Apparatus and methods for treating excess intraocular fluid

I. CROSS-REFERENCE TO RELATED APPLICATIONS

0001This application claims the benefit of priority of U.S. Provisional Application No. 61/433,131, filed Jan. 14, 2011, the entire contents of which are incorporated by reference.

II. FIELD OF THE INVENTION

0002This application relates to apparatus and methods for draining excess intraocular fluid, for example, resulting from glaucoma.

III. BACKGROUND OF THE INVENTION

0003Glaucoma affects about 70 million people worldwide, and is a disorder associated with high pressure in the eye resulting from the generation of excess intraocular fluid (aqueous humor). Aqueous humor is produced at a rate of 2-3 μl/min by the ciliary body and it maintains a constant intraocular pressure (IOP) around 12-20 mm Hg. Aqueous humor exits the eye primarily through the trabecular meshwork and Schlemm's canal, where it eventually drains to the episcleral veins. Maintaining intraocular pressure within appropriate ranges is critical to health of the eye, and depends on aqueous humor dynamics, namely the production rate from the ciliary body (aqueous humor inflow) and its outflow rate through the trabeculum. The most frequent glaucoma is called open-angle glaucoma, and results from an increase in the fluidic resistance of the trabecular meshwork. Left untreated, this disease typically causes damage to the optic nerve, with consequent loss of vision, initially peripheral, but progressively leading to total blindness. Unfortunately, glaucoma is often asymptomatic until late in the progress of the disease.

0004Traditionally, glaucoma is treated using medication, for example, the daily application of eye drops, such as Brinzolamide ophthalmic, that reduce production of aqueous humor. Such medications do not cure glaucoma, and must be continue to be taken to maintain intraocular pressures within accepted limits. In certain cases, such treatment may fail and other surgical treatments are employed, such as filter procedures or placement of a glaucoma drainage device. Glaucoma drainage devices reduce intraocular fluid pressure by providing an artificial drainage pathway, thus maintaining a low intraocular pressure (“IOP”).

0005Previously-known glaucoma drainage devices usually comprise a structure having a drainage tube that is inserted through a small incision made in the conjunctiva. The surgeon then makes a tiny incision in the sclera of the eye and creates an opening for the drainage implant device. The drainage tube is placed such that the opening of the tube is disposed in the anterior chamber of the eye within the aqueous humor. The tube is sutured in place with the drainage device attached to the sclera of the eye. Many surgeons will place an absorbable suture around the tube at the time of surgery to prevent overfiltration through the device until a fibrous capsule has formed. Accordingly, such devices typically are not functional until about 3 to 8 weeks after the procedure, so as to prevent over-filtration.

0006An exemplary previously-known passive glaucoma drainage device is described in U.S. Pat. No. 4,457,757 to Molteno. The device described in that patent comprises a tube of a biologically inert silicone configured to be inserted into the eye to drain aqueous humor from the anterior chamber of the eye. The device does not include a pressure regulating mechanism, but instead relies on the resistance to aqueous flow through the tubing to prevent over drainage.

0007One drawback of devices such as those described in the Molteno patent is that the drainage flow depends on IOP and on the fixed hydrodynamic resistance of the shunt. In many cases, however, the hydrodynamic resistance of the shunt may not be sufficient to reduce high IOP when the resistance to flow is too high, or may lead to over-drainage if the resistance is low. For example, a common problem, which arises shortly after implantation, is hypotony, which occurs when IOP drops below acceptable physiological levels (i.e., IOP<10 mmHg). Hypotony usually takes place the first few days to weeks following the implantation of a glaucoma drainage device, and is a combined result of a low fluidic resistance of both the implant and the distal outflow paths. Hypotony may lead to a number of undesirable effects and complications, such as hypotensive maculopathy, cataract formation and optic nerve edema. Another problem, also related to the fixed fluid resistance of previously known implants, is fibrosis, which appears progressively at long term and which, depending on its extend and severity, may raise the effective fluidic resistance of the implant, thereby raising the IOP to different, often non-physiological, levels.

0008The foregoing drawbacks have been recognized in the prior art, and several improvements have been attempted to improve flow control over the entirely passive system described in Molteno.

0009For example, U.S. Pat. No. 5,411,473 to Ahmed describes a drainage device that includes membrane-type valve. More specifically, Ahmed describes a drainage system including a membrane folded and held in tension between two plates to provide a slit opening, such that the membrane responds to pressure changes to open or close the slit opening. Unfortunately, the operational characteristics of the system depend on the properties of the membrane, which cannot be changed easily once the device is implanted.

0010U.S. Pat. No. 5,300,020 to L'Esperance also describes a drainage system having a flow control element. In this patent, flow is controlled by a plug of absorbable material having porous properties that maintains anterior chamber pressure. Once aqueous humor has been absorbed into the plug, a path of relatively slow drainage flow will be established into the subconjunctival space until an equilibrium of pressures is developed. The pressure release is slow enough to avoid a collapse of the cornea yet sufficient to lower the intraocular pressure. Like the system described in Ahmed, the device described in L'Esperance includes the disadvantage that the porous material has fixed flow characteristics, and cannot be changed to adapt to changes in the progression of the disease.

0011L'Esperance describes a further embodiment comprising a flexible drainage tube with a time-delay valve structure. The valve includes a ball of biocompatible absorbable material that squeezes a portion of the drainage tube closed. As the absorbable material is dissolved by the aqueous humor, the squeezing force applied by the ball drops, progressively reducing the flow resistance of the drainage tube. In yet another embodiment, the time-delay valve comprises polymer components that either inherently, or due to the choice of composition, selectively shrink or stretch to effect opening and/or closure operation of the valve. In both of these latter embodiments, precise adjustment of the drainage flow rate is difficult to achieve, and once the valve control component has dissolved or changed shape, further flow regulation is not possible.

0012Still other examples of previously-known systems are known. U.S. Pat. Nos. 5,626,558 and 6,508,779 to Suson describe a shunt which may be adjusted after implantation by using a low power laser to drill additional openings in the tube wall to adjust the flow rate. U.S. Pat. No. 6,186,974 to Allan et al. describes a drainage shunt having multiple layers, one of which may be a gel that swells upon absorption of fluid to adjust flow rate through the tube. U.S. Pat. No. 6,726,664 to Yaron describes a drainage tube including a distal hook that retains the distal end of the implant within the anterior chamber of the eye, and various means, such as rods or sutures, for partially occluding the lumen of the tube to regulate flow.

0013Other previously-known glaucoma treatment systems include significantly greater complexity to address the drawbacks of the simpler shunt systems described above. For example, U.S. Pat. No. 6,077,299 to Adelberg, et al. describes a non-invasively adjustable valved implant for the drainage of aqueous humor in glaucoma, wherein an implant having an inlet tube is surgically inserted in the anterior chamber of the eye to allow aqueous humor to flow from the anterior chamber to a valve. After passing through a pressure and/or flow regulating valve in the implant, the fluid is dispersed along the periphery of the implant to the interior of the Tenon's capsule where it is absorbed by the body. In one embodiment, the valve inhibits flow below, and allows flow above, a specific pressure difference between the intraocular pressure within the eye and the pressure within the bleb cavity in the Tenon's capsule. The specified pressure difference or set-point is always positive and the valve is always closed in the presence of negative pressure differences, to prevent reverse flow of fluid from the Tenon's capsule back into the anterior chamber of the eye.

0014In Adelberg, the valve is formed by a chamber to which the inlet tube is connected, such that the chamber is closed by a pressure sensitive valve in the shape of a flat cone. The pressure regulation set point of the valve is governed by a flexible diaphragm that cooperated with an armature plate having an inclined surface, and which is configured to slide over a complementary inclined surface attached to the diaphragm. Cooperation of the inclined surface of the plate and the complementary surface causes the diaphragm to deflect depending on where the armature plate is located. The armature plate is rotated, using a rotor and a set of speed-reducing and torque-enhancing gears, to regulate the flow through the device. The characteristics of the valve strongly depend on the configuration of the cone shaped valve. In addition, the regulating mechanism is complex, including many rotating parts and gears, and this complexity poses a risk of malfunction.

