WO2002013727A1 - Stent for implantation into the carotid artery formed by process using intraluminal mapping - Google Patents
Stent for implantation into the carotid artery formed by process using intraluminal mapping Download PDFInfo
- Publication number
- WO2002013727A1 WO2002013727A1 PCT/US2001/024656 US0124656W WO0213727A1 WO 2002013727 A1 WO2002013727 A1 WO 2002013727A1 US 0124656 W US0124656 W US 0124656W WO 0213727 A1 WO0213727 A1 WO 0213727A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- carotid artery
- stent
- internal carotid
- course
- stenting
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/856—Single tubular stent with a side portal passage
Definitions
- the present invention relates to novel apparatus and processes for maintaining patency of body lumens.
- the present invention supplies novel enhanced shaping for stenting devices, which shaping improves the emplacement and/or long term indwelling of customized, 10 optimized or otherwise individuated generally conical/'trumpet-likeVparabolic shaped members having free ends in native vessels, especially the carotid arteries.
- carotid arteries have become prominent as housing target stenotic lesions. This is further bolstered by the ongoing trend that 30 extends patients' viability longer exposing greater number of patients to the need for carotid artery intervention at some point in their medical history.
- the present inventor has had a review of the literature undertaken, and has discovered significant trends impacting the longstanding needs for novel enhanced carotid arterial therapies. It is interesting to note that since the advent of carotid stenting a modicum of confusion has existed with respect to ⁇ the unique geometric and stenotic constraints imposed by the carotid arteries. Such issues are exemplified by the article found at 346:1223 THE LANCET, (4 Nov.
- the present invention concerns a stent for implantation into the carotid artery according to a process whereby the lumen of a vessel is mapped to ensure compliance of the stent geometry and the lumen.
- Stents are endoprostheses in the form of grid supports, which are utilized at places of constriction in body vessels, in order to again produce undisturbed blood flow, inter alia. In some cases they may serve for widening the constriction, so that the inner diameter or the inner lumen of the affected vessel is again brought to the usual width, and further for the stabilization of the vessel wall.
- Conventional stents are formed as tubes or hollow cylinders and are comprised of metal or plastic latticework in various forms.
- balloon-expandable stents which are brought into their final form by means of a balloon catheter
- self- expanding stents comprised of a material with memory effect, which are automatically converted into their final form by heating in the body.
- the possible applications of these stents in vessels of great variability are determined by the various radial diameters, lengths, and flexibility properties.
- combining self-expanding and balloon expandable stents and stent grafts is cointemplated as within the scope of the instant teachings.
- the carotid artery has a division of the vessel (so-called bifurcation) at which the actual common carotid artery (Arteria carotis communis) divides into an internal carotid artery (Arteria carotis interna) and an external carotid artery (Arteria carotis externa).
- bifurcation at which the actual common carotid artery (Arteria carotis communis) divides into an internal carotid artery (Arteria carotis interna) and an external carotid artery (Arteria carotis externa).
- bifurcation one or both vessel outlets are displaced by the wall of the known stents.
- the vessel form usually does not correspond to a tube with a constant internal diameter, but is 'trumpet' or cone-shaped/ conical viewed in an anatomically correct manner, thus continually tapering in one direction.
- This tapering is in fact negligible in the case of the larger vessels, but is particularly clearly pronounced in the carotid artery and is of great importance with respect to the precision of fit of the stent.
- the curve-shaped region is also associated with bending segments in the carotid artery, whereby the direction of principal blood flow varies in all three dimensions in space.
- a radially expandable stent is disclosed in EP 0 884,028 A1 for implantation in a body vessel in the region of a vessel bifurcation. This stent in fact has an enlarged radial opening in the region of the vessel bifurcation, but is formed as a simple tube and is thus not suitable for implantation in the carotid artery.
- WO 99/44,540 discloses a stent for implantation in the carotid artery, also in the region of the bifurcation, but which only has a varying diameter, wherein the central region is more rigid than the two ends. The bendings in the course of the internal and external carotid arteries are not considered.
- the stent also does not have an opening in the region of the vessel bifurcation, but only a larger pore diameter, so that the flow of blood is still hindered strongly, as in previous designs.
- EP 0 923,912 A2 discloses only a common tube-shaped stent with an additional support structure made of a bioresorbable material.
- Objectives and Summary of the Invention are to provide a carotid stent having features derived from geometric measurements of a series of appropriate vessel lumens, and to teach how to do the same.
