent, 0 dependent
- 1Lanzette enthaltend eine Lanzettennadel mit einer Spitze undeinen Lanzettenkörper, der die Lanzettennadel zumindest im Bereich der Spitze vollständig umgibt, wobei die Spitze relativ zum Lanzettenkörper beweglich ist und aus dem Lanzettenkörper austreten kann und der Lanzettenkörper zumindest im Bereich der Spitze der Lanzettennadel aus einem weichen, verformbaren und von der Lanzettennadel mit der Spitze durchstoßbaren Material besteht, dadurch gekennzeichnet, dass die Spitze der Lanzettennadel in dem Material eingebettet ist. lancet containinga lancet needle with a tip anda lancet body of the lancet needle completely, at least in the region of the tip surrounds, wherein the tip is movable relative to the lancet body and the lancet body from can emerge and the lancet body at least in the region of the tip of the lancet needle made of a soft, deformable and of the lancet needle with the tip penetrable material, characterized in that the tip of the lancet needle is embedded in the material.
- 2Lanzette enthaltend eine Lanzettennadel mit einer Spitze undeinen Hohlkörper, der zumindest die Spitze der Lanzettennadel umgibt, wobei die Lanzettennadel im Bereich ihrer Spitze im Hohlkörper beweglich ist und der Hohlkörper zumindest teilweise aus einem weichen, verformbaren und von der Lanzettennadel mit der Spitze durchstoßbaren Material besteht, dadurch gekennzeichnet, dass sich das Material nach dem Zurückziehen der Spitze der Lanzettennadel in den Hohlkörper wieder verschließen kann. lancet containinga lancet needle with a tip anda hollow body which surrounds at least the tip of the lancet needle, the lancet needle in the region of its tip in the hollow body is movable and the hollow body at least partly made of a soft, deformable and of the lancet needle with the tip penetrable material, characterized in that the material after Retraction of the tip of the lancet needle can close again in the hollow body.
- 3Lanzette enthaltend eine Lanzettennadel mit einer Spitze undeinem der Spitze entgegengesetzten Ende sowieeinem ersten Lanzettenkörper oder einem Kopf, der an dem der Spitze entgegengesetzten Ende der Lanzettennadel angeordnet ist und der im Zusammenspiel mit geeigneten Elementen einer Stechhilfe während des Stechvorgangs mit diesem wechselwirken kannsowie 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 weichen, verformbaren und von der Lanzettennadel mit der Spitze durchstoßbaren Material besteht. lancet containinga lancet needle with a tip andone of the end opposite the tip anda first lancet body or a head at the opposite top End of the lancet needle is arranged and in interaction with suitable elements can interact a lancing device during the lancing process with thisand a second lancet body of the lancet needle exclusively in the region Tip completely surrounds the second lancet body in the area of the tip of the lancet needle made of a soft, deformable and of the lancet needle with the tip penetrable material.
- 4Lancet according to claim 3, characterized in that the tip of the lancet needle in is embedded the second lancet body. Lanzette gemäß Anspruch 3, dadurch gekennzeichnet, dass die Spitze der Lanzettennadel in den zweiten Lanzettenkörper eingebettet ist.
- 5Lancet according to claim 3, characterized in that the second lancet body a Hollow body and the hollow body at least partially out of the soft, deformable and consists of the lancet tip penetrable material. Lanzette gemäß Anspruch 3, dadurch gekennzeichnet, dass der zweite Lanzettenkörper ein Hohlkörper ist und der Hohlkörper zumindest teilweise aus dem weichen, verformbaren und von der Lanzettenspitze durchstoßbaren Material besteht.
- 6Lancing device with a drive element, the one with a first lancet body, or Head the opposite to a tip end of a lancet needle in accordance with a of claims 3-5 is arranged, cooperating so that the lancet needle in the puncture direction is moved and a puncturing operation can be performed. Stechhilfe mit einem Antriebselement, das mit einem ersten Lanzettenkörper, oder einem Kopf der an einem einer Spitze entgegengesetzten Ende eine Lanzettennadel gemäß einem der Ansprüche 3-5 angeordnet ist, zusammenwirkt, so dass die Lanzettennadel in Einstichrichtung bewegt wird und ein Stechvorgang ausgeführt werden kann.
- 7A method for driving a lancet comprising a blood collection system Interact a drive element of a lancing device with a first lancet body, or a head of a lancet needle, the opposed at one end of a tip Lancet needle is arranged so that the lancet needle for performing a Lancing process is moved by the drive element in the puncture direction, wherein the tip of the lancet needle is embedded in a soft, deformable material, and the material is pierced by the tip during the lancing process, so that the Tip of the lancet needle is released. Verfahren zum Antreiben einer Lanzette in einem Blutentnahmesystem beinhaltend Wechselwirken eines Antriebselementes einer Stechhilfe mit einem ersten Lanzettenkörper, oder einem Kopf einer Lanzettennadel, der an einem einer Spitze entgegensetzten Ende der Lanzettennadel angeordnet ist, so dass die Lanzettennadel zum Ausführen eines Stechvorganges durch das Antriebselement in Einstichrichtung bewegt wird, wobei die Spitze der Lanzettennadel in einem weichen, verformbaren Material eingebettet ist, und das Material von der Spitze während des Stechvorgangs durchstoßen wird, so dass die Spitze der Lanzettennadel freigegeben wird.
