US20040073231A1 - Sutureless occular surgical methods and instruments for use in such methods - Google Patents
Sutureless occular surgical methods and instruments for use in such methods Download PDFInfo
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- US20040073231A1 US20040073231A1 US10/683,658 US68365803A US2004073231A1 US 20040073231 A1 US20040073231 A1 US 20040073231A1 US 68365803 A US68365803 A US 68365803A US 2004073231 A1 US2004073231 A1 US 2004073231A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/007—Methods or devices for eye surgery
- A61F9/00727—Apparatus for retinal reattachment
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/007—Methods or devices for eye surgery
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Abstract
Featured are new methods for performing intra-ocular surgery that allow surgical personnel to access the intra-ocular volume to perform a surgical procedure or technique but which does not require the use of sutures to seal the sclera and/or conjunctiva following the procedure. The methods of the present invention generally include providing an entry alignment device and inserting the entry alignment device into an eye through both the conjunctiva and sclera so as to form an entry aperture that extends between the exterior of the eye and the intra-ocular volume within the eye. The provided alignment device is configured so as to form or provide an aperture or opening in each of the conjunctiva and sclera of the eye and to maintain these apertures or openings in each of the conjunctiva and sclera aligned during the surgical procedure so these apertures or openings form the entry aperture. In more particular aspects, the provided entry alignment device is sized such that when the entry alignment device is removed from the eye following the completion of the surgical procedure, the aperture or opening formed in the sclera seals without the use of sutures. In a more specific aspect of the present invention, the provided entry alignment device is sized such that the apertures or openings and thus the entry aperture are self sealing. In other embodiments, a plurality of entry alignment devices are provided so a plurality of entry apertures can be formed in the eye. The invention also features a high speed vitreous cutting and aspirating device particularly configured for use in such methods and surgical procedures and techniques as well as the related entry alignment devices and other surgical instruments.
Description
- The present invention relates to methods for performing surgery and instruments used therewith, in particular sutureless surgical methods and techniques and the instrumentalities therefor which do not involve the use of sutures to seal the openings through which the instrumentalities are inserted, and more particularly, to surgical methods involving the eye (e.g., retinal tear or detachment surgery, macular hole surgery as well as the instruments or devices used during such surgical procedures, where the openings in the eye provided for the use of the instruments need not be sealed by suturing.
- Retinal tears can occur when the vitreous, a clear gel-like substance that fills the center of the eye, pulls away from the retina thereby leaving behind a tear or hole in the retina. Rhegmatogenous retinal detachments can result if the retinal breaks (i.e., tears or holes in the retina) are not treated. With retinal breaks, fluid from the vitreous apparently seeps through the retinal break and accumulates under the retina. The degree of detachment is measured by the volume of subretinal fluid present as well as the area of the retina involved. Some symptoms of retinal detachment include the presence of floaters, flashes, shadows or blind areas, decreased visual acuity and metamorphopsia.
- A number of techniques may be employed for treating retinal detachments, including using a scleral buckle, pneumatic retinopexy, cryopexy (i.e. freezing) and photocoagulation using a laser or xenon arc light source. These techniques may be used alone or in combination with each other to treat the retinal detachments. For example, a combination of a scleral buckle and photocoagulation may be used in some cases. Alternatively, retinal tears with little or no nearby detachment may be treated using photocoagulation or cryopexy.
- Current vitreoretinal techniques in which surgical instruments are inserted into the eye require the dissection of the
conjunctiva 4 and the creation of pars plana scleral incisions through thesclera 6. As more clearly illustrated in FIG. 1, the dissection of the conjunctiva typically involves pulling back theconjunctiva 4 about theeye 2 so as to expose large areas of thesclera 6 and the clipping or securing of the conjunctiva in that pulled back state (normal position of conjunctiva shown in phantom). In other words, thesclera 6 is not exposed only in the areas where the pars plana scleral incisions are to be made. As discussed below the area of thesclera 6 through which the infusion cannula would be inserted also would be exposed. - Following the creation of the incisions, surgical instruments are passed through these incisions and the inserted instruments are observed through the pupil using a microscope and corrective optics. These instruments are used to manipulate and/or dissect retinal tissues within the eye as well as to implement the specific retinal treatment technique (e.g., photocoagulation). The scleral incisions created for vitreoretinal surgery are made large enough to accommodate the required instruments, the inserted portions being typically 19 or 20 gauge (approximately 1 mm) in diameter.
- For example, using a laser in the photocoagulation technique, an instrument capable of transmitting bursts of laser light is inserted into the eye and the retinal break is surrounded with one or more rows of a plurality of laser burns or laser heat spots. These laser burns or heat spots produce scars which prevent fluid from passing through and collecting under the retina. In the photocoagulation procedure, a gas is exchanged with the vitreous fluid being aspirated from within the eye so that the gas is intraocular when performing photocoagulation.
- During vitreoretinal surgery, intraocular pressure is maintained by infusing a fluid, such as a buffered saline solution, from an elevated IV bottle into the eye through a cannula. Often the surgical procedures will call for air to be infused through the cannula while the fluid is being drained and/or aspirated through a second port or means. Such a cannula also is passed through an incision or is inserted through the
sclera 6 by a trocar. - After completing the specific treatment procedure, the inserted instruments are removed from the incisions in the sclera. Because the incisions through the sclera are large enough to pass19 or 20 gauge instruments, the incisions are typically too large to self-seal. Thus, the incisions must be sutured shut. Similarly, the infusion cannula is removed from the sclera and the opening or incision in the
sclera 6 for the cannula also is sutured shut. Following the suturing of the scleral incisions, the surgical personnel reposition the conjunctiva in its normal position and reattach the free end(s) of the conjunctiva to theeye 2 using sutures. - While such methods and techniques have proven to be effective in the treatment of vitreoretinal disease, there is a strong motivation to move away from procedures requiring sutures and instead look to greatly simplified sutureless procedures. Thus, it would be desirable to have improved and novel methods to perform such sutureless procedures that would be simpler as compared to prior art methods or techniques as well as to provide improved surgical instruments that are useable during such sutureless procedures and which preferably would be no more difficult to use than existing prior art devices. Such sutureless procedures would preferably be less costly and less intrusive as compared to prior art procedures.
- We have now produced new methods for performing intra-ocular surgery that allow surgical personnel to access the intra-ocular volume (i.e., the interior of the eye) to perform a surgical procedure or technique but which does not require the use of sutures to seal the sclera and/or conjunctiva following the procedure. In more particular aspects of the invention, these methods leave the sclera and/or conjunctiva in a condition following the surgical procedure such that the tissues thereof can seal openings made therein for purposes of performing the intra-ocular surgical procedure. More specifically featured are methods for treating a retinal tear or retinal detachment. The invention also provides the related entry alignment devices and surgical instruments for use in connection with such methods and surgical procedures or techniques.
- The methods of the present invention generally comprise providing an entry alignment device and inserting the entry alignment device into an eye through both the conjunctiva and sclera so as to form an entry aperture that extends between the exterior of the eye and the intra-ocular volume within the eye. The entry alignment device being provided is configured so as to form or provide an aperture or opening in each of the conjunctiva and sclera of the eye and to maintain these apertures or openings in each of the conjunctiva and sclera aligned during the surgical procedure so these apertures or openings form the entry aperture.
- In more particular aspects, the entry alignment device being provided is sized such that when the entry alignment device is removed from the eye following the completion of the surgical procedure, the apertures or openings formed in the conjunctiva and sclera, and thus the entry aperture, are sealed without the use of sutures. In a more specific aspect of the present invention, the entry alignment device being provided is sized such that when the entry alignment device is removed from the eye, the apertures or openings and thus the entry aperture are self sealing.
- According to additional aspects of the present invention, the methods further include providing a plurality of entry alignment devices and inserting each of the plurality of entry alignment devices through the conjunctiva and sclera so as to form a plurality of entry apertures. Additionally, such methods further include providing a surgical instrument having an operable end for insertion through the entry aperture, a portion of the operable end having a cross-sectional diameter not greater than 25 gauge; and inserting the surgical instrument through the entry apertures into the eye. Such surgical instruments include a high-speed vitreous cutter, forceps, scissors, pick, light source, laser light source, fragmentation device, aspirator and a diathermy device or other treatment device as is known in the art.
- Also, an infusion cannula can be provided that has an operable end for insertion into the eye namely through the conjunctiva and the sclera. The operable end preferably has a cross-sectional diameter of not more than 25 gauge and is interconnected to an infusion source. The operable end of such a cannula also is inserted through the conjunctiva and sclera so that fluids such as a gas, can be infused into the eye typically during an eye surgical procedure. Preferably the infusion cannula is a non-traumatic cannula, such as that described in U.S. Ser. No. 09/366,914 the teachings of which are incorporated herein by reference, that minimizes damage to the retina. Also an infusion source contemplated for use with the methods of the present invention includes an in-line humidifier, as described in U.S. Pat. No. 5,997,498 the teachings of which are incorporated herein by reference, so that the gas being infused is humidified.
