EP1742582A1 - Systeme pour l'obturation d'un vaisseau sanguin, en particulier apres une intervention arterielle par catheter - Google Patents

Systeme pour l'obturation d'un vaisseau sanguin, en particulier apres une intervention arterielle par catheter

Info

Publication number
EP1742582A1
EP1742582A1 EP05734012A EP05734012A EP1742582A1 EP 1742582 A1 EP1742582 A1 EP 1742582A1 EP 05734012 A EP05734012 A EP 05734012A EP 05734012 A EP05734012 A EP 05734012A EP 1742582 A1 EP1742582 A1 EP 1742582A1
Authority
EP
European Patent Office
Prior art keywords
shaft
compression surface
bore
occlusion
balloon
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP05734012A
Other languages
German (de)
English (en)
Inventor
Michel DOARÉ
Gerd Stumpp
Albertus Scheule
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of EP1742582A1 publication Critical patent/EP1742582A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646Type of implements
    • A61B2017/00654Type of implements entirely comprised between the two sides of the opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire

Definitions

  • the invention relates to a system for vascular occlusion at a puncture site of a vessel, in particular after arterial catheter intervention.
  • a system for hemostasis is one Artery known that has a puncture site after an arterial catheter intervention.
  • a device which has an elongated, flexible, hollow shaft which can be inserted into the artery through a catheter lock.
  • the shaft carries an anchoring balloon and, at an axial distance from it, a vascular occlusion balloon.
  • the handling takes place in such a way that the shaft is pushed so far into the artery via the catheter lock that the anchoring balloon comes to rest in the artery when it is pushed out of the catheter lock.
  • the shaft and the catheter lock are withdrawn until the widened anchoring balloon rests on the inner wall of the artery, whereupon the catheter lock is pulled off.
  • the extravascular balloon is then expanded, while the anchoring balloon is deflated and the shaft is withdrawn so far that its tip no longer lies in the artery, while the puncture site remains sealed by the correspondingly expanded vascular occlusion balloon.
  • the vascular occlusion balloon is also vented and the entire device is pulled out of the interventional channel. This device is complex and requires a considerable degree of careful handling.
  • the object of the invention is therefore to create a system which allows it to prevent protracted bleeding and large hematomas after puncturing a vessel, in particular an artery, in a relatively simple manner.
  • the new system works with an elongated occlusion means, which has a shaft and a compression surface formed thereon as an end surface, the shaft containing a continuous bore penetrating the compression surface for receiving at least one guide means inserted into the vessel and on the opposite side of the compression surface distal end, with the compression surface advanced in the vicinity of the puncture site, is set up for fixing to the patient at skin level.
  • the elongated occlusion means allows the extravascular pressure on the puncture site to be optimized after the puncture of an arterial vessel, in particular, because the compression surface is in the correct position in close proximity to the puncture site using the guide means that is used in any case during the catheterization, for example a Seidinger wire can be placed to the outer wall of the vessel, the shaft protruding beyond the incision site in the skin allowing a locally concentrated, precisely measured pressure to be exerted on the tissue in the area of the puncture site, so that a secure occlusion of the puncture hole in the vessel wall is achieved ,
  • the duration of the pressure can be chosen arbitrarily, because the shaft of the occlusion agent can be easily fixed at skin level, for example by a bandage or a bandage.
  • the shaft of the occlusion means is preferably essentially cylindrical, but other appropriate cross-sectional shapes, for example oval, can also be used. It is also conceivable to design the shaft with longitudinal ribs or depressions or with a profile shape that results in special flexibility properties. It is also expedient if the shaft has a region with an enlarged cross-sectional area which bears the compression surface.
  • the shaft can, for example, be formed like a stamp and have an essentially smooth-walled shaft part which adjoins the region of enlarged diameter.
  • the region of increased diameter can continuously merge into the smooth-walled shaft part over the length of the shaft.
  • the size of the compression surface is therefore independent of the cross-sectional area of the shaft, so that both elements can be selected appropriately.
  • the compression surface is formed on a shaft which has a substantially identical diameter throughout its entire length.
  • the compression surface itself can be essentially circular, but it is sometimes advantageous if the compression surface is elongated in order to better adapt the pressure area to the course of the vessel and the possibly elongated puncture site.
  • the compression surface is essentially perpendicular to the longitudinal axis of the shaft, but embodiments are also conceivable in which the compression surface runs obliquely to the longitudinal axis of the shaft at an angle deviating from 90 °, in order to take account of the fact to bear that the access channel to the vessel usually forms an acute angle with the longitudinal axis of the vessel.
