System and method for incising tissue

Abstract

To provide an improved method and a system for incising tissues.SOLUTION: An elongate electrode is configured to flex and generate plasma to incise tissue. An electrical energy source operatively coupled to the electrode is configured to provide the electrode with electrical energy to generate the plasma. A tensioning element is operatively coupled to the elongate electrode. The tensioning element can be configured to provide the elongate electrode with tension to allow the elongate electrode to flex in response to the elongate electrode engaging the tissue and generating the plasma. The tensioning element operatively coupled to the flexible elongate electrode may allow for use of a small diameter electrode, such as a 5 μm to 20 μm diameter electrode, which can allow narrow incisions to be formed with decreased tissue damage. In some embodiments, tensioning of the electrode allows the electrode to more accurately incise tissue by decreasing variations in a position of the electrode along the incision path.SELECTED DRAWING: None

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) (Section 119(e) of the United States Patent Act).

[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 the 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. Additionally, 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 in at least some cases and can produce a rougher surface. 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. A scalpel or diamond knife can be used to manually excise two separate flaps into tissue such as scleral and / or corneal tissue in conventional trabeculotomy, 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 taken 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 aperture. However, research related to the present disclosure suggests that the three-dimensional corneal lenticules formed and removed using this technique can be shaped sub-ideally in at least some cases. Also, the amount of time for ablating the tissue that defines the lenticules and the aperture 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 sub-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 ameliorates 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 elongating 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 elongating electrode. The tensioning element can be configured to provide tension to the elongating electrode and enable the elongating electrode to flex in response to the elongating electrode engaging the tissue and generating plasma. In some embodiments, the tensioning element operably coupled to the flexible elongating electrode enables the use of small diameter electrodes, such as electrodes with a diameter of 5 μm to 20 μm, which can enable the formation of a narrow incision with reduced tissue damage. In some embodiments, tensioning of the electrode enables more accurate incision of the tissue by reducing fluctuations in the position of the electrode along the incision path.

[0010] In some embodiments, the elongating electrode is operably coupled to one or more components to enable tissue resection along a path. The elongating 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 the electrodes suspended between the arms. The support structure, one or more arms, and the elongating 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 the tissue and shape the tissue prior to incision using the elongating 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 a support structure and an electrode suspended between the arms, which can provide bidirectional tissue incision and reduce 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 retracted 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, incising the tissue using the first incision, and the support structure and the electrode are retracted 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 with the first pass extends into the gap to provide an excised volume of tissue for subsequent removal and is incised with the second pass. In some embodiments, the excised volume of tissue comprises a thickness profile corresponding to the 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 with the first pass and the second pass, and the corneal flap can subsequently be removed to provide refractive correction.