- 8A method for driving a lancet comprising a blood collection system Interact a drive element of a lancing device with a first lancet body, or a head of a lancet needle, the opposed at one end of a tip Lancet needle so that a lancet needle to execute a lancing process by the Driving member is moved in the puncturing direction, the needle tip of a Cavity is surrounded, at least in part of a soft, deformable Material, and pierce the material of the tip during the lancing process is such that the tip of the lancet needle is released. Verfahren zum Antreiben einer Lanzette in einem Blutentnahmesystem beinhaltend Wechselwirken eines Antriebselementes einer Stechhilfe mit einem ersten Lanzettenkörper, oder einem Kopf einer Lanzettennadel, der an einem einer Spitze entgegensetzten Ende der Lanzettennadel, so dass eine Lanzettennadel zum Ausführen eines Stechvorganges durch das Antriebselement in Einstichrichtung bewegt wird, wobei die Nadelspitze von einem Hohlraum umgeben wird, der zumindest zum Teil aus einem weichen, verformbaren Material besteht, und das Material von der Spitze während des Stechvorgangs durchstoßen wird, so dass die Spitze der Lanzettennadel freigegeben wird.
Independent claims8
61 paragraphs, as filed
The invention relates to a lancet comprising a lancet needle with a tip and a Lancet body of the lancet needle completely, at least in the region of the tip surrounds. Furthermore, the invention relates to a lancet comprising a lancet needle with a tip and a hollow body which surrounds at least the tip of the lancet needle. moreover The invention relates to a lancet magazine containing at least two lancets which each contain a lancet needle with a tip and each in separate, mutually independent chambers of the lancet magazine are housed, each chamber having at least one opening for the exit of the tip of the lancet needle. After all the invention relates to the use of an elastic material as a component of a Lancet or a lancet magazine.
The 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 attracting a blood sample ahead of to be examined individual. While in clinics and at private physicians often too by venipuncture several milliliters of blood examinee are obtained for the analysis, in order, a plurality of to be carried out laboratory tests are sufficient for individual analyzes targeted to a parameter directed, nowadays often from a few microliters of 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 person to be examined with the help to push a sterile, sharp lancet, so a few microliters of blood for analysis to win. This method is particularly suitable, if the analysis of the blood sample can be carried out immediately after the blood collection.
Especially in the area of so-called "home monitoring", ie where medical laymen out simple analyzes of blood to perform, and there in particular for the regular, several times daily performed blood collection by diabetics for monitoring Blood glucose concentration, lancets and associated devices (so-called blood collection devices, Blood lancet devices or - as they are to be hereinafter referred to - Lancing devices), offered the least possible discomfort and reproducible blood collection enable. In addition to the use of lancets with lancing devices the psychological Threshold when the sting of her own body cut, mainly for children have diabetes and depend on regular blood glucose tests, particularly Importance. Examples of lancets and lancing devices are the commercially available Devices (lancing devices) and lancets Glucolet® Bayer AG and Softclix® of Roche called Diagnostics GmbH. Such lancets and devices (lancing devices) are z. B. Object from WO-A 98/48695, EP-A 0,565,970, US 4,442,836 or US 5,554,166.
The 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 possibly to their attachment in a lancing device is in many embodiments most of the lancet needle, a plastic lancet body made of a rigid, injection-moldable Material molded. The tip of the lancet needle is - the unused state - To ensure their sterility surrounded by a protective sheath. This is usually from the same rigid material as the actual lancet body and usually forms this one unit. The protective sheath can before using the lancet from the lancet body are separated and removed from the tip of the lancet needle. Between lancet body and protective cover is for this purpose usually have a predetermined breaking point. After the use of the lancet is the tip of the lancet needle before unprotected and is therefore a potential source of injury to the user and possibly other persons represent.
To avoid accidental injury on a used lancet needle is users usually recommended that the tip of the lancet needle after use into the previously Cases taken to put. However, experience shows that by no means all follow users this recommendation and therefore a large proportion of used lancets with unprotected Tips are discarded. US 5,304,192 and WO 96/02189 propose a Solution to this problem before the lancet, in which the tip of the lancet needle after use can be pushed or pulled in the lancet body. Since the lancet body made in these cases, from a non-elastic, substantially rigid or stiff material is the tip of the lancet needle is indeed hidden in the lancet body, but not perfectly hygienic shielded because the material of the lancet body, a channel remains, the lancet tip is related to the environment in contact via.