0015U.S. Pat. Nos. 6,168,575 and 6,589,198 to Soltanpour et al. describe micro-pump assemblies that may be implanted in the eye for controllably removing excess fluid to treat glaucoma. In these patents, the implantable pumps have a variable pumping rate that may be adjusted either manually or automatically, controlled by the measured intra-ocular pressure. However, these devices have the disadvantage of being complicated and expensive. In addition, because the implantable device contains electronics and a power source, such elements must be miniaturized to fit within in a suitably small sealed enclosure. As for the device described in Adelberg, the risk of malfunction also is high due to the large number of interacting elements present that must cooperate together.

0016Finally, WO 2009/066133 describes an ocular drainage system including a hollow chamber coupled to a drainage tube and a disk disposed within the hollow chamber. Flow from an exit hole of the drainage tube into the hollow chamber is controlled by rotating the disk to align a variable section slit on the disk with the exit hole. Fluid passing through the exit hole and the variable section slit into the hollow chamber is released outside of the implant. Flow through the device is adjusted by magnetically coupling an external adjustment device to the disk, which enables the disk to be rotated non-invasively. A drawback of the system described in this publication, however, is that large torques may be required to rotate the disk within the hollow chamber after implantation, due to deposit of proteinaceous materials from the aqueous humor.

0017In view of the drawbacks of the foregoing prior art devices and methods, it would be desirable to provide an ocular drainage system and methods that are capable of being non-invasively adjusted after implantation to control the hydraulic resistance of the device.

0018It further would be desirable to provide an ocular drainage system having few moving parts, thereby enhancing robustness of the system and reducing the risk of failure arising from having many complex, interacting parts.

0019It further would be desirable to provide an ocular drainage system and methods wherein moving parts of the system are configured to reduce the risk of clogging or becoming inoperative due to the buildup of proteinaceous sediments.

0020Finally, it would be desirable to provide an ocular drainage system and methods that permits the hydraulic resistance of the system to be periodically adjusted in a non-invasive manner.

IV. SUMMARY OF THE INVENTION

0021The present invention overcomes the drawbacks of previously-known ocular drainage systems by providing an implantable device having few moving parts, and which may be non-invasively periodically adjusted to control the fluidic resistance of the device, thereby avoiding hypotony and enabling intraocular pressure to be maintained within desired limits over extended periods. In addition, the ocular drainage device of the present invention is configured so as to minimize buildup of proteinaceous sediment from the aqueous humor on moving parts of the device, thereby ensuring that the implantable device remains functional and adjustable over extended periods.

0022The foregoing advantages are achieved by providing an ocular drainage system comprising an implantable device and an external control unit. The implantable device includes a non-invasively adjustable valve comprising a housing that encloses at least one deformable tube and a disk rotatably mounted within the housing. The housing includes an inlet port that communicates with the anterior chamber of the eye and an outlet port that permits aqueous humor entering the valve via the inlet port to be deposited within, e.g. a bleb formed in the sclera or a glaucoma drainage device in the form of a Seton tube, such as a Baerveldt or a Molteno device.

0023In accordance with one aspect of the present invention, an edge of the disk bears against the drainage tube, so that a selected degree of compression may be applied to the drainage tube depending upon the extent of rotation of the disk. In one embodiment, the disk is eccentrically mounted, comprises a magnetic material or magnetizable metal alloy, and is manipulated non-invasively using the external control unit, which may comprise permanent magnets or an electromagnet. The disk preferably includes one or more ball bearings to reduce the torque required to rotate the disk after implantation. The disk optionally may include a feature that locks the disk in position to prevent inadvertent movement, e.g., due to shock, and requires the application of a minimum threshold torque to adjust the rotation of the disk.

0024In preferred embodiments of the ocular drainage system of the present invention, the housing and disk are curved to accommodate the curvature of the eye, thereby permitting the device to be implanted under a flap formed in the sclera. In addition, the housing may include spaces that accept portions of the drainage tube(s) when the disk is rotated to compress the drainage tube to adjust flow through the device. The deformable tube may extend from the inlet port to the outlet port of the housing, or alternatively, may extend within the housing over the useful arc of contact with the disk. The outlet port may include a single or multiple openings through which fluid may exit the implantable device to the exterior of the eye. As an alternative, a plurality of deformable tubes may be used within the housing, so that rotation of the disk within the implantable device selectively and reversibly closes off a corresponding subset of the plurality of tubes.

0025In accordance with another aspect of the present invention, an external control unit is provided that enables the implantable device to be non-invasively adjusted. In one embodiment, the control unit comprises a sensor for detecting the current orientation of the disk disposed within the implantable device, and one or more magnets that magnetically coupled with the disk to cause the disk to rotate through a selected angle to adjust the fluidic resistance of, and thus flow through, the device. Preferably, the magnets employed in the control unit are electromagnets, and the control unit includes, or can be coupled to, a display that provides a visual confirmation of the degree of adjustment of the implantable device.

0026In an alternative embodiment, the disk is mounted concentrically within the housing and includes a variable thickness rim that forms a cam surface configured to bear against a plurality of movable pins that selectively contact and compress the deformable tube responsive to a selected angular orientation of the cam surface. In yet further embodiments, the disk may be concentrically mounted within the housing and disposed above the deformable tube, which may include a network of connected tubes. A lower surface of the disk includes a plurality of protrusions that selectively contact and compress individual ones of the tubes within the network to increase fluidic resistance through the network responsive to a selected angular orientation of the disk.

0027In still other alternative embodiments, the disk may include circuitry for inducing a local magnetic field in the disk that is out of phase with the magnetic field applied by the control unit. In this configuration, the magnetic field applied by the control unit may be steered to induce a desired degree of rotation of the disk within the implantable device. In another alternative embodiment, the implantable device may be configured as an ultrasonic motor, and the control unit may be coupled ultrasonically to the implantable device, rather than employing magnetic coupling to rotate the disk.

0028Methods of implanting and operating the ocular drainage system of the present invention also are provided.

V. BRIEF DESCRIPTION OF THE DRAWINGS

0029<figref idref="DRAWINGS">FIGS. 1A</figref>, <b>1</b>B and <b>1</b>C are, respectively, a perspective view of an exemplary implantable device of the ocular drainage system of the present invention depicting internal components of the device in a see-through housing (<figref idref="DRAWINGS">FIG. 1A</figref>), illustrating the route of an adjustable fluid path within the housing (<figref idref="DRAWINGS">FIG. 1B</figref>), and illustrating an exploded perspective view depicting the components of the implantable device (<figref idref="DRAWINGS">FIG. 1C</figref>).

0030<figref idref="DRAWINGS">FIGS. 2A and 2B</figref> are, respectively, a side sectional view of the implantable device of <figref idref="DRAWINGS">FIGS. 1</figref> taken along the view line <b>2</b>A-<b>2</b>A and a sectional view taken along view line <b>2</b>B-<b>2</b>B of <figref idref="DRAWINGS">FIG. 2A</figref>.

0031<figref idref="DRAWINGS">FIG. 3</figref> is a detail view of a portion of the implantable device as indicated in <figref idref="DRAWINGS">FIG. 2A</figref>.

0032<figref idref="DRAWINGS">FIG. 4</figref> is a perspective view of the implantable device of the present invention during implantation under a scleral flap formed on the exterior of a patient's eye.

