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WO2025036889A1 - Agencement d'imagerie et procédé d'imagerie de veines - Google Patents

Agencement d'imagerie et procédé d'imagerie de veines Download PDF

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Publication number
WO2025036889A1
WO2025036889A1 PCT/EP2024/072770 EP2024072770W WO2025036889A1 WO 2025036889 A1 WO2025036889 A1 WO 2025036889A1 EP 2024072770 W EP2024072770 W EP 2024072770W WO 2025036889 A1 WO2025036889 A1 WO 2025036889A1
Authority
WO
WIPO (PCT)
Prior art keywords
scanner
imaging apparatus
image
imaging
mount
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.)
Pending
Application number
PCT/EP2024/072770
Other languages
English (en)
Inventor
Stefan Alt
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.)
Sanofi SA
Original Assignee
Sanofi SA
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 Sanofi SA filed Critical Sanofi SA
Publication of WO2025036889A1 publication Critical patent/WO2025036889A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0062—Arrangements for scanning
    • A61B5/0064—Body surface scanning
    • 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
    • A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
    • A61B5/0086—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters using infrared radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4887—Locating particular structures in or on the body
    • A61B5/489—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/742—Details of notification to user or communication with user or patient; User input means using visual displays
    • A61B5/7425—Displaying combinations of multiple images regardless of image source, e.g. displaying a reference anatomical image with a live image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/742—Details of notification to user or communication with user or patient; User input means using visual displays
    • A61B5/745—Details of notification to user or communication with user or patient; User input means using visual displays using a holographic display

Definitions

  • the present disclosure relates to the field of imaging veins of a human or animal body and in particular to an imaging arrangement and a method of imaging veins.
  • Drug delivery devices allowing for multiple discrete or continuous dosing of a required dosage of a liquid medicinal product and further providing administration of such liquid drug to a patient, are as such well known in the prior art. Generally, such devices have substantially the same purpose as that of an ordinary syringe. Some medicaments require administration by way of infusion.
  • IV infusions Patients suffering from certain diseases like, for example, hemophilia or requiring enzyme replacement therapy, have to take regular intravenous (IV) infusions.
  • IV infusions often have to be mixed and prepared, sometimes to the specific needs of the patient, (and sometimes a short time before drug administration) which may include reconstitution of the drug powder from multiple vials using an exact amount of sterile liquids like water and/or saline.
  • this preparation process is typically complex and tedious, it is usually performed by a health care professional in a clinic or pharmacy, potentially using lab equipment.
  • the resulting infusion must be administered within a limited time frame, as it is often sensitive to environmental factors like elevated heat, light, extended movement or shock. Further, the passage of time may reduce the efficacy of the mixture for other reasons, for example if the mixture is prone to separation or demixing over time. Therefore, patients regularly need to come to health care centers to receive their infusions directly after preparation. Some drugs require infusion with defined flow rates over several hours, so patients have to stay in said clinics for a long time, adding to the travel time and overall inconvenience. This is a huge burden to patients, especially if living far away from a suitable clinic. If they are used to the treatment, capable of handling corresponding user tasks and tolerate it well, patients would prefer to receive their regular infusion at home.
  • Puncturing of a blood vessel or vein for administering of a medicament is sometimes quite challenging.
  • a first step it may be required to find a suitable vein and insert a respective intravenous needle into it.
  • Even experienced healthcare professionals frequently have trouble locating a blood vessel or vein suitable for intravenous injection, especially if the patient is obese or has certain other preconditions affecting the peripheral vessels.
  • patients intend to self-administer a medicament they may often lack the experience to reliably find a vein even if no adverse preconditions are given.
  • the imaging arrangement should enable a rather easy and straightforward localization and imaging of subcutaneous blood vessels, such as veins.
  • the imaging arrangement and method of using the same should be particularly suitable for selfadministration of a medicament, in particular for self-conducted intravenous injection procedures.
  • an imaging arrangement for imaging blood vessels or veins of a human or animal body.
  • the imaging arrangement comprises a mount for fastening to a body portion of the human or animal body.
  • the imaging arrangement further comprises an imaging apparatus, which is movably fastenable to the mount.
  • the imaging apparatus comprises a scanner, which is operable to scan a scanning area of the body portion and to generate scanner signals when scanning the body portion, in particular when scanning the scanning area.
  • the imaging apparatus further comprises a signal processor connected to the scanner and operable to process the scanner signals from the scanner to at least one of extracting or recognizing a structure of interest from the scanner signals.
  • the imaging apparatus further comprises a projector connected to the signal processor and operable to project an image of the structure of interest onto a projection area of the body portion.
  • the imaging apparatus is configured such that the projection area and the scanning area substantially overlap.
  • the projector is configured to project an image of the structure of interest in an overlapping configuration with the structure of interest as retrieved from the scanner when scanning the scanning area of the body portion.
  • a structure of interest e.g. a blood vessel or vein
  • the scanner signals e.g. a blood vessel or vein
  • the extracted and/or recognized structure of interest can then be separately projected by the projector onto the projection area, hence onto the surface of the body portion currently or previously inspected by the imaging apparatus.
  • the scanner By making use of a mount in combination with a movable fastening or movable attachment of the imaging apparatus relative to or on the mount the scanner can be moved across the scanning area thereby providing a rather precise imaging or scanning of the scanning area.
  • the projector may be operable to project the image of the extracted or recognized structure of interest onto the projection area, typically onto the scanning area.
  • the projection of the image onto the projection area may be temporarily decoupled from the scanning operation as conducted or executed by the scanner.
  • the image may be projected onto the projection area after the scanner has moved across the scanning area or after a scanning procedure has been terminated. Image projection may also start and/or take place during the scanning operation.
  • the sequential operability of the imaging apparatus namely to project the image of the structure of interest onto the projection area after having conducted a scanning procedure is beneficial in that a user intending to puncture the structure of interest, e.g. a dedicated blood vessel, such as a vein, does not interfere with the scanning procedure.
  • a dedicated blood vessel such as a vein
  • the mount is particularly configured to fix the imaging arrangement to the body portion of the human or animal body.
  • the mount is particularly configured to immovably fix the imaging arrangement, hence the imaging apparatus to the respective body portion. In this way, there can be conducted a rather controlled scanning operation and a projection of the image of the structure of interest onto the projection area.
  • the scanner in a first step and when fastened to the body portion by the mount, the scanner can move or can be moved relative to the mount and hence relative to the body portion of the human or animal body portion to scan the scanning area.
  • the projector can be operated to project an image of the structure of interest that has been recognized or extracted from the scanner signals by the signal processor.
  • the second step can be conducted after completion of the first step.
  • the second step hence the projection of the image may temporally overlap with the first step, i.e. with the scanning of the scanning area. Hence, the projection may already start before completion of the scanning of the scanning area.
  • a scanner movably fastened to the mount is beneficial when the scanner covers the scanning area of the body portion during the scanning process.
  • a scanner movable across the scanning area there can be implemented a comparatively short distance between the scanner and the scanning area and hence between a surface of the scanning area of the body portion and the scanner.
  • numerous different scanning methods such as optical scanning methods or other scanning methods, such as an ultrasound-based scanning, the latter of which may require a direct mechanical contact between the scanning area and the scanner.
  • a movable scanner may not only allow to scan the scanning area at a minimum distance from the body portion but may also provide a comparatively high precision or resolution of the respective scan.
  • the mount a process of self-administering a medicament into the structure of interest, i.e. into a blood vessel or vein currently visualized or imaged by the imaging arrangement an operator, patient or user does no longer have to take care of a correct positioning of the imaging apparatus relative to the body portion that is intended for puncturing. Rather, the imaging apparatus can be held, even fixed in place by the mount, which enables and provides free hands for the user to conduct an intravenous self-administering of a medicament. Any movement of the body portion may be followed by the imaging apparatus since the imaging apparatus is fixed to the body portion by way of the mount.
