Source: http://www.google.com/patents/US6669950?dq=6859936
Timestamp: 2016-09-27 19:36:17
Document Index: 650886480

Matched Legal Cases: ['Application No. 60', 'art 18', 'art 18', 'art 18', 'art 18', 'art 18', 'art 15', 'art 15', 'art 18', 'art 15', 'art 15', 'art 15', 'art 15', 'art 15', 'art 18', 'art 17', 'art 18', 'art 15']

Patent US6669950 - Ophthalmic drug delivery device - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsThe present invention is directed to a drug delivery device for a human eye. The human eye has a sclera, an inferior oblique muscle, and a macula. The device of the present invention includes a pharmaceutically active agent, and a geometry that facilitates the implantation of the device on an outer surface...http://www.google.com/patents/US6669950?utm_source=gb-gplus-sharePatent US6669950 - Ophthalmic drug delivery deviceAdvanced Patent SearchTry the new Google Patents, with machine-classified Google Scholar results, and Japanese and South Korean patents.Publication numberUS6669950 B2Publication typeGrantApplication numberUS 10/187,006Publication dateDec 30, 2003Filing dateJul 1, 2002Priority dateOct 21, 1999Fee statusPaidAlso published asCA2384255A1, CA2384255C, CN1376042A, CN100341470C, DE60018298D1, DE60018298T2, EP1221919A1, EP1221919B1, US6416777, US20030003129, US20040131654, US20040131655, WO2001028474A1Publication number10187006, 187006, US 6669950 B2, US 6669950B2, US-B2-6669950, US6669950 B2, US6669950B2InventorsYoseph YaacobiOriginal AssigneeAlcon, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (60), Non-Patent Citations (6), Referenced by (69), Classifications (13), Legal Events (5) External Links: USPTO, USPTO Assignment, EspacenetOphthalmic drug delivery device
US 6669950 B2Abstract
What is claimed is: 1. A drug delivery device for a human eye, said eye having a sclera, a plurality of extraocular muscles including an inferior oblique muscle, and a macula, said device comprising:
a pharmaceutically active agent; and a body having a geometry that facilitates an implantation of said device on an outer surface of said sclera, beneath said inferior oblique muscle, with said pharmaceutically active agent disposed above said macula, and without disinsertion or cutting of any of said plurality of extraocular muscles. 2. The drug delivery device of claim 1 wherein:
said body comprises a scleral surface and an orbital surface; and said geometry is a generally F-shaped geometry when viewed from said scleral surface or said orbital surface. 3. The drug delivery device of claim 1 wherein:
said body comprises a scleral surface and an orbital surface; and said geometry is a generally C-shaped geometry when viewed from said scleral surface or said orbital surface. 4. The drug delivery device of claim 1 wherein:
said body comprises a scleral surface and an orbital surface; and said geometry is a generally L-shaped geometry when viewed from said scleral surface or said orbital surface. 5. The drug delivery device of claim 1 wherein said human eye comprises a Tenon's capsule, and said body comprises an orbital surface having a radius of curvature that facilitates said implantation of said device below said Tenon's capsule.
6. The drug delivery device of claim 5 wherein said orbital surface comprises a notch for facilitating an accommodation of said inferior oblique muscle during said implantation of said device.
7. The drug delivery device of claim 6 wherein said notch comprises a ramp.
8. The drug delivery device of claim 1 wherein said body has a scleral surface having a radius of curvature substantially equal to the radius of curvature of said human eye.
