Attenuated RF power for automated capsulorhexis

A capsulorhexis apparatus includes a capsulorhexis probe configured for insertion into an eye through an incision and a pulse generator configured to deliver at least one radio-frequency (RF) pulse to the capsulorhexis probe. The delivered RF pulse has a pre-determined attenuation profile such that the power level of the delivered RF pulse is substantially attenuated over the RF pulse's duration. In some embodiments, the pulse generator is configured to deliver a series of two or more RF pulses to the eye, such that the energy of each of the second and subsequent pulses of the series is substantially attenuated relative to the energy of the immediately preceding pulse.

TECHNICAL FIELD

The present invention relates generally to the field of cataract surgery and more particularly to methods and apparatus for performing a capsulorhexis.

BACKGROUND

An accepted treatment for cataracts is surgical removal of the lens and replacement of the lens function by an artificial intraocular lens. In the United States, the majority of cataractous lenses are removed by a surgical technique called phacoemulsification. Prior to removing the cataractous lens, an opening, or rhexis, must be made in the anterior capsule. During phacoemulsification, there is a great deal of tension on the cut edges of the anterior capsulorhexis while the lens nucleus is emulsified. Accordingly, a continuous cut or tear (rhexis), without “tags,” is a critical step in a safe and effective phacoemulsification procedure.

If the capsule is opened with numerous small capsular tears, the small tags that remain can lead to radial capsular tears which may extend into the posterior capsule. Such a radial tear constitutes a complication since it destabilizes the lens for further cataract removal and safe intraocular lens placement within the lens capsule later in the operation. Further, if the posterior capsule is punctured then the vitreous may gain access to the anterior chamber of the eye. If this happens, the vitreous must be removed by an additional procedure with special instruments. The loss of vitreous is also associated with an increased rate of subsequent retinal detachment and/or infection within the eye. Importantly, these complications are potentially blinding.

Conventional equipment used for phacoemulsification includes an ultrasonically driven handpiece with an attached cutting tip. In some of these handpieces, the operative part is a centrally located, hollow resonating bar or horn directly attached to a set of piezoelectric crystals. The crystals supply ultrasonic vibration for driving both the horn and the attached cutting tip during phacoemulsification.

Many of the known devices and methods used for the capsulorhexis procedure require a great deal of skill on the part of the surgeon to produce a continuous curvilinear capsular opening. This is due to the extreme difficulty in controlling the path of the cutting tip of the device. For example, a typical procedure begins with a capsular incision made with a cystotome, e.g., a cutting tip as described above. This incision is then coaxed into a circular or oval shape by pushing the leading edge of the incision in the capsule, using the cystotome as a wedge rather than in a cutting fashion. Alternatively, the initial capsular incision may be torn into a circular shape by grasping the leading edge with fine caliber forceps and advancing the cut. Either of these approaches involves a very challenging maneuver and the tearing motion can sometimes lead to an undesirable tear of the capsule toward the back of the lens, even in the most experienced hands.

Moreover, even if a smooth capsular opening without tags is ultimately produced, the size and/or position of the capsular opening may present a problem. For instance, a capsular opening that is too small can impede the safe removal of the lens nucleus and cortex and prevent proper intraocular lens insertion into the lens capsule. The additional stresses necessary to accomplish the operation with a small or misplaced capsular opening put the eye at risk for zonular and capsular breakage. Either of these complications will likely increase the length and complexity of the operation and may result in vitreous loss.

A continuous, properly positioned, and circular opening is thus highly desirable because it results in: (1) a significant reduction in radial tears and tags within the anterior capsule, (2) capsule integrity necessary for proper centering of a lens prosthesis; (3) safe and effective hydrodissection; and (4) safe use of capsular procedures on patients having poorly visualized capsules and/or small pupil openings. In addition, the capsulorhexis should be properly dimensioned relative to the diameter of the intraocular lens being implanted in order to reduce the chances of a secondary cataract, also called posterior capsule opacification and for use with proposed accommodative intraocular lens designs. Therefore, there is a continuing need for improved devices for performing anterior chamber capsulorhexis.

