EP3136994A1 - Dispositif, système et procédé pour l'application et l'introduction d'au moins une solution de test d'allergène sur et dans la peau d'une partie du corps d'un individu à tester - Google Patents

Dispositif, système et procédé pour l'application et l'introduction d'au moins une solution de test d'allergène sur et dans la peau d'une partie du corps d'un individu à tester

Info

Publication number
EP3136994A1
EP3136994A1 EP15713318.2A EP15713318A EP3136994A1 EP 3136994 A1 EP3136994 A1 EP 3136994A1 EP 15713318 A EP15713318 A EP 15713318A EP 3136994 A1 EP3136994 A1 EP 3136994A1
Authority
EP
European Patent Office
Prior art keywords
holder
skin
puncture
body part
person
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Withdrawn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
EP15713318.2A
Other languages
German (de)
English (en)
Inventor
Cem GEGIN
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.)
Roxall Medizin GmbH
Original Assignee
Roxall Medizin 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 Roxall Medizin GmbH filed Critical Roxall Medizin GmbH
Publication of EP3136994A1 publication Critical patent/EP3136994A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/20—Surgical instruments, devices or methods for vaccinating or cleaning the skin previous to the vaccination
    • A61B17/205—Vaccinating by means of needles or other puncturing devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0035—Vaccination diagnosis other than by injuring the skin, e.g. allergy test patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0077—Devices for viewing the surface of the body, e.g. camera, magnifying lens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/411—Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/44—Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
    • A61B5/441—Skin evaluation, e.g. for skin disorder diagnosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6824—Arm or wrist
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3209—Incision instruments
    • A61B17/32093—Incision instruments for skin incisions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00747—Dermatology
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A61B2017/3409—Needle locating or guiding means using mechanical guide means including needle or instrument drives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A61B2090/065—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/70—Means for positioning the patient in relation to the detecting, measuring or recording means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety

Definitions

  • the invention relates to a device for the automated application and introduction of at least one allergen test solution onto and into the skin of a body part of a person to be tested as part of a prick test. It also relates to a device for applying and introducing at least one allergen test solution onto and into the skin of a body part of a person to be tested by means of a prick test, which device comprises a device as mentioned above and at least one puncture agent. Finally, it relates to a method for applying and introducing at least one allergen test solution onto and into the skin of a body part of a person to be tested which is arranged in a receptacle as part of a prick test.
  • Allergies are a well-known phenomenon in which the immune system of an affected person exhibits certain harmless substances called allergens, a hypersensitivity reaction. Allergies occur in different forms and with reactions to the most diverse allergens causing the respective allergy. For categorization, a distinction is made here between different types of allergies, the clinical classification having types I to IV.
  • the type I allergy is the one that is in focus here. Characteristic of type I allergy is the instantaneous response of the immune system to the formation of classic symptoms, e.g. swelling of the nasal mucosa with secretion (e.g., hay fever) or itchy rashes.
  • Appropriate allergic reactions of the so-called type I allergy are induced by certain pollens, such as e.g. Grass pollen, tree pollen or the like, components in the feces of dust mites (triggers the so-called house dust allergy), animal hair (such as cat or horse hair) and the like.
  • pollens such as e.g. Grass pollen, tree pollen or the like
  • components in the feces of dust mites triggers the so-called house dust allergy
  • animal hair such as cat or horse hair
  • a condition for on the one hand a suitably adapted behavior of the affected person, on the other hand - and in particular - the performance of a hyposensitization, is the exact knowledge of those allergens to which the affected person is allergic.
  • a so-called provocation test which is typically carried out as a prick test, is familiar.
  • This type of test is usually the most reliable way to identify allergens specific to the individual in Type I allergy.
  • a prick test dissolved samples with typical allergens are brought into contact with the skin of the person to be tested, and the skin in the areas in which the contact exists is slightly perforated, in order to advance the substance into the epidermis and skin in order to allow contact with the immune system (in particular the mast cells in the epidermis, the epidermis, which in an allergic reaction release the typical symptoms such as wheals causing histamine).
  • the test allergen applied to the skin is introduced intraepidermally into the skin.
  • comparative solutions of a so-called negative control and a positive control are also applied, which are generally an allergen-free sodium chloride solution (negative control) and e.g. a histamine-containing or codeine phosphate-containing solution (positive control) can act.
  • a predetermined time typically 15 to 20 minutes
  • the reaction of the skin is observed, and in particular the formation of wheals is evaluated as an indicator of a possible allergic reaction, but also the redness of the skin can be evaluated.
  • the wheals formed are assessed for their size (in particular by determining a mean diameter of each wheal) in comparison with corresponding reactions to the negative control ("zero reaction") or the positive control ("reference reaction").
