Ocular implant delivery system and method

Information

  • Patent Grant
  • 8512404
  • Patent Number
    8,512,404
  • Date Filed
    Tuesday, November 20, 2007
    16 years ago
  • Date Issued
    Tuesday, August 20, 2013
    10 years ago
Abstract
A method of inserting an ocular implant into a patient's eye, the ocular implant being mounted on a carrier, the method comprising: inserting a cannula into an anterior chamber of the eye; moving a distal exit port of the cannula into communication with Schlemm's canal; and advancing the ocular implant and carrier through an exit port of the cannula into Schlemm's canal. The invention also provides an ocular implant and delivery system comprising: a cannula comprising a distal exit port adapted to be inserted into a Schlemm's canal portion of an eye; an ocular implant; a carrier disposed within the implant and movable with the implant within the cannula; and a proximal control adapted to be operated from exterior to an eye to move at least one of the carrier and the implant when the distal exit port of the cannula is within the eye.
Description
INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.


FIELD OF THE INVENTION

The present invention relates generally to devices that are implanted within the eye and delivery systems for such devices. More particularly, the present invention relates to delivery system for devices that facilitate the transfer of fluid from within one area of the eye to another area of the eye.


BACKGROUND OF THE INVENTION

According to a draft report by The National Eye Institute (NEI) at The United States National Institutes of Health (NIH), glaucoma is now the leading cause of irreversible blindness worldwide and the second leading cause of blindness, behind cataract, in the world. Thus, the NEI draft report concludes, “it is critical that significant emphasis and resources continue to be devoted to determining the pathophysiology and management of this disease.” Glaucoma researchers have found a strong correlation between high intraocular pressure and glaucoma. For this reason, eye care professionals routinely screen patients for glaucoma by measuring intraocular pressure using a device known as a tonometer. Many modern tonometers make this measurement by blowing a sudden puff of air against the outer surface of the eye.


The eye can be conceptualized as a ball filled with fluid. There are two types of fluid inside the eye. The cavity behind the lens is filled with a viscous fluid known as vitreous humor. The cavities in front of the lens are filled with a fluid know as aqueous humor. Whenever a person views an object, he or she is viewing that object through both the vitreous humor and the aqueous humor.


Whenever a person views an object, he or she is also viewing that object through the cornea and the lens of the eye. In order to be transparent, the cornea and the lens can include no blood vessels. Accordingly, no blood flows through the cornea and the lens to provide nutrition to these tissues and to remove wastes from these tissues. Instead, these functions are performed by the aqueous humor. A continuous flow of aqueous humor through the eye provides nutrition to portions of the eye (e.g., the cornea and the lens) that have no blood vessels. This flow of aqueous humor also removes waste from these tissues.


Aqueous humor is produced by an organ known as the ciliary body. The ciliary body includes epithelial cells that continuously secrete aqueous humor. In a healthy eye, a stream of aqueous humor flows out of the anterior chamber of the eye through the trabecular meshwork and into Schlemm's canal as new aqueous humor is secreted by the epithelial cells of the ciliary body. This excess aqueous humor enters the venous blood stream from Schlemm's canal and is carried along with the venous blood leaving the eye.


When the natural drainage mechanisms of the eye stop functioning properly, the pressure inside the eye begins to rise. Researchers have theorized prolonged exposure to high intraocular pressure causes damage to the optic nerve that transmits sensory information from the eye to the brain. This damage to the optic nerve results in loss of peripheral vision. As glaucoma progresses, more and more of the visual field is lost until the patient is completely blind.


In addition to drug treatments, a variety of surgical treatments for glaucoma have been performed. For example, shunts were implanted to direct aqueous humor from the anterior chamber to the extraocular vein (Lee and Scheppens, “Aqueous-venous shunt and intraocular pressure,” Investigative Opthalmology (February 1966)). Other early glaucoma treatment implants led from the anterior chamber to a sub-conjunctival bleb (e.g., U.S. Pat. No. 4,968,296 and U.S. Pat. No. 5,180,362). Still others were shunts leading from the anterior chamber to a point just inside Schlemm's canal (Spiegel et al., “Schlemm's canal implant: a new method to lower intraocular pressure in patients with POAG?” Ophthalmic Surgery and Lasers (June 1999); U.S. Pat. No. 6,450,984; U.S. Pat. No. 6,450,984). Delivery and deployment systems for some glaucoma implants are described, e.g., in US 2007/0191863 and US 2007/0010827. Surgical devices for accessing Schlemm's canal are described, e.g., in US 2007/0073275 and US 2006/0149194.


SUMMARY OF THE INVENTION

The present invention relates generally to ocular implants (such as, e.g., those used for glaucoma treatment) and their delivery systems. In particular, the invention relates to ocular implants and their delivery systems useful to treat glaucoma.


New glaucoma treatment implants are described in commonly assigned U.S. Ser. No. 11/860,318, “Ocular Implants,” filed Sep. 24, 2007, the disclosure of which is incorporated herein. Prior ocular implant delivery systems cannot effectively be used to deliver and deploy the implants described therein. In addition, delivery systems used to deliver and deploy earlier glaucoma treatment implants fail to address certain delivery system needs.


On aspect of the invention provides a method of inserting an ocular implant into a patient's eye, the ocular implant being mounted on a carrier, with the method including the following steps: inserting a cannula into an anterior chamber of the eye; moving a distal exit port of the cannula into communication with Schlemm's canal; and advancing the ocular implant and carrier through an exit port of the cannula into Schlemm's canal. In embodiments in which the ocular implant has a plurality of openings, the method further includes the step of advancing the ocular implant and carrier into Schlemm's canal with the carrier blocking the implant openings.


