Patent ID: 12220349

The accompanying drawings may be better understood by reference to the following detailed description.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of the disclosure, reference will now be made to the implementations illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is intended. Any alterations and further modifications to the described systems, devices, instruments, methods, and any further application of the principles of the present disclosure are fully contemplated as would normally occur to one skilled in the art to which the disclosure relates. In particular, the features, components, and/or steps described with respect to one implementation may be combined with the features, components, and/or steps described with respect to other implementations of the disclosure. For simplicity, in some instances the same reference numbers are used throughout the drawings to refer to the same or like parts.

FIG.1shows a cross-sectional view of an example of an ultrasonic handpiece100in accordance with the disclosure.FIG.2shows a cut-away view of the ultrasonic handpiece100ofFIG.1.

As can be seen inFIGS.1and2, ultrasonic handpiece100comprises a housing130having a proximal end132and a distal end134, a working tip110that extends from the distal end134of the housing130, and a crystal and horn assembly158positioned within the housing130. The crystal and horn assembly158comprises an ultrasonic horn160and a set of piezoelectric crystals210. The ultrasonic horn160has a proximal end162and a distal end164, and a proximal end112of the working tip110is connected to the distal end164of the ultrasonic horn160. A distal end114of the working tip110comprises a working end120for performing a desired operation, such as a phacoemulsification procedure in an ophthalmic phacoemulsification handpiece. In the illustrated example, the working end120is bent or angled.

The housing130is hollow and defines an internal hollow chamber136in which internal components of the ultrasonic handpiece100are housed and protected. The housing130has an external surface140that can be grasped by an operator of the ultrasonic handpiece100, such as a surgeon. The hollow shell of the housing130has an internal surface142defining the hollow chamber136. At its distal end134, the housing130has an opening154through which the working tip110extends. At its proximal end132, the housing has a port152through which an aspiration luer220extends.

In order to drive vibration of the working tip110, as stated above the proximal end112of the working tip110is connected to the distal end164of the ultrasonic horn160. The connection between the working tip110and the ultrasonic horn160may be made by any suitable connection. For example, the proximal end112of the working tip110may have threads118and the distal end164of the ultrasonic horn160may have threads168by which the working tip110may be connected to the ultrasonic horn160.

The aspiration luer220, the ultrasonic horn160, and the working tip110are generally aligned along a longitudinal axis102of the ultrasonic handpiece100. The longitudinal axis102extends in a longitudinal direction, and each of the aspiration luer220, ultrasonic horn160, and working tip110has a longitudinal axis that is aligned with the longitudinal axis102of the ultrasonic handpiece100.

The aspiration luer220has a channel226extending longitudinally through the aspiration luer220from a proximal end222of the aspiration luer220to a distal end224of the aspiration luer220. The ultrasonic horn160has a channel166extending longitudinally through the ultrasonic horn160from the proximal end162of the ultrasonic horn160to the distal end164of the ultrasonic horn160. The working tip110has a channel116extending longitudinally through the working tip110from the proximal end112of the working tip110to the distal end114of the working tip110. The channel226of the aspiration luer220is open at the proximal end222of the aspiration luer220to provide an aspiration passageway through the housing130. As described further below, suction may be applied to the channel226at the proximal end222of the aspiration luer220. The channels226,166, and116are all aligned and connected to form an elongated aspiration channel280that extends through these components. The working tip110has an opening at its distal end114which may be used for aspiration. For example, by applying suction through the aspiration channel280from the proximal end222of the aspiration luer220, fluid and/or tissue, such as lens or other tissue fragments in a phacoemulsification procedure, may be aspirated through the opening in the distal end114of the working tip110and through the channels226,166, and116.

FIG.3shows a perspective view of the proximal end of the ultrasonic horn160of the ultrasonic handpiece100ofFIG.1. As shown inFIGS.1-3, the ultrasonic horn160comprises a body170, a proximal shaft172, and a distal shaft174. The proximal end162of the ultrasonic horn ends in a proximal end surface190. The set of piezoelectric crystals210is mounted along the proximal shaft172of the ultrasonic horn160. In this example, the set of piezoelectric crystals comprises four piezoelectric crystals211,212,213,214, although numerous variations are possible. In operation, as described further below, the piezoelectric crystals211,212,213,214induce vibration of the ultrasonic horn160.

