WO2003103522A1 - Methodes et dispositifs d'electrolyse electrochirurgicale - Google Patents

Methodes et dispositifs d'electrolyse electrochirurgicale Download PDF

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Publication number
WO2003103522A1
WO2003103522A1 PCT/US2003/018575 US0318575W WO03103522A1 WO 2003103522 A1 WO2003103522 A1 WO 2003103522A1 US 0318575 W US0318575 W US 0318575W WO 03103522 A1 WO03103522 A1 WO 03103522A1
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Prior art keywords
electrolysis
active electrode
sleeve
probe
distal end
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PCT/US2003/018575
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English (en)
Inventor
Wayne K. Ii Auge
Roy E. Morgan
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Map Technologies Llc
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Application filed by Map Technologies Llc filed Critical Map Technologies Llc
Priority to AU2003243534A priority Critical patent/AU2003243534A1/en
Publication of WO2003103522A1 publication Critical patent/WO2003103522A1/fr
Priority to US11/010,174 priority patent/US7819861B2/en
Priority to US11/061,397 priority patent/US7445619B2/en
Priority to US12/239,320 priority patent/US7713269B2/en
Priority to US12/778,036 priority patent/US20110034914A1/en
Priority to US13/736,016 priority patent/US20130123779A1/en

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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
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • 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
    • A61B2018/00565—Bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1472—Probes or electrodes therefor for use with liquid electrolyte, e.g. virtual electrodes

Definitions

  • the present invention relates to methods and devices for electrosurgical electrolysis, including devices that operate in an electrolyzable medium, including an aqueous electrolyzable medium, by means of electrolysis and optionally by means of oxy-hydrogen combustion, together with electrolyzable media for use in treatment and therapeutic methods of electrolysis to effect advantageous tissue changes.
  • Description of Related Art Note that the following discussion refers to a number of publications by author(s) and year of publication, and that due to recent publication dates certain publications are not to be considered as prior art vis-a-vis the present invention. Discussion of such publications herein is given for more complete background and is not to be construed as an admission that such publications are prior art for patentability determination purposes.
  • Electrosurgical methods and devices are used in many medical treatment settings. However, the use of electrosurgical methods and devices designed to specifically induce antimicrobial activity and healing responses during surgical procedures, and particularly to induce antimicrobial activity and healing responses by means only of electrolysis, has not been previously disclosed.
  • the invention provides a device for localized electrolysis for use in treatment or therapy of a patient, and more particularly electrolysis of electrolytes, which electrolytes do not include tissues of the patient.
  • the invention thus includes a device with a variable volume, designed such that at least a portion of the interior includes electrodes for electrolysis, and further designed such that at least one side of the interior is in fluidic contact with the area of the patient to be treated.
  • the device can further include at least one fluidic passage for entry of fluids into the volume to serve as electrolytes.
  • Such fluids can further include therapeutic agents.
  • the invention further includes a device with at least one electrode included within a perforated housing, such that the electrode can be held in proximity to but not touching the tissue to be treated, thereby limiting electrolysis of the tissue to be treated.
  • Such device can further include at least one fluidic passage for entry of fluids into the perforated housing to serve as electrolytes.
  • Such fluids can further include therapeutic agents.
  • the invention provides methods for treatment or modification of tissues by means of locally induced electrolysis, which electrolysis does not include electrolysis of the tissues to be treated.
  • the invention thus includes use of interfacing media or other materials that are applied to the tissues before, after or concurrently with the application of electromagnetic energy to induce electrolysis.
  • the benefits of the electrolysis so produced can include local, in situ production of electrolyzed strong acid water for use as an anti-microbial agent, localized therapeutic heating of a site of trauma or tissue injury, oxygenation of tissues and, through use of any of a variety of agents concurrently administered, enhancement of host healing responses.
  • the invention further includes novel electrolysis interfacing media, including further including non-electrolyzable materials, which non-electrolyzable materials provide a matrix or structure, and optionally further provide therapeutic benefits.
  • a primary object of the present invention is to provide devices and methods relating to electrosurgical electrolysis (sometimes called electrolytic electrosurgery herein).
  • Another object is to provide variable chamber devices for electrosurgical electrolysis. Another object is to devices, including an active electrode and a return electrode, for use in electrosurgical electrolysis. Another object is to provide a cavity or chamber wherein the active electrode of an electrosurgical electrolysis probe is disposed.
  • Another object is to provide variable volume cavities or chambers on probes, preferably wherein the active electrode is disposed, for use in electrosurgical electrolysis.
  • Yet another object of the invention is to provide a variety of electrolytic media for use in electrosurgical electrolysis.
  • Yet another object of the invention is to provide a variety of electrolytic media, including one or more substrates, for use in electrosurgical electrolysis.
  • FIG. 1 A is the stoichiometric chemical equation for chemical reactions related to the invention and known to govern the electrosurgical process;
  • FIG. 1 B is the equation and a view of the acid-base "throttle" effect
  • FIG. 1 C is the equation and a view of the generalized form of the electrolysis and oxy-hydro combustion reaction process
  • FIG. 1 D is the equation and a view of the generalized form of the electrolysis and oxy-hydro combustion reaction process showing the effect of varying molar coefficients;
  • FIG. 2 A is a view of a non-contact electrosurgical probe apparatus of the invention with a retractable transparent elastomeric trumpet electrosurgical chamber
  • FIG. 2 B is a view of the transparent elastomeric trumpet electrosurgical chamber of FIG. 2 A in the fully extended condition with the active and return electrode traces visible;
  • FIG. 3 is a view of a non-contact electrosurgical electrolysis probe apparatus of the invention with a different electrosurgical chamber configuration
  • FIG. 4 is a view of the application of an electrosurgical electrolysis interfacing material of the invention to a wound site;
  • FIG. 5 A is a view of a direct current photo-voltaic wound treatment system of the invention.
  • FIG. 5 B is a view of a direct current photo-voltaic wound treatment system of the invention interacting with an electrosurgical electrolysis interfacing material
  • FIG. 6 is a view of a bone welding system utilizing an electrosurgical electrolysis interfacing material of the invention and an electrosurgical electrolysis probe apparatus;
  • FIG. 7 is a view of an electrosurgical electrolysis scaffold configuration of the invention which provides an alternative configuration of an electrosurgical chamber as depicted in FIG.2 A, FIG 2 B, and FIG. 3;
  • FIG. 8 is a view of an electrosurgical electrolysis trumpet chamber of the invention providing means to perform interfacing material electrolysis for the modification and treatment of cartilage;
  • FIG. 9 is a view of non-contact electrosurgical electrolysis tissue modification wherein cellular permeability changes are induced that allow for the subsequent pressure induced uptake of therapeutic agents;
  • FIG. 10 is a view of an application of the electrosurgical electrolysis interfacing material of the invention upon a wound;
  • FIG. 11 is a view of a multi-modal electrode electrosurgical electrolysis dispensing probe apparatus of the invention.
  • FIG. 12 is a view of a multi-modal electrode electrosurgical electrolysis dispensing apparatus of the invention.
  • FIG. 13 is an electrosurgical electrolysis probe of the invention with an active electrode and a return electrode disposed within a variable volume and flexible cavity;
  • FIG. 14 A is a front, head on view of an electrosurgical electrolysis probe of the invention further including a DC driven igniter or glow plug for ignition of oxy-hydrogen combustion;
  • FIG. 14 B is a transverse view of a probe of the invention with a flexible return electrode
  • FIG. 15 is a view of a probe of the invention with an adjustable insulating cylindrical sleeve and at least one detector.
  • the equations of FIG. 1 A illustrate the chemical equations that describe the overall electrolysis and oxy-hydro reaction, with associated acid-base shifts, resulting from electrolysis of water and subsequent ignition of the resulting oxygen and hydrogen.
  • the physiochemistry of the electrosurgical process consists of an acid-base shift that governs the relative availability of the amount of water that can be consumed as part of an electrolysis chemical reaction.
  • the electrolysis reaction is driven by the high frequency current flowing between active and return electrodes in both the bi-polar and mono-polar modes of operation of electrosurgical probes.
  • This electrolysis and oxy- hydro combustion theory accounts for all necessary chemical and energy constituents that are present as well as the physical observations of light emission and heat generation during the use of such devices.
  • FIG. 1 B illustrate the effect of the acid-base throttling reaction.
  • the oxy- hydro combustion process depicted is dynamic and occurs in a fixed fluid reservoir, which necessarily results in dynamically changing concentrations of salt ions as a function of electrolytic conversion of water to elemental gas.
  • This equation necessarily suggests that as the acid-base shift occurs in the reservoir, less and less water is available for electrolysis.
  • FIG. 1 B where acid-base pair 15 and 20 is shown in increased molar proportion to the normal stoichiometric quantity of base reactions 10.
  • the reduction of available water for electrolysis is evident in the relationship 50 of oxygen and hydrogen gas to the acid-base pair.
  • FIG. 1 C demonstrate a more general case of the electrolysis and oxy- hydro combustion reaction process in which the ionic salt is represented by variable 60, where X is any appropriate group I, period 1-7 element of the periodic table.
  • This generalized reaction illustrates how hydronium and hydroxide ions can contribute to the same overall chemical reaction known as electrolysis and oxy-hydro combustion.
  • the equations of FIG. 1 D demonstrate the more general case of the electrolysis and oxy- hydro combustion reaction process in which the ionic salt is represented by variables 61, consisting of ⁇ , ⁇ , ⁇ , and ⁇ ; wherein, the molar quantities required for stoichiometric combustion are any value that appropriately satisfies the oxidation reduction valence requirements for the overall reaction.
  • This generalized reaction case shows how oxygen and hydrogen requirements can vary and still result in the same overall chemical reaction known as electrolysis and oxy-hydro combustion.
