NZ621163B2 - Intraocular implant cell migration inhibition system - Google Patents
Intraocular implant cell migration inhibition system Download PDFInfo
- Publication number
- NZ621163B2 NZ621163B2 NZ621163A NZ62116312A NZ621163B2 NZ 621163 B2 NZ621163 B2 NZ 621163B2 NZ 621163 A NZ621163 A NZ 621163A NZ 62116312 A NZ62116312 A NZ 62116312A NZ 621163 B2 NZ621163 B2 NZ 621163B2
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- NZ
- New Zealand
- Prior art keywords
- micrometer
- nanometers
- intraocular implant
- elements
- flexible membrane
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- 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
- A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
-
- 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
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
- A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/16—Materials or treatment for tissue regeneration for reconstruction of eye parts, e.g. intraocular lens, cornea
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
- A61L27/3839—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells characterised by the site of application in the body
- A61L27/3869—Epithelial tissues other than skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/58—Materials at least partially resorbable by the body
Abstract
Disclosed is an intraocular implant. The implant includes a biocompatible flexible membrane having flat front and back surfaces disposed a uniform thickness apart and implanted between an intraocular lens and a surface of a posterior capsule of an eye. The biocompatible flexible membrane has an outer boundary which defines a circular area having a diameter of between about 9 millimeters and about 15 millimeters, the outer boundary configured to be located proximate an outer circumference of the posterior capsule. The implant has patterned surface elements coupled to at least one of the front surface and the back surface of the biocompatible flexible membrane. The patterned surface elements have dimensional relations adapted to inhibit migration of cells between the intraocular lens and the surface of the posterior capsule of the eye. The implant further includes an aperture element which defines a passage opening capable of providing fluid communication to the intraocular implant between the front surface and the back surface of the biocompatible flexible membrane, the passage opening configured to intraocularly align in a visual axis of the eye with the outer boundary configured to be located proximate the outer circumference of the posterior capsule, thereby providing a line of sight which passes through the passage opening. r boundary which defines a circular area having a diameter of between about 9 millimeters and about 15 millimeters, the outer boundary configured to be located proximate an outer circumference of the posterior capsule. The implant has patterned surface elements coupled to at least one of the front surface and the back surface of the biocompatible flexible membrane. The patterned surface elements have dimensional relations adapted to inhibit migration of cells between the intraocular lens and the surface of the posterior capsule of the eye. The implant further includes an aperture element which defines a passage opening capable of providing fluid communication to the intraocular implant between the front surface and the back surface of the biocompatible flexible membrane, the passage opening configured to intraocularly align in a visual axis of the eye with the outer boundary configured to be located proximate the outer circumference of the posterior capsule, thereby providing a line of sight which passes through the passage opening.
Description
INTRAOCULAR IMPLANT CELL MIGRATION INHIBITION SYSTEM
This application is a continuation-in-part of United States Patent Application No.
13/136,515, filed August 2, 2011, and United States Patent Application No. 13/479,178, filed
May 23, 2012, each hereby incorporated by reference herein.
I. TECHNICAL FIELD
Generally, an intraocular implant and methods for treating an ocular condition. In
particular, an intraocular implant which implanted between an intraocular lens and the surface
of the posterior capsule of the eye inhibits migration of residual lens epithelial cells after
cataract surgery by providing structural barriers to reduce posterior capsule opacification of
the eye.
II. BACKGROUND
Visually impairing cataract is the leading cause of preventable blindness in the world.
Presently, the only known treatment for cataract is the surgical removal of the opacified lens of
the affected eye and replacement with an artificial intraocular lens, typically including an
intraocular lens optic and haptics (“IOL”). Technological advances in cataract surgery with
IOL implantation have made cataract surgery among the most effective surgical procedures.
Now referring primarily to Figures 1 and 2, which show a top view and a cross section
view of a phakic eye (1). The most common technique of cataract surgery may be
extracapsular cataract extraction (“ECCE”) which involves the creation of an incision (42)
near the outer edge of the cornea (2) and a circular opening (44)(shown in Figures 3 and 4) in
the anterior lens capsule (43)(also herein referred to as the “anterior capsule”) through which
the opacified lens (3) can be removed from the lens capsule (45)(also referred to as the
“capsular bag”). Now referring primarily to Figures 3 and 4 which show a top view and a cross
section view of a pseudophakic eye (4), the lens capsule (45) anchored to the ciliary body (6)
through the zonular fibers (7) can be left substantially intact. The IOL (8) can then be placed
within the lens capsule (45) through the circular opening (44) in the anterior capsule (43). The
IOL (8) can be acted on by zonular forces exerted on the outer circumference of the lens
capsule (45) which establishes the location of the IOL (8) within the lens capsule (45). The
intact posterior capsule (5) acts as a barrier to the vitreous humor (9) within the posterior
segment of the eye.
The most frequent complication to ECCE and other methods of cataract surgery can be
opacification of the posterior capsule (5). Posterior capsule opacification (“PCO”) results from
the migration of residual lens epithelial cells (“LEC”) between the IOL (8) and the surface of
the posterior capsule (5) subsequent to cataract surgery. The residual LECs once located
between the IOL (8) and the surface of the posterior capsule (5) can proliferate leading to
clouding of the normally clear posterior capsule (5). Clouding of the posterior capsule (5) can
decrease visual acuity if the opacification occurs within the visual axis (21).
Visually significant PCO requires an additional surgery to clear the visual axis of the
eye. Presently, the most widely utilized procedure to clear the visual axis of PCO may be
Neodymium: Yttrium-Aluminum-Garnet (“Nd:YAG”) laser capsulotomy. However, there may
be substantial problems with this procedure such as IOL damage, postoperative intraocular
pressure spikes, vitreous floaters, cystoid macular edema, retinal detachment, and IOL
subluxation, or the like. Additionally, pediatric patients can be difficult to treat and a delay in
treatment can lead to irreversible amblyopia. Many underdeveloped countries do not have
access to a Nd:YAG laser and the cost can be prohibitive.
Prevention or inhibition of PCO fall into two broad categories: mechanical and
pharmacological. Mechanical mechanisms to inhibit PCO have primarily focused on
configuration of the IOL (8). Configuring the IOL to include a sharp posterior edge may
provide a structural barrier to the migration of residual LECs between the IOL and the surface
of the posterior capsule (5). Cleary et al., Effect of Square-edged Intraocular Lenses on
Neodymium: YAG Laser Capsulotomy Rates in the United States, J. Cataract & Refractive
Surgery, Vol. 33, p. 1899-1906 (November 2007). However, while introduction of square
edged IOLs appears to have reduced incidence of PCO, a review of Medicare claims data from
1993 to 2003 evidences that the number of laser capsulotomies performed in the United States
to treat PCO in recipients of square edged IOL remains substantial.
Pharmacological mechanisms have been proposed as a way to inhibit or prevent PCO.
The effect of topical treatment with nonsteroidal anti-inflammatory drugs (“NSAIDs”) such as
diclofenac and indomethacin after phacoemulsification do not appear to inhibit PCO. Inan et
al., Effect of Diclofenac on Prevention of Posterior Capsule Opacification in Human Eyes,
Can J Ophthalmol, 41; 624-629 (2006). Additionally, the majority of pharmacological agents
tested in-vitro for inhibition of migration and proliferation of LECs are antimetabolites and
antimitotics which have not been used clinically because of their toxic side effects. Inan UU,
Ozturk F, Kaynak S, et al. Prevention of Posterior Capsule Opacification by Intraoperative
Single-dose Pharmacologic Agents, J Cataract Refract Surg, 27:1079-87(2001); Inan UU,
Ozturk F, Kaynak S. Ilker SS, Ozer E, Güler, Prevention of Posterior Capsule Opacification
by Retinoic Acid and Mitomycin, Graefes Arch Clin Exp Ophthalmol 239: 693-7(2001);
Cortina P, Gomez-Lechon MJ, Navea A, Menezo JL, Terencio MC, Diaz-Llopis, M,
Diclofenac Sodium and Cyclosporine A Inhibit Human Lens Epithelial Cell Proliferation in
Culture, Graefes Arch Clin Exp Ophthalmol 235: 180-5(1997); Ismail MM, Alio JL, Ruiz
Moreno JM, Prevention of Secondary Cataract by Antimitotic Drugs: Experimental Study,
Ophthalmic Res, 28:64-9 (1996); Emery J., Capsular Opacification After Cataract Surgery,
Curr Opin Ophthalmol, 10:73-80 (1999); Hartmann C, Wiedemann P, Gothe K, Weller M,
Heimann K, Prevention of Secondary Cataract by Intracapsular Administration of the
Antibiotic Daunomycin, Ophthalmologie, 4:102-6 (1990).
Also, available is a sealed capsule irrigation device which functions to allow selective
irrigation of the lens capsule with LEC inhibiting pharmacologic agents. Maloof AJ, Neilson
G, Milverton EJ, Pandy SK, Selective and specific targeting of lens epithelial cells during
cataract surgery using sealed-capsule irrigation, J Cataract Refract Surg, 29:1566-68 (2003).
It is not clear, however, that use of the device can be reduced to routine practice. Problems
relating to incomplete seal of the lens capsule (45) resulting in leakage of potentially toxic
chemicals into the anterior chamber (46) of the eye, rupture of the lens capsule (45) during
manipulation of the irrigation device, difficulty in assessing kill of LECs within the lens
capsule (45) and an increase in the duration of routine cataract surgery limit the usefulness of
the irrigation device.
Another prominent problem with routine cataract surgery and other surgical procedures
such as retinal surgery, cornea transplant surgery, glaucoma surgery, or the like, can be
postoperative administration of antibiotics to prevent endophthalmitis. Topical antibiotic and
anti-inflammatory eye drops represent the mainstay of drug delivery for intraocular surgery.
However, there has yet to be a prospective randomized study showing that topical antibiotics
prevent endophthalmitis. Also, because the human cornea acts as a natural barrier to biologic
and chemical insults, intraocular bioavailability usually requires frequent dosing regimens for
each medication. Topical drops can be difficult for young and elderly patients and the drop
schedule can be cumbersome and confusing particularly when following surgery each eye is
on a different drop schedule. These difficulties can result in non-compliance with serious
consequences such as endophthalmitis, glaucoma, and cystoid macular edema. Recent
prospective studies supporting the use of intracameral antibiotic injections for prophylaxis of
endophthalmitis have stirred debate regarding the risks associated with this method of
antibiotic prophylaxis including the short duration of protective effect (possibly less than 24
hours), the introduction of potentially contaminated substances in the anterior chamber,
endothelial cell toxicity, toxic anterior segment syndrome, dilutional and osmolarity errors
during mixing, and the like. Also, the systemic administration of drugs for treatment of
localized ocular conditions may not be preferred because of the inefficiency associated with
indirect delivery of the drugs to a target organ.
Recognizing these disadvantages of conventional delivery of antibiotics and other
drugs to the eye, external ocular inserts were developed utilizing biologically inert materials to
act as a reservoir for slow release of the drug. These external ocular inserts may be placed
within the upper and lower conjunctival fornix of the eye to achieve a uniform sustained rate
of release of drug in therapeutically effective amounts. However, patients can be intolerant of
these devices due to difficulty in insertion and removal and mild to moderate conjunctival
irritation during use which may explain why external ocular inserts have not been widely
accepted in clinical practice.
