US20160302821A1 - Ultrasonic surgical instruments - Google Patents

Ultrasonic surgical instruments Download PDF

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Publication number
US20160302821A1
US20160302821A1 US15/194,408 US201615194408A US2016302821A1 US 20160302821 A1 US20160302821 A1 US 20160302821A1 US 201615194408 A US201615194408 A US 201615194408A US 2016302821 A1 US2016302821 A1 US 2016302821A1
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US
United States
Prior art keywords
cutting blade
jaw member
shaft
tissue
ultrasonic surgical
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US15/194,408
Inventor
Anthony B. Ross
Robert B. Stoddard
James S. Cunningham
William J. Dickhans
Russell D. Hempstead
Eric R. Larson
Duane E. Kerr
William H. Nau, JR.
Arlen K. Ward
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Covidien LP
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Covidien LP
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Filing date
Publication date
Application filed by Covidien LP filed Critical Covidien LP
Priority to US15/194,408 priority Critical patent/US20160302821A1/en
Assigned to TYCO HEALTHCARE GROUP LP reassignment TYCO HEALTHCARE GROUP LP ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: LARSON, ERIC R., HEMPSTEAD, RUSSELL D., DICKHANS, WILLIAM J., CUNNINGHAM, JAMES S., KERR, DUANE E., NAU, WILLIAM H., JR., ROSS, ANTHONY B., STODDARD, ROBERT B., WARD, ARLEN K.
Assigned to COVIDIEN LP reassignment COVIDIEN LP CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: TYCO HEALTHCARE GROUP LP
Publication of US20160302821A1 publication Critical patent/US20160302821A1/en
Abandoned legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • A61B17/295Forceps for use in minimally invasive surgery combined with cutting implements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • A61B2017/00084Temperature
    • A61B2017/00088Temperature using thermistors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • A61B2017/00084Temperature
    • A61B2017/00092Temperature using thermocouples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/00336Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means with a protective sleeve, e.g. retractable or slidable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • A61B2017/320093Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw additional movable means performing cutting operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • A61B2017/320094Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw additional movable means performing clamping operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/00059Material properties
    • A61B2018/00089Thermal conductivity
    • A61B2018/00095Thermal conductivity high, i.e. heat conducting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/00059Material properties
    • A61B2018/00089Thermal conductivity
    • A61B2018/00101Thermal conductivity low, i.e. thermally insulating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/04Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery
    • A61B2090/0472Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery against ultrasound energy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/04Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery

Definitions

  • the present disclosure relates to ultrasonic surgical instruments. More particularly, the present disclosure relates to ultrasonic surgical instruments configured to minimize heat damage to tissue adjacent the tissue of interest.
  • Ultrasonic energy-powered instruments configured to cut and/or fragment tissue are known in the art.
  • Ultrasonic instruments typically, include a transducer that is coupled to a probe/waveguide having an active member (e.g., cutting blade, shear, hook, ball, etc.) at a distal end thereof.
  • an active member e.g., cutting blade, shear, hook, ball, etc.
  • ultrasonic energy is utilized to vibrate (e.g., at frequency usually in the range of 20 KHz to 60 KHz) the active member to treat tissue of interest.
  • Ultrasonic instruments may include any of a variety of probe configurations to achieve a specific surgical result.
  • the probe configuration may include an active member in the form of a cutting blade that is combined with a movable jaw configured to grasp and/or manipulate tissue.
  • Such ultrasonic instruments are primarily used in a variety of medical procedures including open surgical procedures, luminal procedures, and endoscopic procedures.
  • the active member e.g., the cutting blade
  • the active member may reach temperatures greater than 200° C.
  • inadvertent contact between the cutting blade, such as, for example, a lower portion thereof, and tissue, e.g., tissue adjacent the tissue of interest, may cause undesirable heat damage to the tissue.
  • ultrasonic instruments configured to minimize heat damage to tissue adjacent tissue of interest that has been ultrasonically treated may prove useful in the medical art.
  • distal refers to a portion that is being described which is further from a user
  • proximal refers to a portion that is being described which is closer to a user
  • the ultrasonic instrument includes a housing having an elongated shaft extending therefrom.
  • the shaft defines a longitudinal axis therethrough and has a pair of first and second jaw members disposed at a distal end thereof.
  • the first jaw member is movable between an open configuration and a clamping configuration and the second jaw member is translatable along the longitudinal axis from a retracted configuration to an extended configuration.
  • a lever may be operably coupled to the housing and configured to move the first jaw member between the open and clamping configurations.
  • a cutting blade extends at the distal end of the shaft and operably couples to the housing and adjacent the first and second jaw members.
  • the cutting element is coupled to a probe that extends within the shaft.
  • the second jaw member is moveable to the extended configuration to cover a bottom portion of the cutting blade to reduce heat damage to tissue adjacent tissue of interest that has been treated by the cutting blade.
  • a switching mechanism may be disposed on the ultrasonic surgical instrument and configured to actuate the second jaw member to move the second jaw member from the retracted configuration to the extended configuration.
  • At least a portion of the second jaw member may be made from a material having high thermal conductivity to facilitate cooling of the cutting blade. Moreover, a bottom portion of the second jaw member may be covered with an insulative material to reduce thermal spread from the second jaw member to tissue adjacent the tissue of interest.
  • the second jaw member may include at least one temperature sensor thereon configured to detect a temperature of the cutting blade.
  • the temperature sensor(s) may be, but is not limited to, thermocouple or a thermistor.
