WO2007065149A2 - Ocular implant - Google Patents

Ocular implant Download PDF

Info

Publication number
WO2007065149A2
WO2007065149A2 PCT/US2006/061477 US2006061477W WO2007065149A2 WO 2007065149 A2 WO2007065149 A2 WO 2007065149A2 US 2006061477 W US2006061477 W US 2006061477W WO 2007065149 A2 WO2007065149 A2 WO 2007065149A2
Authority
WO
WIPO (PCT)
Prior art keywords
band
needle
eye
medical device
loop
Prior art date
Application number
PCT/US2006/061477
Other languages
French (fr)
Other versions
WO2007065149A3 (en
WO2007065149A9 (en
Inventor
Leonard Pinchuk
Jean-Marie Parel
Original Assignee
Innfocus, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Innfocus, Llc filed Critical Innfocus, Llc
Publication of WO2007065149A2 publication Critical patent/WO2007065149A2/en
Publication of WO2007065149A3 publication Critical patent/WO2007065149A3/en
Publication of WO2007065149A9 publication Critical patent/WO2007065149A9/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/15Implant having one or more holes, e.g. for nutrient transport, for facilitating handling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F9/00Methods 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
    • A61F9/0008Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0017Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F9/00Methods 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
    • A61F9/007Methods or devices for eye surgery
    • A61F9/00727Apparatus for retinal reattachment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/16Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices

