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WO2008148139A1 - Ultrasonic scalpel - Google Patents

Ultrasonic scalpel Download PDF

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Publication number
WO2008148139A1
WO2008148139A1 PCT/AT2007/000213 AT2007000213W WO2008148139A1 WO 2008148139 A1 WO2008148139 A1 WO 2008148139A1 AT 2007000213 W AT2007000213 W AT 2007000213W WO 2008148139 A1 WO2008148139 A1 WO 2008148139A1
Authority
WO
WIPO (PCT)
Prior art keywords
scalpel
sono
blades
cutting
sonic
Prior art date
Application number
PCT/AT2007/000213
Other languages
French (fr)
Inventor
Angelo Troedhan
Andreas Kurrek
Marcel Wainwright
Original Assignee
Angelo Troedhan
Andreas Kurrek
Marcel Wainwright
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Angelo Troedhan, Andreas Kurrek, Marcel Wainwright filed Critical Angelo Troedhan
Priority to PCT/AT2007/000213 priority Critical patent/WO2008148139A1/en
Publication of WO2008148139A1 publication Critical patent/WO2008148139A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/32Surgical cutting instruments
    • A61B17/3209Incision instruments
    • A61B17/3211Surgical scalpels, knives; Accessories therefor
    • A61B17/3213Surgical scalpels, knives; Accessories therefor with detachable blades
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00831Material properties
    • A61B2017/0088Material properties ceramic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320084Irrigation sleeves

Definitions

  • the present invention concerns the field of general medicine, oral medicine and veterinary medicine and all procedures where precise cutting of organic cells and/or tissue, organic and non-organic flexible tissue and/or fibres is necessary.
  • Presently (scalpel or "Stanley-Knive") blades used in medicine and other cutting professions are manufactured on a large industrial scale according to an internationally standardized number system to identify the shape and the size of the scalpel. Every cutting performed with these scalpel blades suffers in its precision from the friction of the scalpel blade to the cutted organic or fibre tissue causing a tearing, distorting and displacing effect to the cutted site when the cutting site is not fixed properly or the tissue layers are too many or too thick. This is caused by the constant and direct contact of the scalpel blade to the cutted tissue during the process of cutting leading to the distortion of the tissue and therefore reducing the precision of the cut.
  • various lasers e.g. CO2, Nd:YAG, Er:YAG, Ho:YAG, Diode, Excimer etc.
  • CO2 nuclear-driven laser
  • Nd:YAG, Er:YAG, Ho:YAG, Diode, Excimer etc. can be used but with a more or less strongly expressed heating and coagulating effect to the cutted organic molecules and therewith on a micro- and macroscopic scale to the border of the performed cut thus enlarging the width of the cut, decreasing it ' s precision and destroying the integrity of organic cells and fibres in a relatively large area on a microscopic scale.
  • Non-touch or “touchless”- cutting procedure by projecting bundled coherent electromagnetic waves ("coherent light”) from the infrared to the ultraviolet range to the cutting site producing heat and thus disrupting the integrity of organic cells and/or fibres.
  • coherent light bundled coherent electromagnetic waves
  • the present invention is a new approach to cutting by projecting sonic/ultrasonic oscillation energy via conventional scalpel blades and/or especially shaped thin and light steel and/or ceramic blades to organic cells, organic and non-organic fibres and/or fibre-tissue with or without a cooling irrigation by various liquids transported to the cutting site by an internal and/or external irrigation channel in or to the device in order to allow cutting procedures with or without thermal side effects such as coagulation of biological tissues and minor blood vessels to achieve hemostasis.
  • Such the SONO-scalpel can be used in three modes: a) normal cutting with scalpel blade, b) sound/ultrasound activated cutting WITH heat-coagulating (hemostatic) effects on organic tissues, c) sound/Ultrasound activated cutting WITHOUT heat-coagulating effects on organic tissues by cooling the cutting blade with cooling liquids transported through an internal irrigation channel and/or an external irrigation hose aimed to the cutting edge of the blade.
  • the invention embodies an insert/tip with rigidly or removeable attached scalpel blades in international standard shapes or specialized designs for specific surgical and/or cutting procedures that can be attached to any sound and/or ultrasound generator by a connector or can be produced with this generator "in one piece”.
  • the present invention is a new approach to cutting by projecting sonic/ultrasonic oscillation energy via conventional scalpel blades and/or especially shaped thin and light steel and/or ceramic blades to organic cells, organic and non-organic fibres and/or fibre-tissue with or without a cooling irrigation by various liquids transported to the cutting site by an internal and/or external irrigation channel in or to the device.
  • the cutting and heating effect of oscillating liquids and/or gasses resembles somehow the disrupting effect of coherent electromagnetic waves ("lasers”) from the infrared to ultraviolet range of electromagnetic frequency in organic molecules on the atomic scale, the disruption of organic cells by heating the inner-cell liquids and organic fibres by mechanically and thermally disrupting the structure of the long molecules on the microscopic and macroscopic scale.
  • laser waves coherent electromagnetic waves
  • the physical effects of coherent electromagnetic and sonic/ultrasonic waves are different on the atomic level on the basis of mere physics (electromagnetic waves: electromagnetic interaction with electrons, ultrasonic waves: mechanical interaction with atomic binding forces i.e. Van der Waal-forces)
  • the microscopic and macroscopic effects are somehow similar in organic molecules, cells and fibres (disruption of organic molecules and cells).
  • the present invention reduces and/or annihilates the unwished physical side effects of both conventional cutting metal and/or ceramic blades and lasers or gives the user the choice to use the side effects selectively:
  • Metal and/or ceramic blades oscillating in the range of 10.000 - 60.000 Hz at an amplitude of 0,0001 to 1 Millimeter need only slight contact to the cutting site even when penetrating into tissue layers more than lmm and thus causes no distortion of the cutted tissue by mere continous friction between the blade and the tissue similar to the "non- contact"- or "touchless”- cutting procedure using electromagnetic waves (i.e.