  • the ultrasonic surgical instrument includes a housing having an elongated shaft extending therefrom.
  • the shaft defines a longitudinal axis therethrough and has a jaw member disposed at a distal end thereof.
  • the jaw member is movable between an open configuration and a clamping configuration.
  • a sheath operably couples to the housing and is coaxially disposed along shaft.
  • the sheath is translatable along the longitudinal axis from a retracted configuration to an extended configuration.
  • a cutting blade extends at a distal end of the shaft and operably couples to the housing and adjacent the jaw member.
  • the sheath is moveable to the extended configuration to cover at least the cutting blade to reduce heat damage to tissue adjacent tissue of interest that has been treated by the cutting blade.
  • a switching mechanism may be disposed on the ultrasonic surgical instrument and configured to actuate the sheath to move the sheath from the retracted configuration to the extended configuration.
  • At least a portion of an interior surface of the sheath may be made from a material having a high thermal conductivity to facilitate cooling the cutting blade.
  • An exterior surface of the sheath may be covered with an insulative material to reduce thermal spread from the sheath to tissue adjacent tissue of interest.
  • the sheath may include at least one temperature sensor thereon configured to detect a temperature of the cutting blade.
  • the temperature sensor(s) may be, but is not limited to, thermocouple or a thermistor.
  • the ultrasonic surgical instrument includes a housing having an elongated shaft extending therefrom.
  • the shaft defines a longitudinal axis therethrough and has a first jaw member disposed at a distal end thereof.
  • the first jaw member is movable between open and clamping configurations.
  • a cutting blade extends at a distal end of the shaft and operably couples to the housing and adjacent the first jaw member.
  • the cutting blade is translatable along the longitudinal axis from a retracted configuration within the shaft to an extended configuration outside the shaft to treat tissue of interest.
  • the cutting blade is moveable to the retracted configuration within the shaft to reduce heat damage to tissue adjacent tissue of interest that has been treated by the cutting blade.
  • a switching mechanism may be disposed on the housing and configured to actuate the cutting blade to move the cutting blade from the retracted configuration to the extended configuration.
  • the shaft may include at least one temperature sensor thereon configured to detect a temperature thereof.
  • the temperature sensor(s) may be, but is not limited to, thermocouple or a thermistor.
  • the ultrasonic surgical instrument may further include a second jaw member that is pivotably coupled to the first jaw member and configured to move between an open configuration and a clamping configuration to facilitate clamping tissue.
  • FIG. 1 is a right, perspective view of an ultrasonic instrument according to an embodiment of the present disclosure
  • FIG. 2 is an enlarged, side, schematic view of a distal end of the ultrasonic instrument depicted in FIG. 1 with a bottom jaw member illustrated in an extended configuration;
  • FIG. 3 is an enlarged, side, schematic of the distal end depicted in FIG. 2 with the bottom jaw member illustrated in a retracted configuration;
  • FIG. 4 is an enlarged, side, schematic of a distal end of an ultrasonic instrument according to another embodiment of the present disclosure with a protective sheath illustrated in a retracted configuration;
  • FIG. 5 is an enlarged, side, schematic with the protective sheath illustrated in an extended configuration
  • FIG. 6 is an enlarged, side, schematic of a distal end of an ultrasonic instrument according to yet another embodiment of the present disclosure with an cutting blade illustrated in an extended configuration;
  • FIG. 7 is an enlarged, side, schematic with the cutting blade illustrated in a retracted configuration.
  • an ultrasonic surgical instrument 2 (instrument 2 ) according to an embodiment of the present disclosure is illustrated.
  • the instrument 2 is described herein as being battery powered.
  • the instrument 2 may be externally powered, e.g., via a remote ultrasonic generator that is coupleable to the instrument 2 .
  • instrument 2 includes a housing 6 configured to house one or more components, e.g., transducer (not explicitly shown), a probe 16 , and electrical circuitry that is configured for electrical communication with a battery assembly 8 of the instrument 2 .
  • a proximal end of housing 6 is configured to releasably couple to an ultrasonic generator 10 and the battery assembly 8 .
  • a distal end of the housing 6 is configured to support and/or couple to a proximal end 22 of a shaft 4 having a longitudinal axis “A-A” defined therethrough.
  • a rotation knob 26 operably couples to housing 6 and is configured to rotate the shaft 4 approximately 360° in either direction about the longitudinal axis “A-A.”
  • Generator 10 includes the transducer that is coupled to the probe 16 via a torque adapter (not explicitly shown) and configured to produce vibratory motion of a cutting blade 17 disposed at a distal end of the probe 16 when a trigger 7 is depressed. This vibratory motion of the cutting blade 17 is utilized to treat tissue of interest.
  • Battery assembly 8 includes a handpiece 24 having a battery (not explicitly shown) operably disposed therein.
  • an end effector 12 includes a pair of first and second jaw members 14 and 15 that are supported at a distal end 18 of the shaft 4 adjacent cutting blade 17 .
  • Jaw member 14 is pivotably supported at the distal end of the shaft 4 via a pivot pin 3 ( FIG. 2 ) and functions as a “clamping jaw.”
  • jaw member 14 is movable relative to the cutting blade 17 (and/or the distal end 18 of the shaft 4 ) between an open configuration ( FIGS. 1 and 2 ) and a clamping configuration ( FIG. 3 ) to clamp tissue when a lever or movable handle 20 ( FIG. 1 ) is actuated.