9. A method of delivering a pharmaceutically active agent to a human eye, said human eye having a sclera, a plurality of extraocular muscles including an inferior oblique muscle, and a macula, comprising the steps of:
providing a drug delivery device comprising: a pharmaceutically active agent; and a body having a geometry that facilitates an implantation of said device on an outer surface of said sclera, beneath said inferior oblique muscle, with said pharmaceutically active agent disposed above said macula, and without disinsertion or cutting of any of said plurality of extraocular muscles; and disposing said device on said outer surface of said sclera, beneath said inferior oblique muscle, and with said pharmaceutically active agent disposed above said macula. 10. The method of claim 9 wherein:
said body comprises a scleral surface and an orbital surface; and said geometry is a generally F-shaped geometry when viewed from said scleral surface or said orbital surface. 11. The method of claim 9 wherein:
said body comprises a scleral surface and an orbital surface; and said geometry is a generally C-shaped geometry when viewed from said scleral surface or said orbital surface. 12. The method of claim 9 wherein:
said body comprises a scleral surface and an orbital surface; and said geometry is a generally L-shaped geometry when viewed from said scleral surface or said orbital surface. Description
This application is a continuation of U.S. application Ser. No. 09/664,790, filed Sep. 19, 2000, now U.S. Pat. No. 6,416,777, which claims priority from U.S. Provisional Application No. 60/160,673, filed Oct. 21, 1999.
FIG. 1 is a side sectional view schematically illustrating the human eye and an ophthalmic drug delivery device implanted in the posterior segment of the eye according to the present invention;
FIG. 2 is detailed cross-sectional view of the eye of FIG. 1 along line 2—2;
FIG. 3 is a three dimensional schematic representation of the human eye in situ;
FIG. 4 shows the eye of FIG. 3 after partial removal of the lateral rectus muscle;
FIG. 5 is a schematic representation of the anterior view of a human eye;
FIG. 6 is a schematic representation of the posterior view of a human eye;
FIG. 7 is a perspective, orbital view of an ophthalmic drug delivery device for the right human eye according to a first preferred embodiment of the present invention;
FIG. 8 is a perspective, orbital view of the ophthalmic drug delivery device of FIGS. 7 and 9 including a ramp for mating with the inferior oblique muscle;
FIG. 9 is a perspective, scleral view of the ophthalmic drug delivery device of FIG. 7;
FIG. 10 is a perspective view of an oval shaped drug core or tablet for use with the ophthalmic drug delivery devices of the present invention;
FIG. 11 is a perspective view of two, mating half-oval shaped drug cores or tablets for use with the ophthalmic drug delivery devices of the present invention;
FIG. 12 is a perspective, orbital view of the ophthalmic drug delivery device of FIGS. 7 and 9 for the left human eye;
FIG. 13 is a perspective, orbital view of the ophthalmic drug delivery device of FIGS. 12 and 14 including a ramp for mating with the inferior oblique muscle;
FIG. 14 is a perspective, scleral view of the ophthalmic drug delivery device of FIGS. 7 and 9 for the left human eye;
FIG. 15 is a perspective, orbital view of the ophthalmic drug delivery of FIGS. 7 and 9 including a tapered longitudinal part of the device;
FIG. 16 is a perspective, orbital view of a shortened version of the ophthalmic drug delivery device of FIGS. 7 and 9;
FIG. 17 is a perspective, orbital view of the ophthalmic drug delivery device of FIG. 16 including a ramp for mating with the inferior oblique muscle;
FIG. 18 is a perspective, orbital view of an ophthalmic drug delivery device for the right human eye according to a second preferred embodiment of the present invention;
FIG. 19 is a perspective, orbital view of the ophthalmic drug delivery device of FIG. 18 including a ramp for mating with the inferior oblique muscle;
FIG. 20 is a perspective, orbital view of an ophthalmic drug delivery device for the right human eye according to a third preferred embodiment of the present invention; and
FIG. 21 is a perspective, orbital view of the ophthalmic drug delivery device of FIG. 20 including a ramp for mating with the inferior oblique muscle.
