US20160128828A1 - Exocapsular device and method for lens stabilization - Google Patents
Exocapsular device and method for lens stabilization Download PDFInfo
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- US20160128828A1 US20160128828A1 US14/748,441 US201514748441A US2016128828A1 US 20160128828 A1 US20160128828 A1 US 20160128828A1 US 201514748441 A US201514748441 A US 201514748441A US 2016128828 A1 US2016128828 A1 US 2016128828A1
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- Prior art keywords
- ring
- eye
- support
- eyelet
- lens
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2/1662—Instruments for inserting intraocular lenses into the eye
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2/1694—Capsular bag spreaders therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
- A61F2002/1683—Intraocular lenses having supporting structure for lens, e.g. haptics having filiform 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/16—Intraocular lenses
- A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
- A61F2002/16902—Separable from intraocular lens
Definitions
- the present disclosure relates generally to a device for implantation into an eye. More specifically, the present disclosure relates to a device including a ring and a support for implantation into the ciliary sulcus for stabilizing an artificial IOL lens during and after intraocular surgery.
- Cataract formation is a leading cause of reversible blindness in the world. Cataracts are caused by a gradual clouding of the lens over an extended period and may result in complete loss of functional vision.
- the human eye includes a compressible lens enveloped by a capsular bag, which is attached to the ciliary muscles by zonules in a 360 degree circle.
- Intracapsular cataract extraction involving complete removal of the lens, the capsular bag enveloping the lens, and the zonules connecting the capsular bag to the scleral wall of the eye was the standard surgical procedure approximately four decades ago.
- IOL intraocular lens
- the capsular bag is a delicate elastic membrane that envelops the tens.
- the capsular bag is connected to the scleral wall of the eye through zonule fibers that function to centralize the lens behind the iris and in alignment with the pupil.
- Rupture of the capsular bag is a relatively common phenomenon even in modern day cataract surgery, and involves a tear in the anterior capsule or posterior capsule or both. In absence of capsular support it is difficult to place an IOL lens in the eye safely. In cases where there is only a posterior capsular rupture, IOL lenses are routinely placed in the sulcus over the annular anterior capsule. However in scenarios where the annular anterior capsule is also ruptured, this becomes untenable.
- an IOL is then implanted in the anterior chamber of the eye, with the haptics of the IOL being received in the anterior chamber angle region between the iris and the cornea.
- the IOL can be sutured to the iris or scleral wall in the posterior chamber, with the haptics of the IOL resting between the iris and the ciliary body.
- the tear and/or missing portion of the capsular bag may allow the IOL to shift or drift into the vitreous of the eye or be decentralized, which would obviously affect vision.
- the device described herein is particularly adapted to be implanted in the sulcus of an eye for long-term stabilization of the IOL both during and after intraocular surgery.
- a device for implantation into an eye includes a ring and at least one support defined internally of the ring.
- the ring includes an open portion defined between a first eyelet on a first end and a second eyelet on a second end. Further, the ring is radially compressible.
- the ring includes an open portion defined between a first eyelet on a first end and a second end. Further, the ring is radially compressible.
- the at least one support has a position on which a lens is nestably engaged with the at least one support above a tear in the capsular bag of the eye.
- the at least one support defines a first edge engaged with the second end of the ring and extending centrally within the ring to a second edge including a second eyelet.
- the device is made of biocompatible material.
- the biocompatibie material is polymetheylmethacrylate.
- the at least one support is a first spoke defining a first edge engaged with the ring and extending centrally within the ring to a second edge.
- the first spoke is positioned substantially parallel to the plane formed by the circumference of the ring.
- the first spoke is positioned at an angle relative to the plane formed by the circumference of the ring.
- the device further includes a second spoke positioned approximately 180 degrees from the first spoke along the circumference of the ring and extending centrally.
- the device further includes a plurality of spokes positioned along the circumference of the ring and extending centrally.
- the second edge of the first spoke is engaged with a central point of a segment positioned perpendicular to the first spoke.
- the at least one support is a chord engaged with, and extending between, a third end and a fourth end of the ring.
- the chord is substantially straight and wherein the engagement of the chord and the ring at the third end and fourth end is curved, thereby minimizing risk of further damage to the eye.
- the chord is arced, curved or undulating.
- the chord is positioned substantially parallel to the plane formed by the circumference of the ring.
- At least a portion of the chord is positioned outside of the plane formed by the circumference of the ring.
- a method of implanting a device into an eye includes providing an embodiment of the device, as described herein.
- the method further includes implanting the device into the ciliary sulcus between the iris and the capsular bag of the eye, the device positioned anterior to a tear in the capsular bag of the eye.
- the method additionally includes positioning the at least one support proximal to the tear, thereby providing stabilization and centralization to a lens implanted into the eye thereafter.
- the ring of the device is engaged with an interior peripheral surface of the ciliary sulcus.
- the method further includes placing a lens in the ciliary sulcus anterior to, and engaged with, the at least one support.
- the lens is an intraocular lens including at least two haptics engaged with an interior peripheral surface of the ciliary sulcus.
- the step of implanting is performed by inserting the device through an incision created by phacoemulsification cataract surgery.
- FIG. 1 is cross-section view of the human eye.
- FIG. 2 is top view of the device including a spoke implanted in an eye according to one or more embodiments of the present invention.
- FIG. 3 is a side view of the device including a spoke according to one or more embodiments of the present invention.
- FIG. 4 is a top view of the device including a chord implanted in an eye according to one or more embodiments of the present invention.
