WO2001087188A2 - Foldable iris fixated intraocular lenses - Google Patents
Foldable iris fixated intraocular lenses Download PDFInfo
- Publication number
- WO2001087188A2 WO2001087188A2 PCT/US2001/014195 US0114195W WO0187188A2 WO 2001087188 A2 WO2001087188 A2 WO 2001087188A2 US 0114195 W US0114195 W US 0114195W WO 0187188 A2 WO0187188 A2 WO 0187188A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- intraocular lens
- lens
- eye
- optic portion
- iol
- Prior art date
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
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2/1602—Corrective lenses for use in addition to the natural lenses of the eyes or for pseudo-phakic eyes
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
- A61F2/1616—Pseudo-accommodative, e.g. multifocal or enabling monovision
Definitions
- the present invention relates to intraocular lenses (lOLs) and a method for making and using the same. More particularly, the present invention relates to anterior chamber iris fixated lOLs designed primarily for refractive correction in phakic eyes where the eye's natural lens remains intact.
- Visual acuity deficiencies such as myopia (nearsightedness), hyperopia (farsightedness), presbyopia (age-related farsightedness), aphakia (absence of the crystalline lens of the eye) and astigmatism (irregular conformation of the cornea of the eye) are typically corrected through the use of refractive lenses such as spectacles or contact lenses.
- refractive lenses such as spectacles or contact lenses.
- IOL implants have been used for years in the anterior or posterior chamber of aphakic eyes as replacements for diseased natural crystalline lenses that have been surgically removed from the eyes.
- Many different IOL designs have been developed over past years and proven successful for use in aphakic eyes.
- the successful IOL designs to date primarily include an optic portion with supports therefor, called haptics, connected to and surrounding at least part of the optic portion.
- the haptic portions of an IOL are designed to support the optic portion of the IOL in the lens capsule, anterior chamber or posterior chamber of an eye once implanted.
- Such softer lOLs may be deformed prior to insertion thereof through an incision in the cornea of an eye. Following insertion of the IOL in an eye, the IOL returns to its original pre-deformed shape due to the memory characteristics of the soft material.
- Softer, more flexible lOLs as just described may be implanted into an eye through an incision that is much smaller, i.e., 2.8 to 3.2 mm, than that necessary for more rigid lOLs, i.e., 4.8 to 6.0 mm.
- a larger incision is necessary for more rigid lOLs because the lens must be inserted through an incision in the cornea slightly larger than that of the diameter of the inflexible IOL optic portion. Accordingly, more rigid lOLs have become less popular in the market since larger incisions have been found to be associated with an increased incidence of postoperative complications, such as induced astigmatism.
- both softer and more rigid lOLs positioned within the angle of the anterior chamber of the eye are subject to compressive forces exerted on the outer edges thereof, which typically occur when an individual squints or rubs the eye.
- Such compressive forces on angle positioned lOLs in either aphakic or phakic eyes may result in tissue damage, decentration of the IOL and/or distortion of the visual image.
- Compressive forces exerted on an angle positioned IOL may also tend to cause movement of the IOL haptics and axial displacement of the IOL along the optical axis of an eye.
- Haptic movement and broad haptic contact in the angle of the anterior chamber of an eye has the potential to cause damage to delicate structures within the eye such as the peripheral corneal endothelium, the trabecular meshwork and/or the iris. Movement of an IOL along the optical axis of an eye has the potential to cause the IOL to contact and damage the delicate corneal endothelial cell layer of the eye. Also, angle positioned lOLs of current designs, whether formed of either softer or more rigid materials, tend to deflect along the optical axis of an eye when the haptics are compressed. IOL manufacturers provide a wide range of IOL sizes to more precisely fit lOLs to each particular patient's eye size. Providing a wide range of IOL sizes is an attempt to minimize the potential for haptic compression and the associated axial displacement of the IOL optic along the optical axis of an eye.
- An anterior chamber iris fixated intraocular lens (IOL) made in accordance with the present invention has an optic portion with an outer peripheral edge and two or more but preferably two, three or four haptic elements for supporting the optic portion in a patient's aphakic or phakic eye. Two, three or four haptic elements are preferred in the present invention to provide a balance between IOL stability and minimized points of fixation on the iris.
- a lens having two haptic elements is balanced or stabilized by having one haptic element formed on one edge of the optic portion and the second haptic element formed on an opposite edge of the optic portion.
