Patent Description:
Ultrasonic surgical instruments include ultrasonic transducers that vibrate attached structures, e.g., blades, to seal, transect, and/or otherwise treat tissue. Some ultrasonic surgical instruments may include, for example, a clamp mechanism to enable clamping of tissue against the blade. Ultrasonic energy transmitted to the blade causes the blade to vibrate at very high frequencies, which allows for heating tissue to treat tissue clamped against or otherwise in contact with the blade. However, rapid movements of the blade against a jaw liner of the clamp mechanism (directly or indirectly) wears out the jaw liner. When the jaw liner is worn beyond a threshold, performance and/or efficacy of the ultrasonic surgical instruments are decreased. Documents <CIT> and <CIT> disclose instruments of the prior art.

Claims <NUM> and <NUM> define the invention and dependent claims disclose embodiments. According to various aspects of the present disclosure, an end effector assembly of an ultrasonic surgical instrument includes an ultrasonic blade mechanically coupled to an ultrasonic transducer configured to transmit ultrasonic vibration energy to the ultrasonic blade and a jaw member movable relative to the ultrasonic blade from a spaced-apart position to an approximated position for clamping tissue therebetween. The jaw member includes a structural body and a jaw liner engaged with the structural body. The jaw liner defines a tissue contacting surface positioned to oppose the ultrasonic blade in the approximated position, and includes a wear indicator disposed within the jaw liner and configured to provide an alert indicating that the jaw liner is worn beyond a pre-determined threshold.

According to aspects of the present disclosure, the jaw liner is made of an insulating material.

According to aspects of the present disclosure, the insulating material is PTFE.

According to further aspects of the present disclosure, the wear indicator is disposed at a predetermined depth within the jaw liner from the tissue contacting surface.

According to still further aspects of the present disclosure, the wear indicator is disposed at the predetermined depth along a longitudinal axis of the structural body.

According to still further aspects of the present disclosure, the predetermined depth is based on a life cycle of the jaw liner.

According to various aspects of the present disclosure, the wear indicator is made of an electrically conductive material.

According to aspects of the present disclosure, when the jaw liner wears out to expose the wear indicator and the jaw member moves to the approximated position, the wear indicator and the ultrasonic blade form an electrically closed circuit.

According to aspects of the present disclosure, the alert is electrically sent when the electrically closed circuit is formed. The alert includes a sound, light, message on a display, haptic vibration, or any combination thereof.

According to further aspects of the present disclosure, the electrically conductive material is graphite.

According to still further aspects of the present disclosure, the alert is an audible sound produced by contact between the wear indicator and the ultrasonic blade. The wear indicator is a metal or ceramic.

According to still further aspects of the present disclosure, when the jaw liner wears out to expose the wear indicator and the jaw member moves to the approximated position, the metal makes an audible sound while the ultrasonic blade vibrates in contact therewith.

According to still further aspects of the present disclosure, when the jaw liner wears out to expose the wear indicator, the color of the wear indicator is visible.

According to still further aspects of the present disclosure, the wear indicator is a ceramic. A resistance value of the wear indicator is lowered as the jaw liner wears out.

According to still further aspects of the present disclosure, an ultrasonic surgical instrument includes a housing, an ultrasonic transducer installed in the housing, adapted to connect to a source of energy, and produce ultrasonic vibration energy, and an end effector, which includes an ultrasonic blade mechanically coupled to the ultrasonic transducer and configured to receive the ultrasonic vibration energy therefrom and a jaw member movable relative to the ultrasonic blade from a spaced-apart position to an approximated position for clamping tissue therebetween. The jaw member includes a structural body and a jaw liner engaged with the structural body. The jaw liner defines a tissue contacting surface positioned to oppose the ultrasonic blade in the approximated position and includes a wear indicator configured to send an alert indicating that the jaw liner is worn beyond a pre-determined threshold.

The present disclosure may be understood by reference to the accompanying drawings, when considered in conjunction with the subsequent, detailed description, in which:.

Aspects of the presently disclosed ultrasonic surgical instruments are described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein the term "distal" refers to the portion of the surgical instrument or component thereof that is closer to the patient, while the term "proximal" refers to the portion or component that is farther from the patient.