In some embodiments, the inserting step includes the step of inserting the cannula through a cornea of the eye. In some embodiments, the passing step includes the step of advancing the ocular implant with a handheld actuator disposed exterior to the eye.


In some embodiments, the advancing step includes the step of moving a blunt distal surface into Schlemm's canal. The advancing step may also include the step of extending the ocular implant 60°-180° around Schlemm's canal.


In some embodiments, the method includes the step of rotating the implant within Schlemm's canal. Some embodiments of the method include the step of disengaging the ocular implant from the carrier, such as by moving at least one of the carrier and the ocular implant with respect to the other by, e.g., applying a distally directed force on the implant while applying a proximally directed force on the carrier. The step of applying a distally directed force may include the step of applying a distally directed force on the ocular implant with a pusher disposed in the cannula.


In some embodiments in which the carrier has a reduced diameter portion, the disengaging step may include the step of orienting the ocular implant with respect to the reduced diameter portion of the carrier. The advancing step may also include the step of advancing the ocular implant with a pusher having an implant engagement mechanism, in which case the disengaging step includes the step of orienting the ocular implant and an implant engagement mechanism of the pusher with respect to the reduced diameter portion of the carrier.


Some embodiments include the step of removing the carrier from the eye. The method may also include the step of ceasing advancement of the implant into Schlemm's canal when a proximal portion of the implant remains in the anterior chamber and a distal portion of the implant lies in Schlemm's canal. The method may also include the delivery of material through the carrier into Schlemm's canal.


Another aspect of the invention provides an ocular implant and delivery system having a cannula with a distal exit port adapted to be inserted into a Schlemm's canal portion of an eye; an ocular implant; a carrier disposed within the implant and movable with the implant within the cannula; and a proximal control adapted to be operated from exterior to an eye to move at least one of the carrier and the implant when the distal exit port of the cannula is within the eye.


In some embodiments, the ocular implant has a plurality of openings and the carrier is oriented to block the openings. The ocular implant and carrier together may form a blunt distal end. In some embodiments, the cannula forms an arc of a circle having, e.g., a radius of curvature less than about 0.1 inches and may have a diameter less than about 0.03 inches.


In some embodiments, the carrier has a larger diameter portion and a smaller diameter portion, with the ocular implant being engaged with the larger diameter portion of the carrier. Such embodiments may also include a pusher disposed within the cannula and engaged with the ocular implant, the pusher being operably connected to the proximal control. The pusher may have an implant engagement mechanism adapted to hold an ocular implant during advancement out of the exit port of the cannula. The ocular implant may be engaged with the implant engagement mechanism when the implant is disposed between the larger diameter portion of the carrier and the implant engagement mechanism, and the ocular implant may be disengaged with the implant engagement mechanism when the implant is disposed between the smaller diameter portion of the carrier and the implant engagement mechanism.


In some embodiments, the carrier has a material delivery lumen in communication with a material inlet in the proximal control.


In some embodiments, the proximal control has a distal handle connected to the cannula and a proximal handle with a carrier movement actuator, the proximal handle and the distal handle being movable with respect to each other. The proximal handle may also have an implant movement actuator.


Another aspect of the invention provides a method of inserting an ocular implant into a patient's eye including the following steps: inserting a cannula into an anterior chamber of the eye; moving a distal cutting portion of the cannula through trabecular meshwork into Schlemm's canal until a cannula stop element engages the trabecular meshwork; and passing the ocular implant through an exit port of the cannula into Schlemm's canal after engaging the stop element with the trabecular meshwork.


In some embodiments, the inserting step includes the step of inserting the cannula through a cornea of the eye. In some embodiments, the passing step includes the step of advancing the ocular implant with a handheld actuator disposed exterior to the eye.


In some embodiments, the passing step includes the step of moving a blunt distal surface into Schlemm's canal. The passing step may also include the step of extending the ocular implant 60°-180° around Schlemm's canal.


The method may also include one or more of the steps of rotating the implant within Schlemm's canal; maintaining forward pressure on the cannula while deforming at least a portion of the cannula during the passing step; and/or disengaging the ocular implant from a delivery tool. In some embodiments in which the delivery tool includes a pusher, the passing step includes the step of advancing a distal portion of the ocular implant through the exit port of the cannula with the pusher.


Some embodiments of the passing step include the step of advancing the implant into Schlemm's canal over a carrier. Such methods may also include the step of removing the carrier from the eye such as, e.g., by disengaging the ocular implant from the carrier. In some embodiments, material is delivered through the carrier into Schlemm's canal. Some embodiments of the invention also include the step of ceasing advancement of the implant into Schlemm's canal when a proximal portion of the implant remains in the anterior chamber and a distal portion of the implant lies in Schlemm's canal.


Yet another aspect of the invention provides an ocular implant system including a cannula with an implant lumen, a distal exit port, a distal cutting portion at least partially defining the exit port, and a stop element limiting passage of the distal cutting portion into an anatomical lumen at a point in which the exit port is within the lumen; and a proximal control adapted to be operated from exterior to an eye when the distal exit port of the cannula is within the eye.


In some embodiments, the cannula forms an arc of a circle having, e.g., a radius of curvature less than about 0.1 inches and/or a diameter less than about 0.03 inches. The cutting portion may have a cutting edge angled with respect to a central axis of the cannula, with the cutting edge being at an angle of between about 10 degrees and about 80 degrees with respect to the central axis in some embodiments. Some embodiments may also have the stop element disposed at a proximal extent of the cutting edge.