  • such a prick test is often carried out so that the test person to be given liquid drops with the respective allergen test solutions and the solutions for the positive control and the negative control on a corresponding skin area in a spaced arrangement, often on the inside of a Forearm, where then in the area of applied liquid drops, the skin is punctured with a so-called lancet (with a typical puncture depth of in the range of one millimeter).
  • lancet with a typical puncture depth of in the range of one millimeter
  • a too deep perforation also carries the risk that the allergen introduced with a test solution comes into contact with the blood circulation and thus leads to systemic side effects, in the worst case to anaphylactic shock.
  • a different puncturing or penetration depth can be observed both in comparison of several pricks made by one and the same person and in comparisons of tests that are carried out by different persons. In both cases there is an uncertainty factor here.
  • This device comprises at least one holder for releasably receiving at least one puncture means for puncturing the skin. Furthermore, the device contains at least one receptacle for a body part of the person to be tested, on which, however, skin is to be applied and introduced with the at least one allergen test solution. Such a recording serves the predetermined placement of the body part in question.
  • the most diverse body parts come into consideration, such as the trunk, wherein e.g. this is placed with the spine in an exposed position so that the at least one allergen test solution in the area of the back, e.g. the shoulder, to be able to raise.
  • the receptacle will be designed such that it is adapted to receive a forearm, in particular in such a way that when the forearm is in the receptacle the inside thereof is exposed for the automated placement and introduction of the at least one allergen Test solution on and in the skin of this underside of the forearm.
  • the device according to the invention further comprises a drive for moving the at least one holder from a first position, in which a puncture means received in the holder is spaced from the skin surface of a body part of the person to be tested located in the holder, in a feed direction, which movement to a penetrating contact of the puncture means received in the holder with the skin of the body part of the person to be tested which is arranged in the receptacle.
  • the puncture agent which was used for applying and introducing the at least one allergen test solution with which the puncture agent was wetted is not supplied by a member of the appropriately trained medical staff, as has hitherto always been customary, and with the skin surface of the skin Body part of the person under test for puncturing the skin in a penetrating portion of the puncture, which penetrates when puncturing the skin in the upper skin layer (the epidermis) brought into contact .. Rather, this is now done automatically mediated by the drive, the holder with the moved thereon arranged puncture means.
  • a pressure limiter connected to the drive which causes the drive to terminate a movement of the holder in the feed direction, if by the movement of the holder in the feed direction a penetrating contact between the puncture means and the skin of the in Receive receiving body part arranged while a predetermined value exceeding pressure is achieved.
  • This pressure limiter essential for the device according to the invention ensures that the drive moves the holder against the skin of the part of the body to be punctured for the application and introduction of the allergen test solution until it reaches the predetermined value of a reliable puncture to achieve.
  • the pressure limiter to be provided according to the invention can be formed in a very different way.
  • a spring-mounted portion may be formed on the holder, which escapes when moving the holder in the feed direction and when the puncture means with the skin due to the force exerted by the increasing pressure force that exceeds the spring force at a threshold pressure, and operated by this dodge an electrical switch which stops the drive and supplies a corresponding stop signal to a drive control, which drive control then causes a stop of the drive.
  • the An horrbeskyr can also one or more An horrsensoren, e.g.
  • the device according to the invention is stopped with respect to the specification of the threshold value for the contact pressure, the overshoot of which stops the drive for stopping the movement in the feed direction, e.g. can be changed by appropriate reprogramming of the control and thus allows subsequent adjustment and calibration of the device in this function.
  • the predetermined value for the pressure upon reaching or exceeding the drive stops the movement in the delivery direction, can be adapted to the person to be tested, e.g.
  • various predetermined values are preset, from which e.g. in a corresponding selection menu based on entries made there to the o.g. "Variables" is adapted and set for the test to be performed.
  • a control can advantageously be provided which stops the movement of the holder in the feed direction by the Antikbegrenzer controls the drive so that not only further movement of the holder is stopped in the feed direction, but thereafter, a movement of the holder is introduced in a direction opposite to the feed direction to the recorded in the holder puncture of the skin to loosen and remove the part of the body of the person to be tested inserted in the receptacle.
  • This control can e.g. be the above-mentioned control.
  • a function may be provided which causes a delay by a predetermined time in the manner of a timer circuit before the drive after a stop of the movement in the delivery direction due to the responsive An horrbegrenzers an introduction of the opposite in the direction of feed executed movement for lifting and releasing the puncture means sets a contact time.
  • This can be a particularly intimate effect of the allergen test solution with the epidermis at the puncture site or at the puncture sites are achieved, this in turn in a very reproducible and thus optimally meaningful for comparison experiments way.
  • the drive during the pressure movement in the feed direction is first stopped when the pressure exceeds the predetermined value, that then again carried out with a larger pressure, jerky feed movement in the feed direction (in the manner of an impulse force) to to ensure a further optimized penetration of the skin.