  • the metal and/or ceramic blades can be cooled by water spray applied to the blade and the cutting site.
  • TKW-Sono-Scalpel can be used in three modes:
  • a cooling liquid spray water, physiological or other saline solutions, other heat absorbing liquids at different temperatures from liquid CO2 over ice-water to room-temperature liquids
  • the present invention combines all advantages of a regular scalpel/cutting blade and electromagnetic cutting devices (lasers) and annihilates the disadvantages of these devices or utilizes them selectively if necessary.
  • the present invention can be manufactured in a way that it connects to and can be coupled to mechanically to all sonic/ultrasonic generators presently available on the market (i.e. mechanical, electromagnetic, piezoelectric sound and ultrasound generators).
  • the present invention is meant to be used in:
  • Human medicine as cutting/preparation and/or coagulating/hemostatic device of soft human tissue e.g. skin, mucosa, connective tissue, blood vessels, liver-, spleen-, lung-, muscle-, brain-, kidney-, intestine-, cartilage-, fibrous-tissue etc. - list is only taxative
  • all specialized fields of surgery in human medicine e.g. general surgery, orthopedic surgery, plastic surgery, intestine surgery, lung surgery, brain surgery, kidney-surgey, cancer surgery, ENT surgery, Dermal surgery, Heart surgery, i.e. all human surgery where cutting and/or modelling of soft and/or cartilage tissue is performed etc. - list is only taxative
  • microscopic and macroscopic level depending on the size of the blades.
  • Dental medicine as cutting/preparation and/or coagulating/hemostatic device of soft human tissue (e.g. skin, mucosa, connective tissue, blood vessels, muscle-, cartilage-, fibrous-tissue etc. - list is only taxative) on microscopic and macroscopic level depending on the size of the blades.
  • soft human tissue e.g. skin, mucosa, connective tissue, blood vessels, muscle-, cartilage-, fibrous-tissue etc. - list is only taxative
  • Veterinary medicine as cutting/preparation and/or coagulating/hemostatic device of soft veterinary tissue e.g. skin, mucosa, connective tissue, blood vessels, liver-, spleen-, lung-, muscle-, brain-, kidney-, intestine-, cartilage-, fibrous-tissue etc. - list is only taxative
  • soft veterinary tissue e.g. skin, mucosa, connective tissue, blood vessels, liver-, spleen-, lung-, muscle-, brain-, kidney-, intestine-, cartilage-, fibrous-tissue etc. - list is only taxative
  • all specialized fields of surgery in veterinary medicine e.g. general surgery, orthopedic surgery, plastic surgery, intestine surgery, lung surgery, brain surgery, kidney-surgey, cancer surgery, ENT surgery, Dermal surgery, Heart surgery, i.e. all veterinary surgery where cutting and/or modelling of soft and/or cartilage tissue is performed etc. - list is only taxative
  • FIG.l and FIG.2 show the insert/tip of the TKW-SONO- Scalpel for use in surgery in all dental/medical and veterinary surgical procedures and cutting processes on all current and future sound and/or ultrasound devices (10.000-60.000 Hz) and the shape of the Basic Body for the sound or ultrasound Insert/tip (universal use with regular scalpel steel blades intl. ID#: 10, 12, 12d, 15a-c, 20, 22 or thin knive blades such as "Stanley-Knives") when attached to the sonic and/or ultrasonic device by screwing or by a snap-in mechanism.
  • the scalpel blade is attached to the insert/tip by a rigid connection (scalpel blade non removable) whereas in FIG.2 the scalpel blade is snapped onto the tip and can be removed.
  • FIG.3 to FIG.7 show the manufacturing process for an insert/tip described in FIG.2
  • FIG.8 and FIG.9 show the manufacturing of a SONO- scalpel with a blade in one piece
  • FIG. 10 and FIG. 11 show the oscillation behaviour of the SONO-scalpel in both variations described in FIG. 1 and FIG. 2
  • FIG. 12 - 18 shows various types of the Sono-Scalpel especially concerning the shape of the scalpel blades meant for microsurgical procedures both removable or “in one piece” and in metal alloy or ceramic.
  • FIG. 19 - 21 show how the SONO-scalpel is connected to various sound or ultrasound generators the prototypes were tested with. Detailed description of embodiments of the invention
  • FIG.l shows the insert/tip with its connector (101) to the sound or ultrasound generator.
  • the connector (101) is attached to the sound or ultrasound device by screw-windings (102) or a snap-on mechanism (103).
  • the hose for an external cooling liquid (104) runs parallel to the connector and aims at the cutting edge of the scalpel blade.
  • the main body of the insert/tip (105) is perforated by an internal irrigation channel (106) that leaves the main body at the sides projecting the cooling liquid to the cutting edge (107) of the scalpel blade (108).
  • the scalpel blade (108) in this variation of the SONO-Scalpel is rigidly attached (manufactured as whole or TIG-welded) to the main body (105)
  • FIG.2 shows the insert/tip with its connector (101) to the sound or ultrasound generator.
  • the connector (101) is attached to the sound or ultrasound device by screw-windings (102) or a snap-on mechanism (103).
  • the hose for an external cooling liquid (104) runs parallel to the connector and aims at the cutting edge of the scalpel blade.
  • the main body of the insert/tip (105) is perforated by an internal irrigation channel (106) that leaves the main body at the sides projecting the cooling liquid to the cutting edge (107) of the scalpel blade (109).
  • the scalpel blade is perforated by an internal irrigation channel (106) that leaves the main body at the sides projecting the cooling liquid to the cutting edge (107) of the scalpel blade (109).
  • FIG.3 shows the raw form ("rawling") of the SONO-scalpel.