- FIG. 5 is a top view of the device including a spoke implanted in an eye according to one or more embodiments of the present invention.
- FIG. 6 is a flow chart illustrating the method of implanting the device into an eye according to one or more embodiments of the present invention.
- the present relates to a device for implantation into an eye 100 .
- the lens 1 is enveloped in the capsular bag 2 which is positioned centrally in the posterior chamber 3 of the eye 100 behind the iris 5 and aligned with the pupil 6 .
- the capsular bag 2 is an elastic membrane or pouch having a generally circular cross-section, and is attached to the ciliary body 7 of the eye 100 through a series of zonules 8 .
- the ciliary body 7 is attached to the sacral wall of the eye 100 .
- the zonules 8 are thin fibers that function to centralize the capsular bag 2 and its enveloped lens 1 in a normal anatomic position within the posterior chamber 3 of the eye 100 .
- the CCC may become unstable and unable to support the intraocular lens (IOL) 44 in the ciliary sulcus 9 or posterior chamber 3 of the eye 100 since the tear(s) 50 extend to the posterior portion of the capsular bag 2 as well.
- the missing portion 52 of the capsular bag 2 may allow the IOL 44 to shift or drift into the vitreous humour of the eye 100 or be decentralized, thereby resulting in general decentration of the lens 44 and an unstable intraocular environment.
- the device 10 of the present invention may be adapted to be implanted in the sulcus 9 fur long-term stabilization of the KA, 44 during and after intraocular surgery.
- the capsular bag 2 of FIG. 1 is fully intact and envelopes the lens 1 of the eye 100 , but following intraocular surgery to remove a cataractous lens, only a residual capsular bag 2 remains.
- a capsular tear 50 as depicted in FIGS. 2 and 4 , is a common occurrence during cataract surgery, causing the bag 2 to become unstable and unfit for implantation of a lens 44 .
- the residual capsular bag 2 includes a posterior portion 58 , an annular capsular flap on the anterior portion 56 , and a generally circular capsutorhexis edge 54 .
- the residual capsular bag 12 is able to support an artificial intraocular lens (IOL) 44 .
- IOL intraocular lens
- the surgeon is unable to place the IOL 44 in the sulcus 9 or in the bag 2 .
- the present invention is particularly suited to aid the surgeon in such situations.
- FIGS. 2 and 4 depicts a device 10 for implantation into an eye 100 according to at least one embodiment of this invention.
- the device may include a ring 12 and at least one support 24 defined internally of the ring 12 .
- the ring 12 may include an open portion 14 defined between a first eyelet 16 on a first end 20 and a second eyelet 18 on a second end 22 .
- the ring 12 may include an open portion 14 defined between a first eyelet 16 on a first end 20 and a second end 22 .
- the eyelets 16 , 18 may be used to position the device 10 within the eye 100 using, for example, a bent-tip instrument.
- the ring 12 may be radially compressible, such that the open portion 14 between the two eyelets 16 , 18 , or between the first eyelet 16 and the second end 22 , may be expanded and contracted when pressure is applied to the circumference of the ring 12 .
- the device 10 is specifically adapted to be implanted into the sulcus 9 of the eye 100 . More particularly, the device 10 may be positioned between the iris 5 and the torn flap of the anterior portion 56 of the capsular bag 2 to engage an inner peripheral surface of the sulcus 9 and to abut against a predetermined diameter of the sulcus 9 (see FIGS. 2, 4 and 5 ). Further, the support 24 may have a position on which a lens 44 may be nestably engaged with the at least one support 24 above a tear 50 in the capsular bag 2 of the eye 100 , thereby providing support to the IOL 44 both during and following intraocular surgery.
- the ring 12 is generally flexible to resist compression in a radial direction within the sulcus 9 .
- the ring 12 has an unflexed diameter of about 12 mm and a radially inward flexed diameter of about 10 mm.
- the unflexed and flexed diameter may vary greatly without departing from the spirit or scope of the present invention,
- the ring's compressibility permits, inter alia, placement in the sulcus 9 such that the ring 12 engages the inner periphery of the sulcus 9 .
- FIG. 2 illustrates one or more embodiments of the invention wherein the at least one support 24 is a first spoke 26 defining a first edge 30 engaged with the ring 12 and extending centrally within the ring 12 to a second edge 32 .
- the device 10 may further include a second spoke 26 positioned approximately 180 degrees from the first spoke 26 along the circumference of the ring 12 , with both spokes 26 extending centrally.
- the device 10 may include a plurality of spokes 26 positioned along the circumference of the ring 12 , with each of the spokes 26 extending centrally.
- spokes 26 may be particularly useful in cases of severe tears 50 of capsular bag 2 where larger portions (e.g., greater than 90 degrees) of the CCC are compromised.
- the additional spokes 26 offer greater stabilization and centralization to the IOL 44 positioned in the sulcus 9 .
- any of the spokes 26 may be positioned substantially parallel to a plane formed by the circumference of the ring 12 .
- the first spoke 26 may be positioned at an angle relative to the plane formed by the circumference of the ring 12 .
- the angle may be between 10 and 20 degrees, less than 10 degrees, or greater than 20 degrees.
- the second edge 32 of the first spoke 26 is engaged with a central point of a segment 34 positioned perpendicular to the first spoke 26 , thereby forming a “T” shape using the spoke 26 and the segment 34 .
- the additional segment 34 advantageously offers greater support and stability to the lens 44 during and after surgery.