[0012] In some embodiments, an elongating electrode is configured to incise tissue such as corneal tissue. An electrical energy source is operably coupled to the elongating 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 elongating electrode and the plate, and the support structure is configured to move the electrode relative to the plate to 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 elongating electrode, wherein the elongating electrode is configured to flex, generate the plasma, and incise the tissue, the elongating electrode; An electrical energy source, wherein the electrical energy source is operably coupled to the elongating electrode and configured to provide electrical energy to the electrode to generate the plasma, and an electrical energy source; A tensioning element operably coupled to the elongating electrode, wherein the tensioning element provides tension to the elongating electrode and is configured to enable the elongating electrode to flex in response to the elongating electrode engaging the tissue and generating the plasma, and 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 elongating electrode into the tissue and incise the tissue. (Item 6) The system according to item 5, 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. (Item 7) The system according to item 6, wherein the gap extends between the incised portion of the elongating electrode, the plurality of arms, and the support structure. (Item 8) The system according to item 6, wherein the gap is sized to receive the incised tissue along the incision formed using the elongating electrode. (Item 9) The support structure is operably coupled to one or more actuators to move the elongating electrode in one or more directions, the system of claim 5. (Item 10) The one or more actuators are configured to move the electrode with a variable speed, the system of claim 9. (Item 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 of claim 1. (Item 12) 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, the system of claim 1. (Item 13) 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, the system of claim 1. (Item 14) The electrodes are configured to sequentially contact a plurality of locations of the tissue to generate the incision, the system of claim 1. (Item 15) The plurality of locations comprises a plurality of intermittent locations, the system of claim 14. (Item 16) The electrodes are configured to evaporate tissue in contact with the electrodes at each of the plurality of intermittent locations, the system of claim 15. (Item 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 of claim 1. (Item 18) 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 system of claim 17. (Item 19) The system according to item 17, wherein each of the plurality of flashes of the 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 along 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 the 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 system according to item 17, wherein the plurality of flashes of the light occur at a first rate with a first speed of the electrode and at a second rate 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. (Item 25) The system according to item 24, wherein the plurality of flashes of the 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, while maintaining the substantially constant rate. (Item 26) The system according to item 1, wherein the extension electrode includes a filament, and the filament includes one or more than one of a wire or a thread. (Item 27) The system according to item 1, wherein the extension electrode includes a wire. (Item 28) 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, for the system according to item 27. (Item 29) The extension electrode has a cross-sectional distance, and the cross-sectional distance is about 25 μm or less, for the system according to item 1. (Item 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, for the system according to item 1. (Item 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, for the system according to item 1. (Item 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 for the system according to item 1. (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, for the system according to item 1. (Item 34) The extension electrode has an axis along the extension direction of the electrode, and the electrode is configured to incise tissue with movement in a direction transverse to the axis, for the system according to item 1. (Item 35) The extension electrode is configured to incise tissue at a speed exceeding about 1 m·s -1 in a direction transverse to the extension direction of the electrode, for the system according to item 1. (Item 36) The elongating electrode is configured to incise tissue at a speed in a range of about 0.5 cm·s -1 to about 10 m·s -1 optionally in a range of about 1 cm·s -1 to about 5 m·s -1 in a lateral direction with respect to the elongating direction of the electrode, the system according to item 1. (Item 37) The electrode is configured to incise the area of tissue at a rate in a range of about 5 mm 2 ·s -1 to about 50,000 mm 2 ·s -1 optionally in a range of about 500 mm 2 ·s -1 to about 25,000 mm 2 ·s -1 the system according to item 1. (Item 38) The electrical energy source is configured to deliver a certain waveform, the waveform comprising one or more 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, the system according to item 1. (Item 39) The waveform comprises the sine wave waveform, the sine wave waveform having a frequency in a range of about 0.5 MHz to about 2 MHz, the system according to item 38. (Item 40) The waveform comprises a combination of the sine wave waveform and the gate waveform, the sine wave waveform having a frequency in a range of about 0.5 MHz to about 2 MHz, the gate waveform having a gate frequency in a range of about 20 kHz to about 80 kHz and a duty cycle in a range of about 35% to about 100%, the system according to item 38. (Item 41) The system according to item 1, further comprising 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 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, as described in item 41. (Item 43) The system of item 42, wherein the waveform comprises a pulsed 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 with respect 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 according to item 49, comprising an actuator operably coupled to the translation element and moving the support structure along an axis of motion. (Item 51) The system according to item 50, wherein the translation element is manually actuated. (Item 52) The system according to 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. (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 shaping 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 elongating electrode, wherein the contact plate engages a portion of the cornea and is configured to shape the cornea prior to incising the cornea using the electrode. (Item 58) The system according to item 57, 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 a difference between the first surface profile and the second surface profile corresponds to a refractive correction of the eye for correcting refractive anomalies of the eye. (Item 59) The system according to item 57, wherein the contact plate includes a freeform optical surface shaped to correct wavefront aberration of the eye. (Item 60) The system according to item 57, wherein the contact plate includes a plurality of independently adjustable actuators for shaping the cornea. (Item 61) The system according to item 60, wherein the contact plate includes a plurality of plates operably coupled to the independently adjustable actuators for shaping the cornea. (Item 62) The system according to 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 a difference between the first position and the second position corresponds to a shape profile of tissue to be excised from the cornea to improve refractive anomalies of the eye. (Item 63) The system according to item 62, wherein the plurality of locations include a plurality of two-dimensional locations, and the shape profile includes a three-dimensional tissue excision profile. (Item 64) 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 according to item 60. (Item 65) The contact plate comprises a deformable membrane operably coupled to the plurality of independently adjustable actuators, the system according to item 60. (Item 66) The contact plate has 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. 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, the system according to item 60. (Item 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 item 57. (Item 68) 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, the system according to item 57. (Item 69) The system according to item 57 further comprises a sterile barrier for placement on the contact plate to maintain the sterility of the eye. (Item 70) 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 according to item 69. (Item 71) The sterilization barrier system according to item 69, comprising a peelable and adherable 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 in the range of about 100 mN to about 500 mN to the electrode, The system according to 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 according to item 1, further comprising. (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 incised tissue, The volume has a certain shape profile, The system according to item 73. (Item 75) The system according to 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 according to 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 system according to item 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 severed when the electrode is retracted proximally. (Item 78) The system according to item 74, wherein the contact plate comprises a first configuration for defining a first surface on a first side of the tissue volume and a second configuration for defining a second surface on a second side of the tissue volume. (Item 79) The system according to item 74, wherein a 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 refractive anomalies of the eye, 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 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 configured to incise the corneal tissue using the electrode; comprising a system. (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 translation of the electrode. (Item 83) The contact plate includes 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 refractive correction of an eye for correcting refractive anomalies of the eye, the system according to item 81. (Item 84) The contact plate includes a freeform optical surface shaped to correct wavefront aberration of an eye, the system according to item 81. (Item 85) The contact plate includes a plurality of independently adjustable actuators for shaping the cornea, the system according to item 81. (Item 86) The contact plate includes a plurality of plates operably coupled to the independently adjustable actuators for shaping the cornea, the system according to item 85. (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 improve refractive anomalies of the eye, the system according to item 86. (Item 88) The plurality of locations includes a plurality of two-dimensional locations, and the shape profile includes a three-dimensional tissue excision profile, the system according to item 87. (Item 89) The plurality of actuators includes at least 10 actuators, optionally, the plurality of actuators includes at least 16 actuators, optionally, the plurality of actuators includes at least 42 actuators, optionally, the plurality of actuators includes at least 100 actuators, the system according to item 85. The contact plate includes a deformable membrane operably coupled to the plurality of independently adjustable actuators, the system according to item 85. (Item 90) The contact plate includes a deformable membrane operably coupled to the plurality of independently adjustable actuators, the system according to item 85. (Item 91) The contact plate includes 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 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 abnormalities of the eye. The system according to 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 according to item 81. (Item 93) The first translation element further includes 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. The system according to item 81. (Item 94) The system according to item 81, further comprising a sterilization barrier for placement on the contact plate to maintain sterility of the eye. (Item 95) 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 system according to item 94. (Item 96) The sterilization barrier includes a peelable and adhesive sterilization barrier. The system according to item 94. (Item 97) The length of the elongated electrode is in the range of 6 mm to 12 mm, The electrode includes 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 elongating electrode, the processor being configured to have instructions to advance the electrode distally and retract the electrode proximally The system according to item 81, further comprising (Item 99) The elongating 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 to incise the cornea using the electrode and to define 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 to move 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, as described in item 99 The described system. (Item 101) The processor is configured to have instructions to advance the electrode distally to define a first surface on a first side of the corneal flap and to retract the electrode proximally to define a second surface on a second side of the corneal flap, as described in item 99 (Item 102) A gap extends between the elongating 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, as described in item 101 (Item 103) The contact plate comprises 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, as described in 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. (Item 105) The system of claim 99, wherein the shape profile comprises a thickness profile. (Item 106) A method for incising tissue using plasma, comprising incising the tissue using an elongated electrode, the elongated electrode being configured to flex, generate the plasma, and incise the tissue. and wherein an electrical energy source is operably coupled to the elongated electrode to provide electrical energy to the electrode and generate the plasma, and a tensioning element is operably coupled to the elongated electrode to provide tension to the elongated electrode and enable the elongated electrode to flex in response to the elongated electrode engaging the tissue and generating the plasma. (Item 107) The method of claim 106, wherein a plurality of arms are operably coupled to the electrode and the tensioning element. (Item 108) The method of claim 107, wherein the electrode is not supported between the two arms. (Item 109) The method of claim 107, wherein the electrode is configured to vibrate in a direction transverse to the elongation axis of the electrode. (Item 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 elongated electrode to incise the tissue. (Item 111) The method of claim 110, wherein the incising portion of the elongated electrode is suspended between the plurality of arms using tension from the tensioning element, and a gap extends between the plurality of arms. (Item 112) The method according to item 111, wherein the gap extends between the incised portion of the extension electrode, the plurality of arms, and the support structure. (Item 113) The method according to item 111, wherein the gap is sized to receive the incised tissue along the incision formed using the extension electrode. (Item 114) The method according to item 110, wherein the support structure is operably coupled to one or more actuators to move the extension electrode in one or more directions. (Item 115) The method according to item 114, wherein the one or more actuators move the electrode with a variable speed. (Item 116) The method according to item 106, 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 117) The method according to item 106, 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 tension the extension electrode. (Item 118) The method according to item 106, wherein an electrode assembly comprising a support structure is operably coupled to a plurality of arms and the tensioning element, and the electrode assembly advances the electrode into tissue and incises the tissue. (Item 119) The method according to item 106, wherein the electrode sequentially contacts a plurality of locations of the tissue to generate the incision. (Item 120) The method according to item 119, wherein the plurality of locations comprises a plurality of intermittent locations. (Item 121) The method according to item 120, wherein the electrode evaporates the tissue in contact with the electrode at each of the plurality of intermittent locations. (Item 122) The method according to item 106, wherein the electrode generates a plurality of flashes of light energy at a plurality of locations while the electrode incises the tissue. (Item 123) The method according to item 122, wherein the plurality of flashes of light energy comprise visible light energy having a wavelength within the range of about 400 nm to about 750 nm. (Item 124) The method according to item 122, wherein each of the plurality of flashes of light energy has a maximum transverse distance of about 1 mm or less. (Item 125) The method according to item 122, wherein the plurality of flashes occur within a time interval of about 250 μs or less, optionally about 25 μs or less. (Item 126) The method according to item 122, 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 127) The method according to item 122, wherein the plurality of flashes of light are dispersed in a plurality of non-overlapping regions. (Item 128) The method according to item 127, wherein the plurality of non-overlapping regions are located along the elongate electrode. (Item 129) The method according to item 122, wherein the plurality of flashes of light occur 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. (Item 130) The method according to item 129, wherein the plurality of flashes of light occur at a substantially constant rate up to about 25% or less, and one or more than one of the pulse rate or burst rate of the waveform with respect to the elongate electrode is varied in response to the varying speed of the electrode while maintaining the substantially constant rate. (Item 131) The method according to item 106, wherein the extension electrode comprises a filament, and the filament comprises one or more than one of a wire or a thread. (Item 132) The method according to item 106, wherein the extension electrode comprises a wire. (Item 133) The method according to item 132, wherein the diameter of the wire is in 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. (Item 134) The method according to item 106, wherein the extension electrode has a cross-sectional distance, and the cross-sectional distance is about 25 μm or less. (Item 135) The method according to item 106, wherein 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. (Item 136) The method according to item 106, wherein 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. (Item 137) The extension electrode is about 0.2 μg·mm -1 ~ about 3 μg·mm -1 and has a mass per unit length in the range of. The method according to item 106. (Item 138) The method according to item 106, wherein the extension electrode 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, and aluminum. (Item 139) The method according to item 106, wherein the extension electrode has an axis along the extension direction of the electrode, and the electrode incises tissue with movement in a direction transverse to the axis. (Item 140) The elongating electrode cuts tissue at a speed exceeding about 1 m·s in a direction transverse to the elongating direction of the electrode, according to the method described in item 106. -1 (Item 141) The elongating electrode cuts tissue at a speed within the range of about 0.5 cm·s to about 10 m·s, optionally within the range of about 1 cm·s to about 5 m·s, in a direction transverse to the elongating direction of the electrode, according to the method described in item 106. -1 ~ about 10 m·s -1 within the range of, optionally, about 1 cm·s -1 ~ about 5 m·s -1 (Item 142) The electrode cuts the area of the tissue at a rate within the range of about 5 mm·s to about 50,000 mm·s, optionally within the range of about 500 mm·s to about 25,000 mm·s, according to the method described in item 106. 2 ·s -1 ~ about 50,000 mm 2 ·s -1 within the range of, optionally, about 500 mm 2 ·s -1 ~ about 25,000 mm 2 ·s -1 (Item 143) The electrical energy source delivers a 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, according to the method described in item 106. (Item 144) The waveform comprises the sine wave waveform, and the sine wave waveform has a frequency within the range of about 0.5 MHz to about 2 MHz, according to the method described in 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 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%, according to the method described in item 143. (Item 146) A controller is operably coupled to the electrical energy source, according to the method described in item 106. (Item 147) The method according to item 146, wherein the controller controls the parameters of the electrical energy source by modulating the 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. (Item 148) The method according to item 147, wherein the waveform comprises a pulsed 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 149) The method according to item 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. (Item 150) The method according to item 149, wherein the controller modulates the substantially constant frequency waveform to produce a burst. (Item 151) The method according to item 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. (Item 152) The method according to item 151, wherein the waveform from the electrical energy source supplies an average power within the range of about 1 W to about 25 W. (Item 153) The method according to item 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 for the support structure. (Item 154) The method according to item 153, wherein the translational 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 155) The method according to item 154, wherein an actuator operably coupled to the translation element moves the support structure along the axis of motion. (Item 156) The method according to item 155, wherein the translation element is manually actuated. (Item 157) The method according to item 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. (Item 158) The method according to item 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. (Item 159) The method according to item 153, 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 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. (Item 161) The method according to item 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 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 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 refractive anomalies of the eye. (Item 164) The method according to item 162, wherein the contact plate comprises a freeform optical surface shaped to correct wavefront aberration of the eye. (Item 165) The method according to item 162, wherein the contact plate comprises a plurality of independently adjustable actuators for shaping the cornea. (Item 166) The method according to item 165, wherein the contact plate comprises 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 refractive anomalies of the eye. (Item 168) The method according to item 167, wherein the plurality of locations comprises a plurality of two-dimensional locations, and the shape profile comprises a three-dimensional tissue excision profile. (Item 169) The plurality of actuators comprises at least 10 actuators, optionally, the plurality of actuators comprises at least 16 actuators, optionally, the plurality The method according to item 165, wherein the number of actuators comprises at least 42 actuators, and 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 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 refractive abnormalities of the eye. The method according to item 165. (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 installed on the contact plate to maintain the 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 to the electrode in the range of about 100 mN to about 500 mN, The method according to item 162. (Item 178) A method for treating refractive eye disorders, the method comprising: incising 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 incising the cornea using the electrode; comprising A method, wherein a support structure moves the electrode relative to the plate and incises 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 incises the corneal tissue. (Item 180) The contact plate comprises 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 the refractive eye disorder according to item 178. The method according to item 178. (Item 181) The method according to item 178, wherein the contact plate comprises a freeform optical surface shaped to correct the 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 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 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 abnormalities of the eye, the method according to item 183. (Item 185) The plurality of locations comprise a plurality of two-dimensional locations, and the shape profile comprises a three-dimensional tissue excision profile, the method according to item 184. (Item 186) 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 method according to item 182. (Item 187) The contact plate comprises a deformable membrane operably coupled to the plurality of independently adjustable actuators, the method according to item 182. (Item 188) 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 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 abnormalities of the eye, the method according to item 182. (Item 189) The contact plate is configured to correct one or more of spherical, cylindrical, coma, spherical aberration, or trefoil of the eye, the method according to item 178. (Item 190) A suction element engages the corneal tissue and holds the corneal tissue in a substantially fixed position in contact with the second translation element while the first translation element moves the electrode and incises the tissue, the method according to item 178. (Item 191) The method according to item 178, wherein a sterilization barrier is installed on the contact plate to maintain the sterility of the eye. (Item 192) The method according to item 191, 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 193) The method according to item 191, wherein the sterilization barrier comprises a peelable and adhesive sterilization 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 for treating refractive anomalies of the 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 wherein the corneal flap has 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 flap and is moved with a second movement to define a second surface on a second side of the corneal flap. (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 flap and is retracted proximally to define a second surface on a second side of the corneal flap. (Item 198) 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 severed when the electrode is retracted proximally, the method of item 197. (Item 199) A 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 method of item 195. (Item 200) A first contact plate comprises a first shape profile for defining a first surface on a first side of the corneal flap and a second shape profile for defining a second surface on a second side of the corneal flap, the method of item 195. (Item 201) The shape profile comprises a thickness profile, the method of item 195. (Item 202) A processor operably coupled to the elongate electrode and configured to move the elongate electrode to sever tissue The system or method according to any one of the preceding items, further comprising (Incorporation by reference)

[0013] All patents, applications, and publications referenced and identified herein are hereby incorporated by reference in their entirety and shall be considered to be fully incorporated herein by reference, even if referenced at any point 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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[0036] 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.

[0037] The systems and methods of the present disclosure are well-suited for incorporation into previous devices and surgical techniques, such as a femtosecond keratome, that create an incision in tissue and form one or more than one of a flap, pocket, or corneal lenticule for removal from the tissue. The methods and systems of the present disclosure are well-suited for combinations with lens removal and prosthetics, 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 created within the capsule to produce a capsulotomy. The incision may be created 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, for example, to improve drainage and / or reduce intraocular pressure ("IOP") for the treatment of glaucoma.

[0038] Referring to incisions within eye tissue, the systems and methods of the present disclosure are also well suited 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 ball tissue, the methods and systems of the present disclosure are also well suited for forming incisions within one or more of collagen tissue, cartilage, stromal tissue, nerve tissue, vascular tissue, muscle, and soft tissue.

[0039] 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 systems 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 related to glaucoma surgery.