On the distal side of the body170, the ultrasonic horn160comprises a reduced-diameter portion178that has a smaller diameter than the body170. The transition from the body170to the reduced-diameter portion forms a shoulder194. The reduced-diameter portion178has an outwardly-facing surface198and is sized to leave a small gap between the outwardly-facing surface198and an inwardly-facing surface146of the internal surface142of the housing130. In order to resiliently support the ultrasonic horn160in this region, a resilient elastomeric O-ring264is positioned between the outwardly-facing surface198of the ultrasonic horn160and the inwardly-facing surface146of the housing130. As described further below, this region in which the ultrasonic horn160is supported by the resilient O-ring264between the housing130and the ultrasonic horn160is a nodal region200of the ultrasonic horn160. In this region, the internal surface142of the housing130may be shaped to have a shoulder144and to present a proximally-facing surface148on the distal side of the O-ring264. The distal end of the body170presents a distally-facing surface198on the proximal side of the O-ring264. A small gap or clearance may exist between the O-ring264and the proximally-facing surface148of the housing130on the distal side of the O-ring264and the distally-facing surface198of the ultrasonic horn160on the proximal side of the O-ring264. In operation of the ultrasonic handpiece100, squeezing of the O-ring264between the proximally-facing surface148of the housing130and the distally-facing surface198of the ultrasonic horn160may serve to limit the amount of distal movement of the ultrasonic horn160.

On the proximal side of the body170, the piezoelectric crystals211,212,213,214are mounted on the proximal shaft172and, in this example, abut against a proximally-facing surface of the body170. The ultrasonic horn160comprises an externally-threaded bolt surface188on which an internally-threaded nut218is threaded to fasten the set of piezoelectric crystals210in place from the proximal side of the set of piezoelectric crystals210.

On the proximal end162of the ultrasonic horn160, proximal to the bolt surface188, the ultrasonic horn160is resiliently suspended with respect to the housing130. Thus, the ultrasonic horn160can be considered to be free “floating,” i.e., resiliently suspended, within the housing130. In the illustrated example, the proximal end162of the ultrasonic horn160is resiliently suspended relative to the housing130through a resilient elastomeric O-ring262that is mounted within the aspiration luer220, as described below.

FIG.4shows a perspective view of the aspiration luer220of the ultrasonic handpiece100ofFIG.1. The aspiration luer220is fixed relative to the housing130at the proximal end132of the housing130. The aspiration luer220comprises a stem230that extends through the port152at the proximal end132of the housing130. The aspiration luer220further comprises a body232that has a diameter larger than the stem230and larger than the port152so that the body232limits proximal movement of the aspiration luer220through the port152during assembly of the device. The aspiration luer220may be rigidly attached to the housing130to prevent longitudinal and rotational movement of the aspiration luer220relative to the housing130. This attachment may be accomplished by mechanical structure and/or one or more adhesives.

As illustrated inFIGS.1and2, the ultrasonic handpiece100comprises a resilient elastomeric O-ring262between the ultrasonic horn160and the aspiration luer220at the proximal end162of the ultrasonic horn160. The ultrasonic horn160comprises an O-ring surface176that faces outwardly, and the aspiration luer220comprises an O-ring surface236that faces inwardly. The O-ring262is positioned between the O-ring surface176of the ultrasonic horn160and the O-ring surface236of the aspiration luer220. The space in which the O-ring262is located may also be bounded on proximal and distal sides of the O-ring262. For example, on the distal side of the O-ring surface176, the ultrasonic horn160may have a larger-diameter portion (e.g., horn key180or another portion as shown) that presents a proximally-facing surface on the distal side of the O-ring262. Similarly, on the proximal side of the O-ring surface236, the aspiration luer220may have a shoulder at a transition of the channel226from a first diameter at the proximal end of the channel226to a larger diameter at an enlarged portion228at the proximal end of the channel226. The shoulder presents a distally-facing surface on the proximal side of the O-ring262. A small gap or clearance may exist between the O-ring262and the adjacent proximally-facing surface and distally-facing surface.