  • This sequence can be specified and controlled again via the advantageously possible control of the drive.
  • an allergen testing solution such is not meant to be merely a solution involving certain allergens, e.g. Grass pollen, birch pollen, allergens from the excrement of house dust mite or the like.
  • certain allergens e.g. Grass pollen, birch pollen, allergens from the excrement of house dust mite or the like.
  • comparative solutions for the negative control and positive control so typically pure saline for the negative control and e.g. a histamine-containing or codeine phosphate-containing solution for the positive control.
  • this is preferably a motor drive.
  • This can e.g. to be an electric motor.
  • other actuators are also suitable for the drive, e.g. Drives via pneumatic or hydraulic cylinders or the like.
  • the holder has an automatic gripper for automatically gripping and releasing a puncture means.
  • This gripper may accordingly be provided with its own drive for moving corresponding gripper parts for gripping or releasing a puncture means. But it can also be realized with a fixed distance over a grip gripping tabs or gripper fingers or similar gripping elements, of which at least one is resiliently formed or stored, wherein the reach is slightly smaller than the width of an attack portion of the puncture means on which the gripper to releasably capturing the same attacks.
  • the gripper holds the puncture means by spring force.
  • a hold can be achieved by positive locking, which can be opened with a resilient deflection of at least one of the gripping elements, so as to release the puncture agent again.
  • the gripper or a differently shaped holding section for detachably connecting the puncturing means to the holder is advantageously designed so as to be pivotable about at least one axis, in particular about at least two axes extending transversely to the feed direction.
  • the gripper or otherwise designed holding section can perform a compensating movement to compensate for a - individually different - Inclination of the surface of the body part relative to the feed direction, in particular in a deviating from 90 ° to this direction angle.
  • the device according to the invention can, according to a particular embodiment of the invention, have a drive which makes it possible to move the holder in at least two linearly independent spatial directions.
  • the feed movement can be carried out, wherein the feed direction corresponding along the vertical, for example, down, runs, whereas in a horizontal direction, a lateral method of the holder is possible, e.g. in order to take a puncture means with the gripper provided according to the advantageous embodiment described above, with which a collection and entry of at least one allergen test solution on and into the skin is to be carried out.
  • At least one tray can be provided in the device according to the invention, on which unused puncture means can be arranged, which are used for a subsequent puncture insert for applying and introducing at least one allergen test solution onto and into the skin operated, driven by the drive approach such a filing and can automatically receive a puncture there.
  • the unused puncture agents may be puncturants that have not yet been wetted with an appropriate allergen test solution.
  • the puncture agent may just as well be wetted with the particular allergen test solution, e.g. by delivering a corresponding puncture means already with appropriate wetting and so introduced into the filing.
  • a plurality of such shelves in particular two, may also be present in order to be able to position more than one unused puncture means in a locally different waiting position.
  • the device according to the invention also has a disposal station for used puncture means, ie puncture means with which an automated application and introduction of at least one allergen test solution has already been carried out on and into the skin of a person to be tested. to be available.
  • the device is set up so that the holder, driven by the drive, can approach the disposal station and automatically deposit a puncture there. Dropping does not necessarily mean that the holder must bring the puncture agent to a contact with the disposal station. He may also drop this, for example, into the disposal station.
  • the disposal station can comprise, for example, a receiving tray for used puncture means or a comparable container, which can in particular be removed from the device in order to empty it.
  • the device may further include a receiving station for receiving at least one allergen test solution, wherein the holder operated by the drive can approach the receiving station such that a puncture means received in the holder with at least one arranged in the receiving station allergen Test solution is wetted.
  • the drive may be controlled such that it is moved out after immersing the puncture in an allergen test solution in the receiving station in an optimal for a droplet formation at the puncture speed from this, and then to be moved in a conveying speed, the one ensures safe adherence of the recorded drop of the allergen test solution to the puncture means and dripping it by, for example prevents too fast or too jerky movements.
  • a device which combines various of the features described above as advantageous in itself, be designed so that at least one tray for unused puncture means is provided, the holder driven by the drive an ecological when a process is started, after one person testing the corresponding body part, eg one of her forearms correctly positioned in the receptacle. If the holder has a gripper, the gripper can grasp the puncture agent and drive out of the tray. A corresponding movement can be for example a vertical movement. Following this, the holder can move the puncture means now releasably attached thereto in the direction of the receiving station, e.g.
  • the holder can in turn drive it back, in the direction of the receptacle and the body part of the person to be tested, e.g. of the forearm, this is e.g. again by means of a horizontal movement to then perform a movement in the feed direction, for example a downward vertical movement, and the puncture means in contact with the skin surface on the body part of the person under test, e.g.
  • a value for the pressure can be specified, which must not be exceeded, but only reached.