In the systems currently commercially available to provide the lancet is carried out for use in lancing devices mostly in loose form. The user manually removes before each Lancing process a lancet from a package, such as a cardboard box containing or a tube in which poured a plurality of lancets disorganized, loose are. Subsequently the lancing device, for example by unscrewing or pulling off a Cap, prepared for receiving the lancet, wherein the lancet holder of 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 from the Package taken lancet is manually inserted into the lancet holder of the lancing device and fixed there. Then you have the protective sheath that surrounds the lancet tip and both this as well as protecting the operator, to be manually removed from the lancet. subsequently the lancing device is sealed with its protective cap. The cap ensures that the lancet from the outside is no longer accessible. usually it has 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 obtaining Blood available.
The large number of manual steps of operation for conventional lancet systems (lancet and lancing) is perceived by users as a disadvantage and is particularly important when restricted Perception in the state of hypoglycaemia problematic. In addition, the Users not prevented a once inserted lancet several times for lancing and to use blood gains. This is the one from hygienic reasons risk, including: if more than one person, the lancet system used, as for example in Surgeries or hospitals may be the case. For another, the repeated use the lancet to increasing pain for the user, because since the lancet for are designed single-use, they are fast with multiple uses dull. There is also with the lancing devices and lancets of the prior art the danger that lancing devices are used with non-matching lancet, ie with lancets, which are not suitable for a particular type lancing device and therefore not optimal lancing results (Reproducibility, pain poverty, resulting blood volume) are achieved, or that the lancets are improperly inserted into the lancing devices. Further may a user at improper use of lancets and lancing devices inadvertently hurt.
Therefore, there is no lack of attempts to eliminate the disadvantages mentioned. Out US 5,514,152, US 5,152,775, WO 98/14125, US 3,030,959, US 4,794,926 and US 5,035,704 lancing devices are known to stockpile several lancets and this succession can use for lancing processes individually. After the lancing process the lancet can be individually removed from the device. The above-mentioned problems of used Lancets are however just as little achieved in these systems with lancet storage as in systems which must be individually fitted with lancet manually.
In 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 lancets in itself, have the disadvantage that the sterility, that is, the sterility of the unused lancet needle, ensuring in particular their peak, not until immediately before the lancing process will and a safe and hygienic disposal of the lancet once used completely is left to the user. In particular, for systems in which unused lancets should be kept next to used lancets, ie in particular in the lancet magazine and corresponding lancing devices, dispense the fact a once used eject lancet immediately and instead the lancets used up to the use the entire lancet supply store, this represents a significant problem.
The object of the invention is to eliminate the disadvantages of the prior art. Especially It is the object of the present invention to provide lancet, in which at least the lancet needle tip in the unused state until immediately before use sterile, that is sanitized, maintained and stored hygienically in the used state can be. Ideally, this task should be solved without the user for is required to take hygienic storage separate measures. In addition, the user should protected from accidental injury by the lancet, in particular the used lancet be.
The object is achieved by the subject matter of the invention as characterized in the claims is solved.
The invention is a lancet containing a lancet needle with a tip and a lancet body, the lancet needle completely, at least in the region of the tip surrounds, wherein, in the lancet of the present invention, the lancet body at least in the Area of the tip of the lancet needle from an elastic material, in which the tip the lancet needle is embedded.
The lancet according to the invention are designed for single use only and should are therefore also called a 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 have needles of a cylindrical shape, since this needle form is particularly well prepared; However, there are also needle shapes with different shape possible. The tip portion of the needle includes the needle tip during normal Use of the lancet is pierced into tissue. The tip of the lancet needle consequently the part of the lancet, the in the skin of the individual to stabbing Touch comes, this possibly hurt and so the outflow of body fluid, in particular Blood or interstitial fluid, causes.
The tip of the lancet needle can for example be rotationally symmetrical, as in Generally, sewing needles at the case. However, it has proved to be advantageous if to one or more sections provide the needle tip. The case arising, for inclined longitudinal axis of the needle, tapered in a tip edge during lancing serve as sharp edge and make the puncturing process less painful than having rotationally symmetric Needles of the case.
The lancet needle of the lancet according to the invention is made of a material that is sufficiently is hard to make a mechanical stress during the injection process, the Edits or any other occurring loads without deformation to survive. Furthermore, the material must be such that during the injection process no particles break off or become detached. Finally the needle material must also so be workable, the needle tip sufficiently pointed and the edges of the needle tip, where appropriate, can be ground sufficiently sharp. Highly suitable materials for the Lancet needle are above all metals and of these in particular stainless steels. However, there are also needles made of ceramics or plastics conceivable. Stainless steel needles are particularly preferred.
According to the invention, at least the tip of the lancet needle of the lancet according to the invention by a plastic body, which are hereinafter referred to as a lancet body is surrounded. It is essential that the lancet body in the area of the tip of the lancet needle consists of an elastic material. At least the tip of the lancet needle is completely surrounded on all sides by this elastic material, that is embedded in this, and so cut off from the surrounding area. The elastic material of the lancet body, which the lancet body completely in different embodiments or only may form part, is characterized in that it is soft, deformable and of the Lancet needle with its tip can be pierced 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, so as to collect blood in the to prick skin to be examined individual. An important property is further, that the elastic material optionally upon retraction of the lancet needle closes in the lancet body back close to the tip of the lancet needle. After this Lancing process, the lancet needle in a preferred embodiment, in reversal brought the movement during the lancing process in its initial position relative to the lancet body are, in the top back completely on all sides by the elastic material of the lancet body is enclosed.