In this specification where reference has been made to patent specifications, other
external documents, or other sources of information, this is generally for the purpose of
providing a context for discussing the features of the invention. Unless specifically stated
otherwise, reference to such external documents is not to be construed as an admission that
such documents, or such sources of information, in any jurisdiction, are prior art, or form part
of the common general knowledge in the art.
III. DISCLOSURE OF INVENTION
In one aspect, the present invention provides an intraocular implant, comprising:
a) a biocompatible flexible membrane having flat front and back surfaces disposed a uniform
thickness apart, said biocompatible flexible membrane configured to be implanted between an
intraocular lens and a surface of a posterior capsule of an eye, said biocompatible flexible
membrane having an outer boundary which defines a circular area having a diameter of
between about 9 millimeters and about 15 millimeters, said outer boundary configured to be
located proximate an outer circumference of said posterior capsule;
b) patterned surface elements coupled to at least one of said front surface and said back surface
of said biocompatible flexible membrane, said patterned surface elements having dimensional
relations adapted to inhibit migration of cells between said intraocular lens and said surface of
said posterior capsule of said eye; and
c) an aperture element which defines a passage opening capable of providing fluid
communication to said intraocular implant between said front surface and said back surface of
said biocompatible flexible membrane, said passage opening configured to intraocularly align
in a visual axis of said eye with said outer boundary configured to be located proximate said
outer circumference of said posterior capsule, thereby providing a line of sight which passes
through said passage opening.
Described herein is an intraocular implant having patterned surface elements which
implanted between an intraocular lens and the surface of the posterior capsule of the eye
provides a mechanical barrier which inhibits migration of residual lens epithelial cells after
cataract surgery for treatment of an ocular condition.
Also described herein is a biocompatible intraocular implant and methods of treatment
of an ocular condition by implantation of the biocompatible intraocular implant inside the eye
with embodiments which can be intraocularly implanted in the posterior capsule of the eye to
provide pharmaceutical barriers to interrupt progression of the ocular condition, the ciliary
sulcus between the iris and the lens, or in the anterior chamber overlaying the iris.
Also described herein is a biocompatible intraocular implant locatable between the
surface of the posterior capsule of the eye and an implanted IOL to provide a mechanical
barrier which inhibits migration of residual lens epithelial cells after cataract surgery by
providing structural barriers to reduce posterior capsule opacification of the eye.
Also described is a biocompatible biodegradable intraocular implant locatable between
the surface of the posterior capsule of the eye and an implanted IOL to provide a
biodegradable mechanical barrier for treatment of an ocular condition.
Also described is a biocompatible biodegradable intraocular implant locatable between
the surface of the posterior capsule of the eye and an implanted IOL which combines a
biocompatible biodegradable material which continually, or substantially continually, releases
a therapeutically effective amount of an active agent to treat an ocular condition.
Also described is a biocompatible biodegradable intraocular implant locatable between
the surface of the posterior capsule of the eye and an implanted IOL during cataract surgery
which by structural or pharmaceutical barriers inhibits migration of residual lens epithelial
cells to the surface of the posterior capsule.
Also described is a biocompatible biodegradable intraocular implant locatable between
the surface of the posterior capsule of the eye and an implanted IOL during cataract surgery
which by structural or pharmaceutical barriers inhibits proliferation of residual lens epithelial
cells to the surface of the posterior capsule as a prophylaxis of PCO.
Also described is a biocompatible or biocompatible biodegradable intraocular implant
locatable anterior to the natural crystalline lens or an implanted IOL within the ciliary sulcus
for administration of one or more active agents.
Also described is a biocompatible or biocompatible biodegradable intraocular implant
locatable in the anterior chamber overlaying the iris.
Naturally, further objects of the invention are disclosed throughout other areas of the
specification, drawings, photographs, and claims.
In the description in this specification reference may be made to subject matter which
is not within the scope of the claims of the current application. That subject matter should be
readily identifiable by a person skilled in the art and may assist in putting into practice the
invention as defined in the claims of this application.
IV. BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a top view of the phakic eye with the natural lens intact.
Figure 2 is a cross section 2-2 of the phakic eye with the natural lens intact.
Figure 3 is a top view of the pseudophakic eye having the natural lens replaced with an
IOL.
Figure 4 is a cross section 4-4 of the pseudophakic eye having the natural lens replaced
with an IOL.
Figure 5 is a front view of a particular embodiment of the intraocular implant of
generally circular configuration.
Figure 6 is a front view of a particular embodiment of the intraocular implant of
generally circular configuration which terminates radially in an annular member.
Figure 7 is a back view of a particular embodiment of the intraocular implant further
providing patterned surface elements.
Figure 8 is enlarged partial back view of the particular embodiment of the intraocular
implant shown in Figure 6 providing patterned surface elements.
Figure 9 is a perspective view of the particular embodiment of the intraocular implant
shown in Figure 5.
Figure 10 is a cross section view 10-10 of the particular embodiment of the implant
shown in Figure 9.
Figure 11 is a cross section view 11-11 of the particular embodiment of the implant
shown in Figure 6.
Figure 12 is a perspective view of a particular embodiment of the intraocular implant.
Figure 13 is a cross section view 13-13 of the particular embodiment of the implant
shown in Figure 12.
Figure 14 is plan view of a particular embodiment of the intraocular implant.
Figure 15 is a cross section view 15-15 of the particular embodiment of the implant
shown in Figure 14.
Figure 16 is a side view of the particular embodiment of the implant shown in Figure
14.
Figure 17 is a front view of a particular embodiment of the intraocular implant which
further provides radial slit elements originating at the outer boundary.
Figure 18 is a front view of a particular embodiment of the intraocular implant which
further provides radial slit elements originating at the aperture element.
Figure 19 is a front view of a particular embodiment of the intraocular implant which
further provides perforation elements.
Figure 20 is a front view of a particular embodiment of the intraocular implant which
further provides two more flexible membrane zones.
Figure 21 is an enlarged partial back view of the particular embodiment of the
intraocular implant shown in Figure 6 which shows a particular embodiment of patterned
surface elements in the form of a plurality of raised elements.
Figure 22 is cross section 22-22 of the patterned surface elements shown in Figure 21.
Figure 23 is an enlarged partial back view of the particular embodiment of the
intraocular implant in Figure 6 which shows a particular embodiment of the patterned surface
elements in the form of a plurality of recessed elements.
Figure 24 is cross section 24-24 of the patterned surface elements shown in Figure 23.
Figure 25 is an enlarged partial back view of the particular embodiment of the
intraocular implant in Figure 6 which shows a particular embodiment of the patterned surface
elements in the form of a plurality of raised elements on the back surface and a plurality of
recessed elements on the front surface.
Figure 26 is cross section 26-26 of the patterned surface elements shown in Figure 25
which shows a plurality of raised elements on the back surface of a particular embodiment of
the intraocular implant and a plurality of recessed elements on the front surface of the
intraocular implant.
Figure 27 is an enlarged partial front view of the particular embodiment of the
intraocular implant shown in Figure 6 which shows another particular embodiment of the
patterned surface elements.
Figure 28 is cross section 28-28 of the patterned surface elements shown in Figure 27.
Figure 29 is an enlarged partial front view of the particular embodiment of the
intraocular implant shown in Figure 6 which shows another particular embodiment of the
patterned surface elements.
Figure 30 is cross section 30-30 of the patterned surface elements shown in Figure 29.
Figure 31 is an enlarged partial front view of the particular embodiment of the
intraocular implant shown in Figure 6 which shows another particular embodiment of the
patterned surface elements.
Figure 32 is cross section 32-32 of the patterned surface elements shown in Figure 31.
Figure 33 is an enlarged partial front view of the particular embodiment of the
intraocular implant shown in Figure 6 which shows another particular embodiment of the
patterned surface elements.
Figure 34 is cross section 34-34 of the patterned surface elements shown in Figure 33.
Figure 35 is a front view of a particular embodiment of the intraocular implant which
further provides one or more boundary recess elements.
Figure 36 is a front view of a particular embodiment of the intraocular implant which
includes both radial slit elements originating from the aperture element and boundary recess
elements which periodically interrupt the outer boundary.
Figure 37 is a perspective view of a plurality of an embodiment of the intraocular
implant which can be stacked front to back.
Figure 38 is a perspective view of an embodiment of the intraocular implant which
further provides radial capillary elements.
Figure 39 is a perspective view of an embodiment of the intraocular implant which
further provides corrugate elements.
Figure 40 shows an embodiment of the intraocular implant held by forceps for
implantation into an eye having the natural lens removed.
Figure 41 is top view of the pseudophakic eye having the natural lens removed
allowing an embodiment of the intraocular implant to be positioned on the surface the
posterior capsule through an opening made in the anterior capsule.
Figure 42 is a cross section view of the pseudophakic eye having the natural lens
removed allowing an embodiment of the intraocular implant to be positioned on the surface
the posterior capsule through an incision made in the anterior capsule.
Figure 43 is a cross section view of the pseudophakic eye having the intraocular
implant of Figure 9 positioned between the surface the posterior capsule and the implanted
IOL.
Figure 44 is a cross section view of the pseudophakic eye having the intraocular
implant of Figure 6 positioned between the surface the posterior capsule and the implanted
IOL.
Figure 45 is a cross section view of the pseudophakic eye having the intraocular
implant of Figure 12 positioned on the surface of the posterior capsule.
Figure 46 is a cross section view of the phakic eye having the intraocular implant of
Figure 9 positioned between the iris and the natural crystalline lens of the eye.
Figure 47 is front view of an embodiment of the intraocular implant affixed to a sterile
card prior to implantation.
Figure 48 is a side view of an embodiment of the intraocular implant affixed to a sterile
card prior to implantation.
V. MODE(S) FOR CARRYING OUT THE INVENTION
Generally, an intraocular implant and methods for treating an ocular condition. In
particular, an intraocular implant which implanted between an intraocular lens and the surface
of the posterior capsule of the eye inhibits migration of residual lens epithelial cells after
cataract surgery by providing structural barriers to reduce posterior capsule opacification of
the eye.
DEFINITIONS
The term “comprising” as used in this specification and claims means “consisting at
least in part of”. When interpreting statements in this specification and claims which include
the term “comprising”, other features besides the features prefaced by this term in each
statement can also be present. Related terms such as “comprise” and “comprised” are to be
interpreted in similar manner.
“A” or “an” entity refers to one or more of that entity; for example, “a polymer” refers
to one or more of those compositions or at least one composition. As such, the terms “a” or
“an”, “one or more” and “at least one” can be used interchangeably herein. Furthermore, the
language “selected from the group consisting of” refers to one or more of the elements in the
list that follows, including combinations of two or more of the elements.
“About” for the purposes of the present invention means that ranges may be expressed
as from "about" one particular value to "about" another particular value. When such a range is
expressed, another embodiment includes from the one particular value to the other particular
value. Similarly, when values are expressed as approximations, by use of the antecedent
"about," it will be understood that the particular value forms another embodiment. In the
context of such a numerical value or range “about” means plus or minus 10% of the numerical
value or range recited or claimed.
