Patent Description:
The phacoemulsification method includes emulsifying, or liquefying, the cataractic lens with an ultrasonically driven needle before the lens is aspirated. 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>.

The handpiece <NUM> includes a distal tip (or 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 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>. Further disclosure about the phase detector <NUM> can be found in <CIT> 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 cararactic 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. This need to move/rotate the entire handpiece creates the aforementioned fatigue to the surgeon's hand and/or wrist during surgery. As such, a new handpiece with features that address these drawbacks is needed.

<CIT> discloses a phacoemulsification transducer or probe utilizing ultrasonic frequencies to treat cataracts, including a rotatable handle to facilitate repositioning of the needle in the eye during surgery while maintaining a comfortable and secure grip on the instrument. The rotatable handle is comprised of a sleeve portion, irrigation tube and connector member. The sleeve portion is secured to the front of the main body of the probe and the connector member is attached to the distal end thereof. <CIT> discloses a phacoemulsification handpiece for cataract removal which includes an easily detachable and disposable outer housing, and a secure sealing system in the are of the interface between the inner body portion of the handpiece and a stainless steel shell. <CIT>, which forms part of the state of the art under Article <NUM>(<NUM>) EPC, discloses a phacoemulsification handpiece having two or more segments coupled together and capable of independently rotating around a longitudinal axis of the handpiece. One of the segments has a tubing/cord management segment.

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 embodiments briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in 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 designate corresponding parts throughout the different views. However, like parts may not always have like reference numerals. 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.

The figures and descriptions provided herein may be simplified to illustrate aspects of the described embodiments that are relevant for a clear understanding of the herein disclosed processes, machines, manufactures, and/or compositions of matter, 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, systems, and methods 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.

Embodiments are provided throughout so that this disclosure is sufficiently thorough and fully conveys the scope of the disclosed embodiments to those who are skilled in the art. Numerous specific details are set forth, such as examples of specific aspects, devices, and methods, 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. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., "between" versus "directly between," "adjacent" versus "directly adjacent"). 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.

The present disclosure relates to ergonomic handpieces, and in particular to a handpiece that has two 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. Thereby, surgeon fatigue is relieved.

In an embodiment, as shown in <FIG> and <FIG>, the handpiece <NUM> has at least two segments, a proximal segment <NUM> and a distal segment <NUM>. Proximal segment <NUM> and distal segment <NUM> are coupled to each other. Proximal segment <NUM> has a first end <NUM> and a second end <NUM>. Distal segment <NUM> has a first end <NUM> and a second end <NUM>. Proximal segment <NUM> is coupled to distal segment <NUM> via the first end <NUM> and second end <NUM>. Proximal segment <NUM> and second segment <NUM> are coupled together by rotating coupler <NUM> using any means known in the art, including, 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> resides 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. In an embodiment, the proximal and/or distal segments may be capable of rotating up to <NUM> degrees. In another embodiment, the rotation may be limited to more substantially less than <NUM> degrees depending upon the freedom of movement desired and the tubing and cabling capabilities, as discussed below. In embodiments, the material of the coupler may be the same as the segment it is connected to, or may be of a different material as referenced above.

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>.

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.

According to an embodiment, a user's hand may grip the distal segment <NUM>, such as between the thumb and pointer finger. This positioning, coupled with a swivel connector <NUM>, allows the user to rotate the distal segment <NUM> independent of proximal segment <NUM>. That is, proximal segment <NUM> may remain partially or substantially stationary while distal end <NUM> is rotatably moved about.

<FIG> illustrates a cross-section, along axis A-A, of handpiece portion "Q" of <FIG>. More specifically, <FIG> illustrates aspiration <NUM> and irrigation <NUM>, from the input tubes <NUM> for both toward the distal segment <NUM>. Also shown electrically associated with cord <NUM> is power into proximal end <NUM>.

A handpiece <NUM> is shown in the cross-sectional illustrations of <FIG> and <FIG>. As shown, the handpiece includes a proximal portion <NUM> and a distal portion <NUM>, which are free to rotate axially about a coupler <NUM>.

Fluidically connected at the proximal end <NUM> are the inputs for irrigation <NUM> and aspiration <NUM>, which are output/ported at the distal end <NUM>. The irrigation and aspiration provided at proximal end inputs <NUM> and <NUM> are carried to the distal end via at least one internal irrigation tube <NUM> and at least one internal aspiration tube <NUM>. Of note, although continuous fluidic communication is thereby provided by internal tubes <NUM>, <NUM> between inputs <NUM>, <NUM> and functionality at the distal end <NUM>, internal tubes may or not be directly connected to inputs <NUM>, <NUM> or distal end outputs <NUM>, <NUM>. Rather, tubes <NUM>, <NUM> may connect to fluid pathways within the proximal end <NUM> that are, in turn, connected to inputs <NUM>, <NUM>; and tubes <NUM>, <NUM> may likewise connect to fluid pathways within distal end <NUM> that are, in turn, connected to outputs <NUM>, <NUM>.