FIGS. 1 through 6 illustrate various portions of the human eye important to a complete understanding of the present invention. Referring first to FIG. 1, a human eye 90 is schematically illustrated. Eye 90 has a cornea 92, a lens 93, vitreous 95, a sclera 100, a choroid 99, a retina 97, and an optic nerve 96. Eye 90 is generally divided into an anterior segment 89 and a posterior segment 88. Anterior segment 89 of eye 90 generally includes the portions of eye 90 anterior of ora serata 11. Posterior segment 88 of eye 90 generally includes the portions of eye 90 posterior of ora serata 11. Retina 97 is physically attached to choroid 99 in a circumferential manner proximate pars plana 13, posteriorly to optic disk 19. Retina 97 has a macula 98 located slightly lateral to optic disk 19. As is well known in the ophthalmic art, macula 98 is comprised primarily of retinal cones and is the region of maximum visual acuity in retina 97. A Tenon's capsule or Tenon's membrane 101 is disposed on sclera 100. A conjunctiva 94 covers a short area of the globe of eye 90 posterior to limbus 115 (the bulbar conjunctiva) and folds up (the upper cul-de-sac) or down (the lower cul-de-sac) to cover the inner areas of upper eyelid 78 and lower eyelid 79, respectively. Conjunctiva 94 is disposed on top of Tenon's capsule 101.
FIG. 3 illustrates a left human eye 90 within its orbit 112. As can be seen from FIG. 3, inferior oblique muscle 107 runs under lateral rectus muscle 105. The insertion line 107 a of inferior oblique muscle 107 into sclera 100 is located just above the superior border of lateral rectus muscle 105. Of course, the position of the inferior oblique muscle in a right human eye 90 is a mirror image to its position on left human eye 90 of FIG. 3. Cornea 92, conjunctiva 94, superior rectus muscle 103, inferior rectus muscle 104, superior oblique muscle 106, and limbus 115 are also shown in FIG. 3.
FIG. 4 similarly shows a left human eye 90 within its orbit 112. However, a portion of lateral rectus muscle 105 is not shown in FIG. 4 to allow visibility of the portion of sclera 100 and optic nerve 96 usually hidden by the muscle. In FIG. 4, an insertion line 107 b of inferior oblique muscle 107 into sclera 100 is lower than insertion line 107 a of FIG. 3, indicating the representative physiological variability of the insertion line of the inferior oblique muscle in the human eye.
FIG. 5 schematically illustrates an anterior view of human eye 90 with its four recti muscles, the superior rectus muscle 103, the medial rectus muscle 108, the inferior rectus muscle 104, and the lateral rectus muscle 105. FIG. 5 also shows the relationship between the limbus, represented in FIG. 5 by circumferential line 115, and the insertion lines of the recti muscles, represented in FIG. 5 by circumferential lines 113.
FIGS. 7 and 9 schematically illustrate an ophthalmic drug delivery device 50 for the right human eye according to a first preferred embodiment of the present invention. Device 50 may be used in any case where localized delivery of a pharmaceutically active agent to the eye is required. Device 50 is particularly useful for localized delivery of pharmaceutically active agents to the posterior segment of the eye. A preferred use for device 50 is the delivery of pharmaceutically active agents to the retina proximate the macula for treating ARMD, choroidial neovascularization (CNV), retinopathies, retinitis, uveitis, macular edema, glaucoma, and neuropathies.
