WO2007032017A2 - Appareil et methode pour devitaliser des contagions virales provenant de lasers medicaux - Google Patents

Appareil et methode pour devitaliser des contagions virales provenant de lasers medicaux Download PDF

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Publication number
WO2007032017A2
WO2007032017A2 PCT/IN2005/000410 IN2005000410W WO2007032017A2 WO 2007032017 A2 WO2007032017 A2 WO 2007032017A2 IN 2005000410 W IN2005000410 W IN 2005000410W WO 2007032017 A2 WO2007032017 A2 WO 2007032017A2
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WIPO (PCT)
Prior art keywords
plasma
laser
air
gas
viral
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PCT/IN2005/000410
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English (en)
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WO2007032017A3 (fr
Inventor
Hamish Chandru Shahani
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Hamish Chandru Shahani
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Publication of WO2007032017A2 publication Critical patent/WO2007032017A2/fr
Publication of WO2007032017A3 publication Critical patent/WO2007032017A3/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/007—Aspiration
    • A61B2218/008—Aspiration for smoke evacuation

Definitions

  • the present invention relates to the field of biohazards affecting medical personnel who utilize lasers for ablative procedures. While performing various forms of laser surgery and electro-cauterization, airborne fumes and particles are usually generated as debris. That debris stems from volatilized tissue, in the form of a plume rich in viable microbial content. Those disease-causing bio-entities can be viral and bacterial and can linger as biota in the zone of operation, if allowed to remain airborne in the operating room, can diffuse into the room space and may settle into the open wounds of the next patient being operated on, potentially resulting in the transmission of that disease to that patient or even the operating personnel.
  • At least one species-Human Papilloma Virus does survive the laser surgery procedure and causes cervical cancer when it lodges in the body .
  • HIV virus that causes AIDS, which may remain in the room air, virulent for brief periods, where the medical procedure has been performed.
  • Invasive laser surgeries are increasingly used by the medical profession for treatment in gynaecology, including cervical dysplasia, venereal warts, endometriosis, fallopian tube procedures and vulvectomys.
  • laser procedures have been used to remove stains, tattoos, treat fungal conditions, and also the removal of birth marks. Lasers are also being used in podiatry for fungal nails, plantal warts, bunionectomys, and neuroma removal. In addition to carcinoma of the larynx in the pulmonary field and also for endotracheal growth vaporization. Brain tumors are also being excised by lasers during neurosurgery.
  • U.S. PAT 5,409,511 laser plume removal system is a ceiling mounted evacuation system utilizing articulating arms and also comprising central components of the system such as a centrifugal separator tank, garbage pump, optional disinfectant tank, vacuum producer and HEPA filter.
  • the operating room is connected to the central components by a piping system that has branch takeoffs that serve numerous outlets.
  • the piping system includes the flexible plastic tubing, as well as a permanent rigid piping.
  • the suction opening that has to be proximate to the laser target site, is connected to tubing located within the articulating arm. This tubing is flexible to allow for movement and rotation of the arm without disturbing the position of the suction throughout the electro-cauterization process.
  • the inner walls of the tubing must be smooth so debris cannot build up and dislodge and fall back by gravity to the suction aspirator.
  • the central system components are located in a mechanical room, connected to the operating rooms served by the laser plume evacuation system.
  • the piping mains join together and are connected to the centrifugal separator tank.
  • the tank separates debris picked up by the system from the air passing though the system.
  • the airborne medical refuse which includes vaporized tissue particles and bone dust is flushed out of the tank, through a small garbage pump, and into the sanitary sewer system.
  • These mobile units recirculate the air back into the operating room, where microscopic particulate matter below 0.1 micron can escape the filtration process and remain suspended for the next operating procedure.
  • An activated charcoal filter is provided before the final high efficiency particulate filter. Air leaves the top of the separator tank and is drawn through the vacuum producers before entering the HEPA filter which captures particles of size 0.3 micron and greater, before air is discharged to the ambient.
  • U.S. PAT 5,047,072 discloses a mobile evacuation unit with means to disinfect the extract air by passage over germicidal UV lamps upto 6000 microwatts per square centimeter, by and as of itself inadequate as a virucidal process. UV light is effective only on vegetative bio-entities. No attempt is made to deal with the deadly 50-100 nanometer size viral pathogens such as HPV 1 HIV and endotoxins that threaten those occupying the operating room.
  • NASA's outer space planetary protection policy is dedicated to elimination of viral spores from direct-contact landers, rovers and probes. Their exhaustive investigations have justified the use of plasma sterilization at their Ames Research Centre, Moffet Field, CaI 94035 where significant and successful methodologies have been evolved and many studies published. One of those reports relating to in-flight removal of viable biological and organic matter from the spacecraft anticipates the use of Martian atmosphere for generation of sterilization plasma, is included in the citation list as it substantiates this patent.
  • U.S. PAT 5,633,424 and U.S. PAT 6,853,142 disclose methods and apparatuses for generating plasma at atmospheric pressure, for deproteinization and rendering sterile airborne viral pathogens.
  • Pathogens are cells containing cytoplasm, a colloidal system of large biochemicals in a complex solution of smaller organic molecules and inorganic salts.
  • the cytoplasm is bounded by a semi-elastic, selectively permeable cell membrane that controls the transport of molecules into and out of the cell.
  • biochemical transport mechanisms that spend energy to bring substances into the cell despite unfavorable concentration gradients across the membrane.
  • Cells are protected by rigid cell walls external to the cell membranes. Certain bacteria, algae and protozoa have gelatinous sheaths of inorganic materials such as silica.
  • Sequence of genes along a thread like chromosome encodes information that controls cellular activity. As units of heredity, genes determine the cellular characteristics passed from one generation to the next. In most cells the chromosomes are surrounded by a membrane to form a conspicuous nucleus. Cells with organized nuclei are described as eukaryotic. Other intracellular structures serve as specialized sites for cellular activities. Photosynthesis is carried out by organelles called chloroplasts. In bacterial and cyanobacteria the chromosomes are not surrounded by a membrane and there is little apparent sub-cellular organization. Lacking a discrete nucleus, these organisms are said to be prokaryotic. Exposing these organisms to sterilizing agents such as mustard chemicals, ultraviolet light or plasma increases mutation rate by damaging chromosomes.