  • the imaging apparatus is movable relative to the mount for scanning the scanning area.
  • the imaging apparatus may be movable relative to the mount for and/or during scanning of the scanning area.
  • the movability of the imaging apparatus and hence of the scanner relative to the mount provides a respective movability of the imaging apparatus and hence of the scanner relative to the body portion of the human or animal body to which the mount is attached or fastened to.
  • a one-dimensional scanner which comprises a scanning line, comprising a length that corresponds to or defines a first dimension of a two-dimensional scanning area.
  • the scanner hence the scanning line may be then moved or swept at a predefined angle, e.g. in a direction perpendicular to the elongation of the scanning line, thus allowing to obtain a two-dimensional image and/or a two-dimensional structure of the scanner signals as the scanner is moved, e.g. swept across or along the scanning area.
  • the moving direction may define a second dimension.
  • the scanner may comprise a line scanner extending perpendicular to a direction of movement of the scanner relative to the mount.
  • a line scanner or a one-dimensional scanner can be used to produce or to provide a two-dimensional scan or image of the scanning area.
  • a distance to the scanning area of the body portion can be reduced to a minimum, thus allowing to increase a spatial resolution of the scanner and/or to improve the precision of the scanning result.
  • the imaging apparatus is slidably movable relative to the mount along a guiding or sliding direction.
  • the imaging apparatus may be slidably movable relative to the mount along a longitudinal sliding or guiding direction.
  • the longitudinal sliding direction may be defined by the movable fastening of the imaging apparatus to the mount.
  • the imaging apparatus may be slidably movable relative to the mount along a longitudinal sliding direction towards a first end or direction of movement and a towards second end or direction, which is opposite to the first end or first direction.
  • the imaging apparatus may be movable back and forth along a sliding direction. It may be movable along a longitudinal proximal direction and may be movable in an opposite direction, e.g. along a longitudinal distal direction.
  • the mount may comprise or define a guiding structure complementary shaped to a counter guiding structure of the imaging apparatus.
  • the guiding structure of the mount comprises at least one or several guiding rails defining the movability of the imaging apparatus relative to the mount.
  • the counter guiding structure of the imaging apparatus may comprise one or numerous gliders complementary or correspondingly shaped to the guide rails or guide rails of the guiding structure of the mount.
  • the imaging apparatus may be fastened, e.g. detachably fastened to the mountain via the guiding structure and the complementary shaped counter guiding structure.
  • the counter guiding structure of the imaging apparatus may comprise a counter fastening structure to cooperate or to engage with a respective fastening structure of the mount.
  • a detachable fastening of the imaging apparatus to the mount allows to replace the imaging apparatus for a given mount and/or to replace the mount for a given imaging apparatus.
  • an imaging apparatus may be used with a large variety of differently shaped mount, which mounts are suitable for fastening to different body portions of the human or animal body.
  • a first mount may be sized and configured for fastening to an elbow.
  • a second mount may be sized and configured for fastening to a wrist.
  • a third mount may be sized and configured for fastening to a leg and a fourth mount may be sized and configured for fastening to an ankle or foot.
  • the various mounts may each comprise a standardized fastening structure complementary shaped to a standardized counter fastening structure of the imaging apparatus.
  • a given imaging apparatus may be selectively connected and fastened to a mount for use with a body portion for which the mount is configured and intended for.
  • the imaging arrangement is reconfigurable can be used and adapted for imaging blood vessels are veins of a large variety of different body portions of a human or animal body.
  • the mount comprises a longitudinally extending guide rail engaged or engageable with a glider of the imaging apparatus. In this way, the imaging apparatus can be slidably moved along the guide rail as provided by the mount.
  • the mount comprises a first guide rail and a second guide rail.
  • first and second guide rails may extend parallel to each other.
  • the imaging apparatus may be mechanically engaged or may be mechanically engageable with both guide rails. In this way, there may be provided a twofold guided movement between the imaging apparatus and the mount, e.g. for scanning the scanning area of the body portion, to which the imaging arrangement is attached to via the mount.
  • the scanner is operable to scan the scanning area while the scanner is subject to a movement relative to the mount.
  • the imaging apparatus comprises a movement detector, which is operable to synchronize a movement of the imaging apparatus with the scanner signals that are obtainable from the scanner while the imaging apparatus is subject to a movement relative to the mount, e.g. during a scanning operation.
  • the movement detector may be operable to quantitatively determine the position and/or a momentary state of movement of the imaging apparatus and/or of the scanner relative to the mount.
  • scanner signals obtained from the scanner when the scanner is in a first position can be precisely mapped to this particular first scanner position.
  • scanner signals obtained when the scanner is at a second position can be precisely mapped to the second position of the scanner.
  • the entirety of the scanner signals obtainable from the scanner over time and while the scanner is moved across the scanning area there can be provided at least a two-dimensional map of scanner signals being indicative of the properties of the scanning area.
  • the movement detector comprises at least one movement sensor operable to quantitatively measure the movement of the imaging apparatus relative to the mount.
  • the movement sensor may be integrated into the scanner or into the imaging apparatus.
  • the movement sensor may be operable to quantitatively measure the movement of the imaging apparatus directly and relative to the mount.
  • the mount may comprise a kind of a scale extending along the movement direction along which the imaging apparatus can be moved relative to the mount.
  • the at least one movement sensor may be operable to quantitatively measure the movement of the imaging apparatus and/or the movement of the scanner directly relative to the scanning area of the body portion.
  • the movement sensor may comprise at least one of a digital camera, an optical sensor, a gyroscope or a solid- state compass.
  • the movement sensor may be implemented as an optical movement sensor.
  • the movement sensor may comprise a light source, such as a light-emitting diode and a corresponding photodiode to detect a movement of the movement sensor relative to a surface.
  • a light source such as a light-emitting diode and a corresponding photodiode to detect a movement of the movement sensor relative to a surface.
  • light emitted by the light emitting diode is directed onto the surface, e.g. onto a surface of the mount or onto a surface of the body portion to be scanned.
  • the movement sensor which may be implemented as an optoelectronic sensor, may be operable to capture successive images of the surface relative to which the movement detector is moved. Images of the surface successively taken by the optoelectronic sensor may be electronically compared by a respective processor.
  • the movement sensor is implemented as an optical movement sensor and comprises an imaging system, such as a digital camera, which is operable to capture images of a surface that is subject to a movement relative to the movement sensor as the imaging apparatus is subject to a movement relative to the mount.
  • the surface imagined or captured by the camera may be provided on one of the mount and the body portion to which the mount is fastened to.
  • the camera may be implemented as a smart phone camera, which cameras are commercially available at moderate costs.
  • the camera may be derived from a smart phone camera. It may comprise a miniaturized optical design.
  • the optical movement sensor may be operable to track a distinguishable structure on the surface, e.g. a characteristic mark on the skin or body portion. In some examples it may be operable to track the outline of a characteristic structure of a body portion, e.g. the outline of an arm or finger.
  • the signal processor may be operable to adapt the position of the imaging of the structure of interest onto the projection area accordingly.
  • the projection of the image of the structure of interest is subject to a respective movement or modification such that the projected image is effectively fixed to the body portion. Any movement of the scanner relative to the body portion during a scanning operation is effectively compensated by the signal processor and/or by the projector in such a way that the image projected onto the projection area does not move relative to the projection area or body portion.
  • the imaging apparatus comprises a housing.
  • the housing comprises a bottom side and at least one sidewall adjacent to the bottom side.
  • One of the scanner and the projector is provided on or is integrated into the bottom side.
  • the other one of the scanner and the projector is provided on or is integrated into the at least one sidewall.
