Systems and methods for incising tissue

Abstract

The elongated electrode is configured to flex, generate plasma, and incise tissue. An electrical energy source operably coupled to the electrode is configured to provide electrical energy to the electrode and generate plasma. A tensioning element is operably coupled to the elongated electrode. The tensioning element can be configured to provide tension to the elongated electrode, allowing the elongated electrode to flex in response to the elongated electrode engaging tissue and generating plasma. The tensioning element operably coupled to the flexible elongated electrode can enable the use of small diameter electrodes, such as 5 μm to 20 μm diameter electrodes, which can allow narrow incisions to be formed with reduced tissue damage. In some embodiments, tensioning the electrode allows the electrode to more precisely incise tissue by reducing variability in the electrode's position along the incision path.

Description

Technical Field

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 931,226, filed on November 6, 2019, entitled "SYSTEMS AND METHODS FOR INCISING TISSUE", and U.S. Provisional Patent Application No. 62 / 966,925, filed on January 28, 2020, entitled "SYSTEM, METHOD, AND APPARATUS FOR CORNEAL RESHAPING BY INTRASTROMAL TISSUE REMOVAL", the entire disclosures of which are incorporated herein by reference under 35 U.S.C. § 119(e).

[0002] The subject matter of this application is related to U.S. Provisional Patent Application No. 62 / 909,092, filed on October 1, 2019, entitled "SYSTEMS AND METHODS FOR THE SEMI-AUTOMATED CREATION OF EXTERNAL INCISIONS TO REDUCE INTRAOCULAR PRESSURE", the entire disclosure of which is incorporated herein by reference.

Background Art

[0003] Tissue ablation and incision can be used in many ways to perform procedures such as surgical techniques. For example, lasers can be used to correct refractive abnormalities such as myopia, remove cataracts, and treat glaucoma and retinal diseases. Tissue ablation and incision can also be used, for example, in orthopedics and cardiology to perform surgical techniques.

[0004] Research related to the present disclosure suggests that the effectiveness and usability of surgical techniques can be related to the limitations of devices used to incise and ablate tissue in at least some cases. For example, lasers such as femtosecond lasers can be complex and treatment can take longer than would be ideal. Also, the tissue removal profile along a laser-induced incision may not be as smooth as would be ideal in at least some cases. Further, in laser treatment, tissue debris and remnants such as plumes associated with laser irradiation can affect the accuracy and effectiveness of ablation and incision.

[0005] Mechanical cutting using blades such as microkeratome blades can be used for some surgical techniques, but research related to the present disclosure suggests that mechanical cutting using blades may not be as accurate as would be ideal and can produce a rougher surface in at least some cases. Mechanical microkeratomes are used to create corneal flaps for surgical techniques such as LASIK, but research related to the present disclosure suggests that mechanical microkeratomes can take somewhat longer than would be ideal and the resulting flaps can be somewhat irregular and rougher than would be ideal in at least some cases. Scalpels or diamond knives can be used to manually excise two separate flaps into tissue such as scleral and / or corneal tissue in conventional trabeculoplasty, but this is technique-dependent and can be somewhat difficult for at least some practitioners, which can result in related postoperative complications. Reducing technique-dependence and postoperative complications would be useful.

[0006] Femtosecond lasers are used to create corneal flaps and pockets, but research related to the present disclosure suggests that the time to form the flaps and pockets can be longer than would be ideal in at least some cases. The small incision lenticule extraction (SMILE) technique is a more recent approach for reshaping the cornea that utilizes a femtosecond laser system to ablate tissue along the boundaries of a three-dimensional corneal lenticule within the corneal stroma, which can be removed through a corneal opening. However, research related to the present disclosure suggests that the three-dimensional corneal lenticules formed and removed using this technique can be shaped quasi-ideally in at least some cases. Also, the amount of time to ablate the tissue that defines the lenticule and the opening can also be somewhat longer than would be ideal.

[0007] Electrodes have been proposed for treating tissue, but previous approaches can result in more tissue damage and less precise incisions than would be ideal. Electrodes that generate plasma have been proposed, but these previous approaches may not be well-suited for cutting large amounts of tissue, and their accuracy can be quasi-ideal in at least some cases.

[0008] In light of the above, there is a need for an improved approach for treating tissue using incisions that addresses at least some of the aforementioned limitations. Ideally, such an approach would reduce complexity and treatment time and provide more precise incisions with improved outcomes. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0009] Embodiments of the present disclosure provide improved methods and systems for incising tissue. In some embodiments, an elongate electrode is configured to flex, generate plasma, and incise tissue. An electrical energy source can be operably coupled to the electrode and configured to provide electrical energy to the electrode to generate plasma. In some embodiments, a tensioning element is operably coupled to the elongate electrode. The tensioning element can be configured to provide tension to the elongate electrode and enable the elongate electrode to flex in response to the elongate electrode engaging tissue and generating plasma. In some embodiments, the tensioning element operably coupled to the flexible elongate electrode enables the use of small diameter electrodes, such as electrodes having a diameter of 5 μm to 20 μm, which can enable a narrow incision to be formed with reduced tissue damage. In some embodiments, tensioning of the electrode enables more accurate incision of tissue by reducing variation in the position of the electrode along the incision path.

[0010] In some embodiments, the elongate electrode is operably coupled to one or more components to enable tissue resection along a path. The elongate electrode can be coupled to a support structure that moves with the electrode and provides an incision along the path. The support structure can be configured to support one or more arms, such as a plurality of arms, and the arms support an electrode suspended between the arms. The support structure, one or more arms, and the elongate electrode may constitute components of an electrode assembly. The electrode assembly can be operably coupled to a translation element and configured to provide translational movement to the electrode for incising tissue. In some embodiments, a contact plate is configured to engage tissue and shape the tissue prior to incision using the elongate electrode, which can provide improved accuracy of the incision and shaping of the tissue to be removed.

[0011] In some embodiments, a gap extends between the support structure and an electrode suspended between the arms, which can provide bidirectional tissue incision and shorten the treatment time. In some embodiments, the gap is sized to receive tissue and extend into the gap when the support structure and the electrode are pulled proximally to incise the tissue. In some embodiments, the support structure and the electrode are advanced into the tissue with a first configuration of one or more contact plates during a first pass, and the tissue is incised using the first incision, and the support structure and the electrode are pulled proximally with a second configuration of one or more contact plates to incise the tissue. In some embodiments, the second configuration is different from the first configuration, and the tissue incised during the first pass extends into the gap to provide an excised volume of tissue for subsequent removal and is incised during a second pass. In some embodiments, the excised volume of tissue comprises a thickness profile corresponding to a difference between a first profile of the first configuration of one or more contact plates and a second profile of the second configuration. In some embodiments, a corneal flap corresponding to refractive correction of the eye is incised during the first pass and the second pass, and the corneal flap can subsequently be removed to provide refractive correction.