  • the compression station is normally flat, but it may also initially area catfish ', be cambered (convex) or concave or formed patterned e.
  • the length of the shaft can be designed to be variable.
  • the shaft e.g. be designed telescopically or have two parts connected by a thread.
  • the shaft is designed with predetermined breaking points spaced apart from one another in the longitudinal direction of the shaft, which make it possible to bring the shaft to an appropriate length by breaking off a shaft section which projects above the skin of the patient when the occlusion agent is inserted.
  • other constructions are also conceivable that enable the shaft length to be adjusted in a simple manner in accordance with the purpose.
  • a closure means can be provided for the bore of the shaft, which is designed, for example, in the form of a stopper.
  • the closure means can have a part which can be inserted into the bore of the shaft and essentially fills the bore over at least a section of its longitudinal extent. If necessary, this can prevent a clot of blood from remaining in the bore.
  • the closure means can also be placed on the shaft in the manner of a cap. In practice, however, the bore can also be simply closed with a cotton plug or the like.
  • the shaft on its distal end has a widening, which is, for example, cap-like and is integrally connected to the shaft or is detachably fastened to it.
  • the cap-like widening can simultaneously form the closure means for the bore in the shaft. The widening at the distal end of the shaft always results in a large-area support on a dressing that fixes the occlusion agent in the skin area, for example in the form of an adhesive bandage, a bandage and the like.
  • the occlusion means has a balloon in the area of the compression surface which can be expanded via a line running through the shaft and allows the compression area to be enlarged after the occlusion means have been placed and to generate an additional pressure effect.
  • the balloon can be arranged, at least partially, lying in a depression in the area of the compression surface and / or in the bore of the shaft, in order to facilitate the introduction of the compression medium into the insertion channel present in the tissue.
  • FIG. 1 is a schematic partial representation of the arterial blood vessel system of a patient with clearing the femoral arterial access area for cardiac catheterization
  • FIG. 2 shows a free-prepared femoral arterial access area of the representation according to FIG. 1, illustrating a puncture site on the ventral side of the common femoral artery,
  • 3 to 9 each show a longitudinal sectional view of the thigh at the puncture site shown in FIG. 2, illustrating essential steps in puncturing the common femoral artery in connection with catheterization and the subsequent occlusion of the puncture site with the inventive vascular occlusion system,
  • FIG. 10 shows an occlusion device of the vascular occlusion system according to the invention in a first embodiment, in a schematic longitudinal sectional view, on a greatly enlarged scale,
  • FIG. 11 shows the occlusion means according to FIG. 1 in a top view of the compression surface
  • FIG. 13 shows the occlusion means according to FIG. 12 in a top view of the compression surface
  • FIG. 16 shows the occlusion means of a vascular occlusion system according to the invention in a fourth embodiment with a shaft that can be changed in length, in a schematic longitudinal section similar to FIG. 12 and on a corresponding scale,
  • FIG. 17 shows the occlusion means of a vascular occlusion system according to the invention in a fifth embodiment, in a schematic longitudinal sectional view similar to FIG. 12, illustrating a balloon arranged in the region of the compression surface in the expanded state,
  • FIG. 18 shows the occlusion means according to FIG. 17 in a top view of the expanded balloon
  • FIG. 19 shows a closure means for one of the occlusion means according to one of FIGS. 10 to 18, in a schematic side view.
  • an access into the femoral artery 3 is created in a thigh of the patient 1 at a puncture site 2, through which a catheter is advanced as far as the heart 300.
  • the puncture site lies approximately " ventrally in the common femoral artery 3, which runs next to the femoral vein 4 and is located between the inguinal ligament (ligamentum inguinale) 5 and the superficial femoral artery 6 and the artery profunda femoris 7.
  • the artery wall at the puncture site 2 is punctured with a hollow needle 10 through the skin 8 of the thigh and the subcutaneous tissue 9 underneath (FIG. 3).
  • a guide means in the form of a guide or so-called Seidinger wire 11 is inserted into the artery 3 through the hollow needle (puncture cannula) 10 and advanced in the direction of the heart (FIG. 4).
  • a vascular lock 12 is inserted into the artery 3 (FIG. 6), whereupon the guide wire 11 is pulled out (FIG. 7), so that the vascular lock 12 for the ( unillustrated) insertion of a diagnostic or therapeutic catheter is free.
  • the catheter can e.g. also be inserted brute (in both directions). Cardiac catheterization is only an illustrative example.
  • the catheter is removed and the vascular lock 12 is removed.
