WO2014089162A1 - Appareil de cathéter intravasculaire auto-rinçant et procédés associés - Google Patents

Appareil de cathéter intravasculaire auto-rinçant et procédés associés Download PDF

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Publication number
WO2014089162A1
WO2014089162A1 PCT/US2013/073025 US2013073025W WO2014089162A1 WO 2014089162 A1 WO2014089162 A1 WO 2014089162A1 US 2013073025 W US2013073025 W US 2013073025W WO 2014089162 A1 WO2014089162 A1 WO 2014089162A1
Authority
WO
WIPO (PCT)
Prior art keywords
sheath
catheter apparatus
medical sensing
sensing catheter
inner structure
Prior art date
Application number
PCT/US2013/073025
Other languages
English (en)
Inventor
Michael Reiter
Dylan VAN HOVEN
Original Assignee
Volcano Corporation
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 Volcano Corporation filed Critical Volcano Corporation
Priority to EP13860023.4A priority Critical patent/EP2928379A4/fr
Priority to CA2893491A priority patent/CA2893491A1/fr
Priority to JP2015545808A priority patent/JP2016504928A/ja
Publication of WO2014089162A1 publication Critical patent/WO2014089162A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/445—Details of catheter construction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • 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
    • A61B5/0066—Optical coherence imaging
    • 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