- As indicated above, the entry alignment devices are generally configured so as to form or provide an aperture or opening in each of the conjunctiva and sclera of the eye and to maintain these apertures or openings aligned during the surgical procedure so these apertures or openings form an entry aperture extending between the exterior of the eye and the intra-ocular volume. The present invention features a number of such entry alignment devices including, but not limited to, a metal cannula, a polyimide cannula, a wire spreader and a shoe-horn style member that are more particularly described below. Some of these entry alignment devices, such as the cannula style of devices, are configured so as to include a lumen that extends between the exterior of the eye and the intra-ocular volume when the device is inserted into the eye. Thus, for this type of entry alignment device the lumen forms the entry aperture and the surgical instruments are inserted through the lumen. Other of the entry alignment devices, such as the wire spreader and the shoe-horn style member, are configured so as to spread apart at least some of the tissue of the conjunctiva and sclera about the entry aperture so as to form an opening in which the surgical instruments can be inserted, which opening would expand outwardly as the instrument is inserted therein.
- Also featured are alignment device insertion tools and a high speed vitreous cutting and aspiration device. The insertion tools are used in conjunction with the entry alignment device to form a trocar to facilitate insertion of the entry alignment device through the conjunctiva and the sclera and to facilitate the formation of an entry aperture. The high speed cutting and aspiration device is particularly configured so that it is capable of cutting and aspirating vitreous material from the intra-ocular volume when the operable end of this device is sized so as to have a cross-sectional diameter of 25 gauge or less. Additionally featured are other surgical instruments discussed below for use with such entry alignment devices.
- Other aspects and embodiments of the invention are discussed below.
- For a fuller understanding of the nature and desired objects of the present invention, reference is made to the following detailed description taken in conjunction with the accompanying drawing figures wherein like reference character denote corresponding parts throughout the several views and wherein:
- FIG. 1 is a cross-sectional schematic view of a non-diseased eye illustrating the prior art technique of pulling back of the conjunctiva;
- FIGS.2-5 are cross-sectional schematic views of an eye undergoing a transconjunctival sutureless vitreoretinal procedure embodying the methodology of the present invention;
- FIG. 6A is an expanded schematic view of a portion of FIG. 3;
- FIG. 6B is an expanded schematic view of a portion of an eye illustrating an alternative method for inserting an entry alignment device into an eye;
- FIGS. 7A,B are front and side views of an entry alignment device according to one embodiment of the present invention;
- FIG. 8 is a perspective view of an entry alignment device according to a second embodiment of the present invention;
- FIG. 9 is a perspective view of an entry alignment device according to a third embodiment of the present invention;
- FIG. 10A is a perspective view of an entry alignment device according to a fourth embodiment of the present invention when inserted into the eye;
- FIG. 10B is a perspective view of an alternative embodiment of the entry alignment device of FIG. 10A;
- FIG. 11 is a perspective view of an entry alignment device according to fifth embodiment of the present invention;
- FIG. 12 is a perspective view of an entry alignment device according to sixth embodiment of the present invention;
- FIGS.13-15 are various views of an exemplary insertion tool for inserting an entry alignment device according to the present invention into an eye;
- FIG. 16 is a perspective view of another exemplary insertion tool for inserting an entry alignment device according to the present invention;
- FIG. 17 is a perspective view of a high speed vitreous cutting device according to the present invention;
- FIG. 18 is an expanded view of the proximal end of the high speed vitreous cutting device illustrated in FIG. 17;
- FIG. 19 is a perspective view of a laser light transmitting source;
- FIG. 20A is a side view of one infusion cannula according to the present invention including a straight through geometry;
- FIG. 20B is a perspective view of another infusion cannula according to the present invention including an at-an-angle geometry;
- FIGS.21-23 are various views of a forceps according to the present invention;
- FIGS.24-25 are various views of a cutting instrument according to the present invention;
- FIG. 26 is a top view of an aspirator according to the present invention;
- FIG. 27A is a top view of a directional extendable pick according to the present invention, with the pick element in the withdrawn position;
- FIG. 271B is a perspective view of the directional extendable pick of FIG. 27A with the pick element in an extended position; and
- FIG. 28 is a perspective view of a plug for use with an entry alignment devices including a lumen therein.
- Referring now to the various figures of the drawing wherein like reference characters refer to like parts, there is shown in FIGS.2-5 cross-sectional schematic view of an eye undergoing a transconjunctival sutureless vitreoretinal surgical procedure that embodies the methodology of the present invention and expanded local views of the schematic views are provided in FIGS. 6A,B. Although the following describes the methodology of the present invention in terms of a vitreoretinal surgical procedure, it should be recognized that other surgical procedures can adapt the methodology of the present invention so as to yield other type of sutureless surgical procedures, such other surgical procedures includes, but is not limited to fluid gas exchange, vitreous hemorrhage, vitrectomy, macular hole and diabetic membrane peeling. Additionally, the surgical procedures includes procedures performed on adults as well as pediatric applications. Reference also should be made to the FIGS. 7-28 for any elements or features not otherwise shown in FIGS. 2-6.
- As preparation, the surgical personnel typically sterilize the eyeball as well as performing other actions that otherwise prepare a given
eye 2 for the surgical procedure to be performed. After preparing theeye 2 for the surgical procedure, the surgical personnel generally would grasp an entry alignment device according to the present invention with a pair of forceps ortweezers 20 or mount the entry alignment device upon an insertion tool such as those shown in FIGS. 13-16. After grasping the entry alignment device or mounting the entry alignment device upon an insertion tool, the surgeon would insert the entry alignment device into the eyeball. This insertion procedure is repeated as needed to insert the number of entry alignment devices required to meet the needs of a given surgical procedure. Typically, eye surgical procedures utilize two surgical instruments at a time, thus in an exemplary embodiment, the surgical personnel would typically insert two entry alignment devices into theeye 2. - In regards to the illustrated embodiment, and also with reference to FIGS. 7A,B, there is shown an
entry alignment device 100 a according to one embodiment of the present invention that includes ahandle portion 102, astop portion 104 and an insertedportion 106, that are interconnected to each other so as to form a shoe-horn type of member. It is within the scope of the present invention for any entry alignment device according to the teachings of the present invention, including those specifically described hereinafter, to be used in the sutureless methods according to the present invention. - As illustrated more clearly in FIG. 2, the surgical personnel grasp the
handle portion 102 of theentry alignment device 100 a with a pair oftweezers 20. The surgical personnel position theentry alignment device 100 a such that thepointed end 108 of the insertedportion 106 is at least pointed towards and preferably also is proximal theconjunctiva 4. A force is then applied to theentry alignment device 100 a so as to cause the inserted portion pointedend 108 to successively pierce and pass through both of theconjunctiva 4 and thesclera 6. Theentry alignment device 100 a also is preferably inserted until thestop portion 104 is proximal to the exterior surface of theeye 2. As indicated above, additionalentry alignment devices 100 a are inserted as required by the needs of the surgical procedure. In the illustrated embodiment, two suchentry alignment devices 100 a are inserted into the eye. - In an exemplary embodiment, and as more clearly shown in FIG. 2, the inserted portion pointed
end 108 is pointed towards the conjunctiva such that a along axis of the insertedportion 106 is orientated so as to be approximately or substantially perpendicular to the exterior surface of the eye at the point of insertion. In this way, the inserted portion pointedend 108 successively pierces and passes through both of theconjunctiva 4 and thesclera 6 generally or substantially perpendicular to each of the conjunctiva and sclera. This is not a limitation, however, as the inserted portion pointedend 108 can be orientated so the long axis is at any angle with respect to the exterior surface of the eye. - Alternatively and as shown in FIG. 6B, the inserted portion pointed