  • the length of the main body (105) varies from 26 ⁇ 126mm excluding the connector (101) to the sound and/or ultrasound generator (electromechanical and/or piezoelectronic impulse device).
  • the Rawling needs minimum 26mm length of the main body (105) excluding the connector (101) for conventional surgical scalpel blades.
  • a Millimeter-Scale (202) is attached to FIG.3-FIG.7 as well as numbers (203) resembling the diameter of the cross sections (201) in mm.
  • the final length of the main body (105) has always to be calculated according to the frequency and amplitude of the sound and/or ultrasound generator.
  • FIG. 4 to FIG.7 shows the process of forming the main body (105) of the SONO-scalpel by reducing the rawling (FIG.l) to its final shape (FIG.7) to receive a standard surgical scalpel blade (FIG.l (109).
  • FIG. 5 During the shaping process (FIG.3.-FIG.7) the internal irrigation channel (106) for the cooling liquid is drilled into the main body (105) of the insert/tip as well as the slits (110) that receive and hold firmly the exchangeable scalpel blade.
  • FIG. 8 shows the raw form ("rawling") of the SONO-scalpel.
  • the length of the main body (105) varies from 5-126mm excluding the connector (101) to the sound and/or ultrasound generator (electromechanical and/or piezoelectronic impulse device).
  • the Rawling needs a length between 5mm to 126mm of the main body (105) excluding the connector (101) and a diameter between 2 and 15 mm (201).
  • a Millimeter-Scale (202) is attached to FIG.8 and FIG.9 as well as numbers (203) resembling the diameter of the cross sections (201) in mm.
  • FIG. 9 shows the final SONO-scalpel with its connector (101) to the sound and/or ultrasound generator, its main body (105) also forming the scalpel blade (108) and the internal irrigation channel (106)
  • FIG. 10 shows the oscillation behaviour of the SONO-scalpel described in FIG. 1 when connected and activated by a sound and/or ultrasound generator: the SONO-scalpel-blade (108) achieves its maximum oscillation amplitude in the distal third to the apex of the scalpel blade.
  • the blade oscillates mainly along the Y-axis (205) between 0,0001mm (206) to lmm (207) amplitude but also along the X-axis (204) between 0,0001mm (208) and lmm (209) depending on the oscillation characteristics of the sound and/or ultrasound device the insert/tip is attached to.
  • the oscillation basic characteristic is a harmonic sinus-curve but can be modulated and/or triggered for various types of biological tissues.
  • the cooling liquid (210) is projected/sprayed via the internal irrigation channel(l ⁇ ) or external irrigation hose (104) towards the cutting edge (107) of the scalpel blade thus preventing a coagulating effect in biological tissues.
  • FIG. 11 shows the oscillation behaviour of the SONO-scalpel described in FIG. 2 when connected and activated by a sound and/or ultrasound generator: the SONO-scalpel-blade (109) achieves its maximum oscillation amplitude in the distal third to the apex of the scalpel blade.
  • the blade oscillates mainly along the Y-axis (205) between 0,0001mm (206) to lmm (207) amplitude but also along the X-axis (204) between 0,0001mm (208) and lmm (209) depending on the oscillation characteristics of the sound and/or ultrasound device the insert/tip is attached to. If a cooling of the oscillating scalpel blade (109) is mandatory the cooling liquid (210) is projected/sprayed via the internal irrigation channel(106) or external irrigation hose (104) towards the cutting edge (107) of the scalpel blade thus preventing a coagulating effect in biological tissues.
  • FIG. 12 shows the design of the SONO-Scalpel for use in microsurgical procedures.
  • the length of the main body (105) varies from 2 - 100mm excluding the connector (101) to the sound and/or ultrasound generator (electromechanical and/or piezoelectronic impulse device).
  • the removable micro-scalpel blade (112) is received by a receptacle (111) in the dimensions of 2-7 x 2-7 x 3-5 mm and arrested by an external snap-in mechanism (113). Numbers (203) are annotated to FIG.12-FIG. 18 resembling the lengths and the diameter of the cross sections (201) in mm.
  • the cooling liquid is transported by the internal cooling channel (106) and/or by an external hose (104) and is essential to the invention.
  • FIG. 13 shows a removable ovoid microscalpel blade (112) that attaches to the receptacle (111) of the insert/tip.
  • the dimensions are typed in bold letters (203) resembling the size in Millimeters.
  • FIG. 14 shows a removable pyramid shaped microscalpel blade (114) that attaches to the receptacle (111) of the insert/tip.
  • the dimensions are typed in bold letters (203) resembling the size in Millimeters.
  • FIG. 15 shows the design of the SONO-Scalpel made in one piece for use in microsurgical procedures.
  • the length of the main body (105) varies from 2 - 100mm excluding the connector (101) to the sound and/or ultrasound generator (electromechanical and/or piezoelectronic impulse device).
  • the ovoid micro-scalpel blade (112) (or any other shape of micro scalpel- blade) is manufactured from one rawling including the connector (101), and the the main body (105) .
  • Numbers (203) are annotated resembling the lengths and the diameter of the cross sections (201) in mm.
  • the cooling liquid is transported by the internal cooling channel (106) and/or by an external hose (104) which is essential to the invention.
  • FIG. 16 shows another variation of the SONO-Scalpel for use in microsurgical procedures in connection with microsurgical ceramic blades.
  • the only difference to FIG. 12 is the receptacle which has a more broad opening to receive the thicker ceramic scalpel-blades (FIG. 17 (115, 116), FIG. 18 (117, 118).
  • FIG. 17 shows a removable ovoid microscalpel ceramic blade in flat view (115) and side view (116) with annotated dimensions in Millimeters typed in bold numbers (203) that attaches to the receptacle FIG. 16 (115) of the insert/tip.