Some embodiments include a carrier disposed within the cannula and adapted to support an implant and sized to pass through the exit port. Such embodiments may also have an ocular implant engaged with the carrier. In embodiments in which the carrier has a larger diameter portion and a smaller diameter portion, the ocular implant may be engaged with the larger diameter portion of the carrier. The carrier may also have a material delivery lumen.


Some embodiments of the invention also include a pusher disposed within the cannula and engaged with the ocular implant, the pusher being operably connected to the proximal control. Such embodiments may also include an implant engagement mechanism adapted to hold an ocular implant during advancement out of the exit port of the cannula.


In some embodiments, the proximal control has a distal handle connected to the cannula and a proximal handle with a carrier movement actuator, the proximal handle and the distal handle being movable with respect to each other. The proximal handle may also have an implant movement actuator.





BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1 shows a partial perspective and partial cross-sectional view of an eye.



FIG. 2 is a partial cross-sectional view and a partial plan view showing an ocular implant being delivered into Schlemm's canal using a delivery system according to this invention.



FIG. 3 is an elevational view of a portion of the cannula of the delivery system of FIG. 2.



FIG. 4 is a side elevational view of a portion of the cannula of FIG. 3.



FIGS. 5 and 6 are further partial cross-sectional views and partial perspective views showing the ocular implant being delivered into Schlemm's canal using a delivery system according to the embodiment of FIG. 2.



FIG. 7 is a partial cross-sectional view and a partial plan view showing the ocular implant and delivery system of FIG. 2 with the implant in place within Schlemm's canal and disengaged from a carrier of the delivery system.



FIG. 8 is a partial cross-sectional view and a partial plan view of an implant in place within Schlemm's canal after delivery.



FIG. 9 is a cross-sectional view of a connection between an ocular implant and its delivery system according to one embodiment of the invention.



FIG. 10 is a perspective view of a portion of a delivery system pusher according to the embodiment of FIG. 9.



FIG. 11 is a partial cross-sectional view and a partial plan view of the ocular implant and delivery system of FIGS. 9 and 10 showing the implant disengaged from the delivery system.



FIG. 12 is a partial cross-sectional view and a partial plan view of aspects of an ocular implant delivery system according to one embodiment of the invention.



FIG. 13 is a partial cross-sectional view and a partial plan view of the portion of the delivery system of FIG. 12 indicated by “A”.



FIG. 14 is a partial cross-sectional view and a partial plan view of an ocular implant delivery system and ocular implant according to another embodiment of the invention.





DETAILED DESCRIPTION OF THE INVENTION

The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered identically. The drawings, which are not necessarily to scale, depict exemplary embodiments and are not intended to limit the scope of the invention. Examples of constructions, materials, dimensions, and manufacturing processes are provided for selected elements. All other elements employ that which is known to those of skill in the field of the invention. Those skilled in the art will recognize that many of the examples provided have suitable alternatives that can be utilized.



FIG. 1 is a stylized depiction of a human eye 10 showing the cornea 12 covering the pupil 14 and iris 16 and the sclera 18 just beyond the iris. The anterior chamber 20 lies behind the cornea and in front of the pupil, iris and lens. As described above, in a healthy eye, aqueous humor flows out of the anterior chamber 20 through the trabecular meshwork 22 and into Schlemm's canal 24, located at the outer edge of the iris 16.



FIGS. 2-8 show an ocular implant 100 being delivered through a cannula 102 into Schlemm's canal 104. (Schlemm's canal is shown in these figures as being straight instead of curved for ease of illustration.) The ocular implant shown is described in more detail in U.S. Ser. No. 11/860,318, “Ocular Implants,” filed Sep. 24, 2007. It should be understood that other ocular implants may be delivered and deployed by the delivery system of this invention.


As shown in FIG. 2, a distal portion of cannula 102 has passed through the cornea to be within the anterior chamber 101 of the eye and has pierced the trabecular meshwork 106 to enable a distal exit port 108 of cannula 102 to communicate with Schlemm's canal 104. In this embodiment, cannula 102 is a rigid curved tube that has a cutting portion 110 at the exit port 108, as shown in more detail in FIGS. 3 and 4. In some embodiments, cannula 102 is curved to achieve tangential entry into Schlemm's canal, such as by forming an arc of a circle having a radius of curvature less than about 0.1 inches. Other embodiments may have other shapes and curves.


In this embodiment, cutting portion 110 is formed from two convex edges 112 meeting at a tip 114. In other embodiments, the cutting edges can be concave or straight. As shown, edges 112 extend from tip 114 to a pair of optional stops 116 formed at the intersection of edges 112 with an optional cannula extension portion 118. As shown in FIG. 2, the distal end of cannula 102 may be advanced within the anterior chamber 101 toward the trabecular meshwork 106. When the distal end of cannula 102 meets the trabecular meshwork, tip 114 and edges 112 of cutting portion 110 are advanced to extend through the trabecular meshwork into Schlemm's canal while extension portion 118 bends back and remains within the anterior chamber 101. Distal movement of cannula 102 ceases when stops 116 engage the trabecular meshwork.


In some embodiments, cannula 102 is formed from transparent polycarbonate tubing having a diameter less than about 0.030 inches, e.g., an outer diameter of 0.028 inches and an inner diameter of 0.014 inches. In embodiments with cutting edges leading to stops, the cutting edges may be at angles of between about 10° and 80° with respect to the cannula's central axis, and the stops may be located approximately one-half diameter inward of tip 114. In embodiments with a cannula extension portion, the extension portion 118 may extend approximately 1.5 mm beyond tip 114. Among other functions, the bending of extension portion 118 while forward pressure is maintained on the cannula (as shown, e.g., in FIG. 2) provides feedback to the user of robust engagement with the trabecular meshwork and accurate positioning of the distal end of the cannula.


