EP0987983A1 - Lancettes a usage unique - Google Patents

Lancettes a usage unique

Info

Publication number
EP0987983A1
EP0987983A1 EP98921493A EP98921493A EP0987983A1 EP 0987983 A1 EP0987983 A1 EP 0987983A1 EP 98921493 A EP98921493 A EP 98921493A EP 98921493 A EP98921493 A EP 98921493A EP 0987983 A1 EP0987983 A1 EP 0987983A1
Authority
EP
European Patent Office
Prior art keywords
cap
holder
needle
blood lancet
disposable blood
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP98921493A
Other languages
German (de)
English (en)
Inventor
Joachim Kohl
Hans-Jürgen KUHR
Herbert Argauer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Roche Diagnostics GmbH
Original Assignee
Roche Diagnostics GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Roche Diagnostics GmbH filed Critical Roche Diagnostics GmbH
Publication of EP0987983A1 publication Critical patent/EP0987983A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/15058—Joining techniques used for protective means
    • A61B5/150618—Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150694—Procedure for removing protection means at the time of piercing
    • A61B5/150717—Procedure for removing protection means at the time of piercing manually removed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15103—Piercing procedure
    • A61B5/15105—Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15142—Devices intended for single use, i.e. disposable

Definitions

  • the present invention relates to a disposable blood lancet for producing small skin openings in order to obtain blood samples for diagnostic purposes.
  • Blood lancets are used in doctors' surgeries and hospitals as well as in the private sector to collect small amounts of blood. A large number of different types of tests or evaluations (microscopic cell count) can be carried out with the blood samples obtained. Optimized blood lancets are particularly necessary in the area of "home monitoring" in order to enable diabetics or other vulnerable patient groups to have their blood checked regularly for certain analytes. Especially in the case of diabetics, the insulin injection must be adapted to food intake, physical activity and other factors in order to keep the patient in the desired range of blood sugar. It is well known that blood sugar levels that deviate too much from the target range have life-threatening consequences (hypoglycemic shock). Even minor deviations from the target area over a longer period of time can result in serious late damage such as blindness and amputations. For these reasons, easy-to-use blood lancets have become increasingly important in recent years.
  • the present invention relates to a blood lancet which can either be handled manually or clamped in a device which carries out a puncturing process with the blood lancet.
  • a number of blood lancets are known in the prior art which are suitable for such a purpose.
  • GB 1,085,141 describes a blood lancet and a manufacturing process for it.
  • the blood lancet shown here has a needle with which the actual stitching process is carried out, as well as an injection molded body in which the Needle is held.
  • the injection molded body has a protection for the needle in the area of the needle tip, which is turned off shortly before use in order to release the needle.
  • the injection molded body lies against the needle tip in the area thereof.
  • this is disadvantageous because twisting or other damage to the needle can occur when the needle guard is twisted off. This is particularly the case when the needle tip is not rotationally symmetrical but has a bevel.
  • Another disadvantage of an attached protection is that plastic particles can be produced when twisting off, which remain on the needle tip and enter the tissue during the stitching process, so that a later healing process is impaired.
  • the needle tip is coated with an after the injection molding process
  • Silicone oil or the like is impossible to reduce the friction in the tissue when the protection is applied to the needle.
  • European patent EPB 0 137 975 (equivalent to US 4,577,630) is also known, which describes a blood lancet in which the needle tip is not directly surrounded by plastic material.
  • the blood lancet described in this document has a needle that is embedded in a holder.
  • a cap can be placed on the holder so that the needle tip is surrounded by the cap but does not touch the cap.
  • twisting of the needle tip or contamination with plastic particles can be prevented.
  • this blood lancet has the disadvantage that a final assembly step for the assembly of the holder and cap and thus also a separate production of the two parts is necessary.
  • the present invention relates to a disposable blood lancet containing a needle with a holding area and a tip area, the holding area being in a holder and the tip area being enclosed by a cap such that the needle is surrounded by a cavity in the tip area.
  • the blood lancet is characterized in that the holder and cap are connected to one another via a predetermined breaking point.
  • the present invention combines the advantages of the lancet types already described above without accepting their disadvantages.
  • the needle tip is surrounded by a cavity and is uraclosed by a cap. This can ensure that the tip is not damaged when the cap is removed, or that plastic parts stick to the tip.
  • the cap also provides protection for the needle tip against external influences that could result in damage or contamination. Because the cap and the holder are connected to one another via a predetermined breaking point, it is clear to the user if the blood lancet has already been used or has otherwise been opened.
  • the cap can be prevented from being arranged in its original position again after the predetermined breaking point has been broken open.
  • the blood lancet of the present invention also offers the advantage that the user can insert the needle into the cap after use, so that the needle no longer poses a risk of injury.