Various methods and devices for automating the capsulorhexis process have been proposed. One approach is described in U.S. patent application Ser. No. 12/618,805, filed 16 Nov. 2009 and titled “Capuslarhexis Device Using Pulsed Electric Fields” (hereinafter “the '805 application”). The '805 application, the entire contents of which are incorporated by reference herein, describes methods and apparatus for performing capsulorhexis using high-frequency electrical currents applied to the anterior lens capsule through a unipolar electrode. The device uses pulsed electric fields to perform the cutting action—the pulsed electric field is generated using a ring electrode, placed against the anterior capsule of the eye, and a grounding electrode located at a different position inside or outside the eye. In some embodiments of this system, the ring electrode comprises a thin, electrically conducting wire. A very small cross-section (e.g., less than about 0.25 millimeters in diameter) will yield high-intensity electric fields close to the wire; these electric fields will reduce in intensity further away from the wire. Because a ground electrode having a much larger cross-section than the cutting electrode is used in this system, the electric fields remain attenuated at the grounding electrode, and a high proportion of the available cutting energy is deposited into a thin region immediately around the cutting electrode's wire.

Another system is described in United States Patent Application Publication No. 2006/0100617, the entire contents of which are incorporated herein by reference. This publication describes an autocapsulorhexis device comprising a circular, flexible ring made of an elastomer or an acrylic or thermoplastic material. Embedded within each of various embodiments of this flexible ring is either a resistance-heating element or a pair of bipolar electrodes, which are energized according to known techniques to produce localized heating on the anterior capsule, so as to define a weakened boundary for an easy detachment of the portion of the capsule within the circular ring. Various other devices have been proposed, many of which depend on resistive-heating cautery elements, such as U.S. Pat. No. 6,066,138, issued May 23, 2000; U.S. Pat. No. 4,481,948, issued Nov. 13, 1984; and WIPO Publication No. WO 2006/109290 A2, published Oct. 19, 2006. The entire contents of each of the references identified in this paragraph are incorporated by reference herein, for the purpose of providing background and context for the present invention.

SUMMARY

A capsulorhexis apparatus includes a capsulorhexis probe configured for insertion into an eye through an incision and a pulse generator configured to deliver at least one radio-frequency (RF) pulse to the capsulorhexis probe. The delivered RF pulse has a pre-determined attenuation profile such that the power level of the delivered RF pulse is substantially attenuated over the RF pulse's duration. In some embodiments, the pulse generator is configured to deliver a series of two or more RF pulses to the eye, such that the energy of each of the second and subsequent pulses of the series is substantially attenuated relative to its predecessor.

In some embodiments, the pre-determined attenuation profile is such that the power level of the delivered RF pulse is reduced by at least one-half over the RF pulse's duration. In these and other embodiments, the pre-determined attenuation profile may be designed to ensure that the delivered RF pulse initiates bubble nucleation in the eye, without excessive coalescence or overheating of the lens capsule beyond the targeted area. In several embodiments, a series of two or more RF pulses are delivered to the eye, in such a manner that the energy of each of the second and subsequent pulses of the series is substantially attenuated relative to its predecessor. In some of these embodiments, the amplitude of each of the second and subsequent pulses of the series is substantially attenuated relative to the amplitude of the immediately preceding pulse. In others, the amplitude of each of the second and subsequent pulses is substantially the same as the amplitude of the first pulse of the series, but the length of each of the second and subsequent pulses of the series is substantially shorter than the length of the immediately preceding pulse.

Methods involving the use of intra-pulse attenuation profiles, in which the pulse power is attenuated over the duration of the pulse, or inter-pulse attenuation profiles, in which the energy of each of a series of pulses is attenuated relative to its predecessor, are disclosed. In some embodiments, both techniques are used. Accordingly, one exemplary method for performing capsulorhexis begins with the insertion of a capsulorhexis probe into the anterior chamber of an eye and the positioning of the cutting portion of the capsulorhexis probe in contact with the anterior lens capsule of the eye. At least one radio-frequency (RF) pulse is then delivered to the eye, via the capsulorhexis probe, according to a pre-determined attenuation profile. This profile is such that the power level of the delivered RF pulse is substantially attenuated over the RF pulse's duration.

Another exemplary method also begins with the insertion of a capsulorhexis probe into the anterior chamber of an eye and the positioning of the cutting portion of the capsulorhexis probe in contact with the anterior lens capsule of the eye. A series of two or more radio-frequency (RF) pulses is then delivered to the eye, via the capsulorhexis probe, such that the energy of each of the second and subsequent pulses of the series is substantially attenuated relative to its predecessor. This use of an inter-pulse attenuation profile may be combined with the use of intra-pulse attenuation profiles, in some embodiments.