  • a short power impulse defined in a previously defined manner can then be effected in the feed direction in order to ensure an even more optimized penetration of the skin. Now - after the stop of the movement and / or after the shock - the pressure for a certain time can be maintained before the holder again moves in the opposite direction to the puncture of the skin of the ingested body part of the person to be tested to solve. Thereafter, the holder may move the puncture means to the disposal station by further movement, e.g.
  • the puncture means may be designed in a manner having a plurality of puncture heads arranged in a spatially separated manner, as described in US Pat. No. 3,556,080.
  • a puncture with twelve puncture heads shown, where the number is not fixed here.
  • ten, eight or six such puncture heads may be present or puncture heads of any other suitable number, e.g. only one such puncture head or three.
  • the arrangement of the puncture heads is not predetermined in the rectangular matrix-like manner, as shown in said document, such an arrangement, however, is recommended as advantageous. With such a device, when using the procedure described above, for example in the receiving station in a suitable arrangement pots or the like.
  • the receiving station for receiving the allergen test solutions can be designed such that a carrier with a corresponding arrangement and number corresponding to the arrangement and number of puncture heads of the puncture means Shape can be introduced there by appropriate shaping in an asymmetrical manner only in a specific orientation there, so that the arrangement of the individual allergen test solutions is always predetermined and is reflected in this arrangement of the loaded with different allergen test solutions puncture sites on the body part in the recording ,
  • the device according to the invention can furthermore not only comprise a receptacle for a body part of a person to be tested, but for example two such receptacles, e.g. to be able to simultaneously record both forearms of a person to be tested.
  • the device may also comprise two holders which, in a further embodiment as already described above, e.g. may be provided with grippers to at the same time prick both forearms or other body parts that are arranged in the recordings can. In this way, an even faster performance of a corresponding test is achieved, the person to be tested is spared a successive, possibly perceived as unpleasant procedure of pricking.
  • an image acquisition means for acquiring a photographic image of the skin surface of a body part arranged in the receptacle (meaning the skin surface in which at least one allergen test solution has been applied, and in that it also has an image evaluation unit connected to the image acquisition means for evaluating the photographic image with regard to skin reactions, in particular with regard to the formation of wheals, in the area or areas of the skin surface, in which or in which allergen test solution (s) has been applied to and into the skin and / or is, has.
  • an image acquisition means for acquiring a photographic image of the skin surface of a body part arranged in the receptacle (meaning the skin surface in which at least one allergen test solution has been applied
  • an image evaluation unit connected to the image acquisition means for evaluating the photographic image with regard to skin reactions, in particular with regard to the formation of wheals, in the area or areas of the skin surface, in which or in which allergen test solution (s) has been applied to and into the skin and / or is
  • a further aspect of the invention consists in a device for applying and introducing at least one allergen test solution onto and into the skin of a body part of a person to be tested as part of a prick test, this device comprising a device according to the features described above and, if necessary with the possible further developments also described above and also at least one with the at least one holder releasably connectable puncture means.
  • This puncture may e.g. again with multiple puncture heads, as shown and described in previously referenced US 3,556,080, but without being limited to the exact number of twelve separate puncture heads, but with flexible design depending on the requirements.
  • the corresponding puncture means may consist of different material, with a biocompatible plastic being preferred here.
  • the puncture agent may also be formed from metal or another suitable material or in composite construction.
  • a puncture section of the puncture means in particular, a design with a stop can be provided which prevents too deep penetration of puncture sections of the puncture means into the puncture thorns into the skin.
  • a design as described in US Pat. No. 5,820,562 not only with regard to a puncture device intended for puncture at one site, but also with a plurality of puncture heads, as described in the already frequently referenced US Pat. No. 3,556,080.
  • Another component of the device may be at least one allergen test solution for wetting the puncture agent.
  • An arrangement of open vessels arranged in predetermined orientation with different allergen test solutions can also be selected here, which are set up in particular for the simultaneous wetting of the puncture heads of a puncture device having a plurality of such puncture heads as described above.
  • a device also image acquisition means for detecting a photographic image of the skin surface of the body part have, on and in the (the skin surface) at least one allergen test solution has been introduced and introduced, and one with the Imaging means connected image evaluation unit for evaluating the photographic image with respect to skin reactions, in particular a formation of wheals, in the area or areas in which or allergen test solution (s) on and in the skin has been introduced and / or . are.
  • Such an image capturing means can, if a device according to the above-described advantageous development is used, in which this is in the region of the recording for the body part, on and in the skin of the allergen test solution (s) and is or are to be, is arranged, is provided to be formed by this image capture means.
  • a device according to the invention it is also within the scope of a device according to the invention that the image acquisition takes place separately from this device in a separate apparatus which can also be operated alone and in isolation.
  • Such an apparatus in itself represents an independent development and can be regarded as a separate invention.
  • the image analysis of the photographically produced images of the skin surface which recordings are typically digital, is in particular set up in such a way that it recognizes the formation of wheals and can determine their average diameter.
