WO2003039345B1 - Stent delivery device with embolic protection - Google Patents

Stent delivery device with embolic protection

Info

Publication number
WO2003039345B1
WO2003039345B1 PCT/US2002/036085 US0236085W WO03039345B1 WO 2003039345 B1 WO2003039345 B1 WO 2003039345B1 US 0236085 W US0236085 W US 0236085W WO 03039345 B1 WO03039345 B1 WO 03039345B1
Authority
WO
WIPO (PCT)
Prior art keywords
recited
stent
dilation
struts
assembly
Prior art date
Application number
PCT/US2002/036085
Other languages
French (fr)
Other versions
WO2003039345A3 (en
WO2003039345A2 (en
Inventor
Richard J Linder
Daryl R Edmiston
Steven W Johnson
Karri L Schlegel
Original Assignee
Rubicon Medical Inc
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 Rubicon Medical Inc filed Critical Rubicon Medical Inc
Priority to DE60226162T priority Critical patent/DE60226162T2/en
Priority to CA002466051A priority patent/CA2466051C/en
Priority to EP02802891A priority patent/EP1441797B1/en
Priority to JP2003541443A priority patent/JP4350514B2/en
Priority to ES02802891T priority patent/ES2301711T3/en
Publication of WO2003039345A2 publication Critical patent/WO2003039345A2/en
Publication of WO2003039345A3 publication Critical patent/WO2003039345A3/en
Publication of WO2003039345B1 publication Critical patent/WO2003039345B1/en

Links

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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
    • 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
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/011—Instruments for their placement or removal
    • 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
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/013—Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • 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
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/018—Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
    • A61F2002/9511—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0073—Quadric-shaped
    • A61F2230/008—Quadric-shaped paraboloidal
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0071—Additional features; Implant or prostheses properties not otherwise provided for breakable or frangible

Abstract

A delivery device(10) adapted to insert and deploy a stent (42) within a body lumen. The delivery device (10) includes a guide member (12) adapted to retain a dilation assembly (40) and a stent (42) within a lumen thereof until the stent is to be deployed into the body lumen. The delivery device (10) is configured to enable simultaneous insertion of the guide member (12), dilation assembly(40) , stent (42), and optional guidewire within a body lumen. Following deploying the stent (42), the delivery device can be removed, while providing the capability of optionally maintaining the guide member(12) or the guidewire to function or act as an exchange wire for additional surgical devices.