  • Jaw member 14 and cutting blade 17 are configured to collectively grasp and ultrasonically treat tissue.
  • the cutting blade is configured to vibrate at a specific frequency (e.g., at a frequency in the range from about 20 KHz to about 60 KHz) to treat tissue.
  • jaw member 15 is translatable along the longitudinal axis “A-A” from a retracted configuration ( FIGS. 1 and 3 ) to an extended configuration ( FIG. 2 ).
  • jaw member 15 is configured to cover (or shield) a bottom portion 19 of the cutting blade 17 to prevent or reduce inadvertent contact between the heated cutting blade 17 and tissue, e.g., tissue that is adjacent tissue of interest that has been ultrasonically treated or is being ultrasonically treated by the cutting blade 17 .
  • Jaw member 15 may be configured to function as a heat sink and dissipate heat from the cutting blade 17 into one or more suitable mediums, e.g., air, to facilitate cooling of cutting blade 17 .
  • jaw member 15 may be made from any suitable material including, but not limited to metal, plastic, ceramic, etc.
  • jaw member 15 is made from a material, e.g., metal (suitable metals may include aluminum alloys, copper, tungsten, etc.), having high thermal conductivity (or high thermal mass) to facilitate cooling cutting blade 17 when the jaw member 15 is positioned adjacent thereto.
  • diamond or diamond dust
  • a bottom portion 21 of the jaw member 15 may be covered with an insulative material, e.g., plastic, ceramic, etc., to reduce thermal spread from the jaw member 15 to tissue adjacent the tissue of interest and/or the shaft 4 .
  • bottom portion 21 is formed from ceramic material.
  • One or more temperature sensors 23 may be positioned on jaw members 14 and 15 .
  • a temperature sensor 23 is positioned on the jaw member 15 and is configured to detect a temperature of the cutting blade 17 when the jaw member 15 is in the extended configuration, see, e.g., FIG. 2 .
  • temperature sensor 23 may be any suitable type of temperature sensor including, but not limited to thermocouples, thermistors and the like.
  • Temperature sensor 23 may be configured to communicate with one or more modules of the generator 10 and/or the battery assembly 8 .
  • temperature sensor 23 may be configured to provide data pertaining to a temperature of the cutting blade 17 to a temperature control module 11 ( FIG. 1 ) of the generator 10 and/or battery assembly 8 .
  • temperature control module 11 is provided with the generator 10 ( FIG. 1 ). The temperature control module 11 may analyze the data pertaining to temperature of the cutting blade 17 and utilize one or more control algorithms to control an output response of the transducer based on this data to regulate a vibration frequency of the probe 16 such that a desired temperature may be maintained at the cutting blade 17 .
  • instrument 2 and the temperature control module 11 may be configured to provide one or more indications, e.g., an audio indication “A”, a visual indication “V”, and so forth, to a user indicating that the cutting blade 17 is sufficiently cooled or at a predetermined safe temperature ( FIG. 1 ).
  • a safe temperature of the cutting blade 17 is a temperature incapable of damaging tissue.
  • a switching mechanism 28 is disposed on the housing 6 and operably couples to jaw member 15 to actuate jaw member 15 and move jaw member 15 from the retracted configuration to the extended configuration.
  • Switching mechanism 28 may be any suitable type of switching mechanism including but not limited to push-buttons, dials, slides, and the like.
  • switching mechanism 28 includes a dial 30 positioned at a distal end of the housing 6 .
  • Dial 30 is configured to move jaw member 15 to the extended configuration when the dial 30 is moved in a counter-clockwise direction and is configured to move jaw member 15 back to the retracted configuration when the dial 30 is moved in a clockwise direction.
  • One or more components such as, for example, drive rods, servos, links, gears and the like may be provided with the instrument 2 to provide mechanical and/or electrical communication between the dial 30 and jaw member 15 .
  • tissue may be positioned between the jaw member 14 and the cutting blade 17 . Subsequently, trigger 7 may be depressed to activate the cutting blade 17 to treat tissue of interest.
  • dial 30 may be actuated to move the jaw member 15 to the extended configuration ( FIG. 2 ) to cover (or shield) cutting blade 17 .
  • jaw member 15 may serve as a heat-sink as a result of the high thermal conductivity associated therewith to facilitate dissipating heat from cutting blade 17 for cooling thereof.
  • dial 30 may be actuated to move jaw member 15 back to the retracted configuration ( FIGS. 1 and 3 ).
  • the sensor(s) 23 and temperature control module 11 may be utilized to monitor the temperature of cutting blade 17 and indicate (e.g., audio indication “A” or visual indication “V”) to a user when cutting blade 17 is sufficiently cooled.
  • a user may employ the cutting blade 17 to grasp and/or manipulate tissue.
  • the unique configuration of the instrument 2 including the jaw member 15 overcomes the aforementioned drawbacks that are typically associated with conventional ultrasonic instruments. That is, the likelihood of heat damage occurring to tissue adjacent tissue of interest that has been ultrasonically treated by the cutting blade 17 is reduced, if not eliminated by the jaw member 15 .
  • instrument 2 has been described herein as including a jaw member 15 that is configured to cover the cutting blade 17 , other devices or methods may be utilized to cover the cutting blade 17 to prevent inadvertent contact between the hot cutting blade 17 and tissue.
  • the instrument 102 ( FIG. 1 ) includes a sheath 125 that is configured to cover the cutting blade 117 and jaw member 114 .
  • Instrument 102 functions similarly to instrument 2 , in view thereof only those features unique to instrument 102 are described in detail.
