Patent Description:
A cataract is an opacity that develops in the lens of an eye. Cataracts are the most significant cause of blindness worldwide. Phacoemulsification is a medically recognized technique utilized for crystalline lens removal, which is a highly prevalent method of treating cataracts.

Phacoemulsification includes emulsifying, or liquefying, the cataractic lens through a corneal and/or scleral incision. A phacoemulsification system <NUM> known in the art is shown in <FIG>. The system <NUM> generally includes a phacoemulsification handpiece <NUM> coupled to an irrigation source <NUM> and more or more aspiration pumps, e.g. pump <NUM>, for insertion into the eye through the incision.

The handpiece <NUM> includes a distal tip (i.e., a needle) <NUM> (shown within the anterior chamber of the patient's eye <NUM>) that emits ultrasonic energy to emulsify the cataractic lens within the patient's eye <NUM>. The handpiece <NUM> further includes: a sleeve <NUM> that surrounds at least a portion of needle <NUM>, and which provides one or more irrigation ports <NUM> proximal to the distal tip <NUM> that are coupled to an irrigation source <NUM> via an irrigation line <NUM>; and an aspiration port <NUM> at the distal tip <NUM> which is coupled to aspiration pump <NUM> via an aspiration line <NUM>. Concomitantly with the emulsification, fluid from the irrigation source <NUM>, which is typically an elevated bottle of saline solution, is irrigated into the eye <NUM> via the irrigation line <NUM> and the irrigation port <NUM>, and the irrigation fluid and emulsified cataractic lens material are aspirated from the eye <NUM> by the aspiration pump <NUM> via the aspiration port <NUM> and the aspiration line <NUM>.

Turning to <FIG>, a functional block diagram of a phacoemulsification system <NUM> known in the art is shown. The system <NUM> includes a control unit <NUM> and a handpiece <NUM> operably coupled together. The control unit <NUM> generally controls the operating parameters of the handpiece <NUM>, e.g., the rate of aspiration A, rate of irrigation (or flow) F, and power P applied to the needle, and hence the eye E. The control unit <NUM> generally includes a microprocessor computer <NUM> which is operably connected to and controls the various other elements of the system <NUM>.

The control unit <NUM> may include an aspiration pump, such as a Venturi (or vacuum-based pump) or a variable speed pump (or a flow based or peristaltic pump) <NUM>, for providing a vacuum/aspiration source, which, in the case of a variable speed pump <NUM>, can be controlled by a pump speed controller <NUM>. The unit <NUM> further includes an ultrasonic power source <NUM> and an ultrasonic power level controller <NUM> for controlling the power P applied to the needle <NUM> of the handpiece <NUM>. A vacuum sensor <NUM> provides an input to the computer <NUM> representing the vacuum level on the output side of the pump <NUM>. Venting may be provided by a vent <NUM>.

The system <NUM> may also include a phase detector <NUM> for providing an input to the computer <NUM> that represents the phase between a sine wave representation of the voltage applied to the handpiece <NUM> and the resultant current into the handpiece <NUM>. The functional representation of the system <NUM> also includes a system bus <NUM> to enable the various elements to be operably in communication with each other.

Turning to <FIG>, the cross-section along the longitudinal axis of a portion of a phacoemulsification handpiece <NUM> known in the art is shown. Generally, the handpiece <NUM> includes a needle <NUM>, defining a lumen that is operatively coupled to an aspiration pump (e.g. aspiration pump <NUM> (<FIG>)), forming an aspiration line <NUM>. At least a portion of the distal end of needle <NUM> is surrounded by sleeve <NUM> and proximal end of the needle <NUM> is coupled to a horn <NUM>, which has its proximal end coupled to a set of piezoelectric crystals <NUM>, shown as three rings. The horn <NUM>, crystals <NUM>, and a proximal portion of the needle <NUM> are enclosed within a handpiece casing <NUM> having an irrigation port coupled to an irrigation line <NUM> defining an irrigation pathway <NUM>. Irrigation pathway <NUM> extends between the wall of sleeve <NUM> and the wall of needle <NUM>, allowing fluid to flow around needle <NUM> and exit one or more ports <NUM> in sleeve <NUM>. The irrigation line <NUM> is coupled to the irrigation source <NUM> (<FIG>).

