Direct visualization system for glaucoma treatment

Information

  • Patent Grant
  • 10085633
  • Patent Number
    10,085,633
  • Date Filed
    Thursday, April 18, 2013
    11 years ago
  • Date Issued
    Tuesday, October 2, 2018
    5 years ago
Abstract
A direct visualization (DV) system and methods are disclosed for measuring one or more anatomical features of the eye, including a depth of the iridocorneal angle of the eye. The DV system can include a wire extending distally from a handle with the wire having one or more indicators for measuring anatomical features of the eye. The DV system can be deployed into the eye and used with minimal trauma to ocular tissues. Furthermore, the DV system can be used independently or alongside other ocular instruments, such as instruments having indicators corresponding to the DV system for correctly implanting ocular implants without the use of a gonio lens.
Description
BACKGROUND

The mechanisms that cause glaucoma are not completely known. It is known that glaucoma results in abnormally high pressure in the eye, which leads to optic nerve damage. Over time, the increased pressure can cause damage to the optic nerve, which can lead to blindness. Treatment strategies have focused on keeping the intraocular pressure down in order to preserve as much vision as possible over the remainder of the patient's life.


Pursuant to such strategies, one or more implants can be delivered into the eye for shunting fluid out of the anterior chamber in order to regulate pressure in the eye. Accurate placement of an implant in the angle of the eye is critical for the targeted effect of reducing intraocular pressure (IOP). Placing an implant too distally into the eye, such as too distally into the supraciliary space, may leave no portion of the implant remaining in the anterior chamber. This may inhibit aqueous outflow, as the fluid will not have a direct communication with the flow target location if there is no opening to the anterior chamber.


Conversely if the implant is placed too proximally in the supraciliary space such that a significant portion of the implant remains in the anterior chamber, damage to the corneal endothelium may result from implants that protrude upwards and touch the cornea. Implants placed too proximally may also touch the iris resulting in increased amounts of pigment dispersion in the eye, which can increase outflow resistance and intraocular pressure by clogging the trabecular meshwork. Correct placement of the implant is desired for a safety and a successful surgical outcome.


Many surgical procedures in ophthalmology require visualization of the iridocorneal angle (sometimes referred to as “the angle”) of the eye. Current techniques include endoscopy and gonioscopy, though both require clinicians to use at least two hands during surgery. This can be cumbersome for the surgeon. Surgical procedures that primarily involve the measurement of the depth of the angle, such as many minimally invasive glaucoma surgeries (MIGS), may benefit from a simplified method of placing implants in the angle of the eye particularly with respect to visualization of the iridocorneal angle.


Proper placement of ophthalmic implants in the angle of the eye can be critical to implant performance. Current visualization techniques may provide satisfactory angle visualization, although current techniques suffer from a multitude of issues. Gonioscopy requires the clinician to use an additional hand during surgery and the gonio lens must be placed directly on the cornea, increasing risk of infection and corneal damage. The surgical microscope used during gonioscopy may also require adjustment for proper angle visualization, which adds to surgery time. Endoscopy also requires the clinician to use an additional hand during surgery and a may involve a larger or second limbal incision for access to the anterior chamber, increasing the potential for surgical complications such as hypotony. Additionally, these techniques are not intuitive to many physicians and require significant training.


In view of the foregoing, there is a need for direct visualization (DV) systems which are configured and adapted for measuring a depth of the iridocorneal angle of the eye. In addition, there is a need for the DV systems to deploy into the eye and be used with minimal trauma to ocular tissues.


SUMMARY

There is a need for improved systems, devices and methods for the treatment of diseases, such as glaucoma.


In a first embodiment, disclosed herein is a device for measuring anatomical features of an eye. The device can include a handle and a wire including a contact tip at a distal end of the wire. In addition, the wire can extend out of the handle and can be configured to be inserted ab-internally and positioned against ocular tissue in the eye. The wire can include at least one indicator for assisting in measuring at least one anatomical feature of the eye.


Also described herein are methods of measuring anatomical features of an eye and implanting an ocular implant. In an embodiment, disclosed is a method including forming an incision in the cornea of the eye into an anterior chamber of the eye. The method can also include introducing through the incision a distal end of a device for measuring at least one anatomical feature of the eye. The device can comprise a handle with a wire extending out of a distal end of the handle. In addition, a distal end of the wire can be configured to be pressed against ocular tissue in the eye. The wire can include at least one indicator for measuring at least one anatomical feature of the eye. The method can also include passing the distal end of the wire through the incision and across the anterior chamber of the eye and positioning the distal end of the wire against ocular tissue below the scleral spur and above the iris. The method can also include measuring at least one anatomical feature of the eye by identifying one or more indicators along a length of the wire relative to one or more anatomical features.


Other features and advantages should be apparent from the following description of various embodiments, which illustrate, by way of example, the principles of the described subject matter.





BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects will now be described in detail with reference to the following drawings.



FIG. 1 shows an example cross-sectional view of a portion of the human eye.



FIG. 2 shows and an example partial cross-sectional view of the eye showing a part of the anterior and posterior chambers of the eye and an ocular implant implanted in the eye.



FIG. 3 shows a perspective view of an embodiment of a direct visualization (DV) system.



FIG. 4 shows an enlarged view of a distal end of the DV system including a part of a DV wire 12 and stopper tube 16.



FIG. 5 shows a cross-sectional view of a portion of the DV system shown in FIG. 3.



FIG. 6 shows the distal end of the DV system shown in FIG. 3 inserted into an eye.



FIG. 7 shows the DV wire of the DV system aligned alongside an implant delivery applier showing the corresponding indicators.



FIG. 8 shows the DV wire inserted into the eye for measuring anatomical features of the eye.



FIG. 9 shows the distal end of the DV wire abutting the base of the angle of the eye and the stopper tube in an advanced position along the DV wire.



FIG. 10 shows the implant delivery applier implanting an ocular implant through the same incision the DV system used in FIGS. 8 and 9.



FIG. 11 shows the indicators on the implant delivery applier being used to determine the proper insertion depth of the implant.



FIG. 12 shows the implant in its implanted state and providing fluid communication between the anterior chamber and the suprachoroidal or supraciliary space.



FIG. 13A shows an embodiment of the implant delivery applier having a feedback mechanism.



FIG. 13B shows the feedback mechanism of the implant delivery applier shown in FIG. 13A in a retracted state.





Like reference symbols in the various drawings indicate like elements.


DETAILED DESCRIPTION

Disclosed is a direct visualization (DV) system configured and adapted for measuring a depth of the iridocorneal angle of the eye. The system is configured to be deployed into the eye and used with minimal trauma to ocular tissues. The system includes a direct visualization (DV) wire with indicators, such as numbers or patterns that indicate or represent known distances. In use, the DV wire can be placed directly against the base of the iridocorneal angle allowing for depth measurements. The system can further include a spring connected to the DV wire. In addition, the spring can have a very low spring constant. The spring can allow the DV wire to abut against the tissues in the eye with low contact force. Such a system may be used independently or alongside other ocular instruments, such as instruments having indicators corresponding to the DV system for correctly implanting ocular implants without the use of a gonio lens.


The disclosed system provides reduced or minimal risk of damaging ocular tissue and has several advantageous qualities over current visualization techniques. The disclosed system requires only one limbal incision, which may be on the scale of 1.0-2.5 mm. For cases where the DV system is used alongside another tool with matching calibrated depth measuring features, the same limbal incision may be used for both the DV system and the additional tool. Once inside the anterior chamber the DV system can interact solely with the aqueous humor and tissues comprising the angle of the eye.



FIG. 1 is a cross-sectional view of a portion of the human eye. The eye is generally spherical and is covered on the outside by the sclera S. The retina lines the inside posterior half of the eye. The retina registers the light and sends signals to the brain via the optic nerve. The bulk of the eye is filled and supported by the vitreous body, a clear, jelly-like substance. The elastic lens L is located near the front of the eye. The lens L provides adjustment of focus and is suspended within a capsular bag from the ciliary body CB, which contains the muscles that change the focal length of the lens. A volume in front of the lens L is divided into two by the iris I, which controls the aperture of the lens and the amount of light striking the retina. The pupil is a hole in the center of the iris I through which light passes. The volume between the iris I and the lens L is the posterior chamber PC. The volume between the iris I and the cornea is the anterior chamber AC. Both chambers are filled with a clear liquid known as aqueous humor.


The ciliary body CB continuously forms aqueous humor in the posterior chamber PC by secretion from the blood vessels. The aqueous humor flows around the lens L and iris I into the anterior chamber and exits the eye through the trabecular meshwork, a sieve-like structure situated at the corner of the iris I and the wall of the eye (the corner is known as the iridocorneal angle). Some of the aqueous humor can filter through the trabecular meshwork near the iris root into Schlemm's canal, a small channel that drains into the ocular veins. A smaller portion rejoins the venous circulation after passing through the ciliary body and eventually through the sclera (the uveoscleral route).



