EP3193758A1 - Procédés et dispositifs pour la vaporisation et l'incision de tissus par chirurgie thermique - Google Patents

Procédés et dispositifs pour la vaporisation et l'incision de tissus par chirurgie thermique

Info

Publication number
EP3193758A1
EP3193758A1 EP15781156.3A EP15781156A EP3193758A1 EP 3193758 A1 EP3193758 A1 EP 3193758A1 EP 15781156 A EP15781156 A EP 15781156A EP 3193758 A1 EP3193758 A1 EP 3193758A1
Authority
EP
European Patent Office
Prior art keywords
tissue
heating element
tip
tissue heating
incision
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP15781156.3A
Other languages
German (de)
English (en)
Inventor
Michael Slatkine
Ronen Shavit
Raphael Shavit
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Novoxel Ltd
Original Assignee
Novoxel Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from PCT/IL2014/051103 external-priority patent/WO2015092791A2/fr
Application filed by Novoxel Ltd filed Critical Novoxel Ltd
Publication of EP3193758A1 publication Critical patent/EP3193758A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/28—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor for heating a thermal probe or absorber
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/082—Inorganic materials
    • A61L31/088—Other specific inorganic materials not covered by A61L31/084 or A61L31/086
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00184—Moving parts
    • A61B2018/0019—Moving parts vibrating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00184—Moving parts
    • A61B2018/00196—Moving parts reciprocating lengthwise
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00452—Skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B2018/2255—Optical elements at the distal end of probe tips
    • A61B2018/2285—Optical elements at the distal end of probe tips with removable, replacable, or exchangable tips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A61B2090/065—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure

Definitions

  • the present invention in some embodiments thereof, relates to devices and methods for incising tissue using a tissue heating and/or vaporizing element and, more particularly, but not exclusively, to devices and methods for sensing when the tissue vaporizing element contacts the tissue to be cut, and optionally synchronizing heating the tissue vaporizing element mainly or even only when the tissue vaporizing element contacts the tissue.
  • ESU Monopolar electrosurgical units
  • return current to ground pads or to metallic instruments such as laparoscope tubes or metallic body implants such as dental implants may cause severe burns and results in medical complications. See for example an article titled "Preventing Patient Thermal Burns from Electrosurgical Instruments, by Anne Reed, Reprinted with permission of Infection Control Today 2013.
  • Monopolar ESUs are not allowed in brain surgery.
  • bipolar ESU provides significant tissue damage.
  • a Shaw scalpel is an example of such a device.
  • the Shaw scalpel is a sharp blade which can be heated by an internal electrical wire up to a temperature of 280 deg C.
  • the controller can control the scalpel blade temperature within a narrow limit.
  • the blade is also sharp enough to permit cold incision.
  • a disadvantage of the Shaw scalpel is its inability to be used in endoscopic procedures as well as its relatively slow heating and cooling time.
  • the Shaw scalpel is used as a continuous incision device, often resulting in peripheral thermal damage which depends on incision speed.
  • depth of incision is not automatically controlled and varies according to user applied vertical and lateral forces. See for example an article titled "Use of the Shay scalpel in head and neck surgery", by Willard E. Fee, published in Otolaryngol Head Neck Surg 89:515-519 (July- Aug) 1981.
  • US patent number 4,736,743 to Daikozono describes a medical laser probe for contact laser surgery wherein a surgical incision, for example, is made by direct and indirect laser heating of the tissue.
  • Direct heating is achieved in the conventional manner by direct laser irradiation of the subject tissue.
  • Indirect heating is achieved through the use of a probe tip specially coated with infrared absorbing material. The material serves to partially absorb and partially transmit the laser energy. The absorbed laser energy heats the probe tip thereby facilitating tissue vaporization when the probe is brought into contact with the tissue. The transmitted laser energy vaporizes the tissue by the conventional irradiation thereof.
  • the tip surface is roughened prior to application of the infrared material to enhance adhesion while an optically transparent material is placed over the tip to preclude material damage or erosion during normal tip use.
  • Sapphire tips are probes attached to a distal end of an optical fiber.
  • a proximal end of the optical fiber is fed with laser light, such as emitted from an Nd:YAG laser and the light is conducted along the optical fiber by total internal reflection.
  • the optical radiation is concentrated at the tip end and is absorbed by tissue, followed by a transfer of heat from the tissue to the tip of the optical fiber, and generating a thin semitransparent layer of carbonized tissue when the optical fiber is in contact with the tissue.
  • the combination of a high temperature distal tip of the optical fiber as well as light absorbed by carbonized tissue vaporizes the tissue and provides an incision upon moving the tip on the tissue. Such an incision is less precise than an incision obtained with a focused C0 2 laser, yet has an advantage of providing tactile feedback.
  • US patent number 6,383,179 to Neuberger describes a device that simultaneously incises an area and cauterizes the desired tissue.
  • the device incorporates laser energy by some means into a mechanical scalpel so that the incised area is cauterized as well.
  • a laser source is coupled by some means to an optically transparent blade such as a diamond knife.
  • the diamond knife is appropriately coated so that radiation only exits at desired areas.
  • optical fibers are embedded into a sharp edge blade scalpel with means to couple to a suitable radiation source.
  • European patent application EP 1563788 describes a method of enhancing the permeability of the skin to an analytic for diagnostic purposes or to a drug for therapeutic purposes describes utilizing micro-pore and optionally sonic energy and a chemical enhancer. If selected, the sonic energy may be modulated by means of frequency modulation, amplitude modulation, phase modulation, and/or combinations thereof.
  • Micro-pore is accomplished by (a) ablating the stratum corneum by localized rapid heating of water such that water is vaporized, thus eroding cells; (b) puncturing the stratum corneum which a micro-lancet calibrated to form a micro-pore of up to about 1000 ⁇ in diameter; (c) ablating the stratum corneum by focusing a tightly focused beam of sonic energy onto the stratum corneum; (d) hydraulically puncturing the stratum corneum with a high-pressure jet of fluid to form a micro-pore of up to about 1000 ⁇ in diameter; or (e) puncturing the stratum corneum with short pulses of electricity to form a micro-pore of up to about 1000 ⁇ in diameter.
  • US patent number 5,498,258 to Hakky describes a device and method for coagulating, lasing, resecting and removing prostate and bladder tissue.
  • the device is a laser resectoscope containing laser induced mechanical cutting.
  • the tips of the cutting blades are coated with Teflon and Stainless Steel to prevent adherence of the lased or resected tissue.
  • the contact laser head and cutting blades are heated by a laser beam. This allows the operator to lase and resect the targeted tissue without impairing the cellular integrity of the tissue. Consequently, the retrieved tissue is preserved for histological analysis.
  • a method is also provided to coagulate, lase, resect and remove tissue from the prostate and bladder areas using the above mentioned laser resectoscope with laser induced heating.
  • US patent number 8,808,311 describes surgical instruments that are coupleable to or have an end effector or a disposable loading unit with an end effector, and at least one micro-electromechanical system (MEMS) device operatively connected to the surgical instrument for at least one of sensing a condition, measuring a parameter and controlling the condition and/or parameter.
  • MEMS micro-electromechanical system
  • Embodiments include an ablation catheter that has an array of ablation elements attached to a deployable carrier assembly.
  • the carrier assembly can be constrained within the lumen of a catheter, and deployed to take on an expanded condition.
  • the carrier assembly includes multiple electrodes that are configured to ablate tissue at low power.
  • Additional embodiments include a system that includes an interface unit for delivering one or more forms of energy to the ablation catheter.
  • a flexible fiber delivers laser optical radiation to various surgical sites by mechanically bending the fiber.
  • the present invention in some embodiments thereof, relates to devices and methods for incising tissue using a tissue heating and/or vaporizing element and, more particularly, but not exclusively, to devices and methods for sensing when the tissue vaporizing element contacts the tissue to be cut, and optionally synchronizing heating the tissue vaporizing element mainly or even only when the tissue vaporizing element contacts the tissue.
  • a device for thermal incision of tissue including a tissue heating element, an oscillatory mechanism that advances the tissue heating element toward tissue and retracts the tissue heating element from tissue, a detector that detects when the tissue heating element contacts the tissue, and a heat controller that controls heating of the tissue heating element, wherein the heat controller for the tissue heating element controls heating the tissue heating element based on detecting when the tissue heating element contacts tissue.
  • the tissue heating element includes a material selected from a group consisting of metal, and metal coated with a bio-compatible coating.
  • the tissue heating element includes a material selected from a group consisting of sapphire, metal, and metal coated with a bio-compatible coating.
  • the tissue heating element includes a material opaque to optical energy emitted from the laser.
  • the invention further including a laser that heats the tissue heating element, and an optical fiber that conducts output of the laser to the tissue, in which a tip of the optical fiber passes heat into the tissue, thereby including the heating element.
  • the tissue heating element includes an electric conducting element.
  • the detector for detecting when the tissue heating element contacts the tissue includes a detector that measures mechanical impedance to advancing the tissue heating element.
  • the oscillatory mechanism that advances the tissue heating element toward tissue and retracts the tissue heating element from tissue is arranged to advance the tissue heating element toward tissue for a distance in a range of 0-20 millimeters beyond where the detector that detects when the tissue heating element contacts the tissue detects the tissue heating element contacting the tissue.
  • the oscillatory mechanism that advances the tissue heating element toward tissue and retracts the tissue heating element from tissue includes an electric motor.
  • the detector that detects when the tissue heating element contacts the tissue includes a detector that measures current to the electric motor.
  • the mechanism that advances the tissue heating element toward tissue and retracts the tissue heating element from tissue includes a linear electric motor.
  • a method for incising tissue including using a device for thermal incision of tissue for automatically advancing a tissue heating element toward tissue, automatically detecting when the tissue heating element contacts tissue, and automatically controlling heating the tissue heating element based on detecting when the tissue heating element contacts tissue.
  • tissue heating element further including automatically advancing the tissue heating element a desired distance measured from a point of contact with the tissue.
