CA2242328A1 - Devices and methods useable for forming small openings in the lens capsules of mammalian eyes - Google Patents
Devices and methods useable for forming small openings in the lens capsules of mammalian eyes Download PDFInfo
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- CA2242328A1 CA2242328A1 CA002242328A CA2242328A CA2242328A1 CA 2242328 A1 CA2242328 A1 CA 2242328A1 CA 002242328 A CA002242328 A CA 002242328A CA 2242328 A CA2242328 A CA 2242328A CA 2242328 A1 CA2242328 A1 CA 2242328A1
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- Prior art keywords
- probe
- electrode
- electrode tip
- lens capsule
- patient
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1402—Probes for open surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
-
- 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
- A61F9/0079—Methods or devices for eye surgery using non-laser electromagnetic radiation, e.g. non-coherent light or microwaves
Abstract
A device and system for creating small, less than 3 mm and preferably about 1 mm in cross dimension, openings in the anterior lens capsule (LC) of a mammalian eye (E) to facilitate insertion of lens reduction/removal device(s) and/or cannulae for injecting flowable lens replacement materials into the lens capsule (LC). The device generally comprises a handpiece (18) having an electrosurgical probe (10) extending forwardly therefrom. The electrosurgical probe (10) incorporates an annular tip electrode (16) which is positionable in contact with the lens capsule (LC), to create the desired less than 3 mm opening therein. The annular electrode tip (16) may be either monopolar or bipolar in design.
Description
CA 02242328 l998-07-06 - W O 98/19615 PCT~US97/20698 D~VICES AND METHODS USEABLE FQR FO~MING SM~LL ~NlN~S I~
T~ T.RNS CAPSIJLE:S OF Mi~MMAT.TAN EYE:S
Field o~ the Invention The present invention relates generally to medica-devices~ and more particularly to an electrical surgical device which is usable to form relatively small (e.g., 1 2mrn) openings in the lens capsule o~ the eye.
Bac~.oulld of the Invention 1~ Cataracts have become one o~ the most common causes o~
visual imp~i rment and blindness in our ageing population.
Surgery is currently the only method o~ restoring vision t~
patients who have become visuall~ impaired or blinded by cataracts.
Traditional cataract removal surgery requires the intact cataract-a~fected lens to be removed through a 7-lOmm incision formed in the anterior aspect of the lens capsule of the eye. ~fter the in-tact cataract affected lens has been removed through the 7-lOmm incision, a prosthetic lens (e.g. r a transparent lens formed of a biocompatable polymer) is then inserted through such 7-lOmm incision and implanted within the lens capsule to serve as a replacement for the previously-removed cataract-affected lens. ~hese classic cataract removal procedures have proven to be successful in restoring vision, but often are associated with post-operative complications due to the large 7-lOmm incision fonmed in the lens capsule.
More recently r another surgical procedure r known as phacoemulsificationr has been developed for removing 3~ cataract-affect lenses. In these phacoemulsification -CA 02242328 l998-07-06 W O 98/19615 PCT~US97/20698 procedures, an ultrasonically vibrating probe is inserted into the lens capsule through an incision formed therein.
The ultrasonically ~ibrating emulsification probe is then manipulated about to ef~ect complete emulsification of the cataract-a~fected lens. The emulsi~ied lens matter is then aspirated out of the lens capsule. Thereafter, the desired prosthetic lens replacement is inserted into the lens capsule. Although the diameter of the phacoemulsification probe may be relatively small, it is still typi~ally necessary to utilize a caps~lar incision of 2.~-6.0mm in length to allow the probe to be manipulated about su~iciently to accomplish complete emulsi~ication and removal of the lens matter. Furthermore, it is often necessar~ to further enlarge the capsular incision through which the phacoemulsification probe was inserted to the usual 7-lOmm size to permit subse~uent insertion of a pre~ormed prosthetic lens implant into the lens capsule.
The need to form a relatively large incision in the anterior lens capsule to permit passage of a prosthetic lens replacement into the lens capsule may soon be obviated due to certain deve~opments in the lens removal/replacement technology. For example, certain iniectable lens replacement materials, known in the art and/or presently being developed, may be passed into the interior of the lens capsule through a needle or tubular cannula. Because these injectable lens replacement materials may be passed into the lens capsule through a relatively smal~ opening, the advent of these injectable lens replacement materials may el;~;n~te any need for the formation of large incisions in the lens capsule to allow a prosthetic lens to be inserted into the lens capsule.
Also, certain rotatable lens removing devices, such as those described in United -States Patent No. 5,437,678 (Sorensen) as well as in United States Patent Applications Serial No. 08/421,421, and 08/658,846 may be inserted into . CA 02242328 1998-07-06 W O 98/19615 PCTrUS97/20698 the lens capsule through small (e.g., less than 3mm) openings and may be held substantially stationary during lens reduction and removal, thereby avoiding any need for ~orming any large (e.g., greatex than 3mm) capsular incision.
In view of the de~elopment of moder~ i~jectable le~s replacement materials and rotatable ~ens removing devices which may be inserted and operated through relatively small openings in the lens capsule, it is now possible to per~orm an entire cataract removal and prosthetic lens replacement, through a small (e.g., less than 3mm) opening in the anterior lens capsule, while allowing the remainder of the anterior lens capsule to remain in-tact and unincised.
However, the process of creating a small (e.g., less 1~ than 3mm~ opening in the anterior lens capsule is problematic due to the tendency of the lens capsule material to tear or "run" when punctured.
Accordingly, there presently exists a need for a new device capable of consistently making smal-l (e.g., less than 3mm) openings in the anterior lens capsu~e of the eye.
SI ry of the Invention The present invention provides electrosurgical devices and methods for forming small (e.g., less than 3~m) openings in the anterior lens capsule of the m~mm~l ;An eye.
In accordance with the invention, there is provided an electrosurgical probe device generally comprising: a) an elongate probe which has a proximal end, a distal end and a longitudinal axis pro~ectable therethrough, and, b) an annular electrode tip located on the distal end of said elongate probe, said annular electrode tip having a lens capsule contacting surface which lies substantially in, or is substantially disposable in, a plane that is non-parallel to the longitudinal axis of the probe, said probe being thereby insertable into the eye ~uch that the len~
capsule contacting surface of the annular electrode tip is in con~act with the lens capsule~ whereby passage of electrLcal current through annular electrode tip will create an opening in the lens capsule.
Further in accordance with the invention, the above-summarized probe device may be of a monopolar or bipolartype. If the device is of a monopolar type, a second electrode (e.g., a plate electrode) will necessarily be attached to, or placed in sufficient proximity to ~e electrically coupled to, the body of the patient to complete an elec~rical circuit or between the electrode tip of the device and the second electrode. On the other hand, i~ the device is of the bipolar type, the second electrode will be formed or mounted upon the body of the probe, and no externally-attached second electrode will be re~uired.
Still further in accordance with the invention, there is provided an electrosurgical system for forming small (e.g., less than 3mm) openings in the anterior lens capsule of the ~-m~ n eye, said system comprising an electrosurgical pro~e device of the above-described 2~ character, further in combination with: a handpiece sized and con~igured to be grasped by the human hand, said handpiece having a distal end and a proximal end; an electrical signal generating apparatus which is connectable to said handpiece, an on/off switch for ~tarting and stopping a flow of current from the electrical signal generating apparatus to the handpiece; connector apparatus to connect the distal end of the handpiece to the prox; m~ 1 - end of said probe device and to pass said electrical current from the hand piece to the annular electrode tip of the probe.
Still fur~her in accordance with the invention, there is provided a method for forming an opening in the lens capsule of the eye, said method generally comprising the steps of: a) providing an electrosurgical probe device comprising an elongate probe having a prox; m~l end, a W O 98/19615 PCTrUS97/20698 distal end, and an electrode tip formed on the distal end thereof; b) inserting the probe into the eye such that the electrode tip is in contact with the lens capsule of the eye; c) passing electrical current through the probe and to the electrode tip, ~aid electrical current being of sufficient magnitude to form an opening in said lens capsule at the location where said electrode tip is i~
contact with the ~ens capsule.
Further objects and advantages of the present invention will become apparent to those skilled in the art upon reading and understanding of the following detailed description and the accompanying drawings.
Brief DescriPtion of the Drawinq~
Figure 1 is a perspective view showing an electrosurgical probe device of the present invention operatively inserted into a human eye.
Figure 2 is a perspective view of a system of the present invention comprising a) an electrical signal generating apparatus, b) a handpiece, and c) an electrosurgical probe device of the present invention mounted on the distal end of the handpiece.