[0012] In some embodiments, an elongate electrode is configured to incise tissue such as corneal tissue. An electrical energy source is operably coupled to the elongate electrode and configured to provide electrical energy to the electrode. A contact plate is configured to engage a portion of tissue such as the cornea and shape the tissue prior to incising the cornea using the electrode. A support structure can be operably coupled to the elongate electrode and the plate, and the support structure is configured to move the electrode relative to the plate and incise the corneal tissue using the electrode. The present invention provides, for example, the following. (Item 1) A system for incising tissue using plasma, An elongated electrode, wherein the elongated electrode is configured to bend, generate the plasma, and incise the tissue, an elongated electrode; An electrical energy source, wherein the electrical energy source is operably coupled to the elongated electrode and configured to provide electrical energy to the electrode to generate the plasma, an electrical energy source; A tensioning element operably coupled to the elongated electrode, the tensioning element being configured to provide tension to the elongated electrode and enable the elongated electrode to bend in response to the elongated electrode engaging the tissue and generating the plasma, a tensioning element A system comprising. (Item 2) The system according to item 1, further comprising a plurality of arms operably coupled to the electrode and the tensioning element. (Item 3) The system according to item 2, wherein the electrode is not supported between the two arms. (Item 4) The system according to item 2, wherein the electrode is configured to vibrate in a direction transverse to the elongation axis of the electrode. (Item 5) The system according to item 2, further comprising a support structure operably coupled to the plurality of arms and the tensioning element, the support structure being configured to advance the plurality of arms and the tensioning element to advance the elongated electrode into the tissue and incise the tissue. (Item 6) The system according to item 5, wherein the incising portion of the elongated electrode is suspended between the plurality of arms using the tension from the tensioning element, and a gap extends between the plurality of arms. (Item 7) The system according to item 6, wherein the gap extends between the incising portion of the elongated electrode, the plurality of arms, and the support structure. (Item 8) The system according to item 6, wherein the gap is sized to receive incised tissue along an incision formed using the elongated electrode. (Item 9) The system according to item 5, wherein the support structure is operably coupled to one or more actuators to move the elongated electrode in one or more directions. (Item 10) The system according to item 9, wherein the one or more actuators are configured to move the electrode with a variable speed. (Item 11) The system according to item 1, wherein the tensioning element is selected from the group consisting of a spring, a coil spring, a leaf spring, a torsion spring, a mesh, a hinge, and an integral hinge. (Item 12) The system according to item 1, wherein the extension electrode comprises a first portion of an extension filament, and the tensioning element comprises a second portion of the extension filament shaped to be tensioned over the extension electrode. (Item 13) The system according to item 1, further comprising an electrode assembly, the electrode assembly comprising a plurality of arms and a support structure operably coupled to the tensioning element, the electrode assembly configured to advance the electrode into tissue and incise the tissue. (Item 14) The system according to item 1, wherein the electrodes are configured to sequentially contact a plurality of locations in the tissue and generate the incision. (Item 15) The system according to item 14, wherein the plurality of locations comprises a plurality of intermittent locations. (Item 16) The system according to item 15, wherein the electrodes are configured to evaporate tissue in contact with the electrodes at each of the plurality of intermittent locations. (Item 17) The system according to item 1, wherein the electrodes are configured to generate a plurality of flashes of light energy at a plurality of locations while the electrodes incise the tissue. (Item 18) The system according to item 17, wherein the plurality of flashes of light energy comprises visible light energy having a wavelength in the range of about 400 nm to about 750 nm. (Item 19) The system according to item 17, wherein each of the plurality of flashes of light energy has a maximum transverse distance of about 1 mm or less. (Item 20) The system according to item 17, wherein the plurality of flashes occur within a time interval of about 250 μs or less, optionally about 25 μs or less. (Item 21) The system according to item 17, wherein the plurality of flashes occur in association with an electrode movement distance of about 100 μm or less, optionally about 10 μm or less. (Item 22) The system according to item 17, wherein the plurality of flashes of light are dispersed in a plurality of non-overlapping regions. (Item 23) The system according to item 22, wherein the plurality of non-overlapping regions are located along the extension electrode. (Item 24) The plurality of flashes of light are generated at a first rate associated with a first speed of the electrode and at a second rate associated with a second speed of the electrode, and the first rate exceeds the second rate when the first speed is less than the second speed, and the first rate is less than the second rate when the first speed exceeds the second speed. The system according to item 17. (Item 25) The plurality of flashes of light are generated at a substantially constant rate up to within about 25%, and one or more than one of the pulse rate or burst rate of the waveform with respect to the extension electrode is varied in response to the varying speed of the electrode, maintaining the substantially constant rate. The system according to item 24. (Item 26) The extension electrode includes a filament, and the filament includes one or more than one of a wire or a thread. The system according to item 1. (Item 27) The extension electrode includes a wire. The system according to item 1. (Item 28) The diameter of the wire is in the range of 5 μm to 200 μm, optionally in the range of about 5 μm to about 100 μm, optionally in the range of about 5 μm to about 50 μm, optionally in the range of about 5 μm to about 25 μm, or optionally in the range of about 5 μm to about 20 μm. The system according to item 27. (Item 29) The extension electrode has a cross-sectional distance, and the cross-sectional distance has a cross-sectional distance of about 25 μm or less. The system according to item 1. (Item 30) The extension electrode operably coupled to the tensioning element has a mechanical resonance frequency in the range of about 1 kHz to about 100 kHz, optionally in the range of about 2 kHz to about 50 kHz. The system according to item 1. (Item 31) The tensioning element is configured to tension the extension electrode with a force in the range of about 20 mN to about 2 N, optionally in the range of about 50 mN to about 1 N, and further optionally in the range of about 100 mN to about 500 mN. The system according to item 1. (Item 32) The extension electrode is about 0.2 μg·mm -1 ~ about 3 μg·mm -1 The system according to item 1, having a mass per unit length within the range of. (Item 33) The extension electrode includes a material selected from the group consisting of tungsten, nitinol, steel, copper, brass, titanium, stainless steel, beryllium-copper alloy, cupronickel alloy, palladium, platinum, platinum-iridium, silver, and aluminum. The system according to item 1. (Item 34) The elongated electrode comprises a shaft along the elongation direction of the electrode, and the electrode is configured to incise tissue as it moves laterally with respect to the shaft, for the system of item 1. (Item 35) The elongated electrode is configured to incise tissue at a speed greater than about 1 m·s -1 in a direction lateral to the elongation direction of the electrode, for the system of item 1. (Item 36) The elongated electrode is configured to incise tissue at a speed in the range of about 0.5 cm·s -1 to about 10 m·s -1 and optionally in the range of about 1 cm·s -1 to about 5 m·s -1in a direction lateral to the elongation direction of the electrode, for the system of item 1. (Item 37) The electrode is configured to incise the area of tissue at a rate in the range of about 5 mm 2 ·s -1 to about 50,000 mm 2 ·s -1 and optionally in the range of about 500 mm 2 ·s -1 to about 25,000 mm 2 ·s -1 for the system of item 1. (Item 38) The electrical energy source is configured to deliver a certain waveform, and the waveform comprises one or more than one of a pulsating waveform, a sine wave waveform, a square waveform, a sawtooth waveform, a triangular waveform, a fixed frequency waveform, a variable frequency waveform, or a gate waveform, for the system of item 1. (Item 39) The waveform comprises the sine wave waveform, and the sine wave waveform has a frequency in the range of about 0.5 MHz to about 2 MHz, for the system of item 38. (Item 40) The waveform comprises a combination of the sine wave waveform and the gate waveform, the sine wave waveform has a frequency in the range of about 0.5 MHz to about 2 MHz, and the gate waveform has a gate frequency in the range of about 20 kHz to about 80 kHz and a duty cycle in the range of about 35% to about 100%, for the system of item 38. (Item 41) The system of item 1 further comprises a controller operably coupled to the electrical energy source. (Item 42) The controller is configured to control the parameters of the electrical energy source by modulating the waveform using parameters selected from the group consisting of voltage, current, carrier frequency, modulation frequency, duty cycle, power set point, power limit, energy per pulse set point, energy per pulse limit, and modulation envelope, for the system of item 41. (Item 43) The system of item 42, wherein the waveform comprises a pulsating voltage waveform comprising a pulse and a substantially constant frequency within the range of about 10 kHz to about 10 MHz, optionally within the range of about 0.5 MHz to about 2 MHz. (Item 44) The system of item 43, wherein the waveform provides energy per pulse within the range of about 0.5 μJ to about 50 μJ, optionally within the range of about 1 μJ to about 10 μJ. (Item 45) The system of item 44, wherein the controller is configured to modulate the substantially constant frequency waveform to produce a burst. (Item 46) The system of item 45, wherein the frequency of the burst is within the range of about 100 Hz to about 3 MHz, optionally within the range of about 1 kHz to about 100 kHz. (Item 47) The system of item 46, wherein the waveform from the electrical energy source is configured to supply an average power within the range of about 1 W to about 25 W. (Item 48) The system of item 5, further comprising a translation element operably coupled to the support structure and configured to direct the support structure along a lateral axis of motion relative to the elongation axis of the electrode. (Item 49) The system of item 48, wherein the translation element is selected from the group consisting of a translation stage, a linear stage, a rotary stage, a rail, a rod, a cylindrical sleeve, a screw, a roller screw, a traveling nut, a rack, a pinion, a belt, a chain, a linear motion bearing, a rotary motion bearing, a cam, a flexure, and a dovetail. (Item 50) The system of item 49, comprising an actuator operably coupled to the translation element and configured to move the support structure along the axis of motion. (Item 51) The system of item 50, wherein the translation element is manually actuated. (Item 52) The system of item 50, wherein the actuator is selected from the group consisting of a motor, a rotary motor, a squiggle motor, a linear motor, a solenoid, a rotary solenoid, a linear solenoid, a voice coil, a spring, a movable coil, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, and a fluid actuator. (Item 53) The system according to item 5, wherein a part of the support structure comprises a material selected from the group consisting of tungsten, nitinol, steel, copper, brass, titanium, stainless steel, beryllium - copper alloy, cupronickel alloy, palladium, platinum, platinum - iridium, silver, aluminum, polyimide, PTFE, polyethylene, polypropylene, polycarbonate, poly(methyl methacrylate), acrylonitrile butadiene styrene, polyamide, polylactic acid, polyoxymethylene, polyether ether ketone, polyvinyl chloride, polylactic acid, glass, and ceramic. (Item 54) The system according to item 48, wherein the translation element comprises a first translation element having a first axis of motion and a second translation element having a second axis of motion different from the first axis of motion. (Item 55) The system according to item 54, wherein each of the first and second translation elements is selected from the group consisting of a translation stage, a linear stage, a rotary stage, a rail, a rod, a cylindrical sleeve, a screw, a roller screw, a traveling nut, a rack, a pinion, a belt, a chain, a linear motion bearing, a rotary motion bearing, a cam, a flexure, and a dovetail joint. (Item 56) The system according to item 55, further comprising a contact plate operably coupled to the second translation element, engaging a part of the tissue, and configured to shape the tissue prior to incising the tissue using the electrode. (Item 57) The system according to item 1, further comprising a contact plate operably coupled to the extension electrode, the contact plate being configured to engage a part of the cornea and shape the cornea prior to incising the cornea using the electrode. (Item 58) The system according to item 57, wherein the contact plate comprises a first contact plate having a first surface profile and a second contact plate having a second surface profile, and the difference between the first surface profile and the second surface profile corresponds to the refractive correction of the eye for correcting the refractive anomaly of the eye. (Item 59) The system according to item 57, wherein the contact plate comprises a free - form optical surface shaped to correct the wavefront aberration of the eye. (Item 60) The system according to item 57, wherein the contact plate comprises a plurality of independently adjustable actuators for shaping the cornea. (Item 61) The system of item 60, wherein the contact plate comprises a plurality of plates operably coupled to the independently adjustable actuator for shaping the cornea. (Item 62) The system of item 61, wherein each of the plurality of plates is configured to be driven to a first position and a second position at each of a plurality of locations, and the difference between the first position and the second position corresponds to a shape profile of tissue to be excised from the cornea to correct a refractive abnormality of the eye. (Item 63) The system of item 62, wherein the plurality of locations comprises a plurality of two-dimensional locations, and the shape profile comprises a three-dimensional tissue excision profile. (Item 64) The system of item 60, wherein the plurality of actuators comprises at least 10 actuators, optionally, the plurality of actuators comprises at least 16 actuators, optionally, the plurality of actuators comprises at least 42 actuators, optionally, the plurality of actuators comprises at least 100 actuators. (Item 65) The system of item 60, wherein the contact plate comprises a deformable membrane operably coupled to the plurality of independently adjustable actuators. (Item 66) The system of item 60, wherein the contact plate comprises a first configuration for a first incision using the electrode along a first incision profile and a second configuration for a second incision using the electrode along a second incision profile, and the difference between the first incision profile and the second incision profile corresponds to the shape of a corneal flap of tissue to be removed from the cornea to treat a refractive abnormality of the eye. (Item 67) The system of item 57, wherein the contact plate is configured to correct one or more of spherical, cylindrical, coma, spherical aberration, or trefoil of the eye. (Item 68) The system of item 57, wherein the first translation element further comprises a suction element for engaging the tissue and holding the tissue in a substantially fixed position in contact with the second translation element while moving the electrode to incise the tissue. (Item 69) The system of item 57, further comprising a sterile barrier for placement on the contact plate to maintain sterility of the eye. (Item 70) The system of item 69, wherein the sterilization barrier comprises a thin conformal barrier for conforming to the shape of the contact plate with the sterilization barrier between the eye and the contact plate. (Item 71) The system of item 69, wherein the sterilization barrier comprises a peelable and adhesive sterilization barrier. (Item 72) The length of the extension electrode is in the range of about 6 mm to about 12 mm, the tissue comprises corneal tissue, the electrode comprises a wire having a diameter in the range of about 5 μm to about 20 μm, the tensioning element is configured to provide a tension to the electrode in the range of about 100 mN to about 500 mN, the system of item 57. (Item 73) A processor operably coupled to the extension electrode, the processor being configured to have instructions for advancing the electrode distally and retracting the electrode proximally. The system of item 1, further comprising the processor. (Item 74) The extension electrode is sized for insertion into the tissue, the processor is configured to have instructions for incising the tissue using the electrode to define a volume of tissue to be incised, the volume having a shape profile, the system of item 73. (Item 75) The system of item 74, wherein the processor is configured to have instructions for moving the electrode with a first movement to define a first surface on a first side of a volume of tissue and with a second movement to define a second surface on a second side of the volume of tissue. (Item 76) The system of item 74, wherein the processor is configured to have instructions for advancing the electrode distally to define a first surface on a first side of a volume of tissue and retracting the electrode proximally to define a second surface on a second side of the volume of tissue. (Item 77) A gap extends between the extension electrode and the support structure, the gap being sized to receive tissue, and the tissue extending into the gap is incised when the electrode is retracted proximally. The system of item 76. (Item 78) The system of item 74, wherein the contact plate comprises a first configuration for defining a first surface on a first side of a volume of tissue and a second configuration for defining a second surface on a second side of the volume of tissue. (Item 79) The system according to item 74, wherein the first contact plate comprises a first shape profile for defining a first surface on a first side of the tissue volume and a second shape profile for defining a second surface on a second side of the tissue volume. (Item 80) The system according to item 74, wherein the shape profile comprises a thickness profile. (Item 81) A system for treating an eye refractive disorder, the system comprising: An elongate electrode for incising corneal tissue; An electrical energy source operably coupled to the elongate electrode and configured to provide electrical energy to the electrode; A contact plate configured to engage a portion of the cornea and to shape the cornea prior to incising the cornea using the electrode; A support structure operably coupled to the elongate electrode and the plate, the support configured to move the electrode relative to the plate and to incise the corneal tissue using the electrode. A system comprising. (Item 82) The system according to item 81, further comprising a translation element operably coupled to the support structure and the elongate electrode and configured to incise the corneal tissue with a translation of the electrode. (Item 83) The system according to item 81, wherein the contact plate comprises a first contact plate having a first surface profile and a second contact plate having a second surface profile, and a difference between the first surface profile and the second surface profile corresponds to an eye refractive correction for correcting the eye refractive disorder. (Item 84) The system according to item 81, wherein the contact plate comprises a freeform optical surface shaped to correct an eye wavefront aberration. (Item 85) The system according to item 81, wherein the contact plate comprises a plurality of independently adjustable actuators for shaping the cornea. (Item 86) The system according to item 85, wherein the contact plate comprises a plurality of plates operably coupled to the independently adjustable actuators for shaping the cornea. (Item 87) Each of the plurality of plates is configured to be driven to a first position and a second position at each of a plurality of locations, and a difference between the first position and the second position corresponds to a shape profile of tissue to be excised from the cornea to correct refractive anomalies of the eye, the system of item 86. (Item 88) The plurality of locations comprises a plurality of two-dimensional locations, and the shape profile comprises a three-dimensional tissue excision profile, the system of item 87. (Item 89) The plurality of actuators comprises at least 10 actuators, optionally, the plurality of actuators comprises at least 16 actuators, optionally, the plurality of actuators comprises at least 42 actuators, optionally, the plurality of actuators comprises at least 100 actuators, the system of item 85. (Item 90) The contact plate comprises a deformable membrane operably coupled to the plurality of independently adjustable actuators, the system of item 85. (Item 91) The contact plate comprises a first configuration for a first incision using the electrodes along a first incision profile and a second configuration for a second incision using the electrodes along a second incision profile, and a difference between the first incision profile and the second incision profile corresponds to a shape of a corneal flap of tissue to be removed from the cornea to treat refractive anomalies of the eye, the system of item 85. (Item 92) The contact plate is configured to correct one or more of spherical, cylindrical, coma, spherical aberration, or trefoil of the eye, the system of item 81. (Item 93) The first translation element further comprises a suction element for engaging the tissue and holding the tissue in a substantially fixed position in contact with the second translation element while moving the electrodes and incising the tissue, the system of item 81. (Item 94) The system of item 81 further comprising a sterile barrier for placement on the contact plate to maintain sterility of the eye. (Item 95) The sterile barrier comprises a thin conformal barrier for conforming to the shape of the contact plate with the sterile barrier between the eye and the contact plate, the system of item 94. (Item 96) The sterilization barrier comprises a peelable and adherable sterilization barrier, the system according to item 94. (Item 97) The length of the extension electrode is in the range of 6 mm to 12 mm, The electrode comprises a wire having a diameter in the range of 5 μm to 20 μm, The tensioning element is configured to provide a tension in the range of 100 mN to 500 mN to the electrode, The system according to item 81. (Item 98) A processor operably coupled to the extension electrode, the processor being configured to have instructions for advancing the electrode distally and retracting the electrode proximally, the processor The system according to item 81, further comprising. (Item 99) The extension electrode is sized for insertion into the cornea of the eye to treat refractive abnormalities of the eye, The processor is configured to have instructions for incising the cornea using the electrode and defining a corneal flap of corneal tissue within a pocket, The corneal flap comprises a shape profile corresponding to the treatment of the refractive abnormality, The system according to item 98. (Item 100) The processor is configured to have instructions for moving the electrode with a first movement to define a first surface on a first side of the corneal flap and with a second movement to define a second surface on a second side of the corneal flap, the system according to item 99. (Item 101) The processor is configured to have instructions for advancing the electrode distally to define a first surface on a first side of the corneal flap and retracting the electrode proximally to define a second surface on a second side of the corneal flap, the system according to item 99. (Item 102) A gap extends between the extension electrode and the support structure, the gap is sized to receive tissue, and the tissue extending into the gap is incised when the electrode is retracted proximally, the system according to item 101. (Item 103) The contact plate comprises a first configuration for defining a first surface on a first side of the corneal flap and a second configuration for defining a second surface on a second side of the corneal flap, the system according to item 99. (Item 104) The system of claim 99, wherein a first contact plate comprises a first shape profile for defining a first surface on a first side of the corneal piece and a second shape profile for defining a second surface on a second side of the corneal piece. (Claim 105) The system of claim 99, wherein the shape profile comprises a thickness profile. (Claim 106) A method for incising tissue using plasma, comprising incising the tissue using an elongating electrode, the elongating electrode being configured to flex and generate the plasma to incise the tissue, wherein an electrical energy source is operably coupled to the elongating electrode to provide electrical energy to the electrode to generate the plasma, a tensioning element is operably coupled to the elongating electrode to provide tension to the elongating electrode, enabling the elongating electrode to flex in response to the elongating electrode engaging the tissue and generating the plasma. (Claim 107) The method of claim 106, wherein a plurality of arms are operably coupled to the electrode and the tensioning element. (Claim 108) The method of claim 107, wherein the electrode is not supported between the two arms. (Claim 109) The method of claim 107, wherein the electrode is configured to vibrate in a direction transverse to the elongation axis of the electrode. (Claim 110) The method of claim 107, wherein a support structure is operably coupled to the plurality of arms and the tensioning element, the support structure advancing the plurality of arms, the tensioning element, and the elongating electrode to incise the tissue. (Claim 111) The method of claim 110, wherein a cutting portion of the elongating electrode is suspended between the plurality of arms using tension from the tensioning element, with a gap extending between the plurality of arms. (Claim 112) The method of claim 111, wherein the gap extends between the cutting portion of the elongating electrode, the plurality of arms, and the support structure. (Claim 113) The method of claim 111, wherein the gap is sized to receive incised tissue along an incision formed using the elongating electrode. (Claim 114) The method of claim 110, wherein the support structure is operably coupled to one or more actuators to move the elongating electrode in one or more directions. (Claim 115) The one or more actuators move the electrode with a variable speed, the method according to item 114. (Item 116) The tensioning element is selected from the group consisting of a spring, a coil spring, a leaf spring, a torsion spring, a mesh, a hinge, and an integral hinge, the method according to item 106. (Item 117) The elongating electrode comprises a first portion of an elongating filament, and the tensioning element comprises a second portion of the elongating filament shaped to be tensioned on the elongating electrode, the method according to item 106. (Item 118) An electrode assembly with a support structure is operably coupled to a plurality of arms and the tensioning element, the electrode assembly advancing the electrode into tissue and incising the tissue, the method according to item 106. (Item 119) The electrode sequentially contacts a plurality of locations of the tissue to generate the incision, the method according to item 106. (Item 120) The plurality of locations comprises a plurality of intermittent locations, the method according to item 119. (Item 121) The electrode evaporates the tissue in contact with the electrode at each of the plurality of intermittent locations, the method according to item 120. (Item 122) The electrode generates a plurality of flashes of light energy at a plurality of locations while the electrode incises the tissue, the method according to item 106. (Item 123) The plurality of flashes of light energy comprises visible light energy having a wavelength in the range of about 400 nm to about 750 nm, the method according to item 122. (Item 124) Each of the plurality of flashes of light energy has a maximum transverse distance of about 1 mm or less, the method according to item 122. (Item 125) The plurality of flashes occur within a time interval of about 250 μs or less, optionally about 25 μs or less, the method according to item 122. (Item 126) The plurality of flashes occur with an electrode movement distance of about 100 μm or less, optionally about 10 μm or less, the method according to item 122. (Item 127) The plurality of flashes of light are dispersed in a plurality of non-overlapping regions, the method according to item 122. (Item 128) The plurality of non-overlapping regions are located along the elongating electrode, the method according to item 127. (Item 129) The plurality of flashes of light are generated at a first rate associated with a first speed of the electrode and at a second rate associated with a second speed of the electrode, and the first rate exceeds the second rate when the first speed is less than the second speed, and the first rate is less than the second rate when the first speed exceeds the second speed, according to the method of item 122. (Item 130) The plurality of flashes of light are generated at a substantially constant rate within about 25%, and one or more than one of the pulse rate or burst rate of the waveform with respect to the extension electrode is varied in response to the varying speed of the electrode, while maintaining the substantially constant rate, according to the method of item 129. (Item 131) The extension electrode includes a filament, and the filament includes one or more than one of a wire or a thread, according to the method of item 106. (Item 132) The extension electrode includes a wire, according to the method of item 106. (Item 133) The diameter of the wire is in the range of 5 μm to 200 μm, optionally in the range of about 5 μm to about 100 μm, optionally in the range of about 5 μm to about 50 μm, optionally in the range of about 5 μm to about 25 μm, or optionally in the range of about 5 μm to about 20 μm, according to the method of item 132. (Item 134) The extension electrode includes a cross-sectional distance, and the cross-sectional distance includes about 25 μm or less, according to the method of item 106. (Item 135) The extension electrode operably coupled to the tensioning element has a mechanical resonance frequency in the range of about 1 kHz to about 100 kHz, optionally in the range of about 2 kHz to about 50 kHz, according to the method of item 106. (Item 136) The tensioning element tensions the extension electrode using a force in the range of about 20 mN to about 2 N, optionally in the range of about 50 mN to about 1 N, and further optionally in the range of about 100 mN to about 500 mN, according to the method of item 106. (Item 137) The extension electrode has a mass per unit length in the range of about 0.2 μg·mm -1 ~ about 3 μg·mm -1 , according to the method of item 106. (Item 138) The extension electrode includes a material selected from the group consisting of tungsten, nitinol, steel, copper, brass, titanium, stainless steel, beryllium-copper alloy, cupronickel alloy, palladium, platinum, platinum-iridium, silver, and aluminum, according to the method of item 106. (Item 139) The elongating electrode comprises a shaft along the elongating direction of the electrode, and the method according to item 106, wherein the electrode incises tissue as it moves laterally with respect to the shaft. (Item 140) The elongating electrode incises tissue at a speed of more than about 1 m·s -1 in a direction lateral to the elongating direction of the electrode, the method according to item 106. (Item 141) The elongating electrode incises tissue at a speed in the range of about 0.5 cm·s -1 to about 10 m·s -1 and optionally in the range of about 1 cm·s -1 to about 5 m·s -1 in a direction lateral to the elongating direction of the electrode, the method according to item 106. (Item 142) The electrode incises the area of the tissue at a rate in the range of about 5 mm 2 ·s -1 to about 50,000 mm 2 ·s -1 and optionally in the range of about 500 mm 2 ·s -1 to about 25,000 mm 2 ·s -1 , the method according to item 106. (Item 143) The electrical energy source delivers a waveform, and the waveform comprises one or more of a pulsating waveform, a sine wave waveform, a square wave waveform, a sawtooth waveform, a triangular waveform, a fixed frequency waveform, a variable frequency waveform, or a gate waveform, the method according to item 106. (Item 144) The waveform comprises the sine wave waveform, and the sine wave waveform has a frequency in the range of about 0.5 MHz to about 2 MHz, the method according to item 143. (Item 145) The waveform comprises a combination of the sine wave waveform and the gate waveform, the sine wave waveform has a frequency in the range of about 0.5 MHz to about 2 MHz, and the gate waveform has a gate frequency in the range of about 20 kHz to about 80 kHz and a duty cycle in the range of about 35% to about 100%, the method according to item 143. (Item 146) A controller is operably coupled to the electrical energy source, the method according to item 106. (Item 147) The controller controls the parameters of the electrical energy source by modulating the waveform using parameters selected from the group consisting of voltage, current, carrier frequency, modulation frequency, duty cycle, power set point, power limit, energy per pulse set point, energy per pulse limit, and modulation envelope, the method according to item 146. (Item 148) The waveform comprises a pulsating voltage waveform having pulses and a substantially constant frequency in the range of about 10 kHz to about 10 MHz and optionally in the range of about 0.5 MHz to about 2 MHz, the method according to item 147. (Item 149) The waveform provides an energy per pulse within a range of from about 0.5 μJ to about 50 μJ, optionally within a range of from about 1 μJ to about 10 μJ, according to the method of item 148. (Item 150) The controller modulates the substantially constant frequency waveform to produce a burst, according to the method of item 149. (Item 151) The frequency of the burst is within a range of from about 100 Hz to about 3 MHz, optionally within a range of from about 1 kHz to about 100 kHz, according to the method of item 150. (Item 152) The waveform from the electrical energy source supplies an average power within a range of from about 1 W to about 25 W, according to the method of item 151. (Item 153) A translation element operably coupled to the support structure directs the support structure along a movement axis transverse to the elongation axis of the electrode, according to the method of item 110. (Item 154) The translation element is selected from the group consisting of a translation stage, a linear stage, a rotary stage, a rail, a rod, a cylindrical sleeve, a screw, a roller screw, a traveling nut, a rack, a pinion, a belt, a chain, a linear motion bearing, a rotary motion bearing, a cam, a flexure, and a dovetail, according to the method of item 153. (Item 155) An actuator operably coupled to the translation element moves the support structure along the movement axis, according to the method of item 154. (Item 156) The translation element is manually actuated, according to the method of item 155. (Item 157) The actuator is selected from the group consisting of a motor, a rotary motor, a squiggle motor, a linear motor, a solenoid, a rotary solenoid, a linear solenoid, a voice coil, a spring, a movable coil, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, and a fluid actuator, according to the method of item 155. (Item 158) A portion of the support structure includes a material selected from the group consisting of tungsten, nitinol, steel, copper, brass, titanium, stainless steel, beryllium-copper alloy, cupronickel alloy, palladium, platinum, platinum-iridium, silver, aluminum, polyimide, PTFE, polyethylene, polypropylene, polycarbonate, poly(methyl methacrylate), acrylonitrile butadiene styrene, polyamide, polylactic acid, polyoxymethylene, polyether ether ketone, polyvinyl chloride, polylactic acid, glass, and ceramic, according to the method of item 110. (Item 159) The method according to item 153, wherein the translation element includes a first translation element having a first axis of motion and a second translation element having a second axis of motion different from the first axis of motion. (Item 160) The method according to item 159, wherein each of the first and second translation elements is selected from the group consisting of a translation stage, a linear stage, a rotary stage, a rail, a rod, a cylindrical sleeve, a screw, a roller screw, a traveling nut, a rack, a pinion, a belt, a chain, a linear motion bearing, a rotary motion bearing, a cam, a flexure, and a dovetail joint. (Item 161) The method according to item 160, wherein a contact plate operably coupled to the second translation element engages a portion of the tissue and shapes the tissue prior to incising the tissue using the electrode. (Item 162) The method according to item 106, wherein a contact plate operably coupled to the extension electrode engages a portion of the cornea and shapes the cornea prior to incising the cornea using the electrode. (Item 163) The method according to item 162, wherein the contact plate includes a first contact plate having a first surface profile and a second contact plate having a second surface profile, and the difference between the first surface profile and the second surface profile corresponds to an eye refractive correction for correcting an eye refractive error of the eye. (Item 164) The method according to item 162, wherein the contact plate includes a freeform optical surface shaped to correct a wavefront aberration of the eye. (Item 165) The method according to item 162, wherein the contact plate includes a plurality of independently adjustable actuators for shaping the cornea. (Item 166) The method according to item 165, wherein the contact plate includes a plurality of plates operably coupled to the independently adjustable actuators for shaping the cornea. (Item 167) The method according to item 166, wherein each of the plurality of plates is driven to a first position and a second position at each of a plurality of locations, and the difference between the first position and the second position corresponds to a shape profile of tissue to be excised from the cornea to improve the eye refractive error of the eye. (Item 168) The method according to item 167, wherein the plurality of locations includes a plurality of two-dimensional locations, and the shape profile includes a three-dimensional tissue excision profile. (Item 169) The method according to item 165, wherein the plurality of actuators comprises at least 10 actuators, optionally, the plurality of actuators comprises at least 16 actuators, optionally, the plurality of actuators comprises at least 42 actuators, optionally, the plurality of actuators comprises at least 100 actuators. (Item 170) The method according to item 165, wherein the contact plate comprises a deformable membrane operably coupled to the plurality of independently adjustable actuators. (Item 171) The method according to item 165, wherein the contact plate comprises a first configuration for a first incision using the electrode along a first incision profile and a second configuration for a second incision using the electrode along a second incision profile, and the difference between the first incision profile and the second incision profile corresponds to the shape of the corneal flap of tissue removed from the cornea to treat the refractive anomaly of the eye. (Item 172) The method according to item 162, wherein the contact plate is configured to correct one or more of spherical, cylindrical, coma, spherical aberration, or trefoil of the eye. (Item 173) The method according to item 162, wherein the suction element engages the tissue while the first translation element moves the electrode and incises the tissue, and holds the tissue in a substantially fixed position in contact with the second translation element. (Item 174) The method according to item 162, wherein a sterilization barrier is disposed on the contact plate to maintain sterility of the eye. (Item 175) The method according to item 174, wherein the sterilization barrier comprises a thin conformal barrier for conforming to the shape of the contact plate with the sterilization barrier between the eye and the contact plate. (Item 176) The method according to item 174, wherein the sterilization barrier comprises a peelable and adhesive sterilization barrier. (Item 177) The length of the extension electrode is in the range of about 6 mm to about 12 mm, the tissue comprises corneal tissue, the electrode comprises a wire having a diameter in the range of about 5 μm to about 20 μm, the tensioning element provides a tension in the range of about 100 mN to about 500 mN to the electrode, The method according to item 162. (Item 178) A method of treating a refractive anomaly of an eye, the method comprising Cutting the corneal tissue by providing electrical energy to the electrode using an elongating electrode; Engaging a portion of the cornea and shaping the cornea using a contact plate prior to cutting the cornea using the electrode; comprising; A method, wherein a support structure moves the electrode relative to the plate and cuts the corneal tissue using the electrode. (Item 179) The method according to item 178, wherein a translation element operably coupled to the support structure and the elongating electrode translates the electrode and cuts the corneal tissue. (Item 180) The method according to item 178, wherein the contact plate comprises a first contact plate having a first surface profile and a second contact plate having a second surface profile, and the difference between the first surface profile and the second surface profile corresponds to a refractive correction of the eye for correcting a refractive anomaly of the eye. (Item 181) The method according to item 178, wherein the contact plate comprises a freeform optical surface shaped to correct a wavefront aberration of the eye. (Item 182) The method according to item 178, wherein the contact plate comprises a plurality of independently adjustable actuators for shaping the cornea. (Item 183) The method according to item 182, wherein the contact plate comprises a plurality of plates operably coupled to the independently adjustable actuators for shaping the cornea. (Item 184) The method according to item 183, wherein each of the plurality of plates is configured to be driven to a first position and a second position at each of a plurality of locations, and the difference between the first position and the second position corresponds to a shape profile of tissue to be excised from the cornea to improve a refractive anomaly of the eye. (Item 185) The method according to item 184, wherein the plurality of locations comprise a plurality of two-dimensional locations and the shape profile comprises a three-dimensional tissue excision profile. (Item 186) The method according to item 182, wherein the plurality of actuators comprise at least 10 actuators, optionally, the plurality of actuators comprise at least 16 actuators, optionally, the plurality of actuators comprise at least 42 actuators, optionally, the plurality of actuators comprise at least 100 actuators. (Item 187) The method according to item 182, wherein the contact plate comprises a deformable membrane operably coupled to the plurality of independently adjustable actuators. (Item 188) The method according to item 182, wherein the contact plate comprises a first configuration for a first incision using the electrode along a first incision profile and a second configuration for a second incision using the electrode along a second incision profile, and the difference between the first incision profile and the second incision profile corresponds to the shape of the corneal flap of tissue to be removed from the cornea to treat the refractive anomaly of the eye. (Item 189) The method according to item 178, wherein the contact plate is configured to correct one or more of spherical, cylindrical, coma, spherical aberration, or trefoil of the eye. (Item 190) The method according to item 178, wherein a suction element engages the corneal tissue while the first translation element moves the electrode and incises the tissue, holding the corneal tissue in a substantially fixed position in contact with the second translation element. (Item 191) The method according to item 178, wherein a sterile barrier is disposed on the contact plate to maintain sterility of the eye. (Item 192) The method according to item 191, wherein the sterile barrier comprises a thin conformal barrier for conforming to the shape of the contact plate with the sterile barrier between the eye and the contact plate. (Item 193) The method according to item 191, wherein the sterile barrier comprises a peelable and adherable sterile barrier. (Item 194) The length of the extension electrode is in the range of 6 mm to 12 mm, the electrode comprises a wire having a diameter in the range of 5 μm to 20 μm, the tensioning element provides a tension in the range of 100 mN to 500 mN to the electrode, The method according to item 178. (Item 195) A method of treating a refractive anomaly of an eye, the method comprising: inserting an extension electrode into the cornea of the eye; using the electrode to incise the cornea and define a corneal flap of corneal tissue within a pocket; removing the corneal flap; and the corneal flap comprises a shape profile corresponding to the treatment of the refractive anomaly. (Item 196) The method according to item 195, wherein the electrode is moved with a first movement to define a first surface on a first side of the corneal piece and is moved with a second movement to define a second surface on a second side of the corneal piece. (Item 197) The method according to item 195, wherein the electrode is advanced distally to define a first surface on a first side of the corneal piece and is retracted proximally to define a second surface on a second side of the corneal piece. (Item 198) The method according to item 197, wherein a gap extends between the elongating electrode and the support structure, the gap is sized to receive tissue, and the tissue extending into the gap is incised when the electrode is retracted proximally. (Item 199) The method according to item 195, wherein the contact plate comprises a first configuration to define a first surface on a first side of the corneal piece and a second configuration to define a second surface on a second side of the corneal piece. (Item 200) The method according to item 195, wherein a first contact plate comprises a first shape profile to define a first surface on a first side of the corneal piece and a second shape profile to define a second surface on a second side of the corneal piece. (Item 201) The method according to item 195, wherein the shape profile comprises a thickness profile. (Item 202) A processor operably coupled to the elongating electrode to move the elongating electrode and incise tissue. The system or method according to any one of the preceding items, further comprising the processor. (Incorporation by reference)

[0013] All patents, applications, and publications referenced and identified in this specification are hereby incorporated by reference in their entirety and are considered to be fully incorporated by reference, even if referenced anywhere in this application.

Brief Description of the Drawings

[0014] A deeper understanding of the features, advantages, and principles of the present disclosure will be obtained by reference to the following detailed description, which describes exemplary embodiments, and the accompanying drawings listed below.

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[0038] Detailed Description The following detailed description provides a deeper understanding of the features and advantages of the present invention as described in this disclosure, according to the embodiments disclosed herein. The detailed description includes many specific embodiments, which are provided by way of example only and should not be construed as limiting the scope of the present invention disclosed herein.

[0039] The systems and methods of the present disclosure are very suitable for incorporation into previous devices and surgical techniques, such as microkeratomes, that incise tissue and form one or more than one of a flap, pocket, or corneal lamella for removal from the tissue, e.g., for incorporation into SMILE. The methods and systems of the present disclosure are very suitable for combinations with lens removal and prostheses, such as removal of the lens nucleus and cortex for placement of an intraocular lens. As a non-limiting example, a plasma-induced incision may be generated within the capsule to produce a capsulotomy. The incision may be generated to produce lens fragments or to simplify lens fragmentation and / or lens removal. The incision may be formed within the retina to produce a pocket or flap. In some embodiments, the incision is formed within the trabecular meshwork (TM) or within the iris to produce an iridotomy, e.g., for improving drainage and / or reducing intraocular pressure ("IOP") for the treatment of glaucoma.

[0040] Referring to incisions within eye tissue, the systems and methods of the present disclosure are also very suitable for forming incisions in non-ophthalmic surgeries such as orthopedic surgery, cardiovascular surgery, neurosurgery, robotic surgery, pulmonary surgery, urological surgery, and soft tissue surgery. Referring to cutting of eye tissue, the methods and systems of the present disclosure are also very suitable for forming incisions within one or more than one of collagen tissue, cartilage, stromal tissue, neural tissue, vascular tissue, muscle, and soft tissue.

[0041] As a non-limiting example, FIG. 1A illustrates various anatomical locations within the eye that may be suitable for practicing the present disclosure. The eye includes a cornea, a limbus, a sclera, a lens capsule, a lens, a retina, an iris, and a trabecular meshwork TM. Although not shown, for purposes of clarity, the Schlemm's canal may be located adjacent to the TM. The system of the present disclosure can be used to treat any of these locations. In some embodiments, the cornea is shaped to provide refractive treatment of the eye. In some embodiments, the sclera is incised, for example, to provide a filtering bleb and treat glaucoma. In some embodiments, at least a portion of the capsule is incised, for example, to access the cortex and nucleus of the lens. In some embodiments, at least a portion of the lens is incised and excised. In some embodiments, the retina is treated, for example, using electrodes. In some embodiments, the iris is incised using electrodes. In some embodiments, tissue associated with the TM and Schlemm's canal is incised with respect to an example referring to glaucoma surgery.