  • tissue heating element further including automatically advancing and retracting the tissue heating element a plurality of times to achieve a desired depth of cumulative advance into the tissue.
  • tissue heating element further including moving the tissue heating element sideways relative to the tissue while advancing and retracting the tissue heating element a plurality of times to achieve an incision into the tissue.
  • the automatically detecting when the tissue heating element contacts tissue includes measuring current to an electric motor.
  • the automatically detecting when the tissue heating element contacts tissue includes measuring a rate of advance of the tissue heating element.
  • the measuring a rate of advance of the tissue heating element includes measuring advance of the tissue heating element and calculating the rate by dividing the advance by a duration of the advance.
  • heating the tissue heating element is controlled to start only after automatically detecting when the tissue heating element contacts tissue.
  • heating the tissue heating element is controlled to start a desired period of time after automatically detecting when the tissue heating element contacts tissue. According to some embodiments of the invention, heating the tissue heating element is controlled to last for a desired period of time and then stop.
  • the desired period of time for heating the tissue is calculated based on an amount of heat required for evaporating a desired volume of tissue.
  • the amount of heat required for evaporating a desired volume of tissue is calculated based on a cross section of the tissue heating element in contact with tissue multiplied by a depth desired for a crater in a single round of advancing the tissue heating element into tissue and retracting the tissue heating element from the tissue.
  • the device for thermal incision of tissue includes a laser for heating the tissue heating element, and an optical fiber for conducting output of the laser to the tissue heating element, and in which the automatically controlling heating the tissue heating element includes causing the laser to produce output.
  • a device for introduction of material through a tissue by vaporizing a crater in the tissue including a tissue heating element, a mechanism that advances the tissue heating element toward tissue, a detector that detects when the tissue heating element contacts the tissue, and a heat controller that controls heating of the tissue heating element, wherein the heat controller for the tissue heating element controls heating the tissue heating element based on detecting when the tissue heating element contacts tissue.
  • a method for introduction of material through a tissue by vaporizing a crater in the tissue including using a device for thermal incision of tissue for automatically advancing a tissue heating element toward tissue, automatically detecting when the tissue heating element contacts tissue, and automatically controlling heating the tissue heating element based on detecting when the tissue heating element contacts tissue.
  • a duration of the crater remaining open to introduction of the material, prior to closure by healing is above 1 hour.
  • contact time of the tissue heating element with tissue is automatically kept shorter than 10 milliseconds.
  • a width of a distal end of a tip of the tissue heating element is less than 150 microns.
  • a tip of the tissue heating element includes a material selected from a group consisting of stainless steel and titanium.
  • the duration is above 6 hours.
  • all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.
  • Figure 1A is a simplified block diagram illustration of a device for incising tissue in surgical procedures according to an example embodiment of the invention
  • Figure IB is a simplified block diagram illustration of a process of linear incision using an example embodiment of the invention.
  • FIGS 1C and ID are more detailed illustrations of line incision produced according to an example embodiment of the invention.
  • Figure IE is a simplified illustration of producing a line incision according to an example embodiment of the invention
  • Figure IF is an illustration of a feature of a hand-piece according to another example embodiment of the invention
  • Figure 1G is a simplified block diagram illustration of a device for incising tissue in surgical procedures according to another example embodiment of the invention.
  • Figures 2A and 2B are simplified block diagram illustrations of interaction between a heated tip and tissue according to example embodiments of the invention
  • Figures 3A and 3B are simplified block diagram illustrations of interaction between prior art surgical laser based sapphire contact tips and tissue;
  • Figures 4 A and 4B are simplified block diagram illustrations of producing an incision of constant depth according to an example embodiment of the invention.
  • Figure 5 is a simplified block diagram illustrations of producing an incision according to a prior art embodiment of conical sapphire tip
  • Figure 6 is a simplified cross-sectional illustration of an example embodiment of the invention.
  • Figure 7 is a simplified flow chart illustration of a method for depth control of craters produced according to an example embodiment of the invention.
  • Figure 8A is an oscilloscope trace of a position of an array of tips and of a driving current of a linear motor driving the array of tips in air according to an example embodiment of the invention
  • Figure 8B is an oscilloscope trace of a position of an array of tips and of a driving current of a linear motor driving the array of tips including a period of time touching impeding skin according to an example embodiment of the invention
  • Figures 9A and 9B are cross section images depicting copper tips coated with a coating of nickel followed by gold according to another example embodiment of the invention.
  • Figure 9C is a graph depicting concentration of elements as a function of distance along the copper tips and the nickel followed by gold coating of the example embodiment of Figures 9A and 9B;
  • Figure 10 is a simplified illustration of treatment probe tips according to example embodiments of the invention
  • Figure 11 is a photograph of a histology cross section of an in vivo human skin vaporized crater produced immediately after treatment according to an example embodiment of the invention
  • Figure 12 is a simplified cross-sectional illustration of an example application of incising tissue according to an example embodiment of the invention.
  • Figure 13 is a simplified cross-sectional illustration of an example application of incising tissue according to an example embodiment of the invention.
  • Figure 14 is a simplified illustration of an array of tips, a hand-held device, and a list of features of the hand-held device according to an example embodiment of the invention
  • FIGS. 15 A, 15B and 15C are simplified illustrations of a process of thermo- mechanical ablation (TMA) according to an example embodiment of the invention
  • Figure 16 is a simplified illustration of a list of various effects produced by applying heated tips according to an example embodiment of the invention.
  • Figure 17 includes nine cross section images depicting tissue treated in various treatment modes using various treatment tips according to various example embodiments of the invention.
  • Figure 18 is a simplified illustration of an array of tips and a description of the array of tips according to an example embodiment of the invention.
  • Figure 19 is a simplified illustration of a barcode optionally used with an array of tips and a description of further optional features associated with the array of tips according to an example embodiment of the invention
  • Figure 20 is a simplified illustration of a hand-piece a description of optional features associated with the hand-piece according to an example embodiment of the invention
  • Figure 21 is a simplified illustration of a system for thermal surgical vaporization and incision of tissue and a description of optional features associated with the system 2102 according to an example embodiment of the invention
  • Figures 22A and 22B include cross section images depicting tissue treated in an experiment and a description of findings associated with the experiment according to an example embodiment of the invention
  • Figure 23 is a table comparing treatment according to an example embodiment of the invention, named Tixel, to treatment with a Fractional C0 2 laser;
  • Figure 24 is a simplified illustration of an array of tips and a treatment system according to an example embodiment of the invention.
  • Figure 25 is a simplified illustration of a hand-piece according to an example embodiment of the invention.
  • Figures 26A-26D are simplified illustrations of a hand-piece according to another example embodiment of the invention.
  • Figure 27 is a simplified illustration of a semi-frontal view of a cross section of a hand-piece according to an example embodiment of the invention.
  • Figure 28 is a simplified illustration of a hand-piece according to yet another example embodiment of the invention.
  • Figure 29 is a simplified illustration of a tip and a description of the tips according to an example embodiment of the invention.
  • Figure 30 is a simplified illustration of a tip and two tables according to an example embodiment of the invention.
  • Figure 31 is an image of an array of tips according to an example embodiment of the invention.
  • Figure 32A is an image of a hand-piece for thermal surgical vaporization and incision of tissue applied to calf's liver according to an example embodiment of the invention
  • Figure 32B is an image of the hand-piece of Figure 32A applied to calf's liver according to an example embodiment of the invention
  • Figure 32C is an image of calf's liver incised with a heated linear tip array according to an example embodiment of the invention.
  • Figure 32D is an image of an array of tips of Figure 32A applied to calf's liver according to yet another example embodiment of the invention.
  • Figure 33 is a simplified illustration of a tip; a tip holder and a table according to an example embodiment of the invention.
  • Figure 34 is a simplified illustration of a tip; a tip holder and a table according to an example embodiment of the invention;
  • Figure 35 is a simplified flow chart illustration of a method for incising tissue according to an example embodiment of the invention.
  • Figure 36 is a simplified flow chart illustration of a method for introduction of material through a tissue by vaporizing a crater in the tissue according to an example embodiment of the invention.
  • the present invention in some embodiments thereof, relates to devices and methods for incising tissue using a tissue vaporizing element and, more particularly, but not exclusively, to devices and methods for sensing when the tissue vaporizing element contacts the tissue to be cut, and optionally synchronizing heating the tissue vaporizing element mainly or even only when the tissue vaporizing element contacts the tissue.
  • An aspect of some embodiments of the invention involves automatically advancing a heating and/or vaporizing element toward tissue, determining when the vaporizing element is in contact with the tissue, heating the vaporizing element so as to vaporize tissue in contact with the vaporizing element, and automatically retracting the vaporizing element from contact with the tissue.
  • tissue vaporizing is used herein as an example, but other effects of heating can be used to assist in tissue incision, such as, by way of some non-limiting examples: vaporizing tissue; liquefying tissue; causing connective tissue to detach; causing tissue cells to explode.
  • heating element in all its grammatical forms is used throughout the present specification and claims interchangeably with a term “heating element” and its corresponding grammatical forms.
  • the above effects on tissue are optionally achieved based on temperature settings, controlling a rate of temperature increase, controlling duration of heating, and so on.
  • An aspect of some embodiments of the invention involves how to sense when the vaporizing element is in contact with the tissue.
  • it is an electric motor, optionally a linear motor, advancing the vaporizing element.
  • the advancing requires advancing against an increased opposition, which, in some embodiments, is optionally sensed.
  • the increased opposition to movement optionally slows down the advance, and the slowing down is optionally sensed.
  • An aspect of some embodiments of the invention involves determining by how much to advance the vaporizing element, and relative to what point in time or space.
  • the distance of advancing is determined relative to a point of contact of the vaporizing element with tissue.
  • the distance of advancing determines a depth of a vaporized crater in tissue produced by the advancing of the vaporizing element.
  • An aspect of some embodiments of the invention involves making repeated advances of the vaporizing element.
  • the repeated advances are made at one location of the tissue, optionally vaporizing a deeper crater in tissue than a single advance.
