Patent Description:
The invention is defined in the independent claims and other embodiments are listed in the dependent claims.

The present disclosure relates generally to an ultrasonic surgical handpiece assembly. The ultrasonic surgical handpiece assembly may include a handpiece comprising a transducer and a horn, wherein the transducer is configured to manipulate the horn to actuate a cutting tip that is coupled to the horn to cut or remove biological material.

Claim <NUM> provides a sleeve for use with an ultrasonic handpiece including a coupling housing comprising a handpiece transceiver and configured to surround a portion of an ultrasonic tip including a cutting feature. The sleeve comprises a hub comprising a proximal portion, a distal portion, and a first lumen extending through the hub. The proximal portion has a first face configured to abut the ultrasonic handpiece and a second face positioned distally of the first face. The sleeve further comprises a tube body comprising a distal end and a proximal end. The tube body extends from the distal portion of the hub and is configured to define a second lumen in fluid communication with the first lumen of the hub. The second lumen is configured to surround the portion of the ultrasonic tip. The sleeve also comprises a tube aperture in an interior surface of the second lumen. The tube aperture is positioned at an intermediate point along the second lumen between the proximal end and distal end of the tube body and such that the tube aperture is facing inward towards the second lumen. An irrigation conduit is adjacent to the second lumen, the irrigation conduit configured to extend from the proximal end of the tube body to the tube aperture. An irrigation aperture and a tip aperture are in the first face, the tip aperture configured to be in communication with the first lumen. An irrigation fitting is positioned within the irrigation aperture of the first face of the hub and in fluid communication with the irrigation tube. The sleeve also comprises at least one retention finger protruding proximally from the first face, the retention finger configured to engage the coupling housing of the ultrasonic handpiece. The sleeve further comprises a cavity defined in the proximal portion of the hub, the cavity comprising an opening in a first surface. A sleeve transceiver is positioned within the cavity and configured to communicate with the corresponding handpiece transceiver.

In an exemplary configuration, an ultrasonic surgical handpiece may be configured for use with an ultrasonic tip assembly including a sleeve comprising at least one retention member. The ultrasonic surgical handpiece may comprise a housing comprising a proximal end and an opposing distal end, said housing configured to define a volume. The ultrasonic surgical handpiece may also comprise a transducer at least partially disposed within the volume defined by the housing, and a horn comprising a first end and an opposing second end. The horn may be configured to be at least partially disposed within the volume defined by the housing, the first end of said horn operatively coupled to the transducer. Wherein the transducer is configured to vibrate/oscillate the horn when operated. The ultrasonic surgical handpiece may also comprise an attachment region formed in the distal end of the housing. The attachment region may define a recess comprising a face and a plurality of side walls configured to receive the sleeve. An attachment element in the face of the recess, wherein the attachment element may be configured to receive the at least one retention member of the sleeve to removably couple the sleeve to the ultrasonic surgical handpiece. The ultrasonic surgical handpiece may further comprise a first fitting extending from the face of the recess and may eb configured to removably couple with the sleeve to provide irrigation to the sleeve, and wherein the second end of the horn is configured to protrude from the face.

In another exemplary configuration, an ultrasonic handpiece assembly may be configured for use with an elongated cutting instrument including an aspiration lumen extending the length of the elongated cutting instrument. The assembly may comprise an ultrasonic handpiece comprising: a housing comprising a proximal end and an opposing distal end, the housing defining a volume and the distal end having a distal face. The handpiece may also comprise a transducer configured to define a first conduit, the transducer at least partially disposed within the volume defined by the housing. The handpiece may also comprise a horn comprising a first end and an opposing second end, the horn configured to be at least partially disposed within the volume defined by the housing. The horn may comprise a second conduit in said horn configured to extend between the first end and the second end of the horn. The horn may also comprise a threaded coupler on the second end of the horn configured to extend from the distal end of the housing and removably couple the horn to the elongated cutting instrument. The assembly may also comprise an irrigation outlet fitting extending from the distal end of the housing and configured to discharge irrigation fluid from the housing. The assembly may also comprise an irrigation sleeve The irrigation sleeve may comprise a hub defining a first lumen and comprising an irrigation inlet fitting, the irrigation inlet fitting configured to engage the irrigation outlet fitting to receive irrigation fluid discharged from the ultrasonic handpiece. The sleeve may also comprise a sleeve body extending distally from the hub, the sleeve body defining a second lumen configured to surround a portion of the elongated cutting instrument when the elongated cutting instrument is inserted into the irrigation sleeve. The sleeve may further comprise a tube aperture in an interior surface of the second lumen, the tube aperture positioned at an intermediate point along the second lumen between a proximal end and a distal end of the sleeve body such that the tube aperture is facing toward the second lumen to provide irrigation fluid to a surgical site and to cool the elongated cutting instrument. The sleeve may also comprise an irrigation conduit running adjacent to the second lumen, the irrigation conduit configured to extend from the irrigation inlet fitting of the sleeve body to the tube aperture to create a fluid passageway for communicating irrigation fluid to the elongated cutting instrument, wherein the irrigation outlet fitting on the housing may be configured to engage the irrigation inlet fitting on the irrigation sleeve when the irrigation sleeve is coupled to the housing such that the irrigation fluid flows entirely within the ultrasonic handpiece and the hub. Furthermore, the first end of the horn may be operatively coupled to the transducer such that the first conduit of the transducer and the second conduit of the horn may define a continuous passageway extending from the proximal end to the distal end of the housing.

According to claim <NUM>, an ultrasonic handpiece assembly is configured for use with an elongated cutting instrument. The assembly comprises an ultrasonic handpiece comprising a housing, a transducer, and a horn. The housing comprises a proximal end and an opposing distal end, the housing defining a volume and the distal end having a distal face. The transducer is configured to define a first conduit, the transducer at least partially disposed within the volume defined by the housing. The horn comprises a first end and an opposing second end, the horn configured to be at least partially disposed within the volume defined by the housing. The horn comprises a second conduit in the horn configured to extend between the first end and the second end of the horn. An irrigation outlet fitting extends from the distal end of the housing and is configured to discharge irrigation fluid from the housing. A threaded coupler is disposed on the second end of the horn and configured to engage the elongated cutting instrument. There is a recess in the distal end of the housing, the recess comprising a recessed face and a plurality of side walls configured to define an asymmetrical shape. The assembly further comprises a handpiece transceiver comprising a handpiece coil comprising a first axis, the handpiece transceiver positioned within one of the plurality of side walls. The assembly also comprises an irrigation sleeve comprising a hub comprising a proximal portion and a distal portion, the proximal portion configured to define an asymmetrical protrusion extending proximally from the distal portion and sized to be inserted within the recess of the housing. The irrigation sleeve also comprises an abutment portion configured to contact the distal face of the ultrasonic handpiece when the asymmetrical protrusion is inserted in the recess of the housing. The asymmetrical protrusion is configured to ensure proper alignment of the irrigation sleeve with the housing. The irrigation sleeve further comprises a sleeve transceiver comprising a sleeve coil and a memory unit, the memory unit storing information pertaining to the optimal driving parameter for the elongated cutting instrument. The sleeve coil has a second axis, wherein the sleeve transceiver is located in a cavity defined in the asymmetrical protrusion of the hub such that the second axis of the sleeve coil is oriented in parallel to the first axis of the handpiece coil.

Claim <NUM> defines a method of assembling an ultrasonic handpiece without using separate irrigation connections to a tip sleeve.

In yet another exemplary configuration, a tubing connector may be configured for integrally connecting an irrigation line, an aspiration line, and a conductor to a proximal portion of an ultrasonic surgical handpiece wherein the ultrasonic surgical handpiece comprises an irrigation fitting and an aspiration fitting that extend proximally from the proximal portion of the handpiece. The tubing connector may comprise a base comprising a distal end and a proximal end. The tubing connector may also comprise a first lumen in said base configured to create a fluid passageway through the base that extends from the distal end to the proximal end of the base. The first lumen may be configured to receive the aspiration line proximate the proximal end of the base. The base may define a groove in a perimeter of the base that extends between the proximal region to the distal region of the base, the groove configured to receive the conductor. A portion of the first lumen proximate the distal end of the base is configured to removably couple with the aspiration fitting of the ultrasonic surgical handpiece via a friction fit, and wherein the tubing connector is configured to reduce strain of the irrigation line and the aspiration line when coupled to the surgical handpiece.

These and other configurations, features, and advantages of the present disclosure will be apparent to those skilled in the art. The present disclosure is not intended to be limited to or by these configurations, embodiments, features, and/or advantages.