  • the puncture hole present at the puncture site 2 must be in the artery wall be closed to prevent bleeding with the complications mentioned above. In practice, this is usually achieved in such a way that, as has also already been explained, after removal of the vascular lock 12, the puncture site 2 is compressed by the doctor or an instructed person by pressure on the skin of the thigh for a period of about 5 minutes and longer until the natural blood clotting closes the puncture hole at the puncture site. This is tedious and time-consuming for the doctor or the instructed person and, moreover, is only insufficiently possible, for example, in obese patients.
  • the new system works with an elongated occlusion means 13 which, in a manner to be explained, is placed in the vicinity of the puncture hole at the puncture site 2 in the perivascular tissue. Pressure is exerted on the occlusion means 13 from the outside, which compresses the perisvascular tissue in the vicinity of the puncture site and thus stops the bleeding. Subsequent fixation of the occlusion agent 13 to the skin level maintains the compression of the perisvascular tissue for the required time without the doctor or the instructed person having to take additional or longer action.
  • the occlusion means 13 is illustrated in various embodiments in FIGS. 9 to 19. It basically has an elongated shaft 14 which is generally cylindrical and smooth-walled and which has on one end face a compression surface 15 which is oriented at right angles to the longitudinal axis 16 of the shaft. There are however, embodiments are also conceivable in which the compression surface 15 is inclined at an angle deviating from 90 ° to the longitudinal axis 16 of the shaft in order to achieve a better adaptation to the anatomical conditions during use.
  • a through hole 17 is contained in the shaft 14. which runs concentrically to the longitudinal axis 16 of the shaft and opens in the region of the compression surface 15.
  • the annular compression surface 15 has the same diameter as the cylindrical shaft 14.
  • surface 15 is formed on the underside of a flange-like area 18 integrally formed on the shaft 14.
  • the flange-like area 18 is essentially disk-shaped and adjoins the shaft 14 at an angle of 90 ° to the longitudinal axis 17 of the shaft, which thus essentially has the shape of a stem
  • the area 18 is rounded at its edge at 19.
  • the cylindrical shaft 14 is provided in a section 21 adjoining the end 20 distal to the compression surface 15 with circumferential grooves 22 which are axially spaced apart and form predetermined breaking points. The shaft 14 can therefore be changed in length in a simple manner by breaking off at one of these predetermined breaking points.
  • FIGS. 14, 15 is in principle similar to that according to FIGS. 12, 13, with the difference, however, that the area 18 of enlarged cross-sectional area, which carries the compression surface 15, continuously at 220 over the length of the shaft 14 in the subsequent smooth-walled Part of the shaft merges. 10 to 13, the compression surface 15 is annular, in the embodiment according to FIGS. 14, 15 it is elongated, as can be seen in particular from FIG. 15.
  • the outline of the "compression surface 15 of the area in which the perisvaskulmaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinemaschinen tissue using the occlusion is compressed 13 are necessary, better adapted to the course of the punctured artery.
  • the compression surface 15 can be circular, elongated or with a different outline shape, which has proven to be advantageous for the respective application.
  • the compression surface 15 can have a depression which at least partially surrounds the bore mouth, as is indicated by dashed lines at 23 in FIGS. 14, 15. This results in an annular compression surface 15, which leads to a corresponding annular pressure distribution during the compression of the perivascular tissue.
  • a rounded cap 24 is placed, which on the one hand forms a closure means for the bore 17 in the shaft 14 and on the other hand represents a widening at the distal shaft end 20, which facilitates the fixing of the occlusion means 13 to the patient, as in FIG Individuals will be explained later.
  • the cap 24 can also be connected to the shaft 14 in a non-detachable manner, for example by being molded onto it, the then continuous bore 17 being able to be closed by its own stopper.
  • the shape of the cap 24 depends on the respective needs and anatomical conditions at the puncture site.
  • the shaft widening formed by it can, for example, also have a more plug-shaped cylindrical shape, as is indicated in FIG. 9 at 24a.
  • the shaft 14 has two coaxial shaft sections 14a, 14b, which are connected to one another by a threaded connector 25, which is connected to the outside by a pushed-on or with one of the shaft parts 14a, 14b connected protective sleeve 26 is covered.
  • the construction allows the shaft length to be optionally adjusted by rotating the shaft part 14a to the needs of the respective application.
  • FIGS. 17, 18 essentially also corresponds to that according to FIG. 14, but here in the region of the compression surface 15, which in this case is annular, a toroidal, expandable balloon 27 is provided, which is supplied via a line 28 running through the bore 17 an expanding agent can be expanded.
  • the balloon 27 is, at least partially, folded into the recess 23 provided in the region 18 with an enlarged diameter, it possibly also being able to be partially received in the bore 17.