In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Those skilled in the art will understand that the present disclosure may be adapted for use with either an endoscopic instrument, a laparoscopic instrument, or an open instrument. It should also be appreciated that different electrical and mechanical connections and other considerations may apply to each particular type of instrument.

Referring to <FIG>, an ultrasonic surgical instrument <NUM> for treating tissue with a portable power source and generator is illustrated. The ultrasonic surgical instrument <NUM> includes a power source <NUM>, a housing <NUM>, a transducer <NUM> including a generator assembly <NUM>, and an elongated assembly <NUM>. The power source <NUM> provides DC power to the transducer <NUM>. In aspects, the power source <NUM> may be a portable power source, such as a battery, that can be attached to the ultrasonic surgical instrument <NUM> to provide DC power at any location. The power source <NUM> may be insertable or integrated into the housing <NUM> so that the ultrasonic surgical instrument <NUM> may be portably carried without disturbances of any cable.

In aspects, the power source <NUM> may include a converter that is connected to an alternating current (AC) power source and converts the AC power to DC power. The AC power source may be of a relatively low frequency, such as about <NUM> hertz (Hz), while the ultrasonic surgical instrument <NUM> operates at a higher frequency. Thus, the power source <NUM> may convert the low frequency AC power to DC power so that the DC power may then be inverted to AC power having a frequency suitable to cause the transducer <NUM> to generate ultrasonic mechanical motions. However, other configurations are also contemplated.

With continued reference to <FIG> and <FIG>, the housing <NUM> includes a handle portion <NUM> having a compartment <NUM>, which may house the power source <NUM>, and a power source door <NUM> that secures the power source <NUM> within the compartment <NUM>. In an aspect, the power source door <NUM> may be configured to form a water-tight, hermetic, or aseptic seal between the interior and the exterior of the compartment <NUM>.

The housing <NUM> also includes a cover <NUM>, which houses the transducer <NUM> and an output device <NUM>. The transducer <NUM> includes a generator assembly <NUM> and a transducer assembly <NUM>, having a transducer body <NUM> and a locking portion <NUM> (<FIG>). The generator assembly <NUM> is electrically coupled to the transducer assembly <NUM> via a pair of contacts <NUM>.

With reference to <FIG>, the transducer <NUM> is illustrated as being separate from the cover <NUM>. When the transducer <NUM> is inserted into and assembled with the cover <NUM>, the pair of contacts <NUM> is connected to the transducer <NUM> so that the rotational movement of the transducer body <NUM> does not disrupt the connection between the transducer body <NUM> and the generator assembly <NUM>, and is capable of freely rotating within the housing <NUM>.

The output device <NUM> outputs information about the ultrasonic surgical instrument <NUM> and may display, for example, a status of a jaw liner <NUM> (FIG. For example, the status may be an alert or warning that the jaw liner <NUM> has been worn out to a level that the jaw liner <NUM> needs to be replaced.

The handle portion <NUM> further includes a trigger <NUM>. When the trigger <NUM> is actuated, the power source <NUM> provides energy to the transducer <NUM> so that the transducer <NUM> is powered to generate ultrasonic mechanical motions along the elongated assembly <NUM>. As the trigger <NUM> is released, the power supply to the transducer <NUM> is terminated.

The generator assembly <NUM> receives the DC power from the power source <NUM> and generates AC signals having a frequency greater than <NUM>. The generator assembly <NUM> can generate signals having a frequency based on a desired mode of operation, which may be at or different from the resonant frequency of the transducer <NUM>.

The transducer body <NUM> of the transducer assembly <NUM> receives the AC signal generated by the generator assembly <NUM> and generates ultrasonic mechanical motion along the elongated assembly <NUM> based on the amplitude and the frequency of the generated AC signal. The transducer body <NUM> includes one or more piezoelectric elements, which converts the generated AC signal into ultrasonic mechanical motions.