The horn <NUM> is typically an integrated metal, such as titanium, structure and often includes a rubber O-ring <NUM> around the mid-section, just before the horn <NUM> tapers to fit with the needle <NUM> at the horn's <NUM> distal end. The O-ring <NUM> snugly fits between the horn <NUM> and the casing <NUM>. The O-ring <NUM> seals the proximal portion of the horn <NUM> from the irrigation pathway <NUM>. Thus, there is a channel of air defined between the horn <NUM> and the casing <NUM>. Descriptions of handpieces known in the art are provided in <CIT>) and <CIT>).

In preparation for operation, a sleeve <NUM> is typically added to the distal end of the handpiece <NUM>, covering the proximal portion of the needle <NUM> (thus, exposing the distal tip of the needle), and the distal end of the irrigation pathway <NUM>, thereby extending the pathway <NUM> and defining an irrigation port <NUM> and/or port <NUM> just before the distal tip of the needle <NUM>. The needle <NUM> and a portion of the sleeve <NUM> are then inserted through the cornea of the eye to reach the cataractic lens.

During operation, the irrigation path <NUM>, the eye's chamber and the aspiration line <NUM> form a fluidic circuit, where irrigation fluid enters the eye's chamber via the irrigation path <NUM>, and is then aspirated through the aspiration line <NUM> along with other materials that the surgeon desires to aspirate out, such as the cataractic lens. If, however, the materials, such as the cataractic lens, are too hard and massive to be aspirated through the aspiration line <NUM>, then the distal end of the needle <NUM> is ultrasonically vibrated and applied to the material to be emulsified into a size and state that can be successfully aspirated.

The needle <NUM> is ultrasonically vibrated by applying electric power to the piezoelectric crystals <NUM>, which in turn, cause the horn <NUM> to ultrasonically vibrate, which in turn, ultrasonically vibrates the needle <NUM>. The electric power is defined by a number of parameters, such as signal frequency and amplitude, and if the power is applied in pulses, then the parameters can further include pulse width, shape, size, duty cycle, amplitude, and so on. These parameters are controlled by the control unit <NUM> and example control of these parameters is described in <CIT>.

With respect to <FIG>, an exemplary handpiece known in the prior art is shown. As discussed above, the distal end <NUM> of the handpiece <NUM> is show with a tip/needle <NUM> and sleeve <NUM> having port <NUM>. The proximal end <NUM> of the of the handpiece <NUM> comprises multiple ports/connector points <NUM>, include a port 406a for connecting to the irrigation line, a port 406b for connecting to the aspiration line, and a connector port 406c for electrical power for the ultrasound.

The location of the ports/connector points <NUM> at the proximal end <NUM> of the handpiece <NUM> are known to create fatigue on the surgeon's hand and wrist due to the invariability in the orientation of the ports/connector points <NUM> in light of the rigidly correspondent weight of the proximal end <NUM> once the irrigation and aspiration lines and the power cord are connected to the handpiece (not shown). This fatigue from orienting the distal end of the handpiece results, in part and as shown in <FIG>, from the typical construction of the handpiece as one-piece metal-type material. Consequently, to adjust or rotate the distal end of the phacoemulsification (phaco) tip/needle requires the entire handpiece and connected lines to be moved/rotated in unison to achieve the desired position.

With regard to achieving the desired position, the emulsifying needle is often bent or has a bevel edge, and thus must be properly positioned to achieve emulsification of the lens. Further, the irrigation ports on the handpiece are optimally oriented so as to direct fluid along the horizontal plane of the eye. As such, in the known art, the surgeon will frequently rotate the handpiece such that the needle tip is at whatever angle is most proper to remove the cataract material, but unfortunately, due to the afore-discussed construction of the typical phacoemulsification handpiece, this rotation of the needle also executes a correspondent rotation away from the optimal position for the irrigation ports.