Claims

50AMENDED CLAIMS[Received by the International Bureau on 21 July 2003 (21.07.03); original claims 1-38 replaced by amended claims 1-47 (6 pages)]
1. A device configured to deliver a stent within a body lumen, the delivery device comprising: a stent adapted to be placed within a body lumen; a dilation assembly configured to support said stent and assist with placing said stent; a guide member comprising a lumen adapted to receive said dilation assembly, said stent, and a guidewire, said guide member further comprising means for applying a restraining force to said dilation assembly and said stent to selectively restrain said dilation assembly and said stent within said lumen; and a filter assembly disposed distally of said dilation assembly upon said guidewire, wherein said filter assembly, said guide member, said dilation assembly, and said stent are simultaneously disposed within the body lumen to deliver said stent to the body lumen.
2. The device as recited in claim 1, wherein at least a portion of said guidewire is disposed within said lumen of said guide member.
3. The device as recited in claim 1, wherein said dilation assembly comprises: a dilation balloon having an interior portion; and a dilation tube in fluid communication with said interior portion of said dilation balloon.
4. The device as recited in claim 3, wherein said dilation assembly further comprises a tubular member, wherein said dilation balloon is disposed about said tubular member.
5. The device as recited in claim 1, wherein said filter assembly comprises: a filter basket; and a filter attached to said filter basket.
6. The device as recited in claim 5, wherein said filter basket comprises one or more struts, wherein at least one of said one or more struts is configured to bias outwardly. 51
7. The device as recited in claim 6, wherein said one or more struts each comprise a distal portion, an intermediate portion, and a proximal portion, wherein said intermediate portion is smaller in cross-section than at least one of said distal portion and said proximal portion.
8. The device as recited in claim 6, wherein said distal portion and said proximal portion having substantially the same cross-sectional area.
9. The device as recited in claim 5, further comprising a restraining member configured to selectively restrain said filter basket between a restrained position and a released position.
10. The device as recited in claim 1, wherein said filter assembly is integrally formed with said guidewire.
11. The device as recited in claim 1 , wherein said guide member comprises a distal end formed with a plurality of struts, said plurality of struts surrounding said dilation assembly and said stent.
12. The device as recited in claim 11, wherein said means for applying said restraining force comprises a restraining member applying said restraining force to said plurality of struts.
13. The device as recited in claim 12, wherein said restraining member is a sleeve with at least a portion of said restraining member acting as a stitching to selectively secure said sleeve around said plurality of struts.
14. The device as recited in claim 12, wherein said restraining member comprises a plurality of hinged portions, said plurality of hinged portions being selectively secured by at least a portion of at least one actuating member.
15. The device as recited in claim 12, wherein said restraining member comprises one or more separable portions coupled to one or more of said plurality of struts.
16. The device as recited in claim 15, wherein at least one actuating member cooperates with said restraining member, wherein said at least one actuating member is adapted to separate one or more of said one or more separable portions to selectively release said plurality of struts.
17. The device as recited in claim 12, wherein said restraining member comprises a cord selectively secured to one or more of said plurality of struts. 52
18. The device as recited in claim 17, wherein said cord is configured with a plurality of hoops, said plurality of hoops being selectively secured by at least a portion of at least one actuating member.
19. The device as recited in claim 12, wherein said restraining member is a cord selectively threaded through one or more of said plurality of struts.
20. The device as recited in claim 12, wherein said restraining member is one or more tubular members individually attached to one or more of said plurality of struts, said one or more tubular members being aligned to receive at least a portion of at least one actuating member.
21. The device as recited in claim 1, wherein said filter assembly comprises an atraumatic tip.
22. A device configured to deliver a stent within a body lumen, the delivery device comprising: a stent adapted to be placed within a body lumen; a dilation assembly configured to assist with placing said stent within the body lumen, said dilation assembly being adapted to cooperate with a guidewire; a guide member comprising a proximal end, a distal end, and a lumen extending at least from said distal end toward said proximal end, said lumen being adapted to receive said dilation assembly, said stent, and a guidewire and said distal end of said guide member being configured to selectively restrain said dilation assembly; and a filter assembly disposed distally of said dilation assembly upon said guidewire, wherein said filter assembly, said guide member, said dilation assembly, and said stent are substantially simultaneously disposed within the body lumen to deliver said stent to the body lumen.
23. The device as recited in claim 22, wherein said dilation assembly comprises: a dilation tube adapted to cooperate with said guidewire; 53
a dilation balloon mounted to said dilation tube, said dilation tube comprising an interior portion; and an inflation tube in fluid communication with said interior portion.
24. The device recited in claim 23, wherein said guidewire is at least partially disposed in said dilation tube.
25. The device as recited in claim 22, wherein said filter assembly comprises: a filter basket; and a filter attached to said filter basket.
26. The device as recited in claim 25, wherein said filter basket comprises one or more struts, wherein at least one of said one or more struts is biased to move outwardly.
27. The device as recited in claim 26, further comprising a restraining member configured to selectively restrain said filter basket between a restrained position and a released position.
28. The device as recited in claim 27, wherein said restraining member is a sleeve selectively secured around said one or more struts.
29. The device as recited in claim 28, wherein at least a portion of said restraining member acts as a stitching to selectively secure said sleeve around said one or more struts.
30. The device as recited in claim 27, wherein said restraining member comprises a plurality of hinged portions, said plurality of hinged portions being selectively secured by at least a portion of at least one actuating member.
31. The device as recited in claim 27, wherein at least a portion of said restraining member passes through a gap between at least two of said one or more struts, wherein said restraining member is selectively secured around said one or more struts.
32. The device as recited in claim 27, wherein said restraining member comprises one or more separable portions coupled to one or more of said one or more struts.
33. The device as recited in claim 32, wherein at least one actuating member cooperates with said restraining member, wherein said at least one actuating member is adapted to separate one or more of said one or more separable portions to selectively release the one or more struts.
34. The device as recited in claim 27, wherein said restraining member comprises a cord selectively secured to one or more of said one or more struts.
35. The device as recited in claim 34, wherein said cord is configured with a plurality of hoops, said plurality of hoops being selectively secured by at least a portion of at least one actuating member.
36. The device as recited in claim 27, wherein said restraining member is a cord selectively threaded through one or more of said one or more struts.
37. The device as recited in claim 27, wherein said restraining member is one or more tubular members individually attached to one or more of said one or more struts, said one or more tubular members being aligned to receive at least a portion of at least one actuating member.
38. A method for delivering a stent to a body lumen, the method comprising the acts of: inserting a delivery device into the body lumen, said delivery device comprising: a dilation assembly, a stent disposed on said dilation assembly, a guide member comprising a lumen adapted to receive said dilation assembly, said stent, and a guidewire, said guide member being configured to selectively restrain said dilation assembly and said stent; and a filter assembly adapted to capture embolic particles, said filtering assembly cooperating with said guide member and being disposed distal to said dilation assembly and said stent; upon deploying said filter assembly to capture embolic particles and releasing said dilation assembly and said stent, deploying said dilation assembly and said stent into the body lumen.
39. The method as recited in claim 38, wherein said dilation assembly comprises a dilation balloon comprising an interior portion and an inflation tube in fluid communication with said interior portion. 55
40. The method as recited in claim 38, further comprising releasing a restraining force applied to said dilation assembly and said stent to enable deploying of said dilation assembly and said stent.
41. The method as recited in claim 40, wherein releasing said restraining force comprises releasing a restraining member surrounding at least a portion of a distal end of said guide member formed with a plurality of struts to enable said plurality of struts to move outwardly.
42. The method as recited in claim 38, further comprising inflating said dilation balloon to expand said stent and implant said stent into a wall of the body lumen.
43. The method recited in claim 38, wherein deploying said dilation assembly comprises displacing said dilation assembly relative to said guide member.
44. The method as recited in claim 38, further comprising deflating said dilation balloon through at least one of an inflation tube and a dilation tube.
45. The method as recited in claim 42, further comprising capturing said filter assembly.
46. A method as recited in claim 42, further comprising removing said guide member, said dilation assembly, and said filter assembly substantially simultaneously from said body lumen.
47. A method as recited in claim 38, further comprising moving said guide member relative to said stent, where said relative movement of said guide member deploys said stent and at least a distal end of said dilation assembly.
PCT/US2002/036085 2001-11-09 2002-11-08 Stent delivery device with embolic protection WO2003039345A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
DE60226162T DE60226162T2 (en) 2001-11-09 2002-11-08 STENT FILLING DEVICE WITH EMBOLITY PROTECTION
CA002466051A CA2466051C (en) 2001-11-09 2002-11-08 Stent delivery device with embolic protection
EP02802891A EP1441797B1 (en) 2001-11-09 2002-11-08 Stent delivery device with embolic protection
JP2003541443A JP4350514B2 (en) 2001-11-09 2002-11-08 Stent delivery device
ES02802891T ES2301711T3 (en) 2001-11-09 2002-11-08 DEVICE FOR PLACEMENT OF A VASCULAR ENDOPROTESIS WITH EMBOLIC PROTECTION.