Referring now to the drawings, exemplary illustrations are shown in detail. Although the drawings represent schematic embodiments, the drawings are not necessarily to scale and certain features may be exaggerated to better illustrate and explain an innovative aspect of an illustrative embodiment. Further, the exemplary illustrations described herein are not intended to be exhaustive or otherwise limiting or restricting to the precise form and configuration shown in the drawings and disclosed in the following detailed description.

As medical professionals strive for reducing the size of the incisions and the amount of recovery time required following invasive medical procedures, the size of medical instruments used in various medical procedures have become smaller. Many of the medical instruments utilized in performing the various medical procedures may include the use of a cutting accessory, such as ultrasonic handpieces, high-speed drills, rotating burs, open-window shavers, and the like. Many of these cutting accessories may require the use of irrigation or aspiration (i.e., suction) to reduce heat and/or remove debris at the surgical site. Similarly, irrigation may be utilized to lubricate a cutting accessory.

One example of a surgical instrument that may utilize irrigation and aspiration systems is an ultrasonic handpiece. Generally, one or more lines may be coupled to the ultrasonic handpiece to supply irrigation and suction. The ultrasonic handpiece may further comprise a sleeve comprising one or more lumens that may be utilized to direct fluid from an irrigation source toward the surgical site and the cutting accessory, i.e., an ultrasonic tip. Irrigation and/or aspiration lines have typically been coupled to the exterior of the ultrasonic handpiece to be coupled to the sleeve. The sleeve and/or cutting accessory may be disposable, resulting in the sleeve and/or cutting accessory only temporarily being attached to the ultrasonic handpiece. The introduction of additional elements, such as the irrigation and/or aspiration lines to the exterior of the handpiece can result in increasing the size, profile, and/or general bulkiness of the ultrasonic handpiece. This may obstruct the medical professional's view and/or distract the medical professional during operation of the medical instrument during the medical procedure. The positioning of the irrigation and/or aspiration lines relative to the ultrasonic handpiece may similarly effect the ergonomics of the ultrasonic handpiece, inhibiting the medical professional's ability to manipulate the ultrasonic handpiece.

Therefore, an ultrasonic surgical handpiece assembly <NUM> may be configured to comprise an ultrasonic handpiece <NUM> including internal irrigation and aspiration lumens to reduce the size of the handpiece and improve ergonomics, such as the ultrasonic surgical handpiece assembly <NUM> illustrated in <FIG>.

Referring to <FIG> and <FIG>, an example configuration of an ultrasonic surgical handpiece assembly <NUM> is illustrated. The ultrasonic surgical handpiece assembly <NUM> may comprise an ultrasonic handpiece <NUM> comprising a proximal end and distal end. The ultrasonic surgical handpiece assembly <NUM> may further comprise sleeve <NUM> and an ultrasonic tip <NUM> that may be coupled to the distal end of the ultrasonic handpiece <NUM>. The sleeve <NUM> may be configured to provide irrigation to the ultrasonic tip <NUM> and/or the surgical site. It is further contemplated that the sleeve <NUM> may also be configured to provide aspiration to the ultrasonic tip <NUM>. The ultrasonic tip <NUM> may comprise a cutting feature <NUM> that is configured to cut, shape, and/or remove biological tissue.

The ultrasonic tip <NUM> may have various features, as described in <CIT>; <CIT>; and <CIT>.

The ultrasonic surgical handpiece assembly <NUM> may also comprise a cable <NUM> or other power cord comprising a power connector <NUM> or adapter configured to couple the ultrasonic surgical handpiece assembly <NUM> to a power supply, such as a control console <NUM> configured to regulate the various aspects of the ultrasonic handpiece <NUM>. For example, the console <NUM> may be configured to regulate the power and the signal supplied to the ultrasonic handpiece <NUM>. The console <NUM> may also be configured to regulate the irrigation and/or aspiration functions of the ultrasonic handpiece <NUM> to optimize performance of the ultrasonic surgical handpiece assembly <NUM>.

Referring to <FIG>, a sectional view of the ultrasonic surgical handpiece assembly <NUM> of <FIG> is provided. The ultrasonic handpiece <NUM> may comprise a proximal housing portion <NUM> and a distal housing portion <NUM>, each of which may be configured to define a void. The proximal housing portion <NUM> and the distal housing portion <NUM> may be configured as two separate components and may be coupled together by a laser weld or similar coupling process. Alternatively, proximal housing portion <NUM> and the distal housing portion <NUM> may including corresponding coupling features configured to couple the proximal housing portion <NUM> and the distal housing portion <NUM> together. It is also contemplated that the proximal housing portion <NUM> and the distal housing portion <NUM> may be configured as a single unitary component.

A transducer <NUM> may be disposed in the void defined by the ultrasonic handpiece <NUM>. The transducer <NUM> may comprise a plurality of driver elements <NUM>, such as piezoelectric crystals arranged in a stacked configuration. The piezoelectric crystals <NUM> may expand and contract based on the varied application of electricity. The transducer <NUM> may comprise a tube <NUM> that defines a lumen <NUM> that extends from the proximal end to the distal end of the transducer <NUM> to create a fluid passageway through the transducer <NUM>. The tube <NUM> may take the form of a post. The tube <NUM> may extend through the collinear longitudinal axes of the driver elements <NUM>. A proximal end mass <NUM> may be located adjacent to the proximal face of the most proximally located driver element <NUM>.

It is further contemplated that the transducer <NUM> may alternatively include a plurality of magnetostrictive elements.

A horn <NUM> may be at least partially disposed within the void defined by ultrasonic handpiece <NUM>. The horn <NUM> may be coupled to the distal end of the transducer <NUM>. The horn <NUM> may be constructed from a rigid steel alloy, titanium or similar material. In operation, as the transducer <NUM> expands and contracts, the horn <NUM> will oscillate. The horn <NUM> may be removably coupled to the transducer <NUM>. For example, the proximal end of the horn <NUM> may comprise a threaded male coupler and the distal end of the transducer <NUM> may comprise a corresponding female threaded coupler. Alternatively, the transducer <NUM> and the horn <NUM> may be permanently coupled via a weld, adhesive, or similar bonding process. The horn <NUM> may be configured to define a second conduit <NUM> that is in fluid communication with the lumen <NUM> defined by the tube <NUM> of the transducer <NUM>. Collectively, the lumen <NUM> through the transducer <NUM> and the second conduit <NUM> through the horn <NUM> form a portion of a continuous fluid passageway that extends from the distal end of the ultrasonic handpiece <NUM> to the proximal end of the ultrasonic handpiece <NUM>. The ultrasonic surgical handpiece assembly <NUM> is constructed so that the driver elements <NUM> are compressed between the proximal end mass <NUM> and the horn <NUM>.

The fluid passageway through the ultrasonic handpiece <NUM> may be utilized to provide irrigation fluid and/or a vacuum through the ultrasonic handpiece <NUM>. The distal end of the horn <NUM> may further comprise a threaded coupler <NUM> that is configured to removably couple the ultrasonic tip <NUM> to ultrasonic handpiece <NUM> via the horn <NUM>. While the threaded coupler <NUM> on the distal end of the horn <NUM> may comprise threads configured to engage corresponding threads on the ultrasonic tip <NUM>, it is further contemplated that other coupling methods may be utilized. For example, the distal end of the horn <NUM> may comprise features that allow snap fit engagement with the ultrasonic tip <NUM>.

The control console <NUM> of the ultrasonic surgical handpiece assembly <NUM> may be configured to source drive signals over the cable <NUM> to which the ultrasonic handpiece <NUM> is connected. In many but not all versions of ultrasonic surgical handpiece assembly <NUM>, the ultrasonic handpiece <NUM> and cable <NUM> are assembled as a single unit. The drive signals are applied to the piezoelectric crystals <NUM>. At any given instant, the same drive signal is applied to each of plurality of piezoelectric crystals <NUM>. The application of the drive signals causes the piezoelectric crystals <NUM> to simultaneously and cyclically expand and contract. A stack of piezoelectric crystals <NUM> is often between <NUM> and <NUM> in length. The distance, the amplitude, of movement over a single expansion/contraction cycle of the piezoelectric crystals <NUM> may be between <NUM> and <NUM> microns. The horn <NUM> may be configured to amplify this movement. Consequently, the distal end of the horn <NUM> and, by extension, the ultrasonic tip <NUM>, when moving from the fully contracted position to the fully extended position typically moves a maximum of <NUM> microns and more often <NUM> microns or less. Some ultrasonic tips <NUM> are further designed to so that the longitudinal extension/retraction of the ultrasonic tip <NUM> may also induces a torsional movement in the cutting feature <NUM>. When ultrasonic handpiece <NUM> is actuated to cause the cyclic movement of the ultrasonic tip <NUM>, the cutting feature <NUM> is considered to be vibrating.