The suspension of the ultrasonic horn160within the aspiration luer220through the resilient O-ring262provides freedom of movement of the ultrasonic horn160relative to the aspiration luer220. The resilient O-ring262at the proximal end162of the ultrasonic horn160serves as a resilient suspension of the ultrasonic horn160within the housing130. In this way, the ultrasonic handpiece100may be described as having a floating ultrasonic horn160, wherein the proximal end162of the ultrasonic horn160is free to move relative to the housing130and is not rigidly mounted relative to the housing130.

In some embodiments, it may be desirable to limit the rotational movement of the ultrasonic horn160within the housing130. Such limitation of rotation can be useful, for example, to allow the working tip110to be threaded onto the ultrasonic horn160by threads118and threads168while limiting the ultrasonic horn160from rotating relative to the housing130in a manner that would interfere with attaching the working tip110.

In the illustrated example, to allow the proximal end162of the ultrasonic horn160to be free to move relative to the housing130while limiting its rotation relative to the housing130, the proximal end162of the ultrasonic horn160comprises a horn key180. The horn key180has a structure for coupling with a handpiece key (for example, a handpiece key240that is part of the aspiration luer220) that is fixed relative to the housing130. In the illustrated example, the coupling of the horn key180to the handpiece key (e.g., handpiece key240) limits rotation of the proximal end162of the ultrasonic horn160relative to the handpiece key and the housing130but does not limit the proximal end162of the ultrasonic horn160from moving in a longitudinal direction relative to the handpiece key and the housing130.

As shown inFIGS.1,2, and4, in the illustrated example, the handpiece key240is part of the aspiration luer220and is located at the distal end224of the aspiration luer220, although other embodiments and locations are possible. As shown inFIGS.3and4, the horn key180and the handpiece key240are shaped for coupling the ultrasonic horn160to the aspiration luer220while both allowing the ultrasonic horn160to move in a longitudinal direction relative to the aspiration luer220and limiting rotation of the ultrasonic horn160within the aspiration luer220. The horn key180has a horn key outer surface182that corresponds to a handpiece key inner surface242of the handpiece key240. For example, the horn key outer surface182may comprise two curved surfaces184,185and two flat surfaces186,187, and the handpiece key inner surface242may comprise two curved surfaces244,245and two flat surfaces246,247. When the device is assembled and the horn key180is coupled to the handpiece key240, the curved surface184is adjacent the curved surface244, the curved surface185is adjacent the curved surface245, the flat surface186is adjacent the flat surface246, and the flat surface187is adjacent the flat surface247. Many other configurations are possible within the scope of enabling the proximal end of the ultrasonic horn160to be free to move relative to the housing130while limiting rotation of the ultrasonic horn160.

The horn key180and corresponding handpiece key240may have some clearance between them to allow some play and some limited rotational movement of the ultrasonic horn160relative to the aspiration luer220. That is, the ability of the proximal end162of the ultrasonic horn160to rotate relative to the handpiece key240and the housing130may be allowed to some limited extent but is limited by the horn key180and handpiece key240. Thus, the proximal end162of the ultrasonic horn160is free to move in the longitudinal direction relative to the housing130while the ability of the proximal end162of the ultrasonic horn160to rotate relative to the housing130may be limited.

The extent of longitudinal movement of the proximal end162of the ultrasonic horn160relative to the housing130may also be limited. For example, the ultrasonic handpiece100may have a dead stop which prevents or limits the extent of longitudinal movement of the ultrasonic horn160in the proximal direction. As one possible stop, the ultrasonic horn160may have a proximally-facing horn stop surface191that abuts against a distally-facing handpiece stop surface251, which prevents or stops proximal movement of the ultrasonic horn160. Thus, the handpiece stop surface251is adapted to cooperate with the horn stop surface191to prevent or limit an extent of longitudinal motion of the ultrasonic horn160in the proximal direction. In the illustrated example, the distally-facing handpiece stop surface251is part of the aspiration luer220. Alternatively, it may be part of the housing130or part of another component rigidly attached to the housing. The extent of distal movement of the ultrasonic horn160may similarly be limited.