  • the DNA molecule has a spiral chain link configuration with a variety of chemical links between the longitudinal members. This cross-linked construction permits the establishment of a variety of circulatory currents in different paths. The various paths having different resonant characteristics permitting selective modification in the DNA molecule by subjecting it to excitation at a frequency or frequencies which establish currents in some paths but not in others.
  • Devitalization relies on exposing the bioburden within the laser plume to a continuous flow of gas plasma. Around the plasma, free electrons gain energy from the imposed electric field and lose this energy through collisions with neutral gas molecules. The energy transfer process, besides dissociating cell-contained moisture, leads to the formation of a variety of highly reactive products including metastable atoms, free radicals and ions.
  • the photonic action may contribute to partial alteration of the disulphide rich protein coat, thus facilitating the diffusion of free radicals, atoms, or excited molecules inside the core region.
  • the high energy protons will produce strong virucidal effects because they correspond to a maximum of absorption by DNA and other nucleic acids.
  • photon energy is quickly dissipated through the various spore layers which may restrict photochemical reactions to outer coats.
  • Such a discharge can be generated by a plasma torch disclosed by U.S. PAT 6,329,628 by means of which a number of excited species, both molecular and atomic, are formed. Mounted as in an array, this plasma torch module is disclosed for deployment to absorb radiation to cloak air craft against enemy radar detection and also to reduce air drag and attenuate sonic boom.
  • This patent has been cited as prior art as it is germane to the construction features of the plasma torch being used by this invention. Most plasma lend themselves to the devitalization mode of operation, since the effectiveness of neutrally active species generated in such a discharge persists substantial distances downstream, away from the cavity itself.
  • Plasma electric probe measurements indicate that plasma potentials are nearly equal to ground potential, thereby practically eliminating energetic particle bombardment/ ⁇ uring processing. This mode of operation is thus well suited for low temperature exposure of heat- labile devices and material, even for extended periods of sterilization time.
  • the interaction of the ionic species generated by the plasma torch with the laser plume extract comprising vaporized tissue accomplishes the devitalization and inhibits viral reproduction in the manner described above.
  • the time duration of the process needed to achieve satisfactory devitalization will vary with other parameters of the discharge such as gas flow, pressure, power density, viral load size.
  • U.S. PAT 5,409,511 and U.S. PAT 5,047,072 have delved into medical lasers and each in their own manner have provided methods and means to sub-serve their objects with incomparable grasp of detail and function.
  • Each of these disclosures and those in the citations list has singular distinguishing attributes; but none has conceived or demonstrated viral devitalization to inhibit bio-risks to medical personnel and patients arising from airborne viral contagions stemming from laser surgical procedures.
  • the main object is to provide a laser plume evacuation system that ensures devitalization and capture of airborne microflora, particularly viruses, resulting from laser vaporization of cells, thus greatly reducing the likelihood of transmission by communicable pathogens, from the surgery site to those medical personnel who are in close proximity; achieving that object by creatively integrating methods and means invented independently in two separate classes of technological endeavours.
  • Another object is to safeguard operating personnel and patients from viral diseases by cross-infection, drawing out all airborne bio-entities away from laser surgery site to devitalize all viables by plasma and finally immobilize the thus annihilated non- viable bio-entities by high efficiency filtration before releasing the resultant sterile air into the operating room.
  • a further object is to enable the surgeon to perform the invasive surgical procedures independently by means of a combination hand-piece that co-axially configures an in-line laser probe and the laser plume aspirator without an assistant being required to track the movement of the laser probe and plume with a separate air suction aspirator.
  • Yet another object is to eliminate volatile organic compounds that are contained in the laser surgery emission.
  • Fig 1 illustrates an overall perspective of the main components of the apparatus inter-connected as an assemblage according to the invention.
  • Fig 2 is a cross-sectional view of a typical laser applicator for excising or ablating human tissue at surgery site, coaxially mounted within the aspirator hand-piece.
  • Fig 3 depicts a cross-section of the co-axially disposed laser applicator and plume aspirator as a single hand-piece such that both functions are in concert.
  • Fig 3a sketches separately configured laser applicator and plume aspirator in accordance with prior art.
  • Fig 4 outlines the air-evacuating device comprising a cylindrical diaphragm and two interlocked valves.
  • Fig 5 shows in partial cross-section the plasma generator causing viral devitalization
  • Fig 6 gives a sectioned view of the HEPA cartridge that immobilizes non-viable particulates and adsorbs volatile organic compounds.
  • Peripherals like gas-lines, valves, power-packs, electro-electronic circuits, control panels, sensors, meters and monitors are not detailed as they are generic requirements of such apparatus and self-evident to those skilled in the art of the system operation.
  • Fig 1 represents an embodiment of this invention comprising a 1.5 mm 0 fibre optic cable transmitting a laser beam from its source hand-piece 2 for a surgeon to direct the laser energy to target surgery site.
  • a 22 mm 0 nozzle slideably inserted into a coaxial aspirator hand-piece 3 leads to a 16 mm 0 flexible tube which connects to the intake valve of a solenoid actuated cylindrical diaphragm air pump 4 that directs the aspirated emission past the ve ⁇ turi and plasma torch 5 onto the high efficiency filter cartridge 6 which captures the airborne particulates within its matrix which is impregnated with a catalytic agent such as titanium dioxide for adsorption of volatile organic compounds.
  • a catalytic agent such as titanium dioxide for adsorption of volatile organic compounds.
  • Fig 5 shows in partial cross-section the plasma generator causing viral devitalization
  • Fig 6 gives a sectioned view of the HEPA cartridge that immobilizes non-viable particulates and adsorbs volatile organic compounds.
  • Peripherals like gas-lines, valves, power-packs, electro-electronic circuits, control panels, sensors, meters and monitors are not detailed as they are generic requirements of such apparatus and self-evident to those skilled in the art of the system operation.
  • Fig 1 represents an embodiment of this invention comprising a 1.5 mm 0 fibre optic cable transmitting a laser beam from its source hand-piece 2 for a surgeon to direct the laser energy to target surgery site.