  • FIG. 18 shows a removable pyramid shaped microscalpel ceramic blade in flat view (117) and side view (118) with annotated dimensions in Millimeters typed in bold numbers (203) that attaches to the receptacle
  • FIG. 19 shows - as an example - the SONO-scalpel ("one piece" - type described in FIG. 9 and FIG. 1) with its connector (101), its main body
  • FIG. 20 shows - again as an example - the SONO-scalpel with removable scalpel blades as described in FIG. 2 with an external cooling liquid hose (104) connected to a battery-driven electromagnetic-mechanic coupled sound and/or ultrasound device (302) working at frequencies of approx. 30.000 Hz.
  • FIG. 21 shows - as an example - the SONO-scalpel with a removable scalpel blade in the shape of a "Stanley-Knive" (119) as described in FIG. 2 with an external cooling liquid hose (104) connected to a battery-driven electromagnetic-mechanic coupled pen-sized sound device (303) working at frequencies of approx. 15.000 Hz.

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Abstract

The present application concerns cutting by projecting sonic/ultrasonic oscillation energy via conventional scalpel blades and/or especially shaped thin and light steel and/or ceramic blades to organic cells, organic and non-organic fibres and/or fibre-tissue with or without a cooling irrigation by various liquids transported to the cutting site by an internal and/or external irrigation channel in or to the device in order to allow cutting procedures with or without thermal side effects' such as coagulation of biological tissues and minor blood vessels to achieve hemostasis. The application embodies an insert/tip with rigidly or removeable attached scalpel blades in international standard shapes or specialized designs for specific surgical and/or cutting procedures that can be attached to any sound and/or ultrasound generator by a connector or can be produced with this generator 'in one piece'.

Description

ULTRASONIC SCALPEL
Refers: PCT/AT 2007/000213 May 7th 2007-06-06
Correction according Article 11 (2)
The applicants/inventors :
1. Dr. Angelo Troedhan, Stein bruchgasse 24, 7062 St. Margarethen/Berg,
Austria, Citizenship : Austria
2. Dr. Andreas Kurrek, Lintorferstrasse 7, 40878 Ratingen, Germany,
Citizenship : Germany
Dr. Marcel Wainwright, Kaiserswerther Markt 25, 40489 Duesseldorf, Germany Citizenship: Germany
apply for an international patent on their invention (brief description):
SOUND/ULTRASOUND SCALPEL FOR USE IN ALL MEDICAL and VETERINARY FIELDS OF SURGERY and ORAL SURGERY and
GENERAL CUTTING PROCEDURES OF ORGANIC and NONORGANIC FIBRES and/or TISSUES
(TKW - Vibro-, Vibra-, Sono-, Sonic-Scalpel TKW - Vibro-, Vibra-, Sono-, Sonic-Blade
TKW - Vibro-, Vibra-, Sono-, Sonic-Knife)
Background to the invention
The present invention concerns the field of general medicine, oral medicine and veterinary medicine and all procedures where precise cutting of organic cells and/or tissue, organic and non-organic flexible tissue and/or fibres is necessary. Presently (scalpel or "Stanley-Knive") blades used in medicine and other cutting professions are manufactured on a large industrial scale according to an internationally standardized number system to identify the shape and the size of the scalpel. Every cutting performed with these scalpel blades suffers in its precision from the friction of the scalpel blade to the cutted organic or fibre tissue causing a tearing, distorting and displacing effect to the cutted site when the cutting site is not fixed properly or the tissue layers are too many or too thick. This is caused by the constant and direct contact of the scalpel blade to the cutted tissue during the process of cutting leading to the distortion of the tissue and therefore reducing the precision of the cut.
To avoid this displacement of the tissue during cutting various lasers (e.g. CO2, Nd:YAG, Er:YAG, Ho:YAG, Diode, Excimer etc.) can be used but with a more or less strongly expressed heating and coagulating effect to the cutted organic molecules and therewith on a micro- and macroscopic scale to the border of the performed cut thus enlarging the width of the cut, decreasing it's precision and destroying the integrity of organic cells and fibres in a relatively large area on a microscopic scale. Physically cutting with lasers is a so-called "non-touch" (or "touchless")- cutting procedure by projecting bundled coherent electromagnetic waves ("coherent light") from the infrared to the ultraviolet range to the cutting site producing heat and thus disrupting the integrity of organic cells and/or fibres.
Brief description of embodiments of the invention fsυmmaryV.
The present invention is a new approach to cutting by projecting sonic/ultrasonic oscillation energy via conventional scalpel blades and/or especially shaped thin and light steel and/or ceramic blades to organic cells, organic and non-organic fibres and/or fibre-tissue with or without a cooling irrigation by various liquids transported to the cutting site by an internal and/or external irrigation channel in or to the device in order to allow cutting procedures with or without thermal side effects such as coagulation of biological tissues and minor blood vessels to achieve hemostasis.
Such the SONO-scalpel can be used in three modes: a) normal cutting with scalpel blade, b) sound/ultrasound activated cutting WITH heat-coagulating (hemostatic) effects on organic tissues, c) sound/Ultrasound activated cutting WITHOUT heat-coagulating effects on organic tissues by cooling the cutting blade with cooling liquids transported through an internal irrigation channel and/or an external irrigation hose aimed to the cutting edge of the blade.
The invention embodies an insert/tip with rigidly or removeable attached scalpel blades in international standard shapes or specialized designs for specific surgical and/or cutting procedures that can be attached to any sound and/or ultrasound generator by a connector or can be produced with this generator "in one piece".
Detailed description of embodiments of the invention
The present invention is a new approach to cutting by projecting sonic/ultrasonic oscillation energy via conventional scalpel blades and/or especially shaped thin and light steel and/or ceramic blades to organic cells, organic and non-organic fibres and/or fibre-tissue with or without a cooling irrigation by various liquids transported to the cutting site by an internal and/or external irrigation channel in or to the device.