  • Sheath 125 operably couples to the housing 6 via one or more suitable coupling methods and is coaxially disposed along shaft 104 .
  • the sheath 125 is translatable along the longitudinal axis “A-A” from a retracted configuration ( FIG. 4 ) to an extended configuration to cover at least a portion of the cutting blade 117 (and/or jaw member 114 ) to reduce heat damage to tissue adjacent tissue of interest that has been treated by cutting blade 117 .
  • sheath 125 is configured to fully cover jaw member 114 and cutting blade 117 .
  • a portion of an interior surface of the sheath 125 is formed from a material 5 b having high thermal conductivity to facilitate cooling the cutting blade 117 .
  • an exterior surface of the sheath 125 is covered with an insulative material 5 a to reduce thermal spread from sheath 125 to tissue adjacent tissue of interest.
  • one or more of the aforementioned temperature sensors 123 may be disposed on sheath 125 and configured to detect a temperature of the cutting blade 117 . In the embodiment illustrated in FIGS. 4 and 5 , temperature sensor 123 is positioned on an interior surface of sheath 125 and is configured to function as described above with respect to sensor 23 .
  • dial 130 is coupled to the sheath 125 to actuate the sheath 125 and move the sheath 125 from the retracted configuration ( FIG. 4 ) to the extended configuration ( FIG. 5 ).
  • Operation of the instrument 102 that includes the sheath 125 is similar to that of instrument 2 that includes the jaw member 15 .
  • dial 130 may be actuated to move sheath 125 to the extended configuration ( FIG. 5 ) to cover the cutting blade 117 and the jaw member 114 .
  • the sheath 125 serves as a “heat-sink” as a result of the high thermal conductivity thereof to facilitate cooling cutting blade 117 .
  • the instrument 102 including the sheath 125 overcomes the aforementioned drawbacks typically associated with conventional ultrasonic surgical instruments and affords the same advantages as the instrument 2 to a user.
  • the instrument 202 ( FIG. 1 ) includes a cutting blade 217 .
  • Instrument 202 functions similarly to instrument 2 , therefore only those features unique to instrument 202 are described in detail.
  • a cutting blade 217 is translatable along the longitudinal axis “A-A” from a retracted configuration ( FIG. 7 ) within the shaft 218 to an extended configuration ( FIG. 6 ) outside the shaft 218 .
  • cutting blade 217 and jaw member 214 are configured to treat tissue of interest as described hereinabove. As can be appreciated, heat damage to tissue adjacent the tissue of interest that has been treated by cutting blade 217 is reduced when cutting blade 217 in the retracted configuration.
  • One or more of the aforementioned temperature sensors 223 may be disposed on an interior surface of the shaft 204 ( FIGS. 6 and 7 ) and configured to function as described above with respect to sensors 23 and 123 .
  • dial 230 is coupled to the cutting blade 217 to actuate the cutting blade 217 and move the cutting blade 217 from the retracted configuration ( FIG. 7 ) to the extended configuration ( FIG. 6 ).
  • the instrument 202 including the cutting blade 217 overcomes the aforementioned drawbacks typically associated with conventional ultrasonic surgical instruments and affords the same advantages as the instruments 2 , 102 to a user.
  • an optional second jaw member 215 may be provided with the instrument 202 to facilitate grasping and/or manipulating tissue, such as, for example, when the cutting blade 217 is in the retracted configuration, see FIG. 7 .
  • the movable handle 20 may be configured to move jaw member 215 from an open configuration to a clamping configuration.
  • the movable handle 20 may be configured to move through a first clamping stroke to close the jaw member 214 and through a second clamping stroke to close the jaw member 215 .
  • Those skilled in the art will appreciate other methods of opening and closing jaw member 215 .
  • the aforementioned jaw members 14 , 15 , 114 , 214 and 215 may be provided with a relatively flat tissue contacting surface ( FIGS. 1-5 ) or a serrated tissue contacting surface ( FIGS. 6 and 7 ).
  • the specific configuration of the tissue contacting surfaces of the aforementioned jaw members 14 , 15 , 114 , 214 and 215 may be altered or modified to achieve a specific tissue effect.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Dentistry (AREA)
  • Ophthalmology & Optometry (AREA)
  • Surgical Instruments (AREA)

Abstract

An ultrasonic surgical instrument is provided. The ultrasonic surgical instrument includes a housing having an elongated shaft extending therefrom. The shaft defines a longitudinal axis therethrough and has at least one jaw member disposed at a distal end thereof. The jaw member(s) is movable between open and clamping configurations. A probe extends through the shaft and operably couples to the housing. The probe includes a cutting blade at a distal end thereof adjacent the jaw member(s) to treat tissue of interest. The jaw member(s) and cutting blade are configured such that heat damage to tissue adjacent tissue of interest that has been treated by the cutting blade is reduced and/or eliminated.

Description

    CROSS-REFERENCE TO RELATED APPLICATIONS
  • The present application claims the benefit of and priority to U.S. Non-Provisional application Ser. No. 14/006,532 filed on Sep. 20, 2013 by Ross et al. which claims the benefit of and priority to U.S. Provisional Application No. 61/469,593 filed on Mar. 30, 2011 by Ross et al. and U.S. Provisional Application No. 61/469,565 filed on Mar. 30, 2011 by Ross et al., the entire contents of both of which are incorporated herein by reference.