FIG. 2 is a cross-sectional, perspective view of a portion of the eye showing the anterior and posterior chambers of the eye. A schematic representation of an embodiment of an implant 105 is shown positioned inside the eye such that a proximal end 110 is located in the anterior chamber 115 and a distal end 120 communicates with and/or is located in or near the suprachoroidal space. It should be appreciated that FIG. 1 and other figures herein are schematic and are not necessarily to scale with respect to size and relative positions of actual eye tissue. Prior to insertion and implantation of an implant, such as the implant shown in FIG. 2, it can be beneficial to first measure the angle of the eye. For example, measuring the angle of the eye can assist in determining the proper size and shape of the implant for implantation, as well as the proper placement of the implant in the eye. At least one benefit of the DV system embodiments disclosed herein includes the ability to assist in determining the proper size and shape of implant as well as properly placing an implant in the eye.



FIG. 3 shows a perspective view of an embodiment of a DV system 10 which can be comprised of a hand-held tool having a DV wire 12 that is movably coupled to an elongated handle 14. At least a portion of the DV wire 12 can be slidably and axially-positioned in a stopper tube 16 affixed to a distal end 19 of the handle 14. Both the stopper tube 16 and the DV wire 12 can extend outward from the distal end 19 of the handle 14. The handle 14 can be sized and shaped to be held in a single hand of a user. In addition, the handle 14 can be configured such that the DV system 10 can be operated single handedly. Furthermore, the handle 14 can have one or more gripping features 18, such as ridges and cutouts, for improved ergonomics and ease of holding.


The DV wire 12 can be coupled to a spring 30 inside the handle 14 which can allow the DV wire 12 to move inward and outward along a longitudinal axis of the DV system 10 and relative to the handle 14 and stopper tube 16. The spring 30 can provide a spring force that can assist in allowing the DV wire 12 to retract proximally into the handle 14 upon an applied force against the distal end of the DV wire 12. The spring constant of the spring 30 can be relatively low such that the DV wire 12 moves relatively easily when a force is applied. In one aspect, the spring constant can be sufficiently low such that the DV wire 12 will yield and ocular tissue is not damaged when the distal tip of the DV wire 12 is pressed against ocular tissue. In addition, a handle plug 32 (as shown in FIG. 5) inside the handle 14 can provide a hard stop for the DV wire 12 which can limit the distance that the DV wire 12 can retract into the stopper tube 16 and handle 14.


In some embodiments the stopper tube 16 can extend straight out of and along the same longitudinal axis as the handle 14. However, in some embodiments the stopper tube 16 can be curved or extend in a variety of other configurations. For example, the stopper tube 16 may be curved which can provide easier access to particular anatomical parts of the eye, such as the base of the iridocorneal angle. The distal end of the stopper tube 16 can have rounded edges which can assist in preventing damage to ocular tissue during use. In addition, the stopper tube 16 can be manufactured out of a variety of materials, such as stainless steel, titanium, plastics, or other equivalent materials, including any number of medical grade materials.



FIG. 4 shows an enlarged view of the DV wire 12 and distal region of the stopper tube 16. The DV wire 12 can have a distal contact tip 20 that can be configured to be pressed against ocular tissue. The contact tip 20 may be rounded or blunt to eliminate or reduce tissue damage by the contact tip 20 when pressed against ocular tissue. In addition, one or more indicators or marks 22 can be positioned along a length of the DV wire 12. In some embodiments, one or more indicators 22 can be positioned along a length of either the DV wire 12 or stopper tube 16. The indicators 22 can assist a user in acquiring measurements of one or more anatomical features of the eye. For example, the distal end of the DV wire 12 can be placed against the base of the angle of the eye such that the user can then determine the depth of the angle.


The indicators 22 can be arranged along the DV wire 12 such that they correspond to a standard form of measurement, i.e., millimeters, fractions of an inch, etc. In such an embodiment, a user can use the DV wire 12 to make specific measurements, including measurements of particular anatomical features of the eye. In some embodiments, the indicators 22 do not correlate with a standard form of measurement and are simply reference points along the DV wire 12. In either embodiment, a user can position the DV wire 12 in the eye and use any of the indicators 22 as reference points relative to various anatomical features in the eye. As will be discussed in greater detail below, the referenced indicators 22 can assist the user in subsequent procedures, including determining an appropriately sized implant for the eye as well as assisting in correctly inserting the implant into the eye.


The DV wire 12 can be manufactured out of a variety of materials, such as stainless steel, titanium, plastics, or other equivalent materials, including any number of medical grade materials. In addition, the DV wire 12 can be at least partially tubular or hollow in order to allow one or more components, such as the measuring features discussed below, to be contained within the DV wire 12, including within the contact tip 20.


The contact tip 20 can be configured to provide sufficient surface area so as to not be traumatic to ocular tissues and/or create accidental cyclodialysis. The indicators 22 can be visible to the physician through the cornea when the DV wire 12 is extended from the stopper tube 16. In addition, the indicators 22 can be visible through the cornea so that a gonio lens is not needed in order to determine the depth of the iridocorneal angle. Furthermore, the DV system 10 can perform sufficient measurements such that a gonio lens is not necessary to perform a procedure. By relieving the need for a gonio lens to conduct a procedure, both procedure time and efficiency can be improved.


The DV wire 12 can be stamped, chemically etched, or marked with any number of patterning techniques in order to provide indicators 22 that can be seen by a user while inserted in the eye. The indicators 22 may exhibit any combination of numbering and or patterning features, with varying degrees of darkness, contrast, size, shape and color.


In some embodiments, the contact tip 20 can include a loop 24 which can provide additional damping when the contact tip 20 is in contact with ocular tissue. In addition, the contact tip 20 can be made out of a material that allows the loop 24 to deform, such as a soft or flexible material, in order to provide a damping effect. The loop 24 can be made out of the same or different material than the rest of the DV wire 12, or the loop 24 can be coated with a material, such as a flexible or soft material.


In some embodiments, deformation of the contact tip 20 or loop 24 can assist in providing a visual cue to the user that the distal end of the DV wire 12, such as the contact tip 20 or loop 24, is in contact with tissue. For example, the contact tip 20 can include one or more features having a spiral cut or any number of a variety of looped patterns which can allow for visually identifiable movements at low forces. Furthermore, deformation of the loop 24 can act as a deformable element which can provide visual cues to the user, such as when the loop 24 is in contact with tissue.


The cross section of the DV wire 12 can be rectangular, although the shape may vary. For example, the DV wire 12 can have a circular, elliptical or any one or more of a variety of cross sections along the length of the DV wire 12. In addition, the edges of the DV wire 12 can be smooth and free of sharp edges to avoid damage to tissue. The proximal end of the DV wire 12 can have ridges for holding the spring 30 in place as well as a hard stop to prevent the spring 30 from sliding off the proximal end.



FIG. 5 shows a cross-sectional view of a part of the DV system 10, including the distal end 19 of the handle 14. The DV wire 12 of the DV system 10 can be coupled to a spring 30 at a proximal region which can bias the DV wire 12 toward a distally outward direction relative to the handle 14. In addition, the spring 30 can resist movement of the DV wire 12 in a proximal direction (i.e., into the handle 14) and urge the DV wire in a distal direction (i.e., out of the handle 14).


The spring 30 can be a low force spring (i.e., a spring constant in the range of 0.001 to 0.100 Newtons). The spring 30 may be made of Nitinol, stainless steel, titanium, plastics, or other equivalent materials, and may exhibit strain induced deformation. Additionally, the spring 30 may be at least one of a tension spring, compression spring, torsion spring, leaf spring, Belleville washer, constant force spring, or urethane spring. The spring 30 may be an ultra-low force spring (i.e., less than 0.001 Newtons) for greater sensitivity, or a higher force spring (i.e., greater than 0.100 Newtons) for overcoming frictional viscous forces of aqueous fluids.


One or more features may be added or removed from the DV system 10 based on its intended use (i.e., disposable, re-usable, etc.). For example, one or more holes through the handle 14 and handle plug 32 may be included in the system in order to allow for sterilization and re-use of the DV system 10. Other features can be implemented for special or improved use of the DV system 10.



FIG. 6 shows an example of a part of the distal region of the DV system 10 inserted in an eye. The DV system 10 can be inserted into the anterior chamber 115 of the eye via a corneal or limbal incision such that the DV wire 12 can pass across the anterior chamber 15 (pursuant to an ab-interno approach) toward the base of the angle, such as below the scleral spur 120 and above the iris 122. The distal end of the DV wire 12, such as the contact tip 20, can be pressed against ocular tissue, as shown by way of example in FIG. 6.


The DV wire 12 can apply a force against ocular tissue while the handle 14 and stopper tube 16 continue to advance in the direction of the eye. The spring 30 can allow the proximal end of the DV wire 20 to travel towards the handle plug 32 while the handle 14 and stopper tube 16 continue to travel in the direction of the eye. In some embodiments, the DV wire 20 can continue to retract into the handle 14 until the proximal end of the DV wire 20 abuts the handle plug 32. Retraction of the DV wire 20 into the stopper tube 16 and handle 14 can indicate to the user that the contact tip 20 of the DV wire 12 is properly positioned, such as the distal end of the DV wire 12 is positioned against the base of the angle. This can assist in at least minimizing damage to the ocular tissue by preventing the user from applying more force than is necessary when attempting to properly position the DV wire 12 in the eye.