The elastic material of the lancet body, which the tip of the lancet needle completely encloses, ensures that the sterility of the lancet needle tip prior to use, preferably until immediately before their use, and where applicable, for a hygienic Enclosing the lancet needle tip after their use. The elastic material is thus germ-tight manner for the ingress or escape of pathogens, depending on whether the Lancet needle is unused or used. In addition the elastic material represents a mechanical Protection for the lancet needle tip is thus preventing even accidental Injury on the lancet needle tip.
As the elastic material for the lancet body of the present invention have Rubber, rubber, silicone, elastomers and in particular thermoplastic elastomers suitable. These include the essential for the present invention properties : they are soft, deformable, can be pierced by the lancet needle without the Lace hurt, and close tightly around the used lancet needle tip. Furthermore They can be used for injection molding processes, the mass production of lancets allow in large numbers.
Thermoplastic elastomers which also elastoplasts or thermal Laste or thermoplastic are called rubbers, ideally have a combination of performance characteristics of elastomers and the processing characteristics of thermoplastics. Thermoplastic Elastomers are for example styrene oligoblock copolymers (so-called TPE-S), thermoplastic polyolefins (TPE-O), thermoplastic polyurethanes (TPE-U), thermoplastic copolyester (TPE-E) and thermoplastic copolyamides (TPE-A). Especially have, for example, thermoplastic elastomers based on styrene-ethylene-butylene-styrene polymers (SEBS polymers, eg. B. Evoprene® of Evode Plastics or Thermolast K from Gummiwerk Kraiburg GmbH) proved to be suitable.
During the lancing process the lancet needle is moved relative to the lancet body. The latter is preferably from the lancing device or the lancing device in position fixed. The lancet needle can be especially formed for the purpose of their drive, for example, have a needle head at the top of the opposite end, or additionally, to the lancet body which surrounds the top, have a further lancet body, which can be gripped by a drive element of the lancing device. The formation of the needle or of the additional lancet body can in suitable manner with a corresponding drive device in the lancing device (lancing) interact.
To achieve the advantage that the lancet needle tip before use hygienically from the elastic Material of the lancet body is enclosed, and after their use also is hygienically surrounded by the elastic material, it is of course necessary, the lancet needle after use, ie after the lancing process, largely in its original to bring relative position with respect to the lancet body containing the elastic material. This can by suitable interaction with a correspondingly adapted lancing be achieved. It is only important that the lancet needle tip after use is again surrounded by the elastic material of the lancet body and thus accidental Hurt is prevented at the needle tip.
To increase the stability of the elastic material it is possible, this rigid with a Material such as a rigid plastic material to connect. The elastic material can, for example on its outer side, which is not the tip of the lancet needle comes into contact with a layer of a rigid material, for example a rigid be plastic stabilized. It is also possible, the lancet body only in the region of the to manufacture lancet needle tip of an elastic material, the rest of the lancet body However, to be made of conventional, rigid plastics. Here can the elastic Material and the rigid material to be bonded to one another or by an injection molding process, For example, a two-component injection molding process, interconnected be. The stiff material of the lancet body ensures a mechanical stabilization the elastic material during the lancing process and simplifies the fixing of the elastic Part of the lancet body during the lancing process by the lancing device.
Another object of the invention is a lancet comprising a lancet needle with a tip and a hollow body which surrounds at least the tip of the lancet needle, wherein when 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 made of an elastic material exists, which can be pierced by the tip of the lancet needle during the lancing process and, where appropriate, after the retraction of the tip of the lancet needle in the Hollow body closes again.
While in the above-described lancet according to the first subject of the invention the lancet needle for the purpose of sterility prior to use and hygienic Seclusion sides completely after use in the region of its tip, thus is surrounded with no space remaining at the tip of an elastic material, which embeds the lancet needle tip in itself, is in the second described now The invention the tip of the lancet needle of a fully sealed surrounded hollow body. Advantageously, this hollow body in the areas which do not come up with the tip of the lancet needle into contact of a rigid, preferably manufactured injection-moldable material. is essential to the invention that the hollow body in the Area where it is pierced during the lancing process the lancet needle tip, from an elastic material.
During the lancing process the lancet needle is moved relative to the hollow body, the lancet body to is moved. Support and drive the lancet needle and fixation of the lancet body can, as described above by suitable constructional measures in the Lancing device can be realized.
The elastic material which constitutes a part of the hollow lancet body is in Lancing operation of the lancet needle tip pierced and closes optionally after retracting the lancet needle tip into the hollow body again and seals so the hollow body from. The lancet needle tip is thus sterile until immediately before use in Hollow body is sealed and hygienic enclosed after use in it.