“Active agent" for the purposes of this invention means any substance used to treat an
ocular condition.
“Biocompatible” for the purposes of this invention means the ability of any material to
perform the intended function of an embodiment of the invention without eliciting any
undesirable local or systemic effects on the recipient and can include non-biodegradable
materials such as: polyurethanes, polyisobutylene, ethylene-alpha-olefin copolymers, acrylic
polymers and copolymers, vinyl halide polymers and copolymers, polyvinyl esters,
polyvinylidene chloride, polyacrylonitrile, polyvinyl ketones, polyvinyl aromatics such as
polystyrene, copolymers of vinyl monomers and olefins such as ethylene-methyl methacrylate
copolymers, acrylonitrile-styrene copolymers, ABS resins, ethylene-vinyl acetate copolymers,
polyamides such as Nylon 66 and polycaprolactone, alkyd resins, polycarbonates,
polyoxyethylenes, polyimides, polyesters, epoxy resins, rayon-triacetate, cellophane, silicon
rubber, silicon hydrogel, or the like, or biodegradable materials, as herein described.
“Biodegradable” for the purposes of this invention means the ability of any
biocompatible material to breakdown within the physiological environment of the eye by one
or more physical, chemical, or cellular processes at a rate consistent with providing structural
or pharmaceutical barriers (or both) at a therapeutic level controllable by selection of a
polymer or mixture of polymers (also referred to as polymeric materials), including, but not
limited to: polylactide polymers (PLA), copolymers of lactic and glycolic acids (PLGA),
polylactic acid-polyethylene oxide copolymers, poly(ε-caprolactone-co-L-lactic acid (PCL-
LA), glycine/PLA copolymers, PLA copolymers involving polyethylene oxides (PEO),
acetylated polyvinyl alcohol (PVA)/polycaprolactone copolymers, hydroxybutyrate-
hydroxyvalerate copolymers, polyesters such as, but not limited to, aspartic acid and different
aliphatic diols, poly(alkylene tartrates) and their copolymers with polyurethanes,
polyglutamates with various ester contents and with chemically or enzymatically degradable
bonds, other biodegradable nonpeptidic polyamides, amino acid polymers, polyanhydride drug
carriers such as, but not limited to, poly(sebacic acid) (PSA), aliphatic-aromatic
homopolymers, and poly(anhydride-co-imides), poly(phosphoesters) by matrix or pendant
delivery systems, poly(phosphazenes), poly(iminocarbonate), crosslinked poly(ortho ester),
hydroxylated polyester-urethanes, or the like. Hydrogels such as methylcellulose which act to
release drug through polymer swelling are specifically excluded from the term.
“Intraocular” for the purposes of this invention means inside the eyeball (also referred
to as an “eye”) and without limitation to the forgoing the anterior chamber, the ciliary sulcus,
and posterior capsule of the eye; however, specifically excluding the external surface of the
eye or intracorneal or intrasclera regions of the eye.
“Localized Region” for the purposes of this invention means substantially within a
localized tissue region of the eye therapeutically affected (whether structurally or
pharmaceutically) by implantation of embodiments of an intraocular implant.
“Ocular condition” for the purposes of this invention means a disease, ailment or
condition which affects or involves the eye or any one of the parts or regions of the eye, such
as PCO. The eye includes the eyeball and the tissues and fluids which constitute the eyeball,
the periocular muscles (such as the oblique and rectus muscles) and the portion of the optic
nerve which is within or adjacent to the eyeball.
“Posterior ocular condition" for the purposes of this invention means a disease, ailment
or condition which affects or involves a posterior ocular region or site such as the choroid or
sclera (in a position posterior to a plane through the posterior wall of the lens capsule),
vitreous, vitreous chamber, retina, optic nerve (i.e. the optic disc), and blood vessels and nerve
which vascularize or innervate a posterior ocular region or site.
“Suitable for implantation” for the purposes of this invention means with regard to
embodiments of the intraocular implant dimensions which allow insertion or implantation
without causing excessive tissue damage.
“Therapeutic level" for the purposes of this invention means an amount or a
concentration of an active agent that has been locally delivered to an ocular region that is
appropriate to reduce, inhibit, or prevent a symptom of an ocular condition.
Now generally referring to Figures 5-39, particular embodiments of the intraocular
implant (11) can provide a biocompatible flexible membrane or a biocompatible biodegradable
flexible membrane (also generally referred to as a “flexible membrane” (12)) having an outer
boundary (13) configured to allow the intraocular implant (11) to locate in the concavity of the
posterior capsule (5) of the pseudophakic eye (4), or other localized region inside the eye such
as the ciliary sulcus or anterior chamber (46) depending on the application. As a non-limiting
example, the intraocular implant (11) can be located in the posterior capsule (5) for the
purpose of isolating the surface of the posterior capsule (5) from migration of residual LECs
after cataract surgery, or reducing or preventing the migration of residual LECs between the
surface of an IOL (8) implanted in the lens capsule (45) and the surface of the posterior
capsule (5).
Intraocular implants (11) suitable for implantation can provide a flexible membrane
(12) having an outer boundary (13) which as a non-limiting example defines a circular area
having a diameter in a range of about 9 millimeters (“mm”) and about 15 mm depending on
the recipient; however, the implant described herein is not so limited, and the outer boundary
(13) can define a substantially circular, ovoid, or other configuration of the outer boundary
(13) suitable for implantation into the concavity of the posterior capsule (5) of the
pseudophakic eye (4), or other localized region inside the eye.
Now referring primarily to Figure 17, particular embodiments of the flexible
membrane (12) can further include one or more radial slit elements (14) cut through the
thickness of the flexible membrane with the radial slit elements (14) originating at the outer
boundary (13) cut a distance radially toward the center of the flexible membrane (12). The one
or more radial slit elements (14) can have sufficient length and width to allow the flexible
membrane (12) to conform to a greater extent with the concavity of the posterior capsule (5) of
the pseudophakic eye (4) or other localized region inside the eye. As one non-limiting
example, the radial slit elements (14) can provide an opening in the flexible membrane (12)
having a greater slit width (15) at the outer boundary (13) of the flexible membrane (12) than
proximate the center of the flexible membrane (12). As a non-limiting example, the flexible
membrane (12) when received by the concavity of the posterior capsule (5) can deform to
reduce the slit width (15) at the outer boundary (13) of the flexible membrane (12).
Now referring primarily to Figures 35 and 36, particular embodiments of the flexible
membrane can further provide one or more boundary recess elements (16) located along the
outer boundary (13) of the flexible membrane (12). The outer boundary (13) of the flexible
membrane (12) can be interrupted once or periodically to provide one or more of the recess
elements (16) which can be configured, for example, as semicircular notches, triangular
notches, indents, or the like which can function to allow added flexure to more readily locate
the flexible membrane in the posterior capsule of the eye (or other localized region), as above
described, or can function to reduce sequestration of peripheral cortical material during the
final irrigation and aspiration steps in cataract surgery.
With respect to the particular embodiments of the intraocular implant shown in Figures
-39 and in particular referring to Figures 5, 9, and 10 as a non-limiting example, the flexible
membrane (12) can have a thickness (17) disposed between a front surface (18) and a back
surface (19)(also referred to as “a first side” and “a second side” or “opposed sides”). As to
particular embodiments of the intraocular implant (11), the front surface (18) and the back
surface (19) can be disposed in substantially parallel opposed relation providing a relatively
uniform thickness of the intraocular implant (11) in a range of about 5 microns (“μm”) and
about 400 μm, as shown by the non-limiting cross section shown in the non-limiting example
of Figure 9. Particular embodiments of the intraocular implant, can have a uniform thickness
(17) in a range selected from the group including: about 5 μm and about 100 μm, about 50 μm
and about 150 μm, about 100 μm and about 200 μm, about 150 μm and about 250 μm, about
200 μm and about 300 μm, about 250 μm and 300 μm, 300 μm and about 400 μm, and about
350 μm and about 400 μm. As to particular embodiments, the edge (80) at the outer boundary
(13) of the intraocular implant (11) can be configured to intersect each of the front surface (18)
and the back surface (19) at substantially right angles as shown in Figure 9. Depending upon
the thickness (17) of the intraocular implant (11), the optical power of the IOL (8) can be
adjusted if necessary. However, embodiments of the intraocular implant are not limited to
having a uniform thickness (17) and certain embodiments of the intraocular implant (11) can
provide a flexible membrane (12) thinner proximate the center and thicker proximate the outer
boundary (13) or can provide a flexible membrane thicker proximate the center and thinner at
the edges depending upon the application. As another non-limiting example, the thickness (17)
of the flexible membrane (12) may be thinner in the center to align with the visual axis of the
pseudophakic eye (4) to increase visual acuity or promote directional biodegradation of the
intraocular implant (11) from the center toward the outer boundary (13).
Now referring primarily to Figures 6, 10, 11, 12, and 13 as non-limiting examples, the
intraocular implant can further include, an annular member (74) joined about, or to the front
surface (18), of the intraocular implant (11). The surface of the edge (80) of the annular
member (74) can define the outer boundary (13) of the intraocular implant (11). The outside
surface of the edge (80) can intersect the back surface (19) of the flexible membrane (12) at an
angle (78) which upon contact with the surface of the posterior capsule (5) can provide a
barrier or impede migration of LECs toward the center of the intraocular implant (11). While
the angle of the intersection (78) of the outside surface of the edge (80) with the back surface
(19) of the intraocular implant (11) can be substantially a right angle; the invention is not so
limited, and embodiments with an angle of intersection between the outside surface of the
edge (80) with the back surface (19) of between about 90 degrees and about 120 degrees but
retains a sharp corner can be suitable.
As to particular embodiments which include the annular member (74), the edge (80)
can have a height (75) substantially greater than the thickness (17) of the flexible membrane
(12). The height (75) of the edge (80) can be within the range of about 10 μm and about 1500
μm depending upon the application. As a non-limiting example, the thickness (17) of the
flexible membrane (12) can be in the range of about 50 μm and about 300 μm while the
annular member (74) can provide an edge (80) having a height (75) in the range of about 300
μm and about 1500 μm; however, the invention is not so limited, and the height (75) of the
edge (80) as to particular embodiments can fall outside of the range depending on the
application.
Now referring primarily to Figure 44 the height (75) of the edge (80) of he annular
member (74) can be sufficiently greater than the thickness (17) of the flexible membrane (12)
to provide an inside surface (77) of the annular member (74) having sufficient height (79) to
engage the haptics (10) of the IOL (8) engaged with the front surface (18) of the intraocular
implant (11).