[0042] In some embodiments, the application of a sufficient voltage, including a periodic or pulsatile voltage to an electrode, within or around a biological tissue (i.e., the "target tissue structure"), can result in the formation of vapor derived from an initial current and / or electric field that heats at least some component of the tissue (e.g., moisture in the tissue) to approximately the evaporation temperature (or "critical temperature", e.g., ~100 °C for pure water at standard pressure) in proximity to the electrode. The contents of such a vapor cavity are then ionized by the electrode voltage, which can disrupt (or equivalently, "ablate") at least a portion of the target tissue structure. In particular, when the pulse duration of the pulsatile voltage waveform is sufficiently short compared to the thermal relaxation time of the target tissue structure, thermal confinement is achieved, and the amount of remaining damaged tissue generated thereby can be minimized. The generation of the vapor can be due to a phase change process, and thus the associated temperature increase can stop via a latent heat process once the evaporation temperature is reached. The volume of the vapor cavity (or equivalently, "bubble") can increase as the amount of vapor increases, and further, can be proportional to the electrode voltage and / or current supplied to the tissue by the electrode as a larger tissue volume is heated. Similarly, the pressure within the bubble can increase as the amount of vapor is increased, and further, can be proportional to the electrode voltage and / or current supplied to the tissue by the electrode as a larger tissue volume is heated. Subsequently, plasma can be formed at least partially within the vapor cavity by ionizing the vapor when the electrode is operated at a voltage large enough such that the resulting electric field strength within the vapor cavity exceeds a discharge threshold and generates plasma-induced ablation (the combination of which can generate a plasma-induced incision when generated along the electrode). As a non-limiting example, the discharge threshold may be selected from the group consisting of an ionization threshold, a breakdown threshold, a dielectric breakdown threshold, a glow discharge threshold, an ablation threshold, a disruption threshold, and combinations thereof. If the electrode voltage is large enough, the resulting electric field strength can enable secondary discharges and produce an arc. Avoiding such arc discharges can be advantageous, as will be explained elsewhere in this specification.The plasma may allow an electric current to flow again through the electrodes, vapor, and tissue, and thus may cause a further temperature increase. The bulk electrode temperature may be directly proportional to the amount of current flowing through the electrode and / or surface collisions of ions and charged particles, chemical reactions, and radiation, which itself may be a function of the amount of plasma generated. Energy may be efficiently delivered to the target tissue structure to achieve thermal confinement within at least a portion of the target tissue structure near the electrode and / or vapor cavity and to generate and / or sustain the vapor cavity. Thermal confinement may be achieved when the energy is deposited within the target at an energy deposition rate that exceeds the energy dissipation rate, such as when the current flows nominally only through the tissue within a time less than or equal to the approximate thermal time constant of the tissue such that the current can be achieved using a periodic or pulsatile voltage. The thermal time constant may be the thermal relaxation time as defined by the size or shape or geometry of the electrode, the size or shape or geometry of the vapor cavity, and combinations thereof. The time constant may alternatively be defined as the mechanical response time such as displacement relaxation due to transient deformation of the tissue adjacent to the collapsing vapor cavity. For a semi-infinite slab of material, the thermal relaxation time τ is approximated by, where d is the distance in the tissue and α is the thermal diffusivity of the tissue. For the sclera and cornea, α is ~0.14 mm·s. For example, for a damage extent of d = ~2 μm, such a thermal relaxation time is τ = ~28 μs. Damage is defined herein as at least partially denatured tissue or at least partially denatured tissue components caused by mechanisms such as plasma, heating to create incisions. Such mechanical response times may be determined by the compressibility and density of the material, which may in turn be related to tissue hydration. For most species, including humans, water may contribute approximately 76% of the weight of the corneal stroma.

Chem.

[0043] In some embodiments, with respect to examples related to soft tissue, the following relationships, namely,

Chem.

Chem.

[0044] In some embodiments, the required voltage and associated energy deposition, respectively, contain a plot 600 of the relationship between the negative voltage threshold for tissue evaporation and the diameter of a length-cylindrical electrode for a ~50 μs pulse, using electrode lengths of ~1 mm, ~2 mm, ~5 mm, and ~10 mm, corresponding to curves 602, 604, 606, and 608, respectively, and can be reduced by decreasing the width of the electrode, as shown in FIG. 1B. Such an electrode can be considered an "elongated electrode" due to the aspect ratio between the width and length of the electrode. That is, the elongated electrode has a cross-sectional distance that is significantly smaller than its incision length. This voltage can be made as low as possible, and cutting using this voltage can be possible when exceeding the voltage breakdown threshold without enabling significant thermionic emission, where "significant" refers to an amount that significantly contributes to tissue thermal damage that exceeds what would otherwise exist. The electric field around the electrode can be proportional to the distance r, as follows, i.e.,

Chemical formula

Chemical formula

Chemical formula

Chemical formula

Chemical formula

Chemical formula

Chemical formula

Chemical formula

[0045] In some embodiments, the discharge can start from the evaporation of the tissue around the electrode and can continue when the voltage is high enough to bridge the ionized gas-filled vapor between the electrode gap and the tissue. If the voltage is not sufficient to maintain such a vapor cavity along the entire length of the electrode, liquid can contact the electrode and allow an electric current to pass through that interface. The depth of heating can be proportional to the length of the liquid-electrode interface. Thus, the extent of the damage zone can increase with a decrease in voltage for a system that would otherwise be fixed. The higher the voltage, the more this can be corrected, but if the voltage exceeds both the negative and positive plasma thresholds, the electrode can become too hot and the plasma discharge can become self-sustaining, as would be described in any location with respect to FIG. 3. Thermionic emission can be avoided and the accompanying damage to the tissue can be limited. Turbulent flow can disrupt the vapor cavity and both the electrode and the tissue can be damaged. The electrode can be thin such that a low voltage can support the vapor cavity and the voltage can slightly exceed the plasma threshold. The thin thickness of the vapor cavity can be maintained around at least a portion of the electrode at a voltage lower than any plasma threshold. Translating the electrode can allow contact with a small area of tissue and can be conceptualized as a single contact point or a point contact. Such a point contact can cause sudden evaporation and ignite a plasma discharge within a proportionally confined volume, thereby disrupting the tissue. After a section of the tissue has been disrupted in this way, a different section of the tissue has already touched at any location of the advancing electrode and can lead to the next evaporation, discharge, and subsequent disruption within this area. The fusion of such disruptions can be considered an incision. The thermal distribution around the point discharge can nominally be spherical. The extent of the heat deposition can be small and r -4can be enlarged, where r is the radius of the discharge, and the tissue damage zone depends here on the radius of the electrical discharge and can depend less on the length of the electrode. When the radius of the punctiform discharge is in the range of ~10 μm, such a sequence of discharges can cut the tissue in a "perforating" or "intermittent" manner by repeatedly disrupting different regions of the tissue (i.e., at discrete locations, or equivalently, in non-overlapping regions) along the electrode length, leaving a damage zone only about a few μm thick. Steady arcs are avoided, and the plasma is made to remain in a glow steady state by repeatedly disrupting regions of the tissue, thereby modulating the electrode voltage and minimizing damage from thermal ions and the resulting thermal effects. The different regions of the tissue within the target tissue structure that can be repeatedly disrupted may or may not be adjacent to each other.

[0046] FIG. 2A illustrates an electrode assembly 4 approaching tissue 2 along direction 12, with a gap 622 existing between the electrode assembly 4 and a tissue region 620, which is the region of the tissue closest to the elongated electrode. In this exemplary embodiment, both ends of the electrode assembly 4 are connected in parallel with driver 18 via connection 20, and the feedback path to driver 18 is via connection 22 from feedback electrode 24. Driver 18 can be regarded as an electrical energy source that provides electrical energy to the electrodes to produce a plasma within the target tissue structure.

[0047] FIG. 2B illustrates an initial momentary connection of tissue 2 and electrode assembly 4 in contact region 620, with gap 622 decreasing to ~0.

[0048] FIG. 2C illustrates the condition where the magnitude of the voltage on the electrode assembly 4 exceeds at least the negative voltage plasma threshold within the region 620 (not shown), which can cause at least the evaporation of the components of the tissue 2 within the tissue region 626, generate a vapor cavity 635, enable the current 624 to flow to the return electrode 24, and generate a damage zone 628. Such a damage zone 628 can, in turn, be limited in extent to the volume of the tissue immediately adjacent to the tissue region 620, and either such tissue regions 625 and 627 can become the next portions of the tissue 2 to cause evaporation in the same manner as the previously performed region 620, as described elsewhere herein, and can generate an intermittent process. The discharge can start from the evaporation of the tissue around the electrode and continue while the voltage bridges the gap vapor between the electrode and the tissue and is high enough to ionize the vapor within the gap. If a portion of such an electrode has no contact with the tissue, for example, when a vapor bubble is formed centered on that region of the electrode, the electrode temperature can rise and the resistivity can increase. For example, the average power can remain constant, but the localized overheating in the region of increased resistivity can cause evaporation and destruction of a portion of the wire, as can occur when a portion of the wire consumes more current than another portion of the wire when a portion of the wire is connected in series to a power source in "power-limiting mode". However, this is reduced, for example, avoided, when the electrodes are placed at a common voltage, as can occur when both ends of the wire are connected at the same location within the circuit (or "node"). In this exemplary configuration, when one portion of the electrode can become more resistive due to overheating and the current can proceed through another portion of the electrode, the current through the heated region decreases, as described previously for the series connection configuration, and can keep the wire from breaking. The speed of the moving electrode can be selected to meet the condition of a certain tension below the breaking tension of the wire. Too little tension can reduce the speed. If the electrode is not in contact with the tissue, there can be no heat transfer from the electrode to the tissue, and the electrode temperature can increase.The arc current can then increase due to the increasing electrode temperature, which can cause a positive feedback loop, which in turn reduces the likelihood that small tissue areas will contact the electrode and produce the aforementioned intermittent discharges, and can cause overheating of the tissue and / or the electrode when the electrode is under relaxation and / or low-tension conditions. Since the plasma threshold is polarity-dependent, the discharge can act as a rectifier, and the rectified current can be used as feedback for cutting at about the minimum negative voltage threshold for plasma discharge, including operation in a glow discharge steady state as a non-limiting example. In this configuration, the damage zone can here depend on the radius of the electrical discharge instead of the electrode length. The perforation sequence of the discharge, whose range is within the ~10 μm range, can result in a damage zone with a thickness between ~1 μm and ~3 μm. The duty cycle of the power supply (e.g., driver 18 or "electrical energy source") can in this configuration be maintained at ~100% due to the perforation discharge process.

[0049] FIG. 2D illustrates conditions where the voltage on electrode assembly 4 may fall below the plasma threshold and fail to maintain a vapor cavity 635, such as in region 626 of the previous figure, and along the electrode assembly 4, the contact region 620 may be extended to produce an extended contact region 630 that is larger than the contact region 620, allowing more current 624 to flow from the electrode assembly 4 through the tissue 2 to the return electrode 24 and producing a damage zone 628 larger than that of FIG. 2C that may extend via heat conduction to a portion of the tissue 2 behind the direction 12. If the electrode voltage cannot maintain the vapor cavity 635 along the electrode, tissue and / or liquid may contact the electrode, allowing a large current to pass through the interface. The extent of damage may be proportional to the length of the electrode-tissue interface, i.e., the extended region 630. Thus, the damage zone extent may increase with a decrease in voltage. Similarly, a large damage zone may occur even when the voltage is not supplied to the electrode prior to its contact with the tissue because a relatively large portion of the electrode may simultaneously contact the tissue before the discharge process starts. To avoid such damage, a supra-threshold voltage may be applied to the electrode as described with respect to FIG. 2C before contacting the tissue and producing an incision. Another method for protecting the tissue from overheating may be by using a non-conductive liquid or viscoelastic substance (e.g., Healon) such as Electro Lube Surgical. Such non-conductive liquids may serve both as a coolant and protection against current-related tissue damage such as electroporation. For example, the non-conductive liquid may be injected into the cutting region to protect tissue in the vicinity of the target tissue that may be within the current return path. The non-conductive liquid may also be cooled prior to use.

[0050] FIG. 2E illustrates the conditions under which the magnitude of the voltage on the electrode assembly 4 can exceed both the negative and positive plasma thresholds, the contact region 620 can extend along the electrode assembly 4 and can exceed that of the evaporation region 626 in FIG. 2C, producing an evaporation region 626. Similarly, more current 624 than in FIG. 2C can flow in this configuration from the electrode assembly 4 through the tissue 2 to the return electrode 24, producing a larger damage zone 628 than in FIG. 2C. An electrode voltage that exceeds both the negative and positive plasma thresholds can heat the electrode to a high enough temperature to provide self-sustaining thermionic emission. Turbulence can interrupt the vapor cavity 635 and damage the electrode and / or tissue.

[0051] The elongate electrode can nominally comprise a circular cross-section (or "rounded") wire, and the reduction in electrode width can be comparable to a reduction in the diameter of the wire (or equivalently, its "cross-sectional distance"). This voltage can still be kept low while rupturing the tissue, to avoid overheating the target tissue as much as possible. The electric field from a nominally cylindrical electrode can tend towards zero at a distance of about the electrode length, which can, in turn, cause an unduly extended damage zone in the tissue when using such an electrode with an aspect ratio >> 1 (e.g., when the electrode comprises a long and thin wire). The intermittent process of tissue disruption as described herein can provide a reduced damage zone due to the inherent interruption of the current flowing through the tissue associated with this approach, since in the absence of tissue disruption, the electrical current can nominally flow substantially only through the tissue when the tissue contacts the electrode.

[0052] Typically circular in cross-section, the wire may be fabricated with a square, hexagonal, flattened rectangular, or other cross-section. Thus, the electrode may alternatively be configured using a conductor of nominally non-circular cross-section, such as one of rectangular cross-section. Such nominally non-circular cross-section wires may be available from Eagle Alloys (Talbott, TN). Rectangular cross-section electrodes may similarly be produced by punching foil sheets such as those that may be available from Eagle Alloys (Talbott, TN). The non-circular cross-section electrode may further be configured such that its thinnest dimension is nominally parallel to the translation direction and provides electrode deformation capabilities along the translation direction and increases stiffness in the orthogonal direction. Conductive wires or threads with a high melting point that form part of an electrical circuit may be referred to as filaments, as will be understood by those skilled in the art.

[0053] Figure 2F illustrates the condition where the electrode assembly 4 may consist of electrode regions 650, 652, and 654, which need not represent the entire incision length. The electrodes as shown are deformed during the incision, with electrode regions 652 and 654 being displaced in the direction of motion 12 while electrode region 650 is not displaced, which can occur when at least one of the electrode regions 650 - 654 is flexible. As a non-limiting example, configuring the electrode assembly 4 to be flexible by using, for at least a single region of the electrode regions 650 - 654, a thin wire or the like can provide such deformation capabilities. In an exemplary embodiment, the most proximal tissue region 620, which is the new region of tissue closest to the electrode, is here approached by electrode region 652, and the most proximal tissue region 620 was the tissue region 625 of Figure 2C and becomes the next portion of tissue 2 for inducing evaporation in the same manner as the previously performed region 620 and can generate an incision for each segment. The shape of tissue 2 is modified by ablation of at least a single tissue region and thus a portion of tissue 2 can be made to induce evaporation in the same manner as the previously performed region 620 and generate an incision for each segment.

[0054] FIG. 3 shows plot 610 which measures the relationship between the polarity-dependent voltage thresholds for evaporation versus pulse duration for negative voltage discharges (curve 614) and positive voltage discharges (curve 612) using a pulsating voltage delivered using a ~8 mm long ~O50 μm tungsten wire electrode immersed in a physiologically balanced salt solution bath, and observes such discharges using a camera. The lower threshold voltage for the negative discharge steady state, due to the accompanying lower current, can serve to create an incision with less damage than that of the positive discharge steady state. Thus, driver 18 can be configured to utilize a negative voltage bias.

[0055] The pulsating voltage waveform can be used to generate a plasma as described. In water, for example, vapor cavities are averaged over a bubble lifetime of ~500 μs away from a ~O20 μm thick electrode operating with a nominally sinusoidal waveform having a peak voltage of ~300 V such that ~0.5 m·s -1Expanding at an average speed, the discharge can be stopped due to the collapse of vapor bubbles (and potentially subsequent cavitation), which can transfer momentum between the material and the electrode. In this configuration, the time required to re-ignite the plasma can be on the order of a few milliseconds, which is long compared to the pulse period of the energization waveform in the ~MHz steady state and may require a significantly higher voltage to sustain the discharge. However, if the distance between the tissue and the electrode surface is reduced, e.g., by moving the electrode, the disruption can be restarted more quickly. The resulting cutting speed produced by the plasma can be referred to herein as the "tissue speed." The frequency of the pulsating electrode voltage is configured within the ~MHz range and may allow for multiple cycles during tissue disruption and / or bubble lifetime. As a non-limiting example, the nominal type of the waveform may be selected from the group consisting of sine wave waveforms, square wave waveforms, triangular wave waveforms, ramp waveforms, periodic waveforms, aperiodic waveforms, and combinations thereof. The amount of time taken for the electrode to move into contact with the tissue and the amount of time taken for evaporation can be longer than the amount of time taken to complete the discharge process. When the electrode does not interrupt the tissue, it can be in a cooled state, and the time during which the electrode is in contact with the tissue and not interrupting the tissue can cause tissue damage due to heat diffusion from the electrode into the tissue, which may, in turn, require more energy to overcome the reduced electrode temperature. Thus, a lower cutting duty cycle can produce greater incidental thermal damage to the tissue than a higher cutting duty cycle.

[0056] In some embodiments, the inability to achieve thermal confinement can result in attendant tissue damage. For example, the velocity at all locations along the electrode may be constant, but the velocity of the tissue along the electrode may not be constant, i.e., there may be a distribution of tissue velocities in both time and space along the cutting edge of the electrode, which can apply to a rigid electrode. The rigid electrode can only move at the same velocity as the slowest cutting velocity it achieves. That is, the rigid electrode needs to cut a complete path along its cutting edge to advance and further incise, and thus, prior to incising, it may be necessary to limit the instantaneous cutting velocity by compressing the tissue region onto the electrode and allowing only the average cutting velocity. The hot spots along the cutting edge of the rigid electrode can provide point evaporation, but those same locations can then remain within the tissue while waiting for similar disruptions at other locations, even with the use of a rigid elongating electrode. The time spent in remaining can be longer than the thermal or mechanical response time of the tissue and can result in attendant damage, particularly in the presence of excess liquid, due to heat dissipation into the tissue. More efficient use of energy can be the drying of the next region of tissue to be incised. Operating the rigid electrode at too high a rate of parallel translation does not allow for complete incision and can cause a "drag force". Attendant damage can thus be reduced if the operating velocity of the electrode nominally adapts to the discharge velocity within the vapor cavity 635.

[0057] In some embodiments, the deformable electrode can move through the material it incises, in accordance with a per-segment velocity profile. That is, unlike conventional rigid electrodes, a portion of the deformable electrode advances into a cavity (or “bubble”) created by an evaporation event, and then evaporates a new region of tissue before other regions along the electrode advance similarly, thus enabling a velocity profile of an instantaneous cutting rate along the electrode. Such a deformable electrode can be kept under tension along its length, which in turn can be determined, at least in part, by an average cutting rate and, at least in part, by a local cutting rate, which itself can be determined, at least in part, by the tension on the electrode, to advance the deformable electrode through the tissue at a rate. The mass (or mass density) and / or stiffness of the deformable electrode can determine, at least in part, its ability to advance into a cavity created by an evaporation event. The average cutting rate can be affected by moving the electrode or electrode assembly (e.g., along the x-axis, where +x can be defined as the direction of the intended incision) using a translation element (or “translation device”) and an actuator. As a non-limiting example, the translation element can be selected from the group consisting of a translation stage, a linear stage, a rotary stage, a rail, a rod, a cylindrical sleeve, a screw, a roller screw, a traveling nut, a rack, a pinion, a belt, a chain, a linear motion bearing, a rotary motion bearing, a cam, a flexure, a dovetail, and combinations thereof. As used herein, the terms “stage” and “slide” are considered equivalents when used to describe a translation element, device, or system. As a non-limiting example, such an actuator can be selected from the group consisting of a motor, a rotary motor, a squiggle motor, a linear motor, a solenoid, a rotary solenoid, a linear solenoid, a voice coil, a spring, a moving coil, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, a fluid actuator, and combinations thereof. Alternatively, the electrode assembly can be manually actuated.

[0058] In some embodiments, the tension may be selected to adapt to the stiffness of the material used to form the electrodes, such that the tension may be represented by the modulus of elasticity. As a non-limiting example, the modulus of elasticity may be selected from the group consisting of the flexural modulus, Young's modulus, bulk modulus, section modulus, and shear modulus. With respect to a deformable electrode supported by a support structure at least at a single end, the modulus of elasticity E of the electrode material is used to determine the tension F with respect to the allowable deflection distance

Chemical formula

Chemical formula

Chemical formula

[0059] In some embodiments, there may be a trade-off, particularly in systems with moving elongate electrodes, between the characteristic range of the electrode (i.e., “dimension” or “thickness” or “size”) (e.g., diameter in the case of a wire or other such elongate electrode) and its corresponding mechanical stability, and thus the strength and durability of the device constructed thereby. Thus, a thin wire electrode that is taut and stretched may provide increased mechanical stability over a slack and thin wire electrode. The increased mechanical stability may represent increased incision accuracy (e.g., such an electrode may be less likely to drift laterally with respect to the incision direction). Alternative embodiments may further comprise a tensioning element mechanically coupled to the electrode to provide a more constant tension on the electrode nominally. A thin deformable elongate electrode as described herein has a fundamental frequency (or equivalently, a mechanical resonance frequency)

Chem.

Chem.

Chem.

Chem.

[0060] In this configuration, such an electrode can be translated in the \(x -\)direction and displaced (\(x=\sim20\,\mu\text{m}\) "deflected"),

Chemical formula

[0061] In some embodiments, thermal confinement can be achieved when the discharge is produced within a single cycle of a pulsed voltage waveform such as within a nanosecond time frame. From the laser-tissue interaction field, it is known that explosive evaporation by a nanosecond pulse can produce a peak temperature of ~200 °C and the volume of the resulting void (or "funnel hole" or "cavity") can exceed the substantially heated volume by ~50%. For example, photoablation is known to produce such damaged volumes. The ejection of vapor and / or moisture and / or debris from the incised area, especially when the deformable electrode contacts the tissue along an area less than its circumference and produces voids larger than the interaction volume as described for the effects of photoablation nanosecond laser pulses, can essentially be provided by a thin deformable electrode that can inhibit the formation of an arc discharge between the electrode and its environment even at high temperatures. This extended damaged volume can assist in the ejection of debris and / or moisture and / or vapor. For example, the energy E required to raise the spherical surface of moisture of ~O10μm from ~20 °C to ~200 °C is,

Chem.

Chem.

Chemical formula

Chemical formula

[0062] FIG. 4 shows that the tensioned electrode assembly 5 can include a tensioning element 700, which in turn can be operably coupled to the electrode 702 such that the electrode 702 can extend (or “deform” or “flex” or “vibrate”) while in contact with tissue 2 (not shown in this figure), and can be attached to the electrode assembly 4 via attachment portions 704 and 706. The cutout portion of the electrode 702 may comprise only a portion of the conductive portion of the electrode 702. The radii 708, which are located on the arms 710 and 712, can provide a smooth surface for the electrode 702 during extension to avoid excessive strain that may be imparted at a steeper transition. The arms 710 and 712 can be considered at least a part of a support structure intended to provide mechanical stability to at least a part of the electrode 702. A gap can exist between the arms 710, 712 and, as shown in this embodiment, can serve to receive tissue before and / or during and / or after the cut. In some embodiments, the electrode assembly 5 comprises a support structure as described herein.

[0063] In some embodiments, a processor, such as a controller, is operably coupled to the elongating electrode and provides movement to the elongating electrode. For example, the processor can be configured to have instructions that control an actuator and provide for movement of one or components of the electrode assembly. In some embodiments, the processor is configured to have instructions, for example, to advance the electrode distally and retract the electrode proximally.