Definitions

  • This invention relates broadly to biocompatible implants for the eye. More particularly, this invention relates to scleral buckle type implants that encircle the equator of the eye.
  • Retinal detachment is a severe ophthalmological problem.
  • Scleral buckling is the traditional method for repairing retinal detachment.
  • the scleral buckle is a soft band currently made of silicone rubber. It is secured to the eye and presses the wall of the eye towards the middle of the eye. This brings the wall of the eye (the sclera) closer to the detached retina and combined with freezing treatment (cryotherapy) or laser treatment helps the retina re-attach.
  • freezing treatment cryotherapy
  • laser treatment helps the retina re-attach.
  • Sometimes scleral buckling is combined with vitrectomy. Also, special gases are sometimes placed in the eye at the time of surgery.
  • the buckle usually remains on the eye forever unless a problem develops and it needs to be removed. It is not visible under normal circumstances. Buckles are rarely removed unless infected or exposed (less than 1 in 100 cases). If there is need for removal, the procedure is extremely difficult due to the fibrous encapsulation of the silicone rubber.
  • Figure 1 shows an eye 1 with an iris 2, cornea 3, and a single rectus muscle 4 (the 3 other rectus muscles are not shown).
  • a prior art scleral buckle device is realized by an encircling band 6 that is looped around the equator 5 of eye 1 , under the rectus muscles 4 and looped back on itself and held in place by a friction fit in loop 7.
  • the buckling component 8, which causes the eye to buckle, is placed under band 6.
  • Band 6 is held in place with numerous mattress sutures 9 that are carefully placed in the sclera. These mattress sutures are usually placed prior to placing the band 6.
  • the traditional scleral buckle is therefore comprised of three components, an encircling band 6, a loop 7 and a buckle component 8.
  • Figure 2 is a cross section view of the encircling band 6 and buckle component 8. Note that the buckle component 8 is not designed to nest in itself.
  • Figures 3A, 3B and 3C show schematics of various prior art scleral buckles as used
  • Implanting a scleral buckle device into the ocular environment is time consuming with procedures lasting from 1 to 2 hours where a significant part of the procedure involves exposing the muscles of the eye and dissecting under these muscles to allow placement of the scleral buckle device.
  • fastening the scleral buckle onto itself is time consuming as the loop needs to be placed over both sides of the belt and often-times requires three hands.
  • the loop and belt need to be sized accurately to prevent slippage of the loop off of the belt.
  • the scleral buckle needs to be placed under the mattress sutures that are placed before installment of the scleral buckle.
  • the buckle component 8 which is placed under the band 6 to press the sclera to reattach the detached retina, must be of the correct thickness to enable this reattachment.
  • numerous thicknesses of buckles are stocked by the ophthalmologist to provide the correct thickness.
  • Age-Related Macular Degeneration is the leading cause of blindness in the elderly. AMD attacks the center of vision and blurs it, making reading, driving, and other detailed tasks difficult or impossible. About 200,000 new cases of ARMD occur each year in the United States alone. Current estimates reveal that approximately forty percent of the population over age 75, and approximately twenty percent of the population over age 60, suffer from some degree of macular degeneration. [0008] Currently, AMD is treated with drugs that are administered through intravitreal injections, repeated every six to eight weeks. This is considered highly undesirable to most patients, and compliance is a major problem. In order to prevent complications related to such injections and to provide better ocular treatment, researchers have suggested various implants aimed at localizing delivery of therapeutic agents to the eye.
  • U.S. Pat. No. 5,824,072 to Wong discloses a nonbiodegradable polymeric implant with a pharmaceutically active agent disposed therein.
  • the pharmaceutically active agent diffuses through the polymer body of the implant into the target tissue.
  • the pharmaceutically active agent may include drugs for the treatment of macular degeneration and diabetic retinopathy.
  • the implant is placed substantially within the tear fluid upon the outer surface of the eye over an avascular region, and may be anchored in the conjunctiva or sclera; episclerally or intrasclerally over an avascular region; substantially within the suprachoroidial space over an avascular region such as the pars plana or a surgically induced avascular region; or in direct communication with the vitreous.
  • U.S. Pat. No. 5,476,511 to Gwon et al. discloses a polymer implant for placement under the conjunctiva of the eye.
  • the implant may be used to deliver neovascular inhibitors for the treatment of AMD.
  • the pharmaceutically active agent diffuses through the polymer body of the implant.
  • a scleral buckle device and components thereof are provided that facilitate quick and efficient implantation into the ocular environment.
  • One or more components of the scleral buckle device can be realized from polymeric material(s), preferably SIBS material, that is loaded with one or more therapeutic agents for time-released delivery therefrom into the ocular environment.
  • the therapeutic agents can be selected as desired to treat a variety of eye diseases such as AMD.
  • the scleral buckle includes an elastomeric band for encircling the eye and a needle integrally affixed to one end of the band.
  • a loop is attached to an end of the band opposite the needle.
  • the loop defines a space sized to permit passage of the needle and the band therethrough.
  • the loop is adapted to keep opposing ends of the band together such that the band realizes a shape that encircles the eye.
  • the scleral buckle includes an elastomeric band for encircling the eye and a needle integrally affixed to one end of the band.
  • a set of holes pass through an end of the band opposite the needle. The holes permit passage of the needle and the band therethrough.
  • the set of holes is adapted to keep opposing ends of the band together such that the band realizes a shape that encircles the eye.
  • FIG. 1 is a schematic diagram of a prior art scleral buckle device, which is implanted into the ocular environment such that it encircles the eye.
  • FIG. 2 is a cross section view of the encircling band and buckle component of the prior art scleral buckle device of FIG. 1.
  • FIGS. 3A and 3B are diagrams of an eye illustrating the repair of a detached retina utilizing the prior art scleral buckle device of FIG. 1.
  • FIG. 3C is a photograph that shows a view of the prior art scleral buckle device of FIG. 1 positioned anteriorly relative to the equator of the globe.
  • FIG. 4 is a schematic view of a scleral buckle device in accordance with the present invention, in its initial configuration before implantation into the ocular environment.
  • FIG. 5 is a cross-sectional schematic view of the loop portion of the scleral buckle device of FIG. 4.
  • FIG. 6 is a schematic view of the scleral buckle device of FIG. 4, in its intended shape for encircling the equator of the eye.
  • FIG. 7 is a cross-sectional schematic view of stacked buckle components for use in conjunction with the scleral buckle device of FIG. 4 in accordance with the present invention; the stacked buckle components of FIG. 7 can also be used in conjunction with the prior art scleral buckle device of FIG. 1 or other scleral buckle devices in accordance with the present invention.
  • FIG. 8 is a schematic view of an alternate embodiment scleral buckle device in accordance with the present invention, in its initial configuration before implantation into the ocular environment.
  • FIG. 9 is a schematic illustration of a drug-eluting implant device in accordance with the present invention, which can be placed on the surface of the eye (or inside a pouch formed in the ocular tissue) to deliver therapeutic agents to the eye or to other parts of the ocular environment.
  • the scleral buckle device 20 includes a band 21 integrally attached to a suture or thread 22 which is integrally attached to a blunt needle 23.
  • a loop 24 On the opposite end of band 21 is a loop 24 that is integrally attached to band 21.
  • Figure 5 shows a cross section through loop 24 at X-X showing loop 24, band 21 and a space 25 disposed between the band 21 and the top wall of the loop 24.
  • the band 21 is permanently adhered to loop 24 at the contact plane 26 of the bottom wall of the loop.
  • the space 25 is sized such that the needle 23 and the opposite end of the loop 24 can be threaded therethrough.
  • FIG. 6 shows the scleral buckle 20 of the present invention in its intended encircling shape.
  • mattress sutures are placed about the equator of the eye in a manner similar to that shown in Figure 1.
  • Buckling component(s) 50 ( Figure 7) may be secured to the eye under the mattress sutures.
  • the needle 23 is threaded under the mattress sutures and rectus muscles of the eye (and over the buckling component(s) 50) and then through the space 25 in loop 24 such that the band 21 encircles the equator 5 of eye.
  • the buckling component(s) 50 when placed under the band 21, are used to press on the sclera to reattach the detached retina.
  • the sutures are tightened thereby tightening the encircling band 21 around the eye.
  • the band 21 can be cut with a scissors to trim of unwanted excess material (e.g., at the arrow 30) to complete the implant.
  • the loop 24 binds the two ends of the band 21 together.
  • loop 24 obviates the previous requirement of "pushing a rope" under the muscles and under the mattress sutures and has been shown to reduce the length of the procedure by at least 15 minutes.
  • the scleral buckle design is effectively secured to the eye with minimal migration and eye irritation.
  • FIG. 7 shows a novel design of a stacked buckle component 50.
  • the stacked buckle component 50 is configured by supplying a long length of buckle (e.g., one of the components 5OA of the stack) to the surgeon. At the operating table, the surgeon can cut the exact length of buckle required and stack them on top of each other to provide the optimum thickness desired.
  • the exemplary stacked configurations shows two buckle components 5OA, 5OB stacked upon one other. Although more then two such components can readily be stacked upon one another for increased thickness.