Once the surgeon becomes aware that the DV wire 20 is properly positioned, the surgeon can then take appropriate measurements, such as of the iridocorneal angle of the eye. Measurements can be made by, for example, referencing the indicators 22 along the DV wire 12 relative to one or more anatomical features of the eye. After measurements have been taken, the surgeon can then retract the distal end of the DV system 10 from the eye. Any number of procedures can follow the removal of the DV system 10, including the insertion of an ocular implant.



FIG. 7 shows the distal end of the DV system 20, including the DV wire 12, aligned alongside a distal end of an implant delivery applier 30. The implant delivery applier 30 can have an elongated body 32 with an adaption feature 34 at a distal end 36 of the elongated body 32. The adaptation feature 34 can be configured to adapt one or more ocular implants 50 to the distal end 36 of the implant delivery applier 30, as shown in FIG. 7. The body 32 of the implant delivery applier 30 can include indicators or marks 38 which correspond with the indicators 22 along the DV wire 12, as also shown in FIG. 7. The corresponding indicators along the implant delivery applier 30 and DV wire 12 can allow measurements and positioning of the DV wire 12 relative to anatomical features of the eye to be easily replicated with the implant delivery applier 30, as will be discussed in greater detail below.



FIGS. 8-11 show an example method of use of the implant delivery applier 30 and DV wire 12 of the DV system 10 having corresponding marks 38 and 22, respectively, for properly inserting an implant in the eye. The method shown can be used, for example, to at least acquire one or more measurements of the eye, determine a properly sized implant and implant the properly sized implant into the eye. Furthermore, this method can be completed without the use of a gonio lens which can improve the time and efficiency of the procedure.


As shown in FIG. 8, a user can first insert the distal end of the DV wire 12 through a corneal or limbal incision along the eye and advance the distal end of the DV wire 12 across the anterior chamber of the eye (pursuant to an ab-interno approach). Viscoelastic substances or balanced saline solutions may be used to maintain the anterior chamber of the eye and open a space comprising a part of the angle of the eye. The incision can be approximately 0.08 mm to 2.0 mm in length and can be either created by the DV wire 12 or a separate instrument. Additionally, the incision can be approximately 1.2 mm to 1.7 mm in length.


The user can advance the DV system 10 and position the distal end of the DV wire 12 against ocular tissue, such as between the scleral spur 120 and iris 122 in order to measure the depth of the iridocorneal angle. The spring loaded feature of the DV wire 12 can assist the user in determining when the distal end, such as the loop 24 or contact tip 20, of the DV wire 12 is in contact with ocular tissue. For example, the user can continue to advance the DV system 10 into the eye until the user begins to observe the stopper tube 16 travel over the DV wire 12. Movement of the stopper tube 16 relative to the DV wire 12 can alert the user that the distal end of the DV wire 12 is positioned against ocular tissue within the eye.


Once the user has determined that the distal end of the DV wire 12 is positioned against the base of the angle of the eye, such as between the scleral spur 120 and iris 122, the user can take measurements of the eye using the DV wire 12. For example, the user can use the indicators 22 along the DV wire 12 to take measurements of certain anatomical features of the eye, including the depth of the angle of the eye. As shown in FIG. 9, the user can view the DV wire 12 along a generally vertical line of sight 40 in order to observe which indicator 22 is aligned with one or more anatomical features of the eye when the distal end of the DV wire 12 is positioned against the base of the angle. For example, the user can view the DV wire 12 along the vertical line of sight 40 and observe which indicator 22 is aligned with, for example, the inner edge of the iris 122. Any number of anatomical features can be measured using the indicators 22 along the DV wire 12 without departing from the scope of this disclosure.


In addition, the user can advance a feature of the DV system 10, such as the stopper tube 16, in order to assist the user in determining which indicator 22 is aligned with certain anatomical features of the eye. FIG. 9 shows an example of the stopper tube 16 being used to assist the user in determining which indicator 22 or part of the DV wire 12 aligns with the inner edge of the iris 122 when the distal end of the DV wire 12 is placed against the base of the iridocorneal angle in order to measure the depth of the angle. The stopper tube 16 can be advanced across the DV wire 12 by simply continuing to advance the DV system 10 after the distal end of the DV wire 12 is positioned against ocular tissue within the angle of the eye, as discussed above.


Once the user has obtained appropriate measurements, the user can remove the DV wire 12 from the eye. The implant 50 coupled to the implant delivery applier 30 can then be inserted into the eye. The same incision that was used to insert the DV wire 12 can be used to insert the implant delivery applier 30 and implant 50. In addition, the implant 50 can be advanced across the eye along the same or similar trajectory such that the distal end of the implant 50 contacts generally the same area of ocular tissue between the scleral spur 120 and iris 122 that the distal end of the DV wire 12 had previously contacted while taking measurements.


As shown in FIGS. 10 and 11, the implant delivery applier 30 can be advanced in order to allow the implant 50 to be inserted into the suprachoroidal or supraciliary space. The user can continue to advance the implant 50 into the suprachoroidal or supraciliary space until one or more indicator 38 along the implant delivery applier 30 aligns with one or more anatomical features of the eye. In particular, the user can advance the implant delivery applier 30 until the same indicator 38 along the implant delivery applier 30 is aligned with the iris 122 as was along the DV wire 12 when the distal end of the DV wire 12 was in contact with the base of the angle (see, for example, FIGS. 9 and 11).


As shown in FIG. 11, the user can advance the implant delivery applier 30 until the user observes a particular anatomical feature of the eye align with an indicator 38 along the implant delivery applier 30 which corresponds to an indicator 22 along the DV wire 12 which had previously been aligned with the same particular anatomical feature, such as when the distal end of the DV wire 12 was in contact with the base of the angle. When this corresponding indicator 38 on the implant delivery applier 30 is aligned with the particular anatomical feature of the eye, the user can determine that the implant 50 is properly positioned in the eye for permanent implantation. For example, proper positioning in the eye for permanent implantation includes positioning the implant so that it can provide fluid communication between the anterior chamber and the suprachoroidal or supraciliary space without discomfort or irritation to the eye. Therefore, once the user has aligned the appropriate indicator 38 along the implant delivery applier 30 with the particular anatomical feature, the user can then release the implant 50 from the implant delivery applier 30 and remove the implant delivery applier 30 from the eye. As shown in FIG. 12, the implant 50 can then remain in the implanted position permanently or for a desired length of time.


The DV wire can be aligned with the implant delivery applier such that the distal end of the DV wire aligns with a position along the length of the head of the implant 50 when the implant 50 is coupled to the implant delivery applier 30. The alignment of the distal end of the DV wire 12 relative to the head of the implant 50 coupled to the implant delivery applier 30 can vary depending on the desired placement of the head relative to the anterior chamber of the eye when the implant 50 is in its permanently implanted position. For example, and shown by way of example in FIG. 12, it may be beneficial to have at least a portion of the head of the implant 50 extend into the anterior chamber of the eye. This can assist in ensuring that the implant 50 provides a fluid pathway between the anterior chamber and supraciliary or suprachoroidal space.



FIGS. 13A-13B shows an embodiment of a feedback mechanism 52 coupled to or comprising the implant delivery applier 30. The feedback mechanism 52 can include a sheath 54 coupled to a spring 56 at a proximal end of sheath 52. In such an embodiment, the spring loaded sheath 54 can be used to indicate depth or acknowledge when a certain landmark has been reached. For example, the sheath 54 can be positioned such that the distal end of the sheath 54 extends a distance over the implant 50 attached to the distal end of the implant delivery applier 30. Upon implantation of the implant 50 within the eye, the sheath 54 can be pushed in the proximal direction, or retracted, when the implant 54 has been implanted to a preferred depth within the eye. Retraction of the sheath 54 can indicate to a user that the sheath 54 has hit a hard stop, such as ocular tissue, and the implant 50 has been properly implanted. The implant 50 can then be released for permanent implantation once proper implant positioning has been determined.


In addition, the feedback mechanism 52 can assist the user in positioning the implant 50 such that the proximal end of the implant 50 is in direct communication with the anterior chamber of the eye in an implanted state. This can ensure that the implant 50 can provide a fluid path from the anterior chamber of the eye to another part of the eye, such as to the suprachoroidal or supraciliary space, and improve fluid flow within the eye.


Furthermore, the DV system 10 can be used for a variety of surgical procedures. For example, the DV system can be used to accurately locate and take measurements relating to a variety of anatomical structures, such as the trabecular meshwork and the Schlemm's Canal. The various measurements taken with the DV system 10 can be used for accurately positioning implants into one or more anatomical structures, including at least the trabecular meshwork and Schlemm's Canal.


Furthermore, in some embodiments, the distal end of the DV system 10, such as the distal end of the DV wire 12, can include non-contact measuring features for determining one or more of a measurement or a distance within the eye. For example, the distal end of the DV wire 12 can include one or more measuring features which can include ultrasound, infrared, optical coherence tomography, or the like. In some embodiments, the measuring features can assist in measuring the relative distance of an anatomical feature of the eye relative to a part of the DV wire 12, such as the distal end. Additionally, the DV wire 12 can include various other features which can assist in providing information to a user, such as pressure and temperature sensors.