Inner core 81 may comprise any ophthalmically acceptable pharmaceutically active agents suitable for localized delivery. Examples of pharmaceutically active agents suitable for inner core 81 are anti-infectives, including, without limitation, antibiotics, antivirals, and antifungals; antiallergenics and mast cell stabilizers; steroidal and non-steroidal anti-inflammatory agents; cyclooxygenase inhibitors, including, without limitation, Cox I and Cox II inhibitors; combinations of anti-infective and anti-inflammatory agents; anti-glaucoma agents, including, without limitation, adrenergics, β-adrenergic blocking agents, α-adrenergic agonists, parasypathomimetic agents, cholinesterase inhibitors, carbonic anhydrase inhibitors, and prostaglandins; combinations of anti-glaucoma agents; antioxidants; nutritional supplements; drugs for the treatment of cystoid macular edema including, without limitation, non-steroidal anti-inflammatory agents; drugs for the treatment of ARMD, including, without limitation, angiogenesis inhibitors and nutritional supplements; drugs for the treatment of herpetic infections and CMV ocular infections; drugs for the treatment of proliferative vitreoretinopathy including, without limitation, antimetabolites and fibrinolytics; wound modulating agents, including, without limitation, growth factors; antimetabolites; neuroprotective drugs, including, without limitation, eliprodil; and angiostatic steroids for the treatment of diseases or conditions of the posterior segment of the eye, including, without limitation, ARMD, CNV, retinopathies, retinitis, uveitis, macular edema, and glaucoma. Such angiostatic steroids are more fully disclosed in U.S. Pat. Nos. 5,679,666 and 5,770,592, which are incorporated herein in their entirety by reference. Preferred ones of such angiostatic steroids include 4,9(11)-Pregnadien-17α,21-diol-3,20-dione and 4,9(11)-Pregnadien-17α,21-diol-3,20-dione-21-acetate. A preferred non-steroidal anti-inflammatory for the treatment of cystoid macular edema is nepafenac. Inner core 81 may also comprise conventional non-active excipients to enhance the stability, solubility, penetrability, or other properties of the active agent or the drug core.
Device 50 is preferably surgically placed directly on the outer surface of sclera 100 below Tenon's capsule 101 with well 20 and inner core 81 directly over the area of sclera 100 above macula 98 using the following preferred technique that is capable of being performed in an outpatient setting. The surgeon first performs an 8 mm peritomy in one of the quadrants of eye 90. Preferably, the surgeon performs the peritomy in the infra-temporal quadrant, about 3 mm posterior to limbus 115 of eye 90. Once this incision is made, the surgeon performs a blunt dissection to separate Tenon's capsule 101 from sclera 100. Using scissors and blunt dissection, an antero-posterior tunnel is formed along the outer surface of sclera 100 and below inferior oblique muscle 107, preferably following the inferior border of lateral rectus muscle 105. The inferior oblique muscle 107 is then engaged with a Jamison muscle hook. The tip of the hook is then advanced just posterior to the inferior oblique muscle to form a portion of the tunnel that will accommodate transversal part 18 of device 50. Once the tunnel is formed, the surgeon uses Nuggett forceps to hold transversal part 18 of device 50 with scleral surface 14 facing sclera 100 and distal end 58 of transversal part 18 away from the surgeon. The surgeon then introduces device 50, distal end 58 first, into the tunnel at the level of the peritomy. Once in the tunnel, the surgeon advances device 50 along the tunnel toward inferior oblique muscle 107 until stopper 36 contacts the anterior border of muscle 107. At the level of the visualized inferior oblique muscle 107, the surgeon rotates device 50 underneath muscle 107 so that transversal portion 18 of device 50 enters the portion of the tunnel just posterior to inferior oblique muscle 107. When the surgeon feels that knee 32 cannot advance any further, the surgeon slightly moves device 50 in an antero-posterior direction to allow for the accommodation of inferior oblique muscle 107 within notch 42 between transversal part 18 and stopper 36. Due to the notch 42 and the location of well 20 near distal end 58 of transversal part 18, inner core 81 is positioned directly over the portion of sclera 100 above macula 98. Proximal end 25 of longitudinal part 15 may then be sutured to sclera 100. The surgeon then closes the peritomy by suturing Tenon's capsule 101 and conjunctiva 94 to sclera 100. After closing, the surgeon places a strip of antibiotic ointment on the surgical wound. All sutures are preferably 7-0 Vicryl sutures. For the treatment of ARMD and CNV, the pharmaceutically active agent of inner core 81 is preferably one of the angiostatic steroids disclosed in U.S. Pat. Nos. 5,679,666 and 5,770,592.