The ultrasonic surgical instrument <NUM> also includes a spindle <NUM>, which is coupled to the elongated assembly <NUM> and allows for rotation of the elongated assembly <NUM> about its longitudinal axis. The elongated assembly <NUM> is attached to the housing <NUM> and is mechanically connected to the transducer <NUM> via the locking portion <NUM> such that as the spindle <NUM> is rotated about the longitudinal axis defined by the elongated assembly <NUM>, the elongated assembly <NUM> and the transducer <NUM> are also rotated correspondingly without affecting the connection between the transducer <NUM> and the elongated assembly <NUM>.

The elongated assembly <NUM> may include an end effector <NUM>, which includes a jaw member <NUM> and a blade <NUM> suitable for sealing, transecting, and/or otherwise treating tissue. The blade <NUM> extends from the outer driver sleeve <NUM>. The elongated assembly <NUM> is mechanically coupled to the transducer body <NUM> via the locking portion <NUM>.

A proximal portion of the outer drive sleeve <NUM> is operably coupled to the trigger <NUM> of the handle portion <NUM>, while a distal portion of the outer drive sleeve <NUM> is operably coupled to the jaw member <NUM>. As such, the trigger <NUM> is selectively actuatable to move the outer drive sleeve <NUM> to pivot the jaw member <NUM> relative to the blade <NUM> of the end effector <NUM> from a spaced-apart position to an approximated position for clamping tissue between the jaw member <NUM> and the blade <NUM>. The spindle <NUM> is rotatable in either direction to rotate the elongated assembly <NUM> in either direction relative to the handle portion <NUM>.

The elongated assembly <NUM> further includes a waveguide <NUM>, which extends through the outer drive sleeve <NUM>. The waveguide <NUM> defines the blade <NUM> at a distal end thereof. The blade <NUM> serves as the blade of the end effector <NUM>. The waveguide <NUM> is mechanically coupled to the transducer <NUM> such that ultrasonic motion produced by the transducer <NUM> is transmitted along the waveguide <NUM> to the blade <NUM> for treating tissue clamped between the blade <NUM> and the jaw member <NUM> or positioned near the blade <NUM>.

The jaw member <NUM> may be formed as a pivoting arm configured to grasp and/or clamp tissue between the jaw member <NUM> and the blade <NUM>. When the jaw member <NUM> and the blade <NUM> grasp tissue and the blade <NUM> conveys the ultrasonic mechanical motions, temperature of the grasped tissue between the blade <NUM> and the jaw member <NUM> increases due to friction created by the ultrasonic mechanical motions. This heating, in turn treats, e.g., seals and/or transects, the tissue. In aspects, the blade <NUM> may vibrate at an appropriate velocity based on a size of the tissue, e.g., blood vessel, to be sealed. By controlling the velocity of the mechanical motions of the blade <NUM>, the heating rate of the tissue, e.g., vessel, may be controlled so that the vessel can be effectively sealed and/or transected.

Referring to <FIG>, the end effector assembly <NUM> of the ultrasonic surgical instrument <NUM> of <FIG> may be utilized with any other suitable surgical instruments and/or surgical systems, including robotic surgical systems. The blade <NUM> may define a linear configuration, a curved configuration, or any other suitable configuration, e.g., straight and/or curved surfaces. With respect to curved configurations, the blade <NUM> may be curved in any direction relative to the jaw member <NUM>, for example, such that the distal tip of the blade <NUM> is curved towards the jaw member <NUM>, away from the jaw member <NUM>, or laterally (in either direction) relative to the jaw member <NUM>.

In aspects, the blade <NUM> defines a generally convex first tissue contacting surface <NUM>, e.g., the surface that opposes the jaw member <NUM> in the approximated position thereof. Generally, the convex first tissue contacting surface <NUM> may be defined by a pair of surfaces 172a, 172b (flat or convex surfaces) that converge at an apex 172c, or may be formed by a continuously arcuate surface defining the apex 172c. The blade <NUM> may further define substantially flat lateral surfaces <NUM> on either side of the first tissue contacting surface <NUM>, and a second tissue contacting surface <NUM> opposite the first tissue contacting surface <NUM> and similarly configured relative thereto, e.g., with surfaces 176a, 176b converging at an apex 176c, although other configurations may be also contemplated.