0033<figref idref="DRAWINGS">FIGS. 5A to 5E</figref> are schematic diagrams showing the amount of constriction imposed on the flow path corresponding to rotation of the disk within the implantable device through selected angles α.

0034<figref idref="DRAWINGS">FIGS. 6A</figref>, <b>6</b>B and <b>6</b>C are, respectively, a perspective view and side view of an alternative embodiment of an exemplary implantable device of the ocular drainage system of the present invention depicting a fluid path, and an exploded perspective view depicting the components of that implantable device.

0035<figref idref="DRAWINGS">FIG. 7</figref> is a plan view of an implantable device of the present invention including a in-series connection to a Seton tube.

0036<figref idref="DRAWINGS">FIG. 8</figref> is another exemplary embodiment of the implantable device of the present invention in which fluidic resistance is controlled by a cam-shaped concentrically mounted disk that acts through a plurality of movable pins.

0037<figref idref="DRAWINGS">FIG. 9</figref> is a further exemplary embodiment of the implantable device of the present invention in which the deformable tube comprises a network of interconnected tubes that are selectively compressed by protrusions extending from a lower surface of the rotatable disk.

0038<figref idref="DRAWINGS">FIGS. 10A and 10B</figref> are, respectively, a perspective view and exploded perspective view of the external control unit of the present invention disposed above an implantable device implanted within an eye.

0039<figref idref="DRAWINGS">FIG. 11</figref> is a detail view showing the location of the position sensor relative to the implantable device.

0040<figref idref="DRAWINGS">FIG. 12</figref> is a perspective view of an alternative embodiment of the an external control unit of the present invention;

0041<figref idref="DRAWINGS">FIG. 13</figref> is a perspective view of a further alternative embodiment of an external control unit of the present invention.

0042<figref idref="DRAWINGS">FIGS. 14</figref> is a perspective view depicting use of the external control unit of <figref idref="DRAWINGS">FIG. 13</figref> to first determine the angular orientation of the disk within the implantable device implanted in a patient's eye prior to adjusting the angular orientation of the disk to adjust fluidic resistance of the implantable device.

VI. DETAILED DESCRIPTION OF THE INVENTION

0043The ocular drainage system of the present invention comprises an implantable device having a valve that may be non-invasively adjusted to control the resistance to flow of aqueous humor from the anterior chamber of the eye, through the valve, and to a sink outside the eye (e.g., a bleb formed under a scleral flap). The ocular drainage system further comprises an external control unit that permits a health care provider to periodically adjust the valve within the implantable device to maintain intraocular pressures within a desired range, thereby reducing the risk of damage to the optic nerve. In accordance with the principles of the present invention, the valve may be periodically adjusted without requiring re-operation, and includes a simplified flow path that reduces the risk of clogging due to proteinaceous buildup.

0044An ocular drainage system constructed in accordance with the principles of the present invention is expected to provide a number of advantages over the prior art devices and methods, including: <ul id="ul0001" list-style="none"><li id="ul0001-0001" num="0000"><ul id="ul0002" list-style="none"><li id="ul0002-0001" num="0045">noninvasive adjustment of fluidic resistance of the shunt over a wide range of values, thereby enabling intraocular pressure to be maintained within desired limits over extended periods of time;</li><li id="ul0002-0002" num="0046">the ability to provide patient-specific adjustments with a simple office visit to a clinician, by which the implantable device may be readily adjusted to apply high fluidic resistance in the early days/weeks postsurgery to avoid hypotony;</li><li id="ul0002-0003" num="0047">the capability to lower resistance of the shunt over the long term, to compensate for increased resistance due to fibrosis at the outlet port; and</li><li id="ul0002-0004" num="0048">simple internal mechanisms within the implantable device having with few moving parts, so that the implantable device remains functional and adjustable over extended periods of time.</li></ul></li></ul>

0049Implantable Device

0050Referring to <figref idref="DRAWINGS">FIGS. 1A</figref>, <b>1</b>B and <b>1</b>C, an exemplary embodiment of the implantable portion of the ocular drainage system of the present invention is described. Implantable device <b>10</b> comprises housing <b>11</b> having upper portion <b>12</b> (for clarity omitted from <figref idref="DRAWINGS">FIG. 1A</figref>) and lower portion <b>13</b>. Inlet port <b>14</b> extends from proximal exterior face <b>15</b> of housing <b>11</b>, while outlet port <b>16</b> is disposed near distal face <b>17</b> of lower portion <b>12</b>. Inlet port <b>14</b> is configured to extend through the wall of the eye and into the anterior chamber when housing <b>11</b> is implanted beneath a flap formed in a patient's sclera. Housing <b>11</b> preferably includes eyelets <b>18</b> that enable the implantable device to be suture to the sclera to retain housing <b>11</b> in position once implanted. Fixing the implantable device with respect to the eye is important for measuring the relative position of disk <b>21</b> using the external control device, as described in further detail below.

0051Deformable tube <b>19</b> has a central lumen, a flow area and a corresponding fluidic resistance in its undeformed state. Deformable tube <b>19</b> extends within housing <b>11</b> and is coupled to, or extends through, inlet port <b>14</b> and outlet port <b>16</b>. In a preferred embodiment, outlet port <b>16</b> is disposed at an angle of about 45° to the axis of symmetry of the implantable device (e.g., at an angle of about 225° from inlet port <b>14</b>) to facilitate connection of the outlet port to a Seton tube, such as a Baerveldt or Molteno device). Deformable tube <b>19</b> is seated in groove <b>20</b> that extends along the circumferences of upper portion <b>12</b> and lower portion <b>13</b> of the housing <b>11</b> between inlet port <b>14</b> and outlet port <b>16</b>.

0052Disk <b>21</b>, which may comprise a magnetic or magnetizable material, is disposed within housing <b>11</b> on axle <b>22</b>, and carries ball bearing <b>23</b> formed by inner ring <b>24</b>, outer ring <b>25</b> and plurality of balls <b>26</b> captured therebetween. Ball bearing <b>23</b> ensures that the torque required to rotate the disk remains low throughout the expected useful lifetime of the implant. Outer edge <b>27</b> of outer ring <b>25</b> bears against deformable tube <b>19</b>. In one embodiment, axle <b>22</b> is disposed through non-concentric opening <b>28</b> of disk <b>21</b>, so that edge <b>27</b> of outer ring <b>25</b> traces an eccentric path when disk <b>21</b> rotates on axle <b>22</b>. In addition, in the embodiment of <figref idref="DRAWINGS">FIGS. 1-3</figref>, axle <b>22</b> is located eccentrically relative to an axis of symmetry of housing <b>11</b>. In this manner, rotation of disk <b>21</b> causes outer edge <b>27</b> of bearing <b>23</b> to apply a cam force to deformable tube <b>19</b>, such that the amount of deformation of deformable tube <b>19</b> corresponds to the angle of rotation of disk <b>21</b>.

0053Disk <b>21</b> preferably comprises a permanent magnet having separate poles, and a distinct axis, lying on the plane of the disk that can be sensed using a magnetic sensor. Suitable materials for disk <b>21</b> include alloys of SmCo or NdFe. As should be appreciated, non-concentric opening <b>28</b> for axle <b>22</b> is placed in disk <b>21</b> so that the magnetic axis of the disk is aligned with a preferred orientation of the disk when assembled with the other components of the implantable device, for the purposes described below. Deformable tube <b>19</b> may comprise a resilient, deformable biocompatible tubing, such as silicone, polyethylene or nylon. Alternatively, as described below, a plurality of deformable tubes may be coupled between inlet port <b>14</b> and outlet port <b>16</b>, such that angular movement of disk <b>21</b> compresses and closes off a corresponding subset of deformable tubes. Housing <b>11</b> preferably is less than about 6 mm in diameter, and comprises a biocompatible, waterproof or water-resistant plastic such as polyether ether ketone (“PEEK”) or polycarbonate. The use of PEEK or simpler polymer is particularly desirable, as it provides long-term structural stability when implanted while also allowing for magnetic coupling between disk <b>21</b> of implantable device <b>10</b> and the magnetic field created by the external control unit, as described below. Ball bearing <b>23</b> may comprise a non-magnetic metal alloy or ceramic material, or alternatively may be made out of rubies or similar materials.