end 108 is orientated so that the long axis of the inserted portion is at an angle with respect to the exterior surface or a normal to the exterior surface. In this alternative arrangement, the angle is such that the inserted portion pointedend 108 successively pierces and passes through both of theconjunctiva 4 and thesclera 6 generally along a bias or diagonal with respect to each of the conjunctiva and sclera. With this alternative arrangement, the entrance for the opening formed in theconjunctiva 4 is spaced a distance along the circumference of the eye from the entrance of the opening formed in thesclera 6. Such a configuration allows theconjunctiva 4, which is readily accessible to the surgeon for sealing, to form another mechanism for sealing thesclera 6. - In conjunction with, prior to, or following the process of inserting the entry alignment devices, the surgical personnel insert an
infusion cannula 200 such as one of the infusion cannulas shown in FIGS. 20A,B, through both of theconjunctiva 4 andsclera 6. Thisinfusion cannula 200 as described below is typically used during the surgical procedure so that fluids can be infused into the intra-ocular volume. As described below in more detail eachentry alignment device 100 a and theinfusion cannula 200 are particularly configured and sized so that their subsequent removal from theconjunctiva 4 andsclera 6 do not involve the use of sutures to seal the openings or apertures that had been formed in the sclera. - After preparing the
eye 2 for the insertion of surgical instruments into the intra-ocular volume, the surgical personnel also typically mount a lens assembly (not shown) onto the cornea of the eye in accordance with known and accepted practices and techniques. This lens assembly is provided so that the surgeon can view the interior of the eye as well as any instruments inserted therein. - Referring now to FIG. 3, after the
eye 2 is so prepared to receive instruments, and in treating a retinal tear or detachment or otherwise treating the posterior segment of the eye, the surgical personnel insert a cutting/aspiratinginstrument 300, such as that shown in FIGS. 17-18, and alight transmitting instrument 400 through the entry apertures formed by theentry alignment devices 100 a and through each of theconjunctiva 4 and thesclera 6. As shown more clearly in FIG. 7B and in FIG. 6A, the insertedportion 106 of the entry alignment device is configured so as to include a dishedportion 107 that extends between thestop portion 104 and thepointed end 108. Thus, the curved exterior surfaces of the inserted or operable ends of theseinstruments portion 107 so as to guide each instrument through theconjunctiva 4 and thesclera 6 into the intra-ocular volume as the instrument is being inserted. - The light-transmitting
apparatus 400 is configured, as is known in the art, so as to be capable of providing a source of light in the intra-ocular volume. Reference shall be made to the discussion concerning the laserlight transmitting source 450 for the structural details of thelight transmitting apparatus 400. The cutting/aspiratinginstrument 300 of the present invention is described in more detail below. - In accordance with known and accepted surgical methods and techniques, the surgical personnel manipulate the
light transmitting instrument 400 so the light therefrom is projected within the intra-ocular volume to illuminate the desired area(s). The high speed cutting/aspiratinginstrument 300 also is disposed in the intra-ocular volume so anend 306 of the insertedmember 304, the portion of the instrument that is inserted into the eye, is proximate the retinal tear. - Initially, the vitreous gel, especially all strands causing traction on the retinal tear are removed or aspirated by means of the cutting/aspirating
instrument 300. As the vitreous gel is being aspirated, the intraocular volume is maintained by a continuous infusion of a fluid, such as a balanced salt solution (BSS), through theinfusion cannula 200. Any subretinal fluid is also aspirated through the retinal tear. As described hereinafter, the cutting/aspiratinginstrument 300 is preferably configured so as to allow the use of entry alignment devices that can be sized so sutures are not required to seal the opening through the sclera. - The vitreous fluid is thereafter aspirated and exchanged with a humidified gas such as air passing through the
infusion cannula 200. For example, the cutting/aspirating instrument is removed from the intra-ocular volume and an aspirator 800, such as that shown in FIG. 26, is inserted through theconjunctiva 4 and thesclera 6 by means of anentry alignment device 100 a as hereinabove described. In the method of the present invention, the gas or air being exchanged is preferably humidified by means of a in-line humidifier such as that described in U.S. Pat. No. 5,997,498, the teachings of which are incorporated herein by reference. - Thereafter, a laser light transmitting instrument450 (see also FIG. 19) is inserted through each of the
conjunctiva 4 andsclera 6 into the intra-ocular volume using anentry alignment device 100 a as described hereinabove (see FIG. 4). The retina surrounding the tear is then repeatedly exposed to the laser light from the laserlight transmitting instrument 450 so as to form a plurality of heat spots on the retina surrounding the retinal tear (see FIG. 5). In particular, the practitioner manipulates the laserlight transmitting instrument 450 so that a plurality of rows of a plurality of such heat spots surrounds the retinal tear. In this way, the retinal tear is photocoagulated with a laser to achieve a thermal adhesive injury. The heat spots also produce scars that prevent fluid from passing through and collecting under the retina. Although the laser photocoagulation technique is illustrated it is within the scope for other techniques known in the art for treating the retinal tear to be used in conjunction with the method of the present invention. - Thereafter, the intra-ocular gas or air, infused while exposing the retina surrounding the retinal tear to laser light, is exchanged for a longer-lasting gas, such as sulfur hexafluorine or perfluoro propane. This longer-lasting gas allows an adequate tamponade time for the therapeutic chorioretinal scar to develop. Preferably, the longer lasting gas being infused also is humidified using an in-line humidifier.
- Although the foregoing describes a procedure using the above-identified instruments, this shall not be construed as a limitation on the method of the present invention. It is within the scope of the present invention for other surgical instruments, including for example the below described
forceps 600,scissors 700, and directionalextendable pick 900, to used or adapted for use with the entry alignment devices and methodology of the present invention. - In the foregoing, a surgical instrument is disposed in an entry aperture thereby preventing or minimizing the potential for leakage of fluid from the intra-ocular volume during the surgical procedure. In the event that one or more instruments are removed from the entry aperture, then the surgical personnel can insert a
plug 160 such as that shown in FIG. 28 into the entry aperture to minimize the potential for leakage. This is a particular concern for entry alignment devices that are configured so as to include a lumen that comprises the entry aperture. - More specifically, the surgical personnel grasp the
handle portion 162 of theplug 160 with a pair oftweezers 20 for example, orient the plug so the pin orrod portion 164 thereof is pointing towards the entry aperture, and insert therod portion 164 into the entry aperture. The surgical personnel continue to insert theplug 160 into the entry aperture until the back surface of theflange portion 166 is proximal to the exterior surface of the eye. The reverse would be done to remove theplug 160 from the entry aperture. - After completing the “in eye” portion of the treatment procedure, the inserted instruments, the
infusion cannula 200 and each of theentry alignment devices 100 a are removed from the eye. As indicated above, theinfusion cannula 200 and theentry alignment devices 100 a are preferably configured so that the opening in each of theconjunctiva 4 andsclera 6 formed by the infusion cannula or the entry alignment device is self-sealing, that is the openings or holes formed therein do not leak when the infusion cannula or entry alignment device are removed. It is within the scope of the present invention, however, to employ non-suture methods such as hydrogel adhesives, clips and conjunctival sealing to help the entry site of thesclera 6 to seal. - The above-described transconjunctival sutureless viroretinal surgcal procedure, is simpler, safer and faster as compared to prior art surgical methods or procedures. The above-described procedure avoids the dissection of the conjunctiva and its subsequent reattachment to the eye, a requirement of existing prior art surgical methods and techniques. The foregoing procedure, in conjunction with the instruments and devices used in conjunction with this procedure, reduce the size or make smaller the incisions that are made through the sclera for the passage of instruments and infusion cannula, and thus reduce trauma to the eye. Further because there is no need to dissect and reattach the conjunctiva, the time required for the surgical procedure to be performed is reduced, thus also reducing the time the patient is on the operating table and the overall cost of the procedure.