[0040] In some embodiments, the application of a sufficient voltage, including a periodic or pulsating voltage to the electrodes, within or around a biological tissue (i.e., the “target tissue structure”), establishes an initial current and / or electric field that can result in the formation of vapor by heating at least some constituent of the tissue (e.g., water 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 electrodes. The contents of such a vapor cavity are then ionized by the electrode voltage and can ablate at least a portion of the target tissue structure. In particular, when the pulse duration of the pulsating 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 result from 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 can be proportional to the electrode voltage and / or current supplied to the tissue by the electrodes as a larger tissue volume is heated. Similarly, the pressure within the bubble can increase as the amount of vapor is increased and can be proportional to the electrode voltage and / or current supplied to the tissue by the electrodes 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 electrodes are 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 electrodes). 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, an ablation threshold, and combinations thereof. If the electrode voltage is large enough, the resulting electric field strength can enable secondary discharges and produce arcs. Avoiding such arc discharges can be advantageous, as will be described elsewhere in this specification.The plasma can allow an electric current to flow again through the electrodes, vapor, and tissue, and thus can cause a further temperature increase. The bulk electrode temperature can be directly proportional to the amount of current flowing through the electrode and / or the surface collisions of ions and charged particles, chemical reactions, and radiation, which itself can be a function of the amount of plasma generated. Energy can be efficiently delivered to the target tissue structure to achieve thermal confinement within at least a portion of the target tissue structure in the vicinity of the electrode and / or vapor cavity and to generate and / or sustain the vapor cavity. Thermal confinement can 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 can 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 a 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 can be 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 range 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, cutting by heating, etc. Such a mechanical response time can be determined by the compressibility and density of the material, which can in turn be related to tissue hydration. For most species, including humans, water can contribute approximately 76% of the weight of the corneal stroma.

Chem.

[0041] In some embodiments, with respect to examples related to soft tissue, the following relationships, namely, [Chemical formula] can be used to approximate the mechanical properties of the tissue, where K and G are the bulk and shear moduli, respectively, [Chemical formula] where β is the tissue compressibility, and the average modulus of the corneal tissue can be in the range between ~1 and ~3 MPa. Thus, a sufficiently concentrated and rapid increase in the temperature of the material (i.e., the tissue or a component or constituent of the tissue) can evaporate an amount of the material. The evaporation can be explosive evaporation that causes tissue interruption, i.e., tissue "disruption", tissue "rupture", and tissue "ablation", also known as tissue "interruption". The extent of the vapor cavity can be essentially mediated by a plasma discharge process as the electric field strength decreases as the square of the distance from the electrode (e.g., ∝r -2 ) and operates as described within at least partially compressible materials due to transient mechanical deformation and displacement of the material such as tissue. The discharge can stop when the bubbles grow to a range where the distance from the electrode surface to the bubble surface at the operating voltage can no longer support the discharge throughout the entire vapor cavity since the electric field strength can be proportionally reduced. Maintaining a glow-type discharge or making an arc-type discharge impossible can be beneficial for producing precise incisions with minimal collateral damage. Flickering of light can accompany the plasma. The rate of the flickering of light can depend on the speed. The intensity of the flickering of light can depend on the energy per pulse or the power to the electrode.

[0042] In some embodiments, the required voltage and associated energy deposition, respectively, using electrode lengths of ~1 mm, ~2 mm, ~5 mm, and ~10 mm corresponding to curves 602, 604, 606, and 608, for a ~50 μs pulse, contain plot 600 of the relationship between the negative voltage threshold for tissue evaporation and the diameter of the long cylindrical electrode, as shown in FIG. 1B, and can be reduced by decreasing the width of the electrode. 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. "Significant" refers to an amount that significantly contributes to tissue thermal damage beyond what would otherwise exist. The electric field around the electrode is as follows, that is,

Chemical formula

Chemical formula

Chemical formula

Chemical formula

Chemical formula

Chemical formula

Chemical formula

Chemical formula

[0043] 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 an otherwise fixed system. 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 the 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 here depends on the radius of the electrical discharge and cannot depend much 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 destroying different regions of the tissue along the electrode length (i.e., in discontinuous locations or equivalently in non-overlapping regions), leaving a damage zone only about a few μm thick. A continuous arc is avoided, and the plasma is made to stay in a glow steady state by repeatedly destroying regions of the tissue, thereby modulating the electrode voltage and minimizing damage from thermions and the resulting thermal effects. The different regions of the tissue within the target tissue structure that can be repeatedly destroyed may or may not be adjacent to each other.

[0044] Figure 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 extended 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.

[0045] Figure 2B illustrates the initial momentary connection of tissue 2 and electrode assembly 4 in contact region 620, with gap 622 decreasing to ~0.

[0046] 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, allow 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 scope to the volume of the tissue directly adjacent to the tissue region 620, and either such tissue regions 625 and 627 can serve as the next portion of the tissue 2 for inducing evaporation in the same manner as the previously performed region 620, as described anywhere in this specification, 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, when a portion of a wire is connected in series to a power source in the "power-limited mode" and consumes more current than another portion of the wire, as can occur, the average power can remain constant, but the localized overheating in the region of increased resistivity can cause a portion of the wire to evaporate and break. 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 to 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 flow through another portion of the electrode, the current through the heated region decreases, as described above 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. When 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 increase in electrode temperature, causing a positive feedback loop, which in turn reduces the likelihood that small tissue areas contact the electrode and produce the aforementioned intermittent discharges. When the electrode is under relaxation and / or low-tension conditions, it can cause overheating of the tissue and / or the electrode. 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 approximately 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 discharge perforation sequence, 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 be maintained at ~100% in this configuration due to the perforation discharge process.

[0047] Figure 2D illustrates conditions where the voltage on electrode assembly 4 may fall below the plasma threshold and fail to maintain vapor cavities 635 such as region 626 in the previous figure, and along electrode assembly 4, the contact region 620 may be extended to produce an extended contact region 630 larger than contact region 620, allowing more current 624 to flow from electrode assembly 4 through tissue 2 to return electrode 24, and through heat conduction, may extend to a portion of tissue 2 behind direction 12 to produce a damage zone 628 larger than that of Figure 2C. When 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 also occur 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 Figure 2C before contacting the tissue and producing an incision. Another way to protect the tissue from overheating may be by using a non-conductive liquid or viscoelastic substance (e.g., Healon) such as Electro Lube Surgical. Such a non-conductive liquid may serve both as a coolant and as protection against current-related tissue damage such as electroporation. For example, the non-conductive liquid may be injected into the cutting area to protect tissue near the target tissue that may be within the current return path. The non-conductive liquid may also be cooled before use.

[0048] Figure 2E illustrates conditions under which the magnitude of the voltage on 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.

[0049] The elongate electrode may nominally comprise a circular cross-section (or "rounded") wire, and the reduction in electrode width may be comparable to a reduction in the diameter of the wire (or equivalently, its "cross-sectional distance"). The 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.

[0050] 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 be similarly generated by punching a foil sheet such as one 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 along the translation direction provides electrode deformation capabilities and increases stiffness in the orthogonal direction. Conductive wires or threads with a high melting point forming part of an electrical circuit may be referred to as filaments, as will be understood by those skilled in the art.

[0051] FIG. 2F illustrates the condition where the electrode assembly 4 can 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 electrode regions 650 - 654 is flexible. As a non-limiting example, configuring the electrode assembly 4 to be flexible by using, for example, a thin wire for at least a single region of electrode regions 650 - 654 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 FIG. 2C and becomes the next portion of tissue 2 for inducing evaporation in the same manner as the previously performed region 620, capable of generating an incision per segment. The shape of tissue 2 is modified by ablation of at least a single tissue region, and thus, evaporation can be induced in a portion of tissue 2 in the same manner as the previously performed region 620, capable of generating an incision per segment.

[0052] 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, may serve to create an incision with less damage than that of the positive discharge steady state. Thus, driver 18 may be configured to utilize a negative voltage bias.

[0053] The pulsating voltage waveform can be used to generate a plasma as described. In water, for example, vapor cavities move away from a ~O20 μm thick electrode operating with a nominally sinusoidal waveform having a peak voltage of ~300 V, averaged over a bubble lifetime of ~500 μs 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 ablation 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 pulsed electrode voltage is configured within the ~MHz range and may allow for multiple cycles during tissue ablation and / or bubble lifetime. As a non-limiting example, the nominal type of the waveform may be selected from the group consisting of a sine wave waveform, a square wave waveform, a triangular wave waveform, a ramp waveform, a periodic waveform, an aperiodic waveform, 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. The time when 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 in turn may 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.

[0054] In some embodiments, the inability to achieve thermal confinement can result in attendant tissue damage. For example, although the velocity is constant at all locations along the electrode, the velocity of the tissue along the electrode may not be constant, i.e., there may be a distribution of tissue velocity 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 in order to advance and further incise, and thus, prior to incision, it may be necessary to limit the instantaneous cutting velocity by compressing the tissue area onto the electrode and allowing only the average cutting velocity. The high temperature spots along the cutting edge of the rigid electrode can provide punctate evaporation, but those same locations can then remain within the tissue, even using a rigid elongating electrode, while waiting for similar disruptions at other locations. The time spent on the remnants is 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 area 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 "traction forces". Attendant damage can thus be reduced if the operating speed of the electrode nominally adapts to the discharge rate within the vapor cavity 635.

[0055] 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 the 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 the average cutting rate and, at least in part, by the 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.

[0056] In some embodiments, the tension may be selected to adapt to the stiffness of the material used to form the electrode such that it can be represented by the elastic modulus. As a non-limiting example, the elastic modulus may be selected from the group consisting of the flexural modulus, Young's modulus, bulk modulus, section modulus, and shear modulus. For a deformable electrode supported by a support structure at least at a single end, the elastic modulus E of the electrode material can be used to determine the tension F with respect to the allowable deflection distance

Chemical formula

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Chemical formula

[0057] 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 tensioned and stretched may provide increased mechanical stability over a relaxed 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 that is mechanically coupled to the electrode and provides a more constant tension nominally on the electrode. A thin deformable elongate electrode as described herein has a fundamental frequency (or equivalently, a mechanical resonance frequency)

Chemical formula

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Chemical formula

Chemical formula

[0058] In this configuration, such an electrode can be translated in the x-direction, displaced ("repelled") by x=~20 μm, [ka] can produce a local peak velocity of x', which is mainly restricted to the movement along the x-axis, which is the incision direction (i.e., parallel to the direction of electrode translation or equivalently, transverse to the elongation direction), thereby minimizing the error transverse to the intended incision direction. Such a configuration can provide reduced thermal damage and / or reduced traction compared to that of a system consisting of rigid electrodes, since primary thermal deposition and / or thermal diffusion can be relatively reduced by better matching the tissue velocity using such deformable electrodes. Such deformable (or "flexible") electrodes may have a local velocity of the electrode inversely proportional to the deflection on the electrode, and the electrode may tend to follow the plasma and relieve the increased tension thereon, moving at a speed exceeding ~1 m·s -1 so that the associated plasma can move faster than it cuts the tissue. When doing so, the electrode can be said to "flex" or "deform" or "vibrate". Thus, an elongated electrode as described herein can vibrate (or equivalently, "deform", or equivalently, "flex") transversely to the elongation axis of the electrode. As a non-limiting example, the following table lists various configurations of electrode materials, sizes, and their corresponding mechanical resonance frequencies.