  • a disposable blood lancet according to the present invention includes a needle with a holding area and a tip area.
  • the holding area of the needle is usually several millimeters long and has an elongated shape.
  • a large number of needles have a holding area with a cylindrical shape, since this needle shape is particularly easy to produce, but holding areas with a different shape are also possible.
  • the tip area of the needle includes the needle tip that is pierced into tissue and can have another area that is located between the needle tip and the holding area and that is located within the cap. The cross-section of this area generally corresponds to that of the holding area.
  • the needle tip can be rotationally symmetrical, for example, as is the case with sewing needles. However, it has proven to be advantageous to attach one or more cuts to the needle tip.
  • the resulting edges which are inclined to the longitudinal axis of the needle, serve as a cutting edge during the puncture and make the puncturing process less painful than is the case with rotationally symmetrical needles.
  • the needle of the blood lancet is made of a material that is sufficiently hard to withstand deformation without any deformation during the puncturing process, the processing steps or any other stresses that may occur. Furthermore, the material must be such that no particles break off or become detached during the puncturing process. Finally, the needle material must also be machinable so that the needle tip can be sharpened sufficiently and the edges of the needle tip can be ground sufficiently sharply.
  • Well-suited materials for the needle are, above all, metals and of these in particular stainless steels, such as, for. B. 1.4301, 1.4310 and 1.44er steels.
  • a holder is used to hold the needle.
  • Plastics in which the needle with its holding area is melted or glued, have proven particularly useful as materials for the holder.
  • the holder has a cavity or a bore which serves to receive the holding area.
  • this cavity or the bore is chosen so that the wall either in the largest possible area on the needle is applied, or runs a short distance from the needle. In this way, the holder and needle can be fixed to one another by melting, gluing or the like.
  • the most common way to generate a holder is to over-mold a needle with plastic.
  • the needle is positioned in the holder so that the tip end protrudes a few millimeters from the holder.
  • the protruding needle end is preferably shorter than 4 mm.
  • the outer shape of the holder can be adapted to the circumstances. If, for example, the blood lancet is to be used manually, one will choose a holder that can be gripped easily and safely. If, on the other hand, the blood lancet is to be used in an automatic lancing device, the outer shape of the holder is selected so that the blood lancet can be positioned and held in the lancing device. With regard to the holding of blood lancets in lancing devices, reference is made in full to the U.S. 5,318,584.
  • An essential feature of the blood lancet according to the invention is that the tip region of the needle is surrounded by a cavity which is formed by a cap.
  • this has the advantage that the tip area is protected both from mechanical influences and from contamination.
  • the design of the cap in such a way that there is a cavity between the tip region and the cap material also has the advantage that removal of the cap from the blood lancet does not lead to any deformation of the needle tip. Through this cavity it is also possible to apply a coating on the needle tip, which facilitates penetration into the skin.
  • the shape of the cap depends on the one hand on the desired cavity and on the shape of the holder to which the cap is attached.
  • the cap is designed in such a way that the cavity around the needle tip is closed. This can prevent contaminants from entering the cavity.
  • the cavity provided by the cap should be dimensioned such that contact between the cap and the needle tip can be avoided with sufficient certainty when the cap is removed.
  • the attachment The cap on the holder results in an opening of the cap, which can be seen when the cap has been removed.
  • the cross section of this opening should be many times larger than the cross section of the needle in the tip region in order to avoid contact of the edge of this opening with the needle when the cap is removed. If a very careful user or automated removal of the cap is required, the distance between the cap and the needle tip or the cross-section of the cap opening can be chosen to be small.
  • the distance between the cap and the needle tip and the cross section of the cap opening will be chosen so large that if the cap and holder are tilted when the cap is removed, the needle tip will not be touched.
  • the ratio of the protruding part of the needle to the cross section of the cap opening is preferably 1: 1 to 2: 1.
  • the cap preferably has a wall thickness between 0.05 and 1 mm. Due to the low thickness of the material, it is also possible to insert the needle into the cap after use.
  • the holder and cap are connected to one another via a predetermined breaking point.
  • This predetermined breaking point is a releasable mechanical connection between the holder and the cap which, after being loosened once, cannot be put together again in such a way that the cap remains on the holder.
  • the feature of the blood lancet referred to as the predetermined breaking point can itself consist of several parts. These parts can, for example, be thin webs which run between the holder and the cap and are broken through when the cap is pulled off or twisted off.
  • the predetermined breaking point can advantageously also be a coherent piece of material (for example a thin plastic layer) which runs between the opening in the cap and the holder.