The lancet of this subject invention can, like the lancet of the above alternative subject invention in addition to the lancet body of the tip Lancet needle encloses, have a further lancet body which in interaction with suitable elements of a lancing device during the lancing process with this interacts. Similarly, the lancet needle can be specially shaped, for example, a head at the top having the opposite end.
For the properties of the elastic material and the connection of the elastic material with the stiff material of the lancet body applies to the above with respect to the first Subject of the invention is said.
In addition, subject matter of the invention is a set of lancets, the at least two of the invention contains lancets which are interconnected. This is the third object the invention.
The lancets of the set of lancets according to the present invention may be of the type be that the lancet needle tip of an elastic material without a hollow space remaining around the tip is completely surrounded on all sides, or embedded, or by the Such that the lancet needle tip is enclosed by a hollow body. The single ones Lancets which each in turn consists of at least a lancet needle and a lancet body exist, are interconnected in the set of lancets according to the invention. Advantageously, the connection is via the lancet body. Preference is identical Lancets interconnected.
The lancet can the set of lancets either thin webs or bridges together or be connected to a carrier strip, for example of paper or plastics, be attached. Preferably, the compound of the lancet is done such that the individual Lancet needles of the individual lancets of the set of lancets in a continuous piece the elastic material are included. The elastic material may in this case the have the form of an elastic band. The elastic band as a connection form for multiple, preferably several identical lancets is preferably for the lancet according to the first aspect of the invention, ie lancets in which the lancet needle tip is completely embedded in the elastic material, is suitable. However, it is also possible to use a elastic band material as a connecting material for the lancet according to the second object the invention ie lancets having a hollow body around the lancet needle tip, use.
In addition, the invention is a lancet magazine with chambers for storage of lancets. The magazine according to the invention containing at least two lancets which each contain a lancet needle with a tip and each in separate, mutually independent chambers of the lancet magazine are housed. In this case, each Chamber at least one opening on the outlet of the tip of the lancet needle. The Lancet magazine of the present invention 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.
Like the set of lancets according to the third object of the invention is the lancet magazine (Fourth subject matter of the invention) of the common store unused Lancets (coffering) and optionally also the storage once for use Lancets (Wiederkassettierung). Unlike the set of lancets, the individual Lancets are not directly connected to each other in the case of the lancet magazine, but are located. in individual chambers of the magazine In this they are independently in front. In the magazine, the chambers are arranged regularly geometrically substantially wherein adjacent chambers, at least one, preferably two joint Wa (e) nd (e) exhibit.
The individual chambers of the magazine have at least one outlet opening for the tip the lancet needle. This outlet opening is according to the invention by an elastic material closed, having the properties mentioned above, the related were discussed with the first aspect of the invention. During the lancing process can penetrate the tip of the lancet needle by the elastic material. The elastic Material joins optionally again during retraction of the lancet needle tip in the chamber of the lancet magazine. The chamber is then resealed.
the chamber of the lancet magazine can then sealed by suitable constructional measures be that the lancet needle is sterile before use in the field of their tip optionally shielded hygienically from the environment after use. For example may comprise a lancet body, the lancet, by suitable shaping of the with respective shapes of the inner wall of the chamber of the lancet magazine interacts, so as to allow a sealing. Essential to the invention is that the opening of the Chamber through which the lancet needle tip passes during the lancing process, from is closed the elastic material.
The arrangement of the individual chambers in the lancet magazine can be arbitrary. For example may include a plurality of lancets chambers may be arranged side by side and so a cuboid substantially or give bolt shaped magazine. 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.
Finally, the subject of the invention is the use of an elastic material as a component a lancet or a lancet magazine, wherein the elastic material to serves, the sterility of at least the tip of a lancet needle in the unused state to receive. In a preferred embodiment, the material may also be used elestische be a hygienic shielding at least the tip of a lancet needle in to achieve the used state.
The inventive use of an elastic material for shielding the top the lancet needle makes it possible to ensure the sterility of an unused lancet needle tip and possibly the used lancet needle tip hygienic shield.
The sterility of the lancet needle tip in the unused state by suitable means, such as gamma irradiation to produce. Once sterilized the lancet needle tips remain by the corresponding lancet body or an appropriate lancet magazine, which include, among other things, an elastic material, is obtained. Unlike the State of the art, where so far no elastic materials for shielding lancet needle tips are described, the use of the elastic material in accordance with However, the present invention also the hygienic shielding the lancet needle tip used. By the use of the elastic material, a possibly short time existing channel through which penetrate the lancet needle for the purpose of piercing may, 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, may not be at the outside world arrive. This is particularly advantageous for disposable lancets which individually be disposed of after use. From quite outstanding importance this property However, for lancet sets and lancet magazines in which in addition to unused well used lancets are stored, and which can then be disposed of as a whole.