A capsulorhexis apparatus for implementing the inventive techniques disclosed herein includes, in some embodiments, a capsulorhexis probe configured for insertion into an eye through an incision and a pulse generator electrically connected to capsulorhexis probe. The pulse generator is configured to deliver at least one radio-frequency (RF) pulse to the capsulorhexis probe, such that the delivered RF pulse has a pre-determined attenuation profile such that the power level of the delivered RF pulse is substantially attenuated over the RF pulse's duration. In some embodiments, the pulse generator is instead configured to deliver a series of two or more RF pulses to the eye, such that the energy of each of the second and subsequent pulses of the series is substantially attenuated relative to its predecessor. In still other embodiments, both techniques are used.

Of course, those skilled in the art will appreciate that the present invention is not limited to the above features, advantages, contexts or examples, and will recognize additional features and advantages upon reading the following detailed description and upon viewing the accompanying drawings.

DETAILED DESCRIPTION

As noted above, various methods and devices for automating the capsulorhexis process have been proposed. For instance, the '805 application, incorporated by reference above, describes methods and apparatus for performing capsulorhexis using high-frequency electrical currents applied to the anterior lens capsule through a unipolar electrode. Other capsulorhexis probe configurations are possible, including those that rely on resistance-heating elements or a pair of bipolar electrodes, which are energized according to known techniques to produce localized heating on the anterior capsule. Common to many of these systems is the use of a high-energy pulse generator to deliver calibrated pulse energy to the surgical site.

Although those skilled in the art will appreciate the broader applicability of several of the inventive techniques and apparatus disclosed herein, these techniques will be described with reference to previously disclosed methods for performing capsulorhexis using pulses applied to a heating element placed against the anterior lens capsule. One such method is described in U.S. Patent Application Publication No. 2010/0094278, titled “Capsularhexis Device with Flexible Heating Element, the entire contents of which are incorporated by reference herein. This approach uses a resistive-heating element formed from an electrically resistive, superelastic wire formed into a loop. The heating element is energized with a short pulse or series of pulses of current. The heating of the loop-shaped element sears the lens capsule, effectively creating a smooth continuous cut on the capsule.

In contrast, the system described in the '805 application uses pulsed electric fields to perform the cutting action—the pulsed electric field is generated using a ring electrode, placed against the anterior capsule of the eye, and a grounding electrode located elsewhere, inside or outside the eye. The ring electrode comprises a thin, electrically conducting wire, since a very thin wire will increase cutting efficiency and reduce far-field effects. A very small cross-section (e.g., less than about 0.25 millimeters in diameter) will yield high-intensity electric fields close to the wire; these electric fields will reduce in intensity further away from the wire. Because the ground electrode has a much larger cross-section than the cutting electrode, the electric fields remain attenuated at the grounding electrode. Thus, a high proportion of the available cutting energy is deposited into a thin region immediately around the cutting electrode's wire.

FIG. 1illustrates the components of an exemplary capsulorhexis apparatus according to some embodiments of the invention. The pictured system includes a pulse generator110, which produces high-frequency pulses for application to the eye through cutting electrode120.FIGS. 2 and 3illustrate details of an exemplary cutting electrode device120. Cutting electrode device120includes a flexible ring122, which a single, ring-shaped, wire electrode128embedded therein. A flexible shaft124connects the flexible ring122to a handle126. An electrical lead (not shown) runs within shaft124and handle126to connect electrode128to the pulse generator110. Simpler embodiments may use only a bare wire loop as the heating element.

The flexible ring portion of the apparatus is dimensioned according to the desired size of the capsulotomy, e.g., with a diameter of approximately 5 millimeters. Those skilled in the art will appreciate that a circular opening is preferred, as illustrated inFIG. 2, to avoid tearing when the portion of the lens capsule within the opening is removed. The ring-shaped wire electrode128defines the boundaries of the portion of the lens capsule that is subjected to the direct heating that results from the energizing of the electrode.

To reduce collateral damage to the rhexis edge caused by overheating so as to improve rhexis strength and extensibility, attenuated pulses and pulse sequences of radio frequency (RF) voltage may be used to drive the capsulorhexis probes discussed above. As is well known to those skilled in the art, an automated capsulorhexis device is often used in the presence of a viscoelastic material that is introduced to the surgical site to protect the corneal endothelium and maintain the anterior chamber during cataract removal. When the capsulorhexis probe is energized, the resulting heating causes explosive boiling in the viscoelastic material. Boiling may occur in the tissue water, as well. The thermal process in the viscoelastic material closely around the energized probe can be divided into three steps: bubble nucleation at the beginning of the pulse, followed by bubble coalescence, and bubble collapse at the end.