Definitions

  • Embodiments of the present disclosure relate generally to the field of medical devices and, more particularly, to apparatus and methods for flushing catheters used in internal vasculature diagnostic procedures.
  • IVUS intravascular ultrasound
  • IVUS techniques are catheter-based and provide a real-time sectional image of the arterial lumen and the arterial wall.
  • An IVUS catheter includes one or more ultrasound transducers at the distal tip of the catheter by which images containing cross-sectional information of the artery under investigation can be determined.
  • IVUS imaging permits visualization of the configuration of the obstructing material and, in varying degrees, the boundaries of the intimal and medial layers of the arterial wall.
  • IVUS imaging catheter system typically includes an arrangement in which a single transducer at the distal end of the catheter is rotated at high speed (up to about 2000 rpm) to generate a rapid series of 360-degree ultra sound sweeps. Such speeds result in generation of up to about thirty images per second, effectively presenting a real-time image of the diseased artery.
  • the transducer is mounted on the end of a drive shaft or cable that is connected to a motor drive at the proximal end of the catheter.
  • the rotating transducer is housed within a sheath that does not interfere with the ultrasound and protects the artery from the rapidly spinning drive shaft.
  • an IVUS imaging (or "sensing") catheter may be advanced to the region of an occlusion using conventional angiographic techniques and then may be operated to provide real-time sectional images of the vascular lumen in the arterial wall, including the occluding material and intimal and medial layers of the artery wall.
  • catheter-based systems for use in visualizing the internal anatomy of body portions implementing sheath-enclosed movable sensing/imaging element disposed on elongated drive shaft or cable structures are also known, including photo-acoustic, optical coherence tomography, phased array/multiple transducer, and spectroscopic systems.
  • the performance of each of the above-mentioned catheter-based systems may be adversely affected by the presence of air within the interior of its sheath portion adjacent the movable sensing element(s) therein. Air bubbles may be present in the sheath prior to the operation of the system, or may be generated during system operation by rotation of the flexible drive shaft or cable disposed proximally of the sensing/imaging element(s). The presence of these air bubbles tends to undesirably corrupt the image or data which the system is designed to generate.
  • a flushing operation is typically performed.
  • a flushing liquid such as a saline solution
  • the sheath typically in the range of from about 0.3 cm to about 20 cm in useable length and in the range of from about 0.05 cm to about 0.1 cm in internal diameter
  • forcing flushing liquid from the proximal end of the sheath distally through its entire length requires significant pressure. It also requires additional parts in the form of an attached one-way check valve and a detachable syringe and hose apparatus, thereby undesirably adding to the cost of the overall system.
  • the check valve also creates an obstruction near the hand piece portion of the system when the sensing/imaging structure is manipulated manually. Furthermore, there is currently no preventive measure for distally blocking air bubbles, released from the inside of the drive cable during system operation, from reaching the sensing/imaging structure and adversely affecting its performance.
  • a medical sensing catheter apparatus which is illustratively an IVUS catheter, but could alternatively be another type of medical sensing catheter such as a photo-acoustic, optical coherence tomography, phased array/multiple transducer, or spectroscopic type of catheter.
  • the catheter structure provides for improved flushing thereof, and illustratively includes an elongated flexible sheath having a proximal end, and an open distal end insertable into a body area of a patient, and an elongated flexible inner structure longitudinally extending through the interior of the sheath and being movable relative thereto.
  • the inner structure has a distal end portion with a sensing element disposed thereon and operative to generate signals useable to create diagnostic information with respect to the patient body area, representatively an artery.
  • the sensing element is an ultrasound transducer.
  • an impeller structure is carried by the inner structure and is operative, in response to rotation of the inner structure relative to the sheath, to flow a flushing liquid from a source thereof proximally through the sheath toward the support structure, along the exterior of the support structure, and then through the substantially barrier free space, in a manner preventing air from being interposed between the support structure and a facing interior side surface portion of the sheath.
  • the impeller structure may be external impeller vanes or a spiraling surface groove externally formed on the distal end portion of the inner structure.
  • blood from within the artery is used as the flushing liquid, and may subsequently be returned to the artery from the substantially barrier free space via an optional blood outlet port formed in the sheath.
  • the interior of the sheath may be flushed in the same manner using a non-blood flushing liquid such as a saline solution.
  • a non-blood flushing liquid such as a saline solution.