[0059] In some embodiments, thermal confinement can be achieved when the discharge is produced within a single cycle of a pulsating voltage waveform, such as within a nanosecond time frame. It has been found that explosive evaporation by a nanosecond pulse from the laser-tissue interaction site 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 a damaged volume. The ejection of vapor and / or moisture and / or debris from the incised area, in particular, when the deformable electrode contacts the tissue along an area that is less than its circumference and produces voids larger than the interaction volume as described with respect to the effects of a photoablation nanosecond laser pulse, 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 a 10 μm sphere from ~20 °C to ~200 °C is However, bubbles smaller than the extent of the electrode can still result in tissue contact along only ~1 / 2 to ~2 / 3 of the electrode circumference (or equivalently, only ~1 / 2 to ~2 / 3 of the electrode diameter geometrically protruding onto the tissue) due to the resulting increase in the funnel hole volume, and can provide a resulting cavity of sufficient extent to allow passage of the entire electrode. In this case, a corresponding reduction in the energy required to induce a plasma can be

Chemical formula

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Chemical formula

Chemical formula

[0060] Figure 4 shows that the tensioned electrode assembly 5 can include a tensioning element 700, which in turn can be operatively 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 attachments 704 and 706. The cutout portion of the electrode 702 may comprise only a part of the conductive portion of the electrode 702. The radii 708 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.

[0061] In some embodiments, a processor, e.g., a controller, is operatively coupled to the extension electrode and provides movement to the extension electrode. For example, the processor can be configured to have instructions provided to control an actuator to move one or a component of the electrode assembly. In some embodiments, the processor is configured to have instructions, e.g., to advance the electrode distally and retract the electrode proximally.

[0062] 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, e.g., 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.

[0063] 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 dissected tissue. In some embodiments, 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. In some embodiments, 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, 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, and the processor is 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, and the total time is, for example, about 10 seconds or less, for example, 5 seconds or less or 2 seconds or less.

[0064] The support structure may be fabricated from materials 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, polyetheretherketone, 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 a target tissue or target tissue structure. The electrode (e.g., electrode 702 or a portion thereof) may at least in part consist of materials 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 in an area to inhibit conduction and / or incision in that area. Alternatively, tubing may be used instead of a 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, polyetheretherketone, 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 is such that it may apply to the electrodes, as may be the case for a ~O12.5 μm tungsten wire with a tension of ~295 mN that can also accommodate an elongation of ~0.5%. The resulting force may be configured to provide a tension such that it is ~80% of the rated or measured yield strength of the electrode or its material. 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., ~O2 Regarding a nominally pure tungsten wire with a diameter of 5 μm, ~80% of the rated yield tension of ~4.7 N or ~3.8 N. 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 consisting of the element electrode 4, the coupler 52, and the electrode mounting portion 17. The electrode mounting portion 17 has meshing features that are compatible with those of the coupler 74, such as threads, fasteners, snap joints, and combinations thereof. The cutting electrode mechanism 502 may further have meshing features that are compatible with those of the couplers 71 and 72. It itself is mechanically coupled to the actuators 50 and 504 respectively, provides a movement axis, moves the electrode assembly 4, and may generate 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 are 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 movement axis 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 translational elements, and mechanical stability and accuracy may be ensured along at least a single direction of movement.

[0065] FIG. 5 shows a tensioned electrode assembly 5 similar to that of FIG. 4, where radius 708 further has an electrode 702 installed therein and is transverse to the intended incision direction, capable of minimizing the positional error due to unintentional electrode movement. In particular, it may include a channel 720. The tensioning element 700 may be configured as an integral hinge (or a hinge as shown) within or along arms 710 and 712. Arms 710 and 712 may be made of 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 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 arm 710 or 712 and an electrically insulating material is selected, electrode 702 may alternatively be adhered or soldered, brazed, and / or welded to an adjacent conductive material on the arm.

[0066] 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. System 800 may comprise 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 may include arms 710 and 712, an electrode 702, and a tensioning element 700 that is operably coupled to the electrode 702 and attached via attachment portions 704 and 706, and that can generate a tensioned electrode assembly 5 such that the tensioning element 700 can extend while the electrode 702 is in contact with the tissue 2. The attachment portions 704 and / or 706 may be achieved via solder, brazing, adhesives, compression joints, crimping, and combinations thereof. The radius 708 located on the arms 710 and 712 may provide a smooth surface for the electrode 702 while it extends to avoid excessive strain such that it 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 to which the electrode 702 is configured, such as the coupler 52 or the electrode mounting portion 17. 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 only those elements that consist at least partially of conductive material as shown and to be a subsystem of the tensioned electrode assembly 5.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 over an area to inhibit conduction and / or incision in that area. Similarly, tubing may be used in place of the 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 ~150Ω and ~500Ω may be placed in line with the electrodes 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 mount 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 threads, clasps, snap joints, and combinations thereof, etc., 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 may also provide 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 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, by way of non-limiting example, pulsations, sine waves, squares, sawteeth, 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 further, electrode velocity v. t may depend thereon. Driver 18 may further be modulated to generate a pulse burst at a modulation frequency between ~100Hz and ~3MHz and generate a duty cycle. 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.

[0067] 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 a plane at that depth beneath the tissue surface can result in a flap with an uncut edge serving as its hinge. The flap can be detached by completing the uncut edge of the exemplary incision. In some embodiments, the 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 a plane at that depth beneath the tissue surface can result in a pocket.

[0068] In some embodiments, due to the plasma discharge at the electrode 702, a significant drop in the input impedance of the driver 18 can cause local current spikes, which in turn can damage the electrode and / or cause tissue damage. The power delivered to the electrode (or equivalently, the "delivered power" or equivalently, the "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 the electrode 702 can be further modulated or adjusted to be proportional to the instantaneous or expected length of tissue engagement and / or the electrode translation speed v t .

[0069] As a non-limiting example, when dissecting the cornea, the voltage may be increased from an initial value corresponding to when the electrode 702 is about to or is expected to initially engage tissue and is nominally oriented toward a more central corneal region to a higher voltage corresponding to when the electrode 702 is 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 continues to traverse the cornea 2 and dissect tissue, with an essentially shorter engagement length, the decrease may be, but need not be, configured to be the opposite of the initial increase. The position of the electrode 702 within the cornea 2 may be inferred using an encoder in the translation subsystem, as described elsewhere herein. In one embodiment, the voltage provided by the driver 18 is such that the tensioned electrode assembly 5 is tensioned by the tensioning element 700 to ∼300 mN and ∼2,000 mm s along the direction 12 with the initial electrode location being about 4 mm to about 7 mm from the side closest to the target tissue to be incised. -2 With a constant acceleration of ~300mm s -1 The maximum rate of (i.e., v t,max ) for the cut portion of the electrode 702, which is translated by a 10 mm length of 10 μm 99.99% pure tungsten wire. It may be configured to deliver a maximum peak-to-peak bipolar nominally sinusoidal voltage of ∼500V (with amplitudes of both ∼+250V and ∼−250V relative to a nominal neutral voltage, which need not be ground voltage), with a PRF (or “carrier frequency”) of ∼1 MHz, which may ramp up from ∼0V to maximum amplitude during the initial ∼50 μs translation, and then ramp down back to ∼0V during the final ∼100 μs translation, as may sometimes be useful. Note that such constant acceleration may result in a linear velocity profile in which the electrodes may be forced to rest inside the target tissue, as may be required to create a flap or corneal strip, as opposed to a full incision, as will be described elsewhere herein.

[0070] 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 operatively 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 a signal from driver 18 and / or responding thereto. Signals from monitor 514 may also be provided to system controller 60, where they are acted upon, thereby controlling the incision generated 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 onto 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 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 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 a foot pedal that communicates a signal to the actuator 50 to move the electrode assembly 4 for use in incising 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.

[0071] In some embodiments, the system controller 60 comprises a processor configured to determine a profile of tissue to be removed from the eye and to 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 the controller 60, the 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.

[0072] 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 contacting tissue 2. Incision 42 may be made within the tissue 2 (in this exemplary embodiment, the cornea and / or corneal stroma) by moving at least a portion of the tensioned electrode assembly 5 along the axis of motion 12 and using actuator 504 to create the pedestal 43. The contact plate 804 may be incorporated to flatten the cornea by moving it along the axis of motion 14 onto 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 enable 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 the 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 the 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 the electrodes 702 and the tensioning elements 700 and forming at least a portion of the electrode assembly 4 and the tensioned electrode assembly 5. Thus, arms 710 and 712 may be regarded as a support structure for the electrodes 702.Alternatively, the support 802 may be operatively 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 operatively coupled to a vacuum pump 850 via a vacuum line 870 to provide 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 that supports 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.

[0073] In some embodiments, system 800 may further be configured such that the tensioned electrode assembly 5 at least partially comprises an electrode 702. The electrode 702 may extend across arms 710 and 712, form a bridging distance of ~12 mm, and may comprise a tungsten wire with a diameter of ~12.5 μm and a purity of at least ~99% that uses a mechanical coil spring to apply a tension of, for example, ~300 mN on the electrode 702.

[0074] In some embodiments, the incision may form a flap or a pocket or a combination thereof based on whether the electrode cutting 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 and outwardly penetrated through the tissue. That is, the flap may be created within the anterior corneal surface by using the contact plate 804 to flatten or otherwise compress the anterior corneal surface, resulting in a lateral dimension for the 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 bridging distance for providing a flap incision). The flap incision may be configured to provide a D-shaped incision 42, as shown, and the linear section of the D-shaped incision may be a hinge portion. Similarly, a pocket incision may be made when the electrode bridging 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, enabling 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 include a non-linearly cut portion). In an alternative embodiment, the driver 18 may supply a sinusoidal 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 the direction of motion 12, as shown in FIGS. 7 and 9, utilize steps 102 - 122 of flowcharts 100 and 200 to achieve a speed of ~200 mm·s -1 to ~0 mm·s -1The electrode translation rate between it (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 part of the tissue (e.g., the "corneal piece" of the tissue within the stroma). During the intermediate period while the electrode moves in the first direction and then in the second direction, the electrode may be utilized for the intermittent power supply to the electrode in coordination with the movement of the electrode and the contact plate 804 so that the electrode provides a nominal voltage of ~0 V. 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.

[0075] Alternatively, variable acceleration may be utilized 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. As a non-limiting example, the range of v within the initial ~50 μs may provide asymmetric acceleration / deceleration such that it is similar to that of the final ~10 μs. t 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.

[0076] 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.

[0077]

[0078] ​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 a list consisting of, for example, 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 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 waveforms may be used to essentially envelop a waveform that includes a pulsating waveform.