In some embodiments, the handle can include a display which can indicate to a user one or more parameters measured by the DV system 10, such as by a measuring feature of the DV system 10. Information displayed on the display can include, for example, at least one or more of a distance measured between the distal end of the DV wire 12 and an anatomical feature, a measurement of an anatomical feature, a pressure exerted by the distal end of the DV wire 12 against tissue, pressure within the eye or temperature.


Although embodiments of various methods and devices are described herein in detail with reference to certain versions, it should be appreciated that other versions, embodiments, methods of use, and combinations thereof are also possible. Therefore the spirit and scope of the appended claims should not be limited to the description of the embodiments contained herein.

Claims
  • 1. A method of measuring an eye, comprising: forming an incision in a cornea of the eye into an anterior chamber of the eye;introducing through the incision a distal end of a first device configured for measuring an anatomical feature of the eye, the first device comprising a handle with a wire extending out of a distal end of the handle and a distal end of the wire configured to be pressed against ocular tissue in the eye, the wire including a first series of symbols positioned along a length of the wire, the first device further comprising a spring coupled to a proximal end of the wire which biases the wire toward a distally outward direction relative to the handle, wherein the wire moves relative to the handle solely as a result of an applied force by the ocular tissue against the distal end of the wire, and wherein the wire extends along a longitudinal axis, and where the distal end of the wire has a transverse dimension relative to the longitudinal axis that is greater than a transverse dimension relative to the longitudinal axis at a location of the wire proximal to the distal end of the wire;passing the distal end of the wire through the incision and across the anterior chamber of the eye;positioning the distal end of the wire against the ocular tissue below a scleral spur and above an iris such that the applied force is generated between the ocular tissue and the distal end of the wire, wherein the applied force overcomes a spring force of the spring such that solely the applied force causes the wire to retract proximally into the handle; andmeasuring the anatomical feature of the eye by identifying one or more symbols of the first series of symbols along the length of the wire relative to an anatomical landmark in the eye;withdrawing the first device from the eye, the first device being designed for only the introducing, passing, positioning, measuring, and withdrawing steps; andinserting an ocular implant coupled to a second device through the incision, the second device comprising an implant delivery applier that includes a second series of symbols that correspond to the first series of symbols positioned along the length of the wire.
  • 2. The method of claim 1, further comprising determining a size of the implant based on the measuring and coupling the implant to a distal end of the implant delivery applier.
  • 3. The method of claim 2, further comprising advancing the implant across the anterior chamber of the eye and implanting the implant into the eye such that the implant forms a fluid communication between the anterior chamber of the eye and a suprachoroidal or supraciliary space.
  • 4. The method of claim 1, wherein each of the symbols of at least one of the first series of symbols and second series of symbols is a number.
  • 5. The method of claim 1, wherein each of the symbols of at least one of the first series of symbols and second series of symbols corresponds to a reference point.
  • 6. The method of claim 1, wherein the transverse dimension of distal end of the wire is a loop.
  • 7. The method of claim 6, wherein the loop is deformable.
REFERENCE TO PRIORITY DOCUMENT

This application claims priority benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application Ser. No. 61/635,471, filed Apr. 19, 2012, and entitled “Direct Visualization System for Glaucoma Treatment.” The priority of the filing date of Apr. 19, 2012 is hereby claimed, and the disclosure of the provisional patent application is hereby incorporated by reference in its entirety.