During delivery, ocular implant 100 is mounted on a carrier 120 which is movable with implant 100 within cannula 102. Among other functions, one particular function of carrier 120 is to block the openings 122 formed in implant 100 so as to minimize interference between the implant and tissue within Schlemm's canal 104 as the implant is advanced. The ocular implant 100 has a blunt distal end 124 in this embodiment to avoid damage to ocular tissue. In other embodiments, the blunt distal end may be provided at least in part by the carrier.


In this embodiment, a pusher 126 is engaged with the proximal end 128 of ocular implant 100, as shown in FIG. 6, to advance the implant through the exit port 108 of cannula 102 and into Schlemm's canal. Carrier 120 extends proximally into pusher 126 to, e.g., a handheld actuator (not shown) exterior to the eye.


When only the proximal end 128 of implant 100 remains in the anterior chamber 101, advancement of the implant into Schlemm's canal ceases. Depending on the design of the ocular implant, the implant may extend 60°-180° around Schlemm's canal at this point. Also, at this time or prior to it, the implant may be rotated within Schlemm's canal to attain the appropriate orientation. A proximal force can then be applied to carrier 120 (by, e.g., an external actuator or control) to withdraw the carrier proximally from the implant 100 while pusher 126 applies a distally directed force (once again by, e.g., an external actuator or control) to hold implant 100 in place, as shown in FIG. 7. Carrier 120 pusher 126 and cannula 102 may then be withdrawn from the eye, leaving the implant in Schlemm's canal with its proximal inlet end 128 within the anterior chamber 101.



FIGS. 9-11 show details of one embodiment of an engagement mechanism between an ocular implant (such as implant 100 shown in FIGS. 2-8) and a delivery system. In this embodiment, carrier 200 has a distal reduced diameter portion 202 and a proximal increased diameter portion 204. The distal end of pusher 206 has an inner lip 207 for engagement with the proximal end 128 of the implant and a collar surrounding the proximal end 128 of the implant. As shown in FIG. 10, one or more longitudinal slits 210 are formed in collar 208 to permit collar 208 to expand radially. In addition, the implant 100 of this embodiment has an open channel proximal end 128, as shown in FIG. 8, which can also be radially expanded. When in the engagement configuration shown in FIG. 9, the carrier's increased diameter portion 204 lies within the proximal end of implant 100, which in turn is disposed within collar 208 of pusher 206. The diameter of carrier portion 204 is larger than the at-rest diameters of collar 208 and implant portion 128, thereby causing collar 208 and implant portion 128 to radially expand from their at-rest shapes. When in this configuration, therefore, the pusher, implant and carrier have a friction fit that permits them to move as a unit.


To disengage the implant from the delivery system, carrier 200 is withdrawn proximally (or, alternatively, the implant is moved forward distally) until the reduced diameter portion 202 lies within the implant's proximal portion 128 and collar 208, as shown in FIG. 11. Since the diameter of reduced diameter portion 202 is less than the at-rest inner diameter of the implant's proximal portion 128, the implant is released from the delivery system carrier. The pusher can then be disengaged from the implant by simply withdrawing the pusher proximally.



FIGS. 12 and 13 show an embodiment of a handheld actuator of the implant and delivery system of this invention. In this embodiment, the actuator functions are divided between two handles, proximal handle 300 and distal handle 302. For ease of illustration, FIGS. 12 and 13 omit the cannula and implant. An ocular implant carrier 304 extends proximally through a pusher 306 into distal handle 302. In this embodiment, pusher 306 has a proximal push tube 308 and a distal reduced diameter push tube 310 bonded to the inside surface of proximal push tube 308. Carrier 304 also extends proximally through a distal sleeve 312 and through a distal portion of a proximal core tube 314. (Proximal core tube 314 is shown in a plan view in FIG. 12 and in cross-section in FIG. 13.) An enlarged proximal end 316 of carrier 304 is disposed within proximal core tube 314 between the proximal end of distal sleeve 312 and a distal stop element 318. The enlarged end 316 of carrier 304 is larger than the inner diameters of sleeve 312 and stop element 318. Thus, carrier 304 can move longitudinally only a limited amount with respect to proximal core tube 314.


A luer fitting 320 (or other suitable connector) at the distal end of distal handle 302 is provided to engage with the proximal end of a cannula (not shown), such as the cannula described above. Advancement of a cannula and implant into a patient's eye can therefore be controlled by movement of distal handle 302 with respect to the eye. In some embodiments, the exterior surface of proximal push tube 308 has at least one flat surface (such as a hexagonal surface) that mates with a corresponding shape on the inner surface of distal handle 302 so that rotation of handle 302 with respect to the cannula rotates the pusher and the implant.


A braided tube 322 extends proximally from a proximal end of distal handle 302 to a distal end of proximal handle 300 through distal and proximal strain relief portions 324 and 326, respectively. Braided tube 322 permits handles 300 and 302 to be rotated with respect to each other, thereby preventing any unintentional rotation of handle 300 from rotating handle 302.


Proximal push tube 308 extends proximally through distal handle 302 and braided tube 322 to a push tube stop 328 within proximal handle 300, to which it is bonded. Stop 328 is held in place within a push tube actuator 332 by a plug 330. In this embodiment, stop 328 and proximal push tube 308 are free to rotate relative to push tube actuator 332. Push tube actuator 332 has exterior threads mating with interior threads of a stationary handle portion 333. Proximal core tube 314 extends further proximally beyond proximal push tube 308 to a core tube stop 334, to which it is bonded. Stop 334 is held in place within a core tube actuator 336 by a domed plug 338. In this embodiment, stop 334 and core proximal core tube 314 are free to rotate relative to core tube actuator 336. Core tube actuator 336 has exterior threads mating with interior threads of push tube actuator 332.


