Ultrasonic surgical instruments

An ultrasonic surgical instrument is provided. The ultrasonic surgical instrument includes a housing having an elongated shaft extending therefrom. The shaft has a jaw member disposed at a distal end thereof. The jaw member is movable between an open configuration and a clamping configuration and includes a tissue contacting surface thereon. A cutting blade extends from a distal end of the shaft and operably couples to the housing and adjacent the jaw member to treat tissue. At least one sensor is configured to sense at least one operational parameter of the ultrasonic surgical instrument. At least one controller in operable communication with the at least one sensor is configured to terminate delivery of ultrasonic energy to the cutting blade when the at least one sensor senses the at least one operational parameter.

BACKGROUND

1. Technical Field

The present disclosure relates to ultrasonic surgical instruments. More particularly, the present disclosure relates to ultrasonic surgical instruments having one or more sensor configurations to prevent wear of tissue contacting surfaces on jaw members of the ultrasonic surgical instrument.

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. In certain instances, a tissue contacting surface (which is typically made from metal) of the movable jaw member may include a polytetrafluoroethylene (PTFE) liner configured to prevent the cutting blade from coming into contact with the tissue contacting surface. Such ultrasonic instruments are primarily used in a variety of medical procedures including open surgical procedures, luminal procedures, and endoscopic procedures.

During use, the movable jaw member provides support for tissue as the cutting blade vibrates to treat tissue. The PTFE liner and/or the tissue contacting surface of the movable jaw member may wear as a result of prolonged use. As can be appreciated, wear of the PTFE liner and/or the tissue contacting surface of the movable jaw member may result in a decreased surgical effect to tissue. That is, as the PTFE liner and/or tissue contacting surface wears, its tissue supporting capabilities may be diminished.

SUMMARY

In view of the foregoing, ultrasonic instruments including one or more sensor configurations to prevent wear of tissue contacting surfaces on jaw members of the ultrasonic surgical instrument 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 includes a jaw member disposed at a distal end thereof. The jaw member is movable between an open configuration and a clamping configuration and includes a tissue contacting surface. A cutting blade extends from a distal end the shaft and operably couples to the housing and adjacent the jaw member to treat tissue. At least one sensor is configured to sense at least one operational parameter of the ultrasonic surgical instrument. At least one controller in operable communication with the at least one sensor is configured to terminate delivery of ultrasonic energy to the cutting blade when the at least one sensor senses the at least one operational parameter. The controller may be a component of a generator of the ultrasonic surgical instrument.

The at least one sensor may be operably coupled to at least one of the jaw member or cutting element. The at least one sensor may be a position sensor, a strain gauge sensor, jaw sensor, a temperature sensor, an acoustic sensor or an impedance sensor.

The at least one operational parameter associated with the ultrasonic surgical instrument may include a change in tissue impedance of tissue being treated, a change in resistance associated with the cutting blade contacting the tissue contacting surface of the jaw member, a change in an acoustic signature of the ultrasonic surgical associated with the cutting blade vibrating against the tissue contacting surface of the jaw member, a change in an amount of ultrasonic power required to treat tissue, a spatial relationship between the jaw member and cutting blade, a change in contact pressure between the jaw member and the cutting blade.

The tissue contacting surface of the jaw member may be coated with at least one lubricious material. The at least one lubricious material may be polytetrafluoroethylene and/or silicone.

The ultrasonic surgical instrument may also include a jaw interlock that is activatable when delivery of ultrasonic energy to the cutting blade is terminated. The jaw interlock may be configured to engage at least one of the jaw member or cutting blade to prevent physical contact therebetween.

An aspect of the present disclosure provides an ultrasonic surgical system. The ultrasonic surgical system includes an ultrasonic surgical instrument. The ultrasonic surgical instrument includes a housing having a shaft extending therefrom. The shaft includes a jaw member disposed at a distal end thereof. The jaw member includes a tissue contacting surface. A cutting blade extends from a distal end of the shaft and operably couples to the housing and adjacent the jaw member to treat tissue. At least one sensor is configured to sense at least one operational parameter of the ultrasonic surgical instrument. At least one controller in operable communication with the at least one sensor is configured to terminate delivery of ultrasonic energy to the cutting blade when the at least one sensor senses the at least one operational parameter, and/or senses a change of the at least one operational parameter. The controller may be a component of a generator of the ultrasonic surgical instrument. The controller may be configured to provide one of an audio and visual indication to a user when the operational parameter, and/or a change thereof, is sensed by the at least one sensor.

The at least one sensor may be operably disposed on at least one of the jaw member or cutting element. The at least one sensor may be a position sensor, a strain gauge sensor, jaw sensor, a temperature sensor, an acoustic sensor, or an impedance sensor.