The control console <NUM> may also include a vacuum pump and controller, and an irrigation pump and a controller. The vacuum pump may be coupled to the ultrasonic surgical handpiece assembly <NUM> via aspiration line <NUM>. The irrigation pump may be coupled to the ultrasonic handpiece assembly <NUM> via irrigation line <NUM>.

The control console <NUM> may have any of the features described in <CIT> and <CIT>.

The ultrasonic handpiece <NUM> may also comprise a tube <NUM> that is at least partially disposed within the ultrasonic handpiece <NUM> and configured to define a lumen <NUM> through the ultrasonic handpiece <NUM> for irrigation and/or suction. The tube <NUM> defines an additional lumen <NUM> through the ultrasonic handpiece <NUM> to the passageway defined by the lumen <NUM> of the transducer <NUM> and the second conduit <NUM> of the horn <NUM>. For example, the tube <NUM> may define an irrigation lumen <NUM> through the ultrasonic handpiece <NUM> and the lumen <NUM> through the transducer <NUM> and the second conduit <NUM> through horn <NUM> may define an aspiration lumen <NUM> through the ultrasonic handpiece <NUM>. Alternatively, the tube <NUM> may define an aspiration passageway <NUM> through the ultrasonic handpiece <NUM> and the lumen <NUM> through the transducer <NUM> and the second conduit <NUM> through the horn <NUM> may define an irrigation passageway through the ultrasonic handpiece <NUM>.

As described above, the irrigation and/or the aspiration passageways are disposed mostly within the ultrasonic handpiece <NUM> to provide ergonomic advantages by eliminating the one or more tubes typically attached to the exterior of the ultrasonic handpieces. It should be understood that while portions of the lines that define the aspiration passageway and/or the irrigation passageway from the proximal end of the ultrasonic surgical handpiece assembly <NUM> to the distal end of the passageway may be exposed, i.e., visible to a user during operation, there are is no need for users to attach any irrigation lines or aspiration lines to the sides of the ultrasonic surgical handpiece assembly <NUM> during use. Instead, the irrigation lines <NUM> and aspiration lines <NUM>, in certain embodiments, solely attach to the proximal end, even the rear face of the proximal end of the ultrasonic handpiece <NUM>. In addition, in certain embodiments, during set-up of the ultrasonic surgical handpiece assembly <NUM>, all of the aspiration and irrigation connections that the sleeve includes are sourced directly from the ultrasonic handpiece <NUM>. In other words, there are no irrigation or aspiration lines that couple to a side of the sleeve <NUM>. Thus, the ultrasonic handpiece <NUM> may include connections for both irrigation and aspiration.

Referring to <FIG>, a sectional view of a portion of the ultrasonic handpiece <NUM> is illustrated. As described above, the transducer <NUM> may comprise a distal end and a proximal end disposed within the void of ultrasonic handpiece <NUM>. The transducer <NUM> may be configured to expand and contract along the longitudinal axis of the transducer <NUM>. The lumen <NUM> through the transducer <NUM> comprises a distal portion and a proximal portion. The horn <NUM> may also be at least partially disposed within the ultrasonic handpiece <NUM>.

The ultrasonic handpiece <NUM> may further comprise a barrier member <NUM> positioned within the void defined by the ultrasonic handpiece <NUM> and configured to define a cavity. The transducer <NUM> may be encased within the barrier member <NUM>, such that the barrier member <NUM> may be configured to assist in mounting and isolating the transducer <NUM> within the ultrasonic handpiece <NUM>. The barrier member <NUM> may not occupy the entirety of the void defined within the ultrasonic handpiece <NUM>. Therefore, the ultrasonic handpiece <NUM> may further comprise a potting element <NUM> or material that is disposed within void defined by the ultrasonic handpiece <NUM>. The potting element <NUM> may be disposed within the void defined by the ultrasonic handpiece <NUM> and exterior to the barrier member <NUM>, such that the potting element <NUM> may occupy or fill the portion of the void within the handpiece <NUM> that is not occupied by the barrier member <NUM> or occluded by the barrier member <NUM>. The potting element <NUM> may be configured to fix the position of the barrier member <NUM> within the void defined by the ultrasonic handpiece <NUM>. The potting element <NUM> may also function as an insulator or dampener configured to prevent the transfer of thermal energy (i.e., heat) and mechanical energy (i.e., vibration) from the transducer <NUM> to the user's hand.

The barrier member <NUM> may further define a channel <NUM> extending in a generally proximal direction from the proximal end of the barrier member <NUM>. The channel <NUM> forms a passageway between the proximal end of the ultrasonic handpiece <NUM> and the tube <NUM> that defines the lumen <NUM> through the transducer <NUM>. The channel <NUM> may further comprise a coupling portion <NUM>, such as a hose barb or similar fitting configured to create a friction fit, that extends proximally from the proximal end of the ultrasonic handpiece <NUM> and is configured to couple the channel <NUM> to the aspiration line <NUM> of the control console <NUM>.

The transducer <NUM> may be partially mounted in the cavity defined by the barrier member <NUM> by a rear seal <NUM> positioned between said proximal end of the transducer <NUM> and an interior surface of the barrier member <NUM>. The rear seal <NUM> may be configured to abut said proximal end of the transducer <NUM> and define a first aperture that is in fluid communication with the lumen <NUM> through the transducer <NUM>. The rear seal <NUM> is positioned to help prevent moisture ingress to the volume that surrounds the transducer <NUM>, in between the barrier member <NUM> and the exterior of the transducer <NUM>. The rear seal <NUM> also functions to prevent moisture from entering between the exterior surface of the tube <NUM> and the interior surface of the transducer <NUM>. The rear seal <NUM> may be formed from an elastomeric material that is resistant to heat and vibration degradation, including those materials that can withstand temperatures of an autoclave process.

The ultrasonic handpiece <NUM> may further comprise a front seal <NUM> disposed radially about an exterior surface of the horn <NUM> to prevent moisture ingress between an interior surface of the distal housing portion <NUM> and the horn <NUM>. This is because the exterior surface of the horn <NUM> will be exposed to liquid during operation of the ultrasonic handpiece <NUM>. The front seal <NUM> may further comprise a plurality of protrusions or bumps configured to facilitate engagement between the horn <NUM> and the distal housing portion <NUM> and prevent ingress of moisture into the void between the horn <NUM> and the distal housing portion <NUM> of the ultrasonic handpiece <NUM>.

The ultrasonic handpiece <NUM> may further comprise a potting seal <NUM> positioned between and engaging both a distal end of the barrier member <NUM> and the proximal end of the horn <NUM>. The potting seal <NUM> may also be configured to contact an interior surface of distal housing portion <NUM> of the ultrasonic handpiece <NUM> that is adjacent to the barrier member <NUM> and the proximal end of the horn <NUM>. The potting seal <NUM> may be configured to abut the distal end of the barrier member <NUM> and define a second aperture for receiving the coupling feature of the horn <NUM>. The potting seal <NUM> may be configured to prevent the potting element <NUM> from entering the barrier member <NUM> and contacting the transducer <NUM> during the potting process. Once the potting element <NUM> is in place, the potting element <NUM> in conjunction with the potting seal <NUM> helps to prevent moisture from entering between the barrier member <NUM> and the horn <NUM>.

Referring to <FIG> and <FIG>, an exemplary configuration of the distal housing portion <NUM> is illustrated. The distal housing portion <NUM> may comprise a coupling feature <NUM> configured to removably couple the distal housing portion <NUM> to a distal portion of the barrier member <NUM> that is disposed within the proximal housing portion <NUM>. The coupling feature <NUM> may comprise a pair of tabs configured to create a snap and/or friction fit with a corresponding coupling feature of the barrier member <NUM>. However, alternative coupling features are also contemplated, such as hooks or protrusions. The coupling feature <NUM> may assist in mounting and/or positioning the barrier member <NUM> within the void defined by the distal housing portion <NUM> and the proximal housing portion <NUM>.