0054Referring now to <figref idref="DRAWINGS">FIGS. 2A</figref>, <b>2</b>B and <b>3</b>, further details of the components of implantable device <b>10</b> are described. <figref idref="DRAWINGS">FIG. 2A</figref> is a view of implantable device <b>10</b> taken along view line <b>2</b>A-<b>2</b>A of <figref idref="DRAWINGS">FIG. 1B</figref>, along a plane that coincides with axis of symmetry of housing <b>11</b>. Consequently, eccentrically located axle <b>22</b> is not visible in <figref idref="DRAWINGS">FIG. 2A</figref>. <figref idref="DRAWINGS">FIG. 2B</figref> provides a view at a 90° angle to that shown in <figref idref="DRAWINGS">FIG. 2A</figref>, and therefore passes through axle <b>22</b>. As depicted in <figref idref="DRAWINGS">FIG. 2B</figref>, an axis A′ through axle <b>22</b> preferably is displaced from the axis of symmetry A of disk <b>21</b> and of housing <b>11</b>, and is thus may be rotated to a position closer to the side of the housing carrying deformable tube <b>19</b>. Alternatively, axle <b>22</b> may be placed concentrically within housing <b>11</b>, but instead disk <b>21</b> may have an eccentric shape so as to progressively deform deformable tube <b>19</b> when rotated about axle <b>22</b>. <figref idref="DRAWINGS">FIG. 3</figref> provides a magnified view of the components within call-out <b>3</b> of <figref idref="DRAWINGS">FIG. 2A</figref>.

0055Implantable device <b>21</b> is in general configured to be implanted within a scleral flap, as commonly currently used in glaucoma filtration surgery. The human eye is a spherical object having a radius of curvature of approximately 11 mm. Although the implantable device may be fabricated as a totally flat device, it is advantageous to have housing <b>11</b> respect the natural radius of curvature. Preferably, housing <b>11</b>, disk <b>21</b> and ball bearing <b>23</b> all are constructed to have a curvature that approximates that of the human eye, so that implantable device <b>10</b> will lie snugly against the exterior of the eye, or beneath a scleral flap. In particular, implantable device <b>10</b> preferably is designed with a consistent curvature, such that the radius of curvature of the lower portion <b>13</b> of housing <b>11</b> is in a range of about 10 mm to about 12 mm, and more preferably about 11 mm. To achieve minimal thickness for the implantable device, disk <b>21</b> also should have the same curvature, as illustrated in <figref idref="DRAWINGS">FIGS. 2A and 2B</figref>.

0056Still referring to <figref idref="DRAWINGS">FIG. 2A</figref>, to facilitate the introduction of inlet port <b>14</b> into the anterior chamber of the eye, inlet port <b>14</b> may include rigid nozzle <b>30</b> connected to proximal face <b>15</b> of housing <b>11</b>. Nozzle <b>30</b> may have a conical or sharpened extremity to facilitate piercing of the scleral tissue and introduction into the anterior chamber. Deformable tube <b>19</b> either may be placed tightly and hermetically within nozzle <b>30</b>, as depicted in <figref idref="DRAWINGS">FIGS. 1A and 2A</figref>, or may be connected in series to nozzle <b>30</b>. Nozzle <b>30</b> preferably is inclined at angle θ with respect to the plane of lower portion <b>13</b> of housing <b>11</b> to facilitate anatomical placement of the implantable device within a scleral flap and insertion of nozzle <b>30</b> into the anterior chamber. Angle θ is selected to ensure that nozzle <b>30</b> does not contact or interfere with the iris when implanted, and preferably lies in the range of about 120° to 160°, and more preferably about 140°.

0057During radial compression of deformable tube <b>19</b>, the tube shortens its dimension in the plane of compression and flattens out, thereby increasing its dimension in the perpendicular plane. To facilitate the compression and deformation of deformable tube <b>19</b>, grooves <b>20</b> and <b>29</b> are formed in lower portion <b>13</b> and upper portion <b>12</b>, respectively, of housing, as depicted in <figref idref="DRAWINGS">FIG. 3</figref>. Grooves <b>20</b> and <b>29</b> accommodate lateral expansion as tube <b>19</b> flattens during radial compression, thereby reducing the resistance of tube <b>19</b> to deformation and, consequently, reducing the torque required to turn disk <b>21</b> through a selected angle to compress and deform tube <b>19</b>.

0058Implantable device <b>10</b> is configured to be implanted within eye E, e.g., under a scleral flap S, in a manner similar to other glaucoma drainage devices, as depicted in <figref idref="DRAWINGS">FIG. 4</figref>. Inlet port <b>14</b> drains aqueous humor from the interior of the eye, typically the anterior chamber, through deformable tube <b>19</b>, to the exterior of the eye, typically inside a cavity formed by the scleral flap cavity. In accordance with the principles of the present invention, the rate of drainage, and consequently, the intraocular pressure (IOP), depends on the fluidic resistance of deformable tube <b>19</b>. This resistance may be adjusted by varying the degree of compression applied to deformation tube <b>19</b> by edge <b>27</b> of outer ring <b>25</b> by rotating disk <b>21</b> on axle <b>22</b>, thus, e.g., reducing the flow area within the tube. Due to the eccentric location of axle <b>22</b> relative to the center of disk <b>21</b>, the amount of compression applied by outer edge <b>27</b> of ball bearing <b>23</b> is a function of the angular position of disk <b>21</b>.

0059Referring now to <figref idref="DRAWINGS">FIGS. 5A to 5E</figref>, the angular position of disk <b>21</b> defines the extent of the zone of the tube that is compressed (shown by the darkened areas in the figures) as well as the level of compression of the tube (shown by the relative thickness of the darkened areas in the figures). <figref idref="DRAWINGS">FIG. 5A</figref> depicts the situation where disk <b>21</b> is at a position where angle α is 0°, corresponding to the diameter of disk <b>21</b> being parallel to the diameter of housing <b>11</b>, and offset distance δ from the side of the housing containing deformable tube <b>19</b>. In this position, disk <b>21</b> applies a minimum compressive force to deformable tube <b>19</b>. <figref idref="DRAWINGS">FIG. 5B</figref> depicts the situation where disk <b>21</b> is at a position where angle α is 180°, corresponding to the diameter of disk <b>21</b> again being parallel to the diameter of housing <b>11</b>, but in this case being offset distance δ′ towards the side of the housing containing deformable tube <b>19</b>. In this position, disk <b>21</b> applies the maximum compressive force on the tube. <figref idref="DRAWINGS">FIGS. 5C through 5E</figref> depict selected intermediate angles of a at 45°, 90° and 135°, corresponding to rotation of disk <b>21</b> through 45° increments that create progressively greater constriction of deformable tube <b>19</b>. In this manner, compression of deformable tube <b>19</b> may be adjusted to provide a wide range of flow restriction.

0060In addition, aqueous humor drained from the eye flows only through the interior of deformable tube <b>19</b>, while compressive force is applied to the exterior of the deformable tube. This configuration ensures that proteinaceous materials contained within the aqueous humor passing through the valve cannot create deposits on the working parts of the adjustable valve, and reducing the risk of component failure and blockage of the implantable device.