- the segment 34 may be positioned in a plane parallel to the plane formed by the circumference of the ring 12 .
- Any of the spokes 26 and segments 34 described herein may have a length, a width, and a shape. In some embodiments the length is between 3 mm and 6 mm, while in other embodiments the length is approximately 4.5 mm. In some embodiments the width is approximately 0.5 mm.
- the shape may be rectangular, triangular, tubular, or arced, As one skilled in the art would appreciate, the length, the width and the shape may vary widely without departing from the spirit or scope of the present invention. Further, the width, length and shape may be vary in relation to the number and position of spokes 26 and segments 34 .
- FIG. 4 depicts the device 10 including a ring 12 and at least one support 24 , wherein the at least one support 24 is a chord 36 engaged with, and extending between, a third end 40 and a fourth end 42 of the ring 12 .
- the ring 12 may extend circumferentially from the first end 20 to the second end 22 , except that the chord 36 disrupts the circumferential nature of the ring 12 at a third end 40 and fourth end 42 ; instead the chord 36 extends within the circumference of the ring 12 .
- the chord 36 may be substantially straight, arced, curved, or undulating. Further the engagement of the chord 36 and the ring 12 at the third end 40 and fourth end 42 may be curved, thereby minimizing risk of further damage to the eye 100 during insertion and while positioned therein.
- the device 10 including a chord 36 may be positioned such that the chord 36 extends across the tear 50 and/or the missing portion 52 of the capsular bag 2 , thereby offering greater stabilization and centralization to the IOL 44 positioned in the sulcus 9 .
- the chord embodiments of the device 10 may vary in length, width and shape. In one embodiment the width of the chord 36 is 0.5 mm. In some embodiments the chord 36 may be positioned substantially parallel to a plane formed by the circumference of the ring 12 . In alternative embodiments, at least a portion of the chord 36 may be positioned outside of the plane formed by the circumference of the ring 12 . For example, an arced or undulating chord 36 may have portions positioned outside of the ring's circumferential plane or may be positioned wholly within the ring's circumferential plane.
- FIG. 5 illustrates a device 10 for implantation into an eye 100 including a ring having an open portion 14 defined between a first eyelet 16 on a first end 20 and a second end 22 .
- the at least one support 24 may define a first edge 30 engaged with the second end 22 of the ring 12 and extending centrally within the ring 12 to a second edge 32 including a second eyelet 18 .
- the device 10 depicted in FIG. 5 may also include any number of spokes 26 or chords 36 , as described supra.
- the device 10 may be made of biocompatible material.
- the biocompatible material is polymethylmethacrylate (PMMA), although those skilled in the art will appreciate that other biocompatible materials suitable for implantation in a sulcus 9 are also available.
- PMMA polymethylmethacrylate
- FIG. 6 illustrates a method of implanting a device 10 into an eye 100 .
- the method includes, in step 601 , providing a device 10 according to any of the embodiments described herein. Further, the method may include, in step 602 , implanting the device 10 into the ciliary sulcus 9 between the iris 5 and the capsular bag 2 of the eye 100 . Implanting may be performed by inserting the device 10 through an incision created by phacoemulsification cataract surgery, as described supra. The incision may be 1 mm in length, but may also be slightly smaller or much larger.
- the method may further include, in step 603 , positioning the at least one support 24 proximal to the tear 50 , thereby providing stabilization and centralization to a lens 44 implanted into the eye 100 thereafter.
- the device 10 may be positioned anterior to a tear 50 in the capsular bag 2 of the eye 100 . Further, the device 10 may be positioned in a circumferential manner within the sulcus 9 such that at least one support 24 is positioned proximal to the tear 50 and/or missing portion 52 of the capsular bag 2 .
- the ring 12 of the device 10 may be engaged with an interior peripheral surface of the ciliary sulcus 9 .
- the method may further include, in step 604 , placing a tens 44 in the ciliary sulcus 9 anterior to, and engaged with, the at least one support 24 .
- the lens 44 may be an intraocular lens (IOL) including at least two haptics 46 engaged with an interior peripheral surface of the ciliary sulcus 9 .
- the placement of the IOL 44 may include placing the haptics 46 in a position proximal to the portions of the capsular bag 2 which are not tom 50 or missing 52 .
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Abstract
A device for implantation into an eye for supporting an intraocular lens during and following surgery. The device may include a ring and at least one support. The ring may have an open portion defined between a first eyelet on a first end and a second eyelet on a second end, the ring being radially compressible. The at least one support may be defined internally of the ring and have a position on which a lens is nestably engaged with the at least one support above a tear in the capsular bag of the eye.
Description
- This application claims the benefit of U.S. Provisional Application No. 62/077,243, filed Nov. 9, 2014, which is herein incorporated by reference in its entirety.
- The present disclosure relates generally to a device for implantation into an eye. More specifically, the present disclosure relates to a device including a ring and a support for implantation into the ciliary sulcus for stabilizing an artificial IOL lens during and after intraocular surgery.
- Various diseases and abnormalities exist that can lead to impaired vision in the human eye. Cataract formation is a leading cause of reversible blindness in the world. Cataracts are caused by a gradual clouding of the lens over an extended period and may result in complete loss of functional vision.
- The human eye includes a compressible lens enveloped by a capsular bag, which is attached to the ciliary muscles by zonules in a 360 degree circle. Intracapsular cataract extraction involving complete removal of the lens, the capsular bag enveloping the lens, and the zonules connecting the capsular bag to the scleral wall of the eye was the standard surgical procedure approximately four decades ago.