  • a method for flushing air from within a medical sensing catheter generally having a construction as described above, the method comprising the steps of (1) configuring the distal end portion of the inner structure to draw a flushing liquid from a source thereof inwardly through the open distal end of the sheath in response to rotation of the distal end portion of the inner structure relative to the sheath; and (2) causing flushing liquid from a source thereof to sequentially flow proximally through the sheath toward the distal end portion of the inner structure, along the exterior of the distal end portion of the inner structure, and then proximally through the substantially barrier free space, in a manner preventing air from being interposed between the distal end portion of said inner structure and a facing interior side surface portion of the sheath, by rotating the inner structure relative to said sheath.
  • either blood or a non-blood flushing liquid may be utilized.
  • the proximally driven flow of flushing liquid through the catheter sheath continuously prevents internal sheath air adjacent the support structure from being undesirably interposed between the transducer and a facing interior side surface portion of the sheath, and also forms a moving liquid barrier that prevents air generated by the rotating inner structure from traveling distally to the transducer carrying support structure.
  • a medical sensing catheter apparatus which is illustratively an IVUS catheter, but could alternatively be another type of medical sensing catheter such as a photo-acoustic, optical coherence tomography, phased array/multiple transducer, or spectroscopic type of catheter.
  • the catheter structure provides for improved flushing thereof and illustratively includes an elongated flexible sheath having a proximal end, and an open distal end insertable into a body area of a patient, and an elongated flexible inner structure longitudinally extending through the interior of the sheath and being movable relative thereto, the inner structure having a distal end portion with a sensing element disposed thereon and operative to generate signals useable to create diagnostic information with respect to the patient body area.
  • annular seal structure is coaxially and externally carried by the inner structure proximally of the sensing element, the seal structure slidingly and sealingly engaging the interior surface of the sheath and being movable with the inner structure relative to the sheath.
  • the annular seal structure permits a distal end portion of the sheath to be flushed in a manner expelling undesirable air therefrom by proximally moving the inner structure relative to the sheath to draw flushing liquid proximally into the sheath through its distal end, and then moving the inner structure distally relative to the sheath to discharge the received fluid, and air therein, outwardly through the distal sheath end to thereby obviate the previous necessity of performing the necessary flushing operation by forcing flushing fluid distally through the entire length of the sheath.
  • an impeller structure is provided on the portion of the inner structure that carries the sensing element and is operative to draw flushing liquid proximally through a distal end portion of the sheath, towards the seal structure, in response to rotation of the inner structure relative to the sheath, to flush a distal tip portion of the sheath without translating the inner structure relative to the sheath.
  • an air flushing method for use with a medical sensing catheter having an elongated flexible sheath with a proximal end and an open distal end insertable into a body area of a patient, and an elongated flexible inner structure longitudinally extending through the interior of the sheath and being movable relative thereto, the inner structure having a distal end portion with a sensing element disposed thereon and operative, during movement of said inner structure relative to said sheath, to generate signals useable to create diagnostic information with respect to the patient body area.
  • the method comprises the steps of flowing a quantity of flushing fluid inwardly through the open distal end of said sheath toward the sensing element, and then discharging at least a portion of the quantity of flushing fluid, and air previously disposed within the interior of the sheath, outwardly through a distal end portion of the sheath.
  • the flowing and discharging steps may respectively include the step of proximally and distally translating the inner structure through the sheath, or may each be performed by rotating the inner structure relative to the sheath.
  • Catheter apparatus and associated flushing methods representatively disclosed herein provide substantial improvements in the overall catheter flushing operation. For example, when blood is utilized as a flushing liquid the necessity for the use of a secondary acoustic media is eliminated, thereby desirably lessening the total material cost for the diagnostic procedure, and also reduces the quantity of particulates that may potentially be introduced into the body using a distally directed flushing procedure. Catheter structure and associated methods representatively disclosed herein further improve work flow and ease of catheter use for the operator, reduce the time needed for the flushing procedure, and improve diagnostic image quality via the elimination of air-related image artifacts.
  • FIG. 1 is a highly schematic partially cross-sectioned view of representative medical sensing catheter apparatus embodying principles of the present invention
  • FIG. 2 is a side elevational view of an alternate embodiment of a transducer support portion of the FIG. 1 catheter apparatus;
  • FIG. 3 is a partially cutaway schematic elevational view of a second embodiment of the FIG. 1 medical sensing catheter apparatus;