[0079] 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 a circular chord length 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, which may be normalized using nominal values for R and v

Chemical formula

[0080] Alternatively, the voltage U required for evaporation is

Chemical formula

Chemical formula

[0081] Alternatively, the energy per cycle provided to the electrode 702 by the driver 18 can 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

[0082] Alternatively, the duty cycle provided to the electrode 702 by the driver 18 can 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

[0083] Alternatively, the voltage provided to the electrode 702 by the driver 18 can 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

[0084] Alternatively, the current limit provided to the electrode 702 by the driver 18 can 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

[0085] Alternatively, the power limit or set point provided to the electrode 702 by the driver 18 can 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 set point that may depend on the value of

[0086] Alternatively, the PRF provided to electrode 702 by 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

[0087] Alternatively, t v may, as described anywhere in this specification, at least in part a depend on the effective incision width y c and / or x

Chemical formula

[0088] Alternatively, when the tensioned electrode assembly 5 is tensioned by the tensioning element 700 to 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 for the incised portion of electrode 702 translated in parallel at a maximum rate of ~200 mm·s -1 The voltage provided by driver 18 may be configured to 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 PRF (or "carrier frequency") of ~1 MHz, to deliver a maximum peak-to-peak bipolar nominal sinusoidal voltage of ~600 V (with amplitudes of both ~+300 V and ~-300 V relative to the nominal neutral voltage), which may be useful when consisting of a ~10 mm long ~O20 μm ~ 99.99% pure tungsten wire.

[0089] 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 can be described anywhere in this specification in relation to the relationship for explaining the controlled power output of the electrodes.

[0090] 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 the duty cycle may ramp up from ~0% to a maximum amplitude between ~70% and ~100% as the speed of the electrode increases from rest (i.e., v t = 0 mm·s -1 ) to its maximum value, and the duty cycle then decreases to ~0% as the electrode speed is reduced back to rest.

[0091] 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 the maximum power output may ramp up from ~0% to a maximum amplitude between ~70% and ~100% as the speed of the electrode increases from rest to its maximum value, and the maximum power output then decreases to ~0% as the electrode speed is reduced back to rest.

[0092] 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 as the speed of the electrode increases from rest to its maximum value, it may gradually increase from ~0% to a maximum amplitude between ~70% and ~100%. Then, as the duty cycle decreases and the electrode speed is reduced to return to rest, it decreases to ~0%.

[0093] FIG. 7 illustrates a method of incising tissue. Flowchart 100 includes steps 102-122 that 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 the vacuum system described above, etc.). Step 110 involves positioning the contact plate at a first position on the tissue. Step 112 involves applying power to the electrodes. Step 114 involves translating (or "moving" or "actuating") the electrodes in a first direction (along the axis of motion 12, the "+x-direction", etc.). Step 116 involves interrupting the power to the electrodes. Step 118 involves removing the vacuum fixation, releasing the tissue, and disengaging the treated eye. Step 120 involves disengaging the electrodes from the tissue that has just been incised. Step 122 involves deactivating the system and disengaging it from the eye. The thin electrodes may be allowed to break as the system is disengaged from the patient. Alternatively, the electrodes may be translated in a second direction that is nominally opposite to the first direction. Alternatively, steps 108 and 110 may be exchanged, and power may be applied to the electrodes once they contact tissue 2. 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 electrodes as described anywhere in this specification, and step 112 may involve a tapered increase in power to the electrodes.

[0094] 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 may be possible.

[0095] 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. 7.

[0096] Figures 8A-8D are shown in a view orthogonal to those of FIGS. 4-6 such that, according to an embodiment of the present disclosure, for the sake of detail, the tensioned electrode assembly 5, where the axis of movement 12 can here be inside and outside the plane of the figure while the axis of movement 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 movement 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 as being 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 the central portion. The suction element 810 can be configured to contact the eye containing the tissue 2 in a region near the outer cornea and / or the limbal corneoscleral 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 cornea surface 842 and a posterior cornea 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 cornea surface 842 and the posterior cornea surface 844. The intraocular lens 840 is shown for the purpose 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 cornea 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.

[0097] Figure 8B shows the system of Figure 8A, where the contact plate 804, and thus the contact element 808, is moved further along the axis of movement 14 and can be assumed to flatten the cornea 843 and the tissue 2 therein. The electrode 702, as described anywhere herein, traverses a path along the axis of movement 12 and incises the tissue 2 by 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.

[0098] Figure 8C shows the system of Figure 8B in a different orientation, 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 proceeding 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 apply when generating a flap incision.

[0099] Figure 8D shows the system of Figures 8A - 8C, where the contact plate 804, and thus the contact element 808, is moved along the axis of movement 14 such that it comes to rest precisely at the apex of the corneal surface 842 as in Figure 8A. This figure shows, here, the incision 45, 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 approximately 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.

[0100] FIG. 9 illustrates a method similar to that of FIG. 7 with additional steps 202-212. Step 116 is optionally performed and may allow the electrode 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 the strain on the non-powered electrode may 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 utilized to generate a non-planar contact plate surface, as will be described with respect to FIGS. 11A and 11B, to provide a desired corneal deformation. Alternatively, a certain contact plate may be replaced in step 202 to provide a desired corneal deformation. The corneal deformation may be intended to generate 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 electrode in a second direction. The second direction may nominally oppose the first direction. Step 208 involves disengaging the electrode from the tissue such that it may occur when the translation of step 206 brings the electrode outside of tissue 2. Step 210 involves turning off the power to the electrode 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.

[0101] 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 may be possible.

[0102] 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.

[0103] 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 and is shown as convex, and in addition, a corneal flap (e.g., corneal flap 820) can be further configured to be incised into the (stromal) tissue 2 of the cornea 843. The difference between the first incision profile and the second incision profile can correspond to the shape of the corneal flap of the tissue to be removed from the cornea to treat refractive abnormalities of the eye.

[0104] FIG. 10A shows a system configured similarly to that of FIG. 8A, with the addition of a curved surface 806 onto 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.

[0105] FIG. 10B shows the system of FIG. 10A, where the contact plate 804, and thus the contact element 808, may be moved further along the axis of movement 14 and may be in contact with the cornea 843 and the tissue 2 therein. Different from 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.

[0106] FIG. 10C shows the system of FIG. 10X in different orientations, as the electrode 702 is translated parallel along the axis of movement 12, such that the incision 45 is seen to progress through the tissue 2 (shown as progressing from left to right in this figure), and is supported by the axes of movement 12 and 14. The actuation of the electrode 702 can be performed at its final position so as to be applicable when generating a flap incision.

[0107] FIG. 10D shows the system of FIG. 10X, where the contact plate 804 has been translated forwardly and the incision 46 is shown herein. Such an incision 46 can form the surface of the base 44 (not shown). The surface shape of the base 44 thus generated can be characterized as the average value of the surface shapes of the anterior corneal surface 842 and the 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.

[0108] FIG. 10E shows the system of FIG. 10X, where the second incision, incision 45, can be generated herein. The configuration of this figure can represent steps 202 - 206 of FIG. 9. Alternatively, the incision 45 can be generated by replacing the contact plate 804 or a part thereof to provide a different surface shape for the incision 45. A flat contact surface may be used for at least one incision.

[0109] Figure 10F shows an eye being treated using the system of the previous Figure 10X, where corneal flap 820 has been incised into the (stromal) tissue 2 of the cornea 843 and is bounded by the surfaces created by incisions 45, 46. Incisions 45, 46 may constitute incision 47 when the electrodes are not used to create a pocket within the cornea but are incised across the entire cornea. The configuration of this figure may represent the result of completing the remaining steps of Figure 9. The shape of the surface created through incisions 45, 46 may be selected to affect the refractive correction of the patient's eye's cornea 843. 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 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, and may be defined to optically balance (or correct) the measured aberration as described.

[0110] In some embodiments, with respect to the cornea, an approximate tissue profile for the tissue to be removed can be represented as follows.

[0111] 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 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.

[0112] Other approaches may also be used, for example, with reference to the SMILE technique, to determine the thickness profile of the tissue to be removed, as would be known to those skilled in the art.

[0113] 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 that refers to small incision corneal flap extraction as described herein. FIG. 11A depicts an adjustable contact plate 804 for each section, which can consist of a subplate (or equivalently, an “element”) 8061 that can form a contact surface 806 and can be stored within a housing 8042 and mounted on a base 8044 together. 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).Such a subplate 8061 is translated, displaced, and has a freeform profile (or "shape" or "surface profile") to address optical aberrations, including higher-order aberrations such as focus shift, radial distortion, spherical, spherical aberration, cylinder, cylindrical aberration, astigmatism, coma, and trefoil, when prescribing the surface shape accuracy for the corneal piece to be removed from the tissue 2 within the cornea 843. A discrete but arbitrarily addressable profile may be used to form the contact surface 806 for each section, which is used to generate the incision 45 and / or the incision 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, 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 to 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, an array 10 of actuators 8100 having a square cross-sectional shape may exist, or an array 14 of such actuators 8100 may exist, or an array 28 of such actuators 8100 may exist, 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 can be, although 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.

[0114] 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 flap 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, and 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. Using step 202 of FIG. 9, rather than repositioning the contact plate 804, 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.

[0115] 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 may 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 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 be the case for 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.

[0116] Figures 12A and 12B are directed to the generation of a disc-shaped corneal flap. FIG. 12A shows a corneal flap 820 consisting of 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 flap, when spread on a flat surface as shown, can appear as a flat disc as shown. FIG. 12B shows a cross-sectional view of the same corneal flap 820 of FIG. 12A. In this embodiment, a nominally planar contact plate is positioned at a first position (or "depth" or "location") to create incision 46 and then translated to a second more anterior (or "proximal") position to create incision 45. In the configuration of this embodiment, the cross-sectional shape 1010 may nominally be rectangular, and the surfaces 451 and 461 may nominally be parallel. Alternatively, incision 45 may be generated at a position posterior (or "distal") to that of incision 46 by appropriate translation of the contact plate.

[0117] FIG. 13 is directed to a plano-convex type corneal flap similar to that of FIG. 12B according to an embodiment of the present disclosure. Here, the corneal flap 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 flap as shown.

[0118] FIG. 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 the incision 45 and a rear surface 461 that can be generated by the 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 of surface for both the surfaces 451 and 461. The configuration of the present embodiment may be utilized to generate a meniscus type corneal piece as shown.

[0119] FIG. 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 the incision 45 and a rear surface 461 that can be generated by the 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 of surface for both the surfaces 451 and 461. The configuration of the present embodiment may be utilized to generate a meniscus type corneal piece as shown.

[0120] FIGS. 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 (after collection, ≤2 days and stored at ~2°C) and subsequently fixed in a 4% paraformaldehyde solution immediately after collection. 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; ~99.99% pure tungsten wire electrode with Φ~15μm and L~10mm; T~290mN; Rear displacement between incisions 45 and 46 with a contact plate (flat) of ~35μm, and configured with 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 stroma 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 a range of ~3μm. 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 ~50μm rear contact plate translation. Again, the thin damage zone is evident.

[0121] 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.

[0122] FIG. 18 shows 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) 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. A 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 in the range of approximately 400 nm to approximately 750 nm.

[0123] 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, including the scleral rim, while limiting tissue damage. According to embodiments of the present disclosure, instead of the conventionally used flap, a pocket in the sclera and / or cornea, including the scleral 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 generated 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.

[0124] 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.

[0125] 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 tissue compartment 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.

[0126] Semi-automated cutting tools can be used to provide improved incisions over those of conventional sharp-edged instruments. Plasma-induced semi-automated cutting tools can be used to provide improved incisions over those of semi-automated cutting tools configured for use in combination with sharp-edged instruments.