Figure 3a is a partial perspective view of a connector assembly, ~ormed on the distal end o~ the handpiece shown in Figure 2.
Figure 3 is a rear perspective view of a monopolar embodiment of the electrosurgical probe device of the present invention.
Figure 4 is a longitudinal sectional view of the monopolar electrosurgical probe device shown in Figure 3.
Figure 5 is a perspective view of a segment of hypotubing from which a notch has been removed to form an annular electrode tip usable in the electrosurgical probe devices of the present invention.
Figure 5a is a perspective view of an ann~lar electrode tip formed from the notched segment of hypotubing shown in Figure 5.
Figure 6 is a perspective cut-away view of the monopolar embodiment shown in Figures 3-4.
Figure 7 is a perspective cut-away view of a first ~ipolar embodiment of an electrosurgical probe device of the present invention.
Figure 8 is a cross sectional view through line 8-8 of Figure 7.
Figure 9 is a longitudinal sectional view of a second (alternative) bipolar embodiment of an electrosurgical probe device of the present invention.
Figure 10 is a cross sectional view through line 10-10 of Figure 9.
Figures lla-llc are graphic representations of power vs. time, illustrating variation in the electrical wa~e forms and power levels which may be utilized in conjunction with the device and system of the present invention.
Detailed DescriPt:ion oE the Prei~e~red Embc--lim~nts The following detailed description and the accompanying drawings are provided for the purpose of illustrating and describing presently preferred embodiments of the invention only, and are not intended to limit $he scope of the invention in any way.
With reference to the drawings, there is provided an electrosurgical probe device 10 which is usable to ~orm small openings (e.g., less than-3mm) in the anterior lens capsule LC of the eye. In general, the electrosurgical probe device 10 comprise6 a proxlmal attachment/contact hub 12 having an elongate probe member 14 extending distally therefrom, and an annular electrode tip 16 mounted on the distal end of the elongate pro~e portion 14. The annular electrode tip 16 is disposed at an angle relative to the longitl-~; nal axis LA of the elongate probe portion 14.
Figure 1 shows a preferre~ method by which the electrosurgical probe device 10 of the present invention W O 98119615 PCTrUS97/20698 may be inserted into the eye E for th~ purpose o~ forming a small te.g., le6s than 3mm) opening in the anterior lens capsule LC of the eye E. It will be noted from Figure 1 that the lens capsule LC is ~uspended within the eye E, behind the anterior chamber AC and cornea C. The lens capsule LC is maintained in its normal anatomical location by various anchoring structure~ o~ the eye, including suspensory ligaments S~ which are located posterior to the iris I of the eye E. In operation, a small incision is formed in the cornea C and the elongate probe porti~n 14 of the device lQ is inserted through such incision, and is advanced through the anterior chamber AC of the eye E until the annular electrode tip 1~ comes into contact with the anterior aspect o~ lens capsule ~C. Thereafter, electrical current is passed through the annular electrode tip 16 so as to cause the tip 14 to penetrate the lens capsule LC t thereby forming an annular opening which is approximately of the same size and configuration as the annular electrode tip 16.
As the annular electrode tip ~6 elec~rosurgically penetrates the lens capsule LC, heat will cauterize or melt the portion of the lens capsule ~C which surrounds the opening formed by the electrode tip 16, thereby strengthening or reinforcing the edges of such opening.
Such strengthening or reinforcement of the periphery of the opening will prevent or deter subsequent tearing, undesired enlargement or extension of the opening as the cataract removal and/or lens replacement instruments are passed ~hrough the opening.
With reference to Figure 2-2a, the electrosurgical probe device 10 of the present invention may be constructed and configured so as to be usable as an attachment to an electrocautery system of a type typically used in ophthalmological surgery. Such electrocau~ery systems typically comprise a handpiece 18, an electrical signal W O98/19615 PCT~US97/20698 generator 20 and an on/off switch such as a ~oot pedal ~2.
One example of a commercially available electrocautery system o~ the type shown in Figures 2-2a is the Surgitron~
Model FFPF available from Ellman International, Inc., 113 5 Railroad Avenue, Hewlett, New York 11557.
In the embodiment shown in Figures 2-2a, a connector assembly 24 is formed on the distal end of the handpiece 18 to facilitate connection with an electrical contact to the electrosurgical probe device 10 of the present invention.
In the embodiment shown, the connector assembly 24 comprises a generally cylindrical, distally extending contact post 26 surrounded by an internally threaded, rotatable, ~uer-lock sleeve 24. The contact post is insertable into a receiving contact bore ~ormed on the proximal end of the probe device 10, and the Luer-lock sleeve is then usable to engage and lock the probe device 10 to the handpiece 18 such that the contact post 26 of handpiece 18 is held in firm electrical contact with the probe device 10.
It will be appreciated that the electrosurgical probe device 10 generally described hereabove, may be specifically constructed in either monopolar or bipolar embodiments, as more fully described herebelow:
i. Monopolar Embo~ L~
Figures 3-6 show a monopolar electrosurgical probe device 10a of the present inventionr which is usable in conjunction with an electrocautery system of the type shown in Figures 2-2a.
As shown in Figures 3-6, the monopolar electrosurgical probe device 10a is constructed such that the annular electrode tip 16a is the only electrode present on the body of the probe device 10a. A second electrode, such as a plate electrode (not shown) r must be separately attached to or brought into proximity with the body of the patient in 3~ order that an electrical circuit or capacitive coupling be W O 98/19615 PCT~US97/20698 completed ~etween the annular electrode tip }6a and such externally-placed second electrode (not shown).
As shown, the proximal hub 12a of the monopolar probe device lOa comprises an electrically conductive, generally cylindrical, hub 30 having a Leur-lock flange 32 ~ormed therearound~ An insulative covering 34, formed o~
polyvinyl chloride ~PVC~ or other suitable plastic, may be formed about the outer surface of the cylindrical hub 30, but should not interfere with the engagement of the Luer-lock ~lange 32 to the internal threads of the rotatablesleeve 28 of the handpiece connector assembly 24.
The distally-extending probe portion 14a of the monopolar probe device lOa may comprise a rigid base tube 36 which is continuous with and protrudes distally from the ~rusto-conical pro~;mal hub 30 as shown. A first hypotube member 38 is inserted into a distal portion of the base tube 36, and extends axially therefrom, as shown. A second hypotu~e member 40 is inserted into a distal portion o~ the ~irst hypotu~e memher 38, and extends distally therefrom, as shown. The annular electrode tip 16a is formed on the distal end of this second hypotube member 40.
One means by which the annular electrode tip may be ~ormed on the distal end of the second hypotube member 40 is illustrated in Figures 5 and ~a. With reference to Figures 5~5a the second hypotube member 40 has a notch 42 cut away therefrom. Such notch 42 is configured such that its distal edge is perpendicular to the longitudinal axis LA of the second hypotube member 40, and its proximal edge is curved or acutely angled relative to such longitudinal axis LA. This results in the formation of a substantially cylindrical ring at the distal end of the second hypotube member 40, such ring being connected by a remnant portion 44 of the second hypotube 40 to that pro~;~l portion of the second hypotube 40 located proximal to the notch 42.
The distal surface DS of the cylindrical ring formed W O 98/19615 PCT~US97/20698 at the distal end of the second ~ypotube member 40 is initially disposed in a plane which is perpendicular to the longitudinal axis LA. ~owever, the remnant portion 44 is bent in a direction away ~rom the longitudinal axis ~A such 5 that the plane P of the distal surface of the ring member at the distal end of the second hypotube member 40 forms an internal angel A relative to the longit~l~;n~l axis L~.
Also, electrically conductive wire 54 is soldered or otherwise affixed to the interior of the second hypotube member 40.
Upon assembly, the pro~;m~l portion of the second hypotu~e member prepared as shown in Figure 5a, is inserted into the distal portion o~ the bore of the first hypotube member 38, and is affixed thereto. Similarly, the first hypotube member 38 is affixed to the base tube 36 which in turn is affixed to the frusto-conical proximal hub 30.
Such direct affixation of the hypotube member 38, base tube 36 and frusto-conical proximal hub 30 ma~ be sufficient to provide reliable electrical contact and conduction therebetween. However, if reliable electrical contact and conduction between such components is not accomplished by their direct a~fixation to one another, an added electrical conductive wire 54 may optionally be soldered or otherwise electrically connected to any or all of the hypotube member 2~ 38, base tube 36 and/or prox;~-l hub 30, to facilitate electrical conduction therebetween.
The angle A of the distal surface DS of the annular electrode tip 16a of the probe device lOa may vary, depending on the intended positioning of the electrosurgical probe device lOa within the eye E.