  • a 22 mm 0 nozzle slideably inserted into a coaxial aspirator hand-piece 3 leads to a 16 mm 0 flexible tube which connects to the intake valve of a solenoid actuated cylindrical diaphragm air pump 4 that directs the aspirated emission past the venturi and plasma torch 5 onto the high efficiency filter cartridge ⁇ which captures the airborne particulates within its matrix which is impregnated with a catalytic agent such as titanium dioxide for adsorption of volatile organic compounds.
  • a catalytic agent such as titanium dioxide for adsorption of volatile organic compounds.
  • Fig 2 and 3A illustrates a typical laser hand-piece attachable to a source of laser energy transmitted by a laser probe 21 having a proximal end 22 that a surgeon can direct to target site for ablative and electro-cauterization procedures.
  • the applicator designated 23 is constructed as a quickly-attachable connector which coaxially fits snugly into the aspirator tube 24 that draws away the airborne plume debris via the 22 mm 0 nozzle thru a 16 mm 0 leader tube 35 as shown in Fig. 3.
  • the Prior art method is illustrated by Fig 3a with the laser probe 21 and the aspirator hand-piece intake tube 24 manipulated separately and independently around the surgery site.
  • a simplified example of the laser hand- piece 2 for ablative procedures comprises the fibre optic 21 focussed on the target surgery site and configured with the laser plume suction inlet nozzle 34 and suction tube
  • a power supply (not shown ) produces an electric field in the gap between the anode and the cathode.
  • the electric field generates excited atoms and secondary electrons that ionize the excited atoms, creating the strongly ionized plasma that devitalizes the viral contaminants picked up at the laser site by the suction inlet nozzle 36.
  • the non-viable airborne viral contagions and other organic volatile compounds are pumped to a high efficiency filter cartridge 6.
  • the air evacuating device comprises a 80 mm 0 x 200 mm long silicone cylindrical diaphragm 41 pumping air by means of reciprocating press plates 42 that are mechanically fastened to the diaphragm and actuated by solenoids 43 .
  • the silicone diaphragm inhibits particulate contaminants from adhering to its inner wall which can agglomerate for sporadic shedding.
  • Fig 5 details a partial cross-sectional view of the plasma generator comprising the height adjustable anode 51 fabricated from either thoriated tungsten or tantalum carbide 3 mm 0 rod, concentrically proximate to a 25 mm 0 silver cathode 52.
  • the plasma generator has a primary annular pathway 53 for gases such as argon, helium, oxygen, freon and nitrogen, those have proved effective and any one of those can be introduced at 54 and in parallel at inlet 55 into a secondary annular pathway 56 egressing around the cathode 52 thus enlarging the field of ionizing electrons generated, in response to the discharge between cathode 52 and anode 51 .
  • the electrodes are separated by an insulating member 57.
  • the plasma discharge of about 250-350 Watts is sustained at relatively lower magnetic co-intensity, preferably in the range of 0.1 W/ cm 2 to 1 W / cm 2 .
  • the electron temperature is on the order of magnitude of 3 eV and the driving frequency is typically about 2.45 MHz 1 while for the prohibitively costly RF systems it is typically 13.66 MHz.
  • Frequency of 2.45 MHz has been found just as effective for dissociating the molecular cell-contained moisture into atomic hydrogen and oxygen, essential for microbial devitalization .
  • relatively low power densities in the range of 0.0125 - 0.025 W / cm 3 are adequate.
  • the anode 51 has an adjustable means to maintain its axial position relative to the cathode micrometrically by a threaded knob, whereby a density of about 10 13 electrons per cubic centimeter uniformly distributed within a zone of approximately 20 cubic centimeter is generated to devitalize organisms.
  • pulsating fields coupled through the plasma to the organisms set up disruptive currents which alter the DNA molecules to an extent sufficient to prevent reproduction.
  • complex resonant current conditions have been observed in effecting a complete kill.
  • circulating electric currents are believed to be a major factor in disrupting the DNA molecule, more complex effects also take place, including electron spin resonance and multiple nuclear magnetic resonance. Both modify the characteristics of the organism. All these effects are believed to be caused, at least to some extent, by response of the organisms to all pulsating fields, electric, magnetic or electromagnetic. Of course, at an appropriate frequency or combination of frequencies.
  • a molecular reaction between the plasma constituents including hydrogen, oxygen and ozone dissociated from the cell-contained moisture destroys the organism.
  • the energy of the photons resulting from the excited condition of the plasma speeds up the chemical reaction so that even oxygen or nitrogen from the atmosphere are effective steriiants. It is safe to estimate that approximately 50 % of the energy of the charged particles is dissipated in penetrating the cell while the other 50 % is utilized in destroying the potential of the organism to reproduce.
  • Fig 6 shows the physical construction of the virus-tight high efficiency particulate capture and volatile organic compounds adsorption cartridge 6 which is about 150 mm 0 and 200 mm in height.
  • the cartridge can immobilize non-viable bio-entities within the depth of the pleated matrix 64.
  • the conical reaction venturi 61 interconnects the plasma generator 5 mounted on a flange 62 which is mounted integrally with the filter cartridge 6.
  • the laser plume exhaust comes in intimate contact with numerous excited atomic and molecular species created by the plasma discharge. The interaction of those plasma species with the laser plume extract, consisting of vaporized tissue accomplishes the devitalization and inhibits viral reproduction.
  • the incident face of the pleated microfiberglass or porous polytetrafluroethylene media is impregnated with catalytic adsorbents such as, but not exclusively, titanium dioxide to eliminate volatile organic compounds within the laser surgery plume extract.
  • catalytic adsorbents such as, but not exclusively, titanium dioxide to eliminate volatile organic compounds within the laser surgery plume extract.
  • the exhausted emission fully satisfies current environmental and personnel safety concerns, the products of the plasma being almost entirely water vapor, carbon dioxide and non-toxic gases normally found in the atmosphere. That treated air exits the perforated cage 65 after 99.999 % retention within the cartridge matrix 64 and the nonviable benign air is released to the surgery room.
  • a piezoelectric pressure sensor not shown
  • the replacement cartridge can be readily press fitted and sealed by means of double elastomeric O rings 63 into the filter retaining register 66.
  • the entire apparatus can be mounted as on a height adjustable tripod 67.
  • the centralized laser plume evacuation system operates through articulating arms in the medical procedure room, although it may also be accessed through wall or ceiling outlets or through a medical gas column and release the exhaust air carrying contagions to the atmosphere, possibly disseminating and exposing non-medical people to risk of viral infection.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Electromagnetism (AREA)
  • Optics & Photonics (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Otolaryngology (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