The distal housing portion <NUM> of the ultrasonic handpiece <NUM> may further comprise a flex circuit <NUM> that may be molded into the distal housing portion <NUM>. The flex circuit <NUM> may be constructed from an electrically conductive material configured to transmit electrical signals between a distal region and proximal region of the flex circuit <NUM>. The flex circuit <NUM> may comprise an attachment portion <NUM> positioned at the proximal region of the flex circuit <NUM> and configured to couple to a processor disposed within the ultrasonic handpiece <NUM> that is configured to communicate with the control console <NUM>. Alternatively, the attachment portion <NUM> of the flex circuit <NUM> may be configured to couple to a wire, cable, or similar conductor that may couple to the control console <NUM> via the cable <NUM>. The processor or wire may be configured to transport electrical signals between the flex circuit <NUM> and the control console <NUM> that may control the power supply, irrigation, and/or aspiration functions of the ultrasonic handpiece <NUM>. The flex circuit <NUM> may also comprise a transceiver <NUM> positioned at the distal region of the flex circuit <NUM>. As will be described below, the position of the transceiver <NUM> in the ultrasonic handpiece <NUM> should be tightly controlled in order to ensure that a corresponding coil of the sleeve <NUM> can be consistently read when the sleeve <NUM> is coupled to the ultrasonic handpiece <NUM>.

Also illustrated in <FIG> is the tube <NUM> defining the lumen <NUM> described above, that is at least partially disposed within the ultrasonic handpiece <NUM>. The tube <NUM> may be at least partially disposed within the distal housing portion <NUM> and the proximal housing portion <NUM>. The tube <NUM> may further comprise a coupling feature <NUM>, such as a hose barb or similar fitting configured to create a friction fit, positioned at proximal end of the tube <NUM> and configured to couple to the tube <NUM> to an irrigation line <NUM> that is routed from the control console <NUM> to the ultrasonic surgical handpiece assembly <NUM>. The irrigation line <NUM> from the console <NUM> may be coupled to the ultrasonic handpiece <NUM> via the hose barb <NUM> to facilitate the flow of irrigation fluid through tube <NUM> within the ultrasonic handpiece <NUM> to the sleeve <NUM> and/or ultrasonic tip <NUM>. In the configuration described above, the irrigation fluid may flow from the proximal end to the distal end of the ultrasonic handpiece <NUM> within the ultrasonic handpiece <NUM> or sleeve <NUM> eliminating the need for bulky irrigation lines coupled to the side of the ultrasonic handpiece <NUM> or the side of the sleeve <NUM>. The routing of irrigation lines through the handpiece <NUM> enables this configuration. Thus, neither the sleeve, nor the ultrasonic handpiece includes an irrigation coupling part along the sides. Alternatively, in other configurations, the tube <NUM> may be coupled to an aspiration line <NUM> via the coupling feature <NUM>. The aspiration line <NUM> may be utilized to draw a vacuum through the tube <NUM>. The tube <NUM> may be in communication with the sleeve <NUM> and/or ultrasonic tip <NUM> to remove biological material and/or fluid from the surgical site.

Referring to <FIG>, an exploded view of the distal housing portion <NUM> of the ultrasonic handpiece <NUM> is illustrated. The distal housing portion <NUM> may comprise a first half <NUM> and a second half <NUM> that are configured to be coupled together to form a portion of the distal housing portion <NUM>. Each of the first half <NUM> and the second half <NUM> may be injection-molded from injection-molded plastic or similar lightweight and durable material. Furthermore, each of the first half <NUM> and the second half <NUM> may be molded to include a groove <NUM> or recessed portion that forms a channel in the distal housing portion <NUM> when the first half <NUM> and the second half <NUM> are coupled together. It is also contemplated that the groove <NUM> may only be formed in one of the first half <NUM> or the second half <NUM>. The groove <NUM> may be configured to receive at least a portion of the flex circuit <NUM>. The groove <NUM> may further comprise a cavity <NUM> at the distal end of the groove <NUM>, wherein the cavity <NUM> is configured to receive the transceiver <NUM> at the distal region of the flex circuit <NUM>. The cavity <NUM> may comprise larger dimensions than the groove <NUM> to accommodate the size of the transceiver <NUM> relative to the flex circuit <NUM> and the cavity <NUM> and the groove <NUM> may be contiguous. While the cavity <NUM> is illustrated as being positioned proximate the distal end of the distal housing portion <NUM>, it is contemplated that the first and second halves <NUM>, <NUM> may be configured wherein the flex circuit <NUM> and the transceiver <NUM> to be positioned at alternative locations. For example, the cavity <NUM> could be positioned closer to the proximal end of the distal housing portion <NUM>. In yet another configuration, the first and second halves <NUM>, <NUM> may be configured to be split along a horizontal axis, as opposed to along a vertical axis, such that the first half <NUM> is positioned superior to the second half <NUM>. In this configuration, the groove <NUM> and the cavity <NUM> may be formed within the interface of the first and second halves <NUM>, <NUM> such that the flex circuit <NUM> and transceiver <NUM> may be positioned on the right or left side of the distal housing portion <NUM>.

The position of the cavity <NUM> should be tightly controlled in order to enable communication between the transceiver <NUM> and RFID tag <NUM> of the sleeve <NUM> (See <FIG>). For example, the cavity <NUM> may be positioned within the distal housing portion <NUM> to reduce the distance between the transceiver <NUM> and the corresponding RFID tag <NUM> of the sleeve <NUM> when the sleeve <NUM> and ultrasonic handpiece <NUM> are coupled together. The cavity <NUM> is positioned to ensure that the plane defined by the transceiver <NUM> is positioned substantially parallel to the plane defined by the RFID tag <NUM> of the sleeve <NUM>.

As described above, the flex circuit <NUM> may comprise a transceiver <NUM> positioned at the distal end of the flex circuit <NUM>. The transceiver <NUM> may comprise an antenna configured to send out a signal to a corresponding RFID tag associated with the sleeve <NUM> and receive a response. The flex circuit <NUM> may be disposed at least partially within the groove <NUM> of the distal housing portion <NUM> when the first half <NUM> and the second half <NUM> are coupled together. The flex circuit <NUM> may generally be formed as a thin strip of ribbon including internal copper elements, such as wiring. The configuration and structure of the flex circuit <NUM> may result in the flex circuit <NUM> being frail or easily damaged. This can make working with and or installing the flex circuit into the distal housing portion <NUM> difficult. For example, one needs to handle the flex circuit in a manner that protects against crushing or breaking. One also wants to be careful to avoid operations that may cause the layers of the flex circuit <NUM> to delaminate. Therefore, the groove <NUM> formed in the distal housing portion <NUM> should avoid sharp bends or turns and seek to provide a smooth transition along the length of the grove <NUM>. During the assembly process, the flex circuit <NUM> is positioned within the groove <NUM> and the transceiver <NUM> within the cavity <NUM> prior to coupling the first half <NUM> and the second half <NUM> of the distal housing portion <NUM>, such that the position of the transceiver <NUM> may be fixed within the distal housing portion <NUM>. It should be appreciated that the transducer need not always be at the distal end of the flex circuit.

Once the first half <NUM> and the second half <NUM> of the distal housing portion <NUM> have been mechanically fit together such that the position of the transceiver <NUM> is fixed, the distal housing portion <NUM> may be over-molded with autoclaveable plastic to produce the final configuration of distal housing portion <NUM> illustrated in the <FIG>. Over-molding the flex circuit <NUM> and transceiver <NUM> within the distal housing portion <NUM> of the ultrasonic handpiece <NUM> with an autoclaveable plastic serves to protect the flex circuit <NUM> from being damaged by heat during the autoclave process utilized to sterilize the ultrasonic handpiece <NUM>. Furthermore, the use of autoclaveable plastic as opposed to plastic having a lower melting point than <NUM> degrees Celsius, allows the distal housing portion <NUM> to be repeatedly subject to autoclave sterilization processes without experiencing significant degradation. Finally, by positioning the flex circuit <NUM> within the groove <NUM> of the first and second halves <NUM>, <NUM> before overmolding with the autoclaveable plastic, the flex circuit <NUM> is sufficiently insulated by the first and second halves <NUM>, <NUM> from the thermal energy of the melted autoclaveable plastic such that the flex circuit <NUM> does not delaminate during the overmolding process. The result of the process described above can be shown in the device illustrated in <FIG> and <FIG>. Autoclaveable plastic should be understood as polymers having a melting point greater than <NUM> degrees Celsius.

While the process of positioning the flex circuit <NUM> is described with respect to the two halves <NUM>, <NUM> of the distal housing portion <NUM>, it should be appreciated that a similar process can be used with any suitable medical device housing where it is important to precisely position a portion of a flex circuit <NUM>, including those medical device housings that do not include two distinct halves.

While not illustrated, the ultrasonic handpiece <NUM> also includes a memory. The memory may contain data describing the characteristics of the ultrasonic handpiece <NUM>. Memory may take the form of an EPROM, an EEPROM or be included with the RFID tag <NUM> described above. The memory, in addition to containing data capable of being read, is able to store data written to the memory after manufacture of the ultrasonic handpiece <NUM>. Ancillary components not illustrated are mounted to the handpiece to facilitate the reading of data from and the writing of data to the memory. These components consist of one or more of the following: conductors; exposed contacts/contact pins; a coil/antenna; or an isolation circuit.