US Referenced Citations (343)
Number Name Date Kind
2990670 Kingsbury Jul 1961 A
3439675 Cohen Apr 1969 A
3767759 Wichterle Oct 1973 A
3788327 Donowitz et al. Jan 1974 A
3915172 Wichterle et al. Oct 1975 A
4037604 Newkirk Jul 1977 A
4402681 Haas et al. Sep 1983 A
4457757 Molteno Jul 1984 A
4521210 Wong Jun 1985 A
4554918 White Nov 1985 A
4604087 Joseph Aug 1986 A
4617715 Koistinen et al. Oct 1986 A
4634418 Binder Jan 1987 A
4722724 Schocket Feb 1988 A
4750901 Molteno Jun 1988 A
4787885 Binder Nov 1988 A
4826478 Schocket May 1989 A
4846172 Berlin Jul 1989 A
4863457 Lee Sep 1989 A
4886488 White Dec 1989 A
4900300 Lee Feb 1990 A
4930512 Henriksen Jun 1990 A
4946436 Smith Aug 1990 A
4968296 Ritch et al. Nov 1990 A
5041081 Odrich Aug 1991 A
5071408 Ahmed Dec 1991 A
5073163 Lippman Dec 1991 A
5092837 Ritch et al. Mar 1992 A
5127901 Odrich Jul 1992 A
5171213 Price, Jr. Dec 1992 A
5178604 Baerveldt et al. Jan 1993 A
5180362 Worst Jan 1993 A
5284476 Koch Feb 1994 A
5300020 L'Esperance, Jr. Apr 1994 A
5338291 Speckman et al. Aug 1994 A
5342370 Simon et al. Aug 1994 A
5346464 Camras Sep 1994 A
5370607 Memmen Dec 1994 A
5372577 Ungerleider Dec 1994 A
5397300 Baerveldt et al. Mar 1995 A
5423777 Tajiri et al. Jun 1995 A
5433701 Rubinstein Jul 1995 A
5443505 Wong et al. Aug 1995 A
5454746 Guegan et al. Oct 1995 A
5476445 Baerveldt et al. Dec 1995 A
5497782 Fugoso Mar 1996 A
5558629 Baerveldt et al. Sep 1996 A
5558630 Fisher Sep 1996 A
RE35390 Smith Dec 1996 E
5601094 Reiss Feb 1997 A
5626558 Suson May 1997 A
5626559 Solomon May 1997 A
5651782 Simon et al. Jul 1997 A
5676944 Alvarado et al. Oct 1997 A
5702414 Richter et al. Dec 1997 A
5704907 Nordquist et al. Jan 1998 A
5713844 Peyman Feb 1998 A
5741292 Mendius Apr 1998 A
5743868 Brown et al. Apr 1998 A
5749879 Middleman et al. May 1998 A
5752928 de Roulhac et al. May 1998 A
5792075 Schwager Aug 1998 A
5807244 Barot Sep 1998 A
5807302 Wandel Sep 1998 A
5868697 Richter et al. Feb 1999 A
5882327 Jacob Mar 1999 A
5893837 Eagles et al. Apr 1999 A
5921918 Riza Jul 1999 A
5941250 Aramant et al. Aug 1999 A
5968058 Richter et al. Oct 1999 A
6007510 Nigam Dec 1999 A
6007511 Prywes Dec 1999 A
6036678 Giungo Mar 2000 A
6050970 Baerveldt Apr 2000 A
6050999 Paraschac et al. Apr 2000 A
6077299 Adelberg et al. Jun 2000 A
6102045 Nordquist et al. Aug 2000 A
6142969 Nigam Nov 2000 A
6152918 Padilla et al. Nov 2000 A
6174307 Daniel et al. Jan 2001 B1
6186974 Allan et al. Feb 2001 B1
6203513 Yaron et al. Mar 2001 B1
6221078 Bylsma Apr 2001 B1
6251090 Avery et al. Jun 2001 B1
6261256 Ahmed Jul 2001 B1
6264668 Prywes Jul 2001 B1
6270472 Antaki et al. Aug 2001 B1
6331313 Wong et al. Dec 2001 B1
6375642 Grieshaber et al. Apr 2002 B1
6383219 Telandro et al. May 2002 B1
6450984 Lynch et al. Sep 2002 B1
6464724 Lynch et al. Oct 2002 B1
6468283 Richter et al. Oct 2002 B1
6471666 Odrich Oct 2002 B1
6471777 Kobayashi et al. Oct 2002 B1
6494857 Neuhann Dec 2002 B1
6508779 Suson Jan 2003 B1
6510600 Yaron et al. Jan 2003 B2
6524275 Lynch et al. Feb 2003 B1
6533768 Hill Mar 2003 B1
6537568 Olejnik et al. Mar 2003 B2
6544208 Ethier et al. Apr 2003 B2
6544249 Yu et al. Apr 2003 B1
6558342 Yaron et al. May 2003 B1
6561974 Grieshaber et al. May 2003 B1
6579256 Hughes Jun 2003 B2
6589203 Mitrev Jul 2003 B1
6595945 Brown Jul 2003 B2
6626858 Lynch et al. Sep 2003 B2
6638239 Bergheim et al. Oct 2003 B1
6648283 Chase et al. Nov 2003 B2
6666841 Gharib et al. Dec 2003 B2
6676607 de Juan, Jr. et al. Jan 2004 B2
6699210 Williams et al. Mar 2004 B2
6699211 Savage Mar 2004 B2
6719750 Varner et al. Apr 2004 B2
6726664 Yaron et al. Apr 2004 B2
6726676 Stegmann et al. Apr 2004 B2
6730056 Ghaem et al. May 2004 B1
6736791 Tu et al. May 2004 B1
6741666 Henry et al. May 2004 B1
6752753 Hoskins et al. Jun 2004 B1
6780164 Bergheim et al. Aug 2004 B2
6783544 Lynch et al. Aug 2004 B2
6786888 Zadno-Azizi et al. Sep 2004 B1
6827699 Lynch et al. Dec 2004 B2
6827700 Lynch et al. Dec 2004 B2
6881197 Nigam Apr 2005 B1
6881198 Brown Apr 2005 B2
6939298 Brown et al. Sep 2005 B2
6955656 Bergheim et al. Oct 2005 B2
6962573 Wilcox Nov 2005 B1
6966888 Cullen et al. Nov 2005 B2
6969384 de Juan, Jr. et al. Nov 2005 B2
6981958 Gharib et al. Jan 2006 B1
6989007 Shadduck Jan 2006 B2
7041077 Shields May 2006 B2
7090681 Weber et al. Aug 2006 B2
7094225 Tu et al. Aug 2006 B2
7135009 Tu et al. Nov 2006 B2
7160264 Lisk, Jr. et al. Jan 2007 B2
7163543 Smedley et al. Jan 2007 B2
7186232 Smedley et al. Mar 2007 B1
7192412 Zhou et al. Mar 2007 B1
7195774 Carvalho et al. Mar 2007 B2
7207965 Simon Apr 2007 B2
7220238 Lynch et al. May 2007 B2
7273475 Tu et al. Sep 2007 B2
7291125 Coroneo Nov 2007 B2
7297130 Bergheim et al. Nov 2007 B2
7331984 Tu et al. Feb 2008 B2
7431710 Tu et al. Oct 2008 B2
7488303 Haffner et al. Feb 2009 B1
7563241 Tu et al. Jul 2009 B2
7708711 Tu et al. May 2010 B2
7850637 Lynch et al. Dec 2010 B2
7857782 Tu et al. Dec 2010 B2
7867186 Haffner et al. Jan 2011 B2
7867205 Bergheim et al. Jan 2011 B2
7972616 Dubrow et al. Jul 2011 B2
8075511 Tu et al. Dec 2011 B2
8172899 Silvestrini et al. May 2012 B2
8337393 Silverstrini et al. Dec 2012 B2
8702727 Harrington et al. Apr 2014 B1
8721656 De Juan, Jr. et al. May 2014 B2
9155656 Schaller et al. Oct 2015 B2
20020013546 Grieshaber et al. Jan 2002 A1
20020013572 Berlin Jan 2002 A1
20020072673 Yamamoto et al. Jun 2002 A1
20020087111 Ethier et al. Jul 2002 A1
20020111608 Baerveldt et al. Aug 2002 A1
20020128613 Nakayama Sep 2002 A1
20020133168 Smedley et al. Sep 2002 A1
20020143284 Tu et al. Oct 2002 A1
20020177856 Richter et al. Nov 2002 A1
20020188282 Greenberg Dec 2002 A1
20020188308 Tu et al. Dec 2002 A1
20020193725 Odrich Dec 2002 A1
20020193804 Tickle Dec 2002 A1
20030028127 Balzum et al. Feb 2003 A1
20030028228 Sand Feb 2003 A1
20030055372 Lynch et al. Mar 2003 A1
20030060752 Bergheim et al. Mar 2003 A1
20030097151 Smedley et al. May 2003 A1
20030097171 Elliott May 2003 A1
20030109883 Matsuzaki et al. Jun 2003 A1
20030135149 Cullen et al. Jul 2003 A1
20030181848 Bergheim et al. Sep 2003 A1
20030187384 Bergheim et al. Oct 2003 A1
20030208163 Yaron et al. Nov 2003 A1
20030229303 Haffner et al. Dec 2003 A1
20030236483 Ren Dec 2003 A1
20030236484 Lynch et al. Dec 2003 A1
20040015140 Shields Jan 2004 A1
20040024345 Gharib et al. Feb 2004 A1
20040088048 Richter et al. May 2004 A1
20040092856 Dahan May 2004 A1
20040097984 Zapata May 2004 A1
20040102729 Haffner et al. May 2004 A1
20040106977 Sullivan 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
20040148022 Eggleston 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
20040225250 Yablonski Nov 2004 A1
20040236343 Taylor et al. Nov 2004 A1
20040249333 Bergheim et al. Dec 2004 A1
20040254517 Quiroz-Mercado et al. Dec 2004 A1
20040254519 Tu et al. Dec 2004 A1
20040254520 Porteous et al. Dec 2004 A1
20040254521 Simon Dec 2004 A1
20040260228 Lynch et al. Dec 2004 A1
20050008673 Snyder et al. Jan 2005 A1
20050049578 Tu et al. Mar 2005 A1
20050085892 Goto et al. Apr 2005 A1
20050090806 Lynch et al. Apr 2005 A1
20050090807 Lynch et al. Apr 2005 A1
20050101967 Weber May 2005 A1
20050107734 Coroneo May 2005 A1
20050119601 Lynch et al. Jun 2005 A9
20050119636 Haffner et al. Jun 2005 A1
20050119737 Bene et al. Jun 2005 A1
20050125003 Pinchuk et al. Jun 2005 A1
20050143817 Hunter et al. Jun 2005 A1
20050149080 Hunter et al. Jul 2005 A1
20050171507 Christian et al. Aug 2005 A1
20050175663 Hunter et al. Aug 2005 A1
20050181011 Hunter et al. Aug 2005 A1
20050181977 Hunter et al. Aug 2005 A1
20050182350 Nigam Aug 2005 A1
20050191331 Hunter et al. Sep 2005 A1
20050192527 Gharib et al. Sep 2005 A1
20050197613 Sniegowski et al. Sep 2005 A1
20050209549 Bergheim et al. Sep 2005 A1
20050209550 Bergheim et al. Sep 2005 A1
20050232972 Odrich Oct 2005 A1
20050244462 Farooq Nov 2005 A1
20050245911 Wright et al. Nov 2005 A1
20050250788 Tu et al. Nov 2005 A1
20050266047 Tu et al. Dec 2005 A1
20050267397 Bhalla Dec 2005 A1
20050267398 Protopsaltis 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