  • Corresponding image analysis software that can detect and measure such structures is available on the market for various other purposes, e.g. in the field of diagnostics in dermatologists (e.g., for early skin cancer detection) use.
  • a person skilled in the art can therefore derive corresponding evaluation devices for the purpose described here based on these known solutions and develop them without inventive effort.
  • another aspect of the solution according to the invention consists in a method for applying and introducing at least one allergen test solution onto and into the skin of a body part of a person to be tested in a prick test, with a detachably connected thereto , puncture means wetted with the allergen test solution for puncturing the skin by means of a drive, which may in particular be a motor drive, from a first position in which the puncture means is spaced from the skin surface of the body part of the person being tested located in the receptacle , as long as in a feed direction, which leads to a penetrating contact of the puncture means received in the holder with the skin of the body arranged in the recording part of the person under test, is moved until a predetermined value of a pressure with which the holder when moving in the delivery direction and Ko nstakt is pressed between the puncture means and the skin of the body part arranged in the receptacle against the skin of the body part arranged in the receptacle is
  • Another advantage of the device, device and method according to the invention especially in comparison with the known manual method with the application of droplets of the allergen test solutions and puncturing with the lancets, consists in the lower consumption of the test solutions. Compared to the typical volume of a drop that is applied to the skin in a conventional procedure, only a fraction of the solution is required for the wetting of the puncture agent according to the invention.
  • FIG. 1 is a perspective view of a device according to the invention for the automated placement and introduction of at least one allergen test solution on and in the skin of a body part of a person to be tested in the context of a prick test (hereinafter also abbreviated automatic prick device called) in a possible embodiment with open cover from the front;
  • a prick test hereinafter also abbreviated automatic prick device called
  • FIG. 2 shows a perspective view of the device according to FIG. 1 from the rear side;
  • FIG. 3 in magnification a view from the front of essential components of the device according to the invention shown in Figure 1;
  • FIG. 4 is a detail view of the device in a viewing angle obliquely from above.
  • FIG. 5 is a view similar to FIG. 3 of a detail of the device with the cover closed; FIG. and
  • FIG. 6 in an enlarged view of the holder of the device held by this puncture.
  • FIG. 1 a possible embodiment of an automatic prick device according to the invention is shown and will be explained below.
  • the figures can also be a device according to the invention for applying and introducing at least one allergen test solution on and in the skin of a body part of a person to be tested in the context of a prick test refer, which includes the device shown and also shown with puncture ,
  • an automatic prick device is generally designated by the reference numeral 1.
  • This first contains a housing 2, on which pivotally hinged a cover 3 is attached.
  • This cover 3 which is in the open position in FIGS. 1 to 4, is shown in closed position in FIG. 5, serves to close an interior region 4 of the automatic prick device 1.
  • a sensor (not shown here) monitors the closed position the cover 3 and prevents operation of the prick device 1 when the cover 3 is not properly closed.
  • the inner area 4 is arranged as an integral part of the automatic prick device 1 by means of a non-illustrated drive automatically movable holder 5, and there is a receptacle 6 for positionally defined placement of a body part, here a forearm, a person to be tested in a position in which the underside of the forearm is exposed facing upwards.
  • a body part here a forearm
  • a handle 7 is arranged, which a person under test, which has positioned her forearm on the receptacle 6, so as to ensure a defined position of the forearm ,
  • the handle 7 may be fixed in terms of its position in the pricking device or in the horizontal and / or vertical direction adjustable and lockable in variable positions to the handle position, for. adapt to different persons to be tested (e.g., a child compared to an adult).
  • one or more sensor may be provided which the presence and correct positioning of a forearm of the person under test in the receptacle 6 and / or with correct handle to Detect the handle 7 and signal this in the housing 2 arranged control of the automatic prick device 1.
  • the control of the prick device 1 can be set up in such a way that a sequence of the same can only be started when the sensor or the sensors in the region of the receptacle 6 and / or of the handle 7 respond accordingly.
  • the automatic prick device 1 has a gripper device, with two mutually opposite each leaving a gap or space between tongues 8.
  • These tongues 8 are resilient, so they can avoid by increasing their distance relative to each other.
  • a longitudinally extending along this distance stop plate 9 is arranged, the meaning of which will be explained in more detail below.
  • a rear wall 10 of the inner region 4 can be seen, in which rear wall 10 guide slots 11 are arranged, pretend or trace the movement distances of the holder 5 moved over the drive.
  • the holder 5 can be moved along these movement paths via the drive arranged in the housing 2, not shown here.
  • a receiving station 12 for receiving allergen test solutions, in this case in various forms, i. with different allergen test solutions, filled in separate pots 13.
  • these are a total of sixteen such pots 13, which are arranged side by side to two groups of eight in the receiving station 12.