This need to move/rotate the entire handpiece also creates fatigue to the surgeon's hand and/or wrist during surgery. As such, a new handpiece with features that address these drawbacks is needed. Therefore, the need exists for a phacoemulsification handpiece that allows for ergonomic rotational movement of the emulsifying needle separately from movement of the irrigation ports.

<CIT> discloses a phacoemulsification system having a handpiece with a needle. <CIT> discloses an ergonomic handpiece with two or more segments coupled together and capable of independently rotating. <CIT> and <CIT> disclose systems for controlling transverse phacoemulsification systems. <CIT> discloses a surgical cutting instrument including an actuator assembly rotatably coupling a hub to a handpiece, where movement of the actuator is not co-axial with the hub axis. <CIT> discloses a tympanostomy tube delivery device with a rotatable flexible shaft. <CIT> discloses an electrosurgery generator for an ultrasonic surgical instrument.

The present invention provides a phacoemulsification handpiece as recited in claim <NUM>. Optional features are recited in the dependent claims.

In order to better appreciate how the above-recited and other advantages and objects of the inventions are obtained, a more particular description of the instruments briefly described above will be rendered by reference to the accompanying drawings. It should be noted that the components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the disclosure. Moreover, in the figures, like reference numerals may or may not designate corresponding parts throughout the different views. Moreover, all illustrations are intended to convey concepts, where relative sizes, shapes and other detailed attributes may be illustrated schematically rather than literally or precisely. More specifically, in the drawings:.

The figures and descriptions provided herein may be simplified to illustrate aspects of the described instruments, while eliminating for the purpose of clarity other aspects that may be found in typical surgical, and particularly ophthalmic surgical, devices, systems, and methods. Those of ordinary skill may thus recognize that other elements and/or steps may be desirable or necessary to implement the devices and systems described herein. Because such elements and steps are well known in the art, and because they do not facilitate a better understanding of the disclosed embodiments, a discussion of such elements and steps may not be provided herein. However, the present disclosure is deemed to inherently include all such elements, variations, and modifications to the described aspects that would be known to those of ordinary skill in the pertinent art.

Numerous specific details are set forth, such as examples of specific aspects and devices, to provide a thorough understanding of embodiments of the present disclosure. Nevertheless, it will be apparent to those skilled in the art that certain specific disclosed details need not be employed, and that embodiments may be embodied in different forms. As such, the exemplary embodiments set forth should not be construed to limit the scope of the disclosure.

For example, as used herein, the singular forms "a", "an" and "the" may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "including," and "having," are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The steps, processes, and operations described herein are not to be construed as necessarily requiring their respective performance in the particular order discussed or illustrated, unless specifically identified as a preferred or required order of performance. It is also to be understood that additional or alternative steps may be employed, in place of or in conjunction with the disclosed aspects.

When an element or layer is referred to as being "on", "upon", "connected to" or "coupled to" another element or layer, it may be directly on, upon, connected or coupled to the other element or layer, or intervening elements or layers may be present, unless clearly indicated otherwise. In contrast, when an element or layer is referred to as being "directly on," "directly upon", "directly connected to" or "directly coupled to" another element or layer, there may be no intervening elements or layers present. Further, as used herein the term "and/or" includes any and all combinations of one or more of the associated listed items.

Yet further, although the terms first, second, third, etc. may be used herein to describe various elements or aspects, these elements or aspects should not be limited by these terms. These terms may be only used to distinguish one element or aspect from another. Thus, terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the disclosure.

Certain types of ocular dysfunction, such as cataracts, are commonly treated with the surgical procedures referenced above, wherein the natural lens is removed from the eye and replaced with a clear artificial intraocular lens (IOL). More specifically, as the lens is emulsified under a vacuum pull, it is aspirated from the eye. Also, during the procedure, irrigation fluid is administered into the eye as the emulsified material is aspirated, thereby maintaining pressure in the interior of the eye.

The embodiments herein may relate to a standard, rigid ultrasonic handpiece, as detailed above. Additionally, the embodiments may relate to a handpiece having a multi-directional, such as flexurally moving, needle, or the embodiments may relate to a rotating handpiece.