  • FIG. 1 A, FIG. 1 B and FIG. 1 C depict theoretical stoichiometric reaction processes induced by application of high frequency electromagnetic energy to a salt ion solution, including salt ion solutions typically found within biologic tissues themselves.
  • the fundamental process is governed by the rate of electrolysis in the initial dissociation of water into oxygen and hydrogen gas, as shown in equations 10.
  • oxy-hydro combustion can be utilized for therapeutic procedures like cutting, ablation, coagulation, vaporization, and other related procedures that are similar to those previously disclosed in the prior art.
  • the oxy-hydro combustion reaction delivers the energy configuration necessary to cause these tissue effects and the host responses thereof as desired and described in those procedures. Electrosurgical methods and devices used for these types of procedures (see U.S. Patent Nos.
  • tissue necrosis occurs to some degree in all methods in the prior art due to their desired goals of tissue cutting, ablation, coagulation, vaporization, and the like.
  • necrosis is typified histologically by karyorrhexis or nuclear picnosis at one end of the spectrum and frank necrosis or vaporization at the other end, followed by host responses directed to the specific level of necrosis induced by the manner of tissue treatment.
  • Electrolysis as the initial functional reaction of electrosurgery has not been explicitly recognized or exploited in the prior art for therapeutic procedures.
  • the methods and devices developed in the prior art to achieve the treatment goals of cutting, ablation, coagulation, vaporization, and the like have been generated without the knowledge of electrolysis as a relevant constituent part of the electrosurgical physiochemical process. This circumstance further clarifies the motivation of prior art to limit methods and devices to cutting, ablation, coagulation, vaporization, and the like that require the higher energy configurations that induce oxy-hydro combustion.
  • methods and devices designed to provide or augment the supply of the constituents of the oxy-hydro combustion reaction have been developed and disclosed in U.S. Patent Application No.
  • 10/119,671 that can bypass the relative need of electrolysis for therapeutic procedures designed to accomplish such related treatment goals as cutting, ablation, coagulation, and vaporization yet in a more expedient and efficient manner.
  • One of the major motivations for these methods and devices, as disclosed in U.S. Patent Application No. 10/119,671 is to decrease tissue electrolysis for these types of treatment procedures since electrolysis induced in tissue itself is very detrimental to tissue cellular structures. It induces not only tissue necrosis quite dramatically but also transfers other significant collateral physiochemical effects that are not necessary and are additionally problematic for the treatment goals of cutting, ablation, coagulation, vaporization, and the like, as will be discussed below.
  • U.S. Patent Application No. 10/119,671 discloses further means to limit these electrolysis related detrimental tissue effects witnessed during the electrosurgical procedures of cutting, ablation, coagulation, vaporization, and the like that are realized through the understanding of the physiochemical occurrences of electrosurgery. Tissue changes and responses thereof are more fully recognized and characterized allowing additional novel uses for the oxy-hydro combustion phenomenon.
  • tissue contact with the working electrode(s) of the instrument probe can be eliminated via the use of a translating sheath that can contain the constituents of the relevant electrosurgical reactions and place the active electrode(s) away from the tissue surface.
  • This procedure as disclosed in U.S. Patent Application No. 10/119,671 benefits the tissue in that the location of electrolysis and oxy-hydro combustion occurrences is shifted from that within the tissue itself (as contemplated and practiced in prior art since the probe electrodes are used to contact the tissue to exert its effects) to that within the surrounding fluid. This shift can be partial or complete based upon the desired tissue effects of electrolysis and oxy-hydro combustion at the treatment locale.
  • tissue electrolysis can be marginalized as a relevant occurrence in the cutting, ablation, coagulation, and vaporization treatment methods that utilize oxy-hydro combustion.
  • Misinterpretation of the multifaceted physiochemical occurrences of electrosurgery in the prior art has inhibited development of advancements and novel methods and devices for electrosurgical treatment beyond those that are related to cutting, ablation, coagulation, vaporization, the host responses thereof, and the like for many years.
  • Disclosed herein are methods and devices for electrosurgery which focus upon the electrolysis that occurs during electrosurgical procedures and exploits its occurrence as the principle means to develop methods and devices that have been heretofore unrecognized for electrosurgery.
  • Electrolysis is a well-described phenomenon resulting from the application of electric current to an electrolyzable solution, such as a water-based solution.
  • an electrolyzable solution such as a water-based solution.
  • at the anode acid is formed by the formation of aqueous hydronium ions and the liberation of oxygen gas
  • base is formed by the formation of hydroxide ions and the liberation of hydrogen gas.
  • electrolysis is performed in a solution of NaCl (as would be typical of tissue in vivo)
  • the anode produces characteristic elements. For example, chloride ions are oxidized to chlorine. Heat is also generated to a low degree, relative to the oxy-hydro combustion reaction, as heat is an artifact of inducing the electrolysis reaction.
  • the gases of oxygen and hydrogen formed may or may not be utilized in an oxy-hydro combustion reaction depending upon whether ignition occurs.
  • Electrolysis has been a well recognized component in many medical applications.
  • treatment induces electrolysis within the tissue itself, termed “tissue electrolysis” (this term is distinct from that disclosed herein where electrolysis is not created in the tissue itself — a process hereafter referred to as “electrosurgical electrolysis” wherein the working electrode(s) do not contact the tissue to be treated and therefore do not induce tissue electrolysis).
  • tissue electrolysis treatment electric current is applied directly to tissue via various forms of electrodes for various goals such as hair removal for hirsutism, cancer cell ablation, and cardiac foci ablation to control arrhythmia. See, for example: Fosh BG ef al. Electrolytic ablation of the rat pancreas: a feasibility trial.
  • Electrosurgery as contemplated and practiced in prior art is another manifestation of this well-described medical application of tissue electrolysis since such methods and devices operate and explicitly employ tissue contact by the working electrode(s) of the instrumentation probes to impart their treatment effects.
  • Electrosurgery, as disclosed in the prior art is designed to cut, ablate, coagulate, or vaporize tissues; and, in these instances, the relevance of electrolysis in any form is far overshadowed by the oxy-hydro combustion portions of the phenomenon.
  • the collateral effects of surrounding tissue electrolysis are problematic for the host healing responses to such treatment, expanding depth of necrosis.
  • a method that clinically is becoming more popular (i.e.
  • tissue electrolysis such as thermal ligament modification
  • the predominant effects of the treatment are those of tissue electrolysis, despite the heretofore lack of recognition as such.
  • the histological findings of tissue treated in such a manner are typical of those induced by tissue electrolysis. Tissue electrolysis effects have been well characterized for many years. Thomsen HK et al. Early epidermal changes in heat- and electrically injured pig skin. I. A light microscopy study. Forensic Sci Int 1981 17(2):133-143; Thomsen HK et al. The effects of direct current, sodium hydroxide and hydrochloric acid on pig epidermis. A light microscopic and electron microscopy study.
  • tissue effects are determined by their constituent make-up.
  • Tissue types with high cellular content demonstrate the most relative necrosis whereas those with lower relative cellular content demonstrate a lesser propensity for necrosis in its varied forms.
  • Tissue types like ligament which are relatively less cellular and composed of primarily extracellular matrix collagen in various cross-linking patterns typically demonstrate shrinkage due to the heat generated by the reactions, since tissue electrolysis most notably affects water-based structures. If too much heat or energy is imparted to a ligamentous structure, however, cutting, ablation, coagulation, or vaporization can occur.
  • Electrosurgical procedures designed to shrink collagen have been well described and utilize lower energy transfer to that tissue type so that necrosis (i.e.
  • Tissue collagen sources demonstrate various shrinkage patterns and profiles as disclosed in U.S. Patent Application No. 09/885,749.
  • the cells in such tissue are exposed to intracellular tissue electrolysis that creates necrosis; but, since collagen based tissue has a low requirement for resident cellular structures, relative to other tissue types, this electrolysis is often not clinically evident as necrosis to current levels of examination.
  • ligament "ablation" have been reported as a complication from prior art electrosurgical treatment as it is currently practiced. Sekiya JK et al.
  • tissue electrolysis induces tissue necrosis followed by a typical healing response to address tissue necrosis and cellular death.
  • Oxy-hydro combustion also induces tissue necrosis, but to a much larger degree than tissue electrolysis due to the heat production and burning/vaporization of organic material that occurs.
  • Electrosurgical procedures designed for cutting, ablation, coagulation, vaporization, and the like could utilize the tissue electrolysis reactions independently as a means to achieve such treatment goals as clearly has been the case in numerous prior art disclosures of tissue electrolysis, yet performed in endoscopic settings. In fact this realization for electrosurgery may allow a decrease in the incidence of iatrogenic damage related to unwanted tissue necrosis (depth of necrosis or collateral damage) that occurs when oxy- hydro combustion is allowed to occur during treatment.
  • Disclosed herein are methods and devices designed to utilize the electrolysis portion of the electrosurgical process in novel and heretofore unrecognized ways that do not rely upon tissue electrolysis, tissue necrosis, or oxy-hydro combustion. Therefore, the methods and devices disclosed are not intended for cutting, ablation, coagulation, vaporization, and the like. Disclosed also are means to contain the electrosurgical physiochemical occurrences to decrease detrimental effects and collateral tissue damage as seen in prior art. Disclosed is the utilization of the electrolysis portion of the electrosurgical reactions to induce antimicrobial effects and host healing responses for various treatment procedures and goals unrelated to cutting, ablation, coagulation, vaporization, and the like.
  • tissue electrolysis induces tissue changes that induce necrosis and other problematic physiochemical collateral tissue effects that would not be helpful for methods and devices designed to induce antimicrobial and host healing responses, other methods and devices are necessary to achieve these treatment goals.
  • the methods and devices disclosed herein center around utilizing interfacing media and/or materials that are applied to tissue in vivo before, after, or concurrently with the application of electromagnetic energy such as radio frequency energy to the interfacing media and/or materials to induce electrolysis within the interfacing media and/or materials, thus activating the interfacing media or material.