Since a phase change in the viscoelastic material occurs at the nucleation stage, high power is needed to initiate the process. However, once the energized probe element is isolated from the liquid by bubbles, the power needed to maintain a given elevated temperature drops dramatically. This is the result of significantly reduced heat dissipation caused by the low thermal conductivity of the vapor, as compared to the thermal conductivity of the surrounding viscoelastic liquid.

In various embodiments of the invention, then, radio-frequency (RF) pulses delivered to the capsulorhexis probe are attenuated, over each pulse's duration. This intra-pulse attenuation adapts the power output to the rapidly varying power requirements, so as to reduce collateral damage to the rhexis edge caused by overheating. An example of an attenuation profile for an RF pulse is given inFIG. 4. A high voltage at the beginning of the pulse can be used to quickly initiate boiling of the viscoelastic material and tissue water. The pulse amplitude is then attenuated at a pre-determined rate or according to an experimentally determined profile so that the temperature at or near the energized capsulorhexis probe can be maintained at a proper level to produce a through cut in the lens capsule, with less thermal damage to the rhexis edge.

The desired attenuation rates or profiles will depend on several factors, including the characteristics of the applied RF energy, the precise configuration of the capsulorhexis probe or probes, and the like. However, those skilled in the art will appreciate that profiles appropriate to a given physical configuration can be determined experimentally. For instance, the nucleation process induced by various pulse attenuation profiles can be observed to identify attenuation profiles that minimize the coalescence of large bubbles around the energized probe. Likewise, the rhexis itself can be directly observed to determine those profiles that effectively cut the lens capsule without excessive damage, such as damage to the extensibility of the capsule.

FIG. 6is a process flow diagram illustrating a method for performing capsulorhexis that exploits the principles discussed above. The process begins, as shown at block610, with the insertion of a capsulorhexis probe into the anterior chamber, and the positioning of the cutting portion of the probe in contact with the anterior lens capsule of the eye, as shown at block620. Any of a wide variety of capsulorhexis probe configurations may be used, provided only that the probe is capable of being energized with pulsed RF energy.

As shown at block630, at least one RF pulse is then delivered to the eye, via the capsularhexis probe. The delivered RF pulse has a pre-determined attenuation profile, such that the power level of the delivered RF pulse is substantially attenuated over the RF pulse's duration. “Substantially attenuated” simply means that the attenuation of power over the course of the pulse is systematic and intentionally induced. Those skilled in the art will appreciate that the generation and delivery of pulsed RF energy to a physical load is inherently imprecise, such that some uncertainties in delivered power and variations in pulse share are unavoidable. In systems employing the intra-pulse attenuation techniques of the present invention, however, the degree of attenuation over an applied pulse exceeds these normal uncertainties and variations.

In some cases, the pre-determined attenuation profile may be such that the power level of the delivered RF pulse is reduced by at least one-half, i.e., 3 dB, over the RF pulse's duration. In others, the degree of attenuation may be far more substantial, e.g., 10, 20, or 30 dB. As discussed above, the particular attenuation profile applied in a given surgical situation may be experimentally determined in advance, and may be designed so that the beginning portion of the delivered RF pulse initiates bubble nucleation in the eye, while the trailing portion is attenuated sufficiently to avoid coalescence of large bubbles and/or to avoid overheating of the lens capsule.

To provide more flexible control of the cutting energy delivered to the surgical site, while further reducing collateral damage caused by thermal denaturation of the tissue, multiple pulses of RF voltage can be used. The duration of these pulses and the timing between them can be designed based on the concept of thermal relaxation time, which is a commonly used parameter for estimating the time required for heat to conduct away from a directly heated tissue region. (For instance, see B. Choi and A. J. Welch, “Analysis of thermal relaxation during laser irradiation of tissue,” Las. Surg. Med. 29, 351-359 (2001).) Because it is desirable to keep the heating effects of the capsulorhexis confined to highly localized area, the characteristic thermal relaxation time of the tissue is a useful guide for determining a maximum length of the applied RF pulses, as well as the time between successive pulses, during which the heated viscoelastic and tissue cools.