- Another object of the present invention is to provide at least a set of design features derived from an empirically determined set of radius ratios and/or an algorithm defining the relationships among the internal carotid artery, external carotid artery and the common carotid artery useful in modeling a desired stent geometry.
- stents for implantation into the internal carotid artery are disclosed, with a lower end and an upper end, wherein the radius from lower end to upper end decreases, characterized by the fact that stent has a tectonic structure in the form of angles and curvatures adapted to the course of the internal carotid artery and that in the region of the outlet of internal carotid artery, a lower end is formed as an ovaloid opening.
- a stent for implantation in the internal carotid artery with a lower end and an upper end, wherein the radius decreases from lower end to upper end, characterized by the fact that a stent having a tectonic structure in the form of angles and curvatures is adapted to the course of internal carotid artery, with a lower end projecting into the common carotid artery and having an ovaloid recess provided in the region of the outlet of the external carotid artery.
- a stenting apparatus configured to correspond to the endoluminal surface of a carotid artery having a tectonic structure in the form of angles and curvatures following the course of a patient's internal carotid artery and having an ovaloid aperture communicating with the external carotid artery, the improvement which comprises a trumpet-like tapered section from proximal to distal ends, whereby the spatial orientation of the stent defines a substantially hyperbolic section adjacent said ovaloid aperture.
- a process for generating a novel enhanced stenting device comprising the steps of; targeting a luminal surface to be mapped, capturing a non-contact picture of the surface data of the luminal surface to be mapped, generating a multiplicity of three-dimensional measuring points, arraying said multiplicity of three-dimensional measuring points within a predetermined lattice structure defining a tectonic structure in the form of angles and curvatures adapted to the course of the mapped luminal surface; providing individuated or otherwise customized sections of geometric scaffolding structure corresponding to the portions arrayed in the lattice by three-dimensional computer modeling to make a virtual stent.
- a stent according to the invention is provided for the region of the branching of the common carotid artery which has an anatomically correct adaptive from, which takes into consideration the special features in the region of the bifurcation of the common carotid artery and of the course of the proximal part of the internal carotid artery, i.e., found directly at the bifurcation of the common carotid artery.
- Fig. 1 shows a schematic, perspective representation (not to scale) of the carotid artery in the region of the bifurcation
- Fig. 2 shows a schematic, perspective representation (not to scale) of a first example of embodiment of a stent according to the invention in the carotid artery;
- Figs. 3a to 3b show schematic, perspective representations (not to scale) of a second example of embodiment of a stent according to the invention in the carotid artery from various perspectives.
- the present inventor has discovered why the conventional tubular stent does not fit into the carotid artery, particularly the bifurcated region within human carotid arteries.
- Empirical studies with casts made from harvested human carotids have shown that curvature in the proximate internal carotid artery [ICA] the differences in cross-sectional area along the course of the ICA and variations in angles found at the bifurcation result in the need for a differently shaped stenting device.
- ICA internal carotid artery
- a computer-aided-design (CAD) system enables the instant teachings to be actualized in a novel enhanced carotid stenting device according to the instant teachings.
- the stent according to the invention for the region of the branching of the common carotid artery has an anatomically correct adaptive from, which takes into consideration the special features in the region of the bifurcation of the common carotid artery and of the course of the proximal part of the internal carotid artery, i.e., found directly at the bifurcation of the common carotid artery.
- the region of the carotid artery 1 that is shown includes as the principal branch the upper region of the common carotid artery [ACC] 2, the vessel forking or bifurcation 3, and as secondary branches, the lower regions of the internal carotid artery (Arteria carotis interna ) ICA 4, and the external carotid artery (Arteria carotis externa ) [ACE].
- the vessel radius of the CCA (1 ) is greatest in the region of common carotid artery 2.
- the internal carotid artery 4 narrows proceeding from the vessel bifurcation 3 so much so that the vessel radii ICA (2), ICA (2 , ICA (2 2 ), ICA (2 3 ) decrease continually.
- the vessel radius of the external carotid artery 5 ECA (3) is smaller than that of the common carotid artery 2 and is also smaller than the vessel radius ICA (2) of internal carotid artery 4.
- the angle ⁇ (the outlet angle of the internal carotid artery) varies; it is different for each person. It has also been demonstrated that the internal carotid artery 4 practically never pursues a linear course. The internal carotid artery 4 curves to a great extent in all three spatial directions.