0061In principle, disk <b>21</b> may be configured to act directly on deformable tube <b>19</b> such that ball bearing <b>23</b> is entirely omitted, and such a configuration represents one possible embodiment of the implantable device. However, depending on the material of which tube <b>19</b> is made, it is possible that friction and/or wear imposed on the tube by repeated adjustment of disk <b>21</b> may pose a potential failure mechanism. Accordingly, in the preceding embodiments, ball bearing <b>23</b> is employed to reduce shear forces applied to the exterior of deformable tube <b>19</b>. In addition, ball bearing <b>23</b> advantageously reduces the torque required to turn disk <b>21</b>. In the embodiments depicted in <figref idref="DRAWINGS">FIGS. 1 through 3</figref>, inner ring <b>24</b> and outer ring <b>25</b> of ball bearing <b>23</b> are especially shaped to yield a concave space there between, which confines plurality of balls <b>26</b>, as shown in <figref idref="DRAWINGS">FIG. 3</figref>. When disk <b>21</b> is turned, inner ring <b>24</b>, coupled to disk <b>21</b> turns and balls <b>26</b> roll. However, outer ring <b>25</b> need not rotate, but rather simply moves radially due to the eccentricity of the disk <b>21</b>. The configuration of the embodiment depicted in <figref idref="DRAWINGS">FIGS. 1-3</figref> therefore causes radial movement of outer ring <b>25</b> to compress deformable tube <b>19</b>, while the absence of circumferential motion of the outer ring eliminates friction on the tube, thereby reducing torque and wear.

0062The proximal end of deformable tube <b>19</b>, i.e., that extends to the exterior of the eye, may exit housing <b>11</b> via a hermetic seal, thus yielding a single outflow point, as shown in the embodiments of <figref idref="DRAWINGS">FIGS. 1 to 3</figref>. However, because fibrotic tissue often forms within the scleral flap and around an implanted device, outlet port <b>16</b> of the implantable device may be become partially blocked, thus increasing thus the effective fluid resistance of the tube. In addition, the preceding embodiments may exhibit strong nonlinear dependence of the fluidic resistance on the level of compression of the deformable tube, thereby limiting the useful angular positions of the disk. An alternative embodiment that is expected to resolve these potential issues, and to provide a more linear response of the fluidic resistance as a function of the angular position of disk <b>21</b>, is described with respect to <figref idref="DRAWINGS">FIGS. 6A to 6C</figref>.

0063In <figref idref="DRAWINGS">FIGS. 6A to 6C</figref>, an alternative embodiment of the implantable device of the present invention is described, in which like primed numbers are used to indicate similar components as described above for the embodiment of <figref idref="DRAWINGS">FIGS. 1 to 3</figref>. Thus, for example, implantable device <b>10</b>′ of <figref idref="DRAWINGS">FIG. 6A</figref> corresponds to implantable device <b>10</b> of <figref idref="DRAWINGS">FIG. 1A</figref>, housing <b>11</b>′ corresponds to housing <b>11</b>, etc. Implantable device <b>10</b>′ differs from implantable device <b>10</b> in that (i) inlet port <b>14</b>′ extends from the surface of lower portion <b>13</b>′, (ii) outlet port <b>16</b>′ is arranged at an angle of about 180° from inlet port <b>14</b>′ and comprises a plurality of holes <b>31</b> formed in the proximal end of deformable tube <b>19</b>′, (iii) ball bearing <b>23</b> (including inner ring <b>24</b>, outer ring <b>25</b> and balls <b>26</b>) are replaced by variable thickness rim <b>27</b>′ and Bellville spring <b>32</b> is employed to tension disk <b>21</b>′ against inadvertent movement.

0064Holes <b>31</b> disposed in outlet port <b>16</b>′ increase the number of exit points for fluid passing the adjustable valve, and increase the diffusion area, thereby facilitating the outflow from implantable device <b>10</b>′, even in event that fibrotic tissue grows around the implantable device after implantation. Belleville spring <b>32</b> applies a preload to disk <b>21</b>′ such that a predetermined minimum torque is required to turn disk <b>21</b>′. Thus, Belleville spring <b>32</b> ensures that disk <b>21</b> does not move inadvertently due to normal eye activity, or mechanical shocks such as are encountered during normal human activity. Alternatively, disk <b>21</b>′ and the mating surface of upper portion <b>12</b>′ or the lower portion <b>13</b>′ of housing <b>11</b>′ may include interacting features, e.g., ridges, that lock the disk in position to prevent inadvertent movement of the disk, e.g., due to shock, and which require the application of a minimum threshold of torque to adjust the rotation of disk <b>21</b>′.

0065Further in accordance with the principles of the present invention, variable thickness rim <b>27</b>′ is designed to overcome potential limitations arising from use of an eccentrically mounted circular disk, as in the embodiment of <figref idref="DRAWINGS">FIGS. 1-3</figref>. In particular, the eccentrically mounted disk <b>21</b> of <figref idref="DRAWINGS">FIGS. 1-3</figref> is symmetric with respect to the angular position of maximum deformation of the tube (180 degrees) as depicted in <figref idref="DRAWINGS">FIGS. 5A-5E</figref>; that is, angular orientations of 135 degrees and 225 degrees produce the amount of compression in deformable tube <b>19</b>. In order to address this concern, rim <b>27</b>′ of the embodiment of <figref idref="DRAWINGS">FIG. 6C</figref> includes a non-uniform radial thickness Th that provides a camming action as disk <b>21</b>′ is rotated. By choosing an appropriate angular distribution of the variable radial thickness Th of rim <b>27</b>′, it is expected that a more linear increase of the hydraulic resistance as function of angular position may be obtained, thereby enabling the range of useful angular orientations of the disk <b>21</b>′ to be expanded. As shown in <figref idref="DRAWINGS">FIG. 6C</figref>, rim <b>27</b>′ may be affixed directly to the outer edge of disk <b>21</b>′. Alternatively, however, a ball bearing construction may be employed to provide some of the other advantages discussed above, such as reduced friction.

0066As a further alternative, instead or, or in addition to, including variable thickness rim <b>27</b>′ on magnetic disk, groove <b>20</b>′ of the embodiment of <figref idref="DRAWINGS">FIGS. 6A-6C</figref> could be formed in the interior of housing <b>11</b>′ so that it is not concentric with respect to disk <b>21</b>′, but instead has a decreasing radius at higher angular orientations of disk <b>21</b>′. In this case, it is expected that adjusting the angular orientation of disk <b>21</b>′ will cause additional compression of deformable tube as the enlarged portion of variable thickness rim <b>27</b>′ approaches the radially closer portion of groove <b>20</b>′.

0067The implantable device of the present invention may be inserted in a scleral flap to regulate drainage of excess intraocular fluid, and thereby regulate IOP in patients afflicted with glaucoma. Aqueous humor passing through the deformable tube and outlet port of the implantable device may exit through the outlet port into the space under the scleral flap, where it will be absorbed by the scleral tissue. More particularly, the fluid will be drained primarily to the connecting vein network. Alternatively, a surgeon may make a second scleral flap with a large cavity beneath it (a bleb) and then make a channel to connect the scleral cavity holding the implantable device to the second cavity. In this case, aqueous humor exiting the outlet port will flow via the channel to the second cavity, where it will be absorbed.

0068Referring now to <figref idref="DRAWINGS">FIG. 7</figref>, a further alternative embodiment of an ocular drainage system constructed in accordance with the principles of the present invention is described, in which implantable device <b>10</b> is connected in series to Seton tube <b>34</b>, such as a Baerveldt or Ahmed-like glaucoma drainage device by elongated tube <b>35</b>. In the embodiment of <figref idref="DRAWINGS">FIG. 7</figref>, the outlet port of implantable device <b>10</b> is connected to the inflow port of Baerveldt tube <b>34</b>, e.g., such as the Baerveldt® BG 103-250 Glaucoma Implant available from Abbott Medical Optics, Inc., Abbott Park, Ill., or other similar device.