[0127] 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.

[0128] FIG. 19A shows flap 40 within tissue 2 as seen above, and FIG. 19B shows the same flap 40 as seen when viewed from section A-A. Flap 40 is constructed from incisions 42 and 44, which create 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 sutured in a butterfly fashion about the missing side of the hinged square, exposing the underlying tissue. Base 43 may be planar or curved. The flap can be detached by completing the fourth side of the exemplary square incision.

[0129] Similar to the configuration of FIGS. 19A and 19B, FIG. 19C shows 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, pocket 41 consists of incision 42, which creates base 43 but lacks incision 44. Again, base 43 may be planar or curved, but this time will depend on the longitudinal shape (or “profile”) of the incision in order to avoid creating incision 44.

[0130] 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 via conductor 20 to a power RF driver 18. Conductor 22 may be connected to the patient to generate electrode 24, which in turn may be part of a feedback path. The RF driver may produce bipolar pulses. Electrode 4 may here be shown as encapsulated within sheath 16, cut away in part for clarity. Movement direction 12 may be used to provide a lateral extent to the incision, and movement direction 14 may be orthogonal to movement direction 12 and 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.

[0131] FIG. 21 is directed to a system similar to that of FIG. 20 configured to generate a flap as viewed from the side and includes an electrode 4, a sheath 16, and an actuator 50, and similarly includes an addition of a probe body 26 oriented at an angle 30 to the surface of tissue 2. The actuator 50 is operably coupled to the electrode 4, and the electrode 4 is translated within the tissue 2 along a motion profile, which is described by the electrode 4 first moving 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, and can move in motion directions 12 and 14 such that it is translated parallel within the tissue 2. This configuration can then generate a flap 40 (not explicitly shown for purposes of clarity) by creating an incision 42 and then an incision 44 and a base 43. As a non-limiting example, an actuator 50 such as a motor or a voice coil can be powered. Alternatively, the actuator 50 can include a series of springs and ratchets or stops and triggers and generate the described motion profile. The element electrodes 4 and / or sheath 6 and / or probe body 26 may be configured as a subsystem that engages with the actuator 50 and the RF driver 18 and is discarded after use. In an alternative embodiment, the flap may be detached by modifying the motion profile, i.e., by first moving in direction 32, then in direction 34, and then in direction 38 which is the opposite direction of direction 32.

[0132] Alternatively, the system of FIG. 21 may be configured such that the actuator 50 translates the electrode 4 first in a direction nominally along angle 30 and then retracts the electrode 4 along a second direction that is nominally opposite the first direction to create a pocket rather than a flap.

[0133] 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. An exemplary 4 mm x 4 mm flap may further be a detached flap.

[0134] Figures 22A - 22C are directed to details of an electrode configured in accordance with an embodiment of the present disclosure, and 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 extended in the orthogonal direction. Such a configuration may provide increased strength in the aforementioned orthogonal direction for improved reliability and strength during tissue incision while maintaining the surface area by reducing dimension 303 to be less than dimension 301. Bend 10 may be made from either the configuration of region 300, the configuration of region 302, or may be 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, has a radius of ~0.5 mm and is made to result in a width 6 of ~4 mm, being nominally the same as the original diameter of ~250 μm of the wire up to the original bend 10, while dimension 303 is configured to be formed to ~400 μm by the aforementioned compression.

[0135] For clarity purposes, electrode 4 has heretofore been shown as U-shaped, but it need not be so. The RF driver 18 can provide an alternating current to electrode 4. Such an alternating current may be, by way of non-limiting example, a sine wave, square wave, sawtooth wave, triangular wave, or a combination thereof. The signal provided by the 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 the RF driver 18 may be between ~500 V and ~2,000 V. In an alternative embodiment, the peak-to-peak voltage provided by the RF driver 18 may be between ~400 V and ~800 V. In one embodiment, the signal of the RF driver 18 may be useful when electrode 4 consists of a tungsten wire having a diameter of ~ 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.

[0136] FIG. 23 pertains to system 400 configured according to an embodiment of the present disclosure. In addition to the elements related to the previous figures, system 400 further includes a controller 60, a power supply 70, a user interface 80, and a coupler 52. Connection 62 connects controller 60 and RF driver 18 and is at least a unidirectional connection. Connection 62 may also be a bidirectional connection, and controller 60 is capable of sensing and / or responding to at least signals from RF driver 18. Such signals may be safety signals regarding the sensed voltage or current. In a further alternative embodiment, RF driver 18 may provide feedback to controller 60, or use such feedback internally, and may share such feedback with controller 60 as a signal. Such feedback may be, for example, EMF or current feedback, and may be useful when electrode 4 contacts 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 controller 60 and actuator 50 and is at least a unidirectional connection. Actuator 50 may consist of at least one electric motor and may further include 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 controller 60 and actuator 50. In a further alternative embodiment, actuator 50 may provide feedback to controller 60, or use such feedback internally, and may share such feedback with controller 60 as a signal. Such feedback may be, for example, force feedback, and may be useful when determining when electrode 4 contacts tissue or when applying excessive force on tissue to be incised. Similarly, connection 67 connects controller 60 and 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 previous 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

[0137] 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 ".

[0138] 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". Further, a description such as "~O12μm" is equivalent to a description of "a diameter of about 12μm".

[0139] The symbol "∝" is used in this specification to indicate proportionality. For example, a description such as "∝r" -2 is equivalent to a description of "proportional to r". -2

[0140] Dot notation is used in this specification to represent compound 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".

[0141] As used in this specification, "mN" refers to "millinewton", which is 10 -3 newtons.

[0142] As described in this specification, the computing devices and systems described and / or illustrated in this specification 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 in this specification. In their most basic configuration, these computing devices may each comprise at least one memory device and at least one physical processor.

[0143] As used herein, the terms "memory" or "memory device" generally refer 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.

[0144] In addition, as used herein, the terms "processor" or "physical processor" generally refer 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 within 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, such as, for example, the activation of parallel processors, or remote processors such as servers, and combinations thereof.

[0145] Although illustrated 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 cause the computing device to perform one or more tasks such as method steps, or may represent or correspond to one or more software applications or programs.

[0146] Additionally, one or more of the devices described herein may transform 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, transform 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.

[0147] 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 (R) disks), optical storage media (e.g., compact discs (CDs), digital video discs (DVDs), and BLU-RAY (R) discs), electronic storage media (e.g., solid state drives and flash media), and non-transitory-type media such as other distributed systems.

[0148] One 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 only as examples 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 illustrated or discussed.

[0149] The various exemplary methods described and / or illustrated herein may also omit one or more 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 steps of any other method as disclosed herein.

[0150] A processor as described herein can be configured to perform one or more steps of any method as disclosed herein. Alternatively, or in combination, a processor can be configured to combine one or more steps of one or more methods as disclosed herein.

[0151] Unless otherwise stated, the terms "connected to" and "coupled to" (and their derivatives) as used in this specification and claims are to be interpreted as enabling both direct and indirect (i.e., via other elements or components) connections.

[0152] Unless otherwise noted, the terms "operatively connected to" and "operatively coupled to" (and their derivatives) as used in this specification and claims are to be interpreted as enabling both direct and indirect (i.e., via other elements or components) connections for the purpose of performing a function.

[0153] In addition, as used in this specification and the claims, the terms "a" and "an" are to be construed to mean "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.

[0154] A processor as disclosed herein can be configured to have instructions for performing any one or more steps of any of the methods disclosed herein.

[0155] It should be understood that the terms "first", "second", "third", etc. can 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 can be referred to as a second layer, element, component, region, or section without departing from the teachings of the present disclosure.

[0156] As used herein, the term "or" is used inclusively to refer to items in the alternative and in combination.

[0157] As used herein, characters such as numbers refer to like elements.

[0158] The present disclosure includes the following numbered appendices.

[0159] Appendix 1. A system for incising tissue using plasma, comprising: an elongating electrode configured to bend, generate plasma, and incise tissue; an electrical energy source operably coupled to the elongating electrode and configured to provide electrical energy to the electrode to generate plasma; and a tensioning element operably coupled to the elongating electrode and configured to provide tension to the elongating electrode, wherein the elongating electrode is configured to be able to bend in response to engaging the tissue and generating plasma.

[0160] Appendix 2. The system according to Appendix 1, further comprising a plurality of arms operably coupled to the electrode and the tensioning element.

[0161] Appendix 3. The system according to Appendix 2, wherein the electrode is not supported between two arms.

[0162] 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.

[0163] 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 elongating electrode into the tissue and advance the plurality of arms and the tensioning element to incise the tissue.

[0164] Appendix 6. The system according to Appendix 5, 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.

[0165] Appendix 7. The system according to Appendix 6, wherein the gap extends between the incising portion of the elongating electrode, the plurality of arms, and the support structure.

[0166] Appendix 8. The system according to Appendix 6, wherein the gap is sized to receive the incised tissue along the incision formed using the elongating electrode.

[0167] 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.

[0168] Appendix 10. One or more actuators are configured to move the electrode with a variable speed, the system according to Appendix 9.

[0169] 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.

[0170] Appendix 12. The extension electrode includes a first portion of the extension filament, and the tensioning element includes a second portion of the extension filament shaped to tension the extension electrode, the system according to Appendix 1.

[0171] 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 being configured to advance the electrode into tissue and incise the tissue, the system according to Appendix 1.

[0172] Appendix 14. The electrodes are configured to sequentially contact a plurality of locations in the tissue to generate an incision, the system according to Appendix 1.

[0173] Appendix 15. The plurality of locations comprises a plurality of intermittent locations, the system according to Appendix 14.

[0174] 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.

[0175] 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.

[0176] 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.

[0177] 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.

[0178] 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.

[0179] Appendix 21. The system described in Appendix 17, where the multiple flashes occur in association with an electrode movement distance of approximately 100 μm or less, optionally approximately 10 μm or less.

[0180] Appendix 22. The system described in Appendix 17, where the multiple flashes of light are dispersed in multiple non - overlapping regions.

[0181] Appendix 23. The system described in Appendix 22, where the multiple non - overlapping regions are located along the extension electrode.

[0182] 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.

[0183] 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 variation speed of the electrode, maintaining a substantially constant rate.

[0184] 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.

[0185] Appendix 27. The extension electrode is the system according to Appendix 1, comprising a wire.

[0186] Appendix 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, for the system according to Appendix 27.

[0187] Appendix 29. The extension electrode has a certain cross-sectional distance, and the cross-sectional distance is 25 μm or less, for the system according to Appendix 1.

[0188] Appendix 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, for the system according to Appendix 1.

[0189] Appendix 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, for the system according to Appendix 1.

[0190] Appendix 32. The extension electrode has a mass per unit length within the range of about 0.2 μg·mm -1 ~ about 3 μg·mm -1 for the system according to Appendix 1.

[0191] Appendix 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, for the system according to Appendix 1.

[0192] Appendix 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 a direction transverse to the axis, for the system according to Appendix 1.

