JP2005508213A - Methods and intrascleral implants for the treatment of glaucoma and presbyopia - Google Patents

Abstract

Intrascleral implant (10) and implantation method for treating intraocular pressure and presbyopia. This implant features a protrusion (48) from the body for securing the device in the cavity (19) formed in the sclera (16) of the body (46) and the eye (12). Optionally, a drug delivery function is provided to allow long-term delivery of the drug to the tissue surrounding the implant.

Description

【Technical field】
[0001]
This application claims the benefit of US Provisional Application No. 60/310027, filed Aug. 3, 2001.
[0002]
The disclosed device relates to an intrascleral implant. More particularly, it relates to a device that is implanted into the sclera of the eye for the treatment of increased intraocular pressure often associated with glaucoma and for the treatment of presbyopia or loss of vision regulation of the eye.
[0003]
Glaucoma is an eye disease in which patients gradually lose vision. Such blindness is caused by damage to the optic nerve that acts like a wire and carries the image from the eyes to the brain. Glaucoma often accompanies high intraocular pressure and is one of the leading causes of neuropathy that causes this blindness. If the eye drainage clogs over time, it is thought that an increase in intraocular pressure occurs. The intraocular pressure rises to a level that causes damage because the correct amount of fluid cannot normally flow out of the eye. If this excess of intraocular pressure is not detected and treated, vision can be gradually lost. Such blindness may occur over time. However, in some cases of glaucoma, intraocular pressure usually rises very quickly. This can happen if the eye drain is blocked or covered, such as a clogged sink when something is covering the drain.
[0004]
Drugs are often used and often effective when intraocular pressure rises slowly. In patients who have experienced such a rapid increase in intraocular pressure, or who have reached a dangerous state after increasing for a long time, serious eye damage and blindness can occur.
[0005]
Surgery has also been used more recently to treat intraocular pressure. Clinical researchers have recently noted that intraocular pressure is reduced by a radial incision in the anterior sclera known as anterior ciliary sclerostomy. Unfortunately, patients who have undergone such a procedure lose their beneficial effects as the incision heals and a wound is formed over a long period of time after the procedure. Therefore, as intraocular pressure rises again after surgery, the likelihood of blindness increases.
[0006]
Another vision-related problem that affects the patient is the problem of presbyopia, a vision condition in which the lens of the patient's eye loses flexibility. This loss of flexibility makes it difficult to focus on close objects. Presbyopia seems to have suddenly occurred when the patient noticed the problem, but the cause of blindness is the actual loss of lens flexibility that has occurred over many years, usually becoming prominent in the early to mid-thirties. Is generally recognized.
[0007]
Treatments to compensate for presbyopia include prescription reading glasses, perspective glasses, contact lenses and laser surgery. However, such corrective lenses are inconvenient for the wearer, and laser surgery on the eye lens poses an inherent risk to vision itself if a mistake is made.
[0008]
Still further, many diseases that attack the eyes and vision require long-term administration of the drug to maintain vision. It would be desirable to provide an easily installed device that provides long-term controlled direct administration of medication to the eye while simultaneously helping to adjust the patient's intraocular pressure and possible vision problems.
[0009]
Thus, simple surgical procedures that would have a lasting effect for relieving intraocular pressure and correcting presbyopia, eliminating or reducing the need for prescription lenses, without dangerous surgery of the ophthalmic lens itself. Medical treatment is required. Such treatment would be further enhanced by the provision of drug delivery systems that can be adjusted for dosage and time, helping to release intraocular pressure and other eye diseases that require accurate and long-term delivery of the drug. .
[Background]
[0010]
In recent years, surgical procedures and implantable devices have been developed to treat presbyopia.
[0011]
US Pat. No. 6,280,468 (Schachar) discloses a scleral aid for the treatment of presbyopia and other eye diseases. Scashire places ciliary muscles around the pupil that place assists in multiple pockets slightly smaller than the implant to exert external pressure on the sclera, thereby allowing the patient to release from presbyopia. Teaching to restore the working distance. However, the scaffolder is oriented to surround the pupil or anterior portion of the eye and lacks anchoring means to hold the implant in the correct position within the sclera for an extended period of time, so that the implant shifts, The effect is reduced or lost. Furthermore, the use of tunnels smaller than the implant tends to destroy the implant. Scashire also lacks the means of drug delivery from the implant. Still further, the implant may actually be removed if it needs to be removed from the eye, especially if it penetrates the outer surface of the eye when it is displaced. Furthermore, the circumferential placement of the implant is not very effective in promoting internal drainage and reducing intraocular pressure.