  • the bottom buckle component 5OB includes a floor 53 and sidewalls 55A and 55B that define an open recess therebetween.
  • the top buckle component 5OA includes a bottom 57 and sidewalls 59A, 59B that nests into the open recess of the bottom buckle 50B.
  • the sidewall 59A of the top buckle component 5OA rests against the corresponding sidewall 55A of the bottom buckle component 50B 1 the sidewall 59B of the top buckle component 5OA rests against the corresponding sidewall 55B of the bottom buckle component 5OB, and the bottom 57 of the top buckle component 5OA rests against the corresponding floor 53 of the bottom buckle component 5OB.
  • the stacked buckle components of FIG. 7 can be used under the encircling band 21 of the scleral buckle device 20 of FIG. 4.
  • the stacked buckle components of FIG. 7 can be used under the encircling band 6 of the prior art scleral buckle device of FIG. 1 , or possibly in conjunction with other scleral buckle devices.
  • the stacked buckle component 50 is(are) realized from a biocompatible elastomer, which is preferably made from a polyolefinic copolymer material having a triblock polymer backbone comprising polystyrene-polyisobutylene-polystyrene, which is herein referred to as "SIBS".
  • SIBS is sticky and will remain stacked in this embodiment without separation; however, to be prudent, the surgeon can place a mattress suture around this assembly to assure that it does not separate.
  • Other sticky biocompatible elastomeric material can be used well.
  • the band 21 and loop 24 are preferably realized from a biocompatible elastomer.
  • the elastomer can be made from SIBS material, silicone rubber, polyurethane, polyolefin, copolymers of nylon, copolymers of polyester, elastin, etc.
  • the materials can also be biodegradable such as polylactic acid or polyglycolic acid, and the like.
  • the preferred material for the band 21 and the loop 24 is SIBS due to its non-inflammatory ability, its low level of encapsulation, its lack of angiogenesis, its lack of degradation, its softness, and its ability to be loaded with drug.
  • the low level of encapsulation of the SIBS material allows for the improved scleral buckle device to be easily removed even after several weeks following implantation.
  • Attaching the needle 23 to the suture thread 22, attaching the suture thread 22 to the band 21 and attaching the loop 24 to the band 21 can be accomplished in a wide variety of ways.
  • the needle 23 can be swaged or epoxied to the suture thread 22, the suture thread 22 can be tied onto, melted into or glued onto the band 21.
  • melting the polymeric band 21 around the suture thread 22 is preferred (insert molding).
  • the loop 24 can be bonded to the band 21 with a solvent such as tetrahydrofuran, toluene and the like.
  • the loop 24 can be bonded to the band 21 with silicone adhesive.
  • SIBS is a polyolefinic copolymer material having a triblock polymer backbone comprising polystyrene-polyisobutylene-polystyrene.
  • SIBS can also be referred to as poly(styrene-b-isobutylene-b-styrene) where b stands for "block”.
  • High molecular weight polyisobutylene (PIB) is a soft elastomeric material with a Shore hardness of approximately 10A to 3OA. When copolymerized with polystyrene, it can be made at hardnesses ranging up to the hardness of polystyrene, which has a Shore hardness of 100D.
  • the SIBS material can have a range of hardnesses from as soft as Shore 10A to as hard as Shore 100D. In this manner, the SIBS material can be adapted to have the desired elastomeric and hardness qualities. Details of the SIBS material is set forth in U.S. Patent Nos. 5,741 ,331; 6,102,939; 6,197,240; 6,545,097, which are hereby incorporated by reference in their entirety.
  • the SIBS material of the scleral buckle may be polymerized under control means using carbocationic polymerization techniques such as those described in U.S. Patent Nos.
  • the styrene and isobutylene copolymer materials are preferably copolymerized in solvents.
  • the SIBS material is preferred due to its non-inflammatory ability, its low level of encapsulation, its lack of angiogenesis, its lack of degradation, its softness and its ability to be loaded with one or more therapeutic agents as described below. [0040] It is expected that alternative polymeric materials are suitable for the practice of the present invention.
  • Such alternative polymeric materials preferably include polyisobutylene-based material capped with a glassy segment.
  • the glassy segment provides a hardener component for the elastomeric polyisobutylene.
  • the glassy segment preferably does not contain any cleavable group which will release in the presence of body fluid in the ocular environment and cause toxic side effects and cell encapsulation.
  • the glassy segment can be a vinyl aromatic polymer (such as styrene, ⁇ -methylstyrene, or a mixture thereof), or a methacrylate polymer (such as methylmethacrylate, ethylmethacrylate, hydroxymethalcrylate, or a mixture thereof).
  • Such materials preferably have a general block structure with a central elastomeric polyolefinic block and thermoplastic end blocks. Even more preferably, such materials have a general structure:
  • X-(AB)n or X-(BA)n includes diblock, triblock and other radial block copolymers
  • A is an elastomeric polyolefinic block
  • B is a thermoplastic block
  • n is a positive whole number
  • X is a starting seed molecule.
  • the elastomeric material of the scleral buckle can be silicone rubber, polyurethane, polyolefin, copolymers of nylon, copolymers of polyester, elastin, etc.
  • a drug-eluding sponge (not shown) may be placed under the band 21.
  • the band 21 and/or the sponge can be loaded with a number of therapeutic agents, including: Paclitaxel, Macugen, Visudyne, Lucentis (rhuFab V2 AMD), Combretastatin A4 Prodrug, Squalamine, SnET2, H8, VEGF Trap, Cand5, LS 11 (Taporfin Sodium), AdPEDF, RetinoStat, Integrin, Panzem, Retaane, Anecortave Acetate, VEGFR-1 mRNA, ARGENT cell-signalling technology, Angiotensin Il Inhibitor, Accutane for Blindness, Macugen (PEGylated aptamer), PTAMD, Optrin, AK-1003, NX 1838, Antagonists of avb3 and 5, Neovastat, Eos 200-F and any other VEGF inhibitor.
  • Other therapeutic agents including:
  • a therapeutic agent of interest can be provided at the same time as the elastomer from which the device or device portion is realized, for example, by adding it to a polymer melt during thermoplastic processing or by adding it to a polymer solution during solvent-based processing.
  • a therapeutic agent can be provided after formation of the device or device portion.
  • the therapeutic agent can be dissolved in a solvent that is compatible with both the device polymer and the therapeutic agent.
  • the device polymer is at most only slightly soluble in this solvent. Subsequently, the solution is contacted with the device or device portion such that the therapeutic agent is loaded (e.g., by leaching/diffusion) into the copolymer.
  • the device or device portion can be immersed or dipped into the solution, the solution can be applied to the device or component, for example, by spraying, printing dip coating, immersing in a fluidized bed and so forth.
  • the device or component can subsequently be dried, with the therapeutic agent remaining therein.
  • the therapeutic agent may be provided within a matrix comprising the polymer of the device or device portion.
  • the therapeutic agent can also be covalently bonded, hydrogen bonded, or electrostatically bound to the polymer of the device.
  • nitric oxide releasing functional groups such as S-nitroso-thiols can be provided in connection with the polymer, or the polymer can be provided with charged functional groups to attach therapeutic groups with oppositely charged functionalities.
  • the therapeutic agent can be precipitated onto one or more surfaces of the device or device portion. These one or more surface(s) can be subsequently covered with a coating of polymer (with or without additional therapeutic agent) as described above.
  • the polymer is "loaded" with therapeutic agent, it is meant that the therapeutic agent is associated with the polymer in a fashion like those discussed above or in a related fashion.
  • the therapeutic agent(s) can be any of those listed above, or other suitable agent.
  • a scleral buckle device 20' in accordance with the present invention includes a band 21' with one end integrally attached to a blunt needle 23'. On the opposite end of band 21', two holes 6OA, 6OB are formed in the band 21'. The two holes 6OA, 6OB are spaced-apart lengthwise adjacent the end of the band 21' and are sized to enable the needle 23' to pass therethrough. For this design, implantation is accomplished in a manner similar to that described above for the scleral buckle of FIG. 4. However, instead of being reattached to itself by means of a loop, the band 21' is reattached to itself by means of the two holes 6OA, 6OB.
  • the needle tip 23' is looped around the eye and then weaved through the two holes 6OA, 6OB of the band 21'.
  • the band 21' follows such that it too passes through the two holes 6OA, 6OB and is reattached to itself.
  • the needle 23' and excess portion of the band 21' are cut off after reattachment.
  • the holes 60A, 6OB are adapted to keep the opposing ends of the band 21' together such that the band' realizes a shape that encircles the eye.
  • the blunt needle 23' is attached directly to the end of the band 21'. Such attachment can be realized by crimping or other suitable means.
  • the embodiment of FIG. 8 can realized from similar materials as that described above with respect to the embodiment of FIG. 4, and can also be loaded with therapeutic agents in the same manner as described above with respect to the embodiment of FIG. 4.
  • the embodiment of FIG. 8 is advantageous in that it has a lower profile and is easier to manufacture than the embodiment of FIG. 4.
  • the device 70 is small in size and preferably generally T- shaped in profile with a characteristic width on the order of .32mm and a characteristic length on the order of 0.395 mm as shown.
  • the device 70 can realized from similar materials as that described above with respect to the embodiment of FIG. 4, and can also be loaded with therapeutic agents in the same manner as described above with respect to the embodiment of FIG. 4.
  • the device 70 includes two holes 72A, 72B that can be used to suture the device to the implant site.
  • the device 70 can be sutured to the sclera or placed in a small pouch under the sclera. It can also be placed in the same area as a scleral buckle, but will not perform the scleral buckling action.

