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 sleeve.

<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 system for use with a cannula, for measuring relative motion during a surgical procedure. The system includes a probe with a tip and means for determining relative motion between the cannula and the probe tip. <CIT> discloses n ophthalmic surgical handpiece comprising a driver coupled to a horn that is coupled to a needle. A lever secures a removable cartridge to the remainder of the handpiece. <CIT> discloses a variable vacuum/variable flow phacoemulsification method. <CIT> discloses a device and method for applying irrigation, aspiration, medication, ultrasonic power and dwell time to biotissue for surgery and treatment.

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

The distal portion may comprise, at a distalmost portion thereof from the proximal portion: an emulsifying needle vibrated by a transducer powered by a power input connected to the power connector, the transducer residing within the distal portion and being associated with a horn proximate the proximal portion; and an irrigation sleeve including an irrigation output. A grip may be about the proximal portion of the lever, and may be associated with the irrigation sleeve. At least one low friction interface may be present between an underside of the grip and the horn.

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, 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.

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 notto be construed as necessarily requiring theirrespectiveperformance 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 coupledto 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 a 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 lever that controls rotation of at least the vibrating tip.

More specifically, in the known art the phacoemulsification needle and the irrigation sleeve and ports rotate together as the surgeon rotates the entire handpiece, as detailed above. The embodiments of the present invention include a grip coupled with the handpiece. The grip may be integral with, or distinct from and placed about, the distal portion of the handpiece. A lever extends outwardly through this grip, and is associated with a transducer, a horn, and/or a needle, such that actuation of this lever rotates at least the needle tip about a longitudinal axis of the handpiece. However, the rotation of the needle notwithstanding, the surgeon is able to hold on to the grip of the handpiece as the lever is actuated so as to maintain the irrigation sleeve, and/or the body of the handpiece, in a stationary position notwithstanding the rotation of at least the needle tip.

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 finger-actuated lever. Therefore, the limited movement requirements of the cables on the end of the handpiece necessary to achieve the desired rotational position of the phacoemulsifying 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 phacoeniulsifluition 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. 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> may have a needle <NUM> connected to a distal-most portion of distal segment <NUM><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>, may be coupled with a rotating element <NUM> on the distal segment <NUM>. By way of example, rotating element <NUM> may be the lever <NUM> shown. The lever <NUM> may be in communication with the transducer/horn <NUM> that vibrates needle <NUM> within the body of the distal segment <NUM>, such as so as to rotate needle <NUM> upon actuation of lever <NUM> without rotation of other aspects of the handpiece <NUM>. Alternatively, the lever <NUM> may be in communication with the irrigation sleeve <NUM>, such as so as to rotate both the irrigation sleeve <NUM> and needle <NUM> upon actuation of lever <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 phacoemulsification handpiece <NUM>, which may be the rigid handpiece discussed above or a rotationally enabled handpiece <NUM> according to the embodiments. As illustrated in <FIG>, an irrigation sleeve <NUM> is provided over a portion of needle <NUM> and/or a portion of the handpiece <NUM>. In some embodiments, the sleeve <NUM> may be corresponded to a grip <NUM> in such a manner that the surgeon is able to hold on to the grip <NUM> to maintain the irrigation sleeve <NUM> in a substantially stationary position.

Also provided is a lever <NUM>, such as may be actuatable by the application or pressure from a finger. Accordingly, a surgeon is able to use a finger on the lever <NUM> and other portions of a hand on the grip <NUM>, in conjunction, in order to rotate the needle <NUM> and in particular, needle tip <NUM> connectively associated with the lever <NUM> independently from the irrigation sleeve <NUM>, or with the irrigation sleeve independently from the body of the handpiece <NUM>. The lever <NUM> may be formed of any hypoallergenic and readily-sterilizable substance, such as metal or plastic.

The grip <NUM> is shown to cover only a portion of the most distal end <NUM> of the handpiece <NUM> in the illustration. However, the skilled artisan will appreciate, in light of this disclosure, that the grip <NUM> may be extended to cover more of the handpiece <NUM>, and/or may be more or less coextensive with the irrigation sleeve <NUM> and/or the tip <NUM>.

As referenced, a lever <NUM> is shown as the aspect by which rotation is imparted to the emulsifying needle <NUM> independent of the grip <NUM>. However, it will be appreciated that other manner of independent rotational elements may be used, rather than the lever <NUM>. By way of example, a rotating wheel may partially or fully circumferentially extend beyond the grip perimeter, such that relative movement may be provided between the transducer/horn/needle and the grip.

Simply put, the handpiece <NUM> may thus include a coupling suitable to couple the rotation actuator <NUM> to the needle <NUM> in such a manner so as to allow for the needle <NUM> to be rotated, such as by actuation of lever <NUM>. The coupling may be, for example, an aspect of the horn, of the handpiece casing, or the like. The sleeve <NUM> may couple with the handpiece and remain stationary upon rotation of the needle <NUM>, or may rotate with the needle <NUM>, by way of example.