  • FIG. 4 is a cross-sectional enlargement of the dashed circle area "4" in FIG. 3;
  • FIGS. 5A-5D sequentially depict, in schematic form, a representative catheter flushing method embodying principles of the present invention
  • FIG. 6 is an enlarged scale schematic cross-sectional view of a distal end portion of an alternate configuration of the catheter apparatus of FIGS. -5D being flushed by an associated alternate flushing method embodying principles of the present invention.
  • FIG. 7 illustrates an alternate configuration of the distal end portion of the inner catheter structure shown in FIG. 6.
  • FIG. 1 Schematically depicted in FIG. 1 is medical sensing catheter apparatus which is representatively in the form of an intravascular catheter 10 that may be operatively inserted in an artery 12 of a patient to perform diagnostic artery imaging procedures.
  • the catheter 10 is an IVUS (Intravascular Ultrasound) catheter of the single rotatable transducer type, but could alternatively be one of a variety of other types of catheter-based systems for use in visualizing the internal anatomy of body portions implementing sheath-enclosed movable sensing/imaging elements disposed on elongated drive shaft or cable structures, including but not limited to photo-acoustic, optical coherence tomography, and spectroscopic systems, without departing from principles of the present invention.
  • IVUS Intravascular Ultrasound
  • Catheter 10 includes an elongated flexible tubular outer sheath 14 having an open distal end 16 and a proximal end 17.
  • the useable length of the sheath 14 i.e., the length thereof operatively insertable into a patient
  • the useable sheath length is in the range of from about 0.3 cm to about 20 cm, and the internal sheath diameter is in the range of from about 0.05 cm to about 0.1 cm.
  • an elongated flexible inner structure 18 comprising an elongated flexible drive shaft or cable 20 with a support structure 22 (typically referred to as a "can") secured to its distal end and carrying a sensing/imaging element illustratively in the form of a single ultrasound transducer 24.
  • the proximal end 17 of the sheath, and the proximal end of the drive shaft or cable 20 therein, are operatively connected to a suitable PIM (patient interface module), of conventional construction, which provides electrical power to the transducer 24 and receives imaging signals therefrom.
  • the PIM may also be operative to selectively drive the inner structure 18 translationally and rotationally relative to the sheath 14 as respectively illustrated by the arrows 26,28 in FIG. 1.
  • a separate drive structure may similarly drive the inner structure 18 relative to the sheath 14, or such translational and rotational movement of the inner structure 18 relative to the sheath 14 may be manually achieved if desired.
  • an impeller structure is externally disposed on the support structure 22 and is illustratively in the form of a plurality of impeller vanes 32 disposed on the support structure portion 22 of the flexible inner structure 18 proximally of the transducer 24.
  • the impeller structure could comprise a suitably spiraled groove 34 formed in the outer side surface of the support structure 22 proximally of the transducer 24.
  • the interior of the sheath 14 may be easily flushed, to expel undesirable air therein, by simply rotating the inner structure 18 relative to the sheath 14 as indicated by the arrow 28.
  • Such rotation by virtue of the impeller structure 32 (or the FIG. 2 impeller structure 34 as the case may be) causes blood 36 from within the artery 12 to be flowed inwardly through the open distal end 16 of the sheath 14, exteriorly along the support structure 22, and then proximally through the substantially barrier-free annular passage 30.
  • the proximally flowing blood 36 is thus utilized as a flushing liquid to rid the interior of the sheath 14 of undesirable air and may be transferred back into the artery 12 via an optional side wall blood exit port 38 formed in the sheath 14.
  • This proximally driven flow of flushing liquid through the sheath 14 continuously prevents internal sheath air adjacent the support structure 22 from being undesirably interposed between the transducer 24 and a facing interior side surface portion of the sheath 14, and also forms a moving liquid barrier that prevents air generated by the rapidly spinning drive shaft or cable 20 from traveling distally to the support structure 22.
  • FIGS. 3 and 4 Schematically depicted in FIGS. 3 and 4 is an alternate embodiment 10a of the previously described medical sensing catheter apparatus 10.
  • Catheter 10a may be operatively inserted in artery 12 of a patient to perform diagnostic artery imaging procedures.
  • the catheter 10a is an IVUS (Intravascular Ultra Sound) catheter of the single rotatable transducer type, but could alternatively be one of a variety of other types of catheter-based systems for use in visualizing the internal anatomy of body portions implementing sheath-enclosed movable sensing/imaging elements disposed on elongated drive shaft structures, including photo-acoustic, optical coherence tomography, phased array/multiple transducer, and spectroscopic systems, without departing from principles of the present invention.
  • IVUS Intravascular Ultra Sound
  • Catheter 10a includes an elongated flexible tubular outer sheath 14a having an open distal end 16a and a proximal end 17a.
  • the useable length of the sheath 14a i.e., the length thereof operatively insertable into a patient is greatly larger than its internal diameter.
  • the useable sheath length is in the range of from about 0,3 cm to about 20 cm, and the internal sheath diameter is in the range of from about 0.05 cm to about 0.1 cm.