  • the sidewall extends at a predefined angle relative to the bottom side.
  • the bottom side may be configured to face towards the scanning area of the body portion.
  • the bottom side of the housing of the imaging apparatus comprises a surface normal that extends substantially parallel to a surface normal of the scanning area of the body portion to be scanned.
  • the sidewall may protrude upwardly from the bottom side and hence away from the scanning area when the imaging apparatus is fixed or attached to the body portion.
  • the sidewall may comprise numerous sidewall section or sidewall portions.
  • the sidewall may be of cylindrical shape.
  • the sidewall may only comprise a single tubular-shaped structure.
  • the housing of the imaging apparatus may be of cubic shape.
  • the sidewall may comprise four individual sidewalls or sidewall portion confining the interior of the imaging apparatus.
  • the scanner and the projector are provided on or is integrated into the sidewall.
  • the scanner and the projector extend at a predefined angle relative to each other, which angle is defined by an angle between the bottom side and the sidewall of the housing.
  • the scanner is provided on or is integrated into the bottom side and the projector is provided on or is integrated into the at least one sidewall.
  • This arrangement provides the benefit that the scanner can be moved across the scanning area at a comparatively small distance, and hence at a distance from the scanning surface that is smaller than a distance between the scanning surface and the projector.
  • the housing of the imaging apparatus may at least partially cover the scanning area as well as the projection area, which may substantially coincide with the scanning area of the body portion. It may be then and e.g. at or near the end of a scanning operation that the imaging apparatus has moved to an end position relative to the mount, in which end position the imaging apparatus no longer covers the scanning area or portions thereof.
  • the projector is located at an elevated position in or on the sidewall of the housing relative to the scanning area of projection area.
  • This position e.g. obtainable at the end of a scanning procedure, may be beneficial to illuminate or to project the image of the structure of interest onto the projection area.
  • the projector may be located at a well-defined distance from a surface of the scanning area or projection area, which distance is larger than a distance between the scanner and the scanning area of projection area, as e.g. measured along a surface normal of the scanning area or projection area.
  • the entirety of the scanning area can be easily illuminated visually and/or optically projected with the structure of interest.
  • a comparatively large distance between the projector on or in the sidewall of the housing and the surface of the scanning area or projection area there can be provided a rather precise optical projection of the structure of interest across the entirety of the projection area.
  • the lateral extent or size of the projection area i.e. the size of the projection area on the body portion of the human or animal body can be increased accordingly, even without implementing rather expensive or elaborate optical projection hardware.
  • the scanner and the projector are configured and arranged such that the scanning area and the projection area substantially overlap.
  • the projector and/or the signal processor configured to control the projector may be operable to adapt for any movement of the imaging apparatus relative to the mount during the stage or step of projecting the image of the structure of interest onto the projection area.
  • the movement detector may not only be used during the scanning of the scanning area but may be also of use during the projection of the structure of interest onto the projection area.
  • a dynamic and variable projection of the image of the structure of interest onto the projection area while the projector and hence the imaging apparatus is subject to a measurable movement With a quantitatively measurable movement of the imaging apparatus relative to the mount the image currently projected by the projector can be modified either by the projector or by the signal processor, e.g. in real time, such that the structure of interest projected onto the projection area remains constant and substantially unmodified even with a moving projector or moving imaging apparatus. This allows to project at least a portion of the structure of interest not only after completion of a moving or scanning operation but also during a scanning operation during which the imaging apparatus is subject to a movement relative to the mount of the imaging arrangement.
  • the imaging apparatus is configured to project an image of at least a portion of the structure of interest onto the projection area during a scanning of the scanning area.
  • the imaging arrangement may rather instantaneously react to temporal varying conditions.
  • the imaging apparatus is configured to project the image of the structure of interest onto the projection area after completion of a scanning of the scanning area.
  • the step of scanning of the scanning area can be separated from the step of projecting the image of the structure of interest onto the projection area.
  • This may be of particular benefit when a user intends to puncture the structure of interest, e.g. a blood vessel or vein while the imaging apparatus projects the image of the structure of interest onto the projection area.
  • the imaging apparatus may be at least temporarily fixed or fixable to the mount during the projection of the image of the structure of interest onto the projection area. An at least temporal fixing of the imaging apparatus to the mount may be of particular benefit to improve the quality of the projection.
  • the imaging apparatus may have to be actively moved relative to the amount by the user himself.
  • the movable fastening of the imaging apparatus to the mount may provide a well-defined mechanical resistance or friction that has to be overruled by a user for moving the imaging apparatus relative to the mount, e.g. for the scanning operation.
  • a guided movability of the imaging apparatus relative to the mount may be provided with at least a first stop defining a well-defined end position for a movement of the imaging apparatus relative to the mount. There may be also a second stop defining a start position of the movable imaging apparatus. Typically, such a stop configuration may be reached at the end of a scanning procedure during which the scanner and/or the imaging apparatus is moved relative to the mount, e.g. across the scanning area of the body portion. In some examples there may not only provided a stop configured to delimit or to define an end position of a movement of the imaging apparatus relative to the mount. Rather, there may be provided also a fastener by way of which the imaging apparatus can be fastened relative to the mount, e.g.
  • stop position is offset from the end position and/or offset from the start position along a movement direction, along which the imaging apparatus and/or the scanner is movable relative to the mount.
  • the scanner comprises one of a scanning light source and a photodetector and an ultrasound transducer.
  • the scanner comprises a combination of a scanning light source and a spatially resolving light detector, such as photo detector. Scanning light generated by the scanning light source may be directed onto the scanning area of the body portion and light reflected from the scanning area is detected by the photo detector.
  • the light source and the corresponding light detector may operate in the infrared or near-infrared spectral range. In other examples they may also operate in the visible spectral range.
  • the scanner comprises an ultra sound transducer, which may require a direct mechanical contact to the scanning area of the body portion in order to provide respective ultra sound-based spatially resolved images.
  • the movability of the scanner relative to the mount allows to implement a large variety of different scanning techniques by way of which a structure of interest, e.g. a blood vessel or vein could be extracted or recognized from the respective scanner signals.
  • a structure of interest e.g. a blood vessel or vein could be extracted or recognized from the respective scanner signals.
  • the light source is an infrared light source and the photodetector is a respective infrared sensitive photo detector.
  • veins or other subcutaneous structures of interest can be easily and clearly recognized and/or extracted from scanner signals as obtained from the photodetector or scanner.
  • the projector of the imaging arrangement comprises a projecting light source and an image projector.
  • the image projector comprises one of a laser projector, a liquid crystal display image projector (LCD) and an LED- or OLED- based image projector.
  • the light source of the image projector is configured to emit light in the visible spectral range.
  • the light source may be monochromatic.
  • the light source is a multicolor light source or the light source comprises numerous light sources that distinguish by the spectrum or color of light emitted therefrom.
  • the image projector is operable to project a first stereo image onto the projection area and is further configured or operable to project a second stereo image onto the projection area.
  • the first stereo image and the second stereo image complement each other to provide a stereoscopic three-dimensional image of the structure of interest.
  • a stereoscopic image for a user being indicative not only of a position but also of a three-dimensional shape or depth of the structure of interest of the respective body portion of the human or animal body.
  • a user may be provided with a three-dimensional impression regarding the position of the structure of interest, e.g. of a dedicated blood vessel or vein below the skin of the body portion of the human or animal body.
  • a depth of the vein underneath the skin could be illustrated in general.
  • the image projector is operable to alternate between a first projection of the first stereo image onto the projection area and a second projection of the second stereo image onto the projection area. Alternating between first and second projections may be conducted in accordance to a predefined time schedule, e.g. in accordance to a predefined switching- or alternating frequency. Concurrently with the alternating between first and second projections onto the projection area there may be provided respective stereoscopic glasses that are synchronizable with the alternating projection of the first and second stereo images.