The invention has the following advantages:<ul><li>The tip of the lancet needle is in all embodiments of the unused state germproof shielded, that is, germs can until immediately before use of the lancet not penetrate to the lancet needle tip. Me After suitable sterilization the lancet tips sterile for a long time. </li><li>The tip of the lancet needle can in all embodiments in the used state be shielded hygienic. Inadvertent contamination of the environment (user, Objects, other lancets) is largely excluded.</li><li>The user of the e rfindungsgemäßen lancet is at from accidental injury a lancet needle used protected. The same goes for persons other than the actual user.</li><li>The lancets and lancing charges of the invention are cost effective in large numbers produce 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>
The invention is further illustrated by the following Figures 1 to 6th
The numbers in the figures denote:<dl tsize="2" 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>
1 shows schematically a longitudinal section through a preferred embodiment of a inventive lancet ready.
2 shows schematically a longitudinal section through an alternative, also preferred embodiment a lancet according to the invention ready.
3 shows schematically a longitudinal section through a further alternative, a preferred Embodiment of the lancet according to the invention ready.
Figure 4 shows a schematic plan view of a preferred embodiment of the invention Set of lancets.
5 shows a schematic longitudinal section through a chamber of a preferred inventive Lancet magazine including a lancet therein ready.
Figure 6 shows a further preferred embodiment of a lancet according to the invention in a schematic sectional view.
The shown in Figure 1 preferred embodiment of the lancet according to the invention (10) contains a lancet needle (1), in the region of its tip (2) of a lancet body (3), which is made of an elastic material, is surrounded. The tip (2) of 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) a recess, which causes the lancet body (3) at least on one Side has an edge (3 '), with the corresponding gripping or holding devices in a can interact lancing device to hold the lancet body (3). Sticking the lancet body (3) is necessary because during the lancing process the lancet needle (1) relative to the lancet body (3) has to be moved and by this in the field of can pass tip (2) of the lancet needle (1) must. 1a shows the lancet (10) at the end of the forward movement of the lancing process.
The recess in the lancet body (3) also serves to reduce the friction forces between the lancet needle (1) and the lancet body (3) during the lancing movement.
The cross section of the lancet needle (1) and the lancet body (3) perpendicular to the longitudinal axis the needle preferably has a round shape. However, it is also possible that the Cross section of any other shape, for example square or rectangular is. It is also not necessary that the lancet needle (1) and the lancet body (3) in the Cross-section have the same shape. For example, the lancet needle (1) may have a structure substantially round cross section and the lancet body (3) has a rectangular cross-section have.
In Figure 2 is a further also preferred embodiment of the invention Lancet (10) shown schematically in longitudinal section. The lancet (10) consists essentially for the same elements as shown in Figure 1, the lancet (10). Deviating from the in figure 1 shown lancet (10) is on one side of the lancet body (3) consisting of elastic material, applying a stabilizing layer (4). This stabilization layer (4) may be adhered to the lancet body (3). However, it is preferred that the stabilizing layer (4) together with the lancet body (3) in an injection molding process is connected to the lancet needle (1).
The stabilization layer (4) is used, a deformation of the elastic lancet body (3) to prevent during the lancing process. In particular, a stretch of the elastic The lancet body (3) can be prevented.
In Figure 3 is another preferred embodiment of the lancet (10) according to the invention illustrated in a schematic longitudinal section. 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 of a lancet body (3) made of an elastic material enclosed. Away from the tip portion (2) of the lancet needle (1) is the lancet needle (1) connected to a lancet body (5) made of a rigid material. The lancet body (5) made of rigid material in turn is to the lancet body (3) made of elastic linked material. To establish the connection surface between the elastic lancet body material (3) to increase and rigid lancet body material (5), can the rigid Lancet body material (5) protrusions 5 'have. The connection between the rigid and an elastic material (3, 5) of the lancet body can turn by gluing or two-component injection molding done.
While in the case of the embodiments according to Figures 1 and 2 a hold of the lancet body (3) during the lancing process by directly acting on the elastic occurs material of the lancet body (3), in the case of the embodiment according to Figure 3 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. It permeates The surface of the elastic lancet body (3). After the lancing process is the Lancet needle (1) attributed accordingly, so that the elastic lancet body (3) can put around the top (2) of the lancet needle (1) again. The lancet body (3, 5) is fixed during the lancing process in place.
4 shows a schematic plan view is mapped to a set of lancets (11). A variety of lancet needles (1) having a tip (2) in this embodiment, the set of lancets (11) in a single band-like lancet body (3) made of elastic material embedded. The set of lancets (11) is suitable for use in an automated system, in which stores a plurality of lancets and used individually for lancing processes can be.
would correspond to a longitudinal section through the longitudinal axis of an individual lancet of the set of lancets (11) essentially the view of the lancet (10) in Figure 1 or 2. The set of lancets (11) - analogous to the lancet of Figure 2 - a stabilization layer (4) (in Figure 4 not shown). This stabilizes the set of lancets (11) as a whole and the individual, gives in contained him lancet not only during the lancing process, but him as a mechanical strength, for example, for automated handling of the set of lancets (11) in a mechanical system for storing and using the lancet may be advantageous.