  • a device from which the vaporizing element advances is held in place, and the advance of the vaporizing element is optionally measured from a first point where the vaporizing element contacts tissue, so that a cumulative depth of the vaporizing of tissue is optionally measured.
  • a desired depth of vaporizing tissue is entered as input to a control unit, and the vaporizing element is optionally advanced, once or repeatedly, until the depth of vaporizing the tissue reaches the desired depth.
  • An aspect of some embodiments of the invention involves making repeated advances of the vaporizing element while also moving the vaporizing element sideways.
  • such repeated cratering of tissue optionally produces an incision in the tissue.
  • a depth of the incision is measured or controlled as described above.
  • An aspect of some embodiments of the invention involves determining when to heat the vaporizing element.
  • the vaporizing element is heated only when in contact with tissue, optionally determined as described above.
  • An aspect of some embodiments of the invention involves determining how much heat to apply to the vaporizing element in a single pulse of advancing and retracting.
  • the amount of heat is calculated based on an amount of heat required for evaporating a desired volume of tissue.
  • the desired volume of tissue is calculated based on a cross section of the vaporizing element in contact with tissue multiplied by a depth desired for a crater in the single pulse.
  • the amount of heat is calculated is calculated to be greater than amount of heat required for evaporating a desired volume of tissue, to allow for vaporized tissue presenting a somewhat insulating barrier to heat conduction from the vaporizing element to the tissue.
  • the amount of heat is calculated is calculated to be greater than amount of heat required for evaporating a desired volume of tissue, to allow for heat losses in the application.
  • An aspect of some embodiments of the invention involves determining how to heat the vaporizing element.
  • the heating is performed by piping laser energy along a fiber optic light guide, such that the laser energy heats a vaporizing element at the end of the fiber optic light guide.
  • a vaporizing element is described in more detail below.
  • materials used to manufacture such a vaporizing element include: sapphire, metal, metal coated with a bio-compatible coating, and so on.
  • the heating is performed by piping laser energy along a fiber optic light guide, such that the laser energy heats the tissue when such heating is desired.
  • the laser energy heats the tissue when such heating is desired.
  • a person skilled in the art will understand that it is still possible to sense when a fiber optic is advanced toward tissue and makes contact with the tissue, so that embodiments described above which utilize sensing when the vaporizing element makes contact with tissue can be understood to mean that the fiber optic makes contact with the tissue.
  • the heating is performed by electric heating of an electric conducting element or an electric conducting foil at the vaporizing element.
  • the electric conducting element or foil is the vaporizing element itself.
  • An aspect of some embodiments of the invention involves dimensions of, and/or a size of, and/or a shape of, the vaporizing element.
  • the size is designed to approximately correspond to a size of a hole or crater which is desired to be made in the tissue.
  • the size is designed to approximately correspond to a width of an incision which is desired to be made in the tissue, by repeatedly making holes side-by-side in the tissue.
  • the shape of the vaporizing element is produced so as to facilitate making the desired hole or incision.
  • the vaporizing element is optionally shaped as an elongated element, facilitating making a linear incision.
  • the vaporizing element is optionally shaped as a linear array of vaporizing elements, also facilitating making a linear incision.
  • An aspect of some embodiments of the invention involves a material selected for making the vaporizing element.
  • the material is selected to have a high heat conductance.
  • the material is selected to have a heat capacity in a specific range, so as to contain enough heat, when heated, to vaporize a desired amount of tissue, corresponding to making a hole or incision of a desired depth in the tissue, and/or so as to lose heat rapidly when not heated, so as to minimize possible damage from having a hot vaporizing element near tissue.
  • An aspect of some embodiments of the invention involves coating the vaporizing element.
  • one or more coating materials optionally in one or more layers, coat a first material which makes up a core of the vaporizing element.
  • the coating prevents the core material from coming in touch with tissue, especially if the core material is not considered safe to contact living tissue, when the core material is cold and/or when the core material is heated to a tissue-vaporizing temperature.
  • the above effects on tissue are optionally achieved based on temperature settings, rate of temperature rise settings, and so on.
  • Lasers used are high power lasers, whose power in key surgical applications may exceed 30 Watts, and some lasers such as used in dentistry may use 5-10 Watts Such lasers are relatively large and expensive. Moreover, such lasers, and even 5W lasers, are subject to high class, mostly class IV, medical regulations, and require stringent safety precautions since they directly interact with tissue. As a result such lasers are in any case very expensive. In addition, operating room staff has to use uncomfortable safety glasses.
  • the tip has a low thermal capacity, such as, by way of a non-limiting example having a thin hollow metallic tip, enabling use of relatively lower power lasers, by way of a non-limiting example lasers with average power of -1— 10 Watts.
  • a pulsed laser may optionally be used, optionally synchronized with tip contact with tissue. Such embodiments potentially use less power.
  • Incision depth is not constant and controlled since operator hand may move at a varying speed and change vertical and lateral incising force and dwell time on tissue.
  • the present invention in some embodiments thereof, relates to surgical methods and devices, and, more particularly, but not exclusively, to methods and devices for incision and vaporization of tissue in surgical procedures, and even more particularly, but not exclusively, to methods and devices for microsurgery such as in neurosurgery, ear-nose-throat (ENT) surgery, dentistry, delivery of drugs through tissue, and laparoscopy, among others.
  • microsurgery such as in neurosurgery, ear-nose-throat (ENT) surgery, dentistry, delivery of drugs through tissue, and laparoscopy, among others.
  • tissue in all its grammatical forms is used throughout the present specification and claims interchangeably with the term “skin” and its corresponding grammatical forms.
  • skin in all its grammatical forms is used throughout the present specification and claims interchangeably with the term “skin” and its corresponding grammatical forms.
  • Various implementations and embodiments of the invention which are described with reference to treating tissue are intended to apply also to treating skin.
  • An aspect of some embodiments of the invention involves using a tip of a heated rod, to produce an incision of tissue with minimal collateral damage and without damaging underlying tissue.
  • a distal end of the tip is mostly metallic.
  • a distal end of the tip is opaque.
  • heated temperatures of the tip are between 100 and 850 degrees Celsius.
  • a vaporizing element such as a vaporizing rod, has a distal end shaped into specific truncated shapes, adapted to supply a large amount of heat in a short amount of time to vaporize tissue, while in some embodiments also avoiding charring of the tissue.
  • holes, grooves, craters and/or indentations are produced in the tissue.
  • conical or pyramidal vaporizing tips are used to incise tissue, potentially reducing or eliminating carbonization.
  • the incising is performed to a constant depth, regardless of speed of application and/or shaking.
  • An aspect of some embodiments of the invention is to accurately vaporize tissue without causing damage to underlying delicate tissue or metallic parts such as, by way of a non-limiting example, implants such as dental implants.
  • An aspect of some embodiments of the invention involves detecting when a surgical distal tip comes in touch with skin.
  • the detection is performed by sensing mechanical resistance of the skin to the tips pushing against it. Detecting when tip(s) come in touch with skin is meaningful when aiming for a specific depth and/or shape of the crater or incision in the surgical site.
  • detection is performed by measuring a speed of advancement of the tip(s), and detecting when the tip(s) movement is slowed by the tissue. In some embodiments detection is performed by measuring electric parameters such as current or voltage or pulse width (under Pulse Width Modulation) required to advance the tip(s). When the tip(s) come into contact with tissue the electric parameters required to maintain the advance are changed, and contact with the tissue is optionally detected.
  • Another aspect of some embodiments of the current invention is vibrating the incision tip toward tissue and back out in order to generate very short contact duration with tissue, resulting in a potentially clean vaporization of an incision and/or a crater.
  • Another aspect of some embodiments of the invention is to vibrate the tip toward tissue and back out at a high frequency, resulting in overlap of vaporized craters and a clean incision.
  • Another aspect of some embodiments of the invention is to vibrate the incision tip toward tissue and back out at a high frequency to practically allow a user to stay a constant distance above tissue surface, the frequency being higher than a user response speed.
  • Another aspect of some embodiments of the invention involves vibrating the incision tip toward and back out of contact with tissue at a frequency high enough to enable automatically producing a constant depth incision by utilizing a tissue contact sensing mechanism.
  • Another aspect of some embodiments of the current invention involves using of a train of pulsed laser radiation delivered through an optical waveguide or fiber toward a vaporizing/incising tip in synchronization with an advance of the tip and its contact with tissue.
  • the laser radiation through the optical waveguide or fiber is deactivated in synchronization with fiber retraction.
  • the synchronization potentially enables generation of extremely precise and safe surgical incisions and/or reduces thermal damage and/or reduces carbonization.
  • Another aspect of some embodiments of the current invention is a utilization of opaque, metallic hollow tips having a short thermal relaxation time in order to rapidly heat the tip up to temperatures as high as 100-850 deg C and deliver most of the energy to the tissue within a short time duration.
  • Another aspect of some embodiments of the invention is to perform extremely precise incision or vaporization of tissue in dentistry and oral maxillofacial surgery, neurosurgery, ENT, endoscopy, GYN including laparoscopy, spinal surgery, and general surgery.
  • Figure 1A is a simplified block diagram illustration of a device 100 for incising tissue in surgical procedures according to an example embodiment of the invention.
  • Figure 1A depicts a hollow metallic tip 1 attached to a distal end of an optical waveguide or fiber 2. Although other tips may be used, Figure 1A describes an application which specifically utilizes hollow tips.
  • the hollow metallic tip 1 may optionally have different shapes such as conical or chisel or spherical or cylindrical or pyramidal.
  • the tip material may have a high thermal conductivity such as 150 - 400 W/m degrees Celsius (such as that of tungsten or copper), and may have low thermal conductivity such as lower than 30W/mdegC (such as stainless steel or titanium), in various applications as will be explained below.
  • the metallic tip 1 is opaque.
  • the optical waveguide 2 is optionally attached to a motor 4, optionally by an attaching element 3.