0069With respect to <figref idref="DRAWINGS">FIG. 8</figref>, yet another embodiment of an implantable device constructed in accordance with the principles of the present invention is described. Implantable device <b>40</b> includes housing <b>41</b> having upper portion <b>42</b> and lower portion <b>43</b>. Inlet port <b>44</b> extends from the proximal exterior face of housing <b>41</b> and is in fluid communication with outlet <b>46</b> via an internal lumen of elastically deformable tube <b>49</b>. Disk <b>51</b> rotates concentrically about axle <b>52</b>, and includes variable thickness rim <b>53</b> that serves to provide a camming action as described hereinafter. Plurality of movable pins <b>54</b> are disposed in radially oriented slots <b>55</b> formed in housing <b>41</b>, and are arranged to reciprocate within slots <b>55</b> in response to cam forces applied by variable thickness rim <b>53</b> and elastic recovery forces of deformable tube <b>49</b>. Accordingly, when disk <b>51</b> is rotated through predetermined angles about axle <b>52</b>, different ones of the plurality of movable pins <b>54</b> are urged against deformable tube <b>49</b>, thereby progressively reducing the flow area, and increasing the fluidic resistance of, implantable device <b>40</b>. Depending on the local thickness of rim <b>53</b>, movable pins <b>54</b> will be pushed at variable degrees along their respective slots and will, correspondingly, compress deformable tube <b>49</b>.

0070Movable pins <b>54</b> preferably have rounded ends to minimize friction with variable thickness rim <b>53</b> and also to provide a rounded compression surface on deformable tube <b>49</b>. The number of movable pins may be selected as a matter of design choice, although with higher numbers of movable pins, higher angular resolution may be obtained in adjusting the effective hydraulic resistance of implantable device <b>40</b>. Advantageously, the embodiment of <figref idref="DRAWINGS">FIG. 8</figref> is expected to provide a wider range of adjustment of fluidic resistance, higher precision in compressing deformable tube <b>49</b>, and the concentrically mounted construction of disk <b>51</b> is expected to be easier to manufacture than the eccentric axle designs described in <figref idref="DRAWINGS">FIGS. 1 and 6</figref>.

0071Referring now to <figref idref="DRAWINGS">FIG. 9</figref>, yet another exemplary embodiment of the implantable device of the present invention is described. Implantable device <b>60</b> includes a housing similar to those depicted in <figref idref="DRAWINGS">FIGS. 1</figref>, <b>6</b> and <b>8</b> (only lower portion <b>61</b> being shown in <figref idref="DRAWINGS">FIG. 9</figref>). Implantable device <b>60</b> differs from preceding embodiments in that, instead of having a single deformable tube disposed in a groove along the periphery of the housing, inlet <b>62</b> is coupled to outlet <b>63</b> by a plurality of separate deformable tubes <b>64</b>. In addition, rather than being configured so that an outer perimeter of an angularly adjustable disk bears against the deformable tube, the disk instead includes a plurality of protrusions <b>65</b> extending from its lower surface. Protrusions <b>65</b> are arranged on the disk so that partial rotation of the disk brings different ones of the protrusions into contact with, and compresses, selected ones of the plurality of deformable tubes <b>64</b>. This in turn enables the total flow area through implantable device <b>60</b>, and thus the fluidic resistance, to be readily adjusted by changing the orientation of the disk within the housing of the implantable device, for example, using the external control units described below.

0072Because the resistance of the network of deformable tubes <b>64</b> depends on the number of tubes running in parallel between inlet <b>62</b> and outlet <b>63</b>, and on the resistance of each tube, by selectively occluding different ones of the tubes at different angular positions, the embodiment of <figref idref="DRAWINGS">FIG. 9</figref> also provides a large number of functional positions having distinctly different resistances. The size of each deformable tube <b>64</b> and the disposition of each protrusion <b>65</b> preferably will be selected so that when rotating the disk in one direction (i.e., counterclockwise) the resistance will increase or decrease in a consistent and quasi-linear fashion. As an example, in the specific angular position of the disk shown in <figref idref="DRAWINGS">FIG. 9</figref>, two protrusions <b>65</b> occlude the two far right deformable tubes <b>64</b>. So in this particular configuration, the resistance of the tube is determined by the sum of the resistances of the three deformable tubes <b>64</b> that remain open.

0073External Control Unit

0074Referring now to <figref idref="DRAWINGS">FIGS. 10A</figref>, <b>10</b>B and <b>11</b>, an exemplary embodiment of the external control unit of the ocular drainage system of the present invention is now described. In each of the figures, control unit <b>70</b> is shown disposed above and spaced apart from implantable device <b>10</b> of the present invention. In one embodiment, control unit <b>70</b> comprises housing <b>71</b> containing position sensor <b>72</b>, electromagnet <b>73</b>, actuator <b>74</b>. Control unit <b>70</b> also may include a display, or may be configured to be coupled to optional conventional processing and display system <b>90</b>, e.g., a suitably programmed personal or laptop computer, using a cable or wirelessly using, e.g., an IEEE 802.11 compliant wireless chip. As will be readily appreciated, control unit <b>70</b> and processor and display system <b>90</b> are not to scale.

0075As depicted in <figref idref="DRAWINGS">FIG. 10B</figref>, control unit <b>70</b> is configured to be positioned above a patient's eye E so that position sensor <b>72</b> may determine the angular orientation a of disk <b>21</b> within implantable device <b>10</b> and generate an output signal for display on processing and display system <b>90</b>. Electromagnet <b>73</b> provides magnetic coupling between the disk within implantable device <b>10</b> and the external control unit, so that using actuator <b>74</b>, a health care provider may adjust the angular orientation a of disk <b>21</b> within the implantable device. Any corresponding movement of the disk, corresponding to an adjustment of the amount of compression of deformable tubing <b>19</b> within the implantable device, is sensed by position sensor <b>72</b> and displayed on control unit <b>70</b> or processing and display system <b>90</b>.

0076As depicted in <figref idref="DRAWINGS">FIGS. 10A and 11</figref>, position sensor <b>72</b> preferably is mounted on circuit board <b>75</b> suspended on sensor stalk <b>76</b>, such that position sensor <b>72</b> is disposed in close proximity to, but not touching, implantable device <b>10</b> during the adjustment process. In this embodiment, position sensor <b>72</b> is a magnetic sensor, and is configured to sense the angular orientation of the disk disposed within the implantable device when electromagnetic <b>73</b> is de-energized. As discussed above, disk <b>21</b> has a distinct magnetic axis which can be sensed by position sensor <b>72</b> to determine the angular orientation a of the disk.

0077Electromagnet <b>73</b> comprises proximal magnetic core <b>78</b>, main magnetic core <b>79</b> and distal magnetic core <b>80</b>. Electric coils <b>81</b> surround main magnetic core <b>79</b> and induce a magnetic field within magnetic cores <b>78</b>, <b>79</b> and <b>80</b>, using methods that are know in the art. The magnet field generated at proximal magnetic cores <b>78</b> magnetically couples the disk in the implantable device to control unit <b>70</b>. Control unit <b>70</b> further comprises rods <b>82</b>, the lower ends of which support bottom cover <b>83</b> and the upper ends of which are connected to distal magnetic core <b>80</b>. Holes <b>84</b> in bottom cover <b>83</b> allow proximal magnetic cores <b>78</b> to pass through the bottom cover so that core <b>78</b> can be disposed in proximity to the implantable device. Preferably, the strength of the magnetic field that couples the disk within the implantable device to the control unit results in a force that is tolerated by the scleral tissue, e.g., less than 1 Newton. In one embodiment, the disk and external control unit each have a magnetic field strength of about 0.8 Tesla, such that a maximum torque of about 1.2 mNm can be applied to the disk, while the estimated vertical force is less than about 0.12 N.