- a lens having three haptic elements is balanced or stabilized by having two spaced haptic elements formed on one edge of the optic portion and the third haptic element formed on an opposite edge of the optic portion or alternatively by having each of the three haptic elements equally spaced around the periphery of the optic portion.
- a lens having four haptic elements is balanced or stabilized by having two spaced haptic elements formed on one edge of the optic portion and two spaced haptic elements formed on an opposite edge of the optic portion or alternatively by having each of the four haptic elements equally spaced around the periphery of the optic portion.
- Each of the haptic elements is preferably of a relatively narrow arch-like form designed to allow the IOL to be easily folded for insertion thereof through a relatively small incision within the eye.
- Each haptic element is designed in the form of a relatively narrow arch with a fixation clamp preferably at the center or peak thereof for ease in fixating the same on the anterior surface of the iris of an eye.
- Each of the haptic elements also has an inner portion and an outer portion with the inner portion being connected to the outer peripheral edge of the optic portion.
- Each haptic element includes two interlocking smooth, serrated or toothed edges on the outer portion thereof to form a fixation clamp.
- the fixation clamps are designed to secure the IOL within the anterior chamber of an eye by engaging the relatively non-mobile outer peripheral edge of the iris of an eye.
- Another object of the present invention is to provide intraocular lenses for use in aphakic and phakic eyes, which eliminate anterior chamber angle contact.
- FIG. 1 illustrates a simplified diagram of an eye 10 showing landmark structures relevant to the implantation of an intraocular lens of the present invention.
- Eye 10 includes an optically clear cornea 12 and an iris 14 with a relatively non-mobile peripheral edge 40.
- a natural crystalline lens 16 and a retina 18 are located behind iris 14 of eye 10.
- Eye 10 also includes anterior chamber 6 with angle 7 located in front of iris 14 and a posterior chamber 8 located between iris 14 and natural lens 16.
- An IOL 26, such as that of the present invention, is preferably implanted in anterior chamber 6 to correct refractive errors while healthy natural lens 16 remains in place (phakic application). However, IOL 26 likewise may be implanted in anterior chamber 6 of aphakic eyes where the natural lens 16 has been removed.
- Eye 10 also includes an optical axis OA-OAthat is an imaginary line that passes through the optical center 20 of anterior surface 22 and posterior surface 24 of lens 16.
- Optical axis OA-OA in the human eye 10 is generally perpendicular to a portion of cornea 12, natural lens 16 and retina 18.
- the IOL of the present invention is designed for implantation in anterior chamber 6 of a patient's eye 10.
- IOL 26 has an optic portion 28 with an outer peripheral edge 30.
- Preferably integrally formed on peripheral edge 30 of optic portion 28 are two or more but preferably two, three or four separate looped or arch-like haptic elements 32.
- Each haptic element 32 is manufactured to have an inner portion 34 and an outer portion 36.
- Inner portions 34 of haptic elements 32 are preferably integrally formed with and permanently connected to outer peripheral edge 30 of optic portion 28. Alternatively however, inner portions 34 of haptic elements 32 may be attached to optic portion 28 by staking, chemical polymerization or other methods known to those skilled in the art.
- Each haptic element 32 also includes at outer portion 36, a fixation clamp 38 in the center or peak 46 thereof designed to engage relatively non-mobile outer peripheral edge 40 of iris 14 in anterior chamber 6.
- IOL 26 is held in proper position in anterior chamber 6 through constant compressive forces exerted by fixation clamps 38 on relatively non-mobile outer peripheral edge 40 of iris 14. Iris fixation of IOL 26 is desired to avoid haptic element 32 contact and damage to delicate tissues within angle 7 of eye 10.
- IOL 26 has relatively narrow arch-like haptic elements 32 formed with a central portion 44 adjacent to inner portion 34 permanently connected to outer peripheral edge 30 of optic portion 28.
- Central portion 44 has a dimension in plane 46-46, best illustrated in Figures 3, 6 and 9, generally parallel to optical axis OA-OA, approximately equal but preferably less than that of plane 48-48, best illustrated in Figures 2, 5 and 8, generally perpendicular to optical axis OA-OA.
- Each half of haptic element 32 is resistant to being deflected or flexed in a direction away from its other half due to each half being biased toward one another in an arch-like design.
- fixation clamps 38 may optionally be slightly bowed to form a slightly convex surface 72 on the posterior surface 74 and a slightly concave surface 76 on the anterior surface 78 of fixation clamps 38.
- Fixation clamps 38 are optionally slightly bowed for ease of fixation on relatively non-mobile peripheral edge 40 of iris 14.