  • the imaging arrangement comprises stereoscopic glasses that are synchronizable with the alternating projection of the first and second stereo images.
  • the synchronization between the alternating projection and the stereoscopic glasses may be provided by the signal processor and/or by a separate synchronizing unit for the stereoscopic projection.
  • the stereoscopic glasses are operable to wirelessly communicate with a respective stereoscopic controller or signal processor of the imaging arrangement so as to provide a respective synchronization.
  • the stereoscopic glasses may be provided with a first lens and with a second lens.
  • Each lens may comprise a shutter, e.g. in form of an electrooptic modulator or electrooptic shutter that is controllable by a local controller of the shutter glasses.
  • a first projection of the first stereo image onto the projection area may temporally overlap with an optical transparency of a first lens of the stereoscopic glasses while a second lens is switched into an opaque or nontransparent mode.
  • the image projector projects the second projection of the second stereo image onto the projection area the configuration of the stereoscopic glasses will be switched concurrently.
  • the first lens may be switched into a non-transparent or opaque configuration while the second lens may be switched into a transparent mode.
  • the first stereo image is of a first color and the second stereo image is of a second color.
  • the first and the second colors may be different and hence distinguishable colors.
  • the first and the second colors are chromatically opposite colors, such as red and cyan.
  • the stereoscopic glasses may comprise a first lens with a first color filter and a second lens with a second color filter.
  • the first color filter corresponds to the first color
  • the second color filter corresponds to the second color.
  • the first and the second stereo images of different color may be projected simultaneously, hence in a temporal overlapping manner onto the projection area.
  • the first and the second stereo images of different colors may be projected onto the projection area at a well-defined lateral offset relative to each other, which provides a three-dimensional impression when viewed through the stereoscopic glasses comprising first and second lenses provided with respective first and second color filters.
  • the scanner of the imaging arrangement may be implemented as a three- dimensional scanner. It may be hence operable to scan a three-dimensional structure of the structure of interest on or underneath the skin of a human or animal body.
  • the projector may not only operable to generate and/or to project an image of the structure of interest as extracted or recognized by the signal processor from the scanner signals.
  • the projector and/or the signal processor may be operable to generate and/or to add additional information obtained from the scanner signals and to provide the additional information in form of at least one of a symbol, a color, a numerical value and to embed this additional information into the image projected onto the projection area of the body portion.
  • the projection could include a highlighting of a dedicated portion of the image of the structure of interest, e.g. together with further useful information of the vein or blood vessel as extracted or recognized from the scanner signals.
  • the additional information in particular a depth of the structure of interest below the scanning area, hence below the surface of the skin actually scanned by the scanner and/or an optimal injection location, could be colored or color-encoded in the projected image.
  • the mount for fastening to the body portion comprises one of a cuff, a collar or a wristband to fasten to a body portion of the human or animal body.
  • the mount may be provided in a variable size and/or may be size adjustable so as to enable a suitable fastening to a variety of different body portions or to body portions of different size.
  • the mount may be dedicated to a specific injection site, e.g. to a crook of an arm, to a forearm, to the back of a hand sof the patient.
  • the mount may be configured as a cuff attachable to other body regions, such as a leg, a calf or foot of a patient.
  • the mount could be configured to press the imaging apparatus and/or the scanner to the skin of the body portion but still allowing for a movement of the imaging apparatus relative to the mount, e.g. along a guiding structure as provided on or inside the mount. Fixation of the mount to the respective body portion can be achieved by flexible materials, straps or Velcro fasteners.
  • the mount e.g. in form of a cuff, collar or wristband could cover a part of the body portion. It may optionally contain a tourniquet to assist the self-injection following the imaging of the vein or blood vessel.
  • the fastener may comprise a sleeve-like shape to enclose a body portion of the human or animal body, which is provided with the scanning area.
  • the mount e.g. the cuff or collar may comprise an aperture extending along a moving direction along which the imaging apparatus is e.g. movable relative to the mount.
  • the imaging apparatus may be movable above the aperture of the mount and the scanning area of the body portion may appear below or through the aperture. This allows for a rather precise fastening of the mount to the body portion while simultaneously providing an unhindered view or inspection of the scanning area of the respective body portion.
  • the aperture in the mount provides an unhindered projection of the image onto the projection area.
  • the signal processor may comprise or provide a digital image processing engine by way of which a structure of interest in the scanner signals can be extracted or recognized.
  • the present disclosure also relates to a method of imaging veins or blood vessels of a human or animal body.
  • the method is to be conducted with an imaging arrangement as described above. Therefore, all effects, features and benefits as described above in connection with the imaging arrangement equally apply to the method of imaging veins or blood vessels of the human or animal body; and vice versa.
  • the method comprises the steps of providing an imaging arrangement as described above and fastening the mount of the imaging arrangement to a body portion of the human or animal body. Thereafter and in a subsequent step a scanning area of the body portion is scanned by using the scanner of the imaging apparatus. By scanning the scanning area there are generated scanner signals as described above. In a subsequent step or concurrent with the scanning of the scanning area a structure of interest is extracted or recognized by processing of the scanner signals.
  • the processing of the scanner signals is typically provided by a signal processor of the imaging apparatus as described above.
  • an image of the structure of interest is generated and projected onto a projection area of the body portion by the projector of the imaging apparatus as described above.
  • the method of imaging blood vessels or veins as described herein allows and provides a rather automated imaging of veins or blood vessels of a body portion.
  • the mount by way of which the imaging arrangement is fastened to the body portion provides free hands to a user, which is of practical use to puncture the vein or blood vessel in a rather easy and straightforward manner.
  • the scanning area is scanned during a movement of the imaging apparatus relative to the mount.
  • the imaging apparatus is moved by a patient or user of the imaging arrangement himself.
  • the imaging apparatus may be swept along a direction of movement as defined by a guiding structure provided by the mount for the imaging apparatus.
  • the imaging apparatus may be at least temporally fixed to the mount, e.g. during and/or for projecting the image of the structure of interest onto the projection area.
  • the image of the structure of interest is projected onto the projection area during or after scanning of the scanning area. Projecting at least a portion of the structure of interest during the scanning of the scanning area may provide an immediate feedback to a user with regards to the scanning quality or scanning result. Projecting the structure of interest onto the projection area after completion of the scanning procedure may provide a complete illustration of the structure of interest, which during the scanning procedure may be at least partially covered by the imaging apparatus and/or by the respective housing.
  • the present disclosure also relates to an imaging arrangement for imaging veins of a human or animal body.
  • the imaging arrangement comprises an imaging apparatus.
  • the imaging apparatuses comprises a scanner operable to scan a scanning area of a body portion of the human or animal body and to generate scanner signals when scanning the body portion.
  • the imaging apparatus further comprises a signal processor connected to the scanner and operable to process the scanner signals from the scanner to at least one of extracting or recognizing a structure of interest from the scanner signals.
  • the imaging apparatus further comprises a display device connected to the signal processor and operable to display an image of the structure of interest on or in relation to the body portion.
  • the imaging arrangement only optionally comprises a mount for fastening to the body portion of the human or animal body.
  • the imaging apparatuses is movably fastenable to the mount or is movably fastened to the mount.
  • the imaging apparatus may be operated standalone, i.e. without the mount, in still other examples the imaging apparatus may be fixed, e.g. immovably fixed to the mount.
  • the display device comprises a projector or image projector as described above, which is operable to project an image of the structure of interest onto a projection area of the body portion.
  • the image projector is operable to project a first stereo image onto the projection area and to project a second stereo image onto the projection area.
  • the first stereo image and the second stereo image complement each other to provide a stereoscopic three- dimensional image of the structure of interest.