[0012]
US Pat. No. 6,102,045 (Nordquist) discloses a method and apparatus for reducing intraocular pressure in the eye. However, a node quist is a filtering implant that extends from the opening of the limbus to the anterior chamber. The node quist lacks the effect of correcting the presbyopia provided by the device with the sclera attached, and the node quist is more difficult to accurately position due to subtle positioning and direct communication with the anterior chamber. In addition, it lacks the ability to leach medicines into the eye, and providing direct communication between the anterior chamber and areas outside the eye increases the risk of infection of the anterior chamber.
[0013]
US Pat. No. 6,079,417 (Fugo) discloses a method and apparatus for reshaping the cornea to alter its topography. However, Fugo lacks the ability to increase drainage from within the eye, which reduces intraocular pressure. Fugo is further designed to attach directly to the cornea layer of the eye.
[0014]
US Pat. No. 5,178,604 (Baerveldt) teaches the use of implants to increase eye drainage and reduce pressure caused by glaucoma. However, Baelberd is simply a tube that communicates directly with the interior room of the eye and does not provide a means for improving presbyopia.
[0015]
Thus, there continues to be a need for reliable surgical methods and aids that help physicians to interrupt relentless cycles that result in blindness and eye damage for patients suffering from elevated intraocular pressure in the eye. Such a device should be able to be inserted into the eye in a manner that is relatively easy for a trained surgeon. Such devices and methods should avoid more subtle structures of the eye and should also avoid direct communication between the eye's internal structure and the outside of the eye to prevent infection. Such a device would provide an auxiliary utility with the desired function of providing a drug delivery system directly from the implant to the eye. Still further, the device implanted by this method should be positioned by the anchor structure to ensure that the implant remains exactly permanent, thereby necessitating repositioning or removal caused by the movable implant. Can be maintained to maintain established vision correction.
DISCLOSURE OF THE INVENTION
[0016]
The above and other problems are solved by the methods and scleral implants described herein for the treatment of glaucoma and presbyopia. This method of inserting the implant requires that incisions be made radially in the anterior sclera. Multiple such incisions are made radially and only in the sclera, currently the best number is four, with one incision each in the quadrant of the eye.
[0017]
Once the incision is made in the appropriate quadrant and properly extended toward the back of the eye, one implant is placed in the space of each incision. The scleral incision is then closed by opposition or using sutures or other means to close the incision, prompting the scleral flap to the surface of the eye that separates it, and rejoining the sclera. .
[0018]
Implants are currently most preferably formed in a single configuration and made from an inert material when in contact with body tissue. Preferred materials include one or a combination from the group consisting of hydroxyapatite, silicone, polymethyl methacrylate, acrylic and tantalum.
[0019]
The single implant may optionally be sawtooth or have one or more holes therethrough to contact and remain in the scleral tissue. In addition, the implant body may also be impregnated with a drug that is then slowly dispensed into the eye tissue, and the dosage and time frame allow for long-term delivery of drug treatment from the implant to the patient's eyes and body. It may have an internal reservoir or coating of medication.
[0020]
Accordingly, it is an object of the present invention to provide a reliable surgical method for placing an implant in the sclera that can be easily performed by a trained surgeon.
[0021]
Another object of the present invention is to provide an implant that can be easily inserted into the scleral layer of the eye during a surgical procedure.
[0022]
Yet another object of the present invention is to provide an implant having an anchor system to ensure that the implant is maintained in the position intended by the surgeon who implants it.
[0023]
Yet another object of the present invention is to provide an apparatus for ophthalmic surgery that can be used to treat presbyopia and increasing intraocular pressure.
[0024]
Still further, it is an object of the present invention to provide an implant with the option of long-term drug delivery directly from the implant to the eye.
[0025]
These and other objects of the present invention will become apparent from the following portions of the specification. The detailed description is intended to fully disclose the present invention and is not limited thereto.
BEST MODE FOR CARRYING OUT THE INVENTION
[0026]
Reference is now made to FIGS. 1-6, which illustrate a preferred embodiment of the disclosed device 10, which shows the preferred position of the device 10 on the eye 12 and the steps of the method of operation. The method of surgical insertion of the implant device 10 is such that the incision is radial to the cornea 22 in the sclera 16, generally along the central axis 14 of the eye 12 shown along line 2-2 in FIG. Need to be done along.