- the subject IOL 26 is preferably produced having an optic portion 28 approximately 4.5 to 9.0 mm, but preferably approximately 5.0 to 6.0 mm and most preferably 5.5 mm in diameter and approximately 0.5 mm to 1.0 mm, but preferably approximately 0.6 to 0.8 mm and most preferably 0.7 mm in thickness at peripheral edge 30.
- Haptic elements 32 extend in a relatively narrow arch-like configuration for ease of implantation through a relatively small surgical incision and increase or decrease in length depending upon the diameter of optic portion 28. As the diameter of optic portion 28 increases, the length of haptic elements 32 decrease. Likewise, as the diameter of optic portion 28 decreases, the length of haptic elements 32 increase.
- haptic elements 32 are formed to be approximately 2.6 to 6.0 mm, but preferably approximately 3.4 to 5.0 mm and most preferably approximately 4.2 mm in length measuring the cord of the arc from the center of inner portion 34 to the center of its corresponding inner portion 34.
- the overall diameter of IOL 26 is approximately 6.0 to 10.0 mm, but preferably approximately 7.0 to 9.0 mm and most preferably approximately 8.0 mm.
- Haptic elements 32 on IOL 26 preferably have vaulted arch-like configurations as illustrated in Figures 3, 6 and 9 to allow appropriate fixation to relatively non-mobile peripheral edge 40 of iris 14 while avoiding contact between the posterior surface 70 of optic portion 28 and the mobile portions 9 of iris 14.
- a vault of approximately 0.5 to 1.0 mm is preferred for central placement of IOL 26 between iris 14 and corneal endothelium 4.
- Central portion 44 of haptic element 32 is approximately 0.5 to 2.5 mm, but preferably approximately 1.0 to 2.0 mm and most preferably 1.6 mm in length; approximately 0.2 to 0.8 mm, but preferably approximately 0.2 to 0.6 mm and most preferably approximately 0.3 mm in thickness in plane 46-46 and approximately 0.2 to1.0 mm, but preferably approximately 0.3 to 0.7 mm and most preferably approximately 0.46 mm in width in plane 48-48.
- Transition portion 50 is approximately 0.4 to 1.1 mm, but preferably approximately 0.5 to 1.0 mm and most preferably approximately 0.8 mm in length.
- Fixation clamps 38 are approximately 0.2 to .0 mm, but preferably approximately 0.4 to 0.6 mm and most preferably approximately 0.5 mm in length and approximately 0.03 to 0.3 mm, but preferably approximately 0.1 to 0.2 mm and most preferably approximately 0.15 mm in thickness in plane 46-46 and approximately 0.05 to 0.5 mm, but preferably approximately 0.1 to 0.4 mm and most preferably approximately 0.3 mm in width in plane 48-48.
- Fixation clamps 38 illustrated in Figures 11 and 12 are two relatively small interlocking smooth, serrated or toothed edges 80 designed for secure fixation of IOL 26 to relatively non-mobile peripheral edge 40 of iris 14.
- haptic elements 32 gradually change from being relatively thin in plane 46-46 at outer portion 36 to being relatively thick at inner portion 34 and optic portion 28, with central portion 44 exhibiting a dimension in plane 46-46 that is near equal but preferably less than that of the width in plane 48-48 to achieve a low profile.
- Fixation clamps 38 of haptic elements 32 are designed to maintain a constant compression force to reliably pinch and/or pierce relatively non-mobile peripheral edge 40 of iris 14 for proper fixation of IOL 26.
- Fixation clamps 38 may be fixated on relatively non-mobile peripheral edge 40 with the use of common surgical forceps 90 or retractor 94.
- IOL 26 is manufactured with a planar or more preferably a bowed fixation clamp 38 as described above, two spaced free tips 92 of common surgical forceps 90 as illustrated in Figure 13 are placed in the two spaced indentations 84 on fixation clamp 38. Handles 100 of surgical forceps 90 are then compressed in an attempt to bring free tips 92 into closer proximity to one another. The compressive forces from free tips 92 on indentations 84 serve to open the two interlocking smooth, serrated or toothed edges 80 of fixation clamp 38.
- spaced indentations 84 may be eliminated by placing two spaced free tips 92 of surgical forceps 90 on exterior edges 37 of outer portion 36 and compressing the same in an attempt to bring free tips 92 into closer proximity to one another.
- the compressive forces from free tips 92 on exterior edges 37 serve to open the two interlocking smooth, serrated or toothed edges 80 of fixation clamps 38.