  • the balloon 17 With occlusion means 13 placed in the perivascular tissue, the balloon 17 makes it possible to increase and / or to control the compression pressure exerted on the tissue because the effective compression surface 15a now lies on the underside of the balloon. It is also possible in this way to increase the compression area laterally.
  • the balloon 27 When the occlusion agent is inserted into the tissue, the balloon 27 is vented so that it prevents the insertion of the occlusion interlocking means not hindered.
  • FIG. 19 finally illustrates a closure means in the form of a stopper 29 for the bore 17 in the shaft 14.
  • the stopper 29 has a button-like handle 30 and a cylindrical stopper part 31 connected to it, which seals into the bore 17 from the distal end 20 of the shaft 14 can be pressed.
  • the plug part 31 is usually only so long that a secure hold in the bore 17 is guaranteed.
  • embodiments are also conceivable in which, as indicated in FIG. 19, it extends over the entire length or a substantial part of the length of the bore 17 in order to completely fill it and thus prevent the formation of a thrombus in the bore 17.
  • the intervention catheter is removed from the vascular lock 12 after the intervention has ended.
  • the guide means in the form of the insertion or Seldinger wire 11 is pushed back into the artery 3 via the vascular lock 12, thus restoring the situation according to FIG. 6.
  • the vascular lock 12 is removed and the occlusion means 13 is advanced over the lying guide or Seidinger wire 11 through the existing access channel to the puncture site 2 in the vicinity of the puncture site 2.
  • the perisvascular tissue 9 is in the area the puncture site 2 is compressed locally by the compression surface 15, as indicated at 32 in FIG.
  • FIG. 8 is now reached, in which the shaft 14 projects beyond the skin 8 of the patient at the incision site. If necessary, a dilator can be used to facilitate the insertion of the occlusion means 13.
  • the length of the shaft 14 of the occlusion means 13 is adapted to the respective anatomical conditions, i.e. essentially the thickness of the perivascular tissue and the subcutaneous tissue 9 in the area of the puncture site 2 is adjusted, unless an occlusion means 13 of suitable fixed shaft length has not been used from the start.
  • the bore 17 on the distal shaft end 20 is closed either by means of the plug 29 (FIG. 19) or an attached cap 24, 24a, and the occlusion means 13 is closed by means of a bandage indicated at 33 in FIGS appropriate bandage fixed at the skin level.
  • the widening at the shaft end formed by the cap 24 or the button 30 (FIG. 19) allows the occlusion agent 13 to be supported on the dressing 33 over a large area, at the same time forming a support on the skin surface. The occlusion means 13 is thereby further stabilized.
  • the balloon 27 is expanded, which, as already mentioned, allows to increase the compression area and to increase and / or to control the compression pressure sensitively without having to change the position of the occlusion means 13 itself.
  • the balloon 27 can also be inserted as a separate part in the manner of a balloon catheter through the bore 17 in the shaft 14 and placed in front of the compression surface 15.
  • the system according to the invention is suitable for all vascular interventions in which a peripheral vascular access is produced.
  • Cardiac catheterization only serves to illustrate the basic mode of operation of the new system, which has already been pointed out.
  • the occlusion means 13 is generally made of a body-compatible and medically approved plastic. Its dimensions depend on the requirements and the anatomical conditions of the respective application. As a non-limiting example, it is stated that the diameter of the bore 17, depending on the diameter of the guide wire 11, is preferably between 0.9 and 1.5 mm and the diameter of the compression surface 15 is preferably in a range from (4) to 6 ( 8) is up to 9 mm. These dimensions apply when using a vessel lock with French size 5 to 11 (1.65 mm diameter to 3.7 mm diameter).
  • the length of the shaft 14 is preferably between 3 and 7 cm, but it basically depends, as already mentioned, on the anatomical conditions of the patient in the area of the puncture site.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un système d'obturation de vaisseau sanguin servant à obturer un vaisseau en un point de ponction, en particulier après une intervention artérielle par cathéter. Ce système comprend un moyen d'occlusion (13) oblong qui présente une tige (14) et une face de compression (15) formée de façon à constituer une face sur ladite tige. La tige présente un alésage (17) traversant, qui passe à travers la face de compression et sert à loger au moins un moyen de guidage (11) introduit dans le vaisseau et elle est conçue, à l'extrémité distale (20) opposée à la face de compression, pour être fixée au patient au niveau de la peau, lorsque ladite face de compression est amenée à proximité du point de ponction (2).
EP05734012A 2004-05-03 2005-04-21 Systeme pour l'obturation d'un vaisseau sanguin, en particulier apres une intervention arterielle par catheter Withdrawn EP1742582A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102004022780A DE102004022780A1 (de) 2004-05-03 2004-05-03 System zum Gefäßverschluss insbesondere nach arterieller Katheterintervention
PCT/EP2005/004287 WO2005107604A1 (fr) 2004-05-03 2005-04-21 Systeme pour l'obturation d'un vaisseau sanguin, en particulier apres une intervention arterielle par catheter