[0027]
In its basic structure, the eye 12 consists of a sphere having a jacket, a central layer and an inner layer. The outer lining is a strong fibrous white that lines and folds the eyelids and inner surface and connects with the conjunctiva 18 which is the mucosa that covers the anterior surface of the eyeball except for the central transparent portion of the outer eye, which is the cornea 20. It consists of a layer-sclera 16. The middle layer contains the pigment and forms the iris 22. The inner layer is the layer that sees light, ie the retina 24. The lens 26 is an oval board sitting behind the iris 22. It is traditionally believed that the cornea 20 collects approximately two-thirds of the light entering the eye 12 and the lens 26 collects one-third. The simple explanation is that lens vision adjustment or focusing is performed by the ciliary muscle 28 pulled by a small band 30 that communicates between the ciliary muscle 28 and the lens 26.
[0028]
As people age, many people have a vision condition that causes the lens 26 to lose some of its flexibility, or the zonule 30 to stretch, making it difficult for the ciliary muscle 28 to focus the lens 26 as needed. Annoying presbyopia that is. By implanting the device 10 using the surgical method shown here, the recombined sclera 16 pulls the device 10 upward and imparts the resulting tension to the ciliary muscle 28, thereby. Patients who tend to give greater working distance or movement, have the ability to lift the lens 26 for better vision adjustment, and have obtained the device using the implant method will then have improved vision. It is done. When the sclera 16 recombines onto the inserted device 10, the scleral tension develops, reducing the equatorial diameter of the lens 26 and slightly extending the zonule 30 to increase the operating range, It is thought that the visual acuity adjustment following the implant operation is increased in combination.
[0029]
When the fluid originally produced in the eye 12 cannot communicate from the trabecular meshwork (similar to a grid on a manhole) to the Schlemm tube, the water distribution pipe of the eye that removes excess fluid and eye waste The accumulation of fluid in the anterior chamber 36 and the posterior chamber 38 causes intraocular pressure in the eye 12. In accordance with the operation of the device 10 described above using an implantation method into the patient's eye, it has been found that draining aqueous fluid from the eye increases the decrease in intraocular pressure. As best understood, the effect of tightening or tensioning the ciliary muscle 28 by clearly tightening the sclera 16 after implantation of the device into the four quadrants of the eye 12, and Having communication with the lens 26, the same area trabecular mesh improves fluid flow at the same time and helps drain fluid from the anterior chamber 36 and posterior chamber 38. Of course, other explanations will be apparent to those skilled in the art, which can be estimated in the current best embodiment, but the patient may follow the implantation of the device 10 using the method disclosed herein, Experience fluid pressure drop in
[0030]
In performing a surgical procedure for insertion of the implant device 10, the surgeon will begin with a small conjunctival peritomy as shown by the conjunctival incision 32 of FIG. In the present best form of the method, multiple conjunctival incisions 32 are made, the current best number is four, and the four of the eyes 12 located between the muscles 48 connected to the exterior of the eye. There is one for each of the split circles. A conjunctival incision 32 exposes the sclera 16, and then within each conjunctival incision 32, a radial incision 34 exits radially or generally through the center of the iris 22 to the back of the eye. It is made along 12 axes 14. A radial incision 34 is best made later, 5 mm from the limbus, substantially 3 mm long and about 600 μm deep. However, it depends on the size of the implanted device 10 and the size of the radial incision can vary for different size devices 10. The orientation of the radial incision 34 substantially collinear with the radius of the circle forming the axis 14 or the iris 22 may produce the best results for both eye 12 eyesight adjustment and increased drainage of the eye 12. I found it.
[0031]
Once the radial incision 34 is complete, properly oriented in the axial direction and placed in the manner described above, the implant device 10 is placed in the space formed by the radial incision 34. At this point, the radial incision 34, such as a suture 44, pulls the scleral flap 21 on the implant device 10 when tension is generated in the sclera 16 when recombined and joins the structure of the sclera 16. It may be closed using a closing means. Those skilled in the art will recognize that other means of closing such incisions are available. In addition, new means are continuously discovered and their use is expected. When the scleral flap 21 recombines with the sclera surrounding the implant device 10 placed in a radial incision, a radial cavity 19 is formed. It is further anticipated that the implantation of the implant device 10 radially oriented away from the cornea 20 can be done in other ways, such as drilling or implantation, or in the future by laser or mechanized means. An important aspect of the device and method described herein is that the implant device 10 is radially oriented and surrounded by a sclera within the formed cavity, and the current best mode is the implant device 10. In accordance with the described surgical method of achieving a radial cavity 19 that retains a radial orientation of the implant device 10 radially with respect to the cornea 20.