The two handle design of this embodiment permits two person operation of the ocular implant and delivery system. In use, an ocular implant (such as that described above) is mounted on carrier 304 and placed within a cannula (such as that described above) attached to luer fitting 320 of distal handle 302. Under visual observation using a goniolens, a surgeon advances the distal end of the cannula through an opening in the patient's cornea into the anterior chamber of the eye by advancing distal handle 302. When the cannula has cut through the trabecular meshwork to place the cannula's distal exit port into communication with Schlemm's canal, an assistant holding proximal handle 300 advances the carrier and implant out of the cannula's distal exit port by simultaneously turning actuators 332 and 336, which, due to the mating threads of actuator 332 and handle portion 333, moves push tube 308 and carrier 304 distally with respect to handle portion 333, distal handle 302 and the cannula.


When the implant has been advanced a sufficient distance into Schlemm's canal, the implant is disengaged from the delivery system by turning actuator 336 with respect to actuator 332 to move the carrier 304 proximally with respect to the push tube 308, thereby keeping the implant stationary while the carrier is withdrawn. After the implant has been deployed and disengaged from the delivery system, the pusher, carrier and cannula are removed from the patient's eye.



FIG. 14 shows yet another embodiment of an ocular implant and delivery system according to the invention. (Elements similar to that of earlier embodiments are given the same element numbers.) This embodiment omits the proximal core tube interacting with the carrier. Instead, the carrier 304 extends proximally through dome plug 338 to a proximal fitting 400 (such as a luer fitting) having in inlet 401 in communication with a central lumen of carrier 304. The ocular implant of this embodiment has a distal exit port 402 lined up with the central lumen of carrier 304. Materials (such as dye, contrast agent, drugs, etc.) can be injected through proximal fitting 400 into carrier 304 and out of the distal exit port 402 of implant 100 into the patient's eye, as needed. As in the earlier embodiment, when the implant has been advanced a sufficient distance into Schlemm's canal, the implant is disengaged from the delivery system by turning actuator 336 with respect to actuator 332 to move the carrier 304 proximally with respect to the push tube 308, thereby keeping the implant stationary while the carrier is withdrawn. After the implant has been deployed and disengaged from the delivery system, the pusher, carrier and cannula are removed from the patient's eye. In some embodiments, implant 100 can be rotated by rotating proximal fitting 400 and carrier 304.