- As indicated above, in the methods according to the present invention there is provided one or more entry alignment device. Each of these entry alignment devices is configured and arranged so it successively pierces and passes through the
conjunctiva 4 and thesclera 6 and so it maintains the alignment of the openings or apertures made in each of the conjunctiva and sclera, thereby forming an entry aperture in the eye that extends between the exterior surface of the eye and the intra-ocular volume. As also indicated above, such entry alignment devices are preferably configured and sized so the opening or aperture in thesclera 6 made by the device is sealable without the use of sutures. There is shown in FIGS. 7-12 various embodiments of entry alignment devices according to the present invention. It should be recognized from the outset that the devices shown in each of FIGS. 7-12 are exemplary and not exhaustive of all possible entry alignment device configurations or designs that can be used in the methods according to the present invention. Reference also should be made to FIGS. 1-6 for any elements of features not specifically shown or specifically described hereinafter in any of FIGS. 7-12. - Referring now to FIGS. 7A,B, there is shown one embodiment of an
entry alignment device 100 a according to the present invention. As described above, such anentry alignment device 100 a includes ahandle portion 102, astop portion 104, and an insertedportion 106 having apointed end 108 and a dishedportion 107. In addition to that described above, the insertedportion 106 is sized so as to have a width that is sufficiently small such that the removal of the inserted portion from thesclera 6 leaves an incision or opening that does not require sutures to seal the opening or incision. In an exemplary embodiment, the width of the inserted portion is about 0.020 inches. Thestop portion 104 has a width and length sufficient to prevent theentry alignment member 100 a from being drawn into the intra-ocular volume during the surgical procedure. - The dished
portion 107 is configured geometrically to complement the geometric shape of the surgical instruments that can be inserted into theeye 2. In the exemplary illustrated embodiments for the surgical instruments herein described, the inserted portion thereof is generally of a cylindrical shape and thus the dishedportion 107 is generally configured so as to be generally arcuate. - The pointed
tip 108 of the inserted portion is generally configured so as to form a non-traumatic tip that minimizes damage to the tissue comprising theconjunctiva 4 and thesclera 6 as well as structures within theeye 2. In an exemplary embodiment, thepointed tip 108 is tri-beveled and sharpened like a needle to facilitate insertion. - The shoe-horn embodiment of the
entry alignment device 100 a is made from any material known in the art which has sufficient rigidity and strength to be inserted into and removed from theconjunctiva 4 andsclera 6 as described above and to withstand in use stresses arising for example from the insertion and/or manipulation of surgical instruments as well motion of the eye or elements thereof. Also, the material shall be inclusive of materials capable of being used with the desired sterility required for the surgical procedure. In exemplary embodiments, this entry alignment device is made from metals such as stainless steel and plastics such as polyimide. - Now referring to FIG. 8 there is shown a second embodiment of an
entry alignment device 100 b according to the present invention that includes aninsertion member 110 and astop member 112 that is affixed about the exterior of theinsertion member 110. Theentry alignment device 100 b of this embodiment is configured and arranged so that in use, the portion of theinsertion member 110 that is below thestop member 112 is passed through each of theconjunctiva 4 and thesclera 6. Additionally, in use theentry alignment member 100 b is inserted until thestop member 112 is proximal the exterior surface of theeye 2 similar to that shown for thestop portion 104 in FIG. 6A. - In the illustrated embodiment, an end of the
insertion member 110 is securably received in thestop member 112. Alternatively, the entry alignment device is constructed such that the insertion and stopmembers insertion member 110 and stopmember 112 are configured and arranged so the insertion member extends through an aperture in the stop member. In this case an end of the insertion member is disposed proximal anend surface 118 of the stop member or the insertion member extends outwardly from the stop portion end surface. Theinsertion member 110 also is a tubular member having alumen 114 extending between the ends of the insertion member and the stop portion includes therein a throughaperture 116 that communicates with the insertion member lumen. In use, thelumen 114 and the throughaperture 116 comprises the entry aperture formed in theeye 2 through which the surgical instruments are inserted. - The
insertion member lumen 114 and stop portion throughaperture 116 are sized and arranged so as to be capable of slidably receiving therein the insertable portions of the surgical instruments. In particular, they are configured so as to complement the geometric arrangement of these insertable portions. In an exemplary embodiment, the diameter of thelumen 114 and the throughaperture 116 are established so as to be capable of receiving therein surgical instruments insertable portions having a cross-sectional diameter of about 25 gauge. Theinsertion member 110 also is configured and sized so that the outer diameter or cross-section thereof is sufficiently small such that the removal of the inserted member from thesclera 6 leaves an incision or opening therein that does not require sutures to seal the opening or incision. It is within the scope of the present invention for theinsertion member 110 to have any outside geometric configuration, including oval and hexagonal, that is otherwise consistent with the teachings of the present invention, specifically thatentry alignment device 100 b removal leaves an opening in the sclera that need not be closed by sutures, more preferably an opening that is self-sealing. - The inserted
end 119 of theinsertion member 110 is illustrated as being substantially flat. It is within the scope of the present invention, however, for the insertedend 119 to be pointed, cut on a bias or other wise configured so as to form a tissue piercing type of end. - The
stop member 112 is configured and arranged so as to provide a sufficient surface area and thickness to prevent theentry alignment member 100 b from being drawn into the intra-ocular volume. Thestop member 112 also is sized so as to provide a sufficiently large surface area for the surgical personnel to be able to identify and locate theentry alignment device 100 b on the exterior surface of the eye. Thestop member 112 also is configured so as to provide a mechanism by which the surgical personnel can grasp theentry alignment device 100 b when it is to be removed from and/or inserted into the eye. In an exemplary embodiment, this grasping mechanism comprises a groove in the vertical surfaces of thestop member 112 or a surface artifact or protrusion on the stop member. - The
insertion member 110 and stopmember 112 are made from any material known in the art that has sufficient rigidity and strength to be inserted into and removed from theconjunctiva 4 andsclera 6 as described above and to withstand in use stresses arising for example from the insertion and/or manipulation of surgical instruments as well motion of the eye or elements thereof. Also, the material shall be inclusive of those materials that are capable of being used with the desired sterility required for the surgical procedure. The materials also should be such that thestop member 112 can be secured or affixed to theinsertion member 110. More particularly, theinsertion member 110 and stopmember 112 are made from metals such as stainless steel and plastics such as polyimide or combinations thereof. - In an exemplary preferred embodiment, the insertion member is made from polyimide and has an outer diameter of about 23-24 gauge (about 0.025-0.022 inches). Such an outer diameter is particularly advantageous because the incision or opening in the sclera is generally self-sealing.
- Now referring to FIG. 9 there is shown an
entry alignment device 100 c according to a third embodiment, in the shape of a conventional cannula, that includes aninsertion member 120 and astop member 122 that is affixed to the insertion member. In a particular embodiment, the insertion member and the stop member form an integral, one-piece structure. Theentry alignment device 100 c of this embodiment is configured and arranged so that in use the portion of theinsertion member 120 that is below thestop member 122 is passed through each of theconjunctiva 4 and thesclera 6. Additionally, in use theentry alignment member 100 b is inserted until thestop member 122 is proximal the exterior surface of theeye 2 similar to that shown for thestop portion 104 in FIG. 6A. - In the illustrated embodiment, the
insertion member 120 is a tubular member having alumen 124 extending between the ends of the insertion member and thestop member 122 includes therein a throughaperture 126 that communicates with the insertion member lumen. In use, thelumen 114 and the throughaperture 116 comprise the entry aperture formed in theeye 2 through which the surgical instruments are inserted. - The
insertion member lumen 124 and stop member throughaperture 126 are sized and arranged so as to be capable of slidably receiving therein the insertable portions of the surgical instruments. In particular, they are configured so as to complement the geometric arrangement of these insertable portions. In an exemplary embodiment, the diameter of thelumen 124 and the throughaperture 126 are established so as to be capable of receiving therein surgical instruments insertable portions having a cross-sectional diameter of about 25 gauge. Theinsertion member 120 also is configured and sized so that the outer diameter or cross-section thereof is sufficiently small such that the removal of the inserted member from thesclera 6 leaves an incision or opening therein that does not require sutures to seal the opening or incision. It is within the scope of the present invention for theinsertion member 120 to have any outside geometric configuration, including oval and hexagonal, that is otherwise consistent with the teachings of the present invention, specifically thatentry alignment device 100 c removal leaves an opening in the sclera that need not be closed by sutures, more preferably an opening that is self-sealing. - The inserted
end 129 of theinsertion member 120 is illustrated as being substantially flat. It is within the scope of the present invention, however, for the insertedend 129 to be pointed and cut on a bias or other wise configured so as to form a tissue piercing type of end. - The
stop member 122 is configured and arranged so as to provide a sufficient surface area and thickness to prevent theentry alignment member 100 c from being drawn into the intra-ocular volume. Thestop member 122 also is sized so as to provide a sufficiently large surface area for the surgical personnel to be able to identify and locate theentry alignment device 100 c on the exterior surface of the eye. Thestop member 122 also includes asurface artifact 123 that is configured so as to provide a mechanism by which the surgical personnel can grasp theentry alignment device 100 c for insertion into and removal from the eye. In an exemplary embodiment, this grasping mechanism is used in conjunction with an insertion tool, such as that shown in FIGS. 13-15 for insertion and/or removal of the device. - The
insertion member 120 and stopmember 122 are made from any material known in the art that has sufficient rigidity and strength to be inserted into and removed from theconjunctiva 4 andsclera 6 as described above and to withstand in use stresses arising for example from the insertion and/or manipulation of surgical instruments as well motion of the eye or elements thereof. Also, the material shall be inclusive of those materials that are capable of being used with the desired sterility required for the surgical procedure. More particularly, theinsertion member 110 and stopmember 112 are made from metals such as stainless steel and plastics such as polyimide or combinations thereof. - In an exemplary embodiment, the insertion member is made from stainless steel has an outer diameter of about 22-23 gauge (about 0.028-0.025 inches).