- Advances in surgery lead to the development of extracapsular cataract extraction, which is performed to remove the cataractous lens while leaving the capsular bag and zonules substantially intact within the posterior chamber of the eye. In this procedure, a capsulorhexis incision is typically performed to remove a generally circular mid-portion of the anterior capsule of the capsular bag, usually leaving the posterior capsule, an annular anterior capsular flap and a generally circular anterior capsulorhexis edge. The cataractous lens is removed from the residual capsular bag and replaced with an artificial intraocular lens (IOL). The IOL customarily includes haptics for engaging an inner peripheral surface of the residual capsular bag and centralize the IOL within the capsular bag.
- Those skilled in the art of ophthalmic surgical procedures will appreciate that the capsular bag is a delicate elastic membrane that envelops the tens. The capsular bag is connected to the scleral wall of the eye through zonule fibers that function to centralize the lens behind the iris and in alignment with the pupil.
- In eye patients with missing or damaged zonules from trauma or disease, the position of the capsular bag within the posterior chamber of the eye is unstable, making removal of the enclosed cataractous lens difficult and implantation of the IOL challenging.
- Rupture of the capsular bag is a relatively common phenomenon even in modern day cataract surgery, and involves a tear in the anterior capsule or posterior capsule or both. In absence of capsular support it is difficult to place an IOL lens in the eye safely. In cases where there is only a posterior capsular rupture, IOL lenses are routinely placed in the sulcus over the annular anterior capsule. However in scenarios where the annular anterior capsule is also ruptured, this becomes untenable.
- When the annular anterior capsule is also ruptured, an IOL is then implanted in the anterior chamber of the eye, with the haptics of the IOL being received in the anterior chamber angle region between the iris and the cornea. Alternatively, the IOL can be sutured to the iris or scleral wall in the posterior chamber, with the haptics of the IOL resting between the iris and the ciliary body. In patients that have had a capsulorhexis tear occurring during phacoemulsification, not only is implantation of the lens more difficult, but the tear and/or missing portion of the capsular bag may allow the IOL to shift or drift into the vitreous of the eye or be decentralized, which would obviously affect vision. The device described herein is particularly adapted to be implanted in the sulcus of an eye for long-term stabilization of the IOL both during and after intraocular surgery.
- Notwithstanding the advancements made in the prior art in the field of alternative lenses, there remains a need fur an implant which improves stabilization of the intraocular environment during and after intraocular surgery Further, a need exists for a device which enables precise and stable implantation of the IOL, lens in the sulcus in spite of a torn capsule, while minimizing the chance of repositioning over time. The ciliary sulcus is amore desirable position for lens implant as compared to the anterior chamber or sclera sutured IOL lenses due to the minimal rate of long term complications.
- Hence there is need to provide an implant that provides long-term intraocular lens centration and stabilization in patients having more significant capsular tears. Disclosed herein are one or more devices and methods that advantageously address these issues.
- This summary is provided to introduce in a simplified form concepts that are further described in the following detailed descriptions. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it to be construed as limiting the scope of the claimed subject matter.
- According to at least one embodiment, a device for implantation into an eye is provided. The device includes a ring and at least one support defined internally of the ring.
- According to one or more embodiments, the ring includes an open portion defined between a first eyelet on a first end and a second eyelet on a second end. Further, the ring is radially compressible.
- According to one or more embodiments, the ring includes an open portion defined between a first eyelet on a first end and a second end. Further, the ring is radially compressible.
- According to one or more embodiments, the at least one support has a position on which a lens is nestably engaged with the at least one support above a tear in the capsular bag of the eye.
- According to one or more embodiments, the at least one support defines a first edge engaged with the second end of the ring and extending centrally within the ring to a second edge including a second eyelet.
- According to one or more embodiments, the device is made of biocompatible material. In some embodiments, the biocompatibie material is polymetheylmethacrylate.
- According to one or more embodiments, the at least one support is a first spoke defining a first edge engaged with the ring and extending centrally within the ring to a second edge.
- According to one or more embodiments, the first spoke is positioned substantially parallel to the plane formed by the circumference of the ring.
- According to one or more embodiments, the first spoke is positioned at an angle relative to the plane formed by the circumference of the ring.
- According to one or more embodiments, the device further includes a second spoke positioned approximately 180 degrees from the first spoke along the circumference of the ring and extending centrally.
- According to one or more embodiments, the device further includes a plurality of spokes positioned along the circumference of the ring and extending centrally.
- According to one or more embodiments, the second edge of the first spoke is engaged with a central point of a segment positioned perpendicular to the first spoke.
- According to one or more embodiments, the at least one support is a chord engaged with, and extending between, a third end and a fourth end of the ring.
- According to one or more embodiments, the chord is substantially straight and wherein the engagement of the chord and the ring at the third end and fourth end is curved, thereby minimizing risk of further damage to the eye.
- According to one or more embodiments, the chord is arced, curved or undulating.
- According to one or more embodiments, the chord is positioned substantially parallel to the plane formed by the circumference of the ring.
- According to one or more embodiments, at least a portion of the chord is positioned outside of the plane formed by the circumference of the ring.
- According to at least one embodiment, a method of implanting a device into an eye is provided. The method includes providing an embodiment of the device, as described herein. The method further includes implanting the device into the ciliary sulcus between the iris and the capsular bag of the eye, the device positioned anterior to a tear in the capsular bag of the eye. The method additionally includes positioning the at least one support proximal to the tear, thereby providing stabilization and centralization to a lens implanted into the eye thereafter.