- the constrictions that occur most frequently (stenosis) of carotid artery 1 are found in the upper region of common carotid artery 2 and in the lower region of internal carotid artery 4.
- the stent must be placed in the region of the internal carotid artery and of the common carotid artery in these cases.
- the outlet of the external carotid artery 5 in the region of the vessel bifurcation 3 in these cases is sealed off by the wall of a conventional stent, so that blood can no longer flow through the external carotid artery 5 or at least the blood flow is severely adversely affected when blood flows into the external carotid artery through the grid network.
- tubular stents currently in general use are not anatomically suitable based upon a series of geometric measurements of human carotids.
- a novel enhanced approach is offered for consideration, in part on the basis of the works discussed below.
- carotid bifurcation samples were harvested from autopsies and respective packets of individuated data points arrayed in a specialized database (EXCEL®, Microsoft Corporation, Redmond, Washington State, U.S.A.) including relevant information from the autopsy register about the cause of death and underlying illnesses in addition to sample side (right versus left) and all height and weight data.
- Casts were prepared from the harvested vessels by suspending them, suitabley prepared at a suspension facility, in the direction of flow. The vessels were then drained with a fast-hardening plastic (PALADUR R, Heraeus Kulzer GmbH, Wehrheim, Germany), and cured for 1/3 of an hour at approximately 23 degrees Celcius. The resulting hardened cast preparations were compared with the harvested vessels, which were preserved in formalin, cataloged and anterior/posterior projections documented photographically.
- PALADUR R Heraeus Kulzer GmbH, Wehrheim, Germany
- Calliper gauge measurements were taken (MITUTOYO® Digital Calliper, Japan) at a resolution of 0.01 mm. Maximum and minimum diameters were measured first in two dimensions, at defined measuring points on the ACC (Dc1 min/Dcmax/Dc2min/Dc2max), ACI (Di1 min/DI1 Max/Di2Min/Di2max and the ACE (Demin/Demax) as well as the carotid bulbus (Cbmin/Cbmax). Cross-sectional area measurement followed, and were based upon prior accepted sites for measuring points known to those skilled in the art.
- novel enhanced and optimized carotid stenting devices of the present invention are based in part on conclusions that median curvatures along the proximal ACI between measuring points 11 and 12 significantly differ from zero, or that the course of the proximal ACI cannot be considered to be rectilinear.
- Table 7 is offered for consideration in these regards, the same being appended to the instant specification and expressly incorporated herein by reference as demonstrative of this geometric conclusion.
- Table 5 is offered for consideration in these regards, the same being appended to the instant specification and expressly incorporated herein by reference as demonstrative of this geometric conclusion about the carotid lumens reviewed.
- BMI Body Mass Index
- Table 11 is offered for consideration in these regards, the same being appended to the instant specification and expressly incorporated herein by reference as demonstrative of this geometric conclusion about the carotid lumens reviewed.
- the three dimensional modeling was also helpful in designing the virtual stent to be placed in the ACC in the bulbus area, the ACI over the outlet area and, preferably, over the recess of an outlet opening for the ACE outlet.
- the involved Surfacer®(V8) software enables saved geometrical data of such a virtual prototype to be converted into manufacturing data (NC data) and then rapidly prototyped.
- NC data manufacturing data
- Those skilled would also be able to readily substitute metals, plastics, shape-memory alloys and the like for stent materials having a desired characteristic.
- Stent 10 has a lower end or an inlet 11 and an upper end 12.
- Inlet 1 1 is found in the region of vessel bifurcation 3 and is shaped in ovaloid form in order not to cover the outlet of the external carotid artery 5.
- Inlet 11 is obliquely sectioned due to the ovaloid structure and partially projects into the common carotid artery by its longer end 11a and thus supports the vessel wall in the region of the outlet of the internal carotid artery at the vessel bifurcation 3.
- the shorter end 1 1 b of inlet 11 supports the internal carotid artery 4 directly at vessel bifurcation 3. In this away, the outlet of internal carotid 4 is securely kept open.
- Stent 10 is also shaped like a cone, wherein the radial diameter varies in the longitudinal course and becomes smaller proceeding from inlet 11 upper end 12, so that it is adapted to the course of internal carotid artery 4.
- stent 10 can be characterized as roughly parabolic, making reference to the three ordinal planes which are shown at each radius-based juncture where measurements are taken.