  • electromagnetic energy such as radio frequency energy
  • the interfacing media or material is preferably acellular to avoid sequelae of "tissue electrolysis"; and, therefore no untoward effects of electrosurgical electrolysis occur within the interfacing media or material which may be problematic for cellular viability.
  • a layered, composite, or hybrid interfacing material (the treatment composite) is one such embodiment in which the activation component consists of an acellular water-based substance that can be activated by electromagnetic energy application to induce electrolysis, which effects are then transferred to the other components which themselves may retain cellular structures required for certain treatment applications.
  • the interfacing media or material may be impregnated with such other elements that may be deemed important for the particular treatment protocol and which may be activated or delivered to the treatment site by the methods and devices disclosed herein.
  • interfacing media or material will be activated either within treatment devices themselves or within other biocompatible chambers designed for specific treatment protocols. These chambers may themselves be therapeutic and part of the treatment composite, complementing the methods and devices disclosed herein.
  • instrumentation devices are disclosed that focus upon the efficient induction of electrosurgical electrolysis relative to the specific interfacing media or materials that also do not allow either tissue electrolysis or the ignition of the products of electrolysis to oxy-hydro combustion that would not be desired in such treatment applications. It is further contemplated that such devices as disclosed herein are to be used with those methods and devices as disclosed in Patent Cooperation Treaty Application Serial
  • Plasmas do not exhibit high impedance characteristics that are common to simple gas volumes. Because they are highly ionized, there are sufficient free electrons to easily conduct current and as such do not provide significant impedance to current flow.
  • the response curve of a typical electrosurgical probe from a power versus impedance standpoint is significantly different from typical plasma behavior.
  • electrical conduction dominates the mode of transmission and impedance slowly rises with the temperature of the fluid.
  • the therm o-chemical approximations of water rather than a 0.9% NaCl aqueous solution can be utilized, again underestimating energy requirements, on the assumption that the initial state of the water starts out at approximately 25° C and must result in full film boiling, approximately 100° C, to sustain the "vapor pocket" required for a "plasma.”
  • Electrolyzed strong acid water also referred to as acidic oxidative potential water, function water, or acqua oxidation water
  • It is a strong acid formed on the anode in the electrolysis of water containing small amounts of NaCl.
  • Its properties generally include a pH between 2.3 and 2.7, an oxidative-reduction potential between 1,000 and 1 ,100 mV, dissolved chlorine between 30 and 40 ppm, and dissolved oxygen between 10 and 30 ppm. These properties exert strong antimicrobial effects.
  • the bactericidal activity of electrolyzed strong acid water containing free chlorine has been recently reviewed. Kiura H etal. Bactericidal activity of electrolyzed acid water from solution containing sodium chloride at low concentration, in comparison with that at high concentration. J Microbiol Methods May 49(3):285-293, 2002.
  • the use of such electrolyzed strong acid water has been limited to that of a disinfectant for the treatment of medical instruments as its properties are too corrosive for tissue application. Newer configurations have been developed that utilize a less strong acid component for similar applications that are less damaging to medical instruments themselves.
  • the bactericidal mechanism of action has been described as including disruption of the bacterium's outer membrane and inactivation of cytoplasmic enzymes.
  • Electrolyzed acid water has also been demonstrated to exert disinfection potential against virus such as hepatitis B and human immunodeficiency virus. Morita ef al. Disinfection potential of electrolyzed solutions containing sodium chloride at low concentrations. J Virol Methods 2000 Mar 85(1 -2):163-174. Electrolysis of 0.05% NaCl in tap water for 45 minutes at room temperature by a 3 A current generated an oxidation-reduction potential of 1053 mV, a pH of 2.34, and a free chlorine content of 4.20 ppm that was effective in modifying antigenicity and infectivity in both a time and concentration dependant manner. Electrolyzed acid water has been used as a disinfectant for other such pathogens such HCV, CMV, and fungi in a similar fashion.
  • Enhancements of host healing responses are induced by this process. Electrolyzed water accelerates the healing of full-thickness cutaneous wounds. Yahagi ef al. Effect of electrolyzed water on wound healing. Artif Organs 2000 Dec 24, 12:984-987. Such healing augmenting properties have been determined to not be due to the antimicrobial properties of the electrolyzed water, but rather to be due to induction of cell migration and proliferation, like fibroblasts, by the reactive oxygen species present in the solution. Operative sites and other wounds typically heal by a defined series of mechanisms, orchestrated by cells at a number of levels.
  • Such cells are ubiquitous in living organisms; and, such cells include types such as connective tissue stem cells, phagocytic cells (histiocytes), protein secreting cells (fibrocytes), and contractile cells (myofibroblasts). These cells are responsible for healing responses and homeostasis in all tissue types like bone, cartilage, ligament, tendon, connective tissue, and the like.
  • the stimulation or chemotaxis of cells to produce products of transcription that participate in the healing response is their predominant orchestrating.
  • Collagens i.e.
  • fibronectins glycoproteins, glycosaminoglycans, proteoglycans, collagenases, proteoglycanases, plasm inogen activators, interleukin-1 , interlukin-6, granulocyte colony-stimulating factors, granulocyte macrophage-colony stimulating factors, transforming alpha and beta growth factors, and tissue inhibitor of metalloprotinases are just some of the products that assist in the healing response orchestrated by these cells. Further, these cells can regulate immunoglobulin synthesis, B cell growth, and bone marrow release of leukocytes.
  • Stimulants to such cell function and migration to an injury or treatment site include mechanical loading like stretch and pressure and from immunologic influences such as platelet derived growth factors, lymphocyte derived chemotactic factor for fibroblasts, hydroxyproline containing peptides, tropoelastin peptides, TGF- ⁇ , and leukotriene B , acid and basic fibroblast growth factors, reactive oxygen species as induced by electrosurgical electrolysis, and the like. It is via the effects of electrolysis, namely low level oxygen free radical production, that such cellular induction occurs initiating this cascade. Further, tumor necrosis factor production and the activity of natural killer cells increase in a similar fashion. Fesenko EE ef al. Immunomodulating properties of bidistilled modified water. Biofizika 2001 Mar-Apr 46(2):353-358].
  • the induction of interfacing media or material electrolysis via the methods and devices disclosed herein allow the use of these cell stimulating properties.
  • Local non-detrimental heat production is induced by this process.
  • Aqueous media or materials when subjected to electrolysis generate a low level of heat. This heat is produced both convectively and conductively during the process with the electrosurgical methods and devices disclosed herein.
  • Normal tissue healing responses are attendant by a slight increase in local temperature. This increase of temperature mobilizes the healing response at many levels such as the host inflammatory response, changing sensitivity of local enzymatic processes, availability of elements such as zinc aiding leukocyte function, inducing increased blood flow and perfusion, and transcription induction of the heat stimulated DNA sequences.
  • the contractile nature of wound healing is related to increased heat at the healing site, aiding the non-contractile elements (as opposed to those based upon active elements like myosin or actin) such as collagen fibrils to contract or shrink.
  • Such heat also suppresses bacterial multiplication, allowing phagocytic cells greater opportunity to remove the microbes.
  • the benefits of systemic fever are mimicked locally.
  • Hyperbaric oxygen treatment is a well known method of aiding tissue healing.
  • Hyperbaric oxygen functions via the elevation of the oxygen partial pressure at a tissue site. See, for example, Senior C. Treatment of diabetic foot ulcers with hyperbaric oxygen. J Wound Care 2000 Apr 9(4):193-197.
  • One mechanism of this function is via cell stimulation. For example, fibroblasts synthesize and modify collagen as part of the wound healing cascade. For such cellular activity, high partial pressures of oxygen are required above that which is normally present in the homeostatic state (when healing responses are not required). The elevation of oxygen partial pressure around a cell induces such cellular activity.
  • Another mechanism by which increasing partial pressure of oxygen can aid tissue healing is by vasodilatation and vascular proliferation.
  • Increasing oxygen partial pressures at the healing treatment site also exerts an antimicrobial effect upon anaerobic organisms.
  • the induction of interfacing media or material electrolysis via the methods and devices disclosed herein allow the use of increased local oxygen partial pressure.
  • the devices and methods disclosed herein are designed (1) to decrease the incidence of operative site and/or wound infection by providing antimicrobial activity and/or augmenting treatment of infected operative sites when necessary, (2) to induce healing responses or therapeutic at the treatment site orchestrated by the stimulation of resident cellular function, (3) to induce healing responses or therapeutic benefits at the treatment site via local non-detrimental heat production, and/or (4) to induce healing responses or therapeutic benefits at the treatment site via oxygenation of the treated tissue and site.
  • Other beneficial effects of the electrolysis reaction will become evident to those skilled in the art when applied via the methods or devices disclosed herein.
  • the methods and devices utilize electromagnetic energy, and preferably radio frequency energy, to induce electrolysis of a water-based media or material that is applied to a treatment site either in vitro or in vivo.
  • Such methods and devices allow utilization of electrosurgical procedures that induce antimicrobial and host healing responses as well as therapeutic benefits by creation of interfacing media and materials which are activated by electromagnetic energy, and preferably radio frequency energy, inducing electrosurgical electrolysis and which thereafter translate these effects to the tissue to which they are in contact.
  • the working electrode(s) of the electrosurgical devices themselves does not directly contact the tissue to be treated, a distinction from the prior art, eliminating the induction of tissue electrolysis that causes necrosis and has been problematic for prior art electrosurgical procedures in treatments other than cutting, ablation, coagulation, vaporization, and the like.
  • the interfacing media or material becomes a treatment vehicle which is activated by the application of electromagnetic energy such as radio frequency energy.
  • the interfacing media or material can be impregnated with any other material that is deemed appropriate for the particular treatment goals that itself can be activated via electrosurgical energy transfer.
  • the treatment chamber that contains the electrosurgical electrolysis itself can be configured in such a manner to augment therapeutic protocols.