- According to one or more embodiments, the ring of the device is engaged with an interior peripheral surface of the ciliary sulcus.
- According to one or more embodiments, the method further includes placing a lens in the ciliary sulcus anterior to, and engaged with, the at least one support.
- According to one or more embodiments, the lens is an intraocular lens including at least two haptics engaged with an interior peripheral surface of the ciliary sulcus.
- According to one or more embodiments, the step of implanting is performed by inserting the device through an incision created by phacoemulsification cataract surgery.
- The previous summary and the following detailed descriptions are to be read in view of the drawings, which illustrate particular exemplary embodiments and features as briefly described below. The summary and detailed descriptions, however, are not limited to only those embodiments and features explicitly illustrated.
-
FIG. 1 is cross-section view of the human eye. -
FIG. 2 is top view of the device including a spoke implanted in an eye according to one or more embodiments of the present invention. -
FIG. 3 is a side view of the device including a spoke according to one or more embodiments of the present invention. -
FIG. 4 is a top view of the device including a chord implanted in an eye according to one or more embodiments of the present invention. -
FIG. 5 is a top view of the device including a spoke implanted in an eye according to one or more embodiments of the present invention. -
FIG. 6 is a flow chart illustrating the method of implanting the device into an eye according to one or more embodiments of the present invention. - These descriptions are presented with sufficient details to provide an understanding of one or more particular embodiments of broader inventive subject matters. These descriptions expound upon and exemplify particular features of those particular embodiments without limiting the inventive subject matters to the explicitly described embodiments and features. Considerations in view of these descriptions will likely give rise to additional and similar embodiments and features without departing from the scope of the inventive subject matters. Although the term “step” may be expressly used or implied relating to features of processes or methods, no implication is made of any particular order or sequence among such expressed or implied steps unless an order or sequence is explicitly stated.
- Any dimensions expressed or implied in the drawings and these descriptions are provided for exemplary purposes. Thus, not all embodiments within the scope of the drawings and these descriptions are made according to such exemplary dimensions. The drawings are not made necessarily to scale. Thus, not all embodiments within the scope of the drawings and these descriptions are made according to the apparent scale of the drawings with regard to relative dimensions in the drawings. However, for each drawing, at least one embodiment is made according to the apparent relative scale of the drawing.
- Referring generally to
FIG. 1 , the present relates to a device for implantation into aneye 100. In a normalhuman eye 100, as depicted inFIG. 1 , the lens 1 is enveloped in thecapsular bag 2 which is positioned centrally in theposterior chamber 3 of theeye 100 behind theiris 5 and aligned with thepupil 6. Thecapsular bag 2 is an elastic membrane or pouch having a generally circular cross-section, and is attached to theciliary body 7 of theeye 100 through a series of zonules 8. Theciliary body 7 is attached to the sacral wall of theeye 100. The zonules 8 are thin fibers that function to centralize thecapsular bag 2 and its enveloped lens 1 in a normal anatomic position within theposterior chamber 3 of theeye 100. - In patients suffering from a tear in the CCC (continuous curvilinear capsulorhexis) during cataract surgery, as illustrated by the
tear 50 inFIGS. 2, 4 and 5 , the CCC may become unstable and unable to support the intraocular lens (IOL) 44 in the ciliary sulcus 9 orposterior chamber 3 of theeye 100 since the tear(s) 50 extend to the posterior portion of thecapsular bag 2 as well. The missingportion 52 of thecapsular bag 2 may allow theIOL 44 to shift or drift into the vitreous humour of theeye 100 or be decentralized, thereby resulting in general decentration of thelens 44 and an unstable intraocular environment. - As is shown in
FIGS. 2, 4 and 5 , thedevice 10 of the present invention may be adapted to be implanted in the sulcus 9 fur long-term stabilization of the KA, 44 during and after intraocular surgery. Thecapsular bag 2 ofFIG. 1 is fully intact and envelopes the lens 1 of theeye 100, but following intraocular surgery to remove a cataractous lens, only aresidual capsular bag 2 remains. As discussed supra, acapsular tear 50, as depicted inFIGS. 2 and 4 , is a common occurrence during cataract surgery, causing thebag 2 to become unstable and unfit for implantation of alens 44. - During the capsulorhexis surgical procedure, an incision is made in the
anterior portion 56 of thecapsular bag 2 to remove a generallycircular mid-portion 60 of theanterior portion 56 of the capsular bag 26. Following this procedure, theresidual capsular bag 2 includes aposterior portion 58, an annular capsular flap on theanterior portion 56, and a generallycircular capsutorhexis edge 54. During an uncomplicated cataract surgery, theresidual capsular bag 12 is able to support an artificial intraocular lens (IOL) 44. In situations where the CCC (continuous curvilinear capsulorhexis) tears, however, such as is depicted inFIGS. 2 and 4 , the surgeon is unable to place theIOL 44 in the sulcus 9 or in thebag 2. The present invention is particularly suited to aid the surgeon in such situations. -
FIGS. 2 and 4 depicts adevice 10 for implantation into aneye 100 according to at least one embodiment of this invention. The device may include aring 12 and at least one support 24 defined internally of thering 12. Thering 12 may include anopen portion 14 defined between afirst eyelet 16 on afirst end 20 and asecond eyelet 18 on asecond end 22. Alternatively, as depicted inFIG. 5 , thering 12 may include anopen portion 14 defined between afirst eyelet 16 on afirst end 20 and asecond end 22. Theeyelets device 10 within theeye 100 using, for example, a bent-tip instrument. - Further, the