- the conical, parabolic, or 'trumpet-shaped' nature of stent 10 is noted as distinct from those generally tubular stents which are known and used conventionally.
- Stent 10 has a tectonic structure, i.e., angles and curvatures in three- dimensional space adapted to the course of internal carotid artery 4.
- Stent 10 according to the invention is characterized by an anatomically corrected adaptive form, as further defined below within the claims that are appended hereto.
- FIGS 3a to 3d show another example of an embodiment of a stent 20 according to the invention.
- Stent 20 also has a lower end 21 and an upper end 22.
- Lower end 21 is now found within the common carotid artery.
- an ovaloid recess 23 is now provided, which lies precisely at the outlet of external carotid artery 5.
- recess 23 Due to the ovaloid formation, recess 23 is also obliquely sectioned and now slightly projects into external carotid artery 5 by its longer end 23a. Shorter end 23b of recess 23 also supports internal carotid artery 4 directly at vessel bifurcation 3. This configuration has the advantage that the restraining or radial forces of stent 20, which keep open the outlet of internal carotid artery 4 at vessel bifurcation 3, already act at the upper end of the common carotid artery and do not excessively load the vessel walls in the region of the vessel bifurcation.
- Stent 20 is also shaped like a cone, as is stent 10, wherein the radial diameter varies in the longitudinal course and becomes smaller from lower end 21 to upper end 22, so that it is adapted to the course of internal carotid artery.
- Stent 20 likewise has a tectonic structure, i.e., it has angles and curvatures in three-dimensional space adapted to the course of internal carotid artery 4, or it is "trumpet-shaped" or roughly parabolic.
- Stent 20 according to the invention is characterized by an anatomically correct adaptive form, whereby it is differentiable from the conventional tubular stenting devices which make up the majority of the prior art disclosures.
- Stent 10 or 20 is comprised of a grid network, which can be formed of metal and/or plastic.
- the material may also be bioresorbable.
- the grid network may be introduced in the desired from by a balloon catheter, or it may have a memory effect, so that it is converted to the desired from automatically by the action of body heat.
- stent 10, 20 can reconstruct the curve-shaped course of the internal carotid artery in three- dimensional space. Bending at a sharp angle is thus avoided. This is shown in Figures 3a to 3d, which show stent 20 from a total of four different perspectives, wherein the three-dimensional curvature of the internal carotid artery 4, which follows stent 20, can be seen. Tables 8, 9 & 10 are offered for consideration in these regards, the same being appended to the instant specification and expressly incorporated herein by reference as demonstrative of this geometric conclusion about the carotid lumens reviewed.
- the adaptation capacity of stent 10, 20 according to the invention can be clearly recognized relative to the potential alignment of the carotid artery in three-dimensional space, of the basis of these different perspectives.
- the lattice frame can be stamped from a tube or produced from wire, for example, bent, braided, knitted, or the like.
- the three-dimensional tectonic structure of stent 10, 20 is formed in production. Production may be conducted to yield various prepared sizes or individually adapted to the individual requirement. Implantation is conducted endoluminally.
- a carotid bifurcation consists of a main branch, the ACC, which divides (but is not bifurcated) into two branches, the ACI and ACE.
- the ACI widens into the proximal part and is 'trumpet-like' and has a greater radius than that of the ACE.
- the final section of the ACC in the bifurcation and immediate ACI outlet may also be described anatomically as the carotid bulbus.
- the course of the ACC remains generally rectilinear having a relatively constant diameter without vascular outlets along its length.
- the ACI is partially linear, but conical or parabolic in the in the immediate outlet area. This means that the ACI is both tubular and conical/parabolic, but mainly curved.
- the ACE has numerous side branches along its length, the first of which is the superior thyroid artery.
- the superior thyroid artery generally originates partly from the bulbus or up to 2 cm distally therefrom.
- the present inventor is unaware of any studies that have developed aspects of the geometry of the carotid bifurcation with the exception of the use of angiography and related techniques.
- the literature ranges from about 5.8 mm to about 8.6mm for the median value of the diameter of the ACC, while the instant teachings provide 5.51 mm to 6.86 mm at C1 and C2. It is noted that with cadavers, "shrinkage" is likely to occur, and the same is expected with all of the instant measurements.
- the median diameter of 5.16 mm DC2min and of 6.36 mm for DCImax were recorded by the present inventor.
- the proximal ACI (next to the outlet) yielded values of between about 5.62 mm and 6.49 mm.