Typically r it will be desirable to position the electrosurgical probe device lOa in a manner similar to that shown in Figure 1. Thus, in most cases, it will be desirable ~or the distal surface DS of the annular electrode tip 16a to form an internal angle A of no less CA 02242328 l998-07-06 ~han 90~ and typically in the range of 90~-1~0~. In the embodiment shown, a fi:rst insulative sheath 50 is heat-shrunk or otherwise secured about the proximal portion of the second hypotube member 40 and the distal portion o~ the first hypotube member 38. This insulative ~heath 50 helps to securely join the first 38 and second 40 hypotube members together and also provides an insulative outer covering thereon. A second insulative sheath 52 is then ~ormed about the proximal portion of the first insulative sheath 50 and about the base tube 36.
The monopolar electrosurgical probe lOa is attachable to the connector assembly 24 of the electrocautery system shown in Figures 2-2a by inserting the contact post 26 of the connector assembly 24 into the proximal hub 30a such 1~ that the outer surface of the contact post 26 is in direct abutting contact with the inner surface of the frusto-conical hub 30a. Thereafter, the rotatable sleeve 24 is rotata~ly advanced such that the internal threads of the rotatable sleeve 34 will engage the Luer-lock flange 32a of the proximal hub 30. In this manner, electrical current ~rom the electrical signal generator 20 will pass through the hand piece 18, from the contact post 26 and to the hub 30a of the probe device lOa. Such current will then pass from the hub 30 through the electrically conductive walls o~ the first 38 and second 40 hypotube members and/or through the electrically conductive wire 54. The current will then pass from the annular electrode tip 16a to a second elec~rode (not shown) which has been attached to or brought into proximity with the patient's body to complete the electrical circuit or establish the required capacitive coupling.
ii. Bipolar EmboAi ~s Figure 7-8 show a first embodiment o~ a bipolar electrosurgical probe lOb of the present invention, while Figures 9-10 show an alternative bipolar electrosurgical W O 98/1961~ PCTrUS97/20698 probe lOc which has a structure substantially similar to (and which shares many common structural attributes with) that of the monopolar embodiment lOa described hereabove and shown in Figures 3-6.
With reference to Figur~ 7-8, this bipolar probe device lQb of the present invention comprises an elongate probe portion 14b formed of an inner tubular electrode member 60, an outer tu~ular electrode member 62 and an insulating tubular she~th 64 positioned therebetween. The inner tubular electrode 60 member, outer tu~ular electrode member 62 and insulative tubular sheath 64 are disposed coaxially about a common longitudinal axis LA. The distal end o~ the inner tubular electrode 60 forms the annular electrode tip 16b. In the embodiment shown, this annular electrode tip 16b is ~ormed ~y cutting the distal end o~
the inner tubular electrode 6Q such that the it's distal sur~ace is perpendicular (i.e., at a 90~ angle) relative to the longitudinal axis LA. It will be appreciated, however, that the dïstal end of the inner tubular electrode 60, the outer tubular electrode 62 and/or the interposed sheath 64, may be cut at various angles relative to the longitudinal axis ~A, so as to provide di~ferent angular dispositions of the annular electrode tip 16b. Similarlyl the distal end of the outer electrode member 62 as well as the insulation sheath 64 may be axially spaced and fastened to one another such that the respective distal ends of the inner tubular electrode 60, insulation sheath 64 and outer electrode members 62 will form such angle.
The elongate probe portion 15b of this first bipolar probe lOb shown in Figure 7-8 extends distally from and is connected to a proximal hub (not shown) which may be substantially the same as the proximal hub 12a described hereabove with respect to the monopolar probe device lOa.
However, in this bipolar embodiment, only the inner tubular electrode 60 is electrically connected to the pro~;~l hub, W O 98/19615 PCTrUS97/20698 a~d the outer tubular electrode 62 is connected separately by a separate electrical connection to the signal generating apparatus 20, thereby completing the desired bipolar circuit of this embodiment As shown in Figure 7~ the distal end o~ the outer tubular electrode 62 may terminate a spaced distance proximal to the distal end of the inner tubular electrode 60. Also, the distal portion of the tubular insulating sheath 64 which protrudes beyond the distal end of t~e ~uter tubular electrode may be tapered, in the manner sho~n in Figure 7. In this manner, when the ~ipolar probe device lOb is inserted into the eye, the distal end of the inner tubular electrode 60 is positioned in contact with the lens capsule ~C. ~hereafter, when energized, electrical current will flow between the distal end of the inner tubular electrode 60 (which forms the annular electrode tip 16b) the adjacent distal portion of the outer tubular electrode 62. Thus, in this first bipolar embodiment, there is no need for a separate external electrode to be attached to or brought into proximity with the patient's body, as is required of the above-described monolar polar probe device lOa.
Figures 9 and ~0 shows an alternative or second embodiment of a bipolar probe device lOc which is similar in construction to the monopolar probe lOa described hereabove. This second embodiment of the bipolar probe lOc comprises a proximal hub 12c having an elongate probe portion 14c extending ~ lly therefrom, in a distal direction. An annular electrode tip 16c is formed on the distal end of the probe portion 14c. The cylindrical hub 30c, first hypotube member 38c, second hypotu~e mem~er 40c, remnant portion 44c, annular electrode 16c and electrically conductive wire 54c are constructed, con~igured and assembled in the same manner as described hereabove with respect to the monopolar embodiment.
CA 02242328 l998-07-06 W O 98/19615 PCT~US97/20698 However, in this second bipolar embodiment, an outer electrode tube 70, formed of electrically conductive material, surrounds the insulative sheet 50c. Such outer electrode tube 70 is connected to an electrically conductive wire 5~ which e~tends through the insulative casing 34c of the proximal hub 12c and i8 connectable to the electrical signal genera~ing device 20. The outer electrode tube 70 is distally coterminous with the insulative sheath ~Oc, such that only the remnant portion 44c of the second hypotube member 40c and the annular electrode tip 16c protrude distally beyond the distal end of the outer_electrotube 70.
In operation, this second bipolar em~odiment of the device lOc is inserted into ~he eye such that a distal portion o~ the probe portion 14c extends thro~gh the anterior chamber AC, and the distal surface DS of the annular electrode tip 16c is in contact with the anterior lens capsule. ~hereafter, electrical current from the electrical signal generator 20 may pass through the electrically conductive wire members 54c, 55 and/or other electrically conductive portions of the pro~e de~ice lOc as described hereabove, such that current will ~low ~rom the annular electrode tip 16c to the distal portion of the outer tubular electrode 40 through the electrically-conductive fluid environment within the anterior chamber ofthe eye.
It will be appreciated that the annular electrode tip 16, 16a, 16b, 16c described hereabove may comprise any appropriate geometrical configuration, and may have an open center (e.g., a ring or hoop) or alternatively may have a solid center (e.g., a disc having a generally annular outer edge). Furthermore, it will be appreciated that the lens capsule contacting surface, such as the distal surface, of the annular electrode tip 16, 16a, 16~, 16c need not be substantially flat or planar, and may be slightly concave - W O 98/19615 PCT~US97/20698 or of any other suitable configuration. In this manner, when reference is made in thi~ patent application to the plane" in which the lens capsule contacting sur~ace of the distal electrode tip lie, it will be appreciated that such plane may ~e projected throu~h a concaved or wavy surface of an average variant thereo~. ~lternatively, in embodiments wherein the lens capsule contacting surface of the annular electrode tip 16, 16a, 16b, 16c is flat, such entire ~lat edge may lie within the referenced plane.
iii. Preferred Methods of OPeratin~ the Devices Any and all of the above-described embodiments of the present invention are preferably operated in accordance with a general method wherein at least a distal portion of the elongate probe porti~n 14, 14a, 14b, 14c is inserted 1~ through an incision in the cornea C and is advanced through the anterior chamber AC until the lens-capsule-contacting distal surface DS of the annular electrode tip 16, 16a, 16b, 16c is in contact with the lens capsule LC. If a monopolar embodiment of the probe device 10a is used a secondary electrode will be attached to or brought into close proximity with the body of the patient at a location which is suitable to complete an electrical circuit between the annular electrode tip 16a of the probe 10a and such second electrode. On the other hand, i~ one of the bipolar embodiments of the probe device 10b, 10c are used, there will be no need to provide a separate second electrode wit~
is attached to or placed in proximity with, the body of the patient.
Therea~ter, the electrical signal generating device 20 is actuated so as to cause current to flow between the annular electrode tip 16, 16a, 16b, 16c and either the separately attached secondary electrode (monopolar embodiment) or the on-board outer electrode tube 62, 70.