ring 12 may be radially compressible, such that theopen portion 14 between the twoeyelets first eyelet 16 and thesecond end 22, may be expanded and contracted when pressure is applied to the circumference of thering 12. - By defining a
ring 12 including anopen portion 14, thedevice 10 is specifically adapted to be implanted into the sulcus 9 of theeye 100. More particularly, thedevice 10 may be positioned between theiris 5 and the torn flap of theanterior portion 56 of thecapsular bag 2 to engage an inner peripheral surface of the sulcus 9 and to abut against a predetermined diameter of the sulcus 9 (seeFIGS. 2, 4 and 5 ). Further, the support 24 may have a position on which alens 44 may be nestably engaged with the at least one support 24 above atear 50 in thecapsular bag 2 of theeye 100, thereby providing support to theIOL 44 both during and following intraocular surgery. - As mentioned supra, the
ring 12 is generally flexible to resist compression in a radial direction within the sulcus 9. In one embodiment, thering 12 has an unflexed diameter of about 12 mm and a radially inward flexed diameter of about 10 mm. As one skilled in the at would appreciate, the unflexed and flexed diameter may vary greatly without departing from the spirit or scope of the present invention, The ring's compressibility permits, inter alia, placement in the sulcus 9 such that thering 12 engages the inner periphery of the sulcus 9. -
FIG. 2 illustrates one or more embodiments of the invention wherein the at least one support 24 is a first spoke 26 defining afirst edge 30 engaged with thering 12 and extending centrally within thering 12 to asecond edge 32. In some embodiments, thedevice 10 may further include a second spoke 26 positioned approximately 180 degrees from the first spoke 26 along the circumference of thering 12, with both spokes 26 extending centrally. Alternatively, thedevice 10 may include a plurality of spokes 26 positioned along the circumference of thering 12, with each of the spokes 26 extending centrally. The use of a two spokes 26 or a plurality of spokes 26 may be particularly useful in cases ofsevere tears 50 ofcapsular bag 2 where larger portions (e.g., greater than 90 degrees) of the CCC are compromised. The additional spokes 26 offer greater stabilization and centralization to theIOL 44 positioned in the sulcus 9. - According to one or more embodiments, any of the spokes 26 may be positioned substantially parallel to a plane formed by the circumference of the
ring 12. In some embodiments, as depicted inFIG. 3 , the first spoke 26 may be positioned at an angle relative to the plane formed by the circumference of thering 12. The angle may be between 10 and 20 degrees, less than 10 degrees, or greater than 20 degrees. By angling the spoke 26 anteriorly, greater support may be offered to theIOL 44 by counteracting the pressure of theIOL 44 after positioning, thereby minimizing the risk of theIOL 44 dislocating in the future. - In one or more embodiments, the
second edge 32 of the first spoke 26 is engaged with a central point of asegment 34 positioned perpendicular to the first spoke 26, thereby forming a “T” shape using the spoke 26 and thesegment 34. Theadditional segment 34 advantageously offers greater support and stability to thelens 44 during and after surgery. some embodiments, thesegment 34 may be positioned in a plane parallel to the plane formed by the circumference of thering 12. Any of the spokes 26 andsegments 34 described herein may have a length, a width, and a shape. In some embodiments the length is between 3 mm and 6 mm, while in other embodiments the length is approximately 4.5 mm. In some embodiments the width is approximately 0.5 mm. The shape may be rectangular, triangular, tubular, or arced, As one skilled in the art would appreciate, the length, the width and the shape may vary widely without departing from the spirit or scope of the present invention. Further, the width, length and shape may be vary in relation to the number and position of spokes 26 andsegments 34. -
FIG. 4 depicts thedevice 10 including aring 12 and at least one support 24, wherein the at least one support 24 is a chord 36 engaged with, and extending between, a third end 40 and a fourth end 42 of thering 12. In other words, thering 12 may extend circumferentially from thefirst end 20 to thesecond end 22, except that the chord 36 disrupts the circumferential nature of thering 12 at a third end 40 and fourth end 42; instead the chord 36 extends within the circumference of thering 12. The chord 36 may be substantially straight, arced, curved, or undulating. Further the engagement of the chord 36 and thering 12 at the third end 40 and fourth end 42 may be curved, thereby minimizing risk of further damage to theeye 100 during insertion and while positioned therein. - As with the spoke embodiments, the
device 10 including a chord 36 may be positioned such that the chord 36 extends across thetear 50 and/or the missingportion 52 of thecapsular bag 2, thereby offering greater stabilization and centralization to theIOL 44 positioned in the sulcus 9. Also, as with the spoke embodiments, the chord embodiments of thedevice 10 may vary in length, width and shape. In one embodiment the width of the chord 36 is 0.5 mm. In some embodiments the chord 36 may be positioned substantially parallel to a plane formed by the circumference of thering 12. In alternative embodiments, at least a portion of the chord 36 may be positioned outside of the plane formed by the circumference of thering 12. For example, an arced or undulating chord 36 may have portions positioned outside of the ring's circumferential plane or may be positioned wholly within the ring's circumferential plane. -