- the median values ranged from at least about 4.04 mm to about 4.69 mm. Table 8 summarizes this set of relationships, and has been previously offered herein for consideration.
- Table 3 Area calculation at measuring points C1 and C2 of the ACC and at measuring points 11 and 12 of the ACI
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Prostheses (AREA)
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2001279207A AU2001279207A1 (en) | 2000-08-16 | 2001-08-04 | Stent for implantation into the carotid artery formed by process using luminal mapping and products by the process |
US09/930,514 US20020068968A1 (en) | 2000-08-16 | 2001-08-15 | Virtual stent making process based upon novel enhanced plate tectonics derived from endoluminal mapping |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE10040630.0 | 2000-08-16 | ||
DE2000140630 DE10040630A1 (de) | 2000-08-16 | 2000-08-16 | Stent zur Implantation in die Halsschlagader |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/930,514 Continuation-In-Part US20020068968A1 (en) | 2000-08-16 | 2001-08-15 | Virtual stent making process based upon novel enhanced plate tectonics derived from endoluminal mapping |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2002013727A1 true WO2002013727A1 (en) | 2002-02-21 |
WO2002013727A8 WO2002013727A8 (en) | 2002-07-04 |
Family
ID=7653019
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2001/024656 WO2002013727A1 (en) | 2000-08-16 | 2001-08-04 | Stent for implantation into the carotid artery formed by process using intraluminal mapping |
Country Status (3)
Country | Link |
---|---|
AU (1) | AU2001279207A1 (de) |
DE (1) | DE10040630A1 (de) |
WO (1) | WO2002013727A1 (de) |
Cited By (8)
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---|---|---|---|---|
WO2003015666A2 (en) * | 2001-08-15 | 2003-02-27 | Edwards Lifesciences Corporation | Virtual stent making process derived from endoluminal mapping |
WO2007104051A2 (en) * | 2006-03-09 | 2007-09-13 | Abbott Laboratories | Stent having contoured proximal end |
EP2431380A2 (de) | 2006-09-11 | 2012-03-21 | Tranzyme Pharma, Inc. | Makrozyklischer Antagonist des Motilinrezeptors zur Behandlung von Magen-Darm-Motilitätsstörungen |
US8167929B2 (en) | 2006-03-09 | 2012-05-01 | Abbott Laboratories | System and method for delivering a stent to a bifurcated vessel |
CN103198202A (zh) * | 2012-12-19 | 2013-07-10 | 首都医科大学 | 颅内动脉瘤介入治疗支架植入图像仿真方法 |
US9402754B2 (en) | 2010-05-18 | 2016-08-02 | Abbott Cardiovascular Systems, Inc. | Expandable endoprostheses, systems, and methods for treating a bifurcated lumen |
WO2017100977A1 (zh) * | 2015-12-14 | 2017-06-22 | 北京阿迈特医疗器械有限公司 | 一种个性化聚合物支架及其制备方法和用途 |
CN108836584A (zh) * | 2018-05-28 | 2018-11-20 | 上海长海医院 | 一种分段式复合密网结构颈动脉支架 |
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EP2431380A2 (de) | 2006-09-11 | 2012-03-21 | Tranzyme Pharma, Inc. | Makrozyklischer Antagonist des Motilinrezeptors zur Behandlung von Magen-Darm-Motilitätsstörungen |
US9402754B2 (en) | 2010-05-18 | 2016-08-02 | Abbott Cardiovascular Systems, Inc. | Expandable endoprostheses, systems, and methods for treating a bifurcated lumen |
CN103198202A (zh) * | 2012-12-19 | 2013-07-10 | 首都医科大学 | 颅内动脉瘤介入治疗支架植入图像仿真方法 |
WO2017100977A1 (zh) * | 2015-12-14 | 2017-06-22 | 北京阿迈特医疗器械有限公司 | 一种个性化聚合物支架及其制备方法和用途 |
CN108025108A (zh) * | 2015-12-14 | 2018-05-11 | 北京阿迈特医疗器械有限公司 | 一种个性化聚合物支架及其制备方法和用途 |
CN108836584A (zh) * | 2018-05-28 | 2018-11-20 | 上海长海医院 | 一种分段式复合密网结构颈动脉支架 |
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WO2002013727A8 (en) | 2002-07-04 |
AU2001279207A1 (en) | 2002-02-25 |
DE10040630A1 (de) | 2002-03-07 |
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