- the open smooth, serrated or toothed edges 80 are then placed on relatively non-mobile peripheral edge 40 of iris 14. Once positioned on iris 14 as described, compressive forces are released from spaced free tips 92 of surgical forceps 90.
- IOL 26 may be positioned on iris 14 by placing two free tips 96 of retractor 94 as illustrated in Figure 14 in the two spaced indentations 84 on fixation clamp 38.
- the handles 98 of retractor 94 are compressed in an attempt to spread apart free tips 96.
- the outwardly applied forces from free tips 96 on indentations 84 serve to open the two interlocking smooth, serrated or toothed edges 80 of fixation clamp 38.
- the need to incorporate or to use spaced indentations 84 may be eliminated by placing free tips 96 of surgical retractor 94 within interior edges 39 of outer portion 36 and compressing handles 98 to spread apart free tips 96.
- the forces from free tips 96 on interior edges 37 serve to open the two interlocking smooth, serrated or toothed edges 80 of fixation clamps 38.
- the open smooth, serrated or toothed edges 80 are then placed on relatively non-mobile peripheral edge 40 of iris 14. Once positioned on iris 14 as described, outwardly applied forces are released from free tips 96 of retractor 94.
- the smooth, serrated or toothed edges 80 of fixation clamp 38 thereby close pinching and/or piercing relatively non-mobile peripheral edge 40 of iris 14.
- Suitable materials for the production of the subject IOL 26 include but are not limited to foldable or compressible materials, such as silicone polymers, hydrocarbon and fluorocarbon polymers, hydrogels, soft acrylic polymers, polyesters, polyamides, polyurethane, silicone polymers with hydrophilic monomer units, fluorine-containing polysiloxane elastomers and combinations thereof.
- foldable or compressible materials such as silicone polymers, hydrocarbon and fluorocarbon polymers, hydrogels, soft acrylic polymers, polyesters, polyamides, polyurethane, silicone polymers with hydrophilic monomer units, fluorine-containing polysiloxane elastomers and combinations thereof.
- Optic portion 28 of IOL 26 can be a positive powered lens from 0 to approximately +40 diopters or a negative powered lens from 0 to approximately -30 diopters.
- Optic portion 28 may be biconvex, planoconvex, plano-concave, biconcave or concave-convex (meniscus), depending upon the power required to achieve the appropriate central and peripheral thickness for efficient handling.
- Optic portion 28 of the subject IOL 26 may optionally be formed with a glare reduction zone 56 of approximately 0.25 to 0.75 mm but more preferably approximately 0.3 to 0.6 mm and most preferably 0.5 mm in width adjacent outer peripheral edge 30 for reducing glare when outer peripheral edge 30 of IOL 26 is struck by light entering eye10 during high light or at other times when pupil 58 is dilated.
- Glare reduction zone 56 is typically fabricated of the same material as optic portion 28, but may be opaque, roughened, textured, colored or patterned in a conventional manner to block or diffuse light in plane with optical axis OA-OA.
- IOL 26 of the present invention provides for a refractive lens suitable for use in anterior chamber 6 of eye 10.
- IOL 26 has haptic elements 32 with functional characteristics that minimize or eliminate axial displacement along optical axis OA-OA of eye 10 and lens contact in the angle 7 of anterior chamber 6 thereby preventing damage to delicate eye tissues such as the trabecular meshwork 17 and the corneal endothelium 4.
- IOL 26, having the specific functional characteristics described herein is also advantageous because one or a few lens sizes suitably fit eyes 10 of most sizes since position of attachment to iris 14 may be varied slightly. By providing a "universal" lens such as that of the present invention, clinical risks to patients due to improperly sized lenses for angle 7 are minimized.