Now referring primarily to Figures 12, 13 and 45, while embodiments of the
intraocular implant (11) shown in Figures 5 through 7, 17 through 20, 35 through 39 and 43
and 44 can be separate from the IOL (8); the invention is not so limited, and particular
embodiments of the intraocular implant can be joined, coupled, or otherwise made one piece
with the IOL (8), or elements of the intraocular implant (11) (such as the patterned surface
elements) can be incorporated into IOL (8) such that the IOL (8) and those incorporated
elements can be provided as a one piece IOL (8). The particular embodiment shown in Figures
12 and 13, shows the IOL (8), the flexible membrane (12) and the annular member (74)
formed as one piece (the haptics (10) being omitted from the embodiment). The flexible
membrane (12) can be joined about the circumference of the IOL. The flexible membrane (12)
can radially extend outwardly to terminate in the edge (80) of the annular member (74). The
dimensional relations of the flexible member (12) and the annular member (74) can be as
above-described. A plurality of radial struts (81) can be coupled to the front surface (18) of the
intraocular implant (11) between the circumference of the IOL (8) and the inside surface (77)
of the annular member (74) having dimensional relations sufficient to maintain the front
surface (18) and the back surface (19) of the flexible membrane (12) and the annular member
(74) in proper relation to the a pseudophakic eye (4) upon implantation as shown in the non-
limiting example of Figure 42. Accordingly, the surgical technique described below can
include the steps of implanting into the lens capsule (45) the IOL (8) joined, coupled or
otherwise made one piece with to the intraocular implant (11) or elements thereof.
Now referring primarily to Figures 6 through 8, Figures 12 through 16, and Figures 21
through 34, particular embodiments of the intraocular implant (11), can provide patterned
surface elements (20) coupled to the back surface (19) of the intraocular implant (11). The
patterned surface elements (20) can be adapted to engage the surface of the posterior capsule
(5) to reduce travel of the intraocular implant (11) or maintain the alignment of the center of
the intraocular implant (11) with the visual axis of the eye (21). The patterned surface
elements (20) can provide an irregular or uniform pattern, texture, or roughness sufficient to
fix or reduce travel of the intraocular implant (11) in the posterior capsule (5).
As to certain embodiments of the intraocular implant (11) the patterned surface
elements (20) can also provide pockets which function to provide a localized space to deliver
or sequester an amount of an active agent (24). The patterned surface elements can be
variously configured to deliver or sequester an active agent (24) depending on the application.
The pattern surface elements (20) can be one piece with the flexible membrane (12) or can be
applied to the flexible membrane (12) as a pattern surface element layer.
As to certain embodiments of the intraocular implant (11), whether in the form of the
implant as shown in the examples of Figures 5 through 11 which can be combined with
otherwise made one piece with the IOL (8) or in the form of the various embodiments of a
one-piece IOL (8) as shown in the examples of Figures 12 through 16, patterned surface
elements (20) can be coupled to the front surface (18) or the back surface (19) of the
intraocular implant (11) to provide an irregular or uniform pattern, texture, roughness, or
dimensional relations sufficient to inhibit migration of cells, such as residual lens epithelial
cells, after cataract surgery by providing structural barriers as shown in the examples of
Figures 21 through 34. The patterned surface elements (20) can be configured to provide a
sufficient structural barrier to the migration of residual lens epithelial cells to eliminate,
substantially eliminate or reduce posterior capsule (5) opacification of the pseudophakic eye
(4). As to certain embodiments, the intraocular implant (11) can include the IOL (8)
comprising an intraocular lens optic (82) and an intraocular lens haptic (83) with patterned
surface elements (20) coupled to at least a part of said IOL (8) while maintaining a line of
sight (21) through the intraocular lens optic (82), the patterned surface elements (20) having
dimensional relations adapted to inhibit migration of cells between the IOL (8) and the surface
of said posterior capsule (5) of the eye.
In general, the patterned surface elements (20) can include a plurality of raised
elements (47) or a plurality of recessed elements (69) which project outwardly or recess
inwardly from the back surface (19) or the front surface (18) of the biocompatible flexible
membrane (12) of the intraocular implant (11) in spaced apart relation to one another.
As to certain embodiments, the plurality of raised elements (47) can be bounded by a
corresponding plurality of channels (48) which form a pattern over the entirety or over a
portion of the back surface (19) or the front surface (18), or both the front surface (18) and the
back surface (19) of the biocompatible flexible membrane (12) of the intraocular implant (11).
The plurality of raised elements (47) can be produced from one or more of the biocompatible
or biodegradable materials, as above described, which as to certain embodiments can be a
material different than used to form the biocompatible or biocompatible biodegradable flexible
membrane (12). The top surface (49) of each of the plurality of raised elements (47) can be
generally flat or planar having a surface area sufficiently small to reduce or prevent adhesion
or migration of residual lens epithelial cells across the plurality of raised elements (47) and
each of the plurality of channels (48) can be sufficiently small to reduce or prevent migration
or adhesion between the plurality of raised elements (47). The plurality of raised elements (47)
can be disposed in spaced apart relation on the back surface (19) or the front surface (18), or
both, of the biocompatible or biocompatible biodegradable flexible membrane (12) to dispose
the plurality of channels in a non-linear path (67) inwardly approaching the center of the
intraocular implant (11). The various embodiments of the patterned surface elements (20) can
occur only on the back surface (19), only on the front surface (18) or can occur on both the
back surface (19) and on the front surface (18).
Embodiments of the top surface (49) of each of the plurality of raised elements can
have a lesser dimension between two sidewalls (50)(see for example Figure 13) in the range of
about 500 nanometers and about 4 micrometers. Depending upon the application, the lesser
dimension can be selected from the group including: about 400 nanometers and about 1
micrometer, about 500 nanometers and about 1.5 micrometers, 1 micrometer an about 2.0
micrometers, 1.5 micrometers and about 2.5 micrometers, 2.0 micrometers and about 3.0
micrometers, 2.5 micrometers and about 3.5 micrometers, 3.0 micrometers and about 4.0
micrometers, and 3.5 micrometers and about 4.0 micrometers, or combinations thereof.
Understandably, the top surface (49) as between two or more of the plurality of raised
elements (47) can be configured in substantially similar configuration and similar in
dimensional relations or as between two or more of the plurality of raised elements (47) can be
substantially different in configuration or irregular in dimensional relations. The lesser
dimension can as to particular embodiments relate to the width of one of the plurality of raised
elements (47) and the greater dimension as to particular embodiments can relate to a length of
one of the plurality of raised elements (47). However, the invention is not so limited; and
numerous and varied embodiments can be produced in which the top surface has an irregular
surface area, or may be substantially circular or can be a regular polygon, or the like, which do
not afford a distinction between width and length. Accordingly, the above dimensions afford
guidance sufficient for the person of ordinary skill in the art to provide a plurality of raised
elements (49) in spaced apart relation having a wide variety of configurations useful in
inhibiting adhesion and migration of cells toward the center of the intraocular implant (11).
The sidewalls (50) of each of the plurality of raised elements (47) can be generally
vertical to the surface of the intraocular implant (11) when the biocompatible flexible
membrane (12) is disposed in a generally flat condition. The sidewalls (50) can have a
sidewall height (51) in the range of about 400 nanometers and about 6 micrometers.
Depending upon the application, the sidewall height (51) can be selected from the group
including: about 400 nanometers and about 1 micrometer, about 500 nanometers and about 1.5
micrometers, 1 micrometer an about 2.0 micrometers, 1.5 micrometers and about 2.5
micrometers, 2.0 micrometers and about 3.0 micrometers, 2.5 micrometers and about 3.5
micrometers, 3.0 micrometers and about 4.0 micrometers, 3.5 micrometers and about 4.5
micrometers, 4.0 micrometers and about 5.0 micrometers, about 4.5 micrometers and about 5.5
micrometers, and about 5.0 micrometers and about 6.0 micrometers, or combinations thereof.
Each of the plurality of channels (48) defined by opposed sidewalls (50) can have a
channel width (61) in the range of about 100 nanometers and about 2.5 micrometers.
Depending upon the application, a suitable channel width (61)(see for example Figure 17) can
be selected from the group including: 100 nanometers and about 300 nanometers, about 200
nanometers and about 400 nanometers, about 300 nanometers and about 500 nanometers,
about 400 nanometers and about 600 nanometers, about 500 nanometers and about 700
nanometers, about 600 nanometers and about 800 nanometers, about 700 nanometers and
about 900 nanometers about 800 nanometers and about 1 micrometer, about 900 nanometers
and about 1.1 micrometer, 1 micrometer an about 1.2 micrometer, 1.1 micrometer and about
1.3 micrometer, 1.2 micrometer and about 1.4 micrometer, 1.3 micrometer and about 1.5
micrometers, 1.4 micrometer and about 1.6 micrometer, 1.5 micrometer and about 1.7
micrometer, 1.6 micrometer and about 1.8 micrometer, 1.7 micrometer and about 1.9
micrometer, and about 1.8 micrometer and about 2 micrometer, or combinations thereof.
Now referring primarily to Figures 21 through 34, which provide non-limiting
examples of raised elements (20) or recessed elements (69) which can be useful in inhibiting
the migration of cells between the back surface (19) of the biocompatible flexible membrane
(12) and the surface of the posterior capsule (5) of the a pseudophakic eye (4) or can be useful
in inhibiting the migration of cells between the front surface (18) and an implanted intraocular
lens (8).
As to the non-limiting example of Figures 21-26, the patterned surface elements (20)
can have the topography (or reverse topography) of a shark’s skin as described in United
States Patent No. 7,650,848, hereby incorporated by reference herein to the extent that that the
description does not conflict with the express description of embodiments of the patterned
surface elements (20). The topography of the shark skin can be scaled to inhibit adhesion and
migration of residual lens epithelial cells between the back surface (19) of the intraocular
implant (11) and the surface of the posterior capsule (5) of the pseudophakic eye (4). As one
non-limiting example, the topography of the shark skin can be characterized by a plurality of
repeating diamond patterns (52) each consisting of a plurality of raised elements (47)
including seven bar elements (53). The diamond pattern (52) can have an overall diamond
length (68) in the range of about 15 micrometers and about 25 micrometers. Each of the seven
bar elements (53) can have a bar width (60) in the range of about 1 micrometer and about 2.5
micrometers and having a corresponding one of a plurality of channels (48) each having
channel width (61) of about 400 nanometers and about 2 micrometer. The seven bar elements
(53) can have a bar length (54) in the range of about 4 micrometers and about 20 micrometers.
The height of the side wall (50) for each of the seven bar elements (53) can be in the range of
about 1 micrometer and about 5 micrometers.
Now referring primarily to Figures 23-24, particular non-limiting examples of the
patterned surface elements (20) can take the form of the topography of a shark’s skin as above
described; however, the plurality of raised elements (47) and plurality of channel (48) can be
replaced by a corresponding plurality of recessed elements (69) having corresponding plurality
of bottom surfaces (70) and spacer elements (71) having a corresponding spacer width (73) to
form substantially the same pattern having substantially the same dimensional relations as
above described. Again, any of patterned surface elements (20) described herein as a plurality
of raised elements (47) and a corresponding plurality of channel elements (48) can take the
constructional form of a plurality of recessed elements (70) and a plurality of spacer elements
(71) having substantially the same or similar pattern or dimensional relations in the ranges
above described.