Abstract

A scleral buckle device and components thereof that facilitate quick and efficient implantation into the ocular environment. One or more components of the scleral buckle device can be realized from polymeric material(s), preferably SIBS material, that is loaded with one or more therapeutic agents for time-released delivery therefrom into the ocular environment. The therapeutic agents can be selected as desired to treat a variety of eye diseases such as age-related macular degeneration.

Description

OCULAR IMPLANT
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims benefits from U.S. Provisional Patent Application No. 60/741,390 filed December 1 , 2005, the contents of which are hereby incorporated herein by reference.
BACKGROUND OF THE INVENTION
FIELD OF THE INVENTION
[0002] This invention relates broadly to biocompatible implants for the eye. More particularly, this invention relates to scleral buckle type implants that encircle the equator of the eye.
STATE OF THE ART
[0003] Retinal detachment (RD) is a severe ophthalmological problem. Scleral buckling is the traditional method for repairing retinal detachment. The scleral buckle is a soft band currently made of silicone rubber. It is secured to the eye and presses the wall of the eye towards the middle of the eye. This brings the wall of the eye (the sclera) closer to the detached retina and combined with freezing treatment (cryotherapy) or laser treatment helps the retina re-attach. Sometimes scleral buckling is combined with vitrectomy. Also, special gases are sometimes placed in the eye at the time of surgery. The buckle usually remains on the eye forever unless a problem develops and it needs to be removed. It is not visible under normal circumstances. Buckles are rarely removed unless infected or exposed (less than 1 in 100 cases). If there is need for removal, the procedure is extremely difficult due to the fibrous encapsulation of the silicone rubber.
[0004] Figure 1 shows an eye 1 with an iris 2, cornea 3, and a single rectus muscle 4 (the 3 other rectus muscles are not shown). A prior art scleral buckle device is realized by an encircling band 6 that is looped around the equator 5 of eye 1 , under the rectus muscles 4 and looped back on itself and held in place by a friction fit in loop 7. The buckling component 8, which causes the eye to buckle, is placed under band 6. Band 6 is held in place with numerous mattress sutures 9 that are carefully placed in the sclera. These mattress sutures are usually placed prior to placing the band 6. The traditional scleral buckle is therefore comprised of three components, an encircling band 6, a loop 7 and a buckle component 8. Figure 2 is a cross section view of the encircling band 6 and buckle component 8. Note that the buckle component 8 is not designed to nest in itself. Figures 3A, 3B and 3C show schematics of various prior art scleral buckles as used in the eye.
[0005] Implanting a scleral buckle device into the ocular environment is time consuming with procedures lasting from 1 to 2 hours where a significant part of the procedure involves exposing the muscles of the eye and dissecting under these muscles to allow placement of the scleral buckle device. In addition, fastening the scleral buckle onto itself is time consuming as the loop needs to be placed over both sides of the belt and often-times requires three hands. Still further, the loop and belt need to be sized accurately to prevent slippage of the loop off of the belt. Still further, the scleral buckle needs to be placed under the mattress sutures that are placed before installment of the scleral buckle. Lastly, the buckle component 8, which is placed under the band 6 to press the sclera to reattach the detached retina, must be of the correct thickness to enable this reattachment. Currently numerous thicknesses of buckles are stocked by the ophthalmologist to provide the correct thickness.
[0006] Thus, there remains a need in the art to simplify the procedure for implanting a scleral buckle type implant for treating retinal detachment.
[0007] Separately, Age-Related Macular Degeneration (AMD) is the leading cause of blindness in the elderly. AMD attacks the center of vision and blurs it, making reading, driving, and other detailed tasks difficult or impossible. About 200,000 new cases of ARMD occur each year in the United States alone. Current estimates reveal that approximately forty percent of the population over age 75, and approximately twenty percent of the population over age 60, suffer from some degree of macular degeneration. [0008] Currently, AMD is treated with drugs that are administered through intravitreal injections, repeated every six to eight weeks. This is considered highly undesirable to most patients, and compliance is a major problem. In order to prevent complications related to such injections and to provide better ocular treatment, researchers have suggested various implants aimed at localizing delivery of therapeutic agents to the eye.
[0009] For example, U.S. Pat. No. 5,824,072 to Wong discloses a nonbiodegradable polymeric implant with a pharmaceutically active agent disposed therein. The pharmaceutically active agent diffuses through the polymer body of the implant into the target tissue. The pharmaceutically active agent may include drugs for the treatment of macular degeneration and diabetic retinopathy. The implant is placed substantially within the tear fluid upon the outer surface of the eye over an avascular region, and may be anchored in the conjunctiva or sclera; episclerally or intrasclerally over an avascular region; substantially within the suprachoroidial space over an avascular region such as the pars plana or a surgically induced avascular region; or in direct communication with the vitreous.
[0010] In another example, U.S. Pat. No. 5,476,511 to Gwon et al. discloses a polymer implant for placement under the conjunctiva of the eye. The implant may be used to deliver neovascular inhibitors for the treatment of AMD. The pharmaceutically active agent diffuses through the polymer body of the implant.
[0011] Each of the above-described implants suffer from limitations, including difficulty in effectively securing the implant to the eye, migration of the implant and eye irritation.
[0012] Thus, there remains a need in the art for a surgically implantable ophthalmic drug delivery device capable of safe, effective, rate-controlled, localized delivery of therapeutic agents for treating AMD or other diseases if the eye.
SUMMARY OF THE INVENTION
[0013] It is therefore an object of the invention to provide a scleral buckle device that simplifies the procedure for implanting the device for treating retinal detachment. [0014] It is another object of the invention to provide such a scleral buckle device that is effectively secured to the eye with minimal migration and eye irritation.
[0015] It is another object of the invention to provide such a scleral buckle design that provides buckles of quantum thickness without requiring an inventory of different sizes.
[0016] In accord with these objects, which will be discussed in detail below, a scleral buckle device and components thereof are provided that facilitate quick and efficient implantation into the ocular environment. One or more components of the scleral buckle device can be realized from polymeric material(s), preferably SIBS material, that is loaded with one or more therapeutic agents for time-released delivery therefrom into the ocular environment. The therapeutic agents can be selected as desired to treat a variety of eye diseases such as AMD.
[0017] According to one embodiment of the invention, the scleral buckle includes an elastomeric band for encircling the eye and a needle integrally affixed to one end of the band. A loop is attached to an end of the band opposite the needle. The loop defines a space sized to permit passage of the needle and the band therethrough. The loop is adapted to keep opposing ends of the band together such that the band realizes a shape that encircles the eye.
[0018] According to another embodiment of the invention, the scleral buckle includes an elastomeric band for encircling the eye and a needle integrally affixed to one end of the band. A set of holes pass through an end of the band opposite the needle. The holes permit passage of the needle and the band therethrough. The set of holes is adapted to keep opposing ends of the band together such that the band realizes a shape that encircles the eye.