  • an elongated flexible inner structure 18a comprising an elongated flexible drive shaft or cable 20a with a housing structure 22a secured to its distal end and carrying a sensing element illustratively in the form of a single ultrasound transducer 24a.
  • the proximal end 17a of the sheath 14a, and the proximal end of the drive cable 20a therein, are operatively connected to a suitable PIM (patient interface module), of conventional construction, which provides electrical power to the transducer 24a and receives imaging signals therefrom.
  • the PIM may also be operative to selectively drive the inner structure 18a translationally and rotationally relative to the sheath 14a as respectively illustrated by the arrows 26a,28a in FIG. 3.
  • a separate drive structure may similarly drive the inner structure 18a relative to the sheath 14a, or such translational and rotational movement of the inner structure 18a relative to the sheath 14a may be manually achieved if desired.
  • the catheter 10a also comprises an annular seal structure 40 which coaxially circumscribes and is anchored to the housing portion 22a of the inner structure 18a proximally adjacent the transducer 24a.
  • the seal structure 40 slidably and sealingly engages the interior surface of the sheath 14a and is translationally and rotationally movable with the inner structure 18a relative to the sheath 14a.
  • the seal structure 40 may be of various types including one or more metal rings (illustratively welded stainless steel rings), a tape material such as a PTFE tape material, or at least one annular resilient seal member overmolded onto the inner structure 18.
  • seal structure 40 permits the sheath portion 14a of the catheter 10a to be flushed, to remove air from its interior, without the previous problems, limitations and disadvantages associated with forcing a flushing liquid distally through the entire length of the interior of the sheath 14a.
  • An example of how such improved flushing may be achieved via the present invention is sequentially depicted in schematic form in FIGS. 5A-5D.
  • the distal sheath end 16a is dipped into a quantity of flushing liquid, representatively a saline solution 42, within a suitable container 44.
  • the inner structure 18a is then raised within the sheath 14a (as indicated by the arrow 46 in FIG. 5A) to its FIG. 5B position.
  • This raising of the seal structure 40 creates a vacuum in the interior portion of the sheath 14a below it, thereby drawing a quantity 42a of the saline solution 42 upwardly into the interior portion of the sheath 14a below the seal structure 40.
  • the distal sheath end 16a is inverted to face upwardly, and the sheath 14 is tapped (as indicated by the arrow 48 in FIG. 5C) to cause air 50 within the sheath 14a distally of the seal structure 40 to rise to the distal sheath end 16a.
  • the inner structure 18a is forced upwardly toward the distal sheath end 16a to thereby discharge saline solution 42a (with the air 50 entrained therein) outwardly through the open distal sheath end 16a, thereby completing the catheter sheath flushing operation.
  • the equipment cost to achieve the necessary flushing is desirably reduced.
  • the efficiency of the flushing operation is also enhanced due to the fact that the seal structure 40 forms a barrier against air bubbles, generated by the rapid operational rotation of the flexible drive cable 20a, distally reaching and interfering with the imaging performance of the transducer 24a.
  • FIG. 6 schematically depicts an alternate flushing method carried out using, in an alternate catheter embodiment 10b, modified sheath and housing structures 14b,22b embodying principles of the present invention.
  • the sheath 14b shown in FIG. 6 is modified by forming a side wall vent opening 54 therein adjacent its open distal end 16b.
  • the housing 22b shown in FIG. 6 is modified by forming externally thereon an impeller structure, representatively a plurality of impeller vanes 56, disposed between the transducer 24b and the seal structure 40b.
  • the inner structure 18b is rotationally driven, as indicated by the arrow 58, without translating the inner structure 18b relative to the sheath 14b.
  • the rotating impeller structure 56 upwardly draws a portion 42b of the saline solution 42 into the interior of the sheath 24b and discharges it (with air from below the seal structure 40) outwardly through the vent opening 54 to complete the flushing operation.
  • FIG. 7 schematically depicts an alternate embodiment 22c of the housing structure 22b shown in FIG. 6.
  • the FIG. 7 housing structure 22c is identical to the FIG. 6 housing structure 22b with the exception that the impeller structure externally formed on the FIG. 6 housing structure 22c (which performs the same function as the vanes 56 in FIG. 6) is defined by a spiraling exterior side wall groove 60 formed in the outer surface of the housing structure 22c and disposed between the transducer 24c and the annular seal structure 40c.
  • the present invention in the illustrative embodiments thereof described above provides substantial improvements in the overall catheter flushing operation.
  • the necessity for the use of a secondary acoustic media is eliminated, thereby desirably lessening the total material cost for the diagnostic procedure, and also reduces the quantity of particulates that may potentially be introduced into the body using a distally directed flushing procedure.
  • the above-described flushing structure and method further improve work flow and ease of use for the operator, reduce the time needed for the flushing procedure, and improve diagnostic image quality via the elimination of air-related image artifacts.