[0193] Supplementary Note 35. The elongating electrode is configured to cut tissue at a speed exceeding approximately 1 m·s in a direction transverse to the elongating direction of the electrode, for the system according to Supplementary Note 1. -1 Supplementary Note 36. The elongating electrode is configured to cut tissue at a speed within the range of approximately 0.5 cm·s to approximately 10 m·s, optionally within the range of approximately 1 cm·s to approximately 5 m·s, in a direction transverse to the elongating direction of the electrode, for the system according to Supplementary Note 1.

[0194] Supplementary Note 37. The electrode is configured to cut the area of tissue at a rate within the range of approximately 5 mm·s to approximately 50,000 mm·s, optionally within the range of approximately 500 mm·s to approximately 25,000 mm·s, for the system according to Supplementary Note 1. -1 Supplementary Note 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 waveform, a triangular waveform, a fixed frequency waveform, a variable frequency waveform, or a gate waveform, for the system according to Supplementary Note 1. -1 Supplementary Note 39. The waveform includes a sine wave waveform, and the sine wave waveform has a frequency within the range of approximately 0.5 MHz to approximately 2 MHz, for the system according to Supplementary Note 38. -1 Supplementary Note 40. The waveform includes a combination of a sine wave waveform and a gate waveform. The sine wave waveform has a frequency within the range of approximately 0.5 MHz to approximately 2 MHz, and the gate waveform has a gate frequency within the range of approximately 20 kHz to approximately 80 kHz and a duty cycle within the range of approximately 35% to approximately 100%, for the system according to Supplementary Note 38. -1 Supplementary Note 36. The elongating electrode is configured to cut tissue at a speed within the range of approximately 0.5 cm·s to approximately 10 m·s, optionally within the range of approximately 1 cm·s to approximately 5 m·s, in a direction transverse to the elongating direction of the electrode, for the system according to Supplementary Note 1.

[0195] Supplementary Note 37. The electrode is configured to cut the area of tissue at a rate within the range of approximately 5 mm·s to approximately 50,000 mm·s, optionally within the range of approximately 500 mm·s to approximately 25,000 mm·s, for the system according to Supplementary Note 1. 2 ·s -1 Supplementary Note 37. The electrode is configured to cut the area of tissue at a rate within the range of approximately 5 mm·s to approximately 50,000 mm·s, optionally within the range of approximately 500 mm·s to approximately 25,000 mm·s, for the system according to Supplementary Note 1. 2 ·s -1 Supplementary Note 37. The electrode is configured to cut the area of tissue at a rate within the range of approximately 5 mm·s to approximately 50,000 mm·s, optionally within the range of approximately 500 mm·s to approximately 25,000 mm·s, for the system according to Supplementary Note 1. 2 ·s -1 Supplementary Note 37. The electrode is configured to cut the area of tissue at a rate within the range of approximately 5 mm·s to approximately 50,000 mm·s, optionally within the range of approximately 500 mm·s to approximately 25,000 mm·s, for the system according to Supplementary Note 1. 2 ·s -1 Supplementary Note 37. The electrode is configured to cut the area of tissue at a rate within the range of approximately 5 mm·s to approximately 50,000 mm·s, optionally within the range of approximately 500 mm·s to approximately 25,000 mm·s, for the system according to Supplementary Note 1.

[0196] Supplementary Note 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 waveform, a triangular waveform, a fixed frequency waveform, a variable frequency waveform, or a gate waveform, for the system according to Supplementary Note 1.

[0197] Supplementary Note 39. The waveform includes a sine wave waveform, and the sine wave waveform has a frequency within the range of approximately 0.5 MHz to approximately 2 MHz, for the system according to Supplementary Note 38.

[0198] Supplementary Note 40. The waveform includes a combination of a sine wave waveform and a gate waveform. The sine wave waveform has a frequency within the range of approximately 0.5 MHz to approximately 2 MHz, and the gate waveform has a gate frequency within the range of approximately 20 kHz to approximately 80 kHz and a duty cycle within the range of approximately 35% to approximately 100%, for the system according to Supplementary Note 38.

[0199] Appendix 41. The system according to Appendix 1, further comprising a controller operably coupled to an electrical energy source.

[0200] 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 set point, power limit, energy per pulse set point, energy per pulse limit, and modulation envelope.

[0201] Appendix 43. The system according to Appendix 42, wherein the waveform comprises a pulsed 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.

[0202] 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.

[0203] Appendix 45. The system according to Appendix 44, wherein the controller is configured to modulate a substantially constant frequency waveform to produce a burst.

[0204] 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.

[0205] 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.

[0206] 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 relative to the elongation axis of the electrode.

[0207] 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, of the system according to Appendix 48.

[0208] Appendix 50. The system according to Appendix 49, comprising an actuator operably coupled to the translation element and moving the support structure along the axis of motion.

[0209] Appendix 51. The translation element is manually operated, of the system according to Appendix 50.

[0210] Appendix 52. 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, of the system according to Appendix 50.

[0211] Appendix 53. A part of the support structure 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, 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, of the system according to Appendix 5.

[0212] Appendix 54. 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, of the system according to Appendix 48.

[0213] 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.

[0214] 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.

[0215] 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.

[0216] Supplementary Note 58. 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. The system according to Supplementary Note 57.

[0217] Supplementary Note 59. The system according to Supplementary Note 57, wherein the contact plate comprises a freeform optical surface shaped to correct the wavefront aberration of the eye.

[0218] Supplementary Note 60. The system according to Supplementary Note 57, wherein the contact plate comprises a plurality of independently adjustable actuators for shaping the cornea.

[0219] Supplementary Note 61. The system according to Supplementary Note 60, wherein the contact plate comprises a plurality of plates operably coupled to independently adjustable actuators for shaping the cornea.

[0220] Appendix 62. The system according to Appendix 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 the shape profile of the tissue to be excised from the cornea to correct refractive anomalies of the eye.

[0221] Appendix 63. The system according to Appendix 62, wherein the plurality of locations comprises a plurality of two-dimensional locations, and the shape profile comprises a three-dimensional tissue excision profile.

[0222] Appendix 64. The system according to Appendix 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.

[0223] Appendix 65. The system according to Appendix 60, wherein the contact plate comprises a deformable membrane operably coupled to a plurality of independently adjustable actuators.

[0224] Appendix 66. The system according to Appendix 60, 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 segment of the tissue to be removed from the cornea to treat refractive anomalies of the eye.

[0225] Appendix 67. The system according to Appendix 57, wherein the contact plate is configured to correct one or more of spherical, cylindrical, coma, spherical aberration, or trefoil of the eye.

[0226] Supplement 68. The system according to Supplement 57, wherein the first translation element further comprises a suction element for engaging the tissue while moving the electrode and incising the tissue, and holding the tissue in a substantially fixed position in contact with the second translation element.

[0227] Supplement 69. The system according to Supplement 57, further comprising a sterile barrier for placement on a contact plate for maintaining the sterility of the eye.

[0228] Supplement 70. The system according to Supplement 69, 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.

[0229] Supplement 71. The system according to Supplement 69, wherein the sterile barrier comprises a peelable and adhesive sterile barrier.

[0230] Supplement 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 in the range of about 100 mN to about 500 mN to the electrode, the system according to Supplement 57.

[0231] Supplement 73. The system according to Supplement 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.

[0232] Supplement 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, the volume having a certain shape profile, the system according to Supplement 73.

[0233] 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 volume of the tissue and with a second movement to define a second surface on a second side of the volume of the tissue.

[0234] 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 volume of the tissue and to retract the electrode proximally to define a second surface on a second side of the volume of the tissue.

[0235] Appendix 77. The system according to Appendix 76, 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.

[0236] 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 volume of the tissue and a second configuration to define a second surface on a second side of the volume of the tissue.

[0237] 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 volume of the tissue and a second shape profile to define a second surface on a second side of the volume of the tissue.

[0238] Appendix 80. The system according to Appendix 74, wherein the shape profile comprises a thickness profile.

[0239] 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 engaging 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 the corneal tissue using the electrode.

[0240] 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 the corneal tissue with the translation of the electrode.

[0241] 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.

[0242] 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.

[0243] Supplement 85. The system according to Supplement 81, wherein the contact plate comprises a plurality of independently adjustable actuators for shaping the cornea.

[0244] 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.

[0245] 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.

[0246] 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.

[0247] 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.

[0248] Appendix 90. The contact plate comprises a deformable membrane operably coupled to a plurality of independently adjustable actuators, the system according to Appendix 85.

[0249] 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.

[0250] 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.

[0251] 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.

[0252] Appendix 94. The system according to Appendix 81, further comprising a sterilization barrier for placement on a contact plate for maintaining the sterility of the eye.

[0253] Appendix 95. The system according to Appendix 94, 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.

[0254] Appendix 96. The system according to Appendix 94, wherein the sterilization barrier comprises a peelable and adhesive sterilization barrier.

[0255] 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.

[0256] 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.

[0257] Appendix 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 and defining a corneal flap of corneal tissue within a pocket using the electrode, and the corneal flap has a shape profile corresponding to the treatment of the refractive abnormality, the system according to Appendix 98.

[0258] 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.

[0259] 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.

[0260] 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.

[0261] 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.

[0262] 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.

[0263] Appendix 105. The system according to Appendix 99, wherein the shape profile comprises a thickness profile.

[0264] Supplement 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, the elongating electrode being capable of flexing in response to the elongating electrode engaging the tissue and generating plasma.

[0265] Supplement 107. The method according to Supplement 106, wherein a plurality of arms are operably coupled to the electrode and the tensioning element.

[0266] Supplement 108. The method according to Supplement 107, wherein the electrode is not supported between two arms.

[0267] Supplement 109. The method according to Supplement 107, wherein the electrode is configured to vibrate in a direction transverse to the elongation axis of the electrode.

[0268] Supplement 110. The method according to Supplement 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 tissue.

[0269] Supplement 111. The method according to Supplement 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.

[0270] Supplement 112. The method according to Supplement 111, wherein the gap extends between the incising portion of the elongating electrode, the plurality of arms, and the support structure.

[0271] Supplement 113. The method according to Supplement 111, wherein the gap is sized to receive incised tissue along an incision formed using the elongating electrode.

[0272] Appendix 114. The support structure is operably coupled to one or more actuators and moves the extension electrode in one or more directions, the method according to Appendix 110.

[0273] Appendix 115. One or more actuators move the electrode with a variable speed, the method according to Appendix 114.

[0274] Appendix 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 Appendix 106.

[0275] Appendix 117. 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 method according to Appendix 106.

[0276] Appendix 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 the tissue and incises the tissue, the method according to Appendix 106.

[0277] Appendix 119. The electrode sequentially contacts a plurality of locations in the tissue and generates an incision, the method according to Appendix 106.

[0278] Appendix 120. The plurality of locations comprises a plurality of intermittent locations, the method according to Appendix 119.

[0279] Appendix 121. The electrode evaporates the tissue in contact with the electrode at each of the plurality of intermittent locations, the method according to Appendix 120.

[0280] Appendix 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 Appendix 106.

[0281] Supplementary Note 123. The method according to Supplementary Note 122, wherein the multiple flashes of light energy have wavelengths within the range of about 400 nm to about 750 nm and comprise visible light energy.

[0282] Supplementary Note 124. The method according to Supplementary Note 122, wherein each of the multiple flashes of light energy has a maximum transverse distance of about 1 mm or less.