- Now referring to FIGS. 10A,B there is shown
entry alignment devices 100 d,e according to a fourth embodiment of the present invention that are formed by shaping a solid or hollow cylindrical member, for example a metal wire, into a predetermined shape or configuration. In FIG. 10A there is shown anentry alignment device 100 d including anarcuate portion 130 from which extends twoleg portions 132 that are spaced from each other and generally parallel to each other. Each leg portion includes anupper segment 134 and alower segment 136, where the lower segment is at an angle with respect to the upper segment so that the upper segment. - The
lower segments 136 are sized so that each extends through theconjunctiva 4 andsclera 6 when disposed in the entry aperture. The angle between theupper segments 134 and thelower segments 136 is established and the upper segments are sized so that the upper segments act as a stop, to limit the amount of insertion as well as to restrain theentry alignment device 100 d from drifting into the intra-ocular volume during the surgical procedure. - In one specific embodiment, the surgical personnel form an entry aperture having the desired size in the
conjunctiva 4 and the sclera using for example by means of a stylet. Thereafter, the surgical personnel insert the leg portionlower segments 136 into the entry aperture about the stylet and following insertion of thelower segments 136 the stylet is removed from the eye. In another specific embodiment, the leg portionlower segments 136 are secured to an insertion device and the portion of the insertion device containing thelower segments 136 is inserted into the eye so as to form the entry aperture in theconjunctiva 4 and thesclera 6. Thereafter, the insertion tool is removed leaving thelower segments 136 in the entry aperture. - The spring resiliency of the
leg portions 132 and thearcuate portion 130 act so as to keep thelower segments 136 spaced from each other when they are disposed in the entry aperture. Consequently, this spring resiliency and thelower segments 136 maintain the entry aperture in the eye and thus also maintains the alignment of the portions of the entry aperture in theconjunctiva 4 and thesclera 6. The leg portionupper segments 134 also comprise a mechanism for limiting the motion of theentry alignment device 100 d into the eye (e.g., act as a stop). - There is shown in FIG. 10B an alternative
entry alignment device 100 e that is similar in most respects to the entry alignment device of FIG. 10A except that in the alternative embodiment, thearcuate portion 130 a is arranged so as to be at an angle with respect to theleg portions 132 to facilitate the removal of theentry alignment device 100 e from the eye upon completion of the surgical procedure. Accordingly, reference shall be made to the foregoing discussion for FIG. 10A for other details of the alternativeentry alignment device 100 e. - In an exemplary preferred embodiment, the entry aperture being formed is sized so as to be capable of receiving therein surgical instruments insertable portions having a cross-sectional diameter of about 25 gauge. The leg portion
lower segments 136 also are preferably spaced from each other so as to maintain two opposing interior surfaces of the entry aperture spaced from each other so as to meet this capability. - The
entry alignment devices 100 d,e are made from any of a number of materials known in the art which have sufficient strength and the desired spring characteristics when in the illustrated shapes to function in the manner described above. Such materials includes metals such as stainless steel and plastics. - There is shown In FIG. 11 an
entry alignment device 100 f according to a fifth embodiment of the present invention that includes astop member 140 and two ormore displacing members 142 that are secured to the stop member. The displacingmembers 142 also extend outwardly, downwardly in the illustrated embodiment, from aback surface 144 of thestop member 140. - The displacing
members 142 are sized so that each extends through theconjunctiva 4 andsclera 6 when disposed in an entry aperture. As with the other above-described entry alignment devices 100 a-e, thestop member 140 is configured and sized so as to limit the amount of insertion, and to restrain theentry alignment device 100 f from drifting into the intra-ocular volume during the surgical procedure as well as to provide a target for the surgical personnel during the procedure. The two or more displacing members are displaced from each other such that when the displacing members are inserted into the entry aperture at least two opposing interior surfaces of the entry aperture are maintained spaced from each other so that surgical instruments can be inserted into the entry aperture. Thestop member 140 also is configured with anaperture 146 that is sized so the surgical instruments can be passed there through. - In use, the surgical personnel mount the entry alignment device on an insertion tool, for example, the insertion tool shown in FIG. 16 so that the displacing members are disposed on either side of the stylet having the generally desired size for an entry aperture. The stylet is inserted into the eye until the stop member back
surface 144 is proximal the exterior surface of the eye, thereby forming the entry aperture in theconjunctiva 4 and thesclera 6. At the same time, the displacingmembers 142 are inserted into the so formed entry aperture so that each extends through each of theconjunctiva 4 and thesclera 6. The stylet is then removed leaving the displacingmembers 142 in the entry aperture - In an exemplary preferred embodiment, the entry aperture being formed is sized so as to be capable of receiving therein surgical instruments insertable portions having a cross-sectional diameter of about 25 gauge. The displacing members also are preferably spaced from each other so as to maintain at least two opposing interior surfaces of the entry aperture spaced from each other so as to meet this capability. The stop member through
aperture 146 also is sized so as to be capable of receiving therein surgical instruments insertable portions having a cross-sectional diameter of about 25 gauge. - The
entry alignment devices 100 f, including thestop member 140 and the displacingmembers 142, are made from any of a number of materials known in the art which have sufficient rigidity and strength to be inserted into and removed from theconjunctiva 4 andsclera 6 as described above and to withstand in use stresses arising for example from the insertion and/or manipulation of surgical instruments as well motion of the eye or elements thereof. Also, the material shall be inclusive of those materials that are capable of being used with the desired sterility required for the surgical procedure. Such materials includes metals such as stainless steel and plastics, such as polyimide. - There is shown in FIG. 12 an
entry alignment device 100 g according to a sixth embodiment of the present invention that includes astop member 150 and ahelical member 152 that is secured to the stop member. Thehelical member 152 also extends outwardly from aback surface 154 of thestop member 150. - The
helical member 152 is sized so that it has an axial length sufficient to extend through theconjunctiva 4 andsclera 6 and into the intra-ocular volume when disposed in an entry aperture. Thehelical member 152 also is sized such that the inner diameter of the helix is large enough for the insertable portions of the surgical instruments to pass there through. As with the other above-described entry alignment devices 100 a-f, thestop member 150 is configured and sized so as to limit the amount of insertion and to restrain theentry alignment device 100 g from drifting into the intra-ocular volume during the surgical procedure as well as to provide a target for the surgical personnel during the procedure. The stop member also is configured with an aperture 156 that is sized so the insertable portions of the surgical instruments can be passed there through. - In use, the surgical personnel insert the
helical member 152 into the eye and twist theentry alignment device 100 g in the appropriate direction so as to in effect screw the entry alignment member into the eye. The surgical personnel continue to twist theentry alignment member 100 g until theback surface 154 thereof is proximal the exterior surface. In this condition, thehelical member 152 extends through each of theconjunctiva 4 and thesclera 6 into the intra-ocular volume. To remove theentry alignment device 100 g the surgical personnel twist the device in an opposite direction, thereby unscrewing the device from the eye. - In an exemplary preferred embodiment, the entry aperture being formed is sized so as to be capable of receiving therein surgical instruments insertable portions having a cross-sectional diameter of about 25 gauge. The inner diameter of the helix as well as the stop member through aperture156 also are sized so as to be capable of receiving therein surgical instruments insertable portions having a cross-sectional diameter of about 25 gauge.
- The
entry alignment devices 100 g, including thestop member 150 and thehelical member 152, is made from any of a number of materials known in the art which have sufficient rigidity and strength to be inserted into and removed from theconjunctiva 4 andsclera 6 as described above and to withstand in use stresses arising for example from the insertion and/or manipulation of surgical instruments as well motion of the eye or elements thereof. Also, the material shall be inclusive of those materials that are capable of being used with the desired sterility required for the surgical procedure. Such materials includes metals such as stainless steel and plastics, such as polyimide. - Referring now to FIGS.13-15, there are shown various views of one exemplary entry alignment
device insertion tool 500 according to the present invention. Such aninsertion tool 500 includes ahandle member 502, amoveable member 504 being moveably disposed with the handle member and a fixedstylet 508 projecting outwardly from oneend 510 of the handle member. Thehandle member 502 is generally configured so as to provide a shape that is readily grasped by the surgical personnel. - The
moveable member 504 includes adevice grasping portion 506 and is pivotably disposed within thehandle member 502 so that thedevice grasping portion 506 can be selectively moved between a grasping position and a mounting position. In the mounting position, as more clearly shown in FIG. 14, themoveable member 504 is depressed into thehandle member 504 so as to cause the device grasping portion 505 to move away from thestylet 508 thus preparing theinsertion tool 500 so an entry alignment device can be mounted thereon. Thereafter themovable member 504 is released thereby preferably causing the device grasping portion to move towards the stylet 505 thereby grasping the device and removably securing the entry alignment device to theinsertion tool 500 as more clearly shown in FIG. 15. - For example, and also with reference to FIG. 9, the
stylet 508 is slid into thelumen 124 of theentry alignment device 100 c until theenlarged portion 512 of the stylet rests against the top surface of thestop member 122. Additionally, the entry alignment device is arranged so the stopmember surface artifact 123 is proximal the side of the stylet enlargedportion 512 where thedevice grasping portion 506 is positioned. When theentry alignment device 100 c is thus disposed on thestylet 508, themoveable member 504 is released so thedevice grasping portion 506 is moved into the grasping position. In the grasping position, and as shown more clearly in FIG. 15, the grasping portion envelops a part of thesurface artifact 123 so as to secure theentry alignment device 100 c to theinsertion tool 500. - In use, the surgical personnel position the pointed end of the