  • BACKGROUND
  • 1. Technical Field
  • The present disclosure relates to ultrasonic surgical instruments. More particularly, the present disclosure relates to ultrasonic surgical instruments configured to minimize heat damage to tissue adjacent the tissue of interest.
  • 2. Description of Related Art
  • Ultrasonic energy-powered instruments configured to cut and/or fragment tissue are known in the art. Ultrasonic instruments, typically, include a transducer that is coupled to a probe/waveguide having an active member (e.g., cutting blade, shear, hook, ball, etc.) at a distal end thereof. In use, ultrasonic energy is utilized to vibrate (e.g., at frequency usually in the range of 20 KHz to 60 KHz) the active member to treat tissue of interest.
  • Ultrasonic instruments may include any of a variety of probe configurations to achieve a specific surgical result. For example, the probe configuration may include an active member in the form of a cutting blade that is combined with a movable jaw configured to grasp and/or manipulate tissue. Such ultrasonic instruments are primarily used in a variety of medical procedures including open surgical procedures, luminal procedures, and endoscopic procedures.
  • During use, the active member, e.g., the cutting blade, may reach temperatures greater than 200° C. At such temperatures, inadvertent contact between the cutting blade, such as, for example, a lower portion thereof, and tissue, e.g., tissue adjacent the tissue of interest, may cause undesirable heat damage to the tissue.
  • SUMMARY
  • In view of the foregoing, ultrasonic instruments configured to minimize heat damage to tissue adjacent tissue of interest that has been ultrasonically treated may prove useful in the medical art.
  • Embodiments of the present disclosure are described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements. As used herein, the term “distal” refers to a portion that is being described which is further from a user, while the term “proximal” refers to a portion that is being described which is closer to a user.
  • An aspect of the present disclosure provides an ultrasonic surgical instrument. The ultrasonic instrument includes a housing having an elongated shaft extending therefrom. The shaft defines a longitudinal axis therethrough and has a pair of first and second jaw members disposed at a distal end thereof. The first jaw member is movable between an open configuration and a clamping configuration and the second jaw member is translatable along the longitudinal axis from a retracted configuration to an extended configuration. A lever may be operably coupled to the housing and configured to move the first jaw member between the open and clamping configurations. A cutting blade extends at the distal end of the shaft and operably couples to the housing and adjacent the first and second jaw members. The cutting element is coupled to a probe that extends within the shaft. The second jaw member is moveable to the extended configuration to cover a bottom portion of the cutting blade to reduce heat damage to tissue adjacent tissue of interest that has been treated by the cutting blade.
  • A switching mechanism may be disposed on the ultrasonic surgical instrument and configured to actuate the second jaw member to move the second jaw member from the retracted configuration to the extended configuration.
  • At least a portion of the second jaw member may be made from a material having high thermal conductivity to facilitate cooling of the cutting blade. Moreover, a bottom portion of the second jaw member may be covered with an insulative material to reduce thermal spread from the second jaw member to tissue adjacent the tissue of interest. The second jaw member may include at least one temperature sensor thereon configured to detect a temperature of the cutting blade. The temperature sensor(s) may be, but is not limited to, thermocouple or a thermistor.
  • An aspect of the present disclosure provides an ultrasonic surgical instrument. The ultrasonic surgical instrument includes a housing having an elongated shaft extending therefrom. The shaft defines a longitudinal axis therethrough and has a jaw member disposed at a distal end thereof. The jaw member is movable between an open configuration and a clamping configuration. A sheath operably couples to the housing and is coaxially disposed along shaft. The sheath is translatable along the longitudinal axis from a retracted configuration to an extended configuration. A cutting blade extends at a distal end of the shaft and operably couples to the housing and adjacent the jaw member. The sheath is moveable to the extended configuration to cover at least the cutting blade to reduce heat damage to tissue adjacent tissue of interest that has been treated by the cutting blade.
  • A switching mechanism may be disposed on the ultrasonic surgical instrument and configured to actuate the sheath to move the sheath from the retracted configuration to the extended configuration.
  • At least a portion of an interior surface of the sheath may be made from a material having a high thermal conductivity to facilitate cooling the cutting blade. An exterior surface of the sheath may be covered with an insulative material to reduce thermal spread from the sheath to tissue adjacent tissue of interest.
  • The sheath may include at least one temperature sensor thereon configured to detect a temperature of the cutting blade. The temperature sensor(s) may be, but is not limited to, thermocouple or a thermistor.
  • An aspect of the present disclosure provides an ultrasonic surgical instrument. The ultrasonic surgical instrument includes a housing having an elongated shaft extending therefrom. The shaft defines a longitudinal axis therethrough and has a first jaw member disposed at a distal end thereof. The first jaw member is movable between open and clamping configurations. A cutting blade extends at a distal end of the shaft and operably couples to the housing and adjacent the first jaw member. The cutting blade is translatable along the longitudinal axis from a retracted configuration within the shaft to an extended configuration outside the shaft to treat tissue of interest. The cutting blade is moveable to the retracted configuration within the shaft to reduce heat damage to tissue adjacent tissue of interest that has been treated by the cutting blade.
  • A switching mechanism may be disposed on the housing and configured to actuate the cutting blade to move the cutting blade from the retracted configuration to the extended configuration.
  • The shaft may include at least one temperature sensor thereon configured to detect a temperature thereof. The temperature sensor(s) may be, but is not limited to, thermocouple or a thermistor.