More specifically, for each of the types of phacoemulsification handpieces referenced throughout-namely a standard, rigid handpiece, a rotationally-enabled handpiece, or a flexurally or multi-direction-capable handpiece-the embodiments provide ergonomic handpiece elements that allow for rotational movement of the emulsifying needle separately from movement of the irrigation sleeve, and/or of the needle and sleeve independently from the body of the handpiece. More particularly, the embodiments provide an external thumb wheel that controls rotation of at least the vibrating tip.

The embodiments may include an external transducer housing having a thumb wheel protruding therethrough. This actuatable thumb wheel may allow the surgeon to adjust the position of the phacoemulsification tip and/or sleeve, such as by rotating the position of the acoustic train that vibrates the needle tip. In short, the thumb wheel is attached or otherwise associated with the acoustic aspects of the tip at a flange thereof. Accordingly, the surgeon may achieve repeated and controlled rotation of the phacoemulsification tip with very minimal surgeon fatigue.

The thumb wheel may be attached to the transducer stack at the flange. However, the thumb wheel may also attach to an external casing that may seal the transducer for autoclaving. In such a circumstance, that external casing may then attach to the transducer stack at the flange.

Thus, the disclosed handpiece may be axially stationary, and/or may operate flexurally, and/or may rotate around its center axis, while the surgeon may independently make fine movements of the tip using the thumb wheel. Therefore, the limited movement requirements of the cables on the end of the handpiece necessary to achieve the desired rotational position of the phacoemulsification tip substantially reduce surgeon fatigue.

A rigid handpiece is detailed above. A rotationally enabled handpiece may have one or more rotatable segments in conjunction with managed, twistable cords and irrigation/aspiration lines, which allows for rotation of the phacoemulsification tip independent of these cords and lines.

In a flexurally-enabled handpiece, the ultrasonic horn may provide both longitudinal motion at the needle tip, and/or transversal/flexural motion at the needle tip, to emulsify the lens of the eye. The transversal motion provides a side-to-side or back-and-forth "sanding" motion at the tip to break up the lens and the longitudinal motion that causes any occluding particulate to move away from the tip.

By way of example of a rotationally enabled handpiece, <FIG> illustrates that the handpiece <NUM> may have at least two segments, a proximal segment/portion <NUM> and a distal segment <NUM>. Proximal segment <NUM> and distal segment <NUM> may be coupled to each other. Proximal segment <NUM> may have a first end <NUM> and a second end <NUM>. Distal segment/portion <NUM> may have a first end <NUM> and a second end <NUM>.

Proximal segment <NUM> may be coupled to distal segment <NUM> via the first end <NUM> and second end <NUM>. Proximal segment <NUM> and second segment <NUM> may be coupled together by coupler <NUM> using any means known in the art, including, but not limited to a low friction stainless steel bearing that freely allows axial rotation between the proximal segment <NUM> and the distal segment <NUM>, such as axial rotation up to <NUM> degrees. In an embodiment, the axial rotation may be up to <NUM> degrees. In another embodiment, the axial rotation may be up to <NUM> degrees.

The coupler <NUM> may reside between the first end <NUM> and the second end <NUM>. In addition, the at least one coupler <NUM> may be a part of the proximal segment <NUM> or the distal segment <NUM>, and provides a swivel feature that allows proximal segment <NUM> and distal segment <NUM> to rotate independently of one another about an axis A-A. In an embodiment, the proximal and/or distal segments may be capable of rotating up to <NUM> degrees.

In an embodiment, the distal segment <NUM> of handpiece <NUM> has a needle <NUM> connected to a distal-most portion of distal segment <NUM>. A sleeve <NUM> may also be coupled with handpiece <NUM> and at least partially surround needle <NUM>. Needle <NUM> and sleeve <NUM> may be separate components attachable to the distal segment <NUM> or may be integrally coupled with the distal segment <NUM> of handpiece <NUM>. Proximal segment <NUM> of handpiece <NUM> includes tubing/cord management section <NUM> that includes one or more port/connector <NUM>.