The ultrasonic surgical instrument may also include a jaw interlock that is activatable when delivery of ultrasonic energy to the cutting blade is terminated. The jaw interlock may be configured to engage at least one of the jaw member or cutting blade to prevent physical contact therebetween. The jaw interlock may be manually activatable via a switching mechanism on the ultrasonic surgical instrument. Alternatively, the jaw interlock may be automatically activatable via the controller.

The at least one operational parameter associated with the ultrasonic surgical instrument may include a change in tissue impedance of tissue being treated, a change in resistance associated with the cutting blade contacting the tissue contacting surface of the jaw member, a change in an acoustic signature of the ultrasonic surgical associated with the cutting blade vibrating against the tissue contacting surface of the jaw member, a change in an amount of ultrasonic power required to treat tissue, a spatial relationship between the jaw member and cutting blade, a change in contact pressure between the jaw member and the cutting blade.

The controller may be in operable communication with an audio detection module of the generator. The audio detection module may be configured to receive audio input from a sensor (e.g., a microphone, transducer, or the like) on the ultrasonic surgical instrument to detect the change in the acoustic signature of the ultrasonic surgical.

The tissue contacting surface of the jaw member may be coated with at least one lubricious material. The at least one lubricious material may be polytetrafluoroethylene and/or silicone.

DETAILED DESCRIPTION

Turning now toFIG. 1, an ultrasonic surgical instrument2(instrument2) according to an embodiment of the present disclosure is illustrated. In the illustrated embodiments, instrument2is described herein as being battery powered. Alternatively, instrument2may be externally powered, e.g., via a remote ultrasonic generator that couples to instrument2. In the latter instance, a cable may couple instrument2to the generator.

Briefly, instrument2includes a housing6configured to house one or more components, e.g., transducer (not explicitly shown), a probe16, and electrical circuitry that is configured for electrical communication with a battery assembly8of instrument2. A proximal end of housing6is configured to releasably couple to an ultrasonic generator10and battery assembly8. A distal end of housing6is configured to support and/or couple to a proximal end22of a shaft4having a longitudinal axis “A-A” defined therethrough. A rotation knob26operably couples to housing6and is configured to rotate shaft4approximately 360° in either direction about the longitudinal axis “A-A.” Generator10includes the transducer that is coupled to probe16via a torque adapter (not explicitly shown) and configured to produce vibratory motion of a cutting blade17(FIGS. 1-2) disposed at a distal end of probe16when a trigger7is depressed. This vibratory motion of cutting blade17is utilized to treat tissue of interest. Battery assembly8includes a handpiece24having a battery (not explicitly shown) operably disposed therein.

With reference toFIGS. 1-2, an end effector12includes a first jaw member14(FIG. 1) that is supported at a distal end18of shaft4adjacent cutting blade17. Jaw member14may be pivotably supported at the distal end of the shaft4via a pivot pin23and functions as a “clamping jaw.” In particular, jaw member14is movable relative to cutting blade17(and/or the distal end18of the shaft4) between an open configuration (FIG. 1) and a clamping configuration (FIG. 2) to clamp tissue when a lever or movable handle20(FIG. 1) is actuated. Jaw member14and cutting blade17are configured to collectively grasp and ultrasonically treat tissue. In particular, with tissue positioned between jaw member14and cutting blade17, 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 toFIG. 2, jaw member14is illustrated including a jaw housing13having a tissue contacting surface15operably coupled thereto. Tissue contacting surface15provides a compliant, temperature resistant and low friction surface for cutting blade17when the jaw member14is in the clamping configuration and cutting blade17is treating tissue, i.e., vibrating.

In the embodiment illustrated inFIGS. 1-2, tissue contacting surface15is provided with a laminate liner25that is flexible (or compliant). In the illustrated embodiment, laminate liner25includes one or more lubricious materials thereon, e.g., polytetrafluoroethylene, silicone, and the like. Alternatively, tissue contacting surface15may be provided without a laminate liner25. The specific configuration of tissue contacting surface15(i.e., with or without a laminate liner25) may depend on a specific type of tissue that is to be treated, a manufacturer's preference, a specific surgical procedure, a specific type of instrument2, and so forth.

In an embodiment, it may prove useful to provide a second jaw member27(shown in phantom inFIG. 2). In this particular embodiment, second jaw member27may include one or more laminate liners25(and operative components associated therewith) thereon configured to provide the same function as described above with respect to jaw member14. Jaw member27may be configured similar to jaw member14to provide the same functions described herein.