Claims
  • 1. An ocular implant and delivery system comprising: a cannula comprising a distal cutting portion, a distal exit port adapted to be inserted into a Schlemm's canal portion of an eye, and a distal stop element;an ocular implant disposed within the cannula and comprising a plurality of openings through a longitudinal side of the implant;a pusher disposed within the cannula and engaged with the ocular implant; anda proximal control operably connected to the pusher and adapted to be operated from exterior to an eye to move the implant when the distal exit port of the cannula is within the eye.
  • 2. The system of claim 1 wherein the cannula forms an arc of a circle.
  • 3. The system of claim 2 wherein the cannula has a radius of curvature less than about 0.1 inches.
  • 4. The system of claim 1 wherein the cannula has a diameter less than about 0.03 inches.
  • 5. The system of claim 1 wherein the cutting portion comprises a cutting edge angled with respect to a central axis of the cannula.
  • 6. The system of claim 5 wherein the cutting edge is at an angle of between about 10 degrees and about 80 degrees with respect to the central axis.
  • 7. The system of claim 5 wherein the stop element is disposed at a proximal extent of the cutting edge.
  • 8. The system of claim 1 wherein the distal cutting portion at least partially defines the exit port.
  • 9. The system of claim 1 further comprising a carrier disposed within the implant, oriented to block the implant openings and movable with the implant within the cannula.
  • 10. The system of claim 9 wherein the ocular implant and carrier together comprise a blunt distal end.
  • 11. The system of claim 9 wherein the carrier has a larger diameter portion and a smaller diameter portion, the ocular implant being engaged with the larger diameter portion of the carrier.
  • 12. The system of claim 11 wherein the pusher comprises an implant engagement mechanism adapted to hold an ocular implant during advancement out of the exit port of the cannula.
  • 13. The system of claim 12 wherein the ocular implant is engaged with the implant engagement mechanism when the implant is disposed between the larger diameter portion of the carrier and the implant engagement mechanism, and the ocular implant is disengaged with the implant engagement mechanism when the implant is disposed between the smaller diameter portion of the carrier and the implant engagement mechanism.
  • 14. The system of claim 12 wherein the engagement mechanism comprises a friction fit between the implant and the carrier.
  • 15. The system of claim 14 wherein the engagement mechanism further comprises a friction fit between the implant and the pusher.
  • 16. The system of claim 12 wherein the engagement mechanism is adapted to attach the implant to the pusher such that the implant and pusher can be moved as a unit.
  • 17. The system of claim 12 wherein the engagement mechanism is adapted to attach the implant to the pusher such that the implant, carrier and pusher can be moved as a unit.
  • 18. The system of claim 9 wherein the carrier comprises a material delivery lumen in communication with a material inlet in the proximal control.
  • 19. The system of claim 9 wherein the proximal control comprises a distal handle connected to the cannula and a proximal handle comprising a carrier movement actuator, the proximal handle and the distal handle being movable with respect to each other.
  • 20. The system of claim 19 wherein the proximal handle further comprises an implant movement actuator.
  • 21. The system of claim 9 wherein the carrier extends proximally into the pusher.
  • 22. The system of claim 9 wherein the carrier is further adapted to move with the implant through the distal exit port of the cannula.
  • 23. The system of claim 22 wherein the proximal control is further adapted to move the carrier through the distal exit port of the cannula and to retract the carrier back into the cannula.
  • 24. The system of claim 1 wherein the distal cutting portion comprises two convex edges meeting at a tip.
US Referenced Citations (223)
Number Name Date Kind
3788327 Donowitz et al. Jan 1974 A
3948271 Akiyama Apr 1976 A
4037604 Newkirk Jul 1977 A
4428746 Mendez Jan 1984 A
4457757 Molteno Jul 1984 A
4722724 Schocket Feb 1988 A
4733665 Palmaz Mar 1988 A
4750901 Molteno Jun 1988 A
4826478 Schocket May 1989 A
4886488 White Dec 1989 A
4934809 Volk Jun 1990 A
4936825 Ungerleider Jun 1990 A
4946436 Smith Aug 1990 A
4968296 Ritch et al. Nov 1990 A
5092837 Ritch et al. Mar 1992 A
5127901 Odrich Jul 1992 A
5178604 Baerveldt et al. Jan 1993 A
5180362 Worst Jan 1993 A
5213569 Davis May 1993 A
5246452 Sinnott Sep 1993 A
5360399 Stegmann Nov 1994 A
5372577 Ungerleider Dec 1994 A
5454796 Krupin Oct 1995 A
5458615 Klemm et al. Oct 1995 A
5591223 Lock et al. Jan 1997 A
5626558 Suson May 1997 A
5792099 DeCamp et al. Aug 1998 A
5807302 Wandel Sep 1998 A
5865831 Cozean et al. Feb 1999 A
5868697 Richter et al. Feb 1999 A
5879319 Pynson et al. Mar 1999 A
5893837 Eagles et al. Apr 1999 A
5948427 Yamamoto et al. Sep 1999 A
5968058 Richter et al. Oct 1999 A