20050283108 Savage Dec 2005 A1
20050287188 Anderson et al. Dec 2005 A1
20050288617 Yaron et al. Dec 2005 A1
20050288619 Gharib et al. Dec 2005 A1
20060004348 Scheller et al. Jan 2006 A1
20060020248 Prescott Jan 2006 A1
20060032507 Tu Feb 2006 A1
20060036207 Koonmen et al. Feb 2006 A1
20060069340 Simon Mar 2006 A1
20060074375 Bergheim et al. Apr 2006 A1
20060084907 Bergheim et al. Apr 2006 A1
20060116626 Smedley et al. Jun 2006 A1
20060149194 Conston et al. Jul 2006 A1
20060155238 Shields Jul 2006 A1
20060173397 Tu et al. Aug 2006 A1
20060195055 Bergheim et al. Aug 2006 A1
20060195056 Bergheim et al. Aug 2006 A1
20060200113 Haffner et al. Sep 2006 A1
20060235367 Takashima et al. Oct 2006 A1
20060241580 Mittelstein et al. Oct 2006 A1
20060241749 Tu et al. Oct 2006 A1
20060276739 Brown Dec 2006 A1
20070010827 Tu et al. Jan 2007 A1
20070088242 Coroneo Apr 2007 A1
20070088424 Greenberg et al. Apr 2007 A1
20070088432 Solovay et al. Apr 2007 A1
20070106235 Coroneo May 2007 A1
20070106236 Coroneo May 2007 A1
20070112292 Tu et al. May 2007 A1
20070118147 Smedley et al. May 2007 A1
20070129717 Brown et al. Jun 2007 A1
20070141106 Bonutti et al. Jun 2007 A1
20070149915 Yablonski Jun 2007 A1
20070191863 De Juan et al. Aug 2007 A1
20070207186 Scanlon et al. Sep 2007 A1
20070233037 Gifford et al. Oct 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
20080015488 Tu et al. Jan 2008 A1
20080045878 Bergheim et al. Feb 2008 A1
20080058704 Hee et al. Mar 2008 A1
20080108933 Yu et al. May 2008 A1
20080147021 Jani Jun 2008 A1
20080151188 Kawai Jun 2008 A1
20080195027 Coroneo Aug 2008 A1
20080200860 Tu et al. Aug 2008 A1
20080228127 Burns et al. Sep 2008 A1
20080234624 Bergheim et al. Sep 2008 A2
20090036819 Tu et al. Feb 2009 A1
20090036840 Viray et al. Feb 2009 A1
20090043321 Conston et al. Feb 2009 A1
20090118702 Lazar May 2009 A1
20090171358 Chang et al. Jul 2009 A1
20090182421 Silvestrini et al. Jul 2009 A1
20090318947 Garcia et al. Dec 2009 A1
20100010416 Juan, Jr. et al. Jan 2010 A1
20100134759 Silvestrini et al. Jun 2010 A1
20100137981 Silvestrini et al. Jun 2010 A1
20100152641 Yablonski Jun 2010 A1
20100211079 Aramant Aug 2010 A1
20100234790 Tu et al. Sep 2010 A1
20100268232 Betz et al. Oct 2010 A1
20100274259 Yaron et al. Oct 2010 A1
20100280317 Silvestrini et al. Nov 2010 A1
20110028883 Juan, Jr. et al. Feb 2011 A1
20110028884 Coroneo Feb 2011 A1
20110087148 Silvestrini et al. Apr 2011 A1
20110087149 Coroneo Apr 2011 A1
20110087150 Coroneo Apr 2011 A1
20110087151 Coroneo Apr 2011 A1
20110098629 Juan, Jr. et al. Apr 2011 A1
20110098809 Wardle et al. Apr 2011 A1
20110112546 Juan, Jr. et al. May 2011 A1
20110196396 Richter et al. Aug 2011 A1
20110238075 Clauson et al. Sep 2011 A1
20110276054 Helmy Nov 2011 A1
20110288525 Hallen et al. Nov 2011 A1
20110306915 De Juan, Jr. et al. Dec 2011 A1
20110313271 Schulman Dec 2011 A1
20120035524 Silvestrini Feb 2012 A1
20120035525 Silvestrini Feb 2012 A1
20120046575 Brown Feb 2012 A1
20120065670 Tiedtke Mar 2012 A1
20120089071 Oliver et al. Apr 2012 A1
20120116504 Lyons et al. May 2012 A1
20120123316 Horvath et al. May 2012 A1
20120123433 Horvath May 2012 A1
20120123434 Grabner et al. May 2012 A1
20120271272 Hammack et al. Oct 2012 A1
20140155805 Schaller et al. Jun 2014 A1
Foreign Referenced Citations (85)
Number Date Country
1285724 Feb 2001 CN
0 228 185 Nov 1986 EP
1184010 Mar 2002 EP
1310222 May 2003 EP
1473004 Nov 2004 EP
1477146 Nov 2004 EP
1418868 Mar 2008 EP
1977724 Oct 2008 EP
2027837 Feb 2009 EP
2101891 Jan 1983 GB
2007-535386 Dec 2007 JP
2010-533565 Oct 2010 JP
2018289 Aug 1994 RU
2056818 Mar 1996 RU
2074686 Mar 1997 RU
2074687 Mar 1997 RU
2157678 Oct 2000 RU
2010121933 Dec 2011 RU
WO-8900869 Feb 1989 WO
WO-9112046 Aug 1991 WO
WO-9219294 Nov 1992 WO
WO-9402081 Feb 1994 WO
WO-9409721 May 1994 WO
WO-9409837 May 1994 WO
WO-9413234 Jun 1994 WO
WO-9508310 Mar 1995 WO
WO-9513765 May 1995 WO
WO-9620742 Jul 1996 WO
WO-9636377 Nov 1996 WO
WO-9744085 Nov 1997 WO
WO-9823237 Jun 1998 WO
WO-9830181 Jul 1998 WO
WO-9926567 Jun 1999 WO
WO-0006223 Feb 2000 WO
WO-0064389 Nov 2000 WO
WO-0064390 Nov 2000 WO
WO-0064391 Nov 2000 WO
WO-0064393 Nov 2000 WO
WO-0064511 Nov 2000 WO
WO-0178631 Oct 2001 WO
WO-0178656 Oct 2001 WO
WO-0197727 Dec 2001 WO
WO-0236052 May 2002 WO
WO-02070045 Sep 2002 WO
WO-02074052 Sep 2002 WO
WO-02080811 Oct 2002 WO
WO-02080829 Oct 2002 WO
WO-02087418 Nov 2002 WO
WO-02087479 Nov 2002 WO
WO-02089699 Nov 2002 WO
WO-02102274 Dec 2002 WO
WO-03015659 Feb 2003 WO
WO-03015667 Feb 2003 WO
WO-03041622 May 2003 WO
WO-03073968 Sep 2003 WO
WO-03096871 Nov 2003 WO
WO-03099175 Dec 2003 WO
WO-2004014218 Feb 2004 WO
WO-2004026106 Apr 2004 WO
WO-2004026347 Apr 2004 WO
WO-2004043231 May 2004 WO
WO-2004056294 Jul 2004 WO
WO-2004060219 Jul 2004 WO
WO-2004062469 Jul 2004 WO
WO-2004073552 Sep 2004 WO
WO-2004110391 Dec 2004 WO
WO-2005016418 Feb 2005 WO
WO-2005046782 May 2005 WO
WO-2005055873 Jun 2005 WO
WO-2005105197 Nov 2005 WO
WO-2005107664 Nov 2005 WO
WO-2005107845 Nov 2005 WO
WO-2006012421 Feb 2006 WO
WO-2006036715 Apr 2006 WO
WO-2007087061 Aug 2007 WO
WO-2007115259 Oct 2007 WO
WO-2007130393 Nov 2007 WO
WO-2008061043 May 2008 WO
WO-2009012406 Jan 2009 WO
WO-2009035562 Mar 2009 WO
WO-2009058929 May 2009 WO
WO-2009158524 Dec 2009 WO
WO-2010065970 Jun 2010 WO
WO-2010115101 Oct 2010 WO
WO-2012019136 Feb 2012 WO
Non-Patent Literature Citations (134)
Entry
Barsky et al. “Evaluation of absorbable gelatin film (Gelfilm) in cyclodialysis clefts” Arch. Ophth. 60(6): 1044-1052,1958.
Bick MW “Use of tantalum for ocular drainage” Arch Ophthal. 42(4): 373-88 (1949).
Bietti “The present state of the use of plastics in eye surgery” Acta Ophthalmol (Copenh) 33(4):337-70 (1955).
Brown et al., “Internal Sclerectomy for Glaucoma Filtering Surgery with an Automated Trephine,” Archives of Ophthalmology, 105:133-136 (1987).
Burchfield JC, Kass MA, Wax MB. Primary valve malfunction of the Krupin eye valve with disk. J Glaucoma. Jun. 1997;6(3):152-6.
Chiou et al. “Ultrasound biomicroscopy of eyes undergoing deep sclerectomy with collagen implant” Br J Ophthalmol 80 (1996), pp. 541-544.
Chylack LT, Bellows AR. Molecular sieving in suprachoroidal fluid formation in man. Invest Ophthalmol Vis Sci 17: 420, 1978.
Classen et al. “A histopathologic and immunohistorchemical analysis of the filtration bleb after unsuccessful glaucoma seton implantation” Am. J. Ophthalmol. 122:205-12 (1996).
Cohen et al. “First day post-operative review following uncomplicated phacoemulsification” Eye 12(4):634-6 (1998).
Collaborative Normal-Tension Study Group. Comparison of glaucomatous progression between untreated patients with normal-tension glaucoma and patients with therapeutically reduced intraocular pressures. Am J Ophthalmol 1998;126:487-97.
Congdon N, O'Colmain B, Klaver CC, et al. Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol 2004;122:477-85.
Coote. “Glaucoma Hollow Fiber Filters—A New Glaucoma Seton. Preliminary Results.” J. Glaucoma. vol. 8 No. 1 Supplement (1999):p.54.
Cullen, et al. “Anterior Chamber of Frontal Sinus Shunt for the Diversion of Aqueous Humor: A Pilot Study in Four Normal Dogs”. Veterinary Ophthalmology. vol. 1. No. 1. (1998):31-39.
Demailly et al. “Non-penetrating deep sclerectomy (NPDS) with or without collagen device (CD) in primary open-angle glaucoma: middle-term retrospective study” International Ophthalmology 20: 131-140, 1997.
Derwent English abstract for EP 1184010, published Mar. 6, 2002 entitled: “Drainage unit for an eye, consists of a hollow line, a distribution member, and a pressure relief valve which only allows water to leave the eye chamber above a certain pressure,” Accession Nbr. 12409716 [351].
Dinakaran et al. “Is the first post-operative day review necessary following uncomplicated hacoemulsification surgery?” Eye, 14(3A):364-6 (2000).
Draeger “Chirurgische Maßnahmen bei kongenitalem Glaukom” (Surgical Interventions in Congenital Glaucoma) Klin Monatsbl Augenheilkd 1993; 202(5): 425-427 [Article in German with English summary included]