  • the pots may be arranged in one or more group (s) in one or more tableau-like carrier (s), which can be placed in the receiving station 12 only in a certain predetermined position and in a defined orientation.
  • it can be ensured that e.g. with a number of such pots stocked and filled in a predetermined sequence with different test solutions pots are placed in a predetermined arrangement.
  • the two vertically extending guide slots 11 shown on the left in FIG. 3 indicate vertically proceeding starting movements of the holder 5 in the direction of the two figure-eight groups of the pots 13 in the receiving station 12.
  • two shelves 14 arranged side by side in the inner area 4, to which the two middle, juxtaposed, vertically extending guide slots 11 lead and in each of which unused puncturing means 15 are arranged.
  • Components of the shelves are here removable trays that can be used on an external shape only in a certain orientation in the prick device 1.
  • These shells can in particular be those carrier shells in which the puncture means 15 have been covered, inserted and sterilized by means of a foil and thus delivered.
  • the trays 14 can be fitted with unused puncture means 15 particularly easy by unsealing such a shell first by peeling off the film and then appropriately inserted into the intended position in the prick device 1.
  • a disposal station 16 can be seen, disposed of in the used puncture means and can be collected.
  • the disposal station 16 is designed here as a collecting tray and can be identical to the trays of the trays 14 in particular. Also to this disposal station 16 performs a corresponding, located in the figure right guide slot 11, wherein in the lower region of the guide slot 11, an ejector 17 is arranged.
  • This ejector 17 has a rounded starting edge, with which a downwardly disposed puncture means 15 is guided past this ejector 17 when moving down the holder 5, this can escape counter to a spring force in the direction of the rear wall 10.
  • the control of the automatic pricking device 1 reverses the movement, lifting the holder 5 again along the vertical course of the corresponding guide slot 11, the puncture means 15 at the trailing edge of the ejector 17 remains hanging and from the gripper, which is formed by the two resilient tongues 8, is released, finally falls into the disposal station 16.
  • an operating and display panel 18 via which the automatic prick device 1 can be operated and controlled with respect to their respective states.
  • a display 19 Part of this control and display panel 18 is a display 19, which may be for example an LCD display.
  • two actuation buttons 20 and 21 can be seen, which are labeled with arrows pointing to the left or right. These are for automatically starting a sequence for automatic pricking, i. ie the automatic application and introduction of allergen test solutions onto and into the skin, a right (right arrow) or left (left arrow) forearm of a person to be tested.
  • Further actuation buttons 22, 28 allow navigation through the display menu of the control (actuation button 22) or a stop input (actuation button 28).
  • the automatic prick device 1 has, as can be seen in particular in Fig. 4, also via an emergency stop switch 23. If this is actuated, a prick process is stopped immediately, moves the driven by the drive holder 5 in a secure position. If the holder 5 is equipped with a puncture means 15, this is disposed of, possibly after only a reset of the emergency stop switch 23 in the disposal station 16, and the holder 5 moves back to a starting position before, when the emergency stop switch 23 has been reset, a new workflow can be started.
  • the automatic prick device 1 is shown with closed cover 3, which covers the inner region 4.
  • closed cover 3 covers the inner region 4.
  • opening 24 in the cover 3 through which the respective forearm of the person under test is guided, so that it can be placed on the receptacle 6.
  • Fig. 6 finally, an enlarged view of the holder 5 is shown as it rests with the tongues 8 on a puncture means 15 and this holds releasably.
  • the puncture means 15 is in this embodiment, with a plurality of puncture heads 25, here eight such puncture heads 25, provided punctured puncture means, in this embodiment, eight punctures with eight different allergen test solutions on and in one on the receptacle 6 of the automatic prick Device 1 stored forearm can be performed simultaneously. Recognizable in this figure are also at each of the puncture heads 25 a plurality of puncture punctures 26 formed on the underside, which provide in a circular arrangement for several simultaneously introduced puncture punctures into the skin during puncturing or pricking.
  • a comb-like extension 27 can be recognized on the puncture means 15.
  • the stop plate 9 Against this comb-like projection 27 is the stop plate 9, thus ensuring a correct horizontal alignment of the puncture means 15 or prevents tilting and evading, in the worst case, a release of the puncture means 15 from the handle of the holder 5 during the pressing and pressing of the puncture means 15 and into the skin of the underside of the forearm of a patient.
  • the pots 13 located there are filled with appropriate allergen test solution, wherein in each of the pots different allergen test solutions may be present, but in one or each of the two grouped into eight pots 13 groups each once the positive control and negative control (For example, a histamine-containing or codeinphosphat inconvenience solution or a pure saline solution) is present for the comparison.
  • the trays 14 are each equipped with a fresh puncture means 15, i. inserted into the appropriate places of the devices, the small bowls with the fresh puncture means 15 in the correct orientation, and it is ensured that the disposal station 16 is emptied or the place of the disposal station is equipped with an empty drip tray. Then the cover 13 is closed. If the associated sensor determines that the cover 13 is correctly closed, the further procedure can be carried out.