Since the lancet body (3) of the set of lancets (11) of an elastic material, it is possible to package the entire set of lancets (11) compact, for example by spirally rolling up around the longitudinal axis of the first lancet needle (2) in the set of lancets (11).
5 shows a schematic longitudinal section through a chamber of a lancet magazine in is of a lancet (10), ready. In lancet magazine, the individual Chambers be arranged as desired. For example, the chambers may next to or behind each other be arranged to form a substantially cuboid magazine or but be arranged radially around a central axis and so substantially a cylindrical form or drum-shaped magazine. The lancet (10) is in the chamber of the Chamber walls (8) enclosed. In the illustrated embodiment of Figure 5 have the Lancet body (7) which surrounds the lancet needle (1) and the chamber wall (8) to each other matched complementary shape so that the area of the tip (2) of the lancet needle (1) a closed cavity therein. 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) during the lancing process by the tip (2) of the lancet be penetrated (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, be used for storing vaccines. The shutter (6) of elastic Material thus ensures a hygienic storage and disposal of an already used lancet (10).
An analog "Septumfunktion" meets the shutter (6) of the lancet body (9) in the Lancet (10) shown in FIG 6. 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 of a rigid material, and the closure (6) of elastic Material is formed. During the lancing process the lancet needle (1) slides with its Point (2) above along its longitudinal axis, while the lancet body (9) by suitable Agent is held stationary in a lancing device. The tip penetrates (2) of Lancet needle (1) the closure (6) made of elastic material. Figure 6a shows the lancet (10) at the end of the forward movement of the lancing process.
The elastic material properties of the closure (6) ensures that after retraction the lancet needle (1) after the lancing process and especially after retraction the tip (2) of the lancet needle (1) into the cavity of the lancet body (9), just that Cavity is closed again.
3 sheets
Sheet 1 Sheet 2 Sheet 3
Every citation, both ways
| Document | Relation | Office | Cited during |
|---|---|---|---|
| EP0931507A1 | Cites | European Patent Office (EPO) | Search report |
| DE4320463A1 | Cites | Germany | Search report |
| US4889117A | Cites | United States of America | Search report |
| US5122123A | Cites | United States of America | Search report |
| US5636640A | Cites | United States of America | Search report |
58 members in 26 offices
Priority claims9
| Document | Office | Kind | Date |
|---|---|---|---|
| 10010694 | Germany | A | |
| 10010694 | Germany | A | |
| 10010694 | Germany | – | |
| 01909796 | European Patent Office (EPO) | A | |
| 01909796 | European Patent Office (EPO) | A | |
| 01909796 | – | – | – |
| 10010694 | – | – | – |
| DE2000110694 | – | – | – |
| EP20010909796 | – | – | – |
Members58
| Document | Office | Kind | |
|---|---|---|---|
| DE10010694A1 | Germany | A1 | |
| CA2401837A1 | Canada | A1 | |
| WO0166010A1 | World Intellectual Property Organization (WIPO) | A1 | |
| AU3741501A | Australia | A | |
| NO20024186D0 | Norway | D0 | |
| NO20024186L | Norway | L | |
| KR20020086603A | Republic of Korea | A | |
| EP1263320A1 | European Patent Office (EPO) | A1 | |
| BR0108963A | Brazil | A | |
| SK12382002A3 | Slovakia | A3 | |
| IL151481D0 | Israel | D0 | |
| CN1411355A | China | A | |
| MXPA02008610A | Mexico | A | |
| HU0300217A2 | Hungary | A2 | |
| CZ20022901A3 | Czechia | A3 | |
| US2003153939A1 | United States of America | A1 | |
| JP2003527897A | Japan | 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 | |
| EP1514515A2This record | European Patent Office (EPO) | A2 | |
| EP1514515A3 | European Patent Office (EPO) | A3 | |
| JP3703765B2 | Japan | B2 | |
| JP2005270679A | Japan | A | |
| CN1748644A | China | A | |
| KR20060058741A | Republic of Korea | A | |
| CN1268287C | China | C | |
| 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 | |
| DE50113265D1 | Germany | D1 | |
| PT1263320E | Portugal | E | |
| CN100370950C | China | C | |
| DK1263320T3 | Denmark | T3 | |
| ES2295138T3 | Spain | T3 | |
| US2009043325A1 | United States of America | A1 | |
| HU226544B1 | Hungary | B1 | |
| SK286932B6 | Slovakia | B6 | |
| CZ301180B6 | Czechia | B6 | |
| CA2401837C | Canada | C | |
| BR0108963B1 | Brazil | B1 | |
| EP1514515B1 | European Patent Office (EPO) | B1 | |
| AT549973T | Austria | T | |
| ES2382708T3 | Spain | T3 | |
| CY1107190T1 | Cyprus | T1 | |
| BR0117208B1 | Brazil | B1 | |
| NO337221B1 | Norway | B1 | |
| US9901296B2 | United States of America | B2 | |
| US2018160957A1 | United States of America | A1 | |