  • One advantage of the embodiment mentioned is that the holder and cap can be produced in one piece.
  • the material of the predetermined breaking point preferably has a thickness of 0.05 to 0.3 mm in the thinnest area. It is also possible that the material of the predetermined breaking point is perforated. Herewith this means both continuous perforations and perforations preferred according to the invention, in which thicker and thinner material regions alternate.
  • the cap can also be glued or welded to the holder and the gluing or welding can serve as a breaking point.
  • the predetermined breaking point is advantageously carried out so that the connection between the cap and the holder is completely closed. This is advantageous in order to prevent contamination with the needle tip. On the other hand, contamination can be avoided even with a non-continuous breaking part if the remaining openings are small enough.
  • Embodiments of the blood lancet are possible in which the cap is still connected to the holder even after the predetermined breaking point has broken. This is the case, for example, if the cap is attached to the holder via a film hinge and a predetermined breaking point is attached to the connection point between the holder and the cap opposite the film hinge. By swiveling the cap around the axis of the film hinge, the predetermined breaking point is broken open and the needle tip is released.
  • embodiments are sometimes less favorable in handling, so that embodiments are preferred according to the invention in which the holder and cap are connected to one another only via a predetermined breaking point and the holder and cap are present separately after breaking through the predetermined breaking point.
  • a blood lancet can be produced by attaching a cap to a holder.
  • this entails both a separate production of the two individual parts and a further assembly step, embodiments are preferred which can be produced in one step in a coherent manner.
  • this goal is initially opposed to the fact that closed cavities cannot be produced by injection molding.
  • an injection molded body is first formed, which has a holding area and also a cap, but the cap is open.
  • the cap is closed.
  • the opened cap which is first sprayed, can have the shape of a funnel, for example, which is connected to the edge of its smaller opening via a sol breaking point with the holding area.
  • the funnel can be closed, for example, by sealing the opening or by closing it with a lid.
  • a lid it is particularly advantageous if it is molded in the same injection molding process so that it is connected to the cap via a flexible piece of material and can be folded onto the cap by bending the piece of material.
  • the cap has a first part which has an opening in a region facing away from the holder and a second part (cover) with which the opening can be completely closed.
  • the production of such a blood lancet is possible by injection molding, in that the lid and the cavity in the opened cap are removed from the mold with a slide.
  • the first and / or second part is provided with a sealing lip which is made of a material which is more elastic than the material of the cap.
  • FIGS. 1-4 The following invention is explained in more detail with reference to FIGS. 1-4:
  • Figure 1 Disposable blood lancet in a perspective view.
  • FIG. 1 Blood lancet under supervision.
  • Figure 3 Longitudinal section through a blood lancet with the cap open.
  • FIG. 1 shows a blood lancet according to the invention in a perspective view. You can see the holder (2) in which the holding area (1) of the needle runs. It can be seen from the figure that the holding area (1) need not be completely surrounded by the material of the holder (2). In the embodiment shown here, the holding area is held in 3 regions, while it is exposed in 2 areas. An embodiment in which the holding area is exposed in at least one area is advantageous since the needle can be fixed in this area during the injection molding process, so that a very precise relative positioning of the needle and holder is possible. Material can also be saved through the recesses in the holder.
  • Figure 1 shows that the holder has notches (20) which serve to fix and position the blood lancet in a lancing device.
  • the holder also has a recess (21) at its rear end, which releases the rear needle end.
  • embodiments are possible which have no recess, but in which the needle end projects beyond the rear edge of the holder.
  • the rear end of the needle is freely accessible
  • the control of the penetration depth is independent of the relative positioning of the holder and housing relative to one another, and the precision of the penetration depth primarily depends on the length tolerance of the needle, which can be controlled very precisely.
  • the cap (3) can also be seen, which is connected to the holder (2) and which surrounds the needle tip.
  • the cap shown here has a part which provides a cavity for the needle tip, and a cover (8) which is connected to the aforementioned part of the cap via a film hinge.
  • FIG. 2 shows a side view of the blood lancet.
  • the cap is closed with the lid (8) so that the needle tip is in a closed cavity.
  • the figure also shows the transition area between the cap and the holder, which is designed as a predetermined breaking point (4).
  • FIG. 3 shows a longitudinal section through a blood lancet with the cap open.
  • the embodiment shown has a cap, the base part of which has a shoulder (10) onto which the lid (8) is folded by pivoting about the axis of the film hinge.
  • the lid (8) has in its interior a recess (11) into which the shoulder (10) snaps in order to seal the cap airtight.
  • FIG. 4 also shows that when the cap is closed, the needle tip (6) is surrounded by a cavity (7) in such a way that it does not touch the cap wall.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dermatology (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