  • the interfacing media or material will be activated either within treatment devices themselves or within other biocompatible chambers designed for specific treatment protocols and that these chambers may themselves be therapeutic and part of an electrosurgical tissue treatment composite.
  • FIG. 2 A illustrates a non-tissue contacting electrode electrosurgical probe apparatus wherein the use of flexible printed electrode trumpet cup 80 on which is disposed electrode traces 200, 210, and 220 that conduct electromagnetic energy.
  • the trumpet cup is retractable via means provided in hand-piece 130 wherein is disposed movable switch 140 that is translatable in proximal and distal directions as shown by arrow 150.
  • movable switch 140 When movable switch 140 is translated, the force of motion is transmitted to actuator/lumen coupler 160 which translates forward force to shape memory extension push-wires 70. Simultaneously coupled at actuator lumen/coupler 160 is flexible injection lumen 120 which translates in tandem with flexible transparent polymer trumpet cup electrode 80.
  • Electrosurgical electrolysis and optionally oxy-hydro combustion, is initiated by activating switch 190.
  • Additional fluids of various types can be injected into the interface chamber via flexible injection tubing 180 and injection adapter 170.
  • FIG. 2 B illustrates the interior of transparent polymer trumpet cup electrode 80 wherein disposed is diverging active electrode trace pattern 220 that conducts electromagnetic energy in opposing semi-circular manner to provide total chamber electrification away from the tissue to be treated, thereby avoiding tissue electrolysis.
  • Electromagnetic energy is supplied via an electrosurgical generator and conducted to switch 190 which closes upon activation to energize active and return conductors 100 and 110.
  • the conductors in turn run the length of malleable support lumen 90 and supply traces 200 and 210 with electromagnetic energy that provides means for the opposing semi-circular electrode patterns 220 to provide trumpet space electrification.
  • the use of the electrified trumpet chamber provides a controllable means by which its content can be altered to treat tissue or to provide further means for infiltrating or bathing tissue and cells with therapeutic components via flexible injection tubing 180 adjacent to such treated tissue.
  • FIG. 3 illustrates a non-tissue contacting washing electrosurgical probe apparatus wherein disposed is a thermal gradient flow delivery system.
  • Intermediary fluid enters the probe via inlet portals 300 which can be regulated by altering the cross-sectional area available for fluid ingress via retranslating inlet portal flow regulator 310.
  • inlet portals 300 can be regulated by altering the cross-sectional area available for fluid ingress via retranslating inlet portal flow regulator 310.
  • inlet portals 300 can be regulated by altering the cross-sectional area available for fluid ingress via retranslating inlet portal flow regulator 310.
  • the entire internal volume of the probe exists in the wetted condition.
  • As electromagnetic energy is delivered to active electrode 250 ordinary propagation heating effects alter the temperature of the fluid immediately proximal to perforated active electrode shield 230. As the temperature of the active electrode 250 continues to rise with increasing energy input so does the surrounding fluid. Because the fluid external to the perforated active electrode shield 230 exists at the free stream temperature (
  • a convective thermal gradient is established.
  • the thermal gradient drives the hotter fluid inside the active electrode/perforated active electrode shield chamber through individual perforations 240, thereby accelerating and helping to laminar the flow.
  • Active electrode 250 is externally insulated by an external insulator sheath 260 which prevents the flow of current between active electrode 250 and return electrode 270 in tandem with internal insulation sheath 320 which runs the entire internal length of lumen.
  • Active electrode 250 is stabilized by active electrode vane supports 290 to prevent electrolysis convection or oxy-hydro combustion cavitation forces from bending the electrode 250 into contact with internal wall sections.
  • Fluid transport is further enhanced by accelerating venturi section 280 that induces a velocity/momentum increase to the fluid as part of the conservation of mass flow.
  • the driving force behind this is the thermal gradient created by active electrode 250 firing and flowing fluid out through perforated active electrode shield chamber 230.
  • What will become apparent to those skilled in the art is the ability to provide localized non- tissue-contacting electrosurgical washing of tissue structures without the need to couple a lumen section to a pressurized fluid feed system.
  • a directed fluid flow is created that can be imparted upon tissue structures within the human body to reap the therapeutic benefits of said flow components.
  • FIG. 2 A, FIG. 2 B, and FIG. 3 describe instrumentation embodiments that can be used with various interfacing media or materials by way of creating a chamber for the electrosurgical electrolysis process whereby the working electrode(s) does not contact the tissue to be treate.d but the interfacing media or material does.
  • various interfacing media and materials such as liquids like endoscopy or tissue irrigants or other configurations like hydrogels, waxes, biopolymers, and the like can be applied, wherein such interfacing materials are placed within the chamber or body of the devices discussed above and then deployed via the effects of the electrosurgical methods disclosed herein.
  • FIG 4, FIG 5 A, FIG 5 B, FIG. 10, and FIG. 11 illustrate methods and devices as applied to tissue wound sites.
  • the interfacing media or materials themselves do not require significant structural rigidity or mechanical strength in order to be effective for treatment goals and can be applied in a less defined or less rigid chamber setting.
  • FIG. 4 illustrates the use of a hydrogel 340 as an interfacing material within a wound site 350.
  • Hydrogel 340 is comprised of hydrophilic polymer that is water soluble in a large range of temperatures and pH. Some such polymers are derived from natural sources known in the art such as agar, gelatin, carboxymethylcellulose, hyaluronan, alginic acid, and many others.
  • the hydrogel may be activated with an electrosurgical probe configuration as disclosed herein to perform electrolysis of the hydrogel as an interfacing media or material.
  • FIG. 5 A and FIG. 5 B illustrates the use of a photo-voltaic wound treatment device 360.
  • Independent tines 370 form a part of active and return electrodes that penetrate the wound site subcutaneously and make physical contact with interfacing media or material 340, thereby inducing a current flow through the interfacing media or material and inducing electrolysis therein.
  • As the electrolysis process progresses within interfacing media or material 340 its viscosity alters both from chemical makeup alterations as well as localized heating induced by electrolysis, contributing to net interfacing media or material propagation 380 deeper into the wound site.
  • the localized electrolysis of the hydrogel as an interfacing media or material induces the benefits disclosed herein.
  • Photonic energy 405 impacts transparent protective coating 420 and traverses to photo-voltaic thin film generator 410.
  • the photonic energy thereby induces a voltage in aggregate that is conducted via active electrode wire 100 to direct current active electrodes 440 that may include a single active electrode film such as a foil or film of silver that behaves like an array of independent electrodes.
  • Current is conducted through interfacing media or material 340 to current return electrode 450 via return electrode conductor 110 to load balancing resistor 470 to close the current loop at the negative side of photovoltaic generator 410.
  • Active and return electrodes are separated by support member 430 comprised from the many varieties of insulating polymers that are biocompatible.
  • Electrode tines 370 are easily manufactured from bioabsorbable substrates coated with thin-films of gelatinized sodium chloride to provide means for a biocompatible, bioabsorbable active and return electrodes. Additionally such bioabsorbable tines can also be manufactured as frangible elements to allow the easy removal of the photo-voltaic adhesive portion by the patient themselves, similar to that of current band-aid technology commercially available over the counter to consumers.
  • FIG. 10 and FIG. 11 illustrate the operation of electrosurgical electrolysis injection application probe apparatus 645, wherein interfacing media or material 340 is a hydrogel including compounds such as calcium carbonate, potassium permanganate, or sodium carbonate which slowly react when subjected to electrosurgical electrolysis.
  • the hydrogel is delivered in the reacting state to wound site 350 and thereafter transdermally closed 400 via suturing.
  • Electromagnetic energy is delivered to the active electrode from electrosurgical generator 700 via cable coupler 670 and conducted to the near distal probe tip.
  • the active electrode is insulated with external insulating sheath 260 to prevent current density depletion prior to reaching the desired location along the electrode.
  • Active and return electrode(s) contacts 680 and 690 provide means to connect conductors to the active and return electrode(s) respectively.
  • Active electrode 660 is positioned and retained by active electrode vane supports 290. Internal return electrode lumen is lined with internal insulating sheath 320 to provide means to achieve the correct current densities in bi-modal (AC/DC) operation to provide active and return electrode specific functions. As syringe plunger 675 is depressed, the interfacing media or material 340 is forced to flow from the lumen tip directing flow 580 toward the treatment site in the reacting state. The reacting interfacing media or material provides a means to deliver the electrolysis products.
  • active and return electrodes 660 and 650 are bi-modal (AC or DC) and can be easily reversed in polarity in the DC condition to provide the benefits of either the anode or cathode products at the treatment site to generate those conditions relevant for the procedure at hand.
  • the interfacing material can be placed within a chamber that is created at a particular therapeutic site application rather than within the electrosurgical probe chamber itself.
  • FIG. 6 illustrates an embodiment of the methods and devices disclosed herein to aid in the treatment of tissue to induce therapeutic effects.
  • FIG. 6 illustrates that bone tissue can be treated as disclosed in U.S. Patent Application No. 09/885749, via the use of various interfacing media or materials.
  • interfacing media or materials 340 delivered via syringe 330 or similar device, provides means for bone segments 490 to be physically welded together as disclosed in said application by providing the means to transmit the electrosurgical electrolysis process to the substrate structures of the bone.
  • the interfacing media or materials are activated with an electrosurgical probe configuration as disclosed herein to perform electrosurgical electrolysis of the interfacing media or materials whereby the prepared bone evacuated intersticies can themselves serve as the reaction chamber similar to that described above in FIG. 2 A, FIG.
  • the evacuated bone intersticies are acellular and provide a biocompatible electrosurgical electrolysis chamber.
  • Human femur bone 500 is treated with interfacing media or materials 340 and briefly activated with shape memory retractable electrolysis probe apparatus 480 to activate the interfacing media or materials without inducing bone tissue or cellular electrolysis.