[0064] In some embodiments, the elongating electrode is sized for insertion into tissue, and the processor is configured to have instructions for using the electrode to incise tissue to define a volume of tissue to be incised within a pocket. The volume can be configured in many ways, but in some embodiments, the volume comprises a shape profile, such as the shape profile of a corneal flap. In some embodiments, the processor is configured to have instructions for moving the electrode with a first movement to define a first incised surface on a first side of the tissue volume, and moving the electrode with a second movement to define a second incised surface on a second side of the tissue volume. In some embodiments, the processor is configured to have instructions for advancing the electrode distally to define a first surface on a first side of the tissue volume and retracting the electrode proximally to define a second surface on a second side of the tissue volume. In some embodiments, a gap extends between the elongating electrode and the support structure, and the gap is sized to receive tissue such that tissue extending into the gap is incised when the electrode is retracted proximally.

[0065] In some embodiments, the movement of the electrode is coordinated with the shape of one or more contact plates to define the volume of the incised tissue. In some embodiments, the contact plate comprises a first configuration to define a first surface over a first side of the tissue volume and a second configuration to define a second surface over a second side of the tissue volume. In some embodiments, a first contact plate comprises a first shape profile to define a first surface over a first side of the tissue volume and a second shape profile to define a second surface over a second side of the tissue volume, for example, the first and second surfaces of a corneal flap comprise that tissue volume. In some embodiments, the contact plate comprises a plurality of actuators operably coupled to a processor, the processor being configured to have instructions to shape the contact plate using a first surface profile for a first incision and to shape the contact plate using a second profile for a second incision. In some embodiments, the processor is configured to have instructions to shape the contact plate using a first profile, incise the first side using the first shape profile, shape the contact plate using a second profile, and incise the second side using the second profile, the total time being, for example, about 10 seconds or less, for example, 5 seconds or less or 2 seconds or less.

[0066] The support structure may be processed from a material selected at least in part from the group consisting of tungsten, nitinol, steel, copper, brass, titanium, stainless steel, beryllium-copper alloy, cupronickel alloy, palladium, platinum, platinum-iridium, silver, aluminum, polyimide, PTFE, polyethylene, polypropylene, polycarbonate, poly(methyl methacrylate), acrylonitrile butadiene styrene, polyamide, polylactic acid, polyoxymethylene, polyether ether ketone, polyvinyl chloride, polylactic acid, glass, ceramic, and combinations thereof. As shown, the tensioning element 700 may be directly connected to at least a portion of the electrode assembly 4 or, alternatively, to at least a portion of a subsequent element such as the coupler 52 or the electrode assembly mounting portion 17 to which the electrode assembly 4 is attached. By way of non-limiting example, the tensioning element 700 may be a spring, coil spring, leaf spring, torsion spring, elastic mesh, hinge, integral hinge, and combinations thereof. The deformable electrode may be supported by the support structure and be enabled to deform while generating a plasma-induced incision within the target tissue or target tissue structure. The electrode (e.g., electrode 702 or a portion thereof) may at least in part consist of a material selected from the group consisting of tungsten, nitinol, steel, copper, brass, titanium, stainless steel, beryllium-copper alloy, cupronickel alloy, palladium, platinum, platinum-iridium, silver, aluminum, and combinations thereof. Alternatively, the electrode may comprise a wire consisting of the same materials enumerated immediately above. Alternatively, the electrode may be coated over an area and inhibit conduction and / or incision in that area. Alternatively, tubing may be used in place of the coating to insulate the area of the electrode. Such a coating or tubing may be selected from the group consisting of polyimide, PTFE, polyethylene, polypropylene, polycarbonate, poly(methyl methacrylate), acrylonitrile butadiene styrene, polyamide, polylactic acid, polyoxymethylene, polyether ether ketone, polyvinyl chloride, polylactic acid, glass, ceramic, and combinations thereof.The electrode (e.g., electrode 702) may be a wire having a diameter between ~3 μm and ~300 μm. Alternatively, the wire may have a diameter between ~10 μm and ~50 μm. Alternatively, the wire may have a diameter between ~12 μm and ~17 μm. The tensioning element 700 may be configured to provide a tension such that the resulting force on the electrode is ~80% of the rated or measured yield strength of the electrode or its material, such that it can also accommodate an elongation of ~0.5% for a ~O12.5 μm tungsten wire with a tension of ~295 mN applied. Optionally, the tension may be between ~50% and ~95% of the yield strength. Optionally, the tension may be between ~70% and ~85% of the yield strength. Other configurations may also be scaled using relationships related to the second moment of cross-section, as described previously herein with respect to the allowable deflection distance (e.g., ~80% of the rated yield tension of ~4.7 N or ~3.8 N for a nominally pure tungsten wire with a diameter of ~O25 μm). The coupler 52 may be operably coupled to the cutting electrode mechanism 502 via the coupler 74. As a non-limiting example, the coupler 74 may be a receptacle configured to receive a disposable module comprising the element electrode 4, the coupler 52, and the electrode mounting portion 17, and the electrode mounting portion 17 may have mating features compatible with those of the coupler 74, such as threads, clips, snap joints, and combinations thereof. The cutting electrode mechanism 502 may further have mating features compatible with those of the couplers 71 and 72, which are themselves mechanically coupled to the actuators 50 and 504, respectively, provide an axis of motion, move the electrode assembly 4, and create an incision within the tissue 2 (not shown). Alternatively, as a non-limiting example, the element electrode 4, the coupler 52, the electrode mounting portion 17, the cutting electrode mechanism 502, and the coupler 74 may be packaged as a disposable module configured to engage with a more complete incision system within the probe body 26, and the electrode or electrode assembly or probe assembly may be actuated along the axis of motion 12.For clarity, although not shown, at least a portion of the probe body 5, including the tensioned electrode assembly 5, is adapted to move using a translational element and may ensure mechanical stability and accuracy along at least a single direction of motion.

[0067] FIG. 5 shows a tensioned electrode assembly 5 similar to that of FIG. 4, where the radius 708 may further minimize the positional error due to an unintentional electrode movement, in which the electrode 702 is installed and is transverse to the intended incision direction. In particular, it may include a channel 720. The tensioning element 700 may be configured as an integral hinge (or hinge as shown) within or along the arms 710 and 712. The arms 710 and 712 may be made of a notched rigid material as shown and may provide an integral hinge 722. As a non-limiting example, materials suitable for generating an integral hinge may be selected from the group consisting of polyethylene, polypropylene, polycarbonate, poly(methyl methacrylate), acrylonitrile butadiene styrene, polyamide, polylactic acid, polyoxymethylene, polyether ether ketone, polyvinyl chloride, beryllium copper, and combinations thereof. If the integral hinge 722 is integral with the arm 710 or 712 and a conductive material can be selected, such cut electrodes may be soldered, brazed, adhered with a conductive adhesive, and / or welded to the arm. If the integral hinge is integral with the arm 710 or 712 and an electrically insulating material is selected, the electrode 702 may alternatively be adhered or soldered, brazed, and / or welded to an adjacent conductive material to the arm.

[0068] FIG. 6 shows a system 800 that is a system for incising tissue such as eye tissue, including a cornea, a limbus, and stromal tissue. The system 800 may include a tensioned electrode assembly 5 similar to those of FIGS. 4 and 5. The electrode assembly 4 may be coupled to the electrode mounting portion 17 via a coupler 52. As a non-limiting example, the coupler 52 may be fabricated to be at least partially electrically insulated. The electrode assembly 4 includes arms 710 and 712, electrodes 702, and a tensioning element 700 that is operably coupled to the electrodes 702 and attached via attachment portions 704 and 706 to create a tensioned electrode assembly 5 that can allow the tensioning element 700 to stretch while the electrodes 702 are in contact with the tissue 2. The attachment portions 704 and / or 706 may be achieved via solder, brazing, adhesion, compression joints, crimping, and combinations thereof. The radius 708 located on the arms 710 and 712 may provide a smooth surface for the electrodes 702 while stretching to avoid excessive strain that can be covered at a steeper angle. The tensioning element 700 may be connected directly to the conductive portion of the electrode 4 or alternatively to a subsequent element such as the coupler 52 or the electrode mounting portion 17 to which the electrodes 702 are configured. The incision may be made by moving along the axis of motion 12. In this exemplary configuration, the tensioned electrode assembly 5 may consist of elements 700, 702, 704, 706, 708, 710, and 712, all of which may be constructed at least partially from at least partially conductive material and thus can be held at substantially the same voltage by a driver 18 (not shown), and all of which can be considered to comprise the tensioned electrode assembly 5. Alternatively, the electrode assembly 4 and the tensioned electrode assembly 5 may be identical. Alternatively, some of the aforementioned elements may consist at least partially of electrically insulating material and thus may not be at the same electrical potential as other elements that consist at least partially of conductive material, and the electrode assembly 4 may be considered to be a subsystem of the tensioned electrode assembly 5 with only those elements that consist at least partially of conductive material as shown.As a non-limiting example, the tensioning element 700 may be a spring, a coil spring, a leaf spring, a torsion spring, an elastic mesh or web, a hinge, an integral hinge, and combinations thereof. The torsion spring may be of the type found in staplers, for example. As a non-limiting example, at least in part, the conductive electrode material may be selected from the group consisting of tungsten, nitinol, steel, copper, brass, titanium, stainless steel, beryllium-copper alloy, cupronickel alloy, palladium, platinum, platinum-iridium, silver, aluminum, and combinations thereof. Alternatively, the electrode 702 may at least in part consist of a wire made of the same material. Alternatively, the electrode assembly 4 may at least in part consist of an element made of an electrically insulating material. Alternatively, the electrode assembly 4 may be coated in an area and inhibit conduction and / or incision in that area. Similarly, tubing may be used instead of a coating to insulate an area of the electrode assembly. As a non-limiting example, such a coating or tubing may be selected from the group consisting of polyimide, PTFE (e.g., Teflon®), polyethylene, polypropylene, polycarbonate, poly(methyl methacrylate), acrylonitrile butadiene styrene, polyamide, polylactic acid, polyoxymethylene, polyether ether ketone, polyvinyl chloride, polylactic acid, glass, ceramic, and combinations thereof. A return electrode (not shown) may be placed on or near the patient's eye and connected to the driver 18. A series load between ~150 Ω and ~500 Ω may be placed in line with the electrode to provide a current limit. The coupler 52 may be operably coupled to the cutting electrode mechanism 502 via the coupler 74. Alternatively, as a non-limiting example, the element electrode 4, the coupler 52, the electrode mounting portion 17, the cutting electrode mechanism 502, the coupler 74, or a subset thereof may be packaged as a disposable module configured to engage the system 800 via couplers 71 and 72, each having mating features compatible with those of the actuators 50 and 504 and thus having, for example, threads, clasps, snap joints, and combinations thereof, within the probe body 26.Actuator 504 provides a movement axis (or equivalently, for example, a "translation" along the movement direction of movement axis 14), and may be coupled to position encoder 51 via connection 53. Both position encoder 51 and actuator 50 may be connected to a translation device and / or actuator driver 57 via connections 55 and 59, respectively. As a non-limiting example, connections 55 and 507 may comprise at least one of the following: a mechanical coupler, an electrical coupler, a magnetic coupler, and an optical coupler. Actuator 504 also provides a movement axis (e.g., movement axis 12) and may be coupled to position encoder 506 via connection 505. Both position encoder 506 and actuator 504 may be connected to actuator driver 508 via connections 509 and 511, respectively. Note that only a single movement axis may be relied upon in practicing certain embodiments of the present disclosure, such as in the generation of a corneal flap using a single incision. Movement axes 14 and 12, which are movement axes for actuators 50 and 504, respectively, may be configured to be orthogonal or at least non-collinear. Actuators 504 and 50 may be configured to operate a tensioned electrode assembly 5 or a portion thereof along movement axes 12 and 14. Position encoders 51 and 506 may be mechanically coupled to a module to which electrode assembly 4 is mechanically coupled thereon via connections 55 and 507, respectively, to provide position information that is more reliable than that which non-collocated sensors may provide. Alternatively, actuator 50 may be configured to correspond to (or "move along") movement axis 14 and may be fabricated to operate (or "translate") contact plate 804. Connection 55 may be made with contact plate 804 or a structure supporting contact plate 804. Driver 18 may be configured to provide a controlled voltage and / or a controlled current to electrode 4. Driver 18 may provide an alternating voltage and / or current waveform to electrode 702.Such waveform types may be selected from the group consisting of, as non-limiting examples, pulsations, sine waves, squares, sawtooths, triangles, fixed frequencies, variable frequencies, and combinations thereof. Driver 18 may be configured to supply a waveform with a peak-to-peak full range voltage between ~50V and ~1,000V. Alternatively, driver 18 may be configured to supply a waveform with a peak-to-peak full range voltage between ~200V and ~500V. Driver 18 may be configured to supply a waveform with a carrier (or "base") frequency between ~10kHz and ~10MHz. Alternatively, driver 18 may be configured to supply a waveform frequency between ~500kHz and ~2MHz. Alternatively, driver 18 may be configured to supply a waveform frequency between ~800kHz and ~1.2MHz. Burst duration may also be used, and furthermore, electrode velocity v. t may depend thereon. Driver 18 may further be modulated to generate a duty cycle with a burst of pulses at a modulation frequency between ~100Hz and ~3MHz. The duty cycle may be between ~0.01% and ~100%. Alternatively, the duty cycle may be between ~50% and ~100%. Alternatively, the duty cycle may be between ~95% and ~100%. Driver 18 may be configured to supply an average power between ~1W and ~25W. Alternatively, driver 18 may be configured to supply an average power between ~12W and ~18W. Driver 18 may be configured to supply an energy per cycle (or equivalently, "energy per pulse") between ~1μJ and ~100μJ. Alternatively, driver 18 may be configured to supply an energy per cycle between ~5μJ and ~50μJ. Alternatively, driver 18 may be configured to supply an energy per cycle between ~10μJ and ~20μJ.

[0069] In some embodiments, the flap can be described as an incision that results in a "flap" of tissue that can be lifted and pivoted on a "hinge" to provide access to the tissue beneath it. As a non-limiting example, cutting through a tissue compartment to a depth of 130 μm and excising the plane at that depth beneath the tissue surface can result in a flap with an uncut edge that serves as its hinge. The flap can be detached by completing the uncut edge of the exemplary incision. In some embodiments, a pocket can be described as an incision that separates a first depth (or layer) of tissue from a second depth (or layer) of the tissue compartment without necessarily creating a flap. As a further non-limiting example, cutting one side of the tissue to a certain depth and excising the plane at that depth beneath the tissue surface can result in a pocket.

[0070] In some embodiments, due to the plasma discharge at electrode 702, a significant drop in the input impedance of driver 18 can cause local current spikes, which can in turn destroy the electrode and / or cause tissue damage. The power delivered to the electrode (or equivalently, "delivered power" or equivalently, "maximum power output") can instead be limited to avoid such situations. The average power suitable for practicing the embodiments of the present disclosure can be, in particular, between ~1 W·mm -1 and ~10 W·mm -1 during glow discharge. The power delivered can be higher during initial exposure to more reliably initiate dielectric breakdown. Alternatively, the voltage and / or current waveform (or alternatively, the power control signal) used to power electrode 702 can further be modulated or adjusted to be proportional to the instantaneous or expected length of tissue engagement and / or the electrode translation speed v t .

[0071] As a non-limiting example, when incising the cornea, the voltage may increase from an initial value corresponding to when the electrode 702 is first about to engage, or first engages, or is expected to first engage the tissue and is nominally directed towards the more central corneal region, to a higher voltage corresponding to when the electrode 702 is traversing, or is expected to traverse, the central cornea and thus has a relatively longer tissue engagement length than initially. The electrode voltage may then be decreased as the electrode 702 traverses the cornea 2 with an essentially shorter engagement length and continues to incise the tissue. The decrease may be configured to be opposite to the initial increase, but this is not necessary. The position of the electrode 702 within the cornea 2 may be inferred using an encoder within the translation subsystem as described anywhere herein. In certain embodiments, the voltage provided by the driver 18 causes the tensioned electrode assembly 5 to be tensioned by the tensioning element 700 up to ~300 mN with the initial electrode location being about 4 mm to about 7 mm from the side closest to the target tissue to be incised, and along direction 12, with a constant acceleration of ~2,000 mm·s -2 with a maximum rate of ~300 mm·s -1 (i.e., v t,max ) for the incising portion of the electrode 702, which may be useful when consisting of a ~10 mm long ~O10 μm ~99.99% pure tungsten wire. During an initial ~50 μs of translation, it may increase gradually from ~0 V to the maximum amplitude, and then during the final ~100 μs of translation, it may decrease gradually back to ~0 V, delivering a maximum peak-to-peak bipolar nominally sinusoidal voltage of ~500 V (not necessarily a ground voltage, with amplitudes of both ~+250 V and ~-250 V with respect to a nominal neutral voltage) with a ~1 MHz PRF (or "carrier frequency"). Note that such a constant acceleration may result in a linear velocity profile such that, as opposed to a complete incision, the electrode may be stationary within the target tissue as required to produce a flap or corneal segment as will be described anywhere herein.

[0072] In some embodiments, monitor 514 may be configured to monitor the voltage and / or current supplied to electrode assembly 4 via connection 516 and provide data regarding the voltage and / or current to driver 18 via connection 518. Data regarding the voltage and / or current of electrode assembly 4 may be in the form of a signal from a comparator. System controller 60 may be operably coupled to driver 18 via connection 62, which may be at least a unidirectional connection. Alternatively, connection 62 may also be a bidirectional connection such that controller 60 is capable of at least sensing signals from and / or responding to driver 18. Signals from monitor 514 may also be provided to and acted upon by system controller 60, thereby controlling the incision created by electrode assembly 4. Monitor 514 may reside within system controller 60 and / or communicate with system controller 60 via driver 18. Such signals may be safety signals regarding the sensed voltage or current, such as when the voltage or current is outside of a defined boundary. In a further alternative embodiment, driver 18 and / or monitor 514 may provide feedback to controller 60 or use such feedback internally. Such feedback may be, by way of non-limiting example, EMF or current feedback and may be useful when electrode assembly 4 contacts tissue and / or in determining the status of the plasma. Such status may be, for example, whether the plasma is in a glow discharge stable state. Connection 65 connects controller 60 and actuator 50 and is at least a unidirectional connection. Actuator 50 may comprise at least one electric motor and may further comprise a position encoder. Connection 65 may alternatively be a bidirectional connection such that signals such as position, velocity, acceleration, out-of-bounds error, etc. are shared between controller 60 and actuator 50.In a further alternative embodiment, the actuator 50 may provide feedback to the controller 60, or use such feedback internally, and may share such feedback with the controller 60 as a signal. Such feedback may be, by way of non-limiting example, force feedback, which may be useful in determining when the electrode assembly 4 contacts tissue or when it applies excessive force to tissue to be incised. Similarly, the connection 67 connects the controller 60 and the power supply 70 and is at least a unidirectional connection. In a further alternative embodiment, the power supply 70 may provide feedback to the controller 60, or use such feedback internally, and may share such feedback with the controller 60 as a signal. Such feedback may be, by way of non-limiting example, an error signal. Such error signals may be temperature error, input voltage error, output voltage error, input current error, output current error, etc. Similarly, the connection 68 connects the controller 60 and the user interface 80 and is at least a unidirectional connection from the user interface 80 to the controller 80. In a further alternative embodiment, the user interface 80 may provide feedback to the controller 60, or use such feedback internally, and may share such feedback with the controller 60 as a signal. For example, the user interface 80 may be a graphical user interface or a button or foot pedal that communicates a signal to the actuator 50 to move the electrode assembly 4 to incise tissue. The actuator drivers 57 and 508 may each be connected to the system controller 60 via the connections 65 and 510, respectively. The user interface 80 is connected to the system controller 60 via the connection 68, and user commands may be transmitted therethrough.

[0073] In some embodiments, the system controller 60 comprises a processor configured to determine a profile of the tissue to be removed from the eye and have instructions for providing refractive correction. The processor can be configured to determine the shape profile of one or more plates used to provide refractive correction for a patient. Also referring to controller 60, controller 60 may comprise components of a distributed computing system and may be operably connected to one or more processors as described herein, such as a distributed processing system.

[0074] In some embodiments, system 800 may further include a contact plate 804, a support element 802, a suction element 810, and an attendant vacuum device that may be used to secure the contact tissue 2. Incision 42 may be made within tissue 2 (cornea and / or corneal stroma in this exemplary embodiment) by moving at least a portion of the tensioned electrode assembly 5 along the axis of movement 12 and using actuator 504 to create pedestal 43. The contact plate 804 may be incorporated to flatten the cornea by moving it along the axis of movement 14 over the anterior surface of the cornea using actuator 50. The contact plate 804 may further include a contact surface 806 (not shown). The contact plate 804 may be used to flatten the cornea, particularly when the contact surface 806 is nominally substantially planar. As a non-limiting example, the contact plate 804 may be configured as a planar glass window to allow visibility therethrough. As a non-limiting example, the contact plate 804 may be made of a material selected from the group consisting of glass, crystalline line, ceramic, metal, polymer, and combinations thereof. A contact element 808 (not shown) may be disposed on the distal surface of the contact plate 804 and may provide a clean and / or sterile surface for contact with tissue 2 and may be configured as a thin, conformal peelable and adhesive sterile barrier, which may also be disposable. As a non-limiting example, the contact element 808 may be made of a material selected from the group consisting of polyethylene (PE), polyvinyl chloride (PVC), polypropylene (PP), stretched PP (OPP), biaxially stretched (BOPP), polyethylene terephthalate (PET), and combinations thereof. The contact plate 804 may be at least partially supported by a support 802. The support 802 may further be a support element of the tensioned electrode assembly 5, such as arms 710 and 712, thereby also supporting electrodes 702 and tensioning elements 700 and forming at least a portion of electrode assembly 4 and tensioned electrode assembly 5. Thus, arms 710 and 712 may be considered a support structure for electrodes 702.Alternatively, the support 802 may be operably coupled to the probe body 26 and / or the sheath 6. Alternatively, the contact plate 804 may be moved relative to the tissue 2 together with the support 802. The suction element 810 may be used to stabilize the eye containing the tissue 2 relative to the contact plate 804 and / or the electrode 4. The suction element 810 may be configured as a nominally open annular ring, as shown, or alternatively, as a single open pocket or any other applicable structure for achieving fixation to the eye, such as a plurality of open pockets. The suction element 810 may be operably coupled to a vacuum pump 850 via a vacuum line 870 to provide a negative pressure within the suction element 810. For patient safety and system reliability, a vacuum switch 852 and / or a vacuum sensor 854 may be installed between the suction element 810 and the vacuum pump 850 and connected via connections 860 and 862, respectively. The system controller 60 may be connected to the vacuum pump 850, the vacuum switch 852, and the vacuum sensor 854 via electrical connections 864, 866, and 868, respectively. In this configuration, the actuator 50 may be configured to correspond to the axis of motion 14 and to actuate (or "translate") the contact plate 804, and the connection 55 may be made to the contact plate 804 or such a structure supporting the contact plate 804. The contact plate 804 may be translated at a rate or speed between ~0.1 mm / s. -1 and ~1,000 mm / s -1 and may be translated at a rate or speed between ~10 mm / s -1 and ~100 mm / s -1 and may be translated at a rate between. The motion corresponding to the actuator 50 may be configured to be at least partially simultaneous with the actuator 504 or its velocity profile.

[0075] In some embodiments, system 800 may further be configured such that the tensioned electrode assembly 5 at least partially comprises electrode 702. Electrode 702 may extend across arms 710 and 712 to form a spanning distance of ~12 mm and may comprise a tungsten wire with a diameter of ~12.5 μm and a purity of at least ~99%, using a mechanical coil spring that applies a tension of, for example, ~300 mN on electrode 702.