Needle <NUM>, or needle <NUM> and irrigation sleeve <NUM>, are coupled with a rotating element <NUM> on an upper aspect of the distal segment <NUM>. Rotating element <NUM> is the thumb wheel <NUM> shown. The thumb wheel <NUM> is in communication with the transducer/horn <NUM> that vibrates needle <NUM> within the body of the distal segment <NUM>, so as to rotate needle <NUM> upon actuation of thumb wheel <NUM> without rotation of other aspects of the handpiece <NUM>. Alternatively, the thumb wheel <NUM> may also be in communication with the irrigation sleeve <NUM>, so as to rotate both the irrigation sleeve <NUM> and needle <NUM> upon actuation of thumb wheel <NUM>.

The one or more port/connector <NUM> has cords <NUM> and/or tubing <NUM> connected thereto. In the known art, these connected cords <NUM> and/or tubing <NUM> lays or rests against a user's hand or wrist as the distal segment <NUM> is moved about.

<FIG> illustrates a front view of a phacoemulsification handpiece <NUM>, which may be the rigid handpiece discussed above or a rotationally-enabled handpiece <NUM>, according to the embodiments. In the embodiment, the handpiece <NUM> shown includes an emulsifying tip <NUM> driven by an internal transducer stack and horn (not shown in <FIG>), and irrigation sleeve <NUM> having one or more irrigation ports 714a.

Also shown is a thumb wheel <NUM> protruding from the uppermost portion (as shown) of the handpiece <NUM>, proximate to the distal portion <NUM> of the handpiece <NUM>. This thumb wheel <NUM> is associated in the body of the handpiece <NUM> with the transducer stack that drives the emulsifying tip <NUM>.

Correspondingly, a rotation of the thumb wheel <NUM> rotates the horn to which the thumb wheel is connected. This rotation, in turn, rotates the emulsifying tip <NUM> driven by the transducer stack and horn. This rotation of the emulsifying tip <NUM> is therefore independent of the movement of the distal portion <NUM> of handpiece <NUM>.

Also illustrated in <FIG> is a feedback aspect <NUM> on thumb wheel <NUM>. The feedback aspect <NUM> may provide tactile feedback to the user as to the rotational position of the emulsifying tip <NUM>. The feedback aspect <NUM> may thus take the form of texture, bumps or lines embedded on wheel <NUM>. In alternative embodiments, feedback aspect <NUM> may take the form of an indicator window, in which indicator markings provide information to the surgeon as to the rotational position of the tip <NUM>; or of a detent at the neutral position, and/or of varying detents indicative of the rotational position of tip <NUM>.

<FIG> is an isometric view of the handpiece <NUM> having a thumb wheel <NUM>. In the illustration, a plurality of cords/tubing <NUM>, such as for feeding power, aspiration, and/or irrigation fluid are provided at the proximal portion <NUM> of the handpiece <NUM>. It is these cords <NUM> that need not be rotated in order to rotate the tip <NUM> using thumb wheel <NUM> in the disclosed embodiments, thereby preventing surgeon fatigue.

Also shown in <FIG> are the tip <NUM>, the transducer stack/horn <NUM> that drives the tip <NUM>, and the thumb wheel <NUM> having feedback aspect <NUM> and which is in rotational communication with the horn <NUM> (such as using the detent and/or the teeth referenced in the discussion of <FIG>) opposite the tip <NUM> within the body of handpiece <NUM>. One or more irrigation ports 714a of irrigation sleeve <NUM> at the distal portion <NUM> of the handpiece <NUM> are additionally shown.

<FIG> is a cross-sectional view of handpiece <NUM> not according to the invention. As illustrated, the thumb wheel <NUM> is connectively associated within the body <NUM> of handpiece <NUM> with the flange <NUM> coupled with horn <NUM> and/or transducer stack <NUM>. Alternatively, transducer stack <NUM> and/or horn <NUM> may be encompassed by an optional casing <NUM> that includes a separate flange <NUM> coupled with the casing and capable of rotationally communicating with thumb wheel <NUM>.