The waveguide <NUM> (<FIG>) or at least the portion of the waveguide <NUM> proximally adjacent the blade <NUM> may define a cylindrical-shaped configuration. Plural tapered surfaces (not shown) may interconnect the cylindrically-shaped waveguide <NUM> with the polygonal (or rounded-edge polygonal) configuration of the blade <NUM> to define smooth transitions between the body of the waveguide <NUM> and the blade <NUM>. Additionally, an inwardly tapered surfaces <NUM> may extend from the lateral surfaces <NUM> at the distal end of the blade <NUM> such that the distal end of the blade <NUM> defines a narrowed configuration as compared to the body of the blade <NUM>.

The first tissue contacting surface <NUM> is configured to contact tissue clamped between the blade <NUM> and the jaw member <NUM> for treating clamped tissue, e.g., sealing and/or transecting the clamped tissue, while a second tissue contacting surface <NUM> may be utilized for, e.g., tissue transection, back scoring, etc. The distal end of the blade <NUM> and/or some or all of the other surfaces of the blade <NUM> may additionally or alternatively be utilized to treat tissue.

The jaw member <NUM> of the end effector assembly <NUM> includes a more-rigid structural body <NUM> and a more-compliant jaw liner <NUM>. The structural body <NUM> may be formed from an electrically conductive material, e.g., stainless steel, or may include electrically conductive portions. The structural body <NUM> includes a pivot (not shown), which pivotably receives the jaw member <NUM> relative to blade <NUM>. This pivot configuration enables transitions between a spaced-apart position and an approximated position to clamp tissue between the blade <NUM> and the jaw liner <NUM> of the jaw member <NUM>.

The jaw liner <NUM> may be made of an insulating material (e.g., PTFE (Teflon)) and include a sensor <NUM> or a wear indicator configured to detect a level of wear thereof. The sensor <NUM> is disposed or impregnated within the jaw liner <NUM> along the longitudinal axis of the structural body <NUM>. In aspects, the longitudinal extension of the sensor <NUM> may be shorter than the length of the structural body <NUM> and/or the jaw liner <NUM>. In this regard, the sensor <NUM> may be disposed near the proximal portion, the distal portion, or in the middle of the structural body <NUM> and/or jaw liner <NUM>. Multiple sensors <NUM> along at least a portion of the length of the jaw liner <NUM> are also contemplated, e.g., proximal, middle, and/or distal sensors <NUM>. Sensor <NUM> is electrically coupled, e.g., via a lead wire, electrically-conductive materials, contacts, and/or any other suitable components, or via a wireless connection, to power source <NUM>, output device <NUM>, and/or transducer <NUM> to enable communication therewith.

The structural body <NUM> of the jaw member <NUM> further includes a backspan 185a and a pair of spaced-apart uprights 185b extending from the backspan 185a in generally perpendicular orientation relative to the backspan 185a and generally parallel orientation relative to one another. The backspan 185a and the uprights 185b cooperate to define a cavity 185c therein, which defines an elongated, generally T-shaped configuration for slidable receipt and retention of the jaw liner <NUM> therein, although other suitable configurations for receiving and retaining the jaw liner <NUM> are also contemplated. The shape of the jaw liner <NUM> may also follow the shape or configuration of the cavity 185c so that the jaw liner <NUM> can be matingly fitted with or received by the cavity 185c.

In aspects, the sensor <NUM> may also serve as a retention for the jaw liner <NUM>. Thus, the shape of the sensor <NUM> may follow a part or all of the shape of the jaw liner <NUM>.