Dr. Angelo Troedhan, Dr. Andreas Kurrek and Dr. Marcel Wainwright have invented and built several prototypes of the TKW-Sono-Scalpel to prove the theory and to put the invention into practice. Although the steel and/or ceramic blades still get in physical contact with the cutted tissue the main cutting effect is caused by the mechanical transferal of oscillation energy to the surrounding tissues, liquids (pure H2O, intra- and/or extracellular liquids, saline solutions, non- oxidative liquids etc.) and gasses (air, He, Xe, N2, CO2, 02, gaseous trace elements etc.) thus disrupting the integrity of organic cells, fibres and/or fibrous tissue. Additionally there is the well documented effect of ultrasound in liquid media which involves a cavitation phenomenon leading to the creation, growth and implosion of bubbles formed when a liquid is subjected to a periodic pressure wave. Under the effect of the ultrasound vibrations of the metal and/or ceramic (scalpel)blade-surface hydrodynamic cavitation bubbles (micro-pressures) are formed in intra- and/or extracellular liquids which implode (negative pressure) in contact with the solid surfaces of cellular membranes and organic molecules that they encounter. These pressure oscillations create a pneumatic effect on organic molecules, cells, organic and nob-organic fibres leading to the gentle, gradual and location-precise disruption of molecular chains in the presence of liquids.
As a side-effect heat is produced by the oscillating metal and/or ceramic blades through the physical mechanism of friction between the oscillating blade and the cutted tissue on one side and the compression of liquids and/or gasses on the other side, in case of cuts deeper than 0,1mm also between the oscillating blade and the organic molecules of the cutted tissue which can be - if necessary - annihilated with a cooling irrigation/vapor spray of cooling liquids transported and vapored to the cutting site by an internal and/or external irrigation channel in or to the device utilizing the oscillations of the present invention for the vaporization of the liquids to obtain a maximum heat absorbing surface of the liquid vapor.
The cutting and heating effect of oscillating liquids and/or gasses resembles somehow the disrupting effect of coherent electromagnetic waves ("lasers") from the infrared to ultraviolet range of electromagnetic frequency in organic molecules on the atomic scale, the disruption of organic cells by heating the inner-cell liquids and organic fibres by mechanically and thermally disrupting the structure of the long molecules on the microscopic and macroscopic scale. Since the physical effects of coherent electromagnetic and sonic/ultrasonic waves are different on the atomic level on the basis of mere physics (electromagnetic waves: electromagnetic interaction with electrons, ultrasonic waves: mechanical interaction with atomic binding forces i.e. Van der Waal-forces) the microscopic and macroscopic effects are somehow similar in organic molecules, cells and fibres (disruption of organic molecules and cells).
The present invention reduces and/or annihilates the unwished physical side effects of both conventional cutting metal and/or ceramic blades and lasers or gives the user the choice to use the side effects selectively:
Metal and/or ceramic blades oscillating in the range of 10.000 - 60.000 Hz at an amplitude of 0,0001 to 1 Millimeter need only slight contact to the cutting site even when penetrating into tissue layers more than lmm and thus causes no distortion of the cutted tissue by mere continous friction between the blade and the tissue similar to the "non- contact"- or "touchless"- cutting procedure using electromagnetic waves (i.e. medical or industrial lasers of different electromagnetic wavelengths) Using a metal and/or ceramic blade oscillating in the range of 10.000 - 60.000 Hz at an amplitude of 0,0001 to 1 Millimeter is independent of the energy-absorption of different electromagnetic wavelengths from infrared to ultraviolet in pure water and/or watery organic and saline solutions (water absorption curve of electromagnetic waves) and causes/produces less heat during cutting procedures in the organic tissue and tissue-fibres compared to cutting with lasers (i.e. medical or industrial lasers of different electromagnetic wavelengths, especially the vastly used Nd:YAG-laser in medicine). Thus efficient cutting with less heating/coagulating side effects in organic molecules is obtained in multiple adherent layers of organic tissues independently from their watery content.
To further reduce or prevent coagulating effects of the metal and/or ceramic blade oscillating in the range of 10.000 - 60.000 Hz at an amplitude of 0,0001 - 1 mm in organic molecules and/or cells by heating caused by friction and compression of gasses the metal and/or ceramic blades can be cooled by water spray applied to the blade and the cutting site.
Thus the TKW-Sono-Scalpel can be used in three modes:
a) as a conventional scalpel/cutting device b) as a pressure-free "non-contact" scalpel/cutting device with fast deep penetrating capabilities without distortion of the cutted tissue AND coagulating/hemostatic effects using no cooling liquid spray (water, physiological or other saline solutions, other heat absorbing liquids) c) as a pressure-free "non-contact" scalpel/cutting device with fast deep penetrating capabilities without distortion of the cutted tissue WITHOUT coagulating/hemostatic effects using a cooling liquid spray (water, physiological or other saline solutions, other heat absorbing liquids at different temperatures from liquid CO2 over ice-water to room-temperature liquids) at different flow rates to achieve the precise cooling effect to reduce or annihilate the heating side effects of the oscillating blade.
Thus the present invention combines all advantages of a regular scalpel/cutting blade and electromagnetic cutting devices (lasers) and annihilates the disadvantages of these devices or utilizes them selectively if necessary.
The present invention can be manufactured in a way that it connects to and can be coupled to mechanically to all sonic/ultrasonic generators presently available on the market (i.e. mechanical, electromagnetic, piezoelectric sound and ultrasound generators).
The present invention is meant to be used in:
Human medicine as cutting/preparation and/or coagulating/hemostatic device of soft human tissue (e.g. skin, mucosa, connective tissue, blood vessels, liver-, spleen-, lung-, muscle-, brain-, kidney-, intestine-, cartilage-, fibrous-tissue etc. - list is only taxative) and all specialized fields of surgery in human medicine (e.g. general surgery, orthopedic surgery, plastic surgery, intestine surgery, lung surgery, brain surgery, kidney-surgey, cancer surgery, ENT surgery, Dermal surgery, Heart surgery, i.e. all human surgery where cutting and/or modelling of soft and/or cartilage tissue is performed etc. - list is only taxative) on microscopic and macroscopic level depending on the size of the blades.