[0019] Additional objects and advantages of the invention will become apparent to those skilled in the art upon reference to the detailed description taken in conjunction with the provided figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1 is a schematic diagram of a prior art scleral buckle device, which is implanted into the ocular environment such that it encircles the eye.
[0021] FIG. 2 is a cross section view of the encircling band and buckle component of the prior art scleral buckle device of FIG. 1.
[0022] FIGS. 3A and 3B are diagrams of an eye illustrating the repair of a detached retina utilizing the prior art scleral buckle device of FIG. 1.
[0023] FIG. 3C is a photograph that shows a view of the prior art scleral buckle device of FIG. 1 positioned anteriorly relative to the equator of the globe.
[0024] FIG. 4 is a schematic view of a scleral buckle device in accordance with the present invention, in its initial configuration before implantation into the ocular environment.
[0025] FIG. 5 is a cross-sectional schematic view of the loop portion of the scleral buckle device of FIG. 4.
[0026] FIG. 6 is a schematic view of the scleral buckle device of FIG. 4, in its intended shape for encircling the equator of the eye.
[0027] FIG. 7 is a cross-sectional schematic view of stacked buckle components for use in conjunction with the scleral buckle device of FIG. 4 in accordance with the present invention; the stacked buckle components of FIG. 7 can also be used in conjunction with the prior art scleral buckle device of FIG. 1 or other scleral buckle devices in accordance with the present invention.
[0028] FIG. 8 is a schematic view of an alternate embodiment scleral buckle device in accordance with the present invention, in its initial configuration before implantation into the ocular environment.
[0029] FIG. 9 is a schematic illustration of a drug-eluting implant device in accordance with the present invention, which can be placed on the surface of the eye (or inside a pouch formed in the ocular tissue) to deliver therapeutic agents to the eye or to other parts of the ocular environment.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0030] Turning now to FIG. 4, a scleral buckle device 20 in accordance with the present invention is shown in schematic form. The scleral buckle device 20 includes a band 21 integrally attached to a suture or thread 22 which is integrally attached to a blunt needle 23. On the opposite end of band 21 is a loop 24 that is integrally attached to band 21. Figure 5 shows a cross section through loop 24 at X-X showing loop 24, band 21 and a space 25 disposed between the band 21 and the top wall of the loop 24. Preferably, the band 21 is permanently adhered to loop 24 at the contact plane 26 of the bottom wall of the loop. The space 25 is sized such that the needle 23 and the opposite end of the loop 24 can be threaded therethrough.
[0031] Figure 6 shows the scleral buckle 20 of the present invention in its intended encircling shape. During use, mattress sutures are placed about the equator of the eye in a manner similar to that shown in Figure 1. Buckling component(s) 50 (Figure 7) may be secured to the eye under the mattress sutures. The needle 23 is threaded under the mattress sutures and rectus muscles of the eye (and over the buckling component(s) 50) and then through the space 25 in loop 24 such that the band 21 encircles the equator 5 of eye. The buckling component(s) 50, when placed under the band 21, are used to press on the sclera to reattach the detached retina. Once the band 21 is in place, the sutures are tightened thereby tightening the encircling band 21 around the eye. The band 21 can be cut with a scissors to trim of unwanted excess material (e.g., at the arrow 30) to complete the implant. The loop 24 binds the two ends of the band 21 together.
[0032] Advantageously, the design of loop 24 obviates the previous requirement of "pushing a rope" under the muscles and under the mattress sutures and has been shown to reduce the length of the procedure by at least 15 minutes. The scleral buckle design is effectively secured to the eye with minimal migration and eye irritation.
[0033] Figure 7 shows a novel design of a stacked buckle component 50. Preferably, the stacked buckle component 50 is configured by supplying a long length of buckle (e.g., one of the components 5OA of the stack) to the surgeon. At the operating table, the surgeon can cut the exact length of buckle required and stack them on top of each other to provide the optimum thickness desired. The exemplary stacked configurations shows two buckle components 5OA, 5OB stacked upon one other. Although more then two such components can readily be stacked upon one another for increased thickness.
[0034] Note that in the exemplary stacked configuration shown, the bottom buckle component 5OB includes a floor 53 and sidewalls 55A and 55B that define an open recess therebetween. The top buckle component 5OA includes a bottom 57 and sidewalls 59A, 59B that nests into the open recess of the bottom buckle 50B. In this nested configuration, the sidewall 59A of the top buckle component 5OA rests against the corresponding sidewall 55A of the bottom buckle component 50B1 the sidewall 59B of the top buckle component 5OA rests against the corresponding sidewall 55B of the bottom buckle component 5OB, and the bottom 57 of the top buckle component 5OA rests against the corresponding floor 53 of the bottom buckle component 5OB.
[0035] The stacked buckle components of FIG. 7 can be used under the encircling band 21 of the scleral buckle device 20 of FIG. 4. Alternatively, the stacked buckle components of FIG. 7 can be used under the encircling band 6 of the prior art scleral buckle device of FIG. 1 , or possibly in conjunction with other scleral buckle devices.
[0036] The stacked buckle component 50 is(are) realized from a biocompatible elastomer, which is preferably made from a polyolefinic copolymer material having a triblock polymer backbone comprising polystyrene-polyisobutylene-polystyrene, which is herein referred to as "SIBS". SIBS is sticky and will remain stacked in this embodiment without separation; however, to be prudent, the surgeon can place a mattress suture around this assembly to assure that it does not separate. Other sticky biocompatible elastomeric material can be used well.
[0037] The band 21 and loop 24 are preferably realized from a biocompatible elastomer. The elastomer can be made from SIBS material, silicone rubber, polyurethane, polyolefin, copolymers of nylon, copolymers of polyester, elastin, etc. The materials can also be biodegradable such as polylactic acid or polyglycolic acid, and the like. The preferred material for the band 21 and the loop 24 is SIBS due to its non-inflammatory ability, its low level of encapsulation, its lack of angiogenesis, its lack of degradation, its softness, and its ability to be loaded with drug. The low level of encapsulation of the SIBS material allows for the improved scleral buckle device to be easily removed even after several weeks following implantation.
[0038] Attaching the needle 23 to the suture thread 22, attaching the suture thread 22 to the band 21 and attaching the loop 24 to the band 21 can be accomplished in a wide variety of ways. For example, the needle 23 can be swaged or epoxied to the suture thread 22, the suture thread 22 can be tied onto, melted into or glued onto the band 21. For thermoforms, melting the polymeric band 21 around the suture thread 22 is preferred (insert molding). For SIBS or polyurethane, the loop 24 can be bonded to the band 21 with a solvent such as tetrahydrofuran, toluene and the like. Alternatively, for silicone rubber bands, the loop 24 can be bonded to the band 21 with silicone adhesive.