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
US34533301P 2001-11-09 2001-11-09
US34466101P 2001-11-09 2001-11-09
US60/344,661 2001-11-09
US60/345,333 2001-11-09
US34109201P 2001-12-12 2001-12-12
US60/341,092 2001-12-12
US34750002P 2002-01-11 2002-01-11
US60/347,500 2002-01-11
US10/290,099 2002-11-07
US10/290,099 US7594926B2 (en) 2001-11-09 2002-11-07 Methods, systems and devices for delivering stents

Publications (3)

Publication Number Publication Date
WO2003039345A2 WO2003039345A2 (en) 2003-05-15
WO2003039345A3 WO2003039345A3 (en) 2003-10-23
WO2003039345B1 true WO2003039345B1 (en) 2003-11-27

Family

ID=27540739

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/US2002/036085 WO2003039345A2 (en) 2001-11-09 2002-11-08 Stent delivery device with embolic protection
PCT/US2002/035942 WO2003041610A2 (en) 2001-11-09 2002-11-08 Stent delivery device

Family Applications After (1)

Application Number Title Priority Date Filing Date
PCT/US2002/035942 WO2003041610A2 (en) 2001-11-09 2002-11-08 Stent delivery device

Country Status (8)

Country Link
US (1) US7594926B2 (en)
EP (3) EP2039306B1 (en)
JP (2) JP4350514B2 (en)
AT (3) ATE392194T1 (en)
CA (2) CA2466051C (en)
DE (2) DE60230175D1 (en)
ES (2) ES2301711T3 (en)
WO (2) WO2003039345A2 (en)

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ATE392194T1 (en) 2008-05-15
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EP1441795A2 (en) 2004-08-04
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DE60226162T2 (en) 2009-04-30
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CA2466051A1 (en) 2003-05-15
US20030149467A1 (en) 2003-08-07
EP2039306A1 (en) 2009-03-25
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WO2003039345A2 (en) 2003-05-15
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