Referring to <FIG>, an exemplary configuration of the interface between the distal housing portion <NUM> and the sleeve <NUM> and/or ultrasonic tip <NUM> is illustrated. <FIG> illustrates a front view of an example configuration of the distal end of the distal housing portion <NUM> described above. This may also be referred to as the distal end of the ultrasonic handpiece <NUM>. The distal end of the ultrasonic handpiece <NUM> may comprise an attachment region <NUM> configured to serve as the interface between the ultrasonic handpiece <NUM> and the sleeve <NUM> and the ultrasonic tip <NUM>. The attachment region <NUM> may comprise a recess <NUM> defined by a proximal surface <NUM> and a distal surface <NUM> that are connected by a plurality of walls <NUM> extending perpendicular to the proximal surface <NUM> and the distal surface <NUM>. The proximal surface <NUM> may comprise an aperture <NUM> including a coupling feature <NUM> at the perimeter of the aperture <NUM> (See <FIG>). The coupling feature <NUM> may comprise a tab, lip, or similar snap fit coupling mechanism.

The distal end of the horn <NUM> may be configured to partially extend through the aperture <NUM> defined in the proximal surface <NUM>, wherein at least a portion of the horn <NUM> and the threaded coupler <NUM> are disposed within the recess <NUM> at the distal end of the ultrasonic handpiece <NUM>. The second conduit <NUM> that extends through the horn <NUM> may similarly open to the recess <NUM>.

The proximal surface <NUM> may further comprise an irrigation coupler <NUM> positioned at the distal end of the tube <NUM> defining the lumen <NUM> through the ultrasonic handpiece <NUM>. The irrigation coupler <NUM> may comprise a fitting, hose barb, or similar coupling member for coupling the distal end of the tube <NUM> to a corresponding irrigation line <NUM> of the sleeve <NUM>. The irrigation coupler <NUM> may be configured to be in fluid communication with the lumen <NUM> disposed within the ultrasonic handpiece <NUM> to provide irrigation fluid to the sleeve <NUM>. The irrigation coupler <NUM> may serve as an inlet or an outlet to transport material and/or fluid between the ultrasonic handpiece <NUM> and sleeve <NUM>.

Referring to <FIG>, a partially exploded view of the interface between the distal end of the ultrasonic handpiece <NUM> and the sleeve <NUM> is illustrated. The sleeve <NUM> may comprise a hub <NUM> positioned at a proximal end of the sleeve <NUM> and a sleeve body <NUM> that extends distally from the hub <NUM>. The sleeve <NUM> may comprise a lumen <NUM> defined by the hub <NUM> and sleeve body <NUM> that extends the length of sleeve <NUM> and is configured to surround at least a portion of the ultrasonic tip <NUM> when coupled to the ultrasonic handpiece <NUM>. The hub <NUM> may comprise a protrusion <NUM> that extends proximally from a distal surface <NUM> of the hub <NUM> and terminates at a proximal surface <NUM>. The proximal surface <NUM> of the protrusion <NUM> may be oriented to be generally parallel to the distal surface <NUM>. The shape of the protrusion <NUM> may be defined by a plurality of external circumferential surfaces <NUM> or wall members that extend between the distal surface <NUM> and the proximal surface <NUM> and are configured to define the outer perimeter of the protrusion <NUM>. The external circumferential surfaces <NUM> may be oriented to be generally perpendicular to the proximal surface <NUM> and/or the distal surface <NUM>. It should be appreciated the shape of the protrusion <NUM> is positioned to fit closely within the recess <NUM>, such that the external circumferential surfaces <NUM> of the protrusion <NUM> engage the walls <NUM> of the recess <NUM>.

However, while not illustrated in the figures, it is further contemplated that the external circumferential surfaces <NUM> of the protrusion <NUM> may be oriented at an angle other than <NUM> degrees relative to the proximal surface <NUM> and/or the distal surface <NUM> in order to create a tapered protrusion <NUM>. For example, the area defined by the external circumferential surfaces <NUM> of the protrusion <NUM> proximate the distal surface <NUM> may be greater than the area of the proximal surface <NUM>.

The hub <NUM> may further comprise a fitting <NUM> extending from the proximal surface <NUM> of the protrusion <NUM>. The fitting <NUM> may be configured to couple to the corresponding fitting <NUM> of the ultrasonic handpiece <NUM>. The fitting <NUM> of the sleeve <NUM> and corresponding fitting <NUM> of the ultrasonic handpiece <NUM> may be configured to facilitate the exchange of fluid between the sleeve <NUM> and the ultrasonic handpiece <NUM>. In particular, the fitting <NUM> is sized to fit within the fitting <NUM> when the sleeve <NUM> is coupled to the ultrasonic handpiece <NUM>. For example, irrigation fluid from the ultrasonic handpiece <NUM> may be dispersed to the sleeve <NUM> through the connection of the fitting <NUM> to the fitting <NUM>. This eliminates the need to connect the sleeve to an irrigation line that is separate from the ultrasonic handpiece <NUM>, e.g., such as an irrigation line that connects to a side of the sleeve <NUM>. Alternatively, a vacuum may be applied to the ultrasonic handpiece <NUM> configured to aspirate material from the sleeve <NUM> through the fittings <NUM> and <NUM> when coupled in an alternative configuration.

The sleeve <NUM> may further comprise a conduit <NUM> formed in the sleeve body <NUM> that runs adjacent to the lumen <NUM> of the sleeve <NUM>. The fitting <NUM> may be coupled to the proximal end of the conduit <NUM>. The conduit <NUM> may be configured to channel irrigation fluid through the sleeve <NUM> separate from the lumen <NUM> of the sleeve <NUM>. The conduit <NUM> may be routed in various ways through the sleeve <NUM>.

The hub <NUM> may further comprise a cavity <NUM> in the protrusion <NUM> that that includes an opening in the proximal surface <NUM> of the protrusion <NUM>. The cavity <NUM> may be configured to at least partially enclose a tag <NUM>, antenna, transceiver, or similar wireless communication device that is configured to communicate with the transceiver <NUM> disposed in the distal housing portion <NUM> of the ultrasonic handpiece <NUM>. For example, the tag <NUM> may comprise an RFID tag <NUM> that may be inserted and/or disposed within the cavity <NUM>. While the figures illustrate the cavity <NUM> and RFID tag <NUM> as being positioned generally near the proximate end of the sleeve <NUM>, it should be understood that the cavity <NUM> and RFID tag <NUM> may be positioned at other locations on or within the sleeve <NUM>. For example, the RFID tag <NUM> may be positioned within one of the other external circumferential surfaces 81A, 81B, or 81D of the protrusion <NUM>. Alternatively, the cavity <NUM> and RFID tag <NUM> may be positioned within the distal surface <NUM> of the hub <NUM>. The RFID tag <NUM> may include a memory unit that stores data and/or information related to one or more properties or characteristics related to the sleeve <NUM> and ultrasonic tip <NUM>. For example, the RFID tag <NUM> may comprise information identifying the type of cutting feature <NUM> disposed on the distal end of the ultrasonic tip <NUM>. The RFID tag <NUM> may also comprise information identifying the type of sleeve <NUM>. This information may be communicated to the ultrasonic handpiece <NUM> and subsequently the console <NUM> so that the console <NUM> may modify power settings, irrigation settings, aspiration settings, and/or other settings intended to optimize the efficiency of the cutting feature <NUM> of the ultrasonic tip <NUM>. This may include control parameters that are not specific to the power and tip to the ultrasonic handpiece <NUM> compatibility settings. The RFID tag <NUM> may also be used to prevent customers from reusing ultrasonic tip <NUM> and/or sleeve <NUM> as part of a sterilization standard or procedure. For example, the ultrasonic tip <NUM> and sleeve <NUM> may be configured as a single use component that is not intended to be sterilized and reused. The RFID tag <NUM> also includes a coil <NUM>. The shape of the protrusion <NUM> and the recess <NUM> are arranged such that the plane defined by the coil <NUM> of the RFID tag <NUM> is generally parallel to the plane defined by the transceiver <NUM>.