FIG. 5 illustrates adevice 10 for implantation into aneye 100 including a ring having anopen portion 14 defined between afirst eyelet 16 on afirst end 20 and asecond end 22. In such an embodiment, the at least one support 24 may define afirst edge 30 engaged with thesecond end 22 of thering 12 and extending centrally within thering 12 to asecond edge 32 including asecond eyelet 18. Thedevice 10 depicted inFIG. 5 , according to alternative embodiments, may also include any number of spokes 26 or chords 36, as described supra. - In one or more embodiments, the
device 10, and/or some or all of its components, may be made of biocompatible material. In some embodiments, the biocompatible material is polymethylmethacrylate (PMMA), although those skilled in the art will appreciate that other biocompatible materials suitable for implantation in a sulcus 9 are also available. -
FIG. 6 illustrates a method of implanting adevice 10 into aneye 100. The method includes, instep 601, providing adevice 10 according to any of the embodiments described herein. Further, the method may include, instep 602, implanting thedevice 10 into the ciliary sulcus 9 between theiris 5 and thecapsular bag 2 of theeye 100. Implanting may be performed by inserting thedevice 10 through an incision created by phacoemulsification cataract surgery, as described supra. The incision may be 1 mm in length, but may also be slightly smaller or much larger. - The method may further include, in
step 603, positioning the at least one support 24 proximal to thetear 50, thereby providing stabilization and centralization to alens 44 implanted into theeye 100 thereafter. Thedevice 10 may be positioned anterior to atear 50 in thecapsular bag 2 of theeye 100. Further, thedevice 10 may be positioned in a circumferential manner within the sulcus 9 such that at least one support 24 is positioned proximal to thetear 50 and/or missingportion 52 of thecapsular bag 2. Thering 12 of thedevice 10 may be engaged with an interior peripheral surface of the ciliary sulcus 9. - Following implantation of the
device 10 into the ciliary sulcus 9, the method may further include, instep 604, placing atens 44 in the ciliary sulcus 9 anterior to, and engaged with, the at least one support 24. Thelens 44 may be an intraocular lens (IOL) including at least twohaptics 46 engaged with an interior peripheral surface of the ciliary sulcus 9. The placement of theIOL 44 may include placing thehaptics 46 in a position proximal to the portions of thecapsular bag 2 which are nottom 50 or missing 52.
Claims (20)
1. A device for implantation into an eye, comprising:
a ring having an open portion defined between a first end and a second end, the ring being radially compressible;
at least one support defined internally of the ring and having a position for nestably engaging a lens, the at least one support being positioned above a tear in the capsular bag of the eye.
2. The device of claim 1 , wherein the device is made of biocompatible material.
3. The device of claim 2 , wherein the biocompatible material is polymetheylmethacrylate.
4. The device of claim 1 , wherein:
the at least one support is a first spoke defining a first edge engaged with the ring and extending centrally within the ring to a second edge; and
the ring further includes a first eyelet on the first end and a second eyelet on the second end.
5. The device of claim 4 , wherein the first spoke is positioned substantially parallel to a plane formed by the circumference of the ring.
6. The device of claim 4 , wherein the first spoke is positioned at an angle relative to a plane formed by the circumference of the ring.
7. The device of claim 4 , further comprising at least a second spoke positioned along the circumference of the ring and extending centrally.
8. The device of claim 4 , wherein the second edge of the first spoke is engaged with a central point of a segment positioned perpendicular to the first spoke.
9. The device of claim 1 , wherein:
the at least one support is a chord engaged with, and extending between, a third end and a fourth end of the ring; and
the ring further includes a first eyelet on the first end and a second eyelet on the second end.
10. The device of claim 9 , wherein the chord is substantially straight and wherein the engagement of the chord and the ring at the third end and fourth end is curved, thereby minimizing risk of further damage to the eye.
11. The device of claim 9 , wherein the chord is arced, curved or undulating.
12. The device of claim 9 , wherein the chord is positioned substantially parallel to a plane formed by the circumference of the ring.
13. The device of claim 9 , wherein at least a portion of the chord is positioned outside of a plane formed by the circumference of the ring.
14. The device of claim 1 , wherein:
the ring further includes a first eyelet on the first end;
the at least one support defines a first edge engaged with the second end of the ring and extending centrally within the ring to a second edge including a second eyelet.
15. A method of implanting a device into an eye, comprising:
providing a device including:
a ring having an open portion defined between a first end and a second end, the ring being radially compressible;
a first eyelet and a second eyelet; and
at least one support defined internally of the ring;
implanting the device into the ciliary sulcus between the iris and the capsular bag of the eye, the device positioned anterior to a tear in the capsular bag of the eye;
positioning the at least one support proximal to the tear, thereby providing stabilization and centralization to a lens implanted into the eye thereafter.
16. The method of claim 15 , wherein the ring of the device is engaged with an interior peripheral surface of the ciliary sulcus.
17. The method of claim 15 , wherein the step of implanting is performed by inserting the device through an incision created by phacoemulsification cataract surgery.
18. The method of claim 15 , further comprising placing a lens in the ciliary sulcus anterior to, and engaged with, the at least one support.
19. The method of claim 18 , wherein the lens is an intraocular lens including at least two haptics engaged with an interior peripheral surface of the ciliary sulcus.