With reference again toFIGS. 1-2, cutting blade17is configured to treat tissue of interest and may be formed from any suitable material, including but not limited to metal, ceramic, or other suitable material. In the illustrated embodiments, cutting blade17may be formed from stainless steel or titanium. Metals of this type are suitable for forming cutting blade17because of their ability to withstand high temperatures and vibrations that are, typically, associated with cutting blade17during operation thereof.

Continuing with reference toFIG. 2, one or more sensors23(FIG. 2) may be positioned on jaw member14and/or cutting blade17. In the embodiment illustrated inFIG. 2, for example, a plurality of sensor(s)23is positioned on both the jaw member14and cutting blade17and are configured to detect one or more operational parameters associated with instrument2. In particular, the sensed operational parameters associated with instrument2are communicated to a controller11and utilized to prevent cutting blade17from coming into contact with tissue contacting surface15of jaw member14and/or coming into contact with laminate liner25that may disposed on jaw member14, e.g., controller11triggers an end-of-duty cycle command to terminate ultrasonic energy to cutting blade17.

The operational parameters associated with instrument2include, but are not limited to a change in tissue impedance of tissue being treated, a change in resistance associated with cutting blade17contacting tissue contacting surface15of jaw member14, a change in an acoustic signature associated with instrument2as a result of cutting blade17vibrating against tissue contacting surface15of jaw member14, a change in an amount of ultrasonic power required to treat tissue, a spatial relationship between jaw member14and cutting blade17, a change in contact pressure between jaw member14and the cutting blade17, or a combination thereof.

Accordingly, sensor(s)23may be a position sensor, a strain gauge sensor, a jaw sensor, a temperature sensor, an acoustic sensor, an impedance sensor, or any combination thereof. (FIG. 2). As can be appreciated, one or more of the sensor(s)23may be positioned on one or both jaw members14and/or cutting blade17.

In some embodiments, for example, a sensor23may be configured to sense impedance of tissue as tissue is being treated. In this embodiment, sensor23may be positioned on jaw member14and cutting blade17, and configured to communicate one or more of the sensed parameters associated with an impedance of tissue, e.g., resistivity of tissue tends to increase during ultrasonic treatment thereof. In this instance, sensor23may be configured to provide an interrogatory pulse through tissue and sense a reflective wave reflected therefrom. One or more properties associated with the reflective wave may be utilized by controller11to determine tissue impedance. If the sensed impedance exceeds a predetermined threshold, controller11may terminate delivery of ultrasonic energy to cutting blade17.

Additionally, or alternatively, sensor23may be positioned on jaw member14and cutting blade17, and configured to communicate one or more sensed parameters associated with jaw member14and cutting blade17, e.g., resistivity between jaw member14and cutting blade17. For example, in this instance, known resistivity (which may be obtained by any suitable means, e.g., empirically) between jaw member14and cutting blade17when jaw member14is in the clamping and open configurations may be utilized to determine a proximity of jaw member14with respect to cutting blade17. If the sensed resistivity exceeds a predetermined threshold, controller11may terminate delivery of ultrasonic energy to cutting blade17.

Additionally, or alternatively, sensor23may be utilized to determine the proximity of jaw member14with respect to cutting blade17to facilitate preventing cutting blade17from contacting tissue contacting surface15of jaw member14and/or coming into contact with laminate liner25that may disposed on jaw member14. If the sensed distance between tissue contacting surface15and cutting blade17is below a predetermined threshold, controller11may terminate delivery of ultrasonic energy to cutting blade17.

Additionally, or alternatively, sensor23may be utilized to detect a pressure between jaw member14and cutting blade17to facilitate preventing cutting blade17contacting tissue contacting surface15of jaw member14and/or coming into contact with laminate liner25that may disposed on jaw member14. In this instance, known closure forces (which may be obtained by any suitable means, e.g., empirically) between jaw member14and cutting blade17when jaw member14is in the clamping configuration and tissue is positioned therebetween may be utilized to determine proximity of jaw member14with respect to cutting blade17. In this particular instance, closure forces may be correlated for specific tissue structure, e.g., large vessels, medium vessels, etc. If the sensed closure force between tissue contacting surface15and cutting blade17exceeds or falls below a predetermined threshold, controller11may terminate delivery of ultrasonic energy to cutting blade17.

Additionally, or alternatively, sensor23may be utilized to determine a temperature of tissue contacting surface15(and/or laminate liner25). In this particular instance, a specific temperature (or an increase in temperature) of tissue contacting surface15(and/or laminate liner25) sensed by sensor23may be indicative of a proximity of cutting blade17with respect to tissue contacting surface15(and/or laminate liner25). For example, a sensed temperature of about 200° C. may correlate to cutting blade17being in close proximity to tissue contacting surface15(and/or laminate liner25) and may trigger termination of ultrasonic energy to cutting blade17.