Any suitable electrical wave ~orm and power level may be used. In this regard, in at least some applications it W O 98/19615 PCTrUS97/20698 will be desirable to use a continuous, pulsed or superpulsed wave form which pro~ides an average power level of approximately 10 watts to form the desired opening in the anterior lens capsule.
In embodiments of the system wherein the wave form is intended to be pulsed or superpulsed, the signal-generating device 20 will preferably include a mechanism for setting ~ the desired pulse duration, pulse train duration, pulse bunch duration and/or duty cycle, examples of which are shown graphically in Figures lla, llb and llc.
With re~erence to lla, there is shown the average power generated by single pulse, of known pulse duration PD.
Figure llb shows the average power generated by a train of individual pulses, each of said individual pulses having a pulse duration PDr and the overall train of pulses having a pulse train duration PTD.
Figure llc shows a superpulsed embodiment of the invention wherein bunches of small individual pulses, each of ~aid individual pulses having a pulse duration PD of 10 milliseconds, are generated periodically on a given repeat period RP.
It will be appreciated that the electrical signal generating device 20 may be preprogrammed to deliver 2~ desired energy levelsr and/or wave ~orm(s) in response to each triggering of a fixed on-off switch. Alternatively, the signal generating device 20 may be rheostatically controlled by way of a ~oot pedal or other type of rheostatic control device r and the amount and duration of energy delivered through the annular electrode tip 16, 16a, 16b, 16c will be determined by the current position of the foot pedal or other rheostatic control mechanism.
In the above-described manner, the electrosurgical probe device lO of the present invention is ~sa~le to form an opening in the lens capsule LC of a size which is only W O98/1961~ PCT~US97120698 slightly larger than the outer diameter of the annular electrode tip 16, 16a, 16b, 16c. Furthermore, when the preferred wave form and power setting are used, the resultant electrosurgical opening of the lens capsule will additionally form a heat-fused region around such openiny, thereby preventing the anterior aspect of the lens capsule ~rom being torn, enlarged or extended during the subsequent insertion and manipulation of the cataract removal device(s) and/or prosthetic lens implant introduction cannula.
The present invention has been described hereabove with reference to certain presently prefèrred em~odiments only. No attempt has been made to exhaustively describe all possible embodiments in which the invention may be practiced. Indeed, various additions, deletions, modifications and alterations may be made to the above-described pre~erred embodiments without departing from the intended spirit and scope of the invention. Accordingly, it is intended that all such reasonable additions, deletions, modifications and alterations be included within the scope of the following claims.
T~ T.RNS CAPSIJLE:S OF Mi~MMAT.TAN EYE:S
Field o~ the Invention The present invention relates generally to medica-devices~ and more particularly to an electrical surgical device which is usable to form relatively small (e.g., 1 2mrn) openings in the lens capsule o~ the eye.
Bac~.oulld of the Invention 1~ Cataracts have become one o~ the most common causes o~
visual imp~i rment and blindness in our ageing population.
Surgery is currently the only method o~ restoring vision t~
patients who have become visuall~ impaired or blinded by cataracts.
Traditional cataract removal surgery requires the intact cataract-a~fected lens to be removed through a 7-lOmm incision formed in the anterior aspect of the lens capsule of the eye. ~fter the in-tact cataract affected lens has been removed through the 7-lOmm incision, a prosthetic lens (e.g. r a transparent lens formed of a biocompatable polymer) is then inserted through such 7-lOmm incision and implanted within the lens capsule to serve as a replacement for the previously-removed cataract-affected lens. ~hese classic cataract removal procedures have proven to be successful in restoring vision, but often are associated with post-operative complications due to the large 7-lOmm incision fonmed in the lens capsule.
More recently r another surgical procedure r known as phacoemulsificationr has been developed for removing 3~ cataract-affect lenses. In these phacoemulsification -CA 02242328 l998-07-06 W O 98/19615 PCT~US97/20698 procedures, an ultrasonically vibrating probe is inserted into the lens capsule through an incision formed therein.
The ultrasonically ~ibrating emulsification probe is then manipulated about to ef~ect complete emulsification of the cataract-a~fected lens. The emulsi~ied lens matter is then aspirated out of the lens capsule. Thereafter, the desired prosthetic lens replacement is inserted into the lens capsule. Although the diameter of the phacoemulsification probe may be relatively small, it is still typi~ally necessary to utilize a caps~lar incision of 2.~-6.0mm in length to allow the probe to be manipulated about su~iciently to accomplish complete emulsi~ication and removal of the lens matter. Furthermore, it is often necessar~ to further enlarge the capsular incision through which the phacoemulsification probe was inserted to the usual 7-lOmm size to permit subse~uent insertion of a pre~ormed prosthetic lens implant into the lens capsule.
The need to form a relatively large incision in the anterior lens capsule to permit passage of a prosthetic lens replacement into the lens capsule may soon be obviated due to certain deve~opments in the lens removal/replacement technology. For example, certain iniectable lens replacement materials, known in the art and/or presently being developed, may be passed into the interior of the lens capsule through a needle or tubular cannula. Because these injectable lens replacement materials may be passed into the lens capsule through a relatively smal~ opening, the advent of these injectable lens replacement materials may el;~;n~te any need for the formation of large incisions in the lens capsule to allow a prosthetic lens to be inserted into the lens capsule.
Also, certain rotatable lens removing devices, such as those described in United -States Patent No. 5,437,678 (Sorensen) as well as in United States Patent Applications Serial No. 08/421,421, and 08/658,846 may be inserted into . CA 02242328 1998-07-06 W O 98/19615 PCTrUS97/20698 the lens capsule through small (e.g., less than 3mm) openings and may be held substantially stationary during lens reduction and removal, thereby avoiding any need for ~orming any large (e.g., greatex than 3mm) capsular incision.
In view of the de~elopment of moder~ i~jectable le~s replacement materials and rotatable ~ens removing devices which may be inserted and operated through relatively small openings in the lens capsule, it is now possible to per~orm an entire cataract removal and prosthetic lens replacement, through a small (e.g., less than 3mm) opening in the anterior lens capsule, while allowing the remainder of the anterior lens capsule to remain in-tact and unincised.
However, the process of creating a small (e.g., less 1~ than 3mm~ opening in the anterior lens capsule is problematic due to the tendency of the lens capsule material to tear or "run" when punctured.
Accordingly, there presently exists a need for a new device capable of consistently making smal-l (e.g., less than 3mm) openings in the anterior lens capsu~e of the eye.
SI ry of the Invention The present invention provides electrosurgical devices and methods for forming small (e.g., less than 3~m) openings in the anterior lens capsule of the m~mm~l ;An eye.
In accordance with the invention, there is provided an electrosurgical probe device generally comprising: a) an elongate probe which has a proximal end, a distal end and a longitudinal axis pro~ectable therethrough, and, b) an annular electrode tip located on the distal end of said elongate probe, said annular electrode tip having a lens capsule contacting surface which lies substantially in, or is substantially disposable in, a plane that is non-parallel to the longitudinal axis of the probe, said probe being thereby insertable into the eye ~uch that the len~
capsule contacting surface of the annular electrode tip is in con~act with the lens capsule~ whereby passage of electrLcal current through annular electrode tip will create an opening in the lens capsule.
Further in accordance with the invention, the above-summarized probe device may be of a monopolar or bipolartype. If the device is of a monopolar type, a second electrode (e.g., a plate electrode) will necessarily be attached to, or placed in sufficient proximity to ~e electrically coupled to, the body of the patient to complete an elec~rical circuit or between the electrode tip of the device and the second electrode. On the other hand, i~ the device is of the bipolar type, the second electrode will be formed or mounted upon the body of the probe, and no externally-attached second electrode will be re~uired.
Still further in accordance with the invention, there is provided an electrosurgical system for forming small (e.g., less than 3mm) openings in the anterior lens capsule of the ~-m~ n eye, said system comprising an electrosurgical pro~e device of the above-described 2~ character, further in combination with: a handpiece sized and con~igured to be grasped by the human hand, said handpiece having a distal end and a proximal end; an electrical signal generating apparatus which is connectable to said handpiece, an on/off switch for ~tarting and stopping a flow of current from the electrical signal generating apparatus to the handpiece; connector apparatus to connect the distal end of the handpiece to the prox; m~ 1 - end of said probe device and to pass said electrical current from the hand piece to the annular electrode tip of the probe.