[0283] Supplementary Note 125. The method according to Supplementary Note 122, wherein the multiple flashes occur within a time interval of about 250 μs or less, optionally about 25 μs or less.

[0284] Supplementary Note 126. The method according to Supplementary Note 122, wherein the multiple flashes occur in association with an electrode movement distance of about 100 μm or less, optionally about 10 μm or less.

[0285] Supplementary Note 127. The method according to Supplementary Note 122, wherein the multiple flashes of light are dispersed in a plurality of non-overlapping regions.

[0286] Supplementary Note 128. The method according to Supplementary Note 127, wherein the plurality of non-overlapping regions are located along the extension electrode.

[0287] Supplementary Note 129. The method according to Supplementary Note 122, wherein 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, 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.

[0288] Supplementary Note 130. The method according to Supplementary Note 129, wherein the multiple 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 variation speed of the electrode to maintain a substantially constant rate.

[0289] 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.

[0290] Supplementary Note 132. The method according to Supplementary Note 106, wherein the extension electrode comprises a wire.

[0291] Supplementary Note 133. The method according to Supplementary Note 132, wherein the diameter of the wire is in 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.

[0292] Supplementary Note 134. The method according to Supplementary Note 106, wherein the extension electrode has a certain cross-sectional distance, and the cross-sectional distance is about 25 μm or less.

[0293] Supplementary Note 135. The method according to Supplementary Note 106, wherein 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.

[0294] Supplementary Note 136. The method according to Supplementary Note 106, wherein 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.

[0295] Supplementary Note 137. The method according to Supplementary Note 106, wherein the extension electrode has a mass per unit length in the range of about 0.2 μg·mm -1 ~ about 3 μg·mm -1 The method according to Supplementary Note 106, wherein the extension electrode has a mass per unit length in the range of about 0.2 μg·mm to about 3 μg·mm.

[0296] Supplementary Note 138. The method according to Supplementary Note 106, wherein the extension electrode 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, and aluminum.

[0297] Supplementary Note 139. The method according to Supplementary Note 106, wherein the extension electrode has an axis along the extension direction of the electrode, and the electrode cuts open the tissue as it moves laterally with respect to the axis.

[0298] Supplementary Note 140. The method according to Supplementary Note 106, wherein the elongated electrode cuts tissue at a speed exceeding approximately 1 m·s in a direction transverse to the elongation direction of the electrode. -1

[0299] Supplementary Note 141. The method according to Supplementary Note 106, wherein the elongated electrode cuts tissue at a speed within the range of approximately 0.5 cm·s -1 to approximately 10 m·s -1 optionally within the range of approximately 1 cm·s -1 to approximately 5 m·s -1 in a direction transverse to the elongation direction of the electrode.

[0300] 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 approximately 5 mm 2 ·s -1 to approximately 50,000 mm 2 ·s -1 optionally within the range of approximately 500 mm 2 ·s -1 to approximately 25,000 mm 2 ·s -1 in a direction transverse to the elongation direction of the electrode.

[0301] 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.

[0302] 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 approximately 0.5 MHz to approximately 2 MHz.

[0303] 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 approximately 0.5 MHz to approximately 2 MHz, and the gate waveform has a gate frequency within the range of approximately 20 kHz to approximately 80 kHz and a duty cycle within the range of approximately 35% to approximately 100%.

[0304] Supplement 146. The method according to Supplement 106, wherein the controller is operably coupled to an electrical energy source.

[0305] Supplement 147. The method according to Supplement 146, wherein the controller controls the parameters of the electrical energy source by modulating a waveform using parameters 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.

[0306] Supplement 148. The method according to Supplement 147, wherein the waveform comprises a pulsed 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.

[0307] Supplement 149. The method according to Supplement 148, wherein the waveform provides an 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.

[0308] Supplement 150. The method according to Supplement 149, wherein the controller modulates a substantially constant frequency waveform to produce a burst.

[0309] 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.

[0310] 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.

[0311] 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.

[0312] 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.

[0313] Appendix 155. The method according to Appendix 154, wherein an actuator operably coupled to the translation element moves the support structure along the motion axis.

[0314] Appendix 156. The method according to Appendix 155, wherein the translation element is manually actuated.

[0315] 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.

[0316] 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.

[0317] 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.

[0318] Appendix 160. The first and second translation elements are each a method according to Appendix 159, 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.

[0319] Appendix 161. A method according to 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.

[0320] Appendix 162. A method according to 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.

[0321] Appendix 163. A method according to 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 the refractive error of the eye.

[0322] Appendix 164. A method according to Appendix 162, wherein the contact plate comprises a freeform optical surface shaped to correct the wavefront aberration of the eye.

[0323] Appendix 165. A method according to Appendix 162, wherein the contact plate comprises a plurality of independently adjustable actuators for shaping the cornea.

[0324] Appendix 166. A method according to Appendix 165, wherein the contact plate comprises a plurality of plates operably coupled to independently adjustable actuators for shaping the cornea.

[0325] 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.

[0326] 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.

[0327] 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.

[0328] 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.

[0329] 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.

[0330] 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.

[0331] 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, holding the tissue in a substantially fixed position in contact with a second translation element.

[0332] Supplementary Note 174. The method according to Supplementary Note 162, wherein the sterilization barrier is installed on the contact plate to maintain the sterility of the eye.

[0333] 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 between the eye and the contact plate.

[0334] Supplementary Note 176. The method according to Supplementary Note 174, wherein the sterilization barrier comprises a peelable and adhesive sterilization barrier.

[0335] 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.

[0336] 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 engaging a part of the cornea 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.

[0337] 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.

[0338] 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 refractive abnormalities of the eye. The method according to Supplementary Note 178.

[0339] 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.

[0340] 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.

[0341] 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.

[0342] 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 anomalies of the eye. The method according to Supplementary Note 183.

[0343] 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.

[0344] 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.

[0345] 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.

[0346] Appendix 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 piece of tissue to be removed from the cornea to treat refractive anomalies of the eye, the method according to Appendix 182.

[0347] Appendix 189. The contact plate is configured to correct one or more of spherical, cylindrical, coma, spherical aberration, or trefoil of the eye, the method according to Appendix 178.

[0348] Appendix 190. The suction element, the first translation element engages the corneal tissue while moving the electrode to incise the tissue, and holds the corneal tissue in a substantially fixed position in contact with the second translation element, the method according to Appendix 178.

[0349] Appendix 191. A sterile barrier is installed on the contact plate to maintain the sterility of the eye, the method according to Appendix 178.

[0350] Appendix 192. The sterile barrier includes 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 method according to Appendix 191.

[0351] Appendix 193. The sterile barrier includes a peelable and adhesive sterile barrier, the method according to Appendix 191.

[0352] Appendix 194. The length of the extension electrode is in the range of 6 mm to 12 mm, the electrode includes 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 according to Appendix 178.

[0353] 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 of corneal tissue within a pocket, and removing the corneal flap, wherein the corneal flap has a shape profile corresponding to the treatment of the refractive disorder.

[0354] 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.

[0355] 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.

[0356] 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.

[0357] 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.

[0358] 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.

[0359] Supplement 201. The method according to Supplement 195, wherein the shape profile comprises a thickness profile.

[0360] The system or method according to any one of the preceding appendices, further comprising a processor operably coupled to the elongating electrode to move the elongating electrode and incise tissue.

[0361] Embodiments of the present disclosure have been illustrated and described as shown herein, but are provided by way of example only. Those skilled in the art will recognize numerous adaptations, changes, 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 invention disclosed herein. Accordingly, the scope of the invention of the present disclosure shall be defined only by the scope of the appended claims and their equivalents.

Claims

1. A system for treating refractive errors of an eye, comprising: an elongated electrode for incising corneal tissue; an electrical energy source operably coupled to the elongated electrode and configured to provide electrical energy to the electrode; a contact plate configured to engage a portion of the cornea and shape the cornea prior to incising the cornea with the electrodes; a support structure operably coupled to the elongated electrode and the plate, the support configured to move the electrode relative to the plate and to use the electrode to incise the corneal tissue; A system comprising:

2. The system described in claim 1, further comprising a translation element operably coupled to the support structure and the elongated electrode, which incise the corneal tissue in response to translation of the electrode.

3. The system described in claim 1, wherein the contact plates comprise 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 a refractive correction of the eye to correct a refractive error of the eye.

4. The system described in claim 1, wherein the contact plate has a freeform optical surface shaped to correct wavefront aberrations in the eye.

5. The system described in claim 1, wherein the contact plate has multiple independently adjustable actuators for shaping the cornea.

6. The system described in claim 5, wherein the contact plate comprises a plurality of plates operably coupled to the independently adjustable actuators for shaping the cornea.

7. The system described in claim 6, 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 refractive error of the eye.

8. The system of claim 7, wherein the multiple locations comprise multiple two-dimensional locations and the shape profile comprises a three-dimensional tissue ablation profile.

9. The system of claim 5, 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.

10. The system described in claim 5, wherein the contact plate comprises a deformable membrane operably coupled to the plurality of independently adjustable actuators.

11. The system described in claim 5, wherein the contact plate has a first configuration for making a first incision using the electrode along a first incision profile and a second configuration for making 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 fragment of tissue to be removed from the cornea to treat refractive error of the eye.

12. The system of claim 1, wherein the contact plate is configured to correct one or more of the sphericity, cylinder, coma, spherical aberration, or trefoil of the eye.

13. The system of claim 1, wherein the first translation element further comprises a suction element for engaging tissue and holding the tissue in a substantially fixed position while in contact with the second translation element while moving the electrode and incising the tissue.

14. The system described in claim 1, further comprising a sterile barrier for placement on the contact plate to maintain a sterile state of the eye.

15. The system described in claim 14, wherein the sterile barrier comprises a thin conformal barrier for conforming to the shape of the contact plate while the sterile barrier is between the eye and the contact plate.

16. The system of claim 14, wherein the sterile barrier comprises a peelable and adhesive sterile barrier.

17. A processor operably coupled to the elongated electrode, the processor configured to have instructions for advancing the electrode distally and retracting the electrode proximally. The system of claim 1 further comprising:

18. The elongated electrode is sized for insertion into the cornea of ​​the eye to treat refractive error of the eye; the processor is configured with instructions for using the electrodes to incise the cornea and define a pocket of corneal tissue; the corneal slice has a shape profile corresponding to the treatment of the refractive error; 20. The system of claim 17.

19. The system described in claim 18, 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 the corneal slice and for moving the electrode with a second movement to define a second surface on a second side of the corneal slice.

20. The system described in claim 18, wherein the processor is configured to have instructions for advancing the electrode distally to define a first surface on a first side of the corneal slice and retracting the electrode proximally to define a second surface on a second side of the corneal slice.

21. The system of claim 20, wherein a gap extends between the elongated 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 pulled proximally.

22. The system described in claim 18, wherein the contact plate has a first configuration for defining a first surface on a first side of the corneal slice and a second configuration for defining a second surface on a second side of the corneal slice.

23. The system described in claim 18, wherein a first contact plate has 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.

24. The system of claim 18, wherein the shape profile comprises a thickness profile.

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