[0032]
After closing the radial incision 34, the conjunctival incision 32 is closed using a cautery or other closing means. Implant device 10 is properly positioned to improve both patient vision and fluid drainage. The implant device 10 can be removed in the reverse order.
[0033]
In the present best form, the implant device 10 used in combination with a surgical method is made from a material that is inert when in contact with body tissue. The implant device 10 as shown occupies a radial cavity 19 formed when the radial incision 34 is closed in the manner described above. When the radial incision 34 is closed and the scleral flap 21 is sutured or reattached to the sclera 16, scleral 16 fastening or tensioning is provided on the implant device 10 during closure. Stretched. Preferred materials include one or a combination of materials selected from the group consisting of hydroxyapatite, silicone, polymethylmethacrylate, acrylic and tantalum. Those skilled in the art will recognize that other materials may be used. New materials are continuously being developed for implants and their use is anticipated.
[0034]
The implant device 10 has a body 46 and means for retaining the device in the radial cavity 19 and preventing it from substantially moving, which in the presently preferred form is provided by an anchor 48 protruding from the body 46. Is done. Other means of securing the device when placed in the radial cavity is achieved by a sawtooth surface 50, curved protrusion 52 or pawl 54 in the body 46 or the outer surface of the hole 56 communicating with the body 46. The Otherwise, one or a combination of such means that prevent the movement of the implant device 10 can be used together.
[0035]
If desired, if the delivery of the drug to the implantation point is desired, the device 10 is surrounded around the drug resident supply device, as many diseases desire such localized delivery. Means are provided for delivering the medicament to the ocular tissue. This drug delivery system maintains the supply of the drug selected on the exterior of the device by a combination of microencapsulated drug coating, or other polymer or extended soluble coating 58, or in solid or liquid form. And can be provided by a reservoir 60 in the body 46 that conveys the drug through the channel 62 to the surrounding tissue. Alternatively, the material from which the device 10 is made can be impregnated with a suitable medicament and secreted over time. When using the reservoir 60, the dosage and delivery time can be adjusted by adjusting the flow rate achieved by the flow path 62, or simply as a coating, adjusting the polymer or other substance in which the drug is dissolved. To provide dissolution that would dispense at the desired leaching time and dose. From the reservoir 60, the device releases the drug at a determined dose for a determined period of time, and then penetrates the sclera 16 and refills the reservoir 60 through one of the channels 62 to replace the hypodermic needle 27. Alternatively, it can be refilled from the flow path 62 by a similar passage designed for such refilling. Refilling can be accomplished without having to remove or obstruct the implant device 10 from safe containment within the radial cavity 19.
[0036]
FIG. 6 shows the device 10 with a round or barrel shaped body 46 rather than the cube or square of FIGS. The body 46 works well in any shape as long as the anchor means shown protrudes therefrom and clamps the device 10 in a radial hole. Although curved protrusions 52 are shown on all sides, in some cases it is beneficial to omit them from one side to allow a smooth transition of the scleral flap 21 on the implant device 10. It can be.
[0037]
Although all of the basic features and properties of the present invention have been described herein with reference to specific embodiments, the foregoing description contemplates variations, various modifications, and substitutional degrees of freedom. In some instances, features of the present invention may be used without a corresponding use of other features without departing from the scope of the present invention. Those skilled in the art may make such substitutions, improvements, and modifications without departing from the spirit and scope of the present invention. Accordingly, all such modifications and changes are included within the scope of the invention as defined in the following claims.
[Brief description of the drawings]
[0038]
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosed apparatus and, together with the detailed description, contribute to the description of the principles of the invention.
FIG. 1 shows a diagram of a plurality of implants arranged radially in the quadrant of an eye and the steps of a method for doing so.
FIG. 2 shows the implant and its placement in the scleral layer of the eye.
FIG. 3 shows a preferred embodiment of an implant showing anchors and optional coatings.
FIG. 4 shows another preferred embodiment of a device having an internal reservoir for holding a medicament to be sent to the outside.
FIG. 5 shows another preferred embodiment of the device showing the anchor on the outside.
FIG. 6 shows another preferred embodiment of a device showing a cylindrical body and an anchor extending from the surface.