At its distal end224, the aspiration luer220may include additional structure as shown. For example, the aspiration luer220may include a ring234. The ring234may serve as a stop surface for a washer216that is placed around the distal end224of the aspiration luer220.

The disclosure herein of an ultrasonic horn that is flexibly suspended or floating at its proximal end and/or an ultrasonic horn that is flexibly suspended or floating at its proximal end and its nodal region with no rigid attachment or fixation points provides advantages over the prior art. The use of a floating ultrasonic horn160as described herein enables the use of a shorter ultrasonic horn160, as described below. This in turn enables the use of a pumping module290located at the proximal end of the ultrasonic handpiece100. The pumping module290may be attached to the proximal end of the housing130, as shown inFIG.1. The shorter ultrasonic horn160enables the use of a shorter housing130which allows the inclusion of the pumping module290while still maintaining an overall length of the ultrasonic handpiece100that is small enough so that it can be handled easily by the operator.

FIG.5shows a perspective view in cross-section of the distal end of the ultrasonic handpiece100ofFIG.1with an irrigation sleeve270in place. The irrigation sleeve270serves to direct an irrigation fluid, e.g., saline, to the distal end114of the working tip110. The housing130has an irrigation supply line268through which an irrigation fluid may be introduced. The housing130has external threads138at its distal end134, and the irrigation sleeve270has internal threads278at its proximal end272by which the irrigation sleeve270may be attached to the housing130. The irrigation sleeve270is positioned around the working tip110to provide a fluid passageway or channel276from the position of its attachment to the housing130through the space between the irrigation sleeve270and the working tip110. The irrigation sleeve270has an opening at its distal end274adjacent the opening at the distal end114of the working tip110. When an irrigation fluid is introduced through the supply line268in the housing130, it passes through the channel276of the irrigation sleeve270and out of the opening at the distal end274of the irrigation sleeve270.

FIG.6shows another cross-sectional view of the ultrasonic handpiece100ofFIG.1. As can be seen inFIG.6, an elastomeric potting compound284such as a silicone adhesive may be introduced into the space around the coupling of the ultrasonic horn160to the aspiration luer220. An elastomeric sleeve282such as a silicone sleeve may be positioned on the outside of the set of piezoelectric crystals210and may serve as an outer boundary for the elastomeric potting compound284. The elastomeric potting compound284and elastomeric sleeve282may help keep components in place while facilitating resilient suspension of the ultrasonic horn160and allowing its freedom of movement as described above.

For operation, the ultrasonic handpiece100may be connected to a control console. For example, the ultrasonic handpiece100may be connected to a control console like the control console of the CENTURION® Vision System of Alcon, headquartered in Fort Worth, Texas. The ultrasonic handpiece100may be connected to the control console by one or more electric cables, for example one or more electric cables that are used for supplying current to the set of piezoelectric crystals210. The ultrasonic handpiece100may also be connected to the control console by one or more tubes, for example one or more tubes that may supply an irrigation fluid from the control console to the proximal end of the irrigation supply line268of the housing130.

In operation of the device, the operator positions the working end120of the working tip110at a desired location, such as adjacent a cataractous lens of a patient. Irrigation fluid such as saline may be supplied from the control console through the irrigation supply line268and irrigation sleeve270. The set of piezoelectric crystals210may be activated by supplying electrical current from the control console to electrical wiring215that connects to the set of piezoelectric crystals210. The activation of the piezoelectric crystals210induces vibration of the ultrasonic horn160. The ultrasonic horn160may have one or more helical grooves192in order to introduce a torsional movement to the vibration. The vibration of the ultrasonic horn160causes vibration of the attached working tip110, which can break up or phacoemulsify the desired tissue such as the cataractous lens. At the same time, the pumping module290may be used to apply suction at the proximal end222of the aspiration luer220and through the aspiration channel280comprising channel226of the aspiration luer220, channel166of the ultrasonic horn160, and channel116of the working tip110, thereby suctioning away fluid and tissue and/or lens fragments that have been separated by the action of the working tip110.