20. The method of claim 15 , further comprising positioning the device within the eye using the eyelets.
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US14/748,441 US20160128828A1 (en) | 2014-11-09 | 2015-06-24 | Exocapsular device and method for lens stabilization |
EP15857304.8A EP3215059A4 (en) | 2014-11-09 | 2015-10-26 | Exocapsular device and method for lens stabilization |
PCT/IB2015/002176 WO2016071755A1 (en) | 2014-11-09 | 2015-10-26 | Exocapsular device and method for lens stabilization |
US16/111,010 US11058533B2 (en) | 2014-11-09 | 2018-08-23 | Exocapsular device and method for lens stabilization |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US201462077243P | 2014-11-09 | 2014-11-09 | |
US14/748,441 US20160128828A1 (en) | 2014-11-09 | 2015-06-24 | Exocapsular device and method for lens stabilization |
Related Child Applications (1)
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US16/111,010 Division US11058533B2 (en) | 2014-11-09 | 2018-08-23 | Exocapsular device and method for lens stabilization |
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US20160128828A1 true US20160128828A1 (en) | 2016-05-12 |
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US14/748,441 Abandoned US20160128828A1 (en) | 2014-11-09 | 2015-06-24 | Exocapsular device and method for lens stabilization |
US16/111,010 Active US11058533B2 (en) | 2014-11-09 | 2018-08-23 | Exocapsular device and method for lens stabilization |
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US16/111,010 Active US11058533B2 (en) | 2014-11-09 | 2018-08-23 | Exocapsular device and method for lens stabilization |
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US (2) | US20160128828A1 (en) |
EP (1) | EP3215059A4 (en) |
WO (1) | WO2016071755A1 (en) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN108938145A (en) * | 2018-07-20 | 2018-12-07 | 陶天畅 | A kind of artificial lens support ring |
US10736735B2 (en) | 2015-04-03 | 2020-08-11 | The Regents Of The University Of Colorado, A Body Corporate | Devices and methods for stabilization of an ocular lens capsule and preventing artificial intraocular lens implant rotation post cataract surgery |
US10973624B1 (en) | 2020-04-29 | 2021-04-13 | Long Bridge Medical, Inc. | Devices to support and position an intraocular lens within the eye and methods of use |
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WO2004041323A2 (en) * | 2002-10-30 | 2004-05-21 | Yablon, Jay, R. | Improved endocapsular tension ring and method of implanting same |
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US20120290086A1 (en) * | 2010-11-03 | 2012-11-15 | Microsurgical Technology, Inc. | Intraocular capsular tension rings |
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DE19637692A1 (en) * | 1996-09-09 | 1998-03-12 | Potsdamer Augenklinik Im Albre | Capsule tensioning ring for stabilising the eye capsule |
AU1712900A (en) * | 1998-11-20 | 2000-06-13 | Staar Surgical Company, Inc. | Posterior chamber intraocular implant device, and packaging therefor |
US6413277B1 (en) * | 2000-05-18 | 2002-07-02 | Tobias H. Neuhann | Method for intraocular lens insertion and apparatus |
CA2473355C (en) * | 2002-01-18 | 2012-01-03 | Michael E. Snyder | Sustained release ophthalmological device and method of making and using the same |
FR2849592B1 (en) * | 2003-01-08 | 2005-03-25 | Ioltechnologie Production | CAPSULAR RING, METHOD OF MANUFACTURING CAPSULAR RING AND CAPSULAR RING ASSEMBLY AND INTRAOCULAR LENS |
US7303582B2 (en) * | 2003-03-21 | 2007-12-04 | Advanced Medical Optics, Inc. | Foldable angle-fixated intraocular lens |
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2015
- 2015-06-24 US US14/748,441 patent/US20160128828A1/en not_active Abandoned
- 2015-10-26 EP EP15857304.8A patent/EP3215059A4/en not_active Withdrawn
- 2015-10-26 WO PCT/IB2015/002176 patent/WO2016071755A1/en active Application Filing
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2018
- 2018-08-23 US US16/111,010 patent/US11058533B2/en active Active
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US5843184A (en) * | 1998-01-26 | 1998-12-01 | Cionni; Robert J. | Endocapsular tension ring and method of implanting same |
WO2004041323A2 (en) * | 2002-10-30 | 2004-05-21 | Yablon, Jay, R. | Improved endocapsular tension ring and method of implanting same |
US20120078363A1 (en) * | 2009-11-17 | 2012-03-29 | Lu Kenneth L | Accommodating intraocular lens |
US20120290086A1 (en) * | 2010-11-03 | 2012-11-15 | Microsurgical Technology, Inc. | Intraocular capsular tension rings |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10736735B2 (en) | 2015-04-03 | 2020-08-11 | The Regents Of The University Of Colorado, A Body Corporate | Devices and methods for stabilization of an ocular lens capsule and preventing artificial intraocular lens implant rotation post cataract surgery |
CN108938145A (en) * | 2018-07-20 | 2018-12-07 | 陶天畅 | A kind of artificial lens support ring |
US10973624B1 (en) | 2020-04-29 | 2021-04-13 | Long Bridge Medical, Inc. | Devices to support and position an intraocular lens within the eye and methods of use |
US11759309B2 (en) | 2020-04-29 | 2023-09-19 | Long Bridge Medical, Inc. | Devices to support and position an intraocular lens within the eye and methods of use |
US12036109B2 (en) | 2020-04-29 | 2024-07-16 | Long Bridge Medical, Inc. | Devices to support and position an intraocular lens within the eye and methods of use |
Also Published As
Publication number | Publication date |
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WO2016071755A1 (en) | 2016-05-12 |
EP3215059A1 (en) | 2017-09-13 |
US11058533B2 (en) | 2021-07-13 |
EP3215059A4 (en) | 2018-08-08 |
US20190133754A1 (en) | 2019-05-09 |
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