[0076] In some embodiments, the incision may form a flap or pocket or a combination thereof based on whether the electrode cut width substantially exceeds or is substantially equal to the lateral extent of the target tissue structure to be incised and whether the electrode is to be laterally penetrated out of the tissue. That is, the flap may be created within the anterior surface of the cornea by using contact plate 804 to flatten or otherwise compress the anterior corneal surface, resulting in a lateral dimension for incision 42 between ~3 mm and ~11 mm, or alternatively between ~8 mm and ~10 mm (all of which may be less than the aforementioned spanning distance for providing a flap incision). The flap incision may be configured to provide a D-shaped incision 42 as shown, and the straight section of the D-shaped incision may be the hinge portion. Similarly, a pocket incision may be created when the electrode spanning distance is less than the lateral extent of the compressed cornea presented to the electrode. Alternatively, a combined flap / pocket incision may be generated using a pocket incision configuration, allowing the electrode to traverse the entire distance through the cornea, resulting in an incision shaped as a fully rounded rectangle or a partially rounded rectangle (e.g., when configured to have a non-linearly cut portion). In an alternative embodiment, driver 18 may supply a sine wave waveform having a peak-to-peak full range voltage of ~250 V at a frequency of ~1 MHz and a power limit of ~15 W, and along movement direction 12, utilize steps 102 - 122 of flowcharts 100 and 200 as shown in FIGS. 7 and 9, from ~200 mm·s -1 to ~0 mm·s -1The electrode translational rate between the electrodes (i.e., while the electrode is stopped at the end of the incision, v t =~0 mm·s -1 ) may be configured to incise corneal tissue. Step 202 of flowchart 200 may apply when the contact plate 804 is moved along the movement direction 14 to remove a portion of the tissue (e.g., the "corneal piece" of the intrastromal tissue), during the intermediate period while the electrode moves in the first direction and then in the second direction, the electrode is provided with a nominal voltage of ~0 V, and it may be used for the interruption of power to the electrode in coordination with the movement of the electrode and the contact plate 804. Alternatively, the electrode voltage and / or power may be a function of the electrode speed and / or position and / or the cutting range, as described anywhere in this specification.

[0077] Alternatively, variable acceleration may be used to generate a motion profile for the electrode that results in a non-linear speed profile. Such a motion profile requires a higher-order control model and incorporates "jerk" and / or "jounce" and / or "snap" and / or "crackle" factors, and as a non-limiting example, provides asymmetric acceleration / deceleration such that the range of v within the initial ~50 μs is similar to that of the final ~10 μs. t

[0078] The speed and / or speed profile and / or the effective incision width may be considered when controlling (e.g., "modulating") the power to the electrode.

[0079] As a non-limiting example, the power to the electrode 702 may be adjusted by selecting the maximum value of a parameter selected from the group consisting of voltage, current, carrier frequency, modulation frequency, duty cycle, power setpoint, power limit, energy per pulse setpoint, energy per pulse limit, and combinations thereof.

[0080] As a non-limiting example, the modulation relationship, which describes the controlled power output of the electrode 702 driven by the driver 18, may be selected from the list consisting of the following, namely, a fixed relationship, a constant relationship, a linear relationship, a non-linear relationship, a logarithmic relationship, a sine wave relationship, an exponential relationship, a polynomial relationship, and combinations thereof. The relationship may be directly proportional or inversely proportional depending on the system configuration and may be determinable using the descriptions and equations included herein. The controlled power output may be regarded as instantaneous power and / or average power and / or peak power. The modulation may be achieved, as a non-limiting example, via the control of the driver 18. The term "modulation" is used herein to indicate the modification of an otherwise consistent output, waveform, or signal. As used herein, "modulating" a waveform is comparable to "enveloping" a waveform, and a "modulation envelope" is comparable to an "envelope". Alternatively, unmodulated may be used to essentially envelope a waveform that includes a pulsating waveform.

[0081] As a non-limiting example, when generating a corneal flap incision, the duty cycle D c may be modulated by utilizing a composite relationship that represents the effective incision width y a which is modeled as the chord length of a circle of radius R that varies as a function of the distance into the target tissue x t multiplied by the velocity profile v c resulting in

Chemical formula

[0082] Alternatively, the voltage U required for evaporation is

Chemical formula

Chemical formula

[0083] Alternatively, the energy per cycle provided to the electrode 702 by the driver 18 may be configured to deliver energy per cycle that depends at least in part on the value of v t and / or depends at least in part on the value of the effective incision width y a

[0084] Alternatively, the duty cycle provided to the electrode 702 by the driver 18 may be configured to deliver a duty cycle that depends at least in part on the value of v t and / or depends at least in part on the value of the effective incision width y a

[0085] Alternatively, the voltage provided to the electrode 702 by the driver 18 may be configured to deliver a voltage that depends at least in part on the value of v t and / or depends at least in part on the value of the effective incision width y a

[0086] Alternatively, the current limit provided to the electrode 702 by the driver 18 may be configured to deliver a current limit that depends at least in part on the value of v t and / or depends at least in part on the value of the effective incision width y a

[0087] Alternatively, the power limit or set point provided to the electrode 702 by the driver 18 may be at least in part v t ​​​​depend on the value of, and / or at least in part, the effective incision width y a and may be configured to deliver a power limit or setpoint that may depend on the value of

[0088] Alternatively, the PRF provided to the electrode 702 by the driver 18 may be at least in part t depend on the value of, and / or at least in part, the effective incision width y a and may be configured to deliver a PRF that may depend on the value of

[0089] Alternatively, t v may, as described anywhere herein, at least in part, the effective incision width y a and / or x c and may depend on,

Chemical formula

[0090] Alternatively, the tensioned electrode assembly 5 is tensioned by the tensioning element 700 up to about 300 mN, and the initial electrode location is between ~2 mm and ~4 mm from the side closest to the target tissue to be incised (i.e., the closest point of the electrode along its axis of movement), along direction 12, at a constant acceleration of ~1,000 mm·s -2 to a maximum rate of ~200 mm·s -1 and is translated in parallel. For the incising portion of the electrode 702, when consisting of a ~10 mm long ~O20 μm ~99.99% pure tungsten wire, the voltage provided by the driver 18 may linearly increase from ~0 V to the maximum amplitude during the initial ~50 μs of the translation and decrease back to ~0 V during the final ~50 μs of the translation, with a ~1 MHz PRF (or "carrier frequency") and deliver a maximum peak-to-peak bipolar nominal sinusoidal voltage of ~600 V (with amplitudes of both ~+300 V and ~-300 V with respect to the nominal neutral voltage).

[0091] In a further alternative embodiment, the duty cycle provided by driver 18 may be configured to deliver a duty cycle that ramps up from ~0% to a maximum amplitude between ~70% and ~100% during the initial ~50 μs of translation and ramps down to approximately 0% during the final ~10 μs of translation. The duty cycle may be generated using a modulation frequency such as a square wave gating function. The square wave gating function may be configured to have variable “on” and / or “off” times. The relationship of the variable “on” and / or “off” times may be such as may be described anywhere in this specification with respect to the relationship for explaining the controlled power output of the electrodes.

[0092] In a further alternative embodiment, the duty cycle provided by driver 18 may be configured to deliver a duty cycle that is at least partially t dependent on the value of v, and may ramp up from ~0% to a maximum amplitude between ~70% and ~100% while the speed of the electrode is increased from rest (i.e., v t = 0 mm·s -1 ) to its maximum value, and the duty cycle may then decrease to ~0% as the electrode speed is reduced back to rest.

[0093] In a further alternative embodiment, the maximum power output provided by driver 18 may be configured to deliver a maximum power output that is at least partially t dependent on the value of v, and may ramp up from ~0% to a maximum amplitude between ~70% and ~100% while the speed of the electrode is increased from rest to its maximum value, and the maximum power output may then decrease to ~0% as the electrode speed is reduced back to rest.

[0094] In a further alternative embodiment, the voltage provided by driver 18 may be at least partially tIt may be configured to deliver a voltage that depends on the value of , and while the speed of the electrode is increased from rest to its maximum value, it may gradually increase from ~0% to a maximum amplitude between ~70% and ~100%. Then, as the electrode speed is reduced to return to rest, the duty cycle is reduced to ~0%.

[0095] Figure 7 illustrates a method of incising tissue. Flowchart 100 includes steps 102 - 122, which may be completed sequentially or in any suitable order. In step 102, an eye is selected for treatment. Step 104 involves activating the system, and step 106 involves positioning the probe on the tissue to be treated. Step 108 involves activating the vacuum system and fixing the tissue against the probe (via a vacuum system as described above). Step 110 involves positioning the contact plate at a first position on the tissue. Step 112 involves applying power to the electrode. Step 114 involves translating (or "moving" or "actuating") the electrode in a first direction (along the axis of movement 12, the "+x - direction", etc.). Step 116 involves interrupting the power to the electrode. Step 118 involves removing the vacuum fixation, releasing the tissue, and disengaging the treated eye. Step 120 involves disengaging the electrode from the just - incised tissue. Step 122 involves de - activating the system and disengaging it from the eye. The thin electrode may be allowed to break as the system is disengaged from the patient. Alternatively, the electrode may be translated in a second direction that is nominally opposite to the first direction. Alternatively, steps 108 and 110 may be exchanged, and once in contact with tissue 2, power may be applied to the electrode. Alternatively, steps 116 - 120 may be excluded to create an excision. Alternatively, steps 116 and 118 may be excluded only if there is a low risk of collateral damage due to tissue heating while the actuator is changing direction. Alternatively, step 116 may involve a tapered reduction in power to the electrode as described anywhere in this specification, and step 112 may involve a tapered increase in power to the electrode.

[0096] FIG. 7 shows a method of incising tissue according to some embodiments, and those skilled in the art will recognize that many adaptations and variations can be made in accordance with the present disclosure. For example, the steps may be performed in any suitable order, some of the steps may be repeated, some of the steps may be omitted, and combinations thereof can be made.

[0097] In some embodiments, a processor as described herein is configured to have instructions for performing one or more of the steps of the method of FIG. 7.

[0098] Figures 8A-8D are directed to details of an embodiment of the present disclosure, where the tensioned electrode assembly 5 is shown in a view orthogonal to that of FIGS. 4-6 such that the axis of motion 12 can here be in and out of the plane of the figure while the axis of motion 14 can be perpendicular, and the steps of FIG. 7 may be followed. FIG. 8A shows that the contact plate 804 can be within the central portion of the support 802 and configured to move relative to the support 802 along the axis of motion 14. The contact surface 806 of the contact plate 804 can be substantially planar and substantially parallel to the cut portion of the electrode 702. The electrode 702 is initially shown here to be behind the cornea. The contact element 808 is disposed on the contact surface 806 and can produce a sterile disposable for use only during a single procedure. The contact element 808 can nominally conform to at least a portion of the contact surface 806. The portion of the contact surface 806 to which the contact element 808 conforms can be a central portion. The suction element 810, as shown, can be configured to contact the eye containing the tissue 2 in the region near the outer cornea and / or the limbal corneal ring 838 and fix and stabilize the cornea 843 (not shown in this figure). Alternatively, the suction element 810 can be contacted at least to the side of the cornea 843 to better stabilize the tissue 2 against the incision of the electrode 702. The cornea 843 can include an anterior corneal surface 842 and a posterior corneal surface 844. In this example, the target tissue 2 is considered to be stromal tissue within the cornea 843 and can be contained between the anterior corneal surface 842 and the posterior corneal surface 844. The intraocular lens 840 is shown for purposes of orientation and can be a natural lens or an artificial prosthetic lens. In this embodiment, the contact element contacts the apex of the anterior corneal surface 842 of the cornea 843. The electrode assembly 4 can include the arms 710 and 712 and the electrode 702 as shown. The configuration of this figure can represent steps 102, 104, and 106 of FIG. 7.

[0099] Figure 8B shows the system of Figure 8A, and it can be supposed that the contact plate 804, and thus the contact element 808, is moved further along the axis of movement 14 to flatten the cornea 843 and the tissue 2 therein. The electrode 702 can incise the tissue 2 by traversing a path along the axis of movement 12 as described anywhere herein, creating an incision 45 and thereby generating a base 43 (not shown in this figure). The configuration of this figure may represent steps 108, 110, 112, and 114 of Figure 7.

[0100] Figure 8C shows the system of Figure 8B in a different orientation, as supported by the axes of movement 12 and 14, such that as the electrode 702 is translated along the axis of movement 12 (shown as progressing from left to right in this figure), the incision 45 is seen to progress through the tissue 2. The actuation of the electrode 702 can be performed at its final position such that it can be applicable when generating a flap incision.

[0101] Figure 8D shows the system of Figures 8A - 8C, and it can be supposed that the contact plate 804, and thus the contact element 808, is moved along the axis of movement 14 to just come to rest at the apex of the corneal surface 842 as in Figure 8A. This figure shows the incision 45 here, which can form a surface for the base 43 (not shown). The surface shape of the base 43 thus generated can be characterized nominally as being substantially that of the anterior corneal surface 842. Alternatively, the surface shape of the central region of the base 43 thus generated (not shown) can be characterized as the average value of at least a part of the surface shapes of the anterior corneal surface 842 and the contact surface 806 (or contact element 808). The average may nominally be an arithmetic mean, geometric mean, harmonic mean, weighted mean, or a combination thereof. The configuration of this figure may represent steps 116, 118, 120, and 122 of Figure 7.

[0102] FIG. 9 illustrates a method similar to that of FIG. 7 with additional steps 202-212, step 116 being optionally performed and allowing the electrodes to be incised during step 202. That is, alternatively, steps 116 and 118 may be excluded only if there is a low risk of collateral damage due to tissue heating while the actuator is changing direction and / or distortion to an electrode not being powered can cause failure of the electrode due to a change in the position of the contact plate. Step 202 involves positioning the contact plate in a second position, which may be a translation of the entire element or a translation of at least a part of the element. The translation of at least a part of the element may be used to create a non-planar contact plate surface and provide a desired corneal deformation, as will be described with respect to FIGS. 11A and 11B. Alternatively, a certain contact plate may be replaced in step 202 to provide a desired corneal deformation. The corneal deformation may be intended to create a surface that defines at least a part of a corneal flap, such as the base 43, to achieve at least a part of a desired three-dimensional tissue resection profile. The corneal flap may subsequently be removed, causing a refractive change in the cornea 843 of the patient's eye. Step 204 may be optionally performed if step 202 is removed, but otherwise may be similar to step 112. Step 206 involves translating the electrodes in a second direction. The second direction may nominally be opposite to the first direction. Step 208 involves disengaging the electrodes from the tissue so as to occur if the translation of step 206 brings the electrodes outside of the tissue 2. Step 210 involves turning off the power to the electrodes and may be similar to step 116 of FIG. 7. Step 212 involves removing the vacuum fixation, freeing the tissue, and disengaging the treated eye and may be similar to step 118 of FIG. 7. Step 122 involves deactivating the system and disengaging it from the eye, similar to step 122 of FIG. 7.

[0103] FIG. 9 shows a method of incising tissue according to some embodiments, and those skilled in the art will recognize that many adaptations and variations can be made in accordance with the present disclosure. For example, the steps may be performed in any suitable order, some of the steps may be repeated, some of the steps may be omitted, and combinations thereof can be made.

[0104] In some embodiments, a processor as described herein is configured to have instructions for performing one or more than one of the steps of the method of FIG. 9.

[0105] FIGS. 10A-10F are directed to a system similar to that of FIGS. 8A-8D, where the shape of the contact surface 806 can be configured other than planar, shown as convex, and further configured such that a corneal flap (e.g., corneal flap 820) can be incised into the (stromal) tissue 2 of the cornea 843. The difference between the first incision profile and the second incision profile may correspond to the shape of the corneal flap of the tissue to be removed from the cornea to treat refractive abnormalities of the eye.

[0106] FIG. 10A shows a system configured similarly to that of FIG. 8A, with the addition of a curved surface 806 on the contact plate 804. Similarly, the contact element 806 is placed on the curved contact surface 806 and nominally conforms to the curvature. The configuration of this figure may represent steps 102-108 of FIGS. 7 and 9.

[0107] FIG. 10B shows the system of FIG. 10A, where the contact plate 804, and thus the contact element 808, can be moved further along the axis of movement 14 and into contact with the cornea 843 and the tissue 2 therein. Unlike the configuration of FIGS. 8A-8C, in the configuration of this figure, the cornea is not necessarily flattened, but is compressed differently to at least partially conform to the curvature of the contact surface 806 (or "shape" if the curvature alone may not be sufficient to properly describe the contact surface 806) to produce the incision 46. The configuration of this figure may represent steps 110-112 of FIGS. 7 and 9.

[0108] FIG. 10C shows the system of FIG. 10X in different orientations, as seen such that incision 45 progresses through tissue 2 as electrode 702 is translated parallel along movement axis 12 (shown as progressing from left to right in this figure), and is supported by movement axes 12 and 14. The actuation of electrode 702 can be done at its final position so as to be applicable when generating a flap incision.

[0109] FIG. 10D shows the system of FIG. 10X, where contact plate 804 has been translated forward and incision 46 is shown here. Such an incision 46 can form the surface of base 44 (not shown). The surface shape of base 44 generated in this way can be characterized as the average value of the surface shapes of anterior corneal surface 842 and contact surface 806 (or contact element 808). The average can nominally be an arithmetic mean, geometric mean, harmonic mean, weighted mean, or a combination thereof.

[0110] FIG. 10E shows the system of FIG. 10X, where incision 45, a second incision, can be generated here. The configuration of this figure can represent steps 202 - 206 of FIG. 9. Alternatively, incision 45 may be generated by replacing contact plate 804 or a part thereof and providing a different surface shape for incision 45. A flat contact surface may be used for at least one incision.

[0111] FIG. 10F shows an eye being treated using the system of the previous FIG. 10X, with corneal flap 820 incised within the (stromal) tissue 2 of cornea 843 and bounded by the surfaces created by incisions 45, 46. Incisions 45, 46 may constitute incision 47 when the electrodes are made to cut across the entire cornea rather than to create a pocket within the cornea. The configuration of this figure may represent the result of completing the remaining steps of FIG. 9. The shape of the surfaces created via incisions 45, 46 may be selected to affect refractive correction to the cornea 843 of the patient's eye. The refractive correction may be defined, at least in part, by diagnostic measurements such as corneal aberration measurement, ocular aberration measurement, wavefront aberration measurement, corneal topography, and combinations thereof, and the nominal shape of the corneal flap may be defined to optically balance (or correct) the measured aberrations as described in Sekundo W. Small Incision Lenticule Extraction (SMILE) Principles, Techniques, Complication Management, and Future Concepts. 2015. Springer Cham Heidelberg and the associated citations therein.

[0112] In some embodiments, for the cornea, an approximate tissue profile for the tissue to be removed can be represented as follows.

[0113] T(x,y) ~= W(x,y) / (n - 1), where T is the thickness in microns, W is the wavefront error in microns, n is the refractive index of the cornea, and x and y are coordinate references corresponding to a plane such as a plane near the pupil or the apex of the cornea. The wavefront error can be represented in many ways, for example, using elevation in microns or individual Zernike coefficients, etc.

[0114] Other approaches may also be used to determine the thickness profile of the tissue to be removed, for example, with reference to the SMILE technique, as would be known to those skilled in the art.

[0115] Figures 11A and 11B are directed to an adjustable contact plate 804 for each section for deforming the cornea to create corneal flaps or incisions for other therapies. The adjustable contact plate 804 is operably coupled to a controller and can be configured to shape the cornea and provide refractive correction with respect to an embodiment referring to small incision corneal flap extraction as described herein. FIG. 11A depicts an adjustable contact plate 804 for each section, which may consist of a subplate (or equivalently, an “element”) 8061 that can form a contact surface 806 and can be housed within a housing 8042 and mounted on a base 8044. FIG. 11B depicts the same contact plate 804 in a cross-sectional view to expose an actuator 8100 that is operably coupled to the subplate 8061 within the housing 8042. In this embodiment, each subplate 8061 is attached to the actuator 8100 as shown and described with respect to the system of FIG. 6, and each subplate 8061 can be individually actuated using additional actuators and associated monitoring and control subsystems (the connections are not shown in this figure). As a non-limiting example, the subplate 8061 may be adhered or soldered to the actuator 8100 using epoxy. The actuator 8100 may be selected from the group consisting of piezoelectric actuators, motors, pneumatic actuators, fluid actuators, and combinations thereof. As shown in the exemplary embodiment, the sub-element 8062 may be constructed using a material selected from the group consisting of glass, ceramic, quartz, silicon, metal, polymer, and combinations thereof. Such a subplate 8061 may be actuated along a movement axis (e.g., movement axis 14).When prescribing the surface shape accuracy for the corneal piece to be removed from the tissue 2 in the cornea 843, such a subplate 8061 is translated (or "displaced") to address optical aberrations, including higher-order aberrations such as defocus, radial distortion, spherical, spherical aberration, cylindrical, cylindrical aberration, astigmatism, coma, and trefoil. It forms a contact surface 806 for each section with a free-form profile (or "shape" or "surface profile") and may generate a discrete but arbitrarily addressable profile for use in generating incisions 45 and / or incisions 46. Such a subplate 8061 is nominally configured to be rectangular as shown, but this is not necessary, and other geometries are also considered within the scope of the present disclosure. A contact element 808 (not shown) may be installed on the distal surface of the contact plate 804 to provide a clean and / or sterile surface for contact with the tissue 2 and may be configured as a thin and conformal peelable and adhesive sterile barrier, which may also be disposable as described anywhere in this specification. Instead of repositioning the contact plate 804 using step 202 of FIG. 9, this embodiment may allow step 202 to be modified to reconfigure the contact plate into a second configuration prior to generating another incision. The number of actuators 8100 may be determined by the spatial resolution requirements of a given prescription and / or the tolerance of the surface shape accuracy. As a non-limiting example, there may be an array 10 of actuators 8100 with a square cross-sectional shape, or an array 14 of such actuators 8100, or an array 28 of such actuators 8100, which are each ~2.0 mm per actuator 8100 when configured to be square-packed within the area of a nominally 12 mm diameter disc-shaped contact surface. 2 , ~1.44 mm 2 , and ~0.80 mm 2results in an area. Alternatively, a more regular array, such as a 4×4 square array, may be used, resulting in 16 actuators 8100. When the regular array of 16 actuators 8100 with a square cross-sectional shape is positioned concentrically with a nominally 12 mm disc-shaped contact surface, the area per actuator is ~9 mm 2 it can be, but the corners of the array can be outside the 12 mm disc boundary. Similarly, a 10×10 square array can result in an area per actuator of ~1.44 mm 2 per actuator.

[0116] Alternatively, a customized contact plate 804 and / or contact surface 806 may be machined to have a surface profile for use in generating incisions 45 and / or 46 to address higher-order aberrations when prescribing the surface shape accuracy for the corneal piece to be removed from the tissue 2 within the cornea 843. Alternatively, such customized contact plates 804 and / or contact surfaces 806 may be used individually in generating incisions 45 and / or 46. Alternatively, a first customized contact plate 804 and / or contact surface 806 may be used in generating incision 45, a second customized contact plate 804 and / or contact surface 806 may be used in generating incision 46, and the first and second customized contact plates 804 and / or contact surfaces 806 may be configured with different surface profiles. Instead of repositioning the contact plate 804 using step 202 of FIG. 9, this embodiment may allow step 202 to be modified such that it is replaced (or “swapped”) with a second contact plate prior to generating another incision. Means for machining such customized contact plates 804 and / or contact surfaces 806 may be selected from the group consisting of additive manufacturing, injection molding, machining, and combinations thereof.