Of note, the thumb wheel <NUM> rotationally communicates with a flange <NUM>, that resides on the horn <NUM>, the stack <NUM>, a casing encompassing the horn and/or the stack, and/or the irrigation sleeve <NUM> using a "notch" <NUM>. Of course, the thumb wheel may be otherwise circumferentially incomplete to allow for the rotational association of the thumb wheel <NUM> with the flange <NUM> within the body housing <NUM>. Yet further, the notch comprises a plurality of teeth which may, for example, "mate" with teeth on the flange <NUM> to allow the rotational force applied to the wheel <NUM> to be imparted to the flange <NUM>.

Also of note in relation to the cross-section of <FIG>, certain aspects within body <NUM> may be routed with the rotation of the flange <NUM> and wheel <NUM> in mind. For example, irrigation line <NUM> may be routed at or near the "bottom" area within the body <NUM> or at any other location in the handpiece, such that it does not travel around or adjacent to, or otherwise interfere with the operation of, the thumb wheel <NUM>.

<FIG> is an additional cross-sectional illustration of a handpiece <NUM> according to the invention. In the illustration, the irrigation line <NUM> is routed through the thumb wheel <NUM>. The illustration shows one or more windows <NUM> in the non-actuatable portion of the thumb wheel <NUM>, and it is through these one or more windows <NUM> that the irrigation <NUM> line, and/or any other line or connection passes. The skilled artisan will appreciate that this window <NUM> may: be one or more in number; may be at a "lower" portion of the thumb wheel <NUM> towards the center thereof; be placed and formed such that flexibility and/or rotatability of line <NUM> is or is not required; and/or may include a low friction surface <NUM> and/or padding about the open aspects thereof, so as not to cut through or otherwise damage line <NUM> during repeated actuation of the thumb wheel <NUM>.

Similarly, <FIG> is a forward cross-sectional view of a handpiece <NUM> according to the invention. In this illustration, the thumb wheel <NUM> includes an actuatable upper portion <NUM> extending outside of the housing <NUM>, which associates with the flange <NUM> within the housing <NUM> via one or more mating sets of gear teeth <NUM>, <NUM>. Also included in the illustration of <FIG> is a window <NUM> through the "lower" portion of the thumb wheel <NUM>, i.e., on a portion thereof opposite the actuatable portion <NUM> and thus "below" the portion of the thumb wheel <NUM> through which the horn passes and in which the gear teeth <NUM> of the thumb wheel associate with the gear teeth <NUM> of the horn flange <NUM>. Through this window <NUM> passes irrigation line <NUM>, and any other line or connections for phacoemulsification may also pass therethrough.

Claim 1:
A phacoemulsification handpiece (<NUM>) comprising:
a proximal portion having a longitudinal axis, and a first end and a second end, wherein at least aspiration, irrigation and power inputs enter the first end;
a distal portion (<NUM>) along the longitudinal axis and comprising, at a distalmost portion thereof from the proximal portion:
a needle configured to be vibrated by a transducer powered by the power input, the transducer residing within the distal portion and being associated with a horn; and characterized in that:
the horn has a circumferential flange (<NUM>); and in that the handpiece further comprises:
a thumb wheel (<NUM>) circumferentially associated with the circumferential flange (<NUM>), and having a portion (<NUM>) thereof extending out of the distal portion (<NUM>) to allow for a user to rotationally actuate the extending portion (<NUM>);
wherein rotational actuation of the thumb wheel (<NUM>) affects a rotation of the circumferential flange (<NUM>),
wherein the thumb wheel (<NUM>) comprises:
a circumferential notch for association with the circumferential flange (<NUM>) within the distal portion (<NUM>) via one or more mating sets of gear teeth (<NUM>, <NUM>), wherein the circumferential flange (<NUM>) of the horn passes through the circumferential notch, and
a window (<NUM>) through a portion of the thumb wheel (<NUM>) that is opposite the extending portion (<NUM>) and below the circumferential notch, wherein an irrigation line (<NUM>) connected to the irrigation input passes through the window (<NUM>).