  • a motor 4 (which may be linear or rotary) is capable of linearly moving the fiber 2 and tip 1 toward and back from a tissue surface 15. Motion velocity as well as position and accelerations are potentially accurately known (based on position accuracy of 5 - 30 microns) and a motor controller 4a optionally senses contact between the tip 1 and the tissue 15, optionally based on resistance of the tissue 15 to the tip 1. Based on sensing tissue contact, the controller 4a optionally controls motor 4 speed, acceleration and position, resulting in potentially accurate control of tip 1 contact duration t with tissue as well as accurate measurement and/or control of a depth of contact.
  • a master clock 5 optionally generates electrical pulses 6 which are optionally fed to one or both of the both laser diode 8 and the motor 4, resulting in synchronization between fiber motion and beam emission from the laser 8.
  • the electric pulses result in an oscillatory motion 7 of the tip 1 whereby tip is optionally heated upon contact with tissue and optionally not heated upon retraction.
  • the short contact duration potentially ensures a high tip temperature such as 400 - 850 degrees Celsius, which potentially enables clean and precise vaporization, regardless of surgeon hand speed.
  • advance of incision tip is measured relative to sensing tissue contact, a depth of incision is potentially constant regardless of surgeon vertical hand movements (even hand shaking) as well as potentially independent of tissue surface curvature.
  • the optionally controlled depth is in a range of 0-20 millimeters.
  • the optionally controlled depth is controlled by measuring a distance the tip of the tissue heating element advances after detecting contact of the tip with tissue.
  • the optionally controlled depth is potentially beneficial in delicate surgical procedures such as opening tissue which covers a dental implant, or such as the vaporization of small lesions on vocal cords or linear incision of fallopian tube wall or vaporization of a brain lesion.
  • Typical parameters for a surgical hand-piece used in general surgery or dentistry include, by way of a non-limiting example:
  • the oscillation frequency depends on incision speed - when a user's hand moves at high speed, for a rapid incision, the frequency is increased and prevents gaps between craters.
  • the oscillation frequency depends on desired depth - optionally preventing overlap between craters so as not to produce a deep crater by advancing twice at a same location, thereby deepening the crater.
  • Tip material tungsten, which is biocompatible and has a high thermal conductivity ( ⁇ 150 W/m degC).
  • Tip wall thickness ⁇ 100- 200 microns.
  • Distal tip temperature while heated 400 -850 degC.
  • Hand-piece length 100 - 200 mm.
  • the fiber 2 section between the laser 8 and the attaching mechanism 3 is flexible, potentially allowing the location of the laser and its power supply to be distant from the surgical hand-piece 18, which includes the motor/controller, the distal section of the fiber 2, and the incision tip 1.
  • the high temperature tip 1 is distant from an optical heating source.
  • Figure 1A also presents a more detailed enlargement of the distal tip 1.
  • the walls of the hollow tip 1 are optionally shaped as a cone in its distal section, and as a cylindrical section in its proximal section, in order to enable firm attachment to the optical waveguide 2.
  • Dimensions of the tip walls are optionally selected (as shown in calculations below) to ensure a high temperature distal end 10 for tissue incision while maintaining approximately body temperature approximately 37 degrees Celsius at a location 12 approximately 300 micron proximally (backward).
  • a short section 11 whereby temperature drops from approximately 400 -850 degC to approximately 37 DegC is approximately 300 micron long.
  • Figure IB is a simplified block diagram illustration of a process of linear incision using an example embodiment of the invention.
  • Figure IB depicts a series of craters 13 produced by a pulsed train of advancing and retracting vaporizing tips 1 while moving a surgical hand-piece with a velocity V. Synchronization of tissue ablation with laser pulses is shown, as well as a lapse of optical heating resulting in a cold tip during a retraction phase. A tip distal end 14a optionally vaporizes craters with very shallow collateral thermal damage 14. When the velocity V is high, potentially only a train of craters is produced, optionally without creating a continuous incision. Such a train of craters is potentially useful in vaporization of thin lesions such as on vocal cords.
  • An advantage of such embodiments is that although a velocity V may be high, tissue vaporization occurs and is clean and homogeneous. This is in contrast to use of state of the art sapphire tips where high speed, faster than energy delivery speed, entails tearing of tissue or thermal damage.
  • Figure 1C shows a tissue incision created by a tip such as the tip of the example embodiment of Figure 1 A, where the velocity V is adjusted according to a pulsation rate. The adjustment causes an optional slight overlap between the craters 13, and produces a char free incision 16 of constant depth.
  • Figure ID shows another view of the incision of Figure 1C. It is noted that if velocity V is slower, an overlap of craters may optionally produce a deeper crater, and still char free.
  • a surgeon may optionally notice the deeper crater, and optionally increase V.
  • Figure IE is a simplified illustration of producing a line incision according to an example embodiment of the invention.
  • Figure IE depicts a simplified illustration of how a surgeon operates an example embodiment of an incision hand-piece 18.
  • the surgeon optionally places the hand-piece 18 on tissue while a tip of the hand-piece 18 is cold.
  • the hand-piece 18 Upon activating the hand-piece 18, optionally by pressing a switch 19 with his finger 20, the hand-piece 18 starts the incision process and creates an incision 21.
  • the surgeon optionally depresses the switch 19.
  • the switch 19 may optionally be a foot-switch.
  • Figure IF is an illustration of a feature of a hand-piece according to another example embodiment of the invention.
  • Figure IF intends to depict that when the tip of the hand-piece is not touching tissue, although a switch 19a may be activated, the tips are cold and situation is safe.
  • FIG. 1G is a simplified block diagram illustration of a device 150 for incising tissue in surgical procedures according to another example embodiment of the invention.
  • Figure 1G shows an embodiment of the invention in which the laser heater is replaced by a current generator 148 which is synchronized with the motor motion. Heating energy is delivered through a wire 149 also shown in the enlarged section of the figure.
  • the electrical wire 149 is thermally coupled to the tip and in some embodiments the treatment tip is optionally coated with an oxidized layer which doesn't conduct electricity.
  • FIGS. 2A and 2B are simplified block diagram illustrations of interaction between a heated tip and tissue according to example embodiments of the invention.
  • Figure 2A presents in more detail an example conical shaped tip 26 with a heating light beam 25.
  • Some example features in Figure 2A are an opaque tip and producing vaporizing energy by transfer of heat from a high temperature distal end 24 of the tip to tissue.
  • Figure 2B presents in more detail an example chisel shaped tip with the heating light beam 25.
  • Some example features in Figure 2B are an opaque tip producing vaporizing energy by transfer of heat from a high temperature distal end of the tip 26 to tissue.
  • FIGS. 3 A and 3B are simplified block diagram illustrations of interaction between prior art surgical laser based sapphire contact tips and tissue;
  • Figures 3A and 3B present a tissue interaction of sapphire or fiber tips of similar shape to sapphire tips. In addition to heat transfer due to tissue carbonization, light propagates into tissue and participates in a heating process.
  • Figures 4A and 4B are simplified block diagram illustrations of producing an incision of constant depth according to an example embodiment of the invention.
  • Curve 40a in Figure 4A presents an example of an irregular movement of a surgeon's hand over tissue at a height H( t) at velocity V.
  • H may vary over time, for example between 1-4 mm.
  • the irregularity may be caused by momentary hand trembling or distraction or poor visibility.
  • a distal end of the hand-piece (the hand-piece excluding a tip) follows a curve 41a. While activating the hand-piece, since tip and fiber 42 optionally advance until tissue contact is established and optionally sensed by a motor controller, vaporization of depth D will occur and be identical along the incision line.
  • Figure 4B also shows a similar effect, in an example where tissue surface is not flat but curved.
  • incision is char free and of constant depth.
  • Figure 5 is a simplified block diagram illustrations of producing an incision according to prior art embodiment of conical Sapphire tip.
  • the irregularity of surgeon hand movement may be translated into an irregular incision of depth D (t). It is noted that using the example embodiment method illustrated in Figures 4A and 4B can potentially correct the irregular incision depth of a sapphire- tipped surgical instrument to have a constant incision depth
  • Table 1 lists some potential differences between features of several types of contact surgical units and an example embodiment of the invention:
  • Tip is Potentially optical radiation semitransparent. NO. Tip is opaque in
  • oscillation frequency is high, such as 30 Hz or somewhat higher, a surgeon may feel as if the surgical hand-piece is in contact with tissue.
  • the heating may operate continuously and the tip will behave as a regular hot knife, optionally with a controlled depth.
  • a small inexpensive industrial diode laser of 5 - 10 Watts can easily provide the power for making such an incision and that the incision speed may potentially be much faster.
  • a desired width is 300 microns which is strong enough for the tip not to break or bend and potentially enables fast cooling upon retraction.
  • FIG. 6 is a simplified cross-sectional illustration of an example embodiment of the invention.
  • motor 4 of Figure 1A may be a rotary motor or a linear motor such as produced by Faulhaber Minimotor SA, Switzerland.
  • FIG 6 presents a more detailed description of the tissue sensing technology which is generally described in figure 1A.
  • a surgical hand-piece 31 may have a "revolver" shape. The surgical hand-piece 31 may also have other shapes not depicted in Figure 6, such as a linear pen shape as described in figure IE and IF.
  • a linear motor 30 is optionally located in the hand-piece 31, which may include also a position encoder 32, as depicted in Figure 6.
  • the position encoder 32 potentially provides a position of a rod 33 which incorporates the optical fiber /lightguide and treatment metallic probe (not shown) described in figure 1A, and which is driven by motor 30, relative to a reference location in the hand-piece 31.
  • the rod 33 and fiber and distal treatment probe are pushed toward tissue (not shown) and back from tissue on which a distal cover 34 is optionally placed.
  • the distal cover 34 may be thin and elongated, for example when the hand-piece has a pen shape.
  • the distal cover 34 may incorporate holes in order to enable suction of air into the hand-piece 31.
  • the hand-piece envelope is made of two parts.
  • the position encoder 32 potentially provides a 1 micron position accuracy and may be a magnetic array type encoder (such as a magnetic type encoder produced by Texas Instruments), or an optical encoder or a Hall Effect detector.
  • the linear motor may be operated at a constant voltage, and the force applied by it on the fiber and treatment probe may be controlled with a controller 35, optionally by modulating the width of pulses applied to the motor (Pulse width modulation - PWM).