Instead of or in addition to the attenuation of the RF voltage within individual pulses, as discussed above in connection withFIGS. 4 and 6, a “global” attenuation profile can be superimposed on the pulse sequence, as illustrated inFIG. 7, to reduce thermal damage caused by accumulation of heat. (FIG. 7is a power profile of the pulse sequence;FIG. 4, in contrast, plots a voltage profile of a pulse with intra-pulse attenuation.) This global attenuation profile might be regarded as defining “inter-pulse” attenuation, in contrast to the “intra-pulse” attenuation illustrated inFIG. 6. As seen inFIG. 7, each of the second and subsequent pulses in the illustrated sequence is substantially attenuated relative to its predecessor. Thus, the energy of each pulse is reduced, compared to the preceding pulse. As a solely illustrative example, the initial power level of each pulse in the series might be attenuated by twenty percent (about 1 dB) relative to its predecessor, while the power levels during the pulse might also be reduced over the course of the pulse, e.g., by one-half or more. Although the illustrated series of pulses includes only monotonically attenuating pulses, other sequences might include several sub-sequences of pulses, wherein each of the second and subsequent pulses in each sub-sequence is substantially attenuated relative to its predecessor, but the power level is “reset” to a higher level at the beginning of each sub-sequence.

FIG. 8illustrates another way to reduce the energy carried by each of a series of pulses delivered to the eye. In the series of pulses pictured inFIG. 8, the amplitude of each pulse in the series is substantially the same, but the duration of each of the second and subsequent pulses is reduced, relative to the immediately preceding pulse. In addition to the reduced pulse duration, the time between pulses may also be varied, so that the root-mean-square power delivered to the eye over any particular interval attenuates according to a desired profile. Like the technique described in connection withFIG. 7, the technique illustrated inFIG. 8may be combined with the intra-pulse attenuation profile discussed earlier, so that the amplitude of each of the pulses in the series attenuates over the duration of the pulse.

In some systems, only inter-pulse attenuation or intra-pulse attenuation might be used, while both techniques may be used in others. In addition to the local and global attenuations in the magnitude of RF voltage, varied pulse lengths, duty cycles, etc., can be used to adapt the RF power output even more accurately to the power needs at different stages of the thermal process. Furthermore, the above-mentioned power schemes may be tuned to enhance the role of explosive boiling of tissue water as a cutting mechanism so as to further reduce thermal damage to the rhexis edge. (The lens capsule contains water. If the heating rate is sufficiently high, explosive boiling of water in tissue may occur and this may lead to localized high pressure, i.e., stress to the tissue, due to confinement of the tissue. Such localized stress may play a role in tissue dissecting. Therefore, the cutting mechanism is a combination of thermal and mechanical effects, and collateral damage to the tissue may be reduced compared to pure thermal cutting.)

FIG. 5illustrates functional elements of a pulse generator110according to some embodiments of the present invention. Pulse generator110includes a main power supply510, which may be operated from an external alternating current source (e.g., 120 volts at 60 Hz) or direct current source. Pulse generator530generates the RF pulses, from the main power supply510, under the control of control circuit520. The RF high-intensity pulses are supplied to the cutting electrode device120through leads550. User interface540provides the operator with appropriate mechanisms for operating the pulse generator110(e.g., switches, touch-screen inputs, or the like), as well as appropriate feedback (e.g., device status, etc.). Further details of a high-intensity pulsed electric field generator apparatus that can readily be adapted according to the techniques described herein are provided in U.S. Patent Application Publication 2007/0156129 A1, published 5 Jul. 2007, the entire contents of which are incorporated herein by reference.

In some embodiments of the present invention, pulse generator110is configured to deliver at least one radio-frequency (RF) pulse to the capsulorhexis probe, wherein the delivered RF pulse has a pre-determined attenuation profile such that the power level of the delivered RF pulse is substantially attenuated over the RF pulse's duration. In other embodiments, the pulse generator110is configured to deliver a series of two or more radio-frequency (RF) pulses to the capsulorhexis probe, such that each of the second and subsequent pulses of the series is substantially attenuated relative to its predecessor. Still other embodiments are configured to provide both features, so that both intra-pulse and inter-pulse attenuation profiles are applied to a series of pulses.

The preceding descriptions of various embodiments of capsulorhexis apparatus and methods for utilizing these devices were given for purposes of illustration and example. Those skilled in the art will appreciate, of course, that the present invention may be carried out in other ways than those specifically set forth herein without departing from essential characteristics of the invention. The present embodiments are thus to be considered in all respects as illustrative and not restrictive, and all changes coming within the meaning and equivalency range of the appended claims are intended to be embraced therein.