Still fur~her in accordance with the invention, there is provided a method for forming an opening in the lens capsule of the eye, said method generally comprising the steps of: a) providing an electrosurgical probe device comprising an elongate probe having a prox; m~l end, a W O 98/19615 PCTrUS97/20698 distal end, and an electrode tip formed on the distal end thereof; b) inserting the probe into the eye such that the electrode tip is in contact with the lens capsule of the eye; c) passing electrical current through the probe and to the electrode tip, ~aid electrical current being of sufficient magnitude to form an opening in said lens capsule at the location where said electrode tip is i~
contact with the ~ens capsule.
Further objects and advantages of the present invention will become apparent to those skilled in the art upon reading and understanding of the following detailed description and the accompanying drawings.
Brief DescriPtion of the Drawinq~
Figure 1 is a perspective view showing an electrosurgical probe device of the present invention operatively inserted into a human eye.
Figure 2 is a perspective view of a system of the present invention comprising a) an electrical signal generating apparatus, b) a handpiece, and c) an electrosurgical probe device of the present invention mounted on the distal end of the handpiece.
Figure 3a is a partial perspective view of a connector assembly, ~ormed on the distal end o~ the handpiece shown in Figure 2.
Figure 3 is a rear perspective view of a monopolar embodiment of the electrosurgical probe device of the present invention.
Figure 4 is a longitudinal sectional view of the monopolar electrosurgical probe device shown in Figure 3.
Figure 5 is a perspective view of a segment of hypotubing from which a notch has been removed to form an annular electrode tip usable in the electrosurgical probe devices of the present invention.
Figure 5a is a perspective view of an ann~lar electrode tip formed from the notched segment of hypotubing shown in Figure 5.
Figure 6 is a perspective cut-away view of the monopolar embodiment shown in Figures 3-4.
Figure 7 is a perspective cut-away view of a first ~ipolar embodiment of an electrosurgical probe device of the present invention.
Figure 8 is a cross sectional view through line 8-8 of Figure 7.
Figure 9 is a longitudinal sectional view of a second (alternative) bipolar embodiment of an electrosurgical probe device of the present invention.
Figure 10 is a cross sectional view through line 10-10 of Figure 9.
Figures lla-llc are graphic representations of power vs. time, illustrating variation in the electrical wa~e forms and power levels which may be utilized in conjunction with the device and system of the present invention.
Detailed DescriPt:ion oE the Prei~e~red Embc--lim~nts The following detailed description and the accompanying drawings are provided for the purpose of illustrating and describing presently preferred embodiments of the invention only, and are not intended to limit $he scope of the invention in any way.
With reference to the drawings, there is provided an electrosurgical probe device 10 which is usable to ~orm small openings (e.g., less than-3mm) in the anterior lens capsule LC of the eye. In general, the electrosurgical probe device 10 comprise6 a proxlmal attachment/contact hub 12 having an elongate probe member 14 extending distally therefrom, and an annular electrode tip 16 mounted on the distal end of the elongate pro~e portion 14. The annular electrode tip 16 is disposed at an angle relative to the longitl-~; nal axis LA of the elongate probe portion 14.
Figure 1 shows a preferre~ method by which the electrosurgical probe device 10 of the present invention W O 98119615 PCTrUS97/20698 may be inserted into the eye E for th~ purpose o~ forming a small te.g., le6s than 3mm) opening in the anterior lens capsule LC of the eye E. It will be noted from Figure 1 that the lens capsule LC is ~uspended within the eye E, behind the anterior chamber AC and cornea C. The lens capsule LC is maintained in its normal anatomical location by various anchoring structure~ o~ the eye, including suspensory ligaments S~ which are located posterior to the iris I of the eye E. In operation, a small incision is formed in the cornea C and the elongate probe porti~n 14 of the device lQ is inserted through such incision, and is advanced through the anterior chamber AC of the eye E until the annular electrode tip 1~ comes into contact with the anterior aspect o~ lens capsule ~C. Thereafter, electrical current is passed through the annular electrode tip 16 so as to cause the tip 14 to penetrate the lens capsule LC t thereby forming an annular opening which is approximately of the same size and configuration as the annular electrode tip 16.
As the annular electrode tip ~6 elec~rosurgically penetrates the lens capsule LC, heat will cauterize or melt the portion of the lens capsule ~C which surrounds the opening formed by the electrode tip 16, thereby strengthening or reinforcing the edges of such opening.
Such strengthening or reinforcement of the periphery of the opening will prevent or deter subsequent tearing, undesired enlargement or extension of the opening as the cataract removal and/or lens replacement instruments are passed ~hrough the opening.
With reference to Figure 2-2a, the electrosurgical probe device 10 of the present invention may be constructed and configured so as to be usable as an attachment to an electrocautery system of a type typically used in ophthalmological surgery. Such electrocau~ery systems typically comprise a handpiece 18, an electrical signal W O98/19615 PCT~US97/20698 generator 20 and an on/off switch such as a ~oot pedal ~2.
One example of a commercially available electrocautery system o~ the type shown in Figures 2-2a is the Surgitron~
Model FFPF available from Ellman International, Inc., 113 5 Railroad Avenue, Hewlett, New York 11557.
In the embodiment shown in Figures 2-2a, a connector assembly 24 is formed on the distal end of the handpiece 18 to facilitate connection with an electrical contact to the electrosurgical probe device 10 of the present invention.
In the embodiment shown, the connector assembly 24 comprises a generally cylindrical, distally extending contact post 26 surrounded by an internally threaded, rotatable, ~uer-lock sleeve 24. The contact post is insertable into a receiving contact bore ~ormed on the proximal end of the probe device 10, and the Luer-lock sleeve is then usable to engage and lock the probe device 10 to the handpiece 18 such that the contact post 26 of handpiece 18 is held in firm electrical contact with the probe device 10.
It will be appreciated that the electrosurgical probe device 10 generally described hereabove, may be specifically constructed in either monopolar or bipolar embodiments, as more fully described herebelow:
i. Monopolar Embo~ L~
Figures 3-6 show a monopolar electrosurgical probe device 10a of the present inventionr which is usable in conjunction with an electrocautery system of the type shown in Figures 2-2a.
As shown in Figures 3-6, the monopolar electrosurgical probe device 10a is constructed such that the annular electrode tip 16a is the only electrode present on the body of the probe device 10a. A second electrode, such as a plate electrode (not shown) r must be separately attached to or brought into proximity with the body of the patient in 3~ order that an electrical circuit or capacitive coupling be W O 98/19615 PCT~US97/20698 completed ~etween the annular electrode tip }6a and such externally-placed second electrode (not shown).
As shown, the proximal hub 12a of the monopolar probe device lOa comprises an electrically conductive, generally cylindrical, hub 30 having a Leur-lock flange 32 ~ormed therearound~ An insulative covering 34, formed o~
polyvinyl chloride ~PVC~ or other suitable plastic, may be formed about the outer surface of the cylindrical hub 30, but should not interfere with the engagement of the Luer-lock ~lange 32 to the internal threads of the rotatablesleeve 28 of the handpiece connector assembly 24.
The distally-extending probe portion 14a of the monopolar probe device lOa may comprise a rigid base tube 36 which is continuous with and protrudes distally from the ~rusto-conical pro~;mal hub 30 as shown. A first hypotube member 38 is inserted into a distal portion of the base tube 36, and extends axially therefrom, as shown. A second hypotu~e member 40 is inserted into a distal portion o~ the ~irst hypotu~e memher 38, and extends distally therefrom, as shown. The annular electrode tip 16a is formed on the distal end of this second hypotube member 40.
One means by which the annular electrode tip may be ~ormed on the distal end of the second hypotube member 40 is illustrated in Figures 5 and ~a. With reference to Figures 5~5a the second hypotube member 40 has a notch 42 cut away therefrom. Such notch 42 is configured such that its distal edge is perpendicular to the longitudinal axis LA of the second hypotube member 40, and its proximal edge is curved or acutely angled relative to such longitudinal axis LA. This results in the formation of a substantially cylindrical ring at the distal end of the second hypotube member 40, such ring being connected by a remnant portion 44 of the second hypotube 40 to that pro~;~l portion of the second hypotube 40 located proximal to the notch 42.
The distal surface DS of the cylindrical ring formed W O 98/19615 PCT~US97/20698 at the distal end of the second ~ypotube member 40 is initially disposed in a plane which is perpendicular to the longitudinal axis LA. ~owever, the remnant portion 44 is bent in a direction away ~rom the longitudinal axis ~A such 5 that the plane P of the distal surface of the ring member at the distal end of the second hypotube member 40 forms an internal angel A relative to the longit~l~;n~l axis L~.
Also, electrically conductive wire 54 is soldered or otherwise affixed to the interior of the second hypotube member 40.