  • The ultrasonic surgical instrument may further include a second jaw member that is pivotably coupled to the first jaw member and configured to move between an open configuration and a clamping configuration to facilitate clamping tissue.
  • BRIEF DESCRIPTION OF THE DRAWING
  • Various embodiments of the present disclosure are described hereinbelow with references to the drawings, wherein:
  • FIG. 1 is a right, perspective view of an ultrasonic instrument according to an embodiment of the present disclosure;
  • FIG. 2 is an enlarged, side, schematic view of a distal end of the ultrasonic instrument depicted in FIG. 1 with a bottom jaw member illustrated in an extended configuration;
  • FIG. 3 is an enlarged, side, schematic of the distal end depicted in FIG. 2 with the bottom jaw member illustrated in a retracted configuration;
  • FIG. 4 is an enlarged, side, schematic of a distal end of an ultrasonic instrument according to another embodiment of the present disclosure with a protective sheath illustrated in a retracted configuration;
  • FIG. 5 is an enlarged, side, schematic with the protective sheath illustrated in an extended configuration;
  • FIG. 6 is an enlarged, side, schematic of a distal end of an ultrasonic instrument according to yet another embodiment of the present disclosure with an cutting blade illustrated in an extended configuration; and
  • FIG. 7 is an enlarged, side, schematic with the cutting blade illustrated in a retracted configuration.
  • DETAILED DESCRIPTION
  • Detailed embodiments of the present disclosure are disclosed herein; however, the disclosed embodiments are merely examples of the disclosure, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
  • Turning now to FIG. 1, an ultrasonic surgical instrument 2 (instrument 2) according to an embodiment of the present disclosure is illustrated. In the illustrated embodiments, the instrument 2 is described herein as being battery powered. Alternatively, the instrument 2 may be externally powered, e.g., via a remote ultrasonic generator that is coupleable to the instrument 2.
  • Briefly, instrument 2 includes a housing 6 configured to house one or more components, e.g., transducer (not explicitly shown), a probe 16, and electrical circuitry that is configured for electrical communication with a battery assembly 8 of the instrument 2. A proximal end of housing 6 is configured to releasably couple to an ultrasonic generator 10 and the battery assembly 8. A distal end of the housing 6 is configured to support and/or couple to a proximal end 22 of a shaft 4 having a longitudinal axis “A-A” defined therethrough. A rotation knob 26 operably couples to housing 6 and is configured to rotate the shaft 4 approximately 360° in either direction about the longitudinal axis “A-A.” Generator 10 includes the transducer that is coupled to the probe 16 via a torque adapter (not explicitly shown) and configured to produce vibratory motion of a cutting blade 17 disposed at a distal end of the probe 16 when a trigger 7 is depressed. This vibratory motion of the cutting blade 17 is utilized to treat tissue of interest. Battery assembly 8 includes a handpiece 24 having a battery (not explicitly shown) operably disposed therein.
  • With reference to FIGS. 2-3, an end effector 12 includes a pair of first and second jaw members 14 and 15 that are supported at a distal end 18 of the shaft 4 adjacent cutting blade 17.
  • Jaw member 14 is pivotably supported at the distal end of the shaft 4 via a pivot pin 3 (FIG. 2) and functions as a “clamping jaw.” In particular, jaw member 14 is movable relative to the cutting blade 17 (and/or the distal end 18 of the shaft 4) between an open configuration (FIGS. 1 and 2) and a clamping configuration (FIG. 3) to clamp tissue when a lever or movable handle 20 (FIG. 1) is actuated. Jaw member 14 and cutting blade 17 are configured to collectively grasp and ultrasonically treat tissue. In particular, with tissue positioned between the jaw member 14 and cutting blade 17, the cutting blade is configured to vibrate at a specific frequency (e.g., at a frequency in the range from about 20 KHz to about 60 KHz) to treat tissue.
  • Continuing with reference to FIGS. 2 and 3, jaw member 15 is translatable along the longitudinal axis “A-A” from a retracted configuration (FIGS. 1 and 3) to an extended configuration (FIG. 2). In the extended configuration, jaw member 15 is configured to cover (or shield) a bottom portion 19 of the cutting blade 17 to prevent or reduce inadvertent contact between the heated cutting blade 17 and tissue, e.g., tissue that is adjacent tissue of interest that has been ultrasonically treated or is being ultrasonically treated by the cutting blade 17.
  • Jaw member 15 may be configured to function as a heat sink and dissipate heat from the cutting blade 17 into one or more suitable mediums, e.g., air, to facilitate cooling of cutting blade 17. To this end, jaw member 15 may be made from any suitable material including, but not limited to metal, plastic, ceramic, etc. In the embodiment illustrated in FIGS. 1-3, jaw member 15 is made from a material, e.g., metal (suitable metals may include aluminum alloys, copper, tungsten, etc.), having high thermal conductivity (or high thermal mass) to facilitate cooling cutting blade 17 when the jaw member 15 is positioned adjacent thereto.
  • In embodiments, it may prove advantageous to provide a portion of the jaw member with diamond (or diamond dust), which has high thermal conductivity, to facilitate cooling the cutting blade 17. Addtionally, or alternatively, in some embodiments, it may prove advantageous to mix diamond or synthetic diamond with one or more of the aforementioned metals. In some embodiments, it may prove advantageous to form the jaw member 15 entirely out of diamond or synthetic diamond material.
  • In embodiments, a bottom portion 21 of the jaw member 15 may be covered with an insulative material, e.g., plastic, ceramic, etc., to reduce thermal spread from the jaw member 15 to tissue adjacent the tissue of interest and/or the shaft 4. In the illustrated embodiment, bottom portion 21 is formed from ceramic material.