Now referring primarily to Figures 25 and 26, particular embodiments of the patterned
surface elements (20) can take the form of a plurality of raised elements (47) on one side of the
biocompatible flexible membrane (12) and a plurality of recessed elements (69) on the
opposed side of the biocompatible flexible membrane (12). While Figures 20 and 21 show a
plurality of raised elements (47) on the back side (19) of the biocompatible flexible membrane
(12) and a plurality of recessed elements (69) on the front side (18) of the biocompatible
flexible membrane (12); the invention is not so limited, and the a plurality of recessed
elements (69) can occur on the back side (19) while the plurality of raised elements can occur
on the front side (18) of the biocompatible flexible membrane (12).
Now referring primarily to Figures 27 and 28, particular embodiments of the patterned
surface elements (20) can take the form of a plurality of raised elements (47) each having a
generally cylindrical configuration in spaced apart relation of columns and rows. Each of the
plurality of raised elements (47) having substantially circular top surface (49) having a
diameter in the range of about 400 nanometers and about 600 nanometers and side wall (50)
having a height of about 400 nanometers and about 600 nanometers. The plurality of raised
elements (47) can be established on centers in the range of about 600 nanometers and about 1
micrometer affording a distance between the sidewalls (50) of between about 200 nanometers
and about 400 nanometers.
Now referring primarily to Figures 29 and 30, particular embodiments of the patterned
surface elements (20) can take the form of a plurality of raised elements (47) in the form of a
plurality of repeating bar patterns (55) each characterized by four bar elements (56) of
substantially equal length in spaced apart generally parallel relation having corresponding
aligned first ends (57) and aligned second ends (58) with a cross bar (59) disposed in generally
perpendicular relation a distance from the aligned first ends (57) or aligned second ends (58)
of the four bar elements (56). Each of the four bar elements (56) can have a width (60) in the
range of about 2 micrometers and about 5 micrometers and having a corresponding one of a
plurality of channels (48) each having width (61) of about 400 nanometers and about 1
micrometer. The four bar elements (56) can each have a length (62) in the range of about 4
micrometers and about 20 micrometers. The height of the side wall (50) of each of the four bar
elements (56) can be in the range of about 1 micrometer and about 3 micrometers. The cross
bar (59) can be disposed a distance from the aligned first ends (57) or aligned second ends (58)
of the four bar elements (56) (or may alternate between the aligned first ends (57) and aligned
second ends (58) as the pattern repeats) in the range of about 400 nanometers and about 1
micrometer. The length of the cross bar (59) can be sufficient to span the distance of the
spaced apart relation of the four bar elements (56). The cross bar (59) having dimensional
relations otherwise similar to the four bar elements (56).
Now referring primarily to Figures 31 and 32, embodiments of the patterned surface
elements (20) can take the form of a plurality of raised elements (47) each having a top surface
(20) of generally hexagonal configuration in regular spaced apart tessellation. Each of the
hexagonal top surface (49) can have a width (60) in the range of about 400 nanometers and
about 600 nanometers and side wall (50) having a height of about 400 nanometers and about
600 nanometers. The corresponding plurality of channels (48) can have a width (61) of about
100 nanometers and about 200 nanometers between each of the plurality of raised elements
(47).
Now referring primarily to Figures 33 and 34, embodiments of the patterned surface
elements (20) can take the form of a plurality of raised elements (47) in the form of a plurality
of bar elements (65) in a herringbone pattern. Each of the plurality of bar elements (65) can be
of substantially equal length in the range of about 4 micrometers and about 20 micrometers
and having a width (61) in the range of about 2 micrometers and about 5 micrometers. The
height of the side walls (51) of each of the plurality of bar elements (65) can be in the range of
about 1 micrometer and about 3 micrometers. The corresponding plurality of channels (48)
between the plurality of bar elements (65) can have a channel width (60) of about 400
nanometers and about 1 micrometer.
Now referring primarily to Figure 19, certain embodiments of the flexible membrane
(12) can further include one or more perforation elements (22) which provide a corresponding
one or more perforation openings (23) which communicate between the front surface (18) and
the back surface (19) of the flexible membrane (12) for the purpose of increasing rate of
biodegradation of the flexible membrane (12) or control release rate of an active agent (24).
The active agent (24)(shown for example in Figures 9, 10 and 13 as a stipple pattern) is not
intended to be limited to those particular embodiments of the intraocular implant (11) or limit
the active agent (24) to any particular composition, particle size, or amount.
Now referring primarily to Figure 37, certain embodiments of the flexible membrane
(12) can further provide two or more flexible membrane layers (25). The two or more
membrane layers (25) can take the form of a first flexible membrane layer (26) and a second
flexible membrane layer (27) or additional flexible membrane layers (28) extruded as a single
piece, coupled together as one unit, or stacked front to back (whether single piece, coupled or
stacked the term “coupled” may be used to refer to the association of a plurality of flexible
membrane layers). Each of the first flexible membrane layer (26) and the second flexible
membrane layer (27) or additional flexible layers (28) can be generated from the same or
different biocompatible biodegradable materials. As a non-limiting example, in an
embodiment described herein for the treatment of PCO, the first flexible membrane layer (26)
can be made of a biocompatible or biocompatible biodegradable material which can have the
back surface (19) disposed adjacent the surface of the posterior capsule (5) to provide both a
structural barrier to the migration of LECs to the surface of the posterior capsule but to further
function as a pharmaceutical barrier which inhibits proliferation or kills LECs by the
substantially continuous release of an active agent (24) such as alkylphosphocholine at a rate
which provides a therapeutic level, such as a localized concentration of about 1.0 millimolar
(“mM”) for a period of at least five days to inhibit or prevent PCO. The front surface (18) of
the first flexible membrane layer (26) can be coupled adjacent the back surface (19) of the
second flexible membrane layer (27) (for example by melt co-extrusion) produced from the
same or different biocompatible biodegradable material and the front surface (18) of the
second flexible membrane layer (27) can be disposed toward an IOL (8) implanted into the
posterior capsule (5) to provide a structural barrier to migration of LECs toward the surface of
the posterior capsule and can further function as a pharmaceutical barrier which inhibits
proliferation or kills LECs by the substantially continuous release of the same active agent
(24) (such as an alkylphosphocholine) or a different active agent (24) such as mitomycin-C at
a therapeutic level, such as a localized concentration of about 0.04 mg/mL, for a period of at
least about five days to inhibit or prevent PCO. Thus, by configuring the layers in different
combinations the rate of release of various active agents can be adjusted depending on the
application.
Now referring primarily to Figure 20, two or more flexible membrane zones (29) can
be established with each flexible membrane zone (29) generated from a particular flexible
membrane material. As to certain embodiments, the two or more flexible membrane zones
(29) can be established as concentric regions with a first annular zone (30) surrounded by a
second annular zone (31). The first annular zone (30) can be of different biocompatible or
biocompatible biodegradable material then the second annular zone (31). For example, the first
annular zone (30) can provide a biocompatible biodegradable material selected for a greater
rate of biodegradation or active agent (24) release (or both) relative to the second annular zone
(31) which can provide a biocompatible biodegradable material selected for a lesser rate of
biodegradation or active agent (24) release (or both). In that configuration of the intraocular
implant (11), the prominent function of the first annular zone (30) can be to provide a
pharmaceutical barrier or treatment of an ocular disorder, while the prominent function of the
second annular zone (31) can be to provide a structural barrier or treatment of an ocular
disorder. In particular embodiments of the intraocular implant for the inhibition of PCO, the
first annular zone can be made of the biocompatible biodegradable material poly(lactide-co-
glycolide) having an active agent (24) such as alkylphosphocholine dispersed substantially
uniformly through out which can provide a pharmaceutical barrier to the proliferation of LECs
on the surface of the posterior capsule (5) to inhibit or prevent PCO by release of a therapeutic
level of alkylphosphocholine of about 1.0 mM for a period of at least about five days. The first
annular zone (30) can substantially biodegrade in the entirety in a period of about five days to
about ten days. The second annular zone can be made of the same biocompatible
biodegradable material having the same or different active agent (24) dispersed substantially
uniformly throughout to provide both a structural barrier to inhibit migration of LECs toward
to the surface of the posterior capsule and can provide a pharmaceutical barrier by release of
the same or different active agent (24) such as alkylphosphocholine at a therapeutic level or
provide a localized concentration of about 1.0 mM for a period of at least twenty days to
inhibit or prevent PCO.
Again referring generally to Figures 5 through 11, 17 through 20, and 35 through 36,
particular embodiments of the intraocular implant (11) can further include an aperture element
(32) having a passage opening (33) sufficiently large to align with the visual axis of the eye
(21) to provide a line of sight which passes through the intraocular implant (11) or the first
annular zone (30) or the second annular zone (31).
While the aperture element (32) shown in Figures 5 through 11, 17 through 20, and 35
through 39 define a substantially circular passage opening having a diameter in the range of
about 1.5 mm and about 9 mm depending upon the application and the recipient; the invention
is not so limited and certain embodiments of the intraocular implant (11) can provide an
aperture element (32) which defines an oval, square, triangle, or other configuration of passage
opening (33) sufficient to provide a line of sight which passes through the intraocular implant
(11). As to those embodiments which are utilized with an intraocular optical implant, such as
an IOL as further described herein, the passage opening (33) can be dimensioned in relation to
the intraocular optical implant to avoid reduction in the field of vision provided by the
intraocular optical implant or to avoid a reduction in clarity of vision within visual field.
Alternately, in those embodiments in which the passage opening (33) has insufficient
dimension to avoid overlaying all or part of the visual field afforded by the intraocular optical
implant, embodiments of the intraocular implant (11) can be further configured to provide an
optical element of sufficient clarity so as not to substantially effect vision within the visual
field afforded by an intraocular implant (11).
Now referring specifically to Figures 18, and 36 through 38, the aperture element (33)
can further include one or more radial slit elements (14) each originating at the aperture
element (33) and terminating at a distance from the outer boundary (13) of the flexible
membrane (12). The one or more radial slit elements (14) can have sufficient length and width
to allow the flexible membrane (12) to conform to a greater extent with the concavity of the
posterior capsule (5)(or other localized region) of the eye and with respect to embodiments of
the intraocular implant (11) which are biodegradable can function to promote directional
biodegradation of the intraocular implant proximate the aperture element toward the outer
boundary (13). Again, the radial slit elements (14) can provide one or more interruptions in the
aperture element (32) which can be of lesser or greater width or length to control the rate at
which the flexible membrane (12) biodegrades within the posterior capsule (5) of the eye.
Now referring primarily to Figure 38, particular embodiments of the intraocular
implant (11) can further provide radial capillaries (34) which communicate between the outer
boundary (13) and the aperture element (32) of the flexible membrane (12) configured to allow
or facilitate circulation of the fluid within the eye, for example, between the flexible
membrane (12) and the posterior capsule (5) of the eye.
Similarly, as shown by Figure 39, particular embodiments of the intraocular implant
(11) can further provide one or more corrugate elements (35) which can be disposed in
substantially linear parallel relation to generate undulations in the flexible membrane (12)
sufficient when the flexible membrane (12) locates against the surface of the posterior capsule
(5)(or surface of a localized region) to provide channels (36) in which the fluids of the eye can
circulate.