[0039] As described above, SIBS is a polyolefinic copolymer material having a triblock polymer backbone comprising polystyrene-polyisobutylene-polystyrene. SIBS can also be referred to as poly(styrene-b-isobutylene-b-styrene) where b stands for "block". High molecular weight polyisobutylene (PIB) is a soft elastomeric material with a Shore hardness of approximately 10A to 3OA. When copolymerized with polystyrene, it can be made at hardnesses ranging up to the hardness of polystyrene, which has a Shore hardness of 100D. Thus, depending on the relative amounts of styrene and isobutylene, the SIBS material can have a range of hardnesses from as soft as Shore 10A to as hard as Shore 100D. In this manner, the SIBS material can be adapted to have the desired elastomeric and hardness qualities. Details of the SIBS material is set forth in U.S. Patent Nos. 5,741 ,331; 6,102,939; 6,197,240; 6,545,097, which are hereby incorporated by reference in their entirety. The SIBS material of the scleral buckle may be polymerized under control means using carbocationic polymerization techniques such as those described in U.S. Patent Nos. 4,276,394; 4,316,973; 4,342,849; 4,910,321 ; 4,929,683; 4,946,899; 5,066,730; 5,122,572; and Re 34,640, each herein incorporated by reference in its entirety. The styrene and isobutylene copolymer materials are preferably copolymerized in solvents. The SIBS material is preferred due to its non-inflammatory ability, its low level of encapsulation, its lack of angiogenesis, its lack of degradation, its softness and its ability to be loaded with one or more therapeutic agents as described below. [0040] It is expected that alternative polymeric materials are suitable for the practice of the present invention. Such alternative polymeric materials preferably include polyisobutylene-based material capped with a glassy segment. The glassy segment provides a hardener component for the elastomeric polyisobutylene. The glassy segment preferably does not contain any cleavable group which will release in the presence of body fluid in the ocular environment and cause toxic side effects and cell encapsulation. The glassy segment can be a vinyl aromatic polymer (such as styrene, α-methylstyrene, or a mixture thereof), or a methacrylate polymer (such as methylmethacrylate, ethylmethacrylate, hydroxymethalcrylate, or a mixture thereof). Such materials preferably have a general block structure with a central elastomeric polyolefinic block and thermoplastic end blocks. Even more preferably, such materials have a general structure:
BAB or ABA (linear triblock),
B(AB)n or a(BA)n (linear alternating block), or
X-(AB)n or X-(BA)n (includes diblock, triblock and other radial block copolymers), where A is an elastomeric polyolefinic block, B is a thermoplastic block, n is a positive whole number and X is a starting seed molecule.
Such materials may be star-shaped block copolymers (where n=3 or more) or multi- dendrite-shaped block copolymers. These materials collectively belong to the polymeric material referred to herein as SIBS material. Alternatively, the elastomeric material of the scleral buckle can be silicone rubber, polyurethane, polyolefin, copolymers of nylon, copolymers of polyester, elastin, etc.
[0041] For treatment of AMD, a drug-eluding sponge (not shown) may be placed under the band 21. The band 21 and/or the sponge can be loaded with a number of therapeutic agents, including: Paclitaxel, Macugen, Visudyne, Lucentis (rhuFab V2 AMD), Combretastatin A4 Prodrug, Squalamine, SnET2, H8, VEGF Trap, Cand5, LS 11 (Taporfin Sodium), AdPEDF, RetinoStat, Integrin, Panzem, Retaane, Anecortave Acetate, VEGFR-1 mRNA, ARGENT cell-signalling technology, Angiotensin Il Inhibitor, Accutane for Blindness, Macugen (PEGylated aptamer), PTAMD, Optrin, AK-1003, NX 1838, Antagonists of avb3 and 5, Neovastat, Eos 200-F and any other VEGF inhibitor. Other therapeutic agents such as 5-FU, Mitomycin C, corticosteroids (corticosteroid triamcinolone acetonide is most common) and antimicrobials can be loaded into the scleral buckle as well.
[0042] If desired, a therapeutic agent of interest can be provided at the same time as the elastomer from which the device or device portion is realized, for example, by adding it to a polymer melt during thermoplastic processing or by adding it to a polymer solution during solvent-based processing. Alternatively, a therapeutic agent can be provided after formation of the device or device portion. As an example of these embodiments, the therapeutic agent can be dissolved in a solvent that is compatible with both the device polymer and the therapeutic agent. Preferably, the device polymer is at most only slightly soluble in this solvent. Subsequently, the solution is contacted with the device or device portion such that the therapeutic agent is loaded (e.g., by leaching/diffusion) into the copolymer. For this purpose, the device or device portion can be immersed or dipped into the solution, the solution can be applied to the device or component, for example, by spraying, printing dip coating, immersing in a fluidized bed and so forth. The device or component can subsequently be dried, with the therapeutic agent remaining therein.
[0043] In another alternative, the therapeutic agent may be provided within a matrix comprising the polymer of the device or device portion. The therapeutic agent can also be covalently bonded, hydrogen bonded, or electrostatically bound to the polymer of the device. As specific examples, nitric oxide releasing functional groups such as S-nitroso-thiols can be provided in connection with the polymer, or the polymer can be provided with charged functional groups to attach therapeutic groups with oppositely charged functionalities.
[0044] In yet another alternative embodiment, the therapeutic agent can be precipitated onto one or more surfaces of the device or device portion. These one or more surface(s) can be subsequently covered with a coating of polymer (with or without additional therapeutic agent) as described above.
[0045] Hence, when it is stated herein that the polymer is "loaded" with therapeutic agent, it is meant that the therapeutic agent is associated with the polymer in a fashion like those discussed above or in a related fashion. The therapeutic agent(s) can be any of those listed above, or other suitable agent.
In an alternate embodiment shown in FIG. 8, a scleral buckle device 20' in accordance with the present invention includes a band 21' with one end integrally attached to a blunt needle 23'. On the opposite end of band 21', two holes 6OA, 6OB are formed in the band 21'. The two holes 6OA, 6OB are spaced-apart lengthwise adjacent the end of the band 21' and are sized to enable the needle 23' to pass therethrough. For this design, implantation is accomplished in a manner similar to that described above for the scleral buckle of FIG. 4. However, instead of being reattached to itself by means of a loop, the band 21' is reattached to itself by means of the two holes 6OA, 6OB. More particularly, the needle tip 23' is looped around the eye and then weaved through the two holes 6OA, 6OB of the band 21'. After the needle 23' passes through the two holes 6OA, 6OB, the band 21' follows such that it too passes through the two holes 6OA, 6OB and is reattached to itself. The needle 23' and excess portion of the band 21' are cut off after reattachment. The holes 60A, 6OB are adapted to keep the opposing ends of the band 21' together such that the band' realizes a shape that encircles the eye. Also note that the blunt needle 23' is attached directly to the end of the band 21'. Such attachment can be realized by crimping or other suitable means. In this configuration, there is no thread joining the needle 23' to the band 21 '. The embodiment of FIG. 8 can realized from similar materials as that described above with respect to the embodiment of FIG. 4, and can also be loaded with therapeutic agents in the same manner as described above with respect to the embodiment of FIG. 4. The embodiment of FIG. 8 is advantageous in that it has a lower profile and is easier to manufacture than the embodiment of FIG. 4.
[0046] Turning now to FIG. 9, a drug delivery device 70 in accordance with the present invention is shown. The device 70 is small in size and preferably generally T- shaped in profile with a characteristic width on the order of .32mm and a characteristic length on the order of 0.395 mm as shown. The device 70 can realized from similar materials as that described above with respect to the embodiment of FIG. 4, and can also be loaded with therapeutic agents in the same manner as described above with respect to the embodiment of FIG. 4. The device 70 includes two holes 72A, 72B that can be used to suture the device to the implant site. The device 70 can be sutured to the sclera or placed in a small pouch under the sclera. It can also be placed in the same area as a scleral buckle, but will not perform the scleral buckling action.
[0047] There have been described and illustrated herein several embodiments of ocular implants and method of implanting same. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. Thus, while particular shapes and dimensions have been disclosed, it will be appreciated that other shapes and dimensions can be used as well. In addition, while particular therapeutic agents have been disclosed, it will be understood that other therapeutic agents can be used. Moreover, while particular biocompatible polymeric materials have been disclosed, it will be understood that other biocompatible polymeric materials can be used. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed.