Upon assembly, the pro~;m~l portion of the second hypotu~e member prepared as shown in Figure 5a, is inserted into the distal portion o~ the bore of the first hypotube member 38, and is affixed thereto. Similarly, the first hypotube member 38 is affixed to the base tube 36 which in turn is affixed to the frusto-conical proximal hub 30.
Such direct affixation of the hypotube member 38, base tube 36 and frusto-conical proximal hub 30 ma~ be sufficient to provide reliable electrical contact and conduction therebetween. However, if reliable electrical contact and conduction between such components is not accomplished by their direct a~fixation to one another, an added electrical conductive wire 54 may optionally be soldered or otherwise electrically connected to any or all of the hypotube member 2~ 38, base tube 36 and/or prox;~-l hub 30, to facilitate electrical conduction therebetween.
The angle A of the distal surface DS of the annular electrode tip 16a of the probe device lOa may vary, depending on the intended positioning of the electrosurgical probe device lOa within the eye E.
Typically r it will be desirable to position the electrosurgical probe device lOa in a manner similar to that shown in Figure 1. Thus, in most cases, it will be desirable ~or the distal surface DS of the annular electrode tip 16a to form an internal angle A of no less CA 02242328 l998-07-06 ~han 90~ and typically in the range of 90~-1~0~. In the embodiment shown, a fi:rst insulative sheath 50 is heat-shrunk or otherwise secured about the proximal portion of the second hypotube member 40 and the distal portion o~ the first hypotube member 38. This insulative ~heath 50 helps to securely join the first 38 and second 40 hypotube members together and also provides an insulative outer covering thereon. A second insulative sheath 52 is then ~ormed about the proximal portion of the first insulative sheath 50 and about the base tube 36.
The monopolar electrosurgical probe lOa is attachable to the connector assembly 24 of the electrocautery system shown in Figures 2-2a by inserting the contact post 26 of the connector assembly 24 into the proximal hub 30a such 1~ that the outer surface of the contact post 26 is in direct abutting contact with the inner surface of the frusto-conical hub 30a. Thereafter, the rotatable sleeve 24 is rotata~ly advanced such that the internal threads of the rotatable sleeve 34 will engage the Luer-lock flange 32a of the proximal hub 30. In this manner, electrical current ~rom the electrical signal generator 20 will pass through the hand piece 18, from the contact post 26 and to the hub 30a of the probe device lOa. Such current will then pass from the hub 30 through the electrically conductive walls o~ the first 38 and second 40 hypotube members and/or through the electrically conductive wire 54. The current will then pass from the annular electrode tip 16a to a second elec~rode (not shown) which has been attached to or brought into proximity with the patient's body to complete the electrical circuit or establish the required capacitive coupling.
ii. Bipolar EmboAi ~s Figure 7-8 show a first embodiment o~ a bipolar electrosurgical probe lOb of the present invention, while Figures 9-10 show an alternative bipolar electrosurgical W O 98/1961~ PCTrUS97/20698 probe lOc which has a structure substantially similar to (and which shares many common structural attributes with) that of the monopolar embodiment lOa described hereabove and shown in Figures 3-6.
With reference to Figur~ 7-8, this bipolar probe device lQb of the present invention comprises an elongate probe portion 14b formed of an inner tubular electrode member 60, an outer tu~ular electrode member 62 and an insulating tubular she~th 64 positioned therebetween. The inner tubular electrode 60 member, outer tu~ular electrode member 62 and insulative tubular sheath 64 are disposed coaxially about a common longitudinal axis LA. The distal end o~ the inner tubular electrode 60 forms the annular electrode tip 16b. In the embodiment shown, this annular electrode tip 16b is ~ormed ~y cutting the distal end o~
the inner tubular electrode 6Q such that the it's distal sur~ace is perpendicular (i.e., at a 90~ angle) relative to the longitudinal axis LA. It will be appreciated, however, that the dïstal end of the inner tubular electrode 60, the outer tubular electrode 62 and/or the interposed sheath 64, may be cut at various angles relative to the longitudinal axis ~A, so as to provide di~ferent angular dispositions of the annular electrode tip 16b. Similarlyl the distal end of the outer electrode member 62 as well as the insulation sheath 64 may be axially spaced and fastened to one another such that the respective distal ends of the inner tubular electrode 60, insulation sheath 64 and outer electrode members 62 will form such angle.
The elongate probe portion 15b of this first bipolar probe lOb shown in Figure 7-8 extends distally from and is connected to a proximal hub (not shown) which may be substantially the same as the proximal hub 12a described hereabove with respect to the monopolar probe device lOa.
However, in this bipolar embodiment, only the inner tubular electrode 60 is electrically connected to the pro~;~l hub, W O 98/19615 PCTrUS97/20698 a~d the outer tubular electrode 62 is connected separately by a separate electrical connection to the signal generating apparatus 20, thereby completing the desired bipolar circuit of this embodiment As shown in Figure 7~ the distal end o~ the outer tubular electrode 62 may terminate a spaced distance proximal to the distal end of the inner tubular electrode 60. Also, the distal portion of the tubular insulating sheath 64 which protrudes beyond the distal end of t~e ~uter tubular electrode may be tapered, in the manner sho~n in Figure 7. In this manner, when the ~ipolar probe device lOb is inserted into the eye, the distal end of the inner tubular electrode 60 is positioned in contact with the lens capsule ~C. ~hereafter, when energized, electrical current will flow between the distal end of the inner tubular electrode 60 (which forms the annular electrode tip 16b) the adjacent distal portion of the outer tubular electrode 62. Thus, in this first bipolar embodiment, there is no need for a separate external electrode to be attached to or brought into proximity with the patient's body, as is required of the above-described monolar polar probe device lOa.
Figures 9 and ~0 shows an alternative or second embodiment of a bipolar probe device lOc which is similar in construction to the monopolar probe lOa described hereabove. This second embodiment of the bipolar probe lOc comprises a proximal hub 12c having an elongate probe portion 14c extending ~ lly therefrom, in a distal direction. An annular electrode tip 16c is formed on the distal end of the probe portion 14c. The cylindrical hub 30c, first hypotube member 38c, second hypotu~e mem~er 40c, remnant portion 44c, annular electrode 16c and electrically conductive wire 54c are constructed, con~igured and assembled in the same manner as described hereabove with respect to the monopolar embodiment.
CA 02242328 l998-07-06 W O 98/19615 PCT~US97/20698 However, in this second bipolar embodiment, an outer electrode tube 70, formed of electrically conductive material, surrounds the insulative sheet 50c. Such outer electrode tube 70 is connected to an electrically conductive wire 5~ which e~tends through the insulative casing 34c of the proximal hub 12c and i8 connectable to the electrical signal genera~ing device 20. The outer electrode tube 70 is distally coterminous with the insulative sheath ~Oc, such that only the remnant portion 44c of the second hypotube member 40c and the annular electrode tip 16c protrude distally beyond the distal end of the outer_electrotube 70.
In operation, this second bipolar em~odiment of the device lOc is inserted into ~he eye such that a distal portion o~ the probe portion 14c extends thro~gh the anterior chamber AC, and the distal surface DS of the annular electrode tip 16c is in contact with the anterior lens capsule. ~hereafter, electrical current from the electrical signal generator 20 may pass through the electrically conductive wire members 54c, 55 and/or other electrically conductive portions of the pro~e de~ice lOc as described hereabove, such that current will ~low ~rom the annular electrode tip 16c to the distal portion of the outer tubular electrode 40 through the electrically-conductive fluid environment within the anterior chamber ofthe eye.
It will be appreciated that the annular electrode tip 16, 16a, 16b, 16c described hereabove may comprise any appropriate geometrical configuration, and may have an open center (e.g., a ring or hoop) or alternatively may have a solid center (e.g., a disc having a generally annular outer edge). Furthermore, it will be appreciated that the lens capsule contacting surface, such as the distal surface, of the annular electrode tip 16, 16a, 16~, 16c need not be substantially flat or planar, and may be slightly concave - W O 98/19615 PCT~US97/20698 or of any other suitable configuration. In this manner, when reference is made in thi~ patent application to the plane" in which the lens capsule contacting sur~ace of the distal electrode tip lie, it will be appreciated that such plane may ~e projected throu~h a concaved or wavy surface of an average variant thereo~. ~lternatively, in embodiments wherein the lens capsule contacting surface of the annular electrode tip 16, 16a, 16b, 16c is flat, such entire ~lat edge may lie within the referenced plane.
iii. Preferred Methods of OPeratin~ the Devices Any and all of the above-described embodiments of the present invention are preferably operated in accordance with a general method wherein at least a distal portion of the elongate probe porti~n 14, 14a, 14b, 14c is inserted 1~ through an incision in the cornea C and is advanced through the anterior chamber AC until the lens-capsule-contacting distal surface DS of the annular electrode tip 16, 16a, 16b, 16c is in contact with the lens capsule LC. If a monopolar embodiment of the probe device 10a is used a secondary electrode will be attached to or brought into close proximity with the body of the patient at a location which is suitable to complete an electrical circuit between the annular electrode tip 16a of the probe 10a and such second electrode. On the other hand, i~ one of the bipolar embodiments of the probe device 10b, 10c are used, there will be no need to provide a separate second electrode wit~
is attached to or placed in proximity with, the body of the patient.