  • the velocity of the rod 33 which is equal to the tip velocity, is optionally monitored by knowing the rod position. Following an advance toward tissue and upon contact with treated tissue (which may also occur after attaining a targeted incision depth) the velocity of rod 33 may be reduced if skin mechanical compliance is low. This may occur, by way of a non-limiting example, on thin tissue such as gums covering bone or when almost reaching a hard dental implant surface.
  • a controller optionally modifies the width of pulses applied to the motor, until velocity is restored.
  • the rod 33 optionally continues its motion until a preselected depth is attained, whereby rod velocity is reversed and tip is retracted.
  • the controller measures rod deceleration, and calculates rod advance distance, in order to both achieve a preset incision depth as well as a tip dwell-duration in tissue.
  • a closed loop control mechanism potentially enables vaporization of craters with excellent depth accuracy (few microns) potentially regardless of tissue type (from mechanical compliance standpoint) and potentially regardless of tissue position (such as with curved tissue as depicted in Figure 4B).
  • requirements for a stability of a surgeon's hand may be reduced or stability of treatment hand in robotic surgery may be reduced, resulting in cost reduction. Since in many treatments there is a direct relation between mechanical skin compliance and clinical side effects, such as damage due to mechanical impact or injury, a beneficial control of side effects is also potentially obtained.
  • Figure 7 is a simplified flow chart illustration of a method for depth control of craters produced according to an example embodiment of the invention.
  • the method depicted in Figure 7 includes:
  • Providing one or more input parameters such as: type of tip, number of tips, shape of tip, dimensions of tip, duration in tissue, tip protrusion from device, pulse repetition rate, heating power level, laser power level, and so on (702);
  • a motor optionally a linear motor, to advance a treatment tip or tips toward tissue, optionally at a rate based on the input parameters, optionally translated to Pulse Width Modulation (PWM) parameters for control of the motor (707);
  • PWM Pulse Width Modulation
  • Reducing tip(s) velocity optionally based on measuring mechanical resistance of the tissue to forward motion into the tissue (715);
  • the tip touches tissue and starts to vaporize the tissue.
  • determining a vaporization depth H is dependent on energy delivered to the tip. Determining a vaporization depth H is optionally performed by determining a time duration for tip contact with tissue and/or by determining a power level of a heating unit such as a laser. Once the vaporization depth H is attained, for example 200 microns, the tissue (crater bottom) starts to resist movement of the tip since it is not being vaporized any more, only potentially heated by contact.
  • a measurement of impedance to tip movement optionally provides data, which in some embodiments is used as a sign that vaporization has ended, and may optionally cause a decision to draw back the tip.
  • estimation of vaporization depth may optionally depend on heating parameters and time duration and depend little on surgeon hand movement, since in the embodiments the depth H depends on contact detection.
  • the vaporization depth has a dependence on contact detection since without contact detection the tip might stay in contact with tissue for a longer duration in the crater, for example 30 millisec, and start heating tissue and cause peripheral thermal damage.
  • a controller automatically selecting new operating parameters based on measurements made, optionally translating the new operating parameters into a new (PWM) program (717);
  • Figure 7 depicts a schematic description of an example embodiment of closed loop control of depth of vaporization of craters regardless of skin compliance and precise vertical position of surgeon hand relative to tissue. By moving surgeon hand a linear array of craters is optionally produced, potentially resulting in a linear incision.
  • tissue contact sensing may be achieved by measuring an electrical impedance between a metallic surgical probe and tissue. As long as the probe tip is not in contact with tissue, electrical resistance may be approximately infinitely large. Upon contact, electrical impedance is reduced dramatically, depending upon tissue type. There are many cases where such a technique is inferior to tissue mechanical impedance sensing, such as sensing a conducting dental implant.
  • a reduction of mechanical impedance while moving forward is measured.
  • the change of impedance is an indication that the treatment tip has drilled a hole in a body membrane such as the tympanic membrane in case of myringotomy and reached a tissue cavity.
  • the motor controller may optionally commands backward retraction.
  • Figure 8A is an oscilloscope trace 1602 of a position of an array of tips and of a driving current of a linear motor driving the array of tips in air according to an example embodiment of the invention.
  • Figure 8B is an oscilloscope trace 1632 of a position of an array of tips and of a driving current of a linear motor driving the array of tips including a period of time touching impeding skin according to an example embodiment of the invention.
  • Figures 8 A and 8B have X-axes 1604 1634 of time, 400 milliseconds per division and Y-axes of tip position 1606 1636, 5 mm per division, and driving current 1608 1638, 1 A per division, of a linear motor controlled using a closed loop control method of Pulse Width Modulation (PWM).
  • PWM Pulse Width Modulation
  • Figure 8A depicts an upper tracel610 showing tip position as a function of time, with the tips moving in air.
  • Section AB of the upper trace 1610 corresponds to the tips advancing
  • section BC of the upper trace 1610 corresponds to the tip at maximal advance
  • section CD of the upper trace 1610 corresponds to a retraction phase of the tips.
  • Figure 8A depicts a lower trace 1612 showing a driving current used to advance the tips.
  • the driving current depicted by the lower trace 1612 appears substantially constant, barring noise artifacts.
  • the driving current depicted by the lower trace 1612 corresponds to mechanical impedance to the tip movement by tissue - no skin contact.
  • Figure 8B depicts an upper trace 1640 showing tip position as a function of time, with the tips moving into contact with tissue, in the example of Figure 8B the tissue is the skin of a finger placed in the path of the tips.
  • Section EF of the upper trace 1640 corresponds to the tips advancing into the tissue, and section GH corresponds to tip retraction.
  • Figure 8B depicts a lower trace 1642 showing a driving current used to advance the tips.
  • the driving current depicted by the lower trace 1642 appears shows a current increase in the section EF.
  • the advancing tip came into contact with the skin at point E and gradually pushed the skin while compressing it.
  • the tip speed is controlled to be constant, as may be seen by the constant slope of the upper trace 1640 over the section EF.
  • the driving current is proportional to the driving force, which is proportional to a resisting force in order to maintain the speed, and the resisting force is believed to be proportional to depth.
  • the driving force and current reach a maximum at point F, which corresponds to the deepest depression.
  • Figure 8B shows a capability of detecting contact with skin as well as optionally determining a depth of depression based on force feedback which in some embodiments relates to the driving current.
  • FIGs 8 A and 8B the inventors have tested the capability of implementation of tissue contact detection as proposed above with a linear motor controlled by PWM of driving current.
  • the upper trace 1640 of figure 8 A describes tip position as function of time in air. Section AB is an advancing section, BC is maximal advance and CD is a retraction phase.
  • the lower trace shows the driving current which is essentially constant. This indicates no mechanical impedance - no skin contact.
  • Figure 8B shows tip position (upper curve 1640) as in Figure 8 A in a case where tissue (finger skin) is located in front of the advancing tips.
  • a lower trace 1642 shows the driving current.
  • a distal end of a treatment tip may have the following shapes: conical, pyramidal, round (spherical), cylindrical flat, chisel or blade. Tips may be hollow with a metallic envelop or non hollow solid.
  • the treatment tips external surface may be biocompatible at working temperature of 300 - 850 degC during an entire procedure duration such as 10 - 30 minutes.
  • tip material should have high thermal conductivity in order to allow fast transfer of heat to vaporized crater volume and supply a latent heat of vaporization necessary to vaporize crater.
  • Tungsten which thermal conductivity is ⁇ 170 W/m sec.
  • a flat tip made of Tungsten at 400 degC is capable of vaporizing ⁇ 30- 50 micron of tissue within ⁇ 1 millisec.
  • vaporization depth triples and can reach - 150 micron. This is due to a geometric property of cones or pyramids to have a volume equal to 1/3 of the volume of a cylinder of identical height and diameters.
  • Tungsten tips of base diameter / width ⁇ 300 -1000 micron and height 1000 micron may be challenging.
  • the Tungsten tip is machined.
  • a conical or pyramidal tip is optionally hollow as presented in Figure 1A and 2A, and is optionally produced by coining or stamping techniques or sintering techniques.
  • a distal end diameter of the conical or pyramidal tip is ⁇ 100-300 micron.
  • Another highly thermally conductive tip material is copper ( ⁇ 400 W/m degC).
  • the pyramidal or conical non hollow tip may optionally be surrounded (coated) with a biocompatible material at high temperatures such as Titanium. Coating the above described tip dimensions made of copper with a titanium pyramidal envelope without significantly lowering thermal conductivity, may be done with an envelope thickness of approximately 50 - 150 micron.
  • the titanium envelope may be produced by machining or by coining or stamping techniques.
  • the copper core material of the tip may be produced by sintering techniques.
  • the tip is a titanium hollow pyramid or cone of thickness
  • tip material is copper and a biocompatible coating is gold, optionally plated onto the copper.
  • a gold layer is not homogeneous: plating thickness is close to 100 micron on distal end of the tip which is in contact with the tissue, while thickness is only ⁇ 5 micron at the tips base. A gradual change of gold plating thickness potentially ensures high stability of high temperature gold where contact with tissue is created, while material amounts and costs are potentially kept low due to a small thickness of plating close to the tip base (including a large part of tip surface area).
  • Figures 9A and 9B are cross section images depicting copper tips 1933 coated with a coating 1936 of nickel followed by gold according to another example embodiment of the invention.
  • Figure 9A depicts a copper base 1933 and copper tips coated with the nickel followed by gold coating 1936.
  • Figure 9B depicts an enlarged section of Figure 9 A, showing one tip 1933, and the nickel followed by gold coating on the tip 1936.
  • Figure 9B shows an approximately 83 micron thick coating at the tip and an approximately 34 micron thick coating on the sides of the tip.
  • Figure 9C is a graph 1940 depicting concentration of elements as a function of distance along the copper tips and the nickel followed by gold coating of the example embodiment of Figures 9A and 9B .
  • the graph 1940 has an X-axis 1942 of distance in microns, and a Y-axis 1944 showing percentage of the elements in the material at the distance measured.