[0117] In some embodiments, the optical prescription may comprise one or more of surface curvature, refractive power in diopters, material properties, refractive index, wavefront measurements of the eye, or thickness. In some embodiments, the surface shape accuracy of the optical system can be defined as a perturbation of the optical surface from the optical prescription. Low-frequency errors are typically defined as irregularities, deviation fringes, or flatness and can tend to transfer light into the first several diffraction rings from the center of the airy disk pattern. This effect can reduce the size of the point spread function without broadening it, and thus can reduce the Strehl ratio. Intermediate frequency errors (or small angle scattering) are defined using slopes or (PSD) requirements and tend to broaden or blur the point spread function (PSF), and can reduce contrast. Both low-frequency and intermediate frequency errors can degrade optical system performance. However, some surface shape accuracy imperfections may be omitted from the surface shape accuracy specification, as may apply in the case of refractive power and occasional astigmatism. The optical system may allow individual optical systems to be focused, decentered, or tilted to compensate for specific aberrations. Surface accuracy and surface shape accuracy are often terms used to capture both regions. To eliminate ambiguity, one may use microns as the unit value in the specification.

[0118] Figures 12A and 12B are directed to the generation of a disc-shaped corneal piece. Figure 12A shows a corneal piece 820 comprising a front surface 451 that can be generated by incision 45 via step 114 of FIGS. 7 and 9, and a rear surface 461 that can be generated by incision 46 via step 118 of FIGS. 7 and 9. A hinge 1020 can be generated via step 202 of FIG. 9, which is a translation of the contact plate to a second position between the generation of incisions 46 and 45. In this figure, the corneal piece can appear as a flat disc as shown when spread out on a flat surface. Figure 12B shows a cross-sectional view of the same corneal piece 820 of FIG. 12A. In this embodiment, a nominally planar contact plate is positioned at a first position (or “depth” or “location”) and can be translated to a second more forward (or “proximal”) position to generate incision 46 and then incision 45. In the configuration of this embodiment, the cross-sectional shape 1010 can be nominally rectangular, and the surfaces 451 and 461 can be nominally parallel. Alternatively, incision 45 can be generated at a position posterior (or “distal”) to that of incision 46 by appropriate translation of the contact plate.

[0119] Figure 13 is directed to a plano-convex type corneal piece similar to that of FIG. 12B according to an embodiment of the present disclosure. Here, the corneal piece 820 comprises a front surface 451 that can be generated by incision 45 and a rear surface 461 that can be generated by incision 46. The contact plate, or elements of the contact plate consisting of a plurality of translatable elements, may be configured to produce a non-planar type surface for the surface 451. The configuration of this embodiment may be utilized to generate a plano-convex type corneal piece as shown.

[0120] Figure 14 is directed to a meniscus-shaped corneal piece similar to that of FIG. 13 according to an embodiment of the present disclosure. Here, the corneal piece 820 includes a front surface 451 that can be generated by incision 45 and a rear surface 461 that can be generated by incision 46. The contact plate, or an element of the contact plate consisting of a plurality of translatable elements, may be configured to produce a non-planar type surface for both surfaces 451 and 461. The configuration of the present embodiment may be utilized to generate a meniscus type corneal piece as shown.

[0121] Figure 15 is directed to a hybrid type corneal piece similar to that of FIG. 14 according to an embodiment of the present disclosure. Here, the corneal piece 820 includes a front surface 451 that can be generated by incision 45 and a rear surface 461 that can be generated by incision 46. The contact plate, or an element of the contact plate consisting of a plurality of translatable elements, may be configured to produce a non-planar type surface for both surfaces 451 and 461. The configuration of the present embodiment may be utilized to generate a meniscus type corneal piece as shown.

[0122] Figures 16A and 16B are directed to histological images of incisions in a porcine cornea generated according to an embodiment of the present disclosure. FIG. 16A shows an image 900, which is a histological microscopic image of a conventional sagittal section (H&E stained) of a porcine cornea that was incised when it was just harvested (stored at ~2°C for ≤2 days after collection) and subsequently fixed in a 4% paraformaldehyde solution. The incision system is as follows, namely, PRF ~1 MHz, V ~±250 V, sine wave waveform, P rms ~15 W; v t,max ~400 mm·s -1 ; ~2,000 mm·s -2Constant acceleration of; ~99.99% pure tungsten wire electrode with Φ ~15 μm and L ~10 mm; T ~290 mN; Rear displacement between incisions 45 and 46 of a ~35 μm contact plate (flat), and a vacuum gauge pressure of ~ -500 mmHg for the suction element 810, as measured by the vacuum sensor 854. The electrode assembly translation was performed using an M-664.164 piezoelectric motor actuator (manufactured by PI, Karlsruhe, Germany). The target tissue 2 is corneal stromal tissue. Incision 45 was separated to expose surfaces 451 and 452. Incision 46 was left intact with the corneal piece 820 in place. Damage may be visible as a darker band along incisions 45 and 46 and may be within the range of ~3 μm. FIG. 16B is similar to that of FIG. 16A but at a higher magnification and shows an image 902 with a different spacing between incisions 45 and 46 using a ~50 μm rear contact plate translation. Again, the thin damage zone is evident.

[0123] FIG. 17 is directed to a plot 910 displaying an exemplary electrode voltage versus time waveform 912 that constitutes a feature, according to an embodiment of the present disclosure. The waveform 912 comprises individual cycles 914. The burst 916 consists of pulses (cycles 914) and is constrained by a modulation envelope 918. The modulation envelope 918 may be configured as a combination of relationships described anywhere in this specification, including pulsation, duty cycle, and modulation (e.g., ramp-up) relationships. Here, for clarity, it is shown at the level of the pulses and bursts, but the entire incision waveform may be similarly configured.

[0124] FIG. 18 has an equivalent sensitivity of 6400 ISO and t shImage 960, which is a 576 pixel × 464 pixel frame that can be acquired using a high-speed digital camera such as the AOSM-VIT4000 (AOS Technologies, Daettwil, Switzerland) when configured to operate at a shutter speed (or "integration time") of ~250 μs. In this figure, a plurality of vapor cavities 635 along image element 962 can indicate an intermittent interruption process, which is similar to that of FIGS. 6-10E, i.e., v t,max ~400 mm·s -1 ; ~2,000 mm·s -2 constant acceleration of; ~Φ13 μm, L ~10 mm, ~≧99.99% pure tungsten wire electrode; T ~280 mN, and configured as a vacuum gauge pressure of ~-640 mmHg for suction element 810 as measured using vacuum sensor 854, nominally utilizing the waveform of FIG. 17, for an incision system, v t *t sh → ~13 μm and PRF*t sh → corresponding to approximately one diametrical electrode translation as ~250 cycles of a ~1 MHz waveform. A plurality of vapor cavities 635 can become visible along image element 962 as electrode 702 (located at image element 962 but otherwise not visible in this figure) is actuated and translated along movement axis 12 in direction 121 to create an incision within cornea 843. The plurality of vapor cavities 635 can comprise a region where light is emitted in association with plasma formation, the light can have a wavelength that is a function of plasma temperature, and can be within the range of approximately 400 nm to approximately 750 nm.

[0125] According to embodiments of the present disclosure, the technique dependence of scleral incision can be reduced by using a plasma-induced cutting tool to semi-automate flap generation, which provides predictable, accurate, and precise incisions in the sclera and / or cornea, limiting tissue damage and including a strong corneal rim. According to embodiments of the present disclosure, instead of a conventionally used flap, a pocket in the sclera and / or cornea including a strong corneal rim may be created. Further embodiments may provide incisions in other tissues such as those listed in FIG. 1A. As non-limiting examples, plasma-induced incisions may be made in the lens capsule to produce a capsulotomy, in the lens to produce lens fragments, or to simplify lens fragmentation and / or lens removal, in the retina to improve drainage and / or lower IOP, in the trabecular meshwork (TM), and in the iris to produce an iridectomy.

[0126] A "flap" of tissue can be described as an incision that results in a "flap" of tissue that can be lifted and pivoted on a "hinge" to provide access to the tissue beneath it. As a non-limiting example, cutting three sides of a square to 50% depth and removing the plane at that 50% depth beneath the edge of the square of tissue can result in a half-thickness flap with the fourth uncut side of the square as its hinge. The flap can be detached by completing the fourth side of the exemplary square incision.

[0127] A pocket can be described as an incision that separates a first depth (or layer) of tissue from a second depth (or layer) of a compartment of tissue without necessarily creating a flap. As a further non-limiting example, cutting one side of a square to 50% depth and removing the plane at that 50% depth beneath the edge of the square of tissue can result in a half-thickness pocket.

[0128] A semi-automated cutting tool can be used to provide an improved incision over that of a conventional sharp-edged instrument. A plasma-induced semi-automated cutting tool can be used to provide an improved incision over that of a semi-automated cutting tool configured for use in combination with a sharp-edged instrument.

[0129] A semi-automated cutting system with at least 1 degree of movement can be used to create 5×5 mm and 4×4 mm flaps instead of generating them manually. For example, a system with both 5 mm wide and 4 mm wide “blades” can be used to create 5×5 mm and 4×4 mm flaps, respectively. The electrode may comprise a wire and / or a blade.

[0130] FIG. 19A shows a flap 40 within tissue 2 as seen above, and FIG. 19B shows the same flap 40 as seen when viewed from section A-A. The flap 40 is constructed from incisions 42 and 44, which create a base 43 and form three sides of a square (in the embodiment of FIGS. 19A-19D, this is the case, but other such shapes are also considered within the scope of the present disclosure). The flap can be lifted and butterfly sutured about the missing side of the hinge square to expose the underlying tissue. The base 43 may be planar or curved. The flap can be detached by completing the fourth side of the exemplary square incision.

[0131] Similar to the configuration of FIGS. 19A and 19B, FIG. 19C shows a pocket 41 within tissue 2 as seen above, and FIG. 19D shows the same pocket 41 as seen when viewed from section A-A. However, in this configuration, the pocket 41 consists of an incision 42, which creates a base 43 but lacks the incision 44. Again, the base 43 may be planar or curved, but this time it will depend on the longitudinal shape (or “profile”) of the incision in order to avoid creating the incision 44.

[0132] FIG. 20 is directed to a system according to an embodiment of the present disclosure configured to generate a rectangular flap or pocket that may be useful for trabeculoplasty for IOP reduction in the treatment of glaucoma. Tissue 2 may be incised using electrode 4, which in this exemplary embodiment is configured in a U-shape of width 6 and length 8 and includes a bend 10. Electrode 4 may be connected to a power RF driver 18 via conductor 20. Conductor 22 may be connected to the patient to generate electrode 24, which may in turn be part of a feedback path. The RF driver may produce bipolar pulses. Electrode 4 may here be shown as encapsulated within sheath 16, partially cut away for clarity. Movement direction 12 may be used to provide a lateral extent to the incision, and movement direction 14 may be perpendicular to the plane defined by the U-shape of width 6 of electrode 4 such that it may be used to generate a tissue flap and / or pocket. Alternatively, movement direction 14 may be employed to generate an incision nominally perpendicular to the surface of tissue 2. Width 6 may be selected to be from 1 mm to 10 mm, specifically 4 mm or 5 mm, as described above. Length 8 may be greater than width 6 and may be configured to transect the tissue by a distance less than length 8. For example, a 4 mm×4 mm flap may be generated by configuring width 6 to be 4 mm and length 8 to be greater than 4 mm such that it transects 4 mm of tissue along movement direction 12.

[0133] FIG. 21 is directed to a system similar to that of FIG. 20 configured to generate a flap as viewed from the side, containing electrode 4, sheath 16, and actuator 50, and similarly, with the addition of probe body 26 oriented at an angle 30 to the surface of tissue 2. Actuator 50 is operably coupled to electrode 4 and electrode 4 is translated within tissue 2 along movement directions 12 and 14 such that electrode 4 is first translated in direction 32, then in direction 34, then in direction 36 which is the opposite direction of direction 34, and then in direction 38 which is the opposite direction of direction 32, as explained by moving along a motion profile. This configuration can then generate flap 40 (not explicitly shown for clarity purposes) by generating incision 42, then incision 44 and base 43. As a non-limiting example, actuator 50 such as a motor or voice coil can be powered. Alternatively, actuator 50 can comprise a series of springs and ratchets or stops and triggers to generate the motion profile described. Element electrodes 4 and / or sheath 6 and / or probe body 26 may be configured as a subsystem that engages actuator 50 and RF driver 18 and is discarded after use. In an alternative embodiment, the flap may be detached by modifying the motion profile, i.e., first moving in direction 32, then in direction 34, and then in direction 38 which is the opposite direction of direction 32.

[0134] Alternatively, the system of FIG. 21 may be configured such that actuator 50 translates electrode 4 first in a direction nominally along angle 30 and then retracts electrode 4 along a second direction nominally opposite the first direction to create a pocket rather than a flap.

[0135] Alternatively, the second electrode may also be used to create a second flap or pocket of a different size and / or shape than the first flap or pocket. For example, a 5 mm x 5 mm flap may first be created, and subsequently, a 4 mm x 4 mm flap may then be created. The exemplary 4 mm x 4 mm flap may further be a detached flap.

[0136] Figures 22A - 22C are directed to details of an electrode configured in accordance with an embodiment of the present disclosure. Electrode 4 comprises regions 300, 302 and bend 10. Nominally, the surface area may be kept constant along electrode 4. As a non-limiting example, electrode 4 may comprise a solid wire with a diameter between ~50 μm and ~300 μm and may be made of a material selected from the group consisting of tungsten, nitinol, steel, copper, stainless steel, beryllium-copper alloy, cupronickel alloy, and aluminum. Further, in an alternative embodiment, the electrode may be at least partially coated with another conductive material such as gold. Region 302 may have the same base structure as region 300 with a modification that it is compressed in a direction parallel to the plane of the image and elongated in an orthogonal direction. Such a configuration may provide increased strength in the aforementioned orthogonal direction for improved reliability and strength while cutting through tissue by reducing dimension 303 to be less than dimension 301 and maintaining the surface area. Bend 10 may be made from either the configuration of region 300, the configuration of region 302, or made to transition between regions 300 and 302. Alternatively, regions 300 and 302 and / or bend 10 may be joined from dissimilar materials. In a further alternative embodiment, electrode 4 may be constructed from a tungsten wire with a diameter of ~250 μm, which is compressed everywhere except in region 300 which is ~3 mm in length. Dimension 301 is centered on region 300 and is made to have a radius of ~0.5 mm and result in a width 6 of ~4 mm, nominally the same as the original diameter of the wire of ~250 μm up to the original bend 10, while dimension 303 is configured to be formed to ~400 μm by the aforementioned compression.

[0137] For clarity purposes, electrode 4 has heretofore been shown as U-shaped, but it need not be so. RF driver 18 can provide an alternating current to electrode 4. Such an alternating current may be, as non-limiting examples, a sine wave, a square wave, a sawtooth wave, a triangular wave, or a combination thereof. The signal provided by RF driver 18 may be configured to have a base (or “carrier”) frequency between ~10 kHz and ~10 MHz, and further may be modulated to include a burst of pulses at a frequency between ~100 Hz and ~3 MHz to generate a duty cycle. The duty cycle may be between ~0.01% and ~100%. In an alternative embodiment, the duty cycle may be between ~60% and ~80%. The peak-to-peak voltage provided by RF driver 18 may be between ~500 V and ~2,000 V. In an alternative embodiment, the peak-to-peak voltage provided by RF driver 18 may be between ~400 V and ~800 V. In one embodiment, the signal of RF driver 18 may be configured to have a peak-to-peak bipolar voltage of ~800 V (with amplitudes of both ~+400 V and ~-400 V) with a carrier frequency of ~1 MHz and a modulation frequency of ~10 kHz, such that it may be useful when electrode 4 consists of a tungsten wire with a diameter of ~100 μm in region 300.

[0138] FIG. 23 is directed to a system 400 configured in accordance with an embodiment of the present disclosure. In addition to elements related to the previous figures, system 400 further comprises a controller 60, a power supply 70, a user interface 80, and a coupler 52. Connection 62 connects the controller 60 and the RF driver 18 and is at least a unidirectional connection. Connection 62 may also be a bidirectional connection, and the controller 60 is capable of sensing and / or responding to at least signals from the RF driver 18. Such signals may be safety signals regarding the sensed voltage or current. In a further alternative embodiment, the RF driver 18 may provide feedback to the controller 60, or use such feedback internally, and may share such feedback with the controller 60 as a signal. Such feedback may be, for example, EMF or current feedback, and may be useful when the electrode 4 contacts the tissue and / or when determining the status of the plasma. Such status may be, for example, whether the plasma is in a glow discharge stable state. Similarly, connection 65 connects the controller 60 and the actuator 50 and is at least a unidirectional connection. The actuator 50 may consist of at least one electric motor and may further comprise a position encoder. Connection 65 may alternatively be a bidirectional connection, and signals such as position, velocity, acceleration, out-of-bounds error, etc. are shared between the controller 60 and the actuator 50. In a further alternative embodiment, the actuator 50 may provide feedback to the controller 60, or use such feedback internally, and may share such feedback with the controller 60 as a signal. Such feedback may be, for example, force feedback, and may be useful when determining when the electrode 4 contacts the tissue or when applying excessive force on the tissue to be incised. Similarly, connection 67 connects the controller 60 and the power supply 70 and is at least a unidirectional connection.In a further alternative embodiment, the power supply 70 may provide feedback to the controller 60, or use such feedback internally, and may share such feedback as a signal with the controller 60. Such feedback may be, for example, an error signal. Such an error signal may be a temperature error, an input voltage error, an output voltage error, an input current error, an output current error, etc. Similarly, the connection 68 connects the controller 60 and the user interface 80 and is at least a unidirectional connection. In a further alternative embodiment, the interface 80 may provide feedback to the controller 60, or use such feedback internally, and may share such feedback as a signal with the controller 60. For example, the user interface 80 may be a graphical user interface or a button that communicates a signal to the actuator 50 to move the electrode 4 for use in incising tissue. This exemplary embodiment of the system 400 also includes a coupler 52, which can couple the electrode 4 to the actuator 50 such that the electrode 4 can be moved as described with respect to the foregoing figures. The coupler 52 may be constructed from an electrically insulating material and may be configured to electrically insulate the electrode 4 from at least one other element of the system 400. The coupler 52, and / or the sheath 16 and the electrode 4 may be incorporated into a subsystem that can be discarded after use. Although not shown, an alternative embodiment is a configuration for the coupler 52 that can be made to connect both sides of the (exemplary) U-shaped electrode 4 to the actuator 50. The electrode 4 can be translated in parallel by the actuator 50 at a rate of ~200 mm·s. -1 at a rate of

[0139] The symbol "~" is used herein as equivalent to "about". For example, a description such as "~100 ms" is equivalent to a description of "about 100 ms", and a description such as "v t =~5 mm·s -1 " is equivalent to a description of "v t is about 5 mm·s -1 ".

[0140] The symbol "O" is used in this specification to indicate that the following value is the diameter. For example, a description such as "O10μm" is equivalent to a description of "a diameter of 10μm". Furthermore, a description such as "~O12μm" is equivalent to a description of "a diameter of approximately 12μm".

[0141] The symbol "∝" is used in this specification to indicate proportionality. For example, a description such as "∝r -2 " is equivalent to a description of " -2 being proportional to r".

[0142] In this specification, the dot notation is used to represent composite units for the sake of clarity and conciseness. For example, the description k=~40N·m -1 is equivalent to a description of "k=~40N / meter".

[0143] As used in this specification, "mN" refers to "millinewton", which is -3 10

[0144] As described in this specification, the computing devices and systems described and / or illustrated herein broadly represent any type or form of computing device or system capable of executing computer-readable instructions such as those contained within the modules described herein. In their most basic configuration, these computing devices may each comprise at least one memory device and at least one physical processor.

[0145] As used herein, the term "memory" or "memory device" generally refers to any type or form of volatile or non-volatile memory device or medium capable of storing data and / or computer-readable instructions. In one embodiment, the memory device may store, load, and / or maintain one or more of the modules described herein. Examples of memory devices include, but are not limited to, random access memory (RAM), read-only memory (ROM), flash memory, hard disk drive (HDD), solid state drive (SSD), optical disk drive, cache, variations or combinations of one or more of the same, or any other suitable storage memory.

[0146] In addition, as used herein, the term "processor" or "physical processor" generally refers to any type or form of hardware-implemented processing unit capable of interpreting and / or executing computer-readable instructions. In one embodiment, the physical processor may access and / or modify one or more modules stored in the memory device described above. Examples of physical processors include, but are not limited to, microprocessors, microcontrollers, central processing units (CPUs), field programmable gate arrays (FPGAs) implementing softcore processors, application specific integrated circuits (ASICs), portions of one or more of the same, variations or combinations of one or more of the same, or any other suitable physical processor. The processor may comprise a distributed processor system, e.g., activation of parallel processors, or remote processors such as servers, and combinations thereof.

[0147] Although shown as separate elements, the method steps described and / or illustrated herein may represent parts of a single application. Additionally, in some embodiments, one or more of these steps, when executed by a computing device, may represent or correspond to one or more software applications or programs that may cause the computing device to perform one or more tasks such as method steps.

[0148] In addition, one or more of the devices described herein may convert data, physical devices, and / or representations of physical devices from one form to another. Additionally, or alternatively, one or more of the modules listed herein may, by executing on a computing device, storing data on a computing device, and / or otherwise interacting with a computing device, convert a processor, volatile memory, non-volatile memory, and / or any other part of a physical computing device from one form of computing device to another form of computing device.

[0149] The term "computer-readable medium" as used herein generally refers to any form of device, carrier, or medium capable of storing or carrying computer-readable instructions. Examples of computer-readable media include, but are not limited to, transmission-type media such as carrier waves, and magnetic storage media (e.g., hard disk drives, tape drives, and floppy (registered trademark) disks), optical storage media (e.g., compact discs (CDs), digital video discs (DVDs), and BLU-RAY (registered trademark) discs), electronic storage media (e.g., solid state drives and flash media), and non-transitory-type media such as other distributed systems.

[0150] Those skilled in the art will recognize that any process or method disclosed herein can be modified in many ways. The process parameters and sequence of steps described and / or illustrated herein are provided as examples only and can be varied as desired. For example, the steps illustrated and / or described herein are shown or discussed in a particular order, but these steps need not necessarily be performed in the order shown or discussed.

[0151] The various exemplary methods described and / or illustrated herein may also omit one or more than one of the steps described or illustrated herein, or may include additional steps in addition to those disclosed. Further, any step of any method as disclosed herein can be combined with any one or more than one step of any other method as disclosed herein.

[0152] A processor as described herein can be configured to perform one or more than one step of any method disclosed herein. Alternatively, or in combination, a processor can be configured to combine one or more than one step of one or more than one method as disclosed herein.

[0153] Unless otherwise described, the terms "connected to" and "coupled to" (and their derivatives) as used in this specification and claims are to be interpreted to allow both direct and indirect (i.e., via other elements or components) connections.

[0154] Unless otherwise noted, the terms "operably connected to" and "operably coupled to" (and their derivatives) as used in this specification and claims are to be interpreted to allow both direct and indirect (i.e., via other elements or components) connections for the purpose of performing a function.

[0155] In addition, as used in this specification and the claims, the terms "a" and "an" are to be interpreted as meaning "at least one of". Finally, for ease of use, the terms "including" and "having" (and their derivatives) as used in this specification and the claims are synonymous with the word "comprising" and shall have the same meaning as that.

[0156] A processor as disclosed herein can be configured to have instructions for carrying out any one or more than one of the steps of any of the methods disclosed herein.

[0157] It should be understood that the terms "first", "second", "third", etc. may be used herein to describe various layers, elements, components, regions, or sections without referring to any particular order or sequence of events. These terms are merely used to distinguish one layer, element, component, region, or section from another. A first layer, element, component, region, or section as described herein may be referred to as a second layer, element, component, region, or section without departing from the teachings of the present disclosure.

[0158] As used herein, the term "or" is used inclusively to refer to items in the alternative and in combination.

[0159] As used herein, characters such as numbers refer to like elements.

[0160] The present disclosure includes the following numbered appendices.