Therea~ter, the electrical signal generating device 20 is actuated so as to cause current to flow between the annular electrode tip 16, 16a, 16b, 16c and either the separately attached secondary electrode (monopolar embodiment) or the on-board outer electrode tube 62, 70.
Any suitable electrical wave ~orm and power level may be used. In this regard, in at least some applications it W O 98/19615 PCTrUS97/20698 will be desirable to use a continuous, pulsed or superpulsed wave form which pro~ides an average power level of approximately 10 watts to form the desired opening in the anterior lens capsule.
In embodiments of the system wherein the wave form is intended to be pulsed or superpulsed, the signal-generating device 20 will preferably include a mechanism for setting ~ the desired pulse duration, pulse train duration, pulse bunch duration and/or duty cycle, examples of which are shown graphically in Figures lla, llb and llc.
With re~erence to lla, there is shown the average power generated by single pulse, of known pulse duration PD.
Figure llb shows the average power generated by a train of individual pulses, each of said individual pulses having a pulse duration PDr and the overall train of pulses having a pulse train duration PTD.
Figure llc shows a superpulsed embodiment of the invention wherein bunches of small individual pulses, each of ~aid individual pulses having a pulse duration PD of 10 milliseconds, are generated periodically on a given repeat period RP.
It will be appreciated that the electrical signal generating device 20 may be preprogrammed to deliver 2~ desired energy levelsr and/or wave ~orm(s) in response to each triggering of a fixed on-off switch. Alternatively, the signal generating device 20 may be rheostatically controlled by way of a ~oot pedal or other type of rheostatic control device r and the amount and duration of energy delivered through the annular electrode tip 16, 16a, 16b, 16c will be determined by the current position of the foot pedal or other rheostatic control mechanism.
In the above-described manner, the electrosurgical probe device lO of the present invention is ~sa~le to form an opening in the lens capsule LC of a size which is only W O98/1961~ PCT~US97120698 slightly larger than the outer diameter of the annular electrode tip 16, 16a, 16b, 16c. Furthermore, when the preferred wave form and power setting are used, the resultant electrosurgical opening of the lens capsule will additionally form a heat-fused region around such openiny, thereby preventing the anterior aspect of the lens capsule ~rom being torn, enlarged or extended during the subsequent insertion and manipulation of the cataract removal device(s) and/or prosthetic lens implant introduction cannula.
The present invention has been described hereabove with reference to certain presently prefèrred em~odiments only. No attempt has been made to exhaustively describe all possible embodiments in which the invention may be practiced. Indeed, various additions, deletions, modifications and alterations may be made to the above-described pre~erred embodiments without departing from the intended spirit and scope of the invention. Accordingly, it is intended that all such reasonable additions, deletions, modifications and alterations be included within the scope of the following claims.
Claims (26)
1. A device useable to form an opening in an anatomical structure such as the lens capsule of a mammalian eye, said device comprising:
an elongate probe having a proximal end, a distal end and a longitudinal axis projectable therethrough:
an annular electrode tip on the distal end of said elongate probe;
said annular electrode tip having a lens capsule contacting surface which lies substantially in a plane that is non-parallel to the longitudinal axis of the probe;
said probe being thereby insertable into the eye such that the lens capsule contacting surface of the annular electrode tip is in contact with the lens capsule, whereby passage of electrical current through annular electrode tip will create an opening in the lens capsule.
an elongate probe having a proximal end, a distal end and a longitudinal axis projectable therethrough:
an annular electrode tip on the distal end of said elongate probe;
said annular electrode tip having a lens capsule contacting surface which lies substantially in a plane that is non-parallel to the longitudinal axis of the probe;
said probe being thereby insertable into the eye such that the lens capsule contacting surface of the annular electrode tip is in contact with the lens capsule, whereby passage of electrical current through annular electrode tip will create an opening in the lens capsule.
2. The device of Claim 1 wherein said device is monopolar, and wherein said device further comprises:
a second electrode which is electrically coupleable to the body of the patient so as to establish at least capacitive coupling between the annular electrode tip of the device and said second electrode.
a second electrode which is electrically coupleable to the body of the patient so as to establish at least capacitive coupling between the annular electrode tip of the device and said second electrode.
3. The device of Claim 2 further comprising:
means for attaching said second electrode to the body of the patient, such that said second electrode is in abutment with the body of the patient.
means for attaching said second electrode to the body of the patient, such that said second electrode is in abutment with the body of the patient.
4. The device of Claim 2 further comprising:
means for maintaining the second electrode at a spaced distance from the body of the patient, such that said second electrode is capacitively coupled to the body of the patient.
means for maintaining the second electrode at a spaced distance from the body of the patient, such that said second electrode is capacitively coupled to the body of the patient.
5. The device of Claim 1 wherein said device is bipolar, and wherein said probe further comprises:
a second electrode formed on said probe in sufficient proximity to said annular electrode tip so as to complete an electrical circuit between said annular electrode tip and said second electrode, when said probe is inserted into the eye such that the distal surface of the annular electrode tip is in contact with the lens capsule.
a second electrode formed on said probe in sufficient proximity to said annular electrode tip so as to complete an electrical circuit between said annular electrode tip and said second electrode, when said probe is inserted into the eye such that the distal surface of the annular electrode tip is in contact with the lens capsule.
6. The device of Claim 1 wherein said annular electrode tip is formed of:
an electrically conductive tube member having a proximal end, a distal end, and a longitudinal axis projectable therethrough;
a notch being cut away from the tube member adjacent the distal end thereof, such that a ring is formed, said ring being attached to the portion of the tube member which is proximal to said notch by way of a remanent portion of the tube;
the proximal end of said electrically conductive tube member being coaxially mounted on the distal end of the probe such that the ring member formed at the distal end of said tube member forms the annular electrode tip of the probe.
an electrically conductive tube member having a proximal end, a distal end, and a longitudinal axis projectable therethrough;
a notch being cut away from the tube member adjacent the distal end thereof, such that a ring is formed, said ring being attached to the portion of the tube member which is proximal to said notch by way of a remanent portion of the tube;
the proximal end of said electrically conductive tube member being coaxially mounted on the distal end of the probe such that the ring member formed at the distal end of said tube member forms the annular electrode tip of the probe.
7. The device of Claim 1 wherein said annular electrode tip is formed by a loop of wire which is mounted on the distal end of the probe.
8. The device of Claim 1 further comprising an electrically conductive wire which extends from the annular electrode tip to the proximal end of the probe to facilitate the conduction of an electrical current from the proximal end of the tube to the annular electrode tip.
9. The device of Claim 6 wherein said tube member is connected to the proximal end of said probe by an electrically conductive wire to facilitate conduction of an electrical current from the proximal end of the probe to said annular electrode tip formed by said tube member.
10. The device of Claim 7 wherein said loop of wire is connected to the proximal end of the tube by an electrically conducting wire to facilitate conduction of an electrical current from the proximal end of the probe to said annular electrode tip formed by said loop of wire.
11. The device of Claim 6 wherein the distal surface of said ring formed at the distal end of said tube member comprises the lens capsule contacting surface of the annular electrode tip, and wherein said remnant portion of the tube member is bent such that the distal surface of said ring member is disposed in a plane which forms an internal angle of 90-150 degrees relative to said longitudinal axis.
12. An electrosurgical system incorporating the probe device of Claim 1, said system comprising:
a probe device according to Claim 1;
a handpiece sized and configured to be grasped by the human hand, said handpiece having a distal end and a proximal end;
an electrical signal generating apparatus which is connectable to said handpiece;
an on/off switch for starting and stopping a flow of electrical current from the signal generating apparatus to the handpiece;
connector apparatus to connect the distal end of the handpiece to the proximal end of said probe device and to pass said electrical current from the hand piece to the annular electrode tip of the probe.
a probe device according to Claim 1;
a handpiece sized and configured to be grasped by the human hand, said handpiece having a distal end and a proximal end;
an electrical signal generating apparatus which is connectable to said handpiece;
an on/off switch for starting and stopping a flow of electrical current from the signal generating apparatus to the handpiece;
connector apparatus to connect the distal end of the handpiece to the proximal end of said probe device and to pass said electrical current from the hand piece to the annular electrode tip of the probe.