  • a stereoscopic image for a user being indicative not only of a position but also of a three-dimensional shape or depth of the structure of interest of the respective body portion of the human or animal body.
  • the image projector is operable to alternate between a first projection of the first stereo image onto the projection area and a second projection of the second stereo image onto the projection area. Alternating between first and second projections may be conducted in accordance to a predefined time schedule, e.g. in accordance to a predefined switching- or alternating frequency. Concurrently with the alternating between first and second projections onto the projection area there may be provided respective stereoscopic glasses that are synchronizable with the alternating projection of the first and second stereo images.
  • the imaging arrangement comprises stereoscopic glasses that are synchronizable with the alternating projection of the first and second stereo images.
  • the synchronization between the alternating projection and the stereoscopic glasses may be provided by the signal processor and/or by a separate synchronizing unit for the stereoscopic projection.
  • the stereoscopic glasses are operable to wirelessly communicate with a respective stereoscopic controller or signal processor of the imaging arrangement so as to provide a respective synchronization.
  • the stereoscopic glasses may be provided with a first lens and with a second lens.
  • Each lens may comprise a shutter, e.g. in form of an electrooptic modulator or electrooptic shutter that is controllable by a local controller of the shutter glasses.
  • a first projection of the first stereo image onto the projection area may temporally overlap with an optical transparency of a first lens of the stereoscopic glasses while a second lens is switched into an opaque or nontransparent mode.
  • the image projector projects the second projection of the second stereo image onto the projection area the configuration of the stereoscopic glasses will be switched concurrently.
  • the first lens may be switched into a non-transparent or opaque configuration while the second lens may be switched into a transparent mode.
  • the first stereo image is of a first color and the second stereo image is of a second color.
  • the first and the second colors may be different and hence distinguishable colors.
  • the first and the second colors are chromatically opposite colors, such as red and cyan.
  • the stereoscopic glasses may comprise a first lens with a first color filter and a second lens with a second color filter.
  • the first color filter corresponds to the first color
  • the second color filter corresponds to the second color.
  • the first and the second stereo images of different color may be projected simultaneously, hence in a temporal overlapping manner onto the projection area.
  • the first and the second stereo images of different colors may be projected onto the projection area at a well-defined lateral offset relative to each other, which provides a three-dimensional impression when viewed through the stereoscopic glasses comprising first and second lenses provided with respective first and second color filters.
  • the scanner of the imaging arrangement may be implemented as a three- dimensional scanner. It may be hence operable to scan a three-dimensional structure of the structure of interest on or underneath the skin of a human or animal body.
  • the projector may not only operable to generate and/or to project an image of the structure of interest as extracted or recognized by the signal processor from the scanner signals.
  • the projector and/or the signal processor may be operable to generate and/or to add additional information obtained from the scanner signals and to provide the additional information in form of at least one of a symbol, a color, a numerical value and to embed this additional information into the image projected onto the projection area of the body portion.
  • the projection could include a highlighting of a dedicated portion of the image of the structure of interest, e.g. together with further useful information of the vein or blood vessel as extracted or recognized from the scanner signals.
  • the additional information in particular a depth of the structure of interest below the scanning area, hence below the surface of the skin actually scanned by the scanner and/or an optimal injection location, could be colored or color-encoded in the projected image.
  • the display device connected to the signal processor is operable to display an image of the structure of interest in relation to the body portion, e.g. in relation to a position, orientation or movement of the body portion.
  • the display device may comprise a display for visualizing the image of the structure of interest.
  • the display device may be offset from the scanning area and/or offset from the projection area as described above.
  • the display device may be provided as a separate device and may not belong to the imaging apparatus. It may be connected to the imaging apparatus and may be operable to generate images of the structure of interest on or via its own display.
  • the display may comprise one of a head mounted display and a head up display.
  • the display may comprise a display screen that is operable to reproduce or to display the image of the structure of interest on the display screen.
  • the display screen may be implemented as a transparent or partially transparent display that allows and supports an unobstructed view of a person wearing the head mounted display or head up of display.
  • the display is equipped with a motion sensor by way of which a movement of the display relative to the body portion can be quantitatively detected and/or measured.
  • At least one of the signal processor and the display device is operable to overlay the image of the structure of interest with the field of view through the transparent or partially transparent display. At least one of the signal processor and the display device is operable to process signals from the motion sensor so as to keep the image of the structure of interest on the display in an overlapping configuration with the scanned body portion.
  • any movement of the display device relative to the body portion may be tracked and quantitatively measured by the motion sensor thus allowing to reproduce the image of the structure of interest in an overlapping configuration with the field of view through the transparent or partially transparent display and/or allowing to compensate for any movement of the display device relative to the body portion so as to keep the image of the structure of interest in the display in an overlapping and’/or in a substantial non-moving relation to the scanned body portion as seen by a user through the display or display screen.
  • the motion sensor may comprise at least one of a digital camera, an optical sensor, a gyroscope or a solid-state compass.
  • the display device comprises one of a virtual reality (VR) goggle and an augmented reality (AR) goggle.
  • the display device may be operably connected to the signal processor and may be controlled by the signal processor through a wired or wireless data connection.
  • the display device implemented as a VR goggle or AR goggle there can be also provided a three-dimensional image or impression of the structure of interest on or below the skin of the body portion. Puncturing of a blood vessel or vein on or below the skin of the body portion may be thus facilitated.
  • drug or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier.
  • An active pharmaceutical ingredient (“API”) in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.
  • a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases.
  • API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides.
  • siRNA small interfering RNA
  • Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.
  • the drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device.
  • the drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., shorter long-term storage) of one or more drugs.
  • the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years.
  • the drug container may be or may include a dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber.
  • the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and/or during dispensing into the human or animal body.
  • the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing.
  • the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.
  • the drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and/or prophylaxis of many different types of medical disorders.
  • disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism.
  • Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis.
  • APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.
  • APIs for the treatment and/or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof.
  • an insulin e.g., human insulin, or a human insulin analogue or derivative
  • GLP-1 glucagon-like peptide
  • DPP4 dipeptidyl peptidase-4
  • analogue and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and/or exchanging at least one amino acid residue occurring in the naturally occurring peptide and/or by adding at least one amino acid residue.
  • the added and/or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues.
  • Insulin analogues are also referred to as "insulin receptor ligands".
  • the term ..derivative refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids.
  • one or more amino acids occurring in the naturally occurring peptide may have been deleted and/or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.
  • insulin analogues examples include Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.
  • insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega- carboxypentadecanoyl-gamma-L-g
  • GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC- 1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211 , CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-237
  • an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.
  • mipomersen sodium Korean, a benzyl alcohol, a benzyl ether, a benzyl ether, a benzyl ether, a benzyl-containing asen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.
  • DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.
  • hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.
  • Gonadotropine Follitropin, Lutropin, Choriongonadotropin, Menotropin
  • Somatropine Somatropin
  • Desmopressin Terlipressin
  • Gonadorelin Triptorelin
  • Leuprorelin Buserelin
  • Nafarelin Nafarelin
  • Goserelin Goserelin.
  • polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof.
  • a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium.
  • An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.
  • antibody refers to an immunoglobulin molecule or an antigenbinding portion thereof.
  • antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen.
  • the antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody.
  • the antibody has effector function and can fix complement.
  • the antibody has reduced or no ability to bind an Fc receptor.
  • the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region.
  • the term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and/or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).
  • TBTI tetravalent bispecific tandem immunoglobulins
  • CODV cross-over binding region orientation
  • fragment refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and/or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen.
  • Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments.
  • Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.
  • SMIP small modular immunopharmaceuticals
  • CDR complementarity-determining region
  • framework region refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding.
  • framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.
  • antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).