  • the automatic prick device 1 can now be put into operation, which is done by appropriate actuation of the actuation button 20 to 22.
  • the presence of the pots 13, or of the tableau-like carrier (s) with a plurality of pots 13, in the receiving station 12 can be queried as well as the presence of puncture agents in the shelves 14 or of pots equipped with puncture via corresponding sensors and the correct placement of the disposal container in the disposal station 16. If at this point a negative message, the control of the automatic prick device 1 will prevent a run start and possibly, for example 19 output a corresponding warning on the display.
  • a person to be tested now inserts his right or left forearm and places it on the receptacle 6, wherein it encompasses the grip 7. If this is the correct position reached, which can be checked if necessary by a corresponding illumination along a correct alignment line or within a given area, which can be done for example by means of a light emitting diode or laser diode, which is arranged above the receptacle 6 (comparable to the positioning aids in X-ray machines), the prick run can be started.
  • an operator actuates the actuation button 20 or the actuation button 21, depending on whether the left forearm (actuation button 20) or the right forearm (actuation button 21) of the person to be tested is placed on the receptacle 6.
  • the actuation of the corresponding actuating button 20 or 21 now starts the actual prick process.
  • the holder 5 initially moves from the parking position shown in FIG. 3 to one of the trays 14, grips the deposited puncture means 15 there and grips it with the gripper formed by the tongues 8. The holder 5 then moves back and dips the puncture means 15 into one of the two groups of eight of the allergen test solution located in the pots 13.
  • the thus-wetted puncture means returns the holder 5 in the vertical direction and now moves along the horizontally arranged guide slot 11 in the direction of the region of the receptacle.
  • the holder moves vertically with the puncture means held in its gripper in a feed movement along the direction of vertical downward feed direction.
  • the holder 5 moves until a contact between the puncture tips of the puncturing heads 25 of the puncturing means 15 formed by the puncturing mandrels 26 is reached.
  • the holder 5 is now moved so long in the feed vertically downwards in the direction of the forearm, to a arranged in the holder 5, not shown here An horrbegrenzer, a pressure, with the holder 5 and thus held with this puncture 15 against the forearm of the test person is moved, receives, responds, since a preset value is reached or exceeded. Now stops the further Anstellterrorism of the holder 5, in which case a second short pushing movement in the direction of delivery can be done to achieve a reliable puncture of the skin, but this does not necessarily have to happen.
  • the holder 5 dwells in the approached position for a certain time; This period of time may be referred to as contact time. Either immediately or after expiration of the optional contact time, the holder 5 with the puncture means 15 therein is again moved from the forearm of the person to be tested in a vertical upward direction and moves along the horizontal guide slot 11 to above the disposal station 16. There, the holder moves 5 in the vertical direction along the direction of this station 16 extending guide slot 11 down until the puncture means 15 has passed the ejector 17. This can e.g. be displayed by a corresponding sensor on the ejector of a control of the drive or due to a position or Wegbetician the driven moving holder 5.
  • the holder 5 moves up again, wherein the puncture means 15 is retained by the ejector 17 and from the clamping handle of the gripper formed by the tongues 8 solves, in the disposal station 16, ie in this forming collecting container falls into it.
  • the holder 5 subsequently moves again into the waiting position shown in FIG. 3 and is ready to carry out a further test. If the person to be tested is now also pricked on their second forearm with further allergen test solutions, an operator can actuate the second, previously unactuated actuation button 20 or 21, whereby now the sequence described above begins again with the restriction that the holder 5 now the previously unused tray 14 anaide and there still remaining unused puncture 15 engages, with this the not previously approached pots 13 anatomic in the receiving station 12 to moisten the puncture 15 with the allergen test solutions therein, and then goes through the already described process.
  • an image capture e.g. a CCD camera or a comparable digital recording chip to be present after a predetermined waiting time to make a recording of skin reactions at the previously embroidered puncture sites on the forearm of the person under test.
  • an image evaluation device may be included, which evaluates corresponding skin reactions, in particular determined sizes of wheals formed, and about possible allergic reactions and detects this, for example. on the display 19 or an optional printer to be connected as information outputs.
  • an automatic pricking method as described above in particular ensured by the Anticianbegrenzer on the holder 5 and the corresponding control of the movement of the holder 5 along the feed direction and stopping when reaching a predetermined pressure or when exceeding the same, a reliable puncture Get skin of the person to be tested, but without this it comes to injuries due to excessive pressure.
  • a clear assignment of the corresponding pattern on the forearm of the patient is possible and ensured by the predetermined arrangement of the allergen test solutions in the receiving station, without causing confusion here.