  • compressive load 510 is applied to enhance the bone welding procedure and to ensure a good union between the respective segments.
  • the electrosurgical probe is then removed from the treatment site.
  • the character of the interfacing media or materials in this embodiment may be that of a hydrogel or olefin polymer wax preparation as disclosed below, particularly in those instances when a more hydrophobic interfacing media or material is necessary for ease of application.
  • Olefin polymers can be configured to provide a wax-like consistency to such interfacing media or materials in which electrolysis can be achieved.
  • FIG. 7 details biocompatible interfacing media or materials impregnated composite providing scaffolding or a chamber means to support multiple shape configurations.
  • Chamber strands 520 are comprised of biocompatible materials available from an array of formulations and manufacturers.
  • such strands may be constructed of various relative concentrations of a porous copolymer of polyglycolic acid and polylactic acid (for example, D,L [lactide-glycide] PLGA) or other various co-polymers that offer semi-flexible, porous media which may be impregnated with interfacing media or materials 530.
  • porous biocompatible structure of various forms that may be impregnated with the interfacing media or materials disclosed herein include collagen networks, demineralized bone matrix, calcium phosphate cements, ceramics like tricalcium phosphate or hydroxyapatite, non-collagenous proteins, bioactive glasses, fabricated porous metals like tantalum, and the like, or various composites thereof.
  • Biocompatible composite manufacture allows that porous formable composites may be used to provide an in situ "shape-to-fit" configuration.
  • the impregnated combination of porous carrier and interfacing media or materials 540 provides means to perform multiple tissue treatments on both hard and soft tissue wherein the mechanical properties of an interfacing media or materials as disclosed herein alone may be insufficient to provide stabilization or fixation of itself.
  • This hybrid or composite provides the chamber as described above in which the electrosurgical electrolysis process occurs. Further, this composite can be utilized to deliver various therapeutic agents to the treatment site. For example, in the case of bone tissue, various osteoinductive or osteogenic agents (osteogenic protein-1, bone morphogenic protein, and the like) can be delivered to the treatment site whereby the interfacing media or materials is conformed to the treatment site and then activated by the electrosurgical methods and devices disclosed herein. Further yet, the scaffolding material that forms the electrosurgical electrolysis chamber can itself exhibit therapeutic properties. Further, the ability to deliver additional therapeutic agents to the treatment site becomes possible via the activation of the electrosurgical electrolysis process.
  • osteoinductive or osteogenic agents osteoogenic protein-1, bone morphogenic protein, and the like
  • FIG. 8 illustrates the operation of flexible retractable transparent polymer trumpet cup electrosurgical probe apparatus 480 with the use of the above embodiment.
  • Flexible retractable transparent polymer trumpet cup electrosurgical probe 480 is extended to provide the largest trumpet exposed electrode area possible.
  • Biocompatible interfacing media or materials 540 are applied to chondral defect 550 and held in place by compaction with the un-activated extended trumpet cup electrode of probe 480.
  • Probe 480 is then centered over interfacing media or materials 540 (or alternatively delivered by the trumpet chamber itself) and compressed against the surface of the chondral area, capturing a volumetric portion of intermediary fluid agent 560 for use in the electrolysis activation process.
  • probe 480 may be temporarily removed to flush trumpet cup treatment volume repositioned against the desired treatment area and injected with additional therapeutic agents that can take advantage of the altered cellular permeability created by the products of electrosurgical electrolysis. These agents may also be delivered via the trumpet chamber itself or alternatively via the methods disclosed in Patent Cooperation Treaty Application
  • Cycling the method in this way provides means to improve cellular uptake of therapeutic agents over a macro area on the micro-scale as discussed in FIG. 9.
  • FIG. 9 provides additional detail of the environment created within trumpet cup 80 volumetric treatment areas.
  • Means are provided via flexible injection lumen 120 outlets to direct the flow of therapeutic agents into the volumetric space.
  • Flow 580 of therapeutic agents is directed at cellular based tissue structures interacting with cell membrane 585 or other tissue matrix components.
  • acid-base shifts which govern permeability regulating pathways 590 across the cell membrane are altered, thereby increasing permeability to intracellular cytoplasm 640.
  • Increased permeability at pathway 590 can be used to infiltrate the cell with therapeutic agents that provide nutrients to cells, increase cell viability, regulate mitochondrial 630 activities and the like.
  • treating the tissue cellular structures with a therapeutic agent that first activates DNA specific transport channel 600, as in an mRNA transport channel infiltration of cell nucleus 620, can be achieved.
  • the nucleic impregnation is accomplished via flushing motion 570 and sequential injection of channel activating compounds to trigger preparation of the cell membrane for the reception of the desired cell structure specific therapeutic agent.
  • the external free stream conditions may vary significantly with little impact to the controllability of the trumpet-cup volumetric environment.
  • agents with mild toxicity may now be considered as those skilled in the art will recognize that such mildly toxic agents may both be applied, allowed to interact with said cellular tissue structures, and subsequently during retraction be evacuated via flexible injection lumen 120 to minimize free stream contamination with such mildly toxic agents.
  • Such agents must be of the type with low acute systemic toxicity and sufficiently low allergenic response as to be flushed from the surgical space quickly and sufficiently enough to prevent negative host response. Similar effects can be obtained with, for example, cellular oxygen radical healing response trigger pathway 605.
  • the configuration of the methods and devices disclosed herein creates an electrosurgical electrolysis-activated treatment composite.
  • the treatment composite is a combination of (1) the electrosurgical electrolysis interfacing media or material, (2) the biocompatible scaffolding or chamber creation materials, which may themselves be therapeutic, and within which the interfacing media or material functions, and (3) the other bioactive elements either within the interfacing media or material or within the biocompatible scaffolding or chamber that aid in specific therapeutic and treatment goals.
  • a more rigid deployment of the interfacing material is preferred in an environment with varying levels of confinement or chamber configuration.
  • FIG. 10 depicts hydrogel interfacing material 340 applied to open wound closure site 350 by means of electrolysis injection application probe 645 which also includes electrosurgical console power supply input 670 powered by multi-modal (AC/DC) electrosurgical console 700.
  • electrosurgical console power supply input 670 includes active electrode contact 680 and return electrode contact 690, with input 670 connected to a power supply.
  • FIG. 12 is another embodiment of the methods and devices disclosed herein whereby an implantable device is utilized to provide both the means to induce electrosurgical electrolysis and the composite as disclosed above.
  • Percutaneous bone pins and fixation devices are utilized wherein percutaneous bone fixation pin 710 is coated with a polymer impregnated with interfacing media or material 720. Bone fixation pin 710 is electrified by electrosurgical console 700 and connected via plug-in adapter 680.
  • Interfacing media or material impregnated polymer 720 is disposed on soft tissue traverse section 390 and muscle section 750 of the bone fixation pin.
  • Proximal to screw fixation point 740 being disposed integrally to shaft section of bone fixation pin, is bone insulating divider 730 a means of preventing tissue electrolysis within the screw fixation bone tissue at the distal portion of the bone fixation pin.
  • interfacing media or material impregnated polymer 720 Upon activation of the electrified section of bone fixation pin 710 exudes liberated products of electrosurgical electrolysis to the soft tissue. This action works against environmental assault via healing wounds at bone fixation pin protrusion points of epidermis 390.
  • bone fixation pin 710 acts as the active electrode (the return electrode is not shown and is connected remotely as in the mono-polar electrosurgical approach) and conducts electromagnetic energy to the return electrode at sufficiently low current density levels as to prevent tissue electrolysis and subsequent necrosis.
  • Other configurations will become apparent such as use of a screw or anchor as the fixation device, impregnated as discussed with interfacing media or materials, composites, and other therapeutic agents, and then activated by electrosurgical means that are conducted via the screw driver or insertion device for the particular implant device. Further, these implantable devices may themselves be composed of such materials or composites as discussed above.
  • FIG. 13 shows yet another embodiment of the invention, an electrolysis probe with both the active and return electrode disposed within a cavity.
  • lumen support member 1500 is connected to distal insulator support structure 1450, to which is connected a variable volume electrochemical or electrolysis cell spacer 1400.
  • the cell spacer 1400 can translate in a proximal and distal direction as shown by arrow 1350.
  • return electrodes 1200 and active electrode 1250 are disposed within the cell spacer 1400, with acid-base shift density lines 1300 visible on operation.
  • FIG. 14 A depicts another embodiment, wherein DC driven igniter or glow plug 900 is provided.
  • conductively doped polymer electrode 850 and variable volume electrochemical return electrode and cell spacer 800 produce oxygen and hydrogen by means of electrolysis, which gases are optionally ignited by means of igniter 900.
  • distal support insulator may optionally support igniter 900.
  • FIG. 14 B depicts an embodiment wherein internal surface conductive coating 1000 on the interior of variable volume electrochemical cell spacer and insulator 800 serves as the return electrode, connected to a power supply by means of lead 1100.
  • Active electrolysis electrode 1050 is similarly connected to a power supply by means of electrode lead 1100.
  • the cell spacer and insulator 800 is disposed within probe lumen element 1150, and is preferably movably disposed within probe lumen element 1150.
  • FIG. 15 depicts an embodiment of an electrosurgical probe which provides a means for maintaining the optimal spacing of active electrode 1600, disposed distal from the primary lumen 1640 which also acts as a return electrode.
  • Actuating arm 1631 which in turn is driven by electric positioning motor 1630, actuates translatable sheath 1610.
  • Translatable sheath 1610 thus can extend the insulating properties of insulator 1650 beyond the end profile or position of active electrode 1600, providing means to create a variable volume localized chamber when the translatable sheath 1610 is extended.
  • translatable sheath 1610 can be mechanically actuated, including by means of a thumb control, which may incorporate gears or other means of transferring energy, utilized by the operator.
  • translatable sheath 1610 may, in one embodiment, simply be frictionally engage with a thumb control or other means of movement, may be mechanically actuated, or may be electro-mechanically actuated.