The RFID tag <NUM> in the sleeve <NUM> may be understood as the tip memory. The ultrasonic tip <NUM> and the sleeve <NUM> are typically packaged together in a kit. The data contained in the RFID tag <NUM> may be used control actuation of the ultrasonic tip <NUM>. The coil <NUM> embedded in the sleeve <NUM> is coupled to memory unit of the RFID tag <NUM>. As described above, the RFID tag <NUM> may be used to prevent customers from reusing ultrasonic tip <NUM> and/or sleeve <NUM>. In combination with the memory unit, the RFID tag <NUM> may be further configured to track and/or count the number of uses and limit the number of times a tip is used. For example, the RFID tag <NUM> may be configured to store on the memory unit the number and/or amount of time the ultrasonic tip <NUM> and sleeve <NUM> are operated. The RFID tag <NUM> and memory unit may be configured to prevent actuation of the tip a define number of uses. The defined number of uses may be passed on wear and effectiveness of the ultrasonic tip <NUM> and/or sleeve <NUM>, in order to prevent or predict failure.

As illustrated in <FIG>, the tag <NUM> may be secured in the cavity <NUM> by a pin <NUM>. The pin <NUM> may comprise a plastic or alloy material and be configured to create a friction fit within the opening of the cavity <NUM> to secure the RFID tag <NUM> within the cavity <NUM> and protect it from being damaged. Alternatively, the pin <NUM> may comprise a seal such as an elastomeric O-ring. In yet another configuration, the pin <NUM> may comprise an epoxy, glue, sealant, or similar compound configured to secure the tag <NUM> within the cavity <NUM> and protect the tag from damage. It is further contemplated that the RFID tag <NUM> may be injection molded or heat staked into the sleeve <NUM>. The RFID may also take other forms of tags.

The protrusion <NUM> may be configured in a complementary shape to the one defined by the recess <NUM> at the distal end of the ultrasonic handpiece <NUM>, wherein the protrusion <NUM> is configured to be disposed within the recess <NUM> when the sleeve <NUM> is coupled to the ultrasonic handpiece <NUM>. Furthermore, the shape of the recess <NUM> and the protrusion <NUM> may be configured to align the sleeve <NUM> relative to the ultrasonic handpiece <NUM>, as well as prevent rotational movement of the sleeve <NUM> relative to the ultrasonic handpiece <NUM>. For example, as illustrated in <FIG>, the recess <NUM> of the ultrasonic handpiece <NUM> comprises a plurality of walls <NUM> that define the perimeter of the recess <NUM>. In the example configuration of the recess <NUM> illustrated in <FIG>, the walls 77A, 77B, 77C, and 77D define a doghouse-like shape, wherein you have two opposing walls 77A, 77B, that are generally parallel to one another. The two opposing walls 77A, 77B are connected by a third wall 77C that is generally perpendicular to the two opposing walls 77A, 77B. A fourth wall 77D, that connects the two opposing walls 77A, 77B opposite the third wall 77C, may comprise a generally arch-like shape. The plurality of external circumferential surfaces 81A, 81B, 81C, and 81D that define the outer perimeter of the protrusion <NUM> may then be configured to define a doghouse-like shape that corresponds to the shape of the recess <NUM>. While not illustrated in the figures, it is contemplated that the walls 77A, 77B, 77C, and 77D of the recess <NUM> and the corresponding external circumferential surfaces 81A, 81B, 81C, and 81D of the protrusion <NUM> may be configured to define alternative shapes. For example, the walls <NUM> and external circumferential surfaces <NUM> may define a rectangular shape, a star shape, an oval shape, a triangular shape or other similar shape. While the protrusion <NUM> and the recess <NUM> illustrated in the figures include complementary shapes, it is further also contemplated that the protrusion <NUM> and the recess <NUM> may have slightly different shapes, so long as the protrusion <NUM> may be disposed within the recess <NUM>. For example, the protrusion <NUM> on the sleeve <NUM> may be configured to comprise several more external circumferential surfaces <NUM> to the protrusion by creating a chamfer between 81C and 81A and/or 81B and it would still insert and function in the ultrasonic handpiece <NUM>.

The shape of the protrusion <NUM> and the recess <NUM> may further be configured to orient the tag <NUM> that is disposed in the cavity <NUM> of the hub <NUM> relative to the transceiver <NUM> disposed in the distal housing portion <NUM> of the ultrasonic handpiece <NUM>. Utilizing the shape of the protrusion <NUM> and the recess <NUM> to orient the tag <NUM> relative to the transceiver <NUM> can improve the reliable establishment of communication between the tag <NUM> relative and the transceiver <NUM>. For example, as illustrated in <FIG>, the tag <NUM> and the transceiver <NUM> are positioned such that the tag <NUM> and the transceiver <NUM> at least partially overlap in an axial sense when the sleeve <NUM> is coupled to the ultrasonic handpiece <NUM>. Furthermore, the cavity <NUM> in the hub <NUM> and the cavity <NUM> in the distal housing portion <NUM> of the ultrasonic handpiece <NUM> may be oriented such that a first longitudinal axis of the tag <NUM> and a second longitudinal axis of transceiver <NUM> are generally parallel to one another. The protrusion <NUM> and the distal housing portion <NUM> may further be configured to reduce the distance between the cavity <NUM> in the hub <NUM> and the cavity <NUM> in the distal housing portion <NUM> to further improve communication between the tag <NUM> and the transceiver <NUM>.

The hub <NUM> may further comprise a plurality of retention fingers <NUM> that extend distally from the proximal surface <NUM> of the protrusion <NUM>. The plurality of retention fingers <NUM> may be spaced about the perimeter of the lumen <NUM> defined in the proximal surface <NUM>. The plurality of retention fingers <NUM> may further comprise a tab <NUM>, bump, or protrusion configured to engage the coupling feature <NUM> at the perimeter of the aperture <NUM> in the proximal surface <NUM> of the recess <NUM> in the ultrasonic handpiece <NUM>. The tab <NUM> of each of the plurality of retention fingers <NUM> may engage the coupling feature <NUM> of the recess <NUM> to create a snap-fit and/or friction fit to removably couple the sleeve <NUM> to the ultrasonic handpiece <NUM>. The plurality of retention fingers <NUM> may comprise a very compliant material like a silicone rubber, or a metal material such as a leaf spring. While not illustrated in the figures, it is contemplated that the sleeve <NUM> may be coupled to the ultrasonic handpiece <NUM> in a number of other ways. For example, the hub <NUM> hub may be configured without and retention fingers <NUM>, and the irrigation coupler <NUM> of the ultrasonic handpiece <NUM> may be mated with the irrigation fitting <NUM> of the sleeve <NUM> to form the primary retention mechanism. In yet another configuration, the protrusion <NUM> may comprise a compliant material, which contains the RFID tag <NUM> despised within a slit in the material, and the protrusion <NUM> may create an interference fit with the cavity <NUM>.

Referring to <FIG>, a sectional view of an example configuration of the interface between the distal housing portion <NUM> of the ultrasonic handpiece <NUM> and the sleeve <NUM> and ultrasonic tip <NUM> is illustrated. As illustrated in <FIG>, the distal surface <NUM> of the distal housing portion <NUM> may abut the distal surface <NUM> of the protrusion <NUM> when the sleeve <NUM> is coupled to the ultrasonic handpiece <NUM>. This may assist in forming a stable connection between the sleeve <NUM> to the ultrasonic handpiece <NUM>. Similarly, the proximal surface <NUM> of the distal housing portion <NUM> may abut the proximal surface <NUM> of the protrusion <NUM> when the protrusion <NUM> is disposed within the recess <NUM> to couple the sleeve <NUM> to the ultrasonic handpiece <NUM>. However, it is also possible that there may be a gap between the proximal surface <NUM> of the distal housing portion <NUM> and the proximal surface <NUM> of the protrusion <NUM> when the distal surface <NUM> of the distal housing portion <NUM> abuts the distal surface <NUM> of the protrusion <NUM>.

In operation, the method of coupling the sleeve <NUM> to the ultrasonic handpiece <NUM> may comprise providing the ultrasonic handpiece <NUM> described above, wherein the ultrasonic handpiece <NUM> includes the irrigation tube <NUM> configured to communicate irrigation fluid through the ultrasonic handpiece <NUM>. The ultrasonic handpiece <NUM> may also include the attachment portion <NUM> positioned proximate the distal end of the ultrasonic handpiece <NUM>. The attachment portion <NUM> may comprise the recess <NUM> describes above, wherein the recess is defined by a plurality of side walls <NUM> configured to define a void, such as an asymmetric void. The attachment region <NUM> may also comprise an aperture or similar attachment element.

The method of coupling the sleeve <NUM> to the ultrasonic handpiece <NUM> may further comprise providing the sleeve <NUM> described above, wherein the sleeve <NUM> comprises the hub <NUM> that includes a proximal surface <NUM> and a distal surface <NUM>. The proximal surface <NUM> may optionally comprise one or more retention fingers <NUM> and be configured to define an asymmetrical protrusion <NUM> extending proximally from the distal surface <NUM>. The protrusion <NUM> may be sized to be inserted within the recess <NUM> of the ultrasonic handpiece <NUM>.