Abstract
Description
Claims
Priority Applications (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP01932899A EP1289452B1 (en) | 2000-05-15 | 2001-05-03 | Foldable iris fixated intraocular lenses |
CA002407432A CA2407432C (en) | 2000-05-15 | 2001-05-03 | Foldable iris fixated intraocular lenses |
BR0111161-2A BR0111161A (en) | 2000-05-15 | 2001-05-03 | Iris-attached foldable intraocular lens |
DE60121582T DE60121582T2 (en) | 2000-05-15 | 2001-05-03 | FOLDABLE INTRAOCULAR LENS ATTACHED TO IRIS |
AU2001259384A AU2001259384A1 (en) | 2000-05-15 | 2001-05-03 | Foldable iris fixated intraocular lenses |
MXPA02011286A MXPA02011286A (en) | 2000-05-15 | 2001-05-03 | Foldable iris fixated intraocular lenses. |
JP2001583659A JP2003533274A (en) | 2000-05-15 | 2001-05-03 | Fixed iris foldable intraocular lens |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/570,721 US6554860B2 (en) | 2000-05-15 | 2000-05-15 | Foldable iris fixated intraocular lenses |
US09/570,721 | 2000-05-15 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2001087188A2 true WO2001087188A2 (en) | 2001-11-22 |
WO2001087188A3 WO2001087188A3 (en) | 2002-07-11 |
Family
ID=24280778
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2001/014195 WO2001087188A2 (en) | 2000-05-15 | 2001-05-03 | Foldable iris fixated intraocular lenses |
Country Status (12)
Country | Link |
---|---|
US (1) | US6554860B2 (en) |
EP (1) | EP1289452B1 (en) |
JP (1) | JP2003533274A (en) |
CN (1) | CN1214768C (en) |
AR (1) | AR032882A1 (en) |
AU (1) | AU2001259384A1 (en) |
BR (1) | BR0111161A (en) |
CA (1) | CA2407432C (en) |
DE (1) | DE60121582T2 (en) |
ES (1) | ES2267768T3 (en) |
MX (1) | MXPA02011286A (en) |
WO (1) | WO2001087188A2 (en) |
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US6395028B1 (en) | 2001-07-18 | 2002-05-28 | Alcon Universal Ltd. | Anterior chamber phakic lens |
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- 2001-05-03 EP EP01932899A patent/EP1289452B1/en not_active Expired - Lifetime
- 2001-05-03 AU AU2001259384A patent/AU2001259384A1/en not_active Abandoned
- 2001-05-03 DE DE60121582T patent/DE60121582T2/en not_active Expired - Fee Related
- 2001-05-03 JP JP2001583659A patent/JP2003533274A/en not_active Withdrawn
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Cited By (11)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2002047584A1 (en) * | 2000-12-11 | 2002-06-20 | Bausch & Lomb Incorporated | Iris fixated intraocular lenses |
US8486140B2 (en) | 2001-01-30 | 2013-07-16 | Timothy R. Willis | Refractive intraocular implant lens and method |
US8551164B2 (en) | 2001-01-30 | 2013-10-08 | Timothy R. Willis | Refractive intraocular implant lens and method |
US6395028B1 (en) | 2001-07-18 | 2002-05-28 | Alcon Universal Ltd. | Anterior chamber phakic lens |
US6562070B2 (en) | 2001-07-18 | 2003-05-13 | Alcon, Inc. | Anterior chamber phakic lens |
US7179292B2 (en) | 2002-03-15 | 2007-02-20 | Ophtec B.V. | Intraocular lens for implantation in an eye and instrument and methods for insertion of such a lens |
US8317860B2 (en) | 2002-04-17 | 2012-11-27 | Novartis Ag | Stable anterior chamber phakic lenses |
EP1402851A1 (en) * | 2002-09-24 | 2004-03-31 | Cesar C. Dr. Carriazo | Implant for altering the iris color |
US7037337B2 (en) | 2002-09-24 | 2006-05-02 | Carriazo Cesar C | Implant for altering the iris color and method of locating and fixing an implant for altering the iris color |
WO2011139394A3 (en) * | 2010-04-26 | 2011-12-22 | Ayhan Basoglu | Ocular implant iris diaphragm |
US10695166B2 (en) | 2015-08-14 | 2020-06-30 | Timothy R. Willis | Intraocular lenses (IOLs) and related assemblies and intraocular attachment methods |
Also Published As
Publication number | Publication date |
---|---|
US6554860B2 (en) | 2003-04-29 |
ES2267768T3 (en) | 2007-03-16 |
DE60121582T2 (en) | 2007-07-05 |
AU2001259384A1 (en) | 2001-11-26 |
DE60121582D1 (en) | 2006-08-31 |
EP1289452A2 (en) | 2003-03-12 |
BR0111161A (en) | 2003-04-08 |
CN1430494A (en) | 2003-07-16 |
CN1214768C (en) | 2005-08-17 |
CA2407432C (en) | 2007-01-09 |
AR032882A1 (en) | 2003-12-03 |
MXPA02011286A (en) | 2003-04-25 |
JP2003533274A (en) | 2003-11-11 |
WO2001087188A3 (en) | 2002-07-11 |
CA2407432A1 (en) | 2001-11-22 |
EP1289452B1 (en) | 2006-07-19 |
US20020193877A1 (en) | 2002-12-19 |
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