Referring to <FIG>, transverse, cross-sectional views of the end effector assembly <NUM> of <FIG> are illustrated. The sensor <NUM> is disposed or impregnated within the jaw liner <NUM> at a predetermined distance D from a contacting surface <NUM> of the jaw liner <NUM>. The predetermined distance D is based on a life cycle of the jaw liner <NUM>, meaning that the desired level of performance and/or efficacy may not be met when the jaw liner <NUM> wears out more than the predetermined depth D. The contacting surface <NUM> can be contacted by tissue or the apex 172c of the blade <NUM>. The shape of the sensor <NUM> may be rectangular or in any shape extending along the longitudinal direction of the structural body <NUM> of the jaw member <NUM>. The location of the sensor <NUM> within the jaw liner <NUM> may be vertically aligned with the apex 172c of the blade <NUM>. As surgical operations are performed by the ultrasonic surgical instrument <NUM>, the contacting surface <NUM> of the jaw liner <NUM> is worn out and recedes, decreasing a thickness or depth of the jaw liner <NUM>. When the jaw liner <NUM> has been worn out and the contacting surface <NUM> recedes the predetermined depth D, the sensor <NUM> is exposed and contacts tissue or the apex 172c of the blade <NUM> as shown in <FIG>.

In aspects, the sensor <NUM> may be an electrically conductive material (e.g., graphite, silver, gold, copper, etc.). When the contacting surface <NUM> reveals the sensor <NUM>, the apex 172c or tissue may contact the surface of the sensor <NUM>, thereby completing an electrically closed circuit. The electrically closed circuit may be completed between the electrically conductive material and the blade <NUM> or in any other suitable manner. This closed circuit may electrically trigger an alert indicating that the jaw liner <NUM> is to be replaced. The alert may be provided by output device <NUM>, e.g., a message displayed on a display, a flashing light, haptic feedback which causes the ultrasonic surgical instrument <NUM> to vibrate, an audible sound by a speaker, or any combination thereof. The alert is not limited to this list but can include any other means readily available to persons of skill in the art. As an alternative to or in addition to an alert, the closed circuit condition may terminate the supply of power from the power source <NUM>, disable transducer <NUM>, or otherwise impede further activation to inhibit damage to the instrument and/or patient.

In aspects, the sensor <NUM> may be a pressure sensor. Thus, when the pressure sensor <NUM> is revealed and pressure by the blade <NUM> or tissue is applied to the pressure sensor <NUM>, an alert or other response is triggered.

In aspects, the sensor <NUM> may be a metal plate. When the apex 172c of the blade <NUM> vibrates while contacting the metal plate, friction between the metal plate and the apex 172c makes audible sounds so that the user is alerted to stop the procedure and/or replace the jaw liner <NUM>. In aspects, the metal plate may have saw-tooth shapes or any repetitive shapes on the surface facing the blade <NUM> so that audible sounds are amplified when the apex 172c vibrates against the surface of the metal plate. In further aspects, the sensor <NUM> may be made of any materials (e.g., ceramic, etc.) other than the metal but still configured to provide an audible sound.

In aspects, the sensor <NUM> is made of a colored material. When the colored material is exposed from the jaw liner <NUM>, its user may be able to see a change in color in the middle of the jaw liner <NUM>. The color of the colored material may be red, yellow, florescent, or any other color outstanding/different from the color of the jaw liner <NUM>. Thus, when the sensor <NUM> is revealed, the user is readily alerted.

In aspects, the sensor <NUM> may be a resistive sensor, which is semiconductive. When the liner <NUM> wears out, thereby decreasing the thickness of the liner <NUM>, the resistance of the sensor <NUM> also decreases. If the resistance value of the sensor <NUM> becomes lower than a predetermined threshold, the alert is triggered.

Claim 1:
An end effector assembly (<NUM>) for
an ultrasonic surgical instrument, the end effector assembly comprising:
an ultrasonic blade (<NUM>) mechanically coupled to an ultrasonic transducer (<NUM>) configured to transmit ultrasonic vibration energy to the ultrasonic blade; and
a jaw member (<NUM>) movable relative to the ultrasonic blade from a spaced-apart position to an approximated position for clamping tissue therebetween,
wherein the jaw member includes:
a structural body (<NUM>); and
a jaw liner (<NUM>) engaged with the structural body, the jaw liner defining a tissue contacting surface (<NUM>) positioned to oppose the ultrasonic blade in the approximated position and characterised by the jaw liner including a wear indicator (<NUM>) configured to send an alert indicating that the jaw liner is worn beyond a pre-determined threshold.