  • One or more temperature sensors 23 (FIG. 2) may be positioned on jaw members 14 and 15. In the embodiment illustrated in FIGS. 1-3, for example, a temperature sensor 23 is positioned on the jaw member 15 and is configured to detect a temperature of the cutting blade 17 when the jaw member 15 is in the extended configuration, see, e.g., FIG. 2. With this purpose in mind, temperature sensor 23 may be any suitable type of temperature sensor including, but not limited to thermocouples, thermistors and the like.
  • Temperature sensor 23 may be configured to communicate with one or more modules of the generator 10 and/or the battery assembly 8. In one particular embodiment, for example, temperature sensor 23 may be configured to provide data pertaining to a temperature of the cutting blade 17 to a temperature control module 11 (FIG. 1) of the generator 10 and/or battery assembly 8. In the illustrated embodiments, temperature control module 11 is provided with the generator 10 (FIG. 1). The temperature control module 11 may analyze the data pertaining to temperature of the cutting blade 17 and utilize one or more control algorithms to control an output response of the transducer based on this data to regulate a vibration frequency of the probe 16 such that a desired temperature may be maintained at the cutting blade 17. In one particular embodiment, instrument 2 and the temperature control module 11 may be configured to provide one or more indications, e.g., an audio indication “A”, a visual indication “V”, and so forth, to a user indicating that the cutting blade 17 is sufficiently cooled or at a predetermined safe temperature (FIG. 1). As defined herein, a safe temperature of the cutting blade 17 is a temperature incapable of damaging tissue.
  • Referring again to FIG. 1, a switching mechanism 28 is disposed on the housing 6 and operably couples to jaw member 15 to actuate jaw member 15 and move jaw member 15 from the retracted configuration to the extended configuration. Switching mechanism 28 may be any suitable type of switching mechanism including but not limited to push-buttons, dials, slides, and the like. In accordance with the instant disclosure, switching mechanism 28 includes a dial 30 positioned at a distal end of the housing 6. Dial 30 is configured to move jaw member 15 to the extended configuration when the dial 30 is moved in a counter-clockwise direction and is configured to move jaw member 15 back to the retracted configuration when the dial 30 is moved in a clockwise direction. One or more components, such as, for example, drive rods, servos, links, gears and the like may be provided with the instrument 2 to provide mechanical and/or electrical communication between the dial 30 and jaw member 15.
  • During use of one particular embodiment of the instrument 2, tissue may be positioned between the jaw member 14 and the cutting blade 17. Subsequently, trigger 7 may be depressed to activate the cutting blade 17 to treat tissue of interest.
  • As noted above, the cutting blade 17 may become hot due to the vibratory motion thereof. In accordance with the instant disclosure, dial 30 may be actuated to move the jaw member 15 to the extended configuration (FIG. 2) to cover (or shield) cutting blade 17. As noted above, in the extended configuration, jaw member 15 may serve as a heat-sink as a result of the high thermal conductivity associated therewith to facilitate dissipating heat from cutting blade 17 for cooling thereof.
  • Once cutting blade 17 is sufficiently cooled, dial 30 may be actuated to move jaw member 15 back to the retracted configuration (FIGS. 1 and 3). In one particular embodiment, the sensor(s) 23 and temperature control module 11 may be utilized to monitor the temperature of cutting blade 17 and indicate (e.g., audio indication “A” or visual indication “V”) to a user when cutting blade 17 is sufficiently cooled. In certain instances, in this cooled state, a user may employ the cutting blade 17 to grasp and/or manipulate tissue.
  • The unique configuration of the instrument 2 including the jaw member 15 overcomes the aforementioned drawbacks that are typically associated with conventional ultrasonic instruments. That is, the likelihood of heat damage occurring to tissue adjacent tissue of interest that has been ultrasonically treated by the cutting blade 17 is reduced, if not eliminated by the jaw member 15.
  • While the instrument 2 has been described herein as including a jaw member 15 that is configured to cover the cutting blade 17, other devices or methods may be utilized to cover the cutting blade 17 to prevent inadvertent contact between the hot cutting blade 17 and tissue.
  • With reference to FIGS. 4 and 5, the instrument 102 (FIG. 1) includes a sheath 125 that is configured to cover the cutting blade 117 and jaw member 114. Instrument 102 functions similarly to instrument 2, in view thereof only those features unique to instrument 102 are described in detail.
  • Sheath 125 operably couples to the housing 6 via one or more suitable coupling methods and is coaxially disposed along shaft 104. The sheath 125 is translatable along the longitudinal axis “A-A” from a retracted configuration (FIG. 4) to an extended configuration to cover at least a portion of the cutting blade 117 (and/or jaw member 114) to reduce heat damage to tissue adjacent tissue of interest that has been treated by cutting blade 117. In the embodiment illustrated in FIGS. 4 and 5, sheath 125 is configured to fully cover jaw member 114 and cutting blade 117.
  • Similar to jaw member 15, a portion of an interior surface of the sheath 125 is formed from a material 5 b having high thermal conductivity to facilitate cooling the cutting blade 117. Additionally, or alternatively, an exterior surface of the sheath 125 is covered with an insulative material 5 a to reduce thermal spread from sheath 125 to tissue adjacent tissue of interest. Further, one or more of the aforementioned temperature sensors 123 (FIGS. 4 and 5) may be disposed on sheath 125 and configured to detect a temperature of the cutting blade 117. In the embodiment illustrated in FIGS. 4 and 5, temperature sensor 123 is positioned on an interior surface of sheath 125 and is configured to function as described above with respect to sensor 23.