Referring in general to Figures 5-39, embodiments of the intraocular implant can
further include an active agent (24)(shown as stipple pattern in Figures 18, 19, and 36 although
the invention is not so limited) mixed with or dispersed in the biodegradable polymer of the
flexible membrane (12). The composition of the biodegradable polymers of the flexible
membrane (12) of the intraocular implant (11) can be varied to provide a continuous or
substantially continuous release of a therapeutic level of a particular active agent (24) or a
particular mixture of active agents (24) effective for the ocular condition being treated. Active
agents (24) that can be used include, but are not limited to (either alone or in combination):
ace-inhibitors, endogenous cytokines, agents that influence the basement membrane, agents
that influence the growth of endothelial or epithelial cells, adrenergic agonists or blockers,
cholinergic agonists or blockers, aldose reductase inhibitors, analgesics, anesthetics,
antiallergics, anti-inflammatory agents, antihypertensives, pressors, antibacterials, antivirals,
antifungals, antiprotozoals, anti-infectives, antitumor agents, antimetabolites such as
daunomycin, antiangiogenic agents, tyrosine kinase inhibitors, antibiotics such as
aminoglycosides such as gentamicin, kanamycin, neomycin, and vancomycin; amphenicols
such as chloramphenicol; cephalosporins, such as cefazolin HCl; penicillins such as
ampicillin, penicillin, carbenicillin, oxycillin, methicillin; lincosamides such as lincomycin;
polypeptide antibiotics such as polymixin and bacitracin; tetracyclines such as tetracycline,
minocycline, and doxycycline; quinolones such as ciprofloxacin, moxifloxacin, gatifloxacin,
and levofloxacin; sulfonamides such as chloramine T; sulfones such as sulfanilic acid; anti-
viral drugs such as acyclovir, gancyclovir, vidarabine, azidothymidine, dideoxyinosine,
dideoxycytosine; epinephrine; isoflurphate; adriamycin; bleomycin; mitomycin; ara-C;
actinomycin D; scopolamine; and the like, analgesics, such as codeine, morphine, ketorolac,
naproxen, an anesthetic, lidocaine; beta.-adrenergic blocker or beta.-adrenergic agonist such as
ephedrine, and epinephrine; aldose reductase inhibitor such as epalrestat, ponalrestat, sorbinil,
tolrestat; antiallergic such as cromolyn, beclomethasone, dexamethasone, and flunisolide;
colchicine, anihelminthic agents such as ivermectin and suramin sodium; antiamebic agents
such as chloroquine and chlortetracycline; and antifungal agents such as amphotericin; anti-
angiogenesis compounds such as anecortave acetate; retinoids such as Tazarotene, anti-
glaucoma agents such as brimonidine (Alphagan and Alphagan P), acetozolamide, bimatoprost
(Lumigan), timolol, mebefunolol; memantine; alpha-2 adrenergic receptor agonists; 2-
methoxyestradiol; anti-neoplastics such as vinblastine, vincristine, interferons; alpha, beta and
gamma., antimetabolites such as folic acid analogs, purine analogs, and pyrimidine analogs;
immunosuppressants such as azathyprine, cyclosporine and mizoribine; miotic agents, such as
carbachol, mydriatic agents such as atropine, etc., protease inhibitors such as aprotinin,
camostat, gabexate, vasodilators such as bradykinin, epidermal growth factor, basic fibroblast
growth factor, nerve growth factors, steroidal anti-inflammatory agents such as 21-
acetoxypregnenolone, alclometasone, algestone, amcinonide, beclomethasone, betamethasone,
budesonide, chloroprednisone, clobetasol, clobetasone, clocortolone, cloprednol,
corticosterone, cortisone, cortivazol, deflazacort, desonide, desoximetasone, dexamethasone,
diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort, flucloronide, flumethasone,
flunisolide, fluocinolone acetonide, fluocinonide, fluocortin butyl, fluocortolone,
fluorometholone, fluperolone acetate, fluprednidene acetate, fluprednisolone, flurandrenolide,
fluticasone propionate, formocortal, halcinonide, halobetasol propionate, halometasone,
halopredone acetate, hydrocortamate, hydrocortisone, loteprednol etabonate, mazipredone,
medrysone, meprednisone, methylprednisolone, mometasone furoate, paramethasone,
prednicarbate, prednisolone, prednisolone 25-diethylamino-acetate, prednisolone sodium
phosphate, prednisone, prednival, prednylidene, rimexolone, tixocortol, triamcinolone,
triamcinolone acetonide, triamcinolone benetonide, triamcinolone hexacetonide; vascular
endothelial growth factor inhibitors such as bevacizumab, ranibisumab, pegatanib;
transforming growth factor inhibitors; fibroblast growth factor inhibitors, and any of their
derivatives.
As to particular embodiments of the intraocular implant the active agent (24) can be
dispersed throughout the biocompatible biodegradable polymer of the flexible membrane (12)
by mixing the active agent (24) into the melted biodegradable polymer and then solidifying the
resulting biodegradable polymer by cooling, having the active agent (24) substantially
uniformly dispersed throughout. The biodegradable polymer or mixture of biodegradable
polymers can be selected to have a melting point that is below the temperature at which the
active agent (24) becomes reactive or degrades. Alternatively, the active agent (24) can be
dispersed throughout the biodegradable polymer by solvent casting, in which the
biodegradable polymer is dissolved in a solvent, and the active agent (24) dissolved or
dispersed in the solution. The solvent is then evaporated, leaving the active agent (24) in the
polymeric matrix of the biodegradable material. Solvent casting requires that the
biodegradable polymer be soluble in organic solvents. Alternatively, the biodegradable
intraocular implant (11) can be placed in a solvent having a concentration of the active agent
(24) dissolved and in which the biodegradable intraocular implant swells. Swelling of the
biodegradable intraocular implant draws in an amount of the active agent (24). The solvent can
then be evaporated leaving the active agent (24) within the flexible membrane (12) of the
biodegradable intraocular implant (12). As to each method of dispersing the active agent (24)
through out the biodegradable polymer of the flexible membrane (12), therapeutic levels of
active agent (24) can be included in biocompatible biodegradable polymer to treat a particular
ocular condition. The biodegradable polymer usually comprises at least about 10, at least
about 20, at least about 30, at least about 40, at least about 50, at least about 60, at least about
70, at least about 80, or at least about 90 weight percent of the implant with the balance of the
weight being the active agent (24) or other non-active agents (37) dispersed in the
biocompatible biodegradable polymer (shown as open stipples in Figures 9 and 13; however,
the non-active agents are not limited to these particular embodiments of the flexible membrane
(12)).
Other non-active agents (37) may be included in the biocompatible biodegradable
polymer formulation for a variety of purposes. For example, buffering agents and
preservatives may be employed. Preservatives which may be used include, but are not limited
to, sodium bisulfite, sodium bisulfate, sodium thiosulfate, benzalkonium chloride,
chlorobutanol, thimerosal, phenylmercuric acetate, phenylmercuric nitrate, methylparaben,
polyvinyl alcohol and phenylethyl alcohol. Examples of buffering agents that may be
employed include, but are not limited to, sodium carbonate, sodium borate, sodium phosphate,
sodium acetate, sodium bicarbonate, and the like, as approved by the FDA for the desired
route of administration. Electrolytes such as sodium chloride and potassium chloride may also
be included in the formulation.
A non-limiting example of producing biodegradable embodiments the intraocular
implant for treating an ocular condition such as PCO can be made by mixing an active agent
(24) and biodegradable polymer to form an active agent polymer material. The active agent
polymer material can be extruded or molded to form embodiments of the biocompatible
biodegradable intraocular implant (11) or flexible membrane (12) having active agent release
characteristics at a therapeutic level. As but one non-limiting example, the intraocular implant
(11) can substantially continuously release active agent (24) to provide a localized
concentration of alkylphosphocholine at therapeutic levels of about 0.5 mM to 1.5 mM for at
least 5 days or release mitomycin-C to provide a localized concentration of 0.04 mg/mL, or
both, for a period of at least about five days to inhibit or prevent PCO. It is to be understood
that this specific example of providing an embodiment of an intraocular implant (11) for the
inhibition or prevention of PCO, is not intended to be limiting, and embodiments of the
intraocular implant (11) can be utilized to treat a wide range of ocular conditions including
posterior ocular conditions or anterior chamber conditions of the eye.
Embodiments of the biocompatible flexible membrane (12) or the biocompatible
biodegradable flexible membrane (12) can be made by a variety of methods, and while not
particularly limited, examples of molding methods which can be used to form a film or sheet
includes T-die molding, inflation molding, calender molding, heat press molding, spin cast
molding, injection molding, cast molding, or the like.
The intraocular implant (11) of a biodegradable polymer can be molded in thinner
thickness in order to increase biodegradability, but its thickness can be freely adjusted to
satisfy strength, flexibility and release of active agents (24) to achieve therapeutically effective
levels localized to the site of implantation of the intraocular implant. Thickness of the flexible
membrane can be in the range of about 5 μm to about 300 μm, or about 10 μm to 100 μm.
Elastic modulus of the flexible can generally be 1,200 MPa or less, more preferably 600 MPa
or less. Tensile strength can fall in the range of about 10 MPa to 100 MPa, more preferably in
a range of 15 MPa to 70 MPa, further more preferably in a range of 20 MPa to 50 MPa.
Again referring primarily to Figures 1-4, as above described the most common surgical
technique of cataract surgery may be ECCE (although use of the intraocular implant (11) is not
limited to cataract surgery or to any particular technique of cataract surgery) which involves
the creation of a circular opening (44) in the anterior lens capsule (43) through which the
opacified lens (3) can be removed. The remaining portion of the lens capsule (45), anchored to
the ciliary body (6) through the zonular fibers (7) can be left intact. The IOL (8) can then be
placed within the lens capsule (45). The IOL (8) can be acted on by zonular forces exerted on
the outer circumference of the lens capsule (45) which establishes the location of the IOL (8)
within the lens capsule (45). The intact posterior capsule (5) acts as a barrier to the vitreous
humor (9).
Now referring primarily to Figures 40 through 42, following cataract extraction and
cortex removal by ECCE or other surgical procedures to treat other ocular conditions,
embodiments of the biocompatible or biocompatible biodegradable intraocular implant (11)
can be held in forceps (38) as shown for example in Figure 40. Embodiments of the intraocular
implant (11) may also be removably fixed to the surface of a small card (41)(or intraocular
implant packaging substrate) from which it can be lifted with the forceps (38) prior to insertion
into the eye as shown for example in Figures 41 and 42. The intraocular implant (11) can be
folded upon itself to reduce the apparent dimension for passage through the corneal or scleral
incision (42) as well as circular opening (44) in the anterior lens capsule (43) surrounded by
the pupil (39) of the iris (40), as shown in Figures 40-42.
Now referring specifically to Figure 42, which provides an example of a non-limiting
method, the intraocular implant (11) can be positioned within localized region of the lens
capsule (45) having a front surface (18)(which can further provide patterned surface elements
(20) as above described) proximate the surface or engaging the surface of the posterior capsule
(5). The passage opening (33), of embodiments of the intraocular implant (11) which provide
an aperture element (32), can be aligned with the visual axis of the eye (21) to provide a line of
sight which passes through the passage opening (33) of the intraocular implant (11)(or the first
annular zone or the second annular zone of the intraocular implant). The IOL (8) can then be
located inside the lens capsule (45) by conventional methods to overlay the intraocular implant
(11) placed in the cavity of the posterior capsule (5).