Claims

WHAT IS CLAIMED IS:
1. A medical device comprising:
an elastomeric band for encircling the eye and a needle integrally affixed to one end of the band.
2. A medical device according to claim 1, further comprising:
a loop attached to an end of the band opposite the needle, the loop defining a space sized to permit passage of the needle and the band therethrough.
3. A medical device according to claim 2, wherein:
the loop is adapted to keep opposing ends of the band together such that the band realizes a shape that encircles the eye.
4. A medical device according to claim 1, further comprising:
a set of holes through an end of the band opposite the needle, the holes permitting passage of the needle and the band therethrough.
5. A medical device according to claim 4, wherein:
the set of holes is adapted to keep opposing ends of the band together such that the band realizes a shape that encircles the eye.
6. A medical device according to claim 1, wherein:
the band is realized from SIBS material.
7. A medical device according to claim 6, wherein:
said SIBS material comprises a polyolefinic copolymer material having a triblock polymer backbone comprising polystyrene-polyisobutylene-polystyrene.
8. A medical device according to the claim 1 , including:
at least one element loaded with a therapeutic agent.
9. A medical device according to claim 8, wherein:
the therapeutic agent comprises at least one of: Paclitaxel, Macugen, Visudyne, Lucentis (rhuFab V2 AMD), Combretastatin A4 Prodrug, Squalamine, SnET2, H8, VEGF Trap, Candδ, LS 11 (Taporfin Sodium), AdPEDF, RetinoStat, Integrin, Panzem, Retaane, Anecortave Acetate, VEGFR- 1 mRNA, ARGENT cell- signalling technology, Angiotensin Il Inhibitor, Accutane for Blindness, Macugen (PEGylated aptamer), PTAMD, Optrin, AK-1003, NX 1838, Antagonists of avb3 and 5, Neovastat, Eos 200-F, any other VEGF inhibitor, 5-FU, Mitomycin C, corticosteroids (corticosteroid triamcinolone acetonide is most common), and antimicrobials.
10. A medical method for treating retinal detachment comprising:
providing the medical device of claim 1 ;
placing mattress sutures about the equator of the eye; and
threading the needle and the opposite end of the band under the mattress sutures and rectus muscles of the eye.
11. A medical method according to claim 10, wherein:
the medical device includes a loop attached to an end of the band opposite the needle, the loop defining a space sized to permit passage of the needle, and the needle is threaded through the space defined by the loop such that the band encircles the equator of eye.
12. A medical method according to claim 10, wherein:
the medical device includes a set of holes through an end of the band opposite the needle, the holes permitting passage of the needle and the band therethrough, and the needle is threaded through the holes of the band such that the band encircles the equator of eye.
13. A medical method according to claim 10, further comprising:
securing at least one buckling component under the band.
14. A medical method according to claim 13, wherein:
the at least one buckling component comprises multiple buckling components that are stacked atop one another as desired.
15. A medical method according to claim 10, further comprising:
trimming excess material of the band.
16. An ocular implant comprising:
an elastomeric band for encircling the eye and multiple buckling components disposed under the elastomeric band, the multiple buckling components stacked atop one another.
17. An ocular implant according to claim 16, wherein:
the multiple bucking components are realized from SIBS material.
18. An ocular implant according to claim 17, wherein:
the band is realized from SIBS material.
19. An ocular implant according to claim 18, wherein:
said SIBS material comprises a polyolefinic copolymer material having a triblock polymer backbone comprising polystyrene-polyisobutylene-polystyrene.
20. An ocular implant according to claim 16, wherein:
at least one of the multiple buckling components is loaded with a therapeutic agent.
21. An ocular implant according to claim 20, wherein:
the band is loaded with a therapeutic agent.
22. An ocular implant according to claim 21 , wherein:
the therapeutic agent comprises at least one of: Paclitaxel, Macugen, Visudyne, Lucentis (rhuFab V2 AMD), Combretastatin A4 Prodrug, Squalamine, SnET2, H8, VEGF Trap, Candδ, LS 11 (Taporfin Sodium), AdPEDF, RetinoStat, Integrin, Panzem, Retaane, Anecortave Acetate, VEGFR-1 mRNA, ARGENT cell- signalling technology, Angiotensin Il Inhibitor, Accutane for Blindness, Macugen (PEGylated aptamer), PTAMD, Optrin, AK-1003, NX 1838, Antagonists of avb3 and 5, Neovastat, Eos 200-F, any other VEGF inhibitor, 5-FU, Mitomycin C, corticosteroids (corticosteroid triamcinolone acetonide is most common), and antimicrobials.
PCT/US2006/061477 2005-12-01 2006-12-01 Ocular implant WO2007065149A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US74139005P 2005-12-01 2005-12-01
US60/741,390 2005-12-01