stylet 508 at the desired location for an entry aperture or access port and insert the stylet pointed end into the eye so as to successively pierce and pass through theconjunctiva 4 and thesclera 6 and so as to simultaneously insert the device insertedmember 120 therein. The pointed end of thestylet 508 is preferably beveled and sharpened like a needle to facilitate insertion of the stylet into and through theconjunctiva 4 and thesclera 6. Insertion is stopped when the back surface of thestop member 122 is resting upon the exterior surface of the eye. Themovable member 504 is again depressed so thedevice grasping portion 506 moves away from theentry alignment device 100 c thereby freeing the device. The surgical personnel, while maintaining the movable member depressed withdraw thestylet 508 from thedevice lumen 124, thus leaving theentry alignment device 100 c disposed in the eye. - Referring now to FIG. 16, there is shown another exemplary entry alignment
device insertion tool 550 according to the present invention. Such aninsertion tool 500 includes ahandle member 552 and astylet 554 affixed to and extending outwardly from an end of the handle member. Thehandle member 552 is generally configured so as to provide a shape that is readily grasped by the surgical personnel. - The
stylet 554 is a generally cylindrical member being sized so as to be capable of being received in the lumen of an entry alignment device. The stylet includes astop 556 that is generally in the form of an enlarged region of the cylindrical member area to restrain motion of the entry alignment device along the length of the stylet. Theend 558 of thestylet 554 opposite thehandle member 552 is preferably beveled (e.g. tri-leveled) and sharpened like a needle to facilitate insertion of the stylet into and through theconjunctiva 4 and thesclera 6. - For example, and with reference to FIG. 8, the surgical personnel slid the
stylet 554 through thelumen 114 of theentry alignment device 100 b until the top surface of thestop member 112 rests against thestylet stop 556. In use, the surgical personnel position the stylet pointedend 558 at the desired location for an entry aperture or access port and insert the pointed end into the eye so as to successively pierce and pass through theconjunctiva 4 and thesclera 6 and so as to simultaneously insert thedevice insertion member 110 therein. Insertion is stopped when the back surface of thestop member 112 is resting upon the exterior surface of the eye. The surgical personnel, then withdraw thestylet 554 from thedevice lumen 114, thus leaving theentry alignment device 100 b disposed in the eye. - Referring now to FIGS.17-18 there is shown a high-speed vitreous cutting and aspirating
device 300 according to the present invention that includes aninterface member 302, an insertedmember 304 having alumen 314 and aside aperture 308 proximal to an end thereof. The cutting and aspiratingdevice 300 further includes amoveable member 310, having aguillotine end 312 for cutting, that is disposed within thelumen 314 and operably and mechanically connect to theinterface member 302. - An end of the
interface member 302 is secured to acutter head 330 such as the Lightning Cutter manufactured by Bausch and Lomb, which cutter head is operably and mechanically connected to themoveable member 310 via theinterface member 302 so that the moveable member moves cyclically back and forth within thelumen 314 responsive to the cutter head. More specifically, the moveablemember guillotine end 312 is moved back and forth across theside aperture 308 proximal theend 306 of the insertedmember 304, whereby material disposed in the side aperture is successively cut by theguillotine end 312. Theinterface member 302 includes asuction port 320 that is connected to a suction source (not shown) by asuction line 322. Thesuction port 320 is in fluid communication with thelumen 314 so that fluid and cut material is drawn up through the lumen about themovable member 310 and out the suction port. - The inserted
member 304 is configured and sized so as to be useable with an entry alignment device of the present invention. More particularly, the insertedmember 304 also is configured and sized so the outer diameter or cross-section thereof is sufficiently small such that the removal of the inserted member from thesclera 6 leaves an incision or opening therein that does not require sutures to seal the opening or incision. In an exemplary embodiment, the outer diameter or cross-section of the insertedmember 304 is about 25 gauge. - The
moveable member 310 is moved cyclically by thecutter head 330 so that the cut vitreous material can be continuously aspirated from thelumen 314 without clogging thereof. In preferred embodiments, themoveable member 310 is operated such that theguillotine end 312 makes about 1000 cuts per minute (cpm), more preferably at least 1000 cpm and in a more specific embodiment is operated in the range of from about 1000 to 1500 cpm. Such cut rates have been found to be particularly advantageous because vitreous material being cut by theguillotine end 312 is successfully and continuously aspirated out of thesuction port 320 without clogging of thelumen 314 of an insertedmember 304 having an outer diameter of 25 gauge. Tests also have shown that there is clogging of the lumen for a cutting and aspirating device having an inserted member outer diameter of about 25 gauge when using prior art pneumatic cutter heads to drive the moveable member. - Additionally, the suction pressure developed at the suction source or
suction port 320 is sufficient to readily draw the cut material and any fluid up through the lumen and out of the suction port. In an exemplary embodiment, the suction pressure is about 400 mmHg and more particularly the suction pressure is 400 mmHG or greater. - Referring now to FIG. 19, there is shown a perspective view of a laser
light transmitting source 450 according to the present invention that includes ahandle portion 452, ainsertable member 454 and anoptical cable 456. Thehandle member 452 is generally configured so as to provide a shape that is readily grasped by the surgical personnel. - The
optical cable 456 is any of a number of optical cables known in the art that can communicate light between the ends of the cable. Theoptical cable 456 also includes the optical couplers that optically couple the cable to another component such as a light source. One end of theoptical cable 456 is optically coupled to a light source (not shown) and the other end of the optical cable is optically coupled to theinsertable member 454. Theinsertable member 454 is configured so as to include a lumen that forms a passage for the light coming from theoptical cable 456. In this way, the light being generated by the light source is projected from theopen end 458 of theinsertable member 454 onto the desired area of the eye as hereinabove described. - The
insertable member 454 is configured and sized so as to be useable with an entry alignment device of the present invention. More particularly, theinsertable member 454 also is configured and sized so the outer diameter or cross-section thereof is sufficiently small such that the removal of the insertable member from thesclera 6 leaves an incision or opening therein that does not require sutures to seal the opening or incision. In an exemplary embodiment, the outer diameter or cross-section of theinsertable member 454 is about 25 gauge. - Now referring to FIGS. 20A,B there is shown two
exemplary infusion cannulas 200 a,b according to the present invention. Referring to FIG. 20A, theinfusion cannula 200 a includes a nozzle portion 202 a, astop portion 204 and a insertedportion 206. The nozzle portion 202 a is a generally cylindrical hollow member that extends outwardly from thestop portion 204. The nozzle portion 202 a is configured so as to receive thereabout aninlet line 220 that is interconnected to an infusion source, for example an elevated bottle of balanced saline solution or a source of pressurized gas such as air. - The
stop portion 204 is configured and arranged so as to provide a sufficient surface area and thickness to prevent theinfusion cannula 200 a from being drawn or drifting into the intra-ocular volume of the eye. Thestop portion 204 and the insertedportion 206 are configured so as to include in each a lumen that communicates with each other and the lumen in thenozzle portion 202. In this way, the fluid from the infusion source flows through the successive lumens and into the intra-ocular volume of the eye. - The
insertable portion 206 is configured and sized so the outer diameter or cross-section thereof is sufficiently small such that the removal of the insertable portion from thesclera 6 leaves an incision or opening therein that does not require sutures to seal the opening or incision. In an exemplary embodiment, the outer diameter or cross-section of theinsertable portion 206 is about 25 gauge. In more particular embodiments, the insertedend 208 of theinsertable portion 206 is beveled, preferably tri-beveled, and sharpened like a needle so as to minimize trauma and damage to the tissues of eye, as the inserted end pierces and passes through theconjunctiva 4 and thesclera 6 into the intra-ocular volume. Theinsertable portion 206 is configured with a retainingball 207 or other surface artifact that helps to constrain thecannula 200 a within thesclera 6. - There is shown in FIG. 20B another
infusion cannula 200 b according to the present invention that includes anozzle portion 202 b, astop portion 204 and aninsertable portion 206. Thenozzle portion 200 b of this embodiment differs from that described for the other infusion cannula embodiment illustrated in FIG. 20A in that a portion of thenozzle portion 204 is arcuate so the inlet line connection of the nozzle portion is at an angle with respect to the lumen of the insertable portion. In the illustrated embodiment, the inlet line connection is at 90 degrees angle, however other angles are contemplated for use in the present invention. Reference shall be made to the foregoing discussion for the other infusion cannula embodiment illustrated in FIG. 20A for other details or features. - Now referring to FIGS.21-23 there are shown various views of a
forceps 600 according to the present invention, that includes ahandle member 610 and ahead 630, a portion of which is configurable for insertion into the intra-ocular volume. Thehandle member 610 is generally configured so as to provide a shape that is readily grasped by the surgical personnel and so as to include one ormore actuation members 612. Thehandle member 610 is further configured such when theactuation members 612 are moved in one direction an axial movement or force is generated by the handle member in one direction and when the actuation members are moved in another direction an axial movement or force is generated by the handle member in opposite direction. In an exemplary embodiment, the product sold under than name of ErgoTec by Bausch and Lomb comprises thehandle member 610 according to the present invention. - The
head 630 includes amechanical interconnecting portion 632, aninsertable portion 634 having alumen 636 and asloped end 638, and amoveable member 640 having asloped end 642 that is disposed in the lumen. As shown in phantom in FIG. 23, thesloped end 638 preferably is formed by machining away all but a small segment of the insertable portion and bending this small segment upwardly to form the sloped end. - The