  • PCSK-9 mAb e.g., Alirocumab
  • anti IL-6 mAb e.g., Sarilumab
  • anti IL-4 mAb e.g., Dupilumab
  • Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device.
  • Pharmaceutically acceptable salts are for example acid addition salts and basic salts.
  • An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E).
  • needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems.
  • the container may be a replaceable container or an integrated non-replaceable container.
  • a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).
  • Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).
  • a single-dose container system may involve a needle-based injection device with a replaceable container.
  • each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation).
  • each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).
  • a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container.
  • each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation).
  • each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).
  • Fig. 1 schematically illustrates one example of a mount of an imaging arrangement fastened to a body portion of the human or animal body
  • Fig. 2 shows another example of a mount fastened to a body portion
  • FIG. 3 schematically illustrates an imaging apparatus of the imaging arrangement, which is fastened by way of a mount to the body portion during a scanning and/or projecting operation
  • Fig. 4 illustrates the imaging apparatus to the during a projection of an image of a structure of interest
  • Fig. 5 schematically illustrates a block diagram of the imaging arrangement when fastened to a body portion as seen along a direction of movement
  • Fig. 6 shows a side view of the imaging apparatus during or after scanning of the scanning area
  • Fig. 7 shows a partial view of the scanner
  • Fig. 8 is a flowchart of a method of imaging veins or blood vessels of a human or animal body
  • Fig. 9 shows an example of a scanner
  • Fig. 10 shows an example of a projector
  • Fig. 11 shows another example of a projector in combination with stereoscopic glasses for three-dimensional illustration of an image of the structure of interest in the projection area.
  • FIG. 1 there is provided an isolated illustration of a mount 50 of an imaging arrangement 1 for imaging blood vessels 8 or veins 9 of a human or animal body.
  • the imaging arrangement 1 comprises the mount 50 and an imaging apparatus 10, which is separately illustrated in Figs. 3 and 4.
  • the complete imaging arrangement 1 is schematically illustrated in Fig. 5.
  • the mount 50 is configured for fastening the imaging arrangement 1 and hence the imaging apparatus 10 to a body portion 4 of a human or animal body.
  • the body portion 4 comprises an arm 5.
  • the mount 50 comprises a body 51 to be wrapped around the body portion 4.
  • the mount 50 comprises a cuff 52 or collar, which can be tightly fastened to the body portion 4. It may be fastened to such an extent to the body portion 4, that it provides a tourniquet to assist an intravenous injection or the like medicament administering procedure.
  • the imaging apparatus 10 as separately illustrated in Figs. 3-6 is movably fastened to the mount 50.
  • the imaging apparatus 10 comprises a scanner 30 which is operable to scan a scanning area 40 of the body portion 4 and to generate scanner signals when scanning the body portion 4.
  • the imaging apparatus 10 further comprises a signal processor 22 connected to the scanner 30.
  • the signal processor 22 is operable to process the scanner signals from the scanner 32 at least for one of extracting or recognizing a structure of interest in 19 from the scanner signals.
  • the structure of interest 19 may comprise or represent a blood vessel 8 or a vein 9 e.g. located underneath the skin 6 of the respective body portion 4, to which the mount 50 and hence the imaging apparatus 10 is attached or fastened to.
  • the imaging apparatus 10 further comprises a projector 32 connected to the signal processor 22 and being operable to project an image 39 of the structure of interest 19 onto a projection area 42 of the body portion 4.
  • the projection of an image 39 is schematically illustrated in Fig.
  • the mount 50 as shown in Fig. 1 may be provided with a fastener 53 to tightly fasten the mount 50 and hence the body 51 of the mount 50 to the body portion 4 of a human body.
  • the body 51 may be of a sleeve like shape. It may be provided with an aperture 56 extending all along and through the cuff 52 or body 51 along the movement direction 2, 3 along which the imaging apparatus 10 may be movably fastened to the mount 50.
  • the body 51 may comprise a first body portion 54 adjacent to the longitudinal aperture 56 and may further comprise a second body portion 55 extending along an opposite end of the aperture 56.
  • the body portions 54, 56 may both adjoin opposite longitudinal sides of the aperture 56. They may form or define opposite circumferential ends of the body 51.
  • the fastener 53 e.g. implemented as a strap, may extend across the aperture 56 so as to tightly fastened the body 51 and hence the cuff 52 to the body portion 4, e.g. to the arm 5.
  • a guiding structures 58 for a longitudinal sliding movement of the imaging apparatus 10 when fastened to the mount 50.
  • the guiding structure 58 may coincide or may form a fastening structure 60 by way of which the imaging apparatus 10 can be detachably fastened to the mount 50.
  • the body 51 comprises a sleeve-shaped structure, which in the upper side as illustrated in Fig. 2 is provided with a longitudinal aperture 56 extending all through the material of the body 51.
  • the longitudinal aperture is shorter than a respective extent of the body 51.
  • a scanning area 40 may be located underneath the aperture 56.
  • the guiding structure 58 may comprise a guiding rail 59 extending along a movement direction 3, 2.
  • the movement direction 3 may be denoted as a proximal movement direction.
  • the movement direction 2 may be denoted as a distal movement direction.
  • the two movement directions 2, 3 face in opposite directions.
  • the guiding structure 58 may extend parallel to the movement direction 2, 3 and may define the respective movement or moving direction along which the imaging apparatus 10 is movably fastenable to the mount 50. In a configuration as e.g. illustrated in Fig.
  • the imaging apparatus 10 is fastened to the guiding structure 58 through a counter fastening structure 20 as provided on or in a housing 11 of the imaging apparatus 10, which counter fastening structure 20 is in mechanical engagement with the fastening structure 60 provided on an outside of the mount 50.
  • the counter fastening structure 20 may comprise a glider 21 to mechanically engage with a longitudinally extending guide rail 59 of the fastening structure 60.
  • the guide rail 59 may define or may coincide with the guiding structure 58.
  • the counter fastening structure 20 may comprise or may form the glider 21 , which is in mechanical engagement with the guide rail 59.
  • the imaging apparatus 10 can be slidably movable relative to the mount 50 by sliding along the guiding structure 58 as provided by the guide rails 59.
  • the guide rails 59 there are provided two parallel extending guide rails 59, each of which forming or constituting a guiding structure 58.
  • Each one of the guide rails 59 is in mechanical engagement with respective gliders 21.
  • the aperture 56 extending all through the body 51 of the mount 50 is located between the guiding structures 58 and hence between the guiding rails 59.
  • the gliders 21 and hence the counter fastening structures 20 of the imaging apparatus 10 may protrude laterally from opposite sidewalls 15, 17 of the housing 11 of the imaging apparatus.
  • a bottom or bottom side 12 of the housing 11 may be located directly above the aperture 56 and hence between the guide rails 59.
  • the bottom side 12 of the imaging apparatus 10 may get in close vicinity with the scanning area 40 and hence with a surface of the skin 6 thus allowing for a precise and comprehensive scanning of the scanning area.
  • the bottom side may even get in direct mechanical and sliding contact with the scanning area 40.
  • the housing 11 of the imaging apparatus 10 may cover at least a portion of the aperture 56 and hence at least a portion of the scanning area 40 located beneath for projecting an image 39 of the structure of interest 19 as derived from the scanning operation it may be intended that the imaging apparatus 10 is moved to an end position along the guiding structure 58 as e.g. indicated in Fig. 4.
  • Fig. 3 there is shown a configuration during a scanning procedure during which the imaging apparatus 10 is moved along the proximal movement direction 3.
  • the projector 32 may be operable to project at least a portion of the image 39 as derived from the scanner signals onto the projection area 42.
  • the entirety of the projection area 42 which may coincide or substantially overlap with the scanning area 40 may not be available for projection because the housing 11 of the imaging apparatus 10 may block a respective projection due to its movement across the scanning area 40 in close vicinity to the surface of the scanning area 40.