<FIG> is a cross-sectional view of aspects of the disclosed embodiments. As shown, the rotating actuator <NUM>, such as lever <NUM>, may be attached to a coupling <NUM> associated with the handpiece <NUM>, which coupling allows for the actuator <NUM> to impart rotation to the needle <NUM>. By way of non-limiting example and as shown, the coupling <NUM> may be: an aspect of the transducer/transducer stack and/or the corresponding horn <NUM>; a portion of the irrigation sleeve <NUM> extending inside the body of the handpiece; a dedicated casing within the body portion that encompasses the needle <NUM> or the needle <NUM> and sleeve <NUM>; and/or a body portion of the handpiece <NUM> at the distal end thereof, so that at least the emulsifying needle <NUM> rotates from the coupling as the lever <NUM> is actuated.

More specifically, the coupling <NUM> may be composed of a uniformity between the lever and the horn <NUM> at point or points on the horn <NUM> distal from the needle tip <NUM>. The lever <NUM> may thus be formed as part of the horn <NUM> to create the coupling, or may be otherwise attached to the horn <NUM>, such as via glue or welding.

The irrigation sleeve <NUM>, which additionally may include and/or cover one or more irrigation ports, may be attached independently to the grip <NUM>. This attachment may be rigid, so as to longitudinally "lock" the sleeve's position and the grip's position. Alternatively, the sleeve <NUM> may be independent from the grip, and may be attached to the lever <NUM> in embodiments in which the sleeve <NUM> and needle are both configured to rotate independently from the body of the handpiece <NUM>.

The grip <NUM> is fittedly placed over or coupled with at least a portion of the handpiece <NUM>, as shown. This fitting may include a contouring of the grip <NUM> to aspects of the handpiece <NUM>. Additionally, this fitting may include an aligning of a slot <NUM> to the lever <NUM>, such that the lever <NUM> extends outwardly from the grip <NUM> to allow for actuation of the lever <NUM>.

The grip <NUM>, the distal end <NUM> of handpiece <NUM>, and/or additional aspects/surfaces between the grip <NUM>, the horn <NUM> and/or the distal end <NUM> with which grip <NUM> is coupled with, may include there-between a low friction surface <NUM>, such as a plurality of bearings. This low friction surface may enable free independent rotation as between the grip <NUM>, the distal end <NUM> of handpiece <NUM> over which the grip <NUM> may be fitted, and/or the horn <NUM> or other feature actuated by movement of lever <NUM>.

<FIG> is an isometric view illustrating an embodiment of translation mechanism <NUM> capable of translating linear motion of the lever <NUM> into rotational motion of the phacoemulsification tip <NUM>. Simply put, it may be logistically easier for a surgeon to move her fingertip forward and back, rather than side to side. Aforward/backmovement(asshownby arrow <NUM>) of the disclosed lever may then drive a first translation element 902a, which communicates with a second translation element 902b of the translation mechanism <NUM> to translate the linear motion of the lever <NUM> into rotational motion of the tip <NUM>.

The translation mechanism may thus be any combination of multiple translation elements suitable to provide the disclosed motion translation. By way of non-limiting example, the translation mechanism may be composed of a cam slot driven by movement of the lever, one or more gears or gear screws, and so on. <FIG> illustrates a first translation element 902a. (e.g. a first gear) driven to rotate by linear movement of the lever <NUM> as shown, and a second translation element 902b (e.g. a second gear) that is communicative with the tip <NUM> and which is rotated (as shown by arrows <NUM>) by the movement of the first gear. Accordingly, the simple gear system illustrated allows movement of the lever forward and backwards by the surgeon's finger to translate into rotation clockwise and counterclockwise of the tip.

<FIG> illustrates one of the foregoing exemplary translational movement embodiments. More particularly, a cam slot <NUM> is illustrated on the horn <NUM> that is associated with the tip. As shown, linear motion as shown by arrow <NUM> on the lever <NUM> is thus translated by the cam slot <NUM> into rotational motion of the tip associated with the horn <NUM>.

Claim 1:
A phacoemulsification handpiece (<NUM>) comprising:
a proximal portion (<NUM>) having a longitudinal axis, and a first end (<NUM>) and a second end (<NUM>), wherein at least aspiration, irrigation and power connectors (<NUM>, <NUM>) couple with the first end (<NUM>);
a distal portion (<NUM>) along the longitudinal axis and comprising a coupling (<NUM>) configured to couple a needle (<NUM>) with the distal portion (<NUM>); and
an irrigation sleeve (<NUM>) provided over a portion of the needle (<NUM>) and over the distal portion (<NUM>) of the handpiece (<NUM>); and characterized by:
a lever (<NUM>) connectively associated with the coupling (<NUM>) and extending outwardly from the longitudinal axis through the distal portion (<NUM>);
wherein actuation of the outwardly extending aspect of the lever (<NUM>) provides a rotation of the coupling (<NUM>) independent of rotation of the distal portion (<NUM>), and rotation of the needle (<NUM>) via the coupling (<NUM>) is independent of rotation of the irrigation sleeve (<NUM>) and movement of the proximal portion (<NUM>) and the distal portion (<NUM>).