Additionally, or alternatively, sensor23may be utilized to determine a change in an acoustic signature associated with instrument2as a result of cutting blade17vibrating against tissue contacting surface15of jaw member14. In this instance, the acoustic signature may be the sound produced by cutting blade17treating tissue; this sound, e.g., acoustic signature, may be stored into memory of controller11. During operation of cutting blade17, sensor23may be configured to detect the sound produced by cutting blade17and provide the sound to controller11for comparison with the acoustic signature stored in memory. If the sound provided to controller11does not match the stored acoustic signature, controller11may trigger termination of ultrasonic energy to cutting blade17. Additionally, or alternatively, a speaker31(FIG. 1) may be provided on instrument2to detect a change in an acoustic signature associated with instrument2, described in more detail below.

Sensor(s)23may be configured to communicate with one or more modules of the generator10and/or the battery assembly8. In one particular embodiment, for example, sensor(s)23may be configured to provide data pertaining to one or more of the aforementioned operational parameters associated with instrument2to controller11(FIG. 2). Controller11may be a component associated with generator10and/or battery assembly8. In the illustrated embodiments, controller11is provided as a component of the generator10(FIG. 2) and analyzes the data pertaining to the aforementioned operational parameters and utilizes one or more control algorithms to control, e.g., terminate, an output response of the transducer based on this data to ensure that cutting blade17does not contact tissue contacting surface15(and/or laminate liner25). In one particular embodiment, instrument2and controller11may 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 an end-of-duty cycle of instrument2.

An audio detection module9(FIG. 2) may be configured to receive an audio signal from speaker31(FIG. 1) and communicate the detected audio signal to controller11. Controller11may analyze the detected audio signal and trigger an end-of-duty cycle command in a manner as described above.

In embodiments, a jaw interlock29(FIG. 2) that is activatable when delivery of ultrasonic energy to cutting blade17is terminated may be configured to engage one or both of jaw member14or cutting blade17to prevent inadvertent contact between cutting blade17and tissue contacting surface15(and/or laminate liner25). To this end, jaw interlock29may be in operable communication with controller11and/or a switching mechanism28(FIG. 1) and may include any suitable components including, but not limited to servos, gears, links, springs, etc., to facilitate engagement between jaw interlock29and jaw member14and/or cutting blade17.

For example, and in one particular embodiment, jaw interlock29may be automatically activatable via controller11when controller11triggers an end-of-duty cycle command to terminate ultrasonic energy to cutting blade17. In this particular embodiment, one or more drive rods (not explicitly shown) may be configured to engage one or both of the jaw member14and cutting blade17. Specifically, the drive may couple to a servo (not explicitly shown) that is in operable communication with controller11and configured to translate the drive rod along the longitudinal axis “A-A.” Translation of the drive rod distally causes a distal end of the drive rod to mechanically engage corresponding proximal ends of jaw member14and cutting blade17. The mechanical engagement may be an indent/detent configuration or other suitable mechanical engagement.

In another embodiment, jaw interlock29may be manually activatable via switching mechanism28, e.g., a dial30. In this particular embodiment, controller11may be configured to provide an audio indicator “A” or a visual indicator “V” to a user when controller11triggers an end-of-duty cycle command to terminate ultrasonic energy to cutting blade17. Dial30may be configured such that rotation thereof translates the drive rod along the longitudinal axis “A-A” to engage jaw interlock29with one or both of jaw member14and/or cutting blade17. As described above, translation of the drive rod distally causes the distal end of the drive rod to mechanically engage corresponding proximal ends of jaw member14and cutting blade17. The mechanical engagement may be an indent/detent configuration or other suitable mechanical engagement.

During use of one particular embodiment of the instrument2, tissue may be positioned between jaw member14and cutting blade17. Subsequently, trigger7may be depressed to activate the cutting blade17to treat tissue of interest.

Once tissue has been sufficiently treated, e.g., dissected, one or more of the aforementioned sensor(s)23may be utilized to detect one or more of the aforementioned operational parameters associated with instrument2. For example, sensor23may be utilized to sense an impedance of tissue during treatment thereof and communicate the sensed tissue impedance to controller11to determine if predetermined threshold impedance has been reached.

If the predetermined threshold impedance has been reached, controller11may trigger an end-of-duty command to terminate ultrasonic energy to cutting blade17, which, in turn, terminates vibration of cutting blade17.

The unique configuration of sensor(s)23and controller11allows cutting blade17to operate without the likelihood of the tissue contacting surface15and/or laminate liner25wearing or breaking down. As a result thereof, the operative life of the jaw member14, laminate liner25and/or cutting blade17is increased when compared to jaw members (and/or cutting blades) associated with conventional ultrasonic instruments.