[0161] Appendix 1. A system for incising tissue using plasma, comprising: an elongated electrode configured to flex, generate plasma, and incise tissue; an electrical energy source operably coupled to the elongated electrode and configured to provide electrical energy to the electrode to generate plasma; and a tensioning element operably coupled to the elongated electrode and configured to provide tension to the elongated electrode, wherein the elongated electrode is configured to be capable of flexing in response to engaging the tissue and generating plasma.

[0162] Appendix 2. The system according to Appendix 1, further comprising a plurality of arms operably coupled to the electrode and the tensioning element.

[0163] Appendix 3. The system according to Appendix 2, wherein the electrode is not supported between two arms.

[0164] Appendix 4. The system according to Appendix 2, wherein the electrode is configured to vibrate in a direction transverse to the elongation axis of the electrode.

[0165] Appendix 5. The system according to Appendix 2, further comprising a support structure operably coupled to the plurality of arms and the tensioning element, wherein the support structure is configured to advance the plurality of arms and the tensioning element to advance the elongated electrode into the tissue to incise the tissue.

[0166] Appendix 6. The system according to Appendix 5, wherein the incising portion of the elongated electrode is suspended between the plurality of arms using the tension from the tensioning element, and a gap extends between the plurality of arms.

[0167] Appendix 7. The system according to Appendix 6, wherein the gap extends between the incising portion of the elongated electrode, the plurality of arms, and the support structure.

[0168] Appendix 8. The system according to Appendix 6, wherein the gap is sized to receive the incised tissue along the incision formed using the elongated electrode.

[0169] Appendix 9. The support structure is operably coupled to one or more actuators to move the extension electrode in one or more directions, the system according to Appendix 5.

[0170] Appendix 10. One or more actuators are configured to move the electrode with a variable speed, the system according to Appendix 9.

[0171] Appendix 11. The tensioning element is selected from the group consisting of a spring, a coil spring, a leaf spring, a torsion spring, a mesh, a hinge, and an integral hinge, the system according to Appendix 1.

[0172] Appendix 12. The extension electrode comprises a first portion of the extension filament, and the tensioning element comprises a second portion of the extension filament shaped to tension the extension electrode, the system according to Appendix 1.

[0173] Appendix 13. Further comprising an electrode assembly, the electrode assembly comprising a support structure operably coupled to a plurality of arms and a tensioning element, the electrode assembly configured to advance the electrode into tissue and incise the tissue, the system according to Appendix 1.

[0174] Appendix 14. The electrodes are configured to sequentially contact a plurality of locations in the tissue and generate an incision, the system according to Appendix 1.

[0175] Appendix 15. The plurality of locations comprises a plurality of intermittent locations, the system according to Appendix 14.

[0176] Appendix 16. The electrodes are configured to evaporate the tissue that contacts the electrodes at each of the plurality of intermittent locations, the system according to Appendix 15.

[0177] Appendix 17. The electrodes are configured to generate a plurality of flashes of light energy at a plurality of locations while the electrodes incise the tissue, the system according to Appendix 1.

[0178] Appendix 18. The system described in Appendix 17, which has multiple flashes of light energy and has visible light energy with wavelengths in the range of approximately 400 nm to approximately 750 nm.

[0179] Appendix 19. The system described in Appendix 17, where each of the multiple flashes of light energy has a maximum transverse distance of approximately 1 mm or less.

[0180] Appendix 20. The system described in Appendix 17, where the multiple flashes occur within a time interval of approximately 250 μs or less, optionally approximately 25 μs or less.

[0181] Appendix 21. The system described in Appendix 17, where the multiple flashes occur along with an electrode movement distance of approximately 100 μm or less, optionally approximately 10 μm or less.

[0182] Appendix 22. The system described in Appendix 17, where the multiple flashes of light are dispersed in multiple non - overlapping regions.

[0183] Appendix 23. The system described in Appendix 22, where the multiple non - overlapping regions are located along the extension electrode.

[0184] Appendix 24. The system described in Appendix 17, where the multiple flashes of light occur at a first rate associated with a first speed of the electrode and a second rate associated with a second speed of the electrode. The first rate exceeds the second rate when the first speed is less than the second speed, and the first rate is less than the second rate when the first speed exceeds the second speed.

[0185] Appendix 25. The system described in Appendix 24, where the multiple flashes of light occur at a substantially constant rate within approximately 25% or less. One or more than one of the pulse rate or burst rate of the waveform with respect to the extension electrode varies in response to the varying speed of the electrode, maintaining a substantially constant rate.

[0186] Appendix 26. The system described in Appendix 1, where the extension electrode comprises a filament, and the filament comprises one or more than one of a wire or a thread.

[0187] Supplementary Note 27. The extension electrode comprises a wire, and the system according to Supplementary Note 1.

[0188] Supplementary Note 28. The diameter of the wire is within the range of 5 μm to 200 μm, optionally from about 5 μm to about 100 μm, optionally from about 5 μm to about 50 μm, optionally from about 5 μm to about 25 μm, or optionally from about 5 μm to about 20 μm, and the system according to Supplementary Note 27.

[0189] Supplementary Note 29. The extension electrode has a certain cross-sectional distance, and the cross-sectional distance is 25 μm or less, and the system according to Supplementary Note 1.

[0190] Supplementary Note 30. The extension electrode operably coupled to the tensioning element has a mechanical resonance frequency within the range of about 1 kHz to about 100 kHz, optionally within the range of about 2 kHz to about 50 kHz, and the system according to Supplementary Note 1.

[0191] Supplementary Note 31. The tensioning element is configured to tension the extension electrode with a force within the range of about 20 mN to about 2 N, optionally within the range of about 50 mN to about 1 N, and further optionally within the range of about 100 mN to about 500 mN, and the system according to Supplementary Note 1.

[0192] Supplementary Note 32. The extension electrode has a mass per unit length within the range of about 0.2 μg·mm -1 to about 3 μg·mm -1 and the system according to Supplementary Note 1.

[0193] Supplementary Note 33. The extension electrode contains a material selected from the group consisting of tungsten, nitinol, steel, copper, brass, titanium, stainless steel, beryllium-copper alloy, cupronickel alloy, palladium, platinum, platinum-iridium, silver, and aluminum, and the system according to Supplementary Note 1.

[0194] Supplementary Note 34. The extension electrode has an axis along the elongation direction of the electrode, and the electrode is configured to incise tissue with movement in the lateral direction with respect to the axis, and the system according to Supplementary Note 1.

[0195] Appendix 35. The extensible electrode is configured to cut tissue at a speed exceeding approximately 1 m·s in a direction transverse to the extension direction of the electrode. The system according to Appendix 1. -1 The system according to Appendix 1, wherein the extensible electrode is configured to cut tissue at a speed exceeding approximately 1 m·s in a direction transverse to the extension direction of the electrode.

[0196] Appendix 36. The extensible electrode is configured to cut tissue at a speed in the range of approximately 0.5 cm·s to approximately 10 m·s, optionally in the range of approximately 1 cm·s to approximately 5 m·s, in a direction transverse to the extension direction of the electrode. The system according to Appendix 1. -1 ~ approximately 10 m·s -1 within the range of, optionally, approximately 1 cm·s -1 ~ approximately 5 m·s -1 The system according to Appendix 1, wherein the extensible electrode is configured to cut tissue at a speed in the range of approximately 0.5 cm·s to approximately 10 m·s, optionally in the range of approximately 1 cm·s to approximately 5 m·s, in a direction transverse to the extension direction of the electrode.

[0197] Appendix 37. The electrode is configured to cut the area of tissue at a rate in the range of approximately 5 mm·s to approximately 50,000 mm·s, optionally in the range of approximately 500 mm·s to approximately 25,000 mm·s. The system according to Appendix 1. 2 ·s -1 ~ approximately 50,000 mm 2 ·s -1 within the range of, optionally, approximately 500 mm 2 ·s -1 ~ approximately 25,000 mm 2 ·s -1 The system according to Appendix 1, wherein the electrode is configured to cut the area of tissue at a rate in the range of approximately 5 mm·s to approximately 50,000 mm·s, optionally in the range of approximately 500 mm·s to approximately 25,000 mm·s.

[0198] Appendix 38. The electrical energy source is configured to deliver a certain waveform, and the waveform includes one or more of a pulsating waveform, a sine wave waveform, a square wave waveform, a sawtooth wave waveform, a triangular wave waveform, a fixed frequency waveform, a variable frequency waveform, or a gate waveform. The system according to Appendix 1.

[0199] Appendix 39. The waveform includes a sine wave waveform, and the sine wave waveform has a frequency in the range of approximately 0.5 MHz to approximately 2 MHz. The system according to Appendix 38.

[0200] Appendix 40. The waveform includes a combination of a sine wave waveform and a gate waveform. The sine wave waveform has a frequency in the range of approximately 0.5 MHz to approximately 2 MHz, and the gate waveform has a gate frequency in the range of approximately 20 kHz to approximately 80 kHz and a duty cycle in the range of approximately 35% to approximately 100%. The system according to Appendix 38.

[0201] Appendix 41. The system according to Appendix 1, further comprising a controller operably coupled to an electrical energy source.

[0202] Appendix 42. The system according to Appendix 41, wherein the controller is configured to control the parameters of the electrical energy source by modulating a waveform using a parameter selected from the group consisting of voltage, current, carrier frequency, modulation frequency, duty cycle, power setpoint, power limit, energy per pulse setpoint, energy per pulse limit, and modulation envelope.

[0203] Appendix 43. The system according to Appendix 42, wherein the waveform comprises a pulsating voltage waveform comprising a pulse and a substantially constant frequency within the range of about 10 kHz to about 10 MHz, optionally within the range of about 0.5 MHz to about 2 MHz.

[0204] Appendix 44. The system according to Appendix 43, wherein the waveform provides energy per pulse within the range of about 0.5 μJ to about 50 μJ, optionally within the range of about 1 μJ to about 10 μJ.

[0205] Appendix 45. The system according to Appendix 44, wherein the controller is configured to modulate a substantially constant frequency waveform to produce a burst.

[0206] Appendix 46. The system according to Appendix 45, wherein the frequency of the burst is within the range of about 100 Hz to about 3 MHz, optionally within the range of about 1 kHz to about 100 kHz.

[0207] Appendix 47. The system according to Appendix 46, wherein the waveform from the electrical energy source is configured to supply an average power within the range of about 1 W to about 25 W.

[0208] Appendix 48. The system according to Appendix 5, further comprising a translation element operably coupled to the support structure and configured to direct the support structure along a lateral axis of motion with respect to the elongation axis of the electrode.

[0209] Appendix 49. The translation element is selected from the group consisting of a translation stage, a linear stage, a rotary stage, a rail, a rod, a cylindrical sleeve, a screw, a roller screw, a traveling nut, a rack, a pinion, a belt, a chain, a linear motion bearing, a rotary motion bearing, a cam, a flexure, and a dovetail, and is the system described in Appendix 48.

[0210] Appendix 50. The system described in Appendix 49, comprising an actuator operably coupled to the translation element to move the support structure along the axis of motion.

[0211] Appendix 51. The system described in Appendix 50, wherein the translation element is manually actuated.

[0212] Appendix 52. The system described in Appendix 50, wherein the actuator is selected from the group consisting of a motor, a rotary motor, a squiggle motor, a linear motor, a solenoid, a rotary solenoid, a linear solenoid, a voice coil, a spring, a movable coil, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, and a fluid actuator.

[0213] Appendix 53. A part of the support structure includes a material selected from the group consisting of tungsten, nitinol, steel, copper, brass, titanium, stainless steel, beryllium-copper alloy, cupronickel alloy, palladium, platinum, platinum-iridium, silver, aluminum, polyimide, PTFE, polyethylene, polypropylene, polycarbonate, poly(methyl methacrylate), acrylonitrile butadiene styrene, polyamide, polylactic acid, polyoxymethylene, polyether ether ketone, polyvinyl chloride, polylactic acid, glass, and ceramic, and is the system described in Appendix 5.

[0214] Appendix 54. The system described in Appendix 48, comprising a first translation element having a first axis of motion and a second translation element having a second axis of motion different from the first axis of motion.

[0215] Supplementary Note 55. The first and second translation elements are each a system according to Supplementary Note 54, selected from the group consisting of a translation stage, a linear stage, a rotary stage, a rail, a rod, a cylindrical sleeve, a screw, a roller screw, a traveling nut, a rack, a pinion, a belt, a chain, a linear motion bearing, a rotary motion bearing, a cam, a flexure, and a dovetail joint.

[0216] Supplementary Note 56. The system according to Supplementary Note 55, further comprising a contact plate operably coupled to the second translation element, engaging a part of the tissue, and shaping the tissue using an electrode prior to incising the tissue.

[0217] Supplementary Note 57. The system according to Supplementary Note 1, further comprising a contact plate operably coupled to the extension electrode, the contact plate being configured to engage a part of the cornea and shape the cornea using an electrode prior to incising the cornea.

[0218] Supplementary Note 58. The contact plate includes a first contact plate having a first surface profile and a second contact plate having a second surface profile, the difference between the first surface profile and the second surface profile corresponding to an eye refractive correction for correcting an eye refractive error, in the system according to Supplementary Note 57.

[0219] Supplementary Note 59. The contact plate includes a freeform optical surface shaped to correct the wavefront aberration of the eye, in the system according to Supplementary Note 57.

[0220] Supplementary Note 60. The contact plate includes a plurality of independently adjustable actuators for shaping the cornea, in the system according to Supplementary Note 57.

[0221] Supplementary Note 61. The contact plate includes a plurality of plates operably coupled to independently adjustable actuators for shaping the cornea, in the system according to Supplementary Note 60.

[0222] Appendix 62. The plurality of plates are each configured to be driven to a first position and a second position at each of a plurality of locations, and the difference between the first position and the second position corresponds to the shape profile of the tissue to be excised from the cornea to correct refractive anomalies of the eye, the system according to Appendix 61.

[0223] Appendix 63. The plurality of locations comprise a plurality of two-dimensional locations, and the shape profile comprises a three-dimensional tissue excision profile, the system according to Appendix 62.

[0224] Appendix 64. The plurality of actuators comprise at least 10 actuators, optionally, the plurality of actuators comprise at least 16 actuators, optionally, the plurality of actuators comprise at least 42 actuators, optionally, the plurality of actuators comprise at least 100 actuators, the system according to Appendix 60.

[0225] Appendix 65. The contact plate comprises a deformable membrane operably coupled to a plurality of independently adjustable actuators, the system according to Appendix 60.

[0226] Appendix 66. The contact plate comprises a first configuration for a first incision using an electrode along a first incision profile and a second configuration for a second incision using an electrode along a second incision profile, and the difference between the first incision profile and the second incision profile corresponds to the shape of the corneal flap of the tissue to be removed from the cornea to treat refractive anomalies of the eye, the system according to Appendix 60.

[0227] Appendix 67. The contact plate is configured to correct one or more of spherical, cylindrical, coma, spherical aberration, or trefoil of the eye, the system according to Appendix 57.

[0228] Appendix 68. The system according to Appendix 57, wherein the first translation element further comprises a suction element for engaging the tissue and holding the tissue in a substantially fixed position in contact with the second translation element while moving the electrode and incising the tissue.

[0229] Appendix 69. The system according to Appendix 57, further comprising a sterilization barrier for installation on a contact plate for maintaining the sterility of the eye.

[0230] Appendix 70. The system according to Appendix 69, wherein the sterilization barrier comprises a thin conformal barrier for conforming to the shape of the contact plate with the sterilization barrier between the eye and the contact plate.

[0231] Appendix 71. The system according to Appendix 69, wherein the sterilization barrier comprises a peelable and adhesive sterilization barrier.

[0232] Appendix 72. The length of the extension electrode is in the range of about 6 mm to about 12 mm, the tissue comprises corneal tissue, the electrode comprises a wire having a diameter in the range of about 5 μm to about 20 μm, and the tensioning element is configured to provide a tension to the electrode in the range of about 100 mN to about 500 mN. The system according to Appendix 57.

[0233] Appendix 73. The system according to Appendix 1, further comprising a processor operably coupled to the extension electrode and configured to have instructions for advancing the electrode distally and retracting the electrode proximally.

[0234] Appendix 74. The extension electrode is sized for insertion into the tissue, the processor is configured to have instructions for incising the tissue using the electrode to define a volume of incised tissue, and the volume has a certain shape profile. The system according to Appendix 73.

[0235] Appendix 75. The system according to Appendix 74, wherein the processor is configured to have instructions to move the electrode with a first movement to define a first surface on a first side of the tissue volume and to move the electrode with a second movement to define a second surface on a second side of the tissue volume.

[0236] Appendix 76. The system according to Appendix 74, wherein the processor is configured to have instructions to advance the electrode distally to define a first surface on a first side of the tissue volume and to retract the electrode proximally to define a second surface on a second side of the tissue volume.

[0237] Appendix 77. The system according to Appendix 76, wherein a gap extends between the elongate electrode and the support structure, the gap is sized to receive tissue, and tissue extending into the gap is incised when the electrode is retracted proximally.

[0238] Appendix 78. The system according to Appendix 74, wherein the contact plate comprises a first configuration to define a first surface on a first side of the tissue volume and a second configuration to define a second surface on a second side of the tissue volume.

[0239] Appendix 79. The system according to Appendix 74, wherein a first contact plate comprises a first shape profile to define a first surface on a first side of the tissue volume and a second shape profile to define a second surface on a second side of the tissue volume.

[0240] Appendix 80. The system according to Appendix 74, wherein the shape profile comprises a thickness profile.

[0241] Supplement 81. A system for treating refractive eye disorders, comprising: an elongate electrode for incising corneal tissue; an electrical energy source operably coupled to the elongate electrode and configured to provide electrical energy to the electrode; a contact plate engageable with a portion of the cornea and configured to shape the cornea prior to incising the cornea using the electrode; and a support structure operably coupled to the elongate electrode and the plate, the support structure configured to move the electrode relative to the plate and to incise corneal tissue using the electrode.

[0242] Supplement 82. The system according to Supplement 81, further comprising a translation element operably coupled to the support structure and the elongate electrode and configured to incise corneal tissue as the electrode translates.

[0243] Supplement 83. The system according to Supplement 81, wherein the contact plate comprises a first contact plate having a first surface profile and a second contact plate having a second surface profile, and the difference between the first surface profile and the second surface profile corresponds to a refractive correction of the eye for correcting a refractive eye disorder.

[0244] Supplement 84. The system according to Supplement 81, wherein the contact plate comprises a freeform optical surface shaped to correct the wavefront aberration of the eye.

[0245] Supplement 85. The system according to Supplement 81, wherein the contact plate comprises a plurality of independently adjustable actuators for shaping the cornea.

[0246] Supplement 86. The system according to Supplement 85, wherein the contact plate comprises a plurality of plates operably coupled to independently adjustable actuators for shaping the cornea.

[0247] Appendix 87. The plurality of plates are each configured to be driven to a first position and a second position at each of a plurality of locations, and the difference between the first position and the second position corresponds to the shape profile of the tissue to be excised from the cornea to correct refractive anomalies of the eye, the system according to Appendix 86.

[0248] Appendix 88. The plurality of locations comprise a plurality of two-dimensional locations, and the shape profile comprises a three-dimensional tissue excision profile, the system according to Appendix 87.

[0249] Appendix 89. The plurality of actuators comprise at least 10 actuators, optionally, the plurality of actuators comprise at least 16 actuators, optionally, the plurality of actuators comprise at least 42 actuators, optionally, the plurality of actuators comprise at least 100 actuators, the system according to Appendix 85.

[0250] Appendix 90. The contact plate comprises a deformable membrane operably coupled to a plurality of independently adjustable actuators, the system according to Appendix 85.

[0251] Appendix 91. The contact plate comprises a first configuration for a first incision using an electrode along a first incision profile and a second configuration for a second incision using an electrode along a second incision profile, and the difference between the first incision profile and the second incision profile corresponds to the shape of the corneal flap of the tissue to be removed from the cornea to treat refractive anomalies of the eye, the system according to Appendix 85.

[0252] Appendix 92. The contact plate is configured to correct one or more of spherical, cylindrical, coma, spherical aberration, or trefoil of the eye, the system according to Appendix 81.

[0253] Appendix 93. The system according to Appendix 81, wherein the first translation element further comprises a suction element for engaging the tissue and holding the tissue in a substantially fixed position in contact with the second translation element while moving the electrode and incising the tissue.

[0254] Appendix 94. The system according to Appendix 81, further comprising a sterile barrier for placement on a contact plate for maintaining the sterility of the eye.

[0255] Appendix 95. The system according to Appendix 94, wherein the sterile barrier comprises a thin conformal barrier for conforming to the shape of the contact plate with the sterile barrier between the eye and the contact plate.

[0256] Appendix 96. The system according to Appendix 94, wherein the sterile barrier comprises a peelable and adhesive sterile barrier.

[0257] Appendix 97. The length of the extension electrode is in the range of 6 mm to 12 mm, the electrode comprises a wire having a diameter in the range of 5 μm to 20 μm, and the tensioning element is configured to provide a tension in the range of 100 mN to 500 mN to the electrode, the system according to Appendix 81.

[0258] Appendix 98. The system according to Appendix 81, further comprising a processor operably coupled to the extension electrode and configured to have instructions for advancing the electrode distally and retracting the electrode proximally.

[0259] Appendix 99. The extension electrode is sized for insertion into the cornea of the eye to treat refractive abnormalities of the eye, and the processor is configured to have instructions for incising the cornea and defining a corneal flap of corneal tissue within a pocket using the electrode, the corneal flap having a shape profile corresponding to the treatment of the refractive abnormality, the system according to Appendix 98.

[0260] Appendix 100. The system according to Appendix 99, wherein the processor is configured to have instructions to move the electrode with a first movement to define a first surface on a first side of the corneal piece and to move the electrode with a second movement to define a second surface on a second side of the corneal piece.

[0261] Appendix 101. The system according to Appendix 99, wherein the processor is configured to have instructions to advance the electrode distally to define a first surface on a first side of the corneal piece and to retract the electrode proximally to define a second surface on a second side of the corneal piece.

[0262] Appendix 102. The system according to Appendix 101, wherein a gap extends between the elongate electrode and the support structure, the gap is sized to receive tissue, and the tissue extending into the gap is incised when the electrode is retracted proximally.

[0263] Appendix 103. The system according to Appendix 99, wherein the contact plate comprises a first configuration to define a first surface on a first side of the corneal piece and a second configuration to define a second surface on a second side of the corneal piece.

[0264] Appendix 104. The system according to Appendix 99, wherein the first contact plate comprises a first shape profile to define a first surface on a first side of the corneal piece and a second shape profile to define a second surface on a second side of the corneal piece.

[0265] Appendix 105. The system according to Appendix 99, wherein the shape profile comprises a thickness profile.

[0266] Supplementary Note 106. A method for incising tissue using plasma, comprising the step of incising tissue using an elongating electrode configured to flex, generate plasma, and incise tissue, an electrical energy source being operably coupled to the elongating electrode to provide electrical energy to the electrode to generate plasma, a tensioning element being operably coupled to the elongating electrode to provide tension to the elongating electrode, and the elongating electrode being capable of flexing in response to the elongating electrode engaging the tissue and generating plasma.

[0267] Supplementary Note 107. The method according to Supplementary Note 106, wherein a plurality of arms are operably coupled to the electrode and the tensioning element.

[0268] Supplementary Note 108. The method according to Supplementary Note 107, wherein the electrode is not supported between two arms.

[0269] Supplementary Note 109. The method according to Supplementary Note 107, wherein the electrode is configured to vibrate in a direction transverse to the elongation axis of the electrode.

[0270] Supplementary Note 110. The method according to Supplementary Note 107, wherein a support structure is operably coupled to the plurality of arms and the tensioning element, and the support structure advances the plurality of arms, the tensioning element, and the elongating electrode to incise tissue.