6007511 Prywes Dec 1999 A
6050970 Baerveldt Apr 2000 A
6102045 Nordquist et al. Aug 2000 A
6186974 Allan et al. Feb 2001 B1
6221078 Bylsma Apr 2001 B1
6238409 Hojeibane May 2001 B1
D444874 Haffner et al. Jul 2001 S
6375642 Grieshaber et al. Apr 2002 B1
6409752 Boatman et al. Jun 2002 B1
6450984 Lynch et al. Sep 2002 B1
6464724 Lynch et al. Oct 2002 B1
6471666 Odrich Oct 2002 B1
6494857 Neuhann Dec 2002 B1
6508779 Suson Jan 2003 B1
6524275 Lynch et al. Feb 2003 B1
6533764 Haffner et al. Mar 2003 B1
6533768 Hill Mar 2003 B1
6544208 Ethier et al. Apr 2003 B2
6544249 Yu et al. Apr 2003 B1
6626858 Lynch et al. Sep 2003 B2
6638239 Bergheim et al. Oct 2003 B1
6666841 Gharib et al. Dec 2003 B2
6699210 Williams et al. Mar 2004 B2
6699211 Savage Mar 2004 B2
6726676 Stegmann et al. Apr 2004 B2
D490152 Myall et al. May 2004 S
6730056 Ghaem et al. May 2004 B1
6736791 Tu et al. May 2004 B1
6780164 Bergheim et al. Aug 2004 B2
6783544 Lynch et al. Aug 2004 B2
6827699 Lynch et al. Dec 2004 B2
6827700 Lynch et al. Dec 2004 B2
6881198 Brown Apr 2005 B2
6939298 Brown et al. Sep 2005 B2
6955656 Bergheim et al. Oct 2005 B2
6962573 Wilcox Nov 2005 B1
6981958 Gharib et al. Jan 2006 B1
6989007 Shadduck Jan 2006 B2
7094225 Tu et al. Aug 2006 B2
7135009 Tu et al. Nov 2006 B2
7147650 Lee Dec 2006 B2
7163543 Smedley et al. Jan 2007 B2
7186232 Smedley et al. Mar 2007 B1
7192412 Zhou et al. Mar 2007 B1
7207965 Simon Apr 2007 B2
7207980 Christian et al. Apr 2007 B2
7220238 Lynch et al. May 2007 B2
7273475 Tu et al. Sep 2007 B2
7297130 Bergheim et al. Nov 2007 B2
7331984 Tu et al. Feb 2008 B2
7699882 Stamper et al. Apr 2010 B2
7931596 Rachlin et al. Apr 2011 B2
7967772 McKenzie et al. Jun 2011 B2
8012115 Karageozian Sep 2011 B2
8034105 Stegmann et al. Oct 2011 B2
8123729 Yamamoto et al. Feb 2012 B2
8372026 Schieber et al. Feb 2013 B2
20010002438 Sepetka et al. May 2001 A1
20020003546 Mochimaru et al. Jan 2002 A1
20020013546 Grieshaber et al. Jan 2002 A1
20020013572 Berlin Jan 2002 A1
20020072673 Yamamoto et al. Jun 2002 A1
20020133168 Smedley et al. Sep 2002 A1
20020143284 Tu et al. Oct 2002 A1
20030004457 Andersson Jan 2003 A1
20030055372 Lynch et al. Mar 2003 A1
20030060748 Baikoff Mar 2003 A1
20030060752 Bergheim et al. Mar 2003 A1
20030093084 Nissan et al. May 2003 A1
20030097151 Smedley et al. May 2003 A1
20030181848 Bergheim et al. Sep 2003 A1
20030187384 Bergheim et al. Oct 2003 A1
20030229303 Haffner et al. Dec 2003 A1
20030236483 Ren Dec 2003 A1
20030236484 Lynch et al. Dec 2003 A1
20040024345 Gharib et al. Feb 2004 A1
20040024453 Castillejos Feb 2004 A1
20040082939 Berlin Apr 2004 A1
20040088048 Richter et al. May 2004 A1
20040098124 Freeman et al. May 2004 A1
20040102729 Haffner et al. May 2004 A1
20040106975 Solovay et al. Jun 2004 A1
20040111050 Smedley et al. Jun 2004 A1
20040127843 Tu et al. Jul 2004 A1
20040147870 Burns et al. Jul 2004 A1
20040193095 Shadduck Sep 2004 A1
20040193262 Shadduck Sep 2004 A1
20040210181 Vass et al. Oct 2004 A1
20040210185 Tu et al. Oct 2004 A1
20040216749 Tu Nov 2004 A1
20040225357 Worst et al. Nov 2004 A1
20040249333 Bergheim et al. Dec 2004 A1
20040254519 Tu et al. Dec 2004 A1
20040254520 Porteous et al. Dec 2004 A1
20040260228 Lynch et al. Dec 2004 A1
20050041200 Rich Feb 2005 A1
20050049578 Tu et al. Mar 2005 A1
20050090806 Lynch et al. Apr 2005 A1
20050090807 Lynch et al. Apr 2005 A1
20050101967 Weber et al. May 2005 A1
20050107734 Coroneo May 2005 A1
20050119601 Lynch et al. Jun 2005 A9
20050119636 Haffner et al. Jun 2005 A1
20050125003 Pinchuk et al. Jun 2005 A1
20050131514 Hijlkema et al. Jun 2005 A1
20050154443 Linder et al. Jul 2005 A1
20050165385 Simon Jul 2005 A1
20050192527 Gharib et al. Sep 2005 A1
20050197667 Chan et al. Sep 2005 A1
20050203542 Weber et al. Sep 2005 A1
20050209549 Bergheim et al. Sep 2005 A1
20050209550 Bergheim et al. Sep 2005 A1
20050244464 Hughes Nov 2005 A1
20050250788 Tu et al. Nov 2005 A1
20050260186 Bookbinder et al. Nov 2005 A1
20050266047 Tu et al. Dec 2005 A1
20050271704 Tu et al. Dec 2005 A1
20050273033 Grahn et al. Dec 2005 A1
20050277864 Haffner et al. Dec 2005 A1
20050288619 Gharib et al. Dec 2005 A1
20050288745 Andersen et al. Dec 2005 A1
20060020247 Kagan et al. Jan 2006 A1
20060032507 Tu Feb 2006 A1
20060052879 Kolb Mar 2006 A1
20060069340 Simon Mar 2006 A1
20060074375 Bergheim et al. Apr 2006 A1
20060079828 Brown Apr 2006 A1
20060084907 Bergheim et al. Apr 2006 A1
20060106370 Baerveldt et al. May 2006 A1
20060116626 Smedley et al. Jun 2006 A1
20060149194 Conston et al. Jul 2006 A1
20060154981 Klimko et al. Jul 2006 A1
20060155238 Shields Jul 2006 A1
20060155300 Stamper et al. Jul 2006 A1
20060173397 Tu et al. Aug 2006 A1
20060189915 Camras et al. Aug 2006 A1
20060189916 Bas et al. Aug 2006 A1
20060189917 Mayr et al. Aug 2006 A1
20060195055 Bergheim et al. Aug 2006 A1
20060195056 Bergheim et al. Aug 2006 A1
20060195187 Stegmann et al. Aug 2006 A1
20060200113 Haffner et al. Sep 2006 A1
20060241749 Tu et al. Oct 2006 A1
20070010827 Tu et al. Jan 2007 A1
20070073275 Conston et al. Mar 2007 A1
20070088432 Solovay et al. Apr 2007 A1
20070106200 Levy May 2007 A1