As a non-limiting example, Figure 43 shows the IOL (8) overlying the intraocular
implant (11) with the passage opening (33) of the aperture element (32) centered underneath
the IOL (8). If centration of the intraocular implant (11) is not adequate, it can be readily
manipulated into position with a Sinskey Hook or similar instrument. Once implanted into the
eye, particular embodiments of the biocompatible biodegradable intraocular implant (12) can
biodegrade as above described with normal turnover of the fluid of the eye.
Now referring primarily to Figure 44, a non-limiting example of an embodiment of the
intraocular implant (11) shown in Figures 6 and 11 having an annular member (74) can be
placed in the cavity of the posterior capsule (5) with the edge (80) of the annular member (74)
located proximate the perimeter of the sulcus (81) of the lens capsule (45). The IOL (8) can be
located in the lens capsule (45) by conventional methods to overlay the intraocular implant
(11) with the haptics (10) engaged with the inside surface (77) of the annular member (74) and
the lens of the IOL (8) substantially centered with the visual axis (21).
Now referring primarily to Figure 45, a non-limiting example of a one-piece
intraocular implant (11) as shown in Figures 12 and 13 can be placed in the cavity of the
posterior capsule (5) with the edge (80) of the annular member (74) located proximate the
sulcus of the lens capsule (45). The one piece IOL (8) can be located in the lens capsule (45)
by conventional methods to align the lens of the one piece IOL (8) with the visual axis (21).
Now referring primarily to Figure 45, in those surgical procedures in which the natural
crystalline lens (3) is not removed such as retinal surgery, cornea transplant surgery, glaucoma
surgery, or the like, or in cataract surgery in which the intraocular implant (11) is not located
posterior the IOL (8) (for example, due to posterior capsule tear), the intraocular implant (12)
can be placed anterior to the natural lens (3) or the IOL (8) within the ciliary sulcus.
Now referring primarily to Figures 47 and 48, contemplated herein is a intraocular
implant packaging substrate (41) on which embodiments of the intraocular implant (11) can be
releasably fixed. The intraocular implant (11) can be removed by manipulation with forceps
(38) for use in various applications as above described.
As can be easily understood from the foregoing, the basic concepts of the present
invention may be embodied in a variety of ways. The invention involves numerous and varied
embodiments of an intraocular implant (11) which as to particular embodiments can be used
but is not limited to control of migration of residual lens epithelial cells between the posterior
surface of an IOL (8) and the surface of the posterior capsule (5) of the eye to reduce
opacification of the posterior capsule (5).
As such, the particular embodiments or elements of the invention disclosed by the
description or shown in the figures or tables accompanying this application including the best
mode are not intended to be limiting, but rather exemplary of the numerous and varied
embodiments generically encompassed by the invention or equivalents encompassed with
respect to any particular element thereof. In addition, the specific description of a single
embodiment or element of the invention may not explicitly describe all embodiments or
elements possible; many alternatives are implicitly disclosed by the description and figures.
It should be understood that each element of an apparatus or each step of a method may
be described by an apparatus term or method term. Such terms can be substituted where
desired to make explicit the implicitly broad coverage to which this invention is entitled. As
but one example, it should be understood that all steps of a method may be disclosed as an
action, a means for taking that action, or as an element which causes that action. Similarly,
each element of an apparatus may be disclosed as the physical element or the action which that
physical element facilitates. As but one example, the disclosure of “an implant” should be
understood to encompass disclosure of the act of “implanting” -- whether explicitly discussed
or not -- and, conversely, were there effectively disclosure of the act of “implanting”, such a
disclosure should be understood to encompass disclosure of “an implant” and even a “means
for implanting.” Such alternative terms for each element or step are to be understood to be
explicitly included in the description.
In addition, as to each term used it should be understood that unless its utilization in
this application is inconsistent with such interpretation, common dictionary definitions should
be understood to included in the description for each term as contained in the Random House
Webster’s Unabridged Dictionary, second edition, each definition hereby incorporated by
reference.
Thus, the applicant(s) should be understood to claim at least: i) each of the intraocular
implants herein disclosed and described, ii) the related methods disclosed and described, iii)
similar, equivalent, and even implicit variations of each of these devices and methods, iv)
those alternative embodiments which accomplish each of the functions shown, disclosed, or
described, v) those alternative designs and methods which accomplish each of the functions
shown as are implicit to accomplish that which is disclosed and described, vi) each feature,
component, and step shown as separate and independent inventions, vii) the applications
enhanced by the various systems or components disclosed, viii) the resulting products
produced by such systems or components, ix) methods and apparatuses substantially as
described hereinbefore and with reference to any of the accompanying examples, x) the
various combinations and permutations of each of the previous elements disclosed.
The background section of this patent application provides a statement of the field of
endeavor to which the invention pertains. This section may also incorporate or contain
paraphrasing of certain United States patents, patent applications, publications, or subject
matter of the claimed invention useful in relating information, problems, or concerns about the
state of technology to which the invention is drawn toward. It is not intended that any United
States patent, patent application, publication, statement or other information cited or
incorporated herein be interpreted, construed or deemed to be admitted as prior art with
respect to the invention.
The claims set forth in this specification, if any, are hereby incorporated by reference
as part of this description of the invention, and the applicant expressly reserves the right to use
all of or a portion of such incorporated content of such claims as additional description to
support any of or all of the claims or any element or component thereof, and the applicant
further expressly reserves the right to move any portion of or all of the incorporated content of
such claims or any element or component thereof from the description into the claims or vice-
versa as necessary to define the matter for which protection is sought by this application or by
any subsequent application or continuation, division, or continuation-in-part application
thereof, or to obtain any benefit of, reduction in fees pursuant to, or to comply with the patent
laws, rules, or regulations of any country or treaty, and such content incorporated by reference
shall survive during the entire pendency of this application including any subsequent
continuation, division, or continuation-in-part application thereof or any reissue or extension
thereon.
The claims set forth in this specification, if any, are further intended to describe the
metes and bounds of a limited number of the preferred embodiments of the invention and are
not to be construed as the broadest embodiment of the invention or a complete listing of
embodiments of the invention that may be claimed. The applicant does not waive any right to
develop further claims based upon the description set forth above as a part of any continuation,
division, or continuation-in-part, or similar application.
Claims (37)
1. An intraocular implant, comprising: a) a biocompatible flexible membrane having flat front and back surfaces disposed a uniform thickness apart, said biocompatible flexible membrane configured to be implanted between an 5 intraocular lens and a surface of a posterior capsule of an eye, said biocompatible flexible membrane having an outer boundary which defines a circular area having a diameter of between about 9 millimeters and about 15 millimeters, said outer boundary configured to be located proximate an outer circumference of said posterior capsule; b) patterned surface elements coupled to at least one of said front surface and said back surface 10 of said biocompatible flexible membrane, said patterned surface elements having dimensional relations adapted to inhibit migration of cells between said intraocular lens and said surface of said posterior capsule of said eye; and c) an aperture element which defines a passage opening capable of providing fluid communication to said intraocular implant between said front surface and said back surface of 15 said biocompatible flexible membrane, said passage opening configured to intraocularly align in a visual axis of said eye with said outer boundary configured to be located proximate said outer circumference of said posterior capsule, thereby providing a line of sight which passes through said passage opening.
2. The intraocular implant of claim 1, wherein said aperture element defines a generally 20 circular passage opening.
3. The intraocular implant of claim 2, wherein said generally circular passage opening has a diameter in the range of about 1.5 millimeter to about 9 millimeters.
4. The intraocular implant of claim 1, wherein said patterned surface elements couple to said back surface of said biocompatible flexible membrane, said patterned surface elements 25 adapted to engage said surface of said posterior capsule of said eye.
5. The intraocular implant of claim 1, wherein said patterned surface elements couple to said front surface of said biocompatible flexible membrane, said patterned surface elements adapted to engage said intraocular implant.
6. The intraocular implant of claim 1, wherein said patterned surface elements couple to said back surface and to said front surface of said biocompatible flexible membrane.
7. The intraocular implant of claim 1, wherein said patterned surface elements are selected from the group consisting of: a plurality of raised elements which project outwardly from said 5 surface of said biocompatible flexible membrane in spaced apart relation, said plurality of raised elements bounded by a corresponding plurality of channels, and a plurality of recessed elements which project inwardly from said surface of said biocompatible flexible membrane in spaced apart relation, said plurality of recessed elements bounded by a corresponding plurality of spacer elements. 10
8. The intraocular implant of claim 7, wherein each of said plurality of raised elements and each of said plurality of channel elements or each of said plurality of recessed elements and each of said plurality of spacer elements have dimensions sufficiently less than each one of said cells.
9. The intraocular implant of claim 8, wherein said cells comprise lens epithelial cells. 15
10. The intraocular implant of claim 7, wherein said plurality of raised surface elements and said plurality of recessed elements coupled to said biocompatible flexible membrane in spaced apart relation correspondingly dispose said plurality of channel elements or said plurality of spacer elements in a non-linear path inwardly approaching a center of said intraocular implant.
11. The intraocular implant of claim 7, wherein each of said plurality of channel elements has 20 a channel width in a range of about 100 nanometers and about 2 micrometers.
12. The intraocular implant of claim 11, wherein each of said plurality of channel elements has a channel width selected from the group consisting of: 100 nanometers and about 300 nanometers, about 200 nanometers and about 400 nanometers, about 300 nanometers and about 500 nanometers, about 400 nanometers and about 600 nanometers, about 500 25 nanometers and about 700 nanometers, about 600 nanometers and about 800 nanometers, about 700 nanometers and about 900 nanometers, about 800 nanometers and about 1 micrometer, about 900 nanometers and about 1.1 micrometer, 1 micrometer an about 1.2 micrometer, 1.1 micrometer and about 1.3 micrometer, 1.2 micrometer and about 1.4 micrometer, 1.3 micrometer and about 1.5 micrometers, 1.4 micrometer and about 1.6 30 micrometer, 1.5 micrometer and about 1.7 micrometer, 1.6 micrometer and about 1.8 micrometer, 1.7 micrometer and about 1.9 micrometer, and about 1.8 micrometer and about 2 micrometer, and combinations thereof.
13. The intraocular implant of claim 7, wherein each of said plurality of raised elements has a top surface having a lesser dimension in a range of about 500 nanometers and about 4 5 micrometers.
14. The intraocular implant of claim 13, wherein said lesser dimension is selected from the group consisting of: about 400 nanometers and about 1 micrometer, about 500 nanometers and about 1.5 micrometer, 1 micrometer an about 2.0 micrometer, 1.5 micrometer and about 2.5 micrometer, 2.0 micrometer and about 3.0 micrometer, 2.5 micrometer and about 3.5 10 micrometers, 3.0 micrometer and about 4.0 micrometer, and 3.5 micrometer and about 4.0 micrometer, and combinations thereof.