FIG. 8 illustrates an ophthalmic drug delivery device 60, a slight modification of ophthalmic drug delivery device 50 that is useful for certain implantations of the present invention. As shown in FIG. 8, device 60 has a geometry substantially similar to device 50 of FIGS. 7 and 9, with the exception that a ramp 45 has been added to orbital surface 12 of body 21 proximate notch 42. Ramp 45 is a slanted surface that preferably travels from scleral surface 14, on a first end, to orbital surface 12 on a second end. Alternatively, ramp 45 may travel from a location within edge 24 of longitudinal part 15, on a first end, to orbital surface 12 on a second end. Ramp 45 facilitates the accommodation of inferior oblique muscle 107 within notch 42 between transversal part 18 and stopper 36 when device 60 is implanted within eye 90, as described hereinabove in connection with device 50. Device 60 may be made using techniques substantially similar to device 50.
FIGS. 12 and 14 schematically illustrates an ophthalmic drug delivery device 70 for the left human eye. The geometry of device 70 is a mirror image of the geometry of device 50 for the right human eye as described hereinabove in connection with FIGS. 7 and 9. The use of device 70 is substantially identical to the use of device 50, and device 70 may be made using techniques substantially similar to device 50.
FIG. 13 illustrates an ophthalmic drug delivery device 75 for the left human eye, a slight modification of ophthalmic drug delivery device 70 that is useful for certain implantations of the present invention. The geometry and use of device 75 of FIG. 13 is substantially similar to the geometry and use of device 60 of FIG. 8, except that device 75 is a mirror image of device 60.
FIG. 15 schematically illustrates an ophthalmic drug delivery device 30, a slight modification of ophthalmic drug delivery device 50 that is useful for certain implantations of the present invention. As shown in FIG. 15, device 30 has a geometry substantially similar to device 50 of FIGS. 7 and 9, with the exception that longitudinal part 15 has a tapered thickness, when viewed from edge 24, preferably beginning at a location 33 and continuing to proximal end 25. This portion of longitudinal part 15 is disposed anteriorly within eye 90 and may be visible to others. Therefore, due to this tapered thickness, device 30 may be more comfortable or cosmetically acceptable to the patient. The use of device 30 of FIG. 15 is substantially similar to the use of device 50, and device 30 may be made using techniques substantially similar to device 50.
FIG. 16 schematically illustrates an ophthalmic drug delivery device 40, a slight modification of ophthalmic drug delivery device 50 that is useful for certain implantations of the present invention. As shown in FIG. 16, device 40 has a geometry substantially similar to device 50 of FIGS. 7 and 9, with the exception that a length of longitudinal part 15 in device 40 has been shortened relative to device 50. Similar to device 30, this shortening of longitudinal part 15 may result in device 40 being more comfortable or cosmetically acceptable to the patient. The use of device 40 of FIG. 16 is substantially similar to the use of device 50, and device 40 may be made using techniques substantially similar to device 50.
FIG. 17 illustrates an ophthalmic drug delivery device 80, a slight modification of ophthalmic drug delivery device 40 that is useful for certain implantations of the present invention. As shown in FIG. 17, device 80 has a geometry substantially similar to device 40 of FIG. 16, with the exception that a ramp 45 has been added to orbital surface 12 of body 21 proximate notch 42. Ramp 45 is a slanted surface that preferably travels from scleral surface 14, on a first end, to orbital surface 12 on a second end. Alternatively, ramp 45 may travel from a point within edge 24 of longitudinal part 15, on a first end, to orbital surface 12 on a second end. Ramp 45 facilitates the accommodation of inferior oblique muscle 107 within notch 42 between transversal part 18 and stopper 36 when device 80 is implanted within eye 90, as described hereinabove in connection with device 50. Device 80 may be made using techniques substantially similar to device 50.