Dental medicine (Dentistry) as cutting/preparation and/or coagulating/hemostatic device of soft human tissue (e.g. skin, mucosa, connective tissue, blood vessels, muscle-, cartilage-, fibrous-tissue etc. - list is only taxative) on microscopic and macroscopic level depending on the size of the blades.
Veterinary medicine as cutting/preparation and/or coagulating/hemostatic device of soft veterinary tissue (e.g. skin, mucosa, connective tissue, blood vessels, liver-, spleen-, lung-, muscle-, brain-, kidney-, intestine-, cartilage-, fibrous-tissue etc. - list is only taxative) and all specialized fields of surgery in veterinary medicine (e.g. general surgery, orthopedic surgery, plastic surgery, intestine surgery, lung surgery, brain surgery, kidney-surgey, cancer surgery, ENT surgery, Dermal surgery, Heart surgery, i.e. all veterinary surgery where cutting and/or modelling of soft and/or cartilage tissue is performed etc. - list is only taxative) on microscopic and macroscopic level depending on the size of the blades.
Biology: preparation/dissection of organic tissues including plants on microscopic and macroscopic level on microscopic and macroscopic level depending on the size of the blades.
All manufacturing processes where organic and/or semiorganic fibres and/or tissues have to be cut (organic and non organic fibres and textiles).
All cutting processes of organic and non-organic soft tissues that can be cut with lasers and/or conventional metal and/or ceramic blades Brief description of drawings
DRAWING 1: FIG.l and FIG.2 show the insert/tip of the TKW-SONO- Scalpel for use in surgery in all dental/medical and veterinary surgical procedures and cutting processes on all current and future sound and/or ultrasound devices (10.000-60.000 Hz) and the shape of the Basic Body for the sound or ultrasound Insert/tip (universal use with regular scalpel steel blades intl. ID#: 10, 12, 12d, 15a-c, 20, 22 or thin knive blades such as "Stanley-Knives") when attached to the sonic and/or ultrasonic device by screwing or by a snap-in mechanism. In FIG.l the scalpel blade is attached to the insert/tip by a rigid connection (scalpel blade non removable) whereas in FIG.2 the scalpel blade is snapped onto the tip and can be removed.
DRAWING 2: FIG.3 to FIG.7 show the manufacturing process for an insert/tip described in FIG.2
DRAWING 3: FIG.8 and FIG.9 show the manufacturing of a SONO- scalpel with a blade in one piece
FIG. 10 and FIG. 11 show the oscillation behaviour of the SONO-scalpel in both variations described in FIG. 1 and FIG. 2
DRAWING 4: FIG. 12 - 18 shows various types of the Sono-Scalpel especially concerning the shape of the scalpel blades meant for microsurgical procedures both removable or "in one piece" and in metal alloy or ceramic.
DRAWING 5: FIG. 19 - 21 show how the SONO-scalpel is connected to various sound or ultrasound generators the prototypes were tested with. Detailed description of embodiments of the invention
DRAWING 1:
FIG.l shows the insert/tip with its connector (101) to the sound or ultrasound generator. The connector (101) is attached to the sound or ultrasound device by screw-windings (102) or a snap-on mechanism (103). The hose for an external cooling liquid (104) runs parallel to the connector and aims at the cutting edge of the scalpel blade. The main body of the insert/tip (105) is perforated by an internal irrigation channel (106) that leaves the main body at the sides projecting the cooling liquid to the cutting edge (107) of the scalpel blade (108). The scalpel blade (108) in this variation of the SONO-Scalpel is rigidly attached (manufactured as whole or TIG-welded) to the main body (105)
FIG.2 shows the insert/tip with its connector (101) to the sound or ultrasound generator. The connector (101) is attached to the sound or ultrasound device by screw-windings (102) or a snap-on mechanism (103). The hose for an external cooling liquid (104) runs parallel to the connector and aims at the cutting edge of the scalpel blade. The main body of the insert/tip (105) is perforated by an internal irrigation channel (106) that leaves the main body at the sides projecting the cooling liquid to the cutting edge (107) of the scalpel blade (109). The scalpel blade
(109) in this variation of the SONO-scalpel is removable and attached to the main body (105) by arresting the the scalpel blade (109) in tight slits
(110) encarved into the main body (105) for universal use with regular scalpel steel blades intl. ID#: 10, 12, 12d, 15a-c, 20, 22 (FIG.2 shows regular steel scalpel-blade (109) with intl. ID# 15c)
DRAWING 2: FIG.3 shows the raw form ("rawling") of the SONO-scalpel. The length of the main body (105) varies from 26~126mm excluding the connector (101) to the sound and/or ultrasound generator (electromechanical and/or piezoelectronic impulse device). The Rawling needs minimum 26mm length of the main body (105) excluding the connector (101) for conventional surgical scalpel blades. A Millimeter-Scale (202) is attached to FIG.3-FIG.7 as well as numbers (203) resembling the diameter of the cross sections (201) in mm.
The final length of the main body (105) has always to be calculated according to the frequency and amplitude of the sound and/or ultrasound generator.
FIG. 4 to FIG.7 shows the process of forming the main body (105) of the SONO-scalpel by reducing the rawling (FIG.l) to its final shape (FIG.7) to receive a standard surgical scalpel blade (FIG.l (109).
FIG. 5 During the shaping process (FIG.3.-FIG.7) the internal irrigation channel (106) for the cooling liquid is drilled into the main body (105) of the insert/tip as well as the slits (110) that receive and hold firmly the exchangeable scalpel blade.