13. The system of Claim 12 wherein said probe device is monopolar, and wherein said system further comprises:
a second electrode which is electrically coupleable to the body of the patient so as to establish at least capacitive coupling between the annular electrode tip of the probe device and said second electrode.
a second electrode which is electrically coupleable to the body of the patient so as to establish at least capacitive coupling between the annular electrode tip of the probe device and said second electrode.
14. The system of Claim 13 further comprising:
means for attaching said second electrode to the body of the patient, such that said second electrode is in abutment with the body of the patient.
means for attaching said second electrode to the body of the patient, such that said second electrode is in abutment with the body of the patient.
15. The system of Claim 13 further comprising:
means for maintaining the second electrode at a spaced distance from the body of the patient, such that said second electrode is capacitively coupled to the body of the patient.
means for maintaining the second electrode at a spaced distance from the body of the patient, such that said second electrode is capacitively coupled to the body of the patient.
16. The system of Claim 10 wherein said probe device is bipolar, and wherein said system further comprises:
a second electrode formed on said probe in sufficient proximity to said annular tip electrode to complete an electrical circuit therebetween when said probe is inserted into the eye such that the annular tip electrode is in contact with the lens capsule;
and, connector apparatus for connecting said second electrode to said current generating apparatus so as to complete an electrical circuit between said annular electrode tip and said second electrode.
a second electrode formed on said probe in sufficient proximity to said annular tip electrode to complete an electrical circuit therebetween when said probe is inserted into the eye such that the annular tip electrode is in contact with the lens capsule;
and, connector apparatus for connecting said second electrode to said current generating apparatus so as to complete an electrical circuit between said annular electrode tip and said second electrode.
17. The monopolar device of Claim 6 further comprising an insulating sheath formed around the portion of said probe which is proximal to the annular electrode tip and which resides in the eye when the probe is inserted into the eye such that the lens capsule contacting surface of the electrode tip is in contact with the lens capsule.
18. A method of forming an opening in the lens capsule of the eye, said method comprising the steps of:
a) providing an electrosurgical probe device comprising an elongate probe having a proximal end, a distal end, and an electrode tip formed on the distal end thereof;
b) inserting the probe into the eye such that the electrode tip is in contact with the lens capsule of the eye, c) passing electrical current through the probe and to the electrode tip, said electrical current being of sufficient magnitude to form an opening in said lens capsule at the location where said electrode tip is in contact with the lens capsule.
a) providing an electrosurgical probe device comprising an elongate probe having a proximal end, a distal end, and an electrode tip formed on the distal end thereof;
b) inserting the probe into the eye such that the electrode tip is in contact with the lens capsule of the eye, c) passing electrical current through the probe and to the electrode tip, said electrical current being of sufficient magnitude to form an opening in said lens capsule at the location where said electrode tip is in contact with the lens capsule.
19. The method of Claim 18 wherein the probe device provided in step a is monopolar, and wherein step a further comprises:
electrically coupling a secondary electrode to the body of the patient.
electrically coupling a secondary electrode to the body of the patient.
20. The method of Claim 19 wherein the step of electrically coupling said secondary electrode to the body of the patient comprises attaching said secondary electrode to the body of the patient, in abutting contact therewith.
21. The method of Claim 19 wherein the step of electrically coupling said secondary electrode to the body of the patient comprises positioning said secondary electrode in close but not abutting proximity to the body of the patient to establish capacitive coupling between the body of the patient and said secondary electrode.
22. The method of Claim 18 wherein step c further comprises:
passing an electrical current having a power of approximately 10 watts, through the probe and to the electrode tip.
passing an electrical current having a power of approximately 10 watts, through the probe and to the electrode tip.
23. The method of Claim 18 wherein the electrical current which is passed through the probe in step c of the method comprises pulsed electrical current.
24. The method of Claim 18 wherein the electrical current passed through the probe in step c of the method comprises bunches of pulses of electrical current separated by intervening periods of at least minimal electrical current.
25. The method of Claim 18 wherein the electrical current passed through the probe in step c of the method is super pulsed electrical current.
26. The method of Claim 18 wherein step c further comprises:
passing electrical current of a generally sinusoidal wave form through the probe and to the electrode tip.
passing electrical current of a generally sinusoidal wave form through the probe and to the electrode tip.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/744,404 US5957921A (en) | 1996-11-07 | 1996-11-07 | Devices and methods useable for forming small openings in the lens capsules of mammalian eyes |
| US08/744,404 | 1996-11-07 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2242328A1 true CA2242328A1 (en) | 1998-05-14 |
Family
ID=24992589
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002242328A Abandoned CA2242328A1 (en) | 1996-11-07 | 1997-11-05 | Devices and methods useable for forming small openings in the lens capsules of mammalian eyes |
Country Status (13)
| Country | Link |
|---|---|
| US (2) | US5957921A (en) |
| EP (1) | EP0888088A4 (en) |
| JP (1) | JP2001511662A (en) |
| KR (1) | KR19990077048A (en) |
| CN (1) | CN1146364C (en) |
| AU (1) | AU736683B2 (en) |
| BR (1) | BR9707460A (en) |
| CA (1) | CA2242328A1 (en) |
| CZ (1) | CZ211098A3 (en) |
| IL (1) | IL125156A (en) |
| NO (1) | NO983078L (en) |
| WO (1) | WO1998019615A1 (en) |
| YU (1) | YU28498A (en) |
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- 1997-11-05 WO PCT/US1997/020698 patent/WO1998019615A1/en not_active Application Discontinuation
- 1997-11-05 EP EP97946661A patent/EP0888088A4/en not_active Withdrawn
- 1997-11-05 CA CA002242328A patent/CA2242328A1/en not_active Abandoned
- 1997-11-05 CZ CZ982110A patent/CZ211098A3/en unknown
- 1997-11-05 CN CNB971925755A patent/CN1146364C/en not_active Expired - Fee Related
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- 1997-11-05 KR KR1019980705181A patent/KR19990077048A/en not_active Application Discontinuation
- 1997-11-05 JP JP52188298A patent/JP2001511662A/en active Pending
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1998
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8195286B2 (en) | 1997-01-22 | 2012-06-05 | Abbott Medical Optics Inc. | Control of pulse duty cycle based upon footswitch displacement |
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| US10245179B2 (en) | 2002-10-21 | 2019-04-02 | Johnson & Johnson Surgical Vision, Inc. | System and method for pulsed ultrasonic power delivery employing cavitation effects |
| US10765557B2 (en) | 2002-10-21 | 2020-09-08 | Johnson & Johnson Surgical Vision, Inc. | Modulated pulsed ultrasonic power delivery system and method |
| US8366728B2 (en) | 2006-08-01 | 2013-02-05 | Abbott Medical Optics Inc. | Vacuum sense control for phaco pulse shaping |
| US9226849B2 (en) | 2006-08-01 | 2016-01-05 | Abbott Medical Optics Inc. | Vacuum sense control for phaco pulse shaping |
| US9050627B2 (en) | 2011-09-02 | 2015-06-09 | Abbott Medical Optics Inc. | Systems and methods for ultrasonic power measurement and control of phacoemulsification systems |
| US11877953B2 (en) | 2019-12-26 | 2024-01-23 | Johnson & Johnson Surgical Vision, Inc. | Phacoemulsification apparatus |
Also Published As
| Publication number | Publication date |
|---|---|
| AU5178798A (en) | 1998-05-29 |
| US5957921A (en) | 1999-09-28 |
| IL125156A0 (en) | 1999-01-26 |
| JP2001511662A (en) | 2001-08-14 |
| EP0888088A1 (en) | 1999-01-07 |
| US6142996A (en) | 2000-11-07 |
| NO983078D0 (en) | 1998-07-02 |
| CN1146364C (en) | 2004-04-21 |
| BR9707460A (en) | 2000-01-04 |
| KR19990077048A (en) | 1999-10-25 |
| WO1998019615A1 (en) | 1998-05-14 |
| NO983078L (en) | 1998-09-07 |
| EP0888088A4 (en) | 2000-07-19 |
| YU28498A (en) | 2001-12-26 |
| CN1211908A (en) | 1999-03-24 |
| CZ211098A3 (en) | 1998-11-11 |
| IL125156A (en) | 2003-05-29 |
| AU736683B2 (en) | 2001-08-02 |
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Legal Events
| Date | Code | Title | Description |
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| EEER | Examination request | ||
| FZDE | Discontinued |