  • a first line 1946 in the graph 1940 shows concentration of Gold (Au).
  • a second line 1947 in the graph 1940 shows concentration of Copper (Cu).
  • a third line 1948 in the graph 1940 shows concentration of Nickel (Ni).
  • the gold layer is 83 micron thick at the tip, and a layer of over 60 micron of pure gold is present although the tips were heated to a temperature of 520 degrees C for 50 minutes. Since in some cases a duration of a skin rejuvenation treatment may last close to 20 minutes, the inventors heated the tips for a duration longer than 20 minutes.
  • the array of tips is produced by using sintered copper tips which are electro-coated coated with a 6-20 micron nickel layer and further electro- coated by a 5-10 micron gold layer. It is noted that electroplating may produce a thicker coating at the tips, which are sharp and concentrate electric field. It is believed that electroplating the tips produces a synergy whereby the thicker plating is located where the array meets the tissue, and that the bio-compatible plating over a sintered array of tips is preferably formed by electroplating.
  • the array of tips was heated to a temperature of 520 degrees C for a duration of 50 minutes and tested with an electron microscope for gold layer stability and with X-ray spectroscopy for Cu, Ni and Au concentrations as function of depth. The result showed high gold stability even at the sharp distal end of the tips as well as no diffusion of Cu or Ni to the surface.
  • Figures 9A and 9B present the cross section of a copper tip array plated with gold (each single tip in surgical incision unit may have same properties as each tip in an array of identical tips).
  • the tip has been heated to a temperature of 500 degrees for a duration of 3 hours and tested for diffusion of nickel from nickel plating layer beneath the gold layer as well as copper ions. Diffusion didn't get close to external surface and tips were also tested for toxicity and biocompatibility. Results confirmed both stability and biocompatibility.
  • Figure 10 is a simplified illustration of treatment probe tips according to example embodiments of the invention.
  • Figure 10 presents various shapes of surgical tips 1001 1005 1010 1015 1020 1025 according to various embodiments of the invention.
  • the shapes are: a- semi hollow conical 1001; b- hollow conical 1005; c- chisel 1010 (may be sharp for incision also without heat or not sharp enough for cold incision) d- cylindrical 1015 (solid or hollow); e- spherical 1020 (potentially for use in opening ducts such as blood vessels) f- banana shape 1025 - potentially used for myringotomy.
  • the tips are metallic and opaque.
  • the tips are made from sapphire and/or diamond and/or ceramics such as ALN (Aluminum Nitride). Crater vaporization experiments with various tips materials have been performed by the inventors in order to confirm the dimensions and material selections of tips as described above. Experiments were performed on human skin.
  • Figure 11 is a photograph of a histology cross section of an in vivo human skin vaporized crater produced immediately after treatment according to an example embodiment of the invention.
  • Figure 11 presents a histology cross section 1102 of in vivo human skin vaporized crater 1104 immediately after treatment.
  • the crater 1104 depth is ⁇ 100 micron.
  • the crater 1104 diameter is ⁇ 150 micron.
  • the crater 1104 shape is conical. Collateral damage is mostly less than 80 micron except at the crater 1104 center where it is ⁇ 100 micron. There is no peripheral carbonization.
  • the crater 1104 has been obtained with a copper tip plated with gold and operated at 400 degC.
  • treatment tip can be cleaned and sterilized by heating the tip above 450 - 500 degC for a duration of 2- 5 minutes. At that temperature carbon present in organic material combust and organic material is totally ablated. Inventors have tested that sterilization technique with success.
  • Figure 12 is a simplified cross-sectional illustration of an example application of incising tissue according to an example embodiment of the invention.
  • Figure 12 presents an example of a dental application whereby tissue 122 has to be delicately incised over a titanium metallic implant 121 in order to insert an artificial tooth (following healing from first surgical implantation step).
  • a tip 60 which is optionally chisel-shaped, incises an incision 61 above the dental implant 121.
  • a pulling of tissue 122 with a forceps optionally ensures clear tissue exposure and a capability to incise the tissue 122 layer by layer. Shallow thermal damage further enables to accurately incise tissue layer after layer, each optionally of depth D, until the metallic implant 121 is revealed and exposed. There is potentially no bleeding, and healing from the incision 61 is fast due to very shallow thermal damage.
  • Monopolar devices can't be used in such cases, and sapphire tips or bipolar ESU units produce more thermal damage followed by slower healing.
  • the quantity of heat transferred to the implant 121 is small enough to avoid damage due to contacting the implant 121 surface, due to small contact duration, potentially thanks to optional mechanical impedance sensing, and to a limited volume of the treatment tip 60 which is smaller than the implant 121 volume.
  • a vaporizing element optionally includes a linear array of tips such as 2 to 10 tips.
  • the linear array potentially enhances incision speed.
  • An example of an incision of a calf liver with an array of 4 tips is described below. In the example described below the incision depth was approximately 1 mm, the incision length was 4 cm, the incision duration was 2 seconds, thermal damage was less than 100 microns, and tip temperature was 400 degrees Celsius.
  • a bottom of a hollow channel in a tooth is optionally heated. Such an embodiment is optionally used for sterilization of the bottom of the channel. Sterilization of the channel bottom with current cold devices is difficult. Using laser light emitted from a thin fiber placed near the bottom of the channel may slowly heat the bottom while creating collateral heating and damage. By introducing a coated light-guide/fiber according to an embodiment of the invention into the channel down to its bottom and activating the distal tip the channel bottom is optionally contacted for a short and measurable duration, optionally measured by resistance to tip movement, and sterilize the channel bottom at a temperature between ⁇ 300-800 degC without damaging tissue.
  • Figure 13 is a simplified cross-sectional illustration of an example application of incising tissue according to an example embodiment of the invention.
  • FIG. 13 presents an application of some embodiments of the invention, in a mode suitable for, by way of a non-limiting example, laparoscopic and endoscopic surgery.
  • a surgical unit 1301 includes a laser or electrical heater unit 130, which optionally also incorporates a master clock and a motor controller.
  • the motor may be located either in the unit 130 or closer to a distal tip 132.
  • An energy delivery fiber or cord 131 leads to a laparoscope 134.
  • the distal tip 132 is optionally heated by a train of energy pulses and optionally synchronously oscillates 133.
  • the laparoscope 134 may also include an optical viewing channel 135.
  • the laparoscope is optionally inserted into a body through a puncture in abdominal skin and sub layers 136.
  • the treated organ may be a fallopian tube 138 which is delicately incised 139.
  • additional endoscopic applications include an incision of gallbladder, incision of adhesions, incision of polyps in intestines, incision or vaporization of tumors in a trachea, among many others.
  • an array of tips is used for introduction of drugs through tissue, in some embodiments even with deep crater vaporization.
  • inventors have vaporized arrays of 9x9 craters through the epidermis of a male arm. The craters were measured to have open diameters of 200 to 300 microns. The craters were observed to remain open for a duration of 6 hours. The diameter of each crater was measured as function of depth in the skin with a confocal microscope (mavrick). After 6 hours a drug, in this case liquid yellow florescene -Floreszein SE Thilo Germany- was applied to the skin. The drug was fully absorbed within 2 minutes.
  • a duration during which craters remain open is of significance in drug delivery.
  • the duration potentially depends on opening a crater without incurring deep collateral damage, which might serve as a barrier to drug transfer, and on the crater diameter.
  • deep collateral damage which might serve as a barrier to drug transfer
  • craters diameter By way of a non-limiting example, shallow craters, craters in the stratum cornea only, with too small a diameter may close within a too short duration, such as 30 minutes, before drug is applied.
  • Figure 14 is a simplified illustration of an array of tips 1402, a hand-held device 1404, and a list of features 1406 of the hand-held device 1404, according to an example embodiment of the invention.
  • the list of features includes:
  • the same unit may optionally be used in different applications, for example in different surgical applications, by changing a length and/or a shape of a metallic sheath and/or selection of a heated tip type and/or on operating parameters.
  • the same platform may optionally be used in aesthetics as well as in drug delivery.
  • a metallic thermal tip in some embodiments the treatment tips are reusable.
  • the treatment tips may optionally be sterilized between uses.
  • the treatment tips are optionally sterilized and/or cleaned of any residue by heating to high temperatures which evaporate residue and sterilize the tips, optionally using the device 1404 itself;
  • depth of penetration of the treatment tips may optionally be precisely controlled
  • FIGS 15 A, 15B and 15C are simplified illustrations of a process of thermo-mechanical ablation (TMA) according to an example embodiment of the invention.
  • Figure 15 A depicts a simplified illustration of a tip array 1502 before contact with tissue 1504.
  • Figure 15B depicts a simplified illustration of the tip array 1502 of Figure 15A during a brief contact with the tissue 1504. During at least some of the duration of the contact the tip array is optionally heated, thereby heating the tissue 1504 and producing craters 1506 in the tissue 1504.
  • Figure 15C depicts a simplified illustration of the tissue 1504 with craters 1506 which were formed by the tip array 1502 while the tip array 1502 was heated and in contact with the tissue 1504.
  • FIG. 16 is a simplified illustration of a list 1602 of various effects produced by applying heated tips according to an example embodiment of the invention.
  • the list 1602 enumerates three effects, or treatment modes, including:
  • a vaporization depth may vary, by way of a non-limiting example, from 20 microns to 500 microns, potentially depending on operating parameters and/or on a number of treatment pulses at the same spot;
  • a non-ablative effect 1606 on tissue whereby the tissue's outer layer is not vaporized while underlying holes may optionally be produced.
  • Such an effect may happen for example while treating skin, where the stratum cornea, which is more difficult to vaporize, is not vaporized, while the epidermis, which has a higher water content, does vaporize.
  • the above-described effect produces skin treatment and self-bandage, that is, the stratum corneum acts as a cover to the treated epidermis.
  • the above-described effect is optionally achieved during a shorter duration than with the ablative effect; and
  • permeable channels 1608 production of permeable channels 1608 in tissue, which permeable channels may serve to introduce drugs into the tissue.