La présente invention porte sur des lancettes à usage unique comprenant une aiguille avec, d'une part, la partie par où on la tient (1), placée dans un support (2), tandis que la partie où se trouve la pointe (6) est enveloppée d'une calotte (3) de telle manière qu'elle est entourée par un volume creux (7), ledit support (2) et la calotte (3) étant reliés par un point destiné à la rupture (4).
EP98921493A 1997-04-29 1998-04-28 Lancettes a usage unique Withdrawn EP0987983A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19718081 1997-04-29
DE19718081A DE19718081A1 (de) 1997-04-29 1997-04-29 Einweg Blutlanzette
PCT/EP1998/002502 WO1998048695A1 (fr) 1997-04-29 1998-04-28 Lancettes a usage unique

Publications (1)

Publication Number Publication Date
EP0987983A1 true EP0987983A1 (fr) 2000-03-29

Family

ID=7828103

Family Applications (1)

Application Number Title Priority Date Filing Date
EP98921493A Withdrawn EP0987983A1 (fr) 1997-04-29 1998-04-28 Lancettes a usage unique

Country Status (4)

Country Link
EP (1) EP0987983A1 (fr)
AU (1) AU7432398A (fr)
DE (1) DE19718081A1 (fr)
WO (1) WO1998048695A1 (fr)

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GB9913869D0 (en) * 1999-06-16 1999-08-11 Owen Mumford Ltd Improvements relating to lancets
GB9928876D0 (en) * 1999-12-08 2000-02-02 Owen Mumford Ltd Improvements relating to combined lancets and caps
DE10010694A1 (de) 2000-03-04 2001-09-06 Roche Diagnostics Gmbh Blutlanzette mit hygienischen Spitzenschutz
GB0028926D0 (en) 2000-11-28 2001-01-10 Owen Mumford Ltd Improvements relating to skin prickers
DE10142232B4 (de) 2001-08-29 2021-04-29 Roche Diabetes Care Gmbh Verfahren zur Herstellung eines analytischen Hilfsmittels mit Lanzette und Testelement
DE20114658U1 (de) 2001-09-05 2001-11-15 WILDEN Engineering- und Vertriebsgesellschaft mbH, 92536 Pfreimd Lanzette für die Blutentnahme
DE102004033219A1 (de) 2004-07-09 2006-02-02 Roche Diagnostics Gmbh Verfahren zur selektiven Sterilisation von diagnostischen Testelementen
DE102004048864A1 (de) 2004-10-07 2006-04-13 Roche Diagnostics Gmbh Analytisches Testelement mit drahtloser Datenübertragung
EP1669020A1 (fr) 2004-12-07 2006-06-14 Roche Diagnostics GmbH Etui de rangement avec des fonctions intégrées
EP1868491B1 (fr) 2005-03-24 2011-05-18 Roche Diagnostics GmbH Moyen d'analyse avec lancette et element d'essai
EP1714613A1 (fr) 2005-04-22 2006-10-25 F. Hoffmann-La Roche Ag Moyen d'analyse
EP1894526A1 (fr) 2006-09-04 2008-03-05 F. Hoffmann-la Roche AG Lancette
EP1894525B1 (fr) 2006-09-04 2012-03-07 F. Hoffmann-La Roche AG Emballage pour instruments médicaux hydrophiliques
EP1917909A1 (fr) 2006-10-12 2008-05-07 Roche Diagnostics GmbH Dispositif et procédé pour l'extraction d'échantillon liquides
PL1992283T3 (pl) 2007-05-16 2011-04-29 Hoffmann La Roche System nakłuwający
EP2039293A1 (fr) 2007-09-19 2009-03-25 F. Hoffman-la Roche AG Entraînement de combinaison pour un système d'obtention d'échantillons pour obtenir un échantillon liquide
EP2055472B1 (fr) 2007-10-29 2010-10-13 F. Hoffmann-La Roche AG Procédé de fabrication de rubans avec ressources diagnostiques
US8262685B2 (en) 2009-03-27 2012-09-11 Nipro Corporation Disposable lancing device
PT2243711E (pt) 2009-04-22 2012-10-02 Hoffmann La Roche Fabrico de produtos em fita com meios auxiliares de diagnóstico
IT1397673B1 (it) * 2009-12-15 2013-01-18 Alifax Holding S P A Provetta per analisi diagnostiche
CN103997965A (zh) * 2011-11-02 2014-08-20 林治远 用于皮肤穿透的外科侵入式尖头制品及其用于其制备的方法

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JP2561697Y2 (ja) * 1992-08-28 1998-02-04 アプルス株式会社 ランセット
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Title
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Also Published As

Publication number Publication date
AU7432398A (en) 1998-11-24
DE19718081A1 (de) 1998-11-05
WO1998048695A1 (fr) 1998-11-05

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