  • an asymmetrical shaping in the receiving station 12 and in corresponding matching tableaus with the pots 13 can ensure that only a suitable tableau can be correctly set into the receiving station 12 in a corresponding orientation. The correct positioning can also be monitored by a corresponding sensor.
  • the controller can also have a counter for the prick processes or runs carried out.
  • a counter may e.g. be evaluated to track the consumption of test solution (s) and display a required refilling or replacement of the pots 13. Also maintenance of maintenance intervals can be tracked and necessary maintenance can be displayed.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
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  • Biomedical Technology (AREA)
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  • Immunology (AREA)
  • Vascular Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne un dispositif pour l'application et l'introduction d'au moins une solution de test d'allergène sur et dans la peau d'une partie du corps d'un individu à tester dans le cadre d'un test cutané allergologique. Le dispositif comprend : un support pour la réception amovible d'un moyen de ponction pour ponctionner la peau ; un logement pour une partie du corps ; un entraînement permettant le déplacement du support depuis une position dans laquelle le moyen de ponction est situé à une certaine distance de la surface de la peau de la partie du corps vers une position de distribution, qui conduit à un contact pénétrant du moyen de ponction avec la peau de la partie du corps ; et un limitateur de pression lié à l'entraînement, qui suscite la fin d'un mouvement du support dans la direction de la distribution effectué par l'entraînement, quand, du fait du mouvement du support dans la direction de la distribution, un contact entre le moyen de ponction et la peau est obtenu et une valeur prédéterminée de pression excessive est atteinte. Avec un tel dispositif, on a pour la première fois la possibilité, d'appliquer sur la peau d'un individu à tester des solutions de test d'allergènes dans le cadre des tests cutanés allergologiques en une étape automatisée de manière fiable, reproductible et si possible aussi de manière clairement définie en vue d'une évaluation ultérieure.
EP15713318.2A 2014-05-02 2015-03-26 Dispositif, système et procédé pour l'application et l'introduction d'au moins une solution de test d'allergène sur et dans la peau d'une partie du corps d'un individu à tester Withdrawn EP3136994A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102014106170.5A DE102014106170A1 (de) 2014-05-02 2014-05-02 Vorrichtung, Einrichtung und Verfahren zum Auf- und Einbringen wenigstens einer Allergen-Testlösung auf und in die Haut eines Körperteils einer zu testenden Person
PCT/EP2015/056602 WO2015165665A1 (fr) 2014-05-02 2015-03-26 Dispositif, système et procédé pour l'application et l'introduction d'au moins une solution de test d'allergène sur et dans la peau d'une partie du corps d'un individu à tester

Publications (1)

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EP3136994A1 true EP3136994A1 (fr) 2017-03-08

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EP15713318.2A Withdrawn EP3136994A1 (fr) 2014-05-02 2015-03-26 Dispositif, système et procédé pour l'application et l'introduction d'au moins une solution de test d'allergène sur et dans la peau d'une partie du corps d'un individu à tester

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EP (1) EP3136994A1 (fr)
DE (1) DE102014106170A1 (fr)
WO (1) WO2015165665A1 (fr)

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Publication number Priority date Publication date Assignee Title
CN114271864B (zh) * 2021-12-10 2023-05-16 无锡市第五人民医院 一种用于人体过敏源检测的装置

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GB2317113B (en) * 1996-09-13 1998-11-11 Hsiao Ray Ling Skin allergy test assembly
US5820562A (en) 1997-11-05 1998-10-13 Hsiao; Ray-Ling Skin allergy test device having step-shaped punctures
UY25347A1 (es) * 1998-01-12 1999-05-14 Embrex Inc Procedimiento de inyeccion multiple para el tratamiento de embriones aviarios in ovo, y aparato automatizado para la inyeccion in ovo.
US7962192B2 (en) * 2005-09-30 2011-06-14 Restoration Robotics, Inc. Systems and methods for aligning a tool with a desired location or object
DE202006009246U1 (de) * 2006-06-09 2006-08-17 Schadel, Axel, Priv.-Doz. Dr.med. Vorrichtung zum Einbringen von Substanzen in die Haut eines Lebewesens, insbesondere eines Menschen
US20100100005A1 (en) * 2006-07-11 2010-04-22 Infotonics Technology Center, Inc. Minimally invasive allergy testing system with coated allergens
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WO2011115602A1 (fr) * 2010-03-17 2011-09-22 Nanomed Devices, Inc. Dispositif pédagogique non verbal incorporé pouvant être intégré à des applicateurs
NL2004558C2 (nl) * 2010-04-15 2011-10-18 Lx Consult B V Apparaat voor de behandeling van een tenniselleboog.
FR2969915B1 (fr) * 2011-01-04 2014-01-03 Ergylink Systeme et procede pour analyser au moins une caracteristique de la peau
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DE102014106170A1 (de) 2015-11-05

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