20070106236 Coroneo May 2007 A1
20070112292 Tu et al. May 2007 A1
20070118147 Smedley et al. May 2007 A1
20070179520 West Aug 2007 A1
20070191863 De Juan, Jr. et al. Aug 2007 A1
20070202186 Yamamoto et al. Aug 2007 A1
20070265582 Kaplan et al. Nov 2007 A1
20070270945 Kobayashi et al. Nov 2007 A1
20070276315 Haffner et al. Nov 2007 A1
20070276316 Haffner et al. Nov 2007 A1
20070282244 Tu et al. Dec 2007 A1
20070282245 Tu et al. Dec 2007 A1
20070293807 Lynch et al. Dec 2007 A1
20070298068 Badawi et al. Dec 2007 A1
20080015488 Tu et al. Jan 2008 A1
20080045878 Bergheim et al. Feb 2008 A1
20080058704 Hee et al. Mar 2008 A1
20080228127 Burns et al. Sep 2008 A1
20090005852 Gittings et al. Jan 2009 A1
20090028953 Yamamoto et al. Jan 2009 A1
20090030363 Gellman Jan 2009 A1
20090030381 Lind et al. Jan 2009 A1
20090043321 Conston et al. Feb 2009 A1
20090069786 Vesely et al. Mar 2009 A1
20090104248 Rapacki et al. Apr 2009 A1
20090138081 Bergheim et al. May 2009 A1
20090182421 Silvestrini et al. Jul 2009 A1
20090281520 Highley et al. Nov 2009 A1
20100004580 Lynch et al. Jan 2010 A1
20100057072 Roman et al. Mar 2010 A1
20100121342 Schieber et al. May 2010 A1
20100173866 Hee et al. Jul 2010 A1
20100222733 Schieber et al. Sep 2010 A1
20100234726 Sirimanne et al. Sep 2010 A1
20100234790 Tu et al. Sep 2010 A1
20110009874 Wardle et al. Jan 2011 A1
20110009958 Wardle et al. Jan 2011 A1
20110319806 Wardle Dec 2011 A1
20120010702 Stegmann et al. Jan 2012 A1
20120179087 Schieber et al. Jul 2012 A1
20120323159 Wardle et al. Dec 2012 A1
20130006165 Euteneuer et al. Jan 2013 A1
Foreign Referenced Citations (28)
Number Date Country
199876197 Feb 1999 AU
1950091 Apr 2007 CN
19840047 Mar 2000 DE
1615604 Aug 2009 EP
2193821 Jun 2010 EP
1715827 Dec 2010 EP
2380622 Oct 2011 EP
2468327 Jun 2012 EP
2471563 Jul 2012 EP
1833440 Aug 2012 EP
11123205 May 1999 JP
2007181714 Jul 2007 JP
WO 0007525 Feb 2000 WO
WO 0064389 Nov 2000 WO
WO 0064393 Nov 2000 WO
WO 0197727 Dec 2001 WO
WO 0236052 May 2002 WO
WO 02074052 Sep 2002 WO
WO 02080811 Oct 2002 WO
WO 03015659 Feb 2003 WO
WO 03045290 Jun 2003 WO
WO 2004093761 Nov 2004 WO
WO 2005105197 Nov 2005 WO
WO 2006066103 Jun 2006 WO
WO 2007035356 Mar 2007 WO
WO 2007047744 Apr 2007 WO
WO 2007087061 Aug 2007 WO
WO2008002377 Jan 2008 WO
Non-Patent Literature Citations (20)
Entry
U.S. Appl. No. 60/131,030, filed Apr. 26, 1999, Lynch.
Schieber et al.; U.S. Appl. No. 11/860,318 entitled “Ocular implants,” filed Sep. 24, 2007.
Schieber et al.; U.S. Appl. No. 12/236,225 entitled “Ocular implants with asymmetric flexibility,” filed Sep. 23, 2008.
Schieber et al.; U.S. Appl. No. 12/236,254 entitled “Ocular implant architectures,” filed Sep. 23, 2008.
Bahler, et al.; Trabecular bypass stents decrease intraocular pressure in cultured human anterior segments; Amer. Journal of Ophthalmology; vol. 138, No. 6; pp. 988-994.e2; Dec. 2004.
D'Ermo, et al.; Our results with the operation of ab externo trabeculotomy; Ophthalmologica; vol. 163; pp. 347-355; 1971.
Johnstone et al.; “Microsurgery of Schlemm's Canal and the Human Aqueous Outflow System;” American Journal of Ophthalmology, vol. 76 (6): 906-917; Dec. 1973.
Lee et al.; Aqueous-venous shunt and intraocular pressure. Preliminary report of animal studies; Investigative Ophthalmology; vol. 5; No. 1; pp. 59-64; Feb. 1966.
Mäepea et al.; The pressures in the episcleral veins, schlemm's canal and the trabecular meshwork in monkeys: effects of changes in intraocular pressure; Exp. Eye Res.; vol. 49; pp. 645-663; 1989.
Savage, James; Gonioscopy in the management of glaucoma; Am. Academy of Ophthalmology; Focal Points; vol. XXIV; No. 3; pp. 1-14; Mar. 2006.
Schultz, Jared; Canaloplasty procedure shows promise for open-angle glaucoma in European study; Ocular Surgery News; vol. 34; Mar. 1, 2007.
Spiegel et al.; Schlemm's canal implant: a new method to lower intraocular pressure in patients with POAG?; Ophthalmic Surgery and Lasers; vol. 30; No. 6; pp. 492-494; Jun. 1999.
Ellingsen et al.; Trabeculotomy and sinusotomy in enucleated human eyes; Investigative Ophthalmology; vol. 11; pp. 21-28; Jan. 1972.
Grant; Experimental aqueous perfusion in enucleated human eyes; Archives of Ophthalmology; vol. 69; pp. 783-801; Jun. 1963.
Smit et al.; Effects of viscoelastic injection into schlemm's canal in primate and human eyes; J. Am. Academy of Ophthalmology; vol. 109; No. 4; pp. 786-792; Apr. 2002.
Euteneuer et al.; U.S. Appl. No. 12/398,847 entitled “Methods and Apparatus for Treating Glaucoma,” filed Mar. 5, 2009.
Wardle et al.; U.S. Appl. No. 12/911,451 entitled “Ocular Implant System and Method,” filed Oct. 25, 2010.
Moses, Robert; The effect of intraocular pressure on resistance to outflow; Survey of Ophthalmology; vol. 22; No. 2; pp. 88-100; Sep.-Oct. 1977.
Rosenquist et al.; Outflow resistance of enucleated human eyes at two different perfusion pressures and different extents of trabeculotomy; Current Eye Res.; vol. 8; No. 12; pp. 1233-1240; Dec. 1989.
Wardle et al.; U.S. Appl. No. 13/330,592 entitled “Delivering Ocular Implants Into the Eye,” filed Dec. 19, 2011.
Related Publications (1)
Number Date Country
20090132040 A1 May 2009 US