0078Actuator <b>74</b> may comprise either a manual crank or electric motor, and is configured to make adjustments in the angular orientation of the disk <b>21</b> of the implantable device when magnetically coupled to control unit <b>70</b>. In one embodiment, actuator <b>74</b> comprises an electric motor that is coupled to distal magnetic core and configured to rotate electromagnet <b>73</b> within housing <b>71</b>. As should be appreciated, housing <b>71</b> may he held in the physician's hand, but more preferably is mounted on a rigid support arm that can be positioned within a predetermined distance of the patient's eye. Actuator <b>74</b> may in addition be coupled to processor and display system <b>90</b>, and actuated using software resident on processing and display system <b>90</b> to fine tune adjustment of the implantable device.

0079Control unit <b>70</b> is used to perform two principal tasks as set out in the following paragraphs: (1) sensing the relative angular position of disk <b>21</b> within the implantable device (which defines the operational position of the implantable device) and (2) rotating disk <b>21</b> within the implantable device, either clockwise or counterclockwise, by selected amount to adjust the flow resistance of the implantable device. As noted above, control unit <b>70</b> preferably is mounted fixed in space, for example, suspended above an examination chair in the health care provider's office.

0080A method of using control unit <b>70</b> to adjust the fluidic resistance of the implantable device of the present invention is now described. For a patient in whom an implantable device was previously implanted, a first step of the method may include measuring the patient's intraocular pressure, e.g., using tonometry. Next, the patient may be seated, for example, in and examination chair accessible to control unit <b>70</b>. If the implantable device were previously implanted under a scleral flap along a meridional plane of the eye, just above the iris, the patient may be instructed to look straight down to expose the implant. The control unit may be moved into position at a selected distance above the patient's eye, for example, using a motorized or manually-adjusted articulated support arm.

0081Next, position sensor <b>72</b> measures the location of the magnetic axis of the disk within the implantable device, and its orientation is displayed on processor and display system <b>90</b>. While electromagnet <b>73</b> is de-energized (i.e., no current in the coils), the health care provider manually or automatically rotates the internal mechanism of control unit <b>70</b> so that the edges of the arms of proximal magnetic cores <b>78</b> are concentric with, and aligned with, the magnetic axis of disk <b>21</b> within the implant, as may be determined using the output of the magnetic sensor. This may be facilitated by including a camera on control unit <b>70</b>, such that the orientation of the magnetic axis of the disk of the implantable device may be superimposed on a real-time image of the patient's eye that includes the arms of proximal magnetic cores <b>78</b>.

0082Once the control unit is properly aligned with the implant, electromagnet <b>73</b> is energized to induce a magnetic field that passes through the arms of proximal magnetic cores <b>78</b> having opposite polarity to that of the magnetic fields of disk <b>21</b>, thereby producing a strong phase lock that aligns disk <b>21</b> to the external magnetic field created by control unit <b>70</b>. As should be appreciated, the magnetic field induced by electromagnet <b>73</b> is the direction of the line passing through the tips of the arms of proximal magnetic cores <b>78</b>. Once the phase lock is established, and while keeping the electromagnetic system energized, the health care worker executes a desired rotation of the proximal magnet cores <b>78</b> using actuator <b>74</b>. Because disk <b>21</b> within the implantable device is phase locked to the external magnetic field, it will remain aligned to the external field and will simultaneously undergo the same rotation within the implantable device. As discussed above, the external magnetic field created by electromagnet <b>73</b> is sufficiently strong to apply the torque required to turn the disk within the implantable device, for example, to overcome the preload applied by the locking feature (e.g., Belleville spring), if present, and any frictional resistance.

0083After actuator <b>74</b> has turned the disk through the desired amount, electromagnet <b>73</b> is de-energized, and position sensor <b>72</b> is employed to check the relative rotational position of the disk within the implantable device to verify that the intended rotation has indeed taken place. After allowing a suitable period for pressure to equilibrate within the eye at the new valve setting, the health care provider may again check intraocular pressure within the patient's, e.g., using tonometry.

0084Referring now to <figref idref="DRAWINGS">FIG. 12</figref>, an alternative embodiment of an external control unit is described. External control unit <b>100</b> is a more compact, less complicated and user-friendly version of the embodiment of <figref idref="DRAWINGS">FIGS. 10 and 11</figref>. External control unit <b>100</b> permits the health care provider to perform two essential functions with respect to the implantable device described herein above: (1) measure the functional position of the disk within the implantable device; and (2) perform noninvasive adjustment of the detected functional position, thereby adjusting the drainage characteristics (fluidic resistance) of the implantable device.

0085External control unit <b>100</b> comprised of two main parts, sensor display unit <b>101</b> and an adjustment unit <b>102</b>. Sensor display unit <b>101</b> is configured to be positioned on top of a patient eye's, directly above the implantable device, and contains sensor <b>103</b> for measuring the orientation of the magnetic disk (e.g., disk <b>21</b> or <b>51</b>) within the implantable device. Sensor display unit <b>101</b> also includes array <b>104</b> of LEDs disposed circularly on its periphery to display the measured angular position of the magnetic disk using electronics activated by button <b>105</b>.

0086Adjustment unit <b>102</b> is designed to be positioned co-axially within sensor display unit <b>102</b>, and contains a magnet having poles <b>106</b> and <b>107</b> that creates a strong magnetic field in the vicinity of the implantable device. When positioned within sensor display unit <b>101</b>, poles <b>106</b> and <b>107</b> of magnet in adjustment unit <b>102</b> may be aligned in opposite polarity to the poles of the magnetic disk of the implantable device, whereby a strong magnetic coupling may be achieved. When adjustment unit <b>102</b> is disposed within sensor display unit <b>101</b>, position marks <b>108</b> should be aligned with the LEDs corresponding to the magnetic disk orientation sensed by sensor <b>103</b>. Subsequent rotation of adjustment unit <b>102</b> induces an equivalent rotation of the magnetic disk of the implantable device, thereby adjusting its functional position and the resulting fluidic resistance of the implantable device.

0087Further details regarding implantation of an implantable device as described hereinabove are now provided. The implantable device (e.g., device <b>10</b>, <b>10</b>′, <b>40</b> or <b>60</b>) is implanted using a surgical technique similar to that used for prior art glaucoma drainage devices. As depicted in <figref idref="DRAWINGS">FIG. 4</figref>, a scleral flap is created in a manner analogous to standard trabeculectomy, and the flap is dissected carefully up to clear cornea. The scleral flap is lifted and care is taken to identify the center of the “blue zone” adjacent to clear cornea, which corresponds to the location of the trabecular meshwork. As will be understood by one of skill in the art, the “blue zone” is located posterior to the anterior limbal border, and terminates in midlimbal line. A 26-gauge needle is inserted into the anterior chamber through the center of the “blue zone” at an angle parallel to the iris plane. The inlet port of the implantable device then is inserted all the way into the anterior chamber through the ostium created by the needle. The implantable device is secured in place within the scleral flap by applying sutures through the two eyelets provided (e.g., eyelets <b>18</b> in <figref idref="DRAWINGS">FIG. 1B</figref>). The scleral flap is then sutured in place using a 10-0 nylon suture with a spatulated needle. Finally the conjunctiva is carefully closed by appropriate suturing.

0088Once the implantable device is implanted as described above, the angular orientation of the magnetic disk may be adjusted using the external control unit to adjust the fluidic resistance of the implantable device. The adjustment procedure using the external control unit of <figref idref="DRAWINGS">FIG. 12</figref> includes steps of (1) measuring the functional position of the magnetic disk prior to adjustment; (2) adjusting the functional position of the magnetic disk and (3) measuring and verifying the functional position of the magnetic disk after the adjustment.