  • Fig. 3 there is shown a configuration during a scanning procedure during which the imaging apparatus 10 is moved along the proximal movement direction 3.
  • the projector 32 may be operable to project at least a portion of the image 39 as derived from the scanner signals onto the projection area 42.
  • the entirety of the projection area 42 which may coincide or substantially overlap with the scanning area 40 may not be available for projection because the housing 11 of the imaging apparatus 10 may block a respective projection due to its movement across the scanning area 40 in close vicinity to the surface of the
  • the projector 32 may be particularly configured to project a complete image 39 of the structure of interest 19 onto the projection area 42 when the imaging apparatus 10 has reached an end configuration at a longitudinal end of the guiding structure 58.
  • the imaging apparatus 10 is at a position that substantially coincides with a proximal end of the guiding structure 58.
  • the scanner 30 is typically implemented or provided in or in the bottom side 12 of the housing 11 as illustrated in Fig. 6.
  • the projector 32 is typically provided at an elevated position on or inside a sidewall 14, 15, 16 or 17 of the housing 11. In this way and for an effective projection there can be provided a sufficient projecting distance between the projector 32 and the projection area 42.
  • the projector 32 is provided or integrated into a sidewall 14, 15, 16, 17 of the housing 11 the image 39 of the structure of interest 19 is projected laterally from a side of the imaging apparatus 10 onto the surface of the projecting area 42.
  • This allows for an unhindered access of the projection area 42, e.g. for puncturing the structure of interest 19 with an injection device 45.
  • the structure of interest 19 may comprise or may be a vein 9 intended for puncturing or penetration with an injection device 45, such as a syringe or butterfly needle.
  • the projected image 39 may comprise a projection of the vein 9 or blood vessel 8 and may thus represent a projected imaginary vein 44 overlapping with the vein 9 located underneath a surface of the skin 6. Since the imaging apparatus 10 is kept in a stable position relative to the body portion 4 the projected vein 44 and/or the projected image 39 may be and remain in a stable overlapping configuration with the real structure of interest 19, hence with a real vein 9 located underneath the surface of the skin 6.
  • the lateral projection of the image 39 from a sidewall 14, 15, 16, 17 of the imaging apparatus 10 particularly allows and supports a configuration, in which the imaging apparatus 10 no longer covers a relevant portion of the scanning area 40. This enables an unhindered access of the structure of interest 19 for the injection device 45.
  • the movability of the imaging apparatus 10 relative to the mount 50 and the mount providing a tight fastening to the body portion 4 allows to separate the process of scanning of the scanning area 40 from the process of projecting an image 39 onto the projection area 42. Between the scanning operation and the projection of the image there will be no uncontrolled movement of the imaging apparatus 10 relative to the mount 50 and/or relative to the body portion 4 apart from the intended scanning movement of the imaging apparatus 10 relative to the amount 50 as governed or defined by the guiding structure or guiding structures 58.
  • the imaging apparatus 10 not only comprises the scanner 30, the signal processor 22 and the projector 32 but also an energy storage 24, e.g. in form of a battery, which may be rechargeable.
  • the imaging apparatus 10 may further comprise a movement detector 36, which comprises at least one movement sensor 37, 38 as e.g. separately illustrated in Fig. 7.
  • the movement detector 36 may be operable to synchronize a quantitative movement of the imaging apparatus 10 relative to the mount 50 with the scanner signals obtainable from the scanner 30 while the imaging apparatus 10 is subject to the movement relative to the mount 50.
  • a line scanner e.g. extending perpendicular to the direction of movement 2, 3 can be used to provide a two-dimensional or even three-dimensional image or scan of the scanning area 40.
  • the scanner 30 comprises an elongated structure extending substantially perpendicular with respect to a well-defined angle relative to the direction of movement 3 along which the scanner 30 or the imaging apparatus 10 is movable relative to the mount 50.
  • the scanner 30 comprises an elongated structure extending substantially perpendicular with respect to a well-defined angle relative to the direction of movement 3 along which the scanner 30 or the imaging apparatus 10 is movable relative to the mount 50.
  • the movement sensors 37, 38 may comprise an optoelectronic sensor, e.g. in combination with a respective light source, being operable to capture successive images of the surface of the body portion and/or of a surface of the mount 50. By comparing the successive images, e.g. by an image processing engine a movement and/or a position of the imaging apparatus 10 relative to the respective surface can be quantitatively detected or measured.
  • the movement sensors 37, 38 may be implemented similar to that one of an optical computer mouse.
  • the movement detector 36 provides a quantitative measurement of a movement of the imaging apparatus relative to the mount 50 and/or relative to the body portion 4 to which the mount 50 and hence the imaging arrangement 1 is fastened to.
  • the projector 32 may comprise one or numerous light sources 33.
  • the projector 32 may comprise an image projector 71 by way of which the image 39 of the structure of interest 19 can be protected e.g. as a kind of a projected vein 44 onto the projection area 42.
  • the imaging apparatus 10 may be further provided with a user interface 26.
  • the user interface 26 may comprise at least one of a visual, an acoustic and a haptic indicator. It may comprise a one or two-dimensional display or other visual indicators, such as light sources or LEDs.
  • the user interface 26 may further comprise an input device, e.g. in form of a button or dial operable by a user.
  • the user interface 26 may comprise a touchscreen by way of which a user may interact with the imaging apparatus 10 and by way of which a user may control operation of the imaging apparatus 10.
  • the user interface 26 or portions thereof may be integrated or provided on or in a top side 18 of the housing 11 of the imaging apparatus 10. In some examples the user interface 26 or portions thereof may be provided or integrated in one of the sidewalls 14, 15, 16, 17.
  • the imaging apparatus 10 may be provided with an alignment sensor 35, e.g. comprising an acceleration sensor, e.g. by way of which application of a force effect onto the imaging apparatus 10 can be detected or quantitatively measured.
  • the alignment sensor 35 may comprise or may be implemented as an orientation sensor. It may be operable to determine a momentary orientation of the imaging apparatus 10 relative to ground or relative to the direction of gravity.
  • the alignment sensor 35 may comprise a Gyro sensor.
  • the alignment sensor 35 is operably connected with the signal processor 22, which in turn is operable to process signals generated by the alignment sensor 35. Insofar, signals obtainable from the alignment sensor 35 can be used to improve at least one of the step of scanning and projection.
  • the scanner 30 may comprise a light source 62 and a photodetector 63. Light emanating or emitted by the light source 62 may be directed onto the surface of the scanning area 40. Light reflected from the surface of the scanning area 40 may be then detected by the photodetector 63.
  • the scanner 30 may comprise an ultrasound transducer 64. For obtaining scanner signal the ultrasound transducer 64 should get in direct contact with the surface of the skin 6. As the scanner 30 is moved along a direction of movement 3, 2 a two- or three- dimensional image of a vein 9 or blood vessel 8 and hence of a structure of interest 19 can be obtained and/or captured.
  • a projector 32 comprising an image projector 71, which is operable to project a visual image 39 onto the projection area 42.
  • the projection area 42 may substantially coincide or may spatially overlap with the scanning area 40.
  • the image 39 may overlap with the structure of interest 19.
  • a projected vein 44 may substantially overlap with a real vein 9 or blood vessel 8 underneath a surface of the skin 6.
  • the image projector 71 comprises a laser projector 72. In other examples the image projector 71 comprises a liquid crystal display projector. In still other examples the image projector 71 comprises a LED projector 74. The LED projector may comprise an OLED image projector. With all projector implementations there can be provided a suitable image projection onto the projection area 42.
  • the light source 33 of the projector 32 may comprise a monochromatic light source. In some examples there may be provided numerous light sources 33 each of which comprising or providing a different wavelength and/or a different visible color.