mechanical interconnecting portion 632 is affixed to thehandle member 610 so thehead 630 extends from an end thereof. Themechanical interconnecting portion 632 also is mechanically interconnected to thehandle member 610 and themoveable member 640 such that the moveable member moves back and forth axially in thelumen 636 responsive to the axial movement or force generated by theactuation members 612 of thehandle member 610. In this way, when theactuation members 612 are in a rest position, the movable member slopedend 642 is remote from the insertable portion slopedend 638, leaving a space therebetween. Correspondingly, when theactuation members 612 are actuated, the moveable member slopedend 642 is moved towards the insertable portion slopedend 638 thereby reducing the space therebetween or putting the sloped ends into contact with each other. Preferably, the sloped ends 638, 642 of each of theinsertable portion 634 and themoveable member 640 are configured so the sloped end surfaces are essentially parallel to each other. In other words, the opposing surfaces of the sloped ends 638,642 provide a mechanism by which material can be grasped by the surgical personnel responsive to the movement of theactuation members 612. - In use, the surgical personnel insert the
insertable portion 634 into the entry aperture so thesloped end 638 thereof is dispose in the intra-ocular volume of the eye. Thereafter, the surgical personnel manipulate the forceps so some loose material such as free strand of vitreous gel is disposed in thesloped end 638. The surgical personnel then actuate theactuation members 612 causing themoveable member 640 to moved axially within the lumen towards the insertable portion slopedend 638, to trap the loose material between the opposing faces of the insertable portion sloped end and the moveable member slopedend 642. - The
insertable portion 634 is configured and sized so as to be useable with an entry alignment device of the present invention. More particularly, theinsertable portion 634 also is configured and sized so the outer diameter or cross-section thereof is sufficiently small such that the removal of the insertable portion from thesclera 6 leaves an incision or opening therein that does not require sutures to seal the opening or incision. In an exemplary embodiment, the outer diameter or cross-section of theinsertable portion 634 is about 25 gauge. - Now referring to FIGS.24-25 there are shown various views of a cutting
instrument 700 or scissors according to the present invention, that includes ahandle member 610 and ahead 730, a portion of which is configurable for insertion into the intra-ocular volume. Thehandle member 610 is described hereinabove in connection with FIGS. 21-23 and as such reference should be made to the foregoing discussion as to the operation and structure of the handle member. Thehead 730 includes amechanical interconnecting portion 732, aninsertable portion 734 having alumen 736, and amoveable member 740 having a cuttingend 742, that is disposed in the lumen. The insertable portion also includes afixed end 738 and a bridgingportion 739 that extends between anopen end 737 of the lumen and the fixed end so as to position the fixed end remote from and opposite the lumen open end. - The
mechanical interconnecting portion 732 is affixed to thehandle member 610 so thehead 730 extends from an end thereof. Themechanical interconnecting portion 732 also is mechanically interconnected to thehandle member 610 and themoveable member 740 such that the moveable member moves back and forth axially in thelumen 736 responsive to the axial movement or force generated by theactuation members 612 of thehandle member 610. In this way, when theactuation members 612 are in a rest position, the movablemember cutting end 742 is remote from the insertable portion fixedend 738 leaving a space therebetween. Correspondingly, when theactuation members 612 are actuated, the moveablemember cutting end 742 is moved towards thefixed end 738 so the cutting end contacts the fixed end such that any material disposed between the cuttingend 742 and thefixed end 738 is cut or severed into pieces. As illustrated in FIG. 25, the ends of the cuttingend 742 and thefixed end 738 that are perpendicular to the line of motion can be further machined or beveled so as to form a pick like surface. - In use, the surgical personnel insert the
insertable portion 734 into the entry aperture so thefixed end 738 and lumenopen end 737 thereof are dispose in the intra-ocular volume of the eye. Thereafter, the surgical personnel manipulate the cuttinginstrument 700 so the material to be cut is disposed on the bridgingportion 739 between thefixed end 738 and the cuttingend 742. The surgical personnel then actuate theactuation members 612 causing themoveable member 740 to moved axially within the lumen towards thefixed end 738 and to urge the cuttingend 742 against the fixed end thereby cutting the material trapped therebetween. - The
insertable portion 734 is configured and sized so as to be useable with an entry alignment device of the present invention. More particularly, theinsertable portion 734 also is configured and sized so the outer diameter or cross-section thereof is sufficiently small such that the removal of the insertable portion from thesclera 6 leaves an incision or opening therein that does not require sutures to seal the opening or incision. In an exemplary embodiment, the outer diameter or cross-section of theinsertable portion 734 is about 25 gauge. - Referring now to FIG. 26, there is shown an aspirator800 according to the present invention that includes a
handle portion 802, aninsertable member 804 and ansuction line 806. Thehandle member 802 is generally configured so as to provide a shape that is readily grasped by the surgical personnel and to include therein a lumen so as to fluidly couple a lumen of theinsertable member 804 and thesuction line 806. Thesuction line 806 is coupled to a suction source (not shown) so as to develop a suction within the insertable member lumen such that material or fluid can be drawn though theopen end 808 of the insertable member, up through the lumen and out through thesuction line 806 in the same manner as for other prior art aspirators. - The
insertable member 804 is configured and sized so as to be useable with an entry alignment device of the present invention. More particularly, theinsertable member 804 also is configured and sized so the outer diameter or cross-section thereof is sufficiently small such that the removal of the insertable member from thesclera 6 leaves an incision or opening therein that does not require sutures to seal the opening or incision. In an exemplary embodiment, the outer diameter or cross-section of theinsertable member 804 is about 25 gauge. - Referring now to FIGS. 27A,B there is shown a directional
extendable pick 900 according to the present invention, with thepick portion 906 withdrawn into theinsertable portion 904 as shown in FIG. 27A and with thepick portion 906 extending from the insertable portion as illustrated in FIG. 27B. The directionalextendable pick 900 includes ahandle member 902, theinsertable portion 904 that extends from an end of the handle member, apick portion 906 and aslide member 908 slidably disposed in the handle member. Thehandle member 902 is generally configured so as to provide a shape that is readily grasped by the surgical personnel. - The
insertable portion 904 is configured and arranged with a lumen extending the length thereof in which is slidably disposed thepick portion 906. Thehandle portion 902 also includes therein a lumen proximal the end from which the insertable portion extends in which is received a segment of thepick portion 906. The handle portion lumen communicates with the slotted opening in the top of the handle portion so theslide member 908 is mechanically connected to the pick portion so that the pick portion moves axially within the insertable portion lumen responsive to theslide member 908. - The
pick portion 906 is made of any of a number of materials known in the art that have the rigidity and strength to perform the picking function of the surgical procedure without structurally failing. Such materials include metals such as stainless steel and composite materials such as carbon composites. In a preferred embodiment, thepick portion 906 is made from nitinol. Apick portion 906 made from nitinol is advantageous in that a curved pick portion can be straightened and easily drawn into the straight section of theinsertable portion 904, as shown in FIG. 27A, but which returns to the curved state when it is extend outwardly from the insertable portion. - The
insertable portion 904 is configured and sized so as to be useable with an entry alignment device of the present invention. More particularly, theinsertable portion 904 also is configured and sized so the outer diameter or cross-section thereof is sufficiently small such that the removal of the insertable portion from thesclera 6 leaves an incision or opening therein that does not require sutures to seal the opening or incision. In an exemplary embodiment, the outer diameter or cross-section of theinsertable portion 904 is about 25 gauge. - The invention also includes device kits that comprise one or more entry alignment devices100 according to the present invention with or without the above-described surgical instruments, insertion tools and infusion cannulas. In a more specific embodiment, the device kits include entry alignment devices, a high speed vitreous cutter and an infusion cannula.
- Although a preferred embodiment of the invention has been described using specific terms, such description is for illustrative purposes only, and it is to be understood that changes and variations may be made without departing from the spirit or scope of the following claims.
Claims (41)
1. A method for providing access within an eye during an occular surgical procedure, comprising the steps of:
providing an entry alignment device that is configured so as to provide an entry aperture in each of the conjunctiva and sclera of the eye and maintaining the entry aperture in each of the conjunctiva and sclera aligned during the surgical procedure; and
inserting the entry alignment device into the eye so as to form the entry apertures.
2. The method according to claim 1 , wherein the entry alignment device being provided is sized such that when the entry alignment device is removed from the eye, the entry aperture formed in the conjunctiva and sclera are sealed without the use of sutures.
3. The method according to claim 2 , wherein the entry alignment device being provided is sized such that when the entry alignment device is removed from the eye, the entry aperture is self sealing.
4. The method according to claim 2 , further comprising the steps of:
providing a surgical instrument having an operable end for insertion through the entry aperture in each of the conjunctiva and sclera, a portion of the operable end having a cross-sectional diameter not greater than 25 gauge: and
inserting the surgical instrument through the entry apertures into the eye.
5. The method according to claim 4 , wherein the surgical instrument is selected from the group consisting of a high-speed vitreous cutter, forceps, scissors, pick, light source, laser, fragmentation, diathermy, and aspirator.
6. The method according to claim 2 , wherein the entry alignment device is in the form of one of a metal cannula, a polyimide cannula, a wire spreader and a shoe-horn type member.
7. The method according to claim 1 , wherein there are a plurality of entry alignment devices being provided and wherein the step of inserting includes inserting each of the plurality of entry alignment devices so as to form a plurality of entry apertures in the conjunctiva and the sclera.