FIG. 18 schematically illustrates an ophthalmic drug delivery device 65 for the right human eye according a second preferred embodiment of the present invention. Device 65 may be used in any case where localized delivery of a pharmaceutically active agent to the eye is required. Device 65 is particularly useful for localized delivery of active agents to the posterior segment of the eye. A preferred use for device 65 is the delivery of pharmaceutically active agents to the retina proximate the macula for treating ARMD, choroidial neovascularization (CNV), retinopathies, retinitis, uveitis, macular edema, glaucoma, and neuropathies.
FIG. 19 illustrates an ophthalmic drug delivery device 67, a slight modification of ophthalmic drug delivery device 65 that is useful for certain implantations of the present invention. As shown in FIG. 19, device 67 has a geometry substantially similar to device 65 of FIG. 19, with the exception that a ramp 45 has been added to orbital surface 12 of body 29 proximate notch 42. Ramp 45 is a slanted surface that preferably travels from scleral surface 14, on a first end, to orbital surface 12 on a second end. Alternatively, ramp 45 may travel from a point within edge 24 of longitudinal part 17, on a first end, to orbital surface 12 on a second end. Ramp 45 facilitates the accommodation of inferior oblique muscle 107 within notch 42 between transversal part 18 and stopper 37 when device 67 is implanted within eye 90, as described hereinabove in connection with device 50. Device 67 may be made using techniques substantially similar to device 50.
FIG. 20 schematically illustrates an ophthalmic drug delivery device 52 for the right human eye according a third preferred embodiment of the present invention. Device 52 may be used in any case where localized delivery of a pharmaceutically active agent to the eye is required. Device 52 is particularly useful for localized delivery of active agents to the posterior segment of the eye. A preferred use for device 52 is the delivery of pharmaceutically active agents to the retina proximate the macula for treating ARMD, choroidial neovascularization (CNV), retinopathies, retinitis, uveitis, macular edema, glaucoma, and neuropathies.
FIG. 21 illustrates an ophthalmic drug delivery device 54, a slight modification of ophthalmic drug delivery device 52 that is useful for certain implantations of the present invention. As shown in FIG. 21, device 54 has a geometry substantially similar to device 52 of FIG. 20, with the exception that a ramp 45 has been added to orbital surface 12 of body 29 proximate region 43. Ramp 45 is a slanted surface that preferably travels from scleral surface 14, on a first end, to orbital surface 12 on a second end. Alternatively, ramp 45 may travel from a point within edge 24 of longitudinal part 15, on a first end, to orbital surface 12 on a second end. Ramp 45 facilitates the accommodation of inferior oblique muscle 107 within region 43 when device 54 is implanted within eye 90, as described hereinabove in connection with device 50. Device 54 may be made using techniques substantially similar to device 50.
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Classification424/428, 424/423, 424/427, 424/422International ClassificationA61K9/00, A61F9/00, A61M37/00, A61F9/007Cooperative ClassificationA61F9/00781, A61F9/0017, A61K9/0051European ClassificationA61K9/00M16B, A61F9/00B2Legal EventsDateCodeEventDescriptionJun 24, 2003ASAssignmentOwner name: ALCON, INC., SWITZERLANDFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ALCON UNIVERSAL LTD.;REEL/FRAME:014201/0289Effective date: 20020211Owner name: ALCON, INC., SWITZERLANDFree format text: CHANGE OF NAME;ASSIGNOR:ALCON UNIVERSAL LTD.;REEL/FRAME:014227/0335Effective date: 20020211Jul 2, 2007FPAYFee paymentYear of fee payment: 4May 31, 2011ASAssignmentOwner name: NOVARTIS AG, SWITZERLANDFree format text: MERGER;ASSIGNOR:ALCON, INC.;REEL/FRAME:026376/0076Effective date: 20110408Jun 30, 2011FPAYFee paymentYear of fee payment: 8Jun 17, 2015FPAYFee paymentYear of fee payment: 12RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About 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