Publications (1)

Publication Number Publication Date
EP1742582A1 true EP1742582A1 (fr) 2007-01-17

Family

ID=34967790

Family Applications (1)

Application Number Title Priority Date Filing Date
EP05734012A Withdrawn EP1742582A1 (fr) 2004-05-03 2005-04-21 Systeme pour l'obturation d'un vaisseau sanguin, en particulier apres une intervention arterielle par catheter

Country Status (5)

Country Link
US (1) US20080039888A1 (fr)
EP (1) EP1742582A1 (fr)
JP (1) JP2007536034A (fr)
DE (1) DE102004022780A1 (fr)
WO (1) WO2005107604A1 (fr)

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Publication number Priority date Publication date Assignee Title
US20090093758A1 (en) * 2006-07-24 2009-04-09 Yossi Gross Fibroid treatment apparatus and method
WO2011013127A2 (fr) * 2009-07-27 2011-02-03 Fibro Control, Inc. Structures d'occlusion de l'artère utérine
US8403953B2 (en) * 2009-07-27 2013-03-26 Fibro Control, Inc. Balloon with rigid tube for occluding the uterine artery
TWI635840B (zh) * 2016-08-30 2018-09-21 周佳蓉 血管穿刺封閉器

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US5345927A (en) * 1990-03-02 1994-09-13 Bonutti Peter M Arthroscopic retractors
US5514153A (en) * 1990-03-02 1996-05-07 General Surgical Innovations, Inc. Method of dissecting tissue layers
US5836871A (en) * 1991-05-29 1998-11-17 Origin Medsystems, Inc. Method for lifting a body wall using an inflatable lifting apparatus
US5342393A (en) * 1992-08-27 1994-08-30 Duke University Method and device for vascular repair
US5383896A (en) * 1993-05-25 1995-01-24 Gershony; Gary Vascular sealing device
GB9319056D0 (en) * 1993-09-15 1993-11-03 Surgical Innovations Ltd Haemostat
DE4429230C2 (de) * 1994-08-18 1996-09-19 Harren Ernst Diethelm Punktionsverschluß
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JP2001346887A (ja) * 2000-04-07 2001-12-18 Hideto Oishi 食道瘻ボタン
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Also Published As

Publication number Publication date
US20080039888A1 (en) 2008-02-14
WO2005107604A1 (fr) 2005-11-17
DE102004022780A1 (de) 2005-12-01
JP2007536034A (ja) 2007-12-13

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