15. The intraocular implant of claim 13, wherein each of said plurality of raised elements has a sidewall having a sidewall height between said back surface of said biocompatible flexible membrane and said top surface of each of said plurality of raised elements in a range of about 15 400 nanometers and about 2 micrometers.
16. The intraocular implant of claim 15, wherein said sidewall height is selected from the group consisting of: about 400 nanometers and about 600 nanometers, about 500 nanometers and about 700 nanometers, about 600 nanometers and about 800 nanometers, about 700 nanometers and about 900 nanometers about 800 nanometers and about 1 micrometer, about 20 900 nanometers and about 1.1 micrometer, 1 micrometer an about 1.2 micrometer, 1.1 micrometer and about 1.3 micrometer, 1.2 micrometer and about 1.4 micrometer, 1.3 micrometer and about 1.5 micrometers, 1.4 micrometer and about 1.6 micrometer, 1.5 micrometer and about 1.7 micrometer, 1.6 micrometer and about 1.8 micrometer, 1.7 micrometer and about 1.9 micrometer, and about 1.8 micrometer and about 2 micrometer, and 25 combinations thereof.
17. The intraocular implant of claim 7, wherein said plurality of raised surface elements comprise a plurality of raised bars generally disposed in parallel spaced apart relation to provide said plurality of channels, each of said plurality of bars having a bar width in the range of about 1 micrometer and about 2 micrometers and said sidewall height in a range of about 1 30 micrometer and about 2 micrometers, each of said plurality of channels having a channel width in a range of about 500 nanometers and about 1 micrometer, said plurality of bars having unequal length disposed to form a diamond pattern on said back surface of said biocompatible flexible membrane, said diamond pattern having a diamond length in the range of a about 15 micrometers and about 25 micrometers and a diamond width in a range of about 10 micrometers and about 15 micrometers. 5
18. The intraocular implant of claim 17, wherein said plurality of raised surface elements comprise a plurality of raised bars generally disposed in parallel spaced apart herringbone relation, each of said plurality of bars having a width in a range of about 1 micrometer and about 3 micrometer, and a length in a range of about 5 micrometer and about 15 micrometer, and a height in a range of about 1 micrometer and about 2 micrometer. 10
19. The intraocular implant of claim 7, wherein said plurality of raised surface elements comprise: a) a plurality of raised bars generally disposed in parallel spaced apart relation, each of said plurality of raised bars of having substantially equal length disposed between a first end and a second end, said first ends and said second ends substantially aligned; and 15 b) at least one raised bar disposed in generally parallel perpendicular opposed relation to aligned said first ends or said second ends, each of said bars having a width in a range of about 1 micrometer and about 3 micrometer and a length in a range of about 5 micrometer and about 15 micrometer and a height in a range of about 1 micrometer and about 2 micrometers.
20. The intraocular implant of claim 7, wherein said plurality of raised surface elements 20 comprise a plurality of hexagonal prisms disposed on said back surface of said intraocular implant in regular spaced apart tessellation to provide said top surface in the form of a regular hexagon having a width between a pair of sides in a range of about 400 nanometers and about 600 nanometers, and a sidewall height in a range of about 1 micrometer and about 2 micrometers, and a channel width between each pair of sidewalls of about 100 nanometers and 25 about 200 nanometers.
21. The intraocular implant of claim 7, wherein said plurality of raised surface elements comprise a plurality of cylinders disposed on said back surface of said intraocular implant generally in columns and rows relation to provide said top surface in generally a circular surface having a diameter in a range of about 400 nanometers and about 600 nanometers and a 30 sidewall height in a range of about 1 micrometer and about 2 micrometers, said plurality of cylinders established on centers in a range of about 600 nanometers and about 1 micrometer which establishes said channel width between each pair of sidewalls of about 200 nanometers and about 400 nanometers.
22. The intraocular implant of claim 7, wherein each of said plurality of spacer elements has a 5 spacer width in a range of about 100 nanometers and about 2 micrometers.
23. The intraocular implant of claim 22, wherein each of said plurality of spacer elements has a width selected from the group consisting of 100 nanometers and about 300 nanometers, about 200 nanometers and about 400 nanometers, about 300 nanometers and about 500 nanometers, about 400 nanometers and about 600 nanometers, about 500 nanometers and 10 about 700 nanometers, about 600 nanometers and about 800 nanometers, about 700 nanometers and about 900 nanometers about 800 nanometers and about 1 micrometer, about 900 nanometers and about 1.1 micrometer, 1 micrometer an about 1.2 micrometer, 1.1 micrometer and about 1.3 micrometer, 1.2 micrometer and about 1.4 micrometer, 1.3 micrometer and about 1.5 micrometers, 1.4 micrometer and about 1.6 micrometer, 1.5 15 micrometer and about 1.7 micrometer, 1.6 micrometer and about 1.8 micrometer, 1.7 micrometer and about 1.9 micrometer, and about 1.8 micrometer and about 2 micrometer, and combinations thereof.
24. The intraocular implant of claim 7, wherein each of said plurality of recessed elements has a bottom surface having a lesser dimension in a range of about 500 nanometers and about 4 20 micrometers.
25. The intraocular implant of claim 24, wherein said lesser dimension is selected from the group consisting of about 400 nanometers and about 1 micrometer, about 500 nanometers and about 1.5 micrometer, 1 micrometer an about 2.0 micrometer, 1.5 micrometer and about 2.5 micrometer, 2.0 micrometer and about 3.0 micrometer, 2.5 micrometer and about 3.5 25 micrometers, 3.0 micrometer and about 4.0 micrometer, and 3.5 micrometer and about 4.0 micrometer, and combinations thereof.
26. The intraocular implant of claim 24, wherein each of said plurality of recessed elements has a sidewall having a sidewall height between said surface of said biocompatible flexible membrane and said bottom surface of each of said plurality of recessed elements in a range of 30 about 400 nanometers and about 2 micrometers.
27. The intraocular implant of claim 26, wherein said sidewall height is selected from the group consisting of about 400 nanometers and about 600 nanometers, about 500 nanometers and about 700 nanometers, about 600 nanometers and about 800 nanometers, about 700 nanometers and about 900 nanometers about 800 nanometers and about 1 micrometer, about 5 900 nanometers and about 1.1 micrometer, 1 micrometer an about 1.2 micrometer, 1.1 micrometer and about 1.3 micrometer, 1.2 micrometer and about 1.4 micrometer, 1.3 micrometer and about 1.5 micrometers, 1.4 micrometer and about 1.6 micrometer, 1.5 micrometer and about 1.7 micrometer, 1.6 micrometer and about 1.8 micrometer, 1.7 micrometer and about 1.9 micrometer, and about 1.8 micrometer and about 2 micrometer, and 10 combinations thereof.
28. The intraocular implant of claim 7, wherein said plurality of recessed elements comprise a plurality of recessed bars generally disposed in parallel spaced apart relation to provide said plurality of spacers, each of said plurality of bars having a bar width in the range of about 1 micrometer and about 2 micrometers and said sidewall height in a range of about 1 micrometer 15 and about 2 micrometers, each of said plurality of spacers having a spacer width in a range of about 500 nanometers and about 1 micrometer, said plurality of bars having unequal length disposed to form a diamond pattern on said surface of said biocompatible flexible membrane, said diamond pattern having a diamond length in the range of a about 15 micrometers and about 25 micrometers and a diamond width in a range of about 10 micrometers and about 15 20 micrometers.
29. The intraocular implant of claim 7, wherein said biocompatible flexible membrane is generated from a polymeric material selected from the group consisting of: polyurethane, polyisobutylene, ethylene-alpha-olefin copolymer, acrylic polymers, acrylic copolymers, vinyl halide polymer, vinyl halide copolymer, polyvinyl esters, polyvinylidene chloride, 25 polyacrylonitrile, polyvinyl ketones, polyvinyl aromatic, polystyrene, ethylene-methyl methacrylate copolymers, acrylonitrile-styrene copolymers, ABS resins, ethylene-vinyl acetate copolymers, polyamides, poly[imino(1,6-dioxohexamethylene)imnohexamethylene], polycaprolactone, alkyd resins, polycarbonates, polyoxyethylenes, polyimides, polyesters, epoxy resins, rayon-triacetate, and cellophane, and combinations thereof.
30 30. The intraocular implant of claim 7, wherein said biocompatible flexible membrane comprises a biodegradable biocompatible flexible membrane.
31. The intraocular implant of claim 30, wherein said biodegradable biocompatible flexible membrane is generated from a polymeric material selected from the group consisting of: polylactide polymers, copolymers of lactic and glycolic acids, polylactic acid-polyethylene oxide copolymers, poly(ε-caprolactone-co-L-lactic acid, glycine and polylactide copolymers, 5 polylactide copolymers involving polyethylene oxides, acetylated polyvinyl alcohol and polycaprolactone copolymers, hydroxybutyrate-hydroxyvalerate copolymers, polyesters of aspartic acid and aliphatic dials, poly(alkylene tartrates) and polyurethane copolymers, polyglutamates, biodegradable nonpeptidic polyamides, amino acid polymers, polyanhydride drug carriers poly(sebacic acid), aliphatic-aromatic homopolymers, poly(anhydride-co- 10 imides), poly(phosphoesters), poly(phosphazenes), poly(iminocarbonate), crosslinked poly(ortho ester), hydroxylated polyester-urethanes, hydrogels, and methylcellulose, and combinations thereof.
32. The intraocular implant of claim 17, wherein said pattern surface elements and said biocompatible flexible membrane or said biodegradable biocompatible flexible membrane 15 comprise different said polymeric materials.
33. The intraocular implant of claim 1, further comprising an annular member coupled to said front surface of said biocompatible membrane, said annular member having an edge which defines said outer boundary of said intraocular implant, said edge configured to be located proximate said perimeter of said outer circumference of said posterior capsule of said eye. 20
34. The intraocular implant of claim 33, wherein said edge has an external surface which intersects with said back surface of said intraocular implant at an angle which produces a corner sufficiently sharp to prevent or inhibit migration of cells toward the center of said intraocular implant.
35. The intraocular implant of claim 34, wherein said intersection of said external surface of 25 said edge of said annular member and said back surface of said flexible membrane occurs at an angle of between about 90 degrees and about 120 degrees.
36. The intraocular implant of claim 33, wherein said annular member has sufficient height to engage a haptics of said intraocular lens engaged with said front surface of said biocompatible membrane.
37. The intraocular implant of claim 1 substantially as described herein with reference to any one or more the figures.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/136,515 US8551167B2 (en) | 2008-11-20 | 2011-08-02 | Intraocular implant cell migration inhibition system |
US13/136,515 | 2011-08-02 | ||
US13/479,178 US20120232649A1 (en) | 2008-11-20 | 2012-05-23 | Intraocular Lens Cell Migration Inhibition System |
US13/479,178 | 2012-05-23 | ||
PCT/US2012/049176 WO2013019871A2 (en) | 2011-08-02 | 2012-08-01 | Intraocular implant cell migration inhibition system |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ621163A NZ621163A (en) | 2016-08-26 |
NZ621163B2 true NZ621163B2 (en) | 2016-11-29 |
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