  • a benefit 1610 of the treatment modes is also listed, namely that the treatment modes produce little or no pain, and therefore potentially do not require use of an analgesic.
  • permeable skin or tissue is produced by vaporization of the stratum corneum and optionally some epidermis without coagulation and without producing damage below the epidermis.
  • the above is optionally achieved by a short duration of contact between the tissue heating element and the tissue, such as, by way of a non- limiting example, below 10 milliseconds, or below a range of 1-200 milliseconds.
  • a sharp distal end of a tip of the tissue heating element such, by way of a non-limiting example, a width of a distal end of a tip of the tissue heating element is less than 150 microns, or less than 100 microns, or less than 50 or 20 microns.
  • the above is optionally achieved by using a tip with relatively low heat conduction, at least as compared to copper.
  • the tip may be composed of stainless steel and/or titanium.
  • Figure 17 which includes nine cross section images depicting tissue treated in various treatment modes using various treatment tips according to various example embodiments of the invention.
  • a second cross-sectional image of tissue 1704 which has been treated with an ablative D-type tip with two heating pulses of 9 milliseconds each and a crater formed in the tissue 1704;
  • a third cross-sectional image of tissue 1706 which has been treated with an ablative D-type tip with a single heating pulse of 9 milliseconds and a crater formed in the tissue 1706;
  • a fifth cross-sectional image of tissue 1710 which has been treated with an S- type tip with two heating pulses of 9 milliseconds each and a crater formed in the tissue 1710;
  • a sixth cross-sectional image of tissue 1714 which has been treated with an S- type tip for producing permeable channels with a single heating pulse of 9 milliseconds and a crater formed in the tissue 1714;
  • a seventh cross-sectional image of tissue 1716 which has been treated with an S- type tip for producing permeable channels with a single heating pulse of 9 milliseconds and a crater formed in the tissue 1716;
  • probe tips are also referred to using the following terms: a D-type tip having relatively high thermal conductivity, above - 150 W/degC m;
  • an S-type tip having relatively lower thermal conductivity such as ⁇ 20-150 W/mDegC
  • T-type tip made of Titanium, and generally similar to an S-type tip, having relatively lower thermal conductivity such as ⁇ 20-150 W/mDegC.
  • the D-type tip is potentially more suitable for an ablative, vaporizing, treatment mode.
  • the S-type tip is potentially more suitable for a non-ablative treatment mode.
  • the stratum cornea is potentially wholly or partially removed, potentially resulting in an ablative effect without the stratum corneum remaining as a potential bandage for a produced crater;
  • drug permeation is thought to be potentially enabled by reorganization of the cells in both the stratum corneum and the epidermis, potentially without coagulation which might serves as a barrier to drugs,.
  • the reorganization potentially allows drug permeation through the treated skin.
  • the sharp tips may ablate the stratum corneum when 9 millisecond pulse duration is used.
  • a produced crater appears to lack coagulative collateral damage boundaries.
  • the produced crater is potentially permeable for a relatively long duration, up to 3, or 6, or 12 hours.
  • Figure 18 is a simplified illustration of an array of tips 1802 and a description 1804 of the array of tips 1802 according to an example embodiment of the invention.
  • the description 1804 of the array of tips 1802 includes:
  • the array of tips 1802 is an array of metal tips
  • the array of tips 1802 is an array of tiny sharp pyramidal tips having a width of approximately 100 micron, and a radius of curvature of approximately 50 microns.
  • tip width can range between -100 and 1000 microns
  • tip radius of curvature can range between ⁇ 50 microns and flat surface (corresponding to an infinite radius of curvature).
  • a treated area produced by the array of tips 1802 which includes 9x9 tips as described above is approximately 1 square centimeter;
  • the array of tips 1802 may be heated to a temperature of 400 degrees Celsius, which is similar to a temperature reached when treating tissue with a C0 2 laser.
  • Figure 19 is a simplified illustration of a barcode 1902 optionally used with an array of tips and a description 1904 of further optional features associated with the array of tips according to an example embodiment of the invention.
  • the description 1904 includes optional features associated with the array of tips according to an example embodiment of the invention:
  • the array of tips may optionally include a barcode for optionally describing dimensions, tip shape, individual tip identification number, and so on;
  • the array of tips and/or the barcode may be monitored by a built-in camera in a thermal surgical vaporization and incision of tissue system according to an example embodiment of the invention.
  • the monitoring may be used to read the barcode and enter parameters into the system and/or to display the array of tips as it nears and contacts tissue;
  • the bar code is used for identification of a tip, which optionally serves to count a number of uses of the tip, and optionally used for limiting the number of uses of the tip to be less than a specified number of times.
  • a limitation on the number of uses of a tip can potentially serve for preventing a potential long term damage to a coating of the tip after a specific number of uses at high temperature, such as at 400 degC.
  • a limitation on the number of uses of a tip may be, by way of a non- limiting example, 15 uses, or a range of 3-50 uses;
  • the bar code is used for recording which tip is used for which subject or patient.
  • a tip may be used for several treatments with the same patient, but may in some cases not be used with other patients;
  • the above-mentioned camera may perform an automatic quality check of the array of tips, such as, by way of some non-limiting examples, cleanliness of tips following a use, check if tip sharpness is preserved; if there is carbonization on the tip; if some tips within the array are possibly bent;
  • the array of tips may optionally be automatically cleaned by heating the array of tips to a temperature high enough to vaporize residue which may be left on the array of tips, and also sterilize the array of tips;
  • the array of tips is optionally re-usable
  • the array of tips is good for at least 3,000 heat pulse and/or 15 facial treatment sessions.
  • Figure 20 is a simplified illustration of a handpiece 2002 a description 2004 of optional features associated with the hand-piece 2002 according to an example embodiment of the invention.
  • the description 2004 includes optional features associated with the hand-piece
  • the hand-piece 2002 is small and light (for example 250g) relative to current instruments for thermal surgical vaporization and incision of tissue;
  • use of the hand-piece 2002 requires no optics
  • use of the hand-piece 2002 requires no liquids
  • use of the hand-piece 2002 requires no fan
  • the hand-piece 2002 shape, size, weight provides easy access to many surgical locations
  • the hand-piece 2002 shape, size, weight provides good visibility of a treatment location; and the hand-piece 2002 enables fast treatment.
  • a surgical incision of approximately 1 cm length may be performed in approximately 2 seconds, with a 100 micron depth.
  • the repetition rate of the vaporization tip is 1 Hz, similar to a case of surface ablation in skin fractional vaporization.
  • Small lesions of few mm size, such as, by way of a non-limiting example, 0.5 - 5 mm, height are optionally vaporized within less than a minute.
  • Figure 21 is a simplified illustration of a system 2102 for thermal surgical vaporization and incision of tissue and a description 2104 of optional features associated with the system 2102 according to an example embodiment of the invention.
  • the description 2104 includes optional features associated with the system
  • the system 2102 may be compact enough to be deployed as a desktop system; in some embodiments the system weight may be approximately l-7kg;
  • system 2102 may optionally fold to a portable case for portability
  • the system 2102 optionally provides capability for automatic tip exchange.
  • Figures 22A and 22B include cross section images 2202 2204 depicting tissue treated in an experiment and a description 2206 of findings associated with the experiment according to an example embodiment of the invention.
  • Figure 22A depicts the image 2202 of a crater 2203 as produced on "Day 0", the same day of treatment, caused by evaporation of the stratum corneum and the epidermis of skin tissue and a coagulation portion 2205 in the tissue.
  • the description 2206 of the findings also reports that no edema and no hemorrhage were detected on Day 0.
  • the treatment was a single 14 millisecond pulse of heat.
  • Figure 22B depicts the image 2204 of the tissue depicted in Figure 22A, on "Day 7", seven days after treatment.
  • the image 2204 shows a crust 2207 has developed, shows epidermal regeneration 2209, and shows a cleft 2211 having dimensions of 150 microns x 50 microns with new fibroblast and macrophage cells.
  • Figure 23 is a table 2302 comparing treatment according to an example embodiment of the invention, named Tixel, to treatment with a Fractional C0 2 laser.
  • the table 2302 compares treatments, skin cratering or vaporizing craters in skin, in the above-mentioned modes for delivering a same amount of energy per tissue crater produced:
  • pulse duration in an example Tixel treatment is 10 milliseconds, compared to
  • Fractional C0 2 laser pulse duration of 0.1 milliseconds, for a ratio of 100: 1;
  • a ratio of a number of pain sensations triggered in a Tixel treatment compared to a Fractional C0 2 laser treatment is, by way of a non-limiting example, 1:81, since the Tixel treatment can optionally produce an array of, for example, 81 craters within one potential pain event lasting a few milliseconds, while a C0 2 laser produces the craters sequentially, causing 81 potential pain triggers each lasting a few milliseconds;
  • a size ratio of systems for providing the above treatments in a Tixel treatment system compared to a commercial Fractional C0 2 laser treatment is 1:4;
  • a cost ratio of systems for providing the above treatments in a Tixel treatment system compared to a commercial Fractional C0 2 laser treatment is 1:4;
  • a system weight ratio of systems for providing the above treatments in a Tixel treatment system compared to a commercial Fractional C0 2 laser treatment is 1:4;
  • an expected downtime, typically patient stay-at-home time, ratio of systems for providing the above treatments in a Tixel treatment system compared to a commercial Fractional C0 2 laser treatment is 1:4;
  • Fractional C0 2 laser treatment is about threefold, based on smaller size and weight, lending itself to more uses and easier use.
  • Figure 24 is a simplified illustration of an array of tips 2402 and a treatment system 2404 according to an example embodiment of the invention.
  • Figure 24 also includes text listing three non-limiting examples of three types of tips which may be sued in conjunction with the treatment system 2404, being an S-type tip (not shown); a D-type tip (not shown); and a T-type tip (not shown).
  • Figure 25 is a simplified illustration of a hand- piece 2502 according to an example embodiment of the invention.