The method of coupling the sleeve <NUM> to the ultrasonic handpiece <NUM> may further comprise coupling the ultrasonic handpiece <NUM> to the sleeve <NUM> by inserting the asymmetrical protrusion <NUM> into the asymmetrical void defined by the attachment portion <NUM> such that the one or more retention fingers <NUM> engage the perimeter of the aperture in the distal housing portion <NUM> to create an interference fit between the sleeve <NUM> to the ultrasonic handpiece. As the asymmetrical protrusion <NUM> is inserted into the asymmetrical void defined by the attachment portion <NUM>, the irrigation coupler <NUM> of the ultrasonic handpiece <NUM> may be mated with the irrigation fitting <NUM> of the sleeve <NUM> to form an irrigation passageway between the ultrasonic handpiece <NUM> and the sleeve <NUM> without separately connecting an irrigation line to the irrigation sleeve <NUM>. Thus, the irrigation and the aspiration lines may be coupled to the sleeve and the sleeve may be coupled to the ultrasonic handpiece with a single step - inserting the protrusion of the sleeve into the recess of the ultrasonic handpiece.

The method of coupling the sleeve <NUM> to the ultrasonic handpiece <NUM> may further comprise the step of providing the ultrasonic tip <NUM> described above, wherein the ultrasonic tip <NUM> comprises a threaded coupler <NUM> at the distal end of the ultrasonic tip <NUM> configured to removably secure the ultrasonic tip <NUM> to the threaded coupler <NUM> of the ultrasonic handpiece <NUM>. The ultrasonic tip <NUM> may further comprise a cutting feature <NUM> at the distal end of the ultrasonic tip <NUM>. The method may then comprise coupling the ultrasonic tip <NUM> to the ultrasonic handpiece <NUM> prior to the step of coupling the ultrasonic handpiece <NUM> to the irrigation sleeve <NUM>.

The method of coupling the sleeve <NUM> to the ultrasonic handpiece <NUM> may further comprise the step of inserting the first irrigation coupler <NUM> on a distal end of the irrigation conduit or tube <NUM> of the ultrasonic handpiece <NUM> into a corresponding irrigation fitting <NUM> on the irrigation sleeve <NUM> as the asymmetrical protrusion <NUM> is inserted into the asymmetrical void defined in the attachment portion <NUM>, wherein the irrigation fitting <NUM> is in fluid communication with the conduit <NUM> of the sleeve <NUM> and is configured to provide irrigation fluid to the ultrasonic tip <NUM>.

Referring to <FIG>, <FIG>, an example configuration of the ultrasonic tip <NUM> disposed within the sleeve <NUM> is illustrated. Referring to <FIG>, a sectional view of the ultrasonic tip <NUM> disposed within the sleeve <NUM> is illustrated. As described above, the sleeve <NUM> may comprise the conduit <NUM> formed in the sleeve body <NUM> and runs adjacent to the lumen <NUM> of the sleeve <NUM>. The distal end of the conduit <NUM> may terminate at an aperture <NUM> or nozzle positioned on an interior surface of the lumen <NUM>. The aperture <NUM> may configured to direct fluid radially inward toward the center of the lumen <NUM>. The fluid may then be applied to an exterior surface of the ultrasonic tip <NUM> and/or directed toward the distal end of the sleeve <NUM>, wherein the fluid may exit the lumen <NUM> and be applied to the surgical site.

The sleeve <NUM> may further comprise a seal <NUM>, such as O-ring, disposed within the lumen <NUM> and configured to contact a portion of the ultrasonic tip <NUM> when the sleeve <NUM> is coupled to the ultrasonic handpiece <NUM> and the ultrasonic tip <NUM> is coupled to the ultrasonic handpiece <NUM>. The seal <NUM> may be configured to create a fluid seal between the interior surface of the lumen <NUM> and the exterior surface of the ultrasonic tip <NUM>. For example, the seal <NUM> may be configured to prevent fluid that is between the interior surface of the lumen <NUM> and the exterior surface of the ultrasonic tip <NUM> distal of the seal <NUM> from flowing proximal of the seal <NUM>.

The ultrasonic tip <NUM> may comprise a distal end and a proximal end. The ultrasonic tip <NUM> may include a cutting feature <NUM> at the distal end of ultrasonic tip <NUM> and a coupling feature <NUM>, positioned at the proximate end. The coupling feature <NUM> may be configured to engage the threaded coupler <NUM> of the horn <NUM> to removably couple the ultrasonic tip <NUM> to the ultrasonic handpiece <NUM>. It should be understood that the coupling feature <NUM> of the ultrasonic tip <NUM> should be configured to engage the threaded coupler <NUM> of the horn <NUM>. Thus, if a coupling arrangement other than complementary threads is utilized, the coupling features <NUM>, <NUM> of the ultrasonic tip <NUM> and the horn <NUM> are suitable to engage one another.

The ultrasonic tip <NUM> may be configured to define a lumen <NUM> that extends from the proximal end to the distal end of the ultrasonic tip <NUM>. The lumen <NUM> may be configured to be in fluid communication with the fluid passageway through the ultrasonic handpiece <NUM> that is defined by the conduit <NUM> of the horn <NUM> and the lumen <NUM> of the transducer <NUM> when the ultrasonic tip <NUM> is coupled to the ultrasonic handpiece <NUM>. The lumen <NUM> may be configured to provide irrigation and/or suction at the surgical site based on the system that is coupled to the fluid passageway through the ultrasonic handpiece <NUM> that is defined by the conduit <NUM> of the horn <NUM> and the lumen <NUM> of the transducer <NUM>. For example, if an irrigation system is coupled to the fluid passageway through the ultrasonic handpiece <NUM> that is defined by the conduit <NUM> of the horn <NUM> and the lumen <NUM> of the transducer <NUM>, the lumen <NUM> may be configured to provide irrigation fluid to the surgical site proximate the cutting feature <NUM>. Alternatively, if an aspiration system is coupled to the fluid passageway through the ultrasonic handpiece <NUM> that is defined by the conduit <NUM> of the horn <NUM> and the lumen <NUM> of the transducer <NUM>, the lumen <NUM> may configured to remove fluid and/or material from the surgical site proximate the cutting feature <NUM>.

The ultrasonic tip <NUM> may also comprise an aperture <NUM> that is configured to be in fluid communication with the lumen <NUM>. The aperture <NUM> may be positioned between the proximal end and distal end of the ultrasonic tip <NUM> such that the aperture <NUM> is distal of the seal <NUM> of the sleeve <NUM> when the ultrasonic tip <NUM> is disposed within the lumen <NUM> of the sleeve <NUM>. Furthermore, the aperture <NUM> may positioned on the ultrasonic tip <NUM> such that the aperture <NUM> is surrounded by the sleeve <NUM> when the ultrasonic tip <NUM> is disposed within the lumen <NUM> of the sleeve <NUM>. For example, the aperture <NUM> may be positioned on the ultrasonic tip <NUM> so that the aperture <NUM> is proximal of the distal end of the sleeve <NUM> when the ultrasonic tip <NUM> is disposed within the lumen <NUM> of the sleeve <NUM>.

The ultrasonic tip <NUM> may further comprise a resonator <NUM> positioned between the proximal end and the distal end of the ultrasonic tip <NUM>. This The resonator <NUM> may be configured to translate the longitudinal vibration transmitted from the transducer <NUM> to the ultrasonic tip <NUM> via the mechanical connection created by the horn <NUM> into longitudinal and torsional motion of the ultrasonic tip <NUM> distal to the resonator <NUM>. For example, as the transducer <NUM> expands and contracts, a vibration is created that is transmitted to the ultrasonic tip <NUM> via the horn <NUM>. The portion of the ultrasonic tip <NUM> that is proximal to the resonator <NUM> experiences a longitudinal motion. The resonator <NUM> may then translates the longitudinal motion of the transducer <NUM> and horn <NUM> into a longitudinal and torsional torsion motion in the portion of the ultrasonic tip <NUM> that is distal to the resonator <NUM>. The resonator <NUM> may comprise a nonhomogeneous cross sectional region created by grooves in the outer surface of the ultrasonic tip <NUM>. The grooves may be oriented in a generally spiral-like and helical configuration on the outer surface of the ultrasonic tip <NUM>. This may be accomplished but cutting the grooves in a spiral-like or helical pattern on the outer surface of the ultrasonic tip <NUM>. Alternatively, the spiral-like or helical pattern of the grooves may be accomplished by cutting straight grooves in the outer surface of the ultrasonic tip <NUM>, wherein the grooves are generally parallel to the longitudinal axis of the ultrasonic tip <NUM>, and the ultrasonic tip <NUM> may then be twisted to create the spiral-like or helical pattern of the grooves.