Einmahl et al. “Evaluation of a novel biomaterial in the suprachoroidal space of the rabbit eye” Invest Ophthalmol Vis Sci. 43:1533-1539 (2002).
Ellis, RA “A Reduction of Intraocular Pressure Using Plastics in Surgery” Am J Ophth. 50; 1960, 733-742.
Emi et al. “Hydrostatic pressure of the suprachoroidal space” Invest. Ophthal. Visual Sci. 30(2):233-238 (1989).
Fanous MM, Cohn RA. Propionibacterium endophthalmitis following Molteno tube repositioning. J Glaucoma. Aug. 1997;6(4):201-2.
Friedman DS, Wolfs RC, O'Colmain BJ, et al. Prevalence of open-angle glaucoma among adults in the United States. Arch Ophthalmol 2004;122:532-8.
Fuchs E. “Detachment of the choroid inadvertently during cataract surgery” [German] von Graefes Arch Ophthalmol, 51:199-224 (1900) [Article in German with English summary].
Gills et al. “Action of cyclodialysis utilizing an implant studied by manometry in a human eye” Exp Eye Res 1967; 6:75-78.
Gills JP “Cyclodialysis implants” South Med J. 1967 60(7):692-5.
Gills, “Cyclodialysis Implants in Human Eyes” Am J Ophth 61:1966,841-846.
Goldberg “Management of Uncontrolled Glaucoma With the Molteno System” Australian and New Zealand Journal of Ophthalmology 1987; 15: 97-107.
Gordon MO, Kass. MA, for the Ocular Hypertension Treatment Study Group. The Ocular Hypertension Treatment Study. Design and baseline description of the participants. Arch Ophthalmol 1999:573-83.
Grant, W.M. , MD, Further Studies on Facility of Flow Through the Trabecular Meshwork, A.M.A. Archives of Ophthalmololgy, Oct. 1958, vol. 60, pp. 523-533.
Gross et al. “Surgical therapy of chronic glaucoma in aphakia and pseudophakia” Ophthalmology, 95:1195-201 (1988).
Harper SL, Foster CS. Intraocular lens explantation in uveitis. Int Ophthalmol Clin. 2000 Winter; 40(1):107-16.
Harrington “Cataract and Glaucoma. Management of the coexistent conditions and a description of a new operation combining lens extraction with reverse cyclodialysis.” Am J Ophthalmol. May 1966;61(5 Pt 2):1134-40.
Heijl A, Leske MC, Bengtsson B, et al for the Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression. Results from the Early Manifest Glaucoma Trial. Arch Ophthalmol 2002;120:1268-79.
Heine I. “Cyclodialysis, a new glaucoma operation” [German] Dtsch Med Wochenschr, 31:824-826 (1905).
Hildebrand et al. “Efficacy of anterior chamber decompression in controlling early intraocular pressure spikes after uneventful phacoemulsification” J. Catact Refract Surg., 29:1087-92 (2003).
Hoskins, et al., “Aqueous Humor Outflow”, Becker-Shaffer's Diagnosis and Therapy of the Glaucomas, 6th Edition, Chapter 4, pp. 41-66, 1989.
Howorth D J “Feasibility study for a micromachined glaucoma drainage device” Cranfield University School of industrial and manufacturing science MSc Thesis Academic Year 2001-2002 Sep. 13, 2002.
Hylton et al. “Update on prostaglandin analogs” Curr Opin Ophthalmol, 14:65-9 (2003).
Javitt JC, Chiang YP. Preparing for managed competition. Utilization of ambulatory eye care visits to ophthalmologists. Arch Ophthalmol 1993;111:1034-5.
Jay JL, Allan D. The benefit of early trabeculectomy versus conventional management in primary open-angle glaucoma relative to severity of disease. Eye 1989; 3:528-35.
Jordan J. “A Novel Approach to Suprachoroidal Drainage for the Surgical Treatment of Intractable Glaucoma” J. Glaucoma 15:200-205 (2006).
Jordan JF, Dietlein TS, Dinslage S, Luke C, Konen W, Krieglstein GK. Cyclodialysis ab inferno as a surgical approach to intractable glaucoma. Graefes Arch Clin Exp Ophthalmol. Aug. 2007;245(8):1071-6.
Karlen et al. “Deep sclerectomy with collagen implant: medium term results” Br. J. Ophthalmol, Jan. 1999, 83(1):6-11.
Kass MA, Heuer DK, Higginbotham EJ, et al for the Ocular Hypertension Treatment Study Group. The Ocular HypertensionTreatment Study. A randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol 2002;120:701-13.
Klemm et al. “Die Ultraschallbiomikroskopie als Kriterium der Funktionsprüfung des suprachorioidalen Spaltes nach kammerwinkelchirurgischen Eingriffen” (Ultrasound Biomicroscopic Imaging for Assessment of the Suprachoroidal Cleft after Angle Surgery)“Klinische Monatsblätter für Augenheilkunde 1997; 210: 74-77 [Article in German with English summary included]”.
Klemm et al. “Experimental use of space-retaining substances with extended duration: functional and morphological results” Graefes Arch Clin Exp Ophthalmol Sep. 1995; 233(9):592-7.
Kozlov et al. “Nonpenetrating deep sclerectomy with collagen” Eye microsurgery 3:44-46 (1990) [Russian with English translation].
Krejci “Cyclodialysis with hydroxymethyl methacrylate capillary strip (HCS). Animal experiments with a new approach in glaucoma drainage surgery” Ophthalmologica 1972; 164(2):113-21.
Krejci L. “Microdrainage of anterior chamber of eye glaucoma operation using hydron capillary drain. ” Acta Univ Carol Med Monogr. 1974;(61):1-90.
Kupfer “Studies on intraocular pressure. I. A technique for polyethylene tube implantation into the anterior chamber of the rabbit. ” Arch Ophthalmol. Apr. 1961;65:565-70.
La Rocca “Gonioplasty in Glaucoma a Preliminary Report” Br J Ophth 46:1962, 404-415.
Law et al., “Retinal Complications After Aqueous Shunt Surgical Procedures for Glaucoma” Arch Ophthal.; Dec. 1996; vol. 114:1473-1480.
Lee et al. “Aqueous-venous shunt and intraocular pressure. Preliminary report of animal studies.” Investigative Ophthalmology. vol. 5 No. 1:59-64. Feb. 1966.
Lee et al. “Magnetic resonance imaging of the aqueous flow in eyes implanted with the trabeculo-suprachoroidal glaucoma seton” Invest. Ophthalmol. Vis. Sci. 33:948 (1992).
Lee KY. Trabeculo-suprachoroidal shunt for treating recalcitrant and secondary glaucoma. Presented at the American Academy of Ophthalmology Annual Meeting, Anaheim, CA, 1991.
Leske MC, Heijl A, Hussein M, et al for the Early Manifest Glaucoma Trial Group. Factors for glaucoma progression and the effect of treatment. The Early Manifest Glaucoma Trial. Arch Ophthalmol Jan. 2003;121:48-56.
Lichter PR, Musch DC, Gillespie BW, et al and the CIGTS Study Group. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology 2001;108:1943-53.
Losche W. “Proposals for improvement of cyclodialysis” Klin Monatsblatter Augenheilkd Augenarztl Fortbild 121(6):715-6 (1952) [German].
Marx et al., “Use of the Ganciclovir Implant in the Treatment of Recurrent Cytomegalovirus Retinitis” Arch Ophthal.; Jul. 1996; vol. 114:815-820.
McPherson “Combined Trabeculotomy and Cataract Extraction as a Single Operation” Tr. Am. Ophth. Soc., vol. LXXIV, 1976; 251-260.
Migdal C, Gregory W, Hitchings R. Long term functional outcome after early surgery compared with laser and medicine in open-angle glaucoma. Ophthalmology 1994;101:1651-7.
Miglior S, Pfeiffer N, Zeyen T et al for the European Glaucoma Prevention Study Group. Results of the European Glaucoma Prevention Study. Ophthalmology 2005;112:366-75.
Miglior S, Zeyen T, Pfeiffer N, et al for the European Glaucoma Prevention Study Group. The European Glaucoma Prevention Study design and baseline description of the participants. Ophthalmology 2002;109:1612-21.
Miki, MD et al., “Intraocular Cannula for Continuous, Chronic Drug Delivery-Histopathic Observations and Function” Arch Ophthal.; May 1985; vol. 103:712-717.
Molteno et al. “Long tube implants in the management of glaucoma” South African Medical Journal, Jun. 26, 1976;50(27):1062-6.
Molteno et al. “The Vicryl tie technique for inserting a draining implant in the treatment of secondary glaucoma. ” Australian and New Zealand Journal of Ophthalmology 1986; 14: 343-354.
Moses RA “Detachment of ciliary body-anatomical and physical considerations” Investigative Ophthalmology & Visual Science, Assoc. for Research in Vision and Ophthalmology, US, vol. 4, No. 5, Oct. 1, 1965.
Nesterov AP et al. “Surgical stimulation of the uveoscleral outflow. Experimental studies on enucleated human eyes” Acta Opthalmol (Copenh) June; 57(3):409-17 (1979).