  • sensor 1620 provides primary control variable feedback to differential controller 1701, optionally as an analog input. If the input is analog, it may be output via flip-flop A D conversion to a digital control signal for use by application-specific integrated circuitry logic controller 1711, such as an FPGA, MOSFET, or similar intermediate digital logic gate controlling array.
  • Flash RAM and additional high level input/output governance, is controlled by CPU 1721, utilizing software governed database lookup techniques, such as those commonly known in C or C++ programming code, to provide dual proportional output via Primary RF Output Controller/Generator 1722; and further and optionally also to Electronic Positioning Controller 1723 for simultaneous balanced positioning of translatable sheath 1610 coupled to matched power setting through controller 1722, providing the primary controlling input to match user set-points according to primary control variable known characteristics correlation to a desired set point.
  • Electrical power may be provided by wires connected to a suitable source of power, which may be one or more sources of power, such as a high voltage source for operation of the active electrode and a lower voltage source for operation of the circuits provided.
  • a suitable source of power which may be one or more sources of power, such as a high voltage source for operation of the active electrode and a lower voltage source for operation of the circuits provided.
  • the detector or sensor employed may be any detector or sensor disclosed in Patent Cooperation Treaty Application Serial No. PCT/US03/ , entitled Methods and Devices for Electrosurgery, filed on June 6, 2003, together with any detection circuit, control circuit or related aspects disclosed therein.
  • a flexible electrode may be employed.
  • the electrode itself may be flexible, and the electrode may further be disposed on a flexible substrate.
  • a preferred embodiment is shown in FIG. 2 A, wherein the electrode assembly may be conical or trumpet shaped, so as to conform about and seal an area of tissue to be treated.
  • the flexible active electrode member of the present invention is a molded polymer or dip layered polymer configured in a semi-conical section wherein the distal end forms a horn section when expanded by a plurality of shape-memory wires, such as may be manufactured of nickel- titanium alloy, heat formed into an arc-shape and distally embedded into the perimeter of the polymer horn section.
  • a "ball-wire” may be used in which a soldered spherical ball is distally attached to the shape memory wire.
  • the ball end of the wire is then embedded via insert-molding techniques or dip-layering techniques to position the ball within the material of the distal perimeter of the flexible electrode.
  • Such wire embedding techniques facilitate linear force transmission and thereby distribute the strain loads of expanding the flexible electrode element during the expanding step, so that the flexible electrode member is stretched to its final configuration.
  • the flexible electrode element expands like a centrally expanding fan, with shape-memory alloy wires used in a partially conical section to produce a curved surface that is not self-closing along its distal perimeter.
  • Each of the shape memory wires can be attached to a cannulated support bushing within the probe handle and supported by a track-guided lumen member that provides the lateral translation necessary to drive the support bushing, shape memory wires, and flexible electrode member into its forward and expanded position.
  • the bushing and lumen members can be attached to an actuator and slide switch disposed on the surface of the probe handle so that the user of the device can selectably position the flexible electrode member at various states of expansion, intra-operatively, as deemed appropriate by observed disease state and treatment requirements.
  • Other flexible electrode materials may be employed, such as metallic conductive paint, a metallic based conductive adhesive, a plasma vapor deposited metal, a chemical vapor deposited metal, a thin-film metallic leaf, or a conductively doped substrate.
  • the flexible electrode may be disposed on any of a number of substrates, preferably insulating, including flexible substrates such as a silicone rubber, a polyimide, a fluoro-polymer, a polyester, a polyethylene, a polyurethane, a poly-vinyl chloride, a co-polymer of the foregoing, a tertiary co-polymer of the foregoing or a woven fabric of the foregoing.
  • the electrosurgical electrolysis chamber can be made of any material, including a material that is transparent or translucent, thereby permitting the operator to view operation of the device.
  • a bioactive glass can be used, and is further utilized as a biocompatible osteoconductive or bioconductive materials.
  • the bioactive glass is composed of silica (approximately 45%), calcium oxide (approximately 24.5%), disodium oxide (approximately 24.5%), and pyrophosphate (approximately 6%). These materials can be implanted, bound to collagen or growth factors, fibrin, and other materials and polymers and substances to form a porous matrix within which electrosurgical electrolysis can occur.
  • the matrix provides some compressive strength that is useful in various applications and can be fashioned in many forms including crushed or spherical particles, composite plates, and fibers.
  • the interfacing media or material may display various characteristics that can be centered on the three components which create the electrosurgical activated treatment composite: (1) interfacing media or material, (2) scaffolding or chamber creation in which the interfacing media or material functions, and (3) other bioactive elements that aid in specific therapeutic and treatment goals.
  • Various configurations of this composite are dependant upon treatment application and the need for relative structural rigidity.
  • Liquids The various engineered irrigants as disclosed in U.S. Patent Application Serial No.10/157,651 , entitled Biologically Enhanced Irrigants, can serve as the interfacing media. Examples include aqueous salt solutions such as NaCl, carbonated water (C0 2 ), hyaluronan preparations, and the like. An aqueous component is utilized to generate the electrosurgical electrolysis reaction.
  • aqueous salt solutions such as NaCl, carbonated water (C0 2 ), hyaluronan preparations, and the like.
  • An aqueous component is utilized to generate the electrosurgical electrolysis reaction.
  • Hydrogels are mainly composed of synthetic polymers or biopoiymers such as polysaccharides with varied structures and properties. Substance-holding capacity, nano-structure, chemical structure, and permeability of the hydrogels can be accurately controlled providing numerous options for use of conventional polymer-based hydrogels in this invention. Hydrophilic polymers are useful for a large number of applications in medicine, agriculture, pharmacy, the food industry, cosmetics, construction, and the like and are water soluble at many temperatures and pH. Examples of naturally occurring hydrogels include agar, gelatin, carboxymethylcellulose, hyaluronan, and alginic acid. Natural hydrogel polymers demonstrate both electrolytic properties and biological degradation and thus are very useful for the methods and devices disclosed herein. Other biodegradable polymers that may be utilized include polyesters, polyanhydrides and polyorthoesters which undergo electrolytic chain cleavage, cross-linked polysaccharide hydrogel polymers, and other ionically cross-linked hydrogels.
  • Polysaccharides such as calcium alginate or ionically cross-linked cationic polymers such as chitosan, cationic guar, cationic starch, and polyethylene amine can be utilized as these materials ' are disintegrated in-vivo upon the administration of a chemical trigger material which displaces cross-linking ions.
  • cross-linkable polymers which may be used in the present invention include one or a more of polymers selected from the group consisting of polyhydroxy ethyl methacrylate, polyvinyl alcohol, polyacrylamide, poly (N-vinyl pyrrolidone), polyethylene oxide, hydrolysed polyacrylonitrile, polyacrylic acid, polymethacrylic acid, polyethylene amine, alginic acid, pectinic acid, carboxy methyl cellulose, hyaluronic acid, heparin, heparin sulfate, chitosan, carboxymethyl chitosan, chitin, pullulan, gellan, xanthan, carboxymethyl starch, carboxymethyl dextran, chondroitin sulfate, cationic guar, cationic starch as well as salts and esters thereof.
  • Polymers listed above which are not ionically cross-linkable may be used with polymers which are ionically cross-linkable for certain applications.
  • preferred polymers include one or more of alginic acid, pectinic acid, carboxymethyl cellulose, hyaluronic acid, chitosan, polyvinyl alcohol and salts and esters thereof.
  • Preferred anionic polymers for this application include alginic or pectinic acid; and preferred cationic polymers include chitosan, cationic guar, cationic starch and polyethylene amine.
  • esters of alginic, pectinic or hyaluronic acid and C to C 4 polyalkylene glycols, e.g. propylene glycol, as well as blends containing 1 to 99 wt % of alginic, pectinic or hyaluronic acid with 99 to 1 wt % polyacrylic acid, polymethacrylic acid or polyvinylalcohol.
  • Other preferred blends include alginic acid and polyvinylalcohol combinations.
  • Polyacrylonitrile gels contract when acid environment is applied as that generated by electrolysis of the surrounding media. Such a process only requires 10 V of energy and can be useful in many therapeutic applications of this invention.
  • N-isopropylacrylamide gels demonstrate changing salt concentration like NaCl which in turn changes the gel's volume.
  • Such volume shifts as activated by the electrosurgical means disclosed herein can alter the gel's volume for certain therapeutic applications.
  • Sol-gels can also be used in the invention.
  • Sol-gel reactions provide a variety of inorganic networks from silicon or metal alkoxide monomer precursors to create materials with desirable properties of hardness, optical transparency, chemical durability, tailored porosity, and thermal resistance that are formed in various shapes as generated in the gel state such as monoliths, films, fibers, and monosized powders.
  • Colloidal suspensions and gelation of the sol forms a network in a liquid phase and react with water. Examples include alkoxysilanes, tetramethoxysilane, tetraethoxysilane, aluminates, titanates, and borates.
  • Three reactions are involved in the sol-gel process, including hydrolysis, alcohol condensation, and water condensation.
  • the sol-gel properties are regulated by pH, temperature, reagent concentrations, and catalyst nature, among others which regulates the respective reactions.
  • the electrosurgical electrolysis process has been shown to be useful in the hydrolysis portion of these reactions as discussed below.
  • Electrosurgical methods and devices can be used as activators of the sol-gel to allow changes in the sol-gel that allow for specific treatments. Since the byproducts of the sol-gel are water and alcohol, the process is biocompatible.