Abstract

L'invention concerne un cathéter intravasculaire comportant une gaine allongée entourant une structure intérieure allongée flexible, laquelle peut être déplacée par rapport à la gaine, et diverses formes de réalisation représentatives de l'appareil auto-rinçant porté par la structure intérieure. Un tel appareil auto-rinçant est actionné en réponse au déplacement de la structure intérieure par rapport à la gaine, qui induit un écoulement de fluide de rinçage à partir d'une source de celui-ci, à l'intérieur de la gaine, et l'évacuation ultérieure du fluide de rinçage par la gaine. Dans une forme de réalisation, l'appareil de rinçage comprend une structure d'impulseur, placée sur la structure intérieure. Dans une autre forme de réalisation, la structure de rinçage comprend un joint d'étanchéité annulaire, placé sur la structure intérieure de manière coulissante et à étanchéité contre la surface intérieure de la gaine.
PCT/US2013/073025 2012-12-05 2013-12-04 Appareil de cathéter intravasculaire auto-rinçant et procédés associés WO2014089162A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP13860023.4A EP2928379A4 (fr) 2012-12-05 2013-12-04 Appareil de cathéter intravasculaire auto-rinçant et procédés associés
CA2893491A CA2893491A1 (fr) 2012-12-05 2013-12-04 Appareil de catheter intravasculaire auto-rincant et procedes associes
JP2015545808A JP2016504928A (ja) 2012-12-05 2013-12-04 自己洗浄血管内カテーテル機器および関連する方法

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201261733774P 2012-12-05 2012-12-05
US61/733,774 2012-12-05
US201261737440P 2012-12-14 2012-12-14
US61/737,440 2012-12-14

Publications (1)

Publication Number Publication Date
WO2014089162A1 true WO2014089162A1 (fr) 2014-06-12

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PCT/US2013/073025 WO2014089162A1 (fr) 2012-12-05 2013-12-04 Appareil de cathéter intravasculaire auto-rinçant et procédés associés

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EP (1) EP2928379A4 (fr)
JP (1) JP2016504928A (fr)
CA (1) CA2893491A1 (fr)
WO (1) WO2014089162A1 (fr)

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US11406327B2 (en) 2018-04-17 2022-08-09 Canon U.S.A., Inc. Imaging catheter assembly
JP7227052B2 (ja) * 2019-03-28 2023-02-21 テルモ株式会社 画像診断装置、画像診断システム及びプライミング方法

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US6223085B1 (en) * 1997-05-06 2001-04-24 Urologix, Inc. Device and method for preventing restenosis
US20050091833A1 (en) * 1999-03-03 2005-05-05 Kiepen Horst F. Flexible elongate member having one or more electrical contacts
US20110160758A1 (en) * 2004-03-04 2011-06-30 Straub Medical Ag Catheter for aspirating, fragmenting and removing material
JP2005334107A (ja) * 2004-05-25 2005-12-08 Aloka Co Ltd 超音波探触子
JP2007268133A (ja) * 2006-03-31 2007-10-18 Terumo Corp カテーテル装置

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EP2928379A1 (fr) 2015-10-14
EP2928379A4 (fr) 2016-08-10
CA2893491A1 (fr) 2014-06-12
JP2016504928A (ja) 2016-02-18

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