| BRPI0108963B8 | Brazil | B8 | |
| BRPI0117208B8 | Brazil | B8 |
65 legal events, as 9 offices reported them to INPADOC
Over the term
Point at a mark for the eventEvents
| Event | Code | Office | |
|---|---|---|---|
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Announcement of lapse in spainLapsedFD2A | FD2A | ES | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| ExpiryMK07 | MK07 | AT | |
| Patent expired after termination of 20 yearsExpiredPE20 | PE20 | GB | |
| Patent expired because of reaching the maximum lifetime of a patentExpiredMK | MK | NL | |
| Expiry of rightR071 | R071 | DE | |
| Annual fee paid to national office [announced via postgrant information from national office to epo]GrantedPGFP | PGFP | EP | |
| Annual fee paid to national office [announced via postgrant information from national office to epo]GrantedPGFP | PGFP | EP | |
| Annual fee paid to national office [announced via postgrant information from national office to epo]GrantedPGFP | PGFP | EP | |
| Annual fee paid to national office [announced via postgrant information from national office to epo]GrantedPGFP | PGFP | EP | |
| Annual fee paid to national office [announced via postgrant information from national office to epo]GrantedPGFP | PGFP | EP | |
| Annual fee paid to national office [announced via postgrant information from national office to epo]GrantedPGFP | PGFP | EP | |
| Annual fee paid to national office [announced via postgrant information from national office to epo]GrantedPGFP | PGFP | EP | |
| Fee paymentPLFP | PLFP | FR | |
| Fee paymentPLFP | PLFP | FR | |
| Change of applicant/patenteeR081 | R081 | DE | |
| Fee paymentPLFP | PLFP | FR | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Patent lapsedLapsedMM4A | MM4A | IE | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Patent ceasedCeasedPL | PL | CH | |
| Be: lapsedLapsedBERE | BERE | EP | |
| Be: lapsedLapsedBERE | BERE | EP | |
| No opposition filed against granted patent, or epo opposition proceedings concluded without decisionGrantedR097 | R097 | DE | |
| No opposition filedOpposition26N | 26N | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| No opposition filed within time limitOppositionORIGINAL CODE: 0009261PLBE | PLBE | EP | |
| Information on the status of an ep patent application or granted ep patentGrantedSTATUS: NO OPPOSITION FILED WITHIN TIME LIMITSTAA | STAA | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Translation files for an european patent granted for nl, confirming art. 52 par. 1 or 6 of the patents act 1995GrantedT3 | T3 | NL | |
| Definitive protectionFG2A | FG2A | ES | |
| Dpma publication of mentioned ep patent grantGrantedR096 | R096 | DE | |
| Reference to at number (ep patent enters austrian national phase)REF | REF | AT | |
| European patents granted designating irelandGrantedLANGUAGE OF EP DOCUMENT: GERMANFG4D | FG4D | IE | |
| European patent takes effect as a national patent in ch/liEP | EP | CH | |
| Change of applicant/patenteeR081 | R081 | DE | |
| Divisional application: reference to earlier applicationAC | AC | EP | |
| Designated contracting statesAK | AK | EP | |
| European patent grantedGrantedNOT ENGLISHFG4D | FG4D | GB | |
| (expected) grantORIGINAL CODE: 0009210GRAA | GRAA | EP | |
| Grant fee paidORIGINAL CODE: EPIDOSNIGR3GRAS | GRAS | EP | |
| Despatch of communication of intention to grant a patentORIGINAL CODE: EPIDOSNIGR1GRAP | GRAP | EP | |
| Information provided on ipc code assigned before grantRIC1 | RIC1 | EP | |
| Amendment of ipc main classPREVIOUS MAIN CLASS: A61B0005150000R079 | R079 | DE | |
| First examination report despatched17Q | 17Q | EP | |
| Designation fees paidAKX | AKX | EP | |
| Request for examination filed17P | 17P | EP | |
| Observations by third partiesORIGINAL CODE: EPIDOSNTIPATPAC | TPAC | EP | |
| Designated contracting statesAK | AK | EP | |
| Request for extension of the european patentAX | AX | EP | |
| Search report despatchedORIGINAL CODE: 0009013PUAL | PUAL | EP | |
| Divisional application: reference to earlier applicationAC | AC | EP | |
| Designated contracting statesAK | AK | EP | |
| Request for extension of the european patentAX | AX | EP | |
| Public reference made under article 153(3) epc to a published international application that has entered the european phaseORIGINAL CODE: 0009012PUAI | PUAI | EP |
Numbers
- Publication
- 1514515
- Publication, DOCDB
- 1514515
- Publication, EPODOC
- EP1514515
- Application
- 4026936
- Application, DOCDB
- 04026936
- Application, EPODOC
- EP20040026936
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 15
- A61B5 151
- A61B5 155
- A61B17 20
- A61B17 34
- A61M5 158
- A61M5 32
Designated states22
- 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
- Extension states, 2
- Albania
- North Macedonia