  • the electrosurgical electrolysis system disclosed herein can be utilized to alter the conductive media to a composition conducive for the sol-gel reactions. For example, varying the acid base mileu, the temperature, the presence of hydrogen and oxygen gas, and the varying salt participation in the electrolysis process all can impart changes in the electrosurgical environment of the sol-gel. Both the acid- and the base-catalyzed mechanism can be used and the process allows aggregation. As the sol-gel particles aggregate or inter knit, a gel forms that is utilized during the treatment. The network can then shrink with further condensation providing fixation of biologic materials. Other esterification and depolymerization reactions can be induced thereafter to strengthen the bonds. Such a process is one way in achieving bone welding or tissue fixation by way of electrosurgical electrolysis.
  • sol-gels may be employed with the bioactive glasses described above to provide a tissue composite. Tissue bonds to bioactive glass due to formation of a Si-gel layer on the glass. The Si-rich layer acts as a template for a calcium phosphate precipitation which then bonds to the bone.
  • the electrosurgical electrolysis reactions can be used to facilitate, for example, bone welding.
  • Wax preparations in addition to surgical beeswax are very biocompatible and demonstrate properties that can create an interfacing media or materials useful for many applications when subjected to the electrosurgical electrolysis process disclosed herein.
  • intramolecular anodic olefin coupling reactions with an alkoxy substituent on the allylic carbon of an allylsilane moiety have been useful in translating the effects of electrosurgical energy to tissue.
  • Wax utilized in this fashion can serve at least in part as a piezoelectric polymer transducer.
  • Other examples include biodegradable polymer ceramic composites with wax-like handling properties, polyethylene glycol/microfibrillar collagen composites, bio-erodible polyorthoesters, and wax matrix layers prepared from a physical mixture of lactose and hydrogenated castor oil.
  • Solids Most solids utilized in the methods and devices disclosed herein are used for scaffolding or chamber creating means or treatment enhancing means. In some instances, however, the solids themselves may exhibit electrosurgical electrolysis or become activated by such means.
  • collagen networks can serve as the chamber of the electrosurgical electrolysis process and also be treated by the process (like shrinking).
  • Porous co-polymers of polyglycolic acid and polylactic acid for example, D,L [lactide-glycide] PLGA) or other various copolymers offer semi-flexible, porous media which may be impregnated with said interfacing media or materials.
  • porous biocompatible structure of various forms that may be impregnated with the interfacing media or materials disclosed herein include collagen networks, demineralized bone matrix, calcium phosphate cements, ceramics like tricalcium phosphate or hydroxyapatite, non-collagenous proteins, bioactive glasses, fabricated porous metals like tantalum, and the like, or various composites thereof.
  • Biocompatible composite manufacture allows that porous formable composites may be used to provide an in situ "shape-to-fit" configuration.
  • the impregnated combination of porous carrier and interfacing material provides means to perform multiple tissue treatments on both hard and soft tissue wherein the mechanical properties of an interfacing material as disclosed herein alone may be insufficient to provide stabilization or fixation means of itself.
  • This hybrid or composite provides the chamber in which the electrosurgical electrolysis process occurs. Further, this composite can be utilized to deliver various therapeutic agents to the treatment site. For example, in the case of bone tissue, various osteoinductive or osteogenic agents (osteogenic protein-1 , bone morphogenic protein, and the like) can be delivered to the treatment site within the interfacing media or materials which themselves are within a biocompatible matrix chamber like ⁇ -tricalcium phosphate or evacuated porous interstices of the bone itself and are then conformed to the treatment site and then activated by the electrosurgical methods and devices disclosed herein. In this example, the scaffolding material itself exhibits therapeutic properties.
  • biocompatible dyes may be utilized to distinguish the elements of the interfacing media or material to further guard against unwanted induction of electrolysis of oxy-hydro combustion.
  • Various configurations include compositions including methylene blue tissue dye.
  • Other configurations can be employed that signal the electrosurgical electrolysis reactions such as utilizing an iron(ll) agent containing gallic acid entities which are especially suitable as an oxygen indicator of electrosurgical electrolysis.
  • Surgical procedures inherently involve the introduction of pathogens to the operative field during the procedure. These pathogens can originate for either normal locale colonization, by introduction form the surgeon or other personnel, or form the operating instruments and environment. Standard surgical preparation and draping of the operative field has served as the benchmark of modern surgical site "sterilization". Other methods such as ultraviolet light within the operating room, laminar air flow of the operating room environment, and peri-operative antibiotics have become popular to help decrease the incidence of treatment site infection.
  • treatment site infections account for the largest percentage of the morbidity and mortality associated with surgical procedures. Infectious processes significantly impair the healing process at all treatment sites; therefore, it is paramount that both the infectious potential and the healing responses of a treatment site are addressed concurrently to create the best situation for healing.
  • articular cartilage contouring can be performed via the methods and devices disclosed.
  • Radio frequency energy that is directed in a non-contact fashion via a water-based media electrolysis reaction can impart articular cartilage shaping.
  • an electrosurgical probe as depicted in FIG. 2 A and FIG. 2 B was utilized in a fashion to contain the products of the electrosurgical electrolysis reaction into a local treatment area via the methods and devices disclosed herein as further depicted in FIG. 8.
  • the active electrodes were not allowed to contact the tissue, and by altering the energy configuration, degenerative articular cartilage can be contoured creating a smoother surface beneficial for symptom control.
  • the electrolysis reactions and attendant elements can be used to increase membrane permeability followed by the introduction of therapeutic agents into the cells and/or tissue matrix that otherwise would not be possible to a clinically beneficial degree.
  • cellular membrane permeability is increased as the acid-base shift provides alteration of the Na + -K + pump that maintains cellular and tissue osmotic gradients.
  • the increased permeability induced allow follow-up introduction of therapeutic agents into the treatment site for added efficacy.
  • Hyaluronan is then used to treat the articular cartilage after such electrosurgical treatment.
  • Hyaluronan is a hydrophilic polysaccharide found in all body tissues and fluids and exhibits a wide variety of functions such as lubrication, water homeostasis, filtering effects, regulation of plasma protein distribution, as well as modulating cell proliferation, cell migration, and cellular gene expression (via CD-44 adhesion glycoprotein); anti-inflammatory properties such as prostaglandin, cytokine, and eosinophil regulation as well as accommodating superoxide radicals. These characteristics provide an anabolic effect upon cartilage matrix metabolism; and, when delivered after electrosurgical electrolysis, its efficacy is increased. As another clinical example for further clarification of this disclosure, hard and soft tissue wounds can be treated with such methods and devices.
  • osteomyelitis can be treated by utilization of the methods and devices disclosed herein.
  • Traditional irrigation and debridement can be followed by treatment with the electrosurgical electrolysis process to further add antimicrobial effects and induce a more robust healing response.
  • the electrosurgical apparatus depicted in FIG. 2 A, FIG. 2 B, and FIG. 3 can be used as an electrosurgical electrolysis washing or irrigation device whereby the treated tissue is additionally decontaminated and primed for healing.
  • Soft tissue wound sites can be treated as depicted in FIG. 4, FIG. 5 A, FIG. 5 B, FIG. 10, and FIG. 11 that deliver the beneficial therapeutic effects of this invention either by topical application or by an irrigation type method.
  • collagen tissue can be treated with such methods and devices as depicted in FIG. 6 and FIG. 7. Controlled shrinkage of collagen fibrils is induced by the low level heat production of the electrosurgical electrolysis reactions induced by electromagnetic energy.
  • the collagen may be part of the tissue to be treated or part of the interfacing composite utilized. In the instances where the collagen is part of the tissue to be treated, wound healing can be augmented and ligament tightening procedures can be safely performed. In the instances where the collagen is part of the interfacing composite, bone welding as disclosed in U.S. Patent Application No. 09/885749 can be performed.
  • collagen gels, meshes, sheets, sponges, fleeces, or composites as delivery vehicles for various antimicrobial or healing augmentation agents (osteoinductive, osteoconductive, osteogenic, growth factors, antibiotics, anti-inflammatories, hormones, and the like).
  • antimicrobial or healing augmentation agents osteoinductive, osteoconductive, osteogenic, growth factors, antibiotics, anti-inflammatories, hormones, and the like.
  • the application of the electrosurgical electrolysis process can mold the composite to its therapeutic position while adding further antimicrobial and healing properties.
  • the collagen fibrils can be used with other scaffolding materials such as ceramic scaffolds like hydroxyapetite or tricalcium phosphates, biomaterials like demineralized bone matrix in various forms including gel, paste, putty, solids, and the like.
  • implant devices can be treated with such methods and devices as depicted in FIG. 12.
  • bone pins or screws can be electrified intermittently in a pulsed fashion.
  • this invention can help prevent local pathologic colonization of microbes and also provide a stimulus to the host tissue to seal off the indwelling site.
  • this invention can activate the devices upon insertion to stimulate the electrosurgical effects desired prior to withdrawing the insertion devices from the body tissue.
  • electrosurgical electrolysis and oxy-hydro as described in this invention provides for new and unexpected advantages to the surgeon and patient in improving tissue treatment, providing better control of tissue response and overall efficaciousness of treatments due to improved understanding of physiochemical interactions accurately controlled for such outcomes.
  • embodiments disclosed herein provide means to alter localized tissue chemistry and cellular permeability further allowing improved infiltration capabilities for existing and new therapeutic agents applied directly to tissue structures.
  • knowledge of the actual mechanisms at work in electrosurgery provides new paradigms for treatments heretofore unforeseen such as use of electrolysis products to enhance surgical outcomes.
  • simple extensions to the inventions disclosed herein can further enhance the objectives of this invention.

Abstract

L'invention concerne des méthodes, des dispositifs et des substances destinés à une électrolyse électrochirurgicale. Les dispositifs fonctionnent dans un milieu électrolysable comprenant un milieu aqueux (200) électrolysable par électrolyse, et éventuellement par combustion d'oxy-hydrogène conjointement avec le milieu électrolysable. Les méthodes, dispositifs et des substances sont utilisés dans un traitement et des méthodes thérapeutiques d'électrolyse permettant d'effectuer des modifications tissulaires avantageuses.