In use of the ultrasonic handpiece100, the maximum vibrations are located at, or are approximately adjacent to, the distal end114of the working tip110. The ultrasonic horn160may have little or no amplitude of vibration at, or approximately adjacent to, the single nodal region200. The proximal end162of the ultrasonic horn160is free to move relative to the housing130as described above. Thus, in use, the ultrasonic horn160vibrates the working tip110, and the proximal end162of the ultrasonic horn160moves relative to the housing130, as it is free to do on account of its resilient or flexible suspension.

The use of an ultrasonic horn160that has a floating or flexibly suspended proximal end162facilitates the use of an ultrasonic horn with a single nodal region200. In typical prior art devices, the proximal end of ultrasonic horn is rigidly attached to the housing (directly or indirectly), such as by a bolt connection, and has a nodal region at the area of this rigid attachment. With an ultrasonic horn160that has a floating or flexibly suspended proximal end162as described herein, the proximal end162need not be a nodal region. Thus, the proximal end162is free to vibrate as shown. If a vibrating, non-nodal proximal end of an ultrasonic horn were rigidly attached to the housing, or to one or more other components rigidly attached to the housing, the attachment could cause undesirable adverse consequences, such as resonance dampening, generation of excessive heat, and/or unwanted vibration of the housing.

With an ultrasonic horn160that has a floating or flexibly suspended proximal end162and/or that is floating or flexibly suspended at its proximal end162and its single nodal region200with no rigid fixation points as described herein, unwanted resonance dampening, generation of excessive heat, and/or unwanted vibration of the housing can be avoided. In addition, a shorter ultrasonic horn160can be employed, because its length needs only the single central nodal region200. As an example, an ultrasonic horn as described herein can be approximately 1.5 inches in length, or less than 2 inches in length, shorter than typical ultrasonic horns which can be, for example, 4 inches in length or more.

The use of a shorter ultrasonic horn160enables the use of a shorter housing130, which in turn enables the attachment of a pumping module290at the proximal end132of the housing130while maintaining a desirable ergonomic assembly length and without resulting in an ultrasonic handpiece that is too long to be easily handled by the operator. Placing a pumping module290at the proximal end of the ultrasonic handpiece100means that the distance between the suction pump and the distal end114of the working tip110is reduced. In typical prior devices, the suction pump is located at the control console and connected to the handpiece by long tubing, which may be, for example, six feet in length. With a pumping module290at the proximal end of the ultrasonic handpiece100as described herein, the connection between the suction pump and the distal end114of the working tip is only a few inches of rigid channel length. This results in a better vacuum and improves chamber stability. For example, in the prior art, if there is an occlusion in the line that suddenly clears under heavy vacuum, a large surge in suction can occur, which can be potentially damaging. With a pumping module290at the proximal end of the ultrasonic handpiece100as described herein, the potential for occlusion is reduced, and, moreover, there is less potential for a sudden surge in heavy vacuum suction upon release of an occlusion.

As persons having ordinary skill in the art will appreciate, the systems and methods as disclosed herein have a number of advantages over prior systems and methods. Such advantages include shorter handpieces, the ability to include a pumping module as part of the handpiece while maintaining an ergonomically desirable design, avoidance of resonance dampening, reduced heat generation, reduced vibration, reduced risk of occlusion, more stable vacuum pressure, improved chamber stability, lower cost, and/or improved patient outcome.

Persons of ordinary skill in the art will appreciate that the implementations encompassed by the disclosure are not limited to the particular exemplary implementations described above. In that regard, although illustrative implementations have been shown and described, a wide range of modification, change, and substitution is contemplated in the foregoing disclosure. It is understood that such variations may be made to the foregoing without departing from the scope of the disclosure. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the disclosure.