Referring to <FIG>, an example configuration of the tubing connector <NUM> for use with the ultrasonic handpiece <NUM> as part of the ultrasonic surgical handpiece assembly <NUM> is illustrated. The tubing connector <NUM> may comprise a base <NUM> including a distal end and a proximal end. The base <NUM> may be constructed of a rigid material such as a plastic. Alternatively, the base <NUM> may be constructed of a flexible material or resilient material such as an elastomer.

The base <NUM> may be configured to define one or two lumens <NUM>, <NUM> that extend through the base <NUM>. The lumens <NUM>, <NUM> may define a fluid passageway through the base <NUM> of the tubing connector <NUM> and be configured to be in fluid communication with one or more conduits or lumens through the ultrasonic handpiece <NUM>. For example, a first lumen <NUM> may be configured to be in fluid communication with the passageway that is formed by the conduit <NUM> of the horn <NUM> and the lumen <NUM> of the transducer <NUM> when the tubing connector <NUM> is coupled to the ultrasonic handpiece <NUM>. Additionally, a second lumen <NUM> may be configured to be in fluid communication with the lumen <NUM> that is disposed within the ultrasonic handpiece <NUM> when the tubing connector <NUM> is coupled to the ultrasonic handpiece <NUM>.

The base <NUM> may also define a groove <NUM> in a perimeter of the base <NUM> that extends between the distal end and the proximal end of the base <NUM>. The groove <NUM> may be configured to receive the cable <NUM>, wiring harness, or similar conductor that extends proximally from the proximal end of the ultrasonic handpiece <NUM>. For example, the groove <NUM> of the tubing connector may be configured to receive and partially surround the cable <NUM>, as illustrated in <FIG>. The groove <NUM> may be shaped and/or configured to removably couple the base <NUM> of the tubing connector <NUM> to the cable <NUM> via a friction fit or interference fit. For example, the groove <NUM> may comprise a U-like or crescent shape, wherein the width of the opening of the groove <NUM> at the surface of the base <NUM> is less than the maximum width of the cable <NUM>.

The tubing connector <NUM> may further comprise a resilient member <NUM> that extends proximally from the base <NUM> and is configured to receive the aspiration line <NUM>. The resilient member <NUM> and base <NUM> may be formed as a unitary component, wherein the resilient member <NUM> defines a portion of the lumen <NUM> through the base <NUM>. The resilient member <NUM> may be configured such that the aspiration line <NUM> may be inserted within the lumen <NUM> at the proximal end of the resilient member <NUM>. The aspiration line <NUM> may for a friction fit within the lumen of the resilient member. Alternatively, the aspiration line <NUM> may be coupled to the resilient member <NUM> using a glue, epoxy, or similar adhesive configured to create a chemical bond.

While not illustrated, it is also contemplated that the resilient member <NUM> may be removably coupled to the base <NUM>. For example, a distal end of the resilient member <NUM> may be configured to create a friction with the base <NUM> when inserted in the lumen <NUM>.

While the figures illustrate the aspiration line <NUM> and/or the irrigation line <NUM> as being inserted directly within the lumens <NUM>, <NUM> defined in the base <NUM> of the tubing connector <NUM>, if is further contemplated that the aspiration line <NUM> and/or the irrigation line <NUM> may be coupled to the base <NUM> by a hose barb or similar fitting. For example, proximal end of a hose barb may inserted in the opening of the aspiration line <NUM> and/or the irrigation line <NUM>. The proximal end of the hose barb may then be inserted within the respective lumens <NUM>, <NUM> that are defined in the base <NUM>. The hose barb(s) may be coupled to the base <NUM> via friction fit within the lumens <NUM>, <NUM>, or the hose barb(s) may be coupled to the base <NUM> using an epoxy, glue, sealant, or similar adhesive.

The base <NUM> may be configured to be removably coupled the proximal end of the ultrasonic handpiece <NUM> via and interference fit. The interference fit may be created between the coupling feature <NUM> of the irrigation tube <NUM> and the coupling portion <NUM> of the channel <NUM> and the respective lumens <NUM>, <NUM>. For example, the coupling feature <NUM> and coupling portion <NUM> may each comprise a hose barb or similar fitting configured to be inserted in the corresponding lumens <NUM>, <NUM> to create a friction fit that removably secures the tubing connector <NUM> to the proximal end of the ultrasonic handpiece <NUM>.

Alternatively, while not illustrated in the figures, it is contemplated that the distal end of the base <NUM> may comprise a retention feature such as a tab or finger configured to create a snap-fit with the proximal end of the ultrasonic handpiece <NUM>. For example, the retention feature may comprise a tab or protrusion that encircles a perimeter of the distal end of the base <NUM> and is configured to engage the proximal end of the ultrasonic handpiece <NUM> to removably couple the tubing connector <NUM> to the ultrasonic handpiece <NUM> via a snap fit.

The tubing connector <NUM> may serve as a means of quickly attaching and detaching both the irrigation line <NUM> and the aspiration line <NUM> to the proximal end of the ultrasonic handpiece <NUM>. Furthermore, the tubing connector <NUM> may removably secure the irrigation line and/or aspiration lines <NUM>, <NUM> to the ultrasonic handpiece <NUM> in a manner that reduces the stress on the lines proximate the ultrasonic handpiece <NUM>. The tubing connector <NUM> may reduce bending and/or kinking of the lines proximate the ultrasonic handpiece <NUM>. For example, the resilient member may comprise a resilient material configured to support the aspiration line <NUM> and/or resist bending or kinking the aspiration line <NUM>. Furthermore, the proximal offset created by the resilient member extending proximally from the base <NUM> offsets the location where the aspiration line <NUM> and the irrigation line <NUM> are coupled to the base <NUM>. This may prevent tangling of the lines as the drape off the proximal end of the tubing connector <NUM>. This serves to provide support to the lines <NUM>, <NUM> to resists bending of the line <NUM>, <NUM> proximate the ultrasonic handpiece <NUM> to reduce the occurrence of sharp bends in the lines <NUM>, <NUM> that may restrict flow through the lines <NUM>, <NUM>.

Claim 1:
An irrigation sleeve (<NUM>) for use with an ultrasonic handpiece (<NUM>) including a coupling housing (<NUM>) comprising a handpiece transceiver (<NUM>) and configured to surround a portion of an ultrasonic tip (<NUM>) including a cutting feature (<NUM>), said sleeve (<NUM>) comprising:
a hub (<NUM>) comprising a proximal portion, a distal portion, and a first lumen (<NUM>) extending through said hub (<NUM>), said proximal portion having a first face (<NUM>) configured to abut the ultrasonic handpiece (<NUM>) and a second face (<NUM>) positioned distally of said first face (<NUM>);
a tube body (<NUM>) comprising a distal end and a proximal end, said tube body (<NUM>) extending from said distal portion of said hub (<NUM>) and configured to define a second lumen (<NUM>) in fluid communication with said first lumen (<NUM>) of said hub (<NUM>), said second lumen (<NUM>) configured to surround the portion of the ultrasonic tip (<NUM>);
a tube aperture (<NUM>) in an interior surface of said second lumen (<NUM>), said tube aperture (<NUM>) positioned at an intermediate point along said second lumen (<NUM>) between said proximal end and distal end of said tube body (<NUM>) and such that said tube aperture (<NUM>) is facing inward towards said second lumen (<NUM>);
an irrigation conduit (<NUM>) adjacent to said second lumen (<NUM>), said irrigation conduit (<NUM>) configured to extend from said proximal end of said tube body (<NUM>) to said tube aperture (<NUM>);
an irrigation aperture and a tip aperture in said first face (<NUM>), said tip aperture configured to be in communication with said first lumen (<NUM>);
an irrigation fitting (<NUM>) positioned within said irrigation aperture of said first face (<NUM>) of said hub (<NUM>) and in fluid communication with said irrigation conduit (<NUM>);
at least one retention finger (<NUM>) protruding proximally from said first face (<NUM>), said retention finger (<NUM>) configured to engage the coupling housing (<NUM>) of the ultrasonic handpiece (<NUM>);
a cavity (<NUM>) defined in said proximal portion of said hub (<NUM>), said cavity (<NUM>) comprising an opening in a surface of the hub (<NUM>); and
a sleeve transceiver (<NUM>) positioned within said cavity (<NUM>) and configured to communicate with the corresponding handpiece transceiver (<NUM>).