L'invention concerne un dispositif chirurgical d'évacuation de fumée laser faisant appel à une dévitalisation au plasma en ligne de bioentités virales, et le système de capture de ces bioentités. Ce dispositif d'évacuation comprend une sonde laser d'ablation médicale, coaxialement montée à l'intérieur d'un aspirateur de panache de fumée transportant les débris biologiques aériens d'un tissu vaporisé jusqu'à une cartouche d'immobilisation particulaire hautement efficace, en passant par un générateur de plasma de déprotéinisation virale. La combinaison de ces composants permet d'assurer que l'assemblage rejette un échappement exempt de virus, ce qui évite une infection croisée allant du patient au personnel médical. La pompe à air à membrane remplace le dispositif de soufflage à moteur classique et la pompe sous vide. Cette pompe présente de nombreux sites de logement particulaires, ce qui la rend suffisamment compact et portable, de sorte à occuper moins de place en salle d'opération. Cet appareil n'interfère pas avec le déplacement du personnel médical. La pièce manuelle unique, qui fonctionne à la fois comme une sonde d'ablation et comme un aspirateur, permet au chirurgien de se passer d'assistant, lequel assistant devant suivre de manière synchrone le déplacement du chirurgien, lors d'une chirurgie invasive faisant appel à des dispositifs de l'état de la technique.
PCT/IN2005/000410 2005-09-14 2005-12-13 Appareil et methode pour devitaliser des contagions virales provenant de lasers medicaux WO2007032017A2 (fr)