DRAWING 3:
FIG. 8 shows the raw form ("rawling") of the SONO-scalpel. The length of the main body (105) varies from 5-126mm excluding the connector (101) to the sound and/or ultrasound generator (electromechanical and/or piezoelectronic impulse device). The Rawling needs a length between 5mm to 126mm of the main body (105) excluding the connector (101) and a diameter between 2 and 15 mm (201). A Millimeter-Scale (202) is attached to FIG.8 and FIG.9 as well as numbers (203) resembling the diameter of the cross sections (201) in mm. FIG. 9 shows the final SONO-scalpel with its connector (101) to the sound and/or ultrasound generator, its main body (105) also forming the scalpel blade (108) and the internal irrigation channel (106)
FIG. 10 shows the oscillation behaviour of the SONO-scalpel described in FIG. 1 when connected and activated by a sound and/or ultrasound generator: the SONO-scalpel-blade (108) achieves its maximum oscillation amplitude in the distal third to the apex of the scalpel blade.
The blade oscillates mainly along the Y-axis (205) between 0,0001mm (206) to lmm (207) amplitude but also along the X-axis (204) between 0,0001mm (208) and lmm (209) depending on the oscillation characteristics of the sound and/or ultrasound device the insert/tip is attached to. The oscillation basic characteristic is a harmonic sinus-curve but can be modulated and/or triggered for various types of biological tissues.
If a cooling of the oscillating scalpel blade (108) is mandatory the cooling liquid (210) is projected/sprayed via the internal irrigation channel(lθδ) or external irrigation hose (104) towards the cutting edge (107) of the scalpel blade thus preventing a coagulating effect in biological tissues.
FIG. 11 shows the oscillation behaviour of the SONO-scalpel described in FIG. 2 when connected and activated by a sound and/or ultrasound generator: the SONO-scalpel-blade (109) achieves its maximum oscillation amplitude in the distal third to the apex of the scalpel blade.
The blade oscillates mainly along the Y-axis (205) between 0,0001mm (206) to lmm (207) amplitude but also along the X-axis (204) between 0,0001mm (208) and lmm (209) depending on the oscillation characteristics of the sound and/or ultrasound device the insert/tip is attached to. If a cooling of the oscillating scalpel blade (109) is mandatory the cooling liquid (210) is projected/sprayed via the internal irrigation channel(106) or external irrigation hose (104) towards the cutting edge (107) of the scalpel blade thus preventing a coagulating effect in biological tissues.
DRAWING 4:
FIG. 12 shows the design of the SONO-Scalpel for use in microsurgical procedures. The length of the main body (105) varies from 2 - 100mm excluding the connector (101) to the sound and/or ultrasound generator (electromechanical and/or piezoelectronic impulse device).
The removable micro-scalpel blade (112) is received by a receptacle (111) in the dimensions of 2-7 x 2-7 x 3-5 mm and arrested by an external snap-in mechanism (113). Numbers (203) are annotated to FIG.12-FIG. 18 resembling the lengths and the diameter of the cross sections (201) in mm. The cooling liquid is transported by the internal cooling channel (106) and/or by an external hose (104) and is essential to the invention.
FIG. 13 shows a removable ovoid microscalpel blade (112) that attaches to the receptacle (111) of the insert/tip. The dimensions are typed in bold letters (203) resembling the size in Millimeters.
FIG. 14 shows a removable pyramid shaped microscalpel blade (114) that attaches to the receptacle (111) of the insert/tip. The dimensions are typed in bold letters (203) resembling the size in Millimeters.
FIG. 15 shows the design of the SONO-Scalpel made in one piece for use in microsurgical procedures. The length of the main body (105) varies from 2 - 100mm excluding the connector (101) to the sound and/or ultrasound generator (electromechanical and/or piezoelectronic impulse device). The ovoid micro-scalpel blade (112) (or any other shape of micro scalpel- blade) is manufactured from one rawling including the connector (101), and the the main body (105) . Numbers (203) are annotated resembling the lengths and the diameter of the cross sections (201) in mm. The cooling liquid is transported by the internal cooling channel (106) and/or by an external hose (104) which is essential to the invention.
FIG. 16 shows another variation of the SONO-Scalpel for use in microsurgical procedures in connection with microsurgical ceramic blades. The only difference to FIG. 12 is the receptacle which has a more broad opening to receive the thicker ceramic scalpel-blades (FIG. 17 (115, 116), FIG. 18 (117, 118).
FIG. 17 shows a removable ovoid microscalpel ceramic blade in flat view (115) and side view (116) with annotated dimensions in Millimeters typed in bold numbers (203) that attaches to the receptacle FIG. 16 (115) of the insert/tip.
FIG. 18 shows a removable pyramid shaped microscalpel ceramic blade in flat view (117) and side view (118) with annotated dimensions in Millimeters typed in bold numbers (203) that attaches to the receptacle
FIG. 16 (115) of the insert/tip.
DRAWING 5:
FIG. 19 shows - as an example - the SONO-scalpel ("one piece" - type described in FIG. 9 and FIG. 1) with its connector (101), its main body
(105) including the scalpel blade (108), the internal irrigation channel
(106) projecting the cooling liquid (210) to the cutting edge of the scalpel blade (108) connected with a piezoelectronic ultrasound surgical device (301) with internal cooling by a cooling liquid transported by an external pump working at a modulated and/or unmodulated ultrasonic sinus wave of approx. 30.000 Hz FIG. 20 shows - again as an example - the SONO-scalpel with removable scalpel blades as described in FIG. 2 with an external cooling liquid hose (104) connected to a battery-driven electromagnetic-mechanic coupled sound and/or ultrasound device (302) working at frequencies of approx. 30.000 Hz.
FIG. 21 shows - as an example - the SONO-scalpel with a removable scalpel blade in the shape of a "Stanley-Knive" (119) as described in FIG. 2 with an external cooling liquid hose (104) connected to a battery-driven electromagnetic-mechanic coupled pen-sized sound device (303) working at frequencies of approx. 15.000 Hz.