In an embodiment, tubes <NUM>, <NUM> may be completely enclosed within the respective outer housings 605a, 608a, 610a provided by the proximal end <NUM>, the coupler <NUM>, and the distal end <NUM>. That is, the tubing <NUM>, <NUM> may have a substantially clear movement path <NUM> that extends substantially axially about the circumference within handpiece <NUM> from the proximal end <NUM> to the distal end.

To allow for movement of tubing <NUM>, <NUM> about path <NUM> during the axial rotation allowed by coupler <NUM>, the tubing <NUM>, <NUM> is formed of a flexible and/or substantially elastic composition, such as silicon or the like. This flexibility allows the tubing to move while a surgeon rotates the distal end <NUM> independent of the proximal end <NUM>. Axial rotation up to or beyond about <NUM> degrees is provided by having the flexible silicon tubes inside the handpiece <NUM> twist about the center axis of the handpiece <NUM>.

Needless to say, other lines or tubing entering proximal end <NUM> may also be flexibly provided. By way of non-limiting example, power line <NUM> may also be internally flexible within the handpiece <NUM> to allow for axial twisting about path <NUM>.

Also illustrated in <FIG> is at least one tubing/cord manager. Tubing/cord manager may positionally maintain at least aspects of cords/tubes <NUM>, <NUM>, such as against the inner surface of either or both of housings 605a, 610a, while also allowing freedom to twist about the center axis by tubing <NUM>, <NUM> proximate to coupler <NUM>.

Moreover, internal couplings <NUM>, <NUM>, <NUM> of tubing/cords within handpiece along path <NUM> may be positioned and/or angled to account for the twisting of tubes <NUM>, <NUM> and/or cord within path. By way of example, internal couplings <NUM>, <NUM>, <NUM> may comprise connectivity to tubes <NUM>, <NUM> and/or cords that is angled perpendicularly to the center axis of handpiece <NUM>. This angled connectivity may decrease the alignment of the pulling force as tubing <NUM>, <NUM> (and/or cords) twists with the angle of connection of tubing <NUM>, <NUM> and cords to internal couplings <NUM>, <NUM>, <NUM>. Obviously, this will decrease breakdowns and failures of the coupling, and improve the lifetimes of hardware associated with the couplings <NUM>, <NUM>, <NUM> (shown with greater particularity in <FIG>).

The internal structures needed for activation of ultrasound for the phacoemulsification handpiece, e.g. piezoelectric crystals, may be located in the distal end, the proximal end, or both. In an embodiment, if there are more than two segments, the various internal structures may be located in any segment or in multiple segments.

In addition, one or more O-ring gaskets may be used on the proximal and distal segments to create a seal between the parts and assist with the disclosed rotation. In an additional embodiment, bearings or tubing may be used alone or in combination with another similar feature, e.g., O-ring, bearing, tubing, for creating a seal between the various parts of the handpiece to prevent fluids from entering or exiting the handpiece at these locations.

In an embodiment, the distal segment and proximal segment may be separable to replace the distal segment with another distal segment that may have the same or different needle and/or sleeve. In addition, the proximal segment may be designed to be serializable, and thus reusable. The distal segment may be designed to be disposable or reusable.

In an embodiment, the one or more segments may be of any material suitable for the handpiece application. The segments may be titanium, plastic, rubber, or any similar material. Each segment may have its own material type or the same material type as another segment.

Claim 1:
A phacoemulsification handpiece (<NUM>; <NUM>) comprising:
a first segment (<NUM>; <NUM>) having a longitudinal axis, and a first end (<NUM>) and a second end (<NUM>), wherein at least aspiration (<NUM>), irrigation (<NUM>) and power (<NUM>) inputs enter the first end (<NUM>);
a second segment (<NUM>; <NUM>) along the longitudinal axis and comprising, at a distalmost portion thereof from the first segment (<NUM>), a needle (<NUM>) powered by the power input, an aspiration output, and an irrigation output;
a rotating coupler (<NUM>; <NUM>) capable of coupling the second end (<NUM>) of the first segment (<NUM>) and the second segment (<NUM>) to enable independent axial rotation about the longitudinal axis of the first segment (<NUM>) from the second segment (<NUM>); and
a plurality of flexible tubing (<NUM>, <NUM>) passing along the longitudinal axis within both the first segment (<NUM>; <NUM>) and the second segment (<NUM>; <NUM>), wherein at least a first flexible tube (<NUM>) of the plurality provides continuous fluidic communication between the aspiration input (<NUM>) and the aspiration output, and at least a second flexible tube (<NUM>) of the plurality provides continuous fluidic communication between the irrigation input (<NUM>) and the irrigation output;
wherein during axial rotation of the second segment relative to the first segment, the plurality of flexible tubing flexes within the first and second segments and within the rotating coupler so as to twist about the longitudinal axis .