8. The method according to claim 7 , further comprising the steps of:
providing a surgical instrument having an operable end for insertion through the entry aperture in each of the conjunctiva and sclera, a portion of the operable end having a cross-sectional diameter not greater than 25 gauge; and
inserting the operable end portion of at least one surgical instrument through one of the plurality of entry apertures.
9. The method according to claim 1 , further comprising the steps of:
providing an infusion cannula having an operable end for insertion into the eye, the operable end having a cross-sectional diameter of not more than 25 gauge and being interconnected to an infusion source; and
inserting the cannula operable end through the conjunctiva and sclera.
10. The method according to claim 9 , further comprising the step of sealing the apertures in the conjunctiva and sclera formed by the inserted infusion cannula without the use of sutures.
11. The method according to claim 1 , wherein the step of inserting includes inserting the entry alignment device into the eye so the entry apertures in the conjunctiva and sclera are at an angle with respect to a normal to the eye.
12. The method according to claim 11 , wherein the angle is greater than 45 degrees from the normal.
13. A method for treating a posterior segment of an eye comprising the steps of:
providing a plurality of entry alignment devices that is configured so as to provide an entry aperture in each of the conjunctiva and sclera of the eye and maintaining the entry aperture in each of the conjunctiva and sclera aligned during the surgical procedure;
inserting each of the plurality of entry alignment devices into the eye;
inserting a light source through the entry aperture formed by one of the plurality of entry alignment devices and inserting a high speed vitreous cutting/aspirating instrument in the other of the plurality of entry alignment devices;
removing vitreous gel using the high speed vitreous cutting/aspirating instrument; and
implementing a corrective procedure for the retina.
14. The method of claim 13 , further comprising the steps of:
inserting an operable portion of an infusion cannula through the conjunctiva and the sclera; and
maintaining the intraocular volume by infusing a fluid through the infusion cannula;
infusing a first gas through the infusion cannula while aspirating vitreous fluid; and
exchanging the infused first gas with a second gas following the step of implementing.
15. The method according to claim 13 , wherein the entry alignment device being provided is sized such that when the entry alignment device is removed from the eye, the entry aperture formed in the conjunctiva and sclera are sealed without the use of sutures.
16. The method according to claim 15 , wherein the entry alignment device being provided is sized such that when the entry alignment device is removed from the eye, the entry aperture is self sealing.
17. The method according to claim 15 , wherein the entry alignment device is in the form of one of a metal cannula, a polyimide cannula, a wire spreader and a chisel point member.
18. The method according to claim 13 , further comprising the steps of:
providing an infusion cannula having an operable end for insertion into the eye, the operable end having a cross-sectional diameter of not more than 25 gauge and being interconnected to an infusion source; and
inserting the infusion cannula operable end through the conjunctiva and sclera.
19. The method according to claim 18 , further comprising the step of sealing the apertures in the conjunctiva and sclera formed by the inserted infusion cannula without the use of sutures.
20. The method according to claim 13 , wherein the step of inserting includes inserting the entry alignment device into the eye so the entry apertures in the conjunctiva and sclera are at an angle with respect to a normal to the eye.
21. The method according to claim 20 , wherein the angle is greater than 45 degrees from the normal.
22. The method of claim 14 , further comprising the steps of:
infusing a first gas through the infusion cannula while aspirating vitreous fluid; and
exchanging the infused first gas with a second gas following the step of implementing.
23. A high speed vitreous cutting/aspirating instrument comprising:
an insertion member having a lumen therein and an aperture proximal an end thereof:
wherein the insertion member has a cross-sectional diameter of not more than 25 gauge;
a cutting member moveably disposed within the lumen;
a cutting member driving mechanism being mechanically interconnected to the cutting member that causes the cutting member to move cyclically in an axial direction within the lumen; and
wherein the cutting member driving mechanism is configured so as to drive the cutting member so as make about 1000 cuts per minute past the insertion member aperture.
24. The high speed vitreous cutting/aspirating instrument according to claim 23 , wherein the cutting member driving mechanism is configured so as to drive the cutting member so as make at least 1000 cuts per minute past the insertion member aperture.
25. The high speed vitreous cutting/aspirating instrument according to claim 23 , wherein the cutting member driving mechanism is configured so as to drive the cutting member so as make more than 1000 cuts per minute past the insertion member aperture.
26. The high speed vitreous cutting/aspirating instrument according to claim 23 , wherein the cutting member driving mechanism is configured so as to drive the cutting member so as make between about 1000 and about 1500 cuts per minute past the insertion member aperture.
27. The high speed vitreous cutting/aspirating instrument according to claim 23 , further comprising a suction line being fluidly interconnected to the insertion member lumen, and wherein the suction line is operated so as to develop a vacuum in the lumen of about 400 mmHG.
28. The high speed vitreous cutting/aspirating instrument according to claim 23 , further comprising a suction line being fluidly interconnected to the insertion member lumen, and wherein the suction line is operated so as to develop a vacuum in the lumen greater than 400 mmHG.
29. A device kit including at least one entry alignment device that is configured for insertion into an eye and so as to provide an entry aperture in each of the conjunctiva and sclera of the eye and to maintain the entry aperture formed in each of the conjunctiva and sclera aligned during a surgical procedure.
30. The device kit of claim 29 , wherein the alignment device is sized such that when the entry alignment device is removed from the eye, the entry aperture formed in the sclera is sealed without the use of sutures.
31. The device kit of claim 30 , wherein the alignment device is sized such that the entry aperture formed in the sclera is self-sealing.
32. The device kit of claim 29 , further comprising at least one surgical instrument having an operable end for insertion through the entry aperture provided in the eye by the entry alignment device, a portion of the operable end having a cross-sectional diameter not greater than 25 gauge.
33. The device kit of claim 32 , wherein one of the at least one surgical instrument is a high speed vitreous cutter that is configured and arranged so as to be capable of cutting and aspirating material through the operable end portion having a cross-sectional diameter not greater than 25 gauge.
34. The device kit of claim 33 , wherein the high-speed vitreous cutter includes:
an insertion member having a lumen therein and an aperture proximal an end thereof;
wherein the insertion member has a cross-sectional diameter of not more than 25 gauge;
a cutting member moveably disposed within the lumen;
a cutting member driving mechanism being mechanically interconnected to the cutting member that causes the cutting member to move cyclically in an axial direction within the lumen; and
wherein the cutting member driving mechanism is configured so as to drive the cutting member so as make about 1000 cuts per minute past the insertion member aperture.
35. The device kit of claim 29 , further comprising an infusion cannula having an insertable end for insertion into the eye, a portion of the insertable end having a cross-sectional diameter of not more than 25 gauge.
36. The device kit of claim 29 , wherein the entry alignment device is configured so as to be in the form of one of a metal cannula, a polymide cannula, a wire spreader and a shoe-horn type member.
37. The device of claim 32 , wherein the at least one surgical instrument is selected from the group consisting of a forceps, scissors, pick, light source, laser, fragmentation device, diathermy device and aspirator.
38. A forceps comprising:
a first member having a lumen and a fixed sloping end proximal an open end of the lumen;
a second member being disposed in the lumen and being axially moveable therein, the second member having a sloped end; and
wherein the first and second members are arranged so that the fixed sloping end opposes the second member sloped end.
39. The forceps of claim 39 , wherein the first member is sized so a cross-sectional diameter thereof is about 25 gauge or less.
40. The forceps of claim 39 , further comprising a moving mechanism being mechanically interconnected to the second member so as to selectively move the second member sloped end from a rest position to any number of positions between the fixed sloping end and the rest position so as to grasp material disposed between the fixed sloping end and the second member sloped end.
41. The forceps of claim 38 , wherein the fixed sloping end and the second member sloped end are configured such that opposing surfaces thereof are substantially parallel to each other.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US10/683,658 US20040073231A1 (en) | 2000-03-11 | 2003-10-09 | Sutureless occular surgical methods and instruments for use in such methods |
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US09/523,767 US7077848B1 (en) | 2000-03-11 | 2000-03-11 | Sutureless occular surgical methods and instruments for use in such methods |
US10/683,658 US20040073231A1 (en) | 2000-03-11 | 2003-10-09 | Sutureless occular surgical methods and instruments for use in such methods |
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Also Published As
Publication number | Publication date |
---|---|
CA2679705C (en) | 2012-10-02 |
CN1431889A (en) | 2003-07-23 |
MXPA02008838A (en) | 2004-10-14 |
AU2001247340A1 (en) | 2001-09-24 |
CA2783195A1 (en) | 2001-09-20 |
WO2001068016A3 (en) | 2002-07-25 |
BR0109117A (en) | 2002-11-26 |
US7077848B1 (en) | 2006-07-18 |
WO2001068016A2 (en) | 2001-09-20 |
CA2679705A1 (en) | 2001-09-20 |
CA2402641A1 (en) | 2001-09-20 |
EP1263364A2 (en) | 2002-12-11 |
KR20030034047A (en) | 2003-05-01 |
JP2003526461A (en) | 2003-09-09 |
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