Publications (3)

Publication Number Publication Date
WO2007065149A2 true WO2007065149A2 (en) 2007-06-07
WO2007065149A3 WO2007065149A3 (en) 2007-11-08
WO2007065149A9 WO2007065149A9 (en) 2008-01-31

Family

ID=38092957

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/061477 WO2007065149A2 (en) 2005-12-01 2006-12-01 Ocular implant

Country Status (1)

Country Link
WO (1) WO2007065149A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010135965A1 (en) * 2009-05-26 2010-12-02 The Chinese University Of Hong Kong Scleral buckles for sutureless retinal detachment surgery

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4077562A (en) * 1975-10-20 1978-03-07 Betty Ballin Tie strip
US5098443A (en) * 1989-03-23 1992-03-24 University Of Miami Method of implanting intraocular and intraorbital implantable devices for the controlled release of pharmacological agents
US6197056B1 (en) * 1992-07-15 2001-03-06 Ras Holding Corp. Segmented scleral band for treatment of presbyopia and other eye disorders
US6217594B1 (en) * 1999-10-21 2001-04-17 Retinalabs.Com, Inc. Apparatus, system and method for securing scleral tissue
US6511508B1 (en) * 2000-08-04 2003-01-28 Environmental Robots, Inc. Surgical correction of human eye refractive errors by active composite artificial muscle implants
US20040171750A1 (en) * 2001-06-28 2004-09-02 Hironari Nakabayashi Thermoplastic elastomer composition
US20050255144A1 (en) * 2003-04-09 2005-11-17 Directcontact Llc Methods and articles for the delivery of medicaments to the eye for the treatment of posterior segment diseases

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4077562A (en) * 1975-10-20 1978-03-07 Betty Ballin Tie strip
US5098443A (en) * 1989-03-23 1992-03-24 University Of Miami Method of implanting intraocular and intraorbital implantable devices for the controlled release of pharmacological agents
US6197056B1 (en) * 1992-07-15 2001-03-06 Ras Holding Corp. Segmented scleral band for treatment of presbyopia and other eye disorders
US6217594B1 (en) * 1999-10-21 2001-04-17 Retinalabs.Com, Inc. Apparatus, system and method for securing scleral tissue
US6511508B1 (en) * 2000-08-04 2003-01-28 Environmental Robots, Inc. Surgical correction of human eye refractive errors by active composite artificial muscle implants
US20040171750A1 (en) * 2001-06-28 2004-09-02 Hironari Nakabayashi Thermoplastic elastomer composition
US20050255144A1 (en) * 2003-04-09 2005-11-17 Directcontact Llc Methods and articles for the delivery of medicaments to the eye for the treatment of posterior segment diseases

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010135965A1 (en) * 2009-05-26 2010-12-02 The Chinese University Of Hong Kong Scleral buckles for sutureless retinal detachment surgery
US8349004B2 (en) 2009-05-26 2013-01-08 The Chinese University Of Hong Kong Scleral buckles for sutureless retinal detachment surgery

Also Published As

Publication number Publication date
WO2007065149A3 (en) 2007-11-08
WO2007065149A9 (en) 2008-01-31

Similar Documents

Publication Publication Date Title
US11717441B2 (en) Device for treating glaucoma
US11793672B2 (en) Polymer substrate retinal patch coated with adhesives
EP0544948B1 (en) Intraocular and intraorbital implantable devices for the controlled release of pharmacological agents
US10548769B2 (en) Glaucoma valve, a casing for containing a glaucoma valve, and a glaucoma drainage device comprising the valve and/or the casing
EP2364127A2 (en) Biocompatible biodegradable intraocular implant system
Oshika Transscleral suture fixation of a sublimated posterior chamber lens within the capsular bag
WO2007065149A2 (en) Ocular implant
US20060167422A1 (en) Heat Shrink Scleral Band With Custom-Made Buckle For Retinal Detachment Surgery
CA2056138C (en) Intraocular and intraorbital implantable devices for the controlled release of pharmacological agents
Biardzka et al. Experimental and clinical investigations on the suitability of polydioxanone threads for cerclage of the eyeball
JPH05161716A (en) Apparatus implantable into eye and orbit for controllable release of medicine

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application
DPE1 Request for preliminary examination filed after expiration of 19th month from priority date (pct application filed from 20040101)
NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 06840094

Country of ref document: EP

Kind code of ref document: A2