Nguyen et al., “Complications of Baerveldt Glaucoma Drainage Implants” Arch Ophthal.; May 1998; vol. 116:571-575.
Noecker RJ. Clinical Evaluation of a Novel Gold Micro-Shunt for Reduction of 10 P in Refractory Glaucomas. American Glaucoma Society Annual Meeting, San Francisco, CA, 2007.http://www.glaucomaweb.org/associations/5224/files/AGS%20AM07%20Prgrm%20FINAL.pdf. Accessed Nov. 1, 2008).
O'Brien et al. “Cyclodialysis” Arch Ophthal. 1949;42(5):606-619.
Odrich. “The New Technique During Complex Tube-Shunt Implantation”. J. Glaucoma. vol. 9 No. 3 (2000):278-279.
Olsen, Timothy W., et al., Cannulation of the Suprachoroidal Space: A Novel Drug Delivery Methodology to the Posterior Segment, American Journal of Ophthalmology, vol. 142, No. 5, Nov. 2006, pp. 777-787.e2.
Ozdamar et al. “Suprachoroidal seton implantation in refractory glaucoma: a novel surgical technique” J. Glaucoma Aug. 2003; 12(4):354-9.
Pinnas G. et al. “Cyclodialysis with teflon tube implants” Am J. Ophthalmol Nov. 1969; 68(5):879-883.
Portney GL, “Silicone elastomer implantation cyclodialysis.” Arch Ophthalmol 1973; 89: 10-12.
Primary Open Angle Glaucoma. Preferred Practice Patterns, American Academy of Ophthalmology.http://one.aao.org/CE/PracticeGuidelines/PPP_Content.aspx?cid=a5a59e02-450b-4d50-8091-b2dd2lefl ff2#references (Accessed Nov. 1, 2008).
Pruett et al., “The Fishmouth Phenomenon-II. Wedge Scleral Buckling” Arch Ophthal.; Oct. 1977; vol. 95:1782-1787.
Qadeer “Acrylic Gonio-Subconjunctival Plates in Glaucoma Surgery ” Br J Ophthalmol. Jun. 1954; 38(6): 353-356.
Quigley HA, Vitale S. Models of open-angle glaucoma prevalence and incidence in the United States. Invest Ophthalmol Vis Sci 1997; 38:83-91.
Richards et al. “Artificial Drainage Tubes for Glaucoma” Am J Ophth 60:1965,405-408.
Ritch, et al., “Uveoscleral Outflow”, the Glaucomas. St. Louis: Mosby, 1996; pp. 337-343.
Rohen, Johannes W., Anatomy of the Aqueous Outflow Channels, Glaucoma, vol. 1, Chapter 14, pp. 277-296, Edited by J.E. Cairns, Grune & Stratton, Harcourt Brace Jovanovich Publishers, 1986.
Rosenberg, et al. “Implants in glaucoma surgery” Chapter 88, the Glaucomas, Ritch et al. Eds. 2nd Ed. Mosby St. Louis 1996; p. 1783-1807.
Row H. “Operation to control glaucoma: preliminary report” Arch. Ophthal 12:325 (1934).
Rowan, Patrick J., MD, Combined Cyclodialysis and Cataract Surgery, Ophthalmic Surgery and Lasers, Dec. 1998, vol. 29, No. 12, pp. 962-968 (9 pages).
Sampimon “A New Approach to Filtering Glaucoma Surgery” Ophthalmologica (Basel) 151: 1966, 637-644.
Schappert S. Office visits for glaucoma: United States, 1991-92. Advance data from vital and health statistics. vol. 262. Hyattsville, MD: National Center for Health Statistics, 1995.
Shaffer RN, Weiss DI. Concerning cyclodialysis and hypotony. Arch Ophthalmol 68: 25, 1962.
SOLX Clinical Literature Handout; Industry Show Feb. 2006; “The SOLX Gold Micro-shunt (GMS) treatment”.
Sommer A, Tielsch JM, Katz J, et al. Racial differences in the cause-specific prevalence of blindness in east Baltimore. N Engl J Med 1991;325:1412-7.
Sourdille et al. “Reticulated hyaluronic acid implant in non-perforating trabecular surgery.” J Cataract Refract Surg 25: 332-339. (1999).
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: 492-494. Jun. 1999.
Srinivasan et al. “Microbial contamination of the anterior chamber during phacoemulsification” J. Cataract Refract Surg. 28:2173-6 (2002).
Suguro K, Toris CB, Pederson JE. Uveoscleral outflow following cyclodialysis in the monkey eye using a fluorescent tracer. Invest Ophthalmol Vis Sci 1985: 26, 810.
The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration. The AGIS Investigators. Am J Ophthalmol 2000;130:429-40.
The Advanced Glaucoma Intervention Study (AGIS); 13. Comparison of treatment outcomes within race: 10-year results. Ophthalmology 2004;111:651-64.
The Glaucoma Laser Trial (GLT) and Glaucoma Laser Trial Follow-up Study: 7. Results. Am J Ophthahnol 1995;120:718-31.
The Glaucoma Laser Trial (GLT). 2. Results of argon laser trabeculoplasty versus topical medicines. The Glaucoma Laser Trial Research Group. Ophthalmology 1990;97:1403-13.
Thiagalingam S, Tarongoy P, Hamrah P, Lobo AM, Nagao K, Barsam C, Bellows R, Pineda R. Complications of cosmetic iris implants. J Cataract Refract Surg. Jul. 2008;34(7):1222-4.
Tielsch JM, Sommer A, Katz J, et al. Racial variations in the prevalence of primary open-angle glaucoma. The Baltimore Eye Survey. JAMA 1991;266:369-74.
Toris CB. Extravascular albumin concentration of the uvea. Invest Ophthalmol Vis Sci 1990; 31:43.
Toris et al. “Aqueous humor dynamics in the aging human eye” Am J. Ophthalmol., 127:407-12 (1999).
Toris et al. “Effect of intraocular pressure on uveoscleral outflow following cyclodialysis in the monkey eye.” Investigative Ophthalmology & Visual Science. 26 (1985) 1745-1749.
Trigler L, Proia AD, Freedman SF. Fibrovascular ingrowth as a cause of Ahmed glaucoma valve failure in children. Am J Ophthalmol. Feb. 2006;141(2):388-9.
Troncoso Manuel U., “Cyclodialysis with insertion of metal implant in treatment of glaucoma, a Preliminary Report” Arch. Ophthal. 23:270 (1940).
Troncoso, Manuel U., Tantalum implants for inducing hypotny, Am Journal of Ophthalmology, vol. 32(4):499-508 (1949).
Van der Veen et al. “The gonioseton, a surgical treatment for chronic glaucoma”. Documenta Ophthalmologica; vol. 75, Nos. 3-4, 365-375. (1990).
Vossmerbaeumer U, Ditzen K, Jonas JB. Removal of an intracorneal hydrogel implant for hyperopia after Lasik. J Refract Surg. Jan. 2007;23(1):102-4.
Wagner, Justin A., et al., Characterization of Uveoscleral Outflow in Enucleated Porcine Eyes Perfused under Constant Pressure, Invest Ophthalmol Vis Sci., Published in edited form in Sep. 2004, vol. 45, Issue 9, pp. 3203-3206.
Wamsley S, Moster MR, Rai S, Alvim HS, Fontanarosa J. Results of the use of the Ex-Press miniature glaucoma implant in technically challenging, advanced glaucoma cases: a clinical pilot study. Am J Ophthalmol. Dec. 2004; 138(6): 1049-51.
Yablonski, “Some thoughts on the pressure dependence of uveoscleral flow” Journal of Glaucoma, 12(1):90-92 (2003).
Yablonski, “Trabeculectomy with Internal Tube Shunt: a novel glaucoma surgery” J. Glaucoma 14:91-97 (2005).
Yoo C, Kwon SW, Kim YY. Pericardium plug in the repair of the corneoscleral fistula after ahmed glaucoma valve explantation. Korean J Ophthalmol. Dec. 2008;22(4):268-71.
Zhou et al. “A trabecular bypass flow hypothesis” J Glaucoma. 14(1):74-83 (2005).
Schocket, Stanley S. “Investigations of the Reasons for Success and Failure in the Anterior Shunt-to-the-Encircling-Band Procedure in the Treatment of Refractory Glaucoma.” Tr. Am. Ophth. Soc.vol. LXXXIX. (1986):743-798.
U.S. Appl. No. 13,365,175, filed Feb. 2, 2012, 2012-0220917.
U.S. Appl. No. 14,025,145, filed Sep. 12, 2013, 2014-0012279.
U.S. Appl. No. 14,029,389, filed Sep. 17, 2013, 2014-0081195.
U.S. Appl. No. 14,071,500, filed Nov. 4, 2013. 2014-0066831.
U.S. Appl. No. 14,078,206, filed Nov. 12, 2013, 2014-0135916.
U.S. Appl. No. 14,140,322, filed Dec. 24, 2013, 2014-0107556.
U.S. Appl. No. 14,163,364, filed Jan. 24, 2014, 2014-0213958.
U.S. Appl. No. 14,260,041, filed Apr. 23, 2014, 2014-0323995.
U.S. Appl. No. 14,283,759, filed May 21, 2014, 2014-0364789.
U.S. Appl. No. 14,466,863, filed Aug. 22, 2014, 2014-0378886.
U.S. Appl. No. 14,610,197, filed Jan. 30, 2015, 2015-0223982.
U.S. Appl. No. 14,706,893, filed May 7, 2015, 2015-0238360.
U.S. Appl. No. 14,804,008, filed Jul. 20, 2015, 2015-0320596.
U.S. Appl. No. 14,809,827, filed Jul. 27, 2015, 2016-0022486.
U.S. Appl. No. 14,817,600, filed Aug. 4, 2015, 2015-0335487.
U.S. Appl. No. 14,971,542, filed Dec. 16, 2015, 2016-0175152.
U.S. Appl. No. 14,987,133, filed Jan. 14, 2016, 2016-0193083.
U.S. Appl. No. 15,005,745, filed Jan. 25, 2016, 2016-0135992.
Related Publications (1)
Number Date Country
20130281817 A1 Oct 2013 US
Provisional Applications (1)
Number Date Country
61635471 Apr 2012 US