Claims

1. The Sono-Scalpel as described in FIG. 1 to Rg. 21 as an insert/tip to be used with and manufactured for all current and future sonic and/or ultrasonic surgical devices used in dental/general/veterinary medicine and other sonic or ultrasonic generators built for manufacturing or cutting processes working in the range from 10.000 Hz to 60.000 Hz with an amplitude of 0f0001 to lmm with and/or without external and/or internal cooling-irrigation delivered through an irrigation channel drilled through or carved into the bottom or side of the Sono-Scal pel-Insert or applied by an external irrigation hose connected with a pump in order to deliver the cooling fluid to the cutting edge of the Sono-Scalpel and manufactured in anv metal alloy, resin, organic fibre and/or vibration resistant ceramic material.
2. The Sono-Scalpel-insert is comprising a body . extending between a proximal part adapted for vibration resistant removable or rigid/permanent coupling (welded, screwed, "snap in or on") to a mobile or rigidly installed sound or ultrasound-generator generating sonic or ultrasound vibrations and a distal part intended to reproduce the sonic or ultrasound vibrations
transmitted by the ultrasound generator and deliver it to a cutting device such as surgical scalpel-blades or knive-blades such as "Stanley-Knives". The lenqht of the Sono Scalpel measures from 26 to 126mm excluding the connector to the sonic and/or ultrasonic device ("mechanical and/or piezoelectronic impulse device") and the scalpel- or knive-blade and has a diameter of 2-15mm in a round and/or edged shape¬
s' The basic receptacle of the Sono-Scalpel (105^) needs minimum 26mm length excluding the connector for use with conventional internationally standardized surgical scalpel blades.
4. Length of the Sono-Scalpel is calculated according to overall mass of the Sono-Scalpel depending on the material it is produced with and Frequency/Amplitude of the sonic and/or ultrasonic device/generator in such a wav that the maximum amplitude/energy of the oscillation is concentrated on the first 2/3 of the cutting edge of the scalpel blade.
5. The oscillation amplitude measured at the cutting edge of the scalpel blade reaches from 0f0Oulmm to lmm on the y-axis and/or x-axis (206r 207,208, 209) .
6. The production of the general use Sono-Scalpel is on the basis of general used common steel-scalpel blades or thin knive-blades such as "Stanlev-Knives" ±
7. The Sono-Scalpel is produced either as a removable insert/tip for any sound or ultrasound generator device transforming sound or ultrasound into mechanical oscillations in connection with one or more common internationally standardized surgical scalpel blades CFIG. 1) or one or more thin knive blades known as "Stanley-Knives" which are rigidly fixed to the insert/tip or removable or as a "one-piece"-device rigidly fixed to the ultrasound generator or as a removable insert/tip fitting to various existing and/or future sonic and/or ultrasonic (surgicaO devices (FIG. 2).
8. Claims are added furthermore to ail metal and/or ceramic cutting blades exchangeable or permanently fixed to the invention with an effective cutting edge-size from 0,1mm x 0,1mm to 500mm x 500mm both with internal and/or external irrigation to produce a cooling liquid vapour to the cutting edge which are explicitly produced for the invented Sono-Scalpel except internationally standardized surgical scalpel blades or knive-blades known as "Stanlev-Knives".
PCT/AT2007/000213 2007-06-08 2007-06-08 Ultrasonic scalpel WO2008148139A1 (en)

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EP2551077A1 (en) 2011-07-26 2013-01-30 A O Schallinox GmbH Blade for splitting goods for processing using ultrasound energy and device
WO2013059140A1 (en) * 2011-10-17 2013-04-25 Carefusion 303, Inc. Device for applying medical fluid to and cutting within an area
CN103313676A (en) * 2010-11-09 2013-09-18 基研系统有限公司 Orthodontic stripper, blade and method for removing orthodontic brackets
RU168974U1 (en) * 2016-09-14 2017-02-28 Общество с ограниченной ответственностью Совместное русско-французское предприятие "СпектрАп" SCALPEL
CN107949334A (en) * 2015-08-28 2018-04-20 奥林巴斯株式会社 Surgery systems
WO2020034005A1 (en) 2018-08-15 2020-02-20 Larboard Pty Ltd Device and method for delivering liquids during surgery
CN114569199A (en) * 2022-03-04 2022-06-03 悦兴(厦门)生物科技有限公司 High-toughness ceramic scalpel and operation method thereof
WO2023023022A1 (en) * 2021-08-18 2023-02-23 Mayo Foundation For Medical Education And Research Myectomy devices and methods

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CN103313676A (en) * 2010-11-09 2013-09-18 基研系统有限公司 Orthodontic stripper, blade and method for removing orthodontic brackets
CN102475565A (en) * 2011-05-03 2012-05-30 江苏水木天蓬科技有限公司 Ultrasonic transducer
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CN107949334A (en) * 2015-08-28 2018-04-20 奥林巴斯株式会社 Surgery systems
CN107949334B (en) * 2015-08-28 2020-12-04 奥林巴斯株式会社 Surgical system
RU168974U1 (en) * 2016-09-14 2017-02-28 Общество с ограниченной ответственностью Совместное русско-французское предприятие "СпектрАп" SCALPEL
WO2020034005A1 (en) 2018-08-15 2020-02-20 Larboard Pty Ltd Device and method for delivering liquids during surgery
WO2023023022A1 (en) * 2021-08-18 2023-02-23 Mayo Foundation For Medical Education And Research Myectomy devices and methods
CN114569199A (en) * 2022-03-04 2022-06-03 悦兴(厦门)生物科技有限公司 High-toughness ceramic scalpel and operation method thereof
CN114569199B (en) * 2022-03-04 2023-08-25 悦兴(厦门)生物科技有限公司 High-toughness ceramic surgical knife and operation method thereof

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