  • the hand-piece 2502 is a example "pen-shaped", or elongated shape hand-piece, which is potentially suitable for working in some tighter, more constrained spaces, such as for production of craters on gums in a mouth, for example for application of a drug through the craters produced, or for producing an incision in gums.
  • FIGS. 26A-26D are simplified illustrations of a hand-piece 2602 according to another example embodiment of the invention.
  • the hand-piece 2602 includes an elongated thin and narrow extension, hereby termed sheath 2604, with a treatment tip 2606 at a distal end of the sheath 2604.
  • Figures 26A and 26B show a semi-frontal view and a side view of the hand-piece 2602.
  • Figure 26C shows a side view of a cross section of the hand-piece 2602, including an electronic controller 2608, a mechanical oscillator 2610 or vibration driver 2610, and a laser delivery fiber 2612.
  • Figure 26D shows a semi-frontal view of the cross section of the hand-piece 2602 which was shown in Figure 26C.
  • Figure 27 is a simplified illustration of a semi- frontal view of a cross section of a hand-piece 2702 according to an example embodiment of the invention.
  • the hand-piece 2702 includes a replaceable elongated thin and narrow extension, hereby termed sheath 2704, and various additional extensions 2706 with different shaped tips 2708.
  • Figure 28 is a simplified illustration of a handpiece 2802 according to yet another example embodiment of the invention.
  • the hand-piece 2802 is optionally shaped for self administering skin cratering, potentially for home use.
  • the hand-piece 2802 is shaped and configured with an array of tips for cratering skin, potentially for treating skin to improve drug passing through cratered skin.
  • Figure 29 is a simplified illustration of a tip 2902 and a tip base 2910 and a description 2904 of the tip 2902 according to an example embodiment of the invention.
  • the tip 2902 may be described by dimensions of a radius of curvature 2906 of the tip and by a length 2908 of the tip.
  • the tip 2902 is a portion of the apparatus which is heated and attains high temperatures.
  • the tip 2902 is optionally hollow.
  • the tip base 2910 is optionally hollow. The tip base 2910 serves to attach the tip 2902 to a sheath (not shown).
  • the description 2904 of the tip 2902 includes a description of an example embodiment which assumes a radius of curvature of the tip of 0.3 millimeter.
  • the tip may not have a shape which is defined by a radius of curvature, and a measure of, by way of a non-limiting example, 0.3 millimeters describes a width or a half- width of the tip.
  • the tip 2902 is also described as having a length of 1 millimeter, and a laser source is also described as having 10 Watts intensity. Using different materials for the tip 2902 results in different times for heating the tip 2902 up to 500 degrees Celsius and cooling the tip 2902 back down to -42 degrees Celsius, or approximately body temperature.
  • heating time is optionally approximately 30-100 milliseconds, potentially inversely dependant on thickness of conical envelope, and cooling time is approximately 20 milliseconds.
  • heating time is approximately 3-15 milliseconds
  • cooling time is approximately 3 milliseconds.
  • Figure 30 is a simplified illustration of a tip 3002 and two tables 3004 3006 according to an example embodiment of the invention.
  • the first table 3004 describes units used in describing an example embodiment of a treatment tip and also laser power and a target temperature to which the treatment tip is raised by heating.
  • the second table 3006 includes units and values describing tips of three different materials, Titanium, Tungsten and Copper.
  • the values in table 3006 include:
  • a thermal response time of a treatment tip to being heated by a laser depends on a type of metal used.
  • a thermal response, or relaxation, time is shorter than for a low thermal diffusivity material.
  • Thermal diffusivity depends on mass density, heat capacity and thermal conduction of the metals, as shown in the second table 3006. Tip dimensions, as seen in the first table 3004, potentially affect both vaporization depth and duration.
  • Figure 31 is an image of an array of tips 3102 according to an example embodiment of the invention.
  • the array of tips 3102 includes some pyramidal tips 3104 and some truncated pyramidal tips 3106.
  • the truncated tips enables application of the sharp tips to be used in surgical incision without contact between other tips and the tissue.
  • the example embodiment depicted in Figure 31 depicts four sequential sharp tips, however, in some embodiments more or less than four sharp tips, for example in a range of 1-100 sharp tips, and the sharp tips may or may not be sequential.
  • Figure 32A is an image 3202 of a hand-piece
  • Figure 32A depicts using the hand-piece 3204 for incising into the calf's liver 3206 using heat, that is, by heating tip(s) in touch with the calf's liver.
  • a linear tip array (not visible in Figure 32B because of a direction from which the image 3202 was photographed) was held at an approximately constant temperature of 400 deg Celsius and vibrated at a frequency of optionally 13 Hz. The incision formed is difficult to see, and is marked by an ellipse 3208.
  • Figure 32B is an image 3212 of the hand-piece 3204 of Figure 32A applied to calf's liver 3216 according to an example embodiment of the invention.
  • the array of tips is cold, or at room temperature. It is noted that no incision has been made to the calf's liver 3216 by the hand-piece 3204, and that appearance of the calf's liver 3216 is not intended to depict any incision. It is noted that in the example embodiment of Figure 32B the array of tips does not produce an incision when not heated.
  • Figure 32C is an image of calf's liver incised with a heated linear tip array according to an example embodiment of the invention.
  • calf liver tissue was pulled aside by a forceps (not shown), in order to avoid contact of the calf liver tissue with an upper portion of the incising tips.
  • Figure 32C demonstrates incision quality of an oscillating tip array.
  • the image 3232 depicts an ellipse 3240 surrounding an incision 3238, and demonstrates a lack of bleeding, with a small coagulation depth and lack of carbonization.
  • the incision 3238 is visible seen as a vertical incision 3238 in a center of the image 3232.
  • the incision shows no carbonization and there is a very thin ( ⁇ 50 microns) white coagulation line 3239 on margins of the incision 3238.
  • Figure 32D is an image 3242 of an array of tips 3244 of Figure 32A applied to calf's liver 3246 according to an example embodiment of the invention.
  • Figure 33 is a simplified illustration of a tip 3302; a tip holder 3304 and a table 3306 according to an example embodiment of the invention.
  • the tip holder 3304 is attached to the tip 3302.
  • the table 3306 describes calculation made with relation to heating the tip 3302.
  • a cone-shaped tip 3302 made of Tungsten having a radius of 0.3 millimeters and a tip length of 1 millimeter; a tip holder 3304 or sheath having an inner radius of 4 millimeters, and outer radius of 6 millimeters and a length of 5 centimeters; applying 1000 pulses of heat of 0.21 Joules per pulse, with perfect thermal coupling between the tip 3302 and the holder 3304 and no additional thermal losses to air or water, a temperature rise of the holder will be approximately 9.5 degrees Celsius.
  • the sheath or holder such as the holder/sheath 3304 depicted in Figure 33, is optionally chilled actively with air flow or with a water flow.
  • the sheath or holder such as the holder/sheath 3304 depicted in Figure 33, is not actively chilled.
  • Embodiments which do not use active chilling are suitable when a surgical case lasts just a few minutes, for example between 1-5 minutes, where the holder may be only slightly heated. Such cases are potentially common, since most surgical incisions using an embodiment of the invention are relatively rapid.
  • Figure 34 is a simplified illustration of a tip 3402; a tip holder 3404 and a table 3406 according to an example embodiment of the invention.
  • the tip holder 3404 is attached to the tip 3402.
  • the table 3406 describes calculation made with relation to heating the tip 3402.
  • the table describes the following:
  • Figure 35 is a simplified flow chart illustration of a method for incising tissue according to an example embodiment of the invention.
  • the method illustrated in Figure 35 includes:
  • Figure 36 is a simplified flow chart illustration of a method for introduction of material through a tissue by vaporizing a crater in the tissue according to an example embodiment of the invention.
  • the method illustrated in Figure 36 includes:
  • a device for thermal incision of tissue for (3602) automatically advancing a tissue heating element toward tissue (3604);
  • compositions, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.
  • a compound or “at least one compound” may include a plurality of compounds, including mixtures thereof.
  • range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible sub ranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed sub ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

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Abstract

L'invention a trait à un dispositif d'incision thermique de tissus comprenant un élément de chauffe de tissus, un mécanisme oscillant qui fait avancer l'élément de chauffe vers les tissus et éloigne ledit élément des tissus, un détecteur qui détecte le moment où l'élément de chauffe entre en contact avec les tissus, et un régulateur de chaleur qui régule la chauffe de l'élément de chauffe, le régulateur de chauffe de l'élément de chauffe de tissus régulant la chauffe de l'élément de chauffe de tissus d'après la détection du moment où l'élément de chauffe entre en contact avec des tissus. L'invention concerne également un appareil et des procédés s'y rapportant.
EP15781156.3A 2014-09-15 2015-09-10 Procédés et dispositifs pour la vaporisation et l'incision de tissus par chirurgie thermique Withdrawn EP3193758A1 (fr)

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Application Number Priority Date Filing Date Title
US201462050244P 2014-09-15 2014-09-15
PCT/IL2014/051103 WO2015092791A2 (fr) 2013-12-18 2014-12-16 Dispositifs et méthodes de vaporisation tissulaire
US201562103746P 2015-01-15 2015-01-15
PCT/IL2015/050925 WO2016042547A1 (fr) 2014-09-15 2015-09-10 Procédés et dispositifs pour la vaporisation et l'incision de tissus par chirurgie thermique

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JP (1) JP2017536142A (fr)
KR (1) KR20170058972A (fr)
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PL2459092T3 (pl) 2009-07-27 2020-05-18 Novoxel Ltd. Urządzenie do waporyzacji tkanek
JP2017503564A (ja) 2013-12-18 2017-02-02 ノヴォクセル リミテッド 組織気化装置および方法
CN111616796B (zh) 2014-09-15 2024-04-16 诺服塞尔有限公司 用于热组织汽化和压缩的方法和装置
CN107412957B (zh) * 2017-07-12 2019-09-10 华东师范大学 一种基于光热纳米材料的光热治疗探头
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WO2016042547A1 (fr) 2016-03-24
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IL251151A0 (en) 2017-04-30
KR20170058972A (ko) 2017-05-29

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