0089The foregoing procedure starts by placing sensor display unit <b>101</b> on top of the patient's eye, which is kept still and in a position to best expose the implant. Sensor display unit <b>101</b> is placed in relation to the eye so that sensor <b>103</b> is just above the implantable device. The operator then depresses button <b>105</b>, which causes sensor <b>103</b> to measure of the orientation of the magnetic field created by the magnetic disk of the implantable device. Electronics in sensor display unit read the output sensor <b>103</b> and identify the magnetic field orientation by lighting two diametrically opposed LEDs of LED array <b>104</b>, so that a fictitious line between the two illuminated LEDs matches the direction of the magnetic field. The polarity of the magnetic field also may be displayed by using appropriate LED colors, i.e., red color for North and green for South.

0090Once the direction of the magnetic disk is identified and displayed on sensor display unit <b>101</b>, the operator places adjustment unit <b>108</b> coaxially within sensor display unit <b>101</b> taking care that poles <b>106</b> and <b>107</b> of the adjustment unit are perfectly aligned and in opposite polarity to the magnetic field of the implantable device, as indicated on LED array <b>104</b>. This is facilitated by two color position marks <b>108</b>, indicating the N (green dot) and S (red) pole of the adjustment unit, which are placed permanently and in diametrically opposite positions on the periphery of the adjustment unit, as shown in <figref idref="DRAWINGS">FIG. 12</figref>. Aligning position marks <b>108</b> to the same colored LEDs on sensor display unit <b>101</b> ensures that the two magnets are strongly coupled magnetically and any rotation of the adjustment unit will entrain an equivalent rotation of the magnetic disk within the implantable device. The operator then is free to rotate adjustment unit <b>102</b> clockwise or counterclockwise (while sensor display unit <b>101</b> is held fixed) to either increase or decrease the functional position of the magnetic disk, and thus the fluidic resistance of the implantable device.

0091Once the foregoing adjustment is made, the operator may remove the adjustment unit and depress button <b>105</b> to sense and display a new measurement for the magnetic field, and to verify that the magnetic disk has indeed rotated appropriately. This will be the case when the LEDs of sensor display unit <b>101</b> and position marks <b>108</b> of adjustment unit <b>102</b> again are aligned. It should be noted that the inventive system allows for a relative adjustment of the fluidic resistance of the implant, and does not affect a direct adjustment of the intraocular pressure of the eye. Accordingly, after a suitable period to allow the fluid flow through the implantable device to come to equilibrium, the physician should measure IOP after the adjustment using appropriate means (i.e., tonometry) and, if necessary, repeat the adjustment until the desired IOP is achieved.

0092Referring now to <figref idref="DRAWINGS">FIGS. 13 and 14</figref>, a further alternative embodiment of the external control unit of the present invention is described. External control unit <b>110</b> represents a further effort to reduce the complexity of the external control unit to be used with the implantable device of the present invention, such that external control unit <b>110</b> comprises a simple pen-like unit. More specifically, external control unit <b>110</b> includes flat compass <b>111</b> at one end, spirit level <b>112</b> and permanent magnet <b>113</b> at the other end. Flat compass <b>111</b> is provided for measuring the orientation of the magnetic disk within the implantable device. Magnetic needle <b>114</b> of compass <b>111</b> is colored to indicate the north pole and the transparent cover or the outer rim of housing <b>115</b> contains graduations for easier reading of the angular position of the needle. Permanent magnet <b>113</b> is disposed on the other end of external control unit <b>110</b>, and is used for adjusting the angular orientation of the magnetic disk within the implantable device, as described below. Spirit level <b>112</b> is disposed in the main body of unit <b>110</b> and allows the user (physician) to confirm that the external control unit is in a horizontal position while measuring the magnetic disk orientation, thereby ensuring that a fixed reference frame is provided for all measurements (e.g., before and after each adjustment attempt).

0093A method of adjusting the fluidic resistance of an implantable device is now described with respect to <figref idref="DRAWINGS">FIG. 14</figref>, and includes steps similar to those described above for the preceding embodiments of external control unit.

0094First, a measurement of the functional position of the magnetic disk within the implantable device is taken to determine the current angular position of the magnetic disk. With the patient seated and motionless, and with the head in a vertical position (e.g., immobilized against a typical eye examination frame), the physician pulls on the eyelid to expose the sclera. Compass <b>111</b> is then placed flat on the scleral flap, right above the implantable device, while the physician verifies that unit <b>110</b> is in horizontal position using spirit level <b>112</b>. The angular position of compass needle <b>114</b> is noted, which corresponds to the orientation of the magnetic field emanating from the magnetic disk of the implantable device. It is expected that the magnetic disk of the implantable device will create a magnetic field in its vicinity that is orders of magnitudes greater (e.g., 150 times higher) than the magnetic field of the earth. Accordingly, the earth's magnetic field is not expected to interfere with the ability of compass <b>111</b> to accurately determine the orientation of the magnetic field of the disk within the implant.

0095Next, the physician turns unit <b>110</b> by 180 degrees so that the magnet (e.g., south pole) is adjacent to the sclera and near the position previously indicated by the north pole of compass <b>111</b>. Positioning magnet <b>113</b> in this manner couples magnet <b>113</b> to the magnetic disk of the implantable device. The physician then moves magnet <b>113</b> in a clockwise or counterclockwise direction through a circular arc over the implantable device, causing the magnetic disk of the implantable device to rotate accordingly and increase or decrease the hydraulic resistance of the implantable device.

0096The physician again reverses external control unit <b>110</b> to bring the compass adjacent to the implantable device to sense the orientation of the magnetic field emanating from the implantable device. The physician may then repeat the foregoing steps a number of times until the magnetic disk within the implantable device is confirmed to have moved through a desired angle. The physician preferably then performs a measurement of IOP using a tonometer or similar device. As noted above, this test preferably is performed only after IOP is expected to have reached a new steady state (e.g., after approximately 15-30 minutes). If IOP now is within the physiological or desired range, the procedure is complete. Otherwise further adjustment may be performed.

0097Alternative embodiments of the ocular drainage system of the present invention may include a miniaturized pressure sensor disposed with the implantable device and in communication with inlet port <b>14</b> to measure intraocular pressure. This sensor may be coupled to a miniaturized telemetry system, such as those based on radio frequency identification principles, that may be energized from distance, e.g., by circuitry on control unit <b>40</b>, to emit a signal that can be received and interpreted by an external receiver. This arrangement would provide an easy and non-invasive measurement of intraocular pressure.

0098In further alternative embodiments, disk <b>21</b> within the implantable device may comprise a magnetizable material rather than a permanent magnet, and may further include circuitry for inducing a local magnetic field in the disk that is out of phase with the magnetic field applied by control unit <b>40</b>. In this embodiment, control unit <b>40</b> applies an alternating magnetic field to energize the circuitry disposed within the implantable device to generate a local magnetic field of opposite polarity. In this way, the magnetic field supplied by control unit <b>40</b> may be employed to generate a local magnetic field, and coupling between those fields may be used to steer the disk within the implantable device to induce a desired degree of rotation. As a yet further alternative embodiment, implantable device <b>10</b> may be configured as an ultrasonic motor, in which case control unit <b>40</b> is coupled ultrasonically to the disk disposed within the implantable device, rather than employing magnetic coupling.

0099As a yet further alternative, a plurality of tubes may be substituted for deformable tube <b>19</b> within the housing <b>11</b>. In this embodiment, rotation of the disk within the implantable device selectively and reversibly closes off a corresponding subset of the plurality of tubes, rather than simply deforming a single deformable tube <b>19</b>.

0100While various illustrative embodiments of the invention are described above, it will be apparent to one skilled in the art that various changes and modifications may be made therein without departing from the invention. The appended claims are intended to cover all such changes and modifications that fall within the true spirit and scope of the invention.