PCT/US2003/018575 2000-08-18 2003-06-10 Methodes et dispositifs d'electrolyse electrochirurgicale WO2003103522A1 (fr)

Priority Applications (6)

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AU2003243534A AU2003243534A1 (en) 2002-06-10 2003-06-10 Methods and devices for electrosurgical electrolysis
US11/010,174 US7819861B2 (en) 2001-05-26 2004-12-10 Methods for electrosurgical electrolysis
US11/061,397 US7445619B2 (en) 2000-08-18 2005-02-17 Devices for electrosurgery
US12/239,320 US7713269B2 (en) 2000-08-18 2008-09-26 Devices for electrosurgery
US12/778,036 US20110034914A1 (en) 2000-08-18 2010-05-11 Devices for Electrosurgery
US13/736,016 US20130123779A1 (en) 2000-08-18 2013-01-07 Methods and Devices for Electrosurgery

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US38777502P 2002-06-10 2002-06-10
US60/387,775 2002-06-10

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WO2006082413A1 (fr) 2005-02-04 2006-08-10 The Norfolk And Norwich University Hospital Nhs Trust Appareil avec aiguilles electro-chirurgicales
WO2006111968A2 (fr) 2005-04-22 2006-10-26 Ecpoint Medical Inc. Traitement tissulaire avec du courant continu
ITNA20090036A1 (it) * 2009-06-08 2010-12-09 Promoitalia Group Spa Apparato di medicina estetica che consente l'applicazione contemporanea di radiofrequenza e peeling chimici o l'applicazione sequenziale ed invasiva di radiofrequenza e di acido ialuronico ad alta viscosita'
US8034050B2 (en) 2004-11-15 2011-10-11 Biosense Webster, Inc. Catheter with microfabricated temperature sensing
EP2374426A1 (fr) 2010-04-08 2011-10-12 Nuortho Surgical, Inc. Interfaçage de manipulation de média avec système d'énergie à radiofréquence sans ablation
US8062500B2 (en) 2001-12-05 2011-11-22 Oculus Innovative Sciences, Inc. Method and apparatus for producing negative and positive oxidative reductive potential (ORP) water
US8147444B2 (en) 2006-01-20 2012-04-03 Oculus Innovative Sciences, Inc. Methods of treating or preventing peritonitis with oxidative reductive potential water solution
US8323252B2 (en) 2005-03-23 2012-12-04 Oculus Innovative Sciences, Inc. Method of treating skin ulcers using oxidative reductive potential water solution
US8419727B2 (en) 2010-03-26 2013-04-16 Aesculap Ag Impedance mediated power delivery for electrosurgery
US8475448B2 (en) 2004-11-15 2013-07-02 Biosense Webster, Inc. Catheter with multiple microfabricated temperature sensors
US8623012B2 (en) 2001-08-15 2014-01-07 Nuortho Surgical, Inc. Electrosurgical plenum
US8827992B2 (en) 2010-03-26 2014-09-09 Aesculap Ag Impedance mediated control of power delivery for electrosurgery
US8864759B2 (en) 2004-11-15 2014-10-21 Kimberly-Clark Inc. Methods of treating the sacroiliac region of a patient's body
US8870867B2 (en) 2008-02-06 2014-10-28 Aesculap Ag Articulable electrosurgical instrument with a stabilizable articulation actuator
US8888770B2 (en) 2005-05-12 2014-11-18 Aesculap Ag Apparatus for tissue cauterization
WO2014145148A3 (fr) * 2013-03-15 2014-12-31 Ellman International, Inc. Instruments et systèmes chirurgicaux dotés de multiples modes de traitement et d'opération électrochirurgicale
US9168318B2 (en) 2003-12-30 2015-10-27 Oculus Innovative Sciences, Inc. Oxidative reductive potential water solution and methods of using the same
US9173698B2 (en) 2010-09-17 2015-11-03 Aesculap Ag Electrosurgical tissue sealing augmented with a seal-enhancing composition
US9216053B2 (en) 2002-03-05 2015-12-22 Avent, Inc. Elongate member providing a variation in radiopacity
US9339327B2 (en) 2011-06-28 2016-05-17 Aesculap Ag Electrosurgical tissue dissecting device
US9339323B2 (en) 2005-05-12 2016-05-17 Aesculap Ag Electrocautery method and apparatus
US9364281B2 (en) 2002-03-05 2016-06-14 Avent, Inc. Methods for treating the thoracic region of a patient's body
US9408658B2 (en) 2011-02-24 2016-08-09 Nuortho Surgical, Inc. System and method for a physiochemical scalpel to eliminate biologic tissue over-resection and induce tissue healing
US9498548B2 (en) 2005-05-02 2016-11-22 Oculus Innovative Sciences, Inc. Method of using oxidative reductive potential water solution in dental applications
US9532827B2 (en) 2009-06-17 2017-01-03 Nuortho Surgical Inc. Connection of a bipolar electrosurgical hand piece to a monopolar output of an electrosurgical generator
US9579142B1 (en) 2012-12-13 2017-02-28 Nuortho Surgical Inc. Multi-function RF-probe with dual electrode positioning
US9872724B2 (en) 2012-09-26 2018-01-23 Aesculap Ag Apparatus for tissue cutting and sealing
US9918778B2 (en) 2006-05-02 2018-03-20 Aesculap Ag Laparoscopic radiofrequency surgical device
US9949789B2 (en) 2002-03-05 2018-04-24 Avent, Inc. Methods of treating the sacroiliac region of a patient's body
US10143831B2 (en) 2013-03-14 2018-12-04 Cynosure, Inc. Electrosurgical systems and methods
US10206739B2 (en) 2002-03-05 2019-02-19 Avent, Inc. Electrosurgical device and methods
US10314642B2 (en) 2005-05-12 2019-06-11 Aesculap Ag Electrocautery method and apparatus
US10342825B2 (en) 2009-06-15 2019-07-09 Sonoma Pharmaceuticals, Inc. Solution containing hypochlorous acid and methods of using same
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US10786300B2 (en) 2015-04-13 2020-09-29 Carlos Fernando Bazoberry Radiofrequency denervation needle and method
CN113855212A (zh) * 2021-10-28 2021-12-31 海杰亚（北京）医疗器械有限公司 冷热消融器械、冷热消融系统及其控制方法
US11291496B2 (en) 2002-03-05 2022-04-05 Avent, Inc. Methods of treating the sacroiliac region of a patient's body
USD1005484S1 (en) 2019-07-19 2023-11-21 Cynosure, Llc Handheld medical instrument and docking base
US11819259B2 (en) 2018-02-07 2023-11-21 Cynosure, Inc. Methods and apparatus for controlled RF treatments and RF generator system
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US8623012B2 (en) 2001-08-15 2014-01-07 Nuortho Surgical, Inc. Electrosurgical plenum
US8062500B2 (en) 2001-12-05 2011-11-22 Oculus Innovative Sciences, Inc. Method and apparatus for producing negative and positive oxidative reductive potential (ORP) water
US9820808B2 (en) 2002-03-05 2017-11-21 Avent, Inc. Method for treating the thoracic region of a patient's body
US10206739B2 (en) 2002-03-05 2019-02-19 Avent, Inc. Electrosurgical device and methods
US9364281B2 (en) 2002-03-05 2016-06-14 Avent, Inc. Methods for treating the thoracic region of a patient's body
US9949789B2 (en) 2002-03-05 2018-04-24 Avent, Inc. Methods of treating the sacroiliac region of a patient's body
US11291496B2 (en) 2002-03-05 2022-04-05 Avent, Inc. Methods of treating the sacroiliac region of a patient's body
US9216053B2 (en) 2002-03-05 2015-12-22 Avent, Inc. Elongate member providing a variation in radiopacity
US9168318B2 (en) 2003-12-30 2015-10-27 Oculus Innovative Sciences, Inc. Oxidative reductive potential water solution and methods of using the same
US9642876B2 (en) 2003-12-30 2017-05-09 Sonoma Pharmaceuticals, Inc. Method of preventing or treating sinusitis with oxidative reductive potential water solution
US10016455B2 (en) 2003-12-30 2018-07-10 Sonoma Pharmaceuticals, Inc. Method of preventing or treating influenza with oxidative reductive potential water solution
US8105324B2 (en) 2004-09-24 2012-01-31 The Board Of Trustees Of The Leland Stanford Junior University Methods and devices for the non-thermal, electrically-induced closure of blood vessels
WO2006036706A1 (fr) * 2004-09-24 2006-04-06 The Board Of Trustees Of The Leland Stanford Junior University Methodes et dispositifs de fermeture non thermique de vaisseaux sanguins induite electriquement
US8235989B2 (en) 2004-09-24 2012-08-07 The Board Of Trustees Of The Leland Stanford Junior University Method and device for non-thermal electrically-induced closure of blood vessels by occlusion
US8475448B2 (en) 2004-11-15 2013-07-02 Biosense Webster, Inc. Catheter with multiple microfabricated temperature sensors
US8034050B2 (en) 2004-11-15 2011-10-11 Biosense Webster, Inc. Catheter with microfabricated temperature sensing
US8864759B2 (en) 2004-11-15 2014-10-21 Kimberly-Clark Inc. Methods of treating the sacroiliac region of a patient's body
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US8951249B2 (en) 2005-02-17 2015-02-10 Avent Inc. Electrosurgical device with discontinuous flow density
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US9072726B2 (en) 2006-01-20 2015-07-07 Oculus Innovative Sciences, Inc. Methods of treating or preventing inflammation and hypersensitivity with oxidative reductive potential water solution
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US10342825B2 (en) 2009-06-15 2019-07-09 Sonoma Pharmaceuticals, Inc. Solution containing hypochlorous acid and methods of using same
US9532827B2 (en) 2009-06-17 2017-01-03 Nuortho Surgical Inc. Connection of a bipolar electrosurgical hand piece to a monopolar output of an electrosurgical generator
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