Claims (26)

Strength to treat presbyopia by reducing intraocular pressure, including a long body section sized for implantation into a radially oriented long cavity formed in the scleral tissue of the eye Intramembrane implant. The strength of claim 1, further comprising means for securing the body portion within the elongated cavity, wherein the body portion substantially impedes movement of the elongated body portion within the elongated cavity. Intramembrane implant. The intrascleral implant of claim 2, wherein the means for securing the body portion within the elongated cavity includes at least one post extending from the body portion. The intrascleral implant of claim 2, wherein the means for securing the body portion within the elongate cavity includes at least one curved protrusion extending from the body portion. The intrascleral implant of claim 2, wherein the means for securing the body portion within the elongate cavity includes a saw tooth formed in an outer surface of the body portion. The intrascleral implant of claim 2, wherein the means for securing the body portion within the elongated cavity includes a plurality of columns extending from the body portion. The intrascleral implant of claim 2, wherein the means for securing the body portion within the elongated cavity includes at least one opening formed in a sidewall of the body portion. The means for securing the body portion within the elongated cavity includes at least one pillar extending from the body portion, at least one opening formed in a side wall of the body portion, and at least one extending from the body portion. 3. One or a combination thereof selected from the group of means for fastening the body portion within the elongated cavity comprising a curved protrusion and a sawtooth formed in an outer surface of the body portion. The intrascleral implant as described. The intrascleral implant of claim 1, further comprising means for delivering a dose of medication from the implant resident supply of medication to surrounding tissue. The intrascleral implant of claim 2, further comprising means for delivering a dose of medication from the implant resident supply of medication to surrounding tissue. 9. The intrascleral implant of claim 8 further comprising means for delivering a dose of medication from the implant resident supply of medication to surrounding tissue. 10. The intrascleral implant of claim 9, wherein the means for delivering a dose of medication from the pharmaceutical implant resident supply to surrounding tissue includes a dissolvable coating on the intrascleral implant. Means for delivering a dose of medication from the implant resident supply of medication to surrounding tissue;
A reservoir cavity in the body;
10. The intrascleral implant of claim 9, comprising: the reservoir for maintaining the supply of medication; and at least one flow path connecting the reservoir and tissue surrounding the intrascleral implant. 11. The intrascleral implant of claim 10, wherein the means for delivering a dose of medication from the pharmaceutical implant resident supply to surrounding tissue includes a dissolvable coating on the intrascleral implant. Means for delivering a dose of medication from the implant resident supply of medication to surrounding tissue;
A reservoir cavity in the body;
11. The intrascleral implant of claim 10, comprising: the reservoir holding the supply of medicine; and at least one flow path connecting the reservoir and tissue surrounding the intrascleral implant. 14. The intrascleral implant of claim 13, wherein the reservoir is refillable without removing the intrascleral implant from the elongated cavity. 16. The intrascleral implant of claim 15, wherein the reservoir is refillable without removing the intrascleral implant from the elongated cavity. A method for reducing intraocular pressure, comprising disposing at least one elongate implant in a radial orientation in a cavity in a scleral layer of an eye. A method of treating presbyopia comprising disposing at least one elongate implant in a radial orientation in a cavity in the sclera layer of the eye. A method of reducing intraocular pressure of an eye comprising disposing a plurality of elongated implants in a radial orientation within a cavity in the scleral layer of the eye. A method for treating presbyopia comprising placing a plurality of elongated implants in a radial orientation within a cavity in the sclera layer of the eye. The implant is
An elongated body; and means for securing the body portion within the elongated cavity, the means substantially preventing movement of the elongated body portion within the elongated cavity. 18. The method according to 18. The implant is
An elongated body; and means for securing the body portion within the elongated cavity, the means substantially preventing movement of the elongated body portion within the elongated cavity. 20. The method according to 20. 23. The method of claim 22, wherein the implant further comprises means for delivering a dose of medication from the implant resident supply of medication to surrounding tissue. 24. The method of claim 23, wherein the implant further comprises means for delivering a dose of medication from the implant resident supply of medication to surrounding tissue. The following steps:
Performing conjunctival peritomy with small restrictions;
Making a radially oriented incision through the sclera to form a scleral flap;
Placing a long implant device in a space formed by a radially oriented incision; and recombining a scleral flap covering the long implant device to the sclera, thereby allowing the long implant to A method for reducing intraocular pressure or treating presbyopia by surgically placing an implant comprising forming an enclosing cavity.