  • Unlike dial 30 that is operably coupled to the jaw member 15, dial 130 is coupled to the sheath 125 to actuate the sheath 125 and move the sheath 125 from the retracted configuration (FIG. 4) to the extended configuration (FIG. 5).
  • Operation of the instrument 102 that includes the sheath 125 is similar to that of instrument 2 that includes the jaw member 15. In particular, dial 130 may be actuated to move sheath 125 to the extended configuration (FIG. 5) to cover the cutting blade 117 and the jaw member 114. In the extended configuration, the sheath 125 serves as a “heat-sink” as a result of the high thermal conductivity thereof to facilitate cooling cutting blade 117.
  • The instrument 102 including the sheath 125 overcomes the aforementioned drawbacks typically associated with conventional ultrasonic surgical instruments and affords the same advantages as the instrument 2 to a user.
  • With reference to FIGS. 6 and 7, the instrument 202 (FIG. 1) includes a cutting blade 217. Instrument 202 functions similarly to instrument 2, therefore only those features unique to instrument 202 are described in detail.
  • Unlike the previously described cutting blades 17, 117, a cutting blade 217 is translatable along the longitudinal axis “A-A” from a retracted configuration (FIG. 7) within the shaft 218 to an extended configuration (FIG. 6) outside the shaft 218. In the extended configuration, cutting blade 217 and jaw member 214 are configured to treat tissue of interest as described hereinabove. As can be appreciated, heat damage to tissue adjacent the tissue of interest that has been treated by cutting blade 217 is reduced when cutting blade 217 in the retracted configuration.
  • One or more of the aforementioned temperature sensors 223 (FIGS. 6 and 7) may be disposed on an interior surface of the shaft 204 (FIGS. 6 and 7) and configured to function as described above with respect to sensors 23 and 123.
  • Unlike dials 30, 130 that operably couple to the jaw member 15 and sheath 125, respectively, dial 230 is coupled to the cutting blade 217 to actuate the cutting blade 217 and move the cutting blade 217 from the retracted configuration (FIG. 7) to the extended configuration (FIG. 6).
  • The instrument 202 including the cutting blade 217 overcomes the aforementioned drawbacks typically associated with conventional ultrasonic surgical instruments and affords the same advantages as the instruments 2, 102 to a user.
  • From the foregoing and with reference to the various figure drawings, those skilled in the art will appreciate that certain modifications can also be made to the present disclosure without departing from the scope of the same. For example, and in the embodiment illustrated in FIGS. 6 and 7, an optional second jaw member 215 (FIGS. 6 and 7 illustrate the optional second jaw member 215 in phantom) may be provided with the instrument 202 to facilitate grasping and/or manipulating tissue, such as, for example, when the cutting blade 217 is in the retracted configuration, see FIG. 7. In this particular embodiment, the movable handle 20 may be configured to move jaw member 215 from an open configuration to a clamping configuration. For example, the movable handle 20 may be configured to move through a first clamping stroke to close the jaw member 214 and through a second clamping stroke to close the jaw member 215. Those skilled in the art will appreciate other methods of opening and closing jaw member 215.
  • In embodiments, the aforementioned jaw members 14, 15, 114, 214 and 215 may be provided with a relatively flat tissue contacting surface (FIGS. 1-5) or a serrated tissue contacting surface (FIGS. 6 and 7). The specific configuration of the tissue contacting surfaces of the aforementioned jaw members 14, 15, 114, 214 and 215 may be altered or modified to achieve a specific tissue effect.
  • While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Claims (7)

1-20. (canceled)
21. An ultrasonic surgical instrument, comprising:
a housing having an elongated shaft extending therefrom, the shaft defining a longitudinal axis therethrough and having a first jaw member and a second jaw member disposed at a distal end thereof, the first jaw member movable between an open configuration and a clamping configuration; and
a cutting blade extending at a distal end of the shaft and operably coupled to the housing and adjacent the first jaw member, the cutting blade translatable along the longitudinal axis of the shaft from a retracted configuration positioned within the shaft to an extended configuration positioned outside the shaft to treat tissue of interest,
wherein the cutting blade is moveable to the retracted configuration within the shaft to reduce heat damage to tissue adjacent the tissue of interest, and
wherein the first jaw member or the second jaw member comprise a first portion made of a material having relatively high thermal conductivity and a second portion made of a thermally insulative material.
22. The ultrasonic surgical instrument according to claim 21, wherein a switching mechanism disposed on the housing is configured to actuate the cutting blade and move the cutting blade from the retracted configuration to the extended configuration.
23. The ultrasonic surgical instrument according to claim 21, wherein an interior surface of the shaft includes at least one temperature sensor thereon configured to detect a temperature of the cutting blade.
24. The ultrasonic surgical instrument according to claim 23, wherein the at least one temperature sensor is selected from the group consisting of a thermocouple and a thermistor.
25. The ultrasonic surgical instrument according to claim 21, wherein the second jaw member is pivotably coupled to the first jaw member and configured to move between an open and a clamping configurations to facilitate clamping tissue.
26. The ultrasonic surgical instrument according to claim 21, wherein the cutting blade is coupled to a probe that extends within the shaft.
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WO2012135721A1 (en) 2012-10-04
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