[0271] Supplementary Note 111. The method according to Supplementary Note 110, wherein the incising portion of the elongating electrode is suspended between the plurality of arms using the tension from the tensioning element, and a gap extends between the plurality of arms.

[0272] Supplementary Note 112. The method according to Supplementary Note 111, wherein the gap extends between the incising portion of the elongating electrode, the plurality of arms, and the support structure.

[0273] Supplementary Note 113. The method according to Supplementary Note 111, wherein the gap is sized to receive incised tissue along an incision formed using the elongating electrode.

[0274] Supplementary Note 114. The support structure is operably coupled to one or more actuators and moves the extension electrode in one or more directions, according to the method described in Supplementary Note 110.

[0275] Supplementary Note 115. One or more actuators move the electrode with a variable speed, according to the method described in Supplementary Note 114.

[0276] Supplementary Note 116. The tensioning element is selected from the group consisting of springs, coil springs, leaf springs, torsion springs, meshes, hinges, and integral hinges, according to the method described in Supplementary Note 106.

[0277] Supplementary Note 117. The extension electrode comprises a first portion of an extension filament, and the tensioning element comprises a second portion of the extension filament shaped to tension the extension electrode, according to the method described in Supplementary Note 106.

[0278] Supplementary Note 118. An electrode assembly comprising a support structure is operably coupled to a plurality of arms and tensioning elements, and the electrode assembly advances the electrode into tissue and incises the tissue, according to the method described in Supplementary Note 106.

[0279] Supplementary Note 119. The electrodes sequentially contact a plurality of locations in the tissue and generate an incision, according to the method described in Supplementary Note 106.

[0280] Supplementary Note 120. The plurality of locations comprises a plurality of intermittent locations, according to the method described in Supplementary Note 119.

[0281] Supplementary Note 121. The electrodes evaporate the tissue in contact with the electrodes at each of the plurality of intermittent locations, according to the method described in Supplementary Note 120.

[0282] Supplementary Note 122. The electrodes generate a plurality of flashes of light energy at a plurality of locations while the electrodes incise the tissue, according to the method described in Supplementary Note 106.

[0283] Supplementary Note 123. The method according to Supplementary Note 122, wherein the plurality of flashes of light energy have wavelengths within the range of about 400 nm to about 750 nm and comprise visible light energy.

[0284] Supplementary Note 124. The method according to Supplementary Note 122, wherein each of the plurality of flashes of light energy has a maximum transverse distance of about 1 mm or less.

[0285] Supplementary Note 125. The method according to Supplementary Note 122, wherein the plurality of flashes occur within a time interval of about 250 μs or less, optionally about 25 μs or less.

[0286] Supplementary Note 126. The method according to Supplementary Note 122, wherein the plurality of flashes occur along with an electrode movement distance of about 100 μm or less, optionally about 10 μm or less.

[0287] Supplementary Note 127. The method according to Supplementary Note 122, wherein the plurality of flashes of light are dispersed in a plurality of non-overlapping regions.

[0288] Supplementary Note 128. The method according to Supplementary Note 127, wherein the plurality of non-overlapping regions are located along the extension electrode.

[0289] Supplementary Note 129. The method according to Supplementary Note 122, wherein the plurality of flashes of light occur at a first rate associated with a first speed of the electrode and a second rate associated with a second speed of the electrode, and the first rate exceeds the second rate when the first speed is less than the second speed, and the first rate is less than the second rate when the first speed exceeds the second speed.

[0290] Supplementary Note 130. The method according to Supplementary Note 129, wherein the plurality of flashes of light occur at a substantially constant rate within about 25% or less, and one or more than one of the pulse rate or burst rate of the waveform with respect to the extension electrode is varied in response to the varying speed of the electrode to maintain a substantially constant rate.

[0291] Supplementary Note 131. The method according to Supplementary Note 106, wherein the extension electrode comprises a filament, and the filament comprises one or more than one of a wire or a thread.

[0292] Supplementary Note 132. The elongating electrode is the method described in Supplementary Note 106, which includes a wire.

[0293] Supplementary Note 133. The diameter of the wire is within the range of 5 μm to 200 μm, optionally about 5 μm to about 100 μm, optionally about 5 μm to about 50 μm, optionally about 5 μm to about 25 μm, or optionally about 5 μm to about 20 μm, according to the method described in Supplementary Note 132.

[0294] Supplementary Note 134. The elongating electrode has a certain cross-sectional distance, and the cross-sectional distance is about 25 μm or less, according to the method described in Supplementary Note 106.

[0295] Supplementary Note 135. The elongating electrode operably coupled to the tensioning element has a mechanical resonance frequency within the range of about 1 kHz to about 100 kHz, optionally within the range of about 2 kHz to about 50 kHz, according to the method described in Supplementary Note 106.

[0296] Supplementary Note 136. The tensioning element tensions the elongating electrode using a force within the range of about 20 mN to about 2 N, optionally within the range of about 50 mN to about 1 N, and further optionally within the range of about 100 mN to about 500 mN, according to the method described in Supplementary Note 106.

[0297] Supplementary Note 137. The elongating electrode has a mass per unit length within the range of about 0.2 μg·mm -1 ~about 3 μg·mm -1 according to the method described in Supplementary Note 106.

[0298] Supplementary Note 138. The elongating electrode includes a material selected from the group consisting of tungsten, nitinol, steel, copper, brass, titanium, stainless steel, beryllium-copper alloy, cupronickel alloy, palladium, platinum, platinum-iridium, silver, and aluminum, according to the method described in Supplementary Note 106.

[0299] Supplementary Note 139. The elongating electrode has an axis along the elongation direction of the electrode, and the electrode cuts through the tissue as it moves laterally with respect to the axis, according to the method described in Supplementary Note 106.

[0300] Supplementary Note 140. The method according to Supplementary Note 106, wherein the elongating electrode cuts tissue at a speed exceeding about 1 m·s in a direction transverse to the elongating direction of the electrode. -1

[0301] Supplementary Note 141. The method according to Supplementary Note 106, wherein the elongating electrode cuts tissue at a speed within the range of about 0.5 cm·s -1 to about 10 m·s -1 optionally within the range of about 1 cm·s -1 to about 5 m·s -1 in a direction transverse to the elongating direction of the electrode.

[0302] Supplementary Note 142. The method according to Supplementary Note 106, wherein the electrode cuts the area of tissue at a rate within the range of about 5 mm 2 ·s -1 to about 50,000 mm 2 ·s -1 optionally within the range of about 500 mm 2 ·s -1 to about 25,000 mm 2 ·s -1

[0303] Supplementary Note 143. The method according to Supplementary Note 106, wherein the electrical energy source delivers a waveform, and the waveform comprises one or more of a pulsating waveform, a sine wave waveform, a square wave waveform, a sawtooth waveform, a triangular waveform, a fixed frequency waveform, a variable frequency waveform, or a gate waveform.

[0304] Supplementary Note 144. The method according to Supplementary Note 143, wherein the waveform comprises a sine wave waveform, and the sine wave waveform has a frequency within the range of about 0.5 MHz to about 2 MHz.

[0305] Supplementary Note 145. The method according to Supplementary Note 143, wherein the waveform comprises a combination of a sine wave waveform and a gate waveform, the sine wave waveform has a frequency within the range of about 0.5 MHz to about 2 MHz, and the gate waveform has a gate frequency within the range of about 20 kHz to about 80 kHz and a duty cycle within the range of about 35% to about 100%.

[0306] Supplement 146. The method according to Supplement 106, wherein the controller is operably coupled to an electrical energy source.

[0307] Supplement 147. The method according to Supplement 146, wherein the controller controls the parameters of the electrical energy source by modulating a waveform using a parameter selected from the group consisting of voltage, current, carrier frequency, modulation frequency, duty cycle, power setpoint, power limit, energy per pulse setpoint, energy per pulse limit, and modulation envelope.

[0308] Supplement 148. The method according to Supplement 147, wherein the waveform comprises a pulsating voltage waveform comprising a pulse and a substantially constant frequency within the range of about 10 kHz to about 10 MHz, optionally within the range of about 0.5 MHz to about 2 MHz.

[0309] Supplement 149. The method according to Supplement 148, wherein the waveform provides energy per pulse within the range of about 0.5 μJ to about 50 μJ, optionally within the range of about 1 μJ to about 10 μJ.

[0310] Supplement 150. The method according to Supplement 149, wherein the controller modulates a substantially constant frequency waveform to produce a burst.

[0311] Supplement 151. The method according to Supplement 150, wherein the frequency of the burst is within the range of about 100 Hz to about 3 MHz, optionally within the range of about 1 kHz to about 100 kHz.

[0312] Supplement 152. The method according to Supplement 151, wherein the waveform from the electrical energy source supplies an average power within the range of about 1 W to about 25 W.

[0313] Supplement 153. The method according to Supplement 110, wherein a translational element operably coupled to the support structure is directed along a movement axis transverse to the elongation axis of the electrode with respect to the support structure.

[0314] Appendix 154. The method according to Appendix 153, wherein the translation element is selected from the group consisting of a translation stage, a linear stage, a rotary stage, a rail, a rod, a cylindrical sleeve, a screw, a roller screw, a traveling nut, a rack, a pinion, a belt, a chain, a linear motion bearing, a rotary motion bearing, a cam, a flexure, and a dovetail joint.

[0315] Appendix 155. The method according to Appendix 154, wherein an actuator operatively coupled to the translation element moves the support structure along the motion axis.

[0316] Appendix 156. The method according to Appendix 155, wherein the translation element is manually actuated.

[0317] Appendix 157. The method according to Appendix 155, wherein the actuator is selected from the group consisting of a motor, a rotary motor, a squiggle motor, a linear motor, a solenoid, a rotary solenoid, a linear solenoid, a voice coil, a spring, a movable coil, a piezoelectric actuator, a pneumatic actuator, a hydraulic actuator, and a fluid actuator.

[0318] Appendix 158. The method according to Appendix 110, wherein a part of the support structure comprises a material selected from the group consisting of tungsten, nitinol, steel, copper, brass, titanium, stainless steel, beryllium-copper alloy, cupronickel alloy, palladium, platinum, platinum-iridium, silver, aluminum, polyimide, PTFE, polyethylene, polypropylene, polycarbonate, poly(methyl methacrylate), acrylonitrile butadiene styrene, polyamide, polylactic acid, polyoxymethylene, polyether ether ketone, polyvinyl chloride, polylactic acid, glass, and ceramic.

[0319] Appendix 159. The method according to Appendix 153, wherein the translation element comprises a first translation element having a first motion axis and a second translation element having a second motion axis different from the first motion axis.

[0320] Appendix 160. The first and second translation elements are respectively the methods described in Appendix 159, which are selected from the group consisting of a translation stage, a linear stage, a rotary stage, a rail, a rod, a cylindrical sleeve, a screw, a roller screw, a traveling nut, a rack, a pinion, a belt, a chain, a linear motion bearing, a rotary motion bearing, a cam, a flexure, and a dovetail joint.

[0321] Appendix 161. The method described in Appendix 160, wherein a contact plate operably coupled to the second translation element engages a part of the tissue and shapes the tissue prior to incising the tissue using an electrode.

[0322] Appendix 162. The method described in Appendix 106, wherein a contact plate operably coupled to the extension electrode engages a part of the cornea and shapes the cornea prior to incising the cornea using an electrode.

[0323] Appendix 163. The method described in Appendix 162, wherein the contact plate comprises a first contact plate having a first surface profile and a second contact plate having a second surface profile, and the difference between the first surface profile and the second surface profile corresponds to the refractive correction of the eye for correcting refractive anomalies of the eye.

[0324] Appendix 164. The method described in Appendix 162, wherein the contact plate comprises a freeform optical surface shaped to correct the wavefront aberration of the eye.

[0325] Appendix 165. The method described in Appendix 162, wherein the contact plate comprises a plurality of independently adjustable actuators for shaping the cornea.

[0326] Appendix 166. The method described in Appendix 165, wherein the contact plate comprises a plurality of plates operably coupled to independently adjustable actuators for shaping the cornea.

[0327] Supplementary Note 167. The method according to Supplementary Note 166, wherein a plurality of plates are each driven to a first position and a second position at each of a plurality of locations, and the difference between the first position and the second position corresponds to the shape profile of the tissue to be excised from the cornea to correct refractive anomalies of the eye.

[0328] Supplementary Note 168. The method according to Supplementary Note 167, wherein the plurality of locations comprise a plurality of two-dimensional locations, and the shape profile comprises a three-dimensional tissue excision profile.

[0329] Supplementary Note 169. The method according to Supplementary Note 165, wherein the plurality of actuators comprise at least 10 actuators, optionally, the plurality of actuators comprise at least 16 actuators, optionally, the plurality of actuators comprise at least 42 actuators, optionally, the plurality of actuators comprise at least 100 actuators.

[0330] Supplementary Note 170. The method according to Supplementary Note 165, wherein the contact plate comprises a deformable membrane operably coupled to a plurality of independently adjustable actuators.

[0331] Supplementary Note 171. The method according to Supplementary Note 165, wherein the contact plate comprises a first configuration for a first incision using an electrode along a first incision profile and a second configuration for a second incision using an electrode along a second incision profile, and the difference between the first incision profile and the second incision profile corresponds to the shape of the corneal flap of the tissue removed from the cornea to treat refractive anomalies of the eye.

[0332] Supplementary Note 172. The method according to Supplementary Note 162, wherein the contact plate is configured to correct one or more of spherical, cylindrical, coma, spherical aberration, or trefoil of the eye.

[0333] Supplementary Note 173. The method according to Supplementary Note 162, wherein a suction element engages the tissue while a first translation element moves the electrode and incises the tissue, and holds the tissue in a substantially fixed position in contact with a second translation element.

[0334] Supplementary Note 174. The method according to Supplementary Note 162, wherein a sterilization barrier is installed on the contact plate to maintain the sterility of the eye.

[0335] Supplementary Note 175. The method according to Supplementary Note 174, wherein the sterilization barrier comprises a thin conformal barrier for conforming to the shape of the contact plate with the sterilization barrier being between the eye and the contact plate.

[0336] Supplementary Note 176. The method according to Supplementary Note 174, wherein the sterilization barrier comprises a peelable and adhesive sterilization barrier.

[0337] Supplementary Note 177. The length of the extension electrode is in the range of about 6 mm to about 12 mm, the tissue comprises corneal tissue, the electrode comprises a wire having a diameter in the range of about 5 μm to about 20 μm, and the tensioning element provides a tension in the range of about 100 mN to about 500 mN to the electrode. The method according to Supplementary Note 162.

[0338] Supplementary Note 178. A method for treating refractive abnormalities of the eye, comprising the steps of incising corneal tissue by providing electrical energy to an electrode using an extension electrode, and shaping the cornea using a contact plate prior to incising the cornea using the electrode, wherein a support structure moves the electrode relative to the plate and incises the corneal tissue using the electrode.

[0339] Supplementary Note 179. The method according to Supplementary Note 178, wherein a translation element operably coupled to the support structure and the extension electrode translates the electrode and incises the corneal tissue.

[0340] Supplementary Note 180. The contact plate comprises a first contact plate having a first surface profile and a second contact plate having a second surface profile, and the difference between the first surface profile and the second surface profile corresponds to the refractive correction of the eye for correcting the refractive abnormality of the eye. The method according to Supplementary Note 178.

[0341] Supplementary Note 181. The method according to Supplementary Note 178, wherein the contact plate comprises a freeform optical surface shaped to correct the wavefront aberration of the eye.

[0342] Supplementary Note 182. The method according to Supplementary Note 178, wherein the contact plate comprises a plurality of independently adjustable actuators for shaping the cornea.

[0343] Supplementary Note 183. The method according to Supplementary Note 182, wherein the contact plate comprises a plurality of plates operably coupled to independently adjustable actuators for shaping the cornea.

[0344] Supplementary Note 184. Each of the plurality of plates is configured to be driven to a first position and a second position at each of a plurality of locations, and the difference between the first position and the second position corresponds to the shape profile of the tissue to be excised from the cornea to improve refractive abnormalities of the eye. The method according to Supplementary Note 183.

[0345] Supplementary Note 185. The method according to Supplementary Note 184, wherein the plurality of locations comprises a plurality of two-dimensional locations, and the shape profile comprises a three-dimensional tissue excision profile.

[0346] Supplementary Note 186. The method according to Supplementary Note 182, wherein the plurality of actuators comprises at least 10 actuators, optionally, the plurality of actuators comprises at least 16 actuators, optionally, the plurality of actuators comprises at least 42 actuators, optionally, the plurality of actuators comprises at least 100 actuators.

[0347] Supplementary Note 187. The method according to Supplementary Note 182, wherein the contact plate comprises a deformable membrane operably coupled to a plurality of independently adjustable actuators.

[0348] Supplementary Note 188. The contact plate includes a first configuration for a first incision using an electrode along a first incision profile and a second configuration for a second incision using an electrode along a second incision profile, and the difference between the first incision profile and the second incision profile corresponds to the shape of the corneal segment of the tissue to be removed from the cornea to treat refractive anomalies of the eye, the method described in Supplementary Note 182.

[0349] Supplementary Note 189. The contact plate is configured to correct one or more of spherical, cylindrical, coma, spherical aberration, or trefoil of the eye, the method described in Supplementary Note 178.

[0350] Supplementary Note 190. The suction element, while the first translation element moves the electrode and incises the tissue, engages the corneal tissue and holds the corneal tissue in a substantially fixed position in contact with the second translation element, the method described in Supplementary Note 178.

[0351] Supplementary Note 191. A sterilization barrier is installed on the contact plate to maintain the aseptic state of the eye, the method described in Supplementary Note 178.

[0352] Supplementary Note 192. The sterilization barrier includes a thin conformal barrier for conforming to the shape of the contact plate with the sterilization barrier between the eye and the contact plate, the method described in Supplementary Note 191.

[0353] Supplementary Note 193. The sterilization barrier includes a peelable and adherable sterilization barrier, the method described in Supplementary Note 191.

[0354] Supplementary Note 194. The length of the extension electrode is in the range of 6 mm to 12 mm, the electrode comprises a wire having a diameter in the range of 5 μm to 20 μm, and the tensioning element provides a tension in the range of 100 mN to 500 mN to the electrode, the method described in Supplementary Note 178.

[0355] Supplement 195. A method for treating refractive eye disorders, comprising the steps of inserting an elongate electrode into the cornea of the eye, using the electrode to incise the cornea and define a corneal flap within the cornea tissue in a pocket, and removing the corneal flap, wherein the corneal flap has a shape profile corresponding to the treatment of the refractive disorder.

[0356] Supplement 196. The method according to Supplement 195, wherein the electrode is moved with a first movement to define a first surface on a first side of the corneal flap and is moved with a second movement to define a second surface on a second side of the corneal flap.

[0357] Supplement 197. The method according to Supplement 195, wherein the electrode is advanced distally to define a first surface on a first side of the corneal flap and is retracted proximally to define a second surface on a second side of the corneal flap.

[0358] Supplement 198. The method according to Supplement 197, wherein a gap extends between the elongate electrode and a support structure, the gap is sized to receive tissue, and the tissue extending into the gap is incised when the electrode is retracted proximally.

[0359] Supplement 199. The method according to Supplement 195, wherein a contact plate has a first configuration to define a first surface on a first side of the corneal flap and a second configuration to define a second surface on a second side of the corneal flap.

[0360] Supplement 200. The method according to Supplement 195, wherein a first contact plate has a first shape profile to define a first surface on a first side of the corneal flap and a second shape profile to define a second surface on a second side of the corneal flap.

[0361] Supplement 201. The method according to Supplement 195, wherein the shape profile comprises a thickness profile.

[0362] The system or method according to any one of the preceding appendices, further comprising a processor operably coupled to the extension electrode, moving the extension electrode, and incising tissue.

[0363] While embodiments of the present disclosure have been illustrated and described as herein, they are provided by way of example only. Those skilled in the art will recognize numerous adaptations, modifications, variations, and substitutions without departing from the scope of the present disclosure. Some alternatives and combinations of the embodiments disclosed herein may be utilized without departing from the scope of the present disclosure and the inventions disclosed herein. Accordingly, the scope of the inventions of the present disclosure is to be defined only by the scope of the appended claims and their equivalents.

Claims

1. A system for incising tissue using plasma, comprising: A tensioned electrode assembly, wherein the tensioned electrode assembly comprises: An electrode assembly, wherein the electrode assembly comprises: An elongating electrode configured to flex to generate the plasma for incising the tissue; A plurality of arms configured to support the elongating electrode at two or more points along the length of the elongating electrode; A plurality of attachment portions; A support structure; An electrode assembly comprising the above; A tensioning element operably coupled to the elongating electrode, the tensioning element being configured to provide tension to the elongating electrode and to enable the elongating electrode to flex in response to the elongating electrode engaging the tissue to generate the plasma, and the plurality of arms being coupled to the elongating electrode and the tensioning element; A tensioned electrode assembly comprising the above; An electrical energy source operably coupled to the elongating electrode and configured to provide electrical energy to the electrode to generate the plasma; The support structure is operably coupled to the plurality of arms and the tensioning element and is configured to advance the plurality of arms and the tensioning element into the tissue for incising while maintaining the mechanical stability of the electrode assembly and directing the elongating electrode into the tissue; The plurality of attachment portions include a first attachment portion located on the support structure and a second attachment portion located on one of the plurality of arms; The tensioning element is coupled to the elongating electrode and attached to the support structure via the first attachment portion of the plurality of attachment portions so as to enable the elongating electrode to flex while in contact with the tissue; The plurality of attachment portions enable connection between the tensioning element, the elongating electrode, the one arm, and the support structure; The elongating electrode has a first portion supported by the plurality of arms and having mechanical stability provided by the plurality of arms; A gap exists between the plurality of arms, the gap being configured to receive the tissue before and / or during and / or after generation of the incision.

2. The system according to claim 1, wherein the electrode is configured to vibrate in a direction perpendicular to the elongation axis of the electrode, and the elongation axis extends through the length of the electrode.

3. The system according to claim 1, wherein the support structure is configured to advance the elongating electrode into the tissue and to advance the plurality of arms and the tensioning element to incise the tissue.

4. The system according to claim 3, wherein the incised portion of the elongating electrode is suspended between the plurality of arms using the tension from the tensioning element, and a gap extends between the plurality of arms.

5. The system according to claim 4, wherein the gap extends between the incised portion of the elongating electrode, the plurality of arms, and the support structure.

6. The system according to claim 4, wherein the gap is sized to allow the incised tissue to enter the space between the plurality of arms.

7. The system according to claim 3, wherein the support structure is operably coupled to one or more actuators to move the elongating electrode in one or more directions within the tissue.

8. The system according to claim 7, wherein the one or more actuators are configured to move the electrode at a variable speed.

9. The system according to claim 1, wherein the tensioning element is selected from the group consisting of a spring, a coil spring, a leaf spring, a torsion spring, a mesh, a hinge, and an integral hinge.

10. The system according to claim 1, wherein the elongating electrode comprises a first portion of an elongating filament, and the tensioning element comprises a second portion of the elongating filament shaped to tension the elongating electrode.

11. The system according to claim 1, wherein the electrode assembly is configured to advance the electrode into the tissue and to incise the tissue.

12. The system according to claim 1, wherein the electrode is configured to sequentially contact a plurality of locations of the tissue to generate the incision.

13. The system according to claim 12, wherein the plurality of locations comprises a plurality of intermittent locations.

14. The system according to claim 13, wherein the electrode is configured to evaporate the tissue contacting the electrode at each of the plurality of intermittent locations.

15. The system according to claim 1, wherein the electrode is configured to generate a plurality of flashes of light energy at a plurality of locations while the electrode incises the tissue. **Claim 16** The system according to claim 15, wherein each of the plurality of flashes of light energy has a maximum width of about 1 mm or less. **Claim 17** The system according to claim 15, wherein the plurality of flashes are generated within a time interval of about 250 μs or less, optionally about 25 μs or less.

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