  • a projector 32 comprising an image projector 71, which is capable to generate and/or to project a first stereo image 75 and a second stereo image 85 onto the projection area 42 of the skin 6.
  • the first and the second stereo images 75, 85 may complement each other and/or may constitute a three-dimensional stereoscopic image 90 especially when viewed through stereoscopic glasses 92.
  • the image projector 71 may be configured or operable to alternate between first and second stereo images 75, 85.
  • the respective stereo images 75, 85 may be projected slightly offset as seen in transverse direction.
  • the stereoscopic glasses 92 may be synchronized with the alternating projection of the first and second stereo images 75, 85. Hence, and as long as the first stereo image 75 is projected on the projection area 42 the respective image is only visible through a first lens 93 of the stereoscopic glasses 92. When and as long the second stereo image 85 is projected on to the projection area 42 the respective image is exclusively viewable through the second lens 95 of the stereoscopic glasses 92.
  • the frequency of alternating between first and second stereo images is larger than 10 Hz, larger than 24 Hz or larger than 36 Hz.
  • the stereoscopic glasses 92 may be implemented as so-called shutter glasses.
  • the lenses 93, 95 may be provided with electro-optic modulators or the like electrically controllable shutters by way of which a degree of transparency of each lens 93, 95 a can be instantly switched so that a user is only provided with only one of the two stereoscopic images 75, 85 at a time.
  • the image projector 71 may be operable to project the first stereo image 75 in a first color onto the projection area 42 and to project the second stereo image 85 in a second, and hence in a different color onto the projection area 42.
  • the first lens 93 may be provided with a first color filter 94 corresponding to the first color of the first stereo image 75 and the second lens 95 of the stereoscopic glasses 92 may be provided with a second color filter 96 matching with the color of the second stereo image 85.
  • a user of the imaging arrangement 1 may be provided with a three-dimensional stereoscopic image 90, by way of which puncturing of a blood vessel 8 or vein 9, e.g. with an injection needle or butterfly needle can be facilitated.
  • a display device 91 comprising a display 97 with a display screen, which is at least partially transparent.
  • the display screen may be separated into screen portions for viewing by a left and a right eye of a user. Therefore, the screen or screen portions may effectively coincide with or resemble the lenses 93, 95 as described above in connection with the stereoscopic glasses 92.
  • the display device 91 may be implemented as a AR google or VR google and may be operable to display the image 39 of the structure of interest 19 on the display 97 and to overlap or overlay the image 39 with the structure of interest 19 with a person’s view through the display 97, which is at least partially transparent.
  • the display device 91 may be further equipped with a motion sensor 98 by way of which a motion of the display device 91 relative to the body portion 4 can be quantitatively measured in order to dynamically adapt the reproduction of the image on the display 97 to the movement of them display device 91 relative to the body portion 4.
  • imaging arrangement 1 becomes apparent from the flowchart illustrating a method of imaging veins 9 or blood vessels 8 of a human body by making use of the imaging arrangement 1.
  • an imaging arrangement 1 as described above is provided.
  • the imaging arrangement 1 is attached and/or fastened to a body portion 4 of the human or animal body in step 102.
  • a scanning area 40 of the body portion 4 is scanned by using the scanner 30 of the imaging apparatus 10.
  • the scanning of the scanning area 40 is accompanied by moving the imaging apparatus 10 relative to the mount 50 in accordance to the movement direction and hence in accordance to the movability of the imaging apparatus 10 relative to the mount 50 as defined by the guiding structure 58 of the mount 50.
  • step 106 a structure of interest is extracted or recognized from scanner signals as generated by the scanner 30 when or while scanning the scanning area 40. Extraction or recognition of the structure of interest 19 is typically conducted by an image processing engine, which may be integrated into or provided by the signal processor 22.
  • step 108 there is projected the image 39 of the structure of interest 19 previously extracted or recognized from the scanner signals.
  • the image 39 is projected onto the projection area 42 of the body portion 4 by the projector 32 of the imaging apparatus 10.
  • the step of scanning 104 and the step 108 of projecting of the image 39 may be conducted sequentially or at least in a temporal partially overlapping manner. Hence, in some examples protecting of the image 39 may take place or may start after completion of the scanning in step 104.
  • projecting of the image in step 108 may even start before completion of the scanning in step 104.
  • the image projection in step 108 may be dynamically adapted to the ongoing scanning procedure.
  • the image 39 as projected by the projector 32 may be dynamically adapted to the ongoing scanning procedure, e.g. in real-time.

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

Abstract

Selon un aspect, la présente divulgation concerne un agencement d'imagerie (1) pour imager des veines (9) d'un corps humain ou animal, l'agencement d'imagerie (1) comprenant : - un support (50) destiné à être fixé à une partie de corps (4) du corps humain ou animal, - un appareil d'imagerie (10) pouvant être fixé de façon mobile au support (50), l'appareil d'imagerie (10) comprenant : - un scanner (30) utilisable pour balayer une zone de balayage (40) de la partie de corps (4) et pour générer des signaux de scanner lors du balayage de la partie de corps (4), - un processeur de signal (22) connecté au scanner (30) et utilisable pour traiter les signaux de scanner provenant du scanner (30) pour extraire et/ou reconnaître une structure d'intérêt (19) à partir des signaux de scanner, et - un projecteur (32) connecté au processeur de signal (22) et utilisable pour projeter une image (39) de la structure d'intérêt (19) sur une zone de projection (42) de la partie de corps (4).
PCT/EP2024/072770 2023-08-15 2024-08-13 Agencement d'imagerie et procédé d'imagerie de veines Pending WO2025036889A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP23315315.4 2023-08-15
EP23315315 2023-08-15

Publications (1)

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WO2025036889A1 true WO2025036889A1 (fr) 2025-02-20

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070162094A1 (en) * 2006-01-10 2007-07-12 Ron Goldman Micro vein enhancer
US20080221519A1 (en) * 2005-06-10 2008-09-11 Koninklijke Philips Electronics, N.V. System for Guiding a Probe Over the Surface of the Skin of a Patient or an Animal
WO2010029521A2 (fr) * 2008-09-15 2010-03-18 Moshe Ben Chorin Localisateur de veines et dispositifs associés
WO2013024478A1 (fr) * 2011-08-14 2013-02-21 Uzi Rahum Système de reconnaissance et d'impression d'un vaisseau sanguin à l'aide d'une lumière diffuse
US20150065916A1 (en) * 2013-08-29 2015-03-05 Vasculogic, Llc Fully automated vascular imaging and access system
US20220334251A1 (en) * 2021-04-15 2022-10-20 Bard Access Systems, Inc. Ultrasound Imaging System Having Near-Infrared/Infrared Detection

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080221519A1 (en) * 2005-06-10 2008-09-11 Koninklijke Philips Electronics, N.V. System for Guiding a Probe Over the Surface of the Skin of a Patient or an Animal
US20070162094A1 (en) * 2006-01-10 2007-07-12 Ron Goldman Micro vein enhancer
WO2010029521A2 (fr) * 2008-09-15 2010-03-18 Moshe Ben Chorin Localisateur de veines et dispositifs associés
WO2013024478A1 (fr) * 2011-08-14 2013-02-21 Uzi Rahum Système de reconnaissance et d'impression d'un vaisseau sanguin à l'aide d'une lumière diffuse
US20150065916A1 (en) * 2013-08-29 2015-03-05 Vasculogic, Llc Fully automated vascular imaging and access system
US20220334251A1 (en) * 2021-04-15 2022-10-20 Bard Access Systems, Inc. Ultrasound Imaging System Having Near-Infrared/Infrared Detection

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
"Merck Index"
"Rote Liste", 2014

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