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IN1286/CHE/2005 2005-09-14

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210401451A1 (en) * 2020-06-26 2021-12-30 Terumo Cardiovascular Systems Corporation Endoscopic vessel harvesting devices with conditioning of insufflation gas
WO2022035979A1 (fr) * 2020-08-12 2022-02-17 Patientpocket LLC Système de détoxification de fumée chirurgicale autonome

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4220414A (en) * 1976-05-06 1980-09-02 Barringer Research Limited Laser spectrochemical analysis
US5047072A (en) * 1988-11-10 1991-09-10 Surgical Laser Products, Inc. Ultraviolet air enhancement and laser plume evacuation method and system
US5674219A (en) * 1994-10-06 1997-10-07 Donaldson Company, Inc. Electrosurgical smoke evacuator

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4220414A (en) * 1976-05-06 1980-09-02 Barringer Research Limited Laser spectrochemical analysis
US5047072A (en) * 1988-11-10 1991-09-10 Surgical Laser Products, Inc. Ultraviolet air enhancement and laser plume evacuation method and system
US5674219A (en) * 1994-10-06 1997-10-07 Donaldson Company, Inc. Electrosurgical smoke evacuator

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210401451A1 (en) * 2020-06-26 2021-12-30 Terumo Cardiovascular Systems Corporation Endoscopic vessel harvesting devices with conditioning of insufflation gas
US11877765B2 (en) * 2020-06-26 2024-01-23 Terumo Cardiovascular Systems Corporation Endoscopic vessel harvesting devices with conditioning of insufflation gas
WO2022035979A1 (fr) * 2020-08-12 2022-02-